- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 01.12.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Pulmonary embolism
Symptomtext
pulmonary embolism; This serious case was reported by a consumer and described the occurrence of pulmonary embolism in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Additional patient notes included No prior health conditions. On an unknown date, the patient received Boostrix. On an unknown date, less than 3 months after receiving Boostrix, the patient experienced pulmonary embolism (Verbatim: pulmonary embolism) (serious criteria GSK medically significant). The outcome of the pulmonary embolism was not reported. It was unknown if the reporter considered the pulmonary embolism to be related to Boostrix. It was unknown if the company considered the pulmonary embolism to be related to Boostrix. Additional Information: GSK Receipt Date: 24-NOV-2023 The patient developed pulmonary embolism for 4 times within 2.5 months of receiving the vaccine. No prior health conditions. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pulmonary embolism
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Comments: No prior health conditions
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MS
- Alter
- 79,0
- Geschlecht
- M
- Eingang
- 14.11.2023
- Impfdatum
- 02.11.2023
- Beginn
- 01.11.2023
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Chills
Immediate post-injection reaction
Pain
Pulmonary embolism
Symptomtext
Pulmonary embolism; severe body aching; Chills all over.; This serious case was reported by a physician via sales rep and described the occurrence of pulmonary embolism in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Covid vaccine (patient had been vaccinated for Covid). On 02-NOV-2023, the patient received the 2nd dose of Shingrix. In NOV-2023, immediately after receiving Shingrix, the patient experienced pulmonary embolism (Verbatim: Pulmonary embolism) (serious criteria hospitalization and GSK medically significant), general body pain (Verbatim: severe body aching) and chills (Verbatim: Chills all over.). The outcome of the pulmonary embolism and chills were not reported and the outcome of the general body pain was not resolved. It was unknown if the reporter considered the pulmonary embolism, general body pain and chills to be related to Shingrix. It was unknown if the company considered the pulmonary embolism, general body pain and chills to be related to Shingrix. Additional Information: GSK Receipt Date: 08-Nov-2023 The reporter reported that the patient received Shingrix vaccine and experienced severe body aching and chills all over, this was started immediately. The patient thought maybe he was sore from working in the yard but they did not improve. The patient was admitted to the hospital on 6th November 2023 with pulmonary embolism. The patient finds it odd that it started immediately after getting the vaccine. The reporter did consent to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pulmonary embolism
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 07.11.2023
- Impfdatum
- 18.10.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Vaccine interaction
Symptomtext
Death NOS; Vaccine-vaccine interaction; This serious case was reported by a consumer and described the occurrence of unknown cause of death in a 85-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 18-OCT-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced unknown cause of death (Verbatim: Death NOS) (serious criteria death, hospitalization and GSK medically significant) and vaccine-vaccine interaction (Verbatim: Vaccine-vaccine interaction) (serious criteria clinically significant/intervention required). The outcome of the vaccine-vaccine interaction was unknown. The reported cause of death was unknown. The reporter considered the unknown cause of death and vaccine-vaccine interaction to be related to Arexvy. The company considered the unknown cause of death and vaccine-vaccine interaction to be related to Arexvy. Additional Information: GSK Receipt Date: 03-NOV-2023 The reporter was caregiver. The reporter reported that Arexvy vaccine was killing people and GSK should stop advertising it on television. The patient was in hospital for death NOS. Reporter would report GSK to the authorities and to the FCC (Federal Communications Commission) for promoting a vaccine that was killing people. Reporter reported that GSK was killing people with its vaccines. God Almighty would punish all the employees working for GSK money hungry company and all would be punished very soon and everything that worked for company should be thrown in jail. The reporter did not consent to follow up.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 90,0
- Geschlecht
- M
- Eingang
- 07.11.2023
- Impfdatum
- 27.10.2023
- Beginn
- 03.11.2023
- Tage bis Beginn
- 7,0
- Dosis
- N/A
- Route/Site
- SYR / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Activated partial thromboplastin time normal
Acute myocardial infarction
Alanine aminotransferase normal
Anion gap
Aortic arteriosclerosis
Aortic valve calcification
Aspartate aminotransferase increased
Bacterial test negative
Basophil count decreased
Basophil percentage decreased
Benign prostatic hyperplasia
Bilirubin urine
Blood albumin normal
Blood alkaline phosphatase normal
Blood bilirubin normal
Blood calcium normal
Blood chloride normal
Blood creatine phosphokinase increased
Symptomtext
Document Type: History and Physical Document Subject: History & Physical Note Performed By: MD on November 03, 2023 22:09 EDT Verified By: MD on November 03, 2023 22:09 EDT Encounter Info: Hospital, Inpatient, 11/03/23 - * Final Report * Chief Complaint Fall History of Present Illness/Subjective This is a 90-year-old male with past medical history aortic stenosis, hyperlipidemia, BPH, presenting with complaint of chest pain. Apparently, the patient had a mechanical fall at home last night and spent a good portion of the evening on the ground because he was unable to get up. Creatinine kinase mildly elevated, less than 1000. The patient is typically active, ambulatory with the use of an assist device, lives at home with no significant cognitive impairment. Actually, was anticipating stress testing next week electively and asymptomatically for preparation for possible knee arthroplasty due to osteoarthritis. Does not typically experience anginal pains and denies chest pain at this time. No prior cardiac history. CBC unremarkable, D-dimer elevated, renal function good, blood sugar mildly elevated, LFTs good. Troponin 1090 and reasonably flat, BNP 589, creatinine kinase 963. All imaging including CT of the head, CT cervical spine, CT PE protocol, all grossly unremarkable. There is an age-indeterminate mild endplate vertebral compression deformity in the cervical spine. EKG shows normal sinus rhythm, no ST elevation or depression, no arrhythmia or ectop Review of Systems Denies palpitations, syncope, near syncope, headache, visual changes, numbness, shortness of air, diaphoresis, nausea, vomiting. Remaining 10 point review of systems negative except as noted above. Physical Exam/Objective Vitals & Measurements most recent past 24 hours Hemodynamics Neurologic Patient Weight Patient Height None Reported Constitutional: No acute distress, well-nourished Eyes: PERRLA, EOMI, normal conjunctiva, no scleral icterus ENMT: Moist oral mucosa Neck: Supple, non-tender, intact range of motion Respiratory: Lungs CTAB Cardiovascular: Regular rate and rhythm Gastrointestinal: Soft, non-tender, non-distended Musculoskeletal: No joint swelling, no deformity, intact ROM Integumentary: Intact, warm, dry no rashes Neurologic: Alert & Oriented x 3, no cognitive impairment, no focal deficits Psychiatric: Cooperative, appropriate mood and affect Assessment/Plan 1. NSTEMI (non-ST elevated myocardial infarction) I21.4 Telemetry. Serial cardiac enzymes. Heparin, aspirin, statin, blood pressure is up so we will add transdermal nitroglycerin, as needed morphine. Dr. aware and will see patient in the morning. Transthoracic echocardiogram in the morning as well. We will check a lipid panel and hemoglobin A1c for risk stratification as well. 2. Hyperlipidemia E78.5 Statin 3. BPH (benign prostatic hyperplasia) N40.0 Monitor for signs of retention 4. Rhabdomyolysis M62.82 Mild and generally inconsequential 5. Accidental fall W19.XXXA PT/OT when appropriate Full code Heparin Code Status Full code Chronic Problem List Anemia Aortic stenosis Arthritis of knee BPH (benign prostatic hyperplasia) Encounter for long-term (current) use of medications Familial tremor Hyperglycemia Hyperlipidemia Impingement syndrome, shoulder, left Left carpal tunnel syndrome Low back pain Memory changes Seasonal allergies Medications Home Medications (11) Active aspirin 81 mg oral tablet 81 mg = 1 Tablet, Orally, Daily donepezil 10 mg oral tablet 10 mg = 1 Tablet, Orally, At Bedtime gabapentin 100 mg oral capsule 100 mg = 1 Capsule, Orally, BID, 1 capusule in the morning and afternoon; continue with your 300 mg capsule at bedtime gabapentin 300 mg oral capsule 300 mg = 1 Capsule, Orally, At Bedtime, TAKE 1 CAPSULE BY MOUTH ONCE DAILY AT BEDTIME lisinopril 10 mg oral tablet 10 mg = 1 Tablet, Orally, Daily Mysoline 50 mg oral tablet 100 mg = 2 Tablet, Orally, BID tamsulosin 0.4 mg oral capsule 0.4 mg = 1 Capsule, Orally, Daily Vitamin B-12 Vitamin C , Orally, Daily Zetia 10 mg oral tablet 10 mg = 1 Tablet, Orally, Daily Zinc 140 mg, Orally, Daily Active Scheduled Inpatient Medications Heparin PREMIX + Sodium Chloride 0.45% IV Continuous Per Nomogram 830 Units/hr One-Time Medications Given 11/02/23 00:00:00 TO 11/03/23 22:08:47 None Reported PRN Medications (0600 - 0559) from 11/02 - 11/03 None Reported Allergies No Known Medication Allergies Social History Alcohol Denies Electronic Cigarette/Vaping E-Cigarette Use Never. Substance Abuse Denies Tobacco Tobacco Use: Former smoker, quit more than 30 days ago. Family History Colon cancer stage 1: Brother. Melanoma: Father. Lab Results All Labs Last 24 hours (No Micro or Pathology) Hematology: WBC: 7.4 k/cumm (11/03/23 17:12:00) RBC: 3.78 million/cumm Low (11/03/23 17:12:00) Hgb: 12.2 GM/dL Low (11/03/23 17:12:00) Hct: 36.3 % Low (11/03/23 17:12:00) MCV: 96 fL (11/03/23 17:12:00) MCH: 32.3 pg (11/03/23 17:12:00) MCHC: 33.7 GM/dL (11/03/23 17:12:00) RDW: 13 % (11/03/23 17:12:00) Platelet: 251 k/cumm (11/03/23 17:12:00) MPV: 6.8 fL Low (11/03/23 17:12:00) Neutrophils %: 76 % (11/03/23 17:12:00) Lymphocytes %: 9 % (11/03/23 17:12:00) Monocytes %: 3 % (11/03/23 17:12:00) Eosinophils %: 0 % (11/03/23 17:12:00) Basophils %: 0 % (11/03/23 17:12:00) Absolute Neutrophil: 5.7 k/cumm (11/03/23 17:12:00) Absolute Lymphocyte: 0.7 k/cumm Low (11/03/23 17:12:00) Absolute Monocyte: 1 k/cumm (11/03/23 17:12:00) Absolute Eosinophil: 0 k/cumm (11/03/23 17:12:00) Absolute Basophil: 0 k/cumm (11/03/23 17:12:00) Chemistry: Sodium SerPl QN: 134 mmol/L Low (11/03/23 17:12:00) Potassium SerPl QN: 4.8 mmol/L (11/03/23 17:12:00) Chloride SerPl QN: 99 mmol/L (11/03/23 17:12:00) Carbon Dioxide SerPl QN: 27 mmol/L (11/03/23 17:12:00) Anion Gap: 8 mmol/L (11/03/23 17:12:00) BUN SerPl QN: 27 mg/dL High (11/03/23 17:12:00) Creatinine SerPl QN: 1.06 mg/dL (11/03/23 17:12:00) Estimated GFR (CKD-EPI, no race): 67 mL/min/1.73m2 (11/03/23 17:12:00) Estimated CRCL (CG): 45 mL/min Low (11/03/23 17:12:00) Glucose SerPl QN: 124 mg/dL High (11/03/23 17:12:00) Calcium Total SerPl QN: 9 mg/dL (11/03/23 17:12:00) Alkaline Phos SerPl QN: 111 Units/L (11/03/23 17:12:00) ALT SerPl QN: 22 Units/L (11/03/23 17:12:00) AST SerPl QN: 40 Units/L High (11/03/23 17:12:00) Bilirubin Total SerPl QN: 0.5 mg/dL (11/03/23 17:12:00) Total Protein SerPl QN: 6.8 GM/dL (11/03/23 17:12:00) Albumin SerPl QN: 4 GM/dL (11/03/23 17:12:00) Magnesium SerPl QN: 1.7 mg/dL (11/03/23 17:12:00) CK SerPl QN: 963 Units/L High (11/03/23 17:12:00) Troponin-I High Sensitivity: 1116 ng/L High (11/03/23 18:01:00) BNP Pl QN: 589 pg/mL High (11/03/23 17:12:00) Coagulation: aPTT: 30.8 seconds (11/03/23 17:57:00) D-Dimer Pl QN: 2415 ng/mL DDU High (11/03/23 17:56:00) Urine Studies: Color: Light-Yellow (11/03/23 17:12:00) Clarity: Clear (11/03/23 17:12:00) Specific Gravity: 1.021 (11/03/23 17:12:00) pH: 7 (11/03/23 17:12:00) Protein: 50 Abnormal (11/03/23 17:12:00) Glucose: Normal (11/03/23 17:12:00) Ketones: NEGATIVE (11/03/23 17:12:00) Bilirubin: NEGATIVE (11/03/23 17:12:00) Hgb Ur: Small 1+ Abnormal (11/03/23 17:12:00) Nitrite: NEGATIVE (11/03/23 17:12:00) Urobilinogen: Normal (11/03/23 17:12:00) Leukocyte Esterase Ur: NEGATIVE (11/03/23 17:12:00) WBC: 0-5 (11/03/23 17:12:00) RBC: 6-10 Abnormal (11/03/23 17:12:00) Bacteria: NONE (11/03/23 17:12:00) Squamous Epithelial: NONE (11/03/23 17:12:00) Hyaline Casts: 0-2 (11/03/23 17:12:00) All Other Labs: COVID 19 Specimen Source: Nasopharyngeal (11/03/23 21:03:00) Coronavirus SARS-CoV2 Rapid: Detected Abnormal (11/03/23 21:03:00) Diagnostics Radiology Results - Last 24 hours Across Visits 11/03/2023 17:24 - XR Chest PA or AP Portable IMPRESSION:1. No acute findings in the chest.Thank you for consulting our team of subspecialty radiologists at Radiology. Please contact us with any questions. 11/03/2023 17:39 - CT Head W/o IV Contrast IMPRESSION: 1. No acute intracranial abnormality within technical limitations.-Thank you for consulting our team radiologists Radiology. Please contact us with any questions. 11/03/2023 17:40 - CT Cervical Spine W/o IV Contrast IMPRESSION: 1. No acute fracture or traumatic malalignment of the cervicalspine.2. Mild age-indeterminate T1 superior endplate compression fracture.-Thank you for consulting our team of subspecialty radiologists at Radiology. Please contact us with any questions. 11/03/2023 19:24 - CTA Chest Pulm Embolism W/IV Contrast IMPRESSION:1. Negative for pulmonary embolism. No acute findings in the chest.2. Atherosclerotic disease and dense aortic valvular calcifications. Thank you for consulting our team of subspecialty radiologists at Radiology. Please contact us with any questions. Signature Line Electronically Signed on 11/03/23 22:09 EDT ________________________________________________________ MD
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Acute myocardial infarction
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- -
- Geschlecht
- M
- Eingang
- 24.10.2023
- Impfdatum
- 08.10.2023
- Beginn
- 01.10.2023
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Blood sodium decreased
Blood test normal
Coma
Confusional state
Depressed level of consciousness
Dyspnoea
Platelet count decreased
Thrombocytopenia
Symptomtext
hospital for Coma; confusion; shortness of breath; thrombocytopenia; This serious case was reported by a other health professional and described the occurrence of coma in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included intubation. On 08-OCT-2023, the patient received Arexvy. On 09-OCT-2023, 1 days after receiving Arexvy, the patient experienced coma (Verbatim: hospital for Coma) (serious criteria hospitalization and GSK medically significant). In OCT-2023, the patient experienced confusion (Verbatim: confusion) (serious criteria hospitalization), shortness of breath (Verbatim: shortness of breath) (serious criteria hospitalization) and thrombocytopenia (Verbatim: thrombocytopenia ) (serious criteria hospitalization and GSK medically significant). On 17-OCT-2023, the outcome of the coma was not resolved. The outcome of the confusion, shortness of breath and thrombocytopenia were not reported. It was unknown if the reporter considered the coma, confusion, shortness of breath and thrombocytopenia to be related to Arexvy. It was unknown if the company considered the coma, confusion, shortness of breath and thrombocytopenia to be related to Arexvy. Additional Information: GSK receipt date: 17-Oct-2023 The patient was in his usual state of health up to the day he received the vaccine. 24 hours later he came to the office for his routine visit and had blood work performed that was unremarkable. In October 2023, he was admitted to the hospital with confusion and shortness of breath in the next 72 hours. His labs demonstrated a low sodium, he had thrombocytopenia with platelets of 25,000 and became obtunded. The reporter consented to follow-up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Coma
- Hospital-Tage
- -
- Labordaten
- Test Date: 202310; Test Name: Sodium; Result Unstructured Data: (Test Result:low,Unit:unknown,Normal Low:,Normal High:); Test Date: 202310; Test Name: platelets; Result Unstructured Data: (Test Result:25000,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- Intubation
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 13.10.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cerebrovascular accident
Death
Malaise
Mobility decreased
Upper respiratory tract infection
Symptomtext
had a stroke; upper respiratory infection; sick; in bed; This serious case was reported by a consumer via interactive digital media and described the occurrence of stroke in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced stroke (Verbatim: had a stroke) (serious criteria death and GSK medically significant), upper respiratory tract infection (Verbatim: upper respiratory infection) (serious criteria death), sickness (Verbatim: sick) (serious criteria death) and bedridden (Verbatim: in bed) (serious criteria death). The reported cause of death was stroke, upper respiratory tract infection, sickness and bedridden. It was unknown if the reporter considered the stroke, upper respiratory tract infection, sickness and bedridden to be related to Shingrix. It was unknown if the company considered the stroke, upper respiratory tract infection, sickness and bedridden to be related to Shingrix. Additional Information: GSK Receipt Date: 10-OCT-2023 This case was reported by a patient via interactive digital media. It was reported that the patient was sick in bed with upper respiratory infection and side effects from Shingrix vaccine. The reporter stated that the only person he knew had a stroke afterwards and died within two years of complications. The follow-up could not be possible as no contact details were available.; Reported Cause(s) of Death: Stroke; Upper respiratory tract infection; Sickness; Bedridden
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 25.09.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Herpes zoster
Neoplasm
Vaccination failure
Symptomtext
Unknown cause of death; Shot gave her shingles/ Suspected vaccination failure; Shingles; Tumor; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Unknown cause of death) (serious criteria death and GSK medically significant), vaccination failure (Verbatim: Shot gave her shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and neoplasm (Verbatim: Tumor). The outcome of the vaccination failure was unknown and the outcome of the shingles and neoplasm were not reported. The reported cause of death was unknown. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. The reporter considered the vaccination failure, shingles and neoplasm to be related to Shingles vaccine. It was unknown if the company considered the unknown cause of death to be related to Shingles vaccine. The company considered the vaccination failure, shingles and neoplasm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient's friend via interactive digital media. The reporter reported that the patient's who take vaccines and are lots of prescription drugs end up with skin afflictions. The reporter stated that the heavy metals did not metabolize naturally in the body. The reporter reported that Vaers gov or open Vaers vaccine adverse events report system Over 600,000 reported deaths due to Covid vaccine trash vaccines cause the afflictions observe. The reporter reported that his or her friend died 4 months after received shingles vaccine. The shingles vaccine gave her shingles and a tumor. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 21.08.2023
- Impfdatum
- 11.07.2023
- Beginn
- 01.07.2023
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Cerebral haemorrhage
Cerebral venous thrombosis
Symptomtext
DEVELOPED BRAIN BLEED; CERIBRAL VENOUSTHROMBOCIOUS; This serious case was reported by a nurse via sales rep and described the occurrence of hemorrhage brain in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included Hib (Hiberix) for prophylaxis, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR VACCINE) for prophylaxis and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis. On 11-JUL-2023, the patient received Pediarix, Hiberix, PREVNAR VACCINE and ROTATEQ. In JUL-2023, less than 3 weeks after receiving Pediarix and Hiberix, the patient experienced hemorrhage brain (Verbatim: DEVELOPED BRAIN BLEED) (serious criteria GSK medically significant) and cerebral venous thrombosis (Verbatim: CERIBRAL VENOUSTHROMBOCIOUS) (serious criteria GSK medically significant). The outcome of the hemorrhage brain and cerebral venous thrombosis were not reported. It was unknown if the reporter considered the hemorrhage brain and cerebral venous thrombosis to be related to Pediarix and Hiberix. It was unknown if the company considered the hemorrhage brain and cerebral venous thrombosis to be related to Pediarix and Hiberix. Additional Information: GSK receipt date: 14-AUG-2023 The patient received 2 month vaccines on and went to emergency room on 26th July 2023 and developed brain bleed and ceribral venousthrombocious. In JUL-2023, less than 3 weeks after receiving PREVNAR VACCINE and ROTATEQ, the patient experienced hemorrhage brain and cerebral venous thrombosis. It was unknown if the reporter considered the hemorrhage brain and cerebral venous thrombosis to be related to hemorrhage brain and cerebral venous thrombosis. The reporter agreed to follow up from GlaxoSmithKline (GSK).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebral haemorrhage
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 21.08.2023
- Impfdatum
- 11.07.2023
- Beginn
- 01.07.2023
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Cerebral haemorrhage
Cerebral venous thrombosis
Symptomtext
DEVELOPED BRAIN BLEED; CERIBRAL VENOUSTHROMBOCIOUS; This serious case was reported by a nurse via sales rep and described the occurrence of hemorrhage brain in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included Hib (Hiberix) for prophylaxis, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR VACCINE) for prophylaxis and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis. On 11-JUL-2023, the patient received Pediarix, Hiberix, PREVNAR VACCINE and ROTATEQ. In JUL-2023, less than 3 weeks after receiving Pediarix and Hiberix, the patient experienced hemorrhage brain (Verbatim: DEVELOPED BRAIN BLEED) (serious criteria GSK medically significant) and cerebral venous thrombosis (Verbatim: CERIBRAL VENOUSTHROMBOCIOUS) (serious criteria GSK medically significant). The outcome of the hemorrhage brain and cerebral venous thrombosis were not reported. It was unknown if the reporter considered the hemorrhage brain and cerebral venous thrombosis to be related to Pediarix and Hiberix. It was unknown if the company considered the hemorrhage brain and cerebral venous thrombosis to be related to Pediarix and Hiberix. Additional Information: GSK receipt date: 14-AUG-2023 The patient received 2 month vaccines on and went to emergency room on 26th July 2023 and developed brain bleed and ceribral venousthrombocious. In JUL-2023, less than 3 weeks after receiving PREVNAR VACCINE and ROTATEQ, the patient experienced hemorrhage brain and cerebral venous thrombosis. It was unknown if the reporter considered the hemorrhage brain and cerebral venous thrombosis to be related to hemorrhage brain and cerebral venous thrombosis. The reporter agreed to follow up from GlaxoSmithKline (GSK).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebral haemorrhage
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 21.08.2023
- Impfdatum
- 11.07.2023
- Beginn
- 01.07.2023
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Cerebral haemorrhage
Cerebral venous thrombosis
Symptomtext
DEVELOPED BRAIN BLEED; CERIBRAL VENOUSTHROMBOCIOUS; This serious case was reported by a nurse via sales rep and described the occurrence of hemorrhage brain in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included Hib (Hiberix) for prophylaxis, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR VACCINE) for prophylaxis and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis. On 11-JUL-2023, the patient received Pediarix, Hiberix, PREVNAR VACCINE and ROTATEQ. In JUL-2023, less than 3 weeks after receiving Pediarix and Hiberix, the patient experienced hemorrhage brain (Verbatim: DEVELOPED BRAIN BLEED) (serious criteria GSK medically significant) and cerebral venous thrombosis (Verbatim: CERIBRAL VENOUSTHROMBOCIOUS) (serious criteria GSK medically significant). The outcome of the hemorrhage brain and cerebral venous thrombosis were not reported. It was unknown if the reporter considered the hemorrhage brain and cerebral venous thrombosis to be related to Pediarix and Hiberix. It was unknown if the company considered the hemorrhage brain and cerebral venous thrombosis to be related to Pediarix and Hiberix. Additional Information: GSK receipt date: 14-AUG-2023 The patient received 2 month vaccines on and went to emergency room on 26th July 2023 and developed brain bleed and ceribral venousthrombocious. In JUL-2023, less than 3 weeks after receiving PREVNAR VACCINE and ROTATEQ, the patient experienced hemorrhage brain and cerebral venous thrombosis. It was unknown if the reporter considered the hemorrhage brain and cerebral venous thrombosis to be related to hemorrhage brain and cerebral venous thrombosis. The reporter agreed to follow up from GlaxoSmithKline (GSK).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebral haemorrhage
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 21.08.2023
- Impfdatum
- 11.07.2023
- Beginn
- 01.07.2023
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Cerebral haemorrhage
Cerebral venous thrombosis
Symptomtext
DEVELOPED BRAIN BLEED; CERIBRAL VENOUSTHROMBOCIOUS; This serious case was reported by a nurse via sales rep and described the occurrence of hemorrhage brain in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included Hib (Hiberix) for prophylaxis, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR VACCINE) for prophylaxis and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis. On 11-JUL-2023, the patient received Pediarix, Hiberix, PREVNAR VACCINE and ROTATEQ. In JUL-2023, less than 3 weeks after receiving Pediarix and Hiberix, the patient experienced hemorrhage brain (Verbatim: DEVELOPED BRAIN BLEED) (serious criteria GSK medically significant) and cerebral venous thrombosis (Verbatim: CERIBRAL VENOUSTHROMBOCIOUS) (serious criteria GSK medically significant). The outcome of the hemorrhage brain and cerebral venous thrombosis were not reported. It was unknown if the reporter considered the hemorrhage brain and cerebral venous thrombosis to be related to Pediarix and Hiberix. It was unknown if the company considered the hemorrhage brain and cerebral venous thrombosis to be related to Pediarix and Hiberix. Additional Information: GSK receipt date: 14-AUG-2023 The patient received 2 month vaccines on and went to emergency room on 26th July 2023 and developed brain bleed and ceribral venousthrombocious. In JUL-2023, less than 3 weeks after receiving PREVNAR VACCINE and ROTATEQ, the patient experienced hemorrhage brain and cerebral venous thrombosis. It was unknown if the reporter considered the hemorrhage brain and cerebral venous thrombosis to be related to hemorrhage brain and cerebral venous thrombosis. The reporter agreed to follow up from GlaxoSmithKline (GSK).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebral haemorrhage
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 16.08.2023
- Impfdatum
- 06.12.2022
- Beginn
- 31.12.2022
- Tage bis Beginn
- 25,0
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Computerised tomogram thorax abnormal
Feeling abnormal
Hyperhidrosis
Laboratory test normal
Loss of consciousness
Pulmonary embolism
Pulmonary thrombosis
Ultrasound scan abnormal
Symptomtext
I experienced a pulmonary embolism about four weeks after getting the injection I've been doing tests and they found nothing wrong with me so it was definitely the injection that cost me to have a Clo; blood clot in my lungs; Sweating; Passed out; almost died; This serious case was reported by a consumer and described the occurrence of pulmonary embolism in a 55-year-old male patient who received Herpes zoster (Zoster vaccine) for prophylaxis. Concomitant products included apixaban (Eliquis). On 06-DEC-2022, the patient received the 2nd dose of Zoster vaccine. On 31-DEC-2022, 25 days after receiving Zoster vaccine, the patient experienced pulmonary embolism (Verbatim: I experienced a pulmonary embolism about four weeks after getting the injection I've been doing tests and they found nothing wrong with me so it was definitely the injection that cost me to have a Clo) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), pulmonary thrombosis (Verbatim: blood clot in my lungs) (serious criteria hospitalization and GSK medically significant), sweating (Verbatim: Sweating) (serious criteria hospitalization), passed out (Verbatim: Passed out) (serious criteria hospitalization and GSK medically significant) and near death experience (Verbatim: almost died) (serious criteria hospitalization and GSK medically significant). The outcome of the pulmonary embolism and passed out were resolved and the outcome of the pulmonary thrombosis, sweating and near death experience were not reported. The reporter considered the pulmonary embolism and pulmonary thrombosis to be related to Zoster vaccine. It was unknown if the reporter considered the sweating, passed out and near death experience to be related to Zoster vaccine. The company considered the pulmonary embolism and pulmonary thrombosis to be related to Zoster vaccine. It was unknown if the company considered the sweating, passed out and near death experience to be related to Zoster vaccine. Additional Information: GSK Receipt date: 09-AUG-2023 The reporter reported about himself, he passed out and he came to all his vitals were fine. Just sweating profusely took him to the hospital could not from that out of you. Nothing was wrong with him. Then he needed to get some kind of answer after CAT (Computerised tomogram) scans ultrasound they found that he had a blood clot in his lungs, so he had a pulmonary embolism. He experienced a pulmonary embolism about four weeks after getting the injection he had been doing tests and they found nothing wrong with him, so it was definitely the injection that cost him. it was December 31 of 2022 that this took place he almost died he had gone through months and months of testing. They found nothing wrong with him that caused him to get this clot. The only conclusion was he had the injection done the beginning of December and now because they could not get a determined answer, he had to be on the rest of his life. The reporter consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pulmonary embolism
- Hospital-Tage
- -
- Labordaten
- Test Date: 202212; Test Name: CAT scans; Result Unstructured Data: (Test Result:blood clot in his lungs and pulmonary embolism,Unit:unknown,Normal Low:,Normal High:); Test Date: 202212; Test Name: ultrasound; Result Unstructured Data: (Test Result:blood clot in his lungs and pulmonary embolism,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- ELIQUIS
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- -
- Geschlecht
- F
- Eingang
- 01.08.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
that almost killed me; This serious case was reported by a nurse via sales rep and described the occurrence of near death experience in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced near death experience (Verbatim: that almost killed me) (serious criteria GSK medically significant). The outcome of the near death experience was not reported. The reporter considered the near death experience to be related to Shingrix. The company considered the near death experience to be related to Shingrix. Additional Information: GSK receipt date: 27-JUL-2023 The reporter quoted that Shingrix, that almost killed him/her and did not elaborate further. The reporter did not agreed to follow up with GlaxoSmithKline.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 31.07.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
shingles booster second shot killed my wife; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: shingles booster second shot killed my wife) (serious criteria death and GSK medically significant). The reported cause of death was unknown. The reporter considered the unknown cause of death to be related to Shingles vaccine. The company considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK receipt date: 27-JUL-2023 This case was reported by a patient via interactive digital media. The case was reported by patient's husband. The reporter stated that shingles booster second shot killed his wife and stated that everybody should be aware and be forewarned about it. The follow-up could not be possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- -
- Geschlecht
- M
- Eingang
- 21.07.2023
- Impfdatum
- 07.03.2014
- Beginn
- 19.03.2014
- Tage bis Beginn
- 12,0
- Dosis
- 1
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Analgesic drug level increased
Autopsy
Blood ethanol normal
Blood immunoglobulin G normal
Blood immunoglobulin M increased
Cardiomegaly
Dilated cardiomyopathy
Drug screen positive
Eosinophilic myocarditis
Histology abnormal
Left ventricular hypertrophy
Lung infiltration
Myocardial necrosis
Myocarditis
Orthopoxvirus test positive
Pneumonitis
Polymerase chain reaction positive
Skin lesion
Symptomtext
Necrotizing eosinophilic myocarditis; Mild concentric left ventricular hypertrophy; Allergic rhinitis; Sudden death; Cardiomegaly; SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT This case was received on 16 June 2014 via a third party query tool search on the VAERS database, under reference number 526687. A 24-year-old male patient had received a SMALLPOX (VACCINIA) LIVE VACCINE (ACAM2000, lot number not reported) on 07 March 2014. On 19 March 2014, 12 days following vaccination, the patient experienced sudden death and cardiomegaly with four chamber dilation. The patient histologic diagnosis was myocarditis. At the time of this report toxicology is still pending. The patient's other medications, current illnesses and history were reported as none. No further information was available at the time of the report. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient outcome was fatal. Follow-up information for this unsolicited report was received from a healthcare professional on 08 December 2014, and included a redacted copy of the autopsy report. The patient was found unresponsive in his quarters. Cause of death was necrotizing eosinophilic myocarditis, and manner of death was natural. A cardiovascular pathology consultation showed predominant interstitial inflammation, a mixed inflammatory infiltrate of macrophages, neutrophils, eosinophils and lymphocytes, and patchy myocyte necrosis. The impression from the consultation was necrotizing eosinophilic myocarditis with mild concentric left ventricular hypertrophy. A lesion on the left shoulder was consistent with recent smallpox vaccination, and recent smallpox vaccination was confirmed by serology. No ethanol was detected in the blood or vitreous fluid. Acetaminophen and diphenhydramine were detected. The opinion of the examiner was that the patient died of necrotizing eosinophilic myocarditis, temporally related with administration of a smallpox vaccination. Cause and effect relationship between smallpox vaccination and death could not be definitively established or ruled out. Follow-up information for this unsolicited report was received from a healthcare professional on 11 December 2014 and included an updated redacted copy of the autopsy report. Diagnostic comments included orthopox was negative by PCR - fresh frozen and tissue extracts from the paraffin blocks. Specimen identification final comment: The assay used to detect the presence of human DNA in the sample provided has been changed from beta actin to RNASEP. A tissue culture was not done. Orthopox IgG was negative. Orthopox and ELISA IgM was positive. The histologic features are predominant interstitial inflammation, a mixed inflammatory infiltrate of macrophages, neutrophiles, eosinophils and lymphocytes and patchy myocyte necrosis. This pattern is that of an aggressive form of hypersensitivity (allergic) myocarditis with myocyte necrosis that has been most frequently associated with a reaction to drugs, especially antibiotics. The following is verbatim from the report: "In this case, the myocarditis seems mostly likely the cause of death. It is impossible to establish a causative link between the myocarditis and the vaccination. However, if there was no other exposure to drugs (especially antibiotics) in this case within the last few weeks to months, then a vaccinia-related myocarditis seems most likely." Documents held by sender: Redacted Autopsy report. Follow-up information derived from a full-text article, was received on 19MAY2023. It described a 24-year-old male patient who had "allergic rhinitis" (PT: Rhinitis allergic), developed "necrotizing eosinophilic myocarditis" (PT: Eosinophilic myocarditis), "mild concentric left ventricular hypertrophy" (PT: Ventricular hypertrophy) and had "sudden death" (PT: Sudden death) following the immunisation with ACAM2000 (smallpox vaccine, live). Case report: The report describes a 24-year-old male patient with good baseline health (prior to immunization), meeting physical fitness standards, and without any diagnoses that impacted the ability to work or receive the smallpox vaccine (SPV). Coronary artery disease or cardiomyopathy was not present in the patient. Reportedly, the patient concomitantly received typhoid Vi (Typhoid vaccine) and human papillomavirus (HPV) vaccine along with smallpox vaccine. Furthermore, the patient did not seek care post vaccination and developed allergic rhinitis for which he received antihistamines (unspecified). The patient underwent certain laboratory investigations which included negative viral polymerase chain reaction (PCR) studies (including vaccinia of the heart tissue) and negative toxicology studies. Additionally, it was reported that the patient was hospitalised (reason unknown), and no arrhythmia was documented. Following 12 days of vaccination, the patient suddenly died. The histology at autopsy confirmed necrotizing eosinophilic myocarditis and mild concentric hypertrophy. The cause of death was reported as hypersensitivity eosinophilic myocarditis. Author's comment: This was very rare case with having a sudden death associated with classic hypersensitivity myocarditis histology. The challenge of causality assessments for complex, prolonged illness following acute presentation before death often involves divergent opinions depending on specialty perspectives within a multidisciplinary review. Based on the above available information in the source document, two individual case safety reports (14000046SP and 12AV00003RG) were created and linked in the database. Company comment: A 24-year-old male patient received ACAM2000 on 07 March 2014. Following the vaccination, the patient developed allergic rhinitis, for which he received unspecified antihistamines. Patient was hospitalized on 19 March 2014 for unknown reasons. 12 days following vaccination, the patient suddenly died. No prior medical history, toxicology reports, or concomitant medications were reported. The histology at autopsy confirmed necrotizing eosinophilic myocarditis and mild concentric left ventricular hypertrophy. The cause of death was reported as hypersensitivity eosinophilic myocarditis. Eosinophilic myocarditis is a rare subtype of myocarditis, recognized by severe heart failure and marked eosinophilia infiltration which is rare and often fatal. Cardiology pathology reports revealed interstitial inflammation and myocyte necrosis, supporting the diagnosis in the autopsy report. Although myocarditis is a listed event for ACAM2000, eosinophilic myocarditis is not listed. Based upon the absence of other known etiologies, and no reported implication to other vaccines, the role of ACAM2000 cannot be ruled out and the causality of rhinitis allergic, eosinophilic myocarditis, ventricular hypertrophy, and sudden death is assessed as possible. The case is considered serious as per medical assessment.; Sender's Comments: A 24-year-old male patient received ACAM2000 on 07 March 2014. Following the vaccination, the patient developed allergic rhinitis, for which he received unspecified antihistamines. Patient was hospitalized on 19 March 2014 for unknown reasons. 12 days following vaccination, the patient suddenly died. No prior medical history, toxicology reports, or concomitant medications were reported. The histology at autopsy confirmed necrotizing eosinophilic myocarditis and mild concentric left ventricular hypertrophy. The cause of death was reported as hypersensitivity eosinophilic myocarditis. Eosinophilic myocarditis is a rare subtype of myocarditis, recognized by severe heart failure and marked eosinophilia infiltration which is rare and often fatal. Cardiology pathology reports revealed interstitial inflammation and myocyte necrosis, supporting the diagnosis in the autopsy report. Although myocarditis is a listed event for ACAM2000, eosinophilic myocarditis is not listed. Based upon the absence of other known etiologies, and no reported implication to other vaccines, the role of ACAM2000 cannot be ruled out and the causality of rhinitis allergic, eosinophilic myocarditis, ventricular hypertrophy, and sudden death is assessed as possible. The case is considered serious as per medical assessment.; Reported Cause(s) of Death: Necrotizing eosinophilic myocarditis
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Sudden death
- Hospital-Tage
- -
- Labordaten
- Test Name: IgG; Result Unstructured Data: Negative; Test Name: IgM; Result Unstructured Data: Positive; Test Name: BMI; Result Unstructured Data: more than 30; Test Name: Histology; Result Unstructured Data: Necrotizing Eosinophilic Myocarditis, Mild concentric hypertrophy; Test Name: Viral polymerase chain rection; Result Unstructured Data: Negative; Test Name: Toxicology test; Result Unstructured Data: Negative
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Comments: Unknown patient history.
- Andere Medikamente
- Typhim vi; Human papilloma vaccine
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- M
- Eingang
- 07.07.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Gait inability
General physical health deterioration
White blood cell count decreased
Symptomtext
Dead; couldn't walk; Decompensated; WBC count plummeted; This serious case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (on an unknown date patient received 1st dose of Shingrix). Concurrent medical conditions included chronic lymphocytic leukemia (had low grade chronic lymphocytic leukemia for 12 to 15 years). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced unknown cause of death (Verbatim: Dead) (serious criteria death and GSK medically significant), unable to walk (Verbatim: couldn't walk), general physical health deterioration (Verbatim: Decompensated) and white blood cell count decreased (Verbatim: WBC count plummeted). The outcome of the unable to walk, general physical health deterioration and white blood cell count decreased were not reported. The reported cause of death was unknown. It was unknown if the reporter considered the unknown cause of death, unable to walk, general physical health deterioration and white blood cell count decreased to be related to Shingrix. It was unknown if the company considered the unknown cause of death, unable to walk, general physical health deterioration and white blood cell count decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 05-JUL-2023 The patient was around 90 years old. The patient was not being treated for chronic lymphocytic leukemia. It was watch and wait at that point for his chronic lymphocytic leukemia. The patient wanted to get Shingrix. His doctor (reporter) said no, doctor did not thought patient should get it but the patient wanted it as he was afraid that getting shingles would kill him. The patient insisted and took both doses within the scheduled period. Immediately patient white blood cell counts plummeted, he could not walk, patient decompensated and was dead within a week. The reporter estimated that this happened 2 to 4 years ago from reporting date. The reporter consented to follow up.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Test Name: WBC count; Result Unstructured Data: (Test Result:plummeted,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- Chronic lymphocytic leukemia (had low grade chronic lymphocytic leukemia for 12 to 15 years)
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- M
- Eingang
- 06.07.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Alanine aminotransferase increased
CD4 lymphocytes
Condition aggravated
Death
HIV infection
Hepatitis B
Hepatitis B DNA increased
Hepatitis B core antibody negative
Hepatitis B surface antibody negative
Hepatitis B surface antigen positive
Immunosuppressant drug therapy
Therapy non-responder
Vaccination failure
Viral load decreased
Viral mutation identified
Symptomtext
vaccination failure; HBsAg was newly reactive; HIV genotype revealed M184V, M41L, L210L, T215T, D67T, M46I, I54V, V82F; HBsAb post-vaccination was nonreactive; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 65-year-old male patient who received HAB (Twinrix adult) for prophylaxis. Co-suspect products included HAB (Twinrix adult) for prophylaxis, HAB (Twinrix adult) for prophylaxis, HBV (Engerix B adult) for prophylaxis, HBV (Engerix B adult) for prophylaxis, abacavir sulphate (Abacavir) for hiv infection, lamivudine (Lamivudine Hiv) for hiv infection, dolutegravir, rilpivirine (Dolutegravir + Rilpivirine) for hiv infection and fosamprenavir + ritonavir for hiv infection. Concurrent medical conditions included treatment failure. Concomitant products included nevirapine. On an unknown date, the patient received the 3rd dose of Twinrix adult 20 ug, the 2nd dose of Twinrix adult 20 ug, the 1st dose of Twinrix adult 20 ug, Engerix B adult 20 ug, Engerix B adult 20 ug, Abacavir, Lamivudine Hiv, Dolutegravir + Rilpivirine and fosamprenavir + ritonavir. On an unknown date, an unknown time after receiving Twinrix adult, Twinrix adult, Twinrix adult, Engerix B adult and Engerix B adult and an unknown time after starting Abacavir, Lamivudine Hiv and Dolutegravir + Rilpivirine, the patient experienced vaccination failure (Verbatim: vaccination failure) (serious criteria GSK medically significant), hepatitis b (Verbatim: HBsAg was newly reactive) (serious criteria GSK medically significant), viral mutation identified (Verbatim: HIV genotype revealed M184V, M41L, L210L, T215T, D67T, M46I, I54V, V82F) and therapy non-responder (Verbatim: HBsAb post-vaccination was nonreactive). The action taken with Abacavir was unknown. The action taken with Lamivudine Hiv was unknown. The action taken with Dolutegravir + Rilpivirine was unknown. The action taken with fosamprenavir + ritonavir was unknown. The outcome of the vaccination failure, viral mutation identified and therapy non-responder were unknown and the outcome of the hepatitis b was resolved. It was unknown if the reporter considered the vaccination failure and hepatitis b to be related to Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Engerix B adult, Engerix B Pre-Filled Syringe Device, Engerix B adult and Engerix B Pre-Filled Syringe Device. The reporter considered the viral mutation identified to be related to Abacavir and Lamivudine Hiv. The reporter considered the hepatitis b to be related to Dolutegravir + Rilpivirine. It was unknown if the company considered the vaccination failure and hepatitis b to be related to Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Engerix B adult, Engerix B Pre-Filled Syringe Device, Engerix B adult and Engerix B Pre-Filled Syringe Device. The company considered the viral mutation identified to be related to Abacavir and Lamivudine Hiv. The company considered the hepatitis b to be related to Dolutegravir + Rilpivirine. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-Jun-2023 This case corresponds to case-1 reported in this literature article. The patient presented with Human immunodeficiency virus (HIV) (CD4 190 cells/mL) diagnosed twenty years prior and virologically suppressed on abacavir (ABC), Lamivudine (3TC), nevirapine (NVP) and ritonavir-boosted fosemprenavir (FPV/r) following initial treatment failure. Hepatitis B surface antigen (HBsAg), Hepatotis B core antibody (HBcAb), and Hepatitis B surface antibody (HBsAb) were nonreactive. The patient received three 20-mcg doses of combined hepatitis A inactivated/HBV recombinant vaccine (Twinrix? GlaxoSmithKline) at zero, one, and six months. HBsAb post-vaccination was nonreactive. The patient received two additional 20-mcg doses of HBV recombinant vaccine (Engerix-B?, GlaxoSmithKline) at zero and three months. HBsAb remained nonreactive. The patient expressed interest in single-tablet anti-retroviral therapy (ART). HIV genotype revealed M184V, M41L, L210L, and T215T mutations, though preserved non-nucleoside reverse transcriptase inhibitor (NNRTI) susceptibility. The patient was switched to Dolutegravir-Rilpivirine (DTG-RPV). The patient presented five months later with alanine aminotransferase (ALT) of 570 IU/mL from normal baseline. HBsAg was newly reactive; Hepatitis B Virus (HBV) DNA was 1.75 million IU/mL. The patient denied recent sexual or needle-borne exposures. Tenofovir disoproxil fumarate (TDF)-emtricitabine (FTC) were initiated. HBV DNA suppression and ALT normalization were achieved after ten months of therapy and maintained for six months before the patient expired from unrelated causes. This case highlighted the risk of HBV infection in persons with vaccine nonresponse, which may be heightened after discontinuing HBV-active ART; Sender's Comments: US-GSK-US2023GSK092142:Same article
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Test Name: alanine transferase; Result Unstructured Data: (Test Result:570,Unit:iu/ml,Normal Low:,Normal High:); Test Name: alanine transferase; Result Unstructured Data: (Test Result:normal,Unit:iu/ml,Normal Low:,Normal High:); Test Name: CD4; Result Unstructured Data: (Test Result:190 cells/ml,Unit:unknown,Normal Low:,Normal High:); Test Name: CD4; Result Unstructured Data: (Test Result:202,Unit:unknown,Normal Low:,Normal High:) at the time of switch; Test Name: HBcAb; Result Unstructured Data: (Test Result:nonreactive,Unit:unknown,Normal Low:,Normal High:); Test Name: HBV DNA; Result Unstructured Data: (Test Result:1.75 million,Unit:iu/ml,Normal Low:,Normal High:); Test Name: HBV DNA; Result Unstructured Data: (Test Result:suppressed,Unit:iu/ml,Normal Low:,Normal High:); Test Name: HBsAb; Result Unstructured Data: (Test Result:nonreactive,Unit:unknown,Normal Low:,Normal High:); Test Name: HBsAb; Result Unstructured Data: (Test Result:nonreactive,Unit:unknown,Normal Low:,Normal High:) post Twinrix vaccination; Test Name: HBsAb; Result Unstructured Data: (Test Result:remained nonreactive,Unit:unknown,Normal Low:,Normal High:) post Engerix vaccination; Test Name: HBsAg; Result Unstructured Data: (Test Result:nonreactive,Unit:unknown,Normal Low:,Normal High:); Test Name: HBsAg; Result Unstructured Data: (Test Result:newly reactive,Unit:unknown,Normal Low:,Normal High:); Test Name: viral load; Result Unstructured Data: (Test Result:virologically suppressed,Unit:unknown,Normal Low:,Normal High:) on abacavir (ABC), 3TC, nevirapine (NVP), and ritonavir-boosted fosemprenavir (FPV/r); Test Name: viral load; Result Unstructured Data: (Test Result:less than 20,Unit:unknown,Normal Low:,Normal High:) at the time of switch; Comments: Mutations: M184V, M41L, L210L, T215T, D67T, M46I, I54V, V82F
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Treatment failure
- Andere Medikamente
- NEVIRAPINE; Abacavir; Lamivudine HIV; Dolutegravir + Rilpivirine; FOSAMPRENAVIR + RITONAVIR
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- M
- Eingang
- 06.07.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Alanine aminotransferase increased
CD4 lymphocytes
Condition aggravated
Death
HIV infection
Hepatitis B
Hepatitis B DNA increased
Hepatitis B core antibody negative
Hepatitis B surface antibody negative
Hepatitis B surface antigen positive
Immunosuppressant drug therapy
Therapy non-responder
Vaccination failure
Viral load decreased
Viral mutation identified
Symptomtext
vaccination failure; HBsAg was newly reactive; HIV genotype revealed M184V, M41L, L210L, T215T, D67T, M46I, I54V, V82F; HBsAb post-vaccination was nonreactive; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 65-year-old male patient who received HAB (Twinrix adult) for prophylaxis. Co-suspect products included HAB (Twinrix adult) for prophylaxis, HAB (Twinrix adult) for prophylaxis, HBV (Engerix B adult) for prophylaxis, HBV (Engerix B adult) for prophylaxis, abacavir sulphate (Abacavir) for hiv infection, lamivudine (Lamivudine Hiv) for hiv infection, dolutegravir, rilpivirine (Dolutegravir + Rilpivirine) for hiv infection and fosamprenavir + ritonavir for hiv infection. Concurrent medical conditions included treatment failure. Concomitant products included nevirapine. On an unknown date, the patient received the 3rd dose of Twinrix adult 20 ug, the 2nd dose of Twinrix adult 20 ug, the 1st dose of Twinrix adult 20 ug, Engerix B adult 20 ug, Engerix B adult 20 ug, Abacavir, Lamivudine Hiv, Dolutegravir + Rilpivirine and fosamprenavir + ritonavir. On an unknown date, an unknown time after receiving Twinrix adult, Twinrix adult, Twinrix adult, Engerix B adult and Engerix B adult and an unknown time after starting Abacavir, Lamivudine Hiv and Dolutegravir + Rilpivirine, the patient experienced vaccination failure (Verbatim: vaccination failure) (serious criteria GSK medically significant), hepatitis b (Verbatim: HBsAg was newly reactive) (serious criteria GSK medically significant), viral mutation identified (Verbatim: HIV genotype revealed M184V, M41L, L210L, T215T, D67T, M46I, I54V, V82F) and therapy non-responder (Verbatim: HBsAb post-vaccination was nonreactive). The action taken with Abacavir was unknown. The action taken with Lamivudine Hiv was unknown. The action taken with Dolutegravir + Rilpivirine was unknown. The action taken with fosamprenavir + ritonavir was unknown. The outcome of the vaccination failure, viral mutation identified and therapy non-responder were unknown and the outcome of the hepatitis b was resolved. It was unknown if the reporter considered the vaccination failure and hepatitis b to be related to Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Engerix B adult, Engerix B Pre-Filled Syringe Device, Engerix B adult and Engerix B Pre-Filled Syringe Device. The reporter considered the viral mutation identified to be related to Abacavir and Lamivudine Hiv. The reporter considered the hepatitis b to be related to Dolutegravir + Rilpivirine. It was unknown if the company considered the vaccination failure and hepatitis b to be related to Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Engerix B adult, Engerix B Pre-Filled Syringe Device, Engerix B adult and Engerix B Pre-Filled Syringe Device. The company considered the viral mutation identified to be related to Abacavir and Lamivudine Hiv. The company considered the hepatitis b to be related to Dolutegravir + Rilpivirine. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-Jun-2023 This case corresponds to case-1 reported in this literature article. The patient presented with Human immunodeficiency virus (HIV) (CD4 190 cells/mL) diagnosed twenty years prior and virologically suppressed on abacavir (ABC), Lamivudine (3TC), nevirapine (NVP) and ritonavir-boosted fosemprenavir (FPV/r) following initial treatment failure. Hepatitis B surface antigen (HBsAg), Hepatotis B core antibody (HBcAb), and Hepatitis B surface antibody (HBsAb) were nonreactive. The patient received three 20-mcg doses of combined hepatitis A inactivated/HBV recombinant vaccine (Twinrix? GlaxoSmithKline) at zero, one, and six months. HBsAb post-vaccination was nonreactive. The patient received two additional 20-mcg doses of HBV recombinant vaccine (Engerix-B?, GlaxoSmithKline) at zero and three months. HBsAb remained nonreactive. The patient expressed interest in single-tablet anti-retroviral therapy (ART). HIV genotype revealed M184V, M41L, L210L, and T215T mutations, though preserved non-nucleoside reverse transcriptase inhibitor (NNRTI) susceptibility. The patient was switched to Dolutegravir-Rilpivirine (DTG-RPV). The patient presented five months later with alanine aminotransferase (ALT) of 570 IU/mL from normal baseline. HBsAg was newly reactive; Hepatitis B Virus (HBV) DNA was 1.75 million IU/mL. The patient denied recent sexual or needle-borne exposures. Tenofovir disoproxil fumarate (TDF)-emtricitabine (FTC) were initiated. HBV DNA suppression and ALT normalization were achieved after ten months of therapy and maintained for six months before the patient expired from unrelated causes. This case highlighted the risk of HBV infection in persons with vaccine nonresponse, which may be heightened after discontinuing HBV-active ART; Sender's Comments: US-GSK-US2023GSK092142:Same article
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Test Name: alanine transferase; Result Unstructured Data: (Test Result:570,Unit:iu/ml,Normal Low:,Normal High:); Test Name: alanine transferase; Result Unstructured Data: (Test Result:normal,Unit:iu/ml,Normal Low:,Normal High:); Test Name: CD4; Result Unstructured Data: (Test Result:190 cells/ml,Unit:unknown,Normal Low:,Normal High:); Test Name: CD4; Result Unstructured Data: (Test Result:202,Unit:unknown,Normal Low:,Normal High:) at the time of switch; Test Name: HBcAb; Result Unstructured Data: (Test Result:nonreactive,Unit:unknown,Normal Low:,Normal High:); Test Name: HBV DNA; Result Unstructured Data: (Test Result:1.75 million,Unit:iu/ml,Normal Low:,Normal High:); Test Name: HBV DNA; Result Unstructured Data: (Test Result:suppressed,Unit:iu/ml,Normal Low:,Normal High:); Test Name: HBsAb; Result Unstructured Data: (Test Result:nonreactive,Unit:unknown,Normal Low:,Normal High:); Test Name: HBsAb; Result Unstructured Data: (Test Result:nonreactive,Unit:unknown,Normal Low:,Normal High:) post Twinrix vaccination; Test Name: HBsAb; Result Unstructured Data: (Test Result:remained nonreactive,Unit:unknown,Normal Low:,Normal High:) post Engerix vaccination; Test Name: HBsAg; Result Unstructured Data: (Test Result:nonreactive,Unit:unknown,Normal Low:,Normal High:); Test Name: HBsAg; Result Unstructured Data: (Test Result:newly reactive,Unit:unknown,Normal Low:,Normal High:); Test Name: viral load; Result Unstructured Data: (Test Result:virologically suppressed,Unit:unknown,Normal Low:,Normal High:) on abacavir (ABC), 3TC, nevirapine (NVP), and ritonavir-boosted fosemprenavir (FPV/r); Test Name: viral load; Result Unstructured Data: (Test Result:less than 20,Unit:unknown,Normal Low:,Normal High:) at the time of switch; Comments: Mutations: M184V, M41L, L210L, T215T, D67T, M46I, I54V, V82F
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Treatment failure
- Andere Medikamente
- NEVIRAPINE; Abacavir; Lamivudine HIV; Dolutegravir + Rilpivirine; FOSAMPRENAVIR + RITONAVIR
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- M
- Eingang
- 06.07.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Alanine aminotransferase increased
CD4 lymphocytes
Condition aggravated
Death
HIV infection
Hepatitis B
Hepatitis B DNA increased
Hepatitis B core antibody negative
Hepatitis B surface antibody negative
Hepatitis B surface antigen positive
Immunosuppressant drug therapy
Therapy non-responder
Vaccination failure
Viral load decreased
Viral mutation identified
Symptomtext
vaccination failure; HBsAg was newly reactive; HIV genotype revealed M184V, M41L, L210L, T215T, D67T, M46I, I54V, V82F; HBsAb post-vaccination was nonreactive; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 65-year-old male patient who received HAB (Twinrix adult) for prophylaxis. Co-suspect products included HAB (Twinrix adult) for prophylaxis, HAB (Twinrix adult) for prophylaxis, HBV (Engerix B adult) for prophylaxis, HBV (Engerix B adult) for prophylaxis, abacavir sulphate (Abacavir) for hiv infection, lamivudine (Lamivudine Hiv) for hiv infection, dolutegravir, rilpivirine (Dolutegravir + Rilpivirine) for hiv infection and fosamprenavir + ritonavir for hiv infection. Concurrent medical conditions included treatment failure. Concomitant products included nevirapine. On an unknown date, the patient received the 3rd dose of Twinrix adult 20 ug, the 2nd dose of Twinrix adult 20 ug, the 1st dose of Twinrix adult 20 ug, Engerix B adult 20 ug, Engerix B adult 20 ug, Abacavir, Lamivudine Hiv, Dolutegravir + Rilpivirine and fosamprenavir + ritonavir. On an unknown date, an unknown time after receiving Twinrix adult, Twinrix adult, Twinrix adult, Engerix B adult and Engerix B adult and an unknown time after starting Abacavir, Lamivudine Hiv and Dolutegravir + Rilpivirine, the patient experienced vaccination failure (Verbatim: vaccination failure) (serious criteria GSK medically significant), hepatitis b (Verbatim: HBsAg was newly reactive) (serious criteria GSK medically significant), viral mutation identified (Verbatim: HIV genotype revealed M184V, M41L, L210L, T215T, D67T, M46I, I54V, V82F) and therapy non-responder (Verbatim: HBsAb post-vaccination was nonreactive). The action taken with Abacavir was unknown. The action taken with Lamivudine Hiv was unknown. The action taken with Dolutegravir + Rilpivirine was unknown. The action taken with fosamprenavir + ritonavir was unknown. The outcome of the vaccination failure, viral mutation identified and therapy non-responder were unknown and the outcome of the hepatitis b was resolved. It was unknown if the reporter considered the vaccination failure and hepatitis b to be related to Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Engerix B adult, Engerix B Pre-Filled Syringe Device, Engerix B adult and Engerix B Pre-Filled Syringe Device. The reporter considered the viral mutation identified to be related to Abacavir and Lamivudine Hiv. The reporter considered the hepatitis b to be related to Dolutegravir + Rilpivirine. It was unknown if the company considered the vaccination failure and hepatitis b to be related to Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Engerix B adult, Engerix B Pre-Filled Syringe Device, Engerix B adult and Engerix B Pre-Filled Syringe Device. The company considered the viral mutation identified to be related to Abacavir and Lamivudine Hiv. The company considered the hepatitis b to be related to Dolutegravir + Rilpivirine. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-Jun-2023 This case corresponds to case-1 reported in this literature article. The patient presented with Human immunodeficiency virus (HIV) (CD4 190 cells/mL) diagnosed twenty years prior and virologically suppressed on abacavir (ABC), Lamivudine (3TC), nevirapine (NVP) and ritonavir-boosted fosemprenavir (FPV/r) following initial treatment failure. Hepatitis B surface antigen (HBsAg), Hepatotis B core antibody (HBcAb), and Hepatitis B surface antibody (HBsAb) were nonreactive. The patient received three 20-mcg doses of combined hepatitis A inactivated/HBV recombinant vaccine (Twinrix? GlaxoSmithKline) at zero, one, and six months. HBsAb post-vaccination was nonreactive. The patient received two additional 20-mcg doses of HBV recombinant vaccine (Engerix-B?, GlaxoSmithKline) at zero and three months. HBsAb remained nonreactive. The patient expressed interest in single-tablet anti-retroviral therapy (ART). HIV genotype revealed M184V, M41L, L210L, and T215T mutations, though preserved non-nucleoside reverse transcriptase inhibitor (NNRTI) susceptibility. The patient was switched to Dolutegravir-Rilpivirine (DTG-RPV). The patient presented five months later with alanine aminotransferase (ALT) of 570 IU/mL from normal baseline. HBsAg was newly reactive; Hepatitis B Virus (HBV) DNA was 1.75 million IU/mL. The patient denied recent sexual or needle-borne exposures. Tenofovir disoproxil fumarate (TDF)-emtricitabine (FTC) were initiated. HBV DNA suppression and ALT normalization were achieved after ten months of therapy and maintained for six months before the patient expired from unrelated causes. This case highlighted the risk of HBV infection in persons with vaccine nonresponse, which may be heightened after discontinuing HBV-active ART; Sender's Comments: US-GSK-US2023GSK092142:Same article
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Test Name: alanine transferase; Result Unstructured Data: (Test Result:570,Unit:iu/ml,Normal Low:,Normal High:); Test Name: alanine transferase; Result Unstructured Data: (Test Result:normal,Unit:iu/ml,Normal Low:,Normal High:); Test Name: CD4; Result Unstructured Data: (Test Result:190 cells/ml,Unit:unknown,Normal Low:,Normal High:); Test Name: CD4; Result Unstructured Data: (Test Result:202,Unit:unknown,Normal Low:,Normal High:) at the time of switch; Test Name: HBcAb; Result Unstructured Data: (Test Result:nonreactive,Unit:unknown,Normal Low:,Normal High:); Test Name: HBV DNA; Result Unstructured Data: (Test Result:1.75 million,Unit:iu/ml,Normal Low:,Normal High:); Test Name: HBV DNA; Result Unstructured Data: (Test Result:suppressed,Unit:iu/ml,Normal Low:,Normal High:); Test Name: HBsAb; Result Unstructured Data: (Test Result:nonreactive,Unit:unknown,Normal Low:,Normal High:); Test Name: HBsAb; Result Unstructured Data: (Test Result:nonreactive,Unit:unknown,Normal Low:,Normal High:) post Twinrix vaccination; Test Name: HBsAb; Result Unstructured Data: (Test Result:remained nonreactive,Unit:unknown,Normal Low:,Normal High:) post Engerix vaccination; Test Name: HBsAg; Result Unstructured Data: (Test Result:nonreactive,Unit:unknown,Normal Low:,Normal High:); Test Name: HBsAg; Result Unstructured Data: (Test Result:newly reactive,Unit:unknown,Normal Low:,Normal High:); Test Name: viral load; Result Unstructured Data: (Test Result:virologically suppressed,Unit:unknown,Normal Low:,Normal High:) on abacavir (ABC), 3TC, nevirapine (NVP), and ritonavir-boosted fosemprenavir (FPV/r); Test Name: viral load; Result Unstructured Data: (Test Result:less than 20,Unit:unknown,Normal Low:,Normal High:) at the time of switch; Comments: Mutations: M184V, M41L, L210L, T215T, D67T, M46I, I54V, V82F
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Treatment failure
- Andere Medikamente
- NEVIRAPINE; Abacavir; Lamivudine HIV; Dolutegravir + Rilpivirine; FOSAMPRENAVIR + RITONAVIR
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- M
- Eingang
- 06.07.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 3
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Alanine aminotransferase increased
CD4 lymphocytes
Condition aggravated
Death
HIV infection
Hepatitis B
Hepatitis B DNA increased
Hepatitis B core antibody negative
Hepatitis B surface antibody negative
Hepatitis B surface antigen positive
Immunosuppressant drug therapy
Therapy non-responder
Vaccination failure
Viral load decreased
Viral mutation identified
Symptomtext
vaccination failure; HBsAg was newly reactive; HIV genotype revealed M184V, M41L, L210L, T215T, D67T, M46I, I54V, V82F; HBsAb post-vaccination was nonreactive; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 65-year-old male patient who received HAB (Twinrix adult) for prophylaxis. Co-suspect products included HAB (Twinrix adult) for prophylaxis, HAB (Twinrix adult) for prophylaxis, HBV (Engerix B adult) for prophylaxis, HBV (Engerix B adult) for prophylaxis, abacavir sulphate (Abacavir) for hiv infection, lamivudine (Lamivudine Hiv) for hiv infection, dolutegravir, rilpivirine (Dolutegravir + Rilpivirine) for hiv infection and fosamprenavir + ritonavir for hiv infection. Concurrent medical conditions included treatment failure. Concomitant products included nevirapine. On an unknown date, the patient received the 3rd dose of Twinrix adult 20 ug, the 2nd dose of Twinrix adult 20 ug, the 1st dose of Twinrix adult 20 ug, Engerix B adult 20 ug, Engerix B adult 20 ug, Abacavir, Lamivudine Hiv, Dolutegravir + Rilpivirine and fosamprenavir + ritonavir. On an unknown date, an unknown time after receiving Twinrix adult, Twinrix adult, Twinrix adult, Engerix B adult and Engerix B adult and an unknown time after starting Abacavir, Lamivudine Hiv and Dolutegravir + Rilpivirine, the patient experienced vaccination failure (Verbatim: vaccination failure) (serious criteria GSK medically significant), hepatitis b (Verbatim: HBsAg was newly reactive) (serious criteria GSK medically significant), viral mutation identified (Verbatim: HIV genotype revealed M184V, M41L, L210L, T215T, D67T, M46I, I54V, V82F) and therapy non-responder (Verbatim: HBsAb post-vaccination was nonreactive). The action taken with Abacavir was unknown. The action taken with Lamivudine Hiv was unknown. The action taken with Dolutegravir + Rilpivirine was unknown. The action taken with fosamprenavir + ritonavir was unknown. The outcome of the vaccination failure, viral mutation identified and therapy non-responder were unknown and the outcome of the hepatitis b was resolved. It was unknown if the reporter considered the vaccination failure and hepatitis b to be related to Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Engerix B adult, Engerix B Pre-Filled Syringe Device, Engerix B adult and Engerix B Pre-Filled Syringe Device. The reporter considered the viral mutation identified to be related to Abacavir and Lamivudine Hiv. The reporter considered the hepatitis b to be related to Dolutegravir + Rilpivirine. It was unknown if the company considered the vaccination failure and hepatitis b to be related to Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Engerix B adult, Engerix B Pre-Filled Syringe Device, Engerix B adult and Engerix B Pre-Filled Syringe Device. The company considered the viral mutation identified to be related to Abacavir and Lamivudine Hiv. The company considered the hepatitis b to be related to Dolutegravir + Rilpivirine. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-Jun-2023 This case corresponds to case-1 reported in this literature article. The patient presented with Human immunodeficiency virus (HIV) (CD4 190 cells/mL) diagnosed twenty years prior and virologically suppressed on abacavir (ABC), Lamivudine (3TC), nevirapine (NVP) and ritonavir-boosted fosemprenavir (FPV/r) following initial treatment failure. Hepatitis B surface antigen (HBsAg), Hepatotis B core antibody (HBcAb), and Hepatitis B surface antibody (HBsAb) were nonreactive. The patient received three 20-mcg doses of combined hepatitis A inactivated/HBV recombinant vaccine (Twinrix? GlaxoSmithKline) at zero, one, and six months. HBsAb post-vaccination was nonreactive. The patient received two additional 20-mcg doses of HBV recombinant vaccine (Engerix-B?, GlaxoSmithKline) at zero and three months. HBsAb remained nonreactive. The patient expressed interest in single-tablet anti-retroviral therapy (ART). HIV genotype revealed M184V, M41L, L210L, and T215T mutations, though preserved non-nucleoside reverse transcriptase inhibitor (NNRTI) susceptibility. The patient was switched to Dolutegravir-Rilpivirine (DTG-RPV). The patient presented five months later with alanine aminotransferase (ALT) of 570 IU/mL from normal baseline. HBsAg was newly reactive; Hepatitis B Virus (HBV) DNA was 1.75 million IU/mL. The patient denied recent sexual or needle-borne exposures. Tenofovir disoproxil fumarate (TDF)-emtricitabine (FTC) were initiated. HBV DNA suppression and ALT normalization were achieved after ten months of therapy and maintained for six months before the patient expired from unrelated causes. This case highlighted the risk of HBV infection in persons with vaccine nonresponse, which may be heightened after discontinuing HBV-active ART; Sender's Comments: US-GSK-US2023GSK092142:Same article
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Test Name: alanine transferase; Result Unstructured Data: (Test Result:570,Unit:iu/ml,Normal Low:,Normal High:); Test Name: alanine transferase; Result Unstructured Data: (Test Result:normal,Unit:iu/ml,Normal Low:,Normal High:); Test Name: CD4; Result Unstructured Data: (Test Result:190 cells/ml,Unit:unknown,Normal Low:,Normal High:); Test Name: CD4; Result Unstructured Data: (Test Result:202,Unit:unknown,Normal Low:,Normal High:) at the time of switch; Test Name: HBcAb; Result Unstructured Data: (Test Result:nonreactive,Unit:unknown,Normal Low:,Normal High:); Test Name: HBV DNA; Result Unstructured Data: (Test Result:1.75 million,Unit:iu/ml,Normal Low:,Normal High:); Test Name: HBV DNA; Result Unstructured Data: (Test Result:suppressed,Unit:iu/ml,Normal Low:,Normal High:); Test Name: HBsAb; Result Unstructured Data: (Test Result:nonreactive,Unit:unknown,Normal Low:,Normal High:); Test Name: HBsAb; Result Unstructured Data: (Test Result:nonreactive,Unit:unknown,Normal Low:,Normal High:) post Twinrix vaccination; Test Name: HBsAb; Result Unstructured Data: (Test Result:remained nonreactive,Unit:unknown,Normal Low:,Normal High:) post Engerix vaccination; Test Name: HBsAg; Result Unstructured Data: (Test Result:nonreactive,Unit:unknown,Normal Low:,Normal High:); Test Name: HBsAg; Result Unstructured Data: (Test Result:newly reactive,Unit:unknown,Normal Low:,Normal High:); Test Name: viral load; Result Unstructured Data: (Test Result:virologically suppressed,Unit:unknown,Normal Low:,Normal High:) on abacavir (ABC), 3TC, nevirapine (NVP), and ritonavir-boosted fosemprenavir (FPV/r); Test Name: viral load; Result Unstructured Data: (Test Result:less than 20,Unit:unknown,Normal Low:,Normal High:) at the time of switch; Comments: Mutations: M184V, M41L, L210L, T215T, D67T, M46I, I54V, V82F
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Treatment failure
- Andere Medikamente
- NEVIRAPINE; Abacavir; Lamivudine HIV; Dolutegravir + Rilpivirine; FOSAMPRENAVIR + RITONAVIR
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 30.06.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anaphylactic reaction
Death
Symptomtext
Anaphylactic reaction; This serious case was reported by a consumer via interactive digital media and described the occurrence of anaphylactic reaction in a child female patient who received DTPa (DTPa vaccine) for prophylaxis. Concurrent medical conditions included allergy (Dairy allergy). Family history included chickenpox and measles. On an unknown date, the patient received DTPa vaccine. On an unknown date, an unknown time after receiving DTPa vaccine, the patient experienced anaphylactic reaction (Verbatim: Anaphylactic reaction) (serious criteria death and GSK medically significant). The reported cause of death was anaphylactic reaction. It was unknown if the reporter considered the anaphylactic reaction to be related to DTPa vaccine. It was unknown if the company considered the anaphylactic reaction to be related to DTPa vaccine. Additional Information: GSK Receipt Date: 26-JUN-2023 This case was reported by a patient via interactive digital media. The reporter was the parent of the patient. The reporter stated that he/she lost her/his 1st child to an anaphylactic reaction to her 2 month DTap vaccine shots as DTap contains dairy and patient seemed to have dairy allergy. The physician stated that the patient would be fine but the parent stated that he/she buried patient 4 days later. The reporter stated that it would be always be a hard pass for him and her. The reporter also stated that they were perfectly fine and their pediatrician was amazed every year when they went for well checks. The reporter's kids were never sick. Four were grown with children of their own, all 100 percent unvaxxed and 100 percent completely healthy. The reporter stated that they had those deadly diseases like chicken pox, measles but they did not ruin their natural immune systems with all the poison, they all came through with very mild, easy cases. The reporter stated to do a little research and be amazed. The reporter stated that he/she was so glad covid has opened so many people's eyes that nothing was safe and effective and that everything in life had risks, and the science is never settled. The reporter stated to remember that cigarettes were good until they were not. The reporter stated that experiment was a great place to start, and stated that the government had used the public as their guinea pigs for years. The follow-up could not be possible as no contact details were available.; Reported Cause(s) of Death: Anaphylactic reaction
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Allergy (Dairy allergy)
- Vorgeschichte
- Medical History/Concurrent Conditions: Chickenpox; Measles
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 30.06.2023
- Impfdatum
- 01.06.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Poisoning
Pyrexia
Symptomtext
Intoxication; high fever; This serious case was reported by a consumer via interactive digital media and described the occurrence of intoxication in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In JUN-2023, the patient received Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced intoxication (Verbatim: Intoxication) (serious criteria death and GSK medically significant) and fever (Verbatim: high fever) (serious criteria death). The patient died in JUN-2023. The reported cause of death was intoxication and fever. It was unknown if the reporter considered the intoxication and fever to be related to Shingles vaccine. It was unknown if the company considered the intoxication and fever to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 24-JUN-2023 This case was received from patient's friend via interactive digital media. This week (reporting week), the patient received Shingles vaccine and in some time she died of intoxication and the high fever. The reporter stated that it was enough and would not get it done.; Reported Cause(s) of Death: intoxication; high fever
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 22.06.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
almost loss my life; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced near death experience (Verbatim: almost loss my life) (serious criteria GSK medically significant and life threatening). The outcome of the near death experience was not reported. It was unknown if the reporter considered the near death experience to be related to Flu vaccine. It was unknown if the company considered the near death experience to be related to Flu vaccine. Additional Information: GSK Receipt Date: 21-JUN-2023 This case was reported the patient via interactive digital media. It was reported that vaccine were so dangerous that patient almost loss his/her life in 2018 from his/her first time ever flu vaccine. Follow-up not possible as no contact details provided.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- -
- Geschlecht
- U
- Eingang
- 26.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Pulmonary embolism
Syncope
Symptomtext
Syncope; Pulmonary embolism; This serious case was reported by a physician via sales rep and described the occurrence of syncope in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced syncope (Verbatim: Syncope) (serious criteria GSK medically significant) and pulmonary embolism (Verbatim: Pulmonary embolism) (serious criteria GSK medically significant). The outcome of the syncope and pulmonary embolism were not reported. It was unknown if the reporter considered the syncope and pulmonary embolism to be related to Shingrix. It was unknown if the company considered the syncope and pulmonary embolism to be related to Shingrix. Additional Information: GSK Receipt Date: 24-MAY-2023 The physician mentioned she had seen a patient who recently received a 2nd dose of Shingrix and the next day the patient experienced syncope and subsequently had a pulmonary embolism. The reporter did not agree to follow up from GlaxoSmithKline.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pulmonary embolism
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 24.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
I was going to die; This serious case was reported by a consumer via market research programs and described the occurrence of near death experience in a elderly female patient who received Flu unspecified (Flu vaccine unspecified) for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis. On an unknown date, the patient received Flu vaccine unspecified and COVID-19 VACCINE. On an unknown date, less than 2 years after receiving Flu vaccine unspecified, the patient experienced near death experience (Verbatim: I was going to die) (serious criteria GSK medically significant and life threatening). The outcome of the near death experience was not reported. It was unknown if the reporter considered the near death experience to be related to Flu vaccine unspecified. It was unknown if the company considered the near death experience to be related to Flu vaccine unspecified. Additional Information: GSK Receipt Date: 18-MAY-2023 The case was reported by a consumer via market research programs. The reporter received flu vaccine and covid vaccine together, after vaccination she experienced terrible and she thought that she was going to die. The reporter reported that she did not receive vaccine last year and she would not ever do it again. The reporter did not consent to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 24.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
I was going to die; This serious case was reported by a consumer via market research programs and described the occurrence of near death experience in a elderly female patient who received Flu unspecified (Flu vaccine unspecified) for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis. On an unknown date, the patient received Flu vaccine unspecified and COVID-19 VACCINE. On an unknown date, less than 2 years after receiving Flu vaccine unspecified, the patient experienced near death experience (Verbatim: I was going to die) (serious criteria GSK medically significant and life threatening). The outcome of the near death experience was not reported. It was unknown if the reporter considered the near death experience to be related to Flu vaccine unspecified. It was unknown if the company considered the near death experience to be related to Flu vaccine unspecified. Additional Information: GSK Receipt Date: 18-MAY-2023 The case was reported by a consumer via market research programs. The reporter received flu vaccine and covid vaccine together, after vaccination she experienced terrible and she thought that she was going to die. The reporter reported that she did not receive vaccine last year and she would not ever do it again. The reporter did not consent to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- M
- Eingang
- 22.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Amphetamines negative
Analgesic drug level therapeutic
Arteriogram coronary abnormal
Barbiturates negative
Benzodiazepine drug level
Bladder catheterisation
Blood bilirubin normal
Blood culture positive
Blood glucose increased
Blood ketone body absent
Blood lactic acid increased
Blood potassium decreased
Blood sodium normal
Blood test abnormal
Blood urine present
Brain injury
Bronchoscopy abnormal
Cardiac arrest
Symptomtext
C. diphtheriae strain infection; unconscious/ state of unresponsiveness; cardiac arrest; lateral wall ischemia; sepsis; leukocytosis; klebsiella pneumoniae; labored breathing; shock; non-structural cardiac disease; anoxic brain injury; status epilepticus; fever; Staphylococcus aureus; Stenotrophomonas maltophilia; weight loss; sinus tachycardia; premature ventricular contraction; C. diphtheriae strain infection; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 18-year-old male patient who received DTPa (Diphtheria tetanus acellular pertussis) for prophylaxis. Co-suspect products included DTPa (Diphtheria tetanus acellular pertussis) for prophylaxis, DTPa (Diphtheria tetanus acellular pertussis) for prophylaxis, DTPa (Diphtheria tetanus acellular pertussis) for prophylaxis and DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. Previously administered products included Hepatitis A and Hepatitis B, human papillomavirus, meningococcal B, pneumococcal, varicella and Influenza. Additional patient notes included patient's family denied history of substance abuse disorders, smoking history, high risk sexual behavior, or recent travel, was not taking any medications and had no known complaints. Family history included heart attack (genetic cardiac abnormality due to a family-reported (but unconfirmed) paternal uncle who passed away suddenly from a heart attack at the age of 40). On an unknown date, the patient received Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis and Tdap Vaccine. On an unknown date, an unknown time after receiving Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis and Tdap Vaccine, the patient experienced vaccination failure (Verbatim: C. diphtheriae strain infection) (serious criteria GSK medically significant), corynebacterium diphtheriae infection (Verbatim: C. diphtheriae strain infection) (serious criteria hospitalization and GSK medically significant), unconscious (Verbatim: unconscious/ state of unresponsiveness) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), cardiac arrest (Verbatim: cardiac arrest) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), ischemia (Verbatim: lateral wall ischemia) (serious criteria hospitalization), sepsis (Verbatim: sepsis) (serious criteria hospitalization and GSK medically significant), leukocytosis (Verbatim: leukocytosis) (serious criteria hospitalization), klebsiella pneumoniae infection (Verbatim: klebsiella pneumoniae) (serious criteria hospitalization), labored breathing (Verbatim: labored breathing) (serious criteria hospitalization and clinically significant/intervention required), shock (Verbatim: shock) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), heart disorder (Verbatim: non-structural cardiac disease) (serious criteria hospitalization), anoxic brain damage (Verbatim: anoxic brain injury) (serious criteria hospitalization and GSK medically significant), status epilepticus (Verbatim: status epilepticus) (serious criteria hospitalization and GSK medically significant), fever (Verbatim: fever) (serious criteria hospitalization), staphylococcus aureus infection (Verbatim: Staphylococcus aureus) (serious criteria hospitalization), stenotrophomonas maltophilia infection (Verbatim: Stenotrophomonas maltophilia) (serious criteria hospitalization and GSK medically significant), weight loss (Verbatim: weight loss) (serious criteria hospitalization), sinus tachycardia (Verbatim: sinus tachycardia) (serious criteria hospitalization) and premature ventricular contractions (Verbatim: premature ventricular contraction) (serious criteria hospitalization). The patient was treated with epinephrine, piperacillin-tazobactam, vancomycin, atropine, naloxone hydrochloride (Narcan), ceftriaxone, amoxicillin + clavulanic acid (Augmentin), cefepime, levetiracetam and sulfamethoxazole + trimethoprim (Trimethoprim-Sulfamethoxazole). The outcome of the vaccination failure was unknown and the outcome of the corynebacterium diphtheriae infection, unconscious, cardiac arrest, ischemia, sepsis, leukocytosis, klebsiella pneumoniae infection, labored breathing, shock, heart disorder, anoxic brain damage, status epilepticus, fever, staphylococcus aureus infection, stenotrophomonas maltophilia infection, weight loss, sinus tachycardia and premature ventricular contractions were resolving. The reporter considered the vaccination failure, corynebacterium diphtheriae infection, unconscious, cardiac arrest, ischemia, sepsis, leukocytosis, heart disorder, anoxic brain damage, status epilepticus, fever, weight loss, sinus tachycardia and premature ventricular contractions to be related to Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis and Tdap Vaccine. It was unknown if the reporter considered the klebsiella pneumoniae infection, labored breathing, shock, staphylococcus aureus infection and stenotrophomonas maltophilia infection to be related to Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis and Tdap Vaccine. The company considered the vaccination failure, corynebacterium diphtheriae infection, unconscious, cardiac arrest, ischemia, sepsis, leukocytosis, heart disorder, anoxic brain damage, status epilepticus, fever, weight loss, sinus tachycardia and premature ventricular contractions to be related to Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis and Tdap Vaccine. It was unknown if the company considered the klebsiella pneumoniae infection, labored breathing, shock, staphylococcus aureus infection and stenotrophomonas maltophilia infection to be related to Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis and Tdap Vaccine. Additional Information: GSK Receipt Date: 8-May-2023 The patient presented to the Emergency Department (ED). The patient was unconscious for approximately 10 minutes during which time the patient did not receive cardiopulmonary resuscitation (CPR). Upon arrival, the patient was found to be in cardiac arrest; the patient was not alert or oriented to person, place, or time, cool to the touch, had no agonal respirations, no radial pulse on palpation, no activity on cardiac monitor, no heartbeat on auscultation, pupils that were equal, and 4 mm dilated but non-reactive. The patient's Glasgow Coma Scale score was 3. A CPR protocol was initiated immediately. Spontaneous circulation was achieved after three rounds of epinephrine administration. The patient was admitted to an isolated room in the Intensive Care Unit (ICU), intubated, and placed on a ventilator with a sedation regimen. A 12- lead EKG was obtained following stabilization of the patient demonstrating ST changes consistent with lateral wall ischemia. Vital signs, laboratory values, including a toxicology screen, and urinalysis were all unremarkable; urine culture had no growth. COVID-19 and Rapid Viral Panel testing, including for influenza were returned as negative. Preliminary treatment for sepsis and leukocytosis included intravenous 3.375 g combination piperacillin-tazobactam q.8.hour. and 1,000 mg vancomycin q.d. Blood samples from two access sites for culture and gram stain were collected. Draws from both sites grew C. diphtheriae (Corynebacterium diphtheriae) (anaerobic bottles) and Klebsiella pneumoniae (both aerobic and anaerobic bottles) as identified with polymerase chain reaction (PCR) analysis. Patient samples were shipped overnight for confirmatory testing. Again, real time PCR amplified C. diphtheriae DNA, but not toxin A or toxin B DNA fragments. The patient's social and vaccination history was ascertained. The patient was reported to have immigrated to this country 3 years prior at the age of 15. The patient attended public high school, which requires by State Public Health law, documentation of the patient's vaccination and medical history by a specific country based primary care physician. The patient's family denied history of substance abuse disorders, smoking history, high risk sexual behavior, or recent travel. The patient was taking no medications and had no known complaints. The patient's primary care pediatrician was contacted who verified this medical and social history and confirmed full and timely vaccination status including for hepatitis A and B, human papillomavirus, meningococcal B, pneumococcal conjugate, varicella and influenza. Documentation was obtained from that source, and per those records the patient received 4 out of 5 recommended DTaP vaccinations- at ages 3 months, 5 months, 8 months, and 2 years in another country. Further, the patient received a TDaP booster in the this country at age 15; therefore, by all accounts our patient had an up-to-date vaccination series. Review of the patient's medical charts revealed one other admission nearly 1 year prior to the current presentation. At that time, the patient also presented in a state of unresponsiveness after the patient was found reportedly "sleeping" in the room by his sibling who described labored breathing. The patient presented to the hospital in a state of shock. The patient received atropine 0.5 mg intravenous (IV) bolus and fluids. The patient was sedated, intubated, and transferred to the ICU. Naloxone (Narcan) 0.4 mg IV was administered empirically, and Psychiatry Services were consulted for possible toxin ingestion. Urine and blood toxicology analysis were unremarkable and urine culture had no growth. COVID-19 PCR testing from nasal swab sample collection was negative. Initial, two-draw blood cultures grew K. pneumoniae after 36 hour in one bottle, and a subsequent second draw 48 hour later had no growth. The patient's antibiotic treatment included four 1 g doses of third-generation cephalosporin (Ceftriaxone) b.i.d. for empiric, broad-spectrum coverage as recommended by the Infectious Disease team which also prescribed a 10-day course with 875/125 mg Amoxicillin/Clavulanate potassium (Augmentin) b.i.d. by mouth outpatient. As the patient could not be directly interviewed during his acute presentations, we cannot be sure whether the patient was experiencing symptoms prior to his presentation. This was in part why the Pediatric Infectious Disease services empirically treated the patient for K. pneumo at the time of the first admission. Further workup included a computerized tomography scan of the cranium, cervical spine, abdomen, thorax; no significant findings were reported. Cardiac electrocardiography (ECG) showed sinus tachycardia and a prolonged QTc interval of 572 ms. Repeat cardiac ECG showed a QTc duration of 579 ms. No medications associated with medication-induced QT syndrome were given during his hospitalization. A limited cardiac echocardiogram study was performed during which coronary arteries were not visualized. The patient was extubated and discharged 4 days following his admission. The patient was scheduled for outpatient follow up with Pediatric Cardiology Services. A stress test performed in that setting was normal with one premature ventricular contraction. Repeat cardiac echocardiogram and CT angiogram of coronary arteries were performed showing non-structural cardiac disease. The patient was referred for genetic testing for further work-up of a suspected genetic cardiac abnormality due to a family-reported (but unconfirmed) paternal uncle who passed away suddenly from a heart attack at the age of 40. The patient did not follow up for this genetic testing, likely due to financial limitations. Progression and resolution of the case Presently, testing confirmed the strain to be non-toxigenic. As per official guidance, the patient was placed on droplet precaution isolation and contact-tracing of household members was conducted. All family members and close contacts were confirmed to be asymptomatic. Nasal swabs of four of the patient's nine immediate household members came back positive for C. diphtheriae, indicating carrier status. In addition to Tdap boosters, Intramuscular Penicillin G for adult, family household and close contacts were chosen for treatment. The patient's antibiotic course of piperacillin-tazobactam was extended, and cefepime 2,000 mg q.d. was added to the regime. Subsequent two-draw blood cultures on days 2 and 5 had no growth. The patient's progress was poor; due to the extended period without protected airway and circulation, the patient suffered irreversible anoxic brain injury. Palliative Care Services were also consulted. Given the patient's prior cardiac history and workup, and current presentation of cardiac arrest with pulseless electrical activity, Electrophysiology (EP) Services was consulted, and the patient was kept on telemetry monitoring as part of his ICU care. That team confirmed the likelihood of a prolonged QTc and recommended continued avoidance of exacerbating medications for which review of concomitant medications was performed. A 2D echocardiogram demonstrated left ejection fraction (LVEF) of 50-55 percent. The patient was not considered a candidate for any EP intervention given his poor functional status and prognosis. On day 2 of admission, the patient deteriorated into status epilepticus and was started on 1,000 mg IV levetiracetam q.12.hour. Overnight on day 2, the patient was noted to have a fever and continued to spike fevers daily (maximum temperature of 39.0 degree Celsius) for a period of 4 days. A suprapubic catheter and feeding tube were placed. On day 9 of the patient's admission, the ventilatory status improved and a tracheostomy was performed, but the patient continued to produce oropharyngeal secretions requiring suctioning every few hours. Two bronchoscopies were performed; cultures of which grew ventilator-associated species- Staphylococcus aureus and Stenotrophomonas maltophilia, for which the patient received 4 doses of 1,000 mg vancomycin q.d. and 12 doses of 160/800 mg trimethoprim-sulfamethoxazole q.12.hour. Over 34 days the patient sustained a 20-pound weight loss, reaching a clinically underweight BMI of 16 despite supplementation with enteral nutrition. The patient's condition ultimately stabilized and was discharged to a long-term care facility 45 days following the admission as per the family's wishes. The author hoped practitioners would consider at which points in the healthcare system efforts could have ameliorated a better outcome and the lingering future threat of disease resulting from infection with non-toxigenic forms of C. diphtheriae in vaccinated populations. The article corresponding to this case is not available for regulatory submission due to copyright restriction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cardiac arrest
- Hospital-Tage
- -
- Labordaten
- Test Name: Amphetamine; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Amphetamine; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Acetaminophen; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Acetaminophen; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Salicylate; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Salicylate; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Barbiturates; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Barbiturates; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Benzodiazepines; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Benzodiazepines; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Bilirubin; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Bilirubin; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: blood cultures; Result Unstructured Data: (Test Result:grew K. pneumoniae,Unit:unknown,Normal Low:,Normal High:) after 36 h in one bottle; Test Name: blood cultures; Result Unstructured Data: (Test Result:No growth of K. pneumoniae,Unit:unknown,Normal Low:,Normal High:) 48 h later; Test Name: blood cultures; Result Unstructured Data: (Test Result:No growth of corynebacterium diphtheriae,Unit:unknown,Normal Low:,Normal High:) on day 2 of current presentation; Test Name: blood cultures; Result Unstructured Data: (Test Result:No growth of corynebacterium diphtheriae,Unit:unknown,Normal Low:,Normal High:) on day 5 of current presentation; Test Name: blood cultures; Result Unstructured Data: (Test Result:Positive-Corynebacterium diphtheriae,Unit:unknown,Normal Low:,Normal High:) current presentation; Test Name: blood cultures; Result Unstructured Data: (Test Result:Positive-Klebsiella,Unit:unknown,Normal Low:,Normal High:) initial presentation; Test Name: blood cultures; Result Unstructured Data: (Test Result:Positive-Klebsiella pneumoniae,Unit:unknown,Normal Low:,Normal High:) current presentation; Test Name: blood cultures; Result Unstructured Data: (Test Result:pneumoniae,Unit:unknown,Normal Low:,Normal High:) initial presentation; Test Name: Glucose; Test Result: 584 mg/dl; Test Name: Glucose; Test Result: 456 mg/dl; Test Name: Ketone; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Ketone; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Lactate; Result Unstructured Data: (Test Result:3.4 mmol/L,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Lactate; Result Unstructured Data: (Test Result:12.8 mmol/L,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: K; Test Result: 4.3 {DF}; Test Name: K; Test Result: 3.2 {DF}; Test Name: Blood Pressure; Result Unstructured Data: (Test Result:89/49 mm Hg,Unit:unknown,Normal Low:,Normal High:); Test Name: Blood Pressure; Result Unstructured Data: (Test Result:92/51 mm Hg,Unit:unknown,Normal Low:,Normal High:); Test Name: Na+; Test Result: 140 {DF}; Test Name: Na+; Test Result: 138 {DF}; Test Name: Urine blood; Result Unstructured Data: (Test Result:Trace,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Urine blood; Result Unstructured Data: (Test Result:Trace,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Body temperature; Result Unstructured Data: (Test Result:max 39 degree C,Unit:unknown,Normal Low:,Normal High:); Test Name: Body temperature; Result Unstructured Data: (Test Result:32.7 degree C,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Body temperature; Result Unstructured Data: (Test Result:36.2 degree C,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Glasgow Coma Scale score; Result Unstructured Data: (Test Result:3,Unit:unknown,Normal Low:,Normal High:); Test Name: CT scan of cervical spine; Result Unstructured Data: (Test Result:no significant findings,Unit:unknown,Normal Low:,Normal High:); Test Name: abdomen CT scan; Result Unstructured Data: (Test Result:no significant findings,Unit:unknown,Normal Low:,Normal High:); Test Name: CT scan of cranium; Result Unstructured Data: (Test Result:no significant findings,Unit:unknown,Normal Low:,Normal High:); Test Name: CT scan thorax; Result Unstructured Data: (Test Result:no significant findings,Unit:unknown,Normal Low:,Normal High:); Test Name: Strain test; Result Unstructured Data: (Test Result:non-toxigenic Corynebacterium diphtheriae strain,Unit:unknown,Normal Low:,Normal High:); Test Name: Cocaine; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Cocaine; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: ejection fraction(left); Result Unstructured Data: (Test Result:50-55,Unit:%,Normal Low:,Normal High:); Test Name: 12 lead EKG; Result Unstructured Data: (Test Result:ST changes consistent with lateral wall ischemia,Unit:unknown,Normal Low:,Normal High:); Test Name: QTc; Result Unstructured Data: (Test Result:likelihood of a prolonged QTc,Unit:unknown,Normal Low:,Normal High:); Test Name: Urine Glucose; Test Result: 1000 mg/dl; Test Name: Urine Glucose; Test Result: 1000 mg/dl; Test Name: Haemoglobin; Test Result: 13.7 mg/dl; Test Name: Haemoglobin; Test Result: 12.4 mg/dl; Test Name: Heart Rate; Result Unstructured Data: (Test Result:37 bpm,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Heart Rate; Result Unstructured Data: (Test Result:54 bpm,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: INR; Result Unstructured Data: (Test Result:1.27,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: INR; Result Unstructured Data: (Test Result:1.33,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Nitrite; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:); Test Name: Nitrite; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:); Test Name: Opiates; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Opiates; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: O2 Saturation; Test Result: 80 %; Test Name: O2 Saturation; Test Result: 95 %; Test Name: Urine pH; Result Unstructured Data: (Test Result:6,Unit:unknown,Normal Low:,Normal High:); Test Name: Urine pH; Result Unstructured Data: (Test Result:6,Unit:unknown,Normal Low:,Normal High:); Test Name: Protein; Test Result: 100 mg/dl; Test Name: Protein; Test Result: 30 mg/dl; Test Name: Respiratory Rate; Result Unstructured Data: (Test Result:10 breaths per min,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Respiratory Rate; Result Unstructured Data: (Test Result:16 breaths per min,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Rapid Viral Panel test including for influenza; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:); Test Name: Covid-19; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Covid-19; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Specific gravity; Result Unstructured Data: (Test Result:1.02,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Specific gravity; Result Unstructured Data: (Test Result:1.01,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Methadone; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Methadone; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Phencyclidine; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Phencyclidine; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: THC; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: THC; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Leukocyte esterase; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Leukocyte esterase; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Urobilinogen; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Urobilinogen; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: WBC; Result Unstructured Data: (Test Result:11.88 billion per litre,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: WBC; Result Unstructured Data: (Test Result:11.80 billion per litre,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Comments: The patient was not alert or oriented to person, place, or time, cool to the touch, had no agonal respirations, no radial pulse on palpation, no activity on cardiac monitor, no heartbeat on auscultation, pupils that were equal, and 4 mm dilated but non-reactive. Blood samples from two access sites for culture and gram stain were collected. Draws from both sites grew C. diphtheriae (anaerobic bottles) and Klebsiella pneumoniae (both aerobic and anaerobic bottles) as identified with (PCR) analysis. Again real time PCR amplified C. diphtheriae DNA, but not toxin A or toxin B DNA. fragments. ECG showed sinus tachycardia and a prolonged QTc interval of 572 ms. Repeat cardiac ECG showed a QTc duration of 579 ms. A limited cardiac echocardiogram study was performed during which coronary arteries were not visualized. A stress test performed in that setting was normal with one premature ventricular contraction. Repeat cardiac echocardiogram and CT angiogram of coronary arteries were performed showing non-structural cardiac disease. Two bronchoscopies were performed; cultures of which grew ventilator-associated species- Staphylococcus aureus and Stenotrophomonas maltophilia. K. pneumoniae was susceptible to Amikacin, Ampicillin/Sulbactam, Aztreonam, Cefazolin, Cefepime, Cefoxitin, Ceftriaxone, Ciprofloxacin, Ertapenem, Gentamicin, Imipenem, Levofloxacin, Meropenem, Piperacillin/Tazobactam, Tobramycin, Trimethoprim/Sulfamethoxazole and resistant to Ampicillin at current and prior presentation. Stenotrophomona maltophilia was susceptible to Ceftazidime, Levofloxacin, Trimethoprim/Sulfamethoxazole at current presentation. Staphylococcus aureus was susceptible to Ampicillin/Sulbactam, Cefazolin, Gentamicin, Oxacillin, Rifampin, Tetra/Doxy, Trimethoprim/Sulfamethoxazole, Vancomycin and resistant to Clindamycin, Erythromycin, Penicillin at current presentation.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Heart attack (paternal uncle); Comments: patient's family denied history of substance abuse disorders, smoking history, high risk sexual behavior, or recent travel, was not taking any medications and had no known complaints
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- M
- Eingang
- 22.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Amphetamines negative
Analgesic drug level therapeutic
Arteriogram coronary abnormal
Barbiturates negative
Benzodiazepine drug level
Bladder catheterisation
Blood bilirubin normal
Blood culture positive
Blood glucose increased
Blood ketone body absent
Blood lactic acid increased
Blood potassium decreased
Blood sodium normal
Blood test abnormal
Blood urine present
Brain injury
Bronchoscopy abnormal
Cardiac arrest
Symptomtext
C. diphtheriae strain infection; unconscious/ state of unresponsiveness; cardiac arrest; lateral wall ischemia; sepsis; leukocytosis; klebsiella pneumoniae; labored breathing; shock; non-structural cardiac disease; anoxic brain injury; status epilepticus; fever; Staphylococcus aureus; Stenotrophomonas maltophilia; weight loss; sinus tachycardia; premature ventricular contraction; C. diphtheriae strain infection; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 18-year-old male patient who received DTPa (Diphtheria tetanus acellular pertussis) for prophylaxis. Co-suspect products included DTPa (Diphtheria tetanus acellular pertussis) for prophylaxis, DTPa (Diphtheria tetanus acellular pertussis) for prophylaxis, DTPa (Diphtheria tetanus acellular pertussis) for prophylaxis and DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. Previously administered products included Hepatitis A and Hepatitis B, human papillomavirus, meningococcal B, pneumococcal, varicella and Influenza. Additional patient notes included patient's family denied history of substance abuse disorders, smoking history, high risk sexual behavior, or recent travel, was not taking any medications and had no known complaints. Family history included heart attack (genetic cardiac abnormality due to a family-reported (but unconfirmed) paternal uncle who passed away suddenly from a heart attack at the age of 40). On an unknown date, the patient received Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis and Tdap Vaccine. On an unknown date, an unknown time after receiving Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis and Tdap Vaccine, the patient experienced vaccination failure (Verbatim: C. diphtheriae strain infection) (serious criteria GSK medically significant), corynebacterium diphtheriae infection (Verbatim: C. diphtheriae strain infection) (serious criteria hospitalization and GSK medically significant), unconscious (Verbatim: unconscious/ state of unresponsiveness) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), cardiac arrest (Verbatim: cardiac arrest) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), ischemia (Verbatim: lateral wall ischemia) (serious criteria hospitalization), sepsis (Verbatim: sepsis) (serious criteria hospitalization and GSK medically significant), leukocytosis (Verbatim: leukocytosis) (serious criteria hospitalization), klebsiella pneumoniae infection (Verbatim: klebsiella pneumoniae) (serious criteria hospitalization), labored breathing (Verbatim: labored breathing) (serious criteria hospitalization and clinically significant/intervention required), shock (Verbatim: shock) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), heart disorder (Verbatim: non-structural cardiac disease) (serious criteria hospitalization), anoxic brain damage (Verbatim: anoxic brain injury) (serious criteria hospitalization and GSK medically significant), status epilepticus (Verbatim: status epilepticus) (serious criteria hospitalization and GSK medically significant), fever (Verbatim: fever) (serious criteria hospitalization), staphylococcus aureus infection (Verbatim: Staphylococcus aureus) (serious criteria hospitalization), stenotrophomonas maltophilia infection (Verbatim: Stenotrophomonas maltophilia) (serious criteria hospitalization and GSK medically significant), weight loss (Verbatim: weight loss) (serious criteria hospitalization), sinus tachycardia (Verbatim: sinus tachycardia) (serious criteria hospitalization) and premature ventricular contractions (Verbatim: premature ventricular contraction) (serious criteria hospitalization). The patient was treated with epinephrine, piperacillin-tazobactam, vancomycin, atropine, naloxone hydrochloride (Narcan), ceftriaxone, amoxicillin + clavulanic acid (Augmentin), cefepime, levetiracetam and sulfamethoxazole + trimethoprim (Trimethoprim-Sulfamethoxazole). The outcome of the vaccination failure was unknown and the outcome of the corynebacterium diphtheriae infection, unconscious, cardiac arrest, ischemia, sepsis, leukocytosis, klebsiella pneumoniae infection, labored breathing, shock, heart disorder, anoxic brain damage, status epilepticus, fever, staphylococcus aureus infection, stenotrophomonas maltophilia infection, weight loss, sinus tachycardia and premature ventricular contractions were resolving. The reporter considered the vaccination failure, corynebacterium diphtheriae infection, unconscious, cardiac arrest, ischemia, sepsis, leukocytosis, heart disorder, anoxic brain damage, status epilepticus, fever, weight loss, sinus tachycardia and premature ventricular contractions to be related to Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis and Tdap Vaccine. It was unknown if the reporter considered the klebsiella pneumoniae infection, labored breathing, shock, staphylococcus aureus infection and stenotrophomonas maltophilia infection to be related to Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis and Tdap Vaccine. The company considered the vaccination failure, corynebacterium diphtheriae infection, unconscious, cardiac arrest, ischemia, sepsis, leukocytosis, heart disorder, anoxic brain damage, status epilepticus, fever, weight loss, sinus tachycardia and premature ventricular contractions to be related to Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis and Tdap Vaccine. It was unknown if the company considered the klebsiella pneumoniae infection, labored breathing, shock, staphylococcus aureus infection and stenotrophomonas maltophilia infection to be related to Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis, Diphtheria tetanus acellular pertussis and Tdap Vaccine. Additional Information: GSK Receipt Date: 8-May-2023 The patient presented to the Emergency Department (ED). The patient was unconscious for approximately 10 minutes during which time the patient did not receive cardiopulmonary resuscitation (CPR). Upon arrival, the patient was found to be in cardiac arrest; the patient was not alert or oriented to person, place, or time, cool to the touch, had no agonal respirations, no radial pulse on palpation, no activity on cardiac monitor, no heartbeat on auscultation, pupils that were equal, and 4 mm dilated but non-reactive. The patient's Glasgow Coma Scale score was 3. A CPR protocol was initiated immediately. Spontaneous circulation was achieved after three rounds of epinephrine administration. The patient was admitted to an isolated room in the Intensive Care Unit (ICU), intubated, and placed on a ventilator with a sedation regimen. A 12- lead EKG was obtained following stabilization of the patient demonstrating ST changes consistent with lateral wall ischemia. Vital signs, laboratory values, including a toxicology screen, and urinalysis were all unremarkable; urine culture had no growth. COVID-19 and Rapid Viral Panel testing, including for influenza were returned as negative. Preliminary treatment for sepsis and leukocytosis included intravenous 3.375 g combination piperacillin-tazobactam q.8.hour. and 1,000 mg vancomycin q.d. Blood samples from two access sites for culture and gram stain were collected. Draws from both sites grew C. diphtheriae (Corynebacterium diphtheriae) (anaerobic bottles) and Klebsiella pneumoniae (both aerobic and anaerobic bottles) as identified with polymerase chain reaction (PCR) analysis. Patient samples were shipped overnight for confirmatory testing. Again, real time PCR amplified C. diphtheriae DNA, but not toxin A or toxin B DNA fragments. The patient's social and vaccination history was ascertained. The patient was reported to have immigrated to this country 3 years prior at the age of 15. The patient attended public high school, which requires by State Public Health law, documentation of the patient's vaccination and medical history by a specific country based primary care physician. The patient's family denied history of substance abuse disorders, smoking history, high risk sexual behavior, or recent travel. The patient was taking no medications and had no known complaints. The patient's primary care pediatrician was contacted who verified this medical and social history and confirmed full and timely vaccination status including for hepatitis A and B, human papillomavirus, meningococcal B, pneumococcal conjugate, varicella and influenza. Documentation was obtained from that source, and per those records the patient received 4 out of 5 recommended DTaP vaccinations- at ages 3 months, 5 months, 8 months, and 2 years in another country. Further, the patient received a TDaP booster in the this country at age 15; therefore, by all accounts our patient had an up-to-date vaccination series. Review of the patient's medical charts revealed one other admission nearly 1 year prior to the current presentation. At that time, the patient also presented in a state of unresponsiveness after the patient was found reportedly "sleeping" in the room by his sibling who described labored breathing. The patient presented to the hospital in a state of shock. The patient received atropine 0.5 mg intravenous (IV) bolus and fluids. The patient was sedated, intubated, and transferred to the ICU. Naloxone (Narcan) 0.4 mg IV was administered empirically, and Psychiatry Services were consulted for possible toxin ingestion. Urine and blood toxicology analysis were unremarkable and urine culture had no growth. COVID-19 PCR testing from nasal swab sample collection was negative. Initial, two-draw blood cultures grew K. pneumoniae after 36 hour in one bottle, and a subsequent second draw 48 hour later had no growth. The patient's antibiotic treatment included four 1 g doses of third-generation cephalosporin (Ceftriaxone) b.i.d. for empiric, broad-spectrum coverage as recommended by the Infectious Disease team which also prescribed a 10-day course with 875/125 mg Amoxicillin/Clavulanate potassium (Augmentin) b.i.d. by mouth outpatient. As the patient could not be directly interviewed during his acute presentations, we cannot be sure whether the patient was experiencing symptoms prior to his presentation. This was in part why the Pediatric Infectious Disease services empirically treated the patient for K. pneumo at the time of the first admission. Further workup included a computerized tomography scan of the cranium, cervical spine, abdomen, thorax; no significant findings were reported. Cardiac electrocardiography (ECG) showed sinus tachycardia and a prolonged QTc interval of 572 ms. Repeat cardiac ECG showed a QTc duration of 579 ms. No medications associated with medication-induced QT syndrome were given during his hospitalization. A limited cardiac echocardiogram study was performed during which coronary arteries were not visualized. The patient was extubated and discharged 4 days following his admission. The patient was scheduled for outpatient follow up with Pediatric Cardiology Services. A stress test performed in that setting was normal with one premature ventricular contraction. Repeat cardiac echocardiogram and CT angiogram of coronary arteries were performed showing non-structural cardiac disease. The patient was referred for genetic testing for further work-up of a suspected genetic cardiac abnormality due to a family-reported (but unconfirmed) paternal uncle who passed away suddenly from a heart attack at the age of 40. The patient did not follow up for this genetic testing, likely due to financial limitations. Progression and resolution of the case Presently, testing confirmed the strain to be non-toxigenic. As per official guidance, the patient was placed on droplet precaution isolation and contact-tracing of household members was conducted. All family members and close contacts were confirmed to be asymptomatic. Nasal swabs of four of the patient's nine immediate household members came back positive for C. diphtheriae, indicating carrier status. In addition to Tdap boosters, Intramuscular Penicillin G for adult, family household and close contacts were chosen for treatment. The patient's antibiotic course of piperacillin-tazobactam was extended, and cefepime 2,000 mg q.d. was added to the regime. Subsequent two-draw blood cultures on days 2 and 5 had no growth. The patient's progress was poor; due to the extended period without protected airway and circulation, the patient suffered irreversible anoxic brain injury. Palliative Care Services were also consulted. Given the patient's prior cardiac history and workup, and current presentation of cardiac arrest with pulseless electrical activity, Electrophysiology (EP) Services was consulted, and the patient was kept on telemetry monitoring as part of his ICU care. That team confirmed the likelihood of a prolonged QTc and recommended continued avoidance of exacerbating medications for which review of concomitant medications was performed. A 2D echocardiogram demonstrated left ejection fraction (LVEF) of 50-55 percent. The patient was not considered a candidate for any EP intervention given his poor functional status and prognosis. On day 2 of admission, the patient deteriorated into status epilepticus and was started on 1,000 mg IV levetiracetam q.12.hour. Overnight on day 2, the patient was noted to have a fever and continued to spike fevers daily (maximum temperature of 39.0 degree Celsius) for a period of 4 days. A suprapubic catheter and feeding tube were placed. On day 9 of the patient's admission, the ventilatory status improved and a tracheostomy was performed, but the patient continued to produce oropharyngeal secretions requiring suctioning every few hours. Two bronchoscopies were performed; cultures of which grew ventilator-associated species- Staphylococcus aureus and Stenotrophomonas maltophilia, for which the patient received 4 doses of 1,000 mg vancomycin q.d. and 12 doses of 160/800 mg trimethoprim-sulfamethoxazole q.12.hour. Over 34 days the patient sustained a 20-pound weight loss, reaching a clinically underweight BMI of 16 despite supplementation with enteral nutrition. The patient's condition ultimately stabilized and was discharged to a long-term care facility 45 days following the admission as per the family's wishes. The author hoped practitioners would consider at which points in the healthcare system efforts could have ameliorated a better outcome and the lingering future threat of disease resulting from infection with non-toxigenic forms of C. diphtheriae in vaccinated populations. The article corresponding to this case is not available for regulatory submission due to copyright restriction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cardiac arrest
- Hospital-Tage
- -
- Labordaten
- Test Name: Amphetamine; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Amphetamine; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Acetaminophen; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Acetaminophen; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Salicylate; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Salicylate; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Barbiturates; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Barbiturates; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Benzodiazepines; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Benzodiazepines; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Bilirubin; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Bilirubin; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: blood cultures; Result Unstructured Data: (Test Result:grew K. pneumoniae,Unit:unknown,Normal Low:,Normal High:) after 36 h in one bottle; Test Name: blood cultures; Result Unstructured Data: (Test Result:No growth of K. pneumoniae,Unit:unknown,Normal Low:,Normal High:) 48 h later; Test Name: blood cultures; Result Unstructured Data: (Test Result:No growth of corynebacterium diphtheriae,Unit:unknown,Normal Low:,Normal High:) on day 2 of current presentation; Test Name: blood cultures; Result Unstructured Data: (Test Result:No growth of corynebacterium diphtheriae,Unit:unknown,Normal Low:,Normal High:) on day 5 of current presentation; Test Name: blood cultures; Result Unstructured Data: (Test Result:Positive-Corynebacterium diphtheriae,Unit:unknown,Normal Low:,Normal High:) current presentation; Test Name: blood cultures; Result Unstructured Data: (Test Result:Positive-Klebsiella,Unit:unknown,Normal Low:,Normal High:) initial presentation; Test Name: blood cultures; Result Unstructured Data: (Test Result:Positive-Klebsiella pneumoniae,Unit:unknown,Normal Low:,Normal High:) current presentation; Test Name: blood cultures; Result Unstructured Data: (Test Result:pneumoniae,Unit:unknown,Normal Low:,Normal High:) initial presentation; Test Name: Glucose; Test Result: 584 mg/dl; Test Name: Glucose; Test Result: 456 mg/dl; Test Name: Ketone; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Ketone; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Lactate; Result Unstructured Data: (Test Result:3.4 mmol/L,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Lactate; Result Unstructured Data: (Test Result:12.8 mmol/L,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: K; Test Result: 4.3 {DF}; Test Name: K; Test Result: 3.2 {DF}; Test Name: Blood Pressure; Result Unstructured Data: (Test Result:89/49 mm Hg,Unit:unknown,Normal Low:,Normal High:); Test Name: Blood Pressure; Result Unstructured Data: (Test Result:92/51 mm Hg,Unit:unknown,Normal Low:,Normal High:); Test Name: Na+; Test Result: 140 {DF}; Test Name: Na+; Test Result: 138 {DF}; Test Name: Urine blood; Result Unstructured Data: (Test Result:Trace,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Urine blood; Result Unstructured Data: (Test Result:Trace,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Body temperature; Result Unstructured Data: (Test Result:max 39 degree C,Unit:unknown,Normal Low:,Normal High:); Test Name: Body temperature; Result Unstructured Data: (Test Result:32.7 degree C,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Body temperature; Result Unstructured Data: (Test Result:36.2 degree C,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Glasgow Coma Scale score; Result Unstructured Data: (Test Result:3,Unit:unknown,Normal Low:,Normal High:); Test Name: CT scan of cervical spine; Result Unstructured Data: (Test Result:no significant findings,Unit:unknown,Normal Low:,Normal High:); Test Name: abdomen CT scan; Result Unstructured Data: (Test Result:no significant findings,Unit:unknown,Normal Low:,Normal High:); Test Name: CT scan of cranium; Result Unstructured Data: (Test Result:no significant findings,Unit:unknown,Normal Low:,Normal High:); Test Name: CT scan thorax; Result Unstructured Data: (Test Result:no significant findings,Unit:unknown,Normal Low:,Normal High:); Test Name: Strain test; Result Unstructured Data: (Test Result:non-toxigenic Corynebacterium diphtheriae strain,Unit:unknown,Normal Low:,Normal High:); Test Name: Cocaine; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Cocaine; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: ejection fraction(left); Result Unstructured Data: (Test Result:50-55,Unit:%,Normal Low:,Normal High:); Test Name: 12 lead EKG; Result Unstructured Data: (Test Result:ST changes consistent with lateral wall ischemia,Unit:unknown,Normal Low:,Normal High:); Test Name: QTc; Result Unstructured Data: (Test Result:likelihood of a prolonged QTc,Unit:unknown,Normal Low:,Normal High:); Test Name: Urine Glucose; Test Result: 1000 mg/dl; Test Name: Urine Glucose; Test Result: 1000 mg/dl; Test Name: Haemoglobin; Test Result: 13.7 mg/dl; Test Name: Haemoglobin; Test Result: 12.4 mg/dl; Test Name: Heart Rate; Result Unstructured Data: (Test Result:37 bpm,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Heart Rate; Result Unstructured Data: (Test Result:54 bpm,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: INR; Result Unstructured Data: (Test Result:1.27,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: INR; Result Unstructured Data: (Test Result:1.33,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Nitrite; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:); Test Name: Nitrite; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:); Test Name: Opiates; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Opiates; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: O2 Saturation; Test Result: 80 %; Test Name: O2 Saturation; Test Result: 95 %; Test Name: Urine pH; Result Unstructured Data: (Test Result:6,Unit:unknown,Normal Low:,Normal High:); Test Name: Urine pH; Result Unstructured Data: (Test Result:6,Unit:unknown,Normal Low:,Normal High:); Test Name: Protein; Test Result: 100 mg/dl; Test Name: Protein; Test Result: 30 mg/dl; Test Name: Respiratory Rate; Result Unstructured Data: (Test Result:10 breaths per min,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Respiratory Rate; Result Unstructured Data: (Test Result:16 breaths per min,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Rapid Viral Panel test including for influenza; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:); Test Name: Covid-19; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Covid-19; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Specific gravity; Result Unstructured Data: (Test Result:1.02,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Specific gravity; Result Unstructured Data: (Test Result:1.01,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Methadone; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Methadone; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Phencyclidine; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Phencyclidine; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: THC; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: THC; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Leukocyte esterase; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Leukocyte esterase; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: Urobilinogen; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: Urobilinogen; Result Unstructured Data: (Test Result:Negative result,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Test Name: WBC; Result Unstructured Data: (Test Result:11.88 billion per litre,Unit:unknown,Normal Low:,Normal High:) Current presentation; Test Name: WBC; Result Unstructured Data: (Test Result:11.80 billion per litre,Unit:unknown,Normal Low:,Normal High:) Prior presentation; Comments: The patient was not alert or oriented to person, place, or time, cool to the touch, had no agonal respirations, no radial pulse on palpation, no activity on cardiac monitor, no heartbeat on auscultation, pupils that were equal, and 4 mm dilated but non-reactive. Blood samples from two access sites for culture and gram stain were collected. Draws from both sites grew C. diphtheriae (anaerobic bottles) and Klebsiella pneumoniae (both aerobic and anaerobic bottles) as identified with (PCR) analysis. Again real time PCR amplified C. diphtheriae DNA, but not toxin A or toxin B DNA. fragments. ECG showed sinus tachycardia and a prolonged QTc interval of 572 ms. Repeat cardiac ECG showed a QTc duration of 579 ms. A limited cardiac echocardiogram study was performed during which coronary arteries were not visualized. A stress test performed in that setting was normal with one premature ventricular contraction. Repeat cardiac echocardiogram and CT angiogram of coronary arteries were performed showing non-structural cardiac disease. Two bronchoscopies were performed; cultures of which grew ventilator-associated species- Staphylococcus aureus and Stenotrophomonas maltophilia. K. pneumoniae was susceptible to Amikacin, Ampicillin/Sulbactam, Aztreonam, Cefazolin, Cefepime, Cefoxitin, Ceftriaxone, Ciprofloxacin, Ertapenem, Gentamicin, Imipenem, Levofloxacin, Meropenem, Piperacillin/Tazobactam, Tobramycin, Trimethoprim/Sulfamethoxazole and resistant to Ampicillin at current and prior presentation. Stenotrophomona maltophilia was susceptible to Ceftazidime, Levofloxacin, Trimethoprim/Sulfamethoxazole at current presentation. Staphylococcus aureus was susceptible to Ampicillin/Sulbactam, Cefazolin, Gentamicin, Oxacillin, Rifampin, Tetra/Doxy, Trimethoprim/Sulfamethoxazole, Vancomycin and resistant to Clindamycin, Erythromycin, Penicillin at current presentation.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Heart attack (paternal uncle); Comments: patient's family denied history of substance abuse disorders, smoking history, high risk sexual behavior, or recent travel, was not taking any medications and had no known complaints
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 15.05.2023
- Impfdatum
- 25.08.2020
- Beginn
- 07.01.2021
- Tage bis Beginn
- 135,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Autonomic nervous system imbalance
Autopsy
Barium swallow abnormal
Biopsy
Biopsy artery normal
Biopsy skin normal
Blood immunoglobulin A decreased
Blood immunoglobulin G decreased
Blood immunoglobulin G increased
Blood immunoglobulin M increased
CSF test abnormal
Computerised tomogram head normal
Condition aggravated
Death
Decreased appetite
Dysarthria
Dysphagia
Ear pain
Symptomtext
Rabies breakthrough infection; Rabies virus infection; right sided facial pain; Nausea; Difficulty swallowing; bilateral shoulder discomfort; Numbness of right arm and shoulder; Ear pain; Decreased apetite; Slurred speech; Night sweats; The first dose of RabAvert administered three days after exposure, the second six, the third ten and the fourth 17 days after exposure; Follow-up information received on 30-APR-2023 Case received from Bavarian Nordic Case reference number US-BN-2021-000045 is a spontaneous case report initially received from a Centers for Disease Control and Prevention (CDC) physician via Bavarian Nordic on 02-Feb-2021 and concerns an 84-year-old male patient. The patient's medical history included s/p ICD (internal cardiac defibrillator) procedure, s/p coronary artery bypass graft (CABG) x 3, hypertension associated with diabetes, hyperlipidemia associated with type 2 diabetes mellitus, benign prostatic hyperplasia with lower urinary tract symptoms, unspecified morphology, coronary artery disease due to lipid rich plaque, controlled type 2 diabetes mellitus with stage 2 chronic kidney disease, without long-term current use of insulin, chronic kidney disease (CKD) stage 2, (grade 2/3) GFR 60-89 ml/min, rhinitis, nonallergic, chronic, Hypergammaglobulinaemia benign monoclonal (MGUS) and metastatic prostate adenocarcinoma. Family history included unspecified cardiovascular disease (father and sister), unspecified cancer (brother), colon cancer (sister), No family history of bleeding disorder/clotting disorder or anesthesia problems and no family history of any neurological disease, had heart attacks in both his mother and father. The patient's concomitant medication details included metoprolol tartrate, Aspirin (acetylsalicylic acid), Glucosamine-Chondroit-Biofl-Mn (glucosamine sulfate/ chondroitin sulfate), sotalol, losartan, Lipitor (atorvastatin) and metformin. On 27-Jul-2020, the patient was bitten on right hand by a bat that was confirmed to be infected with rabies virus by the Direct Fluorescent Antibody test. Unknown if any wound care performed or other medications/vaccines given. Though there was no visible wound, the patient washed hands with soap and water after the exposure. The patient was previously unvaccinated against rabies. On 30-Jul-2020, the bat was captured, tested, and came back positive for rabies. The bat was subsequently identified as a silver-haired bat (Lasionycteris noctivagans) by 12S rRNA gene sequencing, as reported. Four days after exposure, the patient received the first dose of RabAvert (batch number: ARBA651B) intramuscularly at dose of 2.5 units in right deltoid for a bat bite from a known rabid bat (explicitly coded as 'inappropriate schedule of vaccine administered'). On the same day, the patient received human rabies immune globulin (HRIG) Hyperrab S/D, (Immunoglobulin human anti-rabies, Lot no: R2MFD00163, expiry date: 15-Jun-2021) intramuscularly 1700 units in right hand around bite site and remaining in right thigh, then 1500 units (5ml of (300 unit/ml) Lot number: R2MFD00163 (Exp. 15Jun2021)) and 200 units (0.667 ml of (300 units/ml) Lot number: R2MBD00113 (Exp. 11May2021)), also reported as (total dose of 20 IU/kg with as much as possible infiltrated at the bite site and the remaining administered into right thigh. On 02-Aug-2020, three days after the first dose, the patient received the second dose of RabAvert (batch number: ARBA651B) at dose of 2.5 units in left deltoid for a bat bite from a known rabid bat (explicitly coded as inappropriate schedule of vaccine administered). On 06-Aug-2020, seven days after the first dose, the patient received the third dose of RabAvert (batch number: ARBA651B) at dose of 2.5 units in right deltoid for a bat bite from a known rabid bat (explicitly coded as inappropriate schedule of vaccine administered). On 13-Aug-2020, 14 days after the first dose, the patient received the fourth dose of RabAvert (batch number: ARBA651A) at dose of 2.5 units in right deltoid for a bat bite from a known rabid bat (explicitly coded as inappropriate schedule of vaccine administered). On 25-Aug-2020, the patient was vaccinated with a dose of quadrivalent influenza vaccine (brand name: unknown; batch number: not provided), at a dose reported as high dose, via unknown route or site of administration and for unknown indication. Since the patient was not known to have an immunocompromising condition at the time of vaccination, in accordance with guidance, the patient did not receive a 5th vaccine dose and was not advised to undergo antibody titer evaluation. On 07-Jan-2021, approximately five months after bat bite, the patient developed symptoms of rabies that progressed over the course of 17 days, until the patient passed away. Signs and symptoms included fever, right sided facial paralysis/paresthesia/paroxysms with excessive right eye lacrimation, headache, malaise, muscle spasms, autonomic instability, right arm pain/paresthesia, right sided facial pain, bilateral shoulder discomfort, numbness of right arm and shoulders, ear pain, decreased appetite, slurred speech and night sweats. On 09-Jan-2021, the patient presented to emergency department (ED) with elevated erythrocyte sedimentation rate 110 mm/hr and was initially treated for suspect temporal arteritis. The patient was discharged with oxycodone, carbamazepine, and corticosteroids methylprednisolone 250mg intravenously (IV) and prednisone 60mg daily. Computed tomography (CT) of the head was normal. The patient's symptoms persisted. On 11-Jan-2023, the patient was evaluated at the clinic for surgical clearance and during a video appointment on 12-Jan-2021 for preoperative evaluation for a temporal artery biopsy. On 13-Jan-2021, the patient returned to the ED with facial paresthesia, dysphagia, bilateral shoulder and arm myalgias, right arm paresthesia, nausea and vomiting. The patient was discharged with ondansetron for nausea attributed to oxycodone. On 14-Jan-2021, the patient returned to ED again and was hospitalized due to worsening facial pain and paresthesia, generalized sweats, right eye redness and discomfort, facial paralysis on right side, and left ear pain. Laboratory findings included increased gamma monoclonal protein (m-spike 1.86 g/dL), Myeloma/MGUS screen showed low decreased IgA 52 mg/dL (85-370), decreased IgG 485 mg/dL (661-1464), elevated IgM 2699 mg/dL (40-275), no detectable anti-rabies virus IgM by IFA, no detectable rabies virus neutralizing antibody titers by RFFIT and negative for MYD88 L265P alteration. Computed tomography of the head was unremarkable and temporal artery biopsy showed no arteritis. The clinical team considered rabies due to the clinical presentation and confirmed exposure, but as is customary prior to pursuing rabies diagnostic testing and because the patient was given timely and appropriate PEP, first explored other infectious, autoimmune, and paraneoplastic diagnoses. As reported, whole genome sequencing (WGS) of rabies virus (RABV) obtained from the patient and the bat were identical. Serum collected was seropositive to three of the four vaccine antigens by hemagglutination inhibition assay (SS 7), three were elevated levels of Pan Ig and total IgG to multiple influenza antigens and human coronavirus OC-43 spike protein, but negative to spikes and nucleoproteins of SARS-CoV-2 viruses. As reported, the serum contained moderate levels of IgM to several influenza antigens but was negative for IgA to all antigens tested. On 15-Jan-2021, the patient had presence of rabies IgG antibodies in CSF and serum but they were non neutralizing. Cerebrospinal fluid (CSF) analysis revealed ten nucleated cells with lymphocytic predominance, consistent with viral encephalitis. The patient was intubated due to hypoxia and inability to protect his airway. The patient received 30g of intravenous immune globulin (IVIG). On 16-Jan-2023, the patient developed fever which continued until his death, with a maximum recorded temperature 103.1 degrees Fahrenheit (39.5 degrees Celsius). Signs of autonomic dysfunction included labile blood pressures requiring norepinephrine. Serum protein electrophoresis revealed immunoglobulin (Ig) M monoclonal gammopathy of undetermined significance (MGUS) with an elevated gamma monoclonal protein and elevated IgM in the presence of reduced IgA and IgG. Testing for MYD88 L265P alteration, a mutation highly associated with IgM-producing lymphoplasmacytic lymphoma and IgM MGUS, was negative. Other diagnostic tests were non-contributory and the patient did not improve with empiric treatment. Pre-mortem specimens were submitted for rabies testing at the Centers for Disease Control and Prevention (CDC). Plasmapheresis was initiated. On 18-Jan-2021, plasmapheresis was initiated again. On 20-Jan-2021, the patient had presence of rabies IgG antibodies in CSF but it was non-neutralizing. Plasmapheresis was initiated again. On 21-Jan-2021, premortem specimens were submitted for rabies testing. On 22-Jan-2021, 15 days after onset of symptoms, the patient was transitioned to comfort care and supportive care was withdrawn. The patient passed away due to laboratory-confirmed rabies infection. On 26-Jan-2021, CDC confirmed RABV infection. Detection of viral RNA by real-time reverse transcription polymerase chain reaction (RT-PCR) in saliva and detection of anti-rabies antibodies in CSF confirmed the laboratory criteria for rabies diagnosis. Although RABV IgG was detected in the CSF and serum by indirect fluorescence antibody (IFA) test, no RABV neutralizing antibodies were detected in CSF or serum by rapid fluorescent focus inhibition test (RFFIT) indicating absence of immune response to rabies vaccine administered during PEP suggesting immunocompromise. No RABV RNA was detected in nuchal skin biopsy by RT-PCR. The clinicians did not consider the patient immunocompromised when PEP was administered. Laboratory results at the time of hospitalization indicate the patient might have had an undiagnosed underlying immunocompromising condition, however, during life the patient was not known to have an underlying immunocompromising condition. A public health investigation was initiated to understand the reason for rabies breakthrough infection and identify family members and health care professionals (HCP) potentially exposed to rabies virus from the patient. Autopsy report indicates some level of host-related immune dysfunction, which presumably was why this patient developed rabies despite receiving timely post-exposure prophylaxis. Although the patient was elderly, had several chronic conditions at the time of vaccination, and later was found to have MGUS (during hospitalization) and metastatic prostate adenocarcinoma (diagnosed during autopsy). Autopsy demonstrated prostate adenocarcinoma metastatic to bone marrow (Gleason pattern 5+5=10, grade group 5) but without complete obliteration of bone marrow. Regarding bone marrow, lymph nodes and spleen, there was no morphologic or immunophenotypic evidence of lymphoma or plasma cell neoplasm. Brain tissue histopathology revealed meningoencephalitis and immunohistochemistry for RABV showed extensive viral antigen labelling. The reporter provided that they would not necessarily expect this type of immune dysfunction from those conditions. Given no identified issues with rabies biologics and a history of multiple comorbidities including MGUS, immune dysfunction (of unknown etiology) in the patient is the most parsimonious explanation for rabies post-exposure prophylaxis failure in this patient. Other potential causes of PEP failures were ruled out. The reporter assessed the event of 'rabies breakthrough infection' as serious due to fatal outcome and did not provide causality assessment. Additionally, the event of 'rabies breakthrough infection' was assessed as serious due to criteria of hospitalization and medical significance. A memorandum was conducted. The scope and purpose of the memorandum was to present the available stability data for the in-vivo potency assay performed on Rabies Vaccine (Rabipur? & RabAvert?) in order to confirm the product quality and efficacy throughout the entire product shelf life of 48 months that was claimed by the manufacturing authorization holder (GSK Vaccines). The evaluation performed on the extensive database within this memorandum confirmed that there had been no detectable change, as well as no product related out of specification (OOS) result (one OOS was reported after 48 months of shelf life for batch 619011, which was investigated and the result was confirmed to being caused solely by a weakness in the applied analytical method associated to the application of both the vaccine and the challenge virus) in the measured product potency during the entire product shelf life of Rabies Vaccine (Rabipur? & RabAvert?). It was also noted that Rabipur? represented the commercial name for rabies vaccine distributed outside market. This memorandum was based on stability data for the estimated potency (n=169) obtained from the long term storage condition (+2?C to +8 ?C) from 42 independent batches of Rabies Vaccine (Rabipur? & RabAvert?) manufactured since calendar year 2013 using Antigen Concentrate batches manufactured at facility from GSK Vaccines. The obtained analytical results discussed on this memorandum represented the weighted geometric mean value for the estimated potency from at least two independent analytical tests using the in-vivo challenge assay in mice. The assessment of the available stability data for the estimated potency for Rabies Vaccine (Rabipur? & RabAvert?) by the in-vivo challenge assay in mice confirmed the capability of Rabies Vaccine (Rabipur? & RabAvert?) to induce protection against an infection with rabies virus in alignment with the registered specifications (weighted geometric mean estimated potency of not less than 2.5 IU/Ds) without any detectable change during the product shelf life of 48 months at the registered long-term storage condition of +2 ?C to +8 ?C. Therefore, the consistency and stability of the potency of Rabies Vaccine (Rabipur? & RabAvert?) during the registered shelf life was supported by an extensive data base. The vaccination of the patient under investigation in the reported adverse event was performed using GSK Vaccines RabAvert? batches ARBA651A and ARBA651B of 16 to 17 months age at time of administration (Shelf Life Start Date: 19 April 2019; dates of vaccination: 30 July 2020, 02. August 2020, 06 August 2020 and 13 August 2020). The evaluated stability characteristics for Rabies Vaccine (Rabipur? & RabAvert?) did not indicate any product-associated cause for the reported adverse event. A public health investigation was initiated to understand the reason for rabies breakthrough infection and identify family members and health care professionals (HCP) potentially exposed to rabies virus from the patient. Eight family members were assessed for rabies exposure during the patient's infectious period and only the patient's wife was exposed. A total of 324 HCP had contact with the patient during his infectious period. Of these, 174 (54 percent) completed the online risk assessment within 72 hours of it being operational, 312 (96 percent) within 7 days, and all within 14 days. Two (0.6 percent) HCP received PEP due to lack of eye protection during aerosol-generating procedures with the patient. Additional information was received from Bavarian Nordic on 03-Feb-2021 included confirmation that the country of occurrence. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks. Follow up information was received from Bavarian Nordic on 08-Feb-2021: Information included patient's age. Additional information received from Bavarian Nordic on 08-Feb-2021 included updated batch numbers. Additional information received from Bavarian Nordic on 09-Feb-2021 included updated medical history, concomitant medication details, information about autopsy, date of death, confirmation of country of origin, clinical course of events, details of administered RIG (rabies immunoglobulin), bite details and reason for delay vaccination. Additional information received from Bavarian Nordic on 09-Feb-2021 included information about family medical history. Additional information received from Bavarian Nordic on 11-Feb-2021 included information about batch number (administered to patient's wife). As per call with reporter dated 12-Feb-2021, further tests will be conducted and provided upon consolidation as per reporter information disclosed. Additional information received from Bavarian Nordic on 22-Feb-2021 included brand name of the suspect product and updated narrative. Follow up information was received from VAERS (ID: 1498553-1) on 09-Aug-2021: New information included medical history, concomitant medication, laboratory data, symptoms, autopsy results, additional dates for date of death and date of bite. All informations are blended in the narrative above. Follow up information was received from the Manufacturer on 08-Nov-2021: New information included overall conclusion that there was no product-associated cause for the reported adverse event. Follow-up information received from literature article with literature citation: New information included additional reporters, confirmation that the patient was previously unvaccinated against rabies, additional details of HRIG, bat specimen details, exposure date confirmation, additional symptom details including onset date confirmation, emergency department visit with provided treatment, hospitalization, additional investigation, confirmation of date of death, epidemiologic investigation, exposure assessments and local case ID. Event term 'rabies' was updated to 'rabies breakthrough infection' and coded as 'rabies' and 'breakthrough infection'. Non-event of inappropriate schedule of vaccine administered for reported 'the first dose of RabAvert administered three days after exposure, the second six, the third ten and the fourth 17 days after exposure' was added. Case Comment: In this case report, the 84-year-old male patient had a fatal outcome due to the serious events of Rabies and breakthrough infection (seriousness criteria: fatal outcome, hospitalization and medical significance) after a confirmed rabid bat bite. On 27-Jul-2020, the patient was bitten on right hand by a bat that was confirmed to be infected with rabies virus by the Direct Fluorescent Antibody test. Unknown if any wound care performed or other medications/vaccines given. Though there was no visible wound, the patient washed hands with soap and water after the exposure. The patient was previously unvaccinated against rabies. Four days after exposure, the patient received the first dose of RabAvert, intramuscularly at dose of 2.5 units in right deltoid for a bat bite from a known rabid bat, which is considered as inappropriate schedule of vaccine administered. On the same day, the patient received human rabies immune globulin (HRIG). Three days after the first dose, the patient received the second dose of RabAvert at dose of 2.5 units in left deltoid for a bat bite from a known rabid bat, which is considered as inappropriate schedule of vaccine administered. Reportedly, seven days after the first dose, the patient received the third dose of RabAvert, at dose of 2.5 units in right deltoid for a bat bite from a known rabid bat, which is considered as inappropriate schedule of vaccine administered. 14 days after the first dose, the patient received the fourth dose of RabAvert at dose of 2.5 units in right deltoid for a bat bite from a known rabid bat, which is considered as inappropriate schedule of vaccine administered. Reportedly, a month after the bite, the patient was vaccinated with a dose of quadrivalent influenza vaccine. Approximately five months after bat bite, the patient developed symptoms of rabies that progressed over the course of 17 days, until the patient passed away. Laboratory results at the time of hospitalization indicate the patient might have had an undiagnosed underlying immunocompromising condition, however, during life the patient was not known to have an underlying immunocompromising condition. Autopsy report indicates some level of host-related immune dysfunction, which presumably was why this patient developed rabies despite receiving timely post-exposure prophylaxis. Although the patient was elderly, had several chronic conditions at the time of vaccination, and later was found to have MGUS (during hospitalization) and metastatic prostate adenocarcinoma (diagnosed during autopsy). Autopsy demonstrated prostate adenocarcinoma metastatic to bone marrow (Gleason pattern 5+5=10, grade group 5) but without complete obliteration of bone marrow. Regarding bone marrow, lymph nodes and spleen, there was no morphologic or immunophenotypic evidence of lymphoma or plasma cell neoplasm. Brain tissue histopathology revealed meningoencephalitis and immunohistochemistry for RABV showed extensive viral antigen labelling. Given no identified issues with rabies biologics and a history of multiple comorbidities including MGUS, immune dysfunction (of unknown etiology) in the patient is the most parsimonious explanation for rabies post-exposure prophylaxis failure in this patient. Other potential causes of PEP failures were ruled out. Rabies and breakthrough infection are unlisted for RabAvert according to Datasheet. Inappropriate schedule of product administration is considered as listed per company convention. The patients' laboratory reports for serum proteins revealed M-spike with increase in gamma monoclonal protein and he was diagnosed with hypergammaglobulinemia benign monoclonal (MGUS). His relevant concurrent conditions additionally included metastatic prostate adenocarcinoma, diabetes and chronic renal failure. A memorandum was conducted. The purpose of the memorandum was to present the available stability data for the in-vivo potency assay performed on Rabies Vaccine (Rabipur and RabAvert) in order to confirm the product quality and efficacy throughout the entire product shelf life of 48 months. The evaluation performed on the extensive database confirmed that there had been no detectable change, as well as no product related out of specification result in the measured product potency during the entire product shelf life of Rabies Vaccine (Rabipur and RabAvert). The vaccination of the patient under investigation in the reported adverse event was performed using RabAvert of 16 to 17 months age at time of administration. The evaluated stability characteristics for Rabies Vaccine (Rabipur and RabAvert) did not indicate any product-associated cause for the reported adverse event. Considering presence of comorbidities in this elderly patient, and previously unrecognized monoclonal gammopathy of undetermined significance, which could lead to immunosuppression and a higher risk of infection and based on the results and conclusion of the conducted memorandum, the RA assesses the case as not related to product. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as serious due to death, hospitalization and medical significance.; Reported Cause(s) of Death: Rabies
