VAERS Reports 3454N

VAERS 946972

GLAXOSMITHKLINE BIOLOGICALS · ZOSTER (SHINGRIX) · Charge 3454N

kritisch

Staat: MI
Alter: 93,0
Geschlecht: M
Eingang: 15.01.2021
Impfdatum: 08.10.2020
Beginn: 09.10.2020
Tage bis Beginn: 1,0
Dosis: 1
Route/Site: IM / -

Tod: ja Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Cough Death Hyperhidrosis Nausea Respiratory arrest Vomiting

Symptomtext

Patient received first dose of Shingrix and annual flu vaccine on 10/8/20. Patient's home care therapist called on 10/9/20 that patient developed nausea, vomiting, sweating, and cough after receiving the vaccines. Called patient later that day for follow-up and his wife reported he was feeling better, but was not planning to get the second dose of Shingrix in the future. Did not receive further communication regarding the patient, until on 12/24/20 spoke to patient's wife who reports the patient expired on 10/10/20. He went to bed the evening of 10/9/20, she woke up at 1:30AM on 10/10/20 and heard the patient take two deep breaths and then he stopped breathing. She called the funeral home who had her call the police and the medical examiner was notified.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Death
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: None
Vorgeschichte: Benign Prostatic Hypertrophy, Overactive Bladder, Diastolic Congestive Heart Failure, Diabetes Mellitus, Essential Hypertension, Gastroesophageal Reflux Disorder, Generalized Anxiety Disorder, Gout, Hyperlipidemia, Obstructive Sleep Apnea, Osteoarthritis, Paroxysmal Atrial Fibrillation, Cervical Spine Stenosis, Lumbar Spine Stenosis
Andere Medikamente: Fluoxetine, Allopurinol, Omeprazole, Nadolol, Furosemide, Finasteride, Ramipril, Atorvastatin, Hydralazine, Metformin, Tamsulosin
Allergien: Mirtazapine, Myrbetriq, Penicillin
Vorherige Impfungen: -

VAERS 2203408

GLAXOSMITHKLINE BIOLOGICALS · ZOSTER (SHINGRIX) · Charge 3454N

mild

Staat: VT
Alter: 60,0
Geschlecht: M
Eingang: 29.03.2022
Impfdatum: 02.08.2021
Beginn: 01.08.2021
Tage bis Beginn: -
Dosis: 1
Route/Site: IM / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Dysphagia Immediate