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Test Date: 20210114; Test Name: Barium swallow; Result Unstructured Data: (Test Result:Abnormal,Unit:unknown,Normal Low:,Normal High:); Test Name: Biopsy; Result Unstructured Data: (Test Result:no result,Unit:unknown,Normal Low:,Normal High:); Test Date: 20210114; Test Name: Biopsy; Result Unstructured Data: (Test Result:did not show arteritis,Unit:unknown,Normal Low:,Normal High:); Test Date: 20210114; Test Name: Blood immunoglobulin A; Test Result: 52 mg/dl; Test Date: 2021; Test Name: IGA; Result Unstructured Data: (Test Result:decreased,Unit:unknown,Normal Low:,Normal High:); Test Date: 20210114; Test Name: Blood immunoglobulin G; Test Result: 485 mg/dl; Test Date: 20210115; Test Name: Blood immunoglobulin G; Result Unstructured Data: (Test Result:no result,Unit:unknown,Normal Low:661,Normal High:1464) non-neutralizing; Test Date: 20210120; Test Name: Blood immunoglobulin G; Result Unstructured Data: (Test Result:no result,Unit:unknown,Normal Low:661,Normal High:1464) non-neutralizing; Test Date: 2021; Test Name: IGG; Result Unstructured Data: (Test Result:decreased,Unit:unknown,Normal Low:,Normal High:); Test Date: 20210114; Test Name: Blood immunoglobulin M; Test Result: 2699 mg/dl; Test Date: 2021; Test Name: IGM; Result Unstructured Data: (Test Result:elevated,Unit:unknown,Normal Low:,Normal High:); Test Date: 20230116; Test Name: Body temperature; Result Unstructured Data: (Test Result:103.1,Unit:degree F,Normal Low:,Normal High:); Comments: 39.5 degrees Celsius; Test Date: 20210109; Test Name: Computerised tomogram head; Result Unstructured Data: (Test Result:Normal,Unit:unknown,Normal Low:,Normal High:); Test Date: 20210114; Test Name: Computerised tomogram head; Result Unstructured Data: (Test Result:Unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Date: 20230116; Test Name: Electrophoresis protein; Result Unstructured Data: (Test Result:see text below,Unit:unknown,Normal Low:,Normal High:); Comments: immunoglobulin (Ig)M monoclonal gammopathy of undetermined significance (MGUS) with an elevated gamma monoclonal protein and elevated IgM in the presence of reduced IgA and IgG; Test Date: 2021; Test Name: GFR; Result Unstructured Data: (Test Result:60-89,Unit:ml/min,Normal Low:,Normal High:); Test Name: Glomerular filtration rate; Result Unstructured Data: (Test Result:60-89,Unit:ml/min,Normal Low:,Normal High:); Test Date: 2021; Test Name: direct Fluorescent Antibody test; Result Unstructured Data: (Test Result:rabies positive,Unit:unknown,Normal Low:,Normal High:); Test Date: 20210114; Test Name: Monoclonal immunoglobulin present; Result Unstructured Data: (Test Result:1.86,Unit:g/dL,Normal Low:,Normal High:); Test Date: 20210114; Test Name: Protein total; Result Unstructured Data: (Test Result:negative for MYD88 L265P alteration,Unit:unknown,Normal Low:,Normal High:); Test Date: 20210116; Test Name: Protein total; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20210109; Test Name: Red blood cell sedimentation rate; Result Unstructured Data: (Test Result:110,Unit:mm/hr,Normal Low:,Normal High:); Comments: LabComments: Body temperature 16-JAN-23: 39.5 degrees Celsius, Electrophoresis protein 16-JAN-23: immunoglobulin (Ig)M monoclonal gammopathy of undetermined significance (MGUS) with an elevated gamma monoclonal protein and elevated IgM in the presence of reduced IgA and IgG
- Aktuelle Erkrankungen
- Adenocarcinoma of the prostate metastatic; Chronic kidney disease stage 2; Chronic rhinitis (excl allergic); Coronary artery bypass graft ((CABG) x 3); Hyperlipidemia; Hyperplasia of prostate; Immunocompromised; Monoclonal gammopathy of unknown significance; Single vessel disease; Type II diabetes mellitus; Uncontrolled hypertension
- Vorgeschichte
- Medical History/Concurrent Conditions: Cancer (to patient's brother); Cardiovascular disease, unspecified (to patient's father and sister); Colon cancer (to patient's sister); Heart attack (to patient's mother and father); Comments: No family history of bleeding disorder/clotting disorder or anesthesia problems and no family history of any neurological disease
- Andere Medikamente
- METOPROLOL TARTRATE; ASPIRIN; SOTALOL; LOSARTAN; METFORMIN; LIPITOR; GLUCOSAMINE CHONDROITIN; HYPERRAB S/D
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 13.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
1st shot almost killed me; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced near death experience (Verbatim: 1st shot almost killed me) (serious criteria GSK medically significant and life threatening). The outcome of the near death experience was not reported. It was unknown if the reporter considered the near death experience to be related to Shingles vaccine. It was unknown if the company considered the near death experience to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received first dose of Shingles vaccine and experienced almost killed him or her. Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 12.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
That vaccine almost killed me; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced near death experience (Verbatim: That vaccine almost killed me) (serious criteria GSK medically significant and life threatening). The outcome of the near death experience was not reported. It was unknown if the reporter considered the near death experience to be related to Shingles vaccine. It was unknown if the company considered the near death experience to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient did not get the second shot. The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 12.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Herpes zoster
Immunodeficiency
Platelet count decreased
Transfusion
Vaccination failure
Symptomtext
he passed 2 months later; Shingles Vax gave my husband Shingles; compromised immune system; Shingles Vax gave my husband Shingles; wiped out his platelets; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: he passed 2 months later) (serious criteria death and GSK medically significant), vaccination failure (Verbatim: Shingles Vax gave my husband Shingles) (serious criteria GSK medically significant), immunocompromised (Verbatim: compromised immune system) (serious criteria GSK medically significant), shingles (Verbatim: Shingles Vax gave my husband Shingles) and platelets decreased (Verbatim: wiped out his platelets). The patient was treated with blood transfusion, auxiliary products (Blood Transfusion). The outcome of the vaccination failure was unknown and the outcome of the immunocompromised, shingles and platelets decreased were not reported. The reported cause of death was unknown. It was unknown if the reporter considered the unknown cause of death, vaccination failure, immunocompromised, shingles and platelets decreased to be related to Shingles vaccine. It was unknown if the company considered the unknown cause of death, vaccination failure, immunocompromised, shingles and platelets decreased to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 31-MAR-2023. This case was reported by a patient via interactive digital media. The reporter stated that shingles vaccination gave her husband Shingles, wiped out his platelets. The patient required 4 blood transfusions and with his compromised immune system he passed 2 months later. The case was considered as suspected vacciantion failure since the details regarding completion of primary vaccination failure, time to onset for shingles laboratory confirmation of shingles was not reported. The follow-up could not be possible as no contact details were available; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Test Name: Platelets count; Result Unstructured Data: (Test Result:decreased,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 09.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cerebrovascular accident
Symptomtext
stroke after booster; This serious case was reported by a consumer via interactive digital media and described the occurrence of stroke in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced stroke (Verbatim: stroke after booster) (serious criteria GSK medically significant). The outcome of the stroke was not reported. It was unknown if the reporter considered the stroke to be related to Shingles vaccine. It was unknown if the company considered the stroke to be related to Shingles vaccine. Additional Information: GSK receipt date: 31-MAR-2023 The case was received from the consumer interactive digital media. The patient had one had a stroke the day after booster. The follow-up could not be possible as no contact details were available. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments: US-GSK-US2023AMR066269:Same reporter US-GSK-US2023AMR066213:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.04.2023
- Impfdatum
- 01.08.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Blood immunoglobulin G
Blood immunoglobulin M normal
CSF glucose normal
CSF protein normal
CSF test abnormal
Central nervous system vasculitis
Cerebral artery stenosis
Cerebrovascular accident
Colectomy total
Colitis
Computerised tomogram head
Condition aggravated
Cranial nerve disorder
Electroencephalogram abnormal
Eye pain
Lumbar puncture normal
Magnetic resonance imaging head abnormal
Ophthalmic herpes zoster
Symptomtext
Vaccination Failure; cerebral VZV vasculopathy; cerebral VZV vasculopathy; left eye pain; herpes zoster ophthalmicus; possible episode of speech arrest; multiple seizures; This serious case was reported in a literature article and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Literature Reference: Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Herpes zoster (Shingrix) for prophylaxis, prednisone for immunosuppressant drug therapy, infliximab for immunosuppressant drug therapy and tofacitinib for ulcerative colitis. Concurrent medical conditions included ulcerative colitis. In 2018, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In AUG-2021, the patient received the 3rd dose of Shingrix. On an unknown date, the patient started prednisone and infliximab. In FEB-2022, the patient started tofacitinib. In 2021, more than 2 years after receiving Shingrix and Shingrix and an unknown time after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: herpes zoster ophthalmicus) (serious criteria GSK medically significant). In JUL-2021, the patient experienced eye pain (Verbatim: left eye pain). In OCT-2021, the patient experienced speech disorder (Verbatim: possible episode of speech arrest). In 2022, the patient experienced varicella zoster virus infection (Verbatim: cerebral VZV vasculopathy), vasculitis cerebral (Verbatim: cerebral VZV vasculopathy) (serious criteria GSK medically significant) and seizure cerebral (Verbatim: multiple seizures) (serious criteria GSK medically significant). On an unknown date, the patient experienced vaccination failure (Verbatim: Vaccination Failure) (serious criteria GSK medically significant and other: as reported). The patient was treated with acyclovir, valaciclovir (Valacyclovir) and levetiracetam. The action taken with prednisone was unknown. Infliximab was discontinued. Tofacitinib was discontinued. The outcome of the vaccination failure, varicella zoster virus infection, vasculitis cerebral, eye pain, ophthalmic herpes zoster, speech disorder and seizure cerebral were unknown. The reporter considered the vaccination failure, varicella zoster virus infection, vasculitis cerebral, eye pain, ophthalmic herpes zoster, speech disorder and seizure cerebral to be related to Shingrix and Shingrix. The reporter considered the vaccination failure, varicella zoster virus infection, vasculitis cerebral, speech disorder and seizure cerebral to be possibly related to Shingrix. The company considered the vaccination failure, varicella zoster virus infection, vasculitis cerebral, eye pain, ophthalmic herpes zoster, speech disorder and seizure cerebral to be related to Shingrix and Shingrix. The company considered the vaccination failure, varicella zoster virus infection, vasculitis cerebral, speech disorder and seizure cerebral to be possibly related to Shingrix. Additional Information GSK receipt date: 14 Apr 2023 A 72-year-old woman with a history of ulcerative colitis who had received 2 doses of the Shingrix vaccine in 2018 developed left eye pain in July 2021, while on high-dose prednisone and during infliximab induction. She was diagnosed with herpes zoster ophthalmicus (HZO). Infliximab was discontinued, and she received a brief course of intravenous acyclovir followed by indefinite suppressive oral valacyclovir. In August 2021, she received a third dose of the Shingrix vaccine. In September 2021, magnetic resonance imaging of the brain was obtained for persistent eye pain, which revealed enhancement of the left cranial nerve 3 and V1 (not shown). In October 2021, she had a possible episode of speech arrest. In February 2022, she was started on tofacitinib for persistently active ulcerative colitis. The following month, she was admitted after multiple seizures. Tofacitinib was discontinued, and she was started on levetiracetam. A computerized tomography angiogram showed severe, multifocal left middle cerebral artery and left posterior cerebral artery narrowing. Magnetic resonance imaging was significant for multiple chronic-appearing infarcts in the left parietal lobe, new from September 2021, and vessel wall imaging (VWI) demonstrated enhancement of the distal left internal carotid artery, left middle cerebral artery, and left anterior cerebral artery segments consistent with varicella zoster (VZV) vasculopathy. A lumbar puncture showed normal protein and glucose without leukocytosis. VZV polymerase chain reaction was negative, but cerebrospinal fluid (CSF) testing for VZV antibodies was positive (IgG anti-VZV 1:2; IgM anti-VZV negative). Based on these results, she was diagnosed with cerebral VZV vasculopathy and treated with an oral prednisone taper and a 2-week course of intravenous acyclovir.2 In May 2022, she developed worsening colitis symptoms and was offered tofacitinib again to avoid a colectomy. Ten days after restarting tofacitinib, she presented to another hospital after 2 seizures at home. Her admission levetiracetam level was therapeutic and above the serum level obtained when she was previously checked and had excellent seizure control. Repeat magnetic resonance imaging brain revealed no new infarctions but persistent multifocal stenoses and vessel wall enhancement. Despite an additional levetiracetam load, EEG monitoring revealed 5 left hemispheric seizures. Tofacitinib was permanently discontinued, and 4 weeks later, she underwent total colectomy.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- Comments: In Sep 2021, magnetic resonance imaging of the brain was obtained for persistent eye pain which revealed enhancement of the left cranial nerve 3 and V1
- Aktuelle Erkrankungen
- Ulcerative colitis
- Vorgeschichte
- -
- Andere Medikamente
- PREDNISONE; INFLIXIMAB; TOFACITINIB
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.04.2023
- Impfdatum
- 01.08.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Blood immunoglobulin G
Blood immunoglobulin M normal
CSF glucose normal
CSF protein normal
CSF test abnormal
Central nervous system vasculitis
Cerebral artery stenosis
Cerebrovascular accident
Colectomy total
Colitis
Computerised tomogram head
Condition aggravated
Cranial nerve disorder
Electroencephalogram abnormal
Eye pain
Lumbar puncture normal
Magnetic resonance imaging head abnormal
Ophthalmic herpes zoster
Symptomtext
Vaccination Failure; cerebral VZV vasculopathy; cerebral VZV vasculopathy; left eye pain; herpes zoster ophthalmicus; possible episode of speech arrest; multiple seizures; This serious case was reported in a literature article and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Literature Reference: Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Herpes zoster (Shingrix) for prophylaxis, prednisone for immunosuppressant drug therapy, infliximab for immunosuppressant drug therapy and tofacitinib for ulcerative colitis. Concurrent medical conditions included ulcerative colitis. In 2018, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In AUG-2021, the patient received the 3rd dose of Shingrix. On an unknown date, the patient started prednisone and infliximab. In FEB-2022, the patient started tofacitinib. In 2021, more than 2 years after receiving Shingrix and Shingrix and an unknown time after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: herpes zoster ophthalmicus) (serious criteria GSK medically significant). In JUL-2021, the patient experienced eye pain (Verbatim: left eye pain). In OCT-2021, the patient experienced speech disorder (Verbatim: possible episode of speech arrest). In 2022, the patient experienced varicella zoster virus infection (Verbatim: cerebral VZV vasculopathy), vasculitis cerebral (Verbatim: cerebral VZV vasculopathy) (serious criteria GSK medically significant) and seizure cerebral (Verbatim: multiple seizures) (serious criteria GSK medically significant). On an unknown date, the patient experienced vaccination failure (Verbatim: Vaccination Failure) (serious criteria GSK medically significant and other: as reported). The patient was treated with acyclovir, valaciclovir (Valacyclovir) and levetiracetam. The action taken with prednisone was unknown. Infliximab was discontinued. Tofacitinib was discontinued. The outcome of the vaccination failure, varicella zoster virus infection, vasculitis cerebral, eye pain, ophthalmic herpes zoster, speech disorder and seizure cerebral were unknown. The reporter considered the vaccination failure, varicella zoster virus infection, vasculitis cerebral, eye pain, ophthalmic herpes zoster, speech disorder and seizure cerebral to be related to Shingrix and Shingrix. The reporter considered the vaccination failure, varicella zoster virus infection, vasculitis cerebral, speech disorder and seizure cerebral to be possibly related to Shingrix. The company considered the vaccination failure, varicella zoster virus infection, vasculitis cerebral, eye pain, ophthalmic herpes zoster, speech disorder and seizure cerebral to be related to Shingrix and Shingrix. The company considered the vaccination failure, varicella zoster virus infection, vasculitis cerebral, speech disorder and seizure cerebral to be possibly related to Shingrix. Additional Information GSK receipt date: 14 Apr 2023 A 72-year-old woman with a history of ulcerative colitis who had received 2 doses of the Shingrix vaccine in 2018 developed left eye pain in July 2021, while on high-dose prednisone and during infliximab induction. She was diagnosed with herpes zoster ophthalmicus (HZO). Infliximab was discontinued, and she received a brief course of intravenous acyclovir followed by indefinite suppressive oral valacyclovir. In August 2021, she received a third dose of the Shingrix vaccine. In September 2021, magnetic resonance imaging of the brain was obtained for persistent eye pain, which revealed enhancement of the left cranial nerve 3 and V1 (not shown). In October 2021, she had a possible episode of speech arrest. In February 2022, she was started on tofacitinib for persistently active ulcerative colitis. The following month, she was admitted after multiple seizures. Tofacitinib was discontinued, and she was started on levetiracetam. A computerized tomography angiogram showed severe, multifocal left middle cerebral artery and left posterior cerebral artery narrowing. Magnetic resonance imaging was significant for multiple chronic-appearing infarcts in the left parietal lobe, new from September 2021, and vessel wall imaging (VWI) demonstrated enhancement of the distal left internal carotid artery, left middle cerebral artery, and left anterior cerebral artery segments consistent with varicella zoster (VZV) vasculopathy. A lumbar puncture showed normal protein and glucose without leukocytosis. VZV polymerase chain reaction was negative, but cerebrospinal fluid (CSF) testing for VZV antibodies was positive (IgG anti-VZV 1:2; IgM anti-VZV negative). Based on these results, she was diagnosed with cerebral VZV vasculopathy and treated with an oral prednisone taper and a 2-week course of intravenous acyclovir.2 In May 2022, she developed worsening colitis symptoms and was offered tofacitinib again to avoid a colectomy. Ten days after restarting tofacitinib, she presented to another hospital after 2 seizures at home. Her admission levetiracetam level was therapeutic and above the serum level obtained when she was previously checked and had excellent seizure control. Repeat magnetic resonance imaging brain revealed no new infarctions but persistent multifocal stenoses and vessel wall enhancement. Despite an additional levetiracetam load, EEG monitoring revealed 5 left hemispheric seizures. Tofacitinib was permanently discontinued, and 4 weeks later, she underwent total colectomy.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- Comments: In Sep 2021, magnetic resonance imaging of the brain was obtained for persistent eye pain which revealed enhancement of the left cranial nerve 3 and V1
- Aktuelle Erkrankungen
- Ulcerative colitis
- Vorgeschichte
- -
- Andere Medikamente
- PREDNISONE; INFLIXIMAB; TOFACITINIB
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.04.2023
- Impfdatum
- 01.08.2021
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 3
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Blood immunoglobulin G
Blood immunoglobulin M normal
CSF glucose normal
CSF protein normal
CSF test abnormal
Central nervous system vasculitis
Cerebral artery stenosis
Cerebrovascular accident
Colectomy total
Colitis
Computerised tomogram head
Condition aggravated
Cranial nerve disorder
Electroencephalogram abnormal
Eye pain
Lumbar puncture normal
Magnetic resonance imaging head abnormal
Ophthalmic herpes zoster
Symptomtext
Vaccination Failure; cerebral VZV vasculopathy; cerebral VZV vasculopathy; left eye pain; herpes zoster ophthalmicus; possible episode of speech arrest; multiple seizures; This serious case was reported in a literature article and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Literature Reference: Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Herpes zoster (Shingrix) for prophylaxis, prednisone for immunosuppressant drug therapy, infliximab for immunosuppressant drug therapy and tofacitinib for ulcerative colitis. Concurrent medical conditions included ulcerative colitis. In 2018, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In AUG-2021, the patient received the 3rd dose of Shingrix. On an unknown date, the patient started prednisone and infliximab. In FEB-2022, the patient started tofacitinib. In 2021, more than 2 years after receiving Shingrix and Shingrix and an unknown time after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: herpes zoster ophthalmicus) (serious criteria GSK medically significant). In JUL-2021, the patient experienced eye pain (Verbatim: left eye pain). In OCT-2021, the patient experienced speech disorder (Verbatim: possible episode of speech arrest). In 2022, the patient experienced varicella zoster virus infection (Verbatim: cerebral VZV vasculopathy), vasculitis cerebral (Verbatim: cerebral VZV vasculopathy) (serious criteria GSK medically significant) and seizure cerebral (Verbatim: multiple seizures) (serious criteria GSK medically significant). On an unknown date, the patient experienced vaccination failure (Verbatim: Vaccination Failure) (serious criteria GSK medically significant and other: as reported). The patient was treated with acyclovir, valaciclovir (Valacyclovir) and levetiracetam. The action taken with prednisone was unknown. Infliximab was discontinued. Tofacitinib was discontinued. The outcome of the vaccination failure, varicella zoster virus infection, vasculitis cerebral, eye pain, ophthalmic herpes zoster, speech disorder and seizure cerebral were unknown. The reporter considered the vaccination failure, varicella zoster virus infection, vasculitis cerebral, eye pain, ophthalmic herpes zoster, speech disorder and seizure cerebral to be related to Shingrix and Shingrix. The reporter considered the vaccination failure, varicella zoster virus infection, vasculitis cerebral, speech disorder and seizure cerebral to be possibly related to Shingrix. The company considered the vaccination failure, varicella zoster virus infection, vasculitis cerebral, eye pain, ophthalmic herpes zoster, speech disorder and seizure cerebral to be related to Shingrix and Shingrix. The company considered the vaccination failure, varicella zoster virus infection, vasculitis cerebral, speech disorder and seizure cerebral to be possibly related to Shingrix. Additional Information GSK receipt date: 14 Apr 2023 A 72-year-old woman with a history of ulcerative colitis who had received 2 doses of the Shingrix vaccine in 2018 developed left eye pain in July 2021, while on high-dose prednisone and during infliximab induction. She was diagnosed with herpes zoster ophthalmicus (HZO). Infliximab was discontinued, and she received a brief course of intravenous acyclovir followed by indefinite suppressive oral valacyclovir. In August 2021, she received a third dose of the Shingrix vaccine. In September 2021, magnetic resonance imaging of the brain was obtained for persistent eye pain, which revealed enhancement of the left cranial nerve 3 and V1 (not shown). In October 2021, she had a possible episode of speech arrest. In February 2022, she was started on tofacitinib for persistently active ulcerative colitis. The following month, she was admitted after multiple seizures. Tofacitinib was discontinued, and she was started on levetiracetam. A computerized tomography angiogram showed severe, multifocal left middle cerebral artery and left posterior cerebral artery narrowing. Magnetic resonance imaging was significant for multiple chronic-appearing infarcts in the left parietal lobe, new from September 2021, and vessel wall imaging (VWI) demonstrated enhancement of the distal left internal carotid artery, left middle cerebral artery, and left anterior cerebral artery segments consistent with varicella zoster (VZV) vasculopathy. A lumbar puncture showed normal protein and glucose without leukocytosis. VZV polymerase chain reaction was negative, but cerebrospinal fluid (CSF) testing for VZV antibodies was positive (IgG anti-VZV 1:2; IgM anti-VZV negative). Based on these results, she was diagnosed with cerebral VZV vasculopathy and treated with an oral prednisone taper and a 2-week course of intravenous acyclovir.2 In May 2022, she developed worsening colitis symptoms and was offered tofacitinib again to avoid a colectomy. Ten days after restarting tofacitinib, she presented to another hospital after 2 seizures at home. Her admission levetiracetam level was therapeutic and above the serum level obtained when she was previously checked and had excellent seizure control. Repeat magnetic resonance imaging brain revealed no new infarctions but persistent multifocal stenoses and vessel wall enhancement. Despite an additional levetiracetam load, EEG monitoring revealed 5 left hemispheric seizures. Tofacitinib was permanently discontinued, and 4 weeks later, she underwent total colectomy.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- Comments: In Sep 2021, magnetic resonance imaging of the brain was obtained for persistent eye pain which revealed enhancement of the left cranial nerve 3 and V1
- Aktuelle Erkrankungen
- Ulcerative colitis
- Vorgeschichte
- -
- Andere Medikamente
- PREDNISONE; INFLIXIMAB; TOFACITINIB
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 21.04.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Herpes zoster
Myocardial infarction
Vaccination failure
Symptomtext
CARDIAC EPISODE, heart attack; had VACCINE AND HAD A HORRIFIC OUTBREAK, SHINGLES FOLLOWED/Suspected Vaccination Failure; HAD A HORRIFIC OUTBREAK, SHINGLES FOLLOWED; This serious case was reported by a nurse via interactive digital media and described the occurrence of heart attack in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced heart attack (Verbatim: CARDIAC EPISODE, heart attack) (serious criteria hospitalization and GSK medically significant), vaccination failure (Verbatim: had VACCINE AND HAD A HORRIFIC OUTBREAK, SHINGLES FOLLOWED/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: HAD A HORRIFIC OUTBREAK, SHINGLES FOLLOWED). The outcome of the heart attack and shingles were not reported and the outcome of the vaccination failure was unknown. It was unknown if the reporter considered the heart attack, vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the company considered the heart attack, vaccination failure and shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 22-MAR-2023 and 23-MAR-2023 The case was received from the patient via interactive digital media. The patient stated that he/she had vaccine and then later heart attack (cardiac episode) and that left him/her hospitalization and horrific initial outbreak and lasting days . The patient was a retired nurse and had not a clue how horrible shingles truly were until he/she experienced first hand. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Myocardial infarction
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 13.04.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
Vx nearly killed me; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had a bad case of shingles). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced near death experience (Verbatim: Vx nearly killed me) (serious criteria GSK medically significant and life threatening). The outcome of the near death experience was not reported. The reporter considered the near death experience to be related to Shingles vaccine. The company considered the near death experience to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient took the shingles vaccine later to prevent another breakout of shingles. The reporter stated that the shingles vaccine nearly killed him/her so it was need to know there were risks. The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Shingles (had a bad case of shingles)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 12.04.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Herpes zoster
Vaccination failure
Symptomtext
Passed away; Vccine didn?t do one bit of good continued to have outbreaks/suspected vaccination failure; shingles outbreaks; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles several times). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Passed away) (serious criteria death and GSK medically significant), vaccination failure (Verbatim: Vccine didn?t do one bit of good continued to have outbreaks/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles outbreaks). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the company considered the unknown cause of death, vaccination failure and shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 27-MAR-2023 This case was reported by a patient's children via interactive digital media. The reporter stated that when the shingles vaccine came out he/she made sure patient got it. The reporter further stated that shingles vaccine did not do one bit of good. She continued to have outbreaks of shingles until she passed away. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Shingles (had shingles several times)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 05.04.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Guillain-Barre syndrome
Symptomtext
Died; got Guilaine Barre Syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Died) (serious criteria death and GSK medically significant) and guillain barre syndrome (Verbatim: got Guilaine Barre Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death and guillain barre syndrome to be related to Shingles vaccine. It was unknown if the company considered the unknown cause of death and guillain barre syndrome to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-APR-2023 This case was reported by the patient's child friend via interactive digital media. The reporter stated that the patient got that vaccine and got Guillain Barr Syndrome and died. The reporter had asked to do your research properly. Make sure you were willing to take the risks. The reporter had stated that, he/she would not risk it. Follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 01.04.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Herpes zoster
Neoplasm
Vaccination failure
Symptomtext
Die 4 months after shingles shot; Had a break out after shingles shot/Suspected vaccination failure; Break out; Develop a tumor; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Die 4 months after shingles shot) (serious criteria death and GSK medically significant), vaccination failure (Verbatim: Had a break out after shingles shot/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Break out) and neoplasm (Verbatim: Develop a tumor). The outcome of the vaccination failure was unknown and the outcome of the shingles and neoplasm were not reported. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, vaccination failure, shingles and neoplasm to be related to Shingles vaccine. It was unknown if the company considered the unknown cause of death, vaccination failure, shingles and neoplasm to be related to Shingles vaccine. Additional Information: GSK Receipt date: 15-MAR-2023 This case was reported by a patient's friend via interactive digital media. The patient developed a tumor, break out and die 4 months after shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case was 1 of 4 cases, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR118387:Same reporter US-GLAXOSMITHKLINE-US2021AMR263783:Same reporter US-GSK-US2023AMR047859:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.03.2023
- Impfdatum
- -
- Beginn
- 01.02.2023
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Cerebrovascular accident
Computerised tomogram normal
Herpes zoster
Hypoaesthesia
Ultrasound scan normal
Vaccination failure
Symptomtext
had 1st shingles and my 2nd, bit these from Shingles/Suspected Vaccination Failure; bit these from Shingles; fell numbness on Upper right head down to right leg; tiny stroke; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In FEB-2023, less than 2 months after receiving Shingles vaccine and less than 2 years after receiving Shingles vaccine, the patient experienced stroke (Verbatim: tiny stroke) (serious criteria GSK medically significant) and numbness (Verbatim: fell numbness on Upper right head down to right leg). On an unknown date, the patient experienced vaccination failure (Verbatim: had 1st shingles and my 2nd, bit these from Shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: bit these from Shingles). The outcome of the vaccination failure was unknown and the outcome of the stroke and shingles were not reported and the outcome of the numbness was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, stroke, shingles and numbness to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the vaccination failure, stroke, shingles and numbness to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the 1st dose of shingles last year 2022 and his/her 2nd shingles dose in last January or February, he/she forgot the dates. The reporter stated that last February 2023 7.00 pm he/she felt numbness on his/her upper right head down to his/her right body part of his/her right leg. The patient was to emergency hospital and in doctors diagnosed as tiny stroke. The patient was treated with needles on his/her right arm and CT (Computerised tomogram) and ultrasound found nothing. The patient felt still the numbness if his/her right arm sometimes. The patient stated that he/she bit these from shingles and he/she should not get that shingles shots twice. The patient would ask now how safe was your shingles to our health. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- Test Date: 2023; Test Name: CT; Result Unstructured Data: (Test Result:found nothing,Unit:unknown,Normal Low:,Normal High:); Test Date: 2023; Test Name: ultrasound; Result Unstructured Data: (Test Result:found nothing,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.03.2023
- Impfdatum
- -
- Beginn
- 01.02.2023
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Cerebrovascular accident
Computerised tomogram normal
Herpes zoster
Hypoaesthesia
Ultrasound scan normal
Vaccination failure
Symptomtext
had 1st shingles and my 2nd, bit these from Shingles/Suspected Vaccination Failure; bit these from Shingles; fell numbness on Upper right head down to right leg; tiny stroke; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In FEB-2023, less than 2 months after receiving Shingles vaccine and less than 2 years after receiving Shingles vaccine, the patient experienced stroke (Verbatim: tiny stroke) (serious criteria GSK medically significant) and numbness (Verbatim: fell numbness on Upper right head down to right leg). On an unknown date, the patient experienced vaccination failure (Verbatim: had 1st shingles and my 2nd, bit these from Shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: bit these from Shingles). The outcome of the vaccination failure was unknown and the outcome of the stroke and shingles were not reported and the outcome of the numbness was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, stroke, shingles and numbness to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the vaccination failure, stroke, shingles and numbness to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the 1st dose of shingles last year 2022 and his/her 2nd shingles dose in last January or February, he/she forgot the dates. The reporter stated that last February 2023 7.00 pm he/she felt numbness on his/her upper right head down to his/her right body part of his/her right leg. The patient was to emergency hospital and in doctors diagnosed as tiny stroke. The patient was treated with needles on his/her right arm and CT (Computerised tomogram) and ultrasound found nothing. The patient felt still the numbness if his/her right arm sometimes. The patient stated that he/she bit these from shingles and he/she should not get that shingles shots twice. The patient would ask now how safe was your shingles to our health. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- Test Date: 2023; Test Name: CT; Result Unstructured Data: (Test Result:found nothing,Unit:unknown,Normal Low:,Normal High:); Test Date: 2023; Test Name: ultrasound; Result Unstructured Data: (Test Result:found nothing,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 24.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cerebrovascular accident
Herpes zoster
Symptomtext
3 strokes; Shingles of the brain; This serious case was reported by a consumer via interactive digital media and described the occurrence of stroke in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced stroke (Verbatim: 3 strokes) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles of the brain). The outcome of the stroke and shingles were not reported. It was unknown if the reporter considered the stroke and shingles to be related to Shingles vaccine. It was unknown if the company considered the stroke and shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient was reporter's step dad. The patient received Shingles vaccine one year ago and experienced shingles on the brain 7 months ago. The patient had 3 strokes in hours to days and it changed their lives forever. The reporter also had two doses of Shingles vaccine. Follow-up would not possible as no contact details were available.; Sender's Comments: US-GSK-US2023AMR041082:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 24.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cerebrovascular accident
Pruritus
Symptomtext
I had a stroke; This serious case was reported by a consumer via interactive digital media and described the occurrence of stroke in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Family history included shingles (patient's husband). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced stroke (Verbatim: I had a stroke) (serious criteria GSK medically significant). The outcome of the stroke was not reported. It was unknown if the reporter considered the stroke to be related to Shingles vaccine. It was unknown if the company considered the stroke to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 07-MAR-2023 This case was reported by patient via interactive digital media. The reporter had asked that, what was Shingles, since she did not had shingles and she had a stroke her husband get the shingles. The reporter also stated that, she knew what she did too, she had to have scene, but she had got anyway but was a mild so, it was a lot better so she would do it anyway. It was the disease that was born with you and sometimes people get it and sometimes did not, but when it did, it was awful, wherever the itch would happen, as it was terrible. Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Shingles (patient's husband)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 18.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
Near killed my; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced near death experience (Verbatim: Near killed my) (serious criteria GSK medically significant and life threatening). The outcome of the near death experience was not reported. It was unknown if the reporter considered the near death experience to be related to Shingles vaccine. It was unknown if the company considered the near death experience to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by the patient via interactive digital media. The patient received the Shingles shot last week from reporting and reported that never again and dam near killed his/her (unspecified). Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 18.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Neoplasm malignant
Symptomtext
Developed a rare type of cancer in his arm where he was injected; This serious case was reported by a consumer via research programs and described the occurrence of cancer in a adult male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. On an unknown date, the patient received Hz/su + AS01B (unknown arm). On an unknown date, an unknown time after receiving Hz/su + AS01B, the patient experienced cancer (Verbatim: Developed a rare type of cancer in his arm where he was injected) (serious criteria death and GSK medically significant).The reported cause of death was cancer. The reporter considered the cancer to be possibly related to Hz/su + AS01B. The company considered the cancer to be possibly related to Hz/su + AS01B. Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by patient's wife via research programs. The reporter stated that her late husband had vaccine and had developed a rare type of cancer in his arm where he was injected. It spread and killed him. The question was asked to her as what would motivate you to get the Shingles vaccine in the next three months and to which she responded that, to know without a doubt that, the vaccine did not cause her husband's cancer. The reporter had thought that the event might be related to the product/device. The reporter had consented to follow-up.; Reported Cause(s) of Death: cancer
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 08.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Herpes zoster
Pain
Vaccination failure
Symptomtext
got shingles months after her vaccine, death/Suspected vaccination failure; Shingles led to her death, demise; Horrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), shingles (serious criteria death) and pain. On an unknown date, the outcome of the vaccination failure and shingles were fatal and the outcome of the pain was unknown. The reported cause of death was shingles and vaccination failure. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-MAR-2023 Reporter's Comment: This case was reported by a patient's child via interactive digital media. The reporter reported that the patient got shingles a couple months after her Shingles vaccine which led to her death a few months later. She had horrible pain. The reporter stated that he/she was done with these so-called vaccines that did not prevent disease but the CDC (Centers for Disease Control and Prevention) wants them to believe that there some unmeasurable best protection as his/her mother also received Shingles vaccine a few months before she was demise due to shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Shingles; Vaccination failure
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 06.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anaphylactic shock
Illness
Symptomtext
Anaphylactic shock; sick; This case was reported by a consumer via interactive digital media and described the occurrence of anaphylactic shock in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (Family History) (patient's 2 older sisters had shingles and were in pain and discomfort for weeks). On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced anaphylactic shock (serious criteria GSK medically significant) and sickness. On an unknown date, the outcome of the anaphylactic shock and sickness were unknown. The reporter considered the anaphylactic shock to be possibly related to Shingrix. It was unknown if the reporter considered the sickness to be related to Shingrix. Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient reported that he/she had anaphylactic shock from the Shingrix vaccine and recommend people to get a blood test first to see what their immunity levels were. The patient reported that he/she had natural immunity and by getting the shot made sick. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic shock
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Shingles (patient's 2 older sisters had shingles and were in pain and discomfort for weeks)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 06.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
died; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's Comment: This case was reported by a patient's child via interactive digital media. The reporter stated that did not get shingles shot. The patient died after the shingles shot. Additional Supportive Information: The follow up would not possible as no contact details were available. The case had been linked to US2023AMR034315, reported by the same reporter, for a different patient.; Sender's Comments: US-GSK-US2023AMR034315:same reporter, other patient; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 06.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
died; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's Comment: This case was reported by a patient's child via interactive digital media. The reporter stated that did not get shingles shot. The patient died after the shingles shot. Additional Supportive Information: The follow up would not possible as no contact details were available. The case had been linked to US2023AMR034316, reported by the same reporter, for a different patient.; Sender's Comments: US-GSK-US2023AMR034316:same reporter, other patient; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.02.2023
- Impfdatum
- 30.07.2022
- Beginn
- 03.08.2022
- Tage bis Beginn
- 4,0
- Dosis
- UNK
- Route/Site
- SYR / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
Deceased/wrongful death; This case was reported by a lawyer and described the occurrence of death in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 30th July 2022, the patient received Shingrix (intravenous). On 3rd August 2022, 4 days after receiving Shingrix, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The patient died on 3rd August 2022. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to Shingrix. Additional Information: GSK Receipt Date: 22 Feb 2023 Reporter's Comments:The patient allegedly passed away from complications after receiving a shingrix vial kit vaccine.The patient death case arising out of complications from an intravenous vaccine administration which occurred on 30 Jul 2022. The patient was deceased ( date of loss) on 3 Aug 2022 or wrongful . The autopsy was unknown. The patient cause of death was unknown cause of death.; Reported Cause(s) of Death: Deceased
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 15.02.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Herpes zoster
Vaccination failure
Symptomtext
Death Nos; Suspected vaccination failure; Shingles, treated w/remdesivir, died in 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included remdesivir for product used for unknown indication. On an unknown date, the patient received Shingles vaccine and remdesivir at an unknown dose and frequency. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with remdesivir was unknown. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the vaccination failure and shingles were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, vaccination failure and shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 10-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the shot and got shingles 2 times after that. The reporter did not trust the Covid vaccine as the patient passed away last year from the remdesivir they treated and died in 4 days. It was unknown if the reporter considered the death nos, shingles to be related to remdesivir. Additional Supportive Information: The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The case was linked with case US2023AMR023214 reported by same reporter.; Sender's Comments: US-GSK-US2023AMR023214:Same reporter; Reported Cause(s) of Death: Death NOS
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- REMDESIVIR
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 1,3
- Geschlecht
- M
- Eingang
- 14.02.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cardiac arrest
Cardiac failure
Symptomtext
Vx stopped his heart, still in therapies; This case was reported by a consumer via interactive digital media and described the occurrence of cardiac failure in a infant male patient who received DTPa (DTaP vaccine) for prophylaxis. On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced cardiac failure (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the cardiac failure was unknown. The reporter considered the cardiac failure to be related to DTaP vaccine. Additional Information: GSK receipt date: 10-FEB-2023 Reporter's comment: This case was reported by a patient's parent via interactive digital media. The reporter reported that the patient received a dose of DTaP vaccine, and it stopped his heart. The reporter reported that he/she was already in the ambulance on his/her way to the hospital and stated if he/she was not, they would had listed his death as SIDS (sudden infant death syndrome). The patient was 13 (unspecified) now and that vaccine injury still had him in therapies one size did not fit all. Additional Supportive Information: This case was linked with US2023AMR023197 which was reported by same reporter for different patient. Follow-up would not possible as no contact details were available.; Sender's Comments: US-GSK-US2023AMR023197:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cardiac arrest
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 62,0
- Geschlecht
- U
- Eingang
- 08.02.2023
- Impfdatum
- 03.11.2022
- Beginn
- 08.12.2022
- Tage bis Beginn
- 35,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Deep vein thrombosis
Hypoaesthesia
Paraesthesia
Pulmonary embolism
Symptomtext
Bilateral PE; Distal DVT; Numbness; Tingling; This case was reported by a other health professional via sales rep and described the occurrence of pulmonary embolism in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. On 3rd November 2022, the patient received Shingrix. On 8th December 2022, 35 days after receiving Shingrix, the patient experienced pulmonary embolism (serious criteria GSK medically significant), deep vein thrombosis (serious criteria GSK medically significant), numbness and tingling. On an unknown date, the outcome of the pulmonary embolism, deep vein thrombosis, numbness and tingling were unknown. It was unknown if the reporter considered the pulmonary embolism, deep vein thrombosis, numbness and tingling to be related to Shingrix. Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: The healthcare professional reported that the patient received a dose of Shingrix around first week on November 2022 and diagnosed with bilateral pulmonary embolism, distal vein thrombosis and experienced numbness and tingling. Additional Supportive Information: The vaccination date and event onset date captured as per query clarification received.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pulmonary embolism
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 01.02.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Anaphylactic shock
Autoimmune disorder
Hypersensitivity
Symptomtext
anaphylaxis to egg; autoimmune disease / never recovered /spiraled; allergic to all the top 8 allergens; This case was reported by a consumer via interactive digital media and described the occurrence of anaphylactic shock due to eggs in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced anaphylactic shock due to eggs (serious criteria GSK medically significant), autoimmune disorder (serious criteria GSK medically significant) and allergy. On an unknown date, the outcome of the anaphylactic shock due to eggs was unknown and the outcome of the autoimmune disorder and allergy were not recovered/not resolved. The reporter considered the anaphylactic shock due to eggs, autoimmune disorder and allergy to be possibly related to Flu vaccine. Additional Information: GSK receipt date: 24-Jan-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient reported that it did not work for everyone. The patient had received it and autoimmune disease was birth from that moment. The patient also experienced anaphylaxis to egg in the flu shot. The patient immune system never recovered and spiraled. The patient became allergic to all the top eight allergens. The people said how do you know. The patient got shot and went straight to the emergency room. The patient said could no longer get any vaccines. The reporter think that the event might have been related to the product and device. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic shock
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 31.01.2023
- Impfdatum
- 16.09.2022
- Beginn
- 01.09.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cardiac disorder
Death
Ear infection
Pulse absent
Shock
Sudden death
Symptomtext
Shock-associated circulatory or cardiac conditions; cardiac conditions, Unexpected death; Found pulseless; Ear infection; This case was reported by a consumer via other manufacturer and described the occurrence of shock in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylaxis, ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis and TOZINAMERAN (PFIZER CORONAVIRUS VACCINE) for prophylaxis. On 16th September 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device, PREVNAR 13, ROTATEQ and PFIZER CORONAVIRUS VACCINE. In September 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced ear infection (serious criteria death). On 26th September 2022, the patient experienced shock (serious criteria death and GSK medically significant), heart disorder (serious criteria death and GSK medically significant) and pulseless (serious criteria death). On an unknown date, the outcome of the shock, heart disorder, ear infection and pulseless were fatal. The patient died on 26th September 2022. The reported cause of death was shock, heart disorder, pulseless and ear infection. It was unknown if the reporter considered the shock, heart disorder, ear infection and pulseless to be related to Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments: The reporter reported that baby (patient) dies suddenly from cardiac conditions 10 days after receiving 4 vaccines. The patient received Pediarix, FluLaval Seasonal Quadrivalent Influenza, Prevnar13, Rotateq, Pfizer coronavirus vaccine on 16th September 2022 and the baby experienced shock associated circulatory or cardiac conditions. It was an unexpected death, the patient was taking a nap in the afternoon and found pulseless in a crib and died on the 26th September 2022. The baby had an ear infection at the time. It was unknown if the reporter considered the shock, heart disorder, pulseless and ear infection to be related to Prevnar13, Rotateq, Pfizer coronavirus vaccine. Additional Supportive Information: As it was not clear if the patient had ear infection at the time of vaccination or death, hence conservatively captured as event.; Reported Cause(s) of Death: Shock; Heart disorder; Pulseless; Ear infection
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Test Date: 20220926; Test Name: pulse rate; Result Unstructured Data: (Test Result:pulseless,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 31.01.2023
- Impfdatum
- 16.09.2022
- Beginn
- 01.09.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cardiac disorder
Death
Ear infection
Pulse absent
Shock
Sudden death
Symptomtext
Shock-associated circulatory or cardiac conditions; cardiac conditions, Unexpected death; Found pulseless; Ear infection; This case was reported by a consumer via other manufacturer and described the occurrence of shock in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylaxis, ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis and TOZINAMERAN (PFIZER CORONAVIRUS VACCINE) for prophylaxis. On 16th September 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device, PREVNAR 13, ROTATEQ and PFIZER CORONAVIRUS VACCINE. In September 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced ear infection (serious criteria death). On 26th September 2022, the patient experienced shock (serious criteria death and GSK medically significant), heart disorder (serious criteria death and GSK medically significant) and pulseless (serious criteria death). On an unknown date, the outcome of the shock, heart disorder, ear infection and pulseless were fatal. The patient died on 26th September 2022. The reported cause of death was shock, heart disorder, pulseless and ear infection. It was unknown if the reporter considered the shock, heart disorder, ear infection and pulseless to be related to Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments: The reporter reported that baby (patient) dies suddenly from cardiac conditions 10 days after receiving 4 vaccines. The patient received Pediarix, FluLaval Seasonal Quadrivalent Influenza, Prevnar13, Rotateq, Pfizer coronavirus vaccine on 16th September 2022 and the baby experienced shock associated circulatory or cardiac conditions. It was an unexpected death, the patient was taking a nap in the afternoon and found pulseless in a crib and died on the 26th September 2022. The baby had an ear infection at the time. It was unknown if the reporter considered the shock, heart disorder, pulseless and ear infection to be related to Prevnar13, Rotateq, Pfizer coronavirus vaccine. Additional Supportive Information: As it was not clear if the patient had ear infection at the time of vaccination or death, hence conservatively captured as event.; Reported Cause(s) of Death: Shock; Heart disorder; Pulseless; Ear infection
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Test Date: 20220926; Test Name: pulse rate; Result Unstructured Data: (Test Result:pulseless,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 31.01.2023
- Impfdatum
- 16.09.2022
- Beginn
- 01.09.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cardiac disorder
Death
Ear infection
Pulse absent
Shock
Sudden death
Symptomtext
Shock-associated circulatory or cardiac conditions; cardiac conditions, Unexpected death; Found pulseless; Ear infection; This case was reported by a consumer via other manufacturer and described the occurrence of shock in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylaxis, ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis and TOZINAMERAN (PFIZER CORONAVIRUS VACCINE) for prophylaxis. On 16th September 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device, PREVNAR 13, ROTATEQ and PFIZER CORONAVIRUS VACCINE. In September 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced ear infection (serious criteria death). On 26th September 2022, the patient experienced shock (serious criteria death and GSK medically significant), heart disorder (serious criteria death and GSK medically significant) and pulseless (serious criteria death). On an unknown date, the outcome of the shock, heart disorder, ear infection and pulseless were fatal. The patient died on 26th September 2022. The reported cause of death was shock, heart disorder, pulseless and ear infection. It was unknown if the reporter considered the shock, heart disorder, ear infection and pulseless to be related to Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments: The reporter reported that baby (patient) dies suddenly from cardiac conditions 10 days after receiving 4 vaccines. The patient received Pediarix, FluLaval Seasonal Quadrivalent Influenza, Prevnar13, Rotateq, Pfizer coronavirus vaccine on 16th September 2022 and the baby experienced shock associated circulatory or cardiac conditions. It was an unexpected death, the patient was taking a nap in the afternoon and found pulseless in a crib and died on the 26th September 2022. The baby had an ear infection at the time. It was unknown if the reporter considered the shock, heart disorder, pulseless and ear infection to be related to Prevnar13, Rotateq, Pfizer coronavirus vaccine. Additional Supportive Information: As it was not clear if the patient had ear infection at the time of vaccination or death, hence conservatively captured as event.; Reported Cause(s) of Death: Shock; Heart disorder; Pulseless; Ear infection
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Test Date: 20220926; Test Name: pulse rate; Result Unstructured Data: (Test Result:pulseless,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 31.01.2023
- Impfdatum
- 16.09.2022
- Beginn
- 01.09.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cardiac disorder
Death
Ear infection
Pulse absent
Shock
Sudden death
Symptomtext
Shock-associated circulatory or cardiac conditions; cardiac conditions, Unexpected death; Found pulseless; Ear infection; This case was reported by a consumer via other manufacturer and described the occurrence of shock in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylaxis, ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis and TOZINAMERAN (PFIZER CORONAVIRUS VACCINE) for prophylaxis. On 16th September 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device, PREVNAR 13, ROTATEQ and PFIZER CORONAVIRUS VACCINE. In September 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced ear infection (serious criteria death). On 26th September 2022, the patient experienced shock (serious criteria death and GSK medically significant), heart disorder (serious criteria death and GSK medically significant) and pulseless (serious criteria death). On an unknown date, the outcome of the shock, heart disorder, ear infection and pulseless were fatal. The patient died on 26th September 2022. The reported cause of death was shock, heart disorder, pulseless and ear infection. It was unknown if the reporter considered the shock, heart disorder, ear infection and pulseless to be related to Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments: The reporter reported that baby (patient) dies suddenly from cardiac conditions 10 days after receiving 4 vaccines. The patient received Pediarix, FluLaval Seasonal Quadrivalent Influenza, Prevnar13, Rotateq, Pfizer coronavirus vaccine on 16th September 2022 and the baby experienced shock associated circulatory or cardiac conditions. It was an unexpected death, the patient was taking a nap in the afternoon and found pulseless in a crib and died on the 26th September 2022. The baby had an ear infection at the time. It was unknown if the reporter considered the shock, heart disorder, pulseless and ear infection to be related to Prevnar13, Rotateq, Pfizer coronavirus vaccine. Additional Supportive Information: As it was not clear if the patient had ear infection at the time of vaccination or death, hence conservatively captured as event.; Reported Cause(s) of Death: Shock; Heart disorder; Pulseless; Ear infection
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Test Date: 20220926; Test Name: pulse rate; Result Unstructured Data: (Test Result:pulseless,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 18.01.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Blister
Burning sensation
Coma
Fear
Herpes zoster
Vaccination failure
Symptomtext
Got 2 vaccines and turned out it was shingles,suspected vaccination failure; Got it, turned out it was shingles, it sent me to hospital; horrible burning sensation, body was burned all over; coma for 3 months; blisters on buttocks; feel fear,scares me; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), shingles (serious criteria hospitalization), coma (serious criteria hospitalization and GSK medically significant), burning sensation (serious criteria hospitalization), blister and fear. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, blister and fear were unknown and the outcome of the coma was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles, coma, burning sensation, blister and fear to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, blister and fear to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comments: This case was reported via interactive digital media. The patient reported that he/she got it (shingles) and it he/she sent him/her to the hospital it was like if all his/her body was burned all over. The patient went to the doctor and supposedly they gave him/her the wrong medication and it turned out that they sent him/her to another hospital where patient fell in a coma for 3 months and at the end it turned out that it was shingles. The patient get blisters from time to time on buttocks and that was it, the patient the 2 vaccines but nothing to worry about, he/she heal quickly because it scares him/her, when they come out the patient thought he/she was in a horrible burning oven. Additional Supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Coma
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 18.01.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Blister
Burning sensation
Coma
Fear
Herpes zoster
Vaccination failure
Symptomtext
Got 2 vaccines and turned out it was shingles,suspected vaccination failure; Got it, turned out it was shingles, it sent me to hospital; horrible burning sensation, body was burned all over; coma for 3 months; blisters on buttocks; feel fear,scares me; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), shingles (serious criteria hospitalization), coma (serious criteria hospitalization and GSK medically significant), burning sensation (serious criteria hospitalization), blister and fear. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, blister and fear were unknown and the outcome of the coma was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles, coma, burning sensation, blister and fear to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, blister and fear to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comments: This case was reported via interactive digital media. The patient reported that he/she got it (shingles) and it he/she sent him/her to the hospital it was like if all his/her body was burned all over. The patient went to the doctor and supposedly they gave him/her the wrong medication and it turned out that they sent him/her to another hospital where patient fell in a coma for 3 months and at the end it turned out that it was shingles. The patient get blisters from time to time on buttocks and that was it, the patient the 2 vaccines but nothing to worry about, he/she heal quickly because it scares him/her, when they come out the patient thought he/she was in a horrible burning oven. Additional Supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Coma
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 12.01.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
Got that shot, is killing me; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was not recovered/not resolved. The reporter considered the near death experience to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and now it was killing him/her. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 09.01.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Exposure during pregnancy
Near death experience
Symptomtext
Almost died taking the flu shot; Took the flu shot while pregnant; This prospective pregnancy case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Flu vaccine at an unknown time during the pregnancy. On an unknown date, unknown after receiving Flu vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening) and vaccine exposure during pregnancy. The patient was treated with herbals nos (Herbs). On an unknown date, the outcome of the near death experience and vaccine exposure during pregnancy were unknown. The pregnancy was lost to follow up. The reporter considered the near death experience to be possibly related to Flu vaccine. Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient was almost died taking the flu shot while pregnant 18 years ago. The reporter stated that, If it were not herbs it were not right. This pregnancy case was considered as lost to follow up. The reporter thought that the event might had been related to the product/device. Additional Supportive Information: The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 02.12.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
vaccine almost killed my dad; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown. It was unknown if the reporter considered the near death experience to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 28-NOV-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that this vaccine almost killed his dad The follow up would not possible, as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 10.11.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cardiac arrest
Death
Symptomtext
Got all vaccinations, gone within a year...cardiac arrest; This case was reported by a consumer via interactive digital media and described the occurrence of cardiac arrest in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced cardiac arrest (serious criteria death and GSK medically significant). On an unknown date, the outcome of the cardiac arrest was fatal. The reported cause of death was cardiac arrest. It was unknown if the reporter considered the cardiac arrest to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-NOV-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient was the reporter's husband. The reporter said she was not an anti-vaxxer. The reporter mentioned as she received all her vaccinations. Her husband, who had no heart issues received his as well. Within a year he was gone due to cardiac arrest. The reporter was just concerned, not radical. Additional supportive information: This is one of 2 link cases reported by same reporter. Follow up would not possible, as no contact details were available.; Sender's Comments: US-GSK-US2022AMR163337:Same reporter. Reporter's case.; Reported Cause(s) of Death: Cardiac arrest
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cardiac arrest
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AL
- Alter
- 59,0
- Geschlecht
- M
- Eingang
- 03.11.2022
- Impfdatum
- 01.11.2021
- Beginn
- 30.10.2022
- Tage bis Beginn
- 363,0
- Dosis
- UNK
- Route/Site
- SYR / UN
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cardiovascular evaluation
Death
Symptomtext
Patient who received Moderna COVID -19 vaccine and was unexpectedly found deceased in his sleep early around 2 AM on October 30, 2022. Patient recently underwent cardiac stress test before a month or two which was normal. Strongly suspect unexpected death of patient is directly associated with Moderna COVID -19 vaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Recent cardiac stress test, UNK
- Aktuelle Erkrankungen
- Extreme tiredness, SOB; patient underwent stress tests and cardiac workup which showed everything was fine a month before passing away.
- Vorgeschichte
- UNK
- Andere Medikamente
- UNK
- Allergien
- UNK
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.10.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
died from the shinglesvax; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. The reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's comment: This case was reported by the patient's friend via interactive digital media. The reporter stated that the patient recently died from the shingles vaccine, so be careful on what they put inside you. Additional supportive information: Follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WV
- Alter
- -
- Geschlecht
- F
- Eingang
- 20.10.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Abdominal discomfort
Asthenia
Atrial fibrillation
Basedow's disease
Cerebrovascular accident
Chills
Herpes zoster
Illness
Incomplete course of vaccination
Myalgia
Symptomtext
Stroke; Graves' disease; AFIB; Shingles on her finger/underneath her nail; Shivers; Muscle pain; Felt sick to her stomach; Became very ill; Weakness; first dose of SHINGRIX about 5 years ago, and she has not yet received her second dose; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the patient did not receive 2nd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant), graves' disease (serious criteria GSK medically significant), atrial fibrillation (serious criteria GSK medically significant), shingles, shivers, muscle pain, upset stomach, illness, weakness and incomplete course of vaccination. On an unknown date, the outcome of the stroke, graves' disease, atrial fibrillation, shingles and incomplete course of vaccination were unknown and the outcome of the shivers, muscle pain, upset stomach, illness and weakness were recovered/resolved. It was unknown if the reporter considered the stroke, graves' disease, atrial fibrillation, shingles, shivers, muscle pain, upset stomach, illness and weakness to be related to Shingrix. Additional Information: GSK Receipt Date: 14-Oct-2022 Reporter's comment: The reporter was the patient. The patient stated that she received her first dose of Shingrix about 5 years prior to the reporting, and she had not yet received her second dose. The patient stated she became very ill after receiving the first dose, which included shivers, muscle pain, weakness, and felt sick to her stomach. Since receiving her first dose of Shingrix, the patient had a stroke, graves' disease, diagnosed with atrial fibrillation, and had Shingles on her finger/underneath her nail. The reporter did not consent to follow-up. The patient did not wish to consent to follow up with Health-care professional. The patient did not wish to provide date of birth. This case was linked with case US2022148323, reported by the same reporter. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments: US-GSK-US2022148323:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- 77,0
- Geschlecht
- F
- Eingang
- 17.10.2022
- Impfdatum
- 14.10.2022
- Beginn
- 15.10.2022
- Tage bis Beginn
- 1,0
- Dosis
- 4
- Route/Site
- IM / RA
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Death
Resuscitation
Unresponsive to stimuli
Symptomtext
Member received bivalent covid booster on 10/14/2022 and was found unresponsive on 10/15 at 1155, CPR was initiated and member was transfered to the hospital, where she expired.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- NA
- Vorgeschichte
- Type 2 DM with CKD, GERD, Dysphagia, Sleep Apnea, CHF, Breast CA, MDD, AF HLD
- Andere Medikamente
- Losartan, B12, Tramadol, Senna, Toprol, Protonix, Flomax, Insulin, Zoloft, Bumex, ASA, Eliquis, Iron, Gabapentin, Atorvastatin
- Allergien
- Amlodipine and Amoxcillin
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.10.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Influenza
Influenza virus test positive
Intensive care
Respiratory tract infection
Vaccination failure
Symptomtext
Suspected vaccination failure; Influenza; Severe acute respiratory infection; This case was reported in a literature article and described the occurrence of vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Flu vaccine and the 1st dose of Influenza vaccine. On an unknown date, less than 2 years after receiving Flu vaccine and Influenza vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), influenza (serious criteria death and hospitalization) and acute respiratory tract infection (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure and acute respiratory tract infection were unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. The reporter considered the vaccination failure, influenza and acute respiratory tract infection to be related to Flu vaccine and Influenza vaccine. Additional Information: GSK Receipt Date: 10-OCT-2022 Author comment: The case was created given in the article. The patient was a part of study which analyzed data from four countries participating in a multicentre, test-negative design, vaccine effectiveness network including 41 sentinel hospitals. Individuals hospitalized at one of these centres with severe acute respiratory infection were tested for influenza by real-time RT-PCR, and were included in the analysis if they had complete information about their vaccination status and outcomes of their hospital stay. 2747 patients hospitalized with PCR-confirmed influenza virus infection between Jan 1, 2013, and Dec 8, 2019, were included in the study: 649 children (70 [10o8%] fully vaccinated, 193 [29o7%] partially vaccinated) of whom 87 (13o4%) were admitted to ICU and 12 (1o8%) died in hospital; 520 adults with pre-existing medical conditions (118 [22o7%] vaccinated), of whom 139 (26o7%) were admitted to ICU and 55 (10o6%) died in hospital; and 1578 older adults (609 [38o6%] vaccinated), of whom 271 (17o2%) were admitted to ICU and 220 (13o9%) died in hospital. For children aged 6 to 24 months. The participants were categorized as fully vaccinated if they had received two doses of influenza vaccine at least 14 days before symptom onset; and partially vaccinated if they had received only one dose of influenza vaccine at least 14 days before symptom onset. 12 (1o8%) of 649 children aged 6 to 24 months died in hospital: eight (2o1%) of 386 unvaccinated children, three (1o5%) of 193 partially vaccinated children, and one (1o4%) of 70 fully vaccinated children died in hospitalThe patient had real time RT-PCR of nasal swab and was confirmed for influenza infection. The patient had ICU admission and in-hospital death due to influenza. ?Based on sentinel surveillance, the results indicated that influenza vaccination could offer health benefits to some patients hospitalized with breakthrough influenza virus infections. A shorter lengths of hospital stay among partially and fully vaccinated children aged 6 to 24 months and vaccinated adults aged 18 to 64 years with pre-existing medical conditions compared with unvaccinated individuals in the respective age groups was observed. ?Influenza vaccination was associated with illness attenuation among those hospitalized with influenza, although results differed by vaccine target group. These findings might suggest that attenuation of disease severity might be specific to certain target groups, seasons, or settings.' Additional supportive information: This case was considered to be a suspected vaccination failure case, as the details regarding time to onset was unknown. This is 1 of the 3 cases reported in this Literature article.; Reported Cause(s) of Death: Influenza
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Test Name: RT-PCR; Result Unstructured Data: (Test Result:confirmed infection with influenza,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.10.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Influenza
Influenza virus test positive
Intensive care
Respiratory tract infection
Vaccination failure
Symptomtext
Suspected vaccination failure; Influenza; Severe acute respiratory infection; This case was reported in a literature article and described the occurrence of vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Flu vaccine and the 1st dose of Influenza vaccine. On an unknown date, less than 2 years after receiving Flu vaccine and Influenza vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), influenza (serious criteria death and hospitalization) and acute respiratory tract infection (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure and acute respiratory tract infection were unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. The reporter considered the vaccination failure, influenza and acute respiratory tract infection to be related to Flu vaccine and Influenza vaccine. Additional Information: GSK Receipt Date: 10-OCT-2022 Author comment: The case was created given in the article. The patient was a part of study which analyzed data from four countries participating in a multicentre, test-negative design, vaccine effectiveness network including 41 sentinel hospitals. Individuals hospitalized at one of these centres with severe acute respiratory infection were tested for influenza by real-time RT-PCR, and were included in the analysis if they had complete information about their vaccination status and outcomes of their hospital stay. 2747 patients hospitalized with PCR-confirmed influenza virus infection between Jan 1, 2013, and Dec 8, 2019, were included in the study: 649 children (70 [10o8%] fully vaccinated, 193 [29o7%] partially vaccinated) of whom 87 (13o4%) were admitted to ICU and 12 (1o8%) died in hospital; 520 adults with pre-existing medical conditions (118 [22o7%] vaccinated), of whom 139 (26o7%) were admitted to ICU and 55 (10o6%) died in hospital; and 1578 older adults (609 [38o6%] vaccinated), of whom 271 (17o2%) were admitted to ICU and 220 (13o9%) died in hospital. For children aged 6 to 24 months. The participants were categorized as fully vaccinated if they had received two doses of influenza vaccine at least 14 days before symptom onset; and partially vaccinated if they had received only one dose of influenza vaccine at least 14 days before symptom onset. 12 (1o8%) of 649 children aged 6 to 24 months died in hospital: eight (2o1%) of 386 unvaccinated children, three (1o5%) of 193 partially vaccinated children, and one (1o4%) of 70 fully vaccinated children died in hospitalThe patient had real time RT-PCR of nasal swab and was confirmed for influenza infection. The patient had ICU admission and in-hospital death due to influenza. ?Based on sentinel surveillance, the results indicated that influenza vaccination could offer health benefits to some patients hospitalized with breakthrough influenza virus infections. A shorter lengths of hospital stay among partially and fully vaccinated children aged 6 to 24 months and vaccinated adults aged 18 to 64 years with pre-existing medical conditions compared with unvaccinated individuals in the respective age groups was observed. ?Influenza vaccination was associated with illness attenuation among those hospitalized with influenza, although results differed by vaccine target group. These findings might suggest that attenuation of disease severity might be specific to certain target groups, seasons, or settings.' Additional supportive information: This case was considered to be a suspected vaccination failure case, as the details regarding time to onset was unknown. This is 1 of the 3 cases reported in this Literature article.; Reported Cause(s) of Death: Influenza
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Test Name: RT-PCR; Result Unstructured Data: (Test Result:confirmed infection with influenza,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 30.09.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Near death experience
Symptomtext
nearly died; got GBS from the shot, nearly died; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening) and guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the near death experience and guillain barre syndrome were unknown. It was unknown if the reporter considered the near death experience to be related to Shingles vaccine. The reporter considered the guillain barre syndrome to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-SEP-2022 Reporter's Comment: This case was reported by a patient's wife via interactive digital media. The patient got GBS (Guillain Barre syndrome) from the Shingles shot and nearly died. Additional Supportive Information: The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 30.09.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Head discomfort
Head injury
Symptomtext
Death NOS; Was never the same/ complained of vaccine/ picked up off ground/had head hitting repeatedly; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and head discomfort. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the head discomfort was unknown. The reported cause of death was unknown cause of death. The reporter considered the unknown cause of death and head discomfort to be possibly related to Shingles vaccine. Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's comment: This case was reported by the consumer via interactive digital media. The reporter reported that his/her brother in law received a dose of Shingles vaccine and he died a few months later and complained ever since he got it. The reporter said that the patient was never the same. The reporter said that from patient's neighbors had to pick him up off the ground and took the patient inside and hit his head repeatedly. Additional Supportive Information: The follow-up would not possible as no contact details were available. Note: Suspect captured as per narrative as Shingles vaccine conservatively.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 24.09.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Herpes zoster
Vaccination failure
Symptomtext
Got the jab then had shingles / received the vaccine, then had shingles/Suspected vaccination failure; Horrible shingles, died while battling a horrible bout of shingles / suffered from shingles then passed away; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria death and GSK medically significant) and shingles (serious criteria death). On an unknown date, the outcome of the vaccination failure and shingles were fatal. The reported cause of death was shingles and vaccination failure. The reporter considered the vaccination failure and shingles to be possibly related to Shingrix. Additional Information: GSK Receipt Date: 18-SEP-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had a very health friend and never got shingles. The patient got the jab of shingles then suffered horrible shingles for years then passed away. The patient was died while battling horrible bout of shingles. The reporter stated that, the vaccine could lead to you getting shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.; Reported Cause(s) of Death: Shingles; Vaccination failure
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 22.09.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Ophthalmic herpes zoster
Vaccination failure
Symptomtext
Death; suspected vaccination failure/ Got shingles shot. Got shingles in eyes, died in a month; Shingles in eyes, close to brain, died in a month; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the vaccination failure and ophthalmic herpes zoster were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine. Additional Information: GSK receipt date: 17-Sep-2022 Reporter's comment: This case was reported by a patient's friend via interactive digital media. Reporter stated patient got the Shingles vaccine. The patient got shingls in eyes, was too close to patient's brain, however died under a month. Additional supportive information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.; Reported Cause(s) of Death: Death NOS
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 10.09.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Guillain-Barre syndrome
Therapeutic response unexpected
Symptomtext
received shingles shot and died; received shingles shot and it triggered GBS; had cancer, received shingles shot, cancer free; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included cancer. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), guillain barre syndrome (serious criteria GSK medically significant) and unexpected therapeutic effect. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the guillain barre syndrome and unexpected therapeutic effect were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death and unexpected therapeutic effect to be related to Shingles vaccine. The reporter considered the guillain barre syndrome to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-SEP-2022 Reporter's comment: The patient's relative reported this case via interactive digital media. The reporter reported that the patient received Shingles shot and it triggered GBS (Guillain Barre syndrome) and he died cancer free. Additional supportive information: The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Cancer
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 06.09.2022
- Impfdatum
- 01.08.2022
- Beginn
- 01.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Acupuncture
Cerebrovascular accident
Hemiplegia
Symptomtext
lost left side; stroke, lost left side; This case was reported by a consumer via interactive digital media and described the occurrence of left sided paralysis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In August 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced left sided paralysis (serious criteria GSK medically significant) and stroke (serious criteria GSK medically significant). The patient was treated with non-drug therapy (Acupuncture). On an unknown date, the outcome of the left sided paralysis was unknown and the outcome of the stroke was recovering/resolving. It was unknown if the reporter considered the left sided paralysis and stroke to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient received first dose of shingles vaccine last week (before reporting) and the patient was recovering from stroke, where patient lost his/her left side. The patient went for acupuncture to speed up recovery which brought on nerve regeneration, just wondering if GlaxoSmithKline want to check in to that for issue. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 01.09.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cerebrovascular accident
Product use in unapproved indication
Symptomtext
had a stokes; Don't recommend it if recipient is still recovering from shingles; This case was reported by a consumer via interactive digital media and described the occurrence of stroke in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant) and drug use for unapproved indication. On an unknown date, the outcome of the stroke and drug use for unapproved indication were unknown. It was unknown if the reporter considered the stroke to be related to Shingles vaccine. Additional Information: GSK receipt date: 18-Aug-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The patient had a stokes after vaccination. The reporter stated that did not recommend vaccine if recipient was still recovering from shingles. Additional supportive information: The patient received the vaccine when he still having shingles, which led to drug used for unapproved indication. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Shingles
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 16.08.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Herpes zoster
Neoplasm
Vaccination failure
Symptomtext
took vaccine, died 3 months later; got shingles after vaccine/Suspected vaccination failure; got shingles after vaccine; got tumor after vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant), shingles and neoplasm. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the vaccination failure, shingles and neoplasm were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, vaccination failure, shingles and neoplasm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 11-AUG-2022 Reporter's Comment: This case was reported by a patient's friend via interactive digital media. The patient took shingles vaccine. The patient got shingles and tumor after taking the vaccine. The patient died three months later. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. Time to onset for event unknown cause of death was conservatively captured as 3 months as it was not clear if it was after vaccination or other events.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- F
- Eingang
- 16.08.2022
- Impfdatum
- 26.06.2022
- Beginn
- 01.06.2022
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Amnesia
Dysphagia
Electroencephalogram
Fatigue
Gait disturbance
Aphasia
Cerebrovascular accident
Mobility decreased
Neurological symptom
Speech disorder
Immunisation reaction
Laboratory test
Loss of control of legs
Magnetic resonance imaging normal
Malaise
Nausea
Pain in extremity
Panic attack
Symptomtext
stroke like symptoms; Unable to speak; Unable to move easily; This case was reported by a pharmacist via sales rep and described the occurrence of stroke in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 26th June 2022 16:00, the patient received the 2nd dose of Shingles vaccine. In June 2022, less than a day after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant), aphasia and mobility decreased. On an unknown date, the outcome of the stroke, aphasia and mobility decreased were unknown. The reporter considered the stroke, aphasia and mobility decreased to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's Comments: The patient had applied for the claim after Shingles vaccination. On 27th June 2022, the next morning after vaccination, the patient was unable to speak, move easily and she got to her neighbor's house and was transported to the hospital. The patient alleged stroke like symptoms from the vaccine. The consent to follow-up was granted. Additional Supportive Information: Onset date was captured partially, to capture a correct time to onset as per narrative.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 29.07.2022
- Impfdatum
- 01.10.2020
- Beginn
- 20.10.2020
- Tage bis Beginn
- 19,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
my son passed on 20Oct2020 after getting the men B vaccine; This case was reported by a consumer and described the occurrence of unknown cause of death in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. In October 2020, the patient received Meningococcal B vaccine. On 20th October 2020, 4 days after receiving Meningococcal B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 20th October 2020. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Meningococcal B vaccine. Additional Information: GSK Receipt Date: 27-JUL-2022 Reporter's Comment: This case was reported by a patient's parent via interactive digital media. The reporter's son passed 4 days after getting the Meningococcal B vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- M
- Eingang
- 23.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cerebrovascular accident
Incomplete course of vaccination
Symptomtext
Stroke; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of stroke in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient did not receive the 2nd dose of Shingrix and received the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the stroke and incomplete course of vaccination were unknown. It was unknown if the reporter considered the stroke to be related to Shingrix. Additional Information: GSK Receipt Date:15-Jul-2022. Reporter's Comments: The patient's wife reported case on behalf of her husband. The patient received the first dose of Shingrix 3-4 years before the date of reporting. The patient had a stroke two years ago (adverse event -Symptomatic) and wanted to know if patient need to restart the vaccine series. It was also inquired if there was any assistance paid for Shingrix. The patient was provided medical disclaimer and referred to healthcare professional. The reporter consent to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Anxiety
Coma
Symptomtext
had same thing (Literally thought I was going to die); three day coma; This case was reported by a consumer via interactive digital media and described the occurrence of coma in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced coma (serious criteria GSK medically significant) and impending doom. On an unknown date, the outcome of the coma was recovered/resolved and the outcome of the impending doom was unknown. It was unknown if the reporter considered the coma and impending doom to be related to Shingles vaccine. Additional Information: GSK receipt date: 10-Jul-2022 Reporter's comment: The case was reported by the patient's neighbor via interactive digital media. The reporter reported that the patient had same thing (horrific reaction to the shingles shot and thought was going to die) and a three day coma. Additional supportive information: Follow-up could be not possible as no contact details were available. The case was linked with case US2022AMR105421 and US2022AMR105409, reported by same reporter for different patient. As per reported narrative the patient had same thing as reporter therefore conservatively same events were coded this patient also.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR105409:same report, other patient US-GLAXOSMITHKLINE-US2022AMR105421:tag at post
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Coma
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Herpes zoster
Intensive care
Near death experience
Vaccination failure
Symptomtext
nearly died, being in ICU for weeks; got shingles internally/shingles; got shingles internally/suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria hospitalization, GSK medically significant and life threatening), vaccination failure (serious criteria GSK medically significant) and shingles (serious criteria hospitalization). On an unknown date, the outcome of the near death experience, vaccination failure and shingles were unknown. It was unknown if the reporter considered the near death experience, vaccination failure and shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 9-Jul-2022 Reporter's comment: The case was reported by the patient's friend via interactive digital media. The reporter reported that one of his/her friend got shingles internally and nearly died, being in intensive care unit (ICU) for weeks. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR105388, reported by same reporter for different patient. As per reported information, the patient was in ICU for weeks therefore hospitalization was captured for all events except vaccination failure.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR105388:same report, other patient
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Adverse reaction
Completed suicide
Death
Symptomtext
committed suicide; an incurable adverse reaction; This case was reported by a consumer via interactive digital media and described the occurrence of suicide in a 81-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suicide (serious criteria death and GSK medically significant) and adverse reaction. On an unknown date, the outcome of the suicide was fatal and the outcome of the adverse reaction was not recovered/not resolved. The reported cause of death was suicide. The reporter considered the suicide and adverse reaction to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's son/daughter via interactive digital media. The reporter stated that his/ her 81 years old mom committed suicide on 18th August after suffering an incurable adverse reaction to that poison. Additional Supportive Information: The follow-up would not possible as no contact details were available. This case is 1 of 15 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter; Reported Cause(s) of Death: committed suicide
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information: The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information: The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information: The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information: The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information: The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information: The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information: The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information: The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information: The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information: The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information: The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information: The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information: The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information: The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 03.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Acute interstitial pneumonitis
Acute respiratory failure
Alanine aminotransferase increased
Aldolase increased
Anti-cyclic citrullinated peptide antibody negative
Anticoagulant therapy
Antineutrophil cytoplasmic antibody negative
Antinuclear antibody positive
Antisynthetase syndrome
Aspartate aminotransferase increased
Blood alkaline phosphatase normal
Blood creatine phosphokinase normal
Blood lactate dehydrogenase increased
Bronchoalveolar lavage normal
Carbohydrate antigen 19-9 increased
Carcinoembryonic antigen increased
Chest X-ray abnormal
Computerised tomogram thorax abnormal
Symptomtext
Antisynthetase Syndrome; acute interstitial pneumonitis; Acute progressive shortness of breath with walking a couple of blocks; short of breath while talking; mild cough with mild sputum production; night sweats; acute hypoxemic respiratory failure; severely hypoxic; tachypnea; sinus tachycardia; leukocytosis; Skin exam showed hyperkeratotic skin changes at fingertips consistent with mechanic's hand; diffuse bilateral ground-glass alveolar and interstitial infiltrates; mediastinal adenopathy; unprovoked deep vein thrombosis (DVT).; pulmonary embolism; This case was reported in a literature article and described the occurrence of antisynthetase syndrome in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis. The patient's past medical history included rheumatoid arthritis (Family History) (in his grandmother and sister), alopecia (Family History) (son), tonsillectomy, hernia repair and ex-smoker (former smoker who quit 35 years ago with ten pack-year). On an unknown date, the patient received Shingrix and PNEUMOVAX. On an unknown date, 2 days after receiving Shingrix, the patient experienced antisynthetase syndrome (serious criteria hospitalization), acute interstitial pneumonitis (serious criteria hospitalization and GSK medically significant), exertional dyspnea (serious criteria hospitalization), shortness of breath (serious criteria hospitalization), productive cough (serious criteria hospitalization), night sweat (serious criteria hospitalization), acute hypoxic respiratory failure (serious criteria hospitalization and GSK medically significant), hypoxia (serious criteria hospitalization and GSK medically significant), tachypnea (serious criteria hospitalization), sinus tachycardia (serious criteria hospitalization), leukocytosis (serious criteria hospitalization), mechanic's hand (serious criteria hospitalization), bilateral pulmonary infiltrates (serious criteria hospitalization), lymphadenopathy mediastinal (serious criteria hospitalization), deep vein thrombosis (serious criteria hospitalization and GSK medically significant) and pulmonary embolism (serious criteria hospitalization and GSK medically significant). The patient was treated with oxygen (High Flow Oxygen Therapy), methylprednisolone, prednisone, mycophenolate mofetil, enoxaparin, bivalirudin, immunosuppressants nos (Immunosuppressive Therapy (Nos)) and atovaquone. On an unknown date, the outcome of the antisynthetase syndrome, acute interstitial pneumonitis, exertional dyspnea, shortness of breath, productive cough, night sweat, acute hypoxic respiratory failure, hypoxia, tachypnea, sinus tachycardia, mechanic's hand, bilateral pulmonary infiltrates, lymphadenopathy mediastinal, deep vein thrombosis and pulmonary embolism were recovering/resolving and the outcome of the leukocytosis was recovered/resolved. The reporter considered the antisynthetase syndrome, acute interstitial pneumonitis, exertional dyspnea, shortness of breath, productive cough, night sweat, acute hypoxic respiratory failure, hypoxia, tachypnea, sinus tachycardia, leukocytosis, mechanic's hand, bilateral pulmonary infiltrates, lymphadenopathy mediastinal, deep vein thrombosis and pulmonary embolism to be possibly related to Shingrix. Additional Information: GSK Receipt Date: 22-Jun-2022 Author's Comment: The patient's family history was remarkable for rheumatoid arthritis in his grandmother and sister; his son had alopecia. The patient denied any significant medical history. The patient surgical history was notable for tonsillectomy and hernial repair. The patient was a former smoker who quit 35 years ago with ten pack-year smoking history. The patient presented with progressive shortness of breath over 2-3 weeks. The patient's symptoms started two days after receiving pneumococcal (Pneumovax) and zoster (RZV, Shingrix) vaccines. The patient reported feeling quite well until his respiratory symptoms started. Initially, the patient had shortness of breath (SOB) with walking a couple of blocks; by the time he presented to author's institution, the patient was short of breath while talking. The patient reported a mild cough with mild sputum production. The patient also endorsed night sweats, however no fever. The patient denied muscle weakness, muscle pain, joint pain, oral ulcers, skin rash, dysphagia, or Raynaud symptoms. The patient denied recent sick contacts. The patient was evaluated initially at a different medical center where he presented with acute hypoxemic respiratory failure due to unclear etiology. The patient did not respond to initial management and had worsening oxygen requirements. The patient was transferred to author's institution for further workup including evaluation for a lung transplant. Upon presentation to institution, the patient was severely hypoxic and required up to 60 liters 100% FIO2 of high-flow oxygen. The patient's other vitals showed tachypnea with respiratory rate 22-30, temperature max 99.2, sinus tachycardia with heart rate 120, and normal blood pressure. The patient's lungs were clear to auscultation bilaterally, with no rhonchi. Skin exam showed hyperkeratotic skin changes at fingertips consistent with mechanic's hand. The patient's initial comprehensive metabolic panel (CMP) and complete blood count (CBC) were unremarkable except for leukocytosis. The patient tested negative for SARS-CoV-2 COVID-19 twice and bronchoalveolar lavage (BAL) was negative for infections. Chest X-ray (CXR) showed diffuse bilateral ground-glass alveolar and interstitial infiltrates with bibasilar prominence and mediastinal adenopathy. Chest computed tomography (CT) scan showed findings consistent with pneumonitis. Further laboratory results were significant for elevated lactate dehydrogenase (LDH), alanine aminotransferase (ALT), aldolase and positive Anti-Jo-1 antibody. The patient's microbial cell-free DNA molecular testing (Karius) was negative. The patient's presentation raised suspicion for acute interstitial pneumonitis, most likely secondary to inflammatory myopathy. The patient received pulse dose methylprednisolone 1 g intravenous daily for three days, which was subsequently transitioned to prednisone 60 mg daily, in addition to high dose Mycophenolate mofetil. The patient was also started on Atovaquone for Pneumocystis jirovecii (PJP) prophylaxis. The patient was receiving therapeutic doses of enoxaparin for a recent diagnosis of unprovoked deep vein thrombosis (DVT). The patient was switched to bivalirudin as a result of the finding of positive heparin antibodies. The patient's CT chest showed low burden subsegmental pulmonary embolism, for which he underwent inferior vena cava (IVC) filter placement. Carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA-19-9) levels were elevated; however extensive evaluation including positron emission tomography (PET) scan and magnetic resonance imaging (MRI) abdomen did not reveal an underlying malignancy. A diagnosis of acute interstitial pneumonitis most likely secondary to anti-synthetase syndrome was made based on positive anti-Jo-1 antibody, elevated aldolase, ALT, LDH, and mechanic's hand features. The patient significantly improved with therapy; his oxygen requirements markedly decreased. The patient was eventually discharged from the hospital on minimal oxygen support. The patient participated in an outpatient pulmonary rehabilitation program during which he showed consistent improvement in physical endurance and was eventually completely weaned off oxygen. The patient remained on maintenance immunosuppressive therapy. The patient's labs remained stable and follow-up chest CT six months later demonstrated near-complete resolution of initial findings. The author described for the first time an alleged temporal relationship between the administration of Pneumovax and Shingrix vaccines and the development of ASS. Due to the relative rarity of autoimmune conditions compared to vaccine administrations, and due to the wide variability of patients' ages, along with the varying durations of the reported latency periods, it was very hard to draw conclusions about whether vaccines play a role in the development of autoimmune conditions. Additional supportive information: This article corresponding to this case is not available for regulatory submission due to copyright restriction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Acute respiratory failure
- Hospital-Tage
- -
- Labordaten
- Test Name: Alanine aminotransferase; Result Unstructured Data: (Test Result:70,Unit:unit/litre,Normal Low:4,Normal High:51); Test Name: aldolase; Result Unstructured Data: (Test Result:19.0,Unit:unit/litre,Normal Low:1.5,Normal High:4.1); Test Name: Anti-citrullinated peptide (CCP) antibodies; Test Result: Negative ; Test Name: Antineutrophil cytoplasmic autoantibodies (ANCA); Test Result: Negative ; Test Name: Anti-Jo-1 antibody; Test Result: Positive ; Test Name: Aspartate aminotransferase (AST); Result Unstructured Data: (Test Result:39,Unit:unit/litre,Normal Low:5,Normal High:46); Test Name: Lungs auscultation; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: Alkaline phosphatase (ALP); Result Unstructured Data: (Test Result:64,Unit:unit/litre,Normal Low:40,Normal High:129); Test Name: Creatinine Kinase (CK); Result Unstructured Data: (Test Result:60,Unit:unit/litre,Normal Low:24,Normal High:200); Test Name: lactate dehydrogenase; Result Unstructured Data: (Test Result:465,Unit:unit/litre,Normal Low:60,Normal High:200); Test Name: blood pressure; Result Unstructured Data: (Test Result:Normal result,Unit:unknown,Normal Low:,Normal High:); Test Name: Temperature; Result Unstructured Data: (Test Result:Maximum 99.2,Unit:unknown,Normal Low:,Normal High:); Test Name: bronchoalveolar lavage (BAL); Test Result: Negative ; Test Name: Carbohydrate antigen 19-9 (CA-19-9); Result Unstructured Data: (Test Result:37,Unit:unit/litre,Normal Low:0,Normal High:35); Test Name: Carcinoembryonic Antigen (CEA); Result Unstructured Data: (Test Result:6.9,Unit:unit/litre,Normal Low:0,Normal High:5); Test Name: Chest X-ray (CXR); Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: Chest computed tomography (CT) scan; Result Unstructured Data: (Test Result:showed findings consistent with pneumonitis,Unit:unknown,Normal Low:,Normal High:); Test Name: Chest computed tomography (CT) scan; Result Unstructured Data: (Test Result:low burden subsegmental pulmonary embolism,Unit:unknown,Normal Low:,Normal High:); Test Name: Chest computed tomography (CT) scan; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: Skin exam; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: complete blood count; Result Unstructured Data: (Test Result:unremarkable except for leukocytosis,Unit:unknown,Normal Low:,Normal High:); Test Name: heart rate; Result Unstructured Data: (Test Result:120,Unit:unknown,Normal Low:,Normal High:); Test Name: Hepatitis-B core antibody (HBcAb); Test Result: Positive ; Test Name: Hepatitis B surface antigen; Test Result: Negative ; Test Name: Hepatitis C antibody; Test Result: Negative ; Test Name: Heparin antibodies; Test Result: Positive ; Test Name: microbial cell-free DNA molecular testing (Karius); Test Result: Negative ; Test Name: magnetic resonance imaging (MRI) abdomen; Result Unstructured Data: (Test Result:did not reveal an underlying malignancy,Unit:unknown,Normal Low:,Normal High:); Test Name: comprehensive metabolic panel (CMP); Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: positron emission tomography (PET) scan; Result Unstructured Data: (Test Result:did not reveal an underlying malignancy,Unit:unknown,Normal Low:,Normal High:); Test Name: respiratory rate; Result Unstructured Data: (Test Result:20-30,Unit:unknown,Normal Low:,Normal High:); Test Name: SARS-CoV-2 COVID-19; Test Result: Negative ; Test Name: SARS-CoV-2 COVID-19; Test Result: Negative ; Comments: Lungs were clear to auscultation bilaterally, with no rhonchi. Skin exam showed hyperkeratotic skin changes at fingertips consistent with mechanic's hand. Chest X-ray (CXR) showed diffuse bilateral ground-glass alveolar and interstitial infiltrates with bibasilar prominence and mediastinal adenopathy. Follow-up chest CT six months later demonstrated near-complete resolution of initial findings.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Alopecia (son); Ex-smoker (former smoker who quit 35 years ago with ten pack-year); Hernia repair; Rheumatoid arthritis (in his grandmother and sister); Tonsillectomy
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 03.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Acute interstitial pneumonitis
Acute respiratory failure
Alanine aminotransferase increased
Aldolase increased
Anti-cyclic citrullinated peptide antibody negative
Anticoagulant therapy
Antineutrophil cytoplasmic antibody negative
Antinuclear antibody positive
Antisynthetase syndrome
Aspartate aminotransferase increased
Blood alkaline phosphatase normal
Blood creatine phosphokinase normal
Blood lactate dehydrogenase increased
Bronchoalveolar lavage normal
Carbohydrate antigen 19-9 increased
Carcinoembryonic antigen increased
Chest X-ray abnormal
Computerised tomogram thorax abnormal
Symptomtext
Antisynthetase Syndrome; acute interstitial pneumonitis; Acute progressive shortness of breath with walking a couple of blocks; short of breath while talking; mild cough with mild sputum production; night sweats; acute hypoxemic respiratory failure; severely hypoxic; tachypnea; sinus tachycardia; leukocytosis; Skin exam showed hyperkeratotic skin changes at fingertips consistent with mechanic's hand; diffuse bilateral ground-glass alveolar and interstitial infiltrates; mediastinal adenopathy; unprovoked deep vein thrombosis (DVT).; pulmonary embolism; This case was reported in a literature article and described the occurrence of antisynthetase syndrome in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis. The patient's past medical history included rheumatoid arthritis (Family History) (in his grandmother and sister), alopecia (Family History) (son), tonsillectomy, hernia repair and ex-smoker (former smoker who quit 35 years ago with ten pack-year). On an unknown date, the patient received Shingrix and PNEUMOVAX. On an unknown date, 2 days after receiving Shingrix, the patient experienced antisynthetase syndrome (serious criteria hospitalization), acute interstitial pneumonitis (serious criteria hospitalization and GSK medically significant), exertional dyspnea (serious criteria hospitalization), shortness of breath (serious criteria hospitalization), productive cough (serious criteria hospitalization), night sweat (serious criteria hospitalization), acute hypoxic respiratory failure (serious criteria hospitalization and GSK medically significant), hypoxia (serious criteria hospitalization and GSK medically significant), tachypnea (serious criteria hospitalization), sinus tachycardia (serious criteria hospitalization), leukocytosis (serious criteria hospitalization), mechanic's hand (serious criteria hospitalization), bilateral pulmonary infiltrates (serious criteria hospitalization), lymphadenopathy mediastinal (serious criteria hospitalization), deep vein thrombosis (serious criteria hospitalization and GSK medically significant) and pulmonary embolism (serious criteria hospitalization and GSK medically significant). The patient was treated with oxygen (High Flow Oxygen Therapy), methylprednisolone, prednisone, mycophenolate mofetil, enoxaparin, bivalirudin, immunosuppressants nos (Immunosuppressive Therapy (Nos)) and atovaquone. On an unknown date, the outcome of the antisynthetase syndrome, acute interstitial pneumonitis, exertional dyspnea, shortness of breath, productive cough, night sweat, acute hypoxic respiratory failure, hypoxia, tachypnea, sinus tachycardia, mechanic's hand, bilateral pulmonary infiltrates, lymphadenopathy mediastinal, deep vein thrombosis and pulmonary embolism were recovering/resolving and the outcome of the leukocytosis was recovered/resolved. The reporter considered the antisynthetase syndrome, acute interstitial pneumonitis, exertional dyspnea, shortness of breath, productive cough, night sweat, acute hypoxic respiratory failure, hypoxia, tachypnea, sinus tachycardia, leukocytosis, mechanic's hand, bilateral pulmonary infiltrates, lymphadenopathy mediastinal, deep vein thrombosis and pulmonary embolism to be possibly related to Shingrix. Additional Information: GSK Receipt Date: 22-Jun-2022 Author's Comment: The patient's family history was remarkable for rheumatoid arthritis in his grandmother and sister; his son had alopecia. The patient denied any significant medical history. The patient surgical history was notable for tonsillectomy and hernial repair. The patient was a former smoker who quit 35 years ago with ten pack-year smoking history. The patient presented with progressive shortness of breath over 2-3 weeks. The patient's symptoms started two days after receiving pneumococcal (Pneumovax) and zoster (RZV, Shingrix) vaccines. The patient reported feeling quite well until his respiratory symptoms started. Initially, the patient had shortness of breath (SOB) with walking a couple of blocks; by the time he presented to author's institution, the patient was short of breath while talking. The patient reported a mild cough with mild sputum production. The patient also endorsed night sweats, however no fever. The patient denied muscle weakness, muscle pain, joint pain, oral ulcers, skin rash, dysphagia, or Raynaud symptoms. The patient denied recent sick contacts. The patient was evaluated initially at a different medical center where he presented with acute hypoxemic respiratory failure due to unclear etiology. The patient did not respond to initial management and had worsening oxygen requirements. The patient was transferred to author's institution for further workup including evaluation for a lung transplant. Upon presentation to institution, the patient was severely hypoxic and required up to 60 liters 100% FIO2 of high-flow oxygen. The patient's other vitals showed tachypnea with respiratory rate 22-30, temperature max 99.2, sinus tachycardia with heart rate 120, and normal blood pressure. The patient's lungs were clear to auscultation bilaterally, with no rhonchi. Skin exam showed hyperkeratotic skin changes at fingertips consistent with mechanic's hand. The patient's initial comprehensive metabolic panel (CMP) and complete blood count (CBC) were unremarkable except for leukocytosis. The patient tested negative for SARS-CoV-2 COVID-19 twice and bronchoalveolar lavage (BAL) was negative for infections. Chest X-ray (CXR) showed diffuse bilateral ground-glass alveolar and interstitial infiltrates with bibasilar prominence and mediastinal adenopathy. Chest computed tomography (CT) scan showed findings consistent with pneumonitis. Further laboratory results were significant for elevated lactate dehydrogenase (LDH), alanine aminotransferase (ALT), aldolase and positive Anti-Jo-1 antibody. The patient's microbial cell-free DNA molecular testing (Karius) was negative. The patient's presentation raised suspicion for acute interstitial pneumonitis, most likely secondary to inflammatory myopathy. The patient received pulse dose methylprednisolone 1 g intravenous daily for three days, which was subsequently transitioned to prednisone 60 mg daily, in addition to high dose Mycophenolate mofetil. The patient was also started on Atovaquone for Pneumocystis jirovecii (PJP) prophylaxis. The patient was receiving therapeutic doses of enoxaparin for a recent diagnosis of unprovoked deep vein thrombosis (DVT). The patient was switched to bivalirudin as a result of the finding of positive heparin antibodies. The patient's CT chest showed low burden subsegmental pulmonary embolism, for which he underwent inferior vena cava (IVC) filter placement. Carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA-19-9) levels were elevated; however extensive evaluation including positron emission tomography (PET) scan and magnetic resonance imaging (MRI) abdomen did not reveal an underlying malignancy. A diagnosis of acute interstitial pneumonitis most likely secondary to anti-synthetase syndrome was made based on positive anti-Jo-1 antibody, elevated aldolase, ALT, LDH, and mechanic's hand features. The patient significantly improved with therapy; his oxygen requirements markedly decreased. The patient was eventually discharged from the hospital on minimal oxygen support. The patient participated in an outpatient pulmonary rehabilitation program during which he showed consistent improvement in physical endurance and was eventually completely weaned off oxygen. The patient remained on maintenance immunosuppressive therapy. The patient's labs remained stable and follow-up chest CT six months later demonstrated near-complete resolution of initial findings. The author described for the first time an alleged temporal relationship between the administration of Pneumovax and Shingrix vaccines and the development of ASS. Due to the relative rarity of autoimmune conditions compared to vaccine administrations, and due to the wide variability of patients' ages, along with the varying durations of the reported latency periods, it was very hard to draw conclusions about whether vaccines play a role in the development of autoimmune conditions. Additional supportive information: This article corresponding to this case is not available for regulatory submission due to copyright restriction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Acute respiratory failure
- Hospital-Tage
- -
- Labordaten
- Test Name: Alanine aminotransferase; Result Unstructured Data: (Test Result:70,Unit:unit/litre,Normal Low:4,Normal High:51); Test Name: aldolase; Result Unstructured Data: (Test Result:19.0,Unit:unit/litre,Normal Low:1.5,Normal High:4.1); Test Name: Anti-citrullinated peptide (CCP) antibodies; Test Result: Negative ; Test Name: Antineutrophil cytoplasmic autoantibodies (ANCA); Test Result: Negative ; Test Name: Anti-Jo-1 antibody; Test Result: Positive ; Test Name: Aspartate aminotransferase (AST); Result Unstructured Data: (Test Result:39,Unit:unit/litre,Normal Low:5,Normal High:46); Test Name: Lungs auscultation; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: Alkaline phosphatase (ALP); Result Unstructured Data: (Test Result:64,Unit:unit/litre,Normal Low:40,Normal High:129); Test Name: Creatinine Kinase (CK); Result Unstructured Data: (Test Result:60,Unit:unit/litre,Normal Low:24,Normal High:200); Test Name: lactate dehydrogenase; Result Unstructured Data: (Test Result:465,Unit:unit/litre,Normal Low:60,Normal High:200); Test Name: blood pressure; Result Unstructured Data: (Test Result:Normal result,Unit:unknown,Normal Low:,Normal High:); Test Name: Temperature; Result Unstructured Data: (Test Result:Maximum 99.2,Unit:unknown,Normal Low:,Normal High:); Test Name: bronchoalveolar lavage (BAL); Test Result: Negative ; Test Name: Carbohydrate antigen 19-9 (CA-19-9); Result Unstructured Data: (Test Result:37,Unit:unit/litre,Normal Low:0,Normal High:35); Test Name: Carcinoembryonic Antigen (CEA); Result Unstructured Data: (Test Result:6.9,Unit:unit/litre,Normal Low:0,Normal High:5); Test Name: Chest X-ray (CXR); Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: Chest computed tomography (CT) scan; Result Unstructured Data: (Test Result:showed findings consistent with pneumonitis,Unit:unknown,Normal Low:,Normal High:); Test Name: Chest computed tomography (CT) scan; Result Unstructured Data: (Test Result:low burden subsegmental pulmonary embolism,Unit:unknown,Normal Low:,Normal High:); Test Name: Chest computed tomography (CT) scan; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: Skin exam; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: complete blood count; Result Unstructured Data: (Test Result:unremarkable except for leukocytosis,Unit:unknown,Normal Low:,Normal High:); Test Name: heart rate; Result Unstructured Data: (Test Result:120,Unit:unknown,Normal Low:,Normal High:); Test Name: Hepatitis-B core antibody (HBcAb); Test Result: Positive ; Test Name: Hepatitis B surface antigen; Test Result: Negative ; Test Name: Hepatitis C antibody; Test Result: Negative ; Test Name: Heparin antibodies; Test Result: Positive ; Test Name: microbial cell-free DNA molecular testing (Karius); Test Result: Negative ; Test Name: magnetic resonance imaging (MRI) abdomen; Result Unstructured Data: (Test Result:did not reveal an underlying malignancy,Unit:unknown,Normal Low:,Normal High:); Test Name: comprehensive metabolic panel (CMP); Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: positron emission tomography (PET) scan; Result Unstructured Data: (Test Result:did not reveal an underlying malignancy,Unit:unknown,Normal Low:,Normal High:); Test Name: respiratory rate; Result Unstructured Data: (Test Result:20-30,Unit:unknown,Normal Low:,Normal High:); Test Name: SARS-CoV-2 COVID-19; Test Result: Negative ; Test Name: SARS-CoV-2 COVID-19; Test Result: Negative ; Comments: Lungs were clear to auscultation bilaterally, with no rhonchi. Skin exam showed hyperkeratotic skin changes at fingertips consistent with mechanic's hand. Chest X-ray (CXR) showed diffuse bilateral ground-glass alveolar and interstitial infiltrates with bibasilar prominence and mediastinal adenopathy. Follow-up chest CT six months later demonstrated near-complete resolution of initial findings.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Alopecia (son); Ex-smoker (former smoker who quit 35 years ago with ten pack-year); Hernia repair; Rheumatoid arthritis (in his grandmother and sister); Tonsillectomy
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 03.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Blood disorder
Death
Symptomtext
The shot gave my mother a blood disorder that killed her; This case was reported by a consumer via interactive digital media and described the occurrence of blood disorder in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced blood disorder (serious criteria death). On an unknown date, the outcome of the blood disorder was fatal. The reported cause of death was blood disorder. The reporter considered the blood disorder to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 26-Jun-2022 Reporters comment: The case was reported by patient's child via interactive digital media. The shot gave the patient a blood disorder that killed her. The vaccine for them killed the patient. Additional Supportive Information: The follow up was not possible as no contact details were available.; Reported Cause(s) of Death: Blood disorder
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 03.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Guillain-Barre syndrome
Symptomtext
died; GBS as a side effect, and died; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the guillain barre syndrome was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death and guillain barre syndrome to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-JUN-2022 Reporter's Comment: This case was reported by a patient's son/daughter via interactive digital media. The patient got the Shingles vaccine and got Guillain Barre syndrome (GBS) as a side effect. The patient was died. Additional Supportive Information: The follow up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.06.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
Because last one i took nearlykilled me; This case was reported by a consumer via market research programs and described the occurrence of near death experience in a patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. On an unknown date, the patient received Hz/su + AS01B. On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown. The reporter considered the near death experience to be related to Hz/su + AS01B. Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comments: The patient self-reported the case via market research programs. The patient reported that, last one dose of Shingrix, nearly killed him/her
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OR
- Alter
- 71,0
- Geschlecht
- U
- Eingang
- 25.06.2022
- Impfdatum
- 01.04.2022
- Beginn
- 21.04.2022
- Tage bis Beginn
- 20,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Atrial fibrillation
Cerebrovascular accident
Symptomtext
Found out I have atrial fibrillation; Stroke after first dose; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. On 1st April 2022, the patient received the 1st dose of Shingrix. On 21st April 2022, 20 days after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the patient experienced atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke and atrial fibrillation were unknown. It was unknown if the reporter considered the stroke and atrial fibrillation to be related to Shingrix. Linked case(s) involving the same patient: US2022AMR094009 Additional Information: GSK Receipt Date: 16-Jun-2022 Reporter's Comments: The patient self-reported this case. The patient had a stroke after his/her 1st dose of Shingrix vaccine and also found that he/she had atrial fibrillation. The patient had been going to doctor physical once a year and twice a year after he/she turned 65 year old. The patient stated he/she would have to go to assisted living soon. Additional Supportive Information: For tolerance to 2nd dose, refer case US2022AMR094009. GSK note: There was a discrepancy in product onset dates and event onset dates, AI was raised for the same and will be clarified in the next follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR094009:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 31.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Protein total increased
Symptomtext
those lovely shots killed my daddy; shed that spike protein; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included covid-19 (Family History) (the patient's son-in-law had covid-19) and shingles (Family History) (the patient's daughter had shingles). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and protein total increased. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the protein total increased was unknown. The reported cause of death was unknown cause of death. The reporter considered the unknown cause of death to be related to Shingles vaccine. It was unknown if the reporter considered the protein total increased to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comment: This case was reported by patient's daughter via interactive digital media. The patient took the jabs (Shingles vaccine) (though the reporter begged him not to) and he shed that spike protein and suddenly reporter's husband had Covid and reporter had shingles. The reporter stated that, if that was not enough, those lovely shots killed her daddy (patient). The reporter further stated that, all these little birds were chirping source, source would never believe they had been lied too and fooled. The doctors and so many others were kept ringing the alarm, but they would not listen. Additional Supportive Information: The follow up would not possible as no contact details were available. Note: As the information was not clear. Hence, all the information was retained, and case kept valid.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: COVID-19 (the patient's son-in-law had covid-19); Shingles (the patient's daughter had shingles)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 26.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Herpes zoster
Immune system disorder
Neoplasm malignant
Nervous system disorder
Pain
Vaccination failure
Symptomtext
died with shingles, destroying spine and brain; died with shingles, destroying spine and brain; Suspected vaccination failure; cancer; amun system was gone; terrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced shingles (serious criteria death), central nervous system disorder (serious criteria death), vaccination failure (serious criteria GSK medically significant), cancer (serious criteria GSK medically significant), immune system disorder and pain. On an unknown date, the outcome of the shingles and central nervous system disorder were fatal and the outcome of the vaccination failure, cancer, immune system disorder and pain were unknown. The reported cause of death was shingles and central nervous system disorder. It was unknown if the reporter considered the shingles, central nervous system disorder, vaccination failure, cancer, immune system disorder and pain to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 21-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter was the patient's spouse. The patient died with shingles that got into his insides destroying his spine and brain. The patient's immune system was gone due to cancer. The patient had both shingles shots, he could not swollen, he lived 12 days and was in terrible pain. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible, as no contact details were available.; Reported Cause(s) of Death: died with shingles, destroying spine and brain; died with shingles, destroying spine and brain
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 26.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Herpes zoster
Immune system disorder
Neoplasm malignant
Nervous system disorder
Pain
Vaccination failure
Symptomtext
died with shingles, destroying spine and brain; died with shingles, destroying spine and brain; Suspected vaccination failure; cancer; amun system was gone; terrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced shingles (serious criteria death), central nervous system disorder (serious criteria death), vaccination failure (serious criteria GSK medically significant), cancer (serious criteria GSK medically significant), immune system disorder and pain. On an unknown date, the outcome of the shingles and central nervous system disorder were fatal and the outcome of the vaccination failure, cancer, immune system disorder and pain were unknown. The reported cause of death was shingles and central nervous system disorder. It was unknown if the reporter considered the shingles, central nervous system disorder, vaccination failure, cancer, immune system disorder and pain to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 21-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter was the patient's spouse. The patient died with shingles that got into his insides destroying his spine and brain. The patient's immune system was gone due to cancer. The patient had both shingles shots, he could not swollen, he lived 12 days and was in terrible pain. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible, as no contact details were available.; Reported Cause(s) of Death: died with shingles, destroying spine and brain; died with shingles, destroying spine and brain
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- 75,0
- Geschlecht
- F
- Eingang
- 26.04.2022
- Impfdatum
- 10.03.2021
- Beginn
- 11.07.2021
- Tage bis Beginn
- 123,0
- Dosis
- UNK
- Route/Site
- UN / RA
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Central nervous system lesion
Condition aggravated
Death
Magnetic resonance imaging
Multiple sclerosis relapse
Nervous system disorder
Symptomtext
See attachment for complete history and observations - patient apparently suffered fatal interaction when Covid Vaccine interacted with active Multiple Sclerosis relapse. Relapsing-Remitting MS case converted to aggressive Progressive MS, which,over the course of 1 year following the vaccine doses, rapidly accelarated the progression of lesions that cut off central nervous system commumication with legs, then arms, and, finally even lungs. (I attempted to paste the complete report on this form, but it would not accept that kind of input, and the details require more than this page will accept. Please contact me by email as indicated above if you are interested in the details.)
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Numerous MRI images, and symptomatic records at multiple health facilities.
- Aktuelle Erkrankungen
- see #12
- Vorgeschichte
- Multiple Sclerosis
- Andere Medikamente
- Vimpat, metropolol, baclofen, Levothyroxine, duloxetine,
- Allergien
- n'a
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 15.04.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Herpes zoster
Ophthalmic herpes zoster
Vaccination failure
Symptomtext
Late husband had the shot; Suspected vaccination failure; Shingles around eye and topped head, almost lost eye; Shingles topped his head; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the vaccination failure, ophthalmic herpes zoster and herpes zoster were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, vaccination failure, ophthalmic herpes zoster and herpes zoster to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 08-Apr-2022 Reporter's Comments: This case was reported by the patient's spouse via interactive digital media. The reporter's late husband had the shingles shot and shingles attacked him two years later around his eye and topped his head, the patient almost lost his eye. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.03.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Near death experience
Paraplegia
Symptomtext
guillain barre syndrome/paralyzed from neck up; paralyzed from waist down and neck up; Getting the vaccine almost killed me; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), paraplegia (serious criteria GSK medically significant) and near death experience (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome, paraplegia and near death experience were unknown. It was unknown if the reporter considered the guillain barre syndrome, paraplegia and near death experience to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient self-reported this case. The patient received the Shingles vaccine and ended up with Guillain-Barre syndrome. The patient was paralyzed from the waist down and the neck up. Getting the vaccine almost killed the patient. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 62,0
- Geschlecht
- M
- Eingang
- 26.02.2022
- Impfdatum
- 22.10.2021
- Beginn
- 22.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Cardiac arrest
Death
General physical health deterioration
Injection site erythema
Injection site pain
Injection site swelling
Symptomtext
Patient developed increasing pain, redness, and swelling around injection site. Transported to emergency room the following day, 10/23/21. Continued to worsen, went into cardiac arrest and pronounced deceased in the emergency room.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cardiac arrest
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- E/S renal disease w/ dialysis, chronic diastolic heart faiulre, DM II, HTN, glaucoma, normocytic anemia, hyperkalemia, venous ulcer of right leg, peripheral artery disease, gangrene of left foot 11/18/20, dry gangrene 2/20/21, and osteomyelitis and gangrene 3/1/21. No recent flu-like symptoms.
- Andere Medikamente
- None
- Allergien
- Unk
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.01.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
killed my mother; This case was reported by a consumer via interactive digital media and described the occurrence of death in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. The reporter considered the death to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. This vaccine killed the patient's mother. The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 26.01.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cerebrovascular accident
Symptomtext
stroke; This case was reported by a consumer via interactive digital media and described the occurrence of stroke in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was unknown. It was unknown if the reporter considered the stroke to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient's parent. The age at vaccination was not reported. The patient got Shingles shot and week later stroke. The reporter wanted to know if there was any connection. The follow-up would not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CO
- Alter
- 62,0
- Geschlecht
- F
- Eingang
- 21.01.2022
- Impfdatum
- 02.12.2021
- Beginn
- 20.01.2022
- Tage bis Beginn
- 49,0
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cerebrovascular accident
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- 2,0
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- DM, HLD, HTN
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 13.01.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Condition aggravated
Glaucoma
Herpes zoster
Vaccination failure
Symptomtext
Suspected vaccination failure; Now has glaucoma; Now broken out with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included ankle operation (had major surgery on ankle 13 years ago from reporting date) and shingles (on face). On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), glaucoma (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the glaucoma and shingles were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, glaucoma and shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient received new Shingles vaccine, last one months ago from the date of reporting and the patient had broken out with shingles on his back at the time of reporting. The patient now also had glaucoma. The patient asked if this Shingles shot did any good or was it just a money maker. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Glaucoma
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Ankle operation (had major surgery on ankle 13 years ago from reporting date); Shingles (on face)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 88,0
- Geschlecht
- M
- Eingang
- 12.01.2022
- Impfdatum
- 18.02.2021
- Beginn
- 22.12.2021
- Tage bis Beginn
- 307,0
- Dosis
- 2
- Route/Site
- UN / UN
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Death
Symptomtext
Narrative: 87yo male patient with the following: CURRENT PROBLEM LIST: Bladder cancer (SCT 399326009) Sleep Apnea (SCT 73430006) Hearing Loss (SCT 15188001) Health maintenance alteration (SCT 24441001) Obesity (SCT 414916001) Postsurgical Status of Automatic Implantable Cardiac Defibrillator in Situ (ICD-9-CM V45.02) Fitting and Adjustment of Cardiac PacemaTransient Ischemic Attack (ICD-9-CM 435.9) Cholecystectomy (ICD-9-CM 575.9) Allergic Rhinitis (ICD-9-CM 477.9) Diverticulosis (ICD-9-CM 562.10) Spinal stenosis of lumbar region (SCT 18347007) Diabetes mellitus (SCT 73211009) HYPERLIPIDEMIA (ICD-9-CM 272.4) Benign hypertension (SCT 10725009) Ischemic heart disease (SCT 414545008) Pt died on 12/22/2021 at outside facility location. No information in facility chart as pt received most of his care outside the facility. Pt had received 2 covid vaccines outside facility on 1/21 & 2/18 2021. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccination administration.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 11.01.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Condition aggravated
Death
Herpes zoster
Symptomtext
Death NOS; Shingle within the same week, permanent until he died; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and shingles. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the shingles was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death and shingles to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient's relative. The age at vaccination was not reported. The patient received Shingles vaccine when it first came out. Less than a week after receiving Shingles vaccine, the patient got a full-blown shingles breakout within the same week. The patient had permanent shingles until the day he died. This case had been linked with case US2021AMR201151, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR201151:Same reporter.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Shingles
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 87,0
- Geschlecht
- F
- Eingang
- 03.01.2022
- Impfdatum
- 29.12.2021
- Beginn
- 29.12.2021
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- SYR / AR
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: ja
ER: ja
Erholt: nein
Amnesia
Concussion
Fall
Myocardial infarction
Symptomtext
Suffered a heart attack which resulted in a fall from 3 steps to asphalt. Concussion/ memory loss, no broken bones
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Myocardial infarction
- Hospital-Tage
- 6,0
- Labordaten
- 911 - Rushed to Hospital. In-patient hospitalization 6 days and counting. To be released to Re-hab center - unknown at this time. Victim was independently living at time of event.
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- Ocular Migraines, Arthritis
- Andere Medikamente
- Metformin, Lipitor, Losrtan, Asprin
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 29.12.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
got shingles vaccine and died four months later; This case was reported by a consumer via interactive digital media and described the occurrence of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The reporter stated that, the patient got shingles vaccine and died four months later. The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 09.12.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Myocardial infarction
Symptomtext
in the emergency for a heart attack; This case was reported by a consumer via interactive digital media and described the occurrence of heart attack in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced heart attack (serious criteria GSK medically significant). On an unknown date, the outcome of the heart attack was unknown. It was unknown if the reporter considered the heart attack to be related to Shingrix. Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. After receiving Shingrix, the patient was in the emergency for a heart attack. The patient's physician said that the patient was the 6th case of post Shingrix heart attack that week. This case is one of 6 linked cases, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR249784:Same reporter US-GLAXOSMITHKLINE-US2021AMR249783:Same reporter US-GLAXOSMITHKLINE-US2021AMR249782:Same reporter US-GLAXOSMITHKLINE-US2021AMR249785:Same reporter US-GLAXOSMITHKLINE-US2021AMR249781:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Myocardial infarction
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.12.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Completed suicide
Death
Symptomtext
This case was reported by a physician via (Tracking HCP SHINGRIX conversations on social media. Market research programs and described the occurrence of suicide in unspecified number of patients who received Herpes zoster (Hz/su + AS01B) for prophylaxis. On an unknown date, the patient received Hz/su + AS01B. On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced suicide (serious criteria death and GSK medically significant). On an unknown date, the outcome of the suicide was fatal. The reported cause of death was suicide. It was unknown if the reporter considered the suicide to be related to Hz/su + AS01B. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, it was so sad about the suicides post vaccination. The consent to follow up was denied. This case is linked with US2021AMR247029 and US2021AMR246983, reported by the same reporter. Note: The narrative seemed to be a generalized statement but as all the posts were related to SHINGRIX vaccination and its side effects, this case was conservatively processed.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR247029: same reporter US-GLAXOSMITHKLINE-US2021AMR246983: Same reporter - 1st dose US-GLAXOSMITHKLINE-US2021AMR246983: Same reporter - 1st dose US-GLAXOSMITHKLINE-US2021AMR247029:Same reporter.; Reported Cause(s) of Death: Suicide.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- SHINGRIX
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 26.11.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Impaired work ability
Near death experience
Symptomtext
Near death experience; she can no longer work; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening) and inability to work. On an unknown date, the outcome of the near death experience was not recovered/not resolved and the outcome of the inability to work was unknown. It was unknown if the reporter considered the near death experience and inability to work to be related to Shingles vaccine. Additional details were provided as follows: The patient was the reporter's cousin. The age at vaccination was not reported. The reporter stated that the patient nearly died when she had a Shingles vaccine and it happened, initially and every month since, she had nearly died and would for the rest of her life. The reporter stated that the patient needed to get medical treatments, that was financially impossible for her to pay for and she could no longer work. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 23.11.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Pain
Symptomtext
After being vaccinated, was dead within 10 weeks; Pain was so bad; This case was reported by a consumer via social media interactive digital media and described the occurrence of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included neurological disorder nos and shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced death (serious criteria death and GSK medically significant) and pain. The patient was treated with analgesic, nos (Painkiller) and opioids {nos} (Opioids). On an unknown date, the outcome of the death was fatal and the outcome of the pain was unknown. The reported cause of death was death. It was unknown if the reporter considered the death and pain to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by the patient's son/daughter. The age at vaccination was not reported. The reporter stated that the patient had nerve disorder and then got shingles. After being vaccinated with Shingles vaccine the pain was so bad the patient needed pain intervention from a doctor who came to her at home and the reporter stated imagine pain that bad. The reporter stated that no amount of painkiller eased patient's pain, opioids too. The patient was dead within 10 weeks. The follow up would not possible as no contact information was available; Reported Cause(s) of Death: was dead within 10 weeks
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Neurological disorder NOS; Shingles
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 23.11.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cerebrovascular accident
Symptomtext
had a stroke; This case was reported by a consumer via interactive digital media and described the occurrence of stroke in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was unknown. It was unknown if the reporter considered the stroke to be related to Shingles vaccine. Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient stated that, he/she took a single vaccine and about 2 weeks later, had a stroke. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 13.11.2021
- Impfdatum
- 15.03.2021
- Beginn
- 01.05.2021
- Tage bis Beginn
- 47,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Acute disseminated encephalomyelitis
Bedridden
Cerebrovascular accident
Demyelination
Gait disturbance
Hypokinesia
Lymphoma
Neurological symptom
Symptomtext
Stroke; Lymphoma; Lymphoma; Severe demyelination of brain; Neurological disease; Minimal movement in left arm ad left leg; Can't get out of bed or walk without help; Can't get out of bed or walk without help; This case was reported by a other health professional and described the occurrence of stroke in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis and COVID 19 MRNA VACCINE MODERNA for prophylaxis. Previously administered products included Moderna vaccine (received 1st dose on 15th February 2021). On 5th May 2021, the patient received the 1st dose of Shingrix and Tdap Vaccine. On 15th March 2021, the patient received the 2nd dose of COVID 19 MRNA VACCINE MODERNA. In May 2021, less than 3 weeks after receiving Shingrix and Tdap Vaccine, the patient experienced stroke (serious criteria GSK medically significant), acute disseminated encephalomyelitis (serious criteria GSK medically significant), lymphoma (serious criteria GSK medically significant), demyelination (serious criteria GSK medically significant), neurological symptom, movements reduced, bedridden and walking difficulty. On an unknown date, the outcome of the stroke, acute disseminated encephalomyelitis, lymphoma, demyelination, neurological symptom, movements reduced, bedridden and walking difficulty were not recovered/not resolved. It was unknown if the reporter considered the stroke, acute disseminated encephalomyelitis, lymphoma, demyelination, neurological symptom, movements reduced, bedridden and walking difficulty to be related to Shingrix and Tdap Vaccine. Additional details were provided as follows: The reporter was an epidemiology lead. The age at vaccination was not reported. The reporter knew someone whose mother (patient) received the Moderna and Shingrix vaccines and in May 2021, less than 3 weeks after receiving Shingrix and Tdap Vaccine and between 1 and 3 months after receiving Moderna vaccine, the patient developed some neurological symptoms. The symptoms were observed in mid-May 2021 and worsened by the day. The patient went to emergency room on 7th June and again on 14th June 2021. Initial diagnosis on 14th June 2021 was stroke but at the time of reporting it was undiagnosed neurological disease with severe demyelination of the brain. The patient experienced minimal movement in left arm and left leg and could not get out of bed or walk without help. This was reported to VAERS. The patient's son was also told that, it was most likely acute disseminated encephalomyelitis but now another doctor suggested lymphoma. The patient's son said he had been chasing ghosts with the doctors he had been sending the patient to and could not get a clear diagnosis. The reporter was reaching out to GlaxoSmithKline but was not sure if needed to report this to global safety. It was unknown if the reporter considered the stroke, acute disseminated encephalomyelitis, lymphoma, demyelination, neurological symptom, movements reduced, bedridden and walking difficulty to be related to Moderna vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 13.11.2021
- Impfdatum
- 15.03.2021
- Beginn
- 01.05.2021
- Tage bis Beginn
- 47,0
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Acute disseminated encephalomyelitis
Bedridden
Cerebrovascular accident
Demyelination
Gait disturbance
Hypokinesia
Lymphoma
Neurological symptom
Symptomtext
Stroke; Lymphoma; Lymphoma; Severe demyelination of brain; Neurological disease; Minimal movement in left arm ad left leg; Can't get out of bed or walk without help; Can't get out of bed or walk without help; This case was reported by a other health professional and described the occurrence of stroke in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis and COVID 19 MRNA VACCINE MODERNA for prophylaxis. Previously administered products included Moderna vaccine (received 1st dose on 15th February 2021). On 5th May 2021, the patient received the 1st dose of Shingrix and Tdap Vaccine. On 15th March 2021, the patient received the 2nd dose of COVID 19 MRNA VACCINE MODERNA. In May 2021, less than 3 weeks after receiving Shingrix and Tdap Vaccine, the patient experienced stroke (serious criteria GSK medically significant), acute disseminated encephalomyelitis (serious criteria GSK medically significant), lymphoma (serious criteria GSK medically significant), demyelination (serious criteria GSK medically significant), neurological symptom, movements reduced, bedridden and walking difficulty. On an unknown date, the outcome of the stroke, acute disseminated encephalomyelitis, lymphoma, demyelination, neurological symptom, movements reduced, bedridden and walking difficulty were not recovered/not resolved. It was unknown if the reporter considered the stroke, acute disseminated encephalomyelitis, lymphoma, demyelination, neurological symptom, movements reduced, bedridden and walking difficulty to be related to Shingrix and Tdap Vaccine. Additional details were provided as follows: The reporter was an epidemiology lead. The age at vaccination was not reported. The reporter knew someone whose mother (patient) received the Moderna and Shingrix vaccines and in May 2021, less than 3 weeks after receiving Shingrix and Tdap Vaccine and between 1 and 3 months after receiving Moderna vaccine, the patient developed some neurological symptoms. The symptoms were observed in mid-May 2021 and worsened by the day. The patient went to emergency room on 7th June and again on 14th June 2021. Initial diagnosis on 14th June 2021 was stroke but at the time of reporting it was undiagnosed neurological disease with severe demyelination of the brain. The patient experienced minimal movement in left arm and left leg and could not get out of bed or walk without help. This was reported to VAERS. The patient's son was also told that, it was most likely acute disseminated encephalomyelitis but now another doctor suggested lymphoma. The patient's son said he had been chasing ghosts with the doctors he had been sending the patient to and could not get a clear diagnosis. The reporter was reaching out to GlaxoSmithKline but was not sure if needed to report this to global safety. It was unknown if the reporter considered the stroke, acute disseminated encephalomyelitis, lymphoma, demyelination, neurological symptom, movements reduced, bedridden and walking difficulty to be related to Moderna vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 13.11.2021
- Impfdatum
- 15.03.2021
- Beginn
- 01.05.2021
- Tage bis Beginn
- 47,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Acute disseminated encephalomyelitis
Bedridden
Cerebrovascular accident
Demyelination
Gait disturbance
Hypokinesia
Lymphoma
Neurological symptom
Symptomtext
Stroke; Lymphoma; Lymphoma; Severe demyelination of brain; Neurological disease; Minimal movement in left arm ad left leg; Can't get out of bed or walk without help; Can't get out of bed or walk without help; This case was reported by a other health professional and described the occurrence of stroke in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis and COVID 19 MRNA VACCINE MODERNA for prophylaxis. Previously administered products included Moderna vaccine (received 1st dose on 15th February 2021). On 5th May 2021, the patient received the 1st dose of Shingrix and Tdap Vaccine. On 15th March 2021, the patient received the 2nd dose of COVID 19 MRNA VACCINE MODERNA. In May 2021, less than 3 weeks after receiving Shingrix and Tdap Vaccine, the patient experienced stroke (serious criteria GSK medically significant), acute disseminated encephalomyelitis (serious criteria GSK medically significant), lymphoma (serious criteria GSK medically significant), demyelination (serious criteria GSK medically significant), neurological symptom, movements reduced, bedridden and walking difficulty. On an unknown date, the outcome of the stroke, acute disseminated encephalomyelitis, lymphoma, demyelination, neurological symptom, movements reduced, bedridden and walking difficulty were not recovered/not resolved. It was unknown if the reporter considered the stroke, acute disseminated encephalomyelitis, lymphoma, demyelination, neurological symptom, movements reduced, bedridden and walking difficulty to be related to Shingrix and Tdap Vaccine. Additional details were provided as follows: The reporter was an epidemiology lead. The age at vaccination was not reported. The reporter knew someone whose mother (patient) received the Moderna and Shingrix vaccines and in May 2021, less than 3 weeks after receiving Shingrix and Tdap Vaccine and between 1 and 3 months after receiving Moderna vaccine, the patient developed some neurological symptoms. The symptoms were observed in mid-May 2021 and worsened by the day. The patient went to emergency room on 7th June and again on 14th June 2021. Initial diagnosis on 14th June 2021 was stroke but at the time of reporting it was undiagnosed neurological disease with severe demyelination of the brain. The patient experienced minimal movement in left arm and left leg and could not get out of bed or walk without help. This was reported to VAERS. The patient's son was also told that, it was most likely acute disseminated encephalomyelitis but now another doctor suggested lymphoma. The patient's son said he had been chasing ghosts with the doctors he had been sending the patient to and could not get a clear diagnosis. The reporter was reaching out to GlaxoSmithKline but was not sure if needed to report this to global safety. It was unknown if the reporter considered the stroke, acute disseminated encephalomyelitis, lymphoma, demyelination, neurological symptom, movements reduced, bedridden and walking difficulty to be related to Moderna vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 13.11.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Biopsy brain abnormal
Central nervous system lymphoma
Coma
Neurological symptom
Symptomtext
Primary CNS Lymphoma, diagnosis after a high-risk brain biopsy; Was in a coma-like state; Neurological symptoms; This case was reported by a consumer via sales rep and described the occurrence of central nervous system lymphoma in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced central nervous system lymphoma (serious criteria hospitalization and GSK medically significant), coma (serious criteria hospitalization and GSK medically significant) and neurological symptom. The patient was treated with rituximab and methotrexate. On an unknown date, the outcome of the central nervous system lymphoma, coma and neurological symptom were unknown. It was unknown if the reporter considered the central nervous system lymphoma, coma and neurological symptom to be related to Shingrix. Additional details were provided as follows: The case was reported by patient's son. The age at vaccination was not reported. The patient experienced neurological symptoms after 1st dose of shingrix. The patient was currently at the hospital and had been diagnosed with a rare case of Primary CNS Lymphoma. She was in a coma-like state two weeks ago but now after a Rituximab and methotrexate cocktail she was awake and eating/breathing on her own. The diagnosis was made after a high-risk brain biopsy deep near the brain stem. The reporter agree to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Coma
- Hospital-Tage
- -
- Labordaten
- Test Name: brain biopsy; Result Unstructured Data: (Test Result:Primary CNS Lymphoma,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 25,0
- Geschlecht
- F
- Eingang
- 12.11.2021
- Impfdatum
- 29.10.2021
- Beginn
- 06.11.2021
- Tage bis Beginn
- 8,0
- Dosis
- UNK
- Route/Site
- IM / UN
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Death
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Elhers-Danlos, POTs
- Andere Medikamente
- Luvox, Lemectal
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 11.11.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Herpes zoster
Vaccination failure
Symptomtext
He died four years later and still complained with them; Got vx, three weeks later got a bad case, died four years later; This case was reported by a consumer via interactive digital media and described the occurrence of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced death (serious criteria death and GSK medically significant) and shingles. On an unknown date, the outcome of the death was fatal and the outcome of the shingles was not recovered/not resolved. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death and shingles to be related to Shingles vaccine. Additional details provided were as follows: The case was reported by patient's friend. Age at vaccination was not reported. The patient received a dose of Shingles vaccine and three weeks later got a bad case of shingles. He died four years later and still complained with them. Follow-up would not be possible as no contact details provided.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 06.11.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Herpes zoster
Near death experience
Pain
Vaccination failure
Symptomtext
Got both shots. Shingles.; Shingles; almost killed me; pain was excruciating; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization, GSK medically significant and life threatening), shingles (serious criteria hospitalization and life threatening), near death experience (serious criteria GSK medically significant and life threatening) and pain. On an unknown date, the outcome of the vaccination failure, shingles, near death experience and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles, near death experience and pain to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient got both shots of shingles vaccine and experienced shingles. The patient stated that shingles put him/her in the hospital, almost killed him/her. The patient also experienced pain and the pain was excruciating. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 06.11.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Herpes zoster
Near death experience
Pain
Vaccination failure
Symptomtext
Got both shots. Shingles.; Shingles; almost killed me; pain was excruciating; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization, GSK medically significant and life threatening), shingles (serious criteria hospitalization and life threatening), near death experience (serious criteria GSK medically significant and life threatening) and pain. On an unknown date, the outcome of the vaccination failure, shingles, near death experience and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles, near death experience and pain to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient got both shots of shingles vaccine and experienced shingles. The patient stated that shingles put him/her in the hospital, almost killed him/her. The patient also experienced pain and the pain was excruciating. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 05.11.2021
- Impfdatum
- 01.11.2017
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
practically kill me; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In November 2017, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown. The reporter considered the near death experience to be related to Shingles vaccine. Additional details were provided as follows: The case was self-reported by patient. The age at vaccination was not reported. The patient stated that, he/she got the shingles shot and it practically killed him/her. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 04.11.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
General physical health deterioration
Symptomtext
health steadily declined; This case was reported by a consumer via interactive digital media and described the occurrence of general physical health deterioration in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included cancer. On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced general physical health deterioration (serious criteria death). On an unknown date, the outcome of the general physical health deterioration was fatal. The reported cause of death was general physical health deterioration. It was unknown if the reporter considered the general physical health deterioration to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient's friend. The age at vaccination was not reported. The patient was fighting cancer and her physician felt she should get Shingles vaccine and she got Shingles vaccine. The patient's health steadily declined after the vaccine and she passed away within 2 months of the vaccine. The reporter requested not to complicate your body if you were already fighting a life-threatening illness. The reporter was missing his/her friend. The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: health steadily decline
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Cancer
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 30.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
I nearly died; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown. The reporter considered the near death experience to be related to Shingles vaccine. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient nearly died from the first shot. The patient stated that, he/she would have to suffer with them because could not get the second.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 29.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Herpes zoster
Nerve injury
Pain
Vaccination failure
Symptomtext
Had vaccine and had shingles/Suspected vaccination failure; shingles; hospitalized with excrutiating pain, never came out of hospital; hospitalized with nerve damage, never came out of hospital; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria death, hospitalization and GSK medically significant), shingles (serious criteria death and hospitalization), pain (serious criteria death and hospitalization) and nerve damage (serious criteria death and hospitalization). On an unknown date, the outcome of the vaccination failure, shingles, pain and nerve damage were fatal. The reported cause of death was vaccination failure, shingles, pain and nerve damage. It was unknown if the reporter considered the vaccination failure, shingles, pain and nerve damage to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The reporter said you could not prevent shingles with a vaccine. The patient had that Shingles vaccine and had the worst case of shingles ever. The patient landed up in the hospital in excruciating pain and nerve damage. The reporter stated that the patient never came out of the hospital, the reporter said god rest her soul. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.; Reported Cause(s) of Death: hospitalized with nerve damage, never came out of hospital; Had vaccine and had shingles/Suspected vaccination failure; Had vaccine and had shingles/Suspected vaccination failure; hospitalized with excrutiating pain, never came out of hospital
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cerebrovascular accident
Herpes zoster
Hypertension
Injection site pain
Vaccination failure
Symptomtext
The shot is painful, mother got shingles/suspected vaccination failure; blood pressure was so high she had a stroke; shingles; high blood pressure; shot is painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), stroke (serious criteria GSK medically significant), shingles, blood pressure high and injection site pain. On an unknown date, the outcome of the vaccination failure, stroke, shingles, blood pressure high and injection site pain were unknown. It was unknown if the reporter considered the vaccination failure, stroke, shingles, blood pressure high and injection site pain to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient's child. The age at vaccination was not reported. The reporter stated that the Shingles shot was painful. The patient got shingles, then her blood pressure was so high she had a stroke. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting. The case had been linked with US2021AMR222596, reporter's case.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR222596:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- Test Name: Blood pressure; Result Unstructured Data: (Test Result:so high,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 21.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
almost killed my youngest daughter; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. On an unknown date, the patient received dTpa vaccine. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown. The reporter considered the near death experience to be related to dTpa vaccine. Additional details were provided as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The reporter stated that dtap almost killed the patient and also stated it was hard pass for them.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 66,0
- Geschlecht
- F
- Eingang
- 19.10.2021
- Impfdatum
- 31.08.2021
- Beginn
- 16.10.2021
- Tage bis Beginn
- 46,0
- Dosis
- 3
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Blindness unilateral
Cerebrovascular accident
Computerised tomogram head
Echocardiogram
Headache
Magnetic resonance imaging
Tremor
Symptomtext
Pt presented to ED with right sided headache then vision loss in L eye and shaky legs. Diagnosed with CVA.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- 2,0
- Labordaten
- MRI and CT of brain, ECHO
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- emphysema, aortic atherosclerosis, seborrheic keratosis, paroxysmal supraventricular tachycardia, hyperparathyroidism, migraine, myasthenia gravis, GERD, psoriatic arthritis, osteopenia, anxiety
- Andere Medikamente
- citalopram, meloxicam, omeprazole, sumatriptan, verapamil, Vit D, Vit B12, latanoprost eye drops
- Allergien
- sulfa, codeine, meperidine
- Vorherige Impfungen
- -
- Staat
- WI
- Alter
- 74,0
- Geschlecht
- F
- Eingang
- 11.10.2021
- Impfdatum
- 01.03.2021
- Beginn
- 12.09.2021
- Tage bis Beginn
- 195,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Acute respiratory distress syndrome
COVID-19
COVID-19 pneumonia
Condition aggravated
Death
Chest X-ray normal
Dyspnoea
Pyrexia
SARS-CoV-2 test positive
Diabetes mellitus
General physical health deterioration
Hypoxia
Intensive care
Nausea
Oxygen saturation decreased
Positive airway pressure therapy
Vomiting
Symptomtext
ADDENDUM TO PREVIOUS SUBMISSION (VAERS #648055) Pt passed away on 10/9/2021 from complications of COVID-19 "Brief Narrative (including pertinent consultations and lab/radiology results): 74 y.o. female with a past medical history significant for Obesity, DM type II, Depression, COPD, HL, hospital stay 9/12-9/15 for covid, re-admitted 9/16 for nausea, vomiting,worsening hypoxemia. She was vaccinated in March with Pfizer. On this admission, she was on the hospitalist service from 9/16 to 9/21, when she was transferred to the ICU service for ongoing hypoxia. She was on the ICU service 9/21-9/25 and never intubated, but was on max Bipap support and iNO. She was transferred back to the hospitalist service 9/26 but remained in the ICU due to having to be on iNO. Other treatments included tociluzumab, remdesivir, and high dose steroids. Unfortunately, despite all of these treatments, she did not improve, and in fact, worsened to the point where the next step would be intubation. Palliative care was consulted, and she said that she would not want to be on a ventilator long term. If she were intubated, she would likely never be extubated, so being intubated did not align with her wishes. She opted to be DNR/I. The iNo was weaned off, and her oxygen levels decreased despite 100% Bipap. Patient said that she wanted to be made comfortable, so comfort cares were initiated. Her friend was able to come in, and she passed away peacefully. " Date of Death: 10/9/2021 Time of Death: 10:06 pm Autopsy Completed: No IMMEDIATE CAUSE (Final disease or condition resulting in death) Approximate interval: Onset to death (e.g., days, months, years) Primary: Covid 19 pneumonia weeks Secondary: ARDS weeks Secondary: diabetes mellitus years Secondary: N/A N/A Above notes signed by MD in patient's EMR
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 08.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Guillain-Barre syndrome
Symptomtext
died; got GBS; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a 70-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (Family History) (patient's cousin had a shingles but never receive the Shingle shot because it could cause Guillain Barre syndrome). On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the guillain barre syndrome was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death and guillain barre syndrome to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the cousin of the patient. The age at vaccination was not reported. The reporter stated that, my cousin (patient) who got Guillain Barre syndrome and died in a month after the Shingle shot. It took over her whole system and she had no health problems. The reporter said, they would tell you it was very rare but reporter have known 3 people. This is 1 of the 4 linked cases, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR208072:same reporter US-GLAXOSMITHKLINE-US2021AMR208071:same reporter US-GLAXOSMITHKLINE-US2021AMR208073:same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Shingles (patient's cousin had a shingles but never receive the Shingle shot because it could cause Guillain Barre syndrome)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 08.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Pain
Symptomtext
die of Men B; die of Men B, hurt her; This case was reported by a consumer via interactive digital media and described the occurrence of death in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced death (serious criteria death and GSK medically significant) and pain. On an unknown date, the outcome of the death was fatal and the outcome of the pain was unknown. The reported cause of death was unknown cause of death. The reporter considered the death to be related to Meningococcal B vaccine. It was unknown if the reporter considered the pain to be related to Meningococcal B vaccine. Additional details provided were as follows: The case was reported by the patient's parent. The age at vaccination was not reported. The reporter reported that he/she hate what the vaccine did to his/her daughter. The reporter reported that the patient was more likely to get hit by lighting more than once than die of Men B, but they hurt her and they did not care. The reporter stated that they trick people into thinking that all meningitis was the same, but it was not, but they would not benefit if they knew that. Follow-up would not be possible as no contact details provided. Note: The event death was conservatively captured as the information received was not clear as the patient was died from receiving Men B vaccine.; Reported Cause(s) of Death: unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 59,0
- Geschlecht
- M
- Eingang
- 08.10.2021
- Impfdatum
- 21.09.2021
- Beginn
- 21.09.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- SYR / AR
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Asthenia
Cerebral haemorrhage
Cerebral ischaemia
Cerebral thrombosis
Computerised tomogram abnormal
Cerebrovascular accident
Decreased appetite
Dysstasia
Fatigue
Echocardiogram
Hypoaesthesia
Impaired work ability
Nausea
Thrombosis
Magnetic resonance imaging head abnormal
Speech disorder
Syncope
Thrombectomy
Symptomtext
no feeling entire right side- stroke symptoms - collapsed; numbness in right leg; nausea; weakness; Severe dysstasia - Endovascular Thrombectomy procedure . Clots removed; Severe dysstasia - Endovascular Thrombectomy procedure . Clots removed; Tiredness/ fatigue / increased fatigue; lack of apatite; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose of bnt162b2 on 21Sep2021 at 10:00 (at the age of 59-years-old) (lot number: unknown) via unknown route of administration at single dose in arm right for COVID-19 immunization. Medical history and concomitant medications were not reported. There was no other vaccine in four weeks. Patient experienced Tiredness/ fatigue / increased fatigue on 21Sep2021; lack of apatite on 21Sep2021; weakness on 22Sep2021 at 10:00; nausea on 23Sep2021 at 10:00; numbness in right leg on 27Sep2021 at 10:00; no feeling entire right side- stroke symptoms - collapsed on 29Sep2021 at 10:00; Severe dysstasia - Endovascular Thrombectomy procedure, Clots removed on 22Sep2021 at 10:00. The events resulted in Emergency room visit, Hospitalization for three days, Life threatening illness (immediate risk of death from the event), Congenital anomaly. Patient received treatment for all events including Endovascular Thrombectomy. Patient did not have covid prior vaccination. It was not reported if patient had covid tested post vaccination. The outcome of the events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebral haemorrhage
- Hospital-Tage
- 3,0
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 06.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
death; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The patient was the reporter's little brother. The age at vaccination was not reported. The patient died from complications after receiving a Flu shot.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 06.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
died ather shot; This case was reported by a consumer via media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient's friend. The age at vaccination was not reported. The patient just died after Shingles shot. The reporter asked was this coincidence and there were immediate and profound symptoms. The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 29.09.2021
- Impfdatum
- 01.08.2020
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cerebrovascular accident
Symptomtext
stroke; This case was reported by a consumer via interactive digital media and described the occurrence of stroke in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In August 2020, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was unknown. It was unknown if the reporter considered the stroke to be related to Shingles vaccine. Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got a stroke by taking vaccine shingles. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
passed away; This case was reported by a consumer via media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. The reporter considered the unknown cause of death to be related to Shingles vaccine. Additional details were reported as follows: The patient was reporter's sister in law. The age at vaccination was not reported. The patient passed away from getting the Shingles shot during the night she received it. The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 24.09.2021
- Impfdatum
- -
- Beginn
- 11.09.2021
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
passed away; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On 11th September 2021, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 11th September 2021. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by patient's husband. The reporter stated that they lost time when they got the Shingles shots. The patient suffered and contribute to her life. The patient passed away. The reporter advised to get the Shingles shot especially for seniors like him. The follow-up would not possible as no contact details were available. Note: The term suffering was unspecified hence not coded as an event. Also, as per convention it cannot be coded with Ill-defined disorder or unspecified adverse event.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 18.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
almost died; This case was reported by a consumer via media and described the occurrence of near death experience in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown. The reporter considered the near death experience to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated the patient almost died from Meningococcal B vaccine and still 2 years later has repercussions. The reporter stated, this was a for profit vaccine, and would never advise anyone to get it. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 17.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
first one like to have killed me; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown. It was unknown if the reporter considered the near death experience to be related to Shingles vaccine. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient reported that, first dose liked to had killed him/her.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 16.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cerebrovascular accident
Vaccine positive rechallenge
Symptomtext
stroke after each shot; This case was reported by a consumer via interactive digital media and described the occurrence of stroke in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of cerebrovascular accident (1st dose received on an unknown date, refer case US2021AMR193810). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant). Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the stroke was unknown. It was unknown if the reporter considered the stroke to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, he/she know the patient who took the Shingle shot and experienced stroke after the shot.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR193810:same patient/same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 16.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Cerebrovascular accident
Symptomtext
stroke after each shot; This case was reported by a consumer via interactive digital media and described the occurrence of stroke in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was recovered/resolved. It was unknown if the reporter considered the stroke to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, he/she know the patient who took the Shingle shot and experienced stroke after the shot. For the tolerance of the 2nd dose, refer case US2021AMR193830.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR193830:same patient/same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 16.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Blister
Localised infection
Near death experience
Peripheral swelling
Scab
Scar
Sepsis
Symptomtext
died twice and was brought back; had huge blisters all over me; have numerous scars.; This case was reported by a consumer via media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included allergy. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening), blister and scar. On an unknown date, the outcome of the near death experience and blister were unknown and the outcome of the scar was not recovered/not resolved. It was unknown if the reporter considered the near death experience, blister and scar to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles vaccine, took a reaction, died twice and was brought back, and had huge blisters all over and still had numerous scars. After receiving Tuberculosis (TB) vaccine, arm swelled up 3 times bigger and got blood poisoning. Twice after that when tested for employment at a hospital, the patient had the same reaction. Booster vaccine (unknown name vaccine) had to have it 3 times, scabbed up and arm became infected all 3 times. The patient have horrible allergies. The patient said not a fan of vaccines. No contact details were reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Allergy
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 16.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Coma
Herpes zoster
Vaccination failure
Symptomtext
suspected vaccination failure; shingles/ shingles on brain; coma; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), coma (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the coma was recovered/resolved. It was unknown if the reporter considered the vaccination failure, coma and shingles to be related to Shingles vaccine. Additional details were provided as follows: The reporter was known to patient. The age at vaccination was not reported. The reporter stated that, the patient received Shingles shot and ended in a coma a couple of years ago for over a month, they said he had shingles on the brain. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided. The case had been linked with US2021AMR190777, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR190777:same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Coma
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 07.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cerebrovascular accident
Symptomtext
stroke; This case was reported by a consumer via media and described the occurrence of stroke in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was unknown. It was unknown if the reporter considered the stroke to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. A patient got shingles shot and less than a week later she had a stroke. The reporter showed her an article warning of risk of strokes. When the patient confronted, the physician admitted the risk which he had not mentioned to her. But he said there was no way to prove the stroke was from the shot. The reporter said that the patient said could you blame for wondering. No contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 07.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Hypersensitivity
Symptomtext
allergic reaction; This case was reported by a consumer via media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction (serious criteria death and GSK medically significant). On an unknown date, the outcome of the allergic reaction was fatal. The reported cause of death was allergic reaction. It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. After receiving Shingles vaccine, the patient passed due to allergic reaction complications to the Shingles vaccine about a month ago from the date of reporting. This case had been linked with case US2021AMR188176, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR188176:same reporter; Reported Cause(s) of Death: Allergic reaction
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 07.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Hypersensitivity
Symptomtext
allergic reaction; This case was reported by a consumer via media and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction (serious criteria death and GSK medically significant). On an unknown date, the outcome of the allergic reaction was fatal. The reported cause of death was allergic reaction. It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine. Additional details were provided as follows: The case was reported for the reporter's sister in laws mother. The age at vaccination was not reported. After receiving Shingles vaccine, the patient passed due to allergic reaction complications to the Shingles vaccine about a month ago from the date of reporting. This case had been linked with case US2021AMR188219, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR188219:same reporter; Reported Cause(s) of Death: Allergic reaction
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Apparent life threatening event
Near death experience
Symptomtext
nearly killed me; This case was reported by a consumer via media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown. The reporter considered the near death experience to be related to Shingles vaccine. Additional details were provided as follows: The patient had reported for him/herself. The patient reported that Shingles vaccine nearly killed him/her. The patient experienced horrible side effects.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Apparent life threatening event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: ja
ER: unbekannt
Erholt: nein
Death
Paralysis
Symptomtext
Death; received the Vaccination and paralyzed her. Not long after she died; This case was reported by a consumer via media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and paralysis (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the paralysis was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. The reporter considered the paralysis to be related to Shingles vaccine. Additional details were provided as follows: The case was reported for the reporter's friend and ex-coworker. The age at vaccination was not reported. The patient received Shingles vaccine and it paralyzed her. Not long after that, the patient died. The reporter suggested to research and have conversations with the doctor. Reporter stated that, everyone reacted differently from every medication.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 26.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Myocardial infarction
Symptomtext
heart attack; This case was reported by a consumer via media and described the occurrence of heart attack in a 51-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced heart attack (serious criteria GSK medically significant). On an unknown date, the outcome of the heart attack was unknown. It was unknown if the reporter considered the heart attack to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient got the shingle shot and had heart attack, which was more difficult to recover. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Myocardial infarction
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 25.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: ja
ER: unbekannt
Erholt: nein
Cerebrovascular accident
Herpes zoster
Immobile
Incontinence
Vaccination failure
Wheelchair user
Symptomtext
Shingles vaccine, Shingles/ suspected vaccination failure; Loss of mobility, wheelchair; Stroke; Shingles; Incontinence; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included methylenetetrahydrofolate reductase gene mutation (MTHFR). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), immobile (serious criteria disability and GSK medically significant), stroke (serious criteria GSK medically significant), shingles and incontinence. On an unknown date, the outcome of the vaccination failure, immobile, stroke, shingles and incontinence were unknown. The reporter considered the vaccination failure, immobile, stroke, shingles and incontinence to be possibly related to Shingles vaccine. Additional details were reported as follows: The patient was reporter's uncle. The age at vaccination was not reported. The patient did not have shingles exposure before the shot. The patient got the new shingles vaccine. The reporter stated that the patient's vaccine injuries from that deadly shot were too numerous to mention included Shingles, stroke, loss of mobility (wheelchair), incontinence and much more. The reporter stated that the people with Methylenetetrahydrofolate reductase (MTHFR) should never be vaccinated. Polio, of course, and we did not have a booster for that. The reporter worked with Big Pharma and said he or she know them inside and out. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Methylenetetrahydrofolate reductase gene mutation (MTHFR)
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 24.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Herpes zoster
Vaccination failure
Symptomtext
Suspected vaccination failure; Shingles, it killed him; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was fatal. The reported cause of death was shingles. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient's son/ daughter reported the case. The age at vaccination was not reported. The patient got the shot and then had shingles. These were so bad that, it killed the patient. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, the time to onset for event and laboratory confirmation for herpes zoster were not provided.; Reported Cause(s) of Death: shingles
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 24.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anaplastic lymphoma kinase gene mutation
Dehydration
Illness
Near death experience
Non-small cell lung cancer stage IV
Septic shock
Toxicity to various agents
Symptomtext
Almost died with septic shock; NSCLC stage 4 with Alk mutation; Sick; Dehydrated; This case was reported by a consumer via media and described the occurrence of septic shock in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included metformin for diabetes. Concurrent medical conditions included diabetes. On an unknown date, the patient received Shingles vaccine and metformin at an unknown dose and frequency. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced septic shock (serious criteria GSK medically significant and life threatening), non-small cell lung cancer (serious criteria GSK medically significant), sickness and dehydration. The action taken with metformin was unknown. On an unknown date, the outcome of the septic shock, non-small cell lung cancer, sickness and dehydration were unknown. It was unknown if the reporter considered the septic shock, non-small cell lung cancer and dehydration to be related to Shingles vaccine. The reporter considered the sickness to be related to Shingles vaccine. Additional case details were reported as follows: The age at vaccination was not reported. The patient reported case for himself or herself. After vaccination patient was sick. The patient was dehydrated and was on Metformin for diabetes. The patient was almost died with septic shock due to metformin toxicity. Less than 3 months later patient was diagnosed with NSCLC (Non-small cell lung cancer) stage 4 with Alk mutation. The physician never warned the patient of the dangers and informed be careful, it could cost your life As the hospital physician said, it was the perfect storm. The patient still struggle with health yet. It was unknown if the reporter considered the septic shock, non-small cell lung cancer and dehydration to be related to Metformin. The follow up was not required.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Diabetes
- Vorgeschichte
- -
- Andere Medikamente
- METFORMIN
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 24.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Herpes zoster
Vaccination failure
Symptomtext
got it and he has since passed away; had the shingles vaccine and got /suspected vaccination failure; got it and he has since passed away; This case was reported by a consumer via media and described the occurrence of death nos in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced death nos (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the death nos was fatal and the outcome of the vaccination failure and shingles were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death nos, vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient's wife. The age at vaccination was not reported. The reporter stated that the patient had the shingles vaccine and got shingles a few years ago from the date of reporting and he had since passed away. The patient's shingles was much worse and the were told that it would be much worse if they had not had vaccine. The reporter stated that anayone should not think that her or she was 100 percent safe. The reporter further stated that she still agreed to get vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR175880, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR175880:same reporter; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 21.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
Got my vaccine. / about kilt me; This case was reported by a consumer via media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown. It was unknown if the reporter considered the near death experience to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated that he/she got Shingles vaccine and the second one about kilt him/her. The patient stated that still glad he/she got it. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- M
- Eingang
- 17.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Hypersensitivity
Symptomtext
Has passed away; Severe allergic reaction; This case was reported by a nurse via sales rep and described the occurrence of death in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced death (serious criteria death and GSK medically significant) and allergic reaction. On an unknown date, the outcome of the death was fatal and the outcome of the allergic reaction was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death and allergic reaction to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and developed a severe allergic reaction and was categorized as a contraindication to get second dose. The patient passed away since this information was given to the reporter. The reporter consented to follow up. This case has been linked to US2021AMR171275, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR171275:Same reporter.; Reported Cause(s) of Death: Death NOS
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 30.07.2021
- Impfdatum
- 22.07.2021
- Beginn
- 22.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Myocardial infarction
Symptomtext
heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unk) for COVID-19 vaccination. No Medical History information was reported. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria death and medically significant). The patient died on 22-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medications were reported. No laboratory data was provided. No treatment information was provided. Very limited information regarding this event has been provided at this time. No further information is expected at this time. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Myocardial infarction
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 30.07.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cyanosis
Near death experience
Seizure
Symptomtext
almost died; convulsions; turned to blue; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis. On an unknown date, the patient received DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening), convulsion (serious criteria GSK medically significant and life threatening) and cyanosis (serious criteria life threatening). On an unknown date, the outcome of the near death experience, convulsion and cyanosis were unknown. It was unknown if the reporter considered the near death experience, convulsion and cyanosis to be related to DTP vaccine. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. When the patient was baby, he/she almost died from the DTP shot. The patient slipped into convulsions and turned to blue. After that, pertussis part of the shot had left out because, that was protocol. The patient stated that, not everyone should get the pertussis part of the shot.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 21.07.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Herpes zoster
Intensive care
Near death experience
Vaccination failure
Symptomtext
Suspected vaccination failure; GOT shingles / nearly died and was in ICU for weeks; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization, GSK medically significant and life threatening) and shingles (serious criteria hospitalization and life threatening). On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The reporter stated that, the patient nearly died and was in intensive care unit for weeks. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This case had been linked with case US2021AMR156171, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR156171:same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 11.07.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Central nervous system lesion
Death
Symptomtext
got lesion in her BRAIN... IT KILLED HER...; This case was reported by a consumer via interactive digital media and described the occurrence of brain lesion in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included oral lesion (had lesion on lip). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced brain lesion (serious criteria death). On an unknown date, the outcome of the brain lesion was fatal. The reported cause of death was brain lesion. It was unknown if the reporter considered the brain lesion to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient's relative.(son or daughter). The age at vaccination was not reported. The reporter stated that, the patient had lesion on lip, after getting vaccine, the patient had lesion on her brain and it killed her.; Reported Cause(s) of Death: brain lesion
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Oral lesion (had lesion on lip)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- SD
- Alter
- -
- Geschlecht
- F
- Eingang
- 07.07.2021
- Impfdatum
- 04.03.2021
- Beginn
- 02.05.2021
- Tage bis Beginn
- 59,0
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Product dose omission issue
Pulmonary embolism
Symptomtext
Pulmonary embolism; she had to quarantine and was not able to get her second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (she had to quarantine and was not able to get her second dose). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she had to quarantine and was not able to get her second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pulmonary embolism
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 06.07.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Dyspnoea
Product administered to patient of inappropriate age
Symptomtext
He didn't wake up; short of breath; Inappropriate age at vaccine administration; This case was reported by a consumer via interactive digital media and described the occurrence of death nos in a 40-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced death nos (serious criteria death and GSK medically significant), shortness of breath and inappropriate age at vaccine administration. On an unknown date, the outcome of the death nos was fatal and the outcome of the shortness of breath and inappropriate age at vaccine administration were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death nos and shortness of breath to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient was 40 years old who received vaccine, which led to inappropriate age at vaccine administration. The reporter stated that, the patient became short of breath and went to bed instead of going to the hospital and did not wake up.; Reported Cause(s) of Death: Death NOS
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 29.06.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Myocardial infarction
Symptomtext
heart attack caused by this vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of heart attack in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced heart attack (serious criteria death and GSK medically significant). On an unknown date, the outcome of the heart attack was fatal. The reported cause of death was heart attack. The reporter considered the heart attack to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. The reporter stated that, his or her friend died due to heart attack from the vaccine.; Reported Cause(s) of Death: Heart attack
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.06.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
Flu shot almost killed me; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown. The reporter considered the near death experience to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that, the flu shot almost killed her.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 24.06.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Ophthalmic herpes zoster
Skin ulcer
Vaccination failure
Symptomtext
suspected vaccination failure; got them anyway in his eye; sores all over his/ head and on his face; This case was reported by a consumer via social media interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), ophthalmic herpes zoster (serious criteria death and GSK medically significant) and skin ulcer (serious criteria death). On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and skin ulcer were fatal. The reported cause of death was vaccination failure, ophthalmic herpes zoster and skin ulcer. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and skin ulcer to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient received the Shingles vaccine and patient got shingles in his eye. The patient also had sores all over his beautiful bald head and on his face. The reporter stated that the patient passed away without his wife being able to directly kiss him because of that. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Reported Cause(s) of Death: Opthalmic herpes zoster; Skin ulcer
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CT
- Alter
- 39,0
- Geschlecht
- F
- Eingang
- 23.06.2021
- Impfdatum
- 17.05.2021
- Beginn
- 17.05.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Asphyxia
Blood pressure measurement
Chest discomfort
Decreased appetite
Dry mouth
Dyspnoea
Headache
Hypertension
Influenza
Insomnia
Loss of personal independence in daily activities
Myocardial infarction
Palpitations
Pyrexia
Thirst
Weight decreased
Symptomtext
Fever; Headache; FLU; Suffocating; Almost had a heart attack; High blood pressure/pressure rose; Breathing is not well/the breath is short; Feels a pressure in the chest; Lost the desire to eat/doesn't get hungry; Heart was beating fast; Does not sleep well; Very dry mouth; Very thirsty; Has been unable to work; Lost about 8 pounds; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Almost had a heart attack), ASPHYXIA (Suffocating), DYSPNOEA (Breathing is not well/the breath is short), CHEST DISCOMFORT (Feels a pressure in the chest), DECREASED APPETITE (Lost the desire to eat/doesn't get hungry), PALPITATIONS (Heart was beating fast), INSOMNIA (Does not sleep well), DRY MOUTH (Very dry mouth), THIRST (Very thirsty), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has been unable to work), WEIGHT DECREASED (Lost about 8 pounds), PYREXIA (Fever), HEADACHE (Headache), INFLUENZA (FLU) and HYPERTENSION (High blood pressure/pressure rose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. No Medical History information was reported. On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced DYSPNOEA (Breathing is not well/the breath is short) (seriousness criterion hospitalization prolonged), CHEST DISCOMFORT (Feels a pressure in the chest) (seriousness criterion hospitalization prolonged), DECREASED APPETITE (Lost the desire to eat/doesn't get hungry) (seriousness criterion hospitalization prolonged), PALPITATIONS (Heart was beating fast) (seriousness criterion hospitalization prolonged), INSOMNIA (Does not sleep well) (seriousness criterion hospitalization), DRY MOUTH (Very dry mouth) (seriousness criterion hospitalization prolonged), THIRST (Very thirsty) (seriousness criterion hospitalization prolonged), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has been unable to work) (seriousness criterion hospitalization prolonged), WEIGHT DECREASED (Lost about 8 pounds) (seriousness criterion hospitalization prolonged), PYREXIA (Fever) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), INFLUENZA (FLU) (seriousness criterion hospitalization) and HYPERTENSION (High blood pressure/pressure rose) (seriousness criterion hospitalization prolonged). On 19-May-2021, the patient experienced MYOCARDIAL INFARCTION (Almost had a heart attack) (seriousness criteria hospitalization prolonged and medically significant). On 08-Jun-2021, the patient experienced ASPHYXIA (Suffocating) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized from 19-May-2021 to 22-May-2021 due to HYPERTENSION, MYOCARDIAL INFARCTION and PALPITATIONS. On 22-May-2021, MYOCARDIAL INFARCTION (Almost had a heart attack) and HYPERTENSION (High blood pressure/pressure rose) had resolved. At the time of the report, ASPHYXIA (Suffocating), DYSPNOEA (Breathing is not well/the breath is short), CHEST DISCOMFORT (Feels a pressure in the chest), DECREASED APPETITE (Lost the desire to eat/doesn't get hungry), PALPITATIONS (Heart was beating fast), INSOMNIA (Does not sleep well), DRY MOUTH (Very dry mouth), THIRST (Very thirsty), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has been unable to work), WEIGHT DECREASED (Lost about 8 pounds), PYREXIA (Fever), HEADACHE (Headache) and INFLUENZA (FLU) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Blood pressure measurement: high (High) Blood pressure rose. On 19-May-2021, Blood pressure measurement: high (High) Blood pressure rose. Concomitants medications were not reported. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-214924 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Myocardial infarction
- Hospital-Tage
- -
- Labordaten
- Test Date: 20210517; Test Name: Blood pressure; Result Unstructured Data: Blood pressure rose; Test Date: 20210519; Test Name: Blood pressure; Result Unstructured Data: Blood pressure rose
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 18.06.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
got the shot 3 days later he was dead; This case was reported by a consumer via media and described the occurrence of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by reporter for a friend's husband. The patient was in perfect shape but passed away 3 days after his shingles shot.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR131309:Same reporter.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 15.06.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
passed away one week after her shingles shot; This case was reported by a consumer via interactive digital media and described the occurrence of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by reporter for his or her mother. The patient passed away one week after her shingles shot. The reporter stated it was sad but it happened. This case had been linked with case US2021AMR127094, as reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR127094:Same reporter; Reported Cause(s) of Death: unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 01.06.2021
- Impfdatum
- 14.02.2020
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bradycardia
Cerebrovascular accident
Eyelid function disorder
Unresponsive to stimuli
Symptomtext
Stroke; Hemorrhagic Stroke; Intermittent bradycardia; thrombotic stroke; Intracranial hemorrhage; aneurysm; This case was reported by a lawyer and described the occurrence of stroke in a female patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 24th April 2022) for prophylaxis. The initial information was received on 27 May 2021 via medical record (case is now medically confirmed). As per the medical records plaintiff had received Shingrix on 14 February 2020 and 22 May 2020 for Prophylaxis. The patient had stroke , the date of injury was 22 may 2018. On Emergency department visit patient reported intermittent bradycardia and she was no longer opening eyes to voice or even noxious stimuli. Differential diagnoses consider for patient includes intracranial hemorrhage, Aneurysm, Thrombotic stroke and carotid dissection.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 01.06.2021
- Impfdatum
- 14.02.2020
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bradycardia
Cerebrovascular accident
Eyelid function disorder
Unresponsive to stimuli
Symptomtext
Stroke; Hemorrhagic Stroke; Intermittent bradycardia; thrombotic stroke; Intracranial hemorrhage; aneurysm; This case was reported by a lawyer and described the occurrence of stroke in a female patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 24th April 2022) for prophylaxis. The initial information was received on 27 May 2021 via medical record (case is now medically confirmed). As per the medical records plaintiff had received Shingrix on 14 February 2020 and 22 May 2020 for Prophylaxis. The patient had stroke , the date of injury was 22 may 2018. On Emergency department visit patient reported intermittent bradycardia and she was no longer opening eyes to voice or even noxious stimuli. Differential diagnoses consider for patient includes intracranial hemorrhage, Aneurysm, Thrombotic stroke and carotid dissection.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IA
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 26.05.2021
- Impfdatum
- 14.01.2021
- Beginn
- 17.01.2021
- Tage bis Beginn
- 3,0
- Dosis
- UNK
- Route/Site
- IM / UN
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Autopsy
Death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- Autopsy
- Aktuelle Erkrankungen
- Hirschsprung's disease
- Vorgeschichte
- Hirschsprung's disease
- Andere Medikamente
- Acetaminophen prn
- Allergien
- No
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 19.05.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
died Fr the shot; This case was reported by a consumer via media and described the occurrence of unknown cause of death in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. Additional details were provided as follows The reporter was the patient's friend. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. The reporter stated that, the patient died from the shot.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- -
- Geschlecht
- U
- Eingang
- 18.05.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cough
Intensive care
Mobility decreased
Near death experience
Nervous system disorder
Pain
Paralysis
Pneumonia
Seizure
Sepsis
Symptomtext
Was in icu. Particularly paralyzed / Hardly move / almost died; I almost died; Pneumonia; Blood infection; Seziure; Coughing; nerviest system had problems; Pain; could hardly move; This case was reported by a consumer and described the occurrence of paralysis in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included PCV13 PNEUMONIA VACCINE for prophylaxis. On an unknown date, the patient received Shingrix and PCV13 PNEUMONIA VACCINE. On an unknown date, less than a day after receiving Shingrix, the patient experienced paralysis (serious criteria hospitalization, GSK medically significant and life threatening), near death experience (serious criteria GSK medically significant and life threatening), pneumonia (serious criteria hospitalization and GSK medically significant), septicemia (serious criteria hospitalization and GSK medically significant), seizure (serious criteria GSK medically significant), cough, nervous system disorder, pain and mobility decreased. On an unknown date, the outcome of the paralysis, near death experience, pneumonia, septicemia, seizure, cough, nervous system disorder, pain and mobility decreased were unknown. It was unknown if the reporter considered the paralysis, near death experience, pneumonia, septicemia, seizure, cough, nervous system disorder, pain and mobility decreased to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient said that day after the Shingrix and Pneumonia 13 vaccination, the patient was in ICU, particulary paralyzed. The patient reported this to the CDC and asked to get CDC report. No one asked for more information from the patient. The patient now gad seizure and taking medication for that. The physician wanted the next thing to cut into the patient's brain and was fine before the vaccination. The hospital wrote up that had pneumonia and got the blood injection. But the patient knew that got pneumonia after being in hospital for some time and was out of ICU when the patient started coughing. So the bottom line was the patient's nerviest system had problems after shot. Just all of the sudden the patient was in pain and could hardly move in less than 24 hours and he/she almost died and everyone was just blowing it off, but not for patient and never be the same. On an unknown date, less than a day after receiving Pneumonia 13, the patient experienced paralysis (serious criteria hospitalization, GSK medically significant and life threatening), near death experience (serious criteria GSK medically significant and life threatening), pneumonia (serious criteria hospitalization and GSK medically significant), septicemia (serious criteria hospitalization and GSK medically significant), seizure (serious criteria GSK medically significant), cough, nervous system disorder, pain and mobility decreased. On an unknown date, the outcome of the paralysis, near death experience, pneumonia, septicemia, seizure, cough, nervous system disorder, pain and mobility decreased were unknown It was unknown if the reporter considered the paralysis, near death experience, pneumonia, septicemia, seizure, cough, nervous system disorder, pain and mobility decreased to be related to Pneumonia 13.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- -
- Geschlecht
- U
- Eingang
- 18.05.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cough
Intensive care
Mobility decreased
Near death experience
Nervous system disorder
Pain
Paralysis
Pneumonia
Seizure
Sepsis
Symptomtext
Was in icu. Particularly paralyzed / Hardly move / almost died; I almost died; Pneumonia; Blood infection; Seziure; Coughing; nerviest system had problems; Pain; could hardly move; This case was reported by a consumer and described the occurrence of paralysis in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included PCV13 PNEUMONIA VACCINE for prophylaxis. On an unknown date, the patient received Shingrix and PCV13 PNEUMONIA VACCINE. On an unknown date, less than a day after receiving Shingrix, the patient experienced paralysis (serious criteria hospitalization, GSK medically significant and life threatening), near death experience (serious criteria GSK medically significant and life threatening), pneumonia (serious criteria hospitalization and GSK medically significant), septicemia (serious criteria hospitalization and GSK medically significant), seizure (serious criteria GSK medically significant), cough, nervous system disorder, pain and mobility decreased. On an unknown date, the outcome of the paralysis, near death experience, pneumonia, septicemia, seizure, cough, nervous system disorder, pain and mobility decreased were unknown. It was unknown if the reporter considered the paralysis, near death experience, pneumonia, septicemia, seizure, cough, nervous system disorder, pain and mobility decreased to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient said that day after the Shingrix and Pneumonia 13 vaccination, the patient was in ICU, particulary paralyzed. The patient reported this to the CDC and asked to get CDC report. No one asked for more information from the patient. The patient now gad seizure and taking medication for that. The physician wanted the next thing to cut into the patient's brain and was fine before the vaccination. The hospital wrote up that had pneumonia and got the blood injection. But the patient knew that got pneumonia after being in hospital for some time and was out of ICU when the patient started coughing. So the bottom line was the patient's nerviest system had problems after shot. Just all of the sudden the patient was in pain and could hardly move in less than 24 hours and he/she almost died and everyone was just blowing it off, but not for patient and never be the same. On an unknown date, less than a day after receiving Pneumonia 13, the patient experienced paralysis (serious criteria hospitalization, GSK medically significant and life threatening), near death experience (serious criteria GSK medically significant and life threatening), pneumonia (serious criteria hospitalization and GSK medically significant), septicemia (serious criteria hospitalization and GSK medically significant), seizure (serious criteria GSK medically significant), cough, nervous system disorder, pain and mobility decreased. On an unknown date, the outcome of the paralysis, near death experience, pneumonia, septicemia, seizure, cough, nervous system disorder, pain and mobility decreased were unknown It was unknown if the reporter considered the paralysis, near death experience, pneumonia, septicemia, seizure, cough, nervous system disorder, pain and mobility decreased to be related to Pneumonia 13.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 67,0
- Geschlecht
- M
- Eingang
- 05.05.2021
- Impfdatum
- 24.02.2021
- Beginn
- 27.04.2021
- Tage bis Beginn
- 62,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: ja
Angiogram pulmonary abnormal
Pulmonary embolism
Symptomtext
pt developed a pulmonary embolism on 4/27/2021
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pulmonary embolism
- Hospital-Tage
- 1,0
- Labordaten
- +CTA chest, neg hypercoag studies
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- cad, htn, hyperprolactinemia, ddd, hx lung ca ned, prox muscle weakness possible eaton labert
- Andere Medikamente
- none
- Allergien
- nka
- Vorherige Impfungen
- -
- Staat
- CT
- Alter
- -
- Geschlecht
- F
- Eingang
- 04.05.2021
- Impfdatum
- 01.11.2019
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bronchitis
COVID-19
Death
General physical health deterioration
Illness
Pneumonia
Symptomtext
Died of Covid; Got pneumonia as well; Got bronchitis; Flu shot / her / health declined after that; got sick for over a year now; This case was reported by a consumer via other manufacturer and described the occurrence of covid-19 in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis. Concurrent medical conditions included low blood pressure. In November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced covid-19 (serious criteria death), pneumonia (serious criteria GSK medically significant), bronchitis, general physical health deterioration and sickness. On an unknown date, the outcome of the covid-19 was fatal and the outcome of the pneumonia, bronchitis, general physical health deterioration and sickness were unknown. The reported cause of death was covid-19. It was unknown if the reporter considered the covid-19, pneumonia, bronchitis, general physical health deterioration and sickness to be related to Influenza vaccine Quadrivalent 2019-2020 season. Additional details were provided as follows: The case was reported by patient's daughter. The age at vaccination was not reported. In 2019, the patient received Flu vaccine and got bronchitis, and pneumonia as well and ever since she got sick for over a year. The patient's health declined after that. The patient was elderly, so the reporter was very careful in following up on protocol. The reporter stated that the patient died of Covid. The reporter consented to follow up. This is 1 of 3 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR095136:Same reporter US-GLAXOSMITHKLINE-US2021AMR095203:Same reporter. Flu shot reporter's case.; Reported Cause(s) of Death: COVID-19
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Low blood pressure
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cerebrovascular accident
Thrombosis
Symptomtext
stroke; blood clots; This case was reported by a consumer and described the occurrence of stroke in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant) and clot blood (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke and clot blood were unknown. It was unknown if the reporter considered the stroke and clot blood to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received the dose of Shingles vaccine and patient experienced stroke and blood clots. The reporter was talked about covid vaccine and its similar reactions except the stroke and blood clots with shingles vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 23.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anaphylactic shock
Angioedema
Symptomtext
Develop recurring angioedema; She gets to carry an epipen just in case she goes into anaphylactic shock.; This case was reported by a consumer via interactive digital media and described the occurrence of angioedema in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced angioedema (serious criteria GSK medically significant) and anaphylactic shock (serious criteria GSK medically significant). The patient was treated with ambiguous medication nos (Epipen (Nos)). On an unknown date, the outcome of the angioedema was unknown and the outcome of the anaphylactic shock was not recovered/not resolved. The reporter considered the angioedema and anaphylactic shock to be related to Meningococcal B vaccine. Additional details were provided as follows: The reporter was patient's parent. The age at vaccination was not reported. The patient received the vaccine and it caused her to develop recurring angioedema. The patient had to carry an Epipen for the rest of her life just in case she would go into anaphylactic shock.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic shock
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 10.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Symptomtext
died; This case was reported by a consumer via interactive media and described the occurrence of unknown cause of death in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reporter considered the unknown cause of death to be related to Meningococcal B vaccine. Additional details were provided as follows: The case was reported by the sibling of the patient. The age at vaccination was not reported. The reporter stated that the patient died from the vaccine.; Reported Cause(s) of Death: Unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 06.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Symptomtext
I almost died from a flu vaccine in 2007; This case was reported by a consumer and described the occurrence of near death experience in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown. The reporter considered the near death experience to be related to Influenza vaccine. Additional details were provided as follows: Age at vaccination was not reported. The patient almost died from a flu vaccine in 2007. It was reported that the patient would never forget that.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- F
- Eingang
- 05.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: ja
Cardiac arrest
Seizure
Symptomtext
heart stopped for about 30 seconds and then flatlined in ER; had a seizure within 10 mins; This case was reported by a consumer via interactive digital media and described the occurrence of asystole in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, less than an hour after receiving Meningococcal B vaccine, the patient experienced asystole (serious criteria hospitalization and GSK medically significant) and seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the asystole and seizure were recovered/resolved. It was unknown if the reporter considered the asystole and seizure to be related to Meningococcal B vaccine. Additional details were reported as follows: The reporter was patient's parent. The age at vaccination was not reported. The patient received the Meningococcal vaccine and had a seizure within 10 minutes and then her heart stopped for about 30 seconds and then flatlined in emergency room and off to hospital. The reporter stated that the patient was fine and mentioned that just no more vaccines for the patient. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cardiac arrest
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 73,0
- Geschlecht
- M
- Eingang
- 01.04.2021
- Impfdatum
- 07.01.2020
- Beginn
- 23.01.2020
- Tage bis Beginn
- 16,0
- Dosis
- UNK
- Route/Site
- IM / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Condition aggravated
Death
Dementia
Encephalopathy
Parkinson's disease
Symptomtext
Parkinson's Disease; mild dementia; Encephalopathy; This case was reported by a lawyer and described the occurrence of parkinson's disease in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis. The patient's past medical history included parkinson's disease. On 7th January 2020, the patient received Shingrix (intramuscular) 50 mcg. On 23rd January 2020, more than 2 weeks after receiving Shingrix, the patient experienced encephalopathy (serious criteria GSK medically significant). On an unknown date, the patient experienced parkinson's disease (serious criteria death and GSK medically significant) and dementia (serious criteria GSK medically significant). On an unknown date, the outcome of the parkinson's disease was fatal and the outcome of the encephalopathy and dementia were unknown. The patient died on 18th March 2020. The reported cause of death was parkinson's disease. An autopsy was not performed. It was unknown if the reporter considered the parkinson's disease, encephalopathy and dementia to be related to Shingrix. The initial information was received on 31 March 2021 via medical record (case is medically confirmed). As per pharmacy record, the patient ingested Shingrix 50mcg injection administered 0.5 ml in the muscles as directed on 07 January 2020. As per death certificate, patient died on 18 March 2020, the cause of death was Parkinson's Disease. The autopsy was not performed. The manner of death was natural. The patient had parkinsonism by September 2015. Patient has had evidence of parkinsonism and mild dementia. The patient experienced Encephalopathy diagnosed on 23 January 2020. He was hospitalized a day after shingles vaccine at which point he was noted to be encephalopathic. He remains encephalopathic although better than when in hospital.; Reported Cause(s) of Death: Parkinson's Disease
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Parkinson's disease
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- -
- Geschlecht
- U
- Eingang
- 01.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Failure to thrive
Symptomtext
Death NOS; Failure to thrive; This case was reported in a literature article and described the occurrence of unknown cause of death in a adult patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included MENACTRA (batch number UNK, expiry date unknown) for prophylaxis and tralokinumab (batch number UNK, expiry date unknown) for atopic dermatitis. Concurrent medical conditions included atopic dermatitis (Moderate-to-severe). On an unknown date, the patient received Boostrix (intramuscular), MENACTRA (intramuscular) and tralokinumab 600 mg once daily (600 mg daily). On an unknown date, the dose was changed to 300 mg once daily (300 mg daily). On an unknown date, unknown after receiving Boostrix, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and failure to thrive (serious criteria GSK medically significant and other: serious as per reporter). The action taken with tralokinumab was unknown. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the failure to thrive was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death and failure to thrive to be related to Boostrix. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of failure to thrive in a patient aged between 18-54 years old of unspecified gender, who was vaccinated with Boostrix (GlaxoSmithKline) for prophylaxis. The patient was a part of the phase 2, double-blind, randomized, placebo controlled, 30-week trial that objective was to assess immune responses to standard vaccines in tralokinumab-treated adults with moderate-to-severe atopic dermatitis (AD). [The objective of this study was to demonstrate non-inferiority of tralokinumab versus placebo with respect to immune responses of two concomitantly administered, non-live vaccines. The study also aimed to assess efficacy, safety, and tolerability of tralokinumab treatment with concomitantly administered vaccines. ECZTRA 5 (NCT03562377) was a phase 2, double-blind, randomized, placebo controlled, 30-week trial. Eligible adults were randomized 1:1 (tralokinumab 300 mg or placebo, 107:108 every 2 weeks [q2w] for 16 weeks), receiving Tdap (tetanus/diphtheria/pertussis) and meningococcal vaccines at week 12. Primary endpoints were positive anti-tetanus and anti-meningococcal responses (week 12-week 16; non-inferiority margin, -25%; responder, more than 3-fold immunoglobulin-G increase). The study enrolled patients with moderate-to-severe AD, aged 18-54 years, who were candidates for systemic therapy and had a recent (within 1 year) history of inadequate response to topical treatments or for whom topical treatments were medically inadvisable. Other key inclusion criteria included a diagnosis of AD for more than or equal to 1 year, AD involvement of more than or equal to 10% body surface area at screening and baseline, Eczema Area and Severity Index (EASI) more than or equal to 12 at screening and more than or equal to 16 at baseline, and Investigator's Global Assessment (IGA) more than or equal to 3 at screening and baseline. Patients were excluded if administration of either vaccine was contraindicated or medically inadvisable or if they had received any vaccine (except influenza virus vaccines) within 3 months prior to screening, any meningococcal vaccine within 1 year prior to screening, or any tetanus-, diphtheria-, or pertussis-containing vaccine within 5 years prior to screening. Patients were recruited from 11 sites in country and 35 sites in the country by the site's investigator]. In this patient, administration of the tetanus, diphtheria, and pertussis vaccine provided in this trial was not contraindicated or medically inadvisable. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received one dose of Boostrix (Tdap: tetanus, diphtheria, and acellular pertussis) and one dose of Menactra (meningococcal vaccine) administered intramuscularly in the deltoid muscle of the upper arm (one vaccine in each arm), before tralokinumab (batch number not provided for both). The patient randomized to tralokinumab received 300 mg every 2 weeks [q2w] for 16 weeks after initial loading dose (600 mg) on day 0 (baseline). The age of vaccination was not provided. [All patients randomized to tralokinumab received an initial loading dose of 600 mg on day 0 (baseline). At week 12, patients received one dose of combined tetanus, diphtheria, and acellular pertussis (Tdap; Boostrix) vaccine and one dose of meningococcal vaccine (Menactra), administered intramuscularly in the deltoid muscle of the upper arm (one vaccine in each arm), before tralokinumab or placebo injections, and in accordance with local labeling. These vaccines were chosen as they are both common inclusions in country-wide vaccination schedules, and represent different antigen structures (protein and polysaccharide)]. On an unspecified date, an unknown period after the vaccination, the patient had eight serious adverse events (SAEs) within the safety follow-up period. Five of these SAEs contributed to a fatal outcome for this patient. All eight SAEs were assessed as being unrelated to the investigational medicinal product (IMP). An additional SAE reported in the same patient during the treatment period was failure to thrive; also had a fatal outcome and was considered as possibly related to treatment by the investigator. [At week 16, non-inferiority of tralokinumab versus placebo for immune responses to Tdap (91.9% vs 96.1%) and meningococcal (86.0% vs 84.2%) vaccines was demonstrated. During treatment, adverse-event rates were lower for tralokinumab versus placebo; most events were mild or moderate. The primary endpoints were positive anti-tetanus and anti-meningococcal responses from weeks 12-16. A positive anti-tetanus response was defined as having at least a three-fold immunoglobulin (Ig) G increase compared to week 12 if IgG less than or equal to 1.0 IU/mL at week 12 or IgG more than or equal to 2.5 IU/mL if IgG more than 1.0 IU/mL at week 12. A positive anti-meningococcal response was defined as IgG more than or equal to 3.0 mcg/mL with at least a three-fold increase compared to week 12, in three of the four assays used (for each meningococcal subtype included in the vaccine: A, C, W, and Y). Secondary endpoints aimed to assess the efficacy, safety, and tolerability of tralokinumab alongside vaccine administration, using the full analysis set. Upon completing the 16-week treatment period, eligible patients were invited to enter an open-label, long-term, extension trial of tralokinumab under a separate trial protocol (ECZTEND, NCT03587805); patients who used rescue medication in ECZTRA 5 were still eligible for inclusion in ECZTEND. Otherwise, patients were required to complete a 14-week, off-treatment, safety follow-up period. The rate of AEs, the number of moderate AEs, and the number of SAEs were higher in the tralokinumab group compared with the placebo group; this difference was driven by a single patient, in whom 18 of the 24 AEs were reported. The overall rate of AEs in the safety follow-up period was lower in the tralokinumab group versus the placebo group (69.59 vs 118.3 events per 100 patient-years' follow-up, respectively). Overall, 11 SAEs were reported in the safety follow-up period in four patients (two in each treatment group), with more events for tralokinumab (nine) compared with placebo (two). The higher rate in the tralokinumab group was driven by the single patient, in whom eight of the nine SAEs within the safety follow-up period occurred; five of these SAEs contributed to a fatal outcome for this patient. All eight SAEs were assessed as being unrelated to the IMP. An additional SAE reported in the same patient during the treatment period ("failure to thrive") also had a fatal outcome and was considered as possibly related to treatment by the investigator]. On an unspecified date, the patient was died with an unknown cause. It was unknown whether the patient's autopsy was performed or not. This case has been considered serious due to death. The author commented, "The investigator did not believe that tralokinumab was the cause of the SAE, but due to their limited experience with tralokinumab in humans, a causal relationship for such a general symptom as weight loss could not be entirely ruled out. All SAEs reported in this patient were not considered related to tralokinumab by the study sponsor, based on the patient's medical history and concomitant medications. These results indicate that tralokinumab 300 mg every 2 weeks treatment did not affect the immune responses to Tdap or meningococcal vaccines, with vaccine-induced immune response rates within expected ranges. For both vaccines, the 95% CI for treatment differences were within the pre-specified -25% noninferiority margin, thereby demonstrating the noninferiority of tralokinumab compared with placebo with respect to immune responses to each concomitantly administered vaccine. Additionally, tralokinumab was safe and well tolerated when administered concomitantly with the selected vaccines, with a safety profile comparable to three phase 3 trials. In this phase 2 study, the treatment difference versus placebo was similar to that seen in the larger ECZTRA 1 and 2 monotherapy trials, further substantiating the robust efficacy reported at week 16 and over 52 weeks in these phase 3 trials. The results of this study indicate that tralokinumab's specific neutralization of IL-13 does not affect the immune response to concomitantly administered Tdap and meningococcal vaccines, suggesting that standard, non-live vaccines are effective and can be safely prescribed in tralokinumab-treated adults with moderate-to-severe AD without the need for tralokinumab interruption. The effect of tralokinumab on vaccines against viral-borne diseases (such as influenza), however, was not examined, which may be an area for future study to inform vaccination programs and guidelines. In this study, data supports noninferiority of tralokinumab versus placebo for vaccine-induced immune responses to Tdap (91.9% vs 96.1%) and meningococcal (86.0% vs 84.2%) vaccines." The author concluded, "Tralokinumab 300 mg q2w treatment did not affect immune responses to Tdap and meningococcal vaccines, and was well tolerated when administered concomitantly, with safety profile comparable to phase 3 trials."; Reported Cause(s) of Death: unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Atopic dermatitis (Moderate-to-severe)
- Vorgeschichte
- -
- Andere Medikamente
- TRALOKINUMAB
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- -
- Geschlecht
- U
- Eingang
- 01.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Death
Failure to thrive
Symptomtext
Death NOS; Failure to thrive; This case was reported in a literature article and described the occurrence of unknown cause of death in a adult patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included MENACTRA (batch number UNK, expiry date unknown) for prophylaxis and tralokinumab (batch number UNK, expiry date unknown) for atopic dermatitis. Concurrent medical conditions included atopic dermatitis (Moderate-to-severe). On an unknown date, the patient received Boostrix (intramuscular), MENACTRA (intramuscular) and tralokinumab 600 mg once daily (600 mg daily). On an unknown date, the dose was changed to 300 mg once daily (300 mg daily). On an unknown date, unknown after receiving Boostrix, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and failure to thrive (serious criteria GSK medically significant and other: serious as per reporter). The action taken with tralokinumab was unknown. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the failure to thrive was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death and failure to thrive to be related to Boostrix. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of failure to thrive in a patient aged between 18-54 years old of unspecified gender, who was vaccinated with Boostrix (GlaxoSmithKline) for prophylaxis. The patient was a part of the phase 2, double-blind, randomized, placebo controlled, 30-week trial that objective was to assess immune responses to standard vaccines in tralokinumab-treated adults with moderate-to-severe atopic dermatitis (AD). [The objective of this study was to demonstrate non-inferiority of tralokinumab versus placebo with respect to immune responses of two concomitantly administered, non-live vaccines. The study also aimed to assess efficacy, safety, and tolerability of tralokinumab treatment with concomitantly administered vaccines. ECZTRA 5 (NCT03562377) was a phase 2, double-blind, randomized, placebo controlled, 30-week trial. Eligible adults were randomized 1:1 (tralokinumab 300 mg or placebo, 107:108 every 2 weeks [q2w] for 16 weeks), receiving Tdap (tetanus/diphtheria/pertussis) and meningococcal vaccines at week 12. Primary endpoints were positive anti-tetanus and anti-meningococcal responses (week 12-week 16; non-inferiority margin, -25%; responder, more than 3-fold immunoglobulin-G increase). The study enrolled patients with moderate-to-severe AD, aged 18-54 years, who were candidates for systemic therapy and had a recent (within 1 year) history of inadequate response to topical treatments or for whom topical treatments were medically inadvisable. Other key inclusion criteria included a diagnosis of AD for more than or equal to 1 year, AD involvement of more than or equal to 10% body surface area at screening and baseline, Eczema Area and Severity Index (EASI) more than or equal to 12 at screening and more than or equal to 16 at baseline, and Investigator's Global Assessment (IGA) more than or equal to 3 at screening and baseline. Patients were excluded if administration of either vaccine was contraindicated or medically inadvisable or if they had received any vaccine (except influenza virus vaccines) within 3 months prior to screening, any meningococcal vaccine within 1 year prior to screening, or any tetanus-, diphtheria-, or pertussis-containing vaccine within 5 years prior to screening. Patients were recruited from 11 sites in country and 35 sites in the country by the site's investigator]. In this patient, administration of the tetanus, diphtheria, and pertussis vaccine provided in this trial was not contraindicated or medically inadvisable. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received one dose of Boostrix (Tdap: tetanus, diphtheria, and acellular pertussis) and one dose of Menactra (meningococcal vaccine) administered intramuscularly in the deltoid muscle of the upper arm (one vaccine in each arm), before tralokinumab (batch number not provided for both). The patient randomized to tralokinumab received 300 mg every 2 weeks [q2w] for 16 weeks after initial loading dose (600 mg) on day 0 (baseline). The age of vaccination was not provided. [All patients randomized to tralokinumab received an initial loading dose of 600 mg on day 0 (baseline). At week 12, patients received one dose of combined tetanus, diphtheria, and acellular pertussis (Tdap; Boostrix) vaccine and one dose of meningococcal vaccine (Menactra), administered intramuscularly in the deltoid muscle of the upper arm (one vaccine in each arm), before tralokinumab or placebo injections, and in accordance with local labeling. These vaccines were chosen as they are both common inclusions in country-wide vaccination schedules, and represent different antigen structures (protein and polysaccharide)]. On an unspecified date, an unknown period after the vaccination, the patient had eight serious adverse events (SAEs) within the safety follow-up period. Five of these SAEs contributed to a fatal outcome for this patient. All eight SAEs were assessed as being unrelated to the investigational medicinal product (IMP). An additional SAE reported in the same patient during the treatment period was failure to thrive; also had a fatal outcome and was considered as possibly related to treatment by the investigator. [At week 16, non-inferiority of tralokinumab versus placebo for immune responses to Tdap (91.9% vs 96.1%) and meningococcal (86.0% vs 84.2%) vaccines was demonstrated. During treatment, adverse-event rates were lower for tralokinumab versus placebo; most events were mild or moderate. The primary endpoints were positive anti-tetanus and anti-meningococcal responses from weeks 12-16. A positive anti-tetanus response was defined as having at least a three-fold immunoglobulin (Ig) G increase compared to week 12 if IgG less than or equal to 1.0 IU/mL at week 12 or IgG more than or equal to 2.5 IU/mL if IgG more than 1.0 IU/mL at week 12. A positive anti-meningococcal response was defined as IgG more than or equal to 3.0 mcg/mL with at least a three-fold increase compared to week 12, in three of the four assays used (for each meningococcal subtype included in the vaccine: A, C, W, and Y). Secondary endpoints aimed to assess the efficacy, safety, and tolerability of tralokinumab alongside vaccine administration, using the full analysis set. Upon completing the 16-week treatment period, eligible patients were invited to enter an open-label, long-term, extension trial of tralokinumab under a separate trial protocol (ECZTEND, NCT03587805); patients who used rescue medication in ECZTRA 5 were still eligible for inclusion in ECZTEND. Otherwise, patients were required to complete a 14-week, off-treatment, safety follow-up period. The rate of AEs, the number of moderate AEs, and the number of SAEs were higher in the tralokinumab group compared with the placebo group; this difference was driven by a single patient, in whom 18 of the 24 AEs were reported. The overall rate of AEs in the safety follow-up period was lower in the tralokinumab group versus the placebo group (69.59 vs 118.3 events per 100 patient-years' follow-up, respectively). Overall, 11 SAEs were reported in the safety follow-up period in four patients (two in each treatment group), with more events for tralokinumab (nine) compared with placebo (two). The higher rate in the tralokinumab group was driven by the single patient, in whom eight of the nine SAEs within the safety follow-up period occurred; five of these SAEs contributed to a fatal outcome for this patient. All eight SAEs were assessed as being unrelated to the IMP. An additional SAE reported in the same patient during the treatment period ("failure to thrive") also had a fatal outcome and was considered as possibly related to treatment by the investigator]. On an unspecified date, the patient was died with an unknown cause. It was unknown whether the patient's autopsy was performed or not. This case has been considered serious due to death. The author commented, "The investigator did not believe that tralokinumab was the cause of the SAE, but due to their limited experience with tralokinumab in humans, a causal relationship for such a general symptom as weight loss could not be entirely ruled out. All SAEs reported in this patient were not considered related to tralokinumab by the study sponsor, based on the patient's medical history and concomitant medications. These results indicate that tralokinumab 300 mg every 2 weeks treatment did not affect the immune responses to Tdap or meningococcal vaccines, with vaccine-induced immune response rates within expected ranges. For both vaccines, the 95% CI for treatment differences were within the pre-specified -25% noninferiority margin, thereby demonstrating the noninferiority of tralokinumab compared with placebo with respect to immune responses to each concomitantly administered vaccine. Additionally, tralokinumab was safe and well tolerated when administered concomitantly with the selected vaccines, with a safety profile comparable to three phase 3 trials. In this phase 2 study, the treatment difference versus placebo was similar to that seen in the larger ECZTRA 1 and 2 monotherapy trials, further substantiating the robust efficacy reported at week 16 and over 52 weeks in these phase 3 trials. The results of this study indicate that tralokinumab's specific neutralization of IL-13 does not affect the immune response to concomitantly administered Tdap and meningococcal vaccines, suggesting that standard, non-live vaccines are effective and can be safely prescribed in tralokinumab-treated adults with moderate-to-severe AD without the need for tralokinumab interruption. The effect of tralokinumab on vaccines against viral-borne diseases (such as influenza), however, was not examined, which may be an area for future study to inform vaccination programs and guidelines. In this study, data supports noninferiority of tralokinumab versus placebo for vaccine-induced immune responses to Tdap (91.9% vs 96.1%) and meningococcal (86.0% vs 84.2%) vaccines." The author concluded, "Tralokinumab 300 mg q2w treatment did not affect immune responses to Tdap and meningococcal vaccines, and was well tolerated when administered concomitantly, with safety profile comparable to phase 3 trials."; Reported Cause(s) of Death: unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Atopic dermatitis (Moderate-to-severe)
- Vorgeschichte
- -
- Andere Medikamente
- TRALOKINUMAB
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- -
- Geschlecht
- F
- Eingang
- 26.03.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Autopsy
Death
Symptomtext
Patient passed away; This case was reported by a consumer via patient support programs and described the occurrence of unknown cause of death in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. The reporter considered the unknown cause of death to be unrelated to Shingrix. Additional details were as follows: The age at vaccination was not reported. The patient's history was unknown. The patient received Shingrix and died. The cause of death was unknown and autopsy performed was unknown.; Reported Cause(s) of Death: unknown cause of death
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- -
- Geschlecht
- F
- Eingang
- 24.03.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Near death experience
Vaccine positive rechallenge
Symptomtext
almost killed me; This case was reported by a consumer via other manufacturer and described the occurrence of near death experience in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown. The reporter considered the near death experience to be related to Shingrix. Additional details were provided as follows: The case was reported by the patient herself The age at vaccination was not reported. The patient received 1st dose of shingrix and stated that experienced near death experience. The patient also stated that while completing Shingrix series second one was horrible. Almost killed her consider for both dose as it was not confirmed 1st or 2nd dose of Shingrix which almost killed her. No further information available. For further tolerance of 2nd dose refer case US2021AMR063320 reported by same the reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR063320:1st dose
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- -
- Geschlecht
- F
- Eingang
- 17.03.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Feeling abnormal
Near death experience
Vaccine positive rechallenge
Symptomtext
Second dose was horrible / almost killed me; Second dose was horrible / almost killed me; This case was reported by a consumer via other manufacturer and described the occurrence of feels awful in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of near death experience (for tolerance in 1st dose refer case US2021AMR063322). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feels awful (serious criteria life threatening) and near death experience (serious criteria GSK medically significant and life threatening). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feels awful and near death experience were unknown. The reporter considered the feels awful and near death experience to be related to Shingrix. Additional details were provided as follows: Age at vaccination was not reported. The patient said that experience with Shingrix which almost killed her and when completing Shingrix series second one was horrible. Almost killed her consider for both dose as it was not confirmed 1st or 2nd dose of Shingrix which almost killed her.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR063322:1st dose
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Near death experience
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 17.03.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anaphylactic shock
Symptomtext
Had anaphylactic shock; This case was reported by a consumer via other manufacturer and described the occurrence of anaphylactic shock in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced anaphylactic shock (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic shock was unknown. It was unknown if the reporter considered the anaphylactic shock to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The reporter reported for herself. The age at vaccination was not reported. The patient had anaphylactic shock with the flu shot.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic shock
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 12.03.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Acute respiratory failure
Anal incontinence
Anti-aquaporin-4 antibody negative
Antibody test negative
Antinuclear antibody negative
Asthenia
Atelectasis
Blindness
Blood electrolytes normal
Blood glucose normal
C-reactive protein increased
CSF glucose normal
CSF protein increased
CSF test abnormal
Chest X-ray abnormal
Coma scale abnormal
Complement factor normal
Computerised tomogram abnormal
Symptomtext
Influenza-associated encephalopathy/encephalitis (IAE); Influenza B virus infection; status epilepticus; acute respiratory failure; fever/tactile fever; runny nose; generalised fatigue; bowel and bladder incontinence; bowel and bladder incontinence; recurrent, prolonged generalised tonic clonic seizures; respiratory failure; seizures; weak cough; gag reflexes; generalised hypotonia; decreased strength in all extremities; visual impairment; unresponsive; concerns about her vision/patient had no perception of bright light consistent with total blindness; This case was reported in a literature article and described the occurrence of encephalitis in a 4-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine and an unknown time after starting levetiracetam, the patient experienced encephalitis (serious criteria hospitalization and GSK medically significant), influenza b virus infection (serious criteria hospitalization), status epilepticus (serious criteria hospitalization and GSK medically significant), acute respiratory failure (serious criteria hospitalization and GSK medically significant), fever (serious criteria hospitalization), runny nose (serious criteria hospitalization), fatigability generalized (serious criteria hospitalization), unresponsive to stimuli (serious criteria GSK medically significant), bowel incontinence (serious criteria hospitalization), bladder incontinence (serious criteria hospitalization), generalized tonic-clonic seizure (serious criteria hospitalization and GSK medically significant), respiratory failure (serious criteria hospitalization and GSK medically significant), seizure (serious criteria GSK medically significant), blindness (serious criteria GSK medically significant), cough weak, retching, hypotonia, weakness in extremity and visual impairment. The patient was treated with ceftriaxone (Ceftriaxone Disodium), lorazepam, levetiracetam, ibuprofen, paracetamol (Acetaminophen), fosphenytoin, steroids nos (Steroids), immunoglobulins nos (Intravenous Immunoglobulin), oseltamivir, vancomycin and methylprednisolone. On an unknown date, the outcome of the encephalitis, influenza b virus infection, status epilepticus, acute respiratory failure, fever, runny nose, fatigability generalized, bowel incontinence, bladder incontinence, generalized tonic-clonic seizure, respiratory failure, cough weak, retching, hypotonia and weakness in extremity were recovering/resolving and the outcome of the unresponsive to stimuli, seizure, blindness and visual impairment were recovered/resolved. It was unknown if the reporter considered the encephalitis, influenza b virus infection, status epilepticus, acute respiratory failure, fever, runny nose, fatigability generalized, unresponsive to stimuli, bowel incontinence, bladder incontinence, generalized tonic-clonic seizure, respiratory failure, seizure, blindness, cough weak, retching, hypotonia, weakness in extremity and visual impairment to be related to Influenza vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of influenza-associated encephalopathy/encephalitis (IAE) in a 4-years old female patient, who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. The patient was girl. The patient's parents denied vomiting, diarrhoea, dysuria, rash or breathing difficulty. Three household contacts had similar complaints. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided) in the prior season. However, the patient had not received a vaccine for the current season [History revealed that she had an influenza vaccine in the prior season, but she had not received a vaccine for the current season]. On an unspecified date, an unknown period after the vaccination, the patient was transferred to paediatric intensive care unit (PICU) intubated due to status epilepticus and acute respiratory failure. Her symptoms started with fever, runny nose and generalised fatigue 6 days prior to admission. The patient was treated supportively at home with appropriate doses of ibuprofen and acetaminophen. The patient's parents put her to bed on the night before admission. Six hours later, the patient was rushed to the local emergency room (ER) after being found unresponsive with tactile fever, bowel and bladder incontinence. At the ER, the child was afebrile, with heart rate 136 beats per minute, blood pressure 95/57 mm Hg, respiratory rate 22 breaths per minute and oxygen saturation 88% on ambient air. The patient was noted to have recurrent, prolonged generalised tonic clonic seizures, and the patient was treated with multiple doses of intravenous lorazepam and a 20 mg/kg loading dose of levetiracetam. The patient required endotracheal intubation due to respiratory failure in the setting of these seizures and seizure treatments. Her laboratory workup, including electrolytes, liver function tests and complete blood count, was normal. The respiratory viral PCR panel via nasal swab was positive for influenza type B. The patient was transferred to PICU on a mechanical ventilator with propofol infusion for sedation. On arrival to the PICU, the child's vital signs were stable, but her Glasgow coma score was low off sedation, and her pupillary response was sluggish to light bilaterally. Fever and seizures recurred. The patient was treated with additional intravenous lorazepam and an intravenous loading dose of fosphenytoin with subsequent resolution of clinical seizures. The neurology consultation service recommended continuous electroencephalogram (EEG) and maintenance dosing of levetiracetam. EEG was consistent with moderate to severe encephalopathy. There were no seizures during the entirety of her 36-hour recording. Despite discontinuation of sedation on hospital day 1, the child remained unresponsive with weak cough and gag reflexes for the initial 4 days of her admission. The patient had generalised hypotonia and decreased strength in all extremities. Following receipt of steroids and intravenous immunoglobulin (IVIG), there was a gradual improvement in her neurological status starting with spontaneous eye opening and an improved cough/gag reflex. At the time of her extubation on hospital day 12, there were already concerns about her vision. Subsequent ophthalmology exam was significant for minimal pupillary response to light and diffuse visual field restriction in total superior temporal, inferior temporal, superior nasal, inferior nasal fields. The patient had no perception of bright light consistent with total blindness. Perimetry and visual evoked potentials were attempted but not completed as child was younger and not cooperative. By the time of discharge on hospital day 16, she was walking, talking and eating food by mouth; however, the patient still had visual impairment and could not track or reach objects. Blood glucose and serum electrolytes were within normal limits throughout her hospitalisation. Liver and renal function tests were within normal limits. C-reactive protein (CRP) was less than 0.5 mg/dL on admission. CRP was as high as 5.3 mg/dL on hospital day 2, which trended down to normal from hospital day 3. Antinuclear antibody screen was negative, complement levels (C3 and C4) were within normal limits. Chest X-ray showed right upper lobe and left lobe atelectasis, with resolution within few days while intubated. Neuromyelitis optica (NMO)/aquaporin-4-IgG in serum and cerebrospinal fluid (CSF) were negative, and myelin oligodendrocyte glycoprotein (MOG) antibody assay in serum was negative. CSF analysis was normal with nucleated cells of 3/cubic mm, mildly elevated protein at 85 mg/dL and normal glucose at 66 mg/dL. The CSF meningitis/encephalitis PCR panel was negative. A CT scan of her brain on admission showed mild hypodensities in the left temporal and parietal lobes. Subsequent MRI of the brain showed bilateral, symmetric diffusion restriction of the amygdala, hippocampus, putamen, thalami, pons and regions of the peripheral cortex. [MRI brain findings in a patient with influenza-associated encephalitis/encephalopathy showing the involvement of bilateral putamen and thalami. It showed diffusion restriction in diffusion weighted image. It showed diffusion restriction in apparent diffusion coefficient image]. Faint enhancement of the posterior optic nerves was observed bilaterally on the post-contrast images. [MRI brain with and without contrast findings in a patient with influenza-associated encephalitis/encephalopathy showing enhancement of the posterior optic nerves bilaterally]. MRI C-spine was normal without any demyelinating changes. She was also found to be heterozygous for RAN binding protein 2 (RANBP2) gene mutation on further diagnostic investigation. The working diagnosis at this point was acute necrotizing encephalopathy (ANE) secondary to influenza B infection. The differential diagnosis included NMO, MOG antibody associated encephalopathy, vasculitis and bacterial meningitis. Appropriate workup for these alternative diagnoses was negative. The patient was treated for influenza B infection with oseltamivir for 5 days. The patient was also empirically treated with ceftriaxone and vancomycin until blood, urine and CSF cultures returned negative. Given the working diagnosis of ANE, the patient was given pulse dose steroid therapy with methylprednisolone 30 mg/kg/day from hospital days 3-7 followed by a steroid taper over 3 weeks. The patient was also treated with 0.5 g/kg/day IVIG from hospital days 7-10. The patient continued to improve after the hospital discharge, and within a month, The patient had subjectively regained full vision. At her follow-up visit with neurology, The patient was able to identify colours, and The patient could track objects. Visual acuity testing in neurology clinic was limited as the patient did not cooperate with age appropriate visual acuity testing using the tumbling E vision chart. The patient's parents expressed concerns at that appointment for her learning, stating that it seemed difficult for her to retain new information. Neuropsychology evaluation was scheduled. Patient was scheduled to have an ophthalmology appointment the following week but was then lost to follow-up. The child and her family members were referred to genetics clinic, pending additional genetic testing at the time of this case report. This case has been considered as serious due to hospitalization. The author commented, "Influenza-associated neurological manifestations vary from encephalitis/encephalopathy, myelitis, Guillain-Barre syndrome and Reye's syndrome, to ANE. Influenza type A is the predominant cause of IAE in children. IAE is more frequently reported in country than the rest of the world. The incidence of influenza-related neurological complications was 4 cases per 100 000 child-years in the country. Abrupt onset of seizures and loss of consciousness following a short duration of fever are the most common manifestations of IAE. CSF analysis may reveal pleocytosis and/or increased protein; however, normal CSF analysis and negative RT-PCR do not rule out IAE. CT and/or MRI may show diffuse cerebral oedema. Neuroimaging in ANE further shows symmetric necrosis of thalami, cortex, internal capsule and brain stem structures. MRI findings in our index patient were consistent with ANE. Cytokine-mediated vascular inflammation and parenchymal cell apoptosis are the most proposed pathophysiological mechanisms for IAE. While our patient's neurological improvement correlated with receipt of these treatments, it is difficult to interpret whether the treatments caused the improvement or if her improvement was due to the natural course of the illness. Larger studies are needed to determine the efficacy of steroids and IVIG in IAE. Our index case was also found to be heterozygous for RANBP2 gene mutation. This genetic mutation was well studied and was found to be associated with recurrent and familial cases of ANE. Visual defects such as uveitis, optic neuritis, neuroretinitis, retinal infarction and lateral geniculate body (visual pathway relay centre in thalamus) infarction have been reported in paediatric patients with influenza. Blindness in our patient is likely explained by the combination of optic nerve enhancement and ANE affecting the lateral geniculate bodies. Presence of isolated optic nerve enhancement without optic disc oedema in our index case was not reported in previous studies. It was described a child diagnosed with IAE due to influenza B virus infection who developed temporary visual impairment as a sequela." This article corresponding to this case is not available for regulatory submission due to copyright restriction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Acute respiratory failure
- Hospital-Tage
- -
- Labordaten
- Test Name: Antinuclear antibody; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Name: electrolytes; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: serum electrolytes; Result Unstructured Data: (Test Result:within normal limits throughout hospitalisation,Unit:unknown,Normal Low:,Normal High:); Test Name: Blood glucose; Result Unstructured Data: (Test Result:within normal limits throughout hospitalisation,Unit:unknown,Normal Low:,Normal High:); Test Name: Chest X-ray; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: complement levels; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: complement levels; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: CT scan; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: C-reactive protein; Result Unstructured Data: (Test Result:less than 0.5 on admission,Unit:mg/dL,Normal Low:,Normal High:); Test Name: C-reactive protein; Result Unstructured Data: (Test Result:high as 5.3 on hospital day 2,Unit:mg/dL,Normal Low:,Normal High:); Test Name: C-reactive protein; Result Unstructured Data: (Test Result:trended down to normal from hospital day 3,Unit:mg/dL,Normal Low:,Normal High:); Test Name: CSF analysis; Result Unstructured Data: (Test Result:with nucleated cells of 3,Unit:/mm3,Normal Low:,Normal High:); Test Name: csf glucose; Test Result: 66 mg/dl; Test Name: CSF protein; Test Result: 85 mg/dl; Test Name: cerebrospinal fluid test; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: nasal swab; Result Unstructured Data: (Test Result:positive for influenza type B,Unit:unknown,Normal Low:,Normal High:); Test Name: electroencephalogram; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: complete blood count; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: gene test; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: heart rate; Result Unstructured Data: (Test Result:136,Unit:/min,Normal Low:,Normal High:); Test Name: liver function; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: MRI; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: ophthalmology exam; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: oxygen saturation; Result Unstructured Data: (Test Result:88 on ambient air,Unit:%,Normal Low:,Normal High:); Test Name: PCR; Result Unstructured Data: (Test Result:positive for influenza type B,Unit:unknown,Normal Low:,Normal High:); Test Name: PCR; Result Unstructured Data: (Test Result:CSF meningitis/encephalitis PCR panel was negative,Unit:unknown,Normal Low:,Normal High:); Test Name: respiratory rate; Result Unstructured Data: (Test Result:22 breaths,Unit:/min,Normal Low:,Normal High:); Comments: on an unspecified date lab test were performed.on an unspecified date lab test were performed.Glasgow coma score was low off sedation, and her pupillary response was sluggish to light bilaterally.EEG was consistent with moderate to severe encephalopathy.Perimetry and visual evoked potentials were attempted but not completed as child was younger and not cooperative.Chest X-ray showed right upper lobe and left lobe atelectasis, with resolution within few days while intubated.Neuromyelitis optica (NMO)/aquaporin-4-IgG in serum and cerebrospinal fluid (CSF) were negative, and myelin oligodendrocyte glycoprotein (MOG) antibody assay in serum was negative.. A CT scan of her brain on admission showed mild hypodensities in the left temporal and parietal lobes.Subsequent MRI of the brain showed bilateral, symmetric diffusion restriction of the amygdala, hippocampus, putamen, thalami, pons and regions of the peripheral cortex. [MRI brain findings in a patient with influenza-associated encephalitis/encephalopathy showing the involvement of bilateral putamen and thalami. It showed diffusion restriction in diffusion weighted image. It showed diffusion restriction in apparent diffusion coefficient image]. Faint enhancement of the posterior optic nerves was observed bilaterally on the post-contrast images. [MRI brain with and without contrast findings in a patient with influenza-associated encephalitis/encephalopathy showing enhancement of the posterior optic nerves bilaterally]. encephalitis/encephalopathy showing enhancement of the posterior optic nerves bilaterally]. MRI C-spine was normal without any demyelinating changes. She was also found to be heterozygous for RAN binding protein 2 (RANBP2) gene mutation on further diagnostic investigation. The working diagnosis at this point was acute necrotizing encephalopathy (ANE) secondary to influenza B infection.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 78,0
- Geschlecht
- M
- Eingang
- 10.03.2021
- Impfdatum
- 02.03.2021
- Beginn
- 02.03.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Death
Syncope
Symptomtext
Syncopal episode followed by death. Unable to be revived. Coroner's case.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- COPD, hypotension, syncope
- Vorgeschichte
- COPD, hypotension, syncope
- Andere Medikamente
- Spiriva
- Allergien
- unknown
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 05.03.2021
- Impfdatum
- 13.02.2021
- Beginn
- 13.02.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cerebrovascular accident
Dizziness
Headache
Vertigo
Symptomtext
stroke; vertigo attack; severe headaches; severe dizziness; A spontaneous report was received from a consumer who was also a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced severe headaches / headache, severe dizziness / dizziness, vertigo attack / vertigo, and stroke / cerebrovascular accident. The patient's medical history was not provided. No relevant concomitant medications were reported. On 13 Feb 2021, prior to the onset of the events, the patient received their second dose of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 13 Feb 2021, about 12 hours after receiving the vaccine, the patient experienced severe dizziness and severe headaches which lasted for about 4 days. On 17 Feb 2021, while driving, the patient thought he was having a vertigo attack and went to the emergency room. He had a cat scan (results not provided) and was treated with TPA (tissue plasminogen activator). After three days in the hospital, they determined he had a stroke. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, severe headaches, severe dizziness, vertigo attack, and stroke, was not provided.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of cerebrovascular accident among others, 5 days after receiving 2nd dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: No adverse reaction (no adverse reaction reported)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- M
- Eingang
- 23.02.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Cerebrovascular accident
Malaise
Symptomtext
had a stroke; Bell's Palsy; he didnt feel well; This case was reported by a consumer via call center representative and described the occurrence of stroke in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced stroke (serious criteria hospitalization and GSK medically significant), bell's palsy (serious criteria hospitalization and GSK medically significant) and feeling unwell. On an unknown date, the outcome of the stroke, bell's palsy and feeling unwell were unknown. It was unknown if the reporter considered the stroke, bell's palsy and feeling unwell to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that after he got his second dose of shingrix he didnt feel well, went to the hospital, had a stroke and Bell's Palsy. The reporter did not consent to follow-up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Cerebrovascular accident
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 11.02.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Coma
Symptomtext
HPV shot put my neighbors daughter in a coma; This case was reported by a consumer via interactive digital media and described the occurrence of coma in a female patient who received HPV 16-18 (HPV vaccine) for prophylaxis. Concurrent medical conditions included autism. On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced coma (serious criteria GSK medically significant). On an unknown date, the outcome of the coma was unknown. It was unknown if the reporter considered the coma to be related to HPV vaccine. Additional information was provided as follows: The age at vaccination was not reported. The patient received a dose of HPV vaccine and was in coma after the vaccination. The reporter mentioned that, the babies with autism were given HPV shot when they had no way to stop the eugenics programs. Poison pushing establishments have profitted while people have actually suffered. The reporter also mentioned that, there was no accountability on how the doctors were administrating the shots even after reading the pamphlets but again the FDA had ruled that those shots were safe. The case is linked with the case number- US2021AMR028881, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR028881:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Coma
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Autism
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WY
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.01.2021
- Impfdatum
- -
- Beginn
- 01.08.2019
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: ja
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Chemotherapy
Death
Dementia
Fall
Leukaemia
Neoplasm malignant
Symptomtext
she has passed away / had leukemia / was on chemotherapy; she has passed away / had / cancer / was on chemotherapy; she passed / from dementia he thinks; she fell at the house; This case was reported by a consumer via other manufacturer and described the occurrence of leukemia in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included cancer (Family History) (to mother). On an unknown date, the patient received Shingles vaccine. In August 2019, unknown after receiving Shingles vaccine, the patient experienced fall. On an unknown date, the patient experienced leukemia (serious criteria GSK medically significant), cancer (serious criteria GSK medically significant) and dementia (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy) and oxygen. On an unknown date, the outcome of the leukemia, cancer, dementia and fall were unknown. It was unknown if the reporter considered the leukemia, cancer, dementia and fall to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by patient's husband. Age at vaccination was not reported. It was reported that the patient was very tough hard and strong. The reporter stated that the patient had a reaction to shingle shot. The patient had leukemia and cancer and she was on chemotherapy. The patient also had dementia and she fell at house in august 2019. The reporter did not have product information for shingles vaccine lot number etc. The patient went a lot through cancer and was on oxygen 24x7. It was reported that more than a year ago the patient passed away. The patient died from unrelated cause. The reporter did not given consent to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Death
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Cancer (to mother)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 52,0
- Geschlecht
- F
- Eingang
- 06.01.2021
- Impfdatum
- 22.05.2018
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cataract nuclear
Eye pain
Glaucoma
Inflammation
Migraine
Pain
Symptomtext
glaucoma; Eye pain both eyes; burning eyes; Nuclear catarct; possible sinus problems; migraine; This case was reported by a lawyer and described the occurrence of glaucoma in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 22nd May 2018, the patient received Shingrix (intramuscular) .5 mg. On an unknown date, an unknown time after receiving Shingrix, the patient experienced glaucoma (serious criteria GSK medically significant) and eye pain. On an unknown date, the outcome of the glaucoma and eye pain were unknown. It was unknown if the reporter considered the glaucoma and eye pain to be related to Shingrix. The initial information received on 10 December 2020 via medical records. As per records the female patient was non smoker.As per records on 22 May 2018 and on 19 October 2018, she had Shingrix 50mcg injection 0.5 ml into the muscle, repeat in 2 to 6 months. On 19 February 2019, she had follow-up of ocular pain, both eyes. She described to have pain as aching and burning and stated that was an aggravating problem. This eye pain began several months ago and is symptomatic almost constantly. She states that this seems to be gradually improving. On 29 January 2019, she stated eyes have been painful since having the shingles shot. She had Ocular pain, possible sinus problems, Inflammation from shingles shot, nuclear cataract and migraine
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Glaucoma
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- -
- Geschlecht
- F
- Eingang
- 19.12.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anaphylactic reaction
Pancreatic disorder
Unresponsive to stimuli
Symptomtext
Patient was found unresponsive; severe anaphylactic reaction that led to pancreatic complications; severe anaphylactic reaction that led to pancreatic complications; This serious case was reported by a nurse via sales rep and described the occurrence of unresponsive to stimuli in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Patient received 1st dose of shingrix vaccine on unknown date.). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 hrs after receiving Shingrix, the patient experienced unresponsive to stimuli (Verbatim: Patient was found unresponsive) (serious criteria GSK medically significant), anaphylactic reaction (Verbatim: severe anaphylactic reaction that led to pancreatic complications) (serious criteria GSK medically significant) and pancreatic disorder (Verbatim: severe anaphylactic reaction that led to pancreatic complications). The outcome of the unresponsive to stimuli, anaphylactic reaction and pancreatic disorder were not resolved. It was unknown if the reporter considered the unresponsive to stimuli, anaphylactic reaction and pancreatic disorder to be related to Shingrix. It was unknown if the company considered the unresponsive to stimuli, anaphylactic reaction and pancreatic disorder to be related to Shingrix. Additional Information: GSK Receipt Date: 12-DEC-2023 Patient was the mother of nurse practitioner. The reporter reported that the patient received 2nd dose of Shingrix vaccine. After 3 hours after 2nd dose patient found unresponsive. Patient had severe anaphylactic reaction that led to pancreatic complications. Issues were not resolved. The reporter agrees to follow up from GlaxoSmithKline.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic reaction
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 14.12.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Acute motor-sensory axonal neuropathy
Anterior spinal artery syndrome
Anti-VGCC antibody negative
Antiacetylcholine receptor antibody
Antibody test negative
Areflexia
Ascending flaccid paralysis
Asthenia
Blood glucose normal
Borrelia test
Borrelia test negative
CSF protein normal
Corneal light reflex test abnormal
Cranial nerve disorder
Dyspnoea
Electromyogram abnormal
Endotracheal intubation
Extensor plantar response
Symptomtext
GUILLAIN BARRE SYNDROME/ AIDP variant; ascending paralysis; unresponsive to verbal, tactile and noxious stimuli; Acute motor and sensory axonal neuropathy/AMSAN; lower extremity weakness/bilateral lower extremity weakness/reported mild drift of the lower extremity; dyspnea; paresthesias in the distal upper extremities; Weakness rapidly progressed; Plantar responses are mute bilaterally; myoclonus; reported mild drift of the lower extremity; anterior spinal artery syndrome; Weakness in cranial nerves; absent DTRs; chronically ill; pupil sluggishly reactive to light; Oculocephalic reflex absent/No corneal reflexes; This serious case was reported by a consumer via regulatory authority and described the occurrence of guillain barre syndrome in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. The patient's past medical history included hyperlipidemia and tobacco user (previous tobacco smoker). Concurrent medical conditions included hypertension (Chronic medical conditions reported as hypertension,) and seasonal allergy. Additional patient notes included No known allergies to medications, food, or other products. No documented home medications, dietary supplements, or herbal remedies in medical records. The patient drink 2 to 3 beers per day. No documented illnesses reported for client in medical records.. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: GUILLAIN BARRE SYNDROME/ AIDP variant) (serious criteria hospitalization and GSK medically significant), paralysis ascending (Verbatim: ascending paralysis) (serious criteria hospitalization and GSK medically significant), unresponsive to stimuli (Verbatim: unresponsive to verbal, tactile and noxious stimuli) (serious criteria hospitalization and GSK medically significant), acute motor-sensory axonal neuropathy (Verbatim: Acute motor and sensory axonal neuropathy/AMSAN) (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (Verbatim: lower extremity weakness/bilateral lower extremity weakness/reported mild drift of the lower extremity) (serious criteria hospitalization), dyspnea (Verbatim: dyspnea) (serious criteria hospitalization), paresthesia distal (Verbatim: paresthesias in the distal upper extremities) (serious criteria hospitalization), weakness (Verbatim: Weakness rapidly progressed) (serious criteria hospitalization), extensor plantar response (Verbatim: Plantar responses are mute bilaterally) (serious criteria hospitalization), myoclonus (Verbatim: myoclonus) (serious criteria hospitalization), pronator drift (Verbatim: reported mild drift of the lower extremity) (serious criteria hospitalization and GSK medically significant), anterior spinal artery syndrome (Verbatim: anterior spinal artery syndrome) (serious criteria hospitalization and GSK medically significant), paresis cranial nerve (Verbatim: Weakness in cranial nerves) (serious criteria hospitalization), tendon disorder (Verbatim: absent DTRs) (serious criteria hospitalization), illness (Verbatim: chronically ill) (serious criteria hospitalization), pupillary reflex impaired (Verbatim: pupil sluggishly reactive to light) (serious criteria hospitalization) and absent reflex (Verbatim: Oculocephalic reflex absent/No corneal reflexes) (serious criteria hospitalization). The outcome of the guillain barre syndrome, paralysis ascending, unresponsive to stimuli, acute motor-sensory axonal neuropathy, lower extremities weakness of, dyspnea, paresthesia distal, weakness, extensor plantar response, myoclonus, pronator drift, anterior spinal artery syndrome, paresis cranial nerve, tendon disorder, illness, pupillary reflex impaired and absent reflex were not reported. It was unknown if the reporter considered the guillain barre syndrome, paralysis ascending, unresponsive to stimuli, acute motor-sensory axonal neuropathy, lower extremities weakness of, dyspnea, paresthesia distal, weakness, extensor plantar response, myoclonus, pronator drift, anterior spinal artery syndrome, paresis cranial nerve, tendon disorder, illness, pupillary reflex impaired and absent reflex to be related to Arexvy. It was unknown if the company considered the guillain barre syndrome, paralysis ascending, unresponsive to stimuli, acute motor-sensory axonal neuropathy, lower extremities weakness of, dyspnea, paresthesia distal, weakness, extensor plantar response, myoclonus, pronator drift, anterior spinal artery syndrome, paresis cranial nerve, tendon disorder, illness, pupillary reflex impaired and absent reflex to be related to Arexvy. Additional Information: GSK receipt date: 09-NOV-2023 The patient age was between 65 to 79 years old. The patient was initially seen at hospital on 19th October 2023 and transferred to another hospital. He was admitted that same day and required intubation on 23rd October 2023. He was then transferred to third hospital on 27th October 2023 for escalation of care and neuromuscular evaluation and EMG. As per medical records client presented at hospital emergency department as a transfer from another hospital secondary to abrupt onset of lower extremity weakness upon awakening on 19th October 2023. The patient initially reported mild drift of the lower extremity. As per Telehealth neurology, he was recommended to be seen at hospital for possible anterior spinal artery syndrome and requested MRI brain and spine. Upon arrival to hospital patient was noted to have bilateral lower extremity weakness, absent DTRs, eventually developed dyspnea and required intubation. He was reportedly also complaining of paresthesias in the distal upper extremities. Weakness rapidly progressed and is now currently involving cranial nerves. Prior to leaving facility, patient was able to move his head and open eyes. The patient had five rounds of plasma exchange with no significant improvement. As per report MRI and spine unremarkable in facility. A neurology consult was placed for ascending paralysis with concern for GBS. Most recent neurology note from 30th October 2023 stated suspect AIDP variant, likely AMSAN. EMG consistent with diagnosis. Neurology note from 30th October 2023 also reported, in bed, not on sedation chronically ill appearing. The patient was unresponsive to verbal, tactile, and noxious stimuli, breathing synchronous with the ventilator. The pupils were equal and sluggishly reactive to light and oculocephalic reflex absent. No gaze preference or pathologic nystagmus noted, no corneal reflexes, no facial asymmetry noted, no gag or cough reflex per RN, no spontaneous movements, no withdrawal to noxious stimuli applied to any extremities, no posturing, no tremors, myoclonus, adventitious movements noted. Tone was decreased throughout, reflexes absent throughout, plantar responses were mute bilaterally, prognosis for a functional neurologic recovery was poor and multiple other medical conditions being monitored.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Ascending flaccid paralysis
- Hospital-Tage
- -
- Labordaten
- Test Name: Anti-ACH receptor antibodies; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Name: Antibody test; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Comments: Lyme IgG and IgM; Test Name: anti-VG CCR antibody; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Name: HIV test; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20231027; Test Name: Glucose test; Result Unstructured Data: (Test Result:102,Unit:unknown,Normal Low:,Normal High:); Test Date: 20231027; Test Name: Lumbar puncture test; Result Unstructured Data: (Test Result:61,Unit:unknown,Normal Low:,Normal High:); Comments: Protein; Test Name: paraneoplastic panel; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20231027; Test Name: RBC; Result Unstructured Data: (Test Result:1400,Unit:unknown,Normal Low:,Normal High:); Test Date: 20231027; Test Name: WBC count; Result Unstructured Data: (Test Result:Normal,Unit:unknown,Normal Low:,Normal High:); Comments: LabComments: Antibody test : Lyme IgG and IgM, Lumbar puncture test 27-OCT-23: Protein
- Aktuelle Erkrankungen
- Hypertension (Chronic medical conditions reported as hypertension,)
- Vorgeschichte
- Medical History/Concurrent Conditions: Hyperlipidemia; Seasonal allergy; Tobacco user (previous tobacco smoker); Comments: No known allergies to medications, food, or other products. No documented home medications, dietary supplements, or herbal remedies in medical records. The patient drink 2 to 3 beers per day. No documented illnesses reported for client in medical records.
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 11.12.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
Guillain Barre syndrome; This serious case was reported by a consumer via regulatory authority and described the occurrence of guillain barre syndrome in a elderly patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported. It was unknown if the reporter considered the guillain barre syndrome to be related to Arexvy. It was unknown if the company considered the guillain barre syndrome to be related to Arexvy. Additional Information: GSK Receipt Date:04-DEC-2023 The patient self-reported this case. The patient age was in between 65-79 years old. VAERS accepted reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public could submit reports to VAERS. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports might contain information that was incomplete, inaccurate, coincidental, or unverifiable. Most reports to VAERS were voluntary, which mean they were subject to biases. This created specific limitations on how the data can be used scientifically. These systems did not have the same limitations as VAERS and could better assess health risks and possible connections between adverse events and a vaccine. VAERS data were limited to vaccine adverse event reports received between 1990 and the most recent date for which data were available. Follow-up would not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- F
- Eingang
- 08.12.2023
- Impfdatum
- 01.12.2023
- Beginn
- 01.12.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Feeling abnormal
Hyperhidrosis
Loss of consciousness
Pallor
Symptomtext
Pale skin; Sweating; Feeling funny; Lost consciousness; This serious case was reported by a physician via call center representative and described the occurrence of lost consciousness in a 34-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included INFLUENZA VACCINE for prophylaxis. On 01-DEC-2023, the patient received Boostrix (intramuscular) and INFLUENZA VACCINE (intramuscular). On 01-DEC-2023, less than a day after receiving Boostrix and an unknown time after receiving INFLUENZA VACCINE, the patient experienced lost consciousness (Verbatim: Lost consciousness) (serious criteria GSK medically significant), pale skin (Verbatim: Pale skin), sweating (Verbatim: Sweating) and weird feeling (Verbatim: Feeling funny). The outcome of the lost consciousness was resolved (duration 4 min) and the outcome of the pale skin, sweating and weird feeling were resolved. It was unknown if the reporter considered the lost consciousness, pale skin, sweating and weird feeling to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the lost consciousness, pale skin, sweating and weird feeling to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 01-DEC-2023 The physician reported today (on the day of reporting) patient received Boostrix and an unspecified flu vaccine in her clinic today. The physician gave Boostrix first and waited for few minutes and then administered an unspecified flu vaccine. The patient lost consciousness for 4 minutes. The patient was sweaty and pale. She stated the patient felt funny after the Boostrix and before the flu vaccine but did not inform the physician. The emergency services was called but patient was not transported. The patient recovered in just a few minutes and felt well enough to go home. It was unknown if the reporter considered the lost consciousness, pale skin, sweating and weird feeling to be related to Influenza vaccine. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 08.12.2023
- Impfdatum
- 22.10.2019
- Beginn
- 22.10.2019
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Loss of personal independence in daily activities
Paralysis
Paraplegia
Product use in unapproved indication
Magnetic resonance imaging spinal abnormal
Myelitis transverse
Quadriplegia
Symptomtext
now I'm a paraplegic; paraplegic.; Shingrix indication for Transverse Myelitis; This serious case was reported by a consumer and described the occurrence of paralysis in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 5kk99, expiry date 29-OCT-2021) for prophylaxis and myelitis transverse. Concurrent medical conditions included myelitis transverse. On 22-OCT-2019, the patient received Shingrix. On 22-OCT-2019, an unknown time after receiving Shingrix, the patient experienced product use in unapproved indication (Verbatim: Shingrix indication for Transverse Myelitis). On an unknown date, the patient experienced paralysis (Verbatim: now I'm a paraplegic) (serious criteria hospitalization and GSK medically significant) and paraplegia (Verbatim: paraplegic.) (serious criteria GSK medically significant). The outcome of the paralysis and paraplegia were not resolved and the outcome of the product use in unapproved indication was unknown. It was unknown if the reporter considered the paralysis and paraplegia to be related to Shingrix. It was unknown if the company considered the paralysis and paraplegia to be related to Shingrix. Additional Information: GSK Receipt Date: 03-DEC-2023 The patient went to the physician for a routine physical and was stupid enough to say yes when she suggested a shingle vaccine. The patient was a competitive swimmer in excellent physical condition, and now (at the time of reporting) was paraplegic. The patient attorney had been held off for years by yours. The reporter just wanted to say, shingles did not care, neither did GSK. Thank you for screwing up the patient life. The patient received Shingrix for myelitis transverse, which led to product used for unapproved indication. The reporter did not consent to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Myelitis transverse
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 01.12.2023
- Impfdatum
- 19.10.2023
- Beginn
- 20.10.2023
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Dizziness
Electric shock sensation
Symptomtext
Dizziness; Electric shock sensation; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of dizziness in a 44-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) for prophylaxis. Co-suspect products included COVID-19 vaccine for prophylaxis. Concurrent medical conditions included fibromyalgia (patient has Fibromyalgia). Concomitant products included duloxetine hydrochloride (Cymbalta). On 19-OCT-2023, the patient received Fluarix Quadrivalent 2023-2024 season (intramuscular, left arm) and COVID-19 vaccine (intramuscular, right arm) .5 ml. On 20-OCT-2023, 1 days after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced dizziness (Verbatim: Dizziness) and electric shock sensation (Verbatim: Electric shock sensation). The outcome of the dizziness and electric shock sensation were not resolved. It was unknown if the reporter considered the dizziness and electric shock sensation to be related to Fluarix Quadrivalent 2023-2024 season and Fluarix Tetra Pre-Filled Syringe Device. It was unknown if the company considered the dizziness and electric shock sensation to be related to Fluarix Quadrivalent 2023-2024 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date-21-NOV-2023 The reporter reported that the patient experienced electric shock sensation and dizziness after 1 days of vaccination. The patient received Fluarix Quadrivalent vaccine and COVID-19 vaccine at same time. The reporter considered the electric shock sensation and dizziness possible related to Covid19 vaccine. The consent to follow up requested.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Electric shock sensation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Fibromyalgia (patient has Fibromyalgia)
- Vorgeschichte
- -
- Andere Medikamente
- CYMBALTA
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 01.12.2023
- Impfdatum
- 19.10.2023
- Beginn
- 20.10.2023
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Dizziness
Electric shock sensation
Symptomtext
Dizziness; Electric shock sensation; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of dizziness in a 44-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) for prophylaxis. Co-suspect products included COVID-19 vaccine for prophylaxis. Concurrent medical conditions included fibromyalgia (patient has Fibromyalgia). Concomitant products included duloxetine hydrochloride (Cymbalta). On 19-OCT-2023, the patient received Fluarix Quadrivalent 2023-2024 season (intramuscular, left arm) and COVID-19 vaccine (intramuscular, right arm) .5 ml. On 20-OCT-2023, 1 days after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced dizziness (Verbatim: Dizziness) and electric shock sensation (Verbatim: Electric shock sensation). The outcome of the dizziness and electric shock sensation were not resolved. It was unknown if the reporter considered the dizziness and electric shock sensation to be related to Fluarix Quadrivalent 2023-2024 season and Fluarix Tetra Pre-Filled Syringe Device. It was unknown if the company considered the dizziness and electric shock sensation to be related to Fluarix Quadrivalent 2023-2024 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date-21-NOV-2023 The reporter reported that the patient experienced electric shock sensation and dizziness after 1 days of vaccination. The patient received Fluarix Quadrivalent vaccine and COVID-19 vaccine at same time. The reporter considered the electric shock sensation and dizziness possible related to Covid19 vaccine. The consent to follow up requested.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Electric shock sensation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Fibromyalgia (patient has Fibromyalgia)
- Vorgeschichte
- -
- Andere Medikamente
- CYMBALTA
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- -
- Geschlecht
- U
- Eingang
- 16.11.2023
- Impfdatum
- 01.10.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Syncope
Symptomtext
syncope; This serious case was reported by a nurse via sales rep and described the occurrence of syncope in a patient who received Men B NVS (Bexsero) for prophylaxis. In OCT-2023, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced syncope (Verbatim: syncope) (serious criteria GSK medically significant). The outcome of the syncope was not reported. It was unknown if the reporter considered the syncope to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the syncope to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-NOV-2023 The nurse did not provide patient information but said she's had 2 patients experienced syncope after receiving Bexsero injection in the last month. The follow-up would not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 09.11.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Diplopia
Guillain-Barre syndrome
Symptomtext
Guillen Barre symptoms; diplopia; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis. On an unknown date, the patient received Arexvy and FLU VACCINE (NAME UNKNOWN). On an unknown date, an unknown time after receiving Arexvy and an unknown time after receiving FLU VACCINE (NAME UNKNOWN), the patient experienced guillain barre syndrome (Verbatim: Guillen Barre symptoms) (serious criteria GSK medically significant) and diplopia (Verbatim: diplopia). The outcome of the guillain barre syndrome and diplopia were not resolved. The reporter considered the guillain barre syndrome and diplopia to be possibly related to Arexvy. The company considered the guillain barre syndrome and diplopia to be possibly related to Arexvy. Additional Information: GSK receipt date: 02-NOV-2023 The physician thought that patient was experiencing Guillen Barre symptoms and diplopia. The physician thought it could be Arexvy causing the symptoms. It was unknown if the reporter considered the guillain barre syndrome and diplopia to be related to Flu vaccine. The reporter consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 09.11.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Diplopia
Guillain-Barre syndrome
Symptomtext
Guillen Barre symptoms; diplopia; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis. On an unknown date, the patient received Arexvy and FLU VACCINE (NAME UNKNOWN). On an unknown date, an unknown time after receiving Arexvy and an unknown time after receiving FLU VACCINE (NAME UNKNOWN), the patient experienced guillain barre syndrome (Verbatim: Guillen Barre symptoms) (serious criteria GSK medically significant) and diplopia (Verbatim: diplopia). The outcome of the guillain barre syndrome and diplopia were not resolved. The reporter considered the guillain barre syndrome and diplopia to be possibly related to Arexvy. The company considered the guillain barre syndrome and diplopia to be possibly related to Arexvy. Additional Information: GSK receipt date: 02-NOV-2023 The physician thought that patient was experiencing Guillen Barre symptoms and diplopia. The physician thought it could be Arexvy causing the symptoms. It was unknown if the reporter considered the guillain barre syndrome and diplopia to be related to Flu vaccine. The reporter consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- M
- Eingang
- 08.11.2023
- Impfdatum
- 20.10.2023
- Beginn
- 21.10.2023
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Syncope
Symptomtext
Syncope; This serious case was reported by a consumer via sales rep and described the occurrence of syncope in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis. On 20-OCT-2023, the patient received Arexvy and PNEUMOCOCCAL VACCINE. On 21-OCT-2023, 1 days after receiving Arexvy, the patient experienced syncope (Verbatim: Syncope) (serious criteria GSK medically significant). The outcome of the syncope was not reported. It was unknown if the reporter considered the syncope to be related to Arexvy. It was unknown if the company considered the syncope to be related to Arexvy. Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter stated the patient was given both the Arexvy and pneumococcal vaccine on the same time. The patient experienced syncope. It was unknown if the reporter considered the syncope to be related to pneumococcal vaccine. The reporter did not consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- M
- Eingang
- 08.11.2023
- Impfdatum
- 20.10.2023
- Beginn
- 21.10.2023
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Syncope
Symptomtext
Syncope; This serious case was reported by a consumer via sales rep and described the occurrence of syncope in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis. On 20-OCT-2023, the patient received Arexvy and PNEUMOCOCCAL VACCINE. On 21-OCT-2023, 1 days after receiving Arexvy, the patient experienced syncope (Verbatim: Syncope) (serious criteria GSK medically significant). The outcome of the syncope was not reported. It was unknown if the reporter considered the syncope to be related to Arexvy. It was unknown if the company considered the syncope to be related to Arexvy. Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter stated the patient was given both the Arexvy and pneumococcal vaccine on the same time. The patient experienced syncope. It was unknown if the reporter considered the syncope to be related to pneumococcal vaccine. The reporter did not consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 07.11.2023
- Impfdatum
- 01.09.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Seizure
Symptomtext
had mild seizures; This serious case was reported by a consumer via call center representative and described the occurrence of seizure in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Lamictal (had been on Lamictal for several years). In SEP-2023, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced seizure (Verbatim: had mild seizures) (serious criteria GSK medically significant). The outcome of the seizure was resolved. It was unknown if the reporter considered the seizure to be related to Arexvy. It was unknown if the company considered the seizure to be related to Arexvy. Additional Information: GSK receipt date: 1-Nov-2023 The case was received from the patient's sister. According to the reporter the patient received Arexvy vaccine in September 2023 and recently had mild seizures for a couple of days, one seizure last Saturday and two the following day on Sunday. Reporter would talk to the physician before providing consent to them to contact him. Reporter refused to provide zip code, address, initials for the patient and date of birth. Reporter provided consent to be contacted by GlaxoSmithKline.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- M
- Eingang
- 07.11.2023
- Impfdatum
- 18.09.2023
- Beginn
- 01.09.2023
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Vocal cord paralysis
Symptomtext
vocal cord paralysis; This non-serious case was reported by a physician via sales rep and described the occurrence of vocal cord paralysis in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included ELASOMERAN (MODERNA COVID VACCINE) for prophylaxis. Concurrent medical conditions included pulmonary fibrosis and rheumatoid arthritis. On 18-SEP-2023, the patient received Arexvy and MODERNA COVID VACCINE. In SEP-2023, 10 days after receiving Arexvy, the patient experienced vocal cord paralysis (Verbatim: vocal cord paralysis). The patient was treated with non-drug therapy (Physiotherapy). The outcome of the vocal cord paralysis was resolving. It was unknown if the reporter considered the vocal cord paralysis to be related to Arexvy. It was unknown if the company considered the vocal cord paralysis to be related to Arexvy. Additional Information: GSK Receipt Date 31-OCT-2023: The reporter stated the 10 days after both vaccines patient got vocal cord paralysis. The patient was undergoing (Physiotherapy) PT for it (vocal cord paralysis) and doing better. The patient also has comorbidities including pulmonary fibrosis and rheumatoid arthritis. It was unknown if the reporter considered the pulmonary fibrosis, rheumatoid arthritis and vocal cord paralysis to be related to Moderna Covid Vaccine. The reporter consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Vocal cord paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Pulmonary fibrosis; Rheumatoid arthritis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- M
- Eingang
- 07.11.2023
- Impfdatum
- 18.09.2023
- Beginn
- 01.09.2023
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Vocal cord paralysis
Symptomtext
vocal cord paralysis; This non-serious case was reported by a physician via sales rep and described the occurrence of vocal cord paralysis in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included ELASOMERAN (MODERNA COVID VACCINE) for prophylaxis. Concurrent medical conditions included pulmonary fibrosis and rheumatoid arthritis. On 18-SEP-2023, the patient received Arexvy and MODERNA COVID VACCINE. In SEP-2023, 10 days after receiving Arexvy, the patient experienced vocal cord paralysis (Verbatim: vocal cord paralysis). The patient was treated with non-drug therapy (Physiotherapy). The outcome of the vocal cord paralysis was resolving. It was unknown if the reporter considered the vocal cord paralysis to be related to Arexvy. It was unknown if the company considered the vocal cord paralysis to be related to Arexvy. Additional Information: GSK Receipt Date 31-OCT-2023: The reporter stated the 10 days after both vaccines patient got vocal cord paralysis. The patient was undergoing (Physiotherapy) PT for it (vocal cord paralysis) and doing better. The patient also has comorbidities including pulmonary fibrosis and rheumatoid arthritis. It was unknown if the reporter considered the pulmonary fibrosis, rheumatoid arthritis and vocal cord paralysis to be related to Moderna Covid Vaccine. The reporter consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Vocal cord paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Pulmonary fibrosis; Rheumatoid arthritis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 01.11.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Areflexia
Gait disturbance
Guillain-Barre syndrome
Muscular weakness
Computerised tomogram abdomen normal
Computerised tomogram head
Computerised tomogram spine normal
Computerised tomogram thorax normal
Fall
Symptomtext
Guillain; difficulty walking; weakness in LE/ progressive weakness; loss of reflexes; This serious case was reported by a consumer and described the occurrence of atrial fibrillation in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included INFLUENZA VACCINE INACT (FLUZONE HD) for prophylaxis, COVID-19 MRNA BIVALENT for prophylaxis and PCV20 for prophylaxis. On an unknown date, the patient received Arexvy, FLUZONE HD, COVID-19 MRNA BIVALENT and PCV20. On an unknown date, 10 days after receiving Arexvy and an unknown time after receiving COVID-19 MRNA BIVALENT and PCV20, the patient experienced atrial fibrillation (Verbatim: atrial fibrilation) (serious criteria GSK medically significant), guillain barre syndrome (Verbatim: Guillain) (serious criteria GSK medically significant), walking difficulty (Verbatim: difficulty walking), lower extremities weakness of (Verbatim: weakness in LE/ progressive weakness) and reflex loss (Verbatim: loss of reflexes). The patient was treated with anticoagulant (nos) (Anticoagulant) and immunoglobulins nos (Ivig). The outcome of the atrial fibrillation, walking difficulty, lower extremities weakness of and reflex loss were not reported and the outcome of the guillain barre syndrome was not resolved. It was unknown if the reporter considered the atrial fibrillation, guillain barre syndrome, walking difficulty, lower extremities weakness of and reflex loss to be related to Arexvy. It was unknown if the company considered the atrial fibrillation, guillain barre syndrome, walking difficulty, lower extremities weakness of and reflex loss to be related to Arexvy. Additional Information: GSK receipt date: 24-OCT-2023 The patient had difficulty walking, weakness in LE, progressive weakness and loss of reflexes, no LP because had atrial fibrillation (afib) and was on anticoagulant. The patient was diagnosed with Guillain Barre syndrome (GBS) with treatment IVIG for 5 days with no improvement and no worsening. The patient met Brighton level 3 and was discharged to rehabilitation. The confounding factors such as multiple co-ad vaccines like fulsome HD, bivalent mRNA COVID and PCV 20. 10 days after receiving Arexvy, the patient experienced guillain barre syndrome, walking difficulty, weakness and reflex loss. It was unknown if the reporter considered the guillain barre syndrome, walking difficulty, weakness and reflex loss to be related to fulsome HD, bivalent mRNA COVID and PCV 20.; Sender's Comments: US-GSK-US2023AMR149534:Same reporter US-GSK-US2023AMR149213:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Atrial fibrillation
- Vorgeschichte
- -
- Andere Medikamente
- ANTICOAGULANT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 01.11.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Areflexia
Gait disturbance
Guillain-Barre syndrome
Muscular weakness
Computerised tomogram abdomen normal
Computerised tomogram head
Computerised tomogram spine normal
Computerised tomogram thorax normal
Fall
Symptomtext
Guillain; difficulty walking; weakness in LE/ progressive weakness; loss of reflexes; This serious case was reported by a consumer and described the occurrence of atrial fibrillation in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included INFLUENZA VACCINE INACT (FLUZONE HD) for prophylaxis, COVID-19 MRNA BIVALENT for prophylaxis and PCV20 for prophylaxis. On an unknown date, the patient received Arexvy, FLUZONE HD, COVID-19 MRNA BIVALENT and PCV20. On an unknown date, 10 days after receiving Arexvy and an unknown time after receiving COVID-19 MRNA BIVALENT and PCV20, the patient experienced atrial fibrillation (Verbatim: atrial fibrilation) (serious criteria GSK medically significant), guillain barre syndrome (Verbatim: Guillain) (serious criteria GSK medically significant), walking difficulty (Verbatim: difficulty walking), lower extremities weakness of (Verbatim: weakness in LE/ progressive weakness) and reflex loss (Verbatim: loss of reflexes). The patient was treated with anticoagulant (nos) (Anticoagulant) and immunoglobulins nos (Ivig). The outcome of the atrial fibrillation, walking difficulty, lower extremities weakness of and reflex loss were not reported and the outcome of the guillain barre syndrome was not resolved. It was unknown if the reporter considered the atrial fibrillation, guillain barre syndrome, walking difficulty, lower extremities weakness of and reflex loss to be related to Arexvy. It was unknown if the company considered the atrial fibrillation, guillain barre syndrome, walking difficulty, lower extremities weakness of and reflex loss to be related to Arexvy. Additional Information: GSK receipt date: 24-OCT-2023 The patient had difficulty walking, weakness in LE, progressive weakness and loss of reflexes, no LP because had atrial fibrillation (afib) and was on anticoagulant. The patient was diagnosed with Guillain Barre syndrome (GBS) with treatment IVIG for 5 days with no improvement and no worsening. The patient met Brighton level 3 and was discharged to rehabilitation. The confounding factors such as multiple co-ad vaccines like fulsome HD, bivalent mRNA COVID and PCV 20. 10 days after receiving Arexvy, the patient experienced guillain barre syndrome, walking difficulty, weakness and reflex loss. It was unknown if the reporter considered the guillain barre syndrome, walking difficulty, weakness and reflex loss to be related to fulsome HD, bivalent mRNA COVID and PCV 20.; Sender's Comments: US-GSK-US2023AMR149534:Same reporter US-GSK-US2023AMR149213:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Atrial fibrillation
- Vorgeschichte
- -
- Andere Medikamente
- ANTICOAGULANT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 01.11.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Areflexia
Gait disturbance
Guillain-Barre syndrome
Muscular weakness
Computerised tomogram abdomen normal
Computerised tomogram head
Computerised tomogram spine normal
Computerised tomogram thorax normal
Fall
Symptomtext
Guillain; difficulty walking; weakness in LE/ progressive weakness; loss of reflexes; This serious case was reported by a consumer and described the occurrence of atrial fibrillation in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included INFLUENZA VACCINE INACT (FLUZONE HD) for prophylaxis, COVID-19 MRNA BIVALENT for prophylaxis and PCV20 for prophylaxis. On an unknown date, the patient received Arexvy, FLUZONE HD, COVID-19 MRNA BIVALENT and PCV20. On an unknown date, 10 days after receiving Arexvy and an unknown time after receiving COVID-19 MRNA BIVALENT and PCV20, the patient experienced atrial fibrillation (Verbatim: atrial fibrilation) (serious criteria GSK medically significant), guillain barre syndrome (Verbatim: Guillain) (serious criteria GSK medically significant), walking difficulty (Verbatim: difficulty walking), lower extremities weakness of (Verbatim: weakness in LE/ progressive weakness) and reflex loss (Verbatim: loss of reflexes). The patient was treated with anticoagulant (nos) (Anticoagulant) and immunoglobulins nos (Ivig). The outcome of the atrial fibrillation, walking difficulty, lower extremities weakness of and reflex loss were not reported and the outcome of the guillain barre syndrome was not resolved. It was unknown if the reporter considered the atrial fibrillation, guillain barre syndrome, walking difficulty, lower extremities weakness of and reflex loss to be related to Arexvy. It was unknown if the company considered the atrial fibrillation, guillain barre syndrome, walking difficulty, lower extremities weakness of and reflex loss to be related to Arexvy. Additional Information: GSK receipt date: 24-OCT-2023 The patient had difficulty walking, weakness in LE, progressive weakness and loss of reflexes, no LP because had atrial fibrillation (afib) and was on anticoagulant. The patient was diagnosed with Guillain Barre syndrome (GBS) with treatment IVIG for 5 days with no improvement and no worsening. The patient met Brighton level 3 and was discharged to rehabilitation. The confounding factors such as multiple co-ad vaccines like fulsome HD, bivalent mRNA COVID and PCV 20. 10 days after receiving Arexvy, the patient experienced guillain barre syndrome, walking difficulty, weakness and reflex loss. It was unknown if the reporter considered the guillain barre syndrome, walking difficulty, weakness and reflex loss to be related to fulsome HD, bivalent mRNA COVID and PCV 20.; Sender's Comments: US-GSK-US2023AMR149534:Same reporter US-GSK-US2023AMR149213:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Atrial fibrillation
- Vorgeschichte
- -
- Andere Medikamente
- ANTICOAGULANT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 01.11.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Areflexia
Gait disturbance
Guillain-Barre syndrome
Muscular weakness
Computerised tomogram abdomen normal
Computerised tomogram head
Computerised tomogram spine normal
Computerised tomogram thorax normal
Fall
Symptomtext
Guillain; difficulty walking; weakness in LE/ progressive weakness; loss of reflexes; This serious case was reported by a consumer and described the occurrence of atrial fibrillation in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included INFLUENZA VACCINE INACT (FLUZONE HD) for prophylaxis, COVID-19 MRNA BIVALENT for prophylaxis and PCV20 for prophylaxis. On an unknown date, the patient received Arexvy, FLUZONE HD, COVID-19 MRNA BIVALENT and PCV20. On an unknown date, 10 days after receiving Arexvy and an unknown time after receiving COVID-19 MRNA BIVALENT and PCV20, the patient experienced atrial fibrillation (Verbatim: atrial fibrilation) (serious criteria GSK medically significant), guillain barre syndrome (Verbatim: Guillain) (serious criteria GSK medically significant), walking difficulty (Verbatim: difficulty walking), lower extremities weakness of (Verbatim: weakness in LE/ progressive weakness) and reflex loss (Verbatim: loss of reflexes). The patient was treated with anticoagulant (nos) (Anticoagulant) and immunoglobulins nos (Ivig). The outcome of the atrial fibrillation, walking difficulty, lower extremities weakness of and reflex loss were not reported and the outcome of the guillain barre syndrome was not resolved. It was unknown if the reporter considered the atrial fibrillation, guillain barre syndrome, walking difficulty, lower extremities weakness of and reflex loss to be related to Arexvy. It was unknown if the company considered the atrial fibrillation, guillain barre syndrome, walking difficulty, lower extremities weakness of and reflex loss to be related to Arexvy. Additional Information: GSK receipt date: 24-OCT-2023 The patient had difficulty walking, weakness in LE, progressive weakness and loss of reflexes, no LP because had atrial fibrillation (afib) and was on anticoagulant. The patient was diagnosed with Guillain Barre syndrome (GBS) with treatment IVIG for 5 days with no improvement and no worsening. The patient met Brighton level 3 and was discharged to rehabilitation. The confounding factors such as multiple co-ad vaccines like fulsome HD, bivalent mRNA COVID and PCV 20. 10 days after receiving Arexvy, the patient experienced guillain barre syndrome, walking difficulty, weakness and reflex loss. It was unknown if the reporter considered the guillain barre syndrome, walking difficulty, weakness and reflex loss to be related to fulsome HD, bivalent mRNA COVID and PCV 20.; Sender's Comments: US-GSK-US2023AMR149534:Same reporter US-GSK-US2023AMR149213:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Atrial fibrillation
- Vorgeschichte
- -
- Andere Medikamente
- ANTICOAGULANT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 01.11.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Ascending flaccid paralysis
Back pain
CSF protein increased
CSF white blood cell count negative
Gait inability
Gastrostomy
Guillain-Barre syndrome
Immunoglobulin therapy
Mechanical ventilation
Dizziness
Influenza like illness
Injection site pain
Lumbar puncture
Paralysis
Magnetic resonance imaging spinal
Muscular weakness
Paraesthesia
Pain in extremity
Symptomtext
meets Brighton level 2 GBS but outside 42 window of biologic plaus; ascending paralysis; LP with elevated protein (cytoalbuminologic dissociation); back pain; inability to walk; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, 55 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: meets Brighton level 2 GBS but outside 42 window of biologic plaus) (serious criteria GSK medically significant), paralysis ascending (Verbatim: ascending paralysis) (serious criteria GSK medically significant), cerebrospinal fluid protein increased (Verbatim: LP with elevated protein (cytoalbuminologic dissociation)) (serious criteria GSK medically significant), back pain (Verbatim: back pain) and unable to walk (Verbatim: inability to walk). The outcome of the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk were not reported. It was unknown if the reporter considered the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk to be related to Arexvy. It was unknown if the company considered the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk to be related to Arexvy. Additional Information: GSK Receipt Date: 24-OCT-2023 The patient experienced back pain, inability to walk, ascending paralysis, LP (lumbar puncture) with elevated protein (cytoalbuminologic dissociation). The patient was on mechanical ventilation. The patient meets Brighton level 2 GBS (guillain barre syndrome) but outside 42 window of biologic plaus. No confounding but need to look deeper into records. The follow-up could not be possible as no contact details were available. This case had been link with US2023AMR149528 and US2023AMR149534, reported by the same reporter.; Sender's Comments: US-GSK-US2023AMR149528:Same reporter US-GSK-US2023AMR149534:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Ascending flaccid paralysis
- Hospital-Tage
- -
- Labordaten
- Test Date: 2023; Test Name: Lumbar puncture; Result Unstructured Data: (Test Result:elevated protein (cytoalbuminologic dissociation),Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- -
- Geschlecht
- M
- Eingang
- 18.10.2023
- Impfdatum
- 11.10.2023
- Beginn
- 11.10.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Seizure
Syncope
Symptomtext
patient fainted; This serious case was reported by a nurse via sales rep and described the occurrence of faint in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. On 11-OCT-2023, the patient received Bexsero. On 11-OCT-2023, 3 min after receiving Bexsero, the patient experienced faint (Verbatim: patient fainted) (serious criteria GSK medically significant). The outcome of the faint was not reported. It was unknown if the reporter considered the faint to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the faint to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt date: 11-OCT-2023 The nurse wanted to know if you knew of a lot of instances of patients fainting after receiving a dose of Bexsero. She had this happen to approximately 5 in the last year. Bexsero was administered to the patient today, 11 October 2023 and he was standing and talking, while the mother and the nurse were conversing. After about 3-5 minutes the patient fainted and in the nurse's work appeared to be seizing. An ambulance was called and he was taken to a local hospital. The reporter consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 16.10.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Syncope
Symptomtext
Fainting; This serious case was reported by a consumer via interactive digital media and described the occurrence of fainting in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fainting (Verbatim: Fainting) (serious criteria GSK medically significant). The outcome of the fainting was not reported. It was unknown if the reporter considered the fainting to be related to Arexvy. It was unknown if the company considered the fainting to be related to Arexvy. Additional Information: GSK Receipt Date: 09-OCT-2023 This case was reported via interactive digital media. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 13.10.2023
- Impfdatum
- 03.10.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Abdominal pain upper
Eye contusion
Eye swelling
Headache
Palpitations
Syncope
Symptomtext
faint; Heart palpitations; headache; stomachache; brusing and swelling on sight; eye brusing/brusing and swelling on sight; This serious case was reported by a consumer and described the occurrence of faint in a 56-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included COVID 19 VACCINE for prophylaxis. Concomitant products included thyroid bovine and buprenorphine hydrochloride + naloxone hydrochloride (Suboxone). On 03-OCT-2023, the patient received Shingles vaccine and COVID 19 VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced faint (Verbatim: faint) (serious criteria GSK medically significant), palpitation (Verbatim: Heart palpitations), headache (Verbatim: headache), stomach pain (Verbatim: stomachache), eye swelling (Verbatim: brusing and swelling on sight) and eye contusion (Verbatim: eye brusing/brusing and swelling on sight). The outcome of the faint, palpitation, headache, stomach pain, eye swelling and eye contusion were not resolved. It was unknown if the reporter considered the faint, palpitation, headache, stomach pain, eye swelling and eye contusion to be related to Shingles vaccine. It was unknown if the company considered the faint, palpitation, headache, stomach pain, eye swelling and eye contusion to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-OCT-2023 The reporter stated that patient administered the shingles vaccine of unspecified manufacturer. The patient dated heart palpitation, fainted, headache, stomachache and brushing and swelling on sight. All the reported symptoms were ongoing. The patient also got the covid shot too. The symptoms were not treated. The expiry date of shingles vaccine was unknown. It was unknown if the company considered the faint, palpitation, headache, stomach pain, eye swelling and eye contusion to be related to Covid 19 vaccine. The reporter did not consented to contact.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- THYROID BOVINE; SUBOXONE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 09.10.2023
- Impfdatum
- 06.09.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Amnesia
Facial paralysis
Headache
Ischaemic stroke
Lethargy
Hypercoagulation
Inflammation
Middle cerebral artery stroke
Vertigo
Pain
Pain in extremity
Symptomtext
Suffered large MCA Ischemic stroke; facial droop; Memory loss; very lethargic; Sharp pain in head; vertigo; This serious case was reported by a consumer and described the occurrence of ischemic stroke in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included atrial fibrillation, anemia, cholesterol and blood pressure. Concomitant products included flecainide, irbesartan, rosuvastatin, folic acid and cyanocobalamin (Vitamin B12). On 06-SEP-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced ischemic stroke (Verbatim: Suffered large MCA Ischemic stroke) (serious criteria hospitalization and GSK medically significant), facial droop (Verbatim: facial droop) (serious criteria hospitalization and GSK medically significant), memory loss (Verbatim: Memory loss) (serious criteria hospitalization), lethargy (Verbatim: very lethargic) (serious criteria hospitalization), headache (Verbatim: Sharp pain in head) (serious criteria hospitalization) and vertigo (Verbatim: vertigo) (serious criteria hospitalization). The outcome of the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo were not resolved. It was unknown if the reporter considered the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo to be related to Arexvy. It was unknown if the company considered the ischemic stroke, facial droop, memory loss, lethargy, headache and vertigo to be related to Arexvy. Additional Information: GSK receipt date: 2-Oct-2023 The patient suffered large MCA Ischemic stroke, went emergency room and hospitalized trying to recover. The patient's wife had typed all this information into the computer for him. The patient also had memory loss and facial droop and ever since vaccine, the patient had have felt very lethargic since vaccine administration. Sharp pain in head top right and severe vertigo. She too has had serious adverse events from this vaccine. The reporter consented to follow-up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Ischaemic stroke
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Anemia; Atrial fibrillation; Blood pressure; Cholesterol
- Vorgeschichte
- -
- Andere Medikamente
- FLECAINIDE; IRBESARTAN; ROSUVASTATIN; FOLIC ACID; VITAMIN B12
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.09.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Thrombosis
Symptomtext
got 2 blood clots in my left leg; This serious case was reported by a consumer via interactive digital media and described the occurrence of thrombosis leg in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced thrombosis leg (Verbatim: got 2 blood clots in my left leg) (serious criteria GSK medically significant). The outcome of the thrombosis leg was not reported. The reporter considered the thrombosis leg to be possibly related to Shingrix. The company considered the thrombosis leg to be possibly related to Shingrix. Additional Information: GSK Receipt date: 21-SEP-2023 This case was reported by patient via interactive digital media. The patient reported that after 1 Shingles shot, she got 2 blood clots in her left leg. Patient states that she had friends who had shingles. The pain they described sounded unbearable and she educated herself about the risks and what she could do for prevention. The reporter thought that the event might had been related to the drug. Follow up was not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Thrombosis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OR
- Alter
- -
- Geschlecht
- F
- Eingang
- 26.09.2023
- Impfdatum
- -
- Beginn
- 01.06.2023
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Gait inability
Guillain-Barre syndrome
Hypersensitivity
Hypoaesthesia
Tremor
Symptomtext
GBS deficits of hypersensitivity; numbness; hand tremor; could not walk; Guillian-Barre Syndrome; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a 64-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. In JUN-2023, less than a week after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillian-Barre Syndrome) (serious criteria hospitalization and GSK medically significant) and unable to walk (Verbatim: could not walk) (serious criteria hospitalization). On an unknown date, the patient experienced hypersensitivity (Verbatim: GBS deficits of hypersensitivity) (serious criteria hospitalization), numbness (Verbatim: numbness) (serious criteria hospitalization) and tremor of hands (Verbatim: hand tremor) (serious criteria hospitalization). The outcome of the guillain barre syndrome, hypersensitivity, numbness, tremor of hands and unable to walk were not reported. It was unknown if the reporter considered the guillain barre syndrome, hypersensitivity, numbness, tremor of hands and unable to walk to be related to Shingles vaccine. It was unknown if the company considered the guillain barre syndrome, hypersensitivity, numbness, tremor of hands and unable to walk to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-SEP-2023 The patient reported approximately one week or less following first Shingles vaccine she acquired Guillain-Barre Syndrome and was not able to walk and spent 3 weeks in hospital and received the treatment to prevent further neurological damage to nerves and underwent PT and OT (occupational therapy and physical therapy) to relearn to walk and function independently. During the reporting she was in outpatient PT and was working hard in recovery. It was uncertain if her acquired Guillain-Barre Syndrome deficits of hypersensitivity, numbness and hand tremor would improve. Prior to acquiring Guillain-Barre Syndrome there were no infections or other vaccines which contributed to Guillain-Barre Syndrome.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.09.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
The 2nd Shingrix shot gave me Guillan-Barre Syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: The 2nd Shingrix shot gave me Guillan-Barre Syndrome) (serious criteria GSK medically significant).The outcome of the guillain barre syndrome was not reported. The reporter considered the guillain barre syndrome to be related to Shingrix. The company considered the guillain barre syndrome to be related to Shingrix. Additional Information: GSK Receipt date: 18-SEP-2023 This case was reported by a patient via interactive digital media. The Shingrix shot gave him/her Guillan barre syndrome. No he/she could not take any kind of vaccines, not even the flu nor pneumonia vaccine. The reporter stated that think hard about what was the best for you before you commit.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 04.09.2023
- Impfdatum
- 08.08.2022
- Beginn
- 08.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Abdominal discomfort
Ageusia
Anosmia
Blood pressure fluctuation
Blood pressure measurement
Burning sensation
Cardiac disorder
Culture
Ear discomfort
Eye disorder
Headache
Hyperhidrosis
Inappropriate schedule of product administration
Liver disorder
Lung disorder
Palpitations
Paralysis
Renal disorder
Symptomtext
Heart palpitations; Almost paralyzed; Excessive sweating; My blood pressure started being very low now extremely high; TH3 liver elevated; Heart disorder; Lungs disorder; Kidney disorder; Liver disorder; Eyes disorder; Blood clotting; severe Headaches; Blurry vision; Whole body on fire/ face and spine on fire; No taste; Feels like something is attacking my insides my eardrums; No smell; Swallowing stomach; 1st dose Shingrix received on 11-Jan-2022 and 2nd dose on 8-Aug-2022; This serious case was reported by a consumer via other manufacturer and described the occurrence of heart disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and TOZINAMERAN (PFIZER COVID VACCINE) (batch number EL0142) for prophylaxis. Previously administered products included Z Pack with an associated reaction of hypersensitivity, topiramate with an associated reaction of hypersensitivity, metformin with an associated reaction of hypersensitivity, oxycodone with an associated reaction of hypersensitivity and Shingrix (1st dose received on 11th January 2022). Concurrent medical conditions included migraine, fibromyalgia, depression and heart disease, unspecified. Concomitant products included acetylsalicylic acid (Aspirin), metoprolol, atorvastatin, hydrocodone and sertraline hydrochloride (Sertra). On 08-AUG-2022, the patient received the 2nd dose of Shingrix, the 1st dose of Flu vaccine and the 4th dose of PFIZER COVID VACCINE (right arm). On 08-AUG-2022, an unknown time after receiving Shingrix and not applicable after receiving Flu vaccine, the patient experienced drug dose administration interval too long (Verbatim: 1st dose Shingrix received on 11-Jan-2022 and 2nd dose on 8-Aug-2022). On 08-AUG-2022 16:45, the patient experienced heart disorder (Verbatim: Heart disorder) (serious criteria life threatening), lung disorder (Verbatim: Lungs disorder) (serious criteria life threatening), renal disorder (Verbatim: Kidney disorder) (serious criteria life threatening), liver disorder (Verbatim: Liver disorder) (serious criteria life threatening), eye disorder (Verbatim: Eyes disorder) (serious criteria life threatening), clot blood (Verbatim: Blood clotting) (serious criteria GSK medically significant and life threatening), headache (Verbatim: severe Headaches) (serious criteria life threatening), blurred vision (Verbatim: Blurry vision) (serious criteria life threatening), burning sensation (Verbatim: Whole body on fire/ face and spine on fire) (serious criteria life threatening), taste absent (Verbatim: No taste) (serious criteria life threatening), ear discomfort (Verbatim: Feels like something is attacking my insides my eardrums) (serious criteria life threatening), anosmia (Verbatim: No smell) (serious criteria life threatening) and stomach discomfort (Verbatim: Swallowing stomach) (serious criteria life threatening). On an unknown date, the patient experienced palpitation (Verbatim: Heart palpitations) (serious criteria life threatening), paralysis (Verbatim: Almost paralyzed) (serious criteria GSK medically significant and life threatening), excess sweating (Verbatim: Excessive sweating) (serious criteria life threatening), blood pressure fluctuation (Verbatim: My blood pressure started being very low now extremely high) (serious criteria life threatening) and tri-iodothyronine increased (Verbatim: TH3 liver elevated) (serious criteria life threatening). The outcome of the heart disorder, lung disorder, renal disorder, liver disorder, eye disorder, clot blood, headache, blurred vision, burning sensation, taste absent, ear discomfort, anosmia and stomach discomfort were not resolved and the outcome of the palpitation, paralysis, excess sweating, blood pressure fluctuation and tri-iodothyronine increased were not reported and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the heart disorder, lung disorder, renal disorder, liver disorder, eye disorder, clot blood, headache, blurred vision, burning sensation, taste absent, ear discomfort, anosmia, stomach discomfort, palpitation, paralysis, excess sweating, blood pressure fluctuation and tri-iodothyronine increased to be related to Shingrix and Flu vaccine. It was unknown if the company considered the heart disorder, lung disorder, renal disorder, liver disorder, eye disorder, clot blood, headache, blurred vision, burning sensation, taste absent, ear discomfort, anosmia, stomach discomfort, palpitation, paralysis, excess sweating, blood pressure fluctuation and tri-iodothyronine increased to be related to Shingrix and Flu vaccine. Additional Information: GSK Receipt Date: 29-AUG-2023 The patient received Aspirin, metoprolol, atorvastatin, hydrocodone and sertra within 2 weeks of vaccination. The most recent COVID-19 vaccine was administered at pharmacy or drug store. The reporter reported that the patient immunity system was being attacked. The patient reported that no one was doing anything. he or she had been to the emergency room about six times. And stated that send him or her right back to the home with no type of treatment. The patient reported that on 8th August 2023 made a year that he or she had been suffering. The patient reported that after a while he or she thought he or she not going to be living and no one was listened to him or her. On 08-AUG-2022 16:45, less than a day after received Pfizer covid vaccine patient experienced heart disorder, lung disorder, renal disorder, liver disorder, eye disorder, clot blood, headache, blurred vision, burning sensation, taste absent, ear discomfort, anosmia and stomach discomfort. On an unknown date, unknown time after receiving Pfizer covid vaccine the patient experienced palpitation, paralysis, excess sweating, blood pressure fluctuation and tri-iodothyronine increased. It was unknown if the reporter considered the adverse events to be related to Pfizer covid vaccine. Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paralysis
- Hospital-Tage
- -
- Labordaten
- Test Name: Blood pressure; Result Unstructured Data: (Test Result:Low,Unit:unknown,Normal Low:,Normal High:); Test Name: Blood pressure; Result Unstructured Data: (Test Result:Extremely high,Unit:unknown,Normal Low:,Normal High:); Test Name: COVID-19; Result Unstructured Data: (Test Result:not reported,Unit:unknown,Normal Low:,Normal High:); Test Date: 20230201; Test Name: Nasal swab; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20230316; Test Name: Nasal swab; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20230421; Test Name: Nasal swab; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Name: TH3; Result Unstructured Data: (Test Result:Increased,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- Depression; Fibromyalgia; Heart disease, unspecified; Migraine
- Vorgeschichte
- -
- Andere Medikamente
- ASPIRIN; METOPROLOL; ATORVASTATIN; HYDROCODONE; SERTRA
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 04.09.2023
- Impfdatum
- 08.08.2022
- Beginn
- 08.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Abdominal discomfort
Ageusia
Anosmia
Blood pressure fluctuation
Blood pressure measurement
Burning sensation
Cardiac disorder
Culture
Ear discomfort
Eye disorder
Headache
Hyperhidrosis
Inappropriate schedule of product administration
Liver disorder
Lung disorder
Palpitations
Paralysis
Renal disorder
Symptomtext
Heart palpitations; Almost paralyzed; Excessive sweating; My blood pressure started being very low now extremely high; TH3 liver elevated; Heart disorder; Lungs disorder; Kidney disorder; Liver disorder; Eyes disorder; Blood clotting; severe Headaches; Blurry vision; Whole body on fire/ face and spine on fire; No taste; Feels like something is attacking my insides my eardrums; No smell; Swallowing stomach; 1st dose Shingrix received on 11-Jan-2022 and 2nd dose on 8-Aug-2022; This serious case was reported by a consumer via other manufacturer and described the occurrence of heart disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and TOZINAMERAN (PFIZER COVID VACCINE) (batch number EL0142) for prophylaxis. Previously administered products included Z Pack with an associated reaction of hypersensitivity, topiramate with an associated reaction of hypersensitivity, metformin with an associated reaction of hypersensitivity, oxycodone with an associated reaction of hypersensitivity and Shingrix (1st dose received on 11th January 2022). Concurrent medical conditions included migraine, fibromyalgia, depression and heart disease, unspecified. Concomitant products included acetylsalicylic acid (Aspirin), metoprolol, atorvastatin, hydrocodone and sertraline hydrochloride (Sertra). On 08-AUG-2022, the patient received the 2nd dose of Shingrix, the 1st dose of Flu vaccine and the 4th dose of PFIZER COVID VACCINE (right arm). On 08-AUG-2022, an unknown time after receiving Shingrix and not applicable after receiving Flu vaccine, the patient experienced drug dose administration interval too long (Verbatim: 1st dose Shingrix received on 11-Jan-2022 and 2nd dose on 8-Aug-2022). On 08-AUG-2022 16:45, the patient experienced heart disorder (Verbatim: Heart disorder) (serious criteria life threatening), lung disorder (Verbatim: Lungs disorder) (serious criteria life threatening), renal disorder (Verbatim: Kidney disorder) (serious criteria life threatening), liver disorder (Verbatim: Liver disorder) (serious criteria life threatening), eye disorder (Verbatim: Eyes disorder) (serious criteria life threatening), clot blood (Verbatim: Blood clotting) (serious criteria GSK medically significant and life threatening), headache (Verbatim: severe Headaches) (serious criteria life threatening), blurred vision (Verbatim: Blurry vision) (serious criteria life threatening), burning sensation (Verbatim: Whole body on fire/ face and spine on fire) (serious criteria life threatening), taste absent (Verbatim: No taste) (serious criteria life threatening), ear discomfort (Verbatim: Feels like something is attacking my insides my eardrums) (serious criteria life threatening), anosmia (Verbatim: No smell) (serious criteria life threatening) and stomach discomfort (Verbatim: Swallowing stomach) (serious criteria life threatening). On an unknown date, the patient experienced palpitation (Verbatim: Heart palpitations) (serious criteria life threatening), paralysis (Verbatim: Almost paralyzed) (serious criteria GSK medically significant and life threatening), excess sweating (Verbatim: Excessive sweating) (serious criteria life threatening), blood pressure fluctuation (Verbatim: My blood pressure started being very low now extremely high) (serious criteria life threatening) and tri-iodothyronine increased (Verbatim: TH3 liver elevated) (serious criteria life threatening). The outcome of the heart disorder, lung disorder, renal disorder, liver disorder, eye disorder, clot blood, headache, blurred vision, burning sensation, taste absent, ear discomfort, anosmia and stomach discomfort were not resolved and the outcome of the palpitation, paralysis, excess sweating, blood pressure fluctuation and tri-iodothyronine increased were not reported and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the heart disorder, lung disorder, renal disorder, liver disorder, eye disorder, clot blood, headache, blurred vision, burning sensation, taste absent, ear discomfort, anosmia, stomach discomfort, palpitation, paralysis, excess sweating, blood pressure fluctuation and tri-iodothyronine increased to be related to Shingrix and Flu vaccine. It was unknown if the company considered the heart disorder, lung disorder, renal disorder, liver disorder, eye disorder, clot blood, headache, blurred vision, burning sensation, taste absent, ear discomfort, anosmia, stomach discomfort, palpitation, paralysis, excess sweating, blood pressure fluctuation and tri-iodothyronine increased to be related to Shingrix and Flu vaccine. Additional Information: GSK Receipt Date: 29-AUG-2023 The patient received Aspirin, metoprolol, atorvastatin, hydrocodone and sertra within 2 weeks of vaccination. The most recent COVID-19 vaccine was administered at pharmacy or drug store. The reporter reported that the patient immunity system was being attacked. The patient reported that no one was doing anything. he or she had been to the emergency room about six times. And stated that send him or her right back to the home with no type of treatment. The patient reported that on 8th August 2023 made a year that he or she had been suffering. The patient reported that after a while he or she thought he or she not going to be living and no one was listened to him or her. On 08-AUG-2022 16:45, less than a day after received Pfizer covid vaccine patient experienced heart disorder, lung disorder, renal disorder, liver disorder, eye disorder, clot blood, headache, blurred vision, burning sensation, taste absent, ear discomfort, anosmia and stomach discomfort. On an unknown date, unknown time after receiving Pfizer covid vaccine the patient experienced palpitation, paralysis, excess sweating, blood pressure fluctuation and tri-iodothyronine increased. It was unknown if the reporter considered the adverse events to be related to Pfizer covid vaccine. Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paralysis
- Hospital-Tage
- -
- Labordaten
- Test Name: Blood pressure; Result Unstructured Data: (Test Result:Low,Unit:unknown,Normal Low:,Normal High:); Test Name: Blood pressure; Result Unstructured Data: (Test Result:Extremely high,Unit:unknown,Normal Low:,Normal High:); Test Name: COVID-19; Result Unstructured Data: (Test Result:not reported,Unit:unknown,Normal Low:,Normal High:); Test Date: 20230201; Test Name: Nasal swab; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20230316; Test Name: Nasal swab; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20230421; Test Name: Nasal swab; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Name: TH3; Result Unstructured Data: (Test Result:Increased,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- Depression; Fibromyalgia; Heart disease, unspecified; Migraine
- Vorgeschichte
- -
- Andere Medikamente
- ASPIRIN; METOPROLOL; ATORVASTATIN; HYDROCODONE; SERTRA
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 10.08.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Loss of consciousness
Pain
Symptomtext
Unconscious; body was sore; This serious case was reported by a consumer via interactive digital media and described the occurrence of unconscious in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced unconscious (Verbatim: Unconscious) (serious criteria GSK medically significant) and general body pain (Verbatim: body was sore). The outcome of the unconscious was not reported and the outcome of the general body pain was resolved. It was unknown if the reporter considered the unconscious and general body pain to be related to Shingrix. It was unknown if the company considered the unconscious and general body pain to be related to Shingrix. Additional Information: GSK Receipt Date: 04-AUG-2023 The case was received from the patient via interactive digital media. The reporter stated that after receiving the first shot of Shingrix hours after patient was unconscious in ambulance. She do not know if it was related or not to Shingrix. The patient body was sore for a while. The follow-up would not required per process.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.07.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Impaired driving ability
Loss of consciousness
Symptomtext
Passed out; I felt faint; I was driving and I got so dizzy; This serious case was reported by a consumer via interactive digital media and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 7 hrs after receiving Shingles vaccine, the patient experienced passed out (Verbatim: Passed out) (serious criteria GSK medically significant), faint (Verbatim: I felt faint) (serious criteria GSK medically significant) and dizziness (Verbatim: I was driving and I got so dizzy). The outcome of the passed out, faint and dizziness were resolved. It was unknown if the reporter considered the passed out, faint and dizziness to be related to Shingles vaccine. It was unknown if the company considered the passed out, faint and dizziness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that getting vaccinated was very good, but he or she had a horrible reaction. The patient reported that 7 hours after received Shingles vaccine he or she passed out completely, got some rest and on the next day he or she went to the work and he or she was driving and got so dizzy that he or she felt faint luckily he or she had immediate help, otherwise he or she would had an accident, ask the nurse about the reactions, so we should be careful. Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 26.07.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Trigeminal neuralgia
Symptomtext
vaccine caused Trigeminal Neuralgia; vaccine caused Bells Palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: vaccine caused Trigeminal Neuralgia) (serious criteria GSK medically significant) and trigeminal neuralgia (Verbatim: vaccine caused Bells Palsy). The outcome of the bell's palsy and trigeminal neuralgia were not reported. The reporter considered the bell's palsy and trigeminal neuralgia to be related to Shingles vaccine. The company considered the bell's palsy and trigeminal neuralgia to be related to Shingles vaccine. Additional Information: GSK receipt date: 21-JUL-2023 The case was received from the consumer interactive digital media. The reporter stated that vaccine caused Trigeminal Neuralgia and Bells Palsy The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- M
- Eingang
- 03.07.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Arteriogram coronary normal
Cardiac imaging procedure abnormal
Chest pain
Echocardiogram abnormal
Ejection fraction normal
Electrocardiogram ST segment depression
Electrocardiogram T wave inversion
Full blood count normal
Metabolic function test normal
Myocardial oedema
Myocarditis
Troponin
Wall motion score index abnormal
Symptomtext
Shingle vaccine associated myocarditis; myocardial Edema; chest pain radiating to left arm; This serious case was reported in a literature article and described the occurrence of myocarditis in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included gastroesophageal reflux disease. On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, 1 week after receiving Shingrix, the patient experienced myocarditis (Verbatim: Shingle vaccine associated myocarditis) (serious criteria GSK medically significant), myocardial edema (Verbatim: myocardial Edema) (serious criteria GSK medically significant) and chest pain with radiation to left arm (Verbatim: chest pain radiating to left arm). The outcome of the myocarditis, myocardial edema and chest pain with radiation to left arm were not reported. The reporter considered the myocarditis, myocardial edema and chest pain with radiation to left arm to be related to Shingrix. The company considered the myocarditis, myocardial edema and chest pain with radiation to left arm to be related to Shingrix. Additional Information: GSK Receipt date: 22 Jun 2023 A 50 year old male with a history of gastroesophageal reflux disease he received the Shingrix vaccine one week prior to symptoms onset. He presented to the emergency department complaining of chest pain radiating to his left arm that started one day ago. In the emergency department, his blood pressure was 118 79 mmHg, heart rate 63 bpm, and oxygen saturation 99 percent. Complete blood count and basic metabolic profile were within normal limits. High sensitivity troponin at baseline and one hour after the presentation were above 5000 pg per ml. The Electrocardiogram showed ST depression in leads V4 and T wave inversion on leads III, 2, 4, 5, and 6. A bedside transthoracic echocardiogram demonstrated Normal left ventricular systolic function with EF 55 perecnt, with wall motion abnormalities of the inferior wall. He underwent coronary angiography that revealed no significant disease. Cardiac MRI revealed myocardial edema and subepicardial enhancement in the basal inferior and lateral walls which meet the criteria of findings for myocarditis. On the follow up visit after two months, repeated echocardiography showed normal left ventricular systolic function with normal wall motion.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Myocarditis
- Hospital-Tage
- -
- Labordaten
- Test Name: coronary angiography; Result Unstructured Data: (Test Result:revealed no significant disease,Unit:unknown,Normal Low:,Normal High:); Test Name: blood pressure; Result Unstructured Data: (Test Result:118/79 mmHg,Unit:unknown,Normal Low:,Normal High:); Test Name: ejection fraction; Result Unstructured Data: (Test Result:55 %,Unit:unknown,Normal Low:,Normal High:); Test Name: Electrocardiography; Result Unstructured Data: (Test Result:ST depression in lead V4, Twave inversion 2,4,5,6,Unit:unknown,Normal Low:,Normal High:); Test Name: Electrocardiography; Result Unstructured Data: (Test Result:normal left ventricular systolic and wall function,Unit:unknown,Normal Low:,Normal High:); Test Name: Complete blood count; Result Unstructured Data: (Test Result:Within normal limit,Unit:unknown,Normal Low:,Normal High:); Test Name: Heart rate; Result Unstructured Data: (Test Result:63 bpm,Unit:unknown,Normal Low:,Normal High:); Test Name: basic metabolic profile; Result Unstructured Data: (Test Result:Within normal limit,Unit:unknown,Normal Low:,Normal High:); Test Name: oxygen saturation; Result Unstructured Data: (Test Result:99,Unit:unknown,Normal Low:,Normal High:); Test Name: High-sensitivity troponin; Result Unstructured Data: (Test Result:above 5000 pg/mL,Unit:unknown,Normal Low:0,Normal High:75) at baseline and one hour after the presentation; Comments: transthoracic echocardiogram : Normal left ventricular systolic function with EF 55 percent, with wall motion abnormalities of the inferior wall. cardiac MRI : myocardial Edema and subpericardial enhancement in the basal inferior and lateral walls Repeated echocardiography showed normal left ventricular systolic function with normal wall motion.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Gastroesophageal reflux disease
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 30.06.2023
- Impfdatum
- -
- Beginn
- 13.12.2016
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product complaint
Seizure
Symptomtext
Article states seizures from vaccination; Product complaint; This serious case was reported by a consumer and described the occurrence of seizures in a 10-month-old male patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On 13-DEC-2016, an unknown time after receiving Bexsero, the patient experienced seizures (Verbatim: Article states seizures from vaccination) (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the seizures was not reported and the outcome of the pharmaceutical product complaint was unknown. The reporter considered the seizures to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the seizures to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 23-JUN-2023 The patient was in hospital for the article states seizures from vaccination. The patient experienced seizures that could be linked to meningitis b vaccine states the child had seizures as a result of the vaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 26.06.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Seizure
Symptomtext
convulsions; This serious case was reported by a consumer via interactive digital media and described the occurrence of convulsion in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (The patient had shingles before). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced convulsion (Verbatim: convulsions) (serious criteria hospitalization and GSK medically significant). The outcome of the convulsion was not reported. It was unknown if the reporter considered the convulsion to be related to Shingles vaccine. It was unknown if the company considered the convulsion to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-JUN-2023. This case was reported by a patient via interactive digital media. After the second shot patient went into convulsions. The patient went by ambulance to the hospital spent 2 weeks in the hospital 1 week in rehab and another 2 weeks with a home nurse. The patient stated he/she had shingles before far less than what patient went through with the vaccine. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- 14,0
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Shingles (had shingles before)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 26.06.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Incomplete course of vaccination
Syncope
Symptomtext
Fainted; Did not receive second dose; This serious case was reported by a physician and described the occurrence of fainting in a 12-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received the 1st dose of Bexsero (unknown arm) and did not receive the 2nd dose of Bexsero. On an unknown date, 1 day after receiving Bexsero and not applicable after receiving Bexsero, the patient experienced fainting (Verbatim: Fainted) (serious criteria GSK medically significant) and incomplete course of vaccination (Verbatim: Did not receive second dose). The outcome of the fainting was resolved and the outcome of the incomplete course of vaccination was unknown. The reporter considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 20-jun-2023 This report was submitted via the online direct entry reporting system. The patient received first dose of Bexsero prior to going to sleep away camp due to outbreak. She did not receive second dose. She fainted the following day after getting vaccine. That happened about 4 to 5 years prior to the reporting. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Bexsero, which led to incomplete course of vaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 22.06.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Pain
Symptomtext
Guillain Barre; Also very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patients received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre) (serious criteria GSK medically significant) and pain (Verbatim: Also very painful). The outcome of the guillain barre syndrome and pain were unknown. It was unknown if the reporter considered the guillain barre syndrome and pain to be related to Shingles vaccine. It was unknown if the company considered the guillain barre syndrome and pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-JUN-2023 This case was reported by a consumer via interactive digital media. The reporter knew people have gotten Guillain Barre after getting the shot. Also very painful. The reporter wanted to know why get a shot that's not even keeping someone from still getting it.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 16.06.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Balance disorder
Diplopia
IVth nerve paralysis
Symptomtext
diagnosed with 4th cranial nerve palsy; He was seeing double; his balance has been off; This serious case was reported by a consumer via interactive digital media and described the occurrence of ivth nerve palsy in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced ivth nerve palsy (Verbatim: diagnosed with 4th cranial nerve palsy) (serious criteria hospitalization and GSK medically significant), double vision (Verbatim: He was seeing double) (serious criteria hospitalization) and balance disorder (Verbatim: his balance has been off) (serious criteria hospitalization). The outcome of the ivth nerve palsy, double vision and balance disorder were not reported. It was unknown if the reporter considered the ivth nerve palsy, double vision and balance disorder to be related to Shingles vaccine. It was unknown if the company considered the ivth nerve palsy, double vision and balance disorder to be related to Shingles vaccine. Additional Information: GSK receipt date: 13-JUN-2023 This case was reported by a patient's wife via interactive digital media. The reporter asked everyone to be cautious as her husband (patient) had vaccine and a few days later ended up in the hospital. They thought he had a stroke and ruled that out. He was diagnosed with 4th cranial nerve palsy. It had been a long road so far. He was seeing double, and his balance had been off. They had always been pro vaccine but were questioning at that time. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- IVth nerve paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- 57,0
- Geschlecht
- M
- Eingang
- 31.05.2023
- Impfdatum
- 01.05.2023
- Beginn
- 01.05.2023
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Extra dose administered
Syncope
Symptomtext
Third shot he fainted 12 hours after the vaccine was administered; In May 2023 the patient had a third shot of Shingrix (due to a medical clerical error); This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (on February 16, 2018 received 1st shot) and Shingrix (on August 06, 2018 received 2nd shot). In MAY-2023, the patient received the 3rd dose of Shingrix. In MAY-2023, 12 hrs after receiving Shingrix, the patient experienced fainting (Verbatim: Third shot he fainted 12 hours after the vaccine was administered) (serious criteria GSK medically significant) and extra dose administered (Verbatim: In May 2023 the patient had a third shot of Shingrix (due to a medical clerical error)). In MAY-2023, the outcome of the fainting was resolved. The outcome of the extra dose administered was unknown. It was unknown if the reporter considered the fainting to be related to Shingrix. It was unknown if the company considered the fainting to be related to Shingrix. Additional Information: GSK Receipt Date: 20-MAY-2023 and 22-MAY-2023 In 2018 the patient received 2 doses of vaccine On an unspecified day in May 2023 the patient had a third shot of Shingrix (due to a medical clerical error), which led to extra dose administered. The patient stated that he had a stronger reaction to the third shot than the first or second. He stated that first and second shots did not bother him but the third shot he fainted 12 hours after the vaccine was administered. The patient reported that fainting was the low point. He said he had no problems after that, after recovering from fainting. The patient asked if there any need to complete 2 shot series of the new dosages and do the vaccine lasted for lifetime The reporter consented to follow up via email or regular mail. Upon internal review the case was updated on 25-May-2023. summary of changes: Following internal review it was determined initial GSK receipt date was 20-May-2023, which was later than initially reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 22.05.2023
- Impfdatum
- 30.11.2020
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
COVID-19
Loss of consciousness
Symptomtext
Unconscious; Covid 19; This serious case was reported by a other health professional via interactive digital media and described the occurrence of unconscious in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 30-NOV-2020, the patient received the 1st dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced unconscious (Verbatim: Unconscious) (serious criteria GSK medically significant) and covid-19 (Verbatim: Covid 19). The outcome of the unconscious was not reported and the outcome of the covid-19 was resolved. It was unknown if the reporter considered the unconscious and covid-19 to be related to Shingrix. It was unknown if the company considered the unconscious and covid-19 to be related to Shingrix. Additional Information: GSK Receipt Date: 18-MAY-2023 This case was reported by the patient via interactive digital media. The pharmacy told to the patient if had chickenpox at a risk of getting shingles free vaccination would be offered. The patient received 1st shot and after hours later the patient was unconscious in ambulance, not known. The covid end days later. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 19.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anaphylactic reaction
Symptomtext
Near fatal anaphylactic reaction; This serious case was reported by a consumer via market research programs and described the occurrence of anaphylactic reaction in a elderly female patient who received Flu unspecified (Flu vaccine unspecified) for prophylaxis. On an unknown date, the patient received Flu vaccine unspecified. On an unknown date, an unknown time after receiving Flu vaccine unspecified, the patient experienced anaphylactic reaction (Verbatim: Near fatal anaphylactic reaction) (serious criteria GSK medically significant and life threatening). The outcome of the anaphylactic reaction was not reported. The reporter considered the anaphylactic reaction to be possibly related to Flu vaccine unspecified. The company considered the anaphylactic reaction to be possibly related to Flu vaccine unspecified. Additional Information: GSK Receipt Date: 17-MAY-2023 This case was reported by the consumer via research programs. The patient had near fatal anaphylactic reaction to a Flu shot. The reporter thought that the event might have been related to the vaccine. The reporter consented to follow-up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic reaction
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- M
- Eingang
- 19.05.2023
- Impfdatum
- 01.04.2023
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Asthenia
Bell's palsy
Dizziness
Facial paralysis
Herpes zoster oticus
Symptomtext
He then developed facial paralysis; he had Bell's Palsy; he had Ramsay Hunt syndrome; He then developed dizziness; He then developed weakness; This serious case was reported by a physician via sales rep and described the occurrence of facial paralysis in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. In APR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced facial paralysis (Verbatim: He then developed facial paralysis) (serious criteria GSK medically significant), bell's palsy (Verbatim: he had Bell's Palsy) (serious criteria GSK medically significant), ramsay-hunt syndrome (Verbatim: he had Ramsay Hunt syndrome) (serious criteria GSK medically significant), dizziness (Verbatim: He then developed dizziness) and weakness (Verbatim: He then developed weakness). The outcome of the facial paralysis, bell's palsy, ramsay-hunt syndrome, dizziness and weakness were not reported. The reporter considered the facial paralysis, bell's palsy, ramsay-hunt syndrome, dizziness and weakness to be related to Shingrix. The company considered the facial paralysis, bell's palsy, ramsay-hunt syndrome, dizziness and weakness to be related to Shingrix. Additional Information: GSK Receipt Date: 15-MAY-2023 The reporter was a field staff employee. The first dose of Shingrix was received about a month prior to the reporting. The patient was with no comorbid conditions received a dose of Shingrix and then developed dizziness, weakness and facial paralysis. The patient sought care from a neurologist and was told that he had Bell's Palsy or Ramsay Hunt syndrome. The Neurologist told it was caused by the Shingrix vaccine. The patient had no other vaccines on the same day. The patient was now in physical therapy and his balance was better. The reporter agrees to follow up from GlaxoSmithKline.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- -
- Geschlecht
- F
- Eingang
- 18.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Abdominal pain
Abdominal pain lower
Arthralgia
Asthenia
Back pain
Blister
Brain fog
Burning sensation
Chills
Dizziness
Dyspnoea
Fatigue
Feeling cold
Gait inability
Groin pain
Herpes zoster
Lethargy
Loss of consciousness
Symptomtext
Suspected vaccination failure; Almost passed out because my back, side, and hip were covered with blisters; Severe case of shingles; Neuralgia pain in right hip down into groin area /Pain in right TFL (Tensor Fasciae Latae); Blisters broke out; Pain /Pain in right TFL (Tensor Fasciae right TFL (Tensor Fasciae); Could not walk; Could hardly breathe; Could not do (my normal activities); Chills; Nausea; Brain fog; Total lethargy; Fatigue; Right TFL is still firing; Lumbar pain; Abdominal pain; Groin pain; Knee pain; Debilitating; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included Extremely healthy- no medical issues, take no medications, take no (over-the-counter) drugs did not even take aspirin. The patient teach exercise and wellness classes. She was near perfect health wasn't overly stressed. had a relaxed life. She was very strong and healthy and did not get sick. She had a super immune system. The patient never had Covid. she didn't get flu last year or this year. she had good immunity. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), passed out (Verbatim: Almost passed out because my back, side, and hip were covered with blisters) (serious criteria GSK medically significant), shingles (Verbatim: Severe case of shingles), post herpetic neuralgia (Verbatim: Neuralgia pain in right hip down into groin area /Pain in right TFL (Tensor Fasciae Latae)), blister (Verbatim: Blisters broke out), pain (Verbatim: Pain /Pain in right TFL (Tensor Fasciae right TFL (Tensor Fasciae)), unable to walk (Verbatim: Could not walk), difficulty breathing (Verbatim: Could hardly breathe), activities of daily living impaired (Verbatim: Could not do (my normal activities)), chills (Verbatim: Chills), nausea (Verbatim: Nausea), brain fog (Verbatim: Brain fog), lethargy (Verbatim: Total lethargy), fatigue (Verbatim: Fatigue), burning sensation (Verbatim: Right TFL is still firing), lumbar pain (Verbatim: Lumbar pain), abdominal pain (Verbatim: Abdominal pain), groin pain (Verbatim: Groin pain), knee pain (Verbatim: Knee pain) and debility (Verbatim: Debilitating). The patient was treated with acyclovir and gabapentin. The outcome of the vaccination failure was unknown and the outcome of the passed out, shingles, post herpetic neuralgia, blister, pain, unable to walk, difficulty breathing, activities of daily living impaired, nausea, lethargy, lumbar pain, abdominal pain, groin pain, knee pain and debility were resolving and the outcome of the chills, brain fog and fatigue were not reported and the outcome of the burning sensation was not resolved. The reporter considered the vaccination failure and shingles to be related to Shingrix. It was unknown if the reporter considered the passed out, post herpetic neuralgia, blister, pain, unable to walk, difficulty breathing, activities of daily living impaired, chills, nausea, brain fog, lethargy, fatigue, burning sensation, lumbar pain, abdominal pain, groin pain, knee pain and debility to be related to Shingrix and Shingrix. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure and shingles to be related to Shingrix. It was unknown if the company considered the passed out, post herpetic neuralgia, blister, pain, unable to walk, difficulty breathing, activities of daily living impaired, chills, nausea, brain fog, lethargy, fatigue, burning sensation, lumbar pain, abdominal pain, groin pain, knee pain and debility to be related to Shingrix and Shingrix. It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 11-MAY-2023 The patient received both the doses of Shingrix vaccine in 2019. The patient did not have the exact dates of the shots but did provide the pharmacy contact information who should have the dates (and lot numbers) on file. A couple of months ago patient came down with a severe case of shingles in 2023 which has not fully resolved. Patient reported that she started having neuralgia pain in right hip down into my groin area. The patient thought she had a hip problem or pulled a muscle because she was active. This started several months before the blisters broke out. When the blisters broke out she had no warning. She was washing her back and she almost passed out because her back, side, and hip were covered with blisters. The pain became unbearable, then it was in the right TFL (Tensor Fasciae Latae) area and across her lumbar region, right lower quadrant of abdomen felt like she was having appendicitis. Pain was deep in right groin and radiated into right knee. Patient husband took her to the emergency room because her was doubled over in pain and could not walk, could hardly breathe. As soon as they saw the blisters they diagnosed patient with shingles. Patient did two rounds of acyclovir and they prescribed gabapentin for a month. The Physician's Assistant told me to cancel everything for the next 3 to 6 weeks and he was correct. It was debilitating. Patient could not do (normal activities) for almost 2 months. But things were better now the patient was back to teaching, she could mow the lawn, could hike with the dogs. The patient still on the gabapentin. The patient was much better but still had a shadow of the neuralgia pain and her right TFL was still firing. The blisters cleared up. They dried up and they just have marks were they were. She also said that during the shingles outbreak she had chills, was under piles of blankets, could not get warm. The shingles outbreak caused her to have chills, nausea, brain fog, and total lethargy. The reporter asked her if these events had resolved. She said that she still does get chills once in a while. She gets brain fog and fatigue occasionally, but she could function now. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles was unknown at the time of reporting.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Comments: Extremely healthy- no medical issues, take no medications, take no (over-the-counter) drugs did not even take aspirin. The patient teach exercise and wellness classes. She was near perfect health wasn't overly stressed. had a relaxed life. She was very strong and healthy and did not get sick. She had a super immune system. The patient never had Covid. she didn't get flu last year or this year. she had good immunity.
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- -
- Geschlecht
- F
- Eingang
- 18.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Abdominal pain
Abdominal pain lower
Arthralgia
Asthenia
Back pain
Blister
Brain fog
Burning sensation
Chills
Dizziness
Dyspnoea
Fatigue
Feeling cold
Gait inability
Groin pain
Herpes zoster
Lethargy
Loss of consciousness
Symptomtext
Suspected vaccination failure; Almost passed out because my back, side, and hip were covered with blisters; Severe case of shingles; Neuralgia pain in right hip down into groin area /Pain in right TFL (Tensor Fasciae Latae); Blisters broke out; Pain /Pain in right TFL (Tensor Fasciae right TFL (Tensor Fasciae); Could not walk; Could hardly breathe; Could not do (my normal activities); Chills; Nausea; Brain fog; Total lethargy; Fatigue; Right TFL is still firing; Lumbar pain; Abdominal pain; Groin pain; Knee pain; Debilitating; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included Extremely healthy- no medical issues, take no medications, take no (over-the-counter) drugs did not even take aspirin. The patient teach exercise and wellness classes. She was near perfect health wasn't overly stressed. had a relaxed life. She was very strong and healthy and did not get sick. She had a super immune system. The patient never had Covid. she didn't get flu last year or this year. she had good immunity. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), passed out (Verbatim: Almost passed out because my back, side, and hip were covered with blisters) (serious criteria GSK medically significant), shingles (Verbatim: Severe case of shingles), post herpetic neuralgia (Verbatim: Neuralgia pain in right hip down into groin area /Pain in right TFL (Tensor Fasciae Latae)), blister (Verbatim: Blisters broke out), pain (Verbatim: Pain /Pain in right TFL (Tensor Fasciae right TFL (Tensor Fasciae)), unable to walk (Verbatim: Could not walk), difficulty breathing (Verbatim: Could hardly breathe), activities of daily living impaired (Verbatim: Could not do (my normal activities)), chills (Verbatim: Chills), nausea (Verbatim: Nausea), brain fog (Verbatim: Brain fog), lethargy (Verbatim: Total lethargy), fatigue (Verbatim: Fatigue), burning sensation (Verbatim: Right TFL is still firing), lumbar pain (Verbatim: Lumbar pain), abdominal pain (Verbatim: Abdominal pain), groin pain (Verbatim: Groin pain), knee pain (Verbatim: Knee pain) and debility (Verbatim: Debilitating). The patient was treated with acyclovir and gabapentin. The outcome of the vaccination failure was unknown and the outcome of the passed out, shingles, post herpetic neuralgia, blister, pain, unable to walk, difficulty breathing, activities of daily living impaired, nausea, lethargy, lumbar pain, abdominal pain, groin pain, knee pain and debility were resolving and the outcome of the chills, brain fog and fatigue were not reported and the outcome of the burning sensation was not resolved. The reporter considered the vaccination failure and shingles to be related to Shingrix. It was unknown if the reporter considered the passed out, post herpetic neuralgia, blister, pain, unable to walk, difficulty breathing, activities of daily living impaired, chills, nausea, brain fog, lethargy, fatigue, burning sensation, lumbar pain, abdominal pain, groin pain, knee pain and debility to be related to Shingrix and Shingrix. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure and shingles to be related to Shingrix. It was unknown if the company considered the passed out, post herpetic neuralgia, blister, pain, unable to walk, difficulty breathing, activities of daily living impaired, chills, nausea, brain fog, lethargy, fatigue, burning sensation, lumbar pain, abdominal pain, groin pain, knee pain and debility to be related to Shingrix and Shingrix. It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 11-MAY-2023 The patient received both the doses of Shingrix vaccine in 2019. The patient did not have the exact dates of the shots but did provide the pharmacy contact information who should have the dates (and lot numbers) on file. A couple of months ago patient came down with a severe case of shingles in 2023 which has not fully resolved. Patient reported that she started having neuralgia pain in right hip down into my groin area. The patient thought she had a hip problem or pulled a muscle because she was active. This started several months before the blisters broke out. When the blisters broke out she had no warning. She was washing her back and she almost passed out because her back, side, and hip were covered with blisters. The pain became unbearable, then it was in the right TFL (Tensor Fasciae Latae) area and across her lumbar region, right lower quadrant of abdomen felt like she was having appendicitis. Pain was deep in right groin and radiated into right knee. Patient husband took her to the emergency room because her was doubled over in pain and could not walk, could hardly breathe. As soon as they saw the blisters they diagnosed patient with shingles. Patient did two rounds of acyclovir and they prescribed gabapentin for a month. The Physician's Assistant told me to cancel everything for the next 3 to 6 weeks and he was correct. It was debilitating. Patient could not do (normal activities) for almost 2 months. But things were better now the patient was back to teaching, she could mow the lawn, could hike with the dogs. The patient still on the gabapentin. The patient was much better but still had a shadow of the neuralgia pain and her right TFL was still firing. The blisters cleared up. They dried up and they just have marks were they were. She also said that during the shingles outbreak she had chills, was under piles of blankets, could not get warm. The shingles outbreak caused her to have chills, nausea, brain fog, and total lethargy. The reporter asked her if these events had resolved. She said that she still does get chills once in a while. She gets brain fog and fatigue occasionally, but she could function now. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles was unknown at the time of reporting.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Comments: Extremely healthy- no medical issues, take no medications, take no (over-the-counter) drugs did not even take aspirin. The patient teach exercise and wellness classes. She was near perfect health wasn't overly stressed. had a relaxed life. She was very strong and healthy and did not get sick. She had a super immune system. The patient never had Covid. she didn't get flu last year or this year. she had good immunity.
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.05.2023
- Impfdatum
- 01.09.2022
- Beginn
- 02.09.2022
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Seizure
Symptomtext
i went into violent convulsions; This serious case was reported by a consumer via interactive digital media and described the occurrence of convulsion in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 01-SEP-2022, the patient received Shingles vaccine. On 02-SEP-2022, 1 days after receiving Shingles vaccine, the patient experienced convulsion (Verbatim: i went into violent convulsions) (serious criteria GSK medically significant). The outcome of the convulsion was not reported. It was unknown if the reporter considered the convulsion to be related to Shingles vaccine. It was unknown if the company considered the convulsion to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that, he/she took the shingles vaccine. On September 2, exactly 24 hour later, he/she went into violent convulsions. The reporter had stated that, he/she would never again would take any kind of vaccine. The follow up would not possible, as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- -
- Geschlecht
- M
- Eingang
- 13.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anti-glomerular basement membrane antibody negative
Antineutrophil cytoplasmic antibody negative
Antinuclear antibody negative
Antiphospholipid antibodies positive
Arthralgia
Asthenia
Biopsy kidney abnormal
Complement factor C3
Complement factor C4
Electrophoresis protein normal
Gait disturbance
Glomerulonephritis membranous
Guillain-Barre syndrome
Hepatitis viral test negative
Hypertension
Nephrotic syndrome
Nervous system disorder
Oedema
Symptomtext
PLA2R-Antibody Positive Membranous Nephropathy; inflammatory demyelinating radiculopathy/ inflammatory demyelinating polyradiculopathy; joint pain; bilateral extremity paresthesias; marked edema; hypertension; over 20 lbs weight gain; weakness; unsteady gait; proteinuria; nephrotic syndrome; This serious case was reported in a literature article and described the occurrence of membranous nephropathy in a 56-year-old male patient who received Hepatitis B vaccine for prophylaxis. Additional patient notes included No preceding illness. On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, less than a month after receiving Hepatitis B vaccine, the patient experienced membranous nephropathy (Verbatim: PLA2R-Antibody Positive Membranous Nephropathy) (serious criteria GSK medically significant), acute inflammatory demyelinating polyradiculopathy (Verbatim: inflammatory demyelinating radiculopathy/ inflammatory demyelinating polyradiculopathy) (serious criteria GSK medically significant), joint pain (Verbatim: joint pain), paresthesia of limbs (Verbatim: bilateral extremity paresthesias), edema (Verbatim: marked edema), hypertension (Verbatim: hypertension), weight gain (Verbatim: over 20 lbs weight gain), weakness (Verbatim: weakness), unsteady gait (Verbatim: unsteady gait), proteinuria (Verbatim: proteinuria) and nephrotic syndrome (Verbatim: nephrotic syndrome) (serious criteria GSK medically significant). The patient was treated with nsaid's (Nsaids (Unknown)) and prednisone. The outcome of the membranous nephropathy, proteinuria and nephrotic syndrome were resolved and the outcome of the acute inflammatory demyelinating polyradiculopathy and paresthesia of limbs were resolving and the outcome of the joint pain, edema, hypertension, weight gain, weakness and unsteady gait were not reported. The reporter considered the membranous nephropathy, acute inflammatory demyelinating polyradiculopathy, joint pain, paresthesia of limbs, edema, hypertension, weight gain, weakness, unsteady gait, proteinuria and nephrotic syndrome to be related to Hepatitis B vaccine. The company considered the membranous nephropathy, acute inflammatory demyelinating polyradiculopathy, joint pain, paresthesia of limbs, edema, hypertension, weight gain, weakness, unsteady gait, proteinuria and nephrotic syndrome to be related to Hepatitis B vaccine. Additional Information: GSK Receipt Date: 04-MAY-2023 The patient was referred for a second opinion regarding membranous nephropathy (MN). He initially presented with joint pain and bilateral extremity paresthesias. He soon developed marked edema and hypertension, with over 20 lbs weight gain, associated with weakness and unsteady gait. No preceding illness was reported, but he had received hepatitis B vaccination one month prior. He had taken NSAIDs for pain but no other medications. He was found to have 17 grams of proteinuria/24 hs and was diagnosed with nephrotic syndrome. His renal function was normal. Serological workup including Complement factor C3/ Complement factor C4, antinuclear antibody (ANA), rheumatoid factor (RF), antineutrophil cytoplasmic antibody (ANCA), Anti-glomerular basement membrane (anti-GBM) antibodies, hepatitis panel, SPEP, UPEP was negative. A screening colonoscopy 6 years prior and a prostatic specific antigen level were normal. Renal biopsy showed membranous nephropathy. PLA2R was positive (1:40). Concomitantly, he was diagnosed with inflammatory demyelinating polyradiculopathy and was started on prednisone 60 mg daily. Over the next several months he showed neurological improvement, and the steroid dose was titrated down. Proteinuria also improved (less than 1g /24 hrs) and the nephrotic syndrome resolved. Repeat PLA2R levels have been negative. This was the first case of MN associated with a inflammatory demyelinating radiculopathy with PLA2R positivity. The time correlation with the hepatitis B vaccination series raised the possibility that the HBV antigen triggered the autoimmune response. This article is not available for regulatory reporting due to copyright restriction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- Test Name: anti-GBM antibodies; Test Result: Negative ; Test Name: ANCA; Test Result: Negative ; Test Name: ANA; Test Result: Negative ; Test Name: PLA2R-Antibody; Test Result: Positive ; Test Name: PLA2R-Antibody; Test Result: Negative ; Test Name: Renal biopsy; Result Unstructured Data: (Test Result:membranous nephropathy,Unit:unknown,Normal Low:,Normal High:); Test Name: colonoscopy; Result Unstructured Data: (Test Result:Normal level,Unit:unknown,Normal Low:,Normal High:) 6 years prior; Test Name: C3; Test Result: Negative ; Test Name: C4; Test Result: Negative ; Test Name: SPEP; Test Result: Negative ; Test Name: UPEP; Test Result: Negative ; Test Name: hepatitis panel; Test Result: Negative ; Test Name: PSA; Result Unstructured Data: (Test Result:Normal level,Unit:unknown,Normal Low:,Normal High:); Test Name: urine protein; Test Result: 17 g; Test Name: urine protein; Result Unstructured Data: (Test Result:less than 1,Unit:g,Normal Low:,Normal High:) per 24 hrs; Test Name: renal function; Result Unstructured Data: (Test Result:Normal result,Unit:unknown,Normal Low:,Normal High:); Test Name: RF; Test Result: Negative ; Test Name: weight; Result Unstructured Data: (Test Result:20 weight gain,Unit:unknown,Normal Low:,Normal High:) lbs
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Comments: No preceding illness
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 12.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Paralysis
Symptomtext
is paralysed; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced paralysis (Verbatim: is paralysed) (serious criteria GSK medically significant). The outcome of the paralysis was not reported. It was unknown if the reporter considered the paralysis to be related to Shingles vaccine. It was unknown if the company considered the paralysis to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient's parent via interactive digital media. The reporter would never get this shingles vaccine. The reporter stated that adverse reactions were severe. The patient was paralyzed and he/she blamed the shingles vaccine. The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- M
- Eingang
- 09.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Blood test
CSF test
Condition aggravated
Diplegia
Dizziness
Dysuria
Hyperhidrosis
Magnetic resonance imaging spinal abnormal
Myelitis transverse
Paraesthesia
Pulse absent
Sensory loss
Sinus rhythm
Syncope
Unresponsive to stimuli
Urinary retention
Ventricular tachycardia
Symptomtext
ventricular tachycardia; acute transverse myelitis; ascending bilateral lower extremity paresthesia/ The paresthesia progressed fromhis feet to groin; loss of sensation; urination; incomplete bladder emptying/ Urinary retention; ambulatory dysfunction due to difficulty with proprioception of both his legs; acute onset of diaphoresis; lightheadedness; syncopal episode; unresponsive; condition aggravated; This serious case was reported in a literature article and described the occurrence of ventricular tachycardia in a 50-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included psoriatic arthritis. Concomitant products included methotrexate. On an unknown date, the patient received Shingles vaccine (unknown arm). On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced ventricular tachycardia (Verbatim: ventricular tachycardia) (serious criteria GSK medically significant), myelitis transverse (Verbatim: acute transverse myelitis) (serious criteria GSK medically significant), paresthesia lower limb (Verbatim: ascending bilateral lower extremity paresthesia/ The paresthesia progressed fromhis feet to groin), loss of sensation (Verbatim: loss of sensation), urination impaired (Verbatim: urination), incomplete bladder emptying (Verbatim: incomplete bladder emptying/ Urinary retention) (serious criteria GSK medically significant), diplegia of lower limbs (Verbatim: ambulatory dysfunction due to difficulty with proprioception of both his legs) (serious criteria GSK medically significant), diaphoresis (Verbatim: acute onset of diaphoresis), light headedness (Verbatim: lightheadedness), syncopal attack (Verbatim: syncopal episode) (serious criteria GSK medically significant), unresponsive to stimuli (Verbatim: unresponsive) (serious criteria GSK medically significant) and condition aggravated (Verbatim: condition aggravated). The patient was treated with amiodarone and methylprednisolone sodium succinate (Solumedrol). The outcome of the ventricular tachycardia, myelitis transverse, paresthesia lower limb, loss of sensation, urination impaired, incomplete bladder emptying, diplegia of lower limbs, diaphoresis, light headedness, syncopal attack, unresponsive to stimuli and condition aggravated were resolving. The reporter considered the ventricular tachycardia, myelitis transverse, paresthesia lower limb, loss of sensation, urination impaired, incomplete bladder emptying, diplegia of lower limbs, diaphoresis, light headedness, syncopal attack, unresponsive to stimuli and condition aggravated to be possibly related to Shingles vaccine. The company considered the ventricular tachycardia, myelitis transverse, paresthesia lower limb, loss of sensation, urination impaired, incomplete bladder emptying, diplegia of lower limbs, diaphoresis, light headedness, syncopal attack, unresponsive to stimuli and condition aggravated to be possibly related to Shingles vaccine. Additional Information: GSK Receipt Date: 02-May-2023 The author presented a case of 50-year-old male with a history of psoriatic arthritis on methotrexate presented to the emergency room (ER) one week following a shingles vaccine with complaint of ascending bilateral lower extremity paresthesia. The paresthesia progressed from his feet to groin with associated loss of sensation with urination, incomplete bladder emptying, and ambulatory dysfunction due to difficulty with proprioception of both his legs. Examination was significant for diminished light touch, vibration, and temperature sensation of the bilateral lower extremities. Urinary retention was noted and was treated with a foley catheter. MRI imaging of the patient's spine revealed longitudinally extensive T2 hyperintensity from the lower cervical spine to the upper thoracic spine. The patient's ER course was complicated by acute onset of diaphoresis and lightheadedness followed by a syncopal episode. The patient was unresponsive and pulseless, and the telemetry was consistent ventricular tachycardia which was quickly self-limiting with return of mental awareness and normal sinus rhythm. Amiodarone was initiated and the patient remained in normal sinus rhythm. He was treated with 1 g of IV solumedrol for suspected ATM based on clinical presentation and spinal cord appearance on MRI. However, there was no clinical improvement after 5 days of IV steroid treatment and the decision was made to initiate plasmapheresis. Plasmapheresis was well tolerated and the patient's symptoms gradually improved. Extensive blood work and CSF studies failed to determine the etiology of the ATM. The patient's symptoms continued to progress, and he was discharged to a rehab facility with long-term cardiac event monitoring. The author also reported that as the patient in case had a recent Shingles vaccine, which was also live attenuated vaccine of the VZV virus, there was a possible argument that can be made of the link between the patient's ATM and the Shingles vaccine. As varicella was a potential cause of tachycardia via myocarditis, and vaccinations have an association with myocarditis, it was possible that patient's ventricular tachycardia could also be related to the Shingles vaccine
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- Test Name: Pulse less; Result Unstructured Data: (Test Result:less,Unit:unknown,Normal Low:,Normal High:); Test Name: sinus rhythm; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Comments: Examination was significant for diminished light touch, vibration, and temperature sensation of the bilateral lower extremities MRI imaging of the patient's spine revealed longitudinally extensive T2 hyperintensity from the lower cervical spine to the upper thoracic spine the telemetry was consistent ventricular tachycardia which was quickly self-limiting with return of mental awareness and normal sinus rhythm
- Aktuelle Erkrankungen
- Psoriatic arthritis
- Vorgeschichte
- -
- Andere Medikamente
- METHOTREXATE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 05.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Gait disturbance
Guillain-Barre syndrome
Mechanical ventilation
Pain
Paralysis
Symptomtext
went from normal to paralyzed/being paralyzed; Guillain Barre syndrome; Incredible pain; learning to walk again; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced paralysis (Verbatim: went from normal to paralyzed/being paralyzed) (serious criteria GSK medically significant), guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria GSK medically significant), pain (Verbatim: Incredible pain) and walking difficulty (Verbatim: learning to walk again). The outcome of the paralysis and walking difficulty were resolving and the outcome of the guillain barre syndrome and pain were not reported. It was unknown if the reporter considered the paralysis, guillain barre syndrome, pain and walking difficulty to be related to Shingles vaccine. It was unknown if the company considered the paralysis, guillain barre syndrome, pain and walking difficulty to be related to Shingles vaccine. Additional Information: GSK receipt date: 31-MAR-2023 The case was received from the patient via interactive digital media. The patient reported that shingles vaccine greatly increases the risk of developing Guillain Barre Syndrome and you did not want any of that, so look it up. The patient stated that he/she was learning to walk again after being paralyzed for 5 months and possibly kill you. The patient stated that he/she went from normal to paralyzed and in incredible pain plus on the ventilator. The patient stated that, 9 months later he/she was learning to walk again. The patient stated that he/she had rather had shingles again any day over this. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 05.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bedridden
Fall
Paralysis
Symptomtext
paralyzed from the neck down, unable to turn in bed; fall, twice down multiple flights of stairs; Unable to even turn in bed; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced paralysis (Verbatim: paralyzed from the neck down, unable to turn in bed) (serious criteria hospitalization and GSK medically significant), fall (Verbatim: fall, twice down multiple flights of stairs) (serious criteria hospitalization) and bedridden (Verbatim: Unable to even turn in bed) (serious criteria hospitalization). The outcome of the paralysis, fall and bedridden were not reported. It was unknown if the reporter considered the paralysis, fall and bedridden to be related to Shingrix. It was unknown if the company considered the paralysis, fall and bedridden to be related to Shingrix. Additional Information: GSK receipt date: 01-MAY-2023, 02-MAY-2023 This case was reported by patient via interactive digital media. The patient received the shingles vaccine (Shingrix by GSK) and was paralyzed. The patient reported that about a week after receiving the Shingrix vaccine, he started to fall hard around the house for no reason, twice down multiple flights of stairs. The patient reported that within 2 plus weeks he was paralyzed from the neck down, unable to even turn in bed and had to be hospitalized. Follow up would not possible, as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 5,0
- Geschlecht
- F
- Eingang
- 03.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Deafness unilateral
Meningitis bacterial
Seizure
Symptomtext
Seizures; Bacterial meningitis; deaf in one ear; This serious case was reported by a consumer via call center representative and described the occurrence of seizure in a 5-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced seizure (Verbatim: Seizures) (serious criteria GSK medically significant), bacterial meningitis (Verbatim: Bacterial meningitis) (serious criteria GSK medically significant) and deafness unilateral (Verbatim: deaf in one ear) (serious criteria GSK medically significant). The outcome of the seizure and bacterial meningitis were not reported and the outcome of the deafness unilateral was not resolved. It was unknown if the reporter considered the seizure, bacterial meningitis and deafness unilateral to be related to Flu vaccine. It was unknown if the company considered the seizure, bacterial meningitis and deafness unilateral to be related to Flu vaccine. Additional Information: GSK receipt date: 26-APR-2023 This case was reported by the patient's parent via interactive digital media. The patient had got the flu vaccine and started having seizures then it led to bacterial meningitis, now (at the moment of reporting) she was deaf in one ear. The reporter was so overwhelmed right now (at the moment of reporting). Follow-up would not possible, as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Electric shock sensation
Herpes zoster
Ophthalmic herpes zoster
Tympanic membrane disorder
Vaccination failure
Visual impairment
Symptomtext
did have shingles shot had shingles/suspected vaccination failure; Shingles affected vision; shingles on head/Shingles affected one ear drum; shock waves in head; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: did have shingles shot had shingles/suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles affected vision) (serious criteria GSK medically significant), shingles (Verbatim: shingles on head/Shingles affected one ear drum) and electric shock sensation in head (Verbatim: shock waves in head). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were resolved and the outcome of the electric shock sensation in head was not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and electric shock sensation in head to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, shingles and electric shock sensation in head to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 24-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingles on his/her head and affected his/her vision and one ear drum. The patient stated that over 2 months to heal. A year later he/she still had shock waves in his/her head and the patient did have a shingles shot 6 months before. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Electric shock sensation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- F
- Eingang
- 02.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Ascending flaccid paralysis
Guillain-Barre syndrome
Inappropriate schedule of product administration
Lumbar puncture
Symptomtext
Guillian Barre syndrome; Ascending paralysis; 2nd dose in 2022; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (The patient had the 1st dose of Shingrix in 2020.). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillian Barre syndrome) (serious criteria GSK medically significant), paralysis ascending (Verbatim: Ascending paralysis) (serious criteria GSK medically significant) and drug dose administration interval too long (Verbatim: 2nd dose in 2022). The outcome of the guillain barre syndrome and paralysis ascending were not reported and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the guillain barre syndrome and paralysis ascending to be related to Shingrix. It was unknown if the company considered the guillain barre syndrome and paralysis ascending to be related to Shingrix. Additional Information: GSK Receipt Date: 25-APR-2023 The patient received both doses of Shingrix, however patient received the 2nd dose in 2022, which led to drug dose administration interval too long. A few weeks after vaccination, patient developed guillian barre syndrome and developed ascending paralysis. Patient was sent for a lumbar puncture however Doctor does not know results of puncture as of today. The reporter consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Ascending flaccid paralysis
- Hospital-Tage
- -
- Labordaten
- Test Name: Lumbar puncture; Result Unstructured Data: (Test Result:not know results of,Unit:unknown,Normal Low:,Normal High:); Comments: puncture as of today; Comments: LabComments: Lumbar puncture : puncture as of today
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 01.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Burning sensation
Electric shock sensation
Pain
Symptomtext
Had the symptoms, hurts a lot; Burning sensation, fire sensation; Burning sensation or electricity does not go away; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Had the symptoms, hurts a lot), burning sensation (Verbatim: Burning sensation, fire sensation) and electric shock sensation (Verbatim: Burning sensation or electricity does not go away). The outcome of the pain, burning sensation and electric shock sensation were not resolved. It was unknown if the reporter considered the pain, burning sensation and electric shock sensation to be related to Shingles vaccine. It was unknown if the company considered the pain, burning sensation and electric shock sensation to be related to Shingles vaccine. Additional Information: GSK receipt date: 25-MAR-2023 This case was reported by a patient via interactive digital media. The patient put on the shingles vaccine and got all the symptoms but got not blisters it's been 5 months and it still hurts a lot and that burning sensation or electricity does not go away patient don't know what to do. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Electric shock sensation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 01.05.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Symptomtext
I came down with Bells Palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: I came down with Bells Palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was not reported. It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. It was unknown if the company considered the bell's palsy to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that please beware of shingles vaccine. The patient had shingles vaccine and came down with bell's palsy two years later. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR061465, reported by the same reporter, for a different patient.; Sender's Comments: US-GSK-US2023AMR061465:husband?s case
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.04.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Symptomtext
came down with Bells Paulsi; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: came down with Bells Paulsi) (serious criteria GSK medically significant). The outcome of the bell's palsy was not resolved. It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. It was unknown if the company considered the bell's palsy to be related to Shingles vaccine. Additional Information: GSK receipt date: 23-MAR-2023 The case was received from the patient via interactive digital media. The patient stated that he/she had the Shingles shot and came down with Bells Paulsi for the rest of his/her life. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 18.04.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Symptomtext
Bells Palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included sickness (it had been over 6 years since he/she had any kind of sickness) and respiratory disorder (it had been over 6 years since he/she had any kind of respiratory sickness). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: Bells Palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was not reported. It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. It was unknown if the company considered the bell's palsy to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient was a healthy person. The reporter stated that he/she went ahead and got the shingles vaccine. After the shingles vaccine he/she got bell's palsy 2 weeks later. The reporter further stated that it was coincidence. The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Respiratory disorder (it had been over 6 years since he/she had any kind of respiratory sickness); Sickness (it had been over 6 years since he/she had any kind of sickness)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 14.04.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Paralysis
Symptomtext
Was paralyzed; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced paralysis (Verbatim: Was paralyzed) (serious criteria GSK medically significant). The outcome of the paralysis was not reported. It was unknown if the reporter considered the paralysis to be related to Shingles vaccine. It was unknown if the company considered the paralysis to be related to Shingles vaccine. Additional Information: GSK receipt date:10-April-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she got vaccine and was paralyzed. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- M
- Eingang
- 10.04.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: ja
Bell's palsy
Decreased nasolabial fold
Facial asymmetry
Facial paralysis
Facial paresis
Herpes simplex test negative
Magnetic resonance imaging head abnormal
SARS-CoV-2 test negative
Scan with contrast abnormal
Symptomtext
incomplete Bell's Palsy; acute onset right-sided facial weakness/right facial nerve paresis; nasolabial fold flattening drooping/drooping of the right corner of his mouth; enhancement of the tympanic and mastoid segments; This serious case was reported in a literature article and described the occurrence of bell's palsy in a 7-month-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Literature Reference: Additional patient notes included no past medical history, did not take any medications or supplements routinely and had not traveled recently. Family history was negative for any neurological, bleeding or clotting disorders. Absence of erythema migrans by history. Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season (intramuscular). On an unknown date, less than a week after receiving Influenza vaccine Quadrivalent unspecified season and an unknown time after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced bell's palsy (Verbatim: incomplete Bell's Palsy) (serious criteria hospitalization and GSK medically significant), facial weakness (Verbatim: acute onset right-sided facial weakness/right facial nerve paresis) (serious criteria hospitalization), decreased nasolabial fold (Verbatim: nasolabial fold flattening drooping/drooping of the right corner of his mouth) (serious criteria hospitalization) and facial asymmetry (Verbatim: enhancement of the tympanic and mastoid segments) (serious criteria hospitalization). The outcome of the bell's palsy, facial weakness, decreased nasolabial fold and facial asymmetry were resolved. The reporter considered the bell's palsy, facial weakness, decreased nasolabial fold and facial asymmetry to be possibly related to Influenza vaccine Quadrivalent unspecified season. The company considered the bell's palsy, facial weakness, decreased nasolabial fold and facial asymmetry to be possibly related to Influenza vaccine Quadrivalent unspecified season. Additional Information: GSK Receipt Date: 3-Apr-2023 A previously healthy developmentally typical 7-month-old male patient presented to the emergency department with acute onset right-sided facial weakness that parents first noticed earlier in the morning. The patient's exam was notable for subtle right nasolabial fold flattening and drooping of the right corner of his mouth. The patient was able to close both eyelids completely and lift both eyebrows. Of note, the patient received initial intramuscular inactive quadrivalent influenza vaccine at 6-month well-child visit according to the Centers for Disease Control and Prevention (CDC) recommendations and had just received an appropriate booster dose of the intramuscular inactivated quadrivalent influenza vaccine 6 days prior to presentation. Magnetic resonance imaging (MRI) of the brain was performed due to concern for supranuclear involvement of the facial nerve in the setting of bilateral preserved forehead movements. The MRI demonstrated slight asymmetric increase in enhancement of the tympanic and mastoid segments of the right facial nerve. Labs were notable for a negative severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) polymerase chain reaction (PCR) and a negative serum herpes simplex virus (HSV) 1/2 PCR. The patient was not evaluated for Lyme disease, given the absence of erythema migrans by history and exam. The patient had no known exposure to any ticks, especially those from a Lyme endemic region. The patient was discharged home with a diagnosis of right facial nerve paresis. The patient was evaluated by both his pediatrician and a pediatric neurologist following discharge with complete resolution of his facial nerve paresis within 48 hours of symptom onset. The patient had not had further recurrence of symptoms even with continued yearly influenza immunizations and continues to grow and develop normally. Although not conclusive, the close temporal association between his recent inactivated quadrivalent influenza vaccine and onset of facial nerve paresis suggested a possible underlying immunologic reaction. The author emphasized these studies only highlight a potential temporal association between immunizations and development of Bell's palsy; this did not mean the vaccines themselves caused Bell's palsy. This signal of a temporal association between influenza vaccine and Bell's palsy was much less clear in the pediatric population.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- Test Name: SARSCoV-2 polymerase chain reaction; Test Result: Negative ; Test Name: herpes simplex virus (HSV) 1/2 PCR.; Test Result: Negative ; Comments: The Magnetic resonance imaging of the brain with and without contrast demonstrating asymmetric increase in enhancement of the tympanic portion and mastoid segments of the right facial nerve. The tympanic portion of the left facial nerve has normal enhancement.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Comments: no past medical history, did not take any medications or supplements routinely and had not traveled recently. Family history was negative for any neurological, bleeding or clotting disorders. Absence of erythema migrans by history
- Andere Medikamente
- Influenza vaccine Quadrivalent unspecified season
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 07.04.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
Guillain-Barr? syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received MMR (MMR vaccine) for prophylaxis. On an unknown date, the patient received MMR vaccine. On an unknown date, an unknown time after receiving MMR vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barr? syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported. It was unknown if the reporter considered the guillain barre syndrome to be related to MMR vaccine. It was unknown if the company considered the guillain barre syndrome to be related to MMR vaccine. Additional Information: GSK receipt date: 17-Mar-2023 The case was received from the patient's parent via interactive digital media. The reporter stated that they said you can get guillain-barre syndrome from it. That's why the reporter was afraid of the shot. The patient got them from the MMR vaccine and so not sure the reporter want to chance it. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 07.04.2023
- Impfdatum
- -
- Beginn
- 01.03.2023
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Mobility decreased
Musculoskeletal disorder
Nervous system disorder
Paralysis
Symptomtext
her legs dont work at all; Guillain-Barr? syndrome (GBS); serious nervous system disorder; is paralyzed; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Additional patient notes included The patient was completely healthy women in her 50s. On an unknown date, the patient received Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barr? syndrome (GBS)) (serious criteria GSK medically significant), nervous system disorder (Verbatim: serious nervous system disorder) (serious criteria other: serious per reporter) and paralysis (Verbatim: is paralyzed) (serious criteria GSK medically significant). On an unknown date, the patient experienced mobility decreased (Verbatim: her legs dont work at all). The outcome of the guillain barre syndrome, nervous system disorder and paralysis were not recovered/not resolved and the outcome of the mobility decreased was not reported. It was unknown if the reporter considered the guillain barre syndrome, nervous system disorder, paralysis and mobility decreased to be related to Shingles vaccine. It was unknown if the company considered the guillain barre syndrome, nervous system disorder, paralysis and mobility decreased to be related to Shingles vaccine. Additional Information: GSK receipt date: 16-Mar-2023 The case was received from the patient's friend via interactive digital media. The patient got her shingles shot and now (at the time of reporting) had guillain-barre syndrome, a serious nervous system disorder and was paralyzed. The patient's legs did not work at all. The follow-up could not be possible as no contact details were available. The case was linked case US2023AMR050646, reported by same reporter.; Sender's Comments: US-GSK-US2023AMR050646:same reporter - reporter?s case
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Comments: The patient was completely healthy women in her 50s
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 07.04.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
Some get Guilaine Barr Syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Some get Guilaine Barr Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. It was unknown if the company considered the guillain barre syndrome to be related to Shingles vaccine. Additional Information: Gsk Receipt Date: 01-APR-2023 This case was reported by the reporter via interactive digital media. The reporter reported that some patients got Guillain Barre syndrome after taking Shingles vaccine. This case has been linked to the case US2023AMR049581 and US2023AMR049605 reported by the same reporter.; Sender's Comments: US-GSK-US2023AMR049581:Same reporter. US-GSK-US2023AMR049605:Same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 07.04.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Symptomtext
Cousin got Bell's Palsy from it; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: Cousin got Bell's Palsy from it) (serious criteria GSK medically significant). The outcome of the bell's palsy was not reported. It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. It was unknown if the company considered the bell's palsy to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-APR-2023 This case was reported by the reporter via interactive digital media. The reporter reported that his/her cousin got Bell's Palsy after taking Shingles vaccine. This case has been linked to the case US2023AMR049593 and US2023AMR049605 reported by the same reporter.; Sender's Comments: US-GSK-US2023AMR049593:Same reporter. US-GSK-US2023AMR049605:Same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 07.04.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
Got GBS from this vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Got GBS from this vaccine) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported. The reporter considered the guillain barre syndrome to be related to Shingles vaccine. The company considered the guillain barre syndrome to be related to Shingles vaccine. Additional Information: GSK Receipt date: 02-APR-2023 This case was reported by a patient via interactive digital media The reporter reported that he/she got(Guillain Barre syndrome) GBS from this vaccine and shingles would had been much easier.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 05.04.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Facial paralysis
Symptomtext
Face paralyzed; This serious case was reported by a consumer via interactive digital media and described the occurrence of facial paralysis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced facial paralysis (Verbatim: Face paralyzed) (serious criteria GSK medically significant). The outcome of the facial paralysis was not reported. It was unknown if the reporter considered the facial paralysis to be related to Shingles vaccine. It was unknown if the company considered the facial paralysis to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by patient's cousin via interactive digital media. The reporter stated that it was very common, so be careful of vaccine. Follow-up would not possible as no contact details were available. This case had been linked with US2023AMR049000 by same reporter for different patient.; Sender's Comments: US-GSK-US2023AMR049000:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Facial paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Bell's palsy
Symptomtext
Bell's Palsy, with half face without any movement; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: Bell's Palsy, with half face without any movement) (serious criteria GSK medically significant). The outcome of the bell's palsy was recovered/resolved (duration 2 weeks). It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. It was unknown if the company considered the bell's palsy to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The shingles vaccination gave him/her bell's palsy for 2 weeks (with half face without any movement). The reporter stated that no pain but embarrassing. The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 24.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: ja
ER: unbekannt
Erholt: nein
Disability
Guillain-Barre syndrome
Herpes zoster
Symptomtext
Got GB, permanently crippled; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Got GB, permanently crippled) (serious criteria disability and GSK medically significant). The outcome of the guillain barre syndrome was not reported. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. It was unknown if the company considered the guillain barre syndrome to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she have shingles right now and considering the vaccine since the new shingles vaccine is more successful at preventing shingles. The reporter was concerned about guillian barre syndrome from shingles vaccine. The reporter stated that he/she know patient who experienced guillian barre syndrome after received shingles vaccine and he/she was permanently crippled now. The reporter wanted to know if he will going to receive shingles vaccine after recovered from shingles. This case had been linked with US2023AMR040466 by same reporter for different patient. Follow-up would not possible as no contact details were available.; Sender's Comments: US-GSK-US2023AMR040466:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 24.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: ja
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Herpes zoster
Symptomtext
Got GB, permanently crippled; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Got GB, permanently crippled) (serious criteria disability and GSK medically significant). The outcome of the guillain barre syndrome was not reported. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. It was unknown if the company considered the guillain barre syndrome to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter asked that were you going to get the shingles shot after your shingles healed. The reporter had shingles right now and was considering the vaccine since this new one was more successful at preventing it. The reporter was concerned about guillian barre from it though. The reporter knew patient who got GB (guillian barre) after shingles shot and were permanently crippled now. The case had been linked to US2023AMR040477, reported by the same reporter, for a different patient. The follow up would not possible as no contact details were available.; Sender's Comments: US-GSK-US2023AMR040477:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 24.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Seizure
Symptomtext
Seizure; Patient was adminstered DT instead of the DT AP with same day latency; This serious case was reported by a other health professional via other manufacturer and described the occurrence of seizure in a 3-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included DIPHTHERIA VACCINE TOXOID (DIPHTHERIA TOXOID) for prophylaxis. On an unknown date, the patient received Pediarix and DIPHTHERIA TOXOID .5 ml. On an unknown date, an unknown time after receiving Pediarix, the patient experienced seizure (Verbatim: Seizure) (serious criteria GSK medically significant and other: serious as per reporter) and overdose (Verbatim: Patient was adminstered DT instead of the DT AP with same day latency). The outcome of the seizure and overdose were unknown. It was unknown if the reporter considered the seizure to be related to Pediarix and Pediarix Pre-Filled Syringe Device. It was unknown if the company considered the seizure to be related to Pediarix and Pediarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-MAR-2023 The reporter stated that Initial information received from an unsolicited valid serious case. The patient experienced seizure and administering DT instead of the DTAP after receiving vaccines Diphtheria Toxoid and Pediarix.It was unknown if the reporter considered the seizure to be related to DIPHTHERIA VACCINE TOXOID. The patient received Diphtheria Toxoid and Pediarix on same day, which led to overdose of Diphtheria Toxoid.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 24.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Extra dose administered
Seizure
Symptomtext
Seizure; Patient was adminstered DT instead of the DT AP with same day latency; This serious case was reported by a other health professional via other manufacturer and described the occurrence of seizure in a 3-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included DIPHTHERIA VACCINE TOXOID (DIPHTHERIA TOXOID) for prophylaxis. On an unknown date, the patient received Pediarix and DIPHTHERIA TOXOID .5 ml. On an unknown date, an unknown time after receiving Pediarix, the patient experienced seizure (Verbatim: Seizure) (serious criteria GSK medically significant and other: serious as per reporter) and overdose (Verbatim: Patient was adminstered DT instead of the DT AP with same day latency). The outcome of the seizure and overdose were unknown. It was unknown if the reporter considered the seizure to be related to Pediarix and Pediarix Pre-Filled Syringe Device. It was unknown if the company considered the seizure to be related to Pediarix and Pediarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-MAR-2023 The reporter stated that Initial information received from an unsolicited valid serious case. The patient experienced seizure and administering DT instead of the DTAP after receiving vaccines Diphtheria Toxoid and Pediarix.It was unknown if the reporter considered the seizure to be related to DIPHTHERIA VACCINE TOXOID. The patient received Diphtheria Toxoid and Pediarix on same day, which led to overdose of Diphtheria Toxoid.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 24.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Blindness unilateral
Burning sensation
Electric shock sensation
Fear
Herpes zoster
Loss of personal independence in daily activities
Nervous system disorder
Neurological symptom
Pain
Tic
Trigeminal neuralgia
Vaccination failure
Symptomtext
vaccination didn't help at all; Went blind in left eye; Shingles attack don't think you ever completely recover; Lived in fear; Pain; Trigeminal neuralgia in my face fire shooting from one ear to the other/Feel lightning bolts in head-left side/fire shooting through from one ear to the other; Involuntary tics; Nerve disease; can't comb hair, lay my head on pillow; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 89-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (shingles off and on since 35 years of age). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, [the patient experienced vaccination failure (Verbatim: vaccination didn't help at all) (serious criteria GSK medically significant), blindness (Verbatim: Went blind in left eye) (serious criteria GSK medically significant), shingles (Verbatim: Shingles attack don't think you ever completely recover), fear (Verbatim: Lived in fear), pain (Verbatim: Pain), trigeminal neuralgia (Verbatim: Trigeminal neuralgia in my face fire shooting from one ear to the other/Feel lightning bolts in head-left side/fire shooting through from one ear to the other), tic (Verbatim: Involuntary tics), neurological symptom (Verbatim: Nerve disease) and activities of daily living impaired (Verbatim: can't comb hair, lay my head on pillow). The outcome of the vaccination failure was unknown and the outcome of the blindness, shingles, fear, trigeminal neuralgia, tic, neurological symptom and activities of daily living impaired were not reported and the outcome of the pain was recovering/resolving. It was unknown if the reporter considered the vaccination failure, blindness, shingles, fear, pain, trigeminal neuralgia, tic, neurological symptom and activities of daily living impaired to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure, blindness, shingles, fear, pain, trigeminal neuralgia, tic, neurological symptom and activities of daily living impaired to be related to Shingles vaccine. Additional Information: GSK receipt date: 07-MAR-2023 The case was received from the patient via interactive digital media. The patient stated that he/she lived in fear every time and felt the lightning bolts in his/her head-left side. The patient could not comb hair, lay head on a pillow and went blind in left eye. The patient stated that nothing and he/she mean nothing even touches the pain and then developed trigeminal neuralgia in his/her face, the fire shooting through from one ear to the other and the involuntary tics. The patient wondered during the attack what in the world he/she ever do to deserve this pain but God was good, he/she somewhat recovered (did not thought that you ever completely recover) and the vaccination did not helped at all due to the longevity of the shingles. The patient stated that every day and night he/she prayed for a cure for this nerve disease straight from the depths of hell and for the patients who had to endure this devilish pain and stated that god bless you all. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The outcome for event pain was only considered as recovering as per narrative chronology.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Electric shock sensation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Shingles (shingles off and on since 35 years of age)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- -
- Geschlecht
- F
- Eingang
- 20.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incomplete course of vaccination
Pain
Pyrexia
Syncope
Vomiting
Symptomtext
Fainted; Body aches; Vomiting; Fever; never received her second dose; This serious case was reported by a consumer via patient support programs and described the occurrence of fainting in a 64-year-old female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. Co-suspect products included Herpes zoster (Hz/su + AS01B) for prophylaxis. On an unknown date, the patient received the 1st dose of Hz/su + AS01B and the 2nd dose of Hz/su + AS01B. On an unknown date, an unknown time after receiving Hz/su + AS01B and not applicable after receiving Hz/su + AS01B, [the patient experienced fainting (Verbatim: Fainted) (serious criteria GSK medically significant), general body pain (Verbatim: Body aches), vomiting (Verbatim: Vomiting), fever (Verbatim: Fever) and incomplete course of vaccination (Verbatim: never received her second dose). The outcome of the fainting, general body pain, vomiting, fever and incomplete course of vaccination were unknown. It was unknown if the reporter considered the fainting, general body pain, vomiting and fever to be related to Hz/su + AS01B. The company considered the fainting, general body pain, vomiting and fever to be unrelated to Hz/su + AS01B. Additional Information: GSK Receipt Date: 13-MAR-2023 The reporter self-reported this case patient. This report was received when speaking with the customer during an outbound call for the support program. The patient received her first dose of the Shingrix vaccine in either January 2020 or 2021. The patient stated after her first dose she experienced vomiting, body aches, fever, and fainted. Reporter provided permission to contact healthcare professional. The reporter was consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 20.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Intensive care
Symptomtext
Got my shot and ended up in ICU (intensive care unit) for a week; This serious case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced hospitalization (Verbatim: Got my shot and ended up in ICU (intensive care unit) for a week) (serious criteria hospitalization). The outcome of the hospitalization was unknown. It was unknown if the reporter considered the hospitalization to be related to Shingles vaccine. It was unknown if the company considered the hospitalization to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media. Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Intensive care
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 18.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cardiac failure
Cardioversion
Paralysis
Symptomtext
Paralyzed from the neck down; Heart failure, had to be paddled, Up and down; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced paralysis (Verbatim: Paralyzed from the neck down) (serious criteria hospitalization and GSK medically significant) and cardiac failure (Verbatim: Heart failure, had to be paddled, Up and down) (serious criteria hospitalization and GSK medically significant). The outcome of the paralysis was recovering/resolving and the outcome of the cardiac failure was not reported. It was unknown if the reporter considered the paralysis and cardiac failure to be related to Shingles vaccine. It was unknown if the company considered the paralysis and cardiac failure to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a patient's family member via interactive digital media. The patient had her shingle shot and 2 weeks later paralyzed from the neck down. The reporter stated that ambulance rode to hospital, had to be paddled (heart failure) a few days later. The reporter further stated that up and down, today opened her eyes and wiggled her toes and praying for a turnaround. The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 17.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Intensive care
Symptomtext
Guillione barre syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine and Shingles vaccine. On an unknown date, an unknown time after receiving Flu vaccine and Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillione barre syndrome) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was not reported. It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine and Shingles vaccine. It was unknown if the company considered the guillain barre syndrome to be related to Flu vaccine and Shingles vaccine. Additional Information: GSK receipt date: 03-Mar-2023 This case was reported by a patient via interactive digital media. The reporter reported that the patient (friend) received the Flu and both shingles vaccine shot and ended up in ICU with guillione barre syndrome. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR038431 and US2023AMR038429 reported by same reporter. This case was found as duplicate of case US2023AMR038432. All the information from the case US2023AMR038432 was merged into this case. The case US2023AMR038432 was deleted and this case stand as case of record for this patient.; Sender's Comments: US-GSK-US2023AMR038431:Same patient US-GSK-US2023AMR038429:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 17.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Intensive care
Symptomtext
Guillione barre syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine and Shingles vaccine. On an unknown date, an unknown time after receiving Flu vaccine and Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillione barre syndrome) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was not reported. It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine and Shingles vaccine. It was unknown if the company considered the guillain barre syndrome to be related to Flu vaccine and Shingles vaccine. Additional Information: GSK receipt date: 03-Mar-2023 This case was reported by a patient via interactive digital media. The reporter reported that the patient (friend) received the Flu and both shingles vaccine shot and ended up in ICU with guillione barre syndrome. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR038431 and US2023AMR038429 reported by same reporter. This case was found as duplicate of case US2023AMR038432. All the information from the case US2023AMR038432 was merged into this case. The case US2023AMR038432 was deleted and this case stand as case of record for this patient.; Sender's Comments: US-GSK-US2023AMR038431:Same patient US-GSK-US2023AMR038429:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- M
- Eingang
- 15.03.2023
- Impfdatum
- 01.09.2019
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Arthritis
Guillain-Barre syndrome
Incomplete course of vaccination
X-ray limb abnormal
Symptomtext
GBS in thumbs, extremely unlikely diagnosis; Arthritis in hand, more than likely diagnosis; 1st dose on 01Sep2019, 2nd not received; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Zostavax (prior vaccination with Zostavax). In SEP-2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: GBS in thumbs, extremely unlikely diagnosis) (serious criteria GSK medically significant), hand arthritis (Verbatim: Arthritis in hand, more than likely diagnosis) and incomplete course of vaccination (Verbatim: 1st dose on 01Sep2019, 2nd not received). The outcome of the guillain barre syndrome was not recovered/not resolved and the outcome of the hand arthritis was not reported and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the guillain barre syndrome and hand arthritis to be related to Shingrix. It was unknown if the company considered the guillain barre syndrome and hand arthritis to be related to Shingrix. Additional Information: GSK Receipt Date: 08-MAR-2023 The reporter was the patient. He received Shingrix 1st shot in September 2019 and sometime after 1st shot during that period of time his primary care doctor diagnosed him with guillain-barre syndrome (GBS) in both thumbs since then he had had x-rays performed on his hands and the results of the x-rays were that more than likely the correct diagnosis was arthritis and extremely unlikely that the diagnosis was guillain-barre syndrome. The patient concomitant medication included as unspecified injections into his fingers/hands/thumbs. The patient provided limited information. The reporter was unable to ask for his date of birth, doctor of medicine contact information, lot number etc. because he wanted to end the call. The reporter did obtain his mailing address did inform him that safety might send him a letter. Till the time of reporting, the patient did not receive Shingrix 2nd shot yet (and more than 6 months had passed since shot 1), which led to incomplete course of vaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- Test Name: X-rays of hand; Result Unstructured Data: (Test Result:likely the correct diagnosis is arthritis,Unit:unknown,Normal Low:,Normal High:); Comments: more than likely the correct diagnosis is arthritis and extremely unlikely that the diagnosis was GBS
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
Gillian bar syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Gillian bar syndrome) (serious criteria GSK medically significant and life threatening). The outcome of the guillain barre syndrome was not recovered/not resolved. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. It was unknown if the company considered the guillain barre syndrome to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 07-MAR-2023 This case was reported by a patient's friend via interactive digital media. The patient almost died from Gillian Bar Syndrome and was still not right. Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Autoimmune disorder
Bell's palsy
Deafness permanent
Herpes zoster
Herpes zoster oticus
Vaccination failure
Vertigo
Symptomtext
fatal autoimmune disease; had shots still had them twice/ suspected vaccination failure; lost hearing forever totally deaf; Bells Palsy; shingles in ear; still had them twice; Vertigo; This serious case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced autoimmune disorder (Verbatim: fatal autoimmune disease) (serious criteria GSK medically significant and life threatening), vaccination failure (Verbatim: had shots still had them twice/ suspected vaccination failure) (serious criteria GSK medically significant), deafness (Verbatim: lost hearing forever totally deaf) (serious criteria GSK medically significant), bell's palsy (Verbatim: Bells Palsy) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: shingles in ear) (serious criteria GSK medically significant), shingles (Verbatim: still had them twice) and vertigo (Verbatim: Vertigo). The outcome of the autoimmune disorder, vaccination failure, bell's palsy, herpes zoster otitis externa, shingles and vertigo were not reported and the outcome of the deafness was not recovered/not resolved. It was unknown if the reporter considered the autoimmune disorder, vaccination failure, deafness, bell's palsy, herpes zoster otitis externa, shingles and vertigo to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the autoimmune disorder, vaccination failure, deafness, bell's palsy, herpes zoster otitis externa, shingles and vertigo to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shots for shingles and still had them twice . The reporter reported that last time had the shingles in patients ear and totally lost all hearing forever. The reporter reported that It did not come back so patient was totally deaf. The patient was also hit at the same time with Bells Palsy and Vertigo and also had a fatal autoimmune disease. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Autoimmune disorder
Bell's palsy
Deafness permanent
Herpes zoster
Herpes zoster oticus
Vaccination failure
Vertigo
Symptomtext
fatal autoimmune disease; had shots still had them twice/ suspected vaccination failure; lost hearing forever totally deaf; Bells Palsy; shingles in ear; still had them twice; Vertigo; This serious case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced autoimmune disorder (Verbatim: fatal autoimmune disease) (serious criteria GSK medically significant and life threatening), vaccination failure (Verbatim: had shots still had them twice/ suspected vaccination failure) (serious criteria GSK medically significant), deafness (Verbatim: lost hearing forever totally deaf) (serious criteria GSK medically significant), bell's palsy (Verbatim: Bells Palsy) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: shingles in ear) (serious criteria GSK medically significant), shingles (Verbatim: still had them twice) and vertigo (Verbatim: Vertigo). The outcome of the autoimmune disorder, vaccination failure, bell's palsy, herpes zoster otitis externa, shingles and vertigo were not reported and the outcome of the deafness was not recovered/not resolved. It was unknown if the reporter considered the autoimmune disorder, vaccination failure, deafness, bell's palsy, herpes zoster otitis externa, shingles and vertigo to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the autoimmune disorder, vaccination failure, deafness, bell's palsy, herpes zoster otitis externa, shingles and vertigo to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shots for shingles and still had them twice . The reporter reported that last time had the shingles in patients ear and totally lost all hearing forever. The reporter reported that It did not come back so patient was totally deaf. The patient was also hit at the same time with Bells Palsy and Vertigo and also had a fatal autoimmune disease. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- F
- Eingang
- 15.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Condition aggravated
Symptomtext
Bell's palsy on right side of face; This serious case was reported by a other health professional via sales rep and described the occurrence of bell's palsy in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included bell's palsy (previous history of bell's palsy on the left side of her face). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 10 days after receiving Shingrix, the patient experienced bell's palsy (Verbatim: Bell's palsy on right side of face) (serious criteria GSK medically significant). The outcome of the bell's palsy was not reported. It was unknown if the reporter considered the bell's palsy to be related to Shingrix. It was unknown if the company considered the bell's palsy to be related to Shingrix. Additional Information: GSK Receipt Date: 08-MAR-2023 The patient reported that 10 days after she was vaccinated with the Shingrix, she developed bell's palsy on the right side of her face. The reporter agreed to follow up from GlaxoSmithKline.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Bell's palsy (previous history of bell's palsy on the left side of her face)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 13.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Paralysis
Symptomtext
GBS paralyze short or long term side effects/GBS which acquired through the flu shot; GBS from the vaccination which can paralyze short or long term side effects; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced guillain barre syndrome (Verbatim: GBS paralyze short or long term side effects/GBS which acquired through the flu shot) (serious criteria GSK medically significant) and paralysis (Verbatim: GBS from the vaccination which can paralyze short or long term side effects) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome and paralysis were unknown. The reporter considered the guillain barre syndrome to be possibly related to Flu vaccine. It was unknown if the reporter considered the paralysis to be related to Flu vaccine. The company considered the guillain barre syndrome to be possibly related to Flu vaccine. It was unknown if the company considered the paralysis to be related to Flu vaccine. Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter stated that just remember you could be one of the few that got GBS (Guillain Barre syndrome) from the vaccination which could paralyze you for short or long term and leaves side effects that would hang with you for a very long time. The GBS (Guillain Barre syndrome) could be acquired through various vaccinations including the shingle shot and after getting it the patient wished, just had the flu rather than the GBS which he/she acquired through the flu shot. Additional Supportive Information: The follow up would not possible as no contact detail were available. The event paralysis was captured conservatively because as per description it seemed that the reporter himself/herself had experienced it.; Sender's Comments: US-GSK-US2023AMR037296:same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 08.03.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Facial paralysis
Immunisation reaction
Symptomtext
bell's palsy; facial paralysis; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant) and facial paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy and facial paralysis were unknown. The reporter considered the bell's palsy and facial paralysis to be related to Shingles vaccine. Additional Information: GSK Receipt date:01-MAR-2023 Reporter's Comment: This case was reported by a patient's wife via interactive digital media. The reporter reported that two months after her husband had his shingle vaccine and he had facial paralysis, bell's palsy. The doctors said it was from the vaccine no other cause. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 08.02.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
Shingles vaccine is also commonly known to cause it (GBS); This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient got GBS(Guillain barre syndrome) each time and the shingles vaccine was commonly known to cause it. Additional supportive information: According to narrative verbatim the causality was conservatively captured as possible. This case had been linked with US2023AMR017295 by same reporter for different patient Follow-up would not possible as no contact details were available.; Sender's Comments: US-GSK-US2023AMR017295:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 08.02.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
Got GBS from it (flu shot); This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. The reporter considered the guillain barre syndrome to be possibly related to Flu vaccine. Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that her doctor said she must not get flu shots, ever again. Because the patient once got GBS from it, which would happen each time. Additional supportive information: This case had been linked with US2023AMR017300 by same reporter for multiple patients. Follow-up would not possible as no contact details were available; Sender's Comments: US-GSK-US2023AMR017300:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 26.01.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
Shingrix 3 years ago and developed GBS; This case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant and other: serious as per reporter). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix. Additional Information: GSK Receipt Date: 19-Jan-2023 Reporter's Comments: The patient had the Shingrix vaccine 3 years ago from reporting and developed Guillain barre syndrome.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 12.01.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Seizure
Symptomtext
Seizures; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, several days after receiving Flu vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. The reporter considered the seizure to be possibly related to Flu vaccine. Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: The case was received from the patient's parent via interactive digital media. The patient had the flu shot and had seizures days after receiving it. Did the reporter think that the event might have been related to the Product/Device. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 11.01.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Facial paralysis
Illness
Symptomtext
Bell's palsy, half face paralyzed; Got really sick; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant) and sickness. On an unknown date, the outcome of the bell's palsy and sickness were unknown. The reporter considered the bell's palsy and sickness to be possibly related to Flu vaccine. Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: The case was received from the patient's parent via interactive digital media. The patient got the flu shot one year and got really sick while half the face went paralyzed (Bell's palsy). The patient reported this as side effect from the flu shot. The patient stated that it was funny though, so he/she never got another flu though. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 02.01.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Inflammation
Mass
Symptomtext
Can cause you Guillain-Barr? Syndrome, have a niece flat of her back with that; She got cushions; Germ there and it imflamed it; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), mass and inflammation. On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved and the outcome of the mass and inflammation were unknown. It was unknown if the reporter considered the guillain barre syndrome, mass and inflammation to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that they really do not know what caused his/her nieces, but she got cushions and physician stated that the patient already had the germ there and it was imflamed it someway. The physician stated the patient also cause Guillain Barre syndrome and her niece had flat of her back with that now. Additional supportive information: Follow-up would not possible as no contact details were available. This was 1 of the 4 cases, reported by the same reporter; Sender's Comments: US-GSK-US2022AMR193091:Same reporter US-GSK-US2022AMR193110:Same reporter US-GSK-US2022AMR193098:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 30.12.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: ja
ER: unbekannt
Erholt: ja
Guillain-Barre syndrome
Symptomtext
Got GBS, was on a vent for weeks, will always be a cripple & be disabled; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was recovered/resolved. It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine. Additional Information: GSK Receipt Date: 25-Dec-2022. Reporter's Comment: This case was received from patient's friend via interactive digital media. The reporter stated that got a friend (patient) that got it from Flu vaccine. Was on a vent for weeks. The reporter stated this was years ago, the patient said she would always be a cripple and be disabled. The reporter also mentioned the Flu shot could also cause it and got a friend that would always be a cripple from the flu vaccine then got GBS (guillain barre syndrome). Additional Supportive Information: This case was one of 4 cases reported by same reporter. The follow up would not possible as no contact details were available.; Sender's Comments: US-GSK-US2022AMR193091:Same reporter US-GSK-US2022AMR193110:Same reporter US-GSK-US2022AMR193112:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 30.12.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dyspnoea
Endotracheal intubation
Erythema
Headache
Intensive care
Pyrexia
Symptomtext
Difficulty breathing (hospitalized at ICU); Turned very red (hospitalized at ICU); Severe headaches (icy pick) (hospitalized at ICU); Fever of 105 degrees (hospitalized at ICU); This case was reported by a consumer via market research programs and described the occurrence of difficulty breathing in a adult male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. Concurrent medical conditions included asthma (Severe). Concomitant products included salbutamol (Albuterol Neb). On an unknown date, the patient received the 1st dose of Hz/su + AS01B. On an unknown date, 1 hr after receiving Hz/su + AS01B, the patient experienced difficulty breathing (serious criteria hospitalization), erythema (serious criteria hospitalization), headache (serious criteria hospitalization) and fever (serious criteria hospitalization). On an unknown date, the outcome of the difficulty breathing, erythema, headache and fever were recovered/resolved. The reporter considered the difficulty breathing, erythema, headache and fever to be possibly related to Hz/su + AS01B. Additional Information: GSK Receipt Date: 22-DEC-2022 Reporter's comments: The patient had reported that, in 2019 he does not remembered in which month, while he had severe asthma was given the first shot of Shingrix vaccine and within 1-2 hours after taking the shot, the patient had experienced difficulty breathing, had a fever of 105 degree Fahrenheit, he had turned very red and had severe headaches to which he had referred it as ick prick headaches. He was hospitalized in the ICU and was Intubated. He was then discharged after 10 days and the issue was fully recovered. He did not remembered any other details during his hospitalization. The reporter had consented to follow-up. Additional supportive information: Concomitant products included Oral and topical corticosteroids.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Intensive care
- Hospital-Tage
- 10,0
- Labordaten
- Test Date: 2019; Test Name: Body temperature; Result Unstructured Data: (Test Result:105,Unit:degree F,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- Asthma (Severe)
- Vorgeschichte
- -
- Andere Medikamente
- ALBUTEROL NEB
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IA
- Alter
- -
- Geschlecht
- F
- Eingang
- 22.12.2022
- Impfdatum
- 13.03.2020
- Beginn
- 01.03.2020
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Chills
Head injury
Influenza like illness
Syncope
Symptomtext
fainted; hit head; shivering; flu like symptoms; This case was reported by a consumer via sales rep and described the occurrence of faint in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (on18 October 2019 received 1st dose refer link case US2022AMR189646). On 13th March 2020, the patient received the 2nd dose of Shingrix. On 14th March 2020, 1 days after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant) and head injury. In March 2020, the patient experienced shivering and influenza-like symptoms. The patient was treated with intravenous fluid (nos) (Iv Fluids (Not Specified)). On an unknown date, the outcome of the faint, head injury, shivering and influenza-like symptoms were unknown. It was unknown if the reporter considered the faint, head injury, shivering and influenza-like symptoms to be related to Shingrix. Linked case(s) involving the same patient: US2022AMR189646 Additional Information: GSK Receipt Date: 19-DEC-2022 Reporter's Comment: The patient self-reported this case. The reporter reported that after the 2nd dose patient arm was not hurt but, experienced systemic adverse effects of shivering and flu like symptoms, the next morning patient fainted and hit her head. The patient went to a walk-in clinic and received IV (intravenous) liquids. The reporter did not consent to follow up.; Sender's Comments: US-GSK-US2022AMR189646:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- 83,0
- Geschlecht
- M
- Eingang
- 19.12.2022
- Impfdatum
- 23.11.2022
- Beginn
- 24.11.2022
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Alcohol use
Hyporesponsive to stimuli
Injection site pain
Injection site swelling
Loss of consciousness
Muscle tightness
Pyrexia
Symptomtext
Passed out (taken to ER); Swelling at the injection site (while in ER); Pain at the injection site (while in ER); Fever (while in ER); Tightness in his jaw (while in ER); This case was reported by a consumer via call center representative and described the occurrence of passed out in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included ethanol (Ethyl Alcohol) for product used for unknown indication. On 23rd November 2022, the patient received the 1st dose of Shingrix. On 24th November 2022, the patient started Ethyl Alcohol at an unknown dose and frequency. On 24th November 2022, 1 days after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), injection site swelling, injection site pain, fever and tightness of jaw muscles. The action taken with Ethyl Alcohol was unknown. On an unknown date, the outcome of the passed out, injection site swelling, fever and tightness of jaw muscles were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the passed out, injection site swelling, injection site pain, fever and tightness of jaw muscles to be related to Shingrix. Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's comment: The case was self reported by the patient. The patient received first dose of Shingrix and reported that on 24th November 2022 he had been consuming some ETOH (ethanol) for most of the day and then that evening he passed out at the dinner table. The patient reported that an ambulance was called the paramedics were able to get him to begin responding to stimulation and was taken to the emergency room. The reporter reported that while in the ER experienced swelling and pain at the injections site, fever and tightness in jaw. These symptoms had resolved. The reporter consented to follow up. The patient received ETOH (ethyl alcohol) and less than a day experienced passed out, injection site swelling, injection site pain, fever and tightness of jaw muscles. It was unknown if the reporter considered the passed out, injection site swelling, injection site pain, fever and tightness of jaw muscles to be related to Ethyl alcohol. Additional supportive information: Vaccination date captured as 23rd November 2022 as per narrative and same had been asked in query.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 81,0
- Geschlecht
- M
- Eingang
- 16.12.2022
- Impfdatum
- 13.06.2021
- Beginn
- 01.06.2021
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Gait disturbance
Guillain-Barre syndrome
Incomplete course of vaccination
Insomnia
Loss of personal independence in daily activities
Mobility decreased
Movement disorder
Muscle discomfort
Muscular weakness
Myalgia
Pain in extremity
Paraesthesia
Peripheral swelling
Symptomtext
he developed a decrease in range of motion; extreme difficulty walking; extreme difficulty controlling fine motor movements; extreme difficulty sleeping at night.; fingers became puffy; painful to touch/press the extremitie muscles; opening jars/changed the way had to conduct life.; will not proceed with the 2nd vaccine.; diagnosed with Guillain-Barr? Syndrome; weakness in hands and feet, progressed to muscle legs; pain in hands and feet, progressed to muscle legs; paresthesia in hands and feet, progressed to muscle legs; "weird" feeling in hands and feet muscles, it progressed; This case was reported by a physician via call center representative and described the occurrence of guillain barre syndrome in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 13th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On an unknown date, the patient did not receive the 2nd dose of Shingrix ml. In June 2021, 1 week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced muscle discomfort. On 15th July 2021, the patient experienced muscle weakness, pain in hand and paresthesia hand. On an unknown date, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), mobility decreased, walking difficulty, movement disorder, difficulty sleeping, swelling of fingers, muscle pain, activities of daily living impaired and incomplete course of vaccination. On an unknown date, the outcome of the guillain barre syndrome, muscle discomfort, paresthesia hand, mobility decreased, walking difficulty, movement disorder, difficulty sleeping, swelling of fingers, activities of daily living impaired and incomplete course of vaccination were unknown and the outcome of the muscle weakness, pain in hand and muscle pain were recovering/resolving. The reporter considered the guillain barre syndrome to be related to Shingrix. It was unknown if the reporter considered the muscle discomfort, muscle weakness, pain in hand, paresthesia hand, mobility decreased, walking difficulty, movement disorder, difficulty sleeping, swelling of fingers, muscle pain and activities of daily living impaired to be related to Shingrix. Additional Information: GSK Receipt Date: 09 DEC 2022 Reporter's comment: This case was reported by physician (patient). The physician reported that the patient got the first Shingrix vaccine on arm and then a week following the vaccine the patient started getting a weird feeling in the muscles of his hands and feet. Over the new few weeks, this feeling progressed and by 15th July 2021 (1 month later) the patient had weakness, pain, and paresthesia in mainly his hands and feet. Over the following weeks and months, these symptoms progressed to the larger muscle groups in his legs and hands. In the beginning, the pain occurred mainly at rest and movement helped subside the pain and paresthesia, the pain then progressed to occur during movement and the patient developed a decrease in range of motion. Following 6 to 12 months post getting the Shingrix vaccine, the patient had extreme difficulty walking, controlling fine motor movements, opening jars, and sleeping at night. His fingers became puffy and it was very painful to touch, press on the muscles of his extremities. Over the course of the weeks and months following the Shingrix vaccine, the patient was diagnosed with Guillain-Barr? Syndrome. The patient stated that it completely changed the way him and his family had to conduct life. At around the 12-month mark following the Shingrix vaccine, the patient started to see improvements in his motor skills, weakness, and pain. Currently, he was fairly pain free and his motor skills were continuing to progress back to a more normal state. The patient would not proceed with getting the second vaccine. Reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 16.12.2022
- Impfdatum
- 27.01.2017
- Beginn
- 09.10.2022
- Tage bis Beginn
- 2.081,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Immunisation reaction
Shock
Symptomtext
Shock to body (hospitalized for 5 days); This case was reported by a consumer via other manufacturer and described the occurrence of shock in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included treprostinil (Tyvaso) (batch number 2102219, expiry date 30th November 2023) for secondary pulmonary arterial hypertension. Concurrent medical conditions included pulmonary arterial hypertension. On an unknown date, the patient received Shingrix. On 27th January 2017, the patient started Tyvaso (inhaled) 90 ug 4 times daily (360 ug daily). On 9th October 2022, unknown after receiving Shingrix, the patient experienced shock (serious criteria hospitalization, GSK medically significant and other: serious as per reporter). The action taken with Tyvaso was unknown. On 11th October 2022, the outcome of the shock was recovered/resolved. The reporter considered the shock to be possibly related to Shingrix. Additional Information: GSK Receipt Date: 08 DEC 2022 Reporter's comment: The patient received patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) currently delivered by Tyvaso Inhalation Device (TD-300/A), on 27 Jan 2017 for secondary pulmonary arterial hypertension. The current dose was reported as 90 ?g (15 breaths), four times a day (QID) (off label use) via inhalation (IH) route. On an unreported date in Oct 2022, the patient was hospitalized due to issue with shingles vaccine causing a shock to his body (immunisation reaction, hospitalized and shock, medically significant, hospitalized) a month ago for 5 days. He said a nurse checks in with him weekly. On 09 Oct 2022, 5 years 8 months and 13 days after initiating Tyvaso, the patient was hospitalized due to issue with shingles vaccine causing a shock to his body. At the time of reporting, the outcome of immunisation reaction was resolved on 11 Oct 2022. Action taken with Tyvaso was not reported for the events of immunisation reaction and shock. At the time of reporting, the outcome of immunisation reaction and shock was unknown. The reporter did not provide causality for the events of immunisation reaction and shock with Tyvaso. The reporter's causality for the events of immunisation reaction with shingles vaccine was considered to be possibly related. The physician assessed the causal relationship between the Tyvaso and the events of immunisation reaction and shock as not related. The company had assessed the serious adverse events of Immunisation reaction and shock as not related to IH treprostinil and TD300/A device. The events were likely related to administration of Shingrix vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Shock
- Hospital-Tage
- 5,0
- Labordaten
- -
- Aktuelle Erkrankungen
- Pulmonary arterial hypertension
- Vorgeschichte
- -
- Andere Medikamente
- TYVASO
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.12.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
guillian barre syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. The reporter considered the guillain barre syndrome to be related to Shingrix. Additional Information: GSK Receipt Date: 10-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that one Shingrix vaccine gave him/her Guillain Barre syndrome. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 08.12.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Acute motor-sensory axonal neuropathy
Anti-ganglioside antibody negative
Antibody test negative
Antinuclear antibody
Antinuclear antibody negative
Areflexia
Asthenia
CSF glucose normal
CSF lactate normal
CSF oligoclonal band absent
CSF protein increased
Campylobacter test
Condition aggravated
Decreased vibratory sense
Double stranded DNA antibody
Dyspnoea
Dysstasia
Electromyogram abnormal
Symptomtext
Guillain-Barre Syndrome/acute recurrent exacerbation of the AMSAN variant of GBS; gait instability/difficulty walking; endorsed feeling "wobbly/endorsed feeling particularly weak when standing needing to support himself with a wall to remain upright; unable to feel sensations in his fingers and toes; shortness of breath; respiratory distress; globally reduced pinprick sensation; reduced sensation to vibration; impaired proprioception bilaterally below the ankles.; absent deep tendon reflexes in the bilateral upper and lower extremities; weakness in his body/endorsed feeling particularly weak when standing needing to support himself with a wall to remain upright; recurrent, five-minute-long episodes of bilateral Shaking of hands which progressed to his entire body; leg weakness; leg weakness and gait instability lead to three falls; This case was reported in a literature article and described the occurrence of guillain barre syndrome in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included spinal operation (lumbar), total knee replacement (right), weakness generalized (developed weakness in his body), tremor (five-minute-long episodes of bilateral shaking of hands, which progressed to his entire body), lower extremities weakness of, unsteady gait, fall (leg weakness and gait instability lead to three falls), unsteadiness (need to support himself with a wall to remain upright when standing), emergency care (psychiatrist noticed his weakness and was encouraged to visit the emergency department), hypoesthesia, decreased vibratory sense (bilaterally below the ankles), loss of proprioception (impaired proprioception bilaterally below the ankles), tendon reflex absent (had absent deep tendon reflexes in the bilateral upper and lower extremities), guillain barre syndrome (AMSAN variant), hospitalization (upon arrival at the ED, the patient was admitted to neurology) and plasma exchange (five sessions of plasma exchange (PLEX)). Concurrent medical conditions included hypothyroidism, bipolar disorder, obstructive sleep apnea syndrome and hyperlipidemia. Additional patient notes included patient denied recent illnesses, gastrointestinal issues, or travel outside his home. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), gait disturbance (serious criteria hospitalization), unsteadiness (serious criteria hospitalization), loss of sensation (serious criteria hospitalization), shortness of breath (serious criteria hospitalization), respiratory distress (serious criteria hospitalization and GSK medically significant), hypoesthesia (serious criteria hospitalization), decreased vibratory sense (serious criteria hospitalization), loss of proprioception (serious criteria hospitalization), tendon reflex absent (serious criteria hospitalization), weakness generalized (serious criteria hospitalization), tremor (serious criteria hospitalization), lower extremities weakness of (serious criteria hospitalization) and fall (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome, gait disturbance, unsteadiness, loss of sensation, hypoesthesia, decreased vibratory sense, loss of proprioception, tendon reflex absent, weakness generalized, tremor, lower extremities weakness of and fall were recovering/resolving and the outcome of the shortness of breath and respiratory distress were unknown. The reporter considered the guillain barre syndrome, gait disturbance, unsteadiness, loss of sensation, shortness of breath, respiratory distress, hypoesthesia, decreased vibratory sense, loss of proprioception, tendon reflex absent, weakness generalized, tremor, lower extremities weakness of and fall to be possibly related to Shingrix. Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's comments: The patient was 61 years old at the time of initial episode. The patient was with a past medical history of hypothyroidism, bipolar disorder, obstructive sleep apnea, hyperlipidemia, lumbar spine surgery and right total knee replacement. Over the course of two weeks, the patient developed weakness in his body. He had recurrent, five-minute-long episodes of bilateral shaking of hands, which progressed to his entire body. His leg weakness and gait instability lead to three falls. The patient endorsed feeling particularly weak when standing and needing to support himself with a wall to remain upright. The patient denied experiencing vertigo, visual impairment, hearing loss, sensory impairment, headaches, or loss of consciousness. After visiting his psychiatrist, who noticed his weakness, he was encouraged to visit the emergency department (ED). Upon arrival at the ED, the patient was admitted to neurology and underwent further workup. The patient denied recent illnesses, gastrointestinal issues, or travel outside his home. Physical examination showed globally reduced pinprick sensation, reduced sensation to vibration bilaterally below the ankles, and impaired proprioception bilaterally below the ankles. The patient had absent deep tendon reflexes in the bilateral upper and lower extremities. Romberg sign was also present at the time of examination. The patient had no abnormalities on an initial complete blood count, comprehensive metabolic panel, and urinalysis. All hormones and inflammatory mediators were within normal limits. Extractable nuclear antigen panel (ENA), antinuclear antibody (ANA), anti-double stranded DNA (anti-DSDNA), anti-GQ-1B, and anti-GQ-1C were negative. A paraneoplastic panel revealed no abnormalities. Campylobacter jejuni antibodies were negative. A lumbar puncture revealed albuminocytological dissociation-elevated protein with normal leukocyte count. Nerve conduction and Electromyography (EMG) were also done and pointed to a diagnosis of the acute motor and sensory axonal neuropathy (AMSAN) variant of Guillain-Barre Syndrome (GBS). The patient had an elevated protein count. The leukocyte count, glucose and lactic acid were within normal limits. The patient received five sessions of plasma exchange (PLEX) every other day over the course of one week. He received four total sessions. He gradually experienced an improvement in motor and sensory parameters. He was discharged after eight days with referrals to outpatient physical/occupational therapy and neurology. Approximately 10 months later, the patient presented to his neurologist due to one week of difficulty walking. The patient endorsed feeling "wobbly" and unable to feel sensations in his fingers and toes. He also endorsed shortness of breath. Due to possible respiratory distress, his neurologist advised him to go to the emergency department. Upon arrival, the patient was again admitted. The patient denied recent illnesses, gastrointestinal issues, or travel outside his home. The patient said he received a second dose of Shingrix two weeks before symptoms started. Since his symptoms presented nearly identically to the first episode, the patient was diagnosed with acute recurrent exacerbation of the AMSAN variant of GBS. He was monitored for respiratory distress with pulmonary function testing every eight hours. Physical examination showed globally reduced pinprick sensation, reduced sensation to vibration bilaterally below the ankles, and impaired proprioception bilaterally below the ankles. The patient had absent deep tendon reflexes in the bilateral upper and lower extremities. Romberg's sign was unable to be assessed. The patient again received PLEX therapy daily for a total of four sessions. The patient experienced a complete improvement in motor strength. Sensation and reflexes continued to improve but had not yet returned to baseline. After five days of admission, the patient was discharged with recommendations to follow up with his neurologist. The patient had the AMSAN variant in both episodes. The patient had similar symptoms in each episode. His second episode presented with some respiratory distress in addition to previous symptoms similar to the previous episode. The patient was younger than the demographic the FDA released a black box warning for (adults aged 65 and older). This case highlights the difficulty of diagnosing and treating recurrent GBS. It also raises awareness that Shingrix may be related to the development of GBS in younger patients. This case also emphasizes the importance of differentiating GBS from other polyneuropathies. "In addition to the primary trial that showed a modestly increased risk of developing GBS following Shingrix administration, there have been several case reports of this phenomenon. Additionally, recurrent GBS is still poorly understood and its relationship to Shingrix is actively being researched. To our knowledge, this is the first case of GBS recurrence following vaccination with Shingrix. In general, providers are recommended to educate the patient on the efficacy and benefit of vaccines and monitor for any potential GBS-like symptoms following vaccination. Clinicians should be specifically cautious for patients of any age, with a past history of GBS, who are receiving the Shingrix vaccine". Additional supportive information: The article corresponding to this case is not available for regulatory submission due to copyright restriction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- Test Name: ANA; Test Result: Negative ; Test Name: ENA; Test Result: Negative ; Test Name: C. jejuni; Test Result: Negative ; Test Name: CSF Glucose; Test Result: 75 mg/dl; Test Name: CSF Lactic acid; Test Result: 17 mg/dl; Test Name: Oligoclonal bands; Test Result: Negative ; Test Name: CSF protein; Test Result: 84 mg/dl; Test Name: anti-DSDNA; Test Result: Negative ; Test Name: EMG; Result Unstructured Data: (Test Result:AMSAN variant of Guillain-Barre syndrome,Unit:unknown,Normal Low:,Normal High:); Test Name: complete blood count; Result Unstructured Data: (Test Result:No abnormalities,Unit:unknown,Normal Low:,Normal High:); Test Name: A paraneoplastic panel; Result Unstructured Data: (Test Result:no abnormalities,Unit:unknown,Normal Low:,Normal High:); Test Name: anti-GQ-1B; Test Result: Negative ; Test Name: anti-GQ-1C; Test Result: Negative ; Test Name: inflammatory mediators; Result Unstructured Data: (Test Result:within normal limits,Unit:unknown,Normal Low:,Normal High:); Test Name: All hormones; Result Unstructured Data: (Test Result:within normal limits,Unit:unknown,Normal Low:,Normal High:); Test Name: lumbar puncture; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: comprehensive metabolic panel; Result Unstructured Data: (Test Result:No abnormalities,Unit:unknown,Normal Low:,Normal High:); Test Name: Nerve conduction; Result Unstructured Data: (Test Result:AMSAN variant of Guillain-Barre syndrome,Unit:unknown,Normal Low:,Normal High:); Test Name: Physical examination; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: Physical examination; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: Romberg sign; Test Result: Positive ; Test Name: Romberg sign; Result Unstructured Data: (Test Result:unable to be assessed,Unit:unknown,Normal Low:,Normal High:); Test Name: urinalysis; Result Unstructured Data: (Test Result:No abnormalities,Unit:unknown,Normal Low:,Normal High:); Test Name: CSF Leukocyte count; Result Unstructured Data: (Test Result:4,Unit:mm3,Normal Low:0,Normal High:5); Comments: Physical examination showed globally reduced pinprick sensation, reduced sensation to vibration bilaterally below the ankles, and impaired proprioception bilaterally below the ankles. The patient had absent deep tendon reflexes in the bilateral upper and lower extremities. A lumbar puncture revealed albuminocytological dissociation-elevated protein with normal leukocyte count. The patient was monitored for respiratory distress with pulmonary function testing every eight hours.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Bipolar disorder; Decreased vibratory sense (bilaterally below the ankles); Emergency care (psychiatrist noticed his weakness and was encouraged to visit the emergency department); Fall (leg weakness and gait instability lead to three falls); Guillain Barre syndrome (AMSAN variant); Hospitalization (upon arrival at the ED, the patient was admitted to neurology); Hyperlipidemia; Hypoesthesia; Hypothyroidism; Loss of proprioception (impaired proprioception bilaterally below the ankles); Lower extremities weakness of; Obstructive sleep apnea syndrome; Plasma exchange (five sessions of plasma exchange (PLEX)); Spinal operation (lumbar); Tendon reflex absent (had absent deep tendon reflexes in the bilateral upper and lower extremities); Total knee replacement (right); Tremor (five-minute-long episodes of bilateral shaking of hands, which progressed to his entire body); Unsteadiness (need to support himself with a wall to remain upright when standing); Unsteady gait; Weakness generalized (developed weakness in his body); Comments: patient denied recent illnesses, gastrointestinal issues, or travel outside his home state
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 01.12.2022
- Impfdatum
- 25.11.2022
- Beginn
- 26.11.2022
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Rash
Syncope
Symptomtext
rash on breast and tummy; I fainted; This case was reported by a consumer via interactive digital media and described the occurrence of fainting in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 25th November 2022, the patient received the 1st dose of Shingrix. On 26th November 2022, 1 days after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant). On 27th November 2022, the patient experienced rash. On an unknown date, the outcome of the fainting and rash were unknown. It was unknown if the reporter considered the fainting and rash to be related to Shingrix. Additional Information: GSK Receipt Date: 27 NOV 2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that had first dose of Shingrix two days prior to the reporting. The patient fainted next morning. The patient was then detected rash on breast and tummy
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- M
- Eingang
- 01.12.2022
- Impfdatum
- 01.10.2021
- Beginn
- 01.07.2022
- Tage bis Beginn
- 273,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Immunoglobulin therapy
Symptomtext
GBS in Jul2022 (now in physical/home therapy); This case was reported by a consumer via other and described the occurrence of guillain barre syndrome in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. In October 2021, the patient received the 1st dose of Shingrix. In July 2022, between 8 and 10 months after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The patient was treated with immunoglobulin human normal (Gamma Globulin) and non-drug therapy (Physical Therapy). On an unknown date, the outcome of the guillain barre syndrome was recovering/resolving. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix. Linked case(s) involving the same patient: US2022AMR176636 Additional Information: GSK Receipt Date: 23-NOV-2022 Reporter's Comments: The patient had good health before takign vaccine. The patient received Shingrix vaccine in October of 2021. The patient was came down with Gullian Barre in July of 2022. The patient had been through 10 infusions of gamma globulin and now the doing outpatient physical therapy and home therapy. The reporter consented to follow up. Additional supportive information: For 2nd dose refer case US2022AMR176636.; Sender's Comments: US-GSK-US2022AMR176636:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.11.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Seizure
Symptomtext
Seizure; This case was reported by a other health professional via sales rep and described the occurrence of seizure in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. The reporter considered the seizure to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-Nov-2022. Reporter's Comment: The reporter think Seizure not related to product. The reporter agrees to follow up from GlaxoSmithKline
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.11.2022
- Impfdatum
- 09.11.2019
- Beginn
- 01.11.2019
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Abdominal pain
Back pain
Chills
Diarrhoea
Hyperhidrosis
Nausea
Pyrexia
Syncope
Unresponsive to stimuli
Vomiting
Symptomtext
fainted / was found unresponsive / reaction to vaccine; vomited; fever of 104; sweating; chills; nausea; diarrhea; abdominal pain; back pain; This case was reported by a consumer and described the occurrence of faint in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 9th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, 12 hrs after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain. On an unknown date, the outcome of the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain were not recovered/not resolved. It was unknown if the reporter considered the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain to be related to Shingrix. Additional Information: GSK receipt date: 17-Nov-2022 Reporter's comment: The patient received the second dose of Shingrix vaccine. About 12 hours post injection, the patient was fainted and vomited. The patient was found unresponsive in a restaurant bathroom. The patient was taken at home and having fever of 104 and symptoms of sweating, chills, nausea, diarrhea, abdominal pain and back pain through the night. The patients one of friend had recently reported the same adverse reaction following Shingrix dosing. The reporter did not agrees to follow up from GlaxoSmithKline. Less than a day, the patient experienced fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain. Additional supportive information: This case had been linked with US2022AMR171802 same reporter, different patient.; Sender's Comments: US-GSK-US2022AMR171802:same reporter, different patient
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- Test Date: 20191109; Test Name: Body temperature; Result Unstructured Data: (Test Result:104,Unit:degree F,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 73,0
- Geschlecht
- F
- Eingang
- 25.11.2022
- Impfdatum
- 09.11.2019
- Beginn
- 01.11.2019
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Abdominal pain
Back pain
Chills
Diarrhoea
Hyperhidrosis
Inappropriate schedule of product administration
Nausea
Pyrexia
Syncope
Unresponsive to stimuli
Vomiting
Symptomtext
1st dose approx. 30 days prior; fainted, was found unresponsive / reaction to vaccine; vomited; fever of 104; sweating; chills; nausea; diarrhea; abdominal pain; back pain; This case was reported by a consumer and described the occurrence of faint in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX). On 9th November 2019, the patient received Shingrix. On 9th November 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. In November 2019, the patient experienced faint (serious criteria GSK medically significant), vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain. On an unknown date, the outcome of the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the faint, vomiting, fever, sweating, chills, nausea, diarrhea, abdominal pain and back pain to be related to Shingrix. Linked case(s) involving the same patient: US2022AMR171834 Additional Information: GSK receipt date: 17-Nov-2022 Reporter's comment: The patient received the second dose of Shingrix vaccine. About 12 hours post injection, the patient was fainted and vomited. The patient was found unresponsive in a restaurant bathroom. The patient was taken at home and having fever of 104 and symptoms of sweating, chills, nausea, diarrhea, abdominal pain and back pain through the night. The patient also stated that she received 1st dose approximately 30 days prior did not lead any adverse reaction The patients one of friend had recently reported the same adverse reaction following Shingrix dosing. The reporter did not agree to follow up from GlaxoSmithKline. Additional supportive information: The patient received the 2nd dose approximately 30 days prior to 1st dose of Shingrix, which led to shortening of vaccinations schedule. This case had been linked with US2022AMR171834 same reporter, different patient.; Sender's Comments: US-GSK-US2022AMR171834:same reporter ,different patient US-GSK-US2022AMR171947:same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- Test Date: 201911; Test Name: Body temperature; Result Unstructured Data: (Test Result:104,Unit:degree C,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- SHINGRIX
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 22.11.2022
- Impfdatum
- 12.05.2022
- Beginn
- 12.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: ja
Hypoaesthesia
Paralysis
Symptomtext
I was paralyzed (ER); Face was going numb (ER); This case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 12th May 2022, the patient received the 1st dose of Shingrix. On 12th May 2022, less than a day after receiving Shingrix, the patient experienced paralysis (serious criteria hospitalization and GSK medically significant) and numbness facial (serious criteria hospitalization). The patient was treated with steroids nos (Steroids). In May 2022, the outcome of the paralysis and numbness facial were recovered/resolved. It was unknown if the reporter considered the paralysis and numbness facial to be related to Shingrix. Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received dose of Shingrix vaccine and within 3 hours he/she was rushed to the ER (emergency room), his/her face was going numb by the time and he/she got to the hospital, he/she was paralyzed. The patient took 7 days high intravenous steroids and was blessed to be 100 percent ok. The patient stated that he/she never had reaction to vaccines before. This was horrifying. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 18.11.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
got GBS as side affect; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix. Additional Information: GSK receipt date: 12-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received both the Shingrix shot. A week after the second shot, the patient experienced Guillain Barre syndrome (GBS) the side effect from hell. The Guillain Barre syndrome was over year ago from reporting but the patient still dealing with it. Additional Supportive Information: The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- 57,0
- Geschlecht
- M
- Eingang
- 18.11.2022
- Impfdatum
- 03.11.2022
- Beginn
- 01.11.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Asthenia
Chills
Dizziness
Fall
Headache
Loss of consciousness
Myalgia
Nasal injury
Peripheral swelling
Wound
Wound haemorrhage
Symptomtext
passed out; Hit his nose, got a bleeding and open wound; chills; weakness; dizziness; started to fall again.; headache; myalgia,; swollen calf; hit the bridge of this nose; This case was reported by a consumer and described the occurrence of passed out in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 3rd November 2022, the patient received Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), wound bleeding (serious criteria GSK medically significant), chills, weakness, dizziness, fall, headache, myalgia, calf swelling and nose injury. On an unknown date, the outcome of the passed out, wound bleeding, chills, weakness, dizziness, fall and nose injury were unknown and the outcome of the headache, myalgia and calf swelling were recovered/resolved. It was unknown if the reporter considered the passed out, wound bleeding, chills, weakness, dizziness, fall, headache, myalgia, calf swelling and nose injury to be related to Shingrix. Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter stated that, night after the Shingrix shot, the patient had chills, weakness and dizziness. The patient got up to use restroom and passed out on the way. The patient had hit the bridge of this nose on furniture but unsure exactly how it happened. The patient proceeded to bathroom sink and started to fall again. The patient had bleeding and open wound on bridge of nose. The patient went onto had headache myalgia and swollen calf for a few more days. The reporter agreed to follow up from GlaxoSmithKline.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 12.11.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Muscular weakness
Symptomtext
Increased risk of GBS; Severe muscle weakness; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and muscle weakness. On an unknown date, the outcome of the guillain barre syndrome and muscle weakness were unknown. It was unknown if the reporter considered the guillain barre syndrome and muscle weakness to be related to Shingrix. Additional Information: GSK Receipt Date: 06-Nov-2022 Reporter's comment: This case was reported by the patient via interactive digital media. There was an increased risk of Guillain Barre syndrome, severe muscle weakness was observed after vaccination with Shingrix. Additional supportive information: Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- 70,0
- Geschlecht
- F
- Eingang
- 10.11.2022
- Impfdatum
- 27.05.2022
- Beginn
- 27.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Burning sensation
Electric shock sensation
Injection site pain
Pain
Neuralgia
Symptomtext
She got her vaccine, it was real painful in her shoulder, squished the arm real tight, big guy. It was like somebody had hit her in the shoulder. Later in the day it would go to fire feeling, down her arm, inside of her arm and shoot through her lower arm into her thumb on the left side. Now it does not go down to the thumb very often, now goes from shoulder area to elbow area. If she turns her head to the right when she is having this reaction it eases up. You cannot see anything physically wrong, electrical shock like feeling down her arm. She did go to the doctor and he checked the area and felt it was a nerve in her neck that she injured 30 years ago, but feels like it was acting up again. She cannot walk around with her head tilted to the right at all times. It does come and go, and does have to grab her arm. It is better, but it still comes on on occasion. It is not her heart or any other area, just in the area where she got the vaccine. She can move the arm all around, can use the hand, but has the shooting pain in the shoulder. Feels he may have hit a nerve.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Electric shock sensation
- Hospital-Tage
- -
- Labordaten
- None.
- Aktuelle Erkrankungen
- None.
- Vorgeschichte
- Stent placement in her heart, high cholesterol, thyroid removed due to goiter.
- Andere Medikamente
- Sertraline, Synthroid, Atorvastatin, Vitamin D, 81 mg aspirin, Meloxicam, Xanax prn.
- Allergien
- Penicillin. Apricots.
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 68,0
- Geschlecht
- F
- Eingang
- 09.11.2022
- Impfdatum
- 20.05.2022
- Beginn
- 20.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Anticoagulant therapy
Deep vein thrombosis
Insomnia
Limb injury
Symptomtext
Developed a DVT; Injured her foot after vaccination; Difficulty sleeping at night; This case was reported by a consumer via call center representative and described the occurrence of dvt in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 20th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 20th May 2022, less than a day after receiving Shingrix, the patient experienced difficulty sleeping. On an unknown date, the patient experienced dvt (serious criteria GSK medically significant) and foot injury. The patient was treated with apixaban (Eliquis). On an unknown date, the outcome of the dvt and foot injury were unknown and the outcome of the difficulty sleeping was recovered/resolved. It was unknown if the reporter considered the dvt, foot injury and difficulty sleeping to be related to Shingrix. Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment The reporter was patient. The patient reported that received Shingrix in unknown arm. The patient experienced difficulty sleeping that night stated issue resolved. On an unknown date, less than 6 months after receiving Shingrix, the patient injured her foot after that and developed a deep vein thrombosis and was being treated with Eliquis. Reporter did not consent to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Deep vein thrombosis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 09.11.2022
- Impfdatum
- 02.08.2022
- Beginn
- 20.08.2022
- Tage bis Beginn
- 18,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Ischaemic stroke
Symptomtext
an ischemic stroke on August 20; This case was reported by a consumer via interactive digital media and described the occurrence of ischemic stroke in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 2nd August 2022, the patient received the 1st dose of Shingles vaccine. On 20th August 2022, 18 days after receiving Shingles vaccine, the patient experienced ischemic stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the ischemic stroke was unknown. It was unknown if the reporter considered the ischemic stroke to be related to Shingles vaccine. Additional Information: GSK receipt date: 01-NOV- 2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient received first dose of Shingle vaccine and suffered an ischemic stroke. Additional Supportive Information: The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Ischaemic stroke
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 04.11.2022
- Impfdatum
- -
- Beginn
- 01.10.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Dyskinesia
Eyelid function disorder
Symptomtext
Bell's Palsy; Can't blink or close your eye; mouth wandering all over your face; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In October 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant), eyelid function disorder and mouth movement impaired. On an unknown date, the outcome of the bell's palsy, eyelid function disorder and mouth movement impaired were unknown. It was unknown if the reporter considered the bell's palsy, eyelid function disorder and mouth movement impaired to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and 2 weeks ago after taking Shingles shot the patient reported that could not blink or close your eye and mouth wandering all over your face. The patient reported that it's time to wake up to the risk of having Bell's palsy if you take the Shingles shot. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 04.11.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
Guillain-Barre Syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. The reporter considered the guillain barre syndrome to be possibly related to Shingrix. Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that the possible side effects of the Shingrix vaccine, Guillain-Barre Syndrome was listed, and reporter want to know one experiences that side effect, was it permanent. Additional Supportive Information: The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 04.11.2022
- Impfdatum
- 15.08.2022
- Beginn
- 15.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Seizure
Syncope
Symptomtext
seizure; fainted (syncope); This case was reported by a other health professional via other manufacturer and described the occurrence of seizure in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENQUADFI (batch number U7924AAC, expiry date unknown) for prophylaxis. On 15th August 2022, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and MENQUADFI (intramuscular). On 15th August 2022, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced seizure (serious criteria GSK medically significant and other: serious as per reporter) and syncope (serious criteria GSK medically significant and other: serious as per reporter). On 15th August 2022, the outcome of the seizure and syncope were recovered/resolved. It was unknown if the reporter considered the seizure and syncope to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 27-OCT-2022 Reporter's comment: Less than a day after receiving Bexsero and Menquadfi vaccine, the patient had developed a serious event of seizure and fainted (syncope). It was not reported if the patient received a corrective treatment for the events. The reporter considered the seriousness criteria as medically significant for both events. The case listedness was reported as unlisted. The reporter had consented to follow up. It was unknown if the reporter considered the seizure and syncope to be related to Menquadfi.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 03.11.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dysgraphia
Dyspnoea
Gait disturbance
Guillain-Barre syndrome
Loss of personal independence in daily activities
Speech disorder
Symptomtext
Guillain-Barre syndrome; out of his life for a year/ had to learn how to Breathe, Talk, Walk, Write; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and activities of daily living impaired. On an unknown date, the outcome of the guillain barre syndrome and activities of daily living impaired were recovered/resolved. The reporter considered the guillain barre syndrome and activities of daily living impaired to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comment: This case was reported by a patient's friend via interactive digital media. The patient got Guillain-Barre syndrome from the shingles vaccine and he was out of his life for a year and he had to learn how to breathe,talk,walk , write all over again. The patient stated that, you were absolutely correct the commercial states if you get shingles it was weeks of your life well. Additional Supportive Information: The follow up would not possible as no contact details were available. From the narrative it seems that the patient had GBS for 1 year hence outcome was captured as recovered for GBS and other related events.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 12.10.2022
- Impfdatum
- 25.08.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Back pain
Computerised tomogram abdomen abnormal
Diverticulitis
Electric shock sensation
Herpes zoster
Skin burning sensation
Symptomtext
Diverticulitis; Shingles; Pain wraps around to my back; Skin feels burned; Feels like electrical shocks inside; This case was reported by a consumer via interactive digital media and described the occurrence of diverticulitis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 25th August 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced diverticulitis (serious criteria GSK medically significant), shingles, back pain, burning sensation skin and electric shock sensation. On an unknown date, the outcome of the diverticulitis, shingles, back pain, burning sensation skin and electric shock sensation were not recovered/not resolved. It was unknown if the reporter considered the diverticulitis, shingles, back pain, burning sensation skin and electric shock sensation to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had it right now at the time of reporting. The patient had one shingles vaccine on 25th August 2022. The patient having his/her second dose in November 2022. The patient had a CT scan and had diverticulitis in addition to shingles on his/her side. The pain wraps around to his/her back. The patient did not had a rash but his/her skin felt burned and it feels like electrical shocks inside and it was terrible. Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Electric shock sensation
- Hospital-Tage
- -
- Labordaten
- Test Date: 2022; Test Name: CT Scan; Result Unstructured Data: (Test Result:diverticulitis,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 11.10.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Herpes zoster
Herpes zoster oticus
Oral herpes zoster
Pain
Symptomtext
Bell's palsy; she got shingles,They were in her mouth,ear and the back of her head.; she got shingles,They were in her mouth,ear and the back of her head.; "she got shingles,They were in her mouth, ear and the back of her head."; Terrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant), oral herpes zoster, shingles and pain. On an unknown date, the outcome of the bell's palsy and pain were unknown and the outcome of the herpes zoster otitis externa, oral herpes zoster and shingles were not recovered/not resolved. It was unknown if the reporter considered the bell's palsy, herpes zoster otitis externa, oral herpes zoster, shingles and pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comments: This case was reported by a patient's child via interactive digital media. The patient got the Shingles shot and the week before her second one she got shingles. They were in her mouth, ear and the back of her head. The patient was still trying to get over them. The patient also got Belles Palsy from them. The patient was in terrible pain. The reporter stated that hope the patient feel better soon. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 10.10.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Immediate post-injection reaction
Intensive care
Mechanical ventilation
Symptomtext
Guillain-Barre Syndrome, in intensive care on a ventilator for a month; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got Guillain-Barre Syndrome shortly after a shingles vaccine. The patient was in intensive care on a ventilator for a month and in rehab for another 2 months and stated was one of the lucky ones. Still suffering effects after 5 years. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- -
- Geschlecht
- M
- Eingang
- 07.10.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Bell's palsy
Symptomtext
Bell's palsy after 1st dose; This case was reported by a physician via sales rep and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was recovered/resolved. It was unknown if the reporter considered the bell's palsy to be related to Shingrix. Additional Information: GSK Receipt Date: 29-Sep-2022 Reporter's comment: The patient received the first dose of Shingrix. The patient developed Bell 's palsy after 2 weeks of first dose. The conditions was resolved after a month of speech and occupational therapy.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.09.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Blood pressure fluctuation
Dizziness
Electric shock sensation
Headache
Mental impairment
Blood pressure increased
Dizziness postural
Muscle spasms
Pain
Symptomtext
worsened ability to think; Lightheadedness; blood pressure fluctuating between 150/90 to 224/147; electrical shocking; pain; muscle spasm; new non migraine headaches; This case was reported by a consumer via call center representative and described the occurrence of difficulty thinking in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced difficulty thinking (serious criteria GSK medically significant), light headedness, blood pressure fluctuation, electric shock sensation, pain, muscle spasm and headache. On an unknown date, the outcome of the difficulty thinking, light headedness, blood pressure fluctuation, electric shock sensation, pain, muscle spasm and headache were not recovered/not resolved. It was unknown if the reporter considered the difficulty thinking, light headedness, blood pressure fluctuation, electric shock sensation, pain, muscle spasm and headache to be related to Shingrix. Additional Information: Additional Information: GSK receipt date: 16-SEP-2022 Reporters comment: This case was reported by a consumer. The patient receive shingrix vaccine and experienced Lightheadedness, blood pressure fluctuating between 150/90 to 224/147, worsened ability to think, electrical shocking, pain, muscle spasm, new non migraine headaches. The patient reported that he/she was on day three of severe reaction and it did not match extremely limited list of symptoms. The patient wish he/she had the shingles back. The follow up information received on same day and updated the patient initial and contact details
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Electric shock sensation
- Hospital-Tage
- -
- Labordaten
- Test Name: blood pressure; Result Unstructured Data: (Test Result:224/147,Unit:mm Hg,Normal Low:,Normal High:); Comments: fluctuating; Test Name: blood pressure; Result Unstructured Data: (Test Result:150/90,Unit:mm Hg,Normal Low:,Normal High:); Comments: fluctuating; Comments: LabComments: blood pressure : fluctuating, blood pressure : fluctuating
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 24.09.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Electric shock sensation
Symptomtext
having electric type changes/charges in skull; This case was reported by a consumer via interactive digital media and described the occurrence of electric shock sensation in head in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced electric shock sensation in head. On an unknown date, the outcome of the electric shock sensation in head was not recovered/not resolved. It was unknown if the reporter considered the electric shock sensation in head to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that he/she had been experiencing electric type changes/charges in his/her skull. Follow-up would not possible, as no contact, details were available. Additional supportive information: Since, it was a case received via interactive digital media and the patient/reporter does not explicitly stated of having received a shingles vaccine and the therefore, shingles vaccine" is coded as the suspect product, conservatively.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Electric shock sensation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 21.09.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
GBS after flu shot; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a Unknown number of patients who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine. Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The reporter stated that guillain barre syndrome (GBS) it was a horrible disorder. The reporter knew a couple people who got it taking a flu shot. Follow-up would not possible as no contact details were available.; Sender's Comments: US-GSK-US2022AMR133022:same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.09.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Coccydynia
Electric shock sensation
Herpes zoster
Musculoskeletal pain
Pain
Stress
Vaccination failure
Symptomtext
I had the vaccine and I still get them; I still get them, not wide spread/ they'e always around the scar and buttocks; Sharp electric like pain from tailbone to buttocks; Always when there's stress, get very sharp electric like pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included surgery (4 back surgery). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and stress. On an unknown date, the outcome of the vaccination failure, shingles, pain and stress were unknown. It was unknown if the reporter considered the vaccination failure, shingles, pain and stress to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-Aug-2022 Reporter's Comments: The reporter reported the case via interactive digital media. The patient had the vaccine and he/she still got them just not as widespread. Always when there was stress, or he/she got very sharp electric like pain from tailbone to buttocks. The patient had 4 back surgeries and they were always around the scar and buttocks. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Electric shock sensation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Surgery (4 back surgery)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.08.2022
- Impfdatum
- 28.10.2021
- Beginn
- 29.10.2021
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Asthenia
Blood test
Body temperature
Chills
Feeling abnormal
Gait disturbance
Guillain-Barre syndrome
Nausea
Pain in extremity
Pyrexia
Scan
Symptomtext
Symptoms were like Guillain-Barre syndrome; Difficulty walking, needed about 3 people to help to walk; Chills; Fever (101.7f); Nausea; Unstable (feeling abnormal); Energy and strength have not been fully regained; Sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis, COVID-19 VACCINE for prophylaxis, INFLUENZA VACCINE INACT (FLUZONE (FLU SHOT)) for prophylaxis and PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis. Previously administered products included Covid shot with an associated reaction of pain in extremity (the patient received covid shots (1st and 2nd dose ) but not major reaction other than sore arm), Fluzone with an associated reaction of gait disturbance (The reporter also mentioned that the patient had similar reaction when he received Fluzone about year ago) and Pneumovax with an associated reaction of gait disturbance (The reporter also mentioned that the patient had similar reaction when he received Pneumovax about year ago). Concomitant products included INFLUENZA VACCINE (INFLUENZA SHOT). On 28th October 2021, the patient received Shingrix (intramuscular). On an unknown date, the patient received Influenza vaccine (intramuscular), COVID-19 VACCINE, FLUZONE (FLU SHOT) (intramuscular) and PNEUMOVAX. On 29th October 2021, 1 days after receiving Shingrix and unknown after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and manufacturer medically significant), walking difficulty (serious criteria hospitalization), chills (serious criteria hospitalization), fever (serious criteria hospitalization), nausea (serious criteria hospitalization), feeling abnormal (serious criteria hospitalization), asthenia (serious criteria hospitalization) and pain in arm (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome and asthenia were not recovered/not resolved and the outcome of the walking difficulty, chills, fever, nausea and feeling abnormal were recovered/resolved and the outcome of the pain in arm was unknown. The reporter considered the guillain barre syndrome, walking difficulty, chills, fever, nausea, feeling abnormal, asthenia and pain in arm to be related to Shingrix and Influenza vaccine. Additional Information: manufacturer Receipt Date: 18-AUG-2022 Reporter's Comments: The patient who experienced chills, fever (101.7 degree F), nausea, unstable (feeling abnormal), difficulty walking, the patient need about 3 people to help him walk ,energy and strength have not been fully regained, sore arm while receiving vaccine covid-19 vaccine, Shingrix, Pnuemovax, Influenza vaccine and influenza vaccine trival A-B subvirion no preservative vaccine (Fluzone). The reporter reported that on an unknown date patient received influenza trival A-B subvirion no preservative vaccine (Fluzone) via intramuscular route in the left deltoid and lot number not provided, also received Influenza vaccine, Covid-19 vaccine and Pneumovax. The patient received Shingrix via intramuscular route. The patient past medical history, medical treatment, vaccination and family history were not provided. The reporter reported that on an unknown date patient received influenza trival A-B subvirion no preservative vaccine (Fluzone) via intramuscular route in the left deltoid and lot number not provided, also received Influenza vaccine, Covid-19 vaccine and Pneumovax. The reporter reported that on 29th October 2021, patient developed chills, fever(pyrexia), nausea, unstable (feeling abnormal), difficulty walking, energy and strength have not been fully regained, sore arm. The patient needs about 3 people to help him walk. This event was leading to disability. The patient was hospitalized around 4:00pm on the same day for all the events. The patient was discharged from emergency room around 9:30pm on 29th October 2021. It was reported Guillain- Barre syndrome (GBS) had not been diagnosed, but the reporter thinks that symptoms were like GBS. The reporter also mentioned that the patient had similar reaction when he received Fluzone and Pneumovax about year ago. The patient also mentioned that, the patient received flu shot 2 weeks prior to Shingrix vaccine but no adverse reaction. It was unknown if reporter considered the guillain barre syndrome, walking difficulty, chills, fever, nausea, feeling abnormal, asthenia and pain in arm to be related to covid-19 vaccine, Pnuemovax, Influenza vaccine and influenza vaccine trival A-B subvirion no preservative vaccine (fluzone).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- 1,0
- Labordaten
- Test Name: Blood test; Result Unstructured Data: (Test Result:Normal,Unit:unknown,Normal Low:,Normal High:); Test Date: 20211029; Test Name: Body temperature; Result Unstructured Data: (Test Result:101.7,Unit:degree F,Normal Low:,Normal High:); Test Name: Scan; Result Unstructured Data: (Test Result:No sign of stroke,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- INFLUENZA SHOT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.08.2022
- Impfdatum
- 28.10.2021
- Beginn
- 29.10.2021
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Asthenia
Blood test
Body temperature
Chills
Feeling abnormal
Gait disturbance
Guillain-Barre syndrome
Nausea
Pain in extremity
Pyrexia
Scan
Symptomtext
Symptoms were like Guillain-Barre syndrome; Difficulty walking, needed about 3 people to help to walk; Chills; Fever (101.7f); Nausea; Unstable (feeling abnormal); Energy and strength have not been fully regained; Sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis, COVID-19 VACCINE for prophylaxis, INFLUENZA VACCINE INACT (FLUZONE (FLU SHOT)) for prophylaxis and PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis. Previously administered products included Covid shot with an associated reaction of pain in extremity (the patient received covid shots (1st and 2nd dose ) but not major reaction other than sore arm), Fluzone with an associated reaction of gait disturbance (The reporter also mentioned that the patient had similar reaction when he received Fluzone about year ago) and Pneumovax with an associated reaction of gait disturbance (The reporter also mentioned that the patient had similar reaction when he received Pneumovax about year ago). Concomitant products included INFLUENZA VACCINE (INFLUENZA SHOT). On 28th October 2021, the patient received Shingrix (intramuscular). On an unknown date, the patient received Influenza vaccine (intramuscular), COVID-19 VACCINE, FLUZONE (FLU SHOT) (intramuscular) and PNEUMOVAX. On 29th October 2021, 1 days after receiving Shingrix and unknown after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and manufacturer medically significant), walking difficulty (serious criteria hospitalization), chills (serious criteria hospitalization), fever (serious criteria hospitalization), nausea (serious criteria hospitalization), feeling abnormal (serious criteria hospitalization), asthenia (serious criteria hospitalization) and pain in arm (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome and asthenia were not recovered/not resolved and the outcome of the walking difficulty, chills, fever, nausea and feeling abnormal were recovered/resolved and the outcome of the pain in arm was unknown. The reporter considered the guillain barre syndrome, walking difficulty, chills, fever, nausea, feeling abnormal, asthenia and pain in arm to be related to Shingrix and Influenza vaccine. Additional Information: manufacturer Receipt Date: 18-AUG-2022 Reporter's Comments: The patient who experienced chills, fever (101.7 degree F), nausea, unstable (feeling abnormal), difficulty walking, the patient need about 3 people to help him walk ,energy and strength have not been fully regained, sore arm while receiving vaccine covid-19 vaccine, Shingrix, Pnuemovax, Influenza vaccine and influenza vaccine trival A-B subvirion no preservative vaccine (Fluzone). The reporter reported that on an unknown date patient received influenza trival A-B subvirion no preservative vaccine (Fluzone) via intramuscular route in the left deltoid and lot number not provided, also received Influenza vaccine, Covid-19 vaccine and Pneumovax. The patient received Shingrix via intramuscular route. The patient past medical history, medical treatment, vaccination and family history were not provided. The reporter reported that on an unknown date patient received influenza trival A-B subvirion no preservative vaccine (Fluzone) via intramuscular route in the left deltoid and lot number not provided, also received Influenza vaccine, Covid-19 vaccine and Pneumovax. The reporter reported that on 29th October 2021, patient developed chills, fever(pyrexia), nausea, unstable (feeling abnormal), difficulty walking, energy and strength have not been fully regained, sore arm. The patient needs about 3 people to help him walk. This event was leading to disability. The patient was hospitalized around 4:00pm on the same day for all the events. The patient was discharged from emergency room around 9:30pm on 29th October 2021. It was reported Guillain- Barre syndrome (GBS) had not been diagnosed, but the reporter thinks that symptoms were like GBS. The reporter also mentioned that the patient had similar reaction when he received Fluzone and Pneumovax about year ago. The patient also mentioned that, the patient received flu shot 2 weeks prior to Shingrix vaccine but no adverse reaction. It was unknown if reporter considered the guillain barre syndrome, walking difficulty, chills, fever, nausea, feeling abnormal, asthenia and pain in arm to be related to covid-19 vaccine, Pnuemovax, Influenza vaccine and influenza vaccine trival A-B subvirion no preservative vaccine (fluzone).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- 1,0
- Labordaten
- Test Name: Blood test; Result Unstructured Data: (Test Result:Normal,Unit:unknown,Normal Low:,Normal High:); Test Date: 20211029; Test Name: Body temperature; Result Unstructured Data: (Test Result:101.7,Unit:degree F,Normal Low:,Normal High:); Test Name: Scan; Result Unstructured Data: (Test Result:No sign of stroke,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- INFLUENZA SHOT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.08.2022
- Impfdatum
- 28.10.2021
- Beginn
- 29.10.2021
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Asthenia
Blood test
Body temperature
Chills
Feeling abnormal
Gait disturbance
Guillain-Barre syndrome
Nausea
Pain in extremity
Pyrexia
Scan
Symptomtext
Symptoms were like Guillain-Barre syndrome; Difficulty walking, needed about 3 people to help to walk; Chills; Fever (101.7f); Nausea; Unstable (feeling abnormal); Energy and strength have not been fully regained; Sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis, COVID-19 VACCINE for prophylaxis, INFLUENZA VACCINE INACT (FLUZONE (FLU SHOT)) for prophylaxis and PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis. Previously administered products included Covid shot with an associated reaction of pain in extremity (the patient received covid shots (1st and 2nd dose ) but not major reaction other than sore arm), Fluzone with an associated reaction of gait disturbance (The reporter also mentioned that the patient had similar reaction when he received Fluzone about year ago) and Pneumovax with an associated reaction of gait disturbance (The reporter also mentioned that the patient had similar reaction when he received Pneumovax about year ago). Concomitant products included INFLUENZA VACCINE (INFLUENZA SHOT). On 28th October 2021, the patient received Shingrix (intramuscular). On an unknown date, the patient received Influenza vaccine (intramuscular), COVID-19 VACCINE, FLUZONE (FLU SHOT) (intramuscular) and PNEUMOVAX. On 29th October 2021, 1 days after receiving Shingrix and unknown after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and manufacturer medically significant), walking difficulty (serious criteria hospitalization), chills (serious criteria hospitalization), fever (serious criteria hospitalization), nausea (serious criteria hospitalization), feeling abnormal (serious criteria hospitalization), asthenia (serious criteria hospitalization) and pain in arm (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome and asthenia were not recovered/not resolved and the outcome of the walking difficulty, chills, fever, nausea and feeling abnormal were recovered/resolved and the outcome of the pain in arm was unknown. The reporter considered the guillain barre syndrome, walking difficulty, chills, fever, nausea, feeling abnormal, asthenia and pain in arm to be related to Shingrix and Influenza vaccine. Additional Information: manufacturer Receipt Date: 18-AUG-2022 Reporter's Comments: The patient who experienced chills, fever (101.7 degree F), nausea, unstable (feeling abnormal), difficulty walking, the patient need about 3 people to help him walk ,energy and strength have not been fully regained, sore arm while receiving vaccine covid-19 vaccine, Shingrix, Pnuemovax, Influenza vaccine and influenza vaccine trival A-B subvirion no preservative vaccine (Fluzone). The reporter reported that on an unknown date patient received influenza trival A-B subvirion no preservative vaccine (Fluzone) via intramuscular route in the left deltoid and lot number not provided, also received Influenza vaccine, Covid-19 vaccine and Pneumovax. The patient received Shingrix via intramuscular route. The patient past medical history, medical treatment, vaccination and family history were not provided. The reporter reported that on an unknown date patient received influenza trival A-B subvirion no preservative vaccine (Fluzone) via intramuscular route in the left deltoid and lot number not provided, also received Influenza vaccine, Covid-19 vaccine and Pneumovax. The reporter reported that on 29th October 2021, patient developed chills, fever(pyrexia), nausea, unstable (feeling abnormal), difficulty walking, energy and strength have not been fully regained, sore arm. The patient needs about 3 people to help him walk. This event was leading to disability. The patient was hospitalized around 4:00pm on the same day for all the events. The patient was discharged from emergency room around 9:30pm on 29th October 2021. It was reported Guillain- Barre syndrome (GBS) had not been diagnosed, but the reporter thinks that symptoms were like GBS. The reporter also mentioned that the patient had similar reaction when he received Fluzone and Pneumovax about year ago. The patient also mentioned that, the patient received flu shot 2 weeks prior to Shingrix vaccine but no adverse reaction. It was unknown if reporter considered the guillain barre syndrome, walking difficulty, chills, fever, nausea, feeling abnormal, asthenia and pain in arm to be related to covid-19 vaccine, Pnuemovax, Influenza vaccine and influenza vaccine trival A-B subvirion no preservative vaccine (fluzone).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- 1,0
- Labordaten
- Test Name: Blood test; Result Unstructured Data: (Test Result:Normal,Unit:unknown,Normal Low:,Normal High:); Test Date: 20211029; Test Name: Body temperature; Result Unstructured Data: (Test Result:101.7,Unit:degree F,Normal Low:,Normal High:); Test Name: Scan; Result Unstructured Data: (Test Result:No sign of stroke,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- INFLUENZA SHOT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.08.2022
- Impfdatum
- 28.10.2021
- Beginn
- 29.10.2021
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Asthenia
Blood test
Body temperature
Chills
Feeling abnormal
Gait disturbance
Guillain-Barre syndrome
Nausea
Pain in extremity
Pyrexia
Scan
Symptomtext
Symptoms were like Guillain-Barre syndrome; Difficulty walking, needed about 3 people to help to walk; Chills; Fever (101.7f); Nausea; Unstable (feeling abnormal); Energy and strength have not been fully regained; Sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis, COVID-19 VACCINE for prophylaxis, INFLUENZA VACCINE INACT (FLUZONE (FLU SHOT)) for prophylaxis and PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis. Previously administered products included Covid shot with an associated reaction of pain in extremity (the patient received covid shots (1st and 2nd dose ) but not major reaction other than sore arm), Fluzone with an associated reaction of gait disturbance (The reporter also mentioned that the patient had similar reaction when he received Fluzone about year ago) and Pneumovax with an associated reaction of gait disturbance (The reporter also mentioned that the patient had similar reaction when he received Pneumovax about year ago). Concomitant products included INFLUENZA VACCINE (INFLUENZA SHOT). On 28th October 2021, the patient received Shingrix (intramuscular). On an unknown date, the patient received Influenza vaccine (intramuscular), COVID-19 VACCINE, FLUZONE (FLU SHOT) (intramuscular) and PNEUMOVAX. On 29th October 2021, 1 days after receiving Shingrix and unknown after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and manufacturer medically significant), walking difficulty (serious criteria hospitalization), chills (serious criteria hospitalization), fever (serious criteria hospitalization), nausea (serious criteria hospitalization), feeling abnormal (serious criteria hospitalization), asthenia (serious criteria hospitalization) and pain in arm (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome and asthenia were not recovered/not resolved and the outcome of the walking difficulty, chills, fever, nausea and feeling abnormal were recovered/resolved and the outcome of the pain in arm was unknown. The reporter considered the guillain barre syndrome, walking difficulty, chills, fever, nausea, feeling abnormal, asthenia and pain in arm to be related to Shingrix and Influenza vaccine. Additional Information: manufacturer Receipt Date: 18-AUG-2022 Reporter's Comments: The patient who experienced chills, fever (101.7 degree F), nausea, unstable (feeling abnormal), difficulty walking, the patient need about 3 people to help him walk ,energy and strength have not been fully regained, sore arm while receiving vaccine covid-19 vaccine, Shingrix, Pnuemovax, Influenza vaccine and influenza vaccine trival A-B subvirion no preservative vaccine (Fluzone). The reporter reported that on an unknown date patient received influenza trival A-B subvirion no preservative vaccine (Fluzone) via intramuscular route in the left deltoid and lot number not provided, also received Influenza vaccine, Covid-19 vaccine and Pneumovax. The patient received Shingrix via intramuscular route. The patient past medical history, medical treatment, vaccination and family history were not provided. The reporter reported that on an unknown date patient received influenza trival A-B subvirion no preservative vaccine (Fluzone) via intramuscular route in the left deltoid and lot number not provided, also received Influenza vaccine, Covid-19 vaccine and Pneumovax. The reporter reported that on 29th October 2021, patient developed chills, fever(pyrexia), nausea, unstable (feeling abnormal), difficulty walking, energy and strength have not been fully regained, sore arm. The patient needs about 3 people to help him walk. This event was leading to disability. The patient was hospitalized around 4:00pm on the same day for all the events. The patient was discharged from emergency room around 9:30pm on 29th October 2021. It was reported Guillain- Barre syndrome (GBS) had not been diagnosed, but the reporter thinks that symptoms were like GBS. The reporter also mentioned that the patient had similar reaction when he received Fluzone and Pneumovax about year ago. The patient also mentioned that, the patient received flu shot 2 weeks prior to Shingrix vaccine but no adverse reaction. It was unknown if reporter considered the guillain barre syndrome, walking difficulty, chills, fever, nausea, feeling abnormal, asthenia and pain in arm to be related to covid-19 vaccine, Pnuemovax, Influenza vaccine and influenza vaccine trival A-B subvirion no preservative vaccine (fluzone).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- 1,0
- Labordaten
- Test Name: Blood test; Result Unstructured Data: (Test Result:Normal,Unit:unknown,Normal Low:,Normal High:); Test Date: 20211029; Test Name: Body temperature; Result Unstructured Data: (Test Result:101.7,Unit:degree F,Normal Low:,Normal High:); Test Name: Scan; Result Unstructured Data: (Test Result:No sign of stroke,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- INFLUENZA SHOT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.08.2022
- Impfdatum
- 28.10.2021
- Beginn
- 29.10.2021
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Asthenia
Blood test
Body temperature
Chills
Feeling abnormal
Gait disturbance
Guillain-Barre syndrome
Nausea
Pain in extremity
Pyrexia
Scan
Symptomtext
Symptoms were like Guillain-Barre syndrome; Difficulty walking, needed about 3 people to help to walk; Chills; Fever (101.7f); Nausea; Unstable (feeling abnormal); Energy and strength have not been fully regained; Sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis, COVID-19 VACCINE for prophylaxis, INFLUENZA VACCINE INACT (FLUZONE (FLU SHOT)) for prophylaxis and PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis. Previously administered products included Covid shot with an associated reaction of pain in extremity (the patient received covid shots (1st and 2nd dose ) but not major reaction other than sore arm), Fluzone with an associated reaction of gait disturbance (The reporter also mentioned that the patient had similar reaction when he received Fluzone about year ago) and Pneumovax with an associated reaction of gait disturbance (The reporter also mentioned that the patient had similar reaction when he received Pneumovax about year ago). Concomitant products included INFLUENZA VACCINE (INFLUENZA SHOT). On 28th October 2021, the patient received Shingrix (intramuscular). On an unknown date, the patient received Influenza vaccine (intramuscular), COVID-19 VACCINE, FLUZONE (FLU SHOT) (intramuscular) and PNEUMOVAX. On 29th October 2021, 1 days after receiving Shingrix and unknown after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and manufacturer medically significant), walking difficulty (serious criteria hospitalization), chills (serious criteria hospitalization), fever (serious criteria hospitalization), nausea (serious criteria hospitalization), feeling abnormal (serious criteria hospitalization), asthenia (serious criteria hospitalization) and pain in arm (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome and asthenia were not recovered/not resolved and the outcome of the walking difficulty, chills, fever, nausea and feeling abnormal were recovered/resolved and the outcome of the pain in arm was unknown. The reporter considered the guillain barre syndrome, walking difficulty, chills, fever, nausea, feeling abnormal, asthenia and pain in arm to be related to Shingrix and Influenza vaccine. Additional Information: manufacturer Receipt Date: 18-AUG-2022 Reporter's Comments: The patient who experienced chills, fever (101.7 degree F), nausea, unstable (feeling abnormal), difficulty walking, the patient need about 3 people to help him walk ,energy and strength have not been fully regained, sore arm while receiving vaccine covid-19 vaccine, Shingrix, Pnuemovax, Influenza vaccine and influenza vaccine trival A-B subvirion no preservative vaccine (Fluzone). The reporter reported that on an unknown date patient received influenza trival A-B subvirion no preservative vaccine (Fluzone) via intramuscular route in the left deltoid and lot number not provided, also received Influenza vaccine, Covid-19 vaccine and Pneumovax. The patient received Shingrix via intramuscular route. The patient past medical history, medical treatment, vaccination and family history were not provided. The reporter reported that on an unknown date patient received influenza trival A-B subvirion no preservative vaccine (Fluzone) via intramuscular route in the left deltoid and lot number not provided, also received Influenza vaccine, Covid-19 vaccine and Pneumovax. The reporter reported that on 29th October 2021, patient developed chills, fever(pyrexia), nausea, unstable (feeling abnormal), difficulty walking, energy and strength have not been fully regained, sore arm. The patient needs about 3 people to help him walk. This event was leading to disability. The patient was hospitalized around 4:00pm on the same day for all the events. The patient was discharged from emergency room around 9:30pm on 29th October 2021. It was reported Guillain- Barre syndrome (GBS) had not been diagnosed, but the reporter thinks that symptoms were like GBS. The reporter also mentioned that the patient had similar reaction when he received Fluzone and Pneumovax about year ago. The patient also mentioned that, the patient received flu shot 2 weeks prior to Shingrix vaccine but no adverse reaction. It was unknown if reporter considered the guillain barre syndrome, walking difficulty, chills, fever, nausea, feeling abnormal, asthenia and pain in arm to be related to covid-19 vaccine, Pnuemovax, Influenza vaccine and influenza vaccine trival A-B subvirion no preservative vaccine (fluzone).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- 1,0
- Labordaten
- Test Name: Blood test; Result Unstructured Data: (Test Result:Normal,Unit:unknown,Normal Low:,Normal High:); Test Date: 20211029; Test Name: Body temperature; Result Unstructured Data: (Test Result:101.7,Unit:degree F,Normal Low:,Normal High:); Test Name: Scan; Result Unstructured Data: (Test Result:No sign of stroke,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- INFLUENZA SHOT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 23.08.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Computerised tomogram abnormal
Diplopia
Impaired driving ability
Impaired work ability
Loss of personal independence in daily activities
Magnetic resonance imaging abnormal
VIth nerve paralysis
Symptomtext
Sixth nerve palsy at right eye; Double vision/ CAT scan at ER/ admitted to hospital/ MRI and other tests; Could not drive or work/hard to do anything; This case was reported by a consumer and described the occurrence of vith nerve palsy in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced vith nerve palsy (serious criteria hospitalization and GSK medically significant), double vision (serious criteria hospitalization) and activities of daily living impaired. On an unknown date, the outcome of the vith nerve palsy, double vision and activities of daily living impaired were not recovered/not resolved. It was unknown if the reporter considered the vith nerve palsy, double vision and activities of daily living impaired to be related to Shingrix. Additional Information: GSK receipt date: 15-AUG-2022 Reporter's comment: It was reported that the patient wanted to inform about an adverse event after receiving the Shingrix vaccine. The patient stated that approximately 4 to 5 weeks after the Shingrix vaccine, the patient started getting double vision. The double vision got worse until the patient could not drive or work. The patient went to an Eye doctor two weeks ago who told that the patient needs to go to the Emergency Room. The patient received a CAT scan at the ER and was then admitted to the hospital to get an MRI and many other tests. The patient stated that the diagnosis was Sixth Nerve Palsy at right eye and at the time of reporting, it had still not corrected itself and the patient cannot work or drive. The patient stated that the double vision persists and makes it hard to do anything without covering one eye. The patient stated that after doing some research, the patient had found that there had been other reports of Six Nerve Palsy after the old 1 dose Shingles vaccine, but the patient could not find anything about Shingrix. The patient requested let him/her know of any other reports of Sixth Nerve Palsy after the Shingrix vaccine. The patient had also reported this to the Vaccine Adverse Event Reporting System.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- VIth nerve paralysis
- Hospital-Tage
- -
- Labordaten
- Test Date: 2022; Test Name: CAT scan; Result Unstructured Data: (Test Result:Sixth Nerve Palsy in right eye,Unit:unknown,Normal Low:,Normal High:); Test Date: 2022; Test Name: Other tests; Result Unstructured Data: (Test Result:Sixth Nerve Palsy in right eye,Unit:unknown,Normal Low:,Normal High:); Test Date: 2022; Test Name: MRI; Result Unstructured Data: (Test Result:Sixth Nerve Palsy in right eye,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NE
- Alter
- 3,0
- Geschlecht
- F
- Eingang
- 12.08.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: ja
Anti-neuronal antibody
Antibody test negative
Areflexia
Ataxia
Bell's palsy
Bulbar palsy
CSF culture negative
CSF glucose increased
CSF immunoglobulin increased
CSF oligoclonal band absent
Cryptococcus test
Culture negative
Cytomegalovirus test negative
Dysmetria
Dysphagia
CSF protein increased
CSF red blood cell count
CSF white blood cell count negative
Symptomtext
GBS, most consistent with the ABPp variant; acute bulbar palsy; cranial neuropathies; worsening facial weakness/ bilateral upper and lower facial weakness, left worse than right; difficulty walking/displayed a staggering, cautious gait while walking.; hoarse cry/ cried; bilateral facial palsy/left face appeared flat and emotionless with the left eye slightly open without any tears, while the right face was creased with the right eye closed and tears coming out; stopped talking/nonverbal but hummed with a soft voice; gasping to breathe; increased difficulty with eating and drinking; dysphagia/increased difficulty with drinking; Unable to walk without assistance; inspiratory stridor; Reflexes were absent/ Areflexia; dysmetria bilaterally when attempting to grab small items with each hand; Dysphonia; Ataxia/ Ataxic gait; This case was reported in a literature article and described the occurrence of guillain barre syndrome in a 3-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine. On an unknown date, several hours after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), bulbar palsy (serious criteria hospitalization and GSK medically significant), cranial neuropathy (serious criteria hospitalization), facial weakness (serious criteria hospitalization), walking difficulty (serious criteria hospitalization), crying abnormal (serious criteria hospitalization), facial palsy (serious criteria hospitalization and GSK medically significant), speech disorder (serious criteria hospitalization), gasping (serious criteria hospitalization), eating disorder (serious criteria hospitalization), dysphagia (serious criteria hospitalization), unable to walk (serious criteria hospitalization), stridor inspiratory (serious criteria hospitalization), absent reflex (serious criteria hospitalization), dysmetria (serious criteria hospitalization and GSK medically significant), dysphonia (serious criteria hospitalization) and ataxia (serious criteria hospitalization). The patient was treated with acyclovir and immunoglobulins nos (Intravenous Immunoglobulin). On an unknown date, the outcome of the guillain barre syndrome, bulbar palsy, cranial neuropathy, facial weakness, walking difficulty, crying abnormal, facial palsy, speech disorder, gasping, eating disorder, dysphagia, unable to walk, stridor inspiratory, absent reflex, dysmetria, dysphonia and ataxia were recovered/resolved. The reporter considered the guillain barre syndrome, bulbar palsy, cranial neuropathy, facial weakness, walking difficulty, crying abnormal, facial palsy, speech disorder, gasping, eating disorder, dysphagia, unable to walk, stridor inspiratory, absent reflex, dysmetria, dysphonia and ataxia to be related to Influenza vaccine. Additional Information: GSK Receipt Date: 10-Aug-2022 Author's comment: The patient was normally developing right-handed and presented to the emergency department with worsening facial weakness and difficulty walking. The patient was in her usual state of health, with no known recent illnesses, until 5 days prior to presentation. A few hours after receiving her influenza vaccination, the mother noticed that, while the patient cried, her left face appeared flat and emotionless with the left eye slightly open without any tears, while the right face was creased with the right eye closed and tears coming out. The patient was prescribed acyclovir by her pediatrician on the next day for suspected Bell's palsy. Two days later, the patient stopped talking and appeared as if she was gasping to breathe. The patient was also had increased difficulty with eating and drinking and was no longer able to walk without assistance. At the time of her presentation, her lung exam was remarkable for inspiratory stridor. On neurologic exam, the patient was awake and followed commands. The patient was nonverbal but hummed with a soft voice. Her pupils were equal and reactive to light, and gaze was conjugate in all directions. The patient had bilateral upper and lower facial weakness, left worse than right. When the patient laughed, her right lower face moved slightly up, while the left lower face did not move, and the left nasolabial fold remained absent. The patient's strength was full throughout, and she responded to touch in all extremities. Reflexes were absent throughout. The patient had dysmetria bilaterally when attempting to grab small items with each hand. The patient stood without assistance but displayed a staggering, cautious gait while walking. Magnetic resonance imaging (MRI) of the brain with and without contrast revealed abnormal smooth enhancement of the bilateral oculomotor, trigeminal, facial, and vagus nerves. MRI of the entire spine obtained with and without contrast showed similar smooth enhancement of spinal nerve roots at many levels, most conspicuous in the cauda equina and cervicothoracic junction. Lumbar puncture with cerebrospinal fluid (CSF) studies showed white blood cell count of 19 cells/cm2 (normal 0-10) without red blood cells, glucose 81 mg/dL (normal 45-75), and protein 116 mg/dL (normal 15-45). Meningitis panel and CSF cultures were negative. Multiple sclerosis panel showed elevated CSF immunoglobulin G (IgG) with elevated IgG synthesis rate, without oligoclonal bands. Serum and CSF autoimmune encephalopathy panels were negative. Serum acute neuropathy panel was negative for IgM and IgG antibodies against GM1, GD1a, GD1b, GM2, GT1A, and GQ1b. The patient was diagnosed with Guillain-Barre syndrome (GBS), most consistent with the acute bulbar palsy plus (ABPp) variant. The patient received intravenous immunoglobulin 1 mg/kg daily for 2 days. The patient's respiratory status was monitored and without complication, and her symptoms steadily improved over the next 10 days. By hospital discharge, the patient appeared to smile with present bilateral nasolabial folds. Her cry was less hoarse, and she was able to eat soft foods. Reflexes remained absent throughout, and she continued to have mild ataxic gait requiring intermittent assistance. The patient was discharged to inpatient rehabilitation with ongoing physical, occupational, and speech therapy. On three-month follow-up, the patient was back to her normal self, with intact facial strength, fluent speech with normal pitch and no dysarthria, and normal reflexes. No ataxia was observed, as she was able to run, skip, and jump up and down without difficulty. This was the youngest patient in the literature to date who developed the acute bulbar palsy-plus (ABPp) variant of GBS. It was suspected that her influenza vaccine most likely contributed to her development of GBS, given her onset of symptoms just hours after vaccine administration and lack of other known risk factors. This short latency is unusual given that the risk for GBS is expected in the 8 to 21 day window after vaccinations. Additional supportive information: The article corresponding to this case is not available for regulatory submission due to copyright restriction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- Test Name: Anti-Neuronal Nuclear Ab, Type 1 (ANNA-1), CSF (CNS autoimmune panel); Test Result: Negative ; Test Name: Anti-Neuronal Nuclear Ab, Type 1 (ANNA-1), CSF (Serum autoimmune panel); Test Result: Negative ; Test Name: Cryptococcus neoformans/gattii (Meningitis Panel); Result Unstructured Data: (Test Result:Not detected in Meningitis Panel,Unit:unknown,Normal Low:,Normal High:); Test Name: Lumbar puncture with cerebrospinal fluid (CSF) studies; Test Result: 81 mg/dl; Test Name: Lumbar puncture with cerebrospinal fluid (CSF) studies; Test Result: 116 mg/dl; Test Name: Lumbar puncture with cerebrospinal fluid (CSF) studies; Result Unstructured Data: (Test Result:19 cells/cm2 without red blood cells,Unit:unknown,Normal Low:0,Normal High:10); Test Name: Cytomegalovirus (Meningitis Panel); Result Unstructured Data: (Test Result:Not detected,Unit:unknown,Normal Low:,Normal High:); Test Name: Enterovirus (Meningitis Panel); Result Unstructured Data: (Test Result:Not detected,Unit:unknown,Normal Low:,Normal High:); Test Name: Escherichia coli (Meningitis Panel); Result Unstructured Data: (Test Result:Not detected,Unit:unknown,Normal Low:,Normal High:); Test Name: Haemophilus influenzae (Meningitis Panel); Result Unstructured Data: (Test Result:Not detected,Unit:unknown,Normal Low:,Normal High:); Test Name: Herpes Simplex Virus 1 (Meningitis Panel); Result Unstructured Data: (Test Result:Herpes Simplex Virus 1 Not detected,Unit:unknown,Normal Low:,Normal High:); Test Name: Herpes Simplex Virus 2 (Meningitis Panel); Result Unstructured Data: (Test Result:Herpes Simplex Virus 2 Not detected,Unit:unknown,Normal Low:,Normal High:); Test Name: Human herpesvirus 6 (Meningitis Panel); Result Unstructured Data: (Test Result:Not detected,Unit:unknown,Normal Low:,Normal High:); Test Name: CASPR2-IgG CBA, CSF (CNS autoimmune panel); Test Result: Negative ; Test Name: CASPR2-IgG CBA, Serum (Serum autoimmune panel); Test Result: Negative ; Test Name: DPPX Ab IFA, CSF (CNS autoimmune panel); Test Result: Negative ; Test Name: DPPX Ab IFA, Serum (Serum autoimmune panel); Test Result: Negative ; Test Name: GABA-B-R Ab CBA, CSF (CNS autoimmune panel); Test Result: Negative ; Test Name: GABA-B-R Ab CBA, Serum (Serum autoimmune panel); Result Unstructured Data: (Test Result:Negative GABA-B-R Ab CBA, Serum,Unit:unknown,Normal Low:,Normal High:); Test Name: GAD65 Ab Assay, CSF (CNS autoimmune panel); Result Unstructured Data: (Test Result:0 GAD65 Ab Assay, CSF,Unit:nmol/L,Normal Low:,Normal High:less than or equal to 0.02); Test Name: GAD65 Ab Assay, Serum (Serum autoimmune panel); Result Unstructured Data: (Test Result:0 GAD65 Ab Assay, Serum,Unit:unknown,Normal Low:,Normal High:less than or equal to 0.02); Test Name: GFAP IFA, CSF (CNS autoimmune panel); Test Result: Negative ; Test Name: GFAP IFA, Serum (Serum autoimmune panel); Test Result: Negative ; Test Name: Human parechovirus (Meningitis Panel); Result Unstructured Data: (Test Result:Human parechovirus not detected,Unit:unknown,Normal Low:,Normal High:); Test Name: IgG versus Caspr1 (Acute neuropathy panel); Test Result: Negative ; Test Name: IgG versus Contactin-1 (Acute neuropathy panel); Test Result: Negative ; Test Name: IgG versus GalNAc-GD1a (Acute neuropathy panel); Result Unstructured Data: (Test Result:2300 IgG versus GalNAc-GD1a,Unit:unknown,Normal Low:,Normal High:2500); Test Name: IgG versus GD1b (Acute neuropathy panel); Result Unstructured Data: (Test Result:0 IgG versus GD1b,Unit:unknown,Normal Low:,Normal High:3000); Test Name: IgG versus GM1 (Acute neuropathy panel); Result Unstructured Data: (Test Result:0 IgG versus GM1,Unit:unknown,Normal Low:,Normal High:2000); Test Name: IgG versus GQ1b (Acute neuropathy panel); Result Unstructured Data: (Test Result:0 IgG versus GQ1b,Unit:unknown,Normal Low:,Normal High:2000); Test Name: IgG versus GT1a (Acute neuropathy panel); Result Unstructured Data: (Test Result:0 IgG versus GT1a,Unit:unknown,Normal Low:,Normal High:3000); Test Name: IgG versus Neurofascin-140 (Acute neuropathy panel); Test Result: Negative ; Test Name: IgG versus Neurofascin-155 (Acute neuropathy panel); Test Result: Negative ; Test Name: IgG versus Sulfatide (Acute neuropathy panel); Result Unstructured Data: (Test Result:0 IgG versus Sulfatide,Unit:unknown,Normal Low:,Normal High:3000); Test Name: IgG versus ?-Tubulin (Acute neuropathy panel); Result Unstructured Data: (Test Result:0 IgG versus ?-Tubulin,Unit:unknown,Normal Low:,Normal High:2500); Test Name: IgM versus GalNAc-GD1a (Acute neuropathy panel); Result Unstructured Data: (Test Result:0 IgM versus GalNAc-GD1a,Unit:unknown,Normal Low:,Normal High:10000); Test Name: IgM versus GD1a (Acute neuropathy panel); Result Unstructured Data: (Test Result:0 IgM versus GD1a,Unit:unknown,Normal Low:,Normal High:2000); Test Name: IgM versus GD1b (Acute neuropathy panel); Result Unstructured Data: (Test Result:0 IgM versus GD1b,Unit:unknown,Normal Low:,Normal High:3000); Test Name: IgM versus GM1 (Acute neuropathy panel); Result Unstructured Data: (Test Result:0 IgM versus GM1,Unit:unknown,Normal Low:,Normal High:2000); Test Name: IgM versus GM2 (Acute neuropathy panel); Result Unstructured Data: (Test Result:0 IgM versus GM2,Unit:unknown,Normal Low:,Normal High:3000); Test Name: IgM versus Heparan Sulfate (Acute neuropathy panel); Result Unstructured Data: (Test Result:0 IgM versus Heparan Sulfate,Unit:unknown,Normal Low:,Normal High:10000); Test Name: IgM versus Histone H3 (Acute neuropathy panel); Result Unstructured Data: (Test Result:1000 IgM versus Histone H3,Unit:unknown,Normal Low:,Normal High:5000); Test Name: IgM versus Neurofascin-155 (Acute neuropathy panel); Test Result: Negative ; Test Name: IgM versus ?-Tubulin (Acute neuropathy panel); Result Unstructured Data: (Test Result:0 IgM versus ?-Tubulin,Unit:unknown,Normal Low:,Normal High:2500); Test Name: LGI1-IgG CBA, CSF (CNS autoimmune panel); Test Result: Negative ; Test Name: LGI1-IgG CBA, Serum (Serum autoimmune panel); Test Result: Negative ; Test Name: Listeria monocytogenes (Meningitis Panel); Result Unstructured Data: (Test Result:Not detected,Unit:unknown,Normal Low:,Normal High:); Test Name: mGluR1 Ab IFA, CSF (CNS autoimmune panel); Test Result: Negative ; Test Name: mGluR1 Ab IFA, Serum (Serum autoimmune panel); Test Result: Negative ; Test Name: MOG FACS (Serum autoimmune panel); Test Result: Negative ; Test Name: NMDA-R Ab CBA, CSF (CNS autoimmune panel); Test Result: Negative ; Test Name: NMDA-R Ab CBA, Serum (Serum autoimmune panel); Test Result: Negative ; Test Name: NMO/AQP4 FACS, CSF (CNS autoimmune panel); Test Result: Negative ; Test Name: NMO/AQP4 FACS, Serum (Serum autoimmune panel); Test Result: Negative ; Test Name: Peds Autoimmune Eval Reflex (CNS autoimmune panel); Result Unstructured Data: (Test Result:No Peds Autoimmune Eval Reflex added,Unit:unknown,Normal Low:,Normal High:); Test Name: Peds Autoimmune Eval Reflex (Serum autoimmune panel); Result Unstructured Data: (Test Result:No Peds Autoimmune Eval Reflex added,Unit:unknown,Normal Low:,Normal High:); Test Name: Purkinje Cell Cytoplasmic Ab Type TR (PCA-Tr), CSF (CNS autoimmune panel); Test Result: Negative ; Test Name: Purkinje Cell Cytoplasmic Ab Type TR (PCA-Tr), Serum (Serum autoimmune panel); Test Result: Negative ; Test Name: respiratory status; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: MRI of the entire spine; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: MRI brain; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: Neisseria meningitidis (Meningitis Panel); Result Unstructured Data: (Test Result:Not detected,Unit:unknown,Normal Low:,Normal High:); Test Name: Neisseria meningitidis (Meningitis Panel); Result Unstructured Data: (Test Result:Not detected,Unit:unknown,Normal Low:,Normal High:); Test Name: neurologic exam; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: Physical examination; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: lung examination; Result Unstructured Data: (Test Result:remarkable for inspiratory stridor,Unit:unknown,Normal Low:,Normal High:); Test Name: Streptococcus agalactiae (Meningitis Panel); Result Unstructured Data: (Test Result:Not detected,Unit:unknown,Normal Low:,Normal High:); Test Name: Streptococcus pneumoniae (Meningitis Panel); Result Unstructured Data: (Test Result:Not detected,Unit:unknown,Normal Low:,Normal High:); Test Name: Varicella zoster virus (Meningitis Panel); Result Unstructured Data: (Test Result:Not detected,Unit:unknown,Normal Low:,Normal High:); Comments: On neurologic exam, the patient was awake and followed commands. The patient was nonverbal but hummed with a soft voice. The patient's pupils were equal and reactive to light, and gaze was conjugate in all directions. Magnetic resonance imaging (MRI) of the brain with and without contrast revealed abnormal smooth enhancement of the bilateral oculomotor, trigeminal, facial, and vagus nerves. Her oculomotor nerves, along with multiple other cranial nerves, were T2 hyperintense on MRI brain. MRI of the entire spine obtained with and without contrast showed similar smooth enhancement of spinal nerve roots at many levels, most conspicuous in the cauda equina and cervicothoracic junction. Respiratory status was monitored and without complication, and her symptoms steadily improved. Patient's extraocular muscles appeared intact on physical examination.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- M
- Eingang
- 03.08.2022
- Impfdatum
- 15.12.2020
- Beginn
- 24.12.2020
- Tage bis Beginn
- 9,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Diplegia
Guillain-Barre syndrome
Immunisation reaction
Symptomtext
Guillain-Barre Syndrome/vaccine induced acute inflammatory demyelinating polyradiculoneuropathy (AIDP); This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 15th December 2020, the patient received Shingrix. On 24th December 2020, 9 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix. GSK Receipt Date: 28 Jul 2022 Reporter's Comments Plaintiff being administered the Shingrix on 15 Dec 2020.On or about 24 Dec 2020, Plaintiff started experiencing signs and symptoms of Guillain-Barre Syndrome including ascending motor paralysis in his legs and arms.On or about 7 Jan 2021, Plaintiff was diagnosed with vaccine induced acute inflammatory demyelinating polyradiculoneuropathy (AIDP), otherwise known as Guillain-Barre Syndrome.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Paralysis
Symptomtext
a young lady that got it [HPV vaccines] and it paralyzed her for 5 months; This case was reported in a literature article and described the occurrence of paralysis in a female patient who received HPV 16-18 (HPV vaccine) for prophylaxis. On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced paralysis (serious criteria GSK medically significant and other: serious as per reporter). On an unknown date, the outcome of the paralysis was recovered/resolved. The reporter considered the paralysis to be related to HPV vaccine. Additional Information: GSK Receipt Date: 19 Jul 2022 Author Comment: This case refers for a female patient from table no 4 theme 3 as described in the article. The author aimed to identify human papillomavirus (HPV) and HPV vaccine-related knowledge, attitudes, and beliefs among women aged 27-45 years, who became eligible for HPV vaccination in 2018. This study was in the region. The author conducted eight semi-structured text-based synchronous focus groups using an virtual chatroom. Focus group questions covered three areas: 1) knowledge and beliefs about HPV and HPV vaccination, 2) attitudes toward HPV vaccination for oneself, and 3) barriers and facilitators to HPV vaccine uptake. Concerns about HPV vaccine-related side effects were common and identified among participants across all racial/ethnic groups and education levels. The reporter stated that the patient got human papillomavirus vaccine. The reporter had a concern about HPV vaccine side effect and safety vaccination had a serious side effect. The reporter stated that the patient had paralysis for 5 months. "Unanswered questions, low awareness about eligibility, lack of knowledge about the benefits of vaccination after sexual debut, concerns and mistaken beliefs about side effects and safety, and perceived social stigma may serve as key barriers to shared clinical decision-making about HPV vaccination for women ages 27-45 years. Promising intervention strategies for addressing these KAB-related barriers include 1) disseminating basic information about HPV vaccine eligibility, safety, and efficacy that was specific to women aged 27-45 and 2) framing HPV vaccination as taking control of one's health and preventing illness, even after sexual debut."
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Abnormal behaviour
Brain injury
Injury
Pertussis
Seizure
Symptomtext
Intractable seizures; Brain damage; Pertussis; Profoundly injured; functions like 2 to 3 years old; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a 47-year-old female patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced seizure (serious criteria GSK medically significant), brain damage (serious criteria GSK medically significant), pertussis (serious criteria GSK medically significant), injury and behavior abnormal. On an unknown date, the outcome of the seizure, brain damage, pertussis, injury and behavior abnormal were unknown. It was unknown if the reporter considered the seizure, brain damage, pertussis and behavior abnormal to be related to DTP vaccine. The reporter considered the injury to be related to DTP vaccine. Additional Information: GSK Receipt Date: 19-Jul-2022. Reporter's Comments: This case was reported by a patient's parent via interactive digital media. The patient was profoundly injured from first dose of DPT vaccine. The pertussis caused brain damage and intractable seizures. The patient functions like 2 to 3 years old. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Back pain
COVID-19
Electric shock sensation
Headache
Herpes zoster
Nausea
Pain
Vaccination failure
Symptomtext
I had the vaccine and got Shingles/Suspected vaccination failure; I had the vaccine and got Shingles; COVID; worst pain; pain in my back is still there; headache; nausea; electrical shock type feelings; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, covid-19, pain, back pain, headache, nausea and electric shock sensation. On an unknown date, the outcome of the vaccination failure, shingles, covid-19, pain, headache and nausea were unknown and the outcome of the back pain and electric shock sensation were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, covid-19, pain, back pain, headache, nausea and electric shock sensation to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient had the Shingles vaccine before Covid and he/she still got Shingles. The patient said it was the worst pain, headache and nausea ever felt. The shingles were dried up but the pain in his/her back was still there and still had electrical shock type feelings throughout his/her body daily. Additional Supportive Information: This case was considered as suspected vaccination failure as the details regarding completion of primary vaccination, time to onset and laboratory confirmation for shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Electric shock sensation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 23.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Breath holding
Crying
Musculoskeletal stiffness
Seizure
Symptomtext
might be a seizure/possible seizure; stiffening of his arms/stiffening of the body; hold his breath; This case was reported by a physician via other manufacturer and described the occurrence of seizure in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) for prophylaxis. Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVENAR 13) for prophylaxis. Concomitant products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVENAR 13). On an unknown date, the patient received Rotarix lyophilized formulation, Rotarix Oral Applicator Device and the 2nd dose of PREVENAR 13. On an unknown date, less than 2 weeks after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced seizure (serious criteria GSK medically significant), limbs stiffness and breath holding. On an unknown date, the outcome of the seizure, limbs stiffness and breath holding were recovered/resolved. The reporter considered the seizure, limbs stiffness and breath holding to be possibly related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-July-2022 Reporter's comment: The reporter had a patient this past week, from date of reporting who was 4 months old, that had gotten the Prevnar 13 at 2 months old as well, and received the vaccines including the Prevnar 13 and Rotarix. The Rotarix was given first and the second vaccine given was Prevnar 13. The 3rd vaccine that the patient was to receive was the Pentacel for DTaP-IPV/HIB for diphtheria, tetanus, whooping cough and polio. Following the injection of Prevnar 13, the baby, which was reported by the mother and medical assistant, seemed to hold his breath and did not turn cyanotic but had stiffening of his arms outward. The mother came in alerted the reporter and the caller found the baby to be stable and not cyanotic with no seizure. The medical assistant had picked the baby up and gave the injections and the baby started crying. The reporter thought the episode was a breath holding spell but after reading literature on the product insert, he thought this might be a seizure and be reported as a possible vaccine reaction. The medical assistant was very qualified, but the mother panicked and alerted the caller. The medical assistant reported the stiffening of the body and the baby's arms out. No tonic clonic jerking but not certain if this was a breath holding spell. According to the reporter, breathing holding was normally seen in babies 9 to 10 months to a 1 to 1.5 years but could have seizure like activity for breath holding. He had not been able to reach the mother and assumed the mother might had taken the baby elsewhere. He had the packet insert and sees seizure as an adverse effect and mentioned seizures. He was wondering if baby could have had a seizure following the vaccine. He wanted to talk with Pfizer for possible seizures following the Prevnar 13 vaccine and see if the baby was at risk. He asked what the experiences with babies was having seizures after the Prevnar 13 vaccine. The reporter reported the patient got the same vaccine at 2 months of age and this was the second Prevnar 13 vaccine. The reporter declined to complete a report. The reporter consented to follow-up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- PREVENAR 13
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 0,3
- Geschlecht
- M
- Eingang
- 23.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Breath holding
Crying
Musculoskeletal stiffness
Seizure
Symptomtext
might be a seizure/possible seizure; stiffening of his arms/stiffening of the body; hold his breath; This case was reported by a physician via other manufacturer and described the occurrence of seizure in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) for prophylaxis. Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVENAR 13) for prophylaxis. Concomitant products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVENAR 13). On an unknown date, the patient received Rotarix lyophilized formulation, Rotarix Oral Applicator Device and the 2nd dose of PREVENAR 13. On an unknown date, less than 2 weeks after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced seizure (serious criteria GSK medically significant), limbs stiffness and breath holding. On an unknown date, the outcome of the seizure, limbs stiffness and breath holding were recovered/resolved. The reporter considered the seizure, limbs stiffness and breath holding to be possibly related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-July-2022 Reporter's comment: The reporter had a patient this past week, from date of reporting who was 4 months old, that had gotten the Prevnar 13 at 2 months old as well, and received the vaccines including the Prevnar 13 and Rotarix. The Rotarix was given first and the second vaccine given was Prevnar 13. The 3rd vaccine that the patient was to receive was the Pentacel for DTaP-IPV/HIB for diphtheria, tetanus, whooping cough and polio. Following the injection of Prevnar 13, the baby, which was reported by the mother and medical assistant, seemed to hold his breath and did not turn cyanotic but had stiffening of his arms outward. The mother came in alerted the reporter and the caller found the baby to be stable and not cyanotic with no seizure. The medical assistant had picked the baby up and gave the injections and the baby started crying. The reporter thought the episode was a breath holding spell but after reading literature on the product insert, he thought this might be a seizure and be reported as a possible vaccine reaction. The medical assistant was very qualified, but the mother panicked and alerted the caller. The medical assistant reported the stiffening of the body and the baby's arms out. No tonic clonic jerking but not certain if this was a breath holding spell. According to the reporter, breathing holding was normally seen in babies 9 to 10 months to a 1 to 1.5 years but could have seizure like activity for breath holding. He had not been able to reach the mother and assumed the mother might had taken the baby elsewhere. He had the packet insert and sees seizure as an adverse effect and mentioned seizures. He was wondering if baby could have had a seizure following the vaccine. He wanted to talk with Pfizer for possible seizures following the Prevnar 13 vaccine and see if the baby was at risk. He asked what the experiences with babies was having seizures after the Prevnar 13 vaccine. The reporter reported the patient got the same vaccine at 2 months of age and this was the second Prevnar 13 vaccine. The reporter declined to complete a report. The reporter consented to follow-up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- PREVENAR 13
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 23.07.2022
- Impfdatum
- 14.06.2022
- Beginn
- 14.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: ja
Computerised tomogram normal
Dizziness
Fall
Ligament sprain
Loss of consciousness
Magnetic resonance imaging normal
Musculoskeletal discomfort
Nausea
Pelvic discomfort
Urinary tract infection
Symptomtext
Fell when passed out; Passed out twice; left foot/ankle sprain; Urinary tract infection (UTI); Lower back had been bothering her; Pelvic area had been bothering her; Nausea; Dizziness; This case was reported by a other health professional via other manufacturer and described the occurrence of fall in a adult female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. Co-suspect products included eculizumab (Soliris) for neuromyelitis optica spectrum disorder. Concurrent medical conditions included neuromyelitis optica spectrum disorder. On 14th June 2022, the patient received Hz/su + AS01B. On an unknown date, the patient started Soliris 300 mg at an unknown frequency. On 14th June 2022, several hours after receiving Hz/su + AS01B, the patient experienced fall (serious criteria hospitalization), passed out (serious criteria hospitalization and GSK medically significant), sprained ankle (serious criteria hospitalization and clinically significant/intervention required), urinary tract infection (serious criteria hospitalization), musculoskeletal discomfort, pelvic discomfort, nausea and dizziness. The action taken with Soliris was unknown. In June 2022, the outcome of the passed out was recovered/resolved. On an unknown date, the outcome of the fall, sprained ankle, urinary tract infection, musculoskeletal discomfort, pelvic discomfort, nausea and dizziness were unknown. It was unknown if the reporter considered the fall, passed out, sprained ankle, urinary tract infection, musculoskeletal discomfort, pelvic discomfort, nausea and dizziness to be related to Hz/su + AS01B. Additional Information: GSK Receipt Date: 13-JUL-2022 Reporter's Comments: The patient received the varicella-zoster vaccine RGE (CHO) (Shingrix) (dose, route, and frequency were not reported). On an unspecified date, the patient initiated treatment with eculizumab (Soliris) (dose, route, and frequency were not reported) for the treatment of neuromyelitis optic (NMO). The most recent dose of Eculizumab administered prior to the onset of the events was not reported. The batch or lot number and expiration date were reported as unknown. The patient reported that she passed out twice following a varicella-zoster vaccine RGE (CHO) two weeks ago on 14th June 2022. The patient passed out several hours after receiving that vaccine and then passed out later in the evening. The patient fell when she passed out resulting in a left foot or ankle sprain. The patient went to the emergency room for evaluation and they admitted her overnight. The patient had an MRI (Magnetic resonance imaging) and CAT (computed tomography) scan with negative results. The patient was diagnosed with a UTI (Urinary Tract Infection) while at the hospital. It was reported that her lower back and the pelvic area had been bothering her earlier that day. It was also reported that since the vaccine she had intermittent nausea and dizziness. The patient reported that it was her off week from Eculizumab the week she received the vaccine. Action taken with eculizumab in response to the events was not reported. The corrective treatment for the events was not reported. The reporter requested additional information. It was unknown if the reporter considered the fall, passed out, sprained ankle, urinary tract infection, musculoskeletal discomfort, pelvic discomfort, nausea and dizziness to be related to Soliris.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- 1,0
- Labordaten
- Test Date: 20220614; Test Name: CAT scan; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20220614; Test Name: MRI scan; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- Neuromyelitis optica spectrum disorder
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 23.07.2022
- Impfdatum
- 14.06.2022
- Beginn
- 14.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: ja
Computerised tomogram normal
Dizziness
Fall
Ligament sprain
Loss of consciousness
Magnetic resonance imaging normal
Musculoskeletal discomfort
Nausea
Pelvic discomfort
Urinary tract infection
Symptomtext
Fell when passed out; Passed out twice; left foot/ankle sprain; Urinary tract infection (UTI); Lower back had been bothering her; Pelvic area had been bothering her; Nausea; Dizziness; This case was reported by a other health professional via other manufacturer and described the occurrence of fall in a adult female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. Co-suspect products included eculizumab (Soliris) for neuromyelitis optica spectrum disorder. Concurrent medical conditions included neuromyelitis optica spectrum disorder. On 14th June 2022, the patient received Hz/su + AS01B. On an unknown date, the patient started Soliris 300 mg at an unknown frequency. On 14th June 2022, several hours after receiving Hz/su + AS01B, the patient experienced fall (serious criteria hospitalization), passed out (serious criteria hospitalization and GSK medically significant), sprained ankle (serious criteria hospitalization and clinically significant/intervention required), urinary tract infection (serious criteria hospitalization), musculoskeletal discomfort, pelvic discomfort, nausea and dizziness. The action taken with Soliris was unknown. In June 2022, the outcome of the passed out was recovered/resolved. On an unknown date, the outcome of the fall, sprained ankle, urinary tract infection, musculoskeletal discomfort, pelvic discomfort, nausea and dizziness were unknown. It was unknown if the reporter considered the fall, passed out, sprained ankle, urinary tract infection, musculoskeletal discomfort, pelvic discomfort, nausea and dizziness to be related to Hz/su + AS01B. Additional Information: GSK Receipt Date: 13-JUL-2022 Reporter's Comments: The patient received the varicella-zoster vaccine RGE (CHO) (Shingrix) (dose, route, and frequency were not reported). On an unspecified date, the patient initiated treatment with eculizumab (Soliris) (dose, route, and frequency were not reported) for the treatment of neuromyelitis optic (NMO). The most recent dose of Eculizumab administered prior to the onset of the events was not reported. The batch or lot number and expiration date were reported as unknown. The patient reported that she passed out twice following a varicella-zoster vaccine RGE (CHO) two weeks ago on 14th June 2022. The patient passed out several hours after receiving that vaccine and then passed out later in the evening. The patient fell when she passed out resulting in a left foot or ankle sprain. The patient went to the emergency room for evaluation and they admitted her overnight. The patient had an MRI (Magnetic resonance imaging) and CAT (computed tomography) scan with negative results. The patient was diagnosed with a UTI (Urinary Tract Infection) while at the hospital. It was reported that her lower back and the pelvic area had been bothering her earlier that day. It was also reported that since the vaccine she had intermittent nausea and dizziness. The patient reported that it was her off week from Eculizumab the week she received the vaccine. Action taken with eculizumab in response to the events was not reported. The corrective treatment for the events was not reported. The reporter requested additional information. It was unknown if the reporter considered the fall, passed out, sprained ankle, urinary tract infection, musculoskeletal discomfort, pelvic discomfort, nausea and dizziness to be related to Soliris.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- 1,0
- Labordaten
- Test Date: 20220614; Test Name: CAT scan; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20220614; Test Name: MRI scan; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- Neuromyelitis optica spectrum disorder
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 23.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Generalised tonic-clonic seizure
Symptomtext
multiple Grand mal seizures; This case was reported by a consumer via interactive digital media and described the occurrence of grand mal seizure in a male patient who received DTPa (DTaP vaccine) for prophylaxis. On an unknown date, the patient received DTaP vaccine. On an unknown date, less than a day after receiving DTaP vaccine, the patient experienced grand mal seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the grand mal seizure was unknown. It was unknown if the reporter considered the grand mal seizure to be related to DTaP vaccine. Additional Information: GSK Receipt Date: 12-July-2022 Reporter's Comments: This case was received from the patient's parent via interactive digital media. The reporter said that she was lucky that her son did not die from his shot. But what he did was, had multiple Grand Mal Seizures within 4 hours of every one of his DTP shots. After the 3rd time his doctor wrote No Pertussis in red letters on his chart. She also saw to it that his sister only got the TD shot. Additional supportive information: The reporter reported that "had multiple Grand Mal Seizures within 4 hours of every one of his DTP shots" but due to limited information on number of shots and FU-no contact details, only 1 case was created.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Generalised tonic-clonic seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- F
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anion gap
Antiacetylcholine receptor antibody positive
Antibody test negative
Aspartate aminotransferase increased
Asthenia
ASIA syndrome
Abdominal abscess
Abscess drainage
Acid fast bacilli infection
Alanine aminotransferase increased
Autoantibody negative
B-lymphocyte count
B-lymphocyte count increased
Bacillus bacteraemia
Bedridden
Biopsy muscle abnormal
Blood 1,25-dihydroxycholecalciferol increased
Blood 25-hydroxycholecalciferol increased
Symptomtext
generalised pain; Proximal weakness/ too weak to ambulate; left arm swelling/left upper extremity was diffusely swollen from the bicep to the dorsum of the hand; left arm swelling and pain; progressive weakness that involved her bilateral upper and lower extremities; dyspnoea on exertion; palpitations; polydipsia; polyuria; non-bilious non-bloody emesis; hypertensive; ECG demonstrated sinus tachycardia/tachycardic; non-pitting oedema; mild leucocytosis; severe hypercalcaemia/granulomatous hypercalcaemia; fever; subsequently intubated for progressive respiratory insufficiency/ neuromuscular respiratory failure; critical illness myopathy; MRI of her left upper extremity and right thigh revealed diffuse oedema throughout the musculature compatible with myositis; dense lymphohistiocytic infiltrate; cytomegalovirus (CMV) viremia; diverticulitis with associated perforation; dysphagia; acid-fast bacilli bacteraemia; intrabdominal polymicrobial abscesses; beta-lactamase producing Escherichia coli bacterial urinary tract infection; Giant cell myositis (GCM); autoimmune/inflammatory syndrome induced by adjuvants (ASIA); This case was reported in a literature article and described the occurrence of myositis in a adult female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. The patient's past medical history included exeresis (for thymoma) and radiation therapy (for thymoma). Concurrent medical conditions included myasthenia gravis, systemic lupus erythematosus, thymoma (8 years earlier), pleural metastases (residual tumour with pleural metastases) and ill-defined disorder. Additional patient notes included She had no history of a myasthenic crisis.. Concomitant products included prednisone, azathioprine, hydroxychloroquine and vitamins nos (Vitamin Supplements). On an unknown date, the patient received Influenza vaccine. On an unknown date, 3 days after receiving Influenza vaccine, the patient experienced myositis (serious criteria hospitalization), autoimmune/inflammatory syndrome induced by adjuvants (serious criteria GSK medically significant), generalized aching (serious criteria hospitalization), weakness (serious criteria hospitalization), peripheral swelling (serious criteria hospitalization), pain in arm (serious criteria hospitalization), weakness in extremity (serious criteria hospitalization), exertional dyspnea (serious criteria hospitalization), palpitation (serious criteria hospitalization), polydipsia (serious criteria hospitalization), polyuria (serious criteria hospitalization), vomiting (serious criteria hospitalization), hypertension (serious criteria hospitalization), sinus tachycardia (serious criteria hospitalization), non-pitting edema (serious criteria hospitalization), leukocytosis (serious criteria hospitalization), hypercalcemia (serious criteria hospitalization), fever (serious criteria hospitalization), respiratory insufficiency (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), critical illness myopathy (serious criteria hospitalization), macular diffuse edema (serious criteria hospitalization and GSK medically significant), lymphocytic infiltrates nos (serious criteria hospitalization), cytomegalovirus viremia (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), diverticular perforation (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), dysphagia (serious criteria hospitalization and clinically significant/intervention required), bacillus bacteraemia (serious criteria hospitalization and GSK medically significant), abdominal abscess (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and escherichia urinary tract infection (serious criteria hospitalization). The patient was treated with immunoglobulins nos (Immune Globulin, Intravenous), methylprednisolone, operations and procedures (Plasma Exchange), valganciclovir, calcitonin, zoledronic acid (Zolendronic Acid), medication unknown (Fluids) and antibiotics nos (Broad Spectrum Antibiotics (Ingredients Unknown)). On an unknown date, the outcome of the myositis, autoimmune/inflammatory syndrome induced by adjuvants, generalized aching, peripheral swelling, pain in arm, exertional dyspnea, palpitation, polydipsia, polyuria, vomiting, hypertension, sinus tachycardia, non-pitting edema, leukocytosis, fever, respiratory insufficiency, critical illness myopathy, macular diffuse edema, lymphocytic infiltrates nos, cytomegalovirus viremia, diverticular perforation, bacillus bacteraemia, abdominal abscess and escherichia urinary tract infection were unknown and the outcome of the weakness and weakness in extremity were recovering/resolving and the outcome of the hypercalcemia and dysphagia were recovered/resolved. The reporter considered the myositis, autoimmune/inflammatory syndrome induced by adjuvants, generalized aching, weakness, peripheral swelling, pain in arm, weakness in extremity, exertional dyspnea, palpitation, polydipsia, polyuria, vomiting, hypertension, sinus tachycardia, non-pitting edema, leukocytosis, hypercalcemia, fever, respiratory insufficiency, critical illness myopathy, macular diffuse edema, lymphocytic infiltrates nos, cytomegalovirus viremia, diverticular perforation, dysphagia, bacillus bacteraemia, abdominal abscess and escherichia urinary tract infection to be possibly related to Influenza vaccine. Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter Comment: A woman in her late 50s with a history of myasthenia gravis MG, systemic lupus erythematosus and stage IV thymoma with pleural metastases, presented with 3 weeks of generalized pain and weakness after receiving the influenza vaccine. At baseline, the patient was active and independent, on a home medication regimen that included prednisone 5 mg, azathioprine 125 mg and hydroxychloroquine 200 mg daily. She was in her usual state of health until she went for her annual influenza vaccine which she received in her left arm. Three days later, she developed left arm swelling and pain, with progressive weakness that involved her bilateral upper and lower extremities, eventually becoming too weak to ambulate. During this time, she also developed dyspnoea on exertion, palpitations, polydipsia, polyuria and non-bilious non-bloody emesis. Review of systems was negative for diplopia, fevers, chest pain, diarrhea or dysuria. Regarding her thymoma and MG history, the patient was diagnosed with a thymoma 8 years earlier for which she underwent a resection and radiation therapy the following year. Pathological examination revealed a mixed type B2 and B3 thymoma with positive margins, stage IVa, pT4N0, and she was noted to have residual tumour with pleural metastases that were slowly growing and being monitored. She was subsequently diagnosed with MG the year prior to presentation after developing bulbar symptoms and testing positive for acetylcholine binding receptor antibody. She had no history of a myasthenic crisis, and her symptoms were well controlled prior to presentation. On admission, the patient was tachycardic and hypertensive but did not appear in acute distress. She had proximal greater than distal weakness in her bilateral upper and lower extremities (Medical Research Council Scale for muscle strength: 4/5 in deltoids, biceps brachii and triceps but 4+/5 in finger flexors and extensors; 3/5 in iliopsoas and 4/5 at tibialis anterior), 4/5 strength with neck flexion and maximal inspiratory pressure of -30 cm H2O. Her left upper extremity was diffusely swollen from the bicep to the dorsum of the hand with non-pitting oedema. Laboratory studies were notable for a mild leucocytosis, severe hypercalcaemia to 14.2 mg/dL, an elevated creatine kinase (CK) to 1541 U/L, as well as elevated C reactive protein, erythrocyte sedimentation rate, transaminases and lactate dehydrogenase. Her hypercalcaemia was treated with fluids, calcitonin and zolendronic acid. Her home azathioprine and prednisone were continued. She was admitted to the intensive care unit (ICU) for respiratory monitoring and started on a 5-day course of intravenous immune globulin (IVIG) given concern for a myasthenic crisis. On hospital day 2, she developed a fever without a clear infectious source which was treated empirically with broad spectrum antibiotics and was subsequently intubated for progressive respiratory insufficiency. She required mechanical ventilation in the ICU but did not require sedation for the remainder of her hospital course. During her fever workup, a CT of the abdomen and pelvis demonstrated abnormal signal of the proximal thighs and pelvic girdle musculature concerning for myositis. She underwent electromyography of the left arm which demonstrated a diffuse myopathic process without membrane irritability, most consistent with a critical illness myopathy rather than an inflammatory myopathy. Moreover, myositis autoantibody panel and serology for 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase antibody were negative. Subsequently, MRI of her left upper extremity and right thigh revealed diffuse oedema throughout the musculature compatible with Myositis. A muscle biopsy of the right biceps brachii was then performed, which revealed a dense lymphohistiocytic infiltrate with abundant multinucleated giant cells and frequent degenerating/regenerating muscle fibres. Immunohistochemistry revealed abundant CD68-positive macrophages and giant cells, a dense endomysial population of CD3-positive T-lymphocytes and only scattered CD20-positive B-lymphocytes. Immunohistochemistry for Major Histocompatibility Complex I (MHC-I) showed strong and diffuse sarcolemmal staining of the muscle fibres, indicative of upregulation of MHC-I. A stain for acid-fast bacilli did not reveal any acid-fast microorganisms. Notably, this pathology was not characteristic of a hydroxychloroquine myopathy4 and demonstrated an alternate diagnosis of GCM. On admission, her troponin level was normal, and ECG demonstrated sinus tachycardia. On diagnosis of GCM, the patient underwent an echocardiogram to assess for potential cardiac involvement which revealed normal biventricular function. Workup for hypercalcaemia demonstrated a significantly elevated vitamin D 1,25 dihydroxy, which was consistent with a parathyroid hormone independent, granulomatous aetiology. The patient's home vitamin supplements were reviewed by hospital nutritionists and there was no evidence of a supplement that could account for an elevation in vitamin D 1,25 dihydroxy. CT of the chest and abdomen/pelvis obtained during the hospitalisation did not reveal hilar adenopathy or other lesions concerning for sarcoidosis or lymphoma. Her CT chest showed an interval size increase in multiple left pleural droplet thymoma metastases. After initial temporizing treatments on admission and with treatment of the patient's GCM as described below, the patient's hypercalcaemia did not recur during the remainder of her hospital course. She was treated with a 5-day course of IVIG on admission for a presumed myasthenic crisis, and empiric treatment of myositis was initiated on hospital day 10 with 1 mg/kg/day of IV methylprednisolone after the muscle biopsy was obtained. Her CK levels began to decrease within 48 hours of treatment, but her proximal and respiratory weakness remained unchanged. A tracheostomy was performed on hospital day 13. She was treated with 5 days of plasma exchange (PLEX) starting on hospital day 15 for a presumed component of myasthenic crisis to her respiratory weakness. On hospital day 18, she received 3 days of pulse steroids (1 g/day IV methylprednisolone) after her muscle biopsy pathology provided the diagnosis of GCM, after which she resumed 1 mg/kg/day dosing. Her course was complicated by cytomegalovirus (CMV) diverticulitis with associated perforation requiring emergent exploratory laparotomy and hemicolectomy with Hartmann's ostomy on hospital day 22. She was treated with a 3-week course of valganciclovir for CMV viremia that was completed as an outpatient. A gastrostomy tube was placed on hospital day 35 for ongoing dysphagia but she subsequently regained swallowing function and resumed a regular diet while in the hospital. She was discharged home with services after a 6-week hospital course with a tracheostomy and gastrostomy tube still in place, with planned decannulation and closure as an outpatient. At the time of discharge, her proximal strength was slowly improving but the patient was still bed-bound. Her discharge medications included her home azathioprine and prednisone 60 mg daily with plans to complete a slow taper as an outpatient. On returning home, her strength continued to improve, and she was decannulated and took her first steps with a walker approximately 1 month after discharge. She was readmitted to the hospital 2 months after discharge with acid-fast bacilli bacteraemia and intraabdominal polymicrobial abscesses that required percutaneous drainage by an interventional radiologist, and a prolonged antimicrobial course. She was also treated for an extended spectrum beta-lactamase producing Escherichia coli bacterial urinary tract infection during this admission. Her prednisone dose had been decreased to 30 mg daily at time of readmission. Her outpatient rheumatologist and oncologist opted to avoid further immunosuppressive agents given the patient's numerous infections, thus rituximab treatment was deferred in favour of monthly 2 g/kg IVIG treatments. The patient continued to be followed as an outpatient and was more than 6 months post-biopsy. The above case demonstrated important clinical considerations when managing a patient with GCM. While the patient in this case did not develop giant cell myocarditis, it was critical to assess for cardiac involvement in the acute setting, as GCM has been associated with giant cell myocarditis in over 40% of cases reported to date which could lead to a rapid clinical deterioration with a high mortality rate. Regarding treatment, this patient responded to a combination of steroids, IVIG and PLEX therapy for treatment of her comorbid MG. This patient's comorbid MG presented a challenge in selecting an appropriate treatment regimen, as throughout her hospital course, it was unclear if her respiratory failure was secondary to a concomitant myasthenic crisis or diaphragmatic involvement of GCM or both, which could not be delineated in the absence of a diaphragm biopsy. Regarding the patient's diagnosis of GCM, it was important to consider sarcoid myopathy in this case, which could also present as an acute granulomatous myositis. Histologically, sarcoid myopathy presenting as a granulomatous myositis could not definitively be differentiated from GCM given significant overlapping morphologic feature; however, the diagnosis of sarcoid myopathy requires evidence of sarcoid involvement in at least one additional organ system. In this case, there was no clinical evidence of multisystem sarcoidosis, nor identification of non-myopathic sarcoid lesions from extensive imaging which was obtained throughout her hospital course. This case also had several unique clinical features that have thus far only rarely been reported. First was the patient's presentation with severe hypercalcaemia, which was consistent with a granulomatous driven process. Granulomatous hypercalcaemia has been described in cases of sarcoidosis and lymphoma; however, no evidence of these conditions was identified during the patient's workup. Moreover, the patient's hypercalcaemia did not recur after treatment of her GCM. Thus, the aetiology of her granulomatous hypercalcaemia was favoured to be secondary to her GCM, as macrophages and giant cells convert 25-hydroxy vitamin D to 1,25 dihydroxy via increased 1alpha-hydroxylase activity. Still, considering the high morbidity and mortality associated with GCM, clinicians should consider this diagnosis when caring for patients with metastatic thymoma who present with weakness and muscular pain. Finally, it was notable that this patient's symptoms began shortly after receiving the influenza vaccine, suggesting that the effects of the vaccination may have precipitated the onset of GCM in this individual. Previous reports have highlighted an association between vaccine administration and symptom onset of immune-mediated conditions, possibly explained by vaccine adjuvants with inflammatory properties. Such conditions were referred to as autoimmune/inflammatory syndrome induced by adjuvants (ASIA). Within this spectrum of conditions, inflammatory myopathies associated with vaccine administration have been described. Given the temporal association between the patient's receipt of the influenza vaccine and myopathy symptom onset, a diagnosis of ASIA could not be excluded in this case. Importantly, ASIA was an extremely uncommon condition, and a review of the literature found no significant increase in the incidence of inflammatory myopathies following previous vaccination campaigns. Thus, the risk of developing a reactive inflammatory myopathy following vaccine administration pales in comparison to the significant benefits of protection against infection conferred by vaccination. Additional supportive information: This article is not available for regulatory reporting due to copyright restriction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Intensive care
- Hospital-Tage
- -
- Labordaten
- Test Name: Anion gap; Result Unstructured Data: (Test Result:11,Unit:unknown,Normal Low:4,Normal High:14); Test Name: acetylcholine binding receptor antibody; Test Result: Positive ; Test Name: Aspartate transaminase; Result Unstructured Data: (Test Result:184,Unit:u/L,Normal Low:5,Normal High:44); Test Name: muscle biopsy; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: muscle biopsy; Result Unstructured Data: (Test Result:presumed myasthenic crisis,Unit:unknown,Normal Low:,Normal High:); Test Name: muscle biopsy; Result Unstructured Data: (Test Result:diagnosis of GCM,Unit:unknown,Normal Low:,Normal High:); Test Name: Vitamin D, 1,25-dihydroxy total; Result Unstructured Data: (Test Result:greater than 150 (elevated),Unit:ng/L,Normal Low:20,Normal High:79); Test Name: Vitamin D, 25-hydroxy; Result Unstructured Data: (Test Result:56,Unit:ng/L,Normal Low:20,Normal High:50); Test Name: Alkaline phosphatase; Result Unstructured Data: (Test Result:50,Unit:u/L,Normal Low:38,Normal High:108); Test Name: total bilirubin; Test Result: 0.5 mg/dl; Test Name: blood calcium; Result Unstructured Data: (Test Result:severe hypercalcaemia (14.2),Unit:mg/dL,Normal Low:8.4,Normal High:10.5); Test Name: Chloride; Result Unstructured Data: (Test Result:95,Unit:mmol/L,Normal Low:101,Normal High:110); Test Name: creatine kinase; Result Unstructured Data: (Test Result:elevated (1541),Unit:u/L,Normal Low:37,Normal High:241); Test Name: creatine kinase; Result Unstructured Data: (Test Result:began to decrease within 48 hours of treatment,Unit:u/L,Normal Low:37,Normal High:241); Test Name: Creatinine; Test Result: 1.04 mg/dl; Test Name: Glucose; Test Result: 101 mg/dl; Test Name: lactate dehydrogenase; Result Unstructured Data: (Test Result:elevated (1534),Unit:u/L,Normal Low:125,Normal High:243); Test Name: Parathyroid hormone; Result Unstructured Data: (Test Result:22,Unit:ng/L,Normal Low:18,Normal High:90); Test Name: Potassium; Result Unstructured Data: (Test Result:4.1,Unit:mmol/L,Normal Low:3.5,Normal High:5.0); Test Name: Sodium; Result Unstructured Data: (Test Result:133,Unit:mmol/L,Normal Low:135,Normal High:145); Test Name: BUN; Test Result: 37 mg/dl; Test Name: CO2; Result Unstructured Data: (Test Result:27,Unit:mmol/L,Normal Low:22,Normal High:29); Test Name: CT of the abdomen; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: CT of the abdomen; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: CT of the pelvis; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: CT of the pelvis; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: CT of the chest; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: C reactive protein; Result Unstructured Data: (Test Result:elevated (96.7),Unit:mg/L,Normal Low:less than 5.1,Normal High:); Test Name: echocardiogram; Result Unstructured Data: (Test Result:normal biventricular function,Unit:unknown,Normal Low:,Normal High:); Test Name: ECG; Result Unstructured Data: (Test Result:demonstrated sinus tachycardia,Unit:unknown,Normal Low:,Normal High:); Test Name: electromyography of left arm; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: Haemoglobin; Result Unstructured Data: (Test Result:138,Unit:g/L,Normal Low:120,Normal High:155); Test Name: Immunohistochemistry; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: Muscle strength; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: Systemic review; Test Result: Negative ; Test Name: MRI of her left upper extremity and right thigh; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: stain for acid-fast bacilli; Result Unstructured Data: (Test Result:did not reveal any acid-fast microorganisms,Unit:unknown,Normal Low:,Normal High:); Test Name: myositis autoantibody panel; Test Result: Negative ; Test Name: Parathyroid hormone related protein; Result Unstructured Data: (Test Result:0.9,Unit:pmol/L,Normal Low:less than 4.3,Normal High:); Test Name: Pathological examination; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: Platelets; Result Unstructured Data: (Test Result:384,Unit:x10e9/L,Normal Low:140,Normal High:450); Test Name: erythrocyte sedimentation rate; Result Unstructured Data: (Test Result:elevated (19),Unit:mm/hr,Normal Low:0,Normal High:15); Test Name: Alanine transaminase; Result Unstructured Data: (Test Result:elevated (306),Unit:u/L,Normal Low:10,Normal High:61); Test Name: Troponin; Result Unstructured Data: (Test Result:0.04 (normal),Unit:ug/litre,Normal Low:0.00,Normal High:0.04); Test Name: leucocytes; Result Unstructured Data: (Test Result:mild leucocytosis (11.6),Unit:x10e9/L,Normal Low:3.4,Normal High:10); Comments: Review of systems was negative for diplopia, fevers, chest pain, diarrhea or dysuria. Pathological examination revealed a mixed type B2 and B3 thymoma with positive margins, stage IVa, pT4N0, and she was noted to have residual tumour with pleural metastases that were slowly growing and being monitored. Testing positive for acetylcholine binding receptor antibody. Medical Research Council Scale for muscle strength: 4/5 in deltoids, biceps brachii and triceps but 4+/5 in finger flexors and extensors; 3/5 in iliopsoas and 4/5 at tibialis anterior), 4/5 strength with neck flexion and maximal inspiratory pressure of -30 cm H2O. CT of the abdomen and pelvis demonstrated abnormal signal of the proximal thighs and pelvic girdle musculature concerning for myositis. Electromyography of the left arm which demonstrated a diffuse myopathic process without membrane irritability, most consistent with a critical illness myopathy rather than an inflammatory myopathy. myositis autoantibody panel and serology for 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase antibody were negative. MRI of her left upper extremity and right thigh revealed diffuse oedema throughout the musculature compatible with myositis. A muscle biopsy of the right biceps brachii was then performed, which revealed a dense lymphohistiocytic infiltrate with abundant multinucleated giant cells and frequent degenerating/regenerating muscle fibres. Immunohistochemistry revealed abundant CD68-positive macrophages and giant cells, a dense endomysial population of CD3-positive T-lymphocytes and only scattered CD20-positive B-lymphocytes. Immunohistochemistry for Major Histocompatibility Complex I (MHC-I) showed strong and diffuse sarcolemmal staining of the muscle fibres, indicative of upregulation of MHC-I. CT of the chest and abdomen/pelvis obtained during the hospitalisation did not reveal hilar adenopathy or other lesions concerning for sarcoidosis or lymphoma.
- Aktuelle Erkrankungen
- Ill-defined disorder; Myasthenia gravis; Pleural metastases (residual tumour with pleural metastases); Systemic lupus erythematosus; Thymoma (8 years earlier)
- Vorgeschichte
- Medical History/Concurrent Conditions: Exeresis (for thymoma); Radiation therapy (for thymoma); Comments: She had no history of a myasthenic crisis.
- Andere Medikamente
- PREDNISONE; AZATHIOPRINE; HYDROXYCHLOROQUINE; VITAMIN SUPPLEMENTS
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 15.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Diarrhoea
Loss of consciousness
Symptomtext
passed out; diarrhea; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant) and diarrhea. On an unknown date, the outcome of the passed out and diarrhea were unknown. It was unknown if the reporter considered the passed out and diarrhea to be related to Shingrix. Additional Information: GSK Receipt Date: 08-JUL-2022 Reporter's comment: This case was reported by a patient's wife via interactive digital media. The reporter's husband had a bad reaction to the vaccine. The reporter wanted to know what were the components of Shingrix. The reporter was trying to determine if he was allergic to something. The patient had diarrhea and passed out. The reporter ran across one reference for a few allergens in the shot. and wanted to know what was those allergens were so he could avoid them. The reporter was trying to find out what was in there so he/she could research/make a decision.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- -
- Geschlecht
- F
- Eingang
- 08.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Inappropriate schedule of product administration
Nausea
Syncope
Symptomtext
fainted, hospitalized overnight; nauseated, hospitalized overnight; Drug dose administration interval too long; This case was reported by a consumer via call center representative and described the occurrence of syncope in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included vasovagal attack. Concurrent medical conditions included artificial cardiac pacemaker user. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced syncope (serious criteria hospitalization and GSK medically significant), nausea (serious criteria hospitalization) and drug dose administration interval too long. On an unknown date, the outcome of the syncope and nausea were recovered/resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the syncope and nausea to be related to Shingrix. Additional Information: GSK Receipt Date: 01-JUL-2022 Reporter's comments: This case was reported by the patient herself. The reporter stated that she received her first dose of Shingrix about four years prior to the reporting. About 12 hours after the dose, she felt nauseated then fainted. The reporter stated that she was hospitalized overnight for monitoring. The reporter stated that this adverse event was reported in May 2018 through Vaccine Adverse Event Reporting System (VAERS). The reporter stated that her cardiologist felt the syncope may have been due to the nausea. The reporter stated that at the time, her primary physician recommended she would not get the second Shingrix dose, the physician was now recommending her to receive second dose, and she plans to get it. The reporter stated that she had nothing else to report. The reporter consented to follow up and also, may follow up with physician. Additional Supportive Information: Vasovagal episodes was reported as Historical drug as Condition Type however the drug was not reported hence captured currently as Historical Condition. The patient plans to get 2nd dose late, which led to lengthening of vaccination schedule.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Artificial cardiac pacemaker user; Vasovagal attack
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 07.07.2022
- Impfdatum
- 01.06.2022
- Beginn
- 01.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Headache
Loss of consciousness
Pain
Pyrexia
Symptomtext
passed out; high fever; horrible headache; aches; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingles vaccine (received 1st dose on an unknown date). In June 2022, the patient received the 2nd dose of Shingrix. In 2022, 4 days after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant). In June 2022, the patient experienced fever, headache and ache. On an unknown date, the outcome of the passed out was unknown and the outcome of the fever, headache and ache were recovered/resolved. It was unknown if the reporter considered the passed out, fever, headache and ache to be related to Shingrix. Additional Information: GSK Receipt Date: 01-JUL-2022 Reporter's comments: This case was reported by consumer via interactive digital media. This case was reported by the patient's family member. The patient received his 2nd inoculation, 3 days before the date of reporting. The patient had high fever, horrible headache, aches, and on the 4th day seemed fine, then passed out. The reporter asked how long before someone are back to normal health. In June 2022, less than a week after receiving Synflorix, the patient experienced fever, headache and ache. Additional supportive information: Follow-up would not possible, as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- -
- Geschlecht
- F
- Eingang
- 03.07.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anaphylactic reaction
Symptomtext
anaphylactic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. Concurrent medical conditions included allergy to antibiotic (penicillin, aminoglycosides, sulfonamides, ) and drug allergy (dextromethorphan, codeine, morphine). On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown. It was unknown if the reporter considered the anaphylactic reaction to be related to Tdap Vaccine. Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: The patient had an anaphylactic reaction to an unknown Tdap vaccine in the past. The reporter did not gave consent to follow-up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic reaction
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Allergy to antibiotic (penicillin, aminoglycosides, sulfonamides,); Drug allergy (dextromethorphan, codeine, morphine)
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.06.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Bell's palsy
Herpes zoster
Symptomtext
Bell's palsy; shingles (3x's); This case was reported by a consumer via market research programs and described the occurrence of bell's palsy in a patient who received Flu unspecified (Flu vaccine unspecified) for prophylaxis. On an unknown date, the patient received Flu vaccine unspecified. On an unknown date, unknown after receiving Flu vaccine unspecified, the patient experienced bell's palsy (serious criteria GSK medically significant) and shingles. Flu vaccine unspecified was discontinued. On an unknown date, the outcome of the bell's palsy and shingles were recovered/resolved. It was unknown if the reporter considered the bell's palsy and shingles to be related to Flu vaccine unspecified. Additional Information: GSK Receipt Date: 19-May-2022. Reporter's Comments: This case was reported by the patient. The patient used to get seasonal flu shots until the patient started having reactions shingles (3x's), Bell's palsy. So, the patient stopped getting vaccinations and the patient stopped having problems. Additional Supportive Information: The follow-up would not possible as no contact details were available. This was 1 of the 18 cases reported by same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 11.06.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Symptomtext
I had the shot developed Bells Palsy; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown. It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the shingles shot and developed Bell's Palsy. The patient also stated many others also experienced Bells palsy and asked to research it. The patient further stated, some women's face never went back to normal. Additional supportive information: follow up could not be possible, as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 11.06.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
guillian barre syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix. Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient got a Shingrix vaccination and now he/she have had Guillain barre syndrome for four months. Additional Supportive Information: The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- -
- Geschlecht
- U
- Eingang
- 11.06.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Mobility decreased
Pain
Symptomtext
got Gillian Barre Syndrome; pain gets worse and its horrible; partial use of my leg now, The other leg is failing too; This case was reported by a consumer and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), pain and mobility decreased. On an unknown date, the outcome of the guillain barre syndrome, pain and mobility decreased were unknown. The reporter considered the guillain barre syndrome to be related to Shingrix. It was unknown if the reporter considered the pain and mobility decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's Comments: The patient got Guillain Barre syndrome from the vaccination four months ago from reporting date and the pain just got worse and was horrible. The patient also had partial use of his/her leg now and the other leg was failing too. The patient was finally getting to see a neurologist tomorrow. The patient asked what else he/she could do before this gets even more destructive to his/her body.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.06.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
GBS, pt is apprehensive about other vx; This case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix. Additional Information: GSK Receipt Date: 23-Feb-2022 Reporter's Comments: The reporter had a patient who developed GBS (Guillain Barre syndrome) after a dose of Shingrix within 42 days. The patient was due for a Flu shot and COVID-19 booster shot, but was apprehensive about receiving any more vaccinations. The reporter requested any information GlaxoSmithKline could provide. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR086239:same reporter, case deleted
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OK
- Alter
- -
- Geschlecht
- M
- Eingang
- 02.06.2022
- Impfdatum
- 10.05.2022
- Beginn
- 18.05.2022
- Tage bis Beginn
- 8,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Ear pain
Hypoaesthesia oral
Tenderness
Symptomtext
left side of his mouth was "numb"; painful to touch; Bells Palsy effecting left side of face; bad "outer ear" ache, painful to touch; This case was reported by a other health professional via sales rep and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 10th May 2022, the patient received the 1st dose of Shingrix. On 18th May 2022, 8 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), ear pain and tenderness. On 26th May 2022, the patient experienced numbness oral. On an unknown date, the outcome of the bell's palsy, ear pain, numbness oral and tenderness were unknown. The reporter considered the bell's palsy, ear pain, numbness oral and tenderness to be possibly related to Shingrix. Additional Information: GSK Receipt Date: 27-May-2022 Reporter's comments: The patient received Shingrix on 10th May late in the day. The reporter wanted to check the chart again to verify the date being that week and not the following week. On 18th May 2022, the patient complained of a bad outer ear ache. Like all around the left ear lobe. Not tender but painful to even touch. On 26th May 2022, late evening,16 days after receiving Shingrix, he noticed the left side of his mouth was numb. Like he had been to the dentist he said. Early morning on 27th May 2022, symptoms of Bell's Palsy affected the left side of the face. The reporter googled and saw something about if the breve around the ear becomes inflamed then there had been some correlation between the Shingrix vaccine and Bell's palsy.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 31.05.2022
- Impfdatum
- 24.05.2022
- Beginn
- 01.05.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Feeling abnormal
Loss of consciousness
Symptomtext
Found myself kind of like nodding off, passing out; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 24th May 2022, the patient received the 1st dose of Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown. It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient found himself/herself kind of like nodding off, passing out. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Electric shock sensation
Herpes zoster
Vaccination failure
Symptomtext
going through this now after getting 2nd shot/Suspected vaccination failure; going through this now after getting 2nd shot; it's like electrical shocks; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and COVID-19 BOOSTER. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria medically significant), shingles and electric shock sensation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and electric shock sensation were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and electric shock sensation to be related to Shingrix and Shingrix. Additional Information: Receipt Date: 22-MAY-2022 Reporters comment: The case was reported by the patient's brother or sister via interactive digital media and described the occurrence of suspected vaccination failure. The patient received 2nd dose of Shingrix and 4th booster dose of Covid 19 vaccine together. After receiving Shingrix and Covid booster vaccine, the patient was going through shingles at the time of reporting. The reporter stated that, did not know why doctor suggested both the vaccines at same time. The patients told the reporter that, it was like electrical shocks. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Electric shock sensation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Electric shock sensation
Herpes zoster
Vaccination failure
Symptomtext
going through this now after getting 2nd shot/Suspected vaccination failure; going through this now after getting 2nd shot; it's like electrical shocks; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and COVID-19 BOOSTER. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria medically significant), shingles and electric shock sensation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and electric shock sensation were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and electric shock sensation to be related to Shingrix and Shingrix. Additional Information: Receipt Date: 22-MAY-2022 Reporters comment: The case was reported by the patient's brother or sister via interactive digital media and described the occurrence of suspected vaccination failure. The patient received 2nd dose of Shingrix and 4th booster dose of Covid 19 vaccine together. After receiving Shingrix and Covid booster vaccine, the patient was going through shingles at the time of reporting. The reporter stated that, did not know why doctor suggested both the vaccines at same time. The patients told the reporter that, it was like electrical shocks. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Electric shock sensation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Electric shock sensation
Herpes zoster
Vaccination failure
Symptomtext
going through this now after getting 2nd shot/Suspected vaccination failure; going through this now after getting 2nd shot; it's like electrical shocks; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and COVID-19 BOOSTER. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria medically significant), shingles and electric shock sensation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and electric shock sensation were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and electric shock sensation to be related to Shingrix and Shingrix. Additional Information: Receipt Date: 22-MAY-2022 Reporters comment: The case was reported by the patient's brother or sister via interactive digital media and described the occurrence of suspected vaccination failure. The patient received 2nd dose of Shingrix and 4th booster dose of Covid 19 vaccine together. After receiving Shingrix and Covid booster vaccine, the patient was going through shingles at the time of reporting. The reporter stated that, did not know why doctor suggested both the vaccines at same time. The patients told the reporter that, it was like electrical shocks. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Electric shock sensation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 27.05.2022
- Impfdatum
- 01.05.2022
- Beginn
- 01.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
had the shingles shot and now has Gillian Bare; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In May 2022, the patient received Shingles vaccine. In May 2022, less than 3 weeks after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. Additional Information: GSK receipt date: 21-May-2022 Reporter's comment: The case was received from the patient's son/ daughter via interactive digital media. The reporter' father just had the shingles shot 3 weeks ago and now he has had guillain barre syndrome. The reporter want people to knew that you can get it from the shot . Additional Supportive Information: Follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Skull fracture
Syncope
Symptomtext
fracturing skull; collapses on stage, hits floor; This case was reported by a consumer via other manufacturer and described the occurrence of skull fracture in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine and Flu vaccine. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced skull fracture (serious criteria GSK medically significant) and syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the skull fracture and syncope were unknown. It was unknown if the reporter considered the skull fracture and syncope to be related to Shingles vaccine and Flu vaccine. Additional Information: GSK Receipt Date: 23-May-2022 Reporter's Comments: The patient self-reported this case, was a comedian. The patient mocked about having the 3 experimental jabs, plus a shingles and flu vaccine, then instantly collapsed on stage fracturing her skull as she hit the floor. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Skull fracture
Syncope
Symptomtext
fracturing skull; collapses on stage, hits floor; This case was reported by a consumer via other manufacturer and described the occurrence of skull fracture in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine and Flu vaccine. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced skull fracture (serious criteria GSK medically significant) and syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the skull fracture and syncope were unknown. It was unknown if the reporter considered the skull fracture and syncope to be related to Shingles vaccine and Flu vaccine. Additional Information: GSK Receipt Date: 23-May-2022 Reporter's Comments: The patient self-reported this case, was a comedian. The patient mocked about having the 3 experimental jabs, plus a shingles and flu vaccine, then instantly collapsed on stage fracturing her skull as she hit the floor. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- U
- Eingang
- 26.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Herpes zoster
Immunisation
Nerve injury
Toxic shock syndrome streptococcal
Vaccination failure
Symptomtext
had my shingles vaccine, had shingles/Suspected vaccination failure; I had stss; shingles; Nerve damage; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis. On an unknown date, the patient received Shingles vaccine and COVID-19 BOOSTER. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), streptococcal toxic shock syndrome (serious criteria GSK medically significant), shingles and nerve damage. On an unknown date, the outcome of the vaccination failure, streptococcal toxic shock syndrome and shingles were unknown and the outcome of the nerve damage was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, streptococcal toxic shock syndrome, shingles and nerve damage to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's comment: The patient had shingles vaccine before patient moved. The patient had Covid vaccine booster and 2 days later had streptococcal toxic shock syndrome (STSS) as rated getting shingles. The patient's doctor said patient could not have shingles if patient was vaccinated. The patient had them for 2 months and had nerve damage at the time of reporting. It was unknown if the reporter considered the streptococcal toxic shock syndrome, nerve damage and shingles to be related to Covid vaccine booster. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Toxic shock syndrome streptococcal
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- U
- Eingang
- 26.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Herpes zoster
Immunisation
Nerve injury
Toxic shock syndrome streptococcal
Vaccination failure
Symptomtext
had my shingles vaccine, had shingles/Suspected vaccination failure; I had stss; shingles; Nerve damage; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis. On an unknown date, the patient received Shingles vaccine and COVID-19 BOOSTER. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), streptococcal toxic shock syndrome (serious criteria GSK medically significant), shingles and nerve damage. On an unknown date, the outcome of the vaccination failure, streptococcal toxic shock syndrome and shingles were unknown and the outcome of the nerve damage was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, streptococcal toxic shock syndrome, shingles and nerve damage to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's comment: The patient had shingles vaccine before patient moved. The patient had Covid vaccine booster and 2 days later had streptococcal toxic shock syndrome (STSS) as rated getting shingles. The patient's doctor said patient could not have shingles if patient was vaccinated. The patient had them for 2 months and had nerve damage at the time of reporting. It was unknown if the reporter considered the streptococcal toxic shock syndrome, nerve damage and shingles to be related to Covid vaccine booster. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Toxic shock syndrome streptococcal
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Dysstasia
Gait disturbance
Guillain-Barre syndrome
Intensive care
Loss of personal independence in daily activities
Symptomtext
Guillain Barre, ICU for 2 weeks, rehab 3 months; Still have issues with walking; Still have issues with standing a long period of time; Had to learn how to walk,write, eat,and all the basic things in life; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), walking difficulty, difficulty in standing and activities of daily living impaired. On an unknown date, the outcome of the guillain barre syndrome and activities of daily living impaired were unknown and the outcome of the walking difficulty and difficulty in standing were not recovered/not resolved. The reporter considered the guillain barre syndrome to be related to Flu vaccine. It was unknown if the reporter considered the walking difficulty, difficulty in standing and activities of daily living impaired to be related to Flu vaccine. Additional Information: GSK receipt date: 17-MAY-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got Guillain Barre from get the flu shot. The patient ended up in ICU (intensive care unit) for 2 weeks and then ended up in a rehabilitation for 3 months. The patient had to learn how to walk, write, eat and all the basic things in life. 2 years later, the patient still had issues with walking and standing a long period of time. Additional Supportive Information: Follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- 14,0
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 66,0
- Geschlecht
- M
- Eingang
- 13.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Aldolase normal
Anti-ganglioside antibody positive
Antibody test negative
Areflexia
Blood creatine phosphokinase normal
Blood immunoglobulin G normal
Blood immunoglobulin M increased
Borrelia test negative
Conduction disorder
Decreased vibratory sense
Demyelinating polyneuropathy
Demyelination
Electromyogram abnormal
Eyelid ptosis
Full blood count normal
Gait disturbance
Gait inability
General physical health deterioration
Symptomtext
Multifocal Motor Neuropathy; Sensation of blurred vision in the left eye with some drooping; Sensation of blurred vision in the left eye with some drooping; This literature case was retrieved on 04-May-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2245507-1) with additional document received on the same day (being processed together), reported by other healthcare professional and concerned a 66-year-old, male patient. The patient's past medical history included tobacco use. The patient's concomitant medications were not reported. On an unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; route of administration, anatomical location, dose and indication: not reported). The batch number was not reported. On an unspecified date, about ten days after receiving influenza vaccine, the patient presented with right greater than left upper extremity paresthesia as well as bilateral lower extremity weakness (right greater than left), numbness, and tingling in his fingertips. The patient also reported a sensation of blurred vision in the left eye towards the evening with some drooping. He denied any urinary symptoms, dysphagia, shortness of breath, fever, chills, chest pain, or facial droop. Initial vitals recorded on presentation were stable. On an unspecified date, the patient was admitted to hospital. Physical exam was remarkable for decreased overall muscle bulk. Motor exam showed intact strength, 5/5, for bilateral upper and lower extremities. For upper extremity reflex testing, including biceps, triceps, and brachioradialis, the results were 1/4 bilaterally. Patellar and Achilles' tendon reflexes were absent bilaterally with fasciculations noted more prominent over the right lower extremity. Sensory exam was remarkable for diminished vibration sense over toes bilaterally and was intact at the knees and fingertips bilaterally. Light touch was preserved throughout the lower extremities. Lab workup including complete blood count (CBC), comprehensive metabolic panel (CMP), Lyme titers, creatine kinase (CK), aldolase, vitamin D, and B12 levels were within normal range. Myasthenia gravis antibody panel was negative. Magnetic resonance imaging (MRI) of head without contrast showed no acute intracranial abnormality. As the patient was afebrile and CBC was normal and no evidence of mental status changes cerebrospinal fluid (CSF) analysis was not done. He was further evaluated with an electromyography (EMG) with motor and sensory nerve studies. The EMG was interpreted as abnormal due to prolonged latency of right median compound muscle action potential (CMAP), and right peroneal CMAP, low conduction velocity (C.V.) of right ulnar CMAP, and low C.V. of right peroneal CMAP. The latency for right median nerve of elbow was 8.2 ms (reference range: 2.3-7.2 ms). The latency for right peroneal nerve at head of fibula was 11 ms, and at popliteal fossa 13.7 ms (reference range: 2.3-7.2 ms). The conduction velocity of right ulnar nerve at elbow was 48.5 m/s (reference range: 50-70 m/s) and for right peroneal nerve at popliteal fossa was 37.5 m/s (reference range: 40-70 m/s). Sensory nerve action potential (SNAP) was largely normal. The patient was also tested for the anti-GM1 antibody and his anti-GM1 IgM was positive with over 100% (reference range reported as 0- 30) and negative for the anti-GM1 IgG antibody. It was concluded that there was electrophysiologic evidence of a demyelinating motor neuropathy with evidence of conduction block, raising the possibility of atypical Guillain-Barre syndrome (GBS) or other acute inflammatory demyelinating polyneuropathy (AIDP) without evidence of sensory involvement. However, due to his motor involvement as evidenced by EMG studies that were more prominent in the upper than lower extremities, there was also a concern for multifocal motor neuropathy (MMN). On an unspecified date, the patient was diagnosed with multifocal motor neuropathy and was treated with intravenous immune globulin (IVIG) at a dose of 0.4 g/kg daily for five days. The patient completed the course of IVIG with marked improvement of symptoms. On an unspecified date, the patient was discharged to acute inpatient rehabilitation with Physical Therapy (PT) and Occupational Therapy (OT) and was also recommended to follow up as an outpatient. The patient was scheduled to receive 0.5 g/kg IVIG every 28 days following discharge. On an unspecified date, about a month later, prior to the patient's scheduled IVIG infusion, the patient's clinical condition deteriorated at acute inpatient rehabilitation, necessitating him to be readmitted to the hospital. During the hospitalization, the patient was treated with plasmapheresis (five rounds of 3000 ml exchanges with 5% albumin). On an unspecified date, the patient was discharged to acute inpatient rehabilitation. It was noted then that he was unable to ambulate independently following the second hospitalization. However, he was continued on monthly plasmapheresis (one round of 3000 mL exchanges with 5% albumin every 28 days) and participated in aggressive acute inpatient physical and occupational therapy rehabilitation. Two months later, he was able to ambulate without assisted devices. Three months later, he was able to ambulate normally with only sensations of pins and needles in his hands, but with a normal neurologic examination. At the time of initial report, the patient was recovering from the 'vision blurred', 'eyelid ptosis' and multifocal motor neuropathy, as it was reported that the patient continued with monthly plasmapheresis treatment and his disease had remained clinically quiescent for over a year, from the time of initial presentation. This case was rare as the patient developed MMN with high anti-GM1 IgM antibody levels a few days after influenza vaccination. Patient also had motor impairment as evidenced by EMG studies. He was treated with IVIG with an improvement of his symptoms initially; however, later deteriorated and required plasmapheresis which was continued for maintenance therapy. Post-influenza vaccination MMN is a rare entity, which should be a differential in patients presenting with rapidly progressive neurological symptoms and features of GBS as rapid diagnosis and appropriate treatment can have better clinical outcomes. A thorough neurological examination and testing with EMG could aid in prompt diagnosis and management with anti-GM1 antibodies where appropriate. Although the literature review showed IVIG as a mainstay of treatment for MMN, the patient in this case report seemed to have a positive response while on plasmapheresis, after failing IVIG and has put his disease currently into remission. The reporter did not provide a causality assessment. The events of 'vision blurred', 'eyelid ptosis' and multifocal motor neuropathy were considered serious due to hospitalization. In addition the event of multifocal motor neuropathy was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. Company comment: A 66-year-old patient experienced right greater than left upper extremity paresthesia as well as bilateral lower extremity weakness (right greater than left), numbness, and tingling in his fingertips, and blurred vision in the left eye with some drooping reportedly about ten days after receiving the suspect product influenza virus vaccine polyvalent. Thereafter, the EMG was interpreted as abnormal due to prolonged latency of right median compound muscle action potential (CMAP), and right peroneal CMAP, low conduction velocity (C.V.) of right ulnar CMAP, and low C.V. of right peroneal CMAP. The patient was also tested for the anti-GM1 antibody and his anti-GM1 IgM was positive with over 100% (reference range reported as 0- 30) and negative for the anti-GM1 IgG antibody. Based on the given results, the patient was diagnosed with multifocal motor neuropathy (MMN). Due to diagnostic findings and plausible temporal relationship, causality for the reported event is assessed as possibly related. Based on currently available information, causality for blurred vision and eyelid ptosis is unassessable.; Sender's Comments: A 66-year-old patient experienced right greater than left upper extremity paresthesia as well as bilateral lower extremity weakness (right greater than left), numbness, and tingling in his fingertips, and blurred vision in the left eye with some drooping reportedly about ten days after receiving the suspect product influenza virus vaccine polyvalent. Thereafter, the EMG was interpreted as abnormal due to prolonged latency of right median compound muscle action potential (CMAP), and right peroneal CMAP, low conduction velocity (C.V.) of right ulnar CMAP, and low C.V. of right peroneal CMAP. The patient was also tested for the anti-GM1 antibody and his anti-GM1 IgM was positive with over 100% (reference range reported as 0- 30) and negative for the anti-GM1 IgG antibody. Based on the given results, the patient was diagnosed with multifocal motor neuropathy (MMN). Due to diagnostic findings and plausible temporal relationship, causality for the reported event is assessed as possibly related. Based on currently available information, causality for blurred vision and eyelid ptosis is unassessable.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- Test Name: Aldolase; Result Unstructured Data: Within normal range; Test Name: Myasthenia gravis antibody panel; Result Unstructured Data: Negative; Test Name: Anti-GM1 IgM and IgG antibody; Result Unstructured Data: Anti-GM1 IgM was positive with >100% (reference range 0- 30) and negative for the anti-GM1 IgG antibody.; Test Name: Creatine kinase (CK); Result Unstructured Data: Within normal range; Test Name: Lyme titers; Result Unstructured Data: Within normal range; Test Name: Electromyography (EMG) with motor and sensory nerve; Result Unstructured Data: EMG was interpreted as abnormal due to prolonged latency of right median compound muscle action potential (CMAP) and right peroneal CMAP, low conduction velocity (C.V.) of right ulnar CMAP, and low C.V. right peroneal CMAP.; Test Name: Complete blood count (CBC); Result Unstructured Data: Within normal range; Test Name: MRI head without contrast; Result Unstructured Data: No acute intracranial abnormality; Test Name: Comprehensive metabolic panel (CMP); Result Unstructured Data: Within normal range; Test Name: Sensory nerve action potential (SNAP); Result Unstructured Data: Largely normal; Test Name: Neurologic examination; Result Unstructured Data: Normal; Test Name: Motor exam; Result Unstructured Data: Intact strength 5/5 bilateral upper and lower extremities.; Test Name: Physical examination; Result Unstructured Data: Decreased overall muscle bulk; Test Name: Patellar and Achilles' tendon reflex; Result Unstructured Data: patellar and Pchilles' tendon reflexes were absent bilaterally with fasciculations noted more prominent over the right lower extremity; Test Name: Upper extremity reflex testing; Result Unstructured Data: Upper extremity reflex testing including biceps, triceps, and brachioradialis were 1/4 bilaterally; Test Name: Sensory exam; Result Unstructured Data: Light touch was preserved throughout the lower extremities.; Test Name: Vibration sense; Result Unstructured Data: Diminished vibration sense over toes bilaterally; Test Name: Initial vitals; Result Unstructured Data: Stable on presentation; Test Name: Vitamin B12; Result Unstructured Data: Within normal range; Test Name: Vitamin D; Result Unstructured Data: Within normal range
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Tobacco user
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- U
- Eingang
- 10.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Diarrhoea
Loss of consciousness
Mobility decreased
Vomiting
Symptomtext
I passed out; vomited; diarrhea; couldn't get up, lie on bathroom floor; This case was reported by a consumer via call center representative and described the occurrence of passed out in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), vomiting, diarrhea and mobility decreased. On an unknown date, the outcome of the passed out, vomiting, diarrhea and mobility decreased were unknown. It was unknown if the reporter considered the passed out, vomiting, diarrhea and mobility decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 02-MAY-2022 Reporters comment: The patient self-reported the case. After receiving Shingrix, the patient was passed out and experienced vomiting and diarrhea and he/she could only lie on bathroom floor and could not get up. Since the patient had a terrible reaction to 1st dose of Shingles shot, he/she did not get the 2nd shot. The patient needed list of Shingrix ingredients to put on his/her list of things he/she was allergic to. The patient stated that, when he/she told a healthcare person of his/her bad reaction, they asked what ingredients in Shingrix he/she was allergic to.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 07.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Abdominal pain
Abdominal pain upper
Abdominal tenderness
Acute kidney injury
Acute respiratory distress syndrome
Alanine aminotransferase increased
Anion gap
Anti-platelet antibody negative
Antibody test negative
Antineutrophil cytoplasmic antibody
Antineutrophil cytoplasmic antibody negative
Antinuclear antibody negative
Aphthous ulcer
Aspartate aminotransferase increased
Aspergillus test
Bicytopenia
Blood alkaline phosphatase normal
Blood beta-D-glucan positive
Symptomtext
GI bleeding; Hemophagocytic Lymphohistiocytosis; Intense Epigastric pain; Nausea; Vomiting; Diarrhea; Myalgias; Weight loss; Oral aphthous ulcers; Fever 104.6 F; Abdominal pain; Leukocytosis; Lactic acidosis; sepsis, likely secondary to viral etiology and rhabdomyolysis; sepsis, likely secondary to viral etiology and rhabdomyolysis; Refractory shock\ shock; Acute kidney injury due to rhabdomyolysis\ acute renal failure; Bicytopenia; Hyperferritinemia; Hypertriglyceridemia; low NK cell cytotoxicity; Erythema of eyelids; Oral petechiae on a background of pale mucosa; Oral petechiae on a background of pale mucosa; Nonpruritic petechial rash over his anterior chest; epigastric tenderness; Thrombocytopenia; Transaminitis; Myoglobinuria; possible viral infection complicated by rhabdomyolysis; unresponsive; Severe Metabolic acidosis; Hyperkalemia; Muscle damage; Severe acute respiratory distress syndrome (ARDS); positive rhinovirus; Epstein-Barr virus DNA positive; CMV IgG positive; Peptic ulcer; Hypogammaglobulinemia; Hepatitis; This case was reported in a literature article and described the occurrence of gastrointestinal bleeding in a 38-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. The patient's past medical history included systemic lupus erythematosus (Family History) (notable for several family members) and inflammatory arthritis (Family History). On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced gastrointestinal bleeding (serious criteria hospitalization, GSK medically significant and life threatening), hemophagocytic lymphohistiocytosis (serious criteria hospitalization and GSK medically significant), epigastric pain (serious criteria hospitalization), nausea (serious criteria hospitalization), vomiting (serious criteria hospitalization), diarrhea (serious criteria hospitalization), myalgia (serious criteria hospitalization), weight loss (serious criteria hospitalization), ulcer aphthous oral (serious criteria hospitalization), fever (serious criteria hospitalization), abdominal pain (serious criteria hospitalization), leukocytosis (serious criteria hospitalization), lactic acidosis (serious criteria hospitalization and GSK medically significant), viral sepsis (serious criteria hospitalization and GSK medically significant), rhabdomyolysis (serious criteria hospitalization and GSK medically significant), refractory shock (serious criteria hospitalization and GSK medically significant), acute renal failure (serious criteria hospitalization and GSK medically significant), bicytopenia (serious criteria hospitalization and GSK medically significant), hyperferritinemia (serious criteria hospitalization), hypertriglyceridemia (serious criteria hospitalization), cell-mediated cytotoxicity (serious criteria hospitalization), erythema eyelid (serious criteria hospitalization), oral mucosal petechiae (serious criteria hospitalization), pale mucous membrane (serious criteria hospitalization), petechial rash (serious criteria hospitalization), tenderness epigastric (serious criteria hospitalization), thrombocytopenia (serious criteria hospitalization and GSK medically significant), transaminitis (serious criteria hospitalization), myoglobinuria (serious criteria hospitalization), viral infection (serious criteria hospitalization and GSK medically significant), unresponsive to stimuli (serious criteria hospitalization and GSK medically significant), metabolic acidosis (serious criteria hospitalization and GSK medically significant), hyperkalemia (serious criteria hospitalization and GSK medically significant), muscle damage (serious criteria hospitalization), acute respiratory distress syndrome (serious criteria hospitalization and GSK medically significant), rhinovirus infection (serious criteria hospitalization), epstein-barr virus infection (serious criteria hospitalization), cytomegalovirus infection (serious criteria hospitalization and GSK medically significant), peptic ulcer (serious criteria hospitalization and GSK medically significant), hypogammaglobulinemia (serious criteria hospitalization and GSK medically significant) and hepatitis (serious criteria hospitalization and GSK medically significant). The patient was treated with corticosteroid nos (Corticosteroids (Drug Name Unknown)), intravenous immunoglobulin, anakinra, intravenous fluid, cardiovascular system drugs (Vasopressor (Nos)), methylprednisolone and dexamethasone. On an unknown date, the outcome of the gastrointestinal bleeding, hemophagocytic lymphohistiocytosis, epigastric pain, nausea, vomiting, diarrhea, myalgia, weight loss, ulcer aphthous oral, fever, abdominal pain, leukocytosis, viral sepsis, rhabdomyolysis, refractory shock, acute renal failure, bicytopenia, hyperferritinemia, hypertriglyceridemia, cell-mediated cytotoxicity, erythema eyelid, oral mucosal petechiae, pale mucous membrane, petechial rash, tenderness epigastric, thrombocytopenia, transaminitis, myoglobinuria, viral infection, unresponsive to stimuli, metabolic acidosis, hyperkalemia, muscle damage, acute respiratory distress syndrome, rhinovirus infection, epstein-barr virus infection, cytomegalovirus infection, peptic ulcer, hypogammaglobulinemia and hepatitis were recovering/resolving and the outcome of the lactic acidosis was recovered/resolved. The reporter considered the gastrointestinal bleeding, hemophagocytic lymphohistiocytosis, epigastric pain, nausea, vomiting, diarrhea, myalgia, weight loss, ulcer aphthous oral, fever, abdominal pain, leukocytosis, lactic acidosis, viral sepsis, rhabdomyolysis, refractory shock, acute renal failure, bicytopenia, hyperferritinemia, hypertriglyceridemia, cell-mediated cytotoxicity, erythema eyelid, oral mucosal petechiae, pale mucous membrane, petechial rash, tenderness epigastric, thrombocytopenia, transaminitis, myoglobinuria, viral infection, unresponsive to stimuli, metabolic acidosis, hyperkalemia, muscle damage, acute respiratory distress syndrome, rhinovirus infection, epstein-barr virus infection, cytomegalovirus infection, peptic ulcer, hypogammaglobulinemia and hepatitis to be related to Influenza vaccine. Additional Information: GSK Receipt Date: 29-APR-2022 Author comment: The previously health patient was evaluated for intense epigastric pain, nausea, vomiting, and diarrhea one week after he received an inactivated influenza virus vaccination. He also developed myalgia, oral aphthous ulcers, and a weight loss of 5 kg during that period. He denied recent sick contacts or travel outside of New England and has not started any new medications. He identified himself as men who have sex with men (MSM). His last sexual contact was four months ago, and recent HIV testing was negative. His family history was notable for several family members who had systemic lupus erythematosus and inflammatory arthritis. Initial assessment revealed a normal body temperature, heart rate of 140/minute, respiratory rate of 20/minute, blood pressure of 170/130 mm Hg, and oxygen saturation of 100% on room air. Physical exam showed erythema of eyelids, oral aphthous ulcers, oral petechiae on a background of pale mucosa, nonpruritic petechial rash over his anterior chest, and mild-to-moderate epigastric tenderness. The rest of the physical examination was unremarkable. The patient was started on IV fluids with improvements of his vital signs and clearance of lactic acid. Lab work showed markedly elevated CK levels and myoglobinuria on microscopic urine analysis, consistent with rhabdomyolysis. Although he was initially afebrile, he eventually spiked a fever up to 104.6 F. His presentation with systemic illness manifested with GI symptoms, oral ulcers, generalized aches, and rhabdomyolysis was suggestive of possible viral infection complicated by rhabdomyolysis. During his hospitalization, he has rapidly deteriorated. On hospital day 3, he was found unresponsive. Arterial blood analysis showed severe metabolic acidosis (PH 7.20, HCO3 11 mmol/L). He was intubated and transferred to the ICU. Soon after the transfer, he developed shock, requiring multiple vasopressor agents despite ongoing aggressive IV fluid resuscitation. The subsequent laboratory work-up showed progressive elevation of CK levels acute renal failure, and hyperkalemia. Unfortunately, ongoing muscle damage and kidney failure caused persistent hyperkalemia despite hemodialysis. The patient required continuous veno-venous hemofiltration. The underlying cause of the patient's presentation was unclear. He had an extensive infectious work-up. Repeated blood cultures were negative. A viral blood panel was only positive for Epstein- Barr virus (EBV) DNA. EBV IgG was positive but IgM was negative, consistent with past infection. A respiratory viral panel by nasopharyngeal swab showed positive rhinovirus. A CT of the abdomen and pelvis didn't reveal any pathology. Due to ongoing severe acute respiratory distress syndrome (ARDS), the patient's serum was also tested for ?-d-glucan, which appeared to be positive. Subsequently, aspergillus antigen was obtained and was negative. Further work-up of ?-d-glucan warranted bronchoscopy, which was negative for Pneumocystis jiroveci infection. Extensive rheumatological work-up was unrevealing. Extensive infectious work-up showed positive EBV and CMV IgG. Given that his clinical picture could also be triggered by an immune disorder, he underwent additional testing as autoimmune serologies including antinuclear antibody (ANA), rheumatoid factor, and antineutrophil cytoplasmic antibodies (ANCA), which were negative. Complement levels were normal as well. Given severe muscle injury, the patient was also worked up for possible autoimmune myopathies. Anti-PL-7, anti-PL-12, and anti-Mi-2 were all negative. Although ferritin level was initially normal, it has significantly risen, as well as C-reactive protein. Notably, his inflammatory markers spiked on hospital days 6-7 as well as CK level. Fasting lipid profile showed hypertriglyceridemia (triglycerides level peaked at 568 mg/dl). Marked hyperferritinemia in the context of severe systemic inflammatory response raised the suspicion of possible secondary HLH, especially given the recent immunogenic trigger of influenza vaccine and/or possible active viral infection. In addition to elevated C-reactive protein and ferritin, the immunologic panel revealed elevated soluble interleukin-2 receptors (sCD25) and depressed NK cell function, which was pathognomonic for HLH. HLH was confirmed based on HLH-2004 diagnostic criteria, fulfilling six out of the eight criteria and the HLH-probability calculator. For further work-up for HLH, after extended infectious and immunological work-up, flow cytometry revealed absolute CD19+ B-cell lymphopenia as well as absolute CD3+ T-cell lymphopenia, which are nonspecific findings. However, there was no evidence of monoclonal B-cell lymphoproliferative disease. Given that a genetic component might have contributed to the patient's clinical therapy, extended gene testing was done with no evidence of HLH triggering genes. It was thought that HLH had probably developed secondary to an inactivated influenza vaccine. The patient was started on directed therapy according to the HLH protocol. He received pulse dose methylprednisolone 1000 mg for three days followed by a slow steroid taper. Given hypogammaglobulinemia, he was started on intravenous immunoglobulin (IVIG) 10 g weekly to maintain IgG above 700 mg/dL. IgG levels were monitored weekly with slow improvement back to baseline. Unfortunately, he developed severe complications with prolonged steroid use, including life-threatening GI bleed from peptic ulcer and steroids were quickly tapered, he was started on anakinra, a steroid-sparing agent resulting in the slow gradual improvement of clinical status and inflammatory markers trend. After two months, he was discharged to a rehabilitation center where he continued to receive IVIG monthly and daily anakinra. Conclusion: HLH is a severe immune disorder characterized by dysregulation of the natural killer T-cell function, causing macrophage and lymphocyte activation with a subsequent cytokine storm that leads to organ failure and death. HLH can be familial or can be triggered by stimuli, mostly infections, malignancies, rheumatological diseases, or post-vaccination. The presentation includes fairly nonspecific symptoms such as fever, cytopenias, or liver dysfunction. HLH should be suspected in patients with those symptoms, especially in the setting of cytopenia and markedly elevated ferritin levels. The H-score helps predict the probability of HLH. Evidence of hemophagocytosis in bone marrow biopsy increases the likelihood of the diagnosis, but its absence does not rule it out. If suspected, early initiation of HLH targeted therapy with immunosuppressants including steroids may prevent irreversible organ damage and subsequent death. Additional Supportive Information: This article is not available for regulatory reporting due to copyright restriction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Acute respiratory distress syndrome
- Hospital-Tage
- -
- Labordaten
- Test Name: Alanine transaminase; Result Unstructured Data: (Test Result:294 on day 1,Unit:IU/L,Normal Low:,Normal High:); Test Name: Alanine transaminase; Result Unstructured Data: (Test Result:294 on day 5,Unit:IU/L,Normal Low:,Normal High:); Test Name: Alanine transaminase; Result Unstructured Data: (Test Result:735 on day 10,Unit:IU/L,Normal Low:,Normal High:); Test Name: Anion gap; Result Unstructured Data: (Test Result:7 on day 1,Unit:mmol/L,Normal Low:,Normal High:); Test Name: Anion gap; Result Unstructured Data: (Test Result:11 on day 5,Unit:mmol/L,Normal Low:,Normal High:); Test Name: Anion gap; Result Unstructured Data: (Test Result:13 on day 10,Unit:mmol/L,Normal Low:,Normal High:); Test Name: antineutrophil cytoplasmic antibodies; Test Result: Negative ; Test Name: Antinuclear antibody; Test Result: Negative ; Test Name: Aspartate transaminase; Result Unstructured Data: (Test Result:883 on day 1,Unit:IU/L,Normal Low:,Normal High:); Test Name: Aspartate transaminase; Result Unstructured Data: (Test Result:883 on day 5,Unit:IU/L,Normal Low:,Normal High:); Test Name: Aspartate transaminase; Result Unstructured Data: (Test Result:1,841 on day 10,Unit:IU/L,Normal Low:,Normal High:); Test Name: Aspergillus antigen; Test Result: Negative ; Test Name: Autoantibodies to proteinase-3; Result Unstructured Data: (Test Result:Not detected to proteinase-3 and myeloperoxidase,Unit:unknown,Normal Low:,Normal High:); Test Name: Alkaline phosphatase; Result Unstructured Data: (Test Result:84 on day 1,Unit:IU/L,Normal Low:,Normal High:); Test Name: Alkaline phosphatase; Result Unstructured Data: (Test Result:84 on day 5,Unit:IU/L,Normal Low:,Normal High:); Test Name: Alkaline phosphatase; Result Unstructured Data: (Test Result:109 on day 10,Unit:IU/L,Normal Low:,Normal High:); Test Name: Serum test for ?-d-glucan; Test Result: Positive ; Test Name: HCO3; Result Unstructured Data: (Test Result:11,Unit:mmol/L,Normal Low:,Normal High:); Test Name: Total bilirubin; Result Unstructured Data: (Test Result:1.2 on day 1,Unit:mg/dL,Normal Low:,Normal High:); Test Name: Total bilirubin; Result Unstructured Data: (Test Result:1.5 on day 5,Unit:mg/dL,Normal Low:,Normal High:); Test Name: Total bilirubin; Result Unstructured Data: (Test Result:0.9 on day 10,Unit:mg/dL,Normal Low:,Normal High:); Test Name: Chloride; Result Unstructured Data: (Test Result:93 on day 1,Unit:mmol/L,Normal Low:,Normal High:); Test Name: Chloride; Result Unstructured Data: (Test Result:95 on day 5,Unit:mmol/L,Normal Low:,Normal High:); Test Name: Chloride; Result Unstructured Data: (Test Result:98 on day 10,Unit:mmol/L,Normal Low:,Normal High:); Test Name: Creatine kinase; Result Unstructured Data: (Test Result:19,639 on day 1,Unit:IU/L,Normal Low:,Normal High:); Test Name: Creatine kinase; Result Unstructured Data: (Test Result:greater than 160,000 on day 5,Unit:IU/L,Normal Low:,Normal High:); Test Name: Creatine kinase; Result Unstructured Data: (Test Result:81,418 on day 10,Unit:IU/L,Normal Low:,Normal High:); Test Name: Creatinine; Result Unstructured Data: (Test Result:0.65 on day 1,Unit:mg/dL,Normal Low:,Normal High:); Test Name: Creatinine; Result Unstructured Data: (Test Result:3.6 on day 5,Unit:mg/dL,Normal Low:,Normal High:); Test Name: Creatinine; Result Unstructured Data: (Test Result:2.4 on day 10,Unit:mg/dL,Normal Low:,Normal High:); Test Name: Blood culture; Test Result: Negative ; Test Name: HIV viral load; Result Unstructured Data: (Test Result:No detected,Unit:unknown,Normal Low:,Normal High:); Test Name: IgG; Test Result: Negative ; Test Name: IgG; Test Result: Negative ; Test Name: IgG; Test Result: Negative ; Test Name: IgM; Test Result: Negative ; Test Name: IgM; Test Result: Positive ; Test Name: IgM; Test Result: Positive ; Test Name: IgM; Test Result: Negative ; Test Name: IgM; Test Result: Negative ; Test Name: IgM; Test Result: Negative ; Test Name: lactate dehydrogenase; Result Unstructured Data: (Test Result:2,593 on day 1,Unit:IU/L,Normal Low:,Normal High:); Test Name: Lactic acid; Result Unstructured Data: (Test Result:2.5 on day 1,Unit:mmol/L,Normal Low:,Normal High:); Test Name: Lactic acid; Result Unstructured Data: (Test Result:2.5 on day 5,Unit:mmol/L,Normal Low:,Normal High:); Test Name: Lactic acid; Result Unstructured Data: (Test Result:1.8 on day 10,Unit:mmol/L,Normal Low:,Normal High:); Test Name: Blood PH; Result Unstructured Data: (Test Result:7.20,Unit:unknown,Normal Low:,Normal High:); Test Name: Potassium; Result Unstructured Data: (Test Result:5.1 on day 1,Unit:mmol/L,Normal Low:,Normal High:); Test Name: Potassium; Result Unstructured Data: (Test Result:6.9 on day 5,Unit:mmol/L,Normal Low:,Normal High:); Test Name: Potassium; Result Unstructured Data: (Test Result:4.1 on day 10,Unit:mmol/L,Normal Low:,Normal High:); Test Name: Blood pressure; Result Unstructured Data: (Test Result:170/130,Unit:mmHg,Normal Low:,Normal High:); Test Name: Sodium; Result Unstructured Data: (Test Result:131 on day 1,Unit:mmol/L,Normal Low:,Normal High:); Test Name: Sodium; Result Unstructured Data: (Test Result:127 on day 5,Unit:mmol/L,Normal Low:,Normal High:); Test Name: Sodium; Result Unstructured Data: (Test Result:135 on day 10,Unit:mmol/L,Normal Low:,Normal High:); Test Name: Arterial blood analysis; Result Unstructured Data: (Test Result:severe metabolic acidosis,Unit:unknown,Normal Low:,Normal High:); Test Name: triglycerides; Test Result: 568 mg/dl; Test Name: BUN; Result Unstructured Data: (Test Result:25 on day 1,Unit:mg/dL,Normal Low:,Normal High:); Test Name: BUN; Result Unstructured Data: (Test Result:62 on day 5,Unit:mg/dL,Normal Low:,Normal High:); Test Name: BUN; Result Unstructured Data: (Test Result:60 on day 10,Unit:mg/dL,Normal Low:,Normal High:); Test Name: Body temperature; Result Unstructured Data: (Test Result:Normal level initially,Unit:degree F,Normal Low:,Normal High:); Test Name: Body temperature; Result Unstructured Data: (Test Result:104.6,Unit:degree F,Normal Low:,Normal High:); Test Name: Bronchoscopy; Test Result: Negative ; Test Name: CO2; Result Unstructured Data: (Test Result:31 on day 1,Unit:mmol/L,Normal Low:,Normal High:); Test Name: CO2; Result Unstructured Data: (Test Result:21 on day 5,Unit:mmol/L,Normal Low:,Normal High:); Test Name: CO2; Result Unstructured Data: (Test Result:23 on day 10,Unit:mmol/L,Normal Low:,Normal High:); Test Name: Chlamydia trachomatis RNA; Test Result: Negative ; Test Name: Complement level; Test Result: 108 mg/dl; Test Name: Complement factor C4; Test Result: 29 mg/dl; Test Name: CT of abdomen and pelvis; Result Unstructured Data: (Test Result:Didn't reveal any pathology,Unit:unknown,Normal Low:,Normal High:); Test Name: Coronaviruses 229E, NL63; Test Result: Negative ; Test Name: Coxsackie serology; Test Result: Negative ; Test Name: CRP; Result Unstructured Data: (Test Result:14 on day 1,Unit:mg/L,Normal Low:,Normal High:); Test Name: Ehrlichia smears; Test Result: Negative ; Test Name: EBV IgG; Test Result: Positive ; Test Name: Epstein-Barr virus IgM antibody; Test Result: Negative ; Test Name: flow cytometry; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: gene testing; Result Unstructured Data: (Test Result:no evidence of HLH triggering genes,Unit:unknown,Normal Low:,Normal High:); Test Name: Hematocrit; Result Unstructured Data: (Test Result:56.5 on day 1,Unit:%,Normal Low:,Normal High:); Test Name: Hematocrit; Result Unstructured Data: (Test Result:37 on day 5,Unit:%,Normal Low:,Normal High:); Test Name: Hematocrit; Result Unstructured Data: (Test Result:3 on day 10,Unit:%,Normal Low:,Normal High:); Test Name: Hemoglobin; Result Unstructured Data: (Test Result:19.4 on day 1,Unit:g/dL,Normal Low:,Normal High:); Test Name: Hemoglobin; Result Unstructured Data: (Test Result:12.7 on day 5,Unit:g/dL,Normal Low:,Normal High:); Test Name: Hemoglobin; Result Unstructured Data: (Test Result:7.6 on day 10,Unit:g/dL,Normal Low:,Normal High:); Test Name: Heart rate; Result Unstructured Data: (Test Result:140,Unit:/min,Normal Low:,Normal High:); Test Name: Viral hepatitis panel; Test Result: Negative ; Test Name: HIV test; Test Result: Negative ; Test Name: inflammatory markers; Result Unstructured Data: (Test Result:elevated level,Unit:unknown,Normal Low:,Normal High:); Test Name: Influenza A&B Ag; Test Result: Negative ; Test Name: Influenza A&B Ag; Test Result: Negative ; Test Name: Interleukin-2 receptor; Result Unstructured Data: (Test Result:elevated sCD25,Unit:unknown,Normal Low:,Normal High:); Test Name: anti signal recognition particle; Test Result: Negative ; Test Name: H score; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: Myositis panel; Test Result: Negative ; Test Name: Urine Legionella antigen; Test Result: Negative ; Test Name: Lipase; Result Unstructured Data: (Test Result:44 on day 1,Unit:IU/L,Normal Low:,Normal High:); Test Name: nasopharyngeal swab; Test Result: Positive ; Test Name: CD16/CD56% (NK cells); Test Result: 2 %; Test Name: Natural killer cell 50:1; Test Result: 1 %; Test Name: NK 12:1; Test Result: 2 %; Test Name: NK 25:1; Test Result: 2 %; Test Name: NK 6:1; Test Result: 1 %; Test Name: NK lytic units; Result Unstructured Data: (Test Result:0,Unit:unit,Normal Low:,Normal High:greater than or equal to 2.6); Test Name: NK cell; Result Unstructured Data: (Test Result:Low,Unit:unknown,Normal Low:,Normal High:); Test Name: Neisseria gonorrhoeae RNA; Test Result: Negative ; Test Name: Oxygen saturation; Result Unstructured Data: (Test Result:100 on room air,Unit:%,Normal Low:,Normal High:); Test Name: Babesia smear; Test Result: Negative ; Test Name: Physical examination; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: Platelet count; Result Unstructured Data: (Test Result:157 thous on day 1,Unit:/mm3,Normal Low:,Normal High:); Test Name: Platelet count; Result Unstructured Data: (Test Result:77 thous on day 5,Unit:/mm3,Normal Low:,Normal High:); Test Name: Platelet count; Result Unstructured Data: (Test Result:59 thous on day 10,Unit:/mm3,Normal Low:,Normal High:); Test Name: PCR; Test Result: Negative ; Test Name: PCR; Test Result: Negative ; Test Name: PCR; Test Result: Negative ; Test Name: PCR; Test Result: Negative ; Test Name: PCR; Test Result: Negative ; Test Name: PCR; Test Result: Positive ; Test Name: RBC; Result Unstructured Data: (Test Result:6.74 mill on Day 1,Unit:/mm3,Normal Low:,Normal High:); Test Name: RBC; Result Unstructured Data: (Test Result:4.45 mill on Day 5,Unit:/mm3,Normal Low:,Normal High:); Test Name: RBC; Result Unstructured Data: (Test Result:2.6 mill on Day 10,Unit:/mm3,Normal Low:,Normal High:); Test Name: erythrocyte sedimentation rate; Result Unstructured Data: (Test Result:3,Unit:mm/h,Normal Low:,Normal High:); Test Name: Respiratory rate; Result Unstructured Data: (Test Result:20,Unit:/min,Normal Low:,Normal High:); Test Name: Rheumatoid factor; Test Result: Negative ; Test Name: COVID-19 PCR; Test Result: Negative ; Test Name: Ferritin; Result Unstructured Data: (Test Result:430 on day 1,Unit:ng/mL,Normal Low:,Normal High:); Test Name: Ferritin; Result Unstructured Data: (Test Result:2,550 on day 5,Unit:ng/mL,Normal Low:,Normal High:); Test Name: Ferritin; Result Unstructured Data: (Test Result:1,055 on day 10,Unit:ng/mL,Normal Low:,Normal High:); Test Name: Anaplasma Smear test; Test Result: Negative ; Test Name: Rapid strep test (throat); Test Result: Negative ; Test Name: Rapid plasma reagin; Test Result: Negative ; Test Name: viral blood panel; Test Result: Positive ; Test Name: WBC count; Result Unstructured Data: (Test Result:13 thousn on Day 1,Unit:/mm3,Normal Low:,Normal High:); Test Name: WBC count; Result Unstructured Data: (Test Result:24 thous on Day 5,Unit:/mm3,Normal Low:,Normal High:); Test Name: WBC count; Result Unstructured Data: (Test Result:14 thous on Day 10,Unit:/mm3,Normal Low:,Normal High:); Comments: The H-score, which is a clinical tool to estimate the probability of HLH, showed an 88-93% probability of that potentially fatal disorder. Physical exam showed erythema of eyelids, oral aphthous ulcers, oral petechiae on a background of pale mucosa, nonpruritic petechial rash over his anterior chest, and mild-to-moderate epigastric tenderness. The rest of the physical examination was unremarkable. flow cytometry revealed absolute CD19+ B-cell lymphopenia as well as absolute CD3+ T-cell lymphopenia, which are nonspecific findings.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Inflammatory arthritis; Systemic lupus erythematosus (notable for several family members)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 05.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Herpes zoster
Vaccination failure
Symptomtext
Got vaccine & still got Shingles/Suspected vaccination failure; Bells Palsy; Got Shingles on right-side of my face and head; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, bell's palsy and shingles were unknown. It was unknown if the reporter considered the vaccination failure, bell's palsy and shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient got shingles vaccine and still got shingles on right-side of his/her face and head along with bell's palsy. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.04.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Symptomtext
My husband got Bells Palsy; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown. It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's comment: This case was reported by patient's wife via interactive digital media. The patient got Shingles vaccine and experienced bell's palsy which was one of the side effect. Additional supportive information: Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.04.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Herpes zoster
Pain of skin
Vaccination failure
Varicella
Symptomtext
shingles/ suspected vaccination failure; Had chicken pox and Bell's palsy and shingles; shingles; chicken pox; skin hurt; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), bell's palsy (serious criteria GSK medically significant), shingles, chickenpox and skin pain. On an unknown date, the outcome of the vaccination failure, bell's palsy, shingles and chickenpox were unknown and the outcome of the skin pain was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, bell's palsy, shingles, chickenpox and skin pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had chicken pox and Bell's palsy and shingles. The patient had the vaccination and still had days that skin hurts. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- F
- Eingang
- 22.04.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anaphylactic reaction
COVID-19
Taste disorder
Symptomtext
Anaphylaxis; This case was reported by a consumer via other manufacturer and described the occurrence of anaphylaxis in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included urticaria (patient was allergic to Amox and had hives). Concurrent medical conditions included hypertension, nonalcoholic fatty liver disease, obstructive sleep apnea syndrome, gene mutation (heterozygous PRF1 mutation) and penicillin allergy. Concomitant products included levonorgestrel (Mirena Intrauterine Device), sertraline, cetirizine, metoprolol, sennosides (Senna Tabs), magnesium (Magnesium Supplement), colecalciferol (Vitamin D3), paroxetine hydrochloride (Paxil) and spironolactone. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to Shingrix. Additional Information: GSK receipt date: 14-Apr-2022 Reporter's comment: The patient was taking Provigil 250 mg daily for 4 weeks for unknown indication as concomitant medication. Recently, the patient was diagnosed with Covid on 29th March 2022, treated with Pf-07321332, Ritonavir (Paxlovid), 3 tablets twice a day for 5 day and experienced horrid taste in mouth. The reporter consented to follow-up. Additional Supportive Information: It was unknown if the reporter considered the anaphylaxis and hives to be related to Amox. Note: As this case was received for Pfizer product for Covid which patient had received recently and there is no information regarding the vaccination details of Shingrix, therefore conservatively Shingrix was captured as suspect with event anaphylaxis.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic reaction
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Gene mutation (heterozygous PRF1 mutation); Hypertension; Nonalcoholic fatty liver disease; Obstructive sleep apnea syndrome; Penicillin allergy
- Vorgeschichte
- Medical History/Concurrent Conditions: Urticaria (patient was allergic to Amox and had hives)
- Andere Medikamente
- MIRENA INTRAUTERINE DEVICE; SERTRALINE; CETIRIZINE; METOPROLOL; SENNA TABS; MAGNESIUM SUPPLEMENT; VITAMIN D3; PAXIL; SPIRONOLACTONE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 11.04.2022
- Impfdatum
- 01.04.2022
- Beginn
- 01.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Diplopia
Headache
IVth nerve paralysis
Pain in extremity
Pain of skin
Rhinalgia
Symptomtext
right eye IV nerve palsy; vertical diplopia/double vision; soreness in arm; scalp tenderness; headache; pain and soreness in the area of the right superior nasal orbital rim; This case was reported by a consumer and described the occurrence of ivth nerve palsy in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose 2 months ago and had about the normal soreness in his arm, refer case US2022AMR060953). On 1st April 2022, the patient received the 2nd dose of Shingrix. On 2nd April 2022, 1 days after receiving Shingrix, the patient experienced ivth nerve palsy (serious criteria GSK medically significant) and double vision. In April 2022, the patient experienced pain in arm, scalp tenderness, headache and nasal pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the ivth nerve palsy, double vision, pain in arm, scalp tenderness, headache and nasal pain were unknown. It was unknown if the reporter considered the ivth nerve palsy, double vision, pain in arm, scalp tenderness, headache and nasal pain to be related to Shingrix. Linked case(s) involving the same patient: US2022AMR060953 Additional Information: GSK receipt date: 05-Apr-2022 Reporter's comment: The patient received a dose of Shingrix and 1 day after vaccination, the patient woke up with double vision. The reporter's wife was a licensed OD and she was able to determine that he had vertical diplopia from a right eye IV nerve palsy. Less than a week, after receiving the vaccination, the patient also experienced some right sided scalp tenderness, a headache, as well as pain and soreness in the area of the right superior nasal orbital rim. The patient asked if a fourth nerve palsy been reported as an adverse side effect after any other Shingrix vaccinations. The reporter consented to follow-up.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR060953:Same patient/reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- IVth nerve paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- -
- Geschlecht
- M
- Eingang
- 06.04.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Activated partial thromboplastin time prolonged
Bleeding time prolonged
Blood culture
Catheter site haemorrhage
Coagulation factor VIII level abnormal
Coagulation test
Computerised tomogram head normal
Ecchymosis
Factor VIII deficiency
Haemophilia
Injection site discolouration
Injection site haemorrhage
Injection site oedema
Injection site swelling
Intensive care
Oedema peripheral
Peripheral swelling
Platelet count
Symptomtext
Edema of the right thigh; Swollen right thigh; Skin over the swollen right thigh had ecchymosis/ ecchymosis of left hand and forearm; Skin over the swollen right thigh had ecchymosis and discoloration; This case was reported in a literature article and described the occurrence of edema thigh in a 2-day-old male patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included hepatitis B immunoglobulin for prophylaxis and vitamin k1 for prophylaxis. The patient's past medical history included hepatitis b carrier (Family History) (the patient's mother was a hepatitis B virus carrier). Concurrent medical conditions included hemophilia a (factor viii). On an unknown date, the patient received Hepatitis B vaccine (intramuscular) .5 ml, hepatitis B immunoglobulin (intramuscular) .5 ml at an unknown frequency and vitamin k1 (intramuscular) .1 ml at an unknown frequency. On an unknown date, 36 hrs after receiving Hepatitis B vaccine, the patient experienced edema thigh (serious criteria hospitalization), swelling of legs (serious criteria hospitalization), ecchymosis (serious criteria hospitalization) and skin discoloration (serious criteria hospitalization). The patient was treated with antibiotics nos and intravenous fluid (nos). The action taken with vitamin k1 was unknown. On an unknown date, the outcome of the edema thigh, swelling of legs and ecchymosis were recovered/resolved and the outcome of the skin discoloration was unknown. The reporter considered the edema thigh, swelling of legs, ecchymosis and skin discoloration to be related to Hepatitis B vaccine. GSK Receipt Date: 31-Mar-2022 Author Comment: The patient was born at 38 weeks of gestation without complications. There was no abnormality noted at birth. There was no family history of genetic diseases, and prenatal history was unremarkable. Soon after birth, the patient received hepatitis B vaccine and vitamin K1 in right thigh and immunoglobulin in left thigh intramuscularly. The swelling of the right thigh was apparent at about 36 hours after the intramuscular injections. The patient was brought to the baby nursery with edema of the right thigh. On physical examination, the patient appeared well and interactive. He was normocephalic, with normally set ears and without dysmorphic facial features. His lungs were clear to auscultation, with symmetric chest wall expansion. A cardiovascular examination revealed a normal heart rate, with regular rhythm and without murmurs. His abdomen was soft, nontender, and non distended. There was no organomegaly. He had normal genitalia for his age and sex. He had normal range of motion, with normal strength and no head lag. He responded to stimulation, had a symmetric moro reflex, positive suck reflex, and positive palmar grasp reflex. The skin over the swollen right thigh had ecchymosis and discoloration. The infant was transferred to the neonatal intensive care unit (NICU) nursery. A blood culture was obtained, and antibiotics were initiated. Peripheral intravenous (IV) fluid was infused on the left forearm and hand. On the day after NICU admission (day 3 of the patient's life), ecchymosis of his left hand and forearm were noted after removal of the IV angiocatheter. The bleeding at the IV site was noted to prolong. Coagulation (ie, activated partial thromboplastintime [aPTT] and prothrombin time) and platelet count studies were obtained. The aPTT was prolonged. Neurosonogram and cranial CT scans were normal. The diagnosis of hemophilia was made after the factor VIII level confirmed the diagnosis. The patient received factor VIII concentrates. The ecchymosis and swelling gradually resolved without any complications. He was discharged home on day 10 of life. Within a few days of discharge, the patient was seen by pediatric hematologist at the clinic, where his parents were counseled about potential problems (eg, heel sticks, vaccinations, intramuscular injection), including those that may relate to major bleeding, such as intracranial hemorrhage (ICH). Hemophilia A is an inherited bleeding disorder caused by deficiency of coagulation factor VIII. The range of ages for first bleed is wide, with some children having severe bleeding at birth and others who do not experience a bleeding episode until age 4 years. At birth, a diagnosis of hemophilia can be made using cord blood or a venous blood sample. The differential diagnosis of hemophilia includes von Willebrand disease, inherited platelet disorders, factor XI deficiency and factor XIII deficiency. Nicolau syndrome, or embolia cutis medicamentosa, is another condition that would be considered in the differential diagnosis as a complication of intramuscular injection in neonates. Additional Supportive Information: This article is not available for regulatory reporting due to copyright restriction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Intensive care
- Hospital-Tage
- -
- Labordaten
- Test Name: Activated partial thromboplastin time; Result Unstructured Data: (Test Result:Prolonged,Unit:unknown,Normal Low:,Normal High:); Test Name: Auscultation; Result Unstructured Data: (Test Result:Clear with symmetric chest wall expansion,Unit:unknown,Normal Low:,Normal High:); Test Name: Bleeding time; Result Unstructured Data: (Test Result:Prolonged,Unit:unknown,Normal Low:,Normal High:); Test Name: Cardiovascular examination; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: Coagulation factor VIII level; Result Unstructured Data: (Test Result:Hemophilia A diagnosed,Unit:unknown,Normal Low:,Normal High:); Test Name: Cranial CT scans; Result Unstructured Data: (Test Result:Normal result,Unit:unknown,Normal Low:,Normal High:); Test Name: heart rate; Result Unstructured Data: (Test Result:normal value,Unit:unknown,Normal Low:,Normal High:); Test Name: Physical examination; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Name: Palmar grasp reflex; Test Result: Positive ; Test Name: suck reflex; Result Unstructured Data: (Test Result:Symmetric Moro reflex, positive suck reflex,Unit:unknown,Normal Low:,Normal High:); Test Name: Neurosonogram; Result Unstructured Data: (Test Result:Normal neurosonogram,Unit:unknown,Normal Low:,Normal High:); Comments: On physical examination, the patient appeared well and interactive. He was normocephalic, with normally set ears and without dysmorphic facial features. A cardiovascular examination revealed a normal heart rate, with regular rhythm and without murmurs. A blood culture was obtained. Coagulation (ie, activated partial thromboplastintime [aPTT] and prothrombin time) and platelet count studies were obtained. He had normal range of motion, with normal strength and no head lag.
- Aktuelle Erkrankungen
- Hemophilia A (Factor VIII)
- Vorgeschichte
- Medical History/Concurrent Conditions: Hepatitis B carrier (the patient's mother was a hepatitis B virus carrier)
- Andere Medikamente
- VITAMIN K1; HEPATITIS B IMMUNOGLOBULIN
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 05.04.2022
- Impfdatum
- 24.03.2022
- Beginn
- 25.03.2022
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Generalised tonic-clonic seizure
Headache
Symptomtext
Grand Mal seizure; headache; This case was reported by a consumer and described the occurrence of grand mal seizure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 24th March 2022, the patient received Shingles vaccine. On 25th March 2022, 1 days after receiving Shingles vaccine, the patient experienced grand mal seizure (serious criteria GSK medically significant) and headache. The patient was treated with antiepileptics nos (Seizure Medication). On an unknown date, the outcome of the grand mal seizure was unknown and the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the grand mal seizure and headache to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-MAR-2022 Reporter's Comments: The patient was given the vaccine last Thursday afternoon. The next day, in the evening, the patient had a grand mal seizure. The patient had headaches ever since then. The patient had a doctor's appointment on the reporting day and some tests were ordered. The patient was on seizure medication and reported that on the questionnaire, but no one discussed the potential side effects with him/her. The reporter consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Generalised tonic-clonic seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- F
- Eingang
- 25.03.2022
- Impfdatum
- 30.11.2021
- Beginn
- 28.12.2021
- Tage bis Beginn
- 28,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anaphylactic reaction
Eye inflammation
Eye swelling
Rash
Symptomtext
Anaphylactic reaction; Inflammation in eye/ eye swelling; Rash; This case was reported by a physician via other manufacturer and described the occurrence of anaphylactic reaction in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included abaloparatide (Tymlos) for senile osteoporosis. Concurrent medical conditions included senile osteoporosis. On an unknown date, the patient received the 1st dose of Shingrix. On 30th November 2021, the patient started Tymlos (subcutaneous) 80 ug once daily (80 ug daily). On 28th December 2021, unknown after receiving Shingrix, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), eye swelling and rash. Tymlos was continued with no change. On an unknown date, the outcome of the anaphylactic reaction, eye swelling and rash were unknown. It was unknown if the reporter considered the anaphylactic reaction, eye swelling and rash to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient's medical history was not provided. Relevant surgical, social, or substance-usage history was not provided. The patient received 1st dose of Shingrix vaccine and experienced eye swelling, rash, and an anaphylactic reaction. The patient was on Tymlos for the treatment of age-related osteoporosis. The patient's eye doctor advised that the eye Inflammation could be due to Shingrix but was unsure if related to Tymlos. Treatments for the events was not reported. No relevant lab or diagnostic tests were reported. The action taken with Tymlos was did not changed. The outcomes of eye swelling, rash, and an anaphylactic reaction were not reported. It was unknown if the reporter considered the anaphylactic reaction, eye swelling and rash to be related to Tymlos.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic reaction
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Senile osteoporosis
- Vorgeschichte
- -
- Andere Medikamente
- TYMLOS
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- -
- Geschlecht
- F
- Eingang
- 10.03.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Anaphylactic reaction
Erythema
Incomplete course of vaccination
Symptomtext
experienced anaphylaxis and had to go to urgent care.; her stomach was "beet red."; first dose 2.5 years ago, has not received her second; This case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced anaphylaxis (serious criteria GSK medically significant), erythema and incomplete course of vaccination. On an unknown date, the outcome of the anaphylaxis was recovered/resolved and the outcome of the erythema and incomplete course of vaccination were unknown. It was unknown if the reporter considered the anaphylaxis and erythema to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that after receiving the first dose of Shingrix 2.5 years before reporting, she experienced anaphylaxis and had to go to urgent care. The patient stated that her stomach was beet red. The patient received unspecified treatment and anaphylaxis resolved. The patient had not received her second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic reaction
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- SC
- Alter
- -
- Geschlecht
- F
- Eingang
- 08.03.2022
- Impfdatum
- 30.10.2021
- Beginn
- 02.11.2021
- Tage bis Beginn
- 3,0
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Computerised tomogram normal
Laboratory test normal
Paralysis
Speech disorder
Computerised tomogram
Electroencephalogram
Loss of consciousness
Magnetic resonance imaging
Symptomtext
Completely paralyzed, taken to hospital, slowly subsided; Could barely speak; This case was reported by a consumer via call center representative and described the occurrence of paralysis in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 30th October 2021, the patient received the 2nd dose of Shingrix. On 2nd November 2021, 3 days after receiving Shingrix, the patient experienced paralysis (serious criteria hospitalization and GSK medically significant) and speech disorder (serious criteria hospitalization). On an unknown date, the outcome of the paralysis and speech disorder were recovering/resolving. It was unknown if the reporter considered the paralysis and speech disorder to be related to Shingrix. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient became completely paralyzed from the neck down and could barely speak garbled one syllable words. The patient was taken by ambulance to the hospital. The CT (computed tomography) scan and various tests were conducted (the patient was told it was not a stroke or transient ischaemic attack (TIA)). Within 3 to 4 hours at the hospital the paralysis slowly subsided and he/she was able to speak. The patient stated that there had been some minor effects but hopefully it would all subside eventually.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- Test Name: CT scan; Result Unstructured Data: (Test Result:Unknown,Unit:unknown,Normal Low:,Normal High:); Comments: various tests (unspecified) were conducted.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 05.03.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Syncope
Symptomtext
Grade-3 Syncope; This case was reported in a literature article and described the occurrence of syncope in a patient who received Herpes zoster (Zoster VZV-gE-AS01B) for prophylaxis. On an unknown date, the patient received Zoster VZV-gE-AS01B (intramuscular). On an unknown date, less than a week after receiving Zoster VZV-gE-AS01B, the patient experienced syncope (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the syncope was unknown. The reporter considered the syncope to be related to Zoster VZV-gE-AS01B. Additional information was provided as follows: This case was reported in a literature article and described occurrence of Grade-3 Syncope in a patient of unspecified age and gender, who was vaccinated with Shingrix vaccine (GlaxoSmithKline) for prophylaxis. The patient was part of a prospective, open-label, investigator-initiated phase II trial which investigated the efficacy and safety of the recombinant RZV vaccine (SHINGRIX, GlaxoSmithKline Biologicals) in patients with CLL that were either treatment naive chronic lymphocytic leukemia (CLL) or being treated with Bruton tyrosine kinase inhibitor (BTKi) therapy. [Eligible patients had CLL or small lymphocytic lymphoma (SLL). Patients were previously untreated (active surveillance) or received BTKi monotherapy (ibrutinib or acalabrutinib) for at least 6 months before administration of the first vaccine dose. Key exclusion criteria were patients with Richter transformation, uncontrolled/symptomatic infection, intravenous or subcutaneous immunoglobulin (IVIG) replacement within 3 months before vaccination, concomitant immunosuppressive therapy (e.g., systemic steroids, radiotherapy, chemotherapy), and hereditary or acquired immunodeficiency syndrome unrelated to CLL. Patients must have had no active, symptomatic VZV or herpes zoster infection within 12 months prior to vaccination, no exposure to the live VZV vaccine (ZOSTAVAX) within 12 months, and no prior exposure to the RZV vaccine]. No information on patient's medical history or family history or current condition or concomitant medication was provided. On an unspecified date, the patient received Shingrix vaccine intramuscularly (Site of administration unspecified; batch number not provided, dosage unknown). [RZV was given at baseline and at 3 months via intramuscular injection]. The age at vaccination was not provided. On an unspecified date, within 7 days after vaccination the patient experienced grade-3 Syncope. [106 patients were evaluable for primary response assessment of a more than 4-fold increase in VZV antibody titre. RZV was given at baseline and at 3 months via intramuscular injection. Humoral and cellular vaccine response was assessed 6 months after the first vaccine administration (window period: +/- 15 days). Following each vaccine dose, patients received an adverse event diary. Subjects documented any local (injection site) or systemic adverse effects that started within seven days after receiving the first and second vaccine dose. Subjects noted adverse effects on the following scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3). Additionally, subjects had the option to participate in long-term follow-up and receive annual assessment of antibody titer. The humoral response rate to RZV was significantly higher in the TN cohort (76.8%) compared to patients receiving a BTKi. There was no difference in baseline anti-gE titers between the TN and BTKi cohort. 96 patients were evaluable for assessment of cellular immunogenicity. Similar to humoral responses, the rate of cellular immunity was significantly higher in the TN cohort (70.0%) compared to patients treated with a BTKi (41.3%; P = .0072). There was no difference in CD42+ Tcell frequencies at baseline between the TN and BTKi cohort. Among all patients with paired antibody and cellular responses, 69.1% of subjects with a serologic response also had a positive cellular immune response, whereas 39.0% of subjects attained a cellular immune response in absence of a serologic response (P = .0033). Among subjects with a negative serologic response and a positive cellular immune response, 40.0% were TN (n = 6) and 60.0% (n = 9) received a BTKi. There was no significant difference in humoral or cellular responses between ibrutinib or acalabrutinib Treatment. Long-term humoral response was assessed in 26 patients after 12 months and 12 patients after 24 months. The median follow-up in the long-term follow-up cohort was 12 months. Among 26 patients, 21 (80.8%) received BTKi and 5 (19.2%) were patients with TN CLL. 11 (42.3%) patients had a positive serologic response at 6 months (more than or equal to fourfold rise in anti-gE). Antibody titers did not significantly change between 6, 12 and 24 months after vaccination across the entire patient population, within each cohort (TN and BTKi), and among responders and non-responders. There was no significant difference in anti-gE titer changes at 6, 12 and 24 months in TN and BTKi cohort or in responders and non-responders at 6 months. The most frequent local and systemic AEs were injection site pain (97.4%), injection site reaction (70.7%), headache (51.7%), and generalized myalgias (51.7%). Most AEs were grade 1-2, and all AEs resolved or returned to baseline within seven days of vaccine administration. Grade 3 AEs occurred in 17 (14.7%) patients. No grade 4 or higher AEs or treatment-related serious AEs occurred. There were no cases of postherpetic neuralgia during the study period]. This case has been considered as serious as the adverse event was grade-3. Treatment was unknown. Outcome of the event was not reported. The authors commented, "This study confirms the safety and reduced immunogenicity of the RZV vaccine in patients with CLL who are untreated or receiving treatment with a BTKi. The vaccine antibody response rate in the TN CLL cohort (76.8%) is similar compared to responses observed in other hematologic malignancies (80.4%) yet decreased compared to the general population (97.8%). Conversely, BTKi therapy significantly impairs vaccine responses, eliciting humoral responses in only 40.0% of patients. The median foldchange of anti-gE titers after the second vaccine dose were attenuated in both the TN (7.76) and BTKi (3.31) cohort compared to expected fold-change in gE in the general population (39.1). It is conceivable the lower antibody titers confer lower rates of protection against infection, however it is currently unknown what level of gE fold-change provides optimal protection against RZV infection. Notably, in the interim analysis of this study, there was no statistically significant difference in vaccine antibody responses between TN vs. BTKi treated patients. The analysis of the complete study population showed a larger difference between vaccine responses in the TN and BTKi groups which was statistically significant. Long-term antibody titers following RZV vaccination remained stable for at least two years after vaccination." The authors concluded, "In summary, RZV is safe in patients with CLL and can induce both humoral and cellular immune responses in many patients. BTKi treatment was associated with lower humoral and cellular vaccine responses compared to TN patients. All patients with CLL should receive vaccination against novel antigens, ideally before starting a BTKi". The article corresponding to this case is not available for regulatory submission due to copyright restriction. This case is 1 of the 3 cases reported in this literature article.; Sender's Comments: US-GLAXOSMITHKLINE-US2022GSK037189:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 4,0
- Geschlecht
- F
- Eingang
- 05.03.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Anaphylactic reaction
Symptomtext
had anaphylactic reaction, went to ER; This case was reported by a other health professional via sales rep and described the occurrence of anaphylactic reaction in a 4-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and PROQUAD for prophylaxis. On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device and PROQUAD. On an unknown date, less than a year after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced anaphylactic reaction (serious criteria medically significant). On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved. It was unknown if the reporter considered the anaphylactic reaction to be related to Kinrix and Kinrix Pre-Filled Syringe Device.This report is made without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter was an Epidemiologist. The patient had anaphylactic reaction less than a year after receiving Kinrix and ProQuad at 4-year-old visit, the patient went to emergency room to be treated and recovered. It was unknown if the reporter considered the anaphylactic reaction to be related to ProQuad. The reporter agreed to follow up from GlaxoSmithKline.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic reaction
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 4,0
- Geschlecht
- F
- Eingang
- 05.03.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Anaphylactic reaction
Symptomtext
had anaphylactic reaction, went to ER; This case was reported by a other health professional via sales rep and described the occurrence of anaphylactic reaction in a 4-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and PROQUAD for prophylaxis. On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device and PROQUAD. On an unknown date, less than a year after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced anaphylactic reaction (serious criteria medically significant). On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved. It was unknown if the reporter considered the anaphylactic reaction to be related to Kinrix and Kinrix Pre-Filled Syringe Device.This report is made without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter was an Epidemiologist. The patient had anaphylactic reaction less than a year after receiving Kinrix and ProQuad at 4-year-old visit, the patient went to emergency room to be treated and recovered. It was unknown if the reporter considered the anaphylactic reaction to be related to ProQuad. The reporter agreed to follow up from GlaxoSmithKline.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic reaction
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 93,0
- Geschlecht
- F
- Eingang
- 18.02.2022
- Impfdatum
- 12.01.2021
- Beginn
- 06.01.2022
- Tage bis Beginn
- 359,0
- Dosis
- 1
- Route/Site
- IM / UN
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: ja
Aggression
Blood creatinine increased
Blood culture
Blood gases
Blood pH decreased
Brain natriuretic peptide increased
C-reactive protein
COVID-19
COVID-19 pneumonia
Chest X-ray abnormal
Condition aggravated
Cough
Dyspnoea
Electrocardiogram ST segment depression
Electrocardiogram abnormal
Extra dose administered
Fatigue
Haemoglobin decreased
Symptomtext
Pt to ED for respiratory distress and cough. Oxygen saturation on room air was less than 50%, improving to 81% on 12 L of non-rebreather and 100% on 15 L non-rebreather. In severe respiratory distress with rhonchi and had some peripheral edema. Labs showed a creatinine of 1.25. WBC count of 19.0, hemoglobin 9.1. ABG showed a pH of 7.28, PO2 264. BNP level was 406. Chest x-ray showed pleural and parenchymal opacity in the right lung base suggesting a combination of a small pleural effusion and right lower lobe infiltrate. A 12-lead EKG was reviewed showing sinus tachycardia with diffuse ST-segment depressions. Admitted for management of pneumonia COVID + 1/6/21. Found to have troponin elevation. Discharged.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Respiratory distress
- Hospital-Tage
- 12,0
- Labordaten
- see above
- Aktuelle Erkrankungen
- 2/21/21 to 3/31/21 ED for increasing SOB associated with 2 cough and fatigue. Evaluation in the emergency room included a COVID screen which was negative. A subsequent chest x-ray revealed chronic parenchymal changes and she was noted to have chronic nonhealing ulcer of the heel, which was suspected to have osteomyelitis. So, she was admitted for further care and Infectious Disease and Podiatry were consulted. She was placed on broad-spectrum antibiotic therapy. Subsequently, Podiatry evaluated the patient and find no evidence of osteomyelitis and they recommended continuing wound care and obtained blood cultures, sedimentation rate and CRP to evaluate further. Infectious Disease also evaluated the patient. Subsequent imaging failed to reveal any signs of osteomyelitis and she was symptomatically treated. During the course of the hospitalization, she also was seen to have aggressive behavior as part of her vascular dementia, which were treated with initiation of risperidone. she was discharged home via ambulance.
- Vorgeschichte
- Acute encephalopathy,Bilateral pneumonia Chest pain,CVA (cerebral vascular accident); Essential hypertension Hypokalemia Hypomagnesemia Hypoxia Ischemic cardiomyopathy Normochromic normocytic anemia Obesity (BMI 30-39.9) Osteomyelitis Sepsis SIRS (systemic inflammatory response syndrome) UTI (urinary tract infection)
- Andere Medikamente
- amLODIPine (NORVASC) , atorvastatin (LIPITOR); Cholecalciferol (VITAMIN D-1000 MAX ST PO) ferrous sulfate 325 (65 Fe) MG PO Tab furosemide (LASIX) 20 MG PO Tab lisinopril (PRINIVIL, ZESTRIL) 10 MG PO Tab magnesium oxide (MAG-OXIDE) 400 MG P
- Allergien
- No
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- -
- Geschlecht
- U
- Eingang
- 12.02.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Herpes zoster
Incomplete course of vaccination
Symptomtext
Mild bell's palsy-type of reaction,no paralysis took place; I have had 9 episodes of shingles; Received 1 dose/I had a bad reaction, not receive a 2nd dose.; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included splenectomy (had spleen removed in 2012) and shingles (had 9 episodes of shingles). On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), shingles and incomplete course of vaccination. On an unknown date, the outcome of the bell's palsy, shingles and incomplete course of vaccination were unknown. It was unknown if the reporter considered the bell's palsy and shingles to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in 2020 and had shingles and a mild case of bell's palsy type reaction but not paralysis. The patient stated that the vaccine did not prevent further breakouts of shingles. The patient had a bad reaction so did not receive a 2nd dose, which led to incomplete course of vaccination. The patient stated that he/she should checked titer prior to receiving this dose.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Shingles (had 9 episodes of shingles); Splenectomy (had spleen removed in 2012)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- -
- Geschlecht
- U
- Eingang
- 12.02.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Herpes zoster
Incomplete course of vaccination
Symptomtext
Mild bell's palsy-type of reaction,no paralysis took place; I have had 9 episodes of shingles; Received 1 dose/I had a bad reaction, not receive a 2nd dose.; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included splenectomy (had spleen removed in 2012) and shingles (had 9 episodes of shingles). On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), shingles and incomplete course of vaccination. On an unknown date, the outcome of the bell's palsy, shingles and incomplete course of vaccination were unknown. It was unknown if the reporter considered the bell's palsy and shingles to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in 2020 and had shingles and a mild case of bell's palsy type reaction but not paralysis. The patient stated that the vaccine did not prevent further breakouts of shingles. The patient had a bad reaction so did not receive a 2nd dose, which led to incomplete course of vaccination. The patient stated that he/she should checked titer prior to receiving this dose.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Shingles (had 9 episodes of shingles); Splenectomy (had spleen removed in 2012)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 09.02.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Symptomtext
bell's palsy; This case was reported by a pharmacist via sales rep and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown. The reporter considered the bell's palsy to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient developed Bell's Palsy 3 to 4 days following receipt of first dose of Shingrix. The reporter thought this was related to Shingrix. The reporter did not agree to follow up from GlaxoSmithKline.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.02.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: ja
ER: unbekannt
Erholt: nein
Hypoglossal nerve paralysis
Tongue paralysis
Symptomtext
hypoglossal nerve palsy, paralyzed tongue; paralyzed tongue; This case was reported by a consumer via interactive digital media and described the occurrence of hypoglossal nerve paralysis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced hypoglossal nerve paralysis (serious criteria disability and GSK medically significant) and tongue paralysis (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the hypoglossal nerve paralysis and tongue paralysis were not recovered/not resolved. It was unknown if the reporter considered the hypoglossal nerve paralysis and tongue paralysis to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient got first dose and ended up with hypoglossal nerve palsy. The patient stated that it paralyzed his/her tongue permanently. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Hypoglossal nerve paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.02.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Loss of personal independence in daily activities
Nerve block
Post herpetic neuralgia
Shock
Symptomtext
Mild case after 1st shingles vaccine; Postherpetic neuralgia impacts my life every day; it impacts my life everyday; This case was reported by a nurse via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced shingles, post herpetic neuralgia and activities of daily living impaired. On an unknown date, the outcome of the shingles and post herpetic neuralgia were unknown and the outcome of the activities of daily living impaired was not recovered/not resolved. It was unknown if the reporter considered the shingles, post herpetic neuralgia and activities of daily living impaired to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated he/ she put off getting vaccinated. The patient finally got the first shingles vaccine and two months later, came down with a mild case of shingles, as what he/she thought. At first, the patient did not even know what it was, it was on the back. By the time the patient figured out he/she had shingles, it was too late for antivirals. The patient stated it had been 15 months of agony. The patient had post herpetic neuralgia. The patient had a nerve block which helped some. The patient stated, it impacts his/her life every day, he/she would never wish this on anyone and urges everyone to go get vaccinated. The follow-up would not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Shock
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 84,0
- Geschlecht
- F
- Eingang
- 29.01.2022
- Impfdatum
- 04.02.2021
- Beginn
- 04.02.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- UN / UN
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Blood pressure measurement
Cardiac discomfort
Electrocardiogram
Hypertension
Loss of consciousness
Computerised tomogram head
Computerised tomogram normal
Dizziness
Dyspnoea
Electrocardiogram normal
Electrocardiogram ST segment elevation
Palpitations
Vaccination complication
Symptomtext
She was passing out/she was in "poor condition"; They thought she was having a heart attack; Her blood pressure was up; Just a bad reaction to Moderna; This spontaneous case was reported by a nurse and describes the occurrence of LOSS OF CONSCIOUSNESS (She was passing out/she was in "poor condition") in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (She was passing out/she was in "poor condition") (seriousness criterion medically significant), CARDIAC DISCOMFORT (They thought she was having a heart attack), HYPERTENSION (Her blood pressure was up) and VACCINATION COMPLICATION (Just a bad reaction to Moderna). The patient was treated with OXYGEN on 04-Feb-2021 for Adverse event, at an unspecified dose and frequency. In February 2021, LOSS OF CONSCIOUSNESS (She was passing out/she was in "poor condition"), CARDIAC DISCOMFORT (They thought she was having a heart attack), HYPERTENSION (Her blood pressure was up) and VACCINATION COMPLICATION (Just a bad reaction to Moderna) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood pressure measurement: high (High) BP was up. On 04-Feb-2021, Electrocardiogram: results not provided (Inconclusive) Results not provided. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that they told her that she should go to the hospital right away. They sent her in an ambulance to the hospital. During the ride, they gave her oxygen. She doesn't remember receiving any medications in the ambulance or ER It was stated that she stayed in the ER until her signs corrected themselves. She was indicated not to receive the second dose.. She was on medication for blood pressure issues. Company Comment - This spontaneous case concerns a 84 year old female patient with no relevant medical history, who experienced the serious unexpected event of loss of consciousness. The event occurred on the same day after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable as this is the first dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 84 year old female patient with no relevant medical history, who experienced the serious unexpected event of loss of consciousness. The event occurred on the same day after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable as this is the first dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- Test Date: 20210204; Test Name: Blood pressure; Result Unstructured Data: BP was up; Test Date: 20210204; Test Name: ECG; Test Result: Inconclusive ; Result Unstructured Data: Results not provided
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.01.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Abdominal discomfort
Loss of consciousness
Nervousness
Sleep disorder
Symptomtext
passed out; sick to stomach; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced passed out (serious criteria GSK medically significant) and stomach discomfort. On an unknown date, the outcome of the passed out and stomach discomfort were unknown. It was unknown if the reporter considered the passed out and stomach discomfort to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was getting the second shot of shingles vaccine the next day of reporting and was really nervous because he/she woke up during the night after getting the first shot and got really sick to the stomach and actually passed out in the bathroom the night of the shot. The patient stated that he/she was praying that would be the case for his/her second dose. The follow-up would not be possible as no contact details were available. This case has been linked to US2022AMR014021, response to same post.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR014021:Response to same post
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.01.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Balance disorder
Brain injury
Gait inability
Paralysis
Symptomtext
paralyzed; unstable, brain will never fully recover; This case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced paralysis (serious criteria hospitalization and GSK medically significant) and unsteadiness. On an unknown date, the outcome of the paralysis was unknown and the outcome of the unsteadiness was not recovered/not resolved. It was unknown if the reporter considered the paralysis and unsteadiness to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient took the Shingles vaccine 3 years ago from reporting date and ended up in the hospital for two months paralyzed after months of rehab, the patient could walk again but she was unstable, her brain would never fully recover so now she was in an Alzheimer's research group. The patient stated that she was alive but only because of her husband's non-stop care. The sad thing was the doctors and the hospitals did not turn the statistics into the CDC (Centers for disease control and prevention). The follow up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paralysis
- Hospital-Tage
- 60,0
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.01.2022
- Impfdatum
- 19.01.2022
- Beginn
- 01.01.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Discomfort
Dizziness
Feeling abnormal
Hypertension
Loss of consciousness
Syncope
Symptomtext
felt like hit by a moped; enormously dizzy; fainted and blacked out; fainted and blacked out; blood pressure high,149 over 98; This case was reported by a consumer via call center representative and described the occurrence of faint in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 19th January 2022 09:15, the patient received the 1st dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced blood pressure high. On 19th January 2022, the patient experienced faint (serious criteria GSK medically significant), blackout (serious criteria GSK medically significant) and dizziness. On 19th January 2022 17:30, the patient experienced discomfort. In January 2022, the outcome of the faint, blackout and dizziness were recovered/resolved. On an unknown date, the outcome of the discomfort was unknown and the outcome of the blood pressure high was not recovered/not resolved. It was unknown if the reporter considered the faint, blackout, discomfort, dizziness and blood pressure high to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. One day before reporting at 9:15 am, patient received 1st dose of Shingrix vaccine and at 5:30 pm 8 hours 15 minutes after vaccination, the patient was all of the sudden felt like he/she was hit by a moped. The patient reported that he/she understood that this was normal. However, less than a day after vaccination, within 5 minutes of that happening patient then became enormously dizzy to the point where he/she fainted and blacked out completely and came to almost an hour later. Since this happened, patient's blood pressure had been extremely high about 149 over 98 (unit unspecified). The patient was concerned about getting the second dose in March 2022 due to the side effects. The patient enquired of how much immunity did one get after one shot of the vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- Test Date: 202201; Test Name: Blood pressure high; Result Unstructured Data: (Test Result:149 over 98,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- -
- Geschlecht
- U
- Eingang
- 22.01.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Syncope
Symptomtext
syncope; This case was reported by a nurse via sales rep and described the occurrence of syncope in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope was unknown. It was unknown if the reporter considered the syncope to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced syncope following a dose of Bexsero. Consent to follow up was denied.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 14.01.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Chills
Herpes zoster
Loss of consciousness
Pain
Pyrexia
Vaccination failure
Symptomtext
Suspected vaccination failure/Took second dose, got the virus; Passed out; Got the virus; Aches; Fever; Chills; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), shingles, pain, fever and chills. On an unknown date, the outcome of the vaccination failure, passed out, shingles, pain, fever and chills were unknown. It was unknown if the reporter considered the vaccination failure, passed out, shingles, pain, fever and chills to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient took 2nd dose and passed out. On an unknown date, the patient had experienced aches, fever, chills to got that virus. The patient stated that just not him/her but he/she sure went through a lot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 14.01.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Chills
Herpes zoster
Loss of consciousness
Pain
Pyrexia
Vaccination failure
Symptomtext
Suspected vaccination failure/Took second dose, got the virus; Passed out; Got the virus; Aches; Fever; Chills; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), shingles, pain, fever and chills. On an unknown date, the outcome of the vaccination failure, passed out, shingles, pain, fever and chills were unknown. It was unknown if the reporter considered the vaccination failure, passed out, shingles, pain, fever and chills to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient took 2nd dose and passed out. On an unknown date, the patient had experienced aches, fever, chills to got that virus. The patient stated that just not him/her but he/she sure went through a lot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 11.01.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Pericarditis
Pleurisy
Symptomtext
pericarditis; pleurisy; This case was reported by a consumer and described the occurrence of pericarditis in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced pericarditis (serious criteria GSK medically significant) and pleurisy. On an unknown date, the outcome of the pericarditis and pleurisy were not recovered/not resolved. It was unknown if the reporter considered the pericarditis and pleurisy to be related to Shingrix. Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient received a dose of Shingrix and developed pericarditis and pleurisy 3 days after injection. The patient reported that it was now 8 months and he/she still suffering. The patient also stated that he/she also reported this information after a couple days of symptoms and a diagnosis, and asked for update on the same. The reporter consented to follow-up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pericarditis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 08.01.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
reaction too much severe, Gillian Barry Syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. Previously administered products included Prednisone and Antibiotics (2 speculums). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got shingles already and he/she knew the symptoms and to get in to doctor within 1 day. The patient received Prednisone and 2 speculums of antibiotics which knocked the shingles down before weeping stage and nerve damage. After receiving Shingrix, the patient experienced Guillain Barre syndrome. The patient stated that, his/her reaction to Shingrix dose 1 was much too severe to repeat with 2nd dose with chances of more severe Guillain Barre Syndrome reaction which was worse than shingles. The patient had built up a bit of immunity because having had shingles already, plus 1 dose of Shingrix, was better than nothing, and stated get into doctors at first sign of infection. The patient's doctor stated that, shingles caught early was very treatable whereas Guillain Barre syndrome could put in hospital for weeks, sick for a year or two like his/her friend, and high chance of permanent nerve or muscle damage. The patient was that close and stated not worth chancing with 2nd dose of Shingrix. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Shingles
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 29.12.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Loss of consciousness
Symptomtext
Knocked out, could not function; This case was reported by a consumer via other manufacturer and described the occurrence of unconscious in a 70-year-old male patient who received Flu Seasonal QIV Dresden (Flu Seasonal QIV Dresden) for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis and leuprorelin acetate (Eligard) for product used for unknown indication. The subject's past medical history included stent placement. Concurrent medical conditions included malignant neoplasm of prostate. Concomitant products included enzalutamide. On an unknown date, the patient received Flu Seasonal QIV Dresden, COVID-19 VACCINE and Eligard at an unknown dose and frequency. On an unknown date, unknown after receiving Flu Seasonal QIV Dresden, the patient experienced unconscious (serious criteria GSK medically significant and other: Serious as per reporter). The subject was treated with ticagrelor (Brilinta) and acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the unconscious was recovered/resolved. It was unknown if the reporter considered the unconscious to be related to Flu Seasonal QIV Dresden. Additional details were provided are as follows: The patient was enrolled in Astellas sponsored patient support program. The age at vaccination was not reported. The patient did not had known medical history and drug allergy. The patient received a dose of Influenza vaccine, a booster dose of Covid-19 vaccine and leuprorelin (Eligard) on the same day. It was reported that the patient was knocked out to where he could not function for almost 3 days. The patient was treated with Enzalutamide 160 mg once day for malignant neoplasm of prostate. The patient asked to pharmacist about taking Ticagrelor (Brilinta) and aspirin 325 mg together and the patient stated that he had stent put in the place and was started on ticagrelor twice daily and was taking once daily along with aspirin but read aspirin dose might be too high. The pharmacist advised per clinical pharmacist that usually ticagrelor was dosed twice daily (as prescribed) along with aspirin 81 mg and also discuss with MDP who prescribed ticagrelor about decreasing of aspirin dose. The action taken with Enzalutamide, leuprorelin, Covid-19 vaccine and influenza vaccine therapy in response to event was unknown. No lab test information were provided. The sender comment was mentioned as unconsciousness was assessed as serious due to medical significant. It was unknown if the reporter considered the unconscious to be related to leuprorelin and Covid-19 vaccine. Note: Enzalutamide was captured as concomitant as it seems patient was taking it for cancer.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Malignant neoplasm of prostate
- Vorgeschichte
- Medical History/Concurrent Conditions: Stent placement
- Andere Medikamente
- ENZALUTAMIDE; ELIGARD
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 29.12.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Loss of consciousness
Symptomtext
Knocked out, could not function; This case was reported by a consumer via other manufacturer and described the occurrence of unconscious in a 70-year-old male patient who received Flu Seasonal QIV Dresden (Flu Seasonal QIV Dresden) for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis and leuprorelin acetate (Eligard) for product used for unknown indication. The subject's past medical history included stent placement. Concurrent medical conditions included malignant neoplasm of prostate. Concomitant products included enzalutamide. On an unknown date, the patient received Flu Seasonal QIV Dresden, COVID-19 VACCINE and Eligard at an unknown dose and frequency. On an unknown date, unknown after receiving Flu Seasonal QIV Dresden, the patient experienced unconscious (serious criteria GSK medically significant and other: Serious as per reporter). The subject was treated with ticagrelor (Brilinta) and acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the unconscious was recovered/resolved. It was unknown if the reporter considered the unconscious to be related to Flu Seasonal QIV Dresden. Additional details were provided are as follows: The patient was enrolled in Astellas sponsored patient support program. The age at vaccination was not reported. The patient did not had known medical history and drug allergy. The patient received a dose of Influenza vaccine, a booster dose of Covid-19 vaccine and leuprorelin (Eligard) on the same day. It was reported that the patient was knocked out to where he could not function for almost 3 days. The patient was treated with Enzalutamide 160 mg once day for malignant neoplasm of prostate. The patient asked to pharmacist about taking Ticagrelor (Brilinta) and aspirin 325 mg together and the patient stated that he had stent put in the place and was started on ticagrelor twice daily and was taking once daily along with aspirin but read aspirin dose might be too high. The pharmacist advised per clinical pharmacist that usually ticagrelor was dosed twice daily (as prescribed) along with aspirin 81 mg and also discuss with MDP who prescribed ticagrelor about decreasing of aspirin dose. The action taken with Enzalutamide, leuprorelin, Covid-19 vaccine and influenza vaccine therapy in response to event was unknown. No lab test information were provided. The sender comment was mentioned as unconsciousness was assessed as serious due to medical significant. It was unknown if the reporter considered the unconscious to be related to leuprorelin and Covid-19 vaccine. Note: Enzalutamide was captured as concomitant as it seems patient was taking it for cancer.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Malignant neoplasm of prostate
- Vorgeschichte
- Medical History/Concurrent Conditions: Stent placement
- Andere Medikamente
- ENZALUTAMIDE; ELIGARD
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 29.12.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Symptomtext
Bell's palsy, still has it, 2 months; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved. It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter's friend got his 1st one and ended up with bell's palsy and still had it, about 2 months now. It did not seem to want to leave. The reporter asked that what did that tell you. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 24.12.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
got Gilliam Barre Syndrome from first shot; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got guillain barre syndrome after first Shingle shot, rather gave shingles.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 80,0
- Geschlecht
- F
- Eingang
- 23.12.2021
- Impfdatum
- 16.04.2021
- Beginn
- 16.04.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Dizziness
Fall
Hypersensitivity
Hyponatraemia
Incomplete course of vaccination
Incorrect route of product administration
Medical diet
Product administered at inappropriate site
Renal impairment
Seizure like phenomena
Tremor
Symptomtext
is now hyponatremic, has been hospitalized 5 times; is having kidney issues, has been hospitalized 5 times; allergy to a component of the vaccine, has been hospitalized 5 times; started having tremors, has been hospitalized 5 times; cause her to fall to the ground and flop, has been hospitalized 5 times; she will not take the 2nd dose of the Shingrix; Dizzy; administered the vaccine into her stomach, has been hospitalized 5 times; administered the vaccine into her stomach, has been hospitalized 5 times; This case was reported by a consumer via call center representative and described the occurrence of tremor in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 16th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 16th April 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. In August 2021, the patient experienced tremor (serious criteria hospitalization) and fall (serious criteria hospitalization). On an unknown date, the patient experienced hyponatremia (serious criteria hospitalization), kidney dysfunction (serious criteria hospitalization and GSK medically significant), allergic reaction (serious criteria hospitalization), dizziness and incomplete course of vaccination. The patient was treated with furosemide (Lasix). On an unknown date, the outcome of the tremor, hyponatremia and dizziness were not recovered/not resolved and the outcome of the fall, kidney dysfunction, allergic reaction, intramuscular formulation administered by other route, vaccine administered at inappropriate site and incomplete course of vaccination were unknown. The reporter considered the tremor, fall, hyponatremia, kidney dysfunction, allergic reaction and dizziness to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The case was reported by patient herself. The patient received her 1st dose of Shingrix and her physician administered the vaccine into her stomach, which led to intramuscular formulation administered by other route. The patient did not provide any of the information for the vaccine she was given (dose, lot, expiration date). Four months after the Shingrix vaccine, the patient reported she started having tremor that cause her to fell to the ground and flop around like a fish. The patient had been hospitalized 5 times since receiving the Shingrix vaccine but could not provide the exact dates, aside from one of the hospitalizations occurred on Thanksgiving Day. She reported on one of the hospitalizations, she received a Lasix push. The patient reported that she was nowhyponatremic, since moving to her newretirement community where she stated she was fed a lowsodium diet. The patient reported that she had an appointment on the next day of reporting with a nephrologist to discuss the kidney issues she was having. The reporter stated that she thought all these issues are because she had an allergy to a component of the Shingrix vaccine, but she could not state what her allergies are. It was rpeorted that the patient was experiencing dizziness at the time of reporting when she stood up to move to the restroom. This would be months after the reported dose of Shingrix. The patient stated that it was due to the low sodium levels, and kidney issues she had developed. The patient reported, she would not take the 2nd dose of the Shingrix. The reporter consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure like phenomena
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 14.12.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Syncope
Symptomtext
collapsed on floor; This case was reported by a nurse via market research programs and described the occurrence of fainting in a male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. Previously administered products included took old shingles vaccine (received old shingles vaccine on an unknown date). On an unknown date, the patient received the 1st dose of Hz/su + AS01B. On an unknown date, less than a day after receiving Hz/su + AS01B, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was unknown. The reporter considered the fainting to be possibly related to Hz/su + AS01B. Additional details were reported as follows: The age at vaccination was not reported. After received Shingrix the patient collapsed on floor that night and the reporter had to call ambulance to assess. The patient did not received 2nd dose, no money back, but the reporter did more than VAERS. The reporter had not given permission for follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CT
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 12.12.2021
- Impfdatum
- 11.12.2021
- Beginn
- 12.12.2021
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Syncope
Symptomtext
Syncope 190 p 2nd Covid vaccine (Pfizer). Sy Resolved .
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- multi-vitamin for kids
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 07.12.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
got gillian barre; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. The reporter considered the guillain barre syndrome to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The reporter's husband got Guillain barre from shingle shot be careful. No contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.12.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
Guillain-BarrE syndromE; This case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and COVID-19 VACCINE UNKNOWN. On an unknown date, immediately after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. A physician informed me that one of her patients received her 1st dose of Shingrix along with a dose of COVID at a pharmacy. This patient experienced Guillain-Barre syndrome shortly after the doses. The doctor said she believes it could have been the COVID dose. The doctor told patient not to receive 2nd Shingrix dose. The doctor said, she thought the patient already reported this incident and did not have the patients information available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.12.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
Guillain-BarrE syndromE; This case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and COVID-19 VACCINE UNKNOWN. On an unknown date, immediately after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. A physician informed me that one of her patients received her 1st dose of Shingrix along with a dose of COVID at a pharmacy. This patient experienced Guillain-Barre syndrome shortly after the doses. The doctor said she believes it could have been the COVID dose. The doctor told patient not to receive 2nd Shingrix dose. The doctor said, she thought the patient already reported this incident and did not have the patients information available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 24.11.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Consciousness fluctuating
Herpes zoster
Loss of consciousness
Seizure
Vaccination failure
Symptomtext
shots that don't prevent you from getting shingles/Suspected vaccination failure; severe shingles, was hospitalized, from esophagus to stomach; seizures; going in and out of consciousness.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), seizure (serious criteria GSK medically significant and life threatening), loss of consciousness (serious criteria GSK medically significant and life threatening) and shingles (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, seizure, loss of consciousness and shingles were unknown. It was unknown if the reporter considered the vaccination failure, seizure, loss of consciousness and shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by patient's child. The age at vaccination was not reported. The patient received shingles vaccine and the shot almost killed the patient. he ended up in emergency room had seizures and was going in and out of consciousness. The patient also had severe cases of shingles and he was hospitalized four times. The shingles went down to his esophagus into his stomach. The reporter stated that stop pushing the poison shots that did not even prevent from shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 18.11.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Balance disorder
Mobility decreased
Muscle spasms
Seizure
Symptomtext
likened to having seizures; muscle spasms, could not get out of bed; no control of body; could not get out of bed; This case was reported by a consumer via other manufacturer and described the occurrence of seizure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced seizure (serious criteria GSK medically significant), muscle spasm, balance disorder and mobility decreased. On an unknown date, the outcome of the seizure, muscle spasm, balance disorder and mobility decreased were unknown. It was unknown if the reporter considered the seizure, muscle spasm, balance disorder and mobility decreased to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient had very severe muscles spasms, that she likened to having seizures, all night long. The patient had no control of her body and could not get out of bed. The reporter did not have further adverse event information. No additional adverse event reported. No product quality complaint was reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.11.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Amnesia
Fall
Skin abrasion
Syncope
Symptomtext
fainted; I have no memory of the circumstances preceding that; had a small abrasion; fallen on the carpet; This case was reported by a consumer via interactive digital media and described the occurrence of faint in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 hr after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), memory loss, skin abrasion and fall. On an unknown date, the outcome of the faint, memory loss, skin abrasion and fall were unknown. It was unknown if the reporter considered the faint, memory loss, skin abrasion and fall to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2nd dose of Shingrix shot and fainted about an hour later. The patient had no memory of the circumstances preceding after that. The patient had a few sips of alcohol, as it was 5:30 pm in the afternoon. The patient stated that he/she must had fallen on the carpet because the patient had a small abrasion. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- -
- Geschlecht
- U
- Eingang
- 12.11.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Respiratory failure
Symptomtext
Guillain-Barre Syndrome; Respiratory failure; This case was reported in a literature article and described the occurrence of guillain barre syndrome in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant) and respiratory failure (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome and respiratory failure were unknown. The reporter considered the guillain barre syndrome and respiratory failure to be related to Shingrix. Additional information was provided as follows: This case was reported in a literature article and described the occurrence of Guillain-Barre Syndrome in a patient aged 65 years or older of unspecified gender, who was vaccinated with Shingrix (GlaxoSmithKline) for prophylaxis. This case belongs to eTable-8 in supplemental content reported in the literature article. The patient was a part of the cohort study that objective was to use Medicare claims data to evaluate risk of developing Guillain-Barre syndrome following vaccination with zoster vaccine. [This case series cohort study included 849397 recombinant zoster vaccine (RZV or Shingrix) vaccinated and 1817099 zoster vaccine live (ZVL or Zostavax)-vaccinated beneficiaries aged 65 years or older. Self-controlled analyses included events identified from 2113758 eligible RZV-vaccinated beneficiaries 65 years or older. The authors compared the relative risk of Guillain-Barre syndrome after RZV vs ZVL, followed by claims-based and medical record-based self-controlled case series analyses to assess risk of Guillain-Barre syndrome during a post-vaccination risk window (days 1-42) compared with a control window (days 43-183). In self-controlled analyses, RZV vaccinees were observed from 1st October 2017, to 29th February 2020. Study Population included participant RZV and zoster vaccine live (ZVL) vaccinations were identified. To ensure complete capture of RZV vaccinations, authors required continuous Medicare Fee-for-Service. From 1st October 2017, through 6 months after the last RZV vaccination, the end of the study period or death, whichever occurred earlier. Beneficiaries must have aged into Medicare, be aged 65 years or older on 1st October 2017. To reduce potential confounding from specific frail Medicare populations that could have a different association between vaccination and GBS, beneficiaries could not be undergoing long-term dialysis therapy, or admitted to a nursing home, skilled nursing facility, or in hospice at any point during the study period. In addition, the authors excluded any beneficiaries with a historical GBS diagnosis in any diagnosis position from any provider within 6 months prior to the first RZV vaccination, and any beneficiaries receiving RZV administration inconsistent with recommended dosing in the package insert (that was received more than 2 administrations of RZV; or received the second administration within 42 days of the first). The author collected GBS diagnoses from inpatient (IP), outpatient (OP), and carrier (PB) (that was office) claims. Generally, OP claims arise from outpatient procedural and emergency department settings, whereas the PB, or carrier, claims are submitted by professional clinicians in office settings. An incident GBS case was defined as either (1) the first occurrence of a primary discharge diagnosis of GBS in the IP setting post vaccination, or (2) the first occurrence of a GBS diagnosis in any setting and any position followed by a hospitalization within the subsequent 7 days where GBS was the primary discharge diagnosis. In the latter case, the case's onset date was the date of the earlier GBS claim in the 7 days prior. The author used a risk window of 42 days after vaccination because this was generally recommended by the Brighton Collaboration GBS case definition. The author requested medical records for all inpatient GBS cases identified during the original study period (1st October 2017, to 31st March 2019) and conducted medical record review (MRR) for all returned records. Trained abstractors extracted specific information from the medical records, and 2 independent neurologists independently adjudicated the abstracted data using the Brighton Collaboration's case definition for GBS. Abstractors and neurologists were blinded to vaccination histories. Cases identified by this process as Brighton Level 1, 2 or 3 were medical record confirmed GBS cases and were included in a medical record confirmed SCCS analysis. The author also collected information on preceding illnesses potentially associated with GBS, such as respiratory and gastrointestinal illness, to investigate potential confounding. The cohort analysis compared the postvaccination GBS rate for RZV (1st October 2017, to 31st December 2018) to the rate for ZVL when it was predominantly administered (1st October 2012 to 30th September 2017) within the 42-day postvaccination window. Only eligible RZV vaccines with an incident GBS outcome in the risk or control windows were included in the analysis. The risk window was days 1 to 42 postvaccination after the first or second dose of RZV, whereas the control window was days 43 to 183 after a first dose (or until second dose receipt) and days 43 to 183 after a second dose (or until end of study period, disenrollment, or death). The control window was bound at 6 months because additional control time would increase enrollment requirements, thus decreasing the size of eligible population and reducing the power of analyses. Owing to influenza vaccinations' known association with GBS, the authors produced descriptive statistics for influenza vaccinations occurring 42 days before or after RZV vaccination and that were associated with an identified GBS case. Both claims identified and medical record confirmed analyses of hospitalized GBS cases were conducted after all doses. For the secondary analyses, GBS risk was assessed following the first and second RZV doses independently. The author also investigated changes in postvaccination GBS risk over time and patterns of GBS case severity]. The patient was from control window. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received Shingrix vaccine (Route and site of administration unknown; batch number not provided, dosage unknown). The age at vaccination was not reported. On an unspecified date, between 1st October 2017 to 29th February 2020, 43 to 183 days after the vaccination, the patient had Guillain-Barre syndrome (GBS). The patient occurred respiratory failure during the hospital on day 5 post GBS onset. [A total of 1318004 were identified eligible RZV vaccinations (849397 beneficiaries) and 1817099 eligible ZVL vaccinations (1817099 beneficiaries). Amongst the RZV vaccinees, the mean age was 74.8 years at first dose, and 58% were female, whereas among those who received the ZVL vaccine, the mean age was 74.3 years, and 60% were female. After adjusting for age and sex, GBS risk after RZV compared with ZVL was elevated with an RR of 2.34. Out of all eligible RZV vaccinees, 13 claims based GBS cases during the risk period and 8 during the control period were observed. The primary analysis identified an increased risk of GBS in the risk window compared with the control window. The authors found that there were 6.47 excess cases of GBS in the risk window compared with the control window per million vaccinations. The PPV-adjusted AR calculation showed 5.08 excess cases per million vaccinations. Only 2 of the 21 observed claims based GBS cases received an influenza vaccination in the 42 days prior to RZV vaccination; both cases occurred in the control window, so no GBS cases identified in the risk window were preceded by influenza vaccination. In the extended analysis, of the 44 claims based GBS cases, 6 received an influenza vaccination in the 42 days prior to RZV vaccination; 3 cases each in the risk and control windows. The authors' secondary analysis included 950797 first RZV doses and identified an increased risk of GBS. There were 9.50 excess cases for every million vaccinations administered, adjusted for PPV. Seasonality-adjusted analyses produced similar results. Of the 36 total cases requested for MRR across both the cohort and SCCS studies, 28 were returned and reviewed, 22 of which were MRR confirmed by neurologists as a GBS case, resulting in a return rate of 77.78% and a medical record confirmed PPV of 78.57%. Of the confirmed SCCS cases, 7 were in the risk window and 4 were in the control window. The authors found an increased risk of GBS when comparing incidence in the risk and control windows, resulting in a PPV adjusted AR of 5.17 per million doses. The authors' analysis of infectious illnesses preceding GBS onset did not diminish study findings as preceding infection occurred more frequently among cases in the control window. The extended study period SCCS analysis confirmed earlier results by including additional data, which decreased the observed risk from an RR of 4.30 to 2.84; PPV-adjusted AR became 3.13. Initially, the authors did not have sufficient power to conduct second dose only analyses (0 cases were identified). However, after extending the study period for the claims based SCCS analysis, the author identified 15 GBS events occurring after the second dose; this resulted in an RR of 0.22. The authors used two metrics to measure the severity of GBS cases occurring after Shingrix vaccination: (i) occurrence of respiratory failure or mechanical intubation, and (ii) length of hospital stay. The authors produced descriptive statistics determining the number of cases with a claim for respiratory failure or intubation during a hospitalization with a primary GBS diagnosis. The authors used the codes to search for intubation and respiratory failure occurring during the same hospital stay as the primary GBS diagnosis. Cases were additionally assessed for severity based upon the length of stay during a hospitalization with a primary GBS diagnosis]. This case has been considered as serious due to hospitalization. Treatment was unknown. The outcome of the event was not reported. The authors commented, "The CDC VSD signal suggested an association of GBS with RZV. Clinical trial data was not powered to detect a statistical association between the rare event, GBS, and vaccination, and the trials observed an imbalance with more cases occurring after placebo. Our current findings confirm an increased risk of GBS following RZV vaccination in the Medicare population aged 65 years and older. The Medicare cohort analysis showed a statistically significant increased risk of GBS among RZV recipients compared with ZVL recipients. The SCCS medical record confirmed sensitivity analyses, which used the set of GBS cases for which we had the highest degree of certainty, showed an increased risk of GBS following RZV vaccination, with an AR of 5.17 excess GBS cases per million doses during the 42-day risk window following vaccination. The increased risk of GBS following RZV should be considered in the context of the benefits of the vaccine. Herpes zoster is associated with substantial morbidity, including possible persistent pain, and disseminated disease. In clinical trials, RZV reduced the incidence of HZ by 97% in participants aged 50 years and older, and efficacy appeared durable through 4 years after vaccination. Comparatively, clinical trials for ZVL reduced incidence of HZ by 51% in participants aged 60 years and older. If HZ reactivation also triggers cases of GBS, then RZV vaccine could potentially prevent these cases of GBS, and the vaccine could be protective against the outcome. Our study examined the risk of GBS in the 42 days following vaccination, which may not account for potential changes in GBS risk over time owing to wild type HZ reactivation. Recent presentations to ACIP estimated the risk of GBS after HZ reactivation as an RR of 4.0 an AR of 12.8 cases per million HZ episodes. This is statistically similar to the most precise estimates of GBS after RZV identified herein: RR, 2.84 and an AR of 3.13. Using this AR, and the vaccine efficacy of 97%, one would expect 6.26 cases of GBS among a million fully vaccinated individuals (2 doses per individual), whereas one would expect to prevent approximately 7070 HZ reactivations in the same population according to the trial data for those aged 60 to 69 years in the Shingrix Package Insert. Taking into account risk of GBS after HZ reactivation and RZV, it estimated 6.3 excess GBS cases after RZV vaccination in those aged 60 to 69 years compared with 61600 HZ cases averted (including 62 potential deaths, 5500 cases of HZ ocular complications, and 9350 cases of postherpetic neuralgia). These data convey that the risk-benefit balance for RZV remains favorable, and clinicians should continue to offer and discuss RZV vaccination with their patients. This study had several major strengths. First, this is the largest post-market study evaluating GBS risk following RZV vaccination. Further, we use a study population well suited to the analyses being conducted because the Medicare FFS population is the largest cohort of beneficiaries aged 65 years or older with individually linked data (eg, demographic, diagnostic, and vaccination information). We also completed confirmatory SCCS analyses after the initial cohort analyses to reduce the risk of confounding by time-fixed covariates (eg, sex), which potentially provided more precise estimates of increased GBS risk after RZV vaccination. Finally, we completed an MRR and conducted an analysis of medical record confirmed cases to increase the reliability of our results; this also helped increase precision of onset dates and case classification. There are several limitations of this study. First, the cohort and SCCS analyses did not explicitly adjust for preceding illness or other time-varying confounders. However, the potential influence of preceding illnesses was not found to diminish results. Second, using Medicare claims creates the possibility for under-ascertainment of vaccine administration because nontraditional clinical settings may not submit vaccination claims to Medicare, which limits sample size. Third, the risk window for GBS following RZV vaccination is not as well defined as the risk window following influenza vaccination, and we lacked sufficient data to empirically determine the ideal risk window using scanning statistics. Finally, although RZV is approved for individuals aged 50 years or older, our study population only included individuals aged 65 years or older. This study relied on a rather specific GBS case identification algorithm, which provides additional confidence in identification, but may have limited the number of cases included; we only included cases with hospital discharge diagnoses of GBS in the primary position, which may have excluded some GBS cases. However, GBS is a well-defined acute disease that usually requires hospitalization and defining cases as claims with a primary GBS hospitalization results in a higher PPV". The authors concluded, "This collaborative effort between the FDA, CMS and CDC to examine an early VSD statistical signal illustrates the value of multiagency efforts to conduct GBS surveillance in a timely manner. Despite the elevated risk of GBS observed herein, patients and clinicians should be aware of the risk of GBS and consider the benefits of avoiding zoster with an efficacious vaccine. Findings of this case series cohort study indicate a slightly increased risk of Guillain-Barre syndrome during the 42 days following RZV vaccination in the Medicare population, with approximately 3 excess Guillain-Barre syndrome cases per million vaccinations. Clinicians and patients should be aware of this risk, while considering the benefit of decreasing the risk of herpes zoster and its complications through an efficacious vaccine, as risk-benefit balance remains in favor of vaccination". This is 1 of the 2 valid cases reported in the same literature article.; Sender's Comments: US-GLAXOSMITHKLINE-US2021GSK231482:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MD
- Alter
- -
- Geschlecht
- U
- Eingang
- 12.11.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Respiratory failure
Symptomtext
Guillain-Barre Syndrome; Respiratory failure; This case was reported in a literature article and described the occurrence of guillain barre syndrome in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant) and respiratory failure (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome and respiratory failure were unknown. The reporter considered the guillain barre syndrome and respiratory failure to be related to Shingrix. Additional information was provided as follows: This case was reported in a literature article and described the occurrence of Guillain-Barre Syndrome in a patient aged 65 years or older of unspecified gender, who was vaccinated with Shingrix (GlaxoSmithKline) for prophylaxis. This case belongs to eTable-8 in supplemental content reported in the literature article. The patient was a part of the cohort study that objective was to use Insurance claims data to evaluate risk of developing Guillain-Barre syndrome following vaccination with zoster vaccine. [This case series cohort study included 849397 recombinant zoster vaccine (RZV or Shingrix) vaccinated and 1817099 zoster vaccine live (ZVL or Zostavax)-vaccinated beneficiaries aged 65 years or older. Self-controlled analyses included events identified from 2113758 eligible RZV-vaccinated beneficiaries 65 years or older. The authors compared the relative risk of Guillain-Barre syndrome after RZV vs ZVL, followed by claims-based and medical record-based self-controlled case series analyses to assess risk of Guillain-Barre syndrome during a post-vaccination risk window (days 1-42) compared with a control window (days 43-183). In self-controlled analyses, RZV vaccinees were observed from 1st October 2017, to 29th February 2020. Study Population included participant RZV and zoster vaccine live (ZVL) vaccinations were identified. To ensure complete capture of RZV vaccinations, authors required continuous Insurance Fee-for-Service. From 1st October 2017, through 6 months after the last RZV vaccination, the end of the study period or death, whichever occurred earlier. Beneficiaries must have aged into Insurance, be aged 65 years or older on 1st October 2017. To reduce potential confounding from specific frail Insurance populations that could have a different association between vaccination and GBS, beneficiaries could not be undergoing long-term dialysis therapy, or admitted to a nursing home, skilled nursing facility, or in hospice at any point during the study period. In addition, the authors excluded any beneficiaries with a historical GBS diagnosis in any diagnosis position from any provider within 6 months prior to the first RZV vaccination, and any beneficiaries receiving RZV administration inconsistent with recommended dosing in the package insert (that was received more than 2 administrations of RZV; or received the second administration within 42 days of the first). The author collected GBS diagnoses from inpatient (IP), outpatient (OP), and carrier (PB) (that was office) claims. Generally, OP claims arise from outpatient procedural and emergency department settings, whereas the PB, or carrier, claims are submitted by professional clinicians in office settings. An incident GBS case was defined as either (1) the first occurrence of a primary discharge diagnosis of GBS in the IP setting post vaccination, or (2) the first occurrence of a GBS diagnosis in any setting and any position followed by a hospitalization within the subsequent 7 days where GBS was the primary discharge diagnosis. In the latter case, the case's onset date was the date of the earlier GBS claim in the 7 days prior. The author used a risk window of 42 days after vaccination because this was generally recommended by the Brighton Collaboration GBS case definition. The author requested medical records for all inpatient GBS cases identified during the original study period (1st October 2017, to 31st March 2019) and conducted medical record review (MRR) for all returned records. Trained abstractors extracted specific information from the medical records, and 2 independent neurologists independently adjudicated the abstracted data using the Brighton Collaboration's case definition for GBS. Abstractors and neurologists were blinded to vaccination histories. Cases identified by this process as Brighton Level 1, 2 or 3 were medical record confirmed GBS cases and were included in a medical record confirmed Agency analysis. The author also collected information on preceding illnesses potentially associated with GBS, such as respiratory and gastrointestinal illness, to investigate potential confounding. The cohort analysis compared the postvaccination GBS rate for RZV (1st October 2017, to 31st December 2018) to the rate for ZVL when it was predominantly administered (1st October 2012 to 30th September 2017) within the 42-day postvaccination window. Only eligible RZV vaccines with an incident GBS outcome in the risk or control windows were included in the analysis. The risk window was days 1 to 42 postvaccination after the first or second dose of RZV, whereas the control window was days 43 to 183 after a first dose (or until second dose receipt) and days 43 to 183 after a second dose (or until end of study period, disenrollment, or death). The control window was bound at 6 months because additional control time would increase enrollment requirements, thus decreasing the size of eligible population and reducing the power of analyses. Owing to influenza vaccinations' known association with GBS, the authors produced descriptive statistics for influenza vaccinations occurring 42 days before or after RZV vaccination and that were associated with an identified GBS case. Both claims identified and medical record confirmed analyses of hospitalized GBS cases were conducted after all doses. For the secondary analyses, GBS risk was assessed following the first and second RZV doses independently. The author also investigated changes in postvaccination GBS risk over time and patterns of GBS case severity]. The patient was from risk window. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received Shingrix vaccine (Route and site of administration unknown; batch number not provided, dosage unknown). The age at vaccination was not reported. On an unspecified date between 1st October 2017 to 29th February 2020, 1 to 42 days after the vaccination, the patient had Guillain-Barre syndrome (GBS). The patient occurred respiratory failure during the hospital on day 21 post GBS onset. [A total of 1318004 were identified eligible RZV vaccinations (849397 beneficiaries) and 1817099 eligible ZVL vaccinations (1817099 beneficiaries). Amongst the RZV vaccinees, the mean age was 74.8 years at first dose, and 58% were female, whereas among those who received the ZVL vaccine, the mean age was 74.3 years, and 60% were female. After adjusting for age and sex, GBS risk after RZV compared with ZVL was elevated with an RR of 2.34. Out of all eligible RZV vaccinees, 13 claims based GBS cases during the risk period and 8 during the control period were observed. The primary analysis identified an increased risk of GBS in the risk window compared with the control window. The authors found that there were 6.47 excess cases of GBS in the risk window compared with the control window per million vaccinations. The PPV-adjusted AR calculation showed 5.08 excess cases per million vaccinations. Only 2 of the 21 observed claims based GBS cases received an influenza vaccination in the 42 days prior to RZV vaccination; both cases occurred in the control window, so no GBS cases identified in the risk window were preceded by influenza vaccination. In the extended analysis, of the 44 claims based GBS cases, 6 received an influenza vaccination in the 42 days prior to RZV vaccination; 3 cases each in the risk and control windows. The authors' secondary analysis included 950797 first RZV doses and identified an increased risk of GBS. There were 9.50 excess cases for every million vaccinations administered, adjusted for PPV. Seasonality-adjusted analyses produced similar results. Of the 36 total cases requested for MRR across both the cohort and AGENCY studies, 28 were returned and reviewed, 22 of which were MRR confirmed by neurologists as a GBS case, resulting in a return rate of 77.78% and a medical record confirmed PPV of 78.57%. Of the confirmed Agency cases, 7 were in the risk window and 4 were in the control window. The authors found an increased risk of GBS when comparing incidence in the risk and control windows, resulting in a PPV adjusted AR of 5.17 per million doses. The authors' analysis of infectious illnesses preceding GBS onset did not diminish study findings as preceding infection occurred more frequently among cases in the control window. The extended study period Agency analysis confirmed earlier results by including additional data, which decreased the observed risk from an RR of 4.30 to 2.84; PPV-adjusted AR became 3.13. Initially, the authors did not have sufficient power to conduct second dose only analyses (0 cases were identified). However, after extending the study period for the claims based Agency analysis, the author identified 15 GBS events occurring after the second dose; this resulted in an RR of 0.22. The authors used two metrics to measure the severity of GBS cases occurring after Shingrix vaccination: (i) occurrence of respiratory failure or mechanical intubation, and (ii) length of hospital stay. The authors produced descriptive statistics determining the number of cases with a claim for respiratory failure or intubation during a hospitalization with a primary GBS diagnosis. The authors used the codes to search for intubation and respiratory failure occurring during the same hospital stay as the primary GBS diagnosis. Cases were additionally assessed for severity based upon the length of stay during a hospitalization with a primary GBS diagnosis]. This case has been considered as serious due to hospitalization. Treatment was unknown. The outcome of the event was not reported. The authors commented, "The CDC VSD signal suggested an association of GBS with RZV. Clinical trial data was not powered to detect a statistical association between the rare event, GBS, and vaccination, and the trials observed an imbalance with more cases occurring after placebo. Our current findings confirm an increased risk of GBS following RZV vaccination in the Insurance population aged 65 years and older. The Insurance cohort analysis showed a statistically significant increased risk of GBS among RZV recipients compared with ZVL recipients. The Agency medical record confirmed sensitivity analyses, which used the set of GBS cases for which we had the highest degree of certainty, showed an increased risk of GBS following RZV vaccination, with an AR of 5.17 excess GBS cases per million doses during the 42-day risk window following vaccination. The increased risk of GBS following RZV should be considered in the context of the benefits of the vaccine. Herpes zoster is associated with substantial morbidity, including possible persistent pain, and disseminated disease. In clinical trials, RZV reduced the incidence of HZ by 97% in participants aged 50 years and older, and efficacy appeared durable through 4 years after vaccination. Comparatively, clinical trials for ZVL reduced incidence of HZ by 51% in participants aged 60 years and older. If HZ reactivation also triggers cases of GBS, then RZV vaccine could potentially prevent these cases of GBS, and the vaccine could be protective against the outcome. Our study examined the risk of GBS in the 42 days following vaccination, which may not account for potential changes in GBS risk over time owing to wild type HZ reactivation. Recent presentations to Agency estimated the risk of GBS after HZ reactivation as an RR of 4.0 an AR of 12.8 cases per million HZ episodes. This is statistically similar to the most precise estimates of GBS after RZV identified herein: RR, 2.84 and an AR of 3.13. Using this AR, and the vaccine efficacy of 97%, one would expect 6.26 cases of GBS among a million fully vaccinated individuals (2 doses per individual), whereas one would expect to prevent approximately 7070 HZ reactivations in the same population according to the trial data for those aged 60 to 69 years in the Shingrix Package Insert. Taking into account risk of GBS after HZ reactivation and RZV, it estimated 6.3 excess GBS cases after RZV vaccination in those aged 60 to 69 years compared with 61600 HZ cases averted (including 62 potential deaths, 5500 cases of HZ ocular complications, and 9350 cases of postherpetic neuralgia). These data convey that the risk-benefit balance for RZV remains favorable, and clinicians should continue to offer and discuss RZV vaccination with their patients. This study had several major strengths. First, this is the largest post-market study evaluating GBS risk following RZV vaccination. Further, we use a study population well suited to the analyses being conducted because the Insurance population is the largest cohort of beneficiaries aged 65 years or older with individually linked data (eg, demographic, diagnostic, and vaccination information). We also completed confirmatory Agency analyses after the initial cohort analyses to reduce the risk of confounding by time-fixed covariates (eg, sex), which potentially provided more precise estimates of increased GBS risk after RZV vaccination. Finally, we completed an MRR and conducted an analysis of medical record confirmed cases to increase the reliability of our results; this also helped increase precision of onset dates and case classification. There are several limitations of this study. First, the cohort and Agency analyses did not explicitly adjust for preceding illness or other time-varying confounders. However, the potential influence of preceding illnesses was not found to diminish results. Second, using Insurance claims creates the possibility for under-ascertainment of vaccine administration because nontraditional clinical settings may not submit vaccination claims to Insurance, which limits sample size. Third, the risk window for GBS following RZV vaccination is not as well defined as the risk window following influenza vaccination, and we lacked sufficient data to empirically determine the ideal risk window using scanning statistics. Finally, although RZV is approved for individuals aged 50 years or older, our study population only included individuals aged 65 years or older. This study relied on a rather specific GBS case identification algorithm, which provides additional confidence in identification, but may have limited the number of cases included; we only included cases with hospital discharge diagnoses of GBS in the primary position, which may have excluded some GBS cases. However, GBS is a well-defined acute disease that usually requires hospitalization and defining cases as claims with a primary GBS hospitalization results in a higher PPV". The authors concluded, "This collaborative effort between the FDA, CMS and CDC to examine an early VSD statistical signal illustrates the value of multiagency efforts to conduct GBS surveillance in a timely manner. Despite the elevated risk of GBS observed herein, patients and clinicians should be aware of the risk of GBS and consider the benefits of avoiding zoster with an efficacious vaccine. Findings of this case series cohort study indicate a slightly increased risk of Guillain-Barre syndrome during the 42 days following RZV vaccination in the Insurance population, with approximately 3 excess Guillain-Barre syndrome cases per million vaccinations. Clinicians and patients should be aware of this risk, while considering the benefit of decreasing the risk of herpes zoster and its complications through an efficacious vaccine, as risk-benefit balance remains in favor of vaccination". This is 1 of the 2 valid cases reported in the same literature article.; Sender's Comments: US-GLAXOSMITHKLINE-US2021GSK231698:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- M
- Eingang
- 12.11.2021
- Impfdatum
- 20.10.2021
- Beginn
- 01.10.2021
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Symptomtext
developed Bell's palsy; This case was reported by a physician via sales rep and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 20th October 2021, the patient received the 1st dose of Shingrix. In October 2021, 24 hrs after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the bell's palsy was unknown. It was unknown if the reporter considered the bell's palsy to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The first dose of Shingrix was administered to patient approximately on 20th october 2021 and the exact date was unknown at the time of reporting. The patient development Bell's palsy approximately 24 hours upon receipt of the first dose of Shingrix. The patient presented to urgent care and received steroids. The physician followed-up with patient on 25th October 2021 and increased steroid dose because MD felt urgent care prescribed too low of a dose. Additional follow-up with patient had been scheduled. The reporter consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 09.11.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
GB syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. The reporter considered the guillain barre syndrome to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient had shingles shot which caused her to suffer the Guillain Barre syndrome. Follow-up would not be possible as no contact details available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Syncope
Symptomtext
Fainting after getting Shingrix shot; This case was reported by a consumer via (Shingrix GSK) interactive digital media and described the occurrence of faint in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant). On an unknown date, the outcome of the faint was unknown. It was unknown if the reporter considered the faint to be related to Shingrix. Additional details were provided are as follows: The age at vaccination was not reported. The reporter asked that fainting could happen several hours after getting the Shingrix shot. The follow-up could not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- UT
- Alter
- 15,0
- Geschlecht
- F
- Eingang
- 22.10.2021
- Impfdatum
- 29.05.2021
- Beginn
- 29.05.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Abdominal pain
Anaphylactic reaction
Chest discomfort
Dyspnoea
Hypotension
Asthma
Blood magnesium decreased
Blood pressure decreased
Echocardiogram normal
Electrocardiogram normal
Extrasystoles
Intensive care
Malaise
Nausea
Urticaria
Ventricular tachycardia
Vomiting
Symptomtext
In May 2019 at 10 AM, the patient received her first dose of the Pfizer SARS-CoV-2 vaccine. She had no immediate symptoms and felt well for the remainder of the day until approximately 6 PM when she started to feel sick. Prior to feeling sick she had eaten fries and barbecue that were prepared at a friend's house (she has had these foods before and subsequent to this reaction without any symptoms. Her initial symptoms were abdominal pain and nausea. She proceeded to vomit and then felt short of breath and was taken to emergency department. At emergency department she was treated for an asthma exacerbation initially with a DuoNeb and felt better, but 10 to 15 minutes later developed urticaria. She was treated with Decadron, Benadryl, and IV fluids. Her blood pressure later dropped to the 70s systolic and she became altered. She was treated with epinephrine 0.3 mg without improvement and was given a second dose. Her blood pressure improved however she developed shortness of breath again and was started on a epinephrine drip, was given Zofran and was transferred to primary emergency department. These treatments were continued in the emergency department and she was also given famotidine and repeat Zofran dose. She was admitted to the ICU. In the ICU she had runs of V. tach on telemetry. Epinephrine drip was stopped due to worsening ectopy. Her magnesium was repleted. Her echocardiogram and EKGs were normal. She saturated on room air in the ICU. She was started on cetirizine 40 mg daily. She was transferred to the floor and was discharged from the hospital on June 1. She was discharged home with EpiPen.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic reaction
- Hospital-Tage
- 3,0
- Labordaten
- Pending
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 21.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Areflexia
CSF protein increased
Chronic inflammatory demyelinating polyradiculoneuropathy
Condition aggravated
Electromyogram abnormal
Electrophoresis protein normal
Guillain-Barre syndrome
Hypoaesthesia
Hyporeflexia
Muscular weakness
Paraesthesia
Plasmapheresis
Symptomtext
Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy; Chronic inflammatory demyelinating polyneuropathy; weakness in his legs; numbness in his legs; This case was reported in a literature article and described the occurrence of guillain barre syndrome in a elderly male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. (Guillain-Barre syndrome, or acute on chronic inflammatory demyelinating polyneuropathy, following Moderna Covid-19 vaccine.) The patient's past medical history included coronary artery disease (requiring coronary artery bypass graft, coronary artery stents) and sick sinus syndrome (require dual-chamber pacemaker). On an unknown date, the patient received Influenza vaccine. On an unknown date, immediately after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), chronic inflammatory demyelinating polyneuropathy (serious criteria GSK medically significant), lower extremities weakness of and numbness in leg. The patient was treated with operations and procedures (Plasma Exchange) and operations and procedures (Plasmapheresis (Nos)). On an unknown date, the outcome of the guillain barre syndrome and chronic inflammatory demyelinating polyneuropathy were recovering/resolving and the outcome of the lower extremities weakness of and numbness in leg were not recovered/not resolved. It was unknown if the reporter considered the guillain barre syndrome, chronic inflammatory demyelinating polyneuropathy, lower extremities weakness of and numbness in leg to be related to Influenza vaccine. Additional information was reported as follows: This case was reported in a literature article and described the occurrence of Guillain-Barre syndrome (GBS) in a male patient aged between 83 to 87-year old, who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. The patient had medical history of coronary artery disease requiring coronary artery bypass graft, coronary artery stents, and a dual-chamber pacemaker for sick sinus syndrome. No information on patient's family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date in 2017, shortly after receiving the vaccination, the patient had symptoms, laboratory, and electrophysiological features of Guillain-Barre syndrome (GBS)/acute inflammatory demyelinating polyneuropathy (AIDP). Thyroid function tests, hemoglobin A1c, serum protein electrophoresis, syphilis and Lyme titers were unremarkable. The patient had incomplete resolution of symptoms with a course of five plasma exchange treatments. One month after initial diagnosis and treatment, it was determined that the patient's condition had evolved to chronic inflammatory demyelinating polyneuropathy (CIDP), for which the patient received ongoing plasmapheresis on an every two week basis, with symptom improvement but not normalization. [At the time of reporting, the patient was 87 year old and presented with acute worsening weakness and paresthesia of bilateral lower extremities. In March 2021, the patient had onset over twelve hours of significantly worse weakness and numbness in his legs, similar to his prior AIDP/GBS. It was noted that the patient had received a Moderna COVID-19 vaccine twenty-one days prior. His physical exam was notable for normal strength in the upper extremities, with diminished but present reflexes. Lower extremity exam revealed bilateral weakness in the hip, distal extremities, and feet. Ankle and knee reflexes were absent. Cerebrospinal fluid contained elevated protein. Electromyography revealed F-waves in the lower extremities. The patient was treated with a more intensive course of plasmapheresis consisting four treatments over ten days. His strength and sensation improved to baseline over this period]. The authors commented, "We describe a patient with a history of AIDP/GBS, evolving into CIDP, who developed exacerbated CIDP (or AIDP) coinciding with receipt of the Moderna COVID-19 vaccine." The authors concluded, "GBS/AIDP, or exacerbation of CIDP, is herein described to have coincided with the recent Moderna COVID-19 vaccine. More studies are needed to determine whether our patient's clinical deterioration was merely coincident with receipt of vaccine or whether a cause-and-effect relationship exists."
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- Test Date: 2017; Test Name: syphilis and Lyme titers; Result Unstructured Data: (Test Result:syphilis and Lyme titers were unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Date: 2017; Test Name: serum protein electrophoresis; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Date: 2017; Test Name: hemoglobin A1c; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Date: 2017; Test Name: Thyroid function tests; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Coronary artery disease (requiring coronary artery bypass graft, coronary artery stents); Sick sinus syndrome (require dual-chamber pacemaker)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 09.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
got GBS; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. The reporter considered the guillain barre syndrome to be possibly related to Shingles vaccine. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that they would tell you Guillain Barre syndrome was very rare, but the reporter knows the patient who had Guillain Barre syndrome. The reporter stated that he/she would never take the Shingles shot because it could cause Guillain Barre syndrome (GBS). The shot tells you that in the fine print. This case was 1 of the 4 linked cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR208072:same reporter US-GLAXOSMITHKLINE-US2021AMR208069:same reporter US-GLAXOSMITHKLINE-US2021AMR208071:same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 09.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
got GBS; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. The reporter considered the guillain barre syndrome to be possibly related to Shingles vaccine. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that they would tell you Guillain Barre syndrome was very rare, but the reporter knows the patient who had Guillain Barre syndrome. The reporter stated that he/she would never take the Shingles shot because it could cause Guillain Barre syndrome (GBS). The shot tells you that in the fine print. This case was 1 of the 4 linked cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR208069:same reporter US-GLAXOSMITHKLINE-US2021AMR208073:same reporter US-GLAXOSMITHKLINE-US2021AMR208071:same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 09.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
got GBS; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. The reporter considered the guillain barre syndrome to be possibly related to Shingles vaccine. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that they would tell you Guillain Barre syndrome was very rare, but the reporter knows the patient who had Guillain Barre syndrome. The reporter stated that he/she would never take the Shingles shot because it could cause Guillain Barre syndrome (GBS). The shot tells you that in the fine print. This case was 1 of the 4 linked cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR208072:same reporter US-GLAXOSMITHKLINE-US2021AMR208073:same reporter US-GLAXOSMITHKLINE-US2021AMR208069:same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- LA
- Alter
- -
- Geschlecht
- M
- Eingang
- 07.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Asthenia
Guillain-Barre syndrome
Paralysis
Symptomtext
Guillain Barre syndrome; paralysis; weakness; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), paralysis (serious criteria hospitalization and GSK medically significant) and weakness (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome, paralysis and weakness were unknown. It was unknown if the reporter considered the guillain barre syndrome, paralysis and weakness to be related to Shingrix. Additional information: The following receipt of the Shingrix vaccine injections, the patient suffered significant weakness to the point of paralysis, diagnosed by his treating neurologist as Guillain-Barre Syndrome following administration of the shingles medication Shingrix. As a result the patient had undergone substantial hospitalizations and extensive testing and was permanently restricted from receiving any other vaccines.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 06.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Mobility decreased
Walking aid user
Wheelchair user
Symptomtext
guillain barre; has to use a wheelchair and walker; This case was reported by a consumer via media and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and mobility decreased. On an unknown date, the outcome of the guillain barre syndrome and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the guillain barre syndrome and mobility decreased to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient got the shingles vaccine and now has Guillain barre. The patient had to use a wheelchair and walker to get around. The reporter stated that they have a class action lawsuit against the makers of the shingles vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 06.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Bell's palsy
Symptomtext
mild form of Bell's Palsy; This case was reported by a consumer via media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was recovered/resolved. It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient had a mild form of bells palsy after the shingles vaccine. The follow up would not possible as contact information was not available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 04.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Chills
Headache
Loss of consciousness
Nausea
Pyrexia
Symptomtext
passed out; Head ache; nausea; chills; fever; This case was reported by a consumer and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced passed out (serious criteria GSK medically significant), headache, nausea, chills and fever. On an unknown date, the outcome of the passed out, headache, nausea, chills and fever were recovered/resolved. The reporter considered the passed out, headache, nausea, chills and fever to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had a terrible reaction to the 1st of the second dose shingles vaccination. The patient had head ache, passed out the next morning, nausea, chills & fever for a few days. The reactions to the second dose were not quite as severe. For tolerance of second dose refer US2021AMR205343, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR205343:same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 01.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
21-hydroxylase deficiency
Abdominal discomfort
Addison's disease
Adrenocortical insufficiency acute
Alanine aminotransferase increased
Antibody test positive
Aspartate aminotransferase increased
Blood corticotrophin abnormal
Blood culture negative
Blood potassium increased
Blood sodium decreased
Blood testosterone decreased
Blood testosterone free decreased
Blood thyroid stimulating hormone increased
Bradycardia
Cold sweat
Computerised tomogram abdomen normal
Cortisol decreased
Symptomtext
Adrenal crisis; decreased appetite; decreased fluid intake; Lethargic; Cyanotic; bradycardic; low blood pressure; Cold; clammy skin; Skin mottled in color; Hyponatremia; Hyperkalemia; Hypothermia; low cortisol level; autoimmune Addison's disease; euthyroid sick syndrome; mid-abdominal discomfort; vomiting; tingling; numbness of feet and toes; generalized body aches; Fatigue; Malaise; This case was reported in a literature article and described the occurrence of adrenal crisis in a 21-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. Co-suspect products included DTPa (DTaP vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine and DTaP vaccine. On an unknown date, less than a week after receiving Influenza vaccine and DTaP vaccine, the patient experienced adrenal crisis (serious criteria hospitalization and GSK medically significant), general body pain (serious criteria hospitalization), fatigue (serious criteria hospitalization), malaise (serious criteria hospitalization), abdominal discomfort (serious criteria hospitalization), vomiting (serious criteria hospitalization), decreased appetite (serious criteria hospitalization), oligodipsia (serious criteria hospitalization), tingling (serious criteria hospitalization), numbness in feet (serious criteria hospitalization), lethargy (serious criteria hospitalization), cyanosis (serious criteria hospitalization), bradycardia (serious criteria hospitalization and GSK medically significant), low blood pressure (serious criteria hospitalization), cold (serious criteria hospitalization), clamminess (serious criteria hospitalization), mottled skin (serious criteria hospitalization), hyponatremia (serious criteria hospitalization), hyperkalemia (serious criteria hospitalization and GSK medically significant), hypothermia (serious criteria hospitalization and GSK medically significant), cortisol decreased (serious criteria hospitalization), addison's disease (serious criteria hospitalization and GSK medically significant) and euthyroid sick syndrome (serious criteria hospitalization). The patient was treated with ceftriaxone, dexamethasone, hydrocortisone and glucocorticoids nos (Glucocorticoid). On an unknown date, the outcome of the adrenal crisis, abdominal discomfort, decreased appetite, oligodipsia, lethargy, cyanosis, bradycardia, low blood pressure, cold, clamminess, mottled skin, hypothermia, addison's disease and euthyroid sick syndrome were unknown and the outcome of the general body pain, fatigue, malaise, vomiting, tingling, numbness in feet, hyponatremia and hyperkalemia were recovered/resolved and the outcome of the cortisol decreased was recovering/resolving. The reporter considered the adrenal crisis, general body pain, fatigue, malaise, abdominal discomfort, vomiting, decreased appetite, oligodipsia, tingling, numbness in feet, lethargy, cyanosis, bradycardia, low blood pressure, cold, clamminess, mottled skin, hyponatremia, hyperkalemia, hypothermia, cortisol decreased, addison's disease and euthyroid sick syndrome to be related to Influenza vaccine and DTaP vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of adrenal crisis (AC) in a 21-year-old male patient, who was vaccinated with unspecified Influenza vaccine and unspecified Diphtheria, Tetanus, and acellular Pertussis (DTaP) vaccine (manufacturer unknown) for prophylaxis. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified Influenza vaccine and unspecified Diphtheria, Tetanus, and acellular Pertussis (DTaP) vaccine (Route and site of administration unknown; batch number not provided; dosage unknown for both) in preparation for school. The age of vaccination was not provided. On an unspecified date, 1 week after the vaccination, the patient presented to the emergency room (ER) with complaints of generalized body aches, fatigue, and malaise for five days. The patient reported mid-abdominal discomfort associated with scant vomiting for two days with associated decreased appetite and fluid intake. The patient endorsed tingling and numbness of feet and toes for one day. The patient's family had brought the patient to the hospital as the patient had been lethargic and appeared cyanotic. The patient denied fever, chills, rash, joint swelling, joint pain, neck stiffness or pain, sore throat, sinus drainage or pressure, urinary complaints, or bowel changes. The patient also denied recent travel or sick contacts. In the ER, the patient was lethargic, bradycardic with a heart rate of 30 beats per minute and had low blood pressure at 90/60 mmHg. On examination, the patient had a cold, as well as clammy skin that was mottled in color. Initial laboratory testing at the time of admission showed hemoglobin was 16.9 g/dL (normal range: 13.7-17.5), sodium was 102 mmol/L (normal range: 136-145), potassium was 6.2 mmol/L (normal range: 3.5-5.1), aspartate aminotransferase (AST) was 299 U/L (normal range: 15-37) and alanine aminotransferase (ALT) was 124 U/L (normal range: 30-65). Additionally, the patient's urine analysis was unremarkable. The patient was transferred to the Intensive care unit (ICU) and started on fluids and given a prophylactic dose of ceftriaxone. A cortisol level was drawn, and the patient was given a dose of dexamethasone for the possibility of AC in light of concurrent hyponatremia, hyperkalemia, hypotension and hypothermia. The patient's blood pressure, heart rate, and coloration improved. Due to this positive response, the patient started on intravenous (IV) hydrocortisone. Subsequent laboratory testing showed cortisol was 0.69 mcg/dL (normal range: 4.3-22.4), adrenocorticotropic hormone (ACTH) was more than 2000 pg/mL (normal range: 7.2-63.3), dehydroepiandrosterone sulfate (DHEA) was less than 15 mcg/dL (normal range: 80.0-560.0), total testosterone was 200 ng/dL (normal range: 264-916), free testosterone was 0.8 pg/mL (normal range: 9.3-26.5), 21-hydroxylase was 40 U/mL (normal range: less than 1), thyroid-stimulating hormone (TSH) was 5.25 mcInU/mL (micro IU/mL) (normal range: 0.36-3.74) and T4 was 1.62 ng/dL (normal range: 0.89-1.76). The low cortisol level prior to the treatment combined with improvement in clinical status following glucocorticoid treatment was consistent with AC. Further diagnostic laboratory testing demonstrated an elevated Adreno corticotropic hormone (ACTH) along with a decreased dehydroepiandrosterone sulfate (DHEA), total testosterone, and free testosterone. 21-hydroxylase antibodies were elevated, consistent with autoimmune Addison's disease. Thyroid-stimulating hormone (TSH) was slightly elevated, with a normal T4, suggestive of euthyroid sick syndrome. CT abdomen done showed no gross adrenal enlargement or abnormalities. Blood cultures did not grow any organisms. With continued treatment with steroids, the patient's severe hyponatremia and other electrolyte abnormalities were corrected. The endocrinologist recommended starting the patient on maintenance mineralocorticoid on discharge. This case was considered as serious due to Hospitalization. The authors commented, "Our patient did not have a known history of AI prior to admission, nor did he endorse any symptoms prior to his vaccination. However, we speculate that our patient had underlying undiagnosed Adrenal insufficiency (AI). This may be attributed to the already vague symptoms of AI, such as fatigue, weight loss, and loss of appetite, which develop slowly over months. In itself, AI is fairly rare with studies reporting the prevalence ranging from 35-60 per million, thereby making the diagnosis easier to be overlooked. Patients with AI may go undiagnosed until they have significant stressors inducing an AC. In 70-90% of cases of AI, the primary etiology was determined to be autoimmune adrenalitis. As our patient had antibodies against 21-hydroxylase, we believe he had underlying autoimmune Addison's disease. It is important during the time of diagnosis to also assess for other endocrine disorders, as they can occur concurrently and further precipitate AC. Commonly associated disorders include thyroid disease, diabetes mellitus, and, in women, premature ovarian insufficiency. We believe our case is the first presentation of AC induced by influenza and DTaP vaccination in a patient without a known history of AI. Potential causes of AC are usually well-known, with ongoing debates of less common etiologies and arguments around what constitute a significant stressor. Some data suggests that even strong emotional states can precipitate AC. We also consider that our patient had received two vaccines simultaneously, potentially increasing the stressor burden. Typically, for patients with a known history of AI who present with fatigue and gastrointestinal disturbances along with hypotension, AC should be high on the differential. All vaccines are known to cause fever, fatigue, and gastrointestinal disturbances by themselves, thereby making it difficult to diagnose AC. In patients such as ours without a known history of AI who present with shock resistant to vasopressors, AC should be ruled out. Regardless of a clear diagnosis, empiric treatment with steroids should take priority over confirmatory testing in cases of suspected AC. As our patient did not have any prior history, he was educated on the course of the disease and the need for exogenous steroids for maintaining good health. As infections are a major precipitant of AC, receiving future routine vaccinations should not be barred in patients with AI or those who have AC secondary to vaccinations". The authors concluded, "This case demonstrates that vaccines can play the role of a stressor, potentially significant enough to induce AC. We recommend future studies to assess the incidence of AC in patients with and without known AI after vaccinations. We also believe that further studies on preventing AC after vaccinations and the role of stress dose steroids in preventing AC as well as the efficacy of the vaccines are required."
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Intensive care
- Hospital-Tage
- -
- Labordaten
- Test Name: alanine aminotransferase; Result Unstructured Data: (Test Result:124,Unit:u/L,Normal Low:30,Normal High:65); Test Name: aspartate aminotransferase; Result Unstructured Data: (Test Result:299,Unit:u/L,Normal Low:15,Normal High:37); Test Name: adrenocorticotropic hormone; Result Unstructured Data: (Test Result:more than 2000,Unit:pg/mL,Normal Low:7.2,Normal High:63.3); Test Name: adrenocorticotropic hormone; Result Unstructured Data: (Test Result:elevated,Unit:pg/mL,Normal Low:7.2,Normal High:63.3); Test Name: cortisol; Result Unstructured Data: (Test Result:0.69,Unit:mcg/dl,Normal Low:4.3,Normal High:22.4); Test Name: Blood cultures; Result Unstructured Data: (Test Result:did not grow any organisms,Unit:unknown,Normal Low:,Normal High:); Test Name: potassium; Result Unstructured Data: (Test Result:6.2,Unit:mmol/L,Normal Low:3.5,Normal High:5.1); Test Name: blood pressure; Result Unstructured Data: (Test Result:90/60,Unit:mmHg,Normal Low:,Normal High:); Test Name: sodium; Result Unstructured Data: (Test Result:102,Unit:mmol/L,Normal Low:136,Normal High:145); Test Name: total testosterone; Result Unstructured Data: (Test Result:total testosterone was 200,Unit:ng/dL,Normal Low:264,Normal High:916); Test Name: total testosterone; Result Unstructured Data: (Test Result:decreased,Unit:ng/dL,Normal Low:264,Normal High:916); Test Name: free testosterone; Result Unstructured Data: (Test Result:0.8,Unit:pg/mL,Normal Low:9.3,Normal High:26.5); Test Name: free testosterone; Result Unstructured Data: (Test Result:decreased,Unit:pg/mL,Normal Low:9.3,Normal High:26.5); Test Name: thyroid-stimulating hormone; Result Unstructured Data: (Test Result:5.25 micro,Unit:iu/ml,Normal Low:0.36,Normal High:3.74); Test Name: thyroid-stimulating hormone; Result Unstructured Data: (Test Result:elevated,Unit:iu/ml,Normal Low:0.36,Normal High:3.74); Test Name: CT abdomen; Result Unstructured Data: (Test Result:no gross adrenal enlargement or abnormalities,Unit:unknown,Normal Low:,Normal High:); Test Name: dehydroepiandrosterone sulfate; Result Unstructured Data: (Test Result:less than 15,Unit:mcg/dl,Normal Low:80.0,Normal High:560.0); Test Name: dehydroepiandrosterone sulfate; Result Unstructured Data: (Test Result:decreased,Unit:mcg/dl,Normal Low:80.0,Normal High:560.0); Test Name: hemoglobin; Result Unstructured Data: (Test Result:16.9,Unit:g/dL,Normal Low:13.7,Normal High:17.5); Test Name: heart rate; Result Unstructured Data: (Test Result:30,Unit:beats/min,Normal Low:,Normal High:); Test Name: 21-hydroxylase antibodies; Result Unstructured Data: (Test Result:21-hydroxylase was 40 U/,Unit:/ml,Normal Low:less than 1,Normal High:); Test Name: 21-hydroxylase antibodies; Result Unstructured Data: (Test Result:elevated,Unit:/ml,Normal Low:less than 1,Normal High:); Test Name: Laboratory test; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: T4; Result Unstructured Data: (Test Result:1.62,Unit:ng/dL,Normal Low:0.89,Normal High:1.76); Test Name: urine analysis; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Comments: On examination, the patient had a cold, as well as clammy skin that was mottled in color.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 01.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
21-hydroxylase deficiency
Abdominal discomfort
Addison's disease
Adrenocortical insufficiency acute
Alanine aminotransferase increased
Antibody test positive
Aspartate aminotransferase increased
Blood corticotrophin abnormal
Blood culture negative
Blood potassium increased
Blood sodium decreased
Blood testosterone decreased
Blood testosterone free decreased
Blood thyroid stimulating hormone increased
Bradycardia
Cold sweat
Computerised tomogram abdomen normal
Cortisol decreased
Symptomtext
Adrenal crisis; decreased appetite; decreased fluid intake; Lethargic; Cyanotic; bradycardic; low blood pressure; Cold; clammy skin; Skin mottled in color; Hyponatremia; Hyperkalemia; Hypothermia; low cortisol level; autoimmune Addison's disease; euthyroid sick syndrome; mid-abdominal discomfort; vomiting; tingling; numbness of feet and toes; generalized body aches; Fatigue; Malaise; This case was reported in a literature article and described the occurrence of adrenal crisis in a 21-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. Co-suspect products included DTPa (DTaP vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine and DTaP vaccine. On an unknown date, less than a week after receiving Influenza vaccine and DTaP vaccine, the patient experienced adrenal crisis (serious criteria hospitalization and GSK medically significant), general body pain (serious criteria hospitalization), fatigue (serious criteria hospitalization), malaise (serious criteria hospitalization), abdominal discomfort (serious criteria hospitalization), vomiting (serious criteria hospitalization), decreased appetite (serious criteria hospitalization), oligodipsia (serious criteria hospitalization), tingling (serious criteria hospitalization), numbness in feet (serious criteria hospitalization), lethargy (serious criteria hospitalization), cyanosis (serious criteria hospitalization), bradycardia (serious criteria hospitalization and GSK medically significant), low blood pressure (serious criteria hospitalization), cold (serious criteria hospitalization), clamminess (serious criteria hospitalization), mottled skin (serious criteria hospitalization), hyponatremia (serious criteria hospitalization), hyperkalemia (serious criteria hospitalization and GSK medically significant), hypothermia (serious criteria hospitalization and GSK medically significant), cortisol decreased (serious criteria hospitalization), addison's disease (serious criteria hospitalization and GSK medically significant) and euthyroid sick syndrome (serious criteria hospitalization). The patient was treated with ceftriaxone, dexamethasone, hydrocortisone and glucocorticoids nos (Glucocorticoid). On an unknown date, the outcome of the adrenal crisis, abdominal discomfort, decreased appetite, oligodipsia, lethargy, cyanosis, bradycardia, low blood pressure, cold, clamminess, mottled skin, hypothermia, addison's disease and euthyroid sick syndrome were unknown and the outcome of the general body pain, fatigue, malaise, vomiting, tingling, numbness in feet, hyponatremia and hyperkalemia were recovered/resolved and the outcome of the cortisol decreased was recovering/resolving. The reporter considered the adrenal crisis, general body pain, fatigue, malaise, abdominal discomfort, vomiting, decreased appetite, oligodipsia, tingling, numbness in feet, lethargy, cyanosis, bradycardia, low blood pressure, cold, clamminess, mottled skin, hyponatremia, hyperkalemia, hypothermia, cortisol decreased, addison's disease and euthyroid sick syndrome to be related to Influenza vaccine and DTaP vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of adrenal crisis (AC) in a 21-year-old male patient, who was vaccinated with unspecified Influenza vaccine and unspecified Diphtheria, Tetanus, and acellular Pertussis (DTaP) vaccine (manufacturer unknown) for prophylaxis. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified Influenza vaccine and unspecified Diphtheria, Tetanus, and acellular Pertussis (DTaP) vaccine (Route and site of administration unknown; batch number not provided; dosage unknown for both) in preparation for school. The age of vaccination was not provided. On an unspecified date, 1 week after the vaccination, the patient presented to the emergency room (ER) with complaints of generalized body aches, fatigue, and malaise for five days. The patient reported mid-abdominal discomfort associated with scant vomiting for two days with associated decreased appetite and fluid intake. The patient endorsed tingling and numbness of feet and toes for one day. The patient's family had brought the patient to the hospital as the patient had been lethargic and appeared cyanotic. The patient denied fever, chills, rash, joint swelling, joint pain, neck stiffness or pain, sore throat, sinus drainage or pressure, urinary complaints, or bowel changes. The patient also denied recent travel or sick contacts. In the ER, the patient was lethargic, bradycardic with a heart rate of 30 beats per minute and had low blood pressure at 90/60 mmHg. On examination, the patient had a cold, as well as clammy skin that was mottled in color. Initial laboratory testing at the time of admission showed hemoglobin was 16.9 g/dL (normal range: 13.7-17.5), sodium was 102 mmol/L (normal range: 136-145), potassium was 6.2 mmol/L (normal range: 3.5-5.1), aspartate aminotransferase (AST) was 299 U/L (normal range: 15-37) and alanine aminotransferase (ALT) was 124 U/L (normal range: 30-65). Additionally, the patient's urine analysis was unremarkable. The patient was transferred to the Intensive care unit (ICU) and started on fluids and given a prophylactic dose of ceftriaxone. A cortisol level was drawn, and the patient was given a dose of dexamethasone for the possibility of AC in light of concurrent hyponatremia, hyperkalemia, hypotension and hypothermia. The patient's blood pressure, heart rate, and coloration improved. Due to this positive response, the patient started on intravenous (IV) hydrocortisone. Subsequent laboratory testing showed cortisol was 0.69 mcg/dL (normal range: 4.3-22.4), adrenocorticotropic hormone (ACTH) was more than 2000 pg/mL (normal range: 7.2-63.3), dehydroepiandrosterone sulfate (DHEA) was less than 15 mcg/dL (normal range: 80.0-560.0), total testosterone was 200 ng/dL (normal range: 264-916), free testosterone was 0.8 pg/mL (normal range: 9.3-26.5), 21-hydroxylase was 40 U/mL (normal range: less than 1), thyroid-stimulating hormone (TSH) was 5.25 mcInU/mL (micro IU/mL) (normal range: 0.36-3.74) and T4 was 1.62 ng/dL (normal range: 0.89-1.76). The low cortisol level prior to the treatment combined with improvement in clinical status following glucocorticoid treatment was consistent with AC. Further diagnostic laboratory testing demonstrated an elevated Adreno corticotropic hormone (ACTH) along with a decreased dehydroepiandrosterone sulfate (DHEA), total testosterone, and free testosterone. 21-hydroxylase antibodies were elevated, consistent with autoimmune Addison's disease. Thyroid-stimulating hormone (TSH) was slightly elevated, with a normal T4, suggestive of euthyroid sick syndrome. CT abdomen done showed no gross adrenal enlargement or abnormalities. Blood cultures did not grow any organisms. With continued treatment with steroids, the patient's severe hyponatremia and other electrolyte abnormalities were corrected. The endocrinologist recommended starting the patient on maintenance mineralocorticoid on discharge. This case was considered as serious due to Hospitalization. The authors commented, "Our patient did not have a known history of AI prior to admission, nor did he endorse any symptoms prior to his vaccination. However, we speculate that our patient had underlying undiagnosed Adrenal insufficiency (AI). This may be attributed to the already vague symptoms of AI, such as fatigue, weight loss, and loss of appetite, which develop slowly over months. In itself, AI is fairly rare with studies reporting the prevalence ranging from 35-60 per million, thereby making the diagnosis easier to be overlooked. Patients with AI may go undiagnosed until they have significant stressors inducing an AC. In 70-90% of cases of AI, the primary etiology was determined to be autoimmune adrenalitis. As our patient had antibodies against 21-hydroxylase, we believe he had underlying autoimmune Addison's disease. It is important during the time of diagnosis to also assess for other endocrine disorders, as they can occur concurrently and further precipitate AC. Commonly associated disorders include thyroid disease, diabetes mellitus, and, in women, premature ovarian insufficiency. We believe our case is the first presentation of AC induced by influenza and DTaP vaccination in a patient without a known history of AI. Potential causes of AC are usually well-known, with ongoing debates of less common etiologies and arguments around what constitute a significant stressor. Some data suggests that even strong emotional states can precipitate AC. We also consider that our patient had received two vaccines simultaneously, potentially increasing the stressor burden. Typically, for patients with a known history of AI who present with fatigue and gastrointestinal disturbances along with hypotension, AC should be high on the differential. All vaccines are known to cause fever, fatigue, and gastrointestinal disturbances by themselves, thereby making it difficult to diagnose AC. In patients such as ours without a known history of AI who present with shock resistant to vasopressors, AC should be ruled out. Regardless of a clear diagnosis, empiric treatment with steroids should take priority over confirmatory testing in cases of suspected AC. As our patient did not have any prior history, he was educated on the course of the disease and the need for exogenous steroids for maintaining good health. As infections are a major precipitant of AC, receiving future routine vaccinations should not be barred in patients with AI or those who have AC secondary to vaccinations". The authors concluded, "This case demonstrates that vaccines can play the role of a stressor, potentially significant enough to induce AC. We recommend future studies to assess the incidence of AC in patients with and without known AI after vaccinations. We also believe that further studies on preventing AC after vaccinations and the role of stress dose steroids in preventing AC as well as the efficacy of the vaccines are required."
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Intensive care
- Hospital-Tage
- -
- Labordaten
- Test Name: alanine aminotransferase; Result Unstructured Data: (Test Result:124,Unit:u/L,Normal Low:30,Normal High:65); Test Name: aspartate aminotransferase; Result Unstructured Data: (Test Result:299,Unit:u/L,Normal Low:15,Normal High:37); Test Name: adrenocorticotropic hormone; Result Unstructured Data: (Test Result:more than 2000,Unit:pg/mL,Normal Low:7.2,Normal High:63.3); Test Name: adrenocorticotropic hormone; Result Unstructured Data: (Test Result:elevated,Unit:pg/mL,Normal Low:7.2,Normal High:63.3); Test Name: cortisol; Result Unstructured Data: (Test Result:0.69,Unit:mcg/dl,Normal Low:4.3,Normal High:22.4); Test Name: Blood cultures; Result Unstructured Data: (Test Result:did not grow any organisms,Unit:unknown,Normal Low:,Normal High:); Test Name: potassium; Result Unstructured Data: (Test Result:6.2,Unit:mmol/L,Normal Low:3.5,Normal High:5.1); Test Name: blood pressure; Result Unstructured Data: (Test Result:90/60,Unit:mmHg,Normal Low:,Normal High:); Test Name: sodium; Result Unstructured Data: (Test Result:102,Unit:mmol/L,Normal Low:136,Normal High:145); Test Name: total testosterone; Result Unstructured Data: (Test Result:total testosterone was 200,Unit:ng/dL,Normal Low:264,Normal High:916); Test Name: total testosterone; Result Unstructured Data: (Test Result:decreased,Unit:ng/dL,Normal Low:264,Normal High:916); Test Name: free testosterone; Result Unstructured Data: (Test Result:0.8,Unit:pg/mL,Normal Low:9.3,Normal High:26.5); Test Name: free testosterone; Result Unstructured Data: (Test Result:decreased,Unit:pg/mL,Normal Low:9.3,Normal High:26.5); Test Name: thyroid-stimulating hormone; Result Unstructured Data: (Test Result:5.25 micro,Unit:iu/ml,Normal Low:0.36,Normal High:3.74); Test Name: thyroid-stimulating hormone; Result Unstructured Data: (Test Result:elevated,Unit:iu/ml,Normal Low:0.36,Normal High:3.74); Test Name: CT abdomen; Result Unstructured Data: (Test Result:no gross adrenal enlargement or abnormalities,Unit:unknown,Normal Low:,Normal High:); Test Name: dehydroepiandrosterone sulfate; Result Unstructured Data: (Test Result:less than 15,Unit:mcg/dl,Normal Low:80.0,Normal High:560.0); Test Name: dehydroepiandrosterone sulfate; Result Unstructured Data: (Test Result:decreased,Unit:mcg/dl,Normal Low:80.0,Normal High:560.0); Test Name: hemoglobin; Result Unstructured Data: (Test Result:16.9,Unit:g/dL,Normal Low:13.7,Normal High:17.5); Test Name: heart rate; Result Unstructured Data: (Test Result:30,Unit:beats/min,Normal Low:,Normal High:); Test Name: 21-hydroxylase antibodies; Result Unstructured Data: (Test Result:21-hydroxylase was 40 U/,Unit:/ml,Normal Low:less than 1,Normal High:); Test Name: 21-hydroxylase antibodies; Result Unstructured Data: (Test Result:elevated,Unit:/ml,Normal Low:less than 1,Normal High:); Test Name: Laboratory test; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: T4; Result Unstructured Data: (Test Result:1.62,Unit:ng/dL,Normal Low:0.89,Normal High:1.76); Test Name: urine analysis; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Comments: On examination, the patient had a cold, as well as clammy skin that was mottled in color.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 01.10.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Herpes zoster
Symptomtext
Bell's Palsy; shingles; This case was reported by a consumer and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the bell's palsy and shingles were unknown. It was unknown if the reporter considered the bell's palsy and shingles to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had Bells palsy and had shingles 2 times post vaccination. The patient asked if anyone had the shot and still had shingles. The patient stated that he/she was not told anything about needing the 2nd shot.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- -
- Geschlecht
- M
- Eingang
- 16.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
diagnosed with guillain barre syndrome; This case was reported by a physician via other manufacturer and described the occurrence of guillain barre syndrome in a 15-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient was diagnosed with Guillain barre syndrome after receiving the flu vaccine. No further information was provided. No additional adverse effects reported and no product quality complaint.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- GA
- Alter
- -
- Geschlecht
- F
- Eingang
- 16.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Ageusia
Angiogram pulmonary normal
Anxiety
Areflexia
Asthenia
Babinski reflex test
CSF glucose increased
CSF protein increased
Cerebral ischaemia
Chest X-ray normal
Chest discomfort
Chest pain
Computerised tomogram head normal
Demyelinating polyneuropathy
Electrocardiogram normal
Facial paresis
Fine motor skill dysfunction
Gait disturbance
Symptomtext
midline non-radiating, non-exertional chest pain; Headache; Loss of taste; Anxiety; lower extremity weakness; numbness; Achilles reflexes absent; difficulty ambulating; motor weakness; Facial weakness; Guillain Barre Syndrome; degenerative disc disease; acute inflammatory demyelinating polyneuropathy; atypical chest tightness; Paresthesia/paresthesia in her hands and feet; This case was reported in a literature article and described the occurrence of guillain barre syndrome in a 73-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. Concurrent medical conditions included hypertension, dyslipidemia and depression. On an unknown date, the patient received Influenza vaccine. On an unknown date, less than 3 weeks after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), degenerative disc disease (serious criteria hospitalization), demyelinating polyneuropathy (serious criteria hospitalization and GSK medically significant), chest tightness (serious criteria hospitalization), paresthesia (serious criteria hospitalization), chest pain (serious criteria hospitalization), headache (serious criteria hospitalization), taste loss (serious criteria hospitalization), anxiety (serious criteria hospitalization), lower extremities weakness of (serious criteria hospitalization), numbness (serious criteria hospitalization), absent ankle jerk (serious criteria hospitalization), walking difficulty (serious criteria hospitalization), weakness (serious criteria hospitalization) and facial weakness (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome, degenerative disc disease, demyelinating polyneuropathy, chest tightness, paresthesia, chest pain, headache, taste loss, anxiety, lower extremities weakness of, numbness, absent ankle jerk, walking difficulty and facial weakness were unknown and the outcome of the weakness was recovering/resolving. The reporter considered the guillain barre syndrome, degenerative disc disease, demyelinating polyneuropathy, chest tightness, paresthesia, chest pain, headache, taste loss, anxiety, lower extremities weakness of, numbness, absent ankle jerk, walking difficulty, weakness and facial weakness to be related to Influenza vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of Guillain-Barre Syndrome in a 73-year-old female patient who was vaccinated with unspecified Influenza vaccine (manufacturer unknown) for prophylaxis. The patient had hypertension, dyslipidemia, depression. No information on patient's medical history or family history or concomitant medication was provided. On an unspecified date, the patient received unspecified Influenza vaccine (administration route and site unspecified; dosage unknown; batch number not provided). [The patient received the influenza vaccine two weeks prior to initial hospital admission]. The patient's age at the time of vaccination could be 72 or 73 years. On an unspecified date, 2 weeks after the vaccination, the patient had 2 days hospitalization for atypical chest tightness and paresthesia. The patient was hospitalized with midline non-radiating, non-exertional chest pain, new onset headache, loss of taste and paresthesia in her hands and feet. Blood pressure was 180/100. Laboratory, EKG, chest x-ray, CTA chest and CT head were unremarkable. MRI brain showed chronic microvascular ischemic changes. The patient was discharged the next day with a diagnosis of atypical chest pain secondary to anxiety. The patient returned for worsening lower extremity weakness and numbness for four days. Upon return to the hospital, the patient's mental status, cranial nerve exam and motor tone were normal. The patient had symmetric decreased temperature sensation below the elbows and knees and absent vibration sensation in the left lower extremity. Bilateral patellar and Achilles reflexes were absent and Babinski sign was down going. MRI brain was unchanged. MRI lumbar and thoracic spine were unrevealing for cord compression but showed degenerative disease. On admission, symptoms were thought to be from degenerative disc disease and possible conversion. The next day the patient described sensations in her feet like she was wearing a boot and paresthesia in her hands spread to her elbows. With concern for acute inflammatory demyelinating polyneuropathy, the patient was started on intravenous immunoglobulin for five days. On day three, the patient complained of worsening numbness progressing to her abdomen. On day four, the patient had facial weakness and deteriorating fine motor control of her hands. On day seven, lumbar puncture CSF was positive for protein of 154 and glucose of 76, revealing an albumin-cytologic dissociation. At discharge, the patient had difficulty ambulating without a walker. Four weeks later, the patient had improved motor weakness but persistently abnormal gait. This case has been considered as serious due to hospitalization. The author commented, "Guillain-Barre Syndrome (GBS) is the most common cause of acute flaccid paralysis worldwide. We believe the influenza vaccine two weeks prior was the inciting event. With variability in presentation, atypical GBS patients are often misdiagnosed, labeled psychogenic, and sent home only to return with symptoms. The increase in GBS risk seen with vaccines against swine and H1N1 influenza also created a challenge to support the benefits of vaccines. Further exploration is justified to assess the relationship between vaccines and immune-related disorders". The author concluded, "Careful neurological exam and close follow-up are warranted to prevent unnecessary testing and reduce misdiagnosis when considering GBS. The benefit of vaccines in preventing disease need to be weighed against the risk of GBS. Factors that affect susceptibility to develop GBS warrant further investigation". This article corresponding to this case is not available for regulatory submission due to copyright restriction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- Test Name: CTA chest; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: Blood pressure; Result Unstructured Data: (Test Result:180/100,Unit:unknown,Normal Low:,Normal High:); Test Name: chest x-ray; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: CT head; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: CSF glucose; Result Unstructured Data: (Test Result:76,Unit:unknown,Normal Low:,Normal High:); Test Name: CSF protein; Result Unstructured Data: (Test Result:154,Unit:unknown,Normal Low:,Normal High:); Test Name: EKG; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: lumbar puncture CSF; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: MRI brain; Result Unstructured Data: (Test Result:chronic microvascular ischemic changes,Unit:unknown,Normal Low:,Normal High:); Test Name: MRI brain; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: MRI lumbar and thoracic spine; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: mental status exam/cranial nerve exam; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: cranial nerve exam; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Comments: motor tone were normal MRI brain was unchanged. MRI lumbar and thoracic spine were unrevealing for cord compression but showed degenerative disease. lumbar puncture CSF was positive for protein of 154 and glucose of 76, revealing an albumin-cytologic dissociation.
- Aktuelle Erkrankungen
- Depression; Dyslipidemia; Hypertension
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 16.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Chills
Illness
Loss of consciousness
Pyrexia
Symptomtext
practically unconscious sick in bed; got so sick from that first Shingrix vax, horrible; fever for 18 hours; chills for 18 hours; This case was reported by a consumer via interactive digital media and described the occurrence of unconscious in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced unconscious (serious criteria GSK medically significant), sickness, fever and chills. On an unknown date, the outcome of the unconscious, sickness, fever and chills were recovered/resolved. It was unknown if the reporter considered the unconscious, fever and chills to be related to Shingrix. The reporter considered the sickness to be related to Shingrix. Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got so sick from that first Shingrix vaccine. The patient was practically unconscious sick in bed with fever and chills for 18 hours and stated was horrible. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- -
- Geschlecht
- U
- Eingang
- 16.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Syncope
Symptomtext
Not the typical fainting and syncope; This case was reported by a nurse via call center representative and described the occurrence of syncope in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced syncope (serious criteria GSK medically significant). The action taken with Menveo was unknown. On an unknown date, the outcome of the syncope was unknown. It was unknown if the reporter considered the syncope to be related to Menveo. Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter routinely administers Menveo and had the demonstrated wealth of experience with the vaccine. On 2nd August, the they began administering Menveo under a new lot number. The reporter stated that they were alarmed not only at the unusual high rate of adverse event but also the degree and severity of the adverse event where they had not previously witnessed before. These adverse events were documented in the product prescribing information and included over time after the product launch. There was no change in the health care professional administering Menveo and no change in the syringe or needle. The reporter stated that this had not just been your typical adverse reaction of syncope. The reporter had work within the immunization program for 7 years and had never seen these types of reactions. They had all been completely different than your typical fainting and syncope. This case is one of the 4 linked cases, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021167017:Same reporter. Patient 1 atypical case. US-GLAXOSMITHKLINE-US2021AMR167723:Same reporter. Patient 2 atypical case. US-GLAXOSMITHKLINE-US2021AMR167724:Same reporter. Patient 3 atypical case.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- M
- Eingang
- 13.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Aspiration
Blood creatine phosphokinase increased
Blood lactic acid increased
CSF protein normal
Cardiac imaging procedure abnormal
Cardiomyopathy
Decreased vibratory sense
Demyelinating polyneuropathy
Dysarthria
Dysphagia
Echocardiogram
Echocardiogram abnormal
Ejection fraction decreased
Electromyogram abnormal
Extra dose administered
Full blood count normal
Gait inability
Gastrointestinal tube insertion
Symptomtext
Guillain-Barre Syndrome/acute inflammatory demyelinating polyradiculopathy; proximal muscle weakness; inability to ambulate; Dysphagia; could not lift his arms above his head; Pain; deep tendon reflexes; diffuse hypokinesis; non-ischemic cardiomyopathy; Mild dysarthria; sensorimotor polyneuropathy; silent aspiration; This case was reported in a literature article and described the occurrence of guillain barre syndrome in a 79-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine. On an unknown date, 2 weeks after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), proximal muscle weakness (serious criteria hospitalization), unable to walk (serious criteria hospitalization), dysphagia (serious criteria hospitalization), mobility decreased (serious criteria hospitalization), pain (serious criteria hospitalization), tendon reflex decreased (serious criteria hospitalization), hypokinesia (serious criteria hospitalization), non-ischemic cardiomyopathy (serious criteria hospitalization and GSK medically significant), dysarthria (serious criteria hospitalization), mixed sensory & motor neuropathy (serious criteria hospitalization) and silent aspiration (serious criteria hospitalization and GSK medically significant). The patient was treated with immunoglobulins nos (Ivig). On an unknown date, the outcome of the guillain barre syndrome, proximal muscle weakness, unable to walk, dysphagia, mobility decreased, pain, tendon reflex decreased, hypokinesia, non-ischemic cardiomyopathy, dysarthria, mixed sensory & motor neuropathy and silent aspiration were recovering/resolving. The reporter considered the guillain barre syndrome, proximal muscle weakness, unable to walk, dysphagia, mobility decreased, pain, tendon reflex decreased, hypokinesia, non-ischemic cardiomyopathy, dysarthria, mixed sensory & motor neuropathy and silent aspiration to be possibly related to Influenza vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of Guillain-Barre Syndrome in a 79-years old male patient, who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. The patient had no medical history or recent illness. No information on patient's family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received double dose of unspecified influenza vaccine (administration route and site unspecified; batch number not provided). The age of vaccination was not provided. [Eventually, the patient reported receiving a double dose influenza vaccine 2 weeks prior to symptom onset]. On an unspecified date, 2 weeks after the vaccination, the patient presented after overnight onset of proximal muscle weakness and inability to ambulate. Over two days, the patient developed dysphagia and could not lift his arms above his head. Physical exam demonstrated diminished vibration and pain in his lower limbs and 0 to 1+ deep tendon reflexes throughout without myalgias. CBC/BMP were unremarkable. Notable labs included creatinine kinase 274 U/L (30-170 U/L), lactate 2.4 mmol/L (0.67-1.8 mmol/L), and troponin 0.33 ug/L (0-0.5 ug/L). Infectious workup was negative. Family was unaffected. A lumbar puncture revealed protein 45 mg/dL (15-60 mg/dL). Head and spine imaging were unremarkable. Transthoracic echocardiogram (TTE) showed left ventricular ejection fraction (EF) of 20-25% and apical, anterolateral, anteroseptal and inferoseptal wall motion abnormalities. Electromyography (EMG) suggested an axonal demyelinating polyneuropathy but was not diagnostic. The patient received 2 doses of IVIG for presumed Guillain-Barre Syndrome (GBS) without improvement and transferred to the institution. Autoimmune workup was negative. Repeat EMG showed a sensorimotor polyneuropathy with demyelination without myopathic components, confirming acute inflammatory demyelinating polyradiculopathy. Cardiac MRI with gadolinium revealed diffuse hypokinesis without infarction, scarring, or infiltrate, suggesting potential for functional recovery. Guideline directed medical therapy was initiated for non-ischemic cardiomyopathy with reduced EF. Mild dysarthria with silent aspiration required a nasogastric tube. After resuming IVIG for 5 total days of treatment, the patient displayed improvement and transferred to inpatient rehabilitation 15 days after symptom onset. The authors commented, "This case illustrates an unusual presentation of GBS and the need to rapidly initiate appropriate treatment. Proximal weakness remains atypical. Rapidly developing profound weakness is also uncharacteristic, as maximum disability typically takes weeks. Mechanism of myocyte injury in rhabdomyolysis from GBS is unclear. Myocardial involvement varies in severity and appears reversible. Cardiomyopathy in GBS appears rare and incidence remains unknown. Proposed mechanisms for GBS-related cardiomyopathy include autonomic and nervous dysfunction from immune-mediated nerve damage. GBS and influenza vaccinations have been temporally correlated, but little evidence supports a causal relationship. It is unclear if a double-dose vaccination confers greater risk. Mainstay of GBS treatment is prompt IVIG infusion." The authors concluded, "Clinicians should be aware that hyperacute onset of proximal weakness, myositis, and cardiomyopathy are atypical features of GBS. Cardiovascular involvement of GBS may be severe yet reversible with appropriate treatment." This article corresponding to this case is not available for regulatory submission due to copyright restriction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- Test Name: creatinine kinase; Result Unstructured Data: (Test Result:274,Unit:u/L,Normal Low:30,Normal High:170); Test Name: lactate; Result Unstructured Data: (Test Result:2.4,Unit:mmol/L,Normal Low:0.67,Normal High:1.8); Test Name: Transthoracic echocardiogram; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: Electromyography; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: CBC; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: lumbar puncture; Result Unstructured Data: (Test Result:protein 45,Unit:mg/dL,Normal Low:15,Normal High:60); Test Name: Cardiac MRI; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: BMP; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: Infectious test; Result Unstructured Data: (Test Result:Infectious workup was negative,Unit:unknown,Normal Low:,Normal High:); Test Name: Physical examination; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: troponin; Result Unstructured Data: (Test Result:0.33,Unit:ug/litre,Normal Low:0,Normal High:0.5); Comments: Physical exam demonstrated diminished vibration and pain in his lower limbs and 0 to 1+ deep tendon reflexes throughout without myalgias. Transthoracic echocardiogram (TTE) showed left ventricular ejection fraction (EF) of 20-25% and apical, anterolateral, anteroseptal and inferoseptal wall motion abnormalities. Electromyography (EMG) suggested an axonal demyelinating polyneuropathy but was not diagnostic. Autoimmune workup was negative. Repeat EMG showed a sensorimotor polyneuropathy with demyelination without myopathic components, confirming acute inflammatory demyelinating polyradiculopathy. Cardiac MRI with gadolinium revealed diffuse hypokinesis without infarction, scarring, or infiltrate, suggesting potential for functional recovery.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 11.09.2021
- Impfdatum
- 01.11.2020
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Loss of consciousness
Muscular weakness
Symptomtext
passed out on day 3 post vaccine; I think I had Guillen Barre; severe muscle weakness of lower extremity; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a patient who received Herpes zoster (Shingrix) for prophylaxis. In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), guillain barre syndrome (serious criteria GSK medically significant) and lower extremities weakness of. On an unknown date, the outcome of the passed out and guillain barre syndrome were unknown and the outcome of the lower extremities weakness of was not recovered/not resolved. It was unknown if the reporter considered the passed out, guillain barre syndrome and lower extremities weakness of to be related to Shingrix. Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient passed out on day 3 post vaccine and less than a year after vaccination, then had severe muscle weakness of lower extremity, the patient though he/she had Guillen Barre, the patient's doctor would not listen to him/her. The patient still had leg weakness this far out. The patient asked would it get better. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 11.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bedridden
Guillain-Barre syndrome
Symptomtext
Guillen Barre Syndrome; bedfast; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and bedridden. On an unknown date, the outcome of the guillain barre syndrome and bedridden were unknown. It was unknown if the reporter considered the guillain barre syndrome and bedridden to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by the patient's wife. The reporter stated that the patient had been bedfast with Guillen barre syndrome for 3 years. The reporter also asked that could we refer her to someone who might know if this was caused by the shingles vaccine. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 11.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Blood pressure decreased
Dizziness
Feeding disorder
Feeling abnormal
Gait disturbance
Impaired driving ability
Loss of consciousness
Symptomtext
passed out; super dizzy; falling into the walls trying to walk; blood pressure plummets; I can't eat and then drive or do much of anything. It's very strange; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included blood pressure high. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced passed out (serious criteria GSK medically significant), dizziness, walking difficulty, blood pressure decreased and feeling abnormal. On an unknown date, the outcome of the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal were recovered/resolved. It was unknown if the reporter considered the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient came home super dizzy, falling into the walls tried too walk. Ever since the vaccine, the patient every time the patient ate his/her blood pressure plummets and had passed out once. The patient could not eat and then drive or do much of anything and it as very strange. The patient had a weekly medical consultation to try to figure out how to counter that. For 2nd dose, refer case US2021AMR169473, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR178284:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR178285:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR169473:Same reporter, same patient, different dose (2nd)
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Blood pressure high
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 11.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Blood pressure decreased
Dizziness
Fall
Feeding disorder
Feeling abnormal
Gait disturbance
Impaired driving ability
Loss of consciousness
Loss of personal independence in daily activities
Symptomtext
passed out; super dizzy; falling into the walls trying to walk; blood pressure plummets; can?t eat and then drive or do much of anything. It?s very strange; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of dizziness (1st dose received on an unknown date, and also experienced falling into the walls trying to walk, blood pressure plummets, refer case US2021AMR178275). Concurrent medical conditions included blood pressure high. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced passed out (serious criteria GSK medically significant), dizziness, walking difficulty, blood pressure decreased and feeling abnormal. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal were unknown. It was unknown if the reporter considered the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at the vaccination was not reported. The patient came home super dizzy, falling into the walls tried too walk. Ever since the vaccine the patient, every time the patient ate his/her blood pressure plummets and had passed out once. The patient could not eat and then drive or do much of anything and it as very strange. The patient had a weekly medical consultation to try to figure out how to counter that.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR178285:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR178284:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR178275:Same reporter, same patient, different dose (1st)
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Blood pressure high
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 04.09.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anaphylactic reaction
Peripheral swelling
Symptomtext
almost had anaphylaxis; my arm was swollen down to my elbow; This case was reported by a consumer via interactive digital media and described the occurrence of anaphylaxis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant) and swelling arm. On an unknown date, the outcome of the anaphylaxis and swelling arm were unknown. It was unknown if the reporter considered the anaphylaxis and swelling arm to be related to Shingles vaccine. Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had two shingles shots a couple months apart. After the first one patient almost had anaphylaxis and his or her arm was swollen down to elbow and the swelling almost went to neck. Even though the patient had this adverse reaction he or she was still wanting to take the shot because he or she did not want to get shingles. The patient heard how horrible it was so. For tolerance of 2nd dose refer case US2021AMR187628. The follow up was not required.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR187628:same patient, same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic reaction
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Immediate post-injection reaction
Symptomtext
husband got Bell's palsy right after this new vaccine; This case was reported by a consumer via media and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown. It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. Additional case details were reported as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient got Bell's palsy right after this new Shingles vaccine. The reporter asked was this coincidence or not. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.08.2021
- Impfdatum
- 01.11.2020
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Dyspnoea
Pulmonary oedema
Symptomtext
lungs filled up with fluid; trouble breathing; This case was reported by a consumer via interactive digital media and described the occurrence of pulmonary edema in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis. In November 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, the patient received COVID-19 VACCINE. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pulmonary edema (serious criteria hospitalization and GSK medically significant) and difficulty breathing. On an unknown date, the outcome of the pulmonary edema and difficulty breathing were unknown. It was unknown if the reporter considered the pulmonary edema and difficulty breathing to be related to Influenza vaccine Quadrivalent 2020-2021 season. Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the flu shot and have had trouble breathing ever since then. The patient's lungs filled up with fluid and he/she had to go to the hospital. Till the time of reporting, the patient still seeing a lung doctor. The patient said that, no more poison for him/her. The patient reported that, they were no longer giving vaccines, but experimental drugs with MRA in them that destroy your immune system, wake up people. It was unknown if the reporter considered the pulmonary edema and difficulty breathing to be related to Covid vaccine. The follow-up would not possible as no contact details were available. Note: It was unknown if the patient had received Covid vaccine or not, as it was mentioned in source document under product field, hence conservatively captured as suspect. The clarification has been raised for the same.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pulmonary oedema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.08.2021
- Impfdatum
- 01.11.2020
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Dyspnoea
Pulmonary oedema
Symptomtext
lungs filled up with fluid; trouble breathing; This case was reported by a consumer via interactive digital media and described the occurrence of pulmonary edema in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis. In November 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, the patient received COVID-19 VACCINE. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pulmonary edema (serious criteria hospitalization and GSK medically significant) and difficulty breathing. On an unknown date, the outcome of the pulmonary edema and difficulty breathing were unknown. It was unknown if the reporter considered the pulmonary edema and difficulty breathing to be related to Influenza vaccine Quadrivalent 2020-2021 season. Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the flu shot and have had trouble breathing ever since then. The patient's lungs filled up with fluid and he/she had to go to the hospital. Till the time of reporting, the patient still seeing a lung doctor. The patient said that, no more poison for him/her. The patient reported that, they were no longer giving vaccines, but experimental drugs with MRA in them that destroy your immune system, wake up people. It was unknown if the reporter considered the pulmonary edema and difficulty breathing to be related to Covid vaccine. The follow-up would not possible as no contact details were available. Note: It was unknown if the patient had received Covid vaccine or not, as it was mentioned in source document under product field, hence conservatively captured as suspect. The clarification has been raised for the same.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pulmonary oedema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 28.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anxiety
Fear
Guillain-Barre syndrome
Immediate post-injection reaction
Symptomtext
Guillain Barre syndrome; honestly thought she was going to die; This case was reported by a consumer via media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and impending doom. On an unknown date, the outcome of the guillain barre syndrome and impending doom were unknown. It was unknown if the reporter considered the guillain barre syndrome and impending doom to be related to Shingles vaccine. Additional case details were reported as follows: The case was reported by patient's close friend. The age at vaccination was not reported. The patient received shingles shot earlier this reporting year (2021) and immediately developed Guillain Barre syndrome. The patient honestly thought she was going to die. No contact details were reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Gait disturbance
Guillain-Barre syndrome
Intensive care
Walking aid user
Symptomtext
sister had the shingles vaccine and ended up in intensive care with GBS; just starting to walk with a walker after 2 months; This case was reported by a consumer via media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant) and gait disturbance. On an unknown date, the outcome of the guillain barre syndrome and gait disturbance were unknown. It was unknown if the reporter considered the guillain barre syndrome and gait disturbance to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient's sister or brother. The age at vaccination was not reported The reporter stated that, his or her sister had the shingles vaccine and ended up in intensive care with guillain barre syndrome. The patient was just started to walk with a walker after 2 months.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 26.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Bell's palsy
Herpes zoster
Herpes zoster oticus
Vaccination failure
Symptomtext
had 2 Shingle shots just got over them for the third time/suspected vaccination failure; they were inside my ear; bells palsy; got over them for the third time/ they were inside my left side of my head; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant), bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and bell's palsy were unknown and the outcome of the herpes zoster otitis externa and shingles were recovered/resolved. It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, bell's palsy and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was reported. The patient had 2 Shingle shots and just got over shingles for the 3rd time. This time shingles were inside his/her left side of head and inside ear. The patient had bells palsy at the same time and stated that it was rough month. This case was considered as suspected vaccination failure as details regarding completion of time to onset and laboratory confirmation were unknown at the time of reporting.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 26.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Bell's palsy
Herpes zoster
Herpes zoster oticus
Vaccination failure
Symptomtext
had 2 Shingle shots just got over them for the third time/suspected vaccination failure; they were inside my ear; bells palsy; got over them for the third time/ they were inside my left side of my head; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant), bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and bell's palsy were unknown and the outcome of the herpes zoster otitis externa and shingles were recovered/resolved. It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, bell's palsy and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was reported. The patient had 2 Shingle shots and just got over shingles for the 3rd time. This time shingles were inside his/her left side of head and inside ear. The patient had bells palsy at the same time and stated that it was rough month. This case was considered as suspected vaccination failure as details regarding completion of time to onset and laboratory confirmation were unknown at the time of reporting.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 26.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Bell's palsy
Facial paralysis
Incomplete course of vaccination
Symptomtext
Face paralysis; Bells palsy; Incomplete course of vaccination; This case was reported by a consumer via media and described the occurrence of facial paralysis in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced facial paralysis (serious criteria GSK medically significant), bell's palsy (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the facial paralysis and bell's palsy were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the facial paralysis and bell's palsy to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient's child. The age at vaccination was not reported. The patient received single dose of shingles vaccine years ago and experienced facial paralysis. Within days, the patient experienced bell's palsy. Till the time of reporting, patient did not receive 2nd dose of shingles vaccine, which led to incomplete course of vaccination. This case has been linked with the case US2021AMR176003, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176003:Dad's case
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 26.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Bell's palsy
Facial paralysis
Incomplete course of vaccination
Symptomtext
Face paralysis; Bells palsy; Incomplete course of vaccination; This case was reported by a consumer via media and described the occurrence of facial paralysis in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced facial paralysis (serious criteria GSK medically significant), bell's palsy (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the facial paralysis and bell's palsy were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the facial paralysis and bell's palsy to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient's child. The age at vaccination was not reported. The patient received single dose of shingles vaccine years ago and experienced facial paralysis. Within days, the patient experienced bell's palsy. Till the time of reporting, patient did not receive 2nd dose of shingles vaccine, which led to incomplete course of vaccination. This case has been linked with the case US2021AMR176003, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176003:Dad's case
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 26.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Facial paralysis
Herpes zoster oticus
Incomplete course of vaccination
Symptomtext
Face paralysis; Ramsay Hunt Disease; got single dose years ago; This case was reported by a consumer via media and described the occurrence of facial paralysis in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced facial paralysis (serious criteria GSK medically significant), ramsay-hunt syndrome (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the facial paralysis and ramsay-hunt syndrome were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the facial paralysis and ramsay-hunt syndrome to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient's child. The age at vaccination was not reported. The patient received single dose of shingles vaccine years ago and experienced facial paralysis. Within days, the patient experienced Ramsay-Hunt disease. Till the time of reporting, patient did not receive 2nd dose of shingles vaccine, which led to incomplete course of vaccination. This case has been linked with the case US2021AMR176023, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176023:Dad's wife case
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Facial paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 26.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Facial paralysis
Herpes zoster oticus
Incomplete course of vaccination
Symptomtext
Face paralysis; Ramsay Hunt Disease; got single dose years ago; This case was reported by a consumer via media and described the occurrence of facial paralysis in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced facial paralysis (serious criteria GSK medically significant), ramsay-hunt syndrome (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the facial paralysis and ramsay-hunt syndrome were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the facial paralysis and ramsay-hunt syndrome to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient's child. The age at vaccination was not reported. The patient received single dose of shingles vaccine years ago and experienced facial paralysis. Within days, the patient experienced Ramsay-Hunt disease. Till the time of reporting, patient did not receive 2nd dose of shingles vaccine, which led to incomplete course of vaccination. This case has been linked with the case US2021AMR176023, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176023:Dad's wife case
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Facial paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 25.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Vaccination complication
Symptomtext
reaction to the vaccine and almost lost his life. #GBS; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. Additional details were provided as follows: The patient was the reporter's brother. The age at vaccination was not reported. The patient had a reaction to the shingles vaccine and almost lost his life. The reporter hash tagged Guillain Barre syndrome (GBS).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 24.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Rash
Thrombosis
Symptomtext
blood clot; rash; This case was reported by a consumer via media and described the occurrence of clot blood in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced clot blood (serious criteria GSK medically significant and life threatening) and rash. On an unknown date, the outcome of the clot blood and rash were unknown. It was unknown if the reporter considered the clot blood and rash to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter stated that be careful with shingles vaccine if you choose to get it due to horrible side effects. The reporter's friend developed life threating blood clot and horrible rash with the first shot.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR176000:same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Thrombosis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 54,0
- Geschlecht
- M
- Eingang
- 22.08.2021
- Impfdatum
- 21.04.2021
- Beginn
- 15.05.2021
- Tage bis Beginn
- 24,0
- Dosis
- 2
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Facial paralysis
Ocular discomfort
Symptomtext
half of my face paralyzed; My eyes felt like opened more than normal; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (half of my face paralyzed) and OCULAR DISCOMFORT (My eyes felt like opened more than normal) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. UNK and 037B21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 15-May-2021, the patient experienced FACIAL PARALYSIS (half of my face paralyzed) and OCULAR DISCOMFORT (My eyes felt like opened more than normal). At the time of the report, FACIAL PARALYSIS (half of my face paralyzed) and OCULAR DISCOMFORT (My eyes felt like opened more than normal) outcome was unknown. Concomitant product use was not provided by the reporter. The patient refers to be taking injections [sic] as treatment. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Facial paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 21.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Herpes zoster
Vaccination failure
Symptomtext
Supsected vaccination failure; Bells Palsy; internal shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, bell's palsy and shingles were unknown. It was unknown if the reporter considered the vaccination failure, bell's palsy and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got internal shingles along with Bell's palsy. This case was considered as suspected vaccination failure since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 21.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Seizure
Symptomtext
My son / seizures after a DPT shot; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a male patient who received DTPa (DTPa vaccine) for prophylaxis. On an unknown date, the patient received DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. The reporter considered the seizure to be related to DTPa vaccine. Additional details were provided as follows: The patient was the reporter's son. The age at vaccination was not reported. The patient started having seizures after a DPT shot. The doctor said it was the pertussis part that did it. The reporter further mentioned that after that incident, the patient and the rest of the reporter's kids received only DT shots without the pertussis.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 06.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Adverse drug reaction
Guillain-Barre syndrome
Symptomtext
nasty (rare) side effect / Guillain-Barre syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got shingles shot 2 years ago and got a nasty (rare) side effect. The patient experienced Guillen-barre syndrome.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 04.08.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
Guillain Barre Syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and got guillain barre syndrome and could not get any vaccines, till the time of reporting. The patient stated he/she could not get Covid vaccine and be protected. The follow-up would not be possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 77,0
- Geschlecht
- M
- Eingang
- 30.07.2021
- Impfdatum
- 10.01.2020
- Beginn
- 13.01.2020
- Tage bis Beginn
- 3,0
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Catheterisation cardiac
Chest pain
Condition aggravated
Coronary artery disease
Dyspnoea
Incomplete course of vaccination
Pericarditis
Symptomtext
received a cardiac catheterization; has not had his second dose; was diagnosed with / pericarditis; was diagnosed with minimal coronary disease; trouble breathing; sever chest pain; This case was reported by a nurse and described the occurrence of pericarditis in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included pericarditis, coronary disease, chronic lymphocytic leukemia and shingles. On 10th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 13th January 2020, 3 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pericarditis (serious criteria GSK medically significant), coronary disease, difficulty breathing and chest pain. On an unknown date, the patient experienced cardiac catheterization and incomplete course of vaccination. On an unknown date, the outcome of the pericarditis, chest pain and incomplete course of vaccination were not recovered/not resolved and the outcome of the coronary disease, difficulty breathing and cardiac catheterization were unknown. It was unknown if the reporter considered the pericarditis, coronary disease, difficulty breathing, chest pain and cardiac catheterization to be related to Shingrix. Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not applicable for 2nd dose reported. The patient received the 1st dose of Shingrix and 3 days later he had severe chest pain and trouble breathing. The patient went to the emergency department at that time, received a cardiac catheterization, was diagnosed with minimal coronary disease and pericarditis. The patient had not received his 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pericarditis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Chronic lymphocytic leukemia; Coronary disease; Pericarditis; Shingles
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 30.07.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Hyperhidrosis
Injury
Pyrexia
Syncope
Symptomtext
fainted; sweats; fever; sustained injury; This case was reported by a other health professional via sales rep and described the occurrence of faint in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), sweating, fever and injury. On an unknown date, the outcome of the faint, sweating, fever and injury were unknown. It was unknown if the reporter considered the faint, sweating, fever and injury to be related to Shingrix. Additional details were provided as follows: The reporter was the patient's daughter. The age at vaccination was not reported. After receiving Shingrix, the patient had sweats and fever and next day, she fainted and sustained injury.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 19,0
- Geschlecht
- F
- Eingang
- 28.07.2021
- Impfdatum
- 01.12.2020
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Asthma
Depression
Epilepsy
Extrasystoles
Generalised tonic-clonic seizure
Hypoglycaemia
Impaired driving ability
Impaired work ability
Memory impairment
Suicidal ideation
Symptomtext
can't remember things like what day it is or if she's taken her medicine; asthma; She's unable to work or be left alone; Can't drive; hypoglycemic; having seizures/grand mal seizures and she fell out of her chair; doesn't want to live anymore/gone downhill ever since she's received her first dose/unable to be left alone; diagnosed with epilepsy; depression; heart skipping a beat/trouble with her heart; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (having seizures/grand mal seizures and she fell out of her chair), SUICIDAL IDEATION (doesn't want to live anymore/gone downhill ever since she's received her first dose/unable to be left alone) and EPILEPSY (diagnosed with epilepsy) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In December 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (having seizures/grand mal seizures and she fell out of her chair) (seriousness criterion medically significant), SUICIDAL IDEATION (doesn't want to live anymore/gone downhill ever since she's received her first dose/unable to be left alone) (seriousness criterion medically significant), EPILEPSY (diagnosed with epilepsy) (seriousness criterion medically significant), DEPRESSION (depression), EXTRASYSTOLES (heart skipping a beat/trouble with her heart), MEMORY IMPAIRMENT (can't remember things like what day it is or if she's taken her medicine), ASTHMA (asthma), HYPOGLYCAEMIA (hypoglycemic), IMPAIRED WORK ABILITY (She's unable to work or be left alone) and IMPAIRED DRIVING ABILITY (Can't drive). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (having seizures/grand mal seizures and she fell out of her chair), SUICIDAL IDEATION (doesn't want to live anymore/gone downhill ever since she's received her first dose/unable to be left alone), EPILEPSY (diagnosed with epilepsy), DEPRESSION (depression), EXTRASYSTOLES (heart skipping a beat/trouble with her heart), MEMORY IMPAIRMENT (can't remember things like what day it is or if she's taken her medicine), ASTHMA (asthma), HYPOGLYCAEMIA (hypoglycemic), IMPAIRED WORK ABILITY (She's unable to work or be left alone) and IMPAIRED DRIVING ABILITY (Can't drive) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant medication information was not provided. Treatment information was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment Very limited information regarding the events has been provided at this time.; Sender's Comments: Very limited information regarding the events has been provided at this time.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Generalised tonic-clonic seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.07.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dyskinesia
Pyrexia
Seizure
Symptomtext
seizure; uncontrollable jerking of my arms and torso; felt a little feverish; This case was reported by a consumer via media and described the occurrence of seizure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced seizure (serious criteria GSK medically significant), jerkiness and fever. On an unknown date, the outcome of the seizure, jerkiness and fever were recovered/resolved. It was unknown if the reporter considered the seizure, jerkiness and fever to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and felt a little feverish and then had a seizure like system of uncontrollable jerking of arms and torso and lasted about 15 seconds. The reporter asked could that be a reaction to shot. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 23.07.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Seizure
Symptomtext
had a seizure with the Men B vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a 17-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. The reporter considered the seizure to be related to Meningococcal B vaccine. Additional details were provided as follows: The case was reported by the parents of the patient. The age at vaccination was not reported. The reporter stated that, his or her 17 year old son had a seizure with the Meningococcal B vaccine. No further information was reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 17.07.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Symptomtext
had to deal with a side effect of Bell's palsy; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown. It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. Additional information was provided as follows: The case was reported by patient's son/daughter. The age at vaccination was not reported. The patient got vaccine and had to deal with a side effect of Bell's Palsy. The reporter stated, researched for a different route. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 17.07.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Hypersensitivity
Seizure
Symptomtext
allergic to pertussis (had convulsions); was allergic to pertussis; This case was reported by a consumer via interactive digital media and described the occurrence of convulsion in a male patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis. On an unknown date, the patient received DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced convulsion (serious criteria GSK medically significant) and allergy to vaccine. On an unknown date, the outcome of the convulsion and allergy to vaccine were unknown. It was unknown if the reporter considered the convulsion and allergy to vaccine to be related to DTP vaccine. Additional details were provided as follows: The reporter was patient's parent. The age at vaccination was not reported. The patient received DPT vaccine and was allergic to pertussis and had convulsions. The reporter had to sign exempt forms every school year. The reporter stated that for the same reason they would not take pertussis out of the DPT vaccine for people who are allergic to pertussis. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Seizure
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- -
- Geschlecht
- M
- Eingang
- 08.07.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Loss of consciousness
Symptomtext
passed out; This case was reported by a physician via sales rep and described the occurrence of passed out in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was recovered/resolved. The reporter considered the passed out to be unrelated to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in the afternoon at the office. At around 1 am at home, the patient passed out and an ambulance was called. The patient refused to go to hospital as he felt better. The physician had referred the patient to cardiologist for evaluation. The reporter felt that it was not due to the Shingrix shot. The reporter consented to follow up. This case has been linked to US2021012440, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021012440:Same reporter
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Loss of consciousness
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.06.2021
- Impfdatum
- 25.06.2020
- Beginn
- 02.07.2020
- Tage bis Beginn
- 7,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
GBS; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. The initial information received via Medical record on 27 May 2021: On 25 Jun 2020, the patient received Shingrix (unknown). On 02 Jul 2020, the patient experienced guillain barre syndrome. On an unknown date, the outcome of the guillain barre syndrome was unknown.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 63,0
- Geschlecht
- M
- Eingang
- 02.06.2021
- Impfdatum
- 24.09.2020
- Beginn
- 28.09.2020
- Tage bis Beginn
- 4,0
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Bell's palsy
Facial pain
Hypoaesthesia
Lacrimation increased
Sinusitis
Symptomtext
Bells Palsy; numbness (R side of face); Sinusitis; right eye watering non-stop; pain right side of face; This case was reported by a lawyer and described the occurrence of bell's palsy in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no reaction on previous exposure to drug. Concurrent medical conditions included hyperlipidemia. On 24th September 2020, the patient received the 2nd dose of Shingrix (unknown). On 28th September 2020, unknown after receiving Shingrix, the patient experienced sinusitis, watering eyes and facial pain. On an unknown date, the patient experienced bell's palsy (serious criteria GSK medically significant) and numbness facial. On an unknown date, the outcome of the bell's palsy, numbness facial, sinusitis, watering eyes and facial pain were unknown. It was unknown if the reporter considered the bell's palsy, numbness facial, sinusitis, watering eyes and facial pain to be related to Shingrix.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Hyperlipidemia
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- 66,0
- Geschlecht
- M
- Eingang
- 02.06.2021
- Impfdatum
- 07.01.2019
- Beginn
- 08.01.2019
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Influenza
Malaise
Symptomtext
Guillain Barre Syndrome; Malaise; Flu syndrome; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 7th January 2019, the patient received the 1st dose of Shingrix (intramuscular). On 8th January 2019, 1 days after receiving Shingrix, the patient experienced malaise and flu syndrome. On 11th January 2019, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome, malaise and flu syndrome were unknown. It was unknown if the reporter considered the guillain barre syndrome, malaise and flu syndrome to be related to Shingrix. Initial information received via legal complaint on 27 May 2021.The patient received 1st dose of Shingrix on 7 January 2019. The patient experienced malaise and flue syndrome on 8 January 2019 and guillain barre syndrome on 11 January 2019.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 66,0
- Geschlecht
- M
- Eingang
- 02.06.2021
- Impfdatum
- 06.09.2019
- Beginn
- 12.12.2019
- Tage bis Beginn
- 97,0
- Dosis
- 1
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Acoustic neuroma
Ataxia
Balance disorder
Coordination abnormal
Guillain-Barre syndrome
Hypoaesthesia
Paraesthesia
Postural tremor
Tremor
Symptomtext
Numbness; paresthesia starting at toes, progress up to ankle and invalving hand; poor balance; acoustic neuroma; general sense of incordination, decreased sensation; mild ataxia in legs; postural tremors of hands bilaterally; Guillain Barre Syndrome/AIDP; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis. Previously administered products included Shingrix (3 July 2019). On 6th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th December 2019, 97 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix. Initial information received on 27 May 2021 via medical record. The patient received 1st dose of Shingrix on 3 July 2019 and 2nd dose on 6 September 2019. The patient experienced guillain barre syndrome and AIDP on12 December 2019. The patient had numbness, paresthesia starting at toes, progress up to ankle and involving hand, poor balance, acoustic neuroma, general sense of incordination, decreased sensation, mild ataxia in legs, postural tremors of hands bilaterally.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 02.06.2021
- Impfdatum
- 08.12.2020
- Beginn
- 17.01.2021
- Tage bis Beginn
- 40,0
- Dosis
- 2
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Asthenia
Guillain-Barre syndrome
Immunoglobulin therapy
Muscular weakness
Symptomtext
GBS; acute weakness all over extrimities/ Weakness generalised; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis. Concurrent medical conditions included hypertension and gastroesophageal reflux disease. On 8th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 17th January 2021, 40 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and weakness generalized. The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome and weakness generalized were unknown. It was unknown if the reporter considered the guillain barre syndrome and weakness generalized to be related to Shingrix. The initial information was received on 27 May 2021 via medical record ( case is medically confirmed).The patient received his first shingrix vaccine on 30 October 2020 and his second dose on 08 December 2020.The current condition included hypertension, GERD. On 17 January 2021 he had generalized weakness in all extremities. The physician suspected to be GBS and give IVIG treatments, was admitted 2 months for treatment.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Gastroesophageal reflux disease; Hypertension
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 69,0
- Geschlecht
- M
- Eingang
- 02.06.2021
- Impfdatum
- 27.12.2018
- Beginn
- 01.01.2019
- Tage bis Beginn
- 5,0
- Dosis
- 1
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Guillain-Barre syndrome
Muscular weakness
Symptomtext
Guillain Barre syndrome; weakness in arms/ shoulders/ hands; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The initial information was received on 27 May 2021 via medical record (case is now medically confirmed). As per the medical records plaintiff had received Shingrix first shot on 27 December 2018 for Prophylaxis. On 01 January 2019 patient experienced weakness in arms, shoulders and hands. Patient visited hospital for same reasons and admitted on 04 January 2019 where patient was diagnosed with GBS(Guillain Barre syndrome). The patient currently experiences weakness in arms and hands.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 01.06.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Guillain-Barre syndrome
Symptomtext
When is the onset of Guillain-Barre symptoms after a Shingrix shot?; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient was asked about onset of Guillain-Barre symptoms after a Shingrix shot.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.05.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Eyelid ptosis
Facial paralysis
Herpes zoster oticus
Vaccination failure
Symptomtext
I had the shingles vaccine a year later I got the shingles in my left ear/ suspected vaccination failure; shingles in my left ear; The whole left side of my face dropped/ smile is crooked; My left eye droops; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant), facial droop (serious criteria GSK medically significant) and ptosis. On an unknown date, the outcome of the vaccination failure, herpes zoster otitis externa, facial droop and ptosis were unknown. It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, facial droop and ptosis to be related to Shingles vaccine. Additional information was provided as follows: The age at vaccination was not reported. The patient had the shingles vaccine and a year later got the shingles in left ear. The patient also had dropped face on the whole left side with left eye droop and crooked smile. The patient thought of having a stroke. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Facial paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 69,0
- Geschlecht
- F
- Eingang
- 26.05.2021
- Impfdatum
- 01.12.2020
- Beginn
- 01.03.2021
- Tage bis Beginn
- 90,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Electroencephalogram
Fall
Guillain-Barre syndrome
Lumbar puncture
Muscular weakness
Paraesthesia
Scan brain
X-ray
Symptomtext
Diagnosed with GBS / Hospitalized her for 5 nights to undergo testing/ Gullian-Barre Syndrome; Tingling in her arms and legs / Hospitalized her for 5 nights to undergo testing; legs were weak / Hospitalized her for 5 nights to undergo testing; fell down / Hospitalized her for 5 nights to undergo testing; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 VACCINE MODERNA for prophylaxis and COVID-19 VACCINE MODERNA for prophylaxis. On 1st December 2020, the patient received Shingrix. On 15th January 2021, the patient received the 1st dose of COVID-19 VACCINE MODERNA .05 ml. On 12th February 2021, the patient received the 2nd dose of COVID-19 VACCINE MODERNA .05 ml. On 1st March 2021, 90 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity (serious criteria hospitalization), lower extremities weakness of (serious criteria hospitalization) and fall (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome and tingling of extremity were recovering/resolving and the outcome of the lower extremities weakness of and fall were recovered/resolved. It was unknown if the reporter considered the guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall to be related to Shingrix. Additional details were provided as follows: The patient experienced tingling in her arms and legs. The patient went to the physician's office on 1st March 2021 and her legs were weak and she fell down. The patient went to the emergency room, and the neurologist on duty hospitalized her for 5 nights to undergo testing. The patient had a brain scan which was negative, lumbar puncture which was negative and X-Rays were negative. The patient then underwent an electroencephalogram and was diagnosed with guillain barre syndrome. Her symptoms at time of reporting were slightly improved. On 1st March 2021, 45 days after receiving 1st dose and 17 days after receiving 2nd dose of Covid-19 vaccine Moderna, the patient experienced guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall. It was unknown if the reporter considered the guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall to be related to Covid-19 vaccine Moderna and Covid-19 vaccine Moderna. The emergency room visit was required. The reporter did not consent to follow-up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- 5,0
- Labordaten
- Test Date: 202103; Test Name: EEG; Result Unstructured Data: (Test Result:diagnosed with Gullian-Barre Syndrome,Unit:unknown,Normal Low:,Normal High:); Test Date: 202103; Test Name: lumbar puncture; Test Result: Negative ; Test Date: 202103; Test Name: Brain scan; Test Result: Negative ; Test Date: 202103; Test Name: X-ray; Test Result: Negative
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 69,0
- Geschlecht
- F
- Eingang
- 26.05.2021
- Impfdatum
- 01.12.2020
- Beginn
- 01.03.2021
- Tage bis Beginn
- 90,0
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: ja
Erholt: nein
Electroencephalogram
Fall
Guillain-Barre syndrome
Lumbar puncture
Muscular weakness
Paraesthesia
Scan brain
X-ray
Symptomtext
Diagnosed with GBS / Hospitalized her for 5 nights to undergo testing/ Gullian-Barre Syndrome; Tingling in her arms and legs / Hospitalized her for 5 nights to undergo testing; legs were weak / Hospitalized her for 5 nights to undergo testing; fell down / Hospitalized her for 5 nights to undergo testing; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 VACCINE MODERNA for prophylaxis and COVID-19 VACCINE MODERNA for prophylaxis. On 1st December 2020, the patient received Shingrix. On 15th January 2021, the patient received the 1st dose of COVID-19 VACCINE MODERNA .05 ml. On 12th February 2021, the patient received the 2nd dose of COVID-19 VACCINE MODERNA .05 ml. On 1st March 2021, 90 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity (serious criteria hospitalization), lower extremities weakness of (serious criteria hospitalization) and fall (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome and tingling of extremity were recovering/resolving and the outcome of the lower extremities weakness of and fall were recovered/resolved. It was unknown if the reporter considered the guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall to be related to Shingrix. Additional details were provided as follows: The patient experienced tingling in her arms and legs. The patient went to the physician's office on 1st March 2021 and her legs were weak and she fell down. The patient went to the emergency room, and the neurologist on duty hospitalized her for 5 nights to undergo testing. The patient had a brain scan which was negative, lumbar puncture which was negative and X-Rays were negative. The patient then underwent an electroencephalogram and was diagnosed with guillain barre syndrome. Her symptoms at time of reporting were slightly improved. On 1st March 2021, 45 days after receiving 1st dose and 17 days after receiving 2nd dose of Covid-19 vaccine Moderna, the patient experienced guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall. It was unknown if the reporter considered the guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall to be related to Covid-19 vaccine Moderna and Covid-19 vaccine Moderna. The emergency room visit was required. The reporter did not consent to follow-up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- 5,0
- Labordaten
- Test Date: 202103; Test Name: EEG; Result Unstructured Data: (Test Result:diagnosed with Gullian-Barre Syndrome,Unit:unknown,Normal Low:,Normal High:); Test Date: 202103; Test Name: lumbar puncture; Test Result: Negative ; Test Date: 202103; Test Name: Brain scan; Test Result: Negative ; Test Date: 202103; Test Name: X-ray; Test Result: Negative
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 20.05.2021
- Impfdatum
- 13.08.2020
- Beginn
- 01.09.2020
- Tage bis Beginn
- 19,0
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Anal incontinence
Diplegia
Fear
Gait inability
Guillain-Barre syndrome
Lumbar puncture
Paralysis
Urinary incontinence
Symptomtext
Guillain Barre Syndrome; paralysis of her feet up to her waist; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis. On 13th August 2020, the patient received Shingrix (intramuscular). On 1st September 2020, 19 days after receiving Shingrix, the patient experienced paralysis (serious criteria GSK medically significant). On 2nd September 2020, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome and paralysis were unknown. It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to Shingrix. Additional detail: The patient received her Shingrix vaccine on 13 August 2020. By 01 September 2020 she developed paralysis of her feet up to her waist and lost the ability to walk. She also lost control of her bowel and bladder; she was terrified. She was rushed to the hospital on her island where they performed a lumbar puncture and then emergency airlifted her from that hospital she was admitted for a week. She has required extensive treatment and physical therapy for her injury of Guillain Barre Syndrome on 02 September 2020.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- M
- Eingang
- 13.05.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Balance disorder
Fatigue
Syncope
Thirst
Symptomtext
became faint; severe thirst; fatigue; loss of balance; This case was reported by a nurse via sales rep and described the occurrence of faint in a male patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 5 min after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced faint (serious criteria GSK medically significant), thirst, fatigue and loss of balance. On an unknown date, the outcome of the faint, thirst, fatigue and loss of balance were unknown. It was unknown if the reporter considered the faint, thirst, fatigue and loss of balance to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The patient was requested to wait 15 minutes after administration of Bexsero vaccine. The patient waited 5 minutes, entered waiting area of clinic and became faint and additionally had severe thirst, fatigue, loss of balance. The patient was returned to room where kept for 30 minutes minutes. The reporter consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 11.05.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Cardiac discomfort
Cough
Electric shock sensation
Rhinorrhoea
Symptomtext
when she lays down she feels shock on her heart; got a cough; she has the worst runny nose; This case was reported by a consumer via call center representative and described the occurrence of cardiac discomfort in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced cardiac discomfort, cough and runny nose. On an unknown date, the outcome of the cardiac discomfort, cough and runny nose were unknown. It was unknown if the reporter considered the cardiac discomfort, cough and runny nose to be related to Shingles vaccine. Additional details were provided as follows: The reporter is patient's grandchild. The age at vaccination was not reported. The patient got the vaccine and then got a cough, when she layed down she felt shock on her heart and had the worst runny nose. The reporter wanted to know the side effects after shingles vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Electric shock sensation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.04.2021
- Impfdatum
- 16.04.2021
- Beginn
- 01.04.2021
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Pericarditis
Pleurisy
Symptomtext
pericarditis; Pleurisy; This case was reported by a consumer and described the occurrence of pericarditis in a 54-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 16th April 2021, the patient received the 2nd dose of Shingles vaccine. In April 2021, less than a week after receiving Shingles vaccine, the patient experienced pericarditis (serious criteria GSK medically significant) and pleurisy. On an unknown date, the outcome of the pericarditis and pleurisy were unknown. It was unknown if the reporter considered the pericarditis and pleurisy to be related to Shingles vaccine. Additional details were provided as follows: The patient reported case for herself. The age at vaccination was not reported, but the patient could be 54 or 53 years at the time of vaccination. The patient stated she was healthy. She received her shingles vaccine last week from the time of reporting and developed pleurisy and pericarditis 3-4 days later.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pericarditis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Alanine aminotransferase increased
Apnoea
Aspartate aminotransferase increased
Aspiration bone marrow
Bacterial test positive
Blood culture
Blood fibrinogen decreased
Blood immunoglobulin G increased
Blood immunoglobulin M normal
Blood lactate dehydrogenase increased
Blood triglycerides increased
Chest X-ray normal
Clostridium test
Computerised tomogram abdomen
Corynebacterium test
Cough
Cytopenia
Diarrhoea
Symptomtext
erythematous rash; human herpes virus type 6; Hemophagocytic lymphohistiocytosis; desaturation; apnea; fever; diarrhea; vomiting; nasal congestion; cough; irritability; lethargy; Escherichia coli; Rhinovirus infection; enterovirus; tachycardia; varicella-zoster virus; vesicular rash; otitis media; papular; urticarial rash; parainfluenza virus; human metapneumovirus; This case was reported in a literature article and described the occurrence of hemophagocytic lymphohistiocytosis in a infant female patient who received Hepatitis A vaccine for prophylaxis. Co-suspect products included Hib UNK (Hib vaccine) (batch number UNK, expiry date unknown) for prophylaxis, MEASLES MUMPS RUBELLA (batch number UNK, expiry date unknown) for prophylaxis, LIVE VARICELLA VIRUS VACCINE (VARIVAX) (batch number UNK, expiry date unknown) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (batch number UNK, expiry date unknown) for prophylaxis. The patient's past medical history included viral infection (at 9 m;onths of age), fever (triggered by seasonal coronavirus HKU1), seizure (triggered by seasonal coronavirus HKU1 (non-COVID-19) infection.), influenza a virus infection (severe), pneumonia (with very high fever) and respiratory failure (treated with oseltamivir, ceftriaxone, methylprednisolone). Concurrent medical conditions included immunodeficiency (STAT2 Deficiency.). On an unknown date, the patient received Hepatitis A vaccine, Hib vaccine, MEASLES MUMPS RUBELLA, VARIVAX and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE. On an unknown date, 6 days after receiving Hepatitis A vaccine and Hib vaccine, the patient experienced hemophagocytic lymphohistiocytosis (serious criteria hospitalization, GSK medically significant and life threatening), parainfluenzae virus infection (serious criteria GSK medically significant and life threatening), fever (serious criteria hospitalization), diarrhea (serious criteria hospitalization), vomiting (serious criteria hospitalization), nasal congestion (serious criteria hospitalization), cough (serious criteria hospitalization), irritability (serious criteria hospitalization), lethargy (serious criteria hospitalization), escherichia coli infection (serious criteria hospitalization and GSK medically significant), rhinovirus infection (serious criteria hospitalization), enterovirus infection (serious criteria hospitalization and GSK medically significant), tachycardia (serious criteria hospitalization), red rash (serious criteria hospitalization), human herpesvirus 6 infection (serious criteria hospitalization), metapneumovirus infection (serious criteria GSK medically significant), oxygen saturation decreased (serious criteria hospitalization), apnea (serious criteria hospitalization and GSK medically significant), varicella zoster virus infection, vesicular rash, otitis media, papular rash and urticarial rash. The patient was treated with ceftriaxone (Ceftriaxone Sodium) and acyclovir. On an unknown date, the outcome of the hemophagocytic lymphohistiocytosis, parainfluenzae virus infection, fever, diarrhea, vomiting, nasal congestion, cough, irritability, lethargy, escherichia coli infection, rhinovirus infection, tachycardia, red rash, human herpesvirus 6 infection, metapneumovirus infection, oxygen saturation decreased, apnea, varicella zoster virus infection, vesicular rash, otitis media, papular rash and urticarial rash were recovered/resolved and the outcome of the enterovirus infection was unknown. It was unknown if the reporter considered the hemophagocytic lymphohistiocytosis, parainfluenzae virus infection, fever, diarrhea, vomiting, nasal congestion, cough, irritability, lethargy, escherichia coli infection, rhinovirus infection, enterovirus infection, tachycardia, red rash, human herpesvirus 6 infection, metapneumovirus infection, oxygen saturation decreased, apnea, varicella zoster virus infection, vesicular rash, otitis media, papular rash and urticarial rash to be related to Hepatitis A vaccine and Hib vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of hemophagocytic lymphohistiocytosis (HLH) in a female patient aged between 12-13 months old, who was vaccinated with unspecified hepatitis A vaccine and unspecified Haemophilus influenzae type B vaccine (manufacturer unknown for all) for prophylaxis. The patient was born to distantly related but healthy parents at 38 weeks of gestation. Her own medical history was remarkable for significant viral illness: at 9 months of age, the patient had a prolonged febrile illness with seizures, triggered by seasonal coronavirus HKU1 (non-COVID-19) infection. At 10 months of age, the patient experienced severe influenza A (H3) pneumonia with very high fever and progressive respiratory failure despite treatment with oseltamivir, ceftriaxone, methylprednisolone and oxygen delivered by high-flow nasal cannulae. The patient required intubation and mechanical ventilation for 3 days but recovered. Whole exome sequencing of DNA extracted from whole blood of the proband was performed commercially on the Illumina platform by Invitae Corporation. Carriage of the STAT2 variant by the proband, and all family members, was tested by Sanger sequencing of DNA isolated from whole blood by local diagnostic genetic laboratories according to standard methodologies. Suspecting a genetic aetiology in this case, whole exome sequence analysis and addition/deletion testing of 207 genes associated with primary immunodeficiency was undertaken on whole blood DNA from the proband, identifying a homozygous predicted pathogenic variant in STAT2 (c.1999C less than T [p.Arg667Ter]) and a heterozygous variant in DOCK2 [c.54-1Gless than T], the latter of unlikely clinical relevance. Sanger sequencing analysis confirmed the presence of STAT2 c.1999C less than T in the homozygous state in the proband. This variant was heterozygous in both parents and a clinically unaffected sibling, consistent with segregation of an autosomal recessive trait. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, 6 days before onset of illness, the patient received unspecified measles, mumps, and rubella (MMR) vaccine, unspecified hepatitis A vaccine, unspecified Haemophilus influenzae type B vaccine, varivax (varicella zoster virus) vaccine and 13-valent pneumococcal conjugate vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The age of vaccination was not provided but it could be 12 months or 13 months. [Six days before onset of this illness, she had been inoculated with age-appropriate vaccines (MMR, varicella zoster virus, hepatitis A, Haemophilus influenzae type B, and the 13-valent pneumococcal conjugate vaccines) despite nasal congestion and clear rhinorrhea]. On an unspecified date, 6 days after the vaccination, the patient presented with high fever, diarrhea, new onset vomiting, nasal congestion, cough, irritability, and lethargy. On admission, her physical examination only showed nasal congestion. The laboratory parameters were largely unremarkable. On day 4 (d4), the patient's laboratory parameter showed: hemoglobin was 12.1 g/dL (normal range: 10.2-14.7), hematocrit was 34.4 % (normal range: 30.8-43.7), white blood cell count was 7.6x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 4x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 2.3x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 1.2x10e9/L (normal range: 0.3-0.9), platelet count was 242x10e9/L (normal range: 150-450), AST was 66 U/L (normal range: 10.0-37.0), and ALT was 57 U/L (normal range: 5.0-30.0). On day 6 (d6), the patient's laboratory parameter showed: hemoglobin was 10.4 g/dL , hematocrit was 30.1 %, white blood cell count was 3.5x10e9/L, absolute neutrophil count was 2.2x10e9/L, absolute lymphocyte count was 1x10e9/L , absolute monocyte count was 0.2x10e9/L, platelet count was 144x10e9/L , AST was 57 U/L, ALT was 38 U/L and C-reactive protein was 76 mg/L (normal range: 0.0-8.0). On day 7 (d7), the patient's laboratory parameter showed: hemoglobin was 10.1 g/dL (normal range: 10.2-14.7), hematocrit was 29.2 % (normal range: 30.8-43.7), white blood cell count was 2.3x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 1.2x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 1x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 0.1x10e9/L (normal range: 0.3-0.9), and platelet count was 127x10e9/L (normal range: 150-450). On day 8 (d8), the patient's laboratory parameter showed: hemoglobin was 9.4 g/dL (normal range: 10.2-14.7), hematocrit was 26.9 % (normal range: 30.8-43.7), white blood cell count was 1.4x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 0.8x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 0.6x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 9.1x10e9/L (normal range: 0.3-0.9), and platelet count was 107x10e9/L (normal range: 150-450). On day 9 (d9), the patient's laboratory parameter showed: hemoglobin was 9.7 g/dL (normal range: 10.2-14.7), hematocrit was 27 % (normal range: 30.8-43.7), white blood cell count was 1.5x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 0.8x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 0.7x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 0, platelet count was 85x10e9/L, AST was 221 U/L , ALT was 100 U/L, ferritin was 1980 ng/ml, lactate dehydrogenase was 1043 U/L , and triglycerides was 289 mg/dL. On day 10 (d10), the patient's laboratory parameter showed: hemoglobin was 9.8 g/dL, hematocrit was 26.3 %, white blood cell count was 2.7x10e9/L, absolute neutrophil count was 1.1x10e9/, absolute lymphocyte count was 1.3x10e9/L, absolute monocyte count was 0.2, platelet count was 85x10e9/L, AST was 125 U/L, ALT was 94 U/L, D-dimer was more than 9999 ng/ml, fibrinogen was 71 mg/dLand soluble interleukin-2 receptor was 14740 pg/ml. On day 11 (d11), the patient's laboratory parameter showed: hemoglobin was 8.9 g/dL (normal range: 10.2-14.7), hematocrit was 25.7 %, white blood cell count was 3.5x10e9/L, absolute neutrophil count was 1.4x10e9/L, absolute lymphocyte count was 1.7x10e9/L, absolute monocyte count was 0.3, platelet count was 101x10e9/L, AST was 104 U/L, ALT was 85 U/L , and fibrinogen was 65 mg/dL. On day 12 (d12), the patient's laboratory parameter showed: hemoglobin was 8.1 g/dL , hematocrit was 24.5 % , white blood cell count was 5.6x10e9/L, absolute neutrophil count was 2.4x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 2.6x10e9/L , absolute monocyte count was 0.4, platelet count was 135x10e9/L, AST was 82 U/L, and ALT was 78 U/L. On day 15 (d15), the patient's laboratory parameter showed: hemoglobin was 8.9 g/dL, hematocrit was 27.3 %, white blood cell count was 9.1x10e9/L, absolute neutrophil count was 3.1x10e9/L, absolute lymphocyte count was 4.6x10e9/L, absolute monocyte count was 0.7, platelet count was 534x10e9/L AST was 73 U/L and ALT was 55 U/L A partial septic screen yielded more than 100,000 colony forming units/ml of Escherichia coli from urine and a positive PCR for rhinovirus/enterovirus RNA from a nasopharyngeal swab sample. Blood cultures collected on days 4 and 6 and were sterile. High fever continued despite intravenous ceftriaxone for presumed pyelonephritis. The patient was on the Paediatric ward for 2 days with continuing high fever up to 41 degree Celsius. On day 3, the patient was transferred to the Paediatric Intensive Care Unit (PICU) because of poor bilateral lower extremity perfusion that failed to improve on multiple fluid boluses. This was accompanied by persistent tachycardia, increased work of breathing, and a diffuse erythematous rash. Extensive imaging revealed no evidence of an infective focus in the renal tract (ultrasonography), chest (repeated plain x-radiography), abdomen/pelvis (contrast CT) or heart (echocardiography). Virology investigations were consistent with human herpes virus type 6 (HHV6) reactivation, based on positive blood PCR (23,500 (log 4.4) copies/ml of HHV-6 type B), positive HHV6 IgG at 1:80 (negative if less than 1:10) and negative IgM (less than 1:20) on day 6. Testing was not undertaken for MMR viruses; samples were not stored to enable retrospective testing. Persistent high fever was accompanied by worsening cytopenias, elevated triglycerides, elevated ferritin to more than or equal to 500 ng/ml, and elevated soluble interleukin-2 receptor level. These results met 5 of 8 criteria for the diagnosis of hemophagocytic lymphohistiocytosis (HLH). An attempt at bone marrow aspiration on day 9 of admission was aborted due to apnea and profound desaturation. The patient was quickly resuscitated and returned to baseline within a few hours while hematologic parameters began spontaneously improving by day 10. Fever abated after 15 days and the patient was discharged on no antibiotics. Treatment with corticosteroids and/or other immunomodulators was planned after the bone marrow aspiration, but not administered because of clinical and laboratory evidence suggestive of spontaneous HLH resolution on day 10. The diagnosis was considered to be transient HLH triggered by HHV6 infection. Immediately after hospital discharge the patient developed a diffuse vesicular rash from which varicella-zoster virus (VZV) DNA was detected by PCR. This occurred 20 days after receiving the varicella vaccine. The patient was treated with acyclovir for 5 days (20 mg/kg every 6 h) without complication. There was no attempt to ascertain by molecular testing whether VZV was the vaccine strain. However the patient had no exposure to individuals with chickenpox or shingles at home or in hospital. Based on molecular typing of rash-associated virus in post-marketing varicella vaccine surveillance in two countries, the timing of this rash was more consistent with vaccine-strain varicella (median onset 17-21 days post-vaccination) than with wild type varicella (median interval: 7-8 days post-vaccination). Thus on a balance of probabilities, the patient likely experienced dissemination of vaccine-strain VZV rather than wild type varicella. At 14 months of age, immunological work up was undertaken which revealed a polyclonal increase in IgG, protective antibody levels against measles, VZV, diphtheria, and tetanus and normal lymphocyte subset analysis. Immunophenotyping results, (patient II:3) showed total lymphocytes was 3,600 (normal range: 1600-6,700), CD3+ CD4+ was 1,008 (normal range: 1,000-4,600), CD3+ CD8+ was 756 (normal range: 400-2,100), CD3 was 1,368 (normal range: 600-2,700), CD19+ CD3- CD56+ was 216 (normal range: 200-1,200), IgG (mg/dL) was 1,170 (normal range: 300-900), IgG1 was 979 mg/dL (normal range: 160-562), IgG2 was 218 mg/dL (normal range: 24-98), IgG3 was 90 mg/dL (normal range: 17-64), IgG4 was 201 mg/dL (normal range: 0-22), IgM was 63 mg/dL (normal range: 15-70), IgA was 40 mg/dL (normal range: 40-160), IgE was 6 IU/ml (normal range: 0.62-1.6), Tetanus IgG was 4.5 IU/ml (normal range: more than 0.1), Diphtheria IgG was 0.8 IU/ml (normal range: more than 0.1), Measles IgG was more than 300 AU/ml (normal range: more than or equal to 30) and VZV IgG was 1033 Index units (normal range: more than or equal to 135). At 14 months of age, the patient had pulmonary consolidation and fever for 4 days associated with rhinovirus/enterovirus. At 15 months of age, the patient had rhinovirus/enterovirus upper respiratory tract infection with fever for 7 days. At 17 months of age, the patient had suppurative otitis media with fever. At 24 months of age, the patient had febrile parainfluenza virus type 3 upper respiratory tract infection. At 25 months of age, the patient had mixed upper respiratory tract infection with parainfluenza virus type 3, human metapneumovirus, and rhinovirus/enterovirus. At 26 months of age, the patient had upper respiratory tract infection with rhinovirus/enterovirus, with 5 days of fever up to 39.3 degree C and development of lower extremity papular and urticarial rash. Now 3 years of age, her physical growth and developmental milestones had been normal. Further live vaccines had been withheld. Prophylactic immunoglobulin therapy was not felt to be indicated. This case has been considered as serious due to hospitalization. The author commented, "This case informs understanding of the function of STAT2 in both antiviral immunity and immunoregulation. STAT2 is unique among human STATs, by virtue of both its narrow spectrum of activity (within IFN-I/III pathways) and its direct participation in both positive and negative regulation. Defining the molecular and clinical consequences of STAT2 variants provides not only clinically relevant information, but also fundamental insight into the involvement of STAT2, and IFNI/III more generally, in human immunity. It should be noted that severe IAV displays incomplete clinical penetrance in patients with mutated TLR3, IRF7, IRF9, or STAT2. This is not unexpected, since in the context of defects of pathogen defence there are multiple factors that likely contribute to variable expressivity, including: variable pathogen exposure, infecting dose, prior vaccination and compensation by adaptive immunity. Disease caused by live-attenuated parenteral viral vaccines continues to serve as a clear signal of compromised IFNAR signaling. Another novel observation in this case is the occurrence of clinical varicella following VZV immunization, which has not previously been described in STAT2 deficiency. The implication is that vaccine-strain VZV may, like other live-attenuated vaccines such as MMR, be effectively controlled by innate IFNs in vivo, consistent with a previous report of VZV dissemination in a child with IRF9 deficiency. Regrettably in our case, molecular analysis was not undertaken at the time of varicella diagnosis to definitively prove the vaccine origin of VZV, nor was material stored to enable retrospective analysis. It is also notable that dissemination of MMR virus was not identified in this case, despite a suggestive temporal association between administration of MMR and the onset of clinical disease. MMR dissemination is strongly associated with defects of IFN-I/III immunity, but is not inevitable. Again, it should be noted that in our case, blood and/or mucosal samples were not analyzed by PCR for MMR viral detection, and no clinical material was available to retrospectively test. Therefore occult MMR viral replication cannot be excluded as a potential contribution to HLH. The capacity of IFN gamma to compensate for antiviral activity in vitro might suggest a potential therapeutic role in controlling viral replication, however this approach may come at a cost of enhancing hyperinflammation. There have been clinical reports of responsiveness to IVIG or steroids, although in our case the hyperinflammation resolved without specific treatment. More work is needed to dissect the pathomechanism and inform therapeutic strategies." The author concluded, "In summary, this case significantly expands our clinical understanding of STAT2 deficiency. As the first report of life-threatening IAV in STAT2 deficiency, we can now add STAT2 to the list of genes implicated in this phenotype - a list that increasingly emphasizes the importance of IFN-I/III. We also report the first instance of disseminated vaccine-strain VZV in STAT2-deficiency, suggesting a role for innate IFNs in control of live-attenuated VZV vaccines. Finally, as only the second report of HLH in a patient with STAT2-deficiency, this case strengthens the notion that STAT2-deficient patients are vulnerable to hyperinflammation, motivating further investigation of the underlying mechanism(s) and highlighting the enduring capacity of monogenic diseases to uncover novel areas for scientific exploration."
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Intensive care
- Hospital-Tage
- -
- Labordaten
- Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:1.2 on day 7,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:0.8 on day 8,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:0.8 on day 9,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:1.1 on day 10,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:0,2 on day 10,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:1.4 on day 11,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:2.4 on day 12,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:3.1 on day 15,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: physical examination; Result Unstructured Data: (Test Result:showed nasal congestion,Unit:unknown,Normal Low:,Normal High:); Test Name: platelet count; Result Unstructured Data: (Test Result:242,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:144 on day 6,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:127 on day 7,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:107 on day 8,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:85 on day 9,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:85 on day 10,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:101 on day 11,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:135 on day 12,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:534 on day 15,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: PCR; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: PCR; Result Unstructured Data: (Test Result:varicella-zoster virus (VZV) DNA was detected,Unit:unknown,Normal Low:,Normal High:); Test Name: ferritin test; Result Unstructured Data: (Test Result:1980 on day 9,Unit:ng/mL,Normal Low:12,Normal High:207); Test Name: ultrasonography; Result Unstructured Data: (Test Result:no evidence of an infective focus in renal tract,Unit:unknown,Normal Low:,Normal High:); Test Name: VZV IgG; Result Unstructured Data: (Test Result:1033 Index units,Unit:unknown,Normal Low:,Normal High:1033 Index units); Test Name: viral test; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: white blood cell count; Result Unstructured Data: (Test Result:17.6 on day 4,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:3.5 on day 6,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:2.3 on day 7,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:1.4 on day 8,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:1.5 on day 9,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:2. 7 on day 10,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:3.5 on day 11,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:5.6 on day 12,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:9.1 on day 15,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Comments: A partial septic screen yielded more than 100,000 colony forming units/ml of Escherichia coli from urine and a positive PCR for rhinovirus/enterovirus RNA from a nasopharyngeal swab sample. Virology investigations were consistent with human herpes virus type 6 (HHV6) reactivation, based on positive blood PCR (23,500 (log 4.4) copies/ml of HHV-6 type B), positive HHV6 IgG at 1:80 (negative if less than 1:10) and negative IgM (less than 1:20) on day 6. Testing was not undertaken for MMR viruses; samples were not stored to enable retrospective testing. An attempt at bone marrow aspiration on day 9 of admission was aborted due to apnea and profound desaturation. IgG (mg/dL) was 1,170 (normal range: 300-900), IgG1 was 979 mg/dL (normal range: 160-562), IgG2 was 218 mg/dL (normal range: 24-98), IgG3 was 90 mg/dL (normal range: 17-64), IgG4 was 201 mg/dL (normal range: 0-22.At 14 months of age, immunological work up was undertaken which revealed a polyclonal increase in IgG, protective antibody levels against measles, VZV, diphtheria, and tetanus and normal lymphocyte subset analysis. Immunophenotyping results, (patient II:3) showed total lymphocytes was 3,600, CD3+ CD4+ was 1,008 , CD3+ CD8+ was 756 , CD3 was 1,368, CD19+ CD3- CD56+ was 216.; Test Name: ALT; Result Unstructured Data: (Test Result:57 on day 4,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:38 on day 6,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:100 on day 9,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:94 on day 10,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:85 on day 11,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:78 on day 12,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:55 on day 15,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: Antimicrobial susceptibility test; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: AST; Result Unstructured Data: (Test Result:66 on day 4,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:57 on day 6,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:221 on day 9,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:125 on day 10,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:104 on day 11,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:82 on day 12,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:83 on day 15,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: bone marrow aspiration; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: fibrinogen; Result Unstructured Data: (Test Result:71 on day 10,Unit:mg/dL,Normal Low:175,Normal High:375); Test Name: fibrinogen; Result Unstructured Data: (Test Result:65 on day 11,Unit:mg/dL,Normal Low:175,Normal High:375); Test Name: IgA; Test Result: 40 mg/dl; Test Name: IgE; Result Unstructured Data: (Test Result:6,Unit:iu/ml,Normal Low:,Normal High:); Test Name: IgG; Result Unstructured Data: (Test Result:1170 see text,Unit:mg/dL,Normal Low:300,Normal High:900); Test Name: IgM; Test Result: 63 mg/dl; Test Name: lactate dehydrogenase; Result Unstructured Data: (Test Result:1043 on day 9,Unit:u/L,Normal Low:190,Normal High:420); Test Name: triglycerides; Result Unstructured Data: (Test Result:289 on day 9,Unit:mg/dL,Normal Low:30,Normal High:120); Test Name: body temperature; Result Unstructured Data: (Test Result:41,Unit:degree C,Normal Low:,Normal High:); Test Name: body temperature; Result Unstructured Data: (Test Result:39.3 at the age of 26 months,Unit:degree C,Normal Low:,Normal High:); Test Name: chest x ray; Result Unstructured Data: (Test Result:no evidence of an infective focus in renal tract,Unit:unknown,Normal Low:,Normal High:); Test Name: Tetanus IgG; Result Unstructured Data: (Test Result:4.5,Unit:iu/ml,Normal Low:,Normal High:more than 0.1); Test Name: Diphtheria IgG; Result Unstructured Data: (Test Result:0.8,Unit:iu/ml,Normal Low:,Normal High:more than 0.1); Test Name: C-reactive protein; Result Unstructured Data: (Test Result:76 on day 6,Unit:unknown,Normal Low:0.0,Normal High:8.0); Test Name: D-dimer; Result Unstructured Data: (Test Result:was more than 9999 on day 10,Unit:ng/mL,Normal Low:0,Normal High:499); Test Name: hematocrit; Result Unstructured Data: (Test Result:34.4 on day 4,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:30.1 on day 6,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:29.2 on day 7,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:26.9 on day 8,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:27 on day 9,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:26.3 on day 10,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:25.7 on day 11,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:24.5 on day 12,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:27.3 on day 15,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hemoglobin; Result Unstructured Data: (Test Result:12.1 on day 4,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:10.4 on day 6,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:10.1 on day 7,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:9.4 on day 8,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:9.7 on day 9,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:9.8 on day 10,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:8.9 on day 11,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:8.1 on day 12,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:8.9 on day 15,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: interleukin; Result Unstructured Data: (Test Result:14740 on day 10,Unit:pg/mL,Normal Low:less than 1034,Normal High:); Test Name: laboratory test; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:2.3 on day 4,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1 on day 6,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1 on day 2,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:9.1 on day 8,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:0.7 on day 9,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1.7 on day 10,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1.7 on day 11,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:2.6 on day 12,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:4.6 on day 15,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: total lymphocytes; Result Unstructured Data: (Test Result:3,600 (see text),Unit:unknown,Normal Low:1600,Normal High:6700); Test Name: Measles IgG; Result Unstructured Data: (Test Result:more than 300,Unit:AU/ml(Allergen),Normal Low:,Normal High:more than or equal to 30); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:1.2 on day 4,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.2 on day 6,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.1 day 7,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.6 on day 8,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0 on day 9,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:1.4 on day 10,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.3 on day 11,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.4 on day 12,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.7 on day 15,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:4 on day 4,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:2.2 on day 6,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5)
- Aktuelle Erkrankungen
- Immunodeficiency (STAT2 Deficiency.)
- Vorgeschichte
- Medical History/Concurrent Conditions: Fever (triggered by seasonal coronavirus HKU1); Influenza A virus infection (severe); Pneumonia (with very high fever); Respiratory failure (treated with oseltamivir, ceftriaxone, methylprednisolone); Seizure (triggered by seasonal coronavirus HKU1 (non-COVID-19) infection.); Viral infection (at 9 m;onths of age)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Alanine aminotransferase increased
Apnoea
Aspartate aminotransferase increased
Aspiration bone marrow
Bacterial test positive
Blood culture
Blood fibrinogen decreased
Blood immunoglobulin G increased
Blood immunoglobulin M normal
Blood lactate dehydrogenase increased
Blood triglycerides increased
Chest X-ray normal
Clostridium test
Computerised tomogram abdomen
Corynebacterium test
Cough
Cytopenia
Diarrhoea
Symptomtext
erythematous rash; human herpes virus type 6; Hemophagocytic lymphohistiocytosis; desaturation; apnea; fever; diarrhea; vomiting; nasal congestion; cough; irritability; lethargy; Escherichia coli; Rhinovirus infection; enterovirus; tachycardia; varicella-zoster virus; vesicular rash; otitis media; papular; urticarial rash; parainfluenza virus; human metapneumovirus; This case was reported in a literature article and described the occurrence of hemophagocytic lymphohistiocytosis in a infant female patient who received Hepatitis A vaccine for prophylaxis. Co-suspect products included Hib UNK (Hib vaccine) (batch number UNK, expiry date unknown) for prophylaxis, MEASLES MUMPS RUBELLA (batch number UNK, expiry date unknown) for prophylaxis, LIVE VARICELLA VIRUS VACCINE (VARIVAX) (batch number UNK, expiry date unknown) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (batch number UNK, expiry date unknown) for prophylaxis. The patient's past medical history included viral infection (at 9 m;onths of age), fever (triggered by seasonal coronavirus HKU1), seizure (triggered by seasonal coronavirus HKU1 (non-COVID-19) infection.), influenza a virus infection (severe), pneumonia (with very high fever) and respiratory failure (treated with oseltamivir, ceftriaxone, methylprednisolone). Concurrent medical conditions included immunodeficiency (STAT2 Deficiency.). On an unknown date, the patient received Hepatitis A vaccine, Hib vaccine, MEASLES MUMPS RUBELLA, VARIVAX and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE. On an unknown date, 6 days after receiving Hepatitis A vaccine and Hib vaccine, the patient experienced hemophagocytic lymphohistiocytosis (serious criteria hospitalization, GSK medically significant and life threatening), parainfluenzae virus infection (serious criteria GSK medically significant and life threatening), fever (serious criteria hospitalization), diarrhea (serious criteria hospitalization), vomiting (serious criteria hospitalization), nasal congestion (serious criteria hospitalization), cough (serious criteria hospitalization), irritability (serious criteria hospitalization), lethargy (serious criteria hospitalization), escherichia coli infection (serious criteria hospitalization and GSK medically significant), rhinovirus infection (serious criteria hospitalization), enterovirus infection (serious criteria hospitalization and GSK medically significant), tachycardia (serious criteria hospitalization), red rash (serious criteria hospitalization), human herpesvirus 6 infection (serious criteria hospitalization), metapneumovirus infection (serious criteria GSK medically significant), oxygen saturation decreased (serious criteria hospitalization), apnea (serious criteria hospitalization and GSK medically significant), varicella zoster virus infection, vesicular rash, otitis media, papular rash and urticarial rash. The patient was treated with ceftriaxone (Ceftriaxone Sodium) and acyclovir. On an unknown date, the outcome of the hemophagocytic lymphohistiocytosis, parainfluenzae virus infection, fever, diarrhea, vomiting, nasal congestion, cough, irritability, lethargy, escherichia coli infection, rhinovirus infection, tachycardia, red rash, human herpesvirus 6 infection, metapneumovirus infection, oxygen saturation decreased, apnea, varicella zoster virus infection, vesicular rash, otitis media, papular rash and urticarial rash were recovered/resolved and the outcome of the enterovirus infection was unknown. It was unknown if the reporter considered the hemophagocytic lymphohistiocytosis, parainfluenzae virus infection, fever, diarrhea, vomiting, nasal congestion, cough, irritability, lethargy, escherichia coli infection, rhinovirus infection, enterovirus infection, tachycardia, red rash, human herpesvirus 6 infection, metapneumovirus infection, oxygen saturation decreased, apnea, varicella zoster virus infection, vesicular rash, otitis media, papular rash and urticarial rash to be related to Hepatitis A vaccine and Hib vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of hemophagocytic lymphohistiocytosis (HLH) in a female patient aged between 12-13 months old, who was vaccinated with unspecified hepatitis A vaccine and unspecified Haemophilus influenzae type B vaccine (manufacturer unknown for all) for prophylaxis. The patient was born to distantly related but healthy parents at 38 weeks of gestation. Her own medical history was remarkable for significant viral illness: at 9 months of age, the patient had a prolonged febrile illness with seizures, triggered by seasonal coronavirus HKU1 (non-COVID-19) infection. At 10 months of age, the patient experienced severe influenza A (H3) pneumonia with very high fever and progressive respiratory failure despite treatment with oseltamivir, ceftriaxone, methylprednisolone and oxygen delivered by high-flow nasal cannulae. The patient required intubation and mechanical ventilation for 3 days but recovered. Whole exome sequencing of DNA extracted from whole blood of the proband was performed commercially on the Illumina platform by Invitae Corporation. Carriage of the STAT2 variant by the proband, and all family members, was tested by Sanger sequencing of DNA isolated from whole blood by local diagnostic genetic laboratories according to standard methodologies. Suspecting a genetic aetiology in this case, whole exome sequence analysis and addition/deletion testing of 207 genes associated with primary immunodeficiency was undertaken on whole blood DNA from the proband, identifying a homozygous predicted pathogenic variant in STAT2 (c.1999C less than T [p.Arg667Ter]) and a heterozygous variant in DOCK2 [c.54-1Gless than T], the latter of unlikely clinical relevance. Sanger sequencing analysis confirmed the presence of STAT2 c.1999C less than T in the homozygous state in the proband. This variant was heterozygous in both parents and a clinically unaffected sibling, consistent with segregation of an autosomal recessive trait. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, 6 days before onset of illness, the patient received unspecified measles, mumps, and rubella (MMR) vaccine, unspecified hepatitis A vaccine, unspecified Haemophilus influenzae type B vaccine, varivax (varicella zoster virus) vaccine and 13-valent pneumococcal conjugate vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The age of vaccination was not provided but it could be 12 months or 13 months. [Six days before onset of this illness, she had been inoculated with age-appropriate vaccines (MMR, varicella zoster virus, hepatitis A, Haemophilus influenzae type B, and the 13-valent pneumococcal conjugate vaccines) despite nasal congestion and clear rhinorrhea]. On an unspecified date, 6 days after the vaccination, the patient presented with high fever, diarrhea, new onset vomiting, nasal congestion, cough, irritability, and lethargy. On admission, her physical examination only showed nasal congestion. The laboratory parameters were largely unremarkable. On day 4 (d4), the patient's laboratory parameter showed: hemoglobin was 12.1 g/dL (normal range: 10.2-14.7), hematocrit was 34.4 % (normal range: 30.8-43.7), white blood cell count was 7.6x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 4x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 2.3x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 1.2x10e9/L (normal range: 0.3-0.9), platelet count was 242x10e9/L (normal range: 150-450), AST was 66 U/L (normal range: 10.0-37.0), and ALT was 57 U/L (normal range: 5.0-30.0). On day 6 (d6), the patient's laboratory parameter showed: hemoglobin was 10.4 g/dL , hematocrit was 30.1 %, white blood cell count was 3.5x10e9/L, absolute neutrophil count was 2.2x10e9/L, absolute lymphocyte count was 1x10e9/L , absolute monocyte count was 0.2x10e9/L, platelet count was 144x10e9/L , AST was 57 U/L, ALT was 38 U/L and C-reactive protein was 76 mg/L (normal range: 0.0-8.0). On day 7 (d7), the patient's laboratory parameter showed: hemoglobin was 10.1 g/dL (normal range: 10.2-14.7), hematocrit was 29.2 % (normal range: 30.8-43.7), white blood cell count was 2.3x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 1.2x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 1x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 0.1x10e9/L (normal range: 0.3-0.9), and platelet count was 127x10e9/L (normal range: 150-450). On day 8 (d8), the patient's laboratory parameter showed: hemoglobin was 9.4 g/dL (normal range: 10.2-14.7), hematocrit was 26.9 % (normal range: 30.8-43.7), white blood cell count was 1.4x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 0.8x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 0.6x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 9.1x10e9/L (normal range: 0.3-0.9), and platelet count was 107x10e9/L (normal range: 150-450). On day 9 (d9), the patient's laboratory parameter showed: hemoglobin was 9.7 g/dL (normal range: 10.2-14.7), hematocrit was 27 % (normal range: 30.8-43.7), white blood cell count was 1.5x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 0.8x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 0.7x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 0, platelet count was 85x10e9/L, AST was 221 U/L , ALT was 100 U/L, ferritin was 1980 ng/ml, lactate dehydrogenase was 1043 U/L , and triglycerides was 289 mg/dL. On day 10 (d10), the patient's laboratory parameter showed: hemoglobin was 9.8 g/dL, hematocrit was 26.3 %, white blood cell count was 2.7x10e9/L, absolute neutrophil count was 1.1x10e9/, absolute lymphocyte count was 1.3x10e9/L, absolute monocyte count was 0.2, platelet count was 85x10e9/L, AST was 125 U/L, ALT was 94 U/L, D-dimer was more than 9999 ng/ml, fibrinogen was 71 mg/dLand soluble interleukin-2 receptor was 14740 pg/ml. On day 11 (d11), the patient's laboratory parameter showed: hemoglobin was 8.9 g/dL (normal range: 10.2-14.7), hematocrit was 25.7 %, white blood cell count was 3.5x10e9/L, absolute neutrophil count was 1.4x10e9/L, absolute lymphocyte count was 1.7x10e9/L, absolute monocyte count was 0.3, platelet count was 101x10e9/L, AST was 104 U/L, ALT was 85 U/L , and fibrinogen was 65 mg/dL. On day 12 (d12), the patient's laboratory parameter showed: hemoglobin was 8.1 g/dL , hematocrit was 24.5 % , white blood cell count was 5.6x10e9/L, absolute neutrophil count was 2.4x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 2.6x10e9/L , absolute monocyte count was 0.4, platelet count was 135x10e9/L, AST was 82 U/L, and ALT was 78 U/L. On day 15 (d15), the patient's laboratory parameter showed: hemoglobin was 8.9 g/dL, hematocrit was 27.3 %, white blood cell count was 9.1x10e9/L, absolute neutrophil count was 3.1x10e9/L, absolute lymphocyte count was 4.6x10e9/L, absolute monocyte count was 0.7, platelet count was 534x10e9/L AST was 73 U/L and ALT was 55 U/L A partial septic screen yielded more than 100,000 colony forming units/ml of Escherichia coli from urine and a positive PCR for rhinovirus/enterovirus RNA from a nasopharyngeal swab sample. Blood cultures collected on days 4 and 6 and were sterile. High fever continued despite intravenous ceftriaxone for presumed pyelonephritis. The patient was on the Paediatric ward for 2 days with continuing high fever up to 41 degree Celsius. On day 3, the patient was transferred to the Paediatric Intensive Care Unit (PICU) because of poor bilateral lower extremity perfusion that failed to improve on multiple fluid boluses. This was accompanied by persistent tachycardia, increased work of breathing, and a diffuse erythematous rash. Extensive imaging revealed no evidence of an infective focus in the renal tract (ultrasonography), chest (repeated plain x-radiography), abdomen/pelvis (contrast CT) or heart (echocardiography). Virology investigations were consistent with human herpes virus type 6 (HHV6) reactivation, based on positive blood PCR (23,500 (log 4.4) copies/ml of HHV-6 type B), positive HHV6 IgG at 1:80 (negative if less than 1:10) and negative IgM (less than 1:20) on day 6. Testing was not undertaken for MMR viruses; samples were not stored to enable retrospective testing. Persistent high fever was accompanied by worsening cytopenias, elevated triglycerides, elevated ferritin to more than or equal to 500 ng/ml, and elevated soluble interleukin-2 receptor level. These results met 5 of 8 criteria for the diagnosis of hemophagocytic lymphohistiocytosis (HLH). An attempt at bone marrow aspiration on day 9 of admission was aborted due to apnea and profound desaturation. The patient was quickly resuscitated and returned to baseline within a few hours while hematologic parameters began spontaneously improving by day 10. Fever abated after 15 days and the patient was discharged on no antibiotics. Treatment with corticosteroids and/or other immunomodulators was planned after the bone marrow aspiration, but not administered because of clinical and laboratory evidence suggestive of spontaneous HLH resolution on day 10. The diagnosis was considered to be transient HLH triggered by HHV6 infection. Immediately after hospital discharge the patient developed a diffuse vesicular rash from which varicella-zoster virus (VZV) DNA was detected by PCR. This occurred 20 days after receiving the varicella vaccine. The patient was treated with acyclovir for 5 days (20 mg/kg every 6 h) without complication. There was no attempt to ascertain by molecular testing whether VZV was the vaccine strain. However the patient had no exposure to individuals with chickenpox or shingles at home or in hospital. Based on molecular typing of rash-associated virus in post-marketing varicella vaccine surveillance in two countries, the timing of this rash was more consistent with vaccine-strain varicella (median onset 17-21 days post-vaccination) than with wild type varicella (median interval: 7-8 days post-vaccination). Thus on a balance of probabilities, the patient likely experienced dissemination of vaccine-strain VZV rather than wild type varicella. At 14 months of age, immunological work up was undertaken which revealed a polyclonal increase in IgG, protective antibody levels against measles, VZV, diphtheria, and tetanus and normal lymphocyte subset analysis. Immunophenotyping results, (patient II:3) showed total lymphocytes was 3,600 (normal range: 1600-6,700), CD3+ CD4+ was 1,008 (normal range: 1,000-4,600), CD3+ CD8+ was 756 (normal range: 400-2,100), CD3 was 1,368 (normal range: 600-2,700), CD19+ CD3- CD56+ was 216 (normal range: 200-1,200), IgG (mg/dL) was 1,170 (normal range: 300-900), IgG1 was 979 mg/dL (normal range: 160-562), IgG2 was 218 mg/dL (normal range: 24-98), IgG3 was 90 mg/dL (normal range: 17-64), IgG4 was 201 mg/dL (normal range: 0-22), IgM was 63 mg/dL (normal range: 15-70), IgA was 40 mg/dL (normal range: 40-160), IgE was 6 IU/ml (normal range: 0.62-1.6), Tetanus IgG was 4.5 IU/ml (normal range: more than 0.1), Diphtheria IgG was 0.8 IU/ml (normal range: more than 0.1), Measles IgG was more than 300 AU/ml (normal range: more than or equal to 30) and VZV IgG was 1033 Index units (normal range: more than or equal to 135). At 14 months of age, the patient had pulmonary consolidation and fever for 4 days associated with rhinovirus/enterovirus. At 15 months of age, the patient had rhinovirus/enterovirus upper respiratory tract infection with fever for 7 days. At 17 months of age, the patient had suppurative otitis media with fever. At 24 months of age, the patient had febrile parainfluenza virus type 3 upper respiratory tract infection. At 25 months of age, the patient had mixed upper respiratory tract infection with parainfluenza virus type 3, human metapneumovirus, and rhinovirus/enterovirus. At 26 months of age, the patient had upper respiratory tract infection with rhinovirus/enterovirus, with 5 days of fever up to 39.3 degree C and development of lower extremity papular and urticarial rash. Now 3 years of age, her physical growth and developmental milestones had been normal. Further live vaccines had been withheld. Prophylactic immunoglobulin therapy was not felt to be indicated. This case has been considered as serious due to hospitalization. The author commented, "This case informs understanding of the function of STAT2 in both antiviral immunity and immunoregulation. STAT2 is unique among human STATs, by virtue of both its narrow spectrum of activity (within IFN-I/III pathways) and its direct participation in both positive and negative regulation. Defining the molecular and clinical consequences of STAT2 variants provides not only clinically relevant information, but also fundamental insight into the involvement of STAT2, and IFNI/III more generally, in human immunity. It should be noted that severe IAV displays incomplete clinical penetrance in patients with mutated TLR3, IRF7, IRF9, or STAT2. This is not unexpected, since in the context of defects of pathogen defence there are multiple factors that likely contribute to variable expressivity, including: variable pathogen exposure, infecting dose, prior vaccination and compensation by adaptive immunity. Disease caused by live-attenuated parenteral viral vaccines continues to serve as a clear signal of compromised IFNAR signaling. Another novel observation in this case is the occurrence of clinical varicella following VZV immunization, which has not previously been described in STAT2 deficiency. The implication is that vaccine-strain VZV may, like other live-attenuated vaccines such as MMR, be effectively controlled by innate IFNs in vivo, consistent with a previous report of VZV dissemination in a child with IRF9 deficiency. Regrettably in our case, molecular analysis was not undertaken at the time of varicella diagnosis to definitively prove the vaccine origin of VZV, nor was material stored to enable retrospective analysis. It is also notable that dissemination of MMR virus was not identified in this case, despite a suggestive temporal association between administration of MMR and the onset of clinical disease. MMR dissemination is strongly associated with defects of IFN-I/III immunity, but is not inevitable. Again, it should be noted that in our case, blood and/or mucosal samples were not analyzed by PCR for MMR viral detection, and no clinical material was available to retrospectively test. Therefore occult MMR viral replication cannot be excluded as a potential contribution to HLH. The capacity of IFN gamma to compensate for antiviral activity in vitro might suggest a potential therapeutic role in controlling viral replication, however this approach may come at a cost of enhancing hyperinflammation. There have been clinical reports of responsiveness to IVIG or steroids, although in our case the hyperinflammation resolved without specific treatment. More work is needed to dissect the pathomechanism and inform therapeutic strategies." The author concluded, "In summary, this case significantly expands our clinical understanding of STAT2 deficiency. As the first report of life-threatening IAV in STAT2 deficiency, we can now add STAT2 to the list of genes implicated in this phenotype - a list that increasingly emphasizes the importance of IFN-I/III. We also report the first instance of disseminated vaccine-strain VZV in STAT2-deficiency, suggesting a role for innate IFNs in control of live-attenuated VZV vaccines. Finally, as only the second report of HLH in a patient with STAT2-deficiency, this case strengthens the notion that STAT2-deficient patients are vulnerable to hyperinflammation, motivating further investigation of the underlying mechanism(s) and highlighting the enduring capacity of monogenic diseases to uncover novel areas for scientific exploration."
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Intensive care
- Hospital-Tage
- -
- Labordaten
- Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:1.2 on day 7,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:0.8 on day 8,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:0.8 on day 9,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:1.1 on day 10,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:0,2 on day 10,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:1.4 on day 11,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:2.4 on day 12,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:3.1 on day 15,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: physical examination; Result Unstructured Data: (Test Result:showed nasal congestion,Unit:unknown,Normal Low:,Normal High:); Test Name: platelet count; Result Unstructured Data: (Test Result:242,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:144 on day 6,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:127 on day 7,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:107 on day 8,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:85 on day 9,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:85 on day 10,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:101 on day 11,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:135 on day 12,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:534 on day 15,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: PCR; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: PCR; Result Unstructured Data: (Test Result:varicella-zoster virus (VZV) DNA was detected,Unit:unknown,Normal Low:,Normal High:); Test Name: ferritin test; Result Unstructured Data: (Test Result:1980 on day 9,Unit:ng/mL,Normal Low:12,Normal High:207); Test Name: ultrasonography; Result Unstructured Data: (Test Result:no evidence of an infective focus in renal tract,Unit:unknown,Normal Low:,Normal High:); Test Name: VZV IgG; Result Unstructured Data: (Test Result:1033 Index units,Unit:unknown,Normal Low:,Normal High:1033 Index units); Test Name: viral test; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: white blood cell count; Result Unstructured Data: (Test Result:17.6 on day 4,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:3.5 on day 6,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:2.3 on day 7,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:1.4 on day 8,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:1.5 on day 9,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:2. 7 on day 10,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:3.5 on day 11,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:5.6 on day 12,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:9.1 on day 15,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Comments: A partial septic screen yielded more than 100,000 colony forming units/ml of Escherichia coli from urine and a positive PCR for rhinovirus/enterovirus RNA from a nasopharyngeal swab sample. Virology investigations were consistent with human herpes virus type 6 (HHV6) reactivation, based on positive blood PCR (23,500 (log 4.4) copies/ml of HHV-6 type B), positive HHV6 IgG at 1:80 (negative if less than 1:10) and negative IgM (less than 1:20) on day 6. Testing was not undertaken for MMR viruses; samples were not stored to enable retrospective testing. An attempt at bone marrow aspiration on day 9 of admission was aborted due to apnea and profound desaturation. IgG (mg/dL) was 1,170 (normal range: 300-900), IgG1 was 979 mg/dL (normal range: 160-562), IgG2 was 218 mg/dL (normal range: 24-98), IgG3 was 90 mg/dL (normal range: 17-64), IgG4 was 201 mg/dL (normal range: 0-22.At 14 months of age, immunological work up was undertaken which revealed a polyclonal increase in IgG, protective antibody levels against measles, VZV, diphtheria, and tetanus and normal lymphocyte subset analysis. Immunophenotyping results, (patient II:3) showed total lymphocytes was 3,600, CD3+ CD4+ was 1,008 , CD3+ CD8+ was 756 , CD3 was 1,368, CD19+ CD3- CD56+ was 216.; Test Name: ALT; Result Unstructured Data: (Test Result:57 on day 4,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:38 on day 6,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:100 on day 9,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:94 on day 10,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:85 on day 11,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:78 on day 12,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:55 on day 15,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: Antimicrobial susceptibility test; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: AST; Result Unstructured Data: (Test Result:66 on day 4,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:57 on day 6,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:221 on day 9,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:125 on day 10,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:104 on day 11,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:82 on day 12,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:83 on day 15,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: bone marrow aspiration; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: fibrinogen; Result Unstructured Data: (Test Result:71 on day 10,Unit:mg/dL,Normal Low:175,Normal High:375); Test Name: fibrinogen; Result Unstructured Data: (Test Result:65 on day 11,Unit:mg/dL,Normal Low:175,Normal High:375); Test Name: IgA; Test Result: 40 mg/dl; Test Name: IgE; Result Unstructured Data: (Test Result:6,Unit:iu/ml,Normal Low:,Normal High:); Test Name: IgG; Result Unstructured Data: (Test Result:1170 see text,Unit:mg/dL,Normal Low:300,Normal High:900); Test Name: IgM; Test Result: 63 mg/dl; Test Name: lactate dehydrogenase; Result Unstructured Data: (Test Result:1043 on day 9,Unit:u/L,Normal Low:190,Normal High:420); Test Name: triglycerides; Result Unstructured Data: (Test Result:289 on day 9,Unit:mg/dL,Normal Low:30,Normal High:120); Test Name: body temperature; Result Unstructured Data: (Test Result:41,Unit:degree C,Normal Low:,Normal High:); Test Name: body temperature; Result Unstructured Data: (Test Result:39.3 at the age of 26 months,Unit:degree C,Normal Low:,Normal High:); Test Name: chest x ray; Result Unstructured Data: (Test Result:no evidence of an infective focus in renal tract,Unit:unknown,Normal Low:,Normal High:); Test Name: Tetanus IgG; Result Unstructured Data: (Test Result:4.5,Unit:iu/ml,Normal Low:,Normal High:more than 0.1); Test Name: Diphtheria IgG; Result Unstructured Data: (Test Result:0.8,Unit:iu/ml,Normal Low:,Normal High:more than 0.1); Test Name: C-reactive protein; Result Unstructured Data: (Test Result:76 on day 6,Unit:unknown,Normal Low:0.0,Normal High:8.0); Test Name: D-dimer; Result Unstructured Data: (Test Result:was more than 9999 on day 10,Unit:ng/mL,Normal Low:0,Normal High:499); Test Name: hematocrit; Result Unstructured Data: (Test Result:34.4 on day 4,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:30.1 on day 6,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:29.2 on day 7,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:26.9 on day 8,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:27 on day 9,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:26.3 on day 10,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:25.7 on day 11,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:24.5 on day 12,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:27.3 on day 15,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hemoglobin; Result Unstructured Data: (Test Result:12.1 on day 4,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:10.4 on day 6,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:10.1 on day 7,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:9.4 on day 8,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:9.7 on day 9,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:9.8 on day 10,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:8.9 on day 11,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:8.1 on day 12,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:8.9 on day 15,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: interleukin; Result Unstructured Data: (Test Result:14740 on day 10,Unit:pg/mL,Normal Low:less than 1034,Normal High:); Test Name: laboratory test; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:2.3 on day 4,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1 on day 6,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1 on day 2,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:9.1 on day 8,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:0.7 on day 9,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1.7 on day 10,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1.7 on day 11,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:2.6 on day 12,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:4.6 on day 15,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: total lymphocytes; Result Unstructured Data: (Test Result:3,600 (see text),Unit:unknown,Normal Low:1600,Normal High:6700); Test Name: Measles IgG; Result Unstructured Data: (Test Result:more than 300,Unit:AU/ml(Allergen),Normal Low:,Normal High:more than or equal to 30); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:1.2 on day 4,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.2 on day 6,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.1 day 7,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.6 on day 8,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0 on day 9,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:1.4 on day 10,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.3 on day 11,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.4 on day 12,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.7 on day 15,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:4 on day 4,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:2.2 on day 6,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5)
- Aktuelle Erkrankungen
- Immunodeficiency (STAT2 Deficiency.)
- Vorgeschichte
- Medical History/Concurrent Conditions: Fever (triggered by seasonal coronavirus HKU1); Influenza A virus infection (severe); Pneumonia (with very high fever); Respiratory failure (treated with oseltamivir, ceftriaxone, methylprednisolone); Seizure (triggered by seasonal coronavirus HKU1 (non-COVID-19) infection.); Viral infection (at 9 m;onths of age)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Alanine aminotransferase increased
Apnoea
Aspartate aminotransferase increased
Aspiration bone marrow
Bacterial test positive
Blood culture
Blood fibrinogen decreased
Blood immunoglobulin G increased
Blood immunoglobulin M normal
Blood lactate dehydrogenase increased
Blood triglycerides increased
Chest X-ray normal
Clostridium test
Computerised tomogram abdomen
Corynebacterium test
Cough
Cytopenia
Diarrhoea
Symptomtext
erythematous rash; human herpes virus type 6; Hemophagocytic lymphohistiocytosis; desaturation; apnea; fever; diarrhea; vomiting; nasal congestion; cough; irritability; lethargy; Escherichia coli; Rhinovirus infection; enterovirus; tachycardia; varicella-zoster virus; vesicular rash; otitis media; papular; urticarial rash; parainfluenza virus; human metapneumovirus; This case was reported in a literature article and described the occurrence of hemophagocytic lymphohistiocytosis in a infant female patient who received Hepatitis A vaccine for prophylaxis. Co-suspect products included Hib UNK (Hib vaccine) (batch number UNK, expiry date unknown) for prophylaxis, MEASLES MUMPS RUBELLA (batch number UNK, expiry date unknown) for prophylaxis, LIVE VARICELLA VIRUS VACCINE (VARIVAX) (batch number UNK, expiry date unknown) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (batch number UNK, expiry date unknown) for prophylaxis. The patient's past medical history included viral infection (at 9 m;onths of age), fever (triggered by seasonal coronavirus HKU1), seizure (triggered by seasonal coronavirus HKU1 (non-COVID-19) infection.), influenza a virus infection (severe), pneumonia (with very high fever) and respiratory failure (treated with oseltamivir, ceftriaxone, methylprednisolone). Concurrent medical conditions included immunodeficiency (STAT2 Deficiency.). On an unknown date, the patient received Hepatitis A vaccine, Hib vaccine, MEASLES MUMPS RUBELLA, VARIVAX and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE. On an unknown date, 6 days after receiving Hepatitis A vaccine and Hib vaccine, the patient experienced hemophagocytic lymphohistiocytosis (serious criteria hospitalization, GSK medically significant and life threatening), parainfluenzae virus infection (serious criteria GSK medically significant and life threatening), fever (serious criteria hospitalization), diarrhea (serious criteria hospitalization), vomiting (serious criteria hospitalization), nasal congestion (serious criteria hospitalization), cough (serious criteria hospitalization), irritability (serious criteria hospitalization), lethargy (serious criteria hospitalization), escherichia coli infection (serious criteria hospitalization and GSK medically significant), rhinovirus infection (serious criteria hospitalization), enterovirus infection (serious criteria hospitalization and GSK medically significant), tachycardia (serious criteria hospitalization), red rash (serious criteria hospitalization), human herpesvirus 6 infection (serious criteria hospitalization), metapneumovirus infection (serious criteria GSK medically significant), oxygen saturation decreased (serious criteria hospitalization), apnea (serious criteria hospitalization and GSK medically significant), varicella zoster virus infection, vesicular rash, otitis media, papular rash and urticarial rash. The patient was treated with ceftriaxone (Ceftriaxone Sodium) and acyclovir. On an unknown date, the outcome of the hemophagocytic lymphohistiocytosis, parainfluenzae virus infection, fever, diarrhea, vomiting, nasal congestion, cough, irritability, lethargy, escherichia coli infection, rhinovirus infection, tachycardia, red rash, human herpesvirus 6 infection, metapneumovirus infection, oxygen saturation decreased, apnea, varicella zoster virus infection, vesicular rash, otitis media, papular rash and urticarial rash were recovered/resolved and the outcome of the enterovirus infection was unknown. It was unknown if the reporter considered the hemophagocytic lymphohistiocytosis, parainfluenzae virus infection, fever, diarrhea, vomiting, nasal congestion, cough, irritability, lethargy, escherichia coli infection, rhinovirus infection, enterovirus infection, tachycardia, red rash, human herpesvirus 6 infection, metapneumovirus infection, oxygen saturation decreased, apnea, varicella zoster virus infection, vesicular rash, otitis media, papular rash and urticarial rash to be related to Hepatitis A vaccine and Hib vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of hemophagocytic lymphohistiocytosis (HLH) in a female patient aged between 12-13 months old, who was vaccinated with unspecified hepatitis A vaccine and unspecified Haemophilus influenzae type B vaccine (manufacturer unknown for all) for prophylaxis. The patient was born to distantly related but healthy parents at 38 weeks of gestation. Her own medical history was remarkable for significant viral illness: at 9 months of age, the patient had a prolonged febrile illness with seizures, triggered by seasonal coronavirus HKU1 (non-COVID-19) infection. At 10 months of age, the patient experienced severe influenza A (H3) pneumonia with very high fever and progressive respiratory failure despite treatment with oseltamivir, ceftriaxone, methylprednisolone and oxygen delivered by high-flow nasal cannulae. The patient required intubation and mechanical ventilation for 3 days but recovered. Whole exome sequencing of DNA extracted from whole blood of the proband was performed commercially on the Illumina platform by Invitae Corporation. Carriage of the STAT2 variant by the proband, and all family members, was tested by Sanger sequencing of DNA isolated from whole blood by local diagnostic genetic laboratories according to standard methodologies. Suspecting a genetic aetiology in this case, whole exome sequence analysis and addition/deletion testing of 207 genes associated with primary immunodeficiency was undertaken on whole blood DNA from the proband, identifying a homozygous predicted pathogenic variant in STAT2 (c.1999C less than T [p.Arg667Ter]) and a heterozygous variant in DOCK2 [c.54-1Gless than T], the latter of unlikely clinical relevance. Sanger sequencing analysis confirmed the presence of STAT2 c.1999C less than T in the homozygous state in the proband. This variant was heterozygous in both parents and a clinically unaffected sibling, consistent with segregation of an autosomal recessive trait. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, 6 days before onset of illness, the patient received unspecified measles, mumps, and rubella (MMR) vaccine, unspecified hepatitis A vaccine, unspecified Haemophilus influenzae type B vaccine, varivax (varicella zoster virus) vaccine and 13-valent pneumococcal conjugate vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The age of vaccination was not provided but it could be 12 months or 13 months. [Six days before onset of this illness, she had been inoculated with age-appropriate vaccines (MMR, varicella zoster virus, hepatitis A, Haemophilus influenzae type B, and the 13-valent pneumococcal conjugate vaccines) despite nasal congestion and clear rhinorrhea]. On an unspecified date, 6 days after the vaccination, the patient presented with high fever, diarrhea, new onset vomiting, nasal congestion, cough, irritability, and lethargy. On admission, her physical examination only showed nasal congestion. The laboratory parameters were largely unremarkable. On day 4 (d4), the patient's laboratory parameter showed: hemoglobin was 12.1 g/dL (normal range: 10.2-14.7), hematocrit was 34.4 % (normal range: 30.8-43.7), white blood cell count was 7.6x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 4x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 2.3x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 1.2x10e9/L (normal range: 0.3-0.9), platelet count was 242x10e9/L (normal range: 150-450), AST was 66 U/L (normal range: 10.0-37.0), and ALT was 57 U/L (normal range: 5.0-30.0). On day 6 (d6), the patient's laboratory parameter showed: hemoglobin was 10.4 g/dL , hematocrit was 30.1 %, white blood cell count was 3.5x10e9/L, absolute neutrophil count was 2.2x10e9/L, absolute lymphocyte count was 1x10e9/L , absolute monocyte count was 0.2x10e9/L, platelet count was 144x10e9/L , AST was 57 U/L, ALT was 38 U/L and C-reactive protein was 76 mg/L (normal range: 0.0-8.0). On day 7 (d7), the patient's laboratory parameter showed: hemoglobin was 10.1 g/dL (normal range: 10.2-14.7), hematocrit was 29.2 % (normal range: 30.8-43.7), white blood cell count was 2.3x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 1.2x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 1x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 0.1x10e9/L (normal range: 0.3-0.9), and platelet count was 127x10e9/L (normal range: 150-450). On day 8 (d8), the patient's laboratory parameter showed: hemoglobin was 9.4 g/dL (normal range: 10.2-14.7), hematocrit was 26.9 % (normal range: 30.8-43.7), white blood cell count was 1.4x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 0.8x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 0.6x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 9.1x10e9/L (normal range: 0.3-0.9), and platelet count was 107x10e9/L (normal range: 150-450). On day 9 (d9), the patient's laboratory parameter showed: hemoglobin was 9.7 g/dL (normal range: 10.2-14.7), hematocrit was 27 % (normal range: 30.8-43.7), white blood cell count was 1.5x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 0.8x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 0.7x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 0, platelet count was 85x10e9/L, AST was 221 U/L , ALT was 100 U/L, ferritin was 1980 ng/ml, lactate dehydrogenase was 1043 U/L , and triglycerides was 289 mg/dL. On day 10 (d10), the patient's laboratory parameter showed: hemoglobin was 9.8 g/dL, hematocrit was 26.3 %, white blood cell count was 2.7x10e9/L, absolute neutrophil count was 1.1x10e9/, absolute lymphocyte count was 1.3x10e9/L, absolute monocyte count was 0.2, platelet count was 85x10e9/L, AST was 125 U/L, ALT was 94 U/L, D-dimer was more than 9999 ng/ml, fibrinogen was 71 mg/dLand soluble interleukin-2 receptor was 14740 pg/ml. On day 11 (d11), the patient's laboratory parameter showed: hemoglobin was 8.9 g/dL (normal range: 10.2-14.7), hematocrit was 25.7 %, white blood cell count was 3.5x10e9/L, absolute neutrophil count was 1.4x10e9/L, absolute lymphocyte count was 1.7x10e9/L, absolute monocyte count was 0.3, platelet count was 101x10e9/L, AST was 104 U/L, ALT was 85 U/L , and fibrinogen was 65 mg/dL. On day 12 (d12), the patient's laboratory parameter showed: hemoglobin was 8.1 g/dL , hematocrit was 24.5 % , white blood cell count was 5.6x10e9/L, absolute neutrophil count was 2.4x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 2.6x10e9/L , absolute monocyte count was 0.4, platelet count was 135x10e9/L, AST was 82 U/L, and ALT was 78 U/L. On day 15 (d15), the patient's laboratory parameter showed: hemoglobin was 8.9 g/dL, hematocrit was 27.3 %, white blood cell count was 9.1x10e9/L, absolute neutrophil count was 3.1x10e9/L, absolute lymphocyte count was 4.6x10e9/L, absolute monocyte count was 0.7, platelet count was 534x10e9/L AST was 73 U/L and ALT was 55 U/L A partial septic screen yielded more than 100,000 colony forming units/ml of Escherichia coli from urine and a positive PCR for rhinovirus/enterovirus RNA from a nasopharyngeal swab sample. Blood cultures collected on days 4 and 6 and were sterile. High fever continued despite intravenous ceftriaxone for presumed pyelonephritis. The patient was on the Paediatric ward for 2 days with continuing high fever up to 41 degree Celsius. On day 3, the patient was transferred to the Paediatric Intensive Care Unit (PICU) because of poor bilateral lower extremity perfusion that failed to improve on multiple fluid boluses. This was accompanied by persistent tachycardia, increased work of breathing, and a diffuse erythematous rash. Extensive imaging revealed no evidence of an infective focus in the renal tract (ultrasonography), chest (repeated plain x-radiography), abdomen/pelvis (contrast CT) or heart (echocardiography). Virology investigations were consistent with human herpes virus type 6 (HHV6) reactivation, based on positive blood PCR (23,500 (log 4.4) copies/ml of HHV-6 type B), positive HHV6 IgG at 1:80 (negative if less than 1:10) and negative IgM (less than 1:20) on day 6. Testing was not undertaken for MMR viruses; samples were not stored to enable retrospective testing. Persistent high fever was accompanied by worsening cytopenias, elevated triglycerides, elevated ferritin to more than or equal to 500 ng/ml, and elevated soluble interleukin-2 receptor level. These results met 5 of 8 criteria for the diagnosis of hemophagocytic lymphohistiocytosis (HLH). An attempt at bone marrow aspiration on day 9 of admission was aborted due to apnea and profound desaturation. The patient was quickly resuscitated and returned to baseline within a few hours while hematologic parameters began spontaneously improving by day 10. Fever abated after 15 days and the patient was discharged on no antibiotics. Treatment with corticosteroids and/or other immunomodulators was planned after the bone marrow aspiration, but not administered because of clinical and laboratory evidence suggestive of spontaneous HLH resolution on day 10. The diagnosis was considered to be transient HLH triggered by HHV6 infection. Immediately after hospital discharge the patient developed a diffuse vesicular rash from which varicella-zoster virus (VZV) DNA was detected by PCR. This occurred 20 days after receiving the varicella vaccine. The patient was treated with acyclovir for 5 days (20 mg/kg every 6 h) without complication. There was no attempt to ascertain by molecular testing whether VZV was the vaccine strain. However the patient had no exposure to individuals with chickenpox or shingles at home or in hospital. Based on molecular typing of rash-associated virus in post-marketing varicella vaccine surveillance in two countries, the timing of this rash was more consistent with vaccine-strain varicella (median onset 17-21 days post-vaccination) than with wild type varicella (median interval: 7-8 days post-vaccination). Thus on a balance of probabilities, the patient likely experienced dissemination of vaccine-strain VZV rather than wild type varicella. At 14 months of age, immunological work up was undertaken which revealed a polyclonal increase in IgG, protective antibody levels against measles, VZV, diphtheria, and tetanus and normal lymphocyte subset analysis. Immunophenotyping results, (patient II:3) showed total lymphocytes was 3,600 (normal range: 1600-6,700), CD3+ CD4+ was 1,008 (normal range: 1,000-4,600), CD3+ CD8+ was 756 (normal range: 400-2,100), CD3 was 1,368 (normal range: 600-2,700), CD19+ CD3- CD56+ was 216 (normal range: 200-1,200), IgG (mg/dL) was 1,170 (normal range: 300-900), IgG1 was 979 mg/dL (normal range: 160-562), IgG2 was 218 mg/dL (normal range: 24-98), IgG3 was 90 mg/dL (normal range: 17-64), IgG4 was 201 mg/dL (normal range: 0-22), IgM was 63 mg/dL (normal range: 15-70), IgA was 40 mg/dL (normal range: 40-160), IgE was 6 IU/ml (normal range: 0.62-1.6), Tetanus IgG was 4.5 IU/ml (normal range: more than 0.1), Diphtheria IgG was 0.8 IU/ml (normal range: more than 0.1), Measles IgG was more than 300 AU/ml (normal range: more than or equal to 30) and VZV IgG was 1033 Index units (normal range: more than or equal to 135). At 14 months of age, the patient had pulmonary consolidation and fever for 4 days associated with rhinovirus/enterovirus. At 15 months of age, the patient had rhinovirus/enterovirus upper respiratory tract infection with fever for 7 days. At 17 months of age, the patient had suppurative otitis media with fever. At 24 months of age, the patient had febrile parainfluenza virus type 3 upper respiratory tract infection. At 25 months of age, the patient had mixed upper respiratory tract infection with parainfluenza virus type 3, human metapneumovirus, and rhinovirus/enterovirus. At 26 months of age, the patient had upper respiratory tract infection with rhinovirus/enterovirus, with 5 days of fever up to 39.3 degree C and development of lower extremity papular and urticarial rash. Now 3 years of age, her physical growth and developmental milestones had been normal. Further live vaccines had been withheld. Prophylactic immunoglobulin therapy was not felt to be indicated. This case has been considered as serious due to hospitalization. The author commented, "This case informs understanding of the function of STAT2 in both antiviral immunity and immunoregulation. STAT2 is unique among human STATs, by virtue of both its narrow spectrum of activity (within IFN-I/III pathways) and its direct participation in both positive and negative regulation. Defining the molecular and clinical consequences of STAT2 variants provides not only clinically relevant information, but also fundamental insight into the involvement of STAT2, and IFNI/III more generally, in human immunity. It should be noted that severe IAV displays incomplete clinical penetrance in patients with mutated TLR3, IRF7, IRF9, or STAT2. This is not unexpected, since in the context of defects of pathogen defence there are multiple factors that likely contribute to variable expressivity, including: variable pathogen exposure, infecting dose, prior vaccination and compensation by adaptive immunity. Disease caused by live-attenuated parenteral viral vaccines continues to serve as a clear signal of compromised IFNAR signaling. Another novel observation in this case is the occurrence of clinical varicella following VZV immunization, which has not previously been described in STAT2 deficiency. The implication is that vaccine-strain VZV may, like other live-attenuated vaccines such as MMR, be effectively controlled by innate IFNs in vivo, consistent with a previous report of VZV dissemination in a child with IRF9 deficiency. Regrettably in our case, molecular analysis was not undertaken at the time of varicella diagnosis to definitively prove the vaccine origin of VZV, nor was material stored to enable retrospective analysis. It is also notable that dissemination of MMR virus was not identified in this case, despite a suggestive temporal association between administration of MMR and the onset of clinical disease. MMR dissemination is strongly associated with defects of IFN-I/III immunity, but is not inevitable. Again, it should be noted that in our case, blood and/or mucosal samples were not analyzed by PCR for MMR viral detection, and no clinical material was available to retrospectively test. Therefore occult MMR viral replication cannot be excluded as a potential contribution to HLH. The capacity of IFN gamma to compensate for antiviral activity in vitro might suggest a potential therapeutic role in controlling viral replication, however this approach may come at a cost of enhancing hyperinflammation. There have been clinical reports of responsiveness to IVIG or steroids, although in our case the hyperinflammation resolved without specific treatment. More work is needed to dissect the pathomechanism and inform therapeutic strategies." The author concluded, "In summary, this case significantly expands our clinical understanding of STAT2 deficiency. As the first report of life-threatening IAV in STAT2 deficiency, we can now add STAT2 to the list of genes implicated in this phenotype - a list that increasingly emphasizes the importance of IFN-I/III. We also report the first instance of disseminated vaccine-strain VZV in STAT2-deficiency, suggesting a role for innate IFNs in control of live-attenuated VZV vaccines. Finally, as only the second report of HLH in a patient with STAT2-deficiency, this case strengthens the notion that STAT2-deficient patients are vulnerable to hyperinflammation, motivating further investigation of the underlying mechanism(s) and highlighting the enduring capacity of monogenic diseases to uncover novel areas for scientific exploration."
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Intensive care
- Hospital-Tage
- -
- Labordaten
- Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:1.2 on day 7,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:0.8 on day 8,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:0.8 on day 9,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:1.1 on day 10,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:0,2 on day 10,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:1.4 on day 11,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:2.4 on day 12,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:3.1 on day 15,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: physical examination; Result Unstructured Data: (Test Result:showed nasal congestion,Unit:unknown,Normal Low:,Normal High:); Test Name: platelet count; Result Unstructured Data: (Test Result:242,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:144 on day 6,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:127 on day 7,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:107 on day 8,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:85 on day 9,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:85 on day 10,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:101 on day 11,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:135 on day 12,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:534 on day 15,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: PCR; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: PCR; Result Unstructured Data: (Test Result:varicella-zoster virus (VZV) DNA was detected,Unit:unknown,Normal Low:,Normal High:); Test Name: ferritin test; Result Unstructured Data: (Test Result:1980 on day 9,Unit:ng/mL,Normal Low:12,Normal High:207); Test Name: ultrasonography; Result Unstructured Data: (Test Result:no evidence of an infective focus in renal tract,Unit:unknown,Normal Low:,Normal High:); Test Name: VZV IgG; Result Unstructured Data: (Test Result:1033 Index units,Unit:unknown,Normal Low:,Normal High:1033 Index units); Test Name: viral test; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: white blood cell count; Result Unstructured Data: (Test Result:17.6 on day 4,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:3.5 on day 6,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:2.3 on day 7,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:1.4 on day 8,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:1.5 on day 9,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:2. 7 on day 10,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:3.5 on day 11,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:5.6 on day 12,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:9.1 on day 15,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Comments: A partial septic screen yielded more than 100,000 colony forming units/ml of Escherichia coli from urine and a positive PCR for rhinovirus/enterovirus RNA from a nasopharyngeal swab sample. Virology investigations were consistent with human herpes virus type 6 (HHV6) reactivation, based on positive blood PCR (23,500 (log 4.4) copies/ml of HHV-6 type B), positive HHV6 IgG at 1:80 (negative if less than 1:10) and negative IgM (less than 1:20) on day 6. Testing was not undertaken for MMR viruses; samples were not stored to enable retrospective testing. An attempt at bone marrow aspiration on day 9 of admission was aborted due to apnea and profound desaturation. IgG (mg/dL) was 1,170 (normal range: 300-900), IgG1 was 979 mg/dL (normal range: 160-562), IgG2 was 218 mg/dL (normal range: 24-98), IgG3 was 90 mg/dL (normal range: 17-64), IgG4 was 201 mg/dL (normal range: 0-22.At 14 months of age, immunological work up was undertaken which revealed a polyclonal increase in IgG, protective antibody levels against measles, VZV, diphtheria, and tetanus and normal lymphocyte subset analysis. Immunophenotyping results, (patient II:3) showed total lymphocytes was 3,600, CD3+ CD4+ was 1,008 , CD3+ CD8+ was 756 , CD3 was 1,368, CD19+ CD3- CD56+ was 216.; Test Name: ALT; Result Unstructured Data: (Test Result:57 on day 4,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:38 on day 6,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:100 on day 9,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:94 on day 10,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:85 on day 11,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:78 on day 12,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:55 on day 15,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: Antimicrobial susceptibility test; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: AST; Result Unstructured Data: (Test Result:66 on day 4,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:57 on day 6,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:221 on day 9,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:125 on day 10,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:104 on day 11,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:82 on day 12,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:83 on day 15,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: bone marrow aspiration; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: fibrinogen; Result Unstructured Data: (Test Result:71 on day 10,Unit:mg/dL,Normal Low:175,Normal High:375); Test Name: fibrinogen; Result Unstructured Data: (Test Result:65 on day 11,Unit:mg/dL,Normal Low:175,Normal High:375); Test Name: IgA; Test Result: 40 mg/dl; Test Name: IgE; Result Unstructured Data: (Test Result:6,Unit:iu/ml,Normal Low:,Normal High:); Test Name: IgG; Result Unstructured Data: (Test Result:1170 see text,Unit:mg/dL,Normal Low:300,Normal High:900); Test Name: IgM; Test Result: 63 mg/dl; Test Name: lactate dehydrogenase; Result Unstructured Data: (Test Result:1043 on day 9,Unit:u/L,Normal Low:190,Normal High:420); Test Name: triglycerides; Result Unstructured Data: (Test Result:289 on day 9,Unit:mg/dL,Normal Low:30,Normal High:120); Test Name: body temperature; Result Unstructured Data: (Test Result:41,Unit:degree C,Normal Low:,Normal High:); Test Name: body temperature; Result Unstructured Data: (Test Result:39.3 at the age of 26 months,Unit:degree C,Normal Low:,Normal High:); Test Name: chest x ray; Result Unstructured Data: (Test Result:no evidence of an infective focus in renal tract,Unit:unknown,Normal Low:,Normal High:); Test Name: Tetanus IgG; Result Unstructured Data: (Test Result:4.5,Unit:iu/ml,Normal Low:,Normal High:more than 0.1); Test Name: Diphtheria IgG; Result Unstructured Data: (Test Result:0.8,Unit:iu/ml,Normal Low:,Normal High:more than 0.1); Test Name: C-reactive protein; Result Unstructured Data: (Test Result:76 on day 6,Unit:unknown,Normal Low:0.0,Normal High:8.0); Test Name: D-dimer; Result Unstructured Data: (Test Result:was more than 9999 on day 10,Unit:ng/mL,Normal Low:0,Normal High:499); Test Name: hematocrit; Result Unstructured Data: (Test Result:34.4 on day 4,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:30.1 on day 6,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:29.2 on day 7,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:26.9 on day 8,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:27 on day 9,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:26.3 on day 10,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:25.7 on day 11,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:24.5 on day 12,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:27.3 on day 15,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hemoglobin; Result Unstructured Data: (Test Result:12.1 on day 4,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:10.4 on day 6,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:10.1 on day 7,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:9.4 on day 8,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:9.7 on day 9,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:9.8 on day 10,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:8.9 on day 11,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:8.1 on day 12,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:8.9 on day 15,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: interleukin; Result Unstructured Data: (Test Result:14740 on day 10,Unit:pg/mL,Normal Low:less than 1034,Normal High:); Test Name: laboratory test; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:2.3 on day 4,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1 on day 6,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1 on day 2,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:9.1 on day 8,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:0.7 on day 9,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1.7 on day 10,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1.7 on day 11,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:2.6 on day 12,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:4.6 on day 15,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: total lymphocytes; Result Unstructured Data: (Test Result:3,600 (see text),Unit:unknown,Normal Low:1600,Normal High:6700); Test Name: Measles IgG; Result Unstructured Data: (Test Result:more than 300,Unit:AU/ml(Allergen),Normal Low:,Normal High:more than or equal to 30); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:1.2 on day 4,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.2 on day 6,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.1 day 7,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.6 on day 8,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0 on day 9,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:1.4 on day 10,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.3 on day 11,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.4 on day 12,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.7 on day 15,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:4 on day 4,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:2.2 on day 6,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5)
- Aktuelle Erkrankungen
- Immunodeficiency (STAT2 Deficiency.)
- Vorgeschichte
- Medical History/Concurrent Conditions: Fever (triggered by seasonal coronavirus HKU1); Influenza A virus infection (severe); Pneumonia (with very high fever); Respiratory failure (treated with oseltamivir, ceftriaxone, methylprednisolone); Seizure (triggered by seasonal coronavirus HKU1 (non-COVID-19) infection.); Viral infection (at 9 m;onths of age)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Alanine aminotransferase increased
Apnoea
Aspartate aminotransferase increased
Aspiration bone marrow
Bacterial test positive
Blood culture
Blood fibrinogen decreased
Blood immunoglobulin G increased
Blood immunoglobulin M normal
Blood lactate dehydrogenase increased
Blood triglycerides increased
Chest X-ray normal
Clostridium test
Computerised tomogram abdomen
Corynebacterium test
Cough
Cytopenia
Diarrhoea
Symptomtext
erythematous rash; human herpes virus type 6; Hemophagocytic lymphohistiocytosis; desaturation; apnea; fever; diarrhea; vomiting; nasal congestion; cough; irritability; lethargy; Escherichia coli; Rhinovirus infection; enterovirus; tachycardia; varicella-zoster virus; vesicular rash; otitis media; papular; urticarial rash; parainfluenza virus; human metapneumovirus; This case was reported in a literature article and described the occurrence of hemophagocytic lymphohistiocytosis in a infant female patient who received Hepatitis A vaccine for prophylaxis. Co-suspect products included Hib UNK (Hib vaccine) (batch number UNK, expiry date unknown) for prophylaxis, MEASLES MUMPS RUBELLA (batch number UNK, expiry date unknown) for prophylaxis, LIVE VARICELLA VIRUS VACCINE (VARIVAX) (batch number UNK, expiry date unknown) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (batch number UNK, expiry date unknown) for prophylaxis. The patient's past medical history included viral infection (at 9 m;onths of age), fever (triggered by seasonal coronavirus HKU1), seizure (triggered by seasonal coronavirus HKU1 (non-COVID-19) infection.), influenza a virus infection (severe), pneumonia (with very high fever) and respiratory failure (treated with oseltamivir, ceftriaxone, methylprednisolone). Concurrent medical conditions included immunodeficiency (STAT2 Deficiency.). On an unknown date, the patient received Hepatitis A vaccine, Hib vaccine, MEASLES MUMPS RUBELLA, VARIVAX and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE. On an unknown date, 6 days after receiving Hepatitis A vaccine and Hib vaccine, the patient experienced hemophagocytic lymphohistiocytosis (serious criteria hospitalization, GSK medically significant and life threatening), parainfluenzae virus infection (serious criteria GSK medically significant and life threatening), fever (serious criteria hospitalization), diarrhea (serious criteria hospitalization), vomiting (serious criteria hospitalization), nasal congestion (serious criteria hospitalization), cough (serious criteria hospitalization), irritability (serious criteria hospitalization), lethargy (serious criteria hospitalization), escherichia coli infection (serious criteria hospitalization and GSK medically significant), rhinovirus infection (serious criteria hospitalization), enterovirus infection (serious criteria hospitalization and GSK medically significant), tachycardia (serious criteria hospitalization), red rash (serious criteria hospitalization), human herpesvirus 6 infection (serious criteria hospitalization), metapneumovirus infection (serious criteria GSK medically significant), oxygen saturation decreased (serious criteria hospitalization), apnea (serious criteria hospitalization and GSK medically significant), varicella zoster virus infection, vesicular rash, otitis media, papular rash and urticarial rash. The patient was treated with ceftriaxone (Ceftriaxone Sodium) and acyclovir. On an unknown date, the outcome of the hemophagocytic lymphohistiocytosis, parainfluenzae virus infection, fever, diarrhea, vomiting, nasal congestion, cough, irritability, lethargy, escherichia coli infection, rhinovirus infection, tachycardia, red rash, human herpesvirus 6 infection, metapneumovirus infection, oxygen saturation decreased, apnea, varicella zoster virus infection, vesicular rash, otitis media, papular rash and urticarial rash were recovered/resolved and the outcome of the enterovirus infection was unknown. It was unknown if the reporter considered the hemophagocytic lymphohistiocytosis, parainfluenzae virus infection, fever, diarrhea, vomiting, nasal congestion, cough, irritability, lethargy, escherichia coli infection, rhinovirus infection, enterovirus infection, tachycardia, red rash, human herpesvirus 6 infection, metapneumovirus infection, oxygen saturation decreased, apnea, varicella zoster virus infection, vesicular rash, otitis media, papular rash and urticarial rash to be related to Hepatitis A vaccine and Hib vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of hemophagocytic lymphohistiocytosis (HLH) in a female patient aged between 12-13 months old, who was vaccinated with unspecified hepatitis A vaccine and unspecified Haemophilus influenzae type B vaccine (manufacturer unknown for all) for prophylaxis. The patient was born to distantly related but healthy parents at 38 weeks of gestation. Her own medical history was remarkable for significant viral illness: at 9 months of age, the patient had a prolonged febrile illness with seizures, triggered by seasonal coronavirus HKU1 (non-COVID-19) infection. At 10 months of age, the patient experienced severe influenza A (H3) pneumonia with very high fever and progressive respiratory failure despite treatment with oseltamivir, ceftriaxone, methylprednisolone and oxygen delivered by high-flow nasal cannulae. The patient required intubation and mechanical ventilation for 3 days but recovered. Whole exome sequencing of DNA extracted from whole blood of the proband was performed commercially on the Illumina platform by Invitae Corporation. Carriage of the STAT2 variant by the proband, and all family members, was tested by Sanger sequencing of DNA isolated from whole blood by local diagnostic genetic laboratories according to standard methodologies. Suspecting a genetic aetiology in this case, whole exome sequence analysis and addition/deletion testing of 207 genes associated with primary immunodeficiency was undertaken on whole blood DNA from the proband, identifying a homozygous predicted pathogenic variant in STAT2 (c.1999C less than T [p.Arg667Ter]) and a heterozygous variant in DOCK2 [c.54-1Gless than T], the latter of unlikely clinical relevance. Sanger sequencing analysis confirmed the presence of STAT2 c.1999C less than T in the homozygous state in the proband. This variant was heterozygous in both parents and a clinically unaffected sibling, consistent with segregation of an autosomal recessive trait. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, 6 days before onset of illness, the patient received unspecified measles, mumps, and rubella (MMR) vaccine, unspecified hepatitis A vaccine, unspecified Haemophilus influenzae type B vaccine, varivax (varicella zoster virus) vaccine and 13-valent pneumococcal conjugate vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The age of vaccination was not provided but it could be 12 months or 13 months. [Six days before onset of this illness, she had been inoculated with age-appropriate vaccines (MMR, varicella zoster virus, hepatitis A, Haemophilus influenzae type B, and the 13-valent pneumococcal conjugate vaccines) despite nasal congestion and clear rhinorrhea]. On an unspecified date, 6 days after the vaccination, the patient presented with high fever, diarrhea, new onset vomiting, nasal congestion, cough, irritability, and lethargy. On admission, her physical examination only showed nasal congestion. The laboratory parameters were largely unremarkable. On day 4 (d4), the patient's laboratory parameter showed: hemoglobin was 12.1 g/dL (normal range: 10.2-14.7), hematocrit was 34.4 % (normal range: 30.8-43.7), white blood cell count was 7.6x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 4x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 2.3x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 1.2x10e9/L (normal range: 0.3-0.9), platelet count was 242x10e9/L (normal range: 150-450), AST was 66 U/L (normal range: 10.0-37.0), and ALT was 57 U/L (normal range: 5.0-30.0). On day 6 (d6), the patient's laboratory parameter showed: hemoglobin was 10.4 g/dL , hematocrit was 30.1 %, white blood cell count was 3.5x10e9/L, absolute neutrophil count was 2.2x10e9/L, absolute lymphocyte count was 1x10e9/L , absolute monocyte count was 0.2x10e9/L, platelet count was 144x10e9/L , AST was 57 U/L, ALT was 38 U/L and C-reactive protein was 76 mg/L (normal range: 0.0-8.0). On day 7 (d7), the patient's laboratory parameter showed: hemoglobin was 10.1 g/dL (normal range: 10.2-14.7), hematocrit was 29.2 % (normal range: 30.8-43.7), white blood cell count was 2.3x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 1.2x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 1x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 0.1x10e9/L (normal range: 0.3-0.9), and platelet count was 127x10e9/L (normal range: 150-450). On day 8 (d8), the patient's laboratory parameter showed: hemoglobin was 9.4 g/dL (normal range: 10.2-14.7), hematocrit was 26.9 % (normal range: 30.8-43.7), white blood cell count was 1.4x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 0.8x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 0.6x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 9.1x10e9/L (normal range: 0.3-0.9), and platelet count was 107x10e9/L (normal range: 150-450). On day 9 (d9), the patient's laboratory parameter showed: hemoglobin was 9.7 g/dL (normal range: 10.2-14.7), hematocrit was 27 % (normal range: 30.8-43.7), white blood cell count was 1.5x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 0.8x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 0.7x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 0, platelet count was 85x10e9/L, AST was 221 U/L , ALT was 100 U/L, ferritin was 1980 ng/ml, lactate dehydrogenase was 1043 U/L , and triglycerides was 289 mg/dL. On day 10 (d10), the patient's laboratory parameter showed: hemoglobin was 9.8 g/dL, hematocrit was 26.3 %, white blood cell count was 2.7x10e9/L, absolute neutrophil count was 1.1x10e9/, absolute lymphocyte count was 1.3x10e9/L, absolute monocyte count was 0.2, platelet count was 85x10e9/L, AST was 125 U/L, ALT was 94 U/L, D-dimer was more than 9999 ng/ml, fibrinogen was 71 mg/dLand soluble interleukin-2 receptor was 14740 pg/ml. On day 11 (d11), the patient's laboratory parameter showed: hemoglobin was 8.9 g/dL (normal range: 10.2-14.7), hematocrit was 25.7 %, white blood cell count was 3.5x10e9/L, absolute neutrophil count was 1.4x10e9/L, absolute lymphocyte count was 1.7x10e9/L, absolute monocyte count was 0.3, platelet count was 101x10e9/L, AST was 104 U/L, ALT was 85 U/L , and fibrinogen was 65 mg/dL. On day 12 (d12), the patient's laboratory parameter showed: hemoglobin was 8.1 g/dL , hematocrit was 24.5 % , white blood cell count was 5.6x10e9/L, absolute neutrophil count was 2.4x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 2.6x10e9/L , absolute monocyte count was 0.4, platelet count was 135x10e9/L, AST was 82 U/L, and ALT was 78 U/L. On day 15 (d15), the patient's laboratory parameter showed: hemoglobin was 8.9 g/dL, hematocrit was 27.3 %, white blood cell count was 9.1x10e9/L, absolute neutrophil count was 3.1x10e9/L, absolute lymphocyte count was 4.6x10e9/L, absolute monocyte count was 0.7, platelet count was 534x10e9/L AST was 73 U/L and ALT was 55 U/L A partial septic screen yielded more than 100,000 colony forming units/ml of Escherichia coli from urine and a positive PCR for rhinovirus/enterovirus RNA from a nasopharyngeal swab sample. Blood cultures collected on days 4 and 6 and were sterile. High fever continued despite intravenous ceftriaxone for presumed pyelonephritis. The patient was on the Paediatric ward for 2 days with continuing high fever up to 41 degree Celsius. On day 3, the patient was transferred to the Paediatric Intensive Care Unit (PICU) because of poor bilateral lower extremity perfusion that failed to improve on multiple fluid boluses. This was accompanied by persistent tachycardia, increased work of breathing, and a diffuse erythematous rash. Extensive imaging revealed no evidence of an infective focus in the renal tract (ultrasonography), chest (repeated plain x-radiography), abdomen/pelvis (contrast CT) or heart (echocardiography). Virology investigations were consistent with human herpes virus type 6 (HHV6) reactivation, based on positive blood PCR (23,500 (log 4.4) copies/ml of HHV-6 type B), positive HHV6 IgG at 1:80 (negative if less than 1:10) and negative IgM (less than 1:20) on day 6. Testing was not undertaken for MMR viruses; samples were not stored to enable retrospective testing. Persistent high fever was accompanied by worsening cytopenias, elevated triglycerides, elevated ferritin to more than or equal to 500 ng/ml, and elevated soluble interleukin-2 receptor level. These results met 5 of 8 criteria for the diagnosis of hemophagocytic lymphohistiocytosis (HLH). An attempt at bone marrow aspiration on day 9 of admission was aborted due to apnea and profound desaturation. The patient was quickly resuscitated and returned to baseline within a few hours while hematologic parameters began spontaneously improving by day 10. Fever abated after 15 days and the patient was discharged on no antibiotics. Treatment with corticosteroids and/or other immunomodulators was planned after the bone marrow aspiration, but not administered because of clinical and laboratory evidence suggestive of spontaneous HLH resolution on day 10. The diagnosis was considered to be transient HLH triggered by HHV6 infection. Immediately after hospital discharge the patient developed a diffuse vesicular rash from which varicella-zoster virus (VZV) DNA was detected by PCR. This occurred 20 days after receiving the varicella vaccine. The patient was treated with acyclovir for 5 days (20 mg/kg every 6 h) without complication. There was no attempt to ascertain by molecular testing whether VZV was the vaccine strain. However the patient had no exposure to individuals with chickenpox or shingles at home or in hospital. Based on molecular typing of rash-associated virus in post-marketing varicella vaccine surveillance in two countries, the timing of this rash was more consistent with vaccine-strain varicella (median onset 17-21 days post-vaccination) than with wild type varicella (median interval: 7-8 days post-vaccination). Thus on a balance of probabilities, the patient likely experienced dissemination of vaccine-strain VZV rather than wild type varicella. At 14 months of age, immunological work up was undertaken which revealed a polyclonal increase in IgG, protective antibody levels against measles, VZV, diphtheria, and tetanus and normal lymphocyte subset analysis. Immunophenotyping results, (patient II:3) showed total lymphocytes was 3,600 (normal range: 1600-6,700), CD3+ CD4+ was 1,008 (normal range: 1,000-4,600), CD3+ CD8+ was 756 (normal range: 400-2,100), CD3 was 1,368 (normal range: 600-2,700), CD19+ CD3- CD56+ was 216 (normal range: 200-1,200), IgG (mg/dL) was 1,170 (normal range: 300-900), IgG1 was 979 mg/dL (normal range: 160-562), IgG2 was 218 mg/dL (normal range: 24-98), IgG3 was 90 mg/dL (normal range: 17-64), IgG4 was 201 mg/dL (normal range: 0-22), IgM was 63 mg/dL (normal range: 15-70), IgA was 40 mg/dL (normal range: 40-160), IgE was 6 IU/ml (normal range: 0.62-1.6), Tetanus IgG was 4.5 IU/ml (normal range: more than 0.1), Diphtheria IgG was 0.8 IU/ml (normal range: more than 0.1), Measles IgG was more than 300 AU/ml (normal range: more than or equal to 30) and VZV IgG was 1033 Index units (normal range: more than or equal to 135). At 14 months of age, the patient had pulmonary consolidation and fever for 4 days associated with rhinovirus/enterovirus. At 15 months of age, the patient had rhinovirus/enterovirus upper respiratory tract infection with fever for 7 days. At 17 months of age, the patient had suppurative otitis media with fever. At 24 months of age, the patient had febrile parainfluenza virus type 3 upper respiratory tract infection. At 25 months of age, the patient had mixed upper respiratory tract infection with parainfluenza virus type 3, human metapneumovirus, and rhinovirus/enterovirus. At 26 months of age, the patient had upper respiratory tract infection with rhinovirus/enterovirus, with 5 days of fever up to 39.3 degree C and development of lower extremity papular and urticarial rash. Now 3 years of age, her physical growth and developmental milestones had been normal. Further live vaccines had been withheld. Prophylactic immunoglobulin therapy was not felt to be indicated. This case has been considered as serious due to hospitalization. The author commented, "This case informs understanding of the function of STAT2 in both antiviral immunity and immunoregulation. STAT2 is unique among human STATs, by virtue of both its narrow spectrum of activity (within IFN-I/III pathways) and its direct participation in both positive and negative regulation. Defining the molecular and clinical consequences of STAT2 variants provides not only clinically relevant information, but also fundamental insight into the involvement of STAT2, and IFNI/III more generally, in human immunity. It should be noted that severe IAV displays incomplete clinical penetrance in patients with mutated TLR3, IRF7, IRF9, or STAT2. This is not unexpected, since in the context of defects of pathogen defence there are multiple factors that likely contribute to variable expressivity, including: variable pathogen exposure, infecting dose, prior vaccination and compensation by adaptive immunity. Disease caused by live-attenuated parenteral viral vaccines continues to serve as a clear signal of compromised IFNAR signaling. Another novel observation in this case is the occurrence of clinical varicella following VZV immunization, which has not previously been described in STAT2 deficiency. The implication is that vaccine-strain VZV may, like other live-attenuated vaccines such as MMR, be effectively controlled by innate IFNs in vivo, consistent with a previous report of VZV dissemination in a child with IRF9 deficiency. Regrettably in our case, molecular analysis was not undertaken at the time of varicella diagnosis to definitively prove the vaccine origin of VZV, nor was material stored to enable retrospective analysis. It is also notable that dissemination of MMR virus was not identified in this case, despite a suggestive temporal association between administration of MMR and the onset of clinical disease. MMR dissemination is strongly associated with defects of IFN-I/III immunity, but is not inevitable. Again, it should be noted that in our case, blood and/or mucosal samples were not analyzed by PCR for MMR viral detection, and no clinical material was available to retrospectively test. Therefore occult MMR viral replication cannot be excluded as a potential contribution to HLH. The capacity of IFN gamma to compensate for antiviral activity in vitro might suggest a potential therapeutic role in controlling viral replication, however this approach may come at a cost of enhancing hyperinflammation. There have been clinical reports of responsiveness to IVIG or steroids, although in our case the hyperinflammation resolved without specific treatment. More work is needed to dissect the pathomechanism and inform therapeutic strategies." The author concluded, "In summary, this case significantly expands our clinical understanding of STAT2 deficiency. As the first report of life-threatening IAV in STAT2 deficiency, we can now add STAT2 to the list of genes implicated in this phenotype - a list that increasingly emphasizes the importance of IFN-I/III. We also report the first instance of disseminated vaccine-strain VZV in STAT2-deficiency, suggesting a role for innate IFNs in control of live-attenuated VZV vaccines. Finally, as only the second report of HLH in a patient with STAT2-deficiency, this case strengthens the notion that STAT2-deficient patients are vulnerable to hyperinflammation, motivating further investigation of the underlying mechanism(s) and highlighting the enduring capacity of monogenic diseases to uncover novel areas for scientific exploration."
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Intensive care
- Hospital-Tage
- -
- Labordaten
- Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:1.2 on day 7,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:0.8 on day 8,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:0.8 on day 9,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:1.1 on day 10,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:0,2 on day 10,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:1.4 on day 11,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:2.4 on day 12,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:3.1 on day 15,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: physical examination; Result Unstructured Data: (Test Result:showed nasal congestion,Unit:unknown,Normal Low:,Normal High:); Test Name: platelet count; Result Unstructured Data: (Test Result:242,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:144 on day 6,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:127 on day 7,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:107 on day 8,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:85 on day 9,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:85 on day 10,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:101 on day 11,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:135 on day 12,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:534 on day 15,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: PCR; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: PCR; Result Unstructured Data: (Test Result:varicella-zoster virus (VZV) DNA was detected,Unit:unknown,Normal Low:,Normal High:); Test Name: ferritin test; Result Unstructured Data: (Test Result:1980 on day 9,Unit:ng/mL,Normal Low:12,Normal High:207); Test Name: ultrasonography; Result Unstructured Data: (Test Result:no evidence of an infective focus in renal tract,Unit:unknown,Normal Low:,Normal High:); Test Name: VZV IgG; Result Unstructured Data: (Test Result:1033 Index units,Unit:unknown,Normal Low:,Normal High:1033 Index units); Test Name: viral test; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: white blood cell count; Result Unstructured Data: (Test Result:17.6 on day 4,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:3.5 on day 6,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:2.3 on day 7,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:1.4 on day 8,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:1.5 on day 9,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:2. 7 on day 10,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:3.5 on day 11,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:5.6 on day 12,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:9.1 on day 15,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Comments: A partial septic screen yielded more than 100,000 colony forming units/ml of Escherichia coli from urine and a positive PCR for rhinovirus/enterovirus RNA from a nasopharyngeal swab sample. Virology investigations were consistent with human herpes virus type 6 (HHV6) reactivation, based on positive blood PCR (23,500 (log 4.4) copies/ml of HHV-6 type B), positive HHV6 IgG at 1:80 (negative if less than 1:10) and negative IgM (less than 1:20) on day 6. Testing was not undertaken for MMR viruses; samples were not stored to enable retrospective testing. An attempt at bone marrow aspiration on day 9 of admission was aborted due to apnea and profound desaturation. IgG (mg/dL) was 1,170 (normal range: 300-900), IgG1 was 979 mg/dL (normal range: 160-562), IgG2 was 218 mg/dL (normal range: 24-98), IgG3 was 90 mg/dL (normal range: 17-64), IgG4 was 201 mg/dL (normal range: 0-22.At 14 months of age, immunological work up was undertaken which revealed a polyclonal increase in IgG, protective antibody levels against measles, VZV, diphtheria, and tetanus and normal lymphocyte subset analysis. Immunophenotyping results, (patient II:3) showed total lymphocytes was 3,600, CD3+ CD4+ was 1,008 , CD3+ CD8+ was 756 , CD3 was 1,368, CD19+ CD3- CD56+ was 216.; Test Name: ALT; Result Unstructured Data: (Test Result:57 on day 4,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:38 on day 6,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:100 on day 9,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:94 on day 10,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:85 on day 11,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:78 on day 12,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:55 on day 15,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: Antimicrobial susceptibility test; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: AST; Result Unstructured Data: (Test Result:66 on day 4,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:57 on day 6,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:221 on day 9,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:125 on day 10,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:104 on day 11,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:82 on day 12,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:83 on day 15,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: bone marrow aspiration; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: fibrinogen; Result Unstructured Data: (Test Result:71 on day 10,Unit:mg/dL,Normal Low:175,Normal High:375); Test Name: fibrinogen; Result Unstructured Data: (Test Result:65 on day 11,Unit:mg/dL,Normal Low:175,Normal High:375); Test Name: IgA; Test Result: 40 mg/dl; Test Name: IgE; Result Unstructured Data: (Test Result:6,Unit:iu/ml,Normal Low:,Normal High:); Test Name: IgG; Result Unstructured Data: (Test Result:1170 see text,Unit:mg/dL,Normal Low:300,Normal High:900); Test Name: IgM; Test Result: 63 mg/dl; Test Name: lactate dehydrogenase; Result Unstructured Data: (Test Result:1043 on day 9,Unit:u/L,Normal Low:190,Normal High:420); Test Name: triglycerides; Result Unstructured Data: (Test Result:289 on day 9,Unit:mg/dL,Normal Low:30,Normal High:120); Test Name: body temperature; Result Unstructured Data: (Test Result:41,Unit:degree C,Normal Low:,Normal High:); Test Name: body temperature; Result Unstructured Data: (Test Result:39.3 at the age of 26 months,Unit:degree C,Normal Low:,Normal High:); Test Name: chest x ray; Result Unstructured Data: (Test Result:no evidence of an infective focus in renal tract,Unit:unknown,Normal Low:,Normal High:); Test Name: Tetanus IgG; Result Unstructured Data: (Test Result:4.5,Unit:iu/ml,Normal Low:,Normal High:more than 0.1); Test Name: Diphtheria IgG; Result Unstructured Data: (Test Result:0.8,Unit:iu/ml,Normal Low:,Normal High:more than 0.1); Test Name: C-reactive protein; Result Unstructured Data: (Test Result:76 on day 6,Unit:unknown,Normal Low:0.0,Normal High:8.0); Test Name: D-dimer; Result Unstructured Data: (Test Result:was more than 9999 on day 10,Unit:ng/mL,Normal Low:0,Normal High:499); Test Name: hematocrit; Result Unstructured Data: (Test Result:34.4 on day 4,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:30.1 on day 6,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:29.2 on day 7,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:26.9 on day 8,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:27 on day 9,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:26.3 on day 10,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:25.7 on day 11,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:24.5 on day 12,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:27.3 on day 15,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hemoglobin; Result Unstructured Data: (Test Result:12.1 on day 4,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:10.4 on day 6,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:10.1 on day 7,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:9.4 on day 8,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:9.7 on day 9,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:9.8 on day 10,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:8.9 on day 11,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:8.1 on day 12,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:8.9 on day 15,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: interleukin; Result Unstructured Data: (Test Result:14740 on day 10,Unit:pg/mL,Normal Low:less than 1034,Normal High:); Test Name: laboratory test; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:2.3 on day 4,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1 on day 6,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1 on day 2,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:9.1 on day 8,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:0.7 on day 9,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1.7 on day 10,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1.7 on day 11,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:2.6 on day 12,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:4.6 on day 15,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: total lymphocytes; Result Unstructured Data: (Test Result:3,600 (see text),Unit:unknown,Normal Low:1600,Normal High:6700); Test Name: Measles IgG; Result Unstructured Data: (Test Result:more than 300,Unit:AU/ml(Allergen),Normal Low:,Normal High:more than or equal to 30); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:1.2 on day 4,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.2 on day 6,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.1 day 7,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.6 on day 8,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0 on day 9,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:1.4 on day 10,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.3 on day 11,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.4 on day 12,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.7 on day 15,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:4 on day 4,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:2.2 on day 6,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5)
- Aktuelle Erkrankungen
- Immunodeficiency (STAT2 Deficiency.)
- Vorgeschichte
- Medical History/Concurrent Conditions: Fever (triggered by seasonal coronavirus HKU1); Influenza A virus infection (severe); Pneumonia (with very high fever); Respiratory failure (treated with oseltamivir, ceftriaxone, methylprednisolone); Seizure (triggered by seasonal coronavirus HKU1 (non-COVID-19) infection.); Viral infection (at 9 m;onths of age)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 27.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
Alanine aminotransferase increased
Apnoea
Aspartate aminotransferase increased
Aspiration bone marrow
Bacterial test positive
Blood culture
Blood fibrinogen decreased
Blood immunoglobulin G increased
Blood immunoglobulin M normal
Blood lactate dehydrogenase increased
Blood triglycerides increased
Chest X-ray normal
Clostridium test
Computerised tomogram abdomen
Corynebacterium test
Cough
Cytopenia
Diarrhoea
Symptomtext
erythematous rash; human herpes virus type 6; Hemophagocytic lymphohistiocytosis; desaturation; apnea; fever; diarrhea; vomiting; nasal congestion; cough; irritability; lethargy; Escherichia coli; Rhinovirus infection; enterovirus; tachycardia; varicella-zoster virus; vesicular rash; otitis media; papular; urticarial rash; parainfluenza virus; human metapneumovirus; This case was reported in a literature article and described the occurrence of hemophagocytic lymphohistiocytosis in a infant female patient who received Hepatitis A vaccine for prophylaxis. Co-suspect products included Hib UNK (Hib vaccine) (batch number UNK, expiry date unknown) for prophylaxis, MEASLES MUMPS RUBELLA (batch number UNK, expiry date unknown) for prophylaxis, LIVE VARICELLA VIRUS VACCINE (VARIVAX) (batch number UNK, expiry date unknown) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (batch number UNK, expiry date unknown) for prophylaxis. The patient's past medical history included viral infection (at 9 m;onths of age), fever (triggered by seasonal coronavirus HKU1), seizure (triggered by seasonal coronavirus HKU1 (non-COVID-19) infection.), influenza a virus infection (severe), pneumonia (with very high fever) and respiratory failure (treated with oseltamivir, ceftriaxone, methylprednisolone). Concurrent medical conditions included immunodeficiency (STAT2 Deficiency.). On an unknown date, the patient received Hepatitis A vaccine, Hib vaccine, MEASLES MUMPS RUBELLA, VARIVAX and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE. On an unknown date, 6 days after receiving Hepatitis A vaccine and Hib vaccine, the patient experienced hemophagocytic lymphohistiocytosis (serious criteria hospitalization, GSK medically significant and life threatening), parainfluenzae virus infection (serious criteria GSK medically significant and life threatening), fever (serious criteria hospitalization), diarrhea (serious criteria hospitalization), vomiting (serious criteria hospitalization), nasal congestion (serious criteria hospitalization), cough (serious criteria hospitalization), irritability (serious criteria hospitalization), lethargy (serious criteria hospitalization), escherichia coli infection (serious criteria hospitalization and GSK medically significant), rhinovirus infection (serious criteria hospitalization), enterovirus infection (serious criteria hospitalization and GSK medically significant), tachycardia (serious criteria hospitalization), red rash (serious criteria hospitalization), human herpesvirus 6 infection (serious criteria hospitalization), metapneumovirus infection (serious criteria GSK medically significant), oxygen saturation decreased (serious criteria hospitalization), apnea (serious criteria hospitalization and GSK medically significant), varicella zoster virus infection, vesicular rash, otitis media, papular rash and urticarial rash. The patient was treated with ceftriaxone (Ceftriaxone Sodium) and acyclovir. On an unknown date, the outcome of the hemophagocytic lymphohistiocytosis, parainfluenzae virus infection, fever, diarrhea, vomiting, nasal congestion, cough, irritability, lethargy, escherichia coli infection, rhinovirus infection, tachycardia, red rash, human herpesvirus 6 infection, metapneumovirus infection, oxygen saturation decreased, apnea, varicella zoster virus infection, vesicular rash, otitis media, papular rash and urticarial rash were recovered/resolved and the outcome of the enterovirus infection was unknown. It was unknown if the reporter considered the hemophagocytic lymphohistiocytosis, parainfluenzae virus infection, fever, diarrhea, vomiting, nasal congestion, cough, irritability, lethargy, escherichia coli infection, rhinovirus infection, enterovirus infection, tachycardia, red rash, human herpesvirus 6 infection, metapneumovirus infection, oxygen saturation decreased, apnea, varicella zoster virus infection, vesicular rash, otitis media, papular rash and urticarial rash to be related to Hepatitis A vaccine and Hib vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of hemophagocytic lymphohistiocytosis (HLH) in a female patient aged between 12-13 months old, who was vaccinated with unspecified hepatitis A vaccine and unspecified Haemophilus influenzae type B vaccine (manufacturer unknown for all) for prophylaxis. The patient was born to distantly related but healthy parents at 38 weeks of gestation. Her own medical history was remarkable for significant viral illness: at 9 months of age, the patient had a prolonged febrile illness with seizures, triggered by seasonal coronavirus HKU1 (non-COVID-19) infection. At 10 months of age, the patient experienced severe influenza A (H3) pneumonia with very high fever and progressive respiratory failure despite treatment with oseltamivir, ceftriaxone, methylprednisolone and oxygen delivered by high-flow nasal cannulae. The patient required intubation and mechanical ventilation for 3 days but recovered. Whole exome sequencing of DNA extracted from whole blood of the proband was performed commercially on the Illumina platform by Invitae Corporation. Carriage of the STAT2 variant by the proband, and all family members, was tested by Sanger sequencing of DNA isolated from whole blood by local diagnostic genetic laboratories according to standard methodologies. Suspecting a genetic aetiology in this case, whole exome sequence analysis and addition/deletion testing of 207 genes associated with primary immunodeficiency was undertaken on whole blood DNA from the proband, identifying a homozygous predicted pathogenic variant in STAT2 (c.1999C less than T [p.Arg667Ter]) and a heterozygous variant in DOCK2 [c.54-1Gless than T], the latter of unlikely clinical relevance. Sanger sequencing analysis confirmed the presence of STAT2 c.1999C less than T in the homozygous state in the proband. This variant was heterozygous in both parents and a clinically unaffected sibling, consistent with segregation of an autosomal recessive trait. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, 6 days before onset of illness, the patient received unspecified measles, mumps, and rubella (MMR) vaccine, unspecified hepatitis A vaccine, unspecified Haemophilus influenzae type B vaccine, varivax (varicella zoster virus) vaccine and 13-valent pneumococcal conjugate vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The age of vaccination was not provided but it could be 12 months or 13 months. [Six days before onset of this illness, she had been inoculated with age-appropriate vaccines (MMR, varicella zoster virus, hepatitis A, Haemophilus influenzae type B, and the 13-valent pneumococcal conjugate vaccines) despite nasal congestion and clear rhinorrhea]. On an unspecified date, 6 days after the vaccination, the patient presented with high fever, diarrhea, new onset vomiting, nasal congestion, cough, irritability, and lethargy. On admission, her physical examination only showed nasal congestion. The laboratory parameters were largely unremarkable. On day 4 (d4), the patient's laboratory parameter showed: hemoglobin was 12.1 g/dL (normal range: 10.2-14.7), hematocrit was 34.4 % (normal range: 30.8-43.7), white blood cell count was 7.6x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 4x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 2.3x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 1.2x10e9/L (normal range: 0.3-0.9), platelet count was 242x10e9/L (normal range: 150-450), AST was 66 U/L (normal range: 10.0-37.0), and ALT was 57 U/L (normal range: 5.0-30.0). On day 6 (d6), the patient's laboratory parameter showed: hemoglobin was 10.4 g/dL , hematocrit was 30.1 %, white blood cell count was 3.5x10e9/L, absolute neutrophil count was 2.2x10e9/L, absolute lymphocyte count was 1x10e9/L , absolute monocyte count was 0.2x10e9/L, platelet count was 144x10e9/L , AST was 57 U/L, ALT was 38 U/L and C-reactive protein was 76 mg/L (normal range: 0.0-8.0). On day 7 (d7), the patient's laboratory parameter showed: hemoglobin was 10.1 g/dL (normal range: 10.2-14.7), hematocrit was 29.2 % (normal range: 30.8-43.7), white blood cell count was 2.3x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 1.2x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 1x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 0.1x10e9/L (normal range: 0.3-0.9), and platelet count was 127x10e9/L (normal range: 150-450). On day 8 (d8), the patient's laboratory parameter showed: hemoglobin was 9.4 g/dL (normal range: 10.2-14.7), hematocrit was 26.9 % (normal range: 30.8-43.7), white blood cell count was 1.4x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 0.8x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 0.6x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 9.1x10e9/L (normal range: 0.3-0.9), and platelet count was 107x10e9/L (normal range: 150-450). On day 9 (d9), the patient's laboratory parameter showed: hemoglobin was 9.7 g/dL (normal range: 10.2-14.7), hematocrit was 27 % (normal range: 30.8-43.7), white blood cell count was 1.5x10e9/L (normal range: 6.0-17.5), absolute neutrophil count was 0.8x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 0.7x10e9/L (normal range: 4.0-10.5), absolute monocyte count was 0, platelet count was 85x10e9/L, AST was 221 U/L , ALT was 100 U/L, ferritin was 1980 ng/ml, lactate dehydrogenase was 1043 U/L , and triglycerides was 289 mg/dL. On day 10 (d10), the patient's laboratory parameter showed: hemoglobin was 9.8 g/dL, hematocrit was 26.3 %, white blood cell count was 2.7x10e9/L, absolute neutrophil count was 1.1x10e9/, absolute lymphocyte count was 1.3x10e9/L, absolute monocyte count was 0.2, platelet count was 85x10e9/L, AST was 125 U/L, ALT was 94 U/L, D-dimer was more than 9999 ng/ml, fibrinogen was 71 mg/dLand soluble interleukin-2 receptor was 14740 pg/ml. On day 11 (d11), the patient's laboratory parameter showed: hemoglobin was 8.9 g/dL (normal range: 10.2-14.7), hematocrit was 25.7 %, white blood cell count was 3.5x10e9/L, absolute neutrophil count was 1.4x10e9/L, absolute lymphocyte count was 1.7x10e9/L, absolute monocyte count was 0.3, platelet count was 101x10e9/L, AST was 104 U/L, ALT was 85 U/L , and fibrinogen was 65 mg/dL. On day 12 (d12), the patient's laboratory parameter showed: hemoglobin was 8.1 g/dL , hematocrit was 24.5 % , white blood cell count was 5.6x10e9/L, absolute neutrophil count was 2.4x10e9/L (normal range: 1.5-8.5), absolute lymphocyte count was 2.6x10e9/L , absolute monocyte count was 0.4, platelet count was 135x10e9/L, AST was 82 U/L, and ALT was 78 U/L. On day 15 (d15), the patient's laboratory parameter showed: hemoglobin was 8.9 g/dL, hematocrit was 27.3 %, white blood cell count was 9.1x10e9/L, absolute neutrophil count was 3.1x10e9/L, absolute lymphocyte count was 4.6x10e9/L, absolute monocyte count was 0.7, platelet count was 534x10e9/L AST was 73 U/L and ALT was 55 U/L A partial septic screen yielded more than 100,000 colony forming units/ml of Escherichia coli from urine and a positive PCR for rhinovirus/enterovirus RNA from a nasopharyngeal swab sample. Blood cultures collected on days 4 and 6 and were sterile. High fever continued despite intravenous ceftriaxone for presumed pyelonephritis. The patient was on the Paediatric ward for 2 days with continuing high fever up to 41 degree Celsius. On day 3, the patient was transferred to the Paediatric Intensive Care Unit (PICU) because of poor bilateral lower extremity perfusion that failed to improve on multiple fluid boluses. This was accompanied by persistent tachycardia, increased work of breathing, and a diffuse erythematous rash. Extensive imaging revealed no evidence of an infective focus in the renal tract (ultrasonography), chest (repeated plain x-radiography), abdomen/pelvis (contrast CT) or heart (echocardiography). Virology investigations were consistent with human herpes virus type 6 (HHV6) reactivation, based on positive blood PCR (23,500 (log 4.4) copies/ml of HHV-6 type B), positive HHV6 IgG at 1:80 (negative if less than 1:10) and negative IgM (less than 1:20) on day 6. Testing was not undertaken for MMR viruses; samples were not stored to enable retrospective testing. Persistent high fever was accompanied by worsening cytopenias, elevated triglycerides, elevated ferritin to more than or equal to 500 ng/ml, and elevated soluble interleukin-2 receptor level. These results met 5 of 8 criteria for the diagnosis of hemophagocytic lymphohistiocytosis (HLH). An attempt at bone marrow aspiration on day 9 of admission was aborted due to apnea and profound desaturation. The patient was quickly resuscitated and returned to baseline within a few hours while hematologic parameters began spontaneously improving by day 10. Fever abated after 15 days and the patient was discharged on no antibiotics. Treatment with corticosteroids and/or other immunomodulators was planned after the bone marrow aspiration, but not administered because of clinical and laboratory evidence suggestive of spontaneous HLH resolution on day 10. The diagnosis was considered to be transient HLH triggered by HHV6 infection. Immediately after hospital discharge the patient developed a diffuse vesicular rash from which varicella-zoster virus (VZV) DNA was detected by PCR. This occurred 20 days after receiving the varicella vaccine. The patient was treated with acyclovir for 5 days (20 mg/kg every 6 h) without complication. There was no attempt to ascertain by molecular testing whether VZV was the vaccine strain. However the patient had no exposure to individuals with chickenpox or shingles at home or in hospital. Based on molecular typing of rash-associated virus in post-marketing varicella vaccine surveillance in two countries, the timing of this rash was more consistent with vaccine-strain varicella (median onset 17-21 days post-vaccination) than with wild type varicella (median interval: 7-8 days post-vaccination). Thus on a balance of probabilities, the patient likely experienced dissemination of vaccine-strain VZV rather than wild type varicella. At 14 months of age, immunological work up was undertaken which revealed a polyclonal increase in IgG, protective antibody levels against measles, VZV, diphtheria, and tetanus and normal lymphocyte subset analysis. Immunophenotyping results, (patient II:3) showed total lymphocytes was 3,600 (normal range: 1600-6,700), CD3+ CD4+ was 1,008 (normal range: 1,000-4,600), CD3+ CD8+ was 756 (normal range: 400-2,100), CD3 was 1,368 (normal range: 600-2,700), CD19+ CD3- CD56+ was 216 (normal range: 200-1,200), IgG (mg/dL) was 1,170 (normal range: 300-900), IgG1 was 979 mg/dL (normal range: 160-562), IgG2 was 218 mg/dL (normal range: 24-98), IgG3 was 90 mg/dL (normal range: 17-64), IgG4 was 201 mg/dL (normal range: 0-22), IgM was 63 mg/dL (normal range: 15-70), IgA was 40 mg/dL (normal range: 40-160), IgE was 6 IU/ml (normal range: 0.62-1.6), Tetanus IgG was 4.5 IU/ml (normal range: more than 0.1), Diphtheria IgG was 0.8 IU/ml (normal range: more than 0.1), Measles IgG was more than 300 AU/ml (normal range: more than or equal to 30) and VZV IgG was 1033 Index units (normal range: more than or equal to 135). At 14 months of age, the patient had pulmonary consolidation and fever for 4 days associated with rhinovirus/enterovirus. At 15 months of age, the patient had rhinovirus/enterovirus upper respiratory tract infection with fever for 7 days. At 17 months of age, the patient had suppurative otitis media with fever. At 24 months of age, the patient had febrile parainfluenza virus type 3 upper respiratory tract infection. At 25 months of age, the patient had mixed upper respiratory tract infection with parainfluenza virus type 3, human metapneumovirus, and rhinovirus/enterovirus. At 26 months of age, the patient had upper respiratory tract infection with rhinovirus/enterovirus, with 5 days of fever up to 39.3 degree C and development of lower extremity papular and urticarial rash. Now 3 years of age, her physical growth and developmental milestones had been normal. Further live vaccines had been withheld. Prophylactic immunoglobulin therapy was not felt to be indicated. This case has been considered as serious due to hospitalization. The author commented, "This case informs understanding of the function of STAT2 in both antiviral immunity and immunoregulation. STAT2 is unique among human STATs, by virtue of both its narrow spectrum of activity (within IFN-I/III pathways) and its direct participation in both positive and negative regulation. Defining the molecular and clinical consequences of STAT2 variants provides not only clinically relevant information, but also fundamental insight into the involvement of STAT2, and IFNI/III more generally, in human immunity. It should be noted that severe IAV displays incomplete clinical penetrance in patients with mutated TLR3, IRF7, IRF9, or STAT2. This is not unexpected, since in the context of defects of pathogen defence there are multiple factors that likely contribute to variable expressivity, including: variable pathogen exposure, infecting dose, prior vaccination and compensation by adaptive immunity. Disease caused by live-attenuated parenteral viral vaccines continues to serve as a clear signal of compromised IFNAR signaling. Another novel observation in this case is the occurrence of clinical varicella following VZV immunization, which has not previously been described in STAT2 deficiency. The implication is that vaccine-strain VZV may, like other live-attenuated vaccines such as MMR, be effectively controlled by innate IFNs in vivo, consistent with a previous report of VZV dissemination in a child with IRF9 deficiency. Regrettably in our case, molecular analysis was not undertaken at the time of varicella diagnosis to definitively prove the vaccine origin of VZV, nor was material stored to enable retrospective analysis. It is also notable that dissemination of MMR virus was not identified in this case, despite a suggestive temporal association between administration of MMR and the onset of clinical disease. MMR dissemination is strongly associated with defects of IFN-I/III immunity, but is not inevitable. Again, it should be noted that in our case, blood and/or mucosal samples were not analyzed by PCR for MMR viral detection, and no clinical material was available to retrospectively test. Therefore occult MMR viral replication cannot be excluded as a potential contribution to HLH. The capacity of IFN gamma to compensate for antiviral activity in vitro might suggest a potential therapeutic role in controlling viral replication, however this approach may come at a cost of enhancing hyperinflammation. There have been clinical reports of responsiveness to IVIG or steroids, although in our case the hyperinflammation resolved without specific treatment. More work is needed to dissect the pathomechanism and inform therapeutic strategies." The author concluded, "In summary, this case significantly expands our clinical understanding of STAT2 deficiency. As the first report of life-threatening IAV in STAT2 deficiency, we can now add STAT2 to the list of genes implicated in this phenotype - a list that increasingly emphasizes the importance of IFN-I/III. We also report the first instance of disseminated vaccine-strain VZV in STAT2-deficiency, suggesting a role for innate IFNs in control of live-attenuated VZV vaccines. Finally, as only the second report of HLH in a patient with STAT2-deficiency, this case strengthens the notion that STAT2-deficient patients are vulnerable to hyperinflammation, motivating further investigation of the underlying mechanism(s) and highlighting the enduring capacity of monogenic diseases to uncover novel areas for scientific exploration."
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Intensive care
- Hospital-Tage
- -
- Labordaten
- Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:1.2 on day 7,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:0.8 on day 8,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:0.8 on day 9,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:1.1 on day 10,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:0,2 on day 10,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:1.4 on day 11,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:2.4 on day 12,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:3.1 on day 15,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: physical examination; Result Unstructured Data: (Test Result:showed nasal congestion,Unit:unknown,Normal Low:,Normal High:); Test Name: platelet count; Result Unstructured Data: (Test Result:242,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:144 on day 6,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:127 on day 7,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:107 on day 8,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:85 on day 9,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:85 on day 10,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:101 on day 11,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:135 on day 12,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: platelet count; Result Unstructured Data: (Test Result:534 on day 15,Unit:x10e9/L,Normal Low:150,Normal High:450); Test Name: PCR; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: PCR; Result Unstructured Data: (Test Result:varicella-zoster virus (VZV) DNA was detected,Unit:unknown,Normal Low:,Normal High:); Test Name: ferritin test; Result Unstructured Data: (Test Result:1980 on day 9,Unit:ng/mL,Normal Low:12,Normal High:207); Test Name: ultrasonography; Result Unstructured Data: (Test Result:no evidence of an infective focus in renal tract,Unit:unknown,Normal Low:,Normal High:); Test Name: VZV IgG; Result Unstructured Data: (Test Result:1033 Index units,Unit:unknown,Normal Low:,Normal High:1033 Index units); Test Name: viral test; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: white blood cell count; Result Unstructured Data: (Test Result:17.6 on day 4,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:3.5 on day 6,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:2.3 on day 7,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:1.4 on day 8,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:1.5 on day 9,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:2. 7 on day 10,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:3.5 on day 11,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:5.6 on day 12,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Test Name: white blood cell count; Result Unstructured Data: (Test Result:9.1 on day 15,Unit:x10e9/L,Normal Low:6.0,Normal High:17.5); Comments: A partial septic screen yielded more than 100,000 colony forming units/ml of Escherichia coli from urine and a positive PCR for rhinovirus/enterovirus RNA from a nasopharyngeal swab sample. Virology investigations were consistent with human herpes virus type 6 (HHV6) reactivation, based on positive blood PCR (23,500 (log 4.4) copies/ml of HHV-6 type B), positive HHV6 IgG at 1:80 (negative if less than 1:10) and negative IgM (less than 1:20) on day 6. Testing was not undertaken for MMR viruses; samples were not stored to enable retrospective testing. An attempt at bone marrow aspiration on day 9 of admission was aborted due to apnea and profound desaturation. IgG (mg/dL) was 1,170 (normal range: 300-900), IgG1 was 979 mg/dL (normal range: 160-562), IgG2 was 218 mg/dL (normal range: 24-98), IgG3 was 90 mg/dL (normal range: 17-64), IgG4 was 201 mg/dL (normal range: 0-22.At 14 months of age, immunological work up was undertaken which revealed a polyclonal increase in IgG, protective antibody levels against measles, VZV, diphtheria, and tetanus and normal lymphocyte subset analysis. Immunophenotyping results, (patient II:3) showed total lymphocytes was 3,600, CD3+ CD4+ was 1,008 , CD3+ CD8+ was 756 , CD3 was 1,368, CD19+ CD3- CD56+ was 216.; Test Name: ALT; Result Unstructured Data: (Test Result:57 on day 4,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:38 on day 6,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:100 on day 9,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:94 on day 10,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:85 on day 11,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:78 on day 12,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: ALT; Result Unstructured Data: (Test Result:55 on day 15,Unit:u/L,Normal Low:5.0,Normal High:0.30); Test Name: Antimicrobial susceptibility test; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: AST; Result Unstructured Data: (Test Result:66 on day 4,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:57 on day 6,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:221 on day 9,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:125 on day 10,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:104 on day 11,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:82 on day 12,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: AST; Result Unstructured Data: (Test Result:83 on day 15,Unit:u/L,Normal Low:10.0,Normal High:37.0); Test Name: bone marrow aspiration; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Test Name: fibrinogen; Result Unstructured Data: (Test Result:71 on day 10,Unit:mg/dL,Normal Low:175,Normal High:375); Test Name: fibrinogen; Result Unstructured Data: (Test Result:65 on day 11,Unit:mg/dL,Normal Low:175,Normal High:375); Test Name: IgA; Test Result: 40 mg/dl; Test Name: IgE; Result Unstructured Data: (Test Result:6,Unit:iu/ml,Normal Low:,Normal High:); Test Name: IgG; Result Unstructured Data: (Test Result:1170 see text,Unit:mg/dL,Normal Low:300,Normal High:900); Test Name: IgM; Test Result: 63 mg/dl; Test Name: lactate dehydrogenase; Result Unstructured Data: (Test Result:1043 on day 9,Unit:u/L,Normal Low:190,Normal High:420); Test Name: triglycerides; Result Unstructured Data: (Test Result:289 on day 9,Unit:mg/dL,Normal Low:30,Normal High:120); Test Name: body temperature; Result Unstructured Data: (Test Result:41,Unit:degree C,Normal Low:,Normal High:); Test Name: body temperature; Result Unstructured Data: (Test Result:39.3 at the age of 26 months,Unit:degree C,Normal Low:,Normal High:); Test Name: chest x ray; Result Unstructured Data: (Test Result:no evidence of an infective focus in renal tract,Unit:unknown,Normal Low:,Normal High:); Test Name: Tetanus IgG; Result Unstructured Data: (Test Result:4.5,Unit:iu/ml,Normal Low:,Normal High:more than 0.1); Test Name: Diphtheria IgG; Result Unstructured Data: (Test Result:0.8,Unit:iu/ml,Normal Low:,Normal High:more than 0.1); Test Name: C-reactive protein; Result Unstructured Data: (Test Result:76 on day 6,Unit:unknown,Normal Low:0.0,Normal High:8.0); Test Name: D-dimer; Result Unstructured Data: (Test Result:was more than 9999 on day 10,Unit:ng/mL,Normal Low:0,Normal High:499); Test Name: hematocrit; Result Unstructured Data: (Test Result:34.4 on day 4,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:30.1 on day 6,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:29.2 on day 7,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:26.9 on day 8,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:27 on day 9,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:26.3 on day 10,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:25.7 on day 11,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:24.5 on day 12,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hematocrit; Result Unstructured Data: (Test Result:27.3 on day 15,Unit:%,Normal Low:30.8,Normal High:43); Test Name: hemoglobin; Result Unstructured Data: (Test Result:12.1 on day 4,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:10.4 on day 6,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:10.1 on day 7,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:9.4 on day 8,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:9.7 on day 9,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:9.8 on day 10,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:8.9 on day 11,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:8.1 on day 12,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: hemoglobin; Result Unstructured Data: (Test Result:8.9 on day 15,Unit:g/dL,Normal Low:10.2,Normal High:14.7); Test Name: interleukin; Result Unstructured Data: (Test Result:14740 on day 10,Unit:pg/mL,Normal Low:less than 1034,Normal High:); Test Name: laboratory test; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:2.3 on day 4,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1 on day 6,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1 on day 2,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:9.1 on day 8,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:0.7 on day 9,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1.7 on day 10,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:1.7 on day 11,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:2.6 on day 12,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: absolute lymphocyte count; Result Unstructured Data: (Test Result:4.6 on day 15,Unit:x10e9/L,Normal Low:4.0,Normal High:10.5); Test Name: total lymphocytes; Result Unstructured Data: (Test Result:3,600 (see text),Unit:unknown,Normal Low:1600,Normal High:6700); Test Name: Measles IgG; Result Unstructured Data: (Test Result:more than 300,Unit:AU/ml(Allergen),Normal Low:,Normal High:more than or equal to 30); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:1.2 on day 4,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.2 on day 6,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.1 day 7,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.6 on day 8,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0 on day 9,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:1.4 on day 10,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.3 on day 11,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.4 on day 12,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute monocyte count; Result Unstructured Data: (Test Result:0.7 on day 15,Unit:x10e9/L,Normal Low:0.3,Normal High:0.9); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:4 on day 4,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5); Test Name: absolute neutrophil count; Result Unstructured Data: (Test Result:2.2 on day 6,Unit:x10e9/L,Normal Low:1.5,Normal High:8.5)
- Aktuelle Erkrankungen
- Immunodeficiency (STAT2 Deficiency.)
- Vorgeschichte
- Medical History/Concurrent Conditions: Fever (triggered by seasonal coronavirus HKU1); Influenza A virus infection (severe); Pneumonia (with very high fever); Respiratory failure (treated with oseltamivir, ceftriaxone, methylprednisolone); Seizure (triggered by seasonal coronavirus HKU1 (non-COVID-19) infection.); Viral infection (at 9 m;onths of age)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 23.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Abdominal pain
Diarrhoea
Presyncope
Symptomtext
pain all over my abdomen; lbm; I almost collapsed. My daughter brought me to ER; This case was reported by a consumer via interactive digital media and described the occurrence of abdominal pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced abdominal pain, loose bowel and presyncope. Shingles vaccine was discontinued. On an unknown date, the outcome of the abdominal pain, loose bowel and presyncope were recovered/resolved. It was unknown if the reporter considered the abdominal pain, loose bowel and presyncope to be related to Shingles vaccine. Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported. The patient had first shot of the latest shingle vaccine 2 years ago from the reporting date and did not take the 2nd dose because she had the bad reaction. The patient had pain all over her abdomen and lbm (loose bowel movement). The patient was almost collapsed and her daughter brought her to ER (emergency room). The reporter mentioned that, her husband got the first and 2nd dose with no reaction at all. The follow-up would not possible as no contact details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Presyncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 20.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Gait inability
Myelitis transverse
Paralysis
Seizure
Symptomtext
almost dies becomes paralyzed for over one year; seizures; has to live with Transverse myelitis for the rest of their life; has to relearn to walk again; This case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced paralysis (serious criteria GSK medically significant and life threatening), seizure (serious criteria GSK medically significant), myelitis transverse (serious criteria GSK medically significant) and unable to walk. On an unknown date, the outcome of the paralysis and unable to walk were unknown and the outcome of the seizure and myelitis transverse were not recovered/not resolved. The reporter considered the paralysis, seizure, myelitis transverse and unable to walk to be related to Meningococcal B vaccine. Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The reporter said it was hard to forget that the patient was perfectly healthy before the vaccine got the said life saving vaccine and almost died and became paralyzed for over one year and had to relearn to walk again. The patient had seizures and had to live with transverse myelitis for the rest of their life. Also the patient would not be allowed anymore vaccines because they could kill him and patient's kids can't have them either because of the patient's reaction. The reporter commented one size does not fit all and guess you may have forgotten that.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 60,0
- Geschlecht
- F
- Eingang
- 19.04.2021
- Impfdatum
- -
- Beginn
- 01.02.2021
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Anaphylactic reaction
Dizziness
Throat tightness
Tryptase
Symptomtext
anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure; lightheadedness; throat closure; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unk and unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Latex allergy. Concurrent medical conditions included Environmental allergy (dust mites). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure) (seriousness criterion medically significant), DIZZINESS (lightheadedness) and THROAT TIGHTNESS (throat closure). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction/she had symptoms of lightheadedness and sensation of throat closure), DIZZINESS (lightheadedness) and THROAT TIGHTNESS (throat closure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Tryptase: elevated (High) Elevation persisted 3 weeks. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Before her 2nd dose, she pre-treated with Motrin and Claritin. Concomitant product use was not provided by the reporter. Treatment for the event anaphylactic reaction included EpiPen and intravenous Benadryl. Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-073832 (Patient Link).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic reaction
- Hospital-Tage
- -
- Labordaten
- Test Date: 202102; Test Name: tryptase level; Result Unstructured Data: Elevation persisted 3 weeks
- Aktuelle Erkrankungen
- Environmental allergy (dust mites)
- Vorgeschichte
- Medical History/Concurrent Conditions: Latex allergy
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- F
- Eingang
- 12.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Electric shock sensation
Injected limb mobility decreased
Symptomtext
Had an issue with mobility of injected arm for quite a while/issue with injected arm; She had a "zing" down to her fingertips; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injected limb mobility decreased and electric shock sensation. On an unknown date, the outcome of the injected limb mobility decreased was resolved with sequelae and the outcome of the electric shock sensation was unknown. The reporter considered the injected limb mobility decreased to be related to Shingrix. It was unknown if the reporter considered the electric shock sensation to be related to Shingrix. Additional details were provided as follows: The reporter was the neighbor of the patient. The age at vaccination was not reported. The patient received Shingrix and had an issue with mobility of the injected arm for quite a while and also had a zing down to her fingertips. The reporter did not consent to follow-up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Electric shock sensation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 76,0
- Geschlecht
- F
- Eingang
- 10.04.2021
- Impfdatum
- 13.03.2021
- Beginn
- 20.03.2021
- Tage bis Beginn
- 7,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: ja
ER: unbekannt
Erholt: nein
Computerised tomogram head normal
Dyspnoea
Endotracheal intubation
Guillain-Barre syndrome
Immunoglobulin therapy
Loss of consciousness
Magnetic resonance imaging head normal
Mobility decreased
Plasmapheresis
Pneumonia
Quadriplegia
Syncope
Urinary tract infection
Symptomtext
Collapsed on the floor at her home and was transported to the hospital; Diagnosed with Guillain-Barre Syndrome; Is a quadriplegic at this time / cannot move her arms or legs; Is a quadriplegic at this time / cannot move her arms or legs; Breathing difficulty; Recurrent UTI's during her hospital stay; Treated for pneumonia; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 13th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 20th March 2021, 7 days after receiving Shingrix, the patient experienced passed out (serious criteria hospitalization, disability, GSK medically significant and life threatening), guillain barre syndrome (serious criteria hospitalization, disability, GSK medically significant and life threatening), quadriplegia (serious criteria hospitalization, disability, GSK medically significant and life threatening) and mobility decreased (serious criteria hospitalization, disability, GSK medically significant and life threatening). On 2nd April 2021, the patient experienced pneumonia (serious criteria hospitalization, disability, GSK medically significant and life threatening) and urinary tract infection (serious criteria hospitalization, disability and life threatening). On an unknown date, the patient experienced difficulty breathing (serious criteria hospitalization, disability and life threatening). The patient was treated with immunoglobulins nos (Ivig) and operations and procedures (Plasmapheresis (Nos)). On an unknown date, the outcome of the passed out was unknown and the outcome of the guillain barre syndrome, quadriplegia, pneumonia and mobility decreased were not recovered/not resolved and the outcome of the difficulty breathing was recovered/resolved and the outcome of the urinary tract infection was recovering/resolving. It was unknown if the reporter considered the passed out, guillain barre syndrome, quadriplegia, pneumonia, difficulty breathing, urinary tract infection and mobility decreased to be related to Shingrix. Additional details were provided as follows: The case was reported by the patient's daughter. The patient received the Shingrix vaccine into her right arm. Exactly one week later, on 20th March 2021, the patient collapsed on the floor at her home and was transported to the hospital. Eight hours after arriving at the hospital the patient was intubated. A stroke was ruled out by magnetic resonance Imaging and computerized tomography scans. The patient was on IVIG (intravenous immunoglobulins) therapy starting 20th March 2021 for 5 days with no improvement. On 26th March 2021, the neurologist started plasmapheresis therapy and the patient started showing signs of improvement by being able to move her toes. The patient was diagnosed with Guillain-Barre Syndrome and was a quadriplegic at the time of reporting. The intubation tube was removed on 2nd April 2021 and then was able to breath on her own. The patient was treated for pneumonia on the same day. The reporter stated that her mother was able to speak and eat solid food, could also move her fingers and hold a pencil but could not move her arms or legs as of 7th April 2021. The patient also had been treated for recurrent urinary tract infections during her hospital stay. The reporter did not give permission to contact the healthcare professional, but she did give a permission to contact her on behalf of her mother. The reporter asked for the address and fax number of GlaxoSmithKline Legal Department, which was provided to her. She inquired how long it would take to hear from legal department and was informed that she would be contacted within 6 to 8 weeks.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KS
- Alter
- 54,0
- Geschlecht
- F
- Eingang
- 07.04.2021
- Impfdatum
- 25.03.2021
- Beginn
- 30.03.2021
- Tage bis Beginn
- 5,0
- Dosis
- 1
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Hypoaesthesia
Symptomtext
pt. states Sx of numbness in facial area. provider stated it was bell palsy after hearing full report of Sx.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- unk.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- HCTZ
- Allergien
- penicillin
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- -
- Geschlecht
- F
- Eingang
- 06.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Symptomtext
Bell's palsy; This case was reported by a lawyer and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingrix) for prophylaxis. The initial information received on 31 March 2021 (case now medically confirmed). The patient had Shingrix. On an unknown date patient had bell's palsy.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 05.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Herpes zoster
Pain
Paralysis
Vaccination failure
Symptomtext
had two vaccinations for shingles after having it twice / new case case of shingles; paralyzed my left arm and my left side of my back, underArm and chest; new case of shingles; pain is still excruciating; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), paralysis (serious criteria GSK medically significant), shingles and pain. The patient was treated with ambiguous medication nos (Oxy (Nos)). On an unknown date, the outcome of the vaccination failure, paralysis, shingles and pain were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the paralysis and pain to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient himself. The age at vaccination was not reported. The patient started with new case of Shingles in third week, which had all but paralyzed left arm and left side of back, underarm and chest. The pain was still excruciating and did not stop even with Oxy. The patient stated that vaccine did not prevents shingles. This case was considered as suspected vaccination failure as details regarding vaccine and an event onset were unknown at the time of reporting. The information regarding consent to follow up was not reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Shingles
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 05.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Herpes zoster
Pain
Paralysis
Vaccination failure
Symptomtext
had two vaccinations for shingles after having it twice / new case case of shingles; paralyzed my left arm and my left side of my back, underArm and chest; new case of shingles; pain is still excruciating; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), paralysis (serious criteria GSK medically significant), shingles and pain. The patient was treated with ambiguous medication nos (Oxy (Nos)). On an unknown date, the outcome of the vaccination failure, paralysis, shingles and pain were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the paralysis and pain to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient himself. The age at vaccination was not reported. The patient started with new case of Shingles in third week, which had all but paralyzed left arm and left side of back, underarm and chest. The pain was still excruciating and did not stop even with Oxy. The patient stated that vaccine did not prevents shingles. This case was considered as suspected vaccination failure as details regarding vaccine and an event onset were unknown at the time of reporting. The information regarding consent to follow up was not reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Paralysis
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Shingles
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- -
- Geschlecht
- F
- Eingang
- 05.04.2021
- Impfdatum
- 01.11.2020
- Beginn
- 01.02.2021
- Tage bis Beginn
- 92,0
- Dosis
- 2
- Route/Site
- - / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Arthralgia
Joint swelling
Magnetic resonance imaging
Pain in extremity
Peripheral swelling
Thrombosis
Symptomtext
clot; swelling and pain in foot / foot was swollen/swelling and pain in calf; swelling and pain in Ankle/ Ankle was swollen; pain in foot, calf and anckle / foot was sore; pain in foot, calf and anckle / foot was sore; This case was reported by a consumer via other and described the occurrence of clot blood in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and COVID 19 VACCINE for prophylaxis. Concomitant products included COVID 19 VACCINE. In November 2020, the patient received Shingles vaccine. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On 2nd February 2021, the patient received the 2nd dose of COVID 19 VACCINE. On 15th February 2021, between 2 and 4 months after receiving Shingles vaccine and less than 2 years after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced clot blood (serious criteria GSK medically significant). In February 2021, the patient experienced swelling of feet, ankle swelling, foot pain and pain ankle. The patient was treated with rivaroxaban (Xarelto). On an unknown date, the outcome of the clot blood was unknown and the outcome of the swelling of feet, ankle swelling, foot pain and pain ankle were recovering/resolving. It was unknown if the reporter considered the clot blood, swelling of feet, ankle swelling, foot pain and pain ankle to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The reporter was the patient's son. The age at vaccination was not reported. The patient did not have medical history and family history. The patient got the Flu vaccine every year. The patient received 2nd dose of Covid vaccine in left arm. The reporter did not have NDC, lot and expiry date for the patient's 1st and 2nd Covid vaccine. The patient was told by the nurse administering the Covid vaccine that the 2nd dose would be a little bit stronger. Either on 04th February 2021 or 05th February 2021, less than a week after receiving Covid vaccine, less than 4 months after receiving Shingles vaccine and less than 2 years after receiving Flu vaccine, the patient experienced severe swelling and pain in foot, ankle and calf. The patient first noticed left foot was swollen. The patient stated her foot was sore. The reporter did not know if it went to her ankle and then from there. Doctor advised the patient the patient had a clot and was put on Xarelto. An angiography and catheter were suggested to see if she had something closing in her. The patient would be going back in few weeks to see about the clot. The patient had never had this clotting concern before. Reporter clarified that, the patient was going to have another procedure such as angiography or catheter, but the patient had an MRI on 15th February 2021, 13 days after receiving Covid vaccine, and was diagnosed with the clot. The patient spoke with doctor who decided to put the patient on Xarelto. No information of NDC, lot and expiry date or dosing of Xarelto was provided. The reporter thought the patient's clot was weird and odd. At the time of reporting, the pain and swelling were gotten better. No further details were provided. The reporter consented to follow up. It was unknown if the reporter considered the clot blood, swelling of feet, ankle swelling, foot pain and pain ankle to be related to Covid vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Thrombosis
- Hospital-Tage
- -
- Labordaten
- Test Date: 20210215; Test Name: MRI; Result Unstructured Data: (Test Result:clot,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- COVID 19 VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- -
- Geschlecht
- F
- Eingang
- 05.04.2021
- Impfdatum
- 01.11.2020
- Beginn
- 01.02.2021
- Tage bis Beginn
- 92,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Arthralgia
Joint swelling
Magnetic resonance imaging
Pain in extremity
Peripheral swelling
Thrombosis
Symptomtext
clot; swelling and pain in foot / foot was swollen/swelling and pain in calf; swelling and pain in Ankle/ Ankle was swollen; pain in foot, calf and anckle / foot was sore; pain in foot, calf and anckle / foot was sore; This case was reported by a consumer via other and described the occurrence of clot blood in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and COVID 19 VACCINE for prophylaxis. Concomitant products included COVID 19 VACCINE. In November 2020, the patient received Shingles vaccine. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On 2nd February 2021, the patient received the 2nd dose of COVID 19 VACCINE. On 15th February 2021, between 2 and 4 months after receiving Shingles vaccine and less than 2 years after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced clot blood (serious criteria GSK medically significant). In February 2021, the patient experienced swelling of feet, ankle swelling, foot pain and pain ankle. The patient was treated with rivaroxaban (Xarelto). On an unknown date, the outcome of the clot blood was unknown and the outcome of the swelling of feet, ankle swelling, foot pain and pain ankle were recovering/resolving. It was unknown if the reporter considered the clot blood, swelling of feet, ankle swelling, foot pain and pain ankle to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The reporter was the patient's son. The age at vaccination was not reported. The patient did not have medical history and family history. The patient got the Flu vaccine every year. The patient received 2nd dose of Covid vaccine in left arm. The reporter did not have NDC, lot and expiry date for the patient's 1st and 2nd Covid vaccine. The patient was told by the nurse administering the Covid vaccine that the 2nd dose would be a little bit stronger. Either on 04th February 2021 or 05th February 2021, less than a week after receiving Covid vaccine, less than 4 months after receiving Shingles vaccine and less than 2 years after receiving Flu vaccine, the patient experienced severe swelling and pain in foot, ankle and calf. The patient first noticed left foot was swollen. The patient stated her foot was sore. The reporter did not know if it went to her ankle and then from there. Doctor advised the patient the patient had a clot and was put on Xarelto. An angiography and catheter were suggested to see if she had something closing in her. The patient would be going back in few weeks to see about the clot. The patient had never had this clotting concern before. Reporter clarified that, the patient was going to have another procedure such as angiography or catheter, but the patient had an MRI on 15th February 2021, 13 days after receiving Covid vaccine, and was diagnosed with the clot. The patient spoke with doctor who decided to put the patient on Xarelto. No information of NDC, lot and expiry date or dosing of Xarelto was provided. The reporter thought the patient's clot was weird and odd. At the time of reporting, the pain and swelling were gotten better. No further details were provided. The reporter consented to follow up. It was unknown if the reporter considered the clot blood, swelling of feet, ankle swelling, foot pain and pain ankle to be related to Covid vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Thrombosis
- Hospital-Tage
- -
- Labordaten
- Test Date: 20210215; Test Name: MRI; Result Unstructured Data: (Test Result:clot,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- COVID 19 VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- -
- Geschlecht
- F
- Eingang
- 05.04.2021
- Impfdatum
- 01.11.2020
- Beginn
- 01.02.2021
- Tage bis Beginn
- 92,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Arthralgia
Joint swelling
Magnetic resonance imaging
Pain in extremity
Peripheral swelling
Thrombosis
Symptomtext
clot; swelling and pain in foot / foot was swollen/swelling and pain in calf; swelling and pain in Ankle/ Ankle was swollen; pain in foot, calf and anckle / foot was sore; pain in foot, calf and anckle / foot was sore; This case was reported by a consumer via other and described the occurrence of clot blood in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and COVID 19 VACCINE for prophylaxis. Concomitant products included COVID 19 VACCINE. In November 2020, the patient received Shingles vaccine. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On 2nd February 2021, the patient received the 2nd dose of COVID 19 VACCINE. On 15th February 2021, between 2 and 4 months after receiving Shingles vaccine and less than 2 years after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced clot blood (serious criteria GSK medically significant). In February 2021, the patient experienced swelling of feet, ankle swelling, foot pain and pain ankle. The patient was treated with rivaroxaban (Xarelto). On an unknown date, the outcome of the clot blood was unknown and the outcome of the swelling of feet, ankle swelling, foot pain and pain ankle were recovering/resolving. It was unknown if the reporter considered the clot blood, swelling of feet, ankle swelling, foot pain and pain ankle to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The reporter was the patient's son. The age at vaccination was not reported. The patient did not have medical history and family history. The patient got the Flu vaccine every year. The patient received 2nd dose of Covid vaccine in left arm. The reporter did not have NDC, lot and expiry date for the patient's 1st and 2nd Covid vaccine. The patient was told by the nurse administering the Covid vaccine that the 2nd dose would be a little bit stronger. Either on 04th February 2021 or 05th February 2021, less than a week after receiving Covid vaccine, less than 4 months after receiving Shingles vaccine and less than 2 years after receiving Flu vaccine, the patient experienced severe swelling and pain in foot, ankle and calf. The patient first noticed left foot was swollen. The patient stated her foot was sore. The reporter did not know if it went to her ankle and then from there. Doctor advised the patient the patient had a clot and was put on Xarelto. An angiography and catheter were suggested to see if she had something closing in her. The patient would be going back in few weeks to see about the clot. The patient had never had this clotting concern before. Reporter clarified that, the patient was going to have another procedure such as angiography or catheter, but the patient had an MRI on 15th February 2021, 13 days after receiving Covid vaccine, and was diagnosed with the clot. The patient spoke with doctor who decided to put the patient on Xarelto. No information of NDC, lot and expiry date or dosing of Xarelto was provided. The reporter thought the patient's clot was weird and odd. At the time of reporting, the pain and swelling were gotten better. No further details were provided. The reporter consented to follow up. It was unknown if the reporter considered the clot blood, swelling of feet, ankle swelling, foot pain and pain ankle to be related to Covid vaccine.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Thrombosis
- Hospital-Tage
- -
- Labordaten
- Test Date: 20210215; Test Name: MRI; Result Unstructured Data: (Test Result:clot,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- COVID 19 VACCINE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- U
- Eingang
- 01.04.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- PO / MO
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
COVID-19
Coinfection
Intensive care
Rotavirus infection
Rotavirus test positive
Vaccination failure
Symptomtext
Suspected vaccination failure; Rotavirus co-infection; Covid-19 infection; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a child patient who received Rotavirus vaccine for prophylaxis. March-April 2020; 9(5): 519-522.) On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, 3 years after receiving Rotavirus vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), rotavirus infection (serious criteria hospitalization) and covid-19 (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, rotavirus infection and covid-19 were unknown. It was unknown if the reporter considered the vaccination failure, rotavirus infection and covid-19 to be related to Rotavirus vaccine. Additional details were provided as follows: This case was reported in a literature article and described the suspected vaccination failure, in a patient aged between 0-17-year-old of unspecified gender, who was vaccinated with Unspecified Rotavirus vaccine (manufacturer unknown) for prophylaxis. The patient was a part of a study that aimed to characterizes the clinical and epidemiological characteristics of COVID-19 in children in the first month of known community transmission, from 5th March 2020 to 8th April 2020. [In this study, Data were submitted on laboratory-confirmed COVID-19 cases reporting. Additionally, results of COVID-19 laboratory tests were reported duplicated by person to determine the percentage of residents who tested positive for COVID-19]. No information on patient medical or family history or concurrent condition or concomitant medication was reported. On an unknown date, the patient received unspecified rotavirus vaccine (administration site unspecified, dosage unknown, batch number not provided). The age at vaccination was not reported. On an unspecified date between 5th March 2020 to 8th April 2020, 3 years after last recorded rotavirus vaccine administration date, the patient had laboratory confirmed Covid-19 infection. The patient was hospitalized and was evaluated for viral and bacterial co-infection with multiplex respiratory pathogen panels. The patient had positive rotavirus stool antigen and was diagnosed with Rotavirus co-infection. The patient required intensive care unit (ICU) admission. The patient did not meet. [In this study, reported presence of fever and dyspnea were significantly higher in hospitalized patients compared to non-hospitalized patients. Reported presence of fever and dyspnea were significantly higher in hospitalized patients compared to non-hospitalized patients. Of those hospitalized, all either had an underlying comorbidity or co-infection detected; 7 had an underlying comorbidity and 4 had coinfection. Three had a history of chronic lung disease, 2 had a history of cardiac or congenital heart disease, 2 had Trisomy 21, and 2 had immunodeficiency (1 with immune dysfunction related to a genetic disorder; 1 with recent myelosuppressive chemotherapy). One patient who required intensive care had an underlying condition and coinfection. At the time of manuscript submission, the no COVID-19 related pediatric deaths were reported in this cohort. Among 27 patients with known travel history, 2 reported travel within the 14 days prior to symptom onset. Forty (63%) had at least 1 additional household member with laboratory-confirmed COVID-19. Among the 34 unique households with multiple laboratory-confirmed infections, the median number of laboratory-confirmed infections was 2 (range, 2-5), and 31 households had at least 1 adult who also had a laboratory-confirmed infection. For 15 households for which all necessary data to determine transmission were available, 11 were adult-to-child, 2 were child-to-child, and 2 were child-to-adult. None of the 64 pediatric patients were associated with a recognized outbreak in a congregate setting]. The case was considered as suspected vaccination failure being dosing schedule unknown. The case was considered as serious due to suspected vaccination failure. Treatment was unknown. Outcome was not reported. The authors commented "Upon review of testing volume across the city, infants represented 17.5% (183/1044) of all who were known to be tested during this time period and 13% of all pediatric patients, similar to national data. In the infants accounted for 40% of all hospitalizations and 57% of ICU hospitalizations, and many were found to have underlying comorbidities or coinfection, supporting a heightened risk perception for this group of infants or suggesting that risk perception plays a role in hospitalization. A recent research letter revealed coinfection in 24 of 116 specimens positive for SARS-CoV-2; the youngest patient in the SARS-CoV-2 coinfection group was aged 9 years. While patients with coinfections did not differ significantly in age from those infected with SARS-CoV-2 only (mean age, 46.9 years vs 51.1 years, a 4.2-year difference), no specific pediatric data on coinfection and disease severity were presented. Enhanced case investigation of all hospitalized revealed that, as with infants, underlying comorbidities and coinfection might have contributed to severe disease. Of concern was the finding that the majority of cases had multiple persons with confirmed COVID-19 living at home". The authors concluded "Enhanced case investigation of hospitalized patients revealed that underlying comorbidities and coinfection might have contributed to severe disease. Given frequency of household transmission, healthcare providers should consider alternative dispositional planning for affected families of children living with comorbidities". This article is not available for regulatory submission due to copyright restriction.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Intensive care
- Hospital-Tage
- -
- Labordaten
- Test Name: Stool analysis; Result Unstructured Data: (Test Result:positive rotavirus stool antigen,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- AZ
- Alter
- -
- Geschlecht
- F
- Eingang
- 18.03.2021
- Impfdatum
- -
- Beginn
- 13.01.2020
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Asthenia
Carpal tunnel decompression
Dysarthria
Exposure to SARS-CoV-2
Fall
Feeling hot
Guillain-Barre syndrome
Hypoaesthesia
Lymphoedema
Mobility decreased
Neurological symptom
Neuropathy peripheral
Pain
Pruritus
SARS-CoV-2 antibody test negative
SARS-CoV-2 test negative
Tremor
Vaccination complication
Symptomtext
weakness; tremors; couldn't tap the phone with her right hand; melted into chair; Shooting pain; numbness; pruritus; fell; had GBS; lymphedama; Acute onset neurological; neuropathy / couldn't raise her head or arms / slumpimg; slurring / couldn't talk; This case was reported by a other health professional via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2016-2017 season) for prophylaxis. On an unknown date, the patient received FluLaval Quadrivalent 2016-2017 season. On 13th January 2020, more than 2 years after receiving FluLaval Quadrivalent 2016-2017 season, the patient experienced neuropathy (serious criteria GSK medically significant). On an unknown date, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), lymphedema, neurological symptom, slurred speech, weakness, tremor, mobility decreased, feeling hot, shooting pain, numbness, pruritus and fall. On an unknown date, the outcome of the guillain barre syndrome, lymphedema, neurological symptom and weakness were not recovered/not resolved and the outcome of the neuropathy, tremor, mobility decreased, feeling hot, shooting pain, numbness, pruritus and fall were unknown and the outcome of the slurred speech was recovered/resolved. It was unknown if the reporter considered the guillain barre syndrome, neuropathy, lymphedema, neurological symptom, slurred speech, weakness, tremor, mobility decreased, feeling hot, shooting pain, numbness, pruritus and fall to be related to FluLaval Quadrivalent 2016-2017 season. Additional information was provided as follows: The age at vaccination was not reported. The patient lkely had GBS(guillain barre syndrome) reaction to Flulaval 2016-2017 which was acute and complicated. The patient experienced acute onset neurological and lymphedama 16 hrs post vaccination. It took 5 months for symtoms to resolve. 4th-5th January 2020, the patient experienced acute onset similar symptoms which were ongoing. The patient had a suspect exposure to Covid 19 in December 21, 2019. The symptoms began 13 days later including peripheral neuropathy all 4 limbs, severe lyphedema requiring bilateral carpal tunnel surgeries. The patient had persistent shooting pains, numbness, intense pruritus and other. In mid May 2020, the patient tested for Covid AG and AB, result was negative, unknown which manufacturer made tests. The patient stated that she suspected shouldn't get Flulaval Quad again. The patient wanted to know What was the position on She getting Covid vaccine considering severity of adverse run to Flulaval in 2016. The patient would see immunologist day after reporting 3pm MST. The patient stated that she did not want to be one of those patients who stupidly got another rabies vaccine then went on to develop an autoimmune disease. She at time of reporting hd an autoimmune disease from the flu vaccine. With regard to her experience following Flulaval, she stated she was sitting there and felt like she melted into chair. She couldn't talk. She was slurring. The patient couldn't raise her head or arms. She fell out of bed. The neuropathy went on for a while. The symptom of slurring pretty well resolved within 48 hours. The weakness still persisted occasionally. She experienced tremors. This time around she did not have tremors but the neuropathy was ridiculous. The patient finally saw a neurologist. She first talked to them in Jan 2017 and finally saw him 2 to 3 weeks before reporting. She did not know. She said it was idiopathic. She had to retire as a result and has had no paycheck since 2019. Her take was that she visited a large aquarium 4 days before Christmas in 2019. 13 to14 days later she experienced virtually that same symptoms as she had 16 hours post flu vaccine, however that time it was much more, maybe another 25 to 30 percent neurologic, the slurring and slumping. The patient couldn't tap the phone with her right hand to call her internist. She had to use her left hand. And tremors persisted. She had to quit doing surgeries. Fast forward symptoms kind of resolved in terms of fine motor things and no tremors. She had to get injections in her thumbs 6x because of the lymphedema. The reporter was not sure if it was due to exposure to the virus (COVID) or vaccine. The physicians she had been seeing have been contradicting each other. The reporter consented to follow up.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- Test Date: 202005; Test Name: Covid AB; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 202005; Test Name: Covid AG; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:)
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- -
- Geschlecht
- F
- Eingang
- 12.03.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Aphasia
Bell's palsy
Benign salivary gland neoplasm
Dysphagia
Facial nerve disorder
Multiple sclerosis
Parkinson's disease
Parkinsonism
Symptomtext
Bell's palsy; Parkinson's disease; Multiple sclerosis; secondary Parkinsonism; Aphasia; dysphasia; benign parotid neoplasm; facial nerve disorder; Down syndrome; mosaicism; This case was reported by a lawyer and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), parkinson's disease (serious criteria GSK medically significant), multiple sclerosis (serious criteria GSK medically significant), secondary parkinsonism, aphasia, dysphasia, benign parotid tumor and facial nerve disorder. The action taken with Shingrix was unknown. On an unknown date, the outcome of the bell's palsy, parkinson's disease, multiple sclerosis, secondary parkinsonism, aphasia, dysphasia, benign parotid tumor and facial nerve disorder were unknown. It was unknown if the reporter considered the bell's palsy, parkinson's disease, multiple sclerosis, secondary parkinsonism, aphasia, dysphasia, benign parotid tumor and facial nerve disorder to be related to Shingrix. The initial information was received on 24 Feb 2021 via medical record (case is now medically confirmed). On 1 Oct 2015, the patient assessed for Parkinson's disease, secondary Parkinsonism, Multiple sclerosis, Aphasia, dysphasia, Aphonia,Down's syndrome, mosaicism. The patient had benign parotid neoplasm, facial nerve disorder. Therapy for a Dysphagia evaluated. Patient has a past medical history significant for parotid tumor with parotidectomy on June 17, 2014. As per pharmacy record, on 19 August 2020, patient had used Shnigrix vial Kit.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 66,0
- Geschlecht
- M
- Eingang
- 11.03.2021
- Impfdatum
- 07.01.2019
- Beginn
- 08.01.2019
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Coordination abnormal
Dizziness
Erythema
Gait disturbance
Guillain-Barre syndrome
Immunoglobulin therapy
Influenza
Lethargy
Malaise
Muscle strength abnormal
Paraesthesia
Symptomtext
Guillain-Barre syndrome; tingling extended over his entire body; lightheaded; malaise; flu syndrome; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis. On 7th January 2019, the patient received Shingrix (intramuscular). On 8th January 2019, 1 days after receiving Shingrix, the patient experienced malaise and flu syndrome. On 11th January 2019, the patient experienced light headedness. On 14th January 2019, the patient experienced tingling. On an unknown date, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome, malaise, flu syndrome, light headedness and tingling were unknown. It was unknown if the reporter considered the guillain barre syndrome, malaise, flu syndrome, light headedness and tingling to be related to Shingrix. additional details: The initial information was received on 24 February 2021 via medical record (case is medically confirmed). The patient ingested shingrix vaccine on 07 January 2019. January 7, he had the SHINGRIX vaccine. January 8, he had malaise and a flu syndrome. January 11, he felt lightheaded and faint with tingling beginning in his toes, extending up his leg to knees. January 14, the tingling extended over his entire body. His body was red, He felt lethargic. He had no actual muscle weakness but noted decreased functional ability at the gym. The diagnosis of Guillain-Barre was made. He received IVIG in the hospital. The tingling decreased and has receded such that it is present from the knee down through his shins into his feet. He notes the occasional tingling in his hands since the onset of symptoms. His walking and balance are 80% improved. His balance and coordination are improved, and he is not dropping objects.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- -
- Geschlecht
- M
- Eingang
- 11.03.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Areflexia
Asthenia
Atrial fibrillation
Cerebral infarction
Electromyogram abnormal
Encephalomalacia
Endotracheal intubation
Feeding disorder
Guillain-Barre syndrome
Hemiparaesthesia
Hemiparesis
Hemiplegia
Immunoglobulin therapy
Intensive care
Lumbar puncture abnormal
Magnetic resonance imaging head abnormal
Mechanical ventilation
Nerve conduction studies abnormal
Symptomtext
Guillain-Barre Syndrome; Guillain-Barre Syndrome; paresthesias of the right hemibody/weakness of the right hemibody; weakness that progressed to inability to feed himself and ultimately respiratory failure 48 hours later; weakness that progressed to inability to feed himself and ultimately respiratory failure 48 hours later; areflexia; encephalomalacia; weakness that progressed to inability to feed himself and ultimately respiratory failure 48 hours later; This case was reported in a literature article and described the occurrence of guillain barre syndrome in a adult male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. Co-suspect products included Flu unspecified (Influenza vaccine) (batch number UNK, expiry date unknown) for prophylaxis. The patient's past medical history included stroke (cerebral arterystroke) and hemiplegia. On an unknown date, the patient received Influenza vaccine and Influenza vaccine. On an unknown date, less than 2 months after receiving Influenza vaccine and not applicable after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), guillain barre syndrome (serious criteria hospitalization and GSK medically significant), hemiparesthesia (serious criteria hospitalization and GSK medically significant), weakness (serious criteria hospitalization), feeding disorder (serious criteria hospitalization), respiratory failure (serious criteria hospitalization and GSK medically significant), encephalomalacia (serious criteria GSK medically significant) and areflexia (serious criteria hospitalization). The patient was treated with immunoglobulins nos (Intravenous Immunoglobulin), operations and procedures (Plasma Exchange) and operations and procedures (Plasma Exchange). Rechallenge with Influenza vaccine was positive. On an unknown date, the outcome of the guillain barre syndrome was recovered/resolved and the outcome of the guillain barre syndrome, hemiparesthesia, weakness, feeding disorder, respiratory failure, encephalomalacia and areflexia were recovering/resolving. The reporter considered the guillain barre syndrome to be related to Influenza vaccine. The reporter considered the guillain barre syndrome, hemiparesthesia, weakness, feeding disorder, respiratory failure, encephalomalacia and areflexia to be related to Influenza vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of Recurrent Guillain-Barre Syndrome (GBS), in a male patient of unspecified age, who was vaccinated with Unspecified Influenza vaccine (manufacturer unknown) for prophylaxis. No information on patient medical or family history or concurrent condition or concomitant medication was reported. On an unknown date, the patient received Unspecified Influenza vaccine (administration site or route unspecified, dose not reported, batch number not provided). The age at vaccination was not reported. On an unknown date in 2015, an unknown period after vaccination, the patient was diagnosed with GBS. The patient required 18 days of mechanical ventilation for GBS following influenza vaccination. At that time, the patient was treated with intravenous immunoglobulin (IVIG) and plasma exchange (PLEX) and made full recovery. The patient was eventually discharged to a long term acute care hospital. On an unspecified date in 2020, the patient received Unspecified Influenza vaccine (administration site or route unspecified, dose not reported, batch number not provided). The age at vaccination was not reported but it could be between 63 years or 64 years at the time of vaccination. On an unknown date, unknown period after vaccination, the patient developed paresthesias of the right hemibody and weakness that progressed to inability to feed himself and ultimately respiratory failure 48 hours later. Approximately five weeks after receiving Influenza vaccine, the patient was admitted to an outside hospital. Magnetic resonance Imaging (MRI) of the neuraxis showed the prior right MCA stroke (Fluid-attenuated inversion recovery (FLAIR) sequence showed the encephalomalacia from the right middle cerebral artery (MCA) infarct). Initial evaluation in the neurosciences intensive care unit found him to be alert. The patient's negative inspiratory pressure (NIF) was -5cm H2O (normal more than 60 cm H2O) and right upper and lower extremity power 0/5 with 0/4 reflexes. The patient was on apixaban for atrial fibrillation; thus, initial lumbar puncture was deferred while waiting for clearance of the medication. Given patient history and examination, PLEX was started. The patient received 5 sessions over a period of 8 days. Lumbar puncture was performed and showed normal cell counts with elevated protein (108 mg/dl (normal 15-45 mg/dl)). Nerve conduction study (NCS) showed prolonged motor distal latencies and severely slowed conduction velocities with reduced compound motor action potential (CMAP). Sural sensory response was normal. F waves were absent. Electromyography (EMG) showed fibrillation potentials (+1) in the right deltoid along with severely decreased recruitment in the right triceps and right tibialis anterior. These diagnostic tests were consistent with GBS and the patient was diagnosed with recurrent GBS. At the age of 64 years, the patient with history remote right middle cerebral artery (MCA) stroke and left hemiplegia was transferred from an outside hospital for ascending weakness of the right hemibody, areflexia, and acute respiratory failure requiring intubation. The patient continued to improve clinically. By day seven, right upper extremity strength had improved to 3+/5 and lower extremity at least 3-/5 in proximal muscle groups. Patellar muscle stretch reflex improved to 1+/4 but Achilles reflex remained 0/4. The patient was successfully extubated and eventually transferred to a long term acute care hospital for anticipated long-term rehabilitation and treatment. The case was considered as serious due to hospitalization. The authors commented "We report a case of recurrent GBS. In both incidences, separated by approximately five years, the influenza vaccine was given within 6 weeks prior to symptom onset. There may be an increased risk for developing GBS from pandemic influenza vaccinations (such as H1N1) compared to seasonal vaccination. Notably, the patient described in our case did not meet all of the characteristics. He was older and had a classic GBS presentation. His presentation, however, was milder than his initial GBS. There likely is a genetic or immunologic host susceptibility that plays a role in recurrent GBS. The Advisory Committee on Immunization Practices currently notes a precaution for revaccination in patients with a history of GBS after an influenza vaccine. The committee also states that influenza vaccination may outweigh the possible risk for certain patients who have a history of GBS within six weeks of influenza vaccine if they are at higher risk for severe complications from influenza. Although recurrence risk is documented to be low, clear risk factors for recurrent GBS have not been consistently defined in the literature. Further studies are needed to determine which patients are at the highest risk for recurrent GBS". The authors concluded "The risk of GBS following vaccination is low at one to three cases per million patients vaccinated. Additionally, the incidence of GBS recurrence after vaccines appears low but has not been well described. However, despite the low incidence, it is important to carefully weigh risks and benefits of revaccination."
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- Test Date: 2020; Test Name: Electromyography; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Date: 2020; Test Name: Lumbar puncture; Result Unstructured Data: (Test Result:normal cells,Unit:unknown,Normal Low:,Normal High:); Test Date: 2020; Test Name: Magnetic resonance Imaging; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Date: 2020; Test Name: Nerve conduction study; Result Unstructured Data: (Test Result:See text,Unit:unknown,Normal Low:,Normal High:); Test Date: 2020; Test Name: blood protein; Test Result: 108 mg/dl; Comments: Magnetic resonance Imaging (MRI) of the neuraxis showed the prior right MCA stroke (Fluid-attenuated inversion recovery (FLAIR) sequence showed the encephalomalacia from the right middle cerebral artery (MCA) infarct). Nerve conduction study (NCS) showed prolonged motor distal latencies and severely slowed conduction velocities with reduced compound motor action potential (CMAP). Sural sensory response was normal. F waves were absent. Electromyography (EMG) showed fibrillation potentials (+1) in the right deltoid along with severely decreased recruitment in the right triceps and right tibialis anterior. These diagnostic tests were consistent with GBS and the patient was diagnosed with recurrent GBS.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Hemiplegia; Stroke (cerebral arterystroke)
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- -
- Geschlecht
- F
- Eingang
- 11.03.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Angiotensin converting enzyme
Areflexia
Asthenia
Blood creatine phosphokinase normal
C-reactive protein normal
CSF protein increased
CSF test abnormal
CSF white blood cell count negative
Dysphagia
Dysphonia
Electrophoresis protein
Fall
Glycosylated haemoglobin normal
Guillain-Barre syndrome
HIV test negative
Hepatitis viral test negative
Magnetic resonance imaging head normal
Muscular weakness
Symptomtext
Guillain-Barre Syndrome; leg weakness/decreased strength in lower extremities; falls; dysphagia; diffuse areflexia of the biceps, triceps, brachioradialis, patellar and ankles; decreased sensation in the calves; hypophonia; This case was reported in a literature article and described the occurrence of guillain barre syndrome in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included breast cancer. On an unknown date, the patient received Shingrix. On an unknown date, 9 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (serious criteria hospitalization), fall (serious criteria hospitalization), dysphagia (serious criteria hospitalization), areflexia (serious criteria hospitalization), loss of sensation (serious criteria hospitalization) and hypophonia (serious criteria hospitalization). The patient was treated with immunoglobulins nos (Ivig). On an unknown date, the outcome of the guillain barre syndrome, fall, loss of sensation and hypophonia were unknown and the outcome of the lower extremities weakness of and areflexia were recovering/resolving and the outcome of the dysphagia was recovered/resolved. The reporter considered the guillain barre syndrome, lower extremities weakness of, fall, dysphagia, areflexia, loss of sensation and hypophonia to be related to Shingrix. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of Guillain-Barre Syndrome (GBS), in a female patient aged 66-year-old, who was vaccinated with Shingrix (GlaxoSmithKline) for prophylaxis. The patient was an old physically active woman with a history of breast cancer in remission. No information on patient family history or concurrent conditions or concomitant medication was reported. On an unknown date, the patient received Shingrix (administration route or site not reported; dosage unknown, batch number not provided). The age at vaccination was not reported but it could be between 65 years or 66 years at the time of vaccination. On an unknown date, 9 days after vaccination, the patient experienced sudden onset of leg weakness. On an unknown date, the patient presented with a sudden onset of leg weakness, which spread proximally over two days resulting in 3 falls and a mild associated dysphagia. She denied recent travel or sick contacts. The patient neurological exam revealed decreased strength in lower extremities (4/5 hip flexion, 4/5 knee extensors/flexors), decreased sensation in the calves and diffuse areflexia of the biceps, triceps, brachioradialis, patellar and ankles. Human Immunodeficiency Virus (HIV), Rapid Plasma Reagin (RPR) and a viral hepatitis panel were non-reactive. glycosylated hemoglobin (A1c), creatine kinase (CK), B12, CK, serum protein electrophoresis (SPEP), angiotensin- converting enzyme (ACE), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) were all within normal limits. A contrast magnetic resonance imaging (MRI) of the complete spine and MRI brain were without acute pathology. Analysis of her cerebro-spinal fluid (CSF) revealed cytoalbuminologic dissociation concerning for GBS: protein-53.2 mg/dL, WBCs 1. Therapy with IVIG was initiated but on the second day, the patient's weakness progressed to the upper extremities, her dysphagia worsened and hypophonia developed. The patient was transferred to the intensive care unit. With completion of 5 days of IVIG, the NIF normalized, dysphagia resolved, mild improvement was seen in hip flexion strength bilaterally and her upper extremity strength remained stable. The patient was ultimately discharged to an acute rehabilitation facility. The case was considered as serious due to hospitalization. The authors commented "In 2004, causality was confirmed between the 1976 influenza vaccine and GBS. The association between GBS and other vaccines remains anecdotal due to a paucity of available data. The adjuvant recombinant zoster vaccine (RZV) was first marketed in October 2017 for the prevention of herpes zoster in individuals aged more than or equal to50 years. A pooled analysis of two large randomized trials in 2019 did not show an increased risk of developing a new potential immunemediated disease (pIMD) or exacerbation of an underlying pIMD in RZV recipients aged more than equal to 50. Our patient's GBS onset developed 9 days after vaccine administration. To our knowledge, there is only one other reported case of Zoster vaccination associated GBS in the literature.". The authors concluded "Although there is no established connection between RZV and GBS, our case should alert clinicians to recognize this serious adverse effect and promptly advise their patients for hospitalization. As more post vaccination GBS cases are recognized and reported worldwide, providers will be more primed to discuss this potential side effect with their patients prior to vaccination". Upon SERM review on 1 MARCH 2021,following correction has been performed Breast cancer was updated as medical history instead of concurrent condition as it is in healed state.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- -
- Labordaten
- Test Name: angiotensin- converting enzyme; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: creatine kinase; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: C-reactive protein; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: CSF protein; Test Result: 53.2 mg/dl; Test Name: cerebrospinal fluid analysis; Result Unstructured Data: (Test Result:revealed cytoalbuminologic dissociation,Unit:unknown,Normal Low:,Normal High:); Test Name: CSF WBC; Result Unstructured Data: (Test Result:1,Unit:unknown,Normal Low:,Normal High:); Test Name: serum protein electrophoresis; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: glycosylated hemoglobin; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: viral hepatitis panel; Result Unstructured Data: (Test Result:non reactive,Unit:unknown,Normal Low:,Normal High:); Test Name: Human Immunodeficiency Virus test; Result Unstructured Data: (Test Result:non reactive,Unit:unknown,Normal Low:,Normal High:); Test Name: magnetic resonance imaging spine and MRI brain; Result Unstructured Data: (Test Result:without acute pathology,Unit:unknown,Normal Low:,Normal High:); Test Name: erythrocyte sedimentation rate; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: Rapid Plasma Reagin; Result Unstructured Data: (Test Result:non reactive,Unit:unknown,Normal Low:,Normal High:); Comments: On an unspecified date, Lab test were performed. The patient neurological exam revealed decreased strength in lower extremities (4/5 hip flexion, 4/5 knee extensors/flexors), decreased sensation in the calves and diffuse areflexia of the biceps, triceps, brachioradialis, patellar and ankles.
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Medical History/Concurrent Conditions: Breast cancer
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- FL
- Alter
- -
- Geschlecht
- U
- Eingang
- 11.03.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- IM / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Bell's palsy
Symptomtext
Bell's Palsy; This case was reported by a lawyer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix (intravenous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced Bell's palsy. The action taken with Shingrix was unknown. On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to Shingrix. Additional information:The patient had Shingrix and experienced Bell's palsy.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Bell's palsy
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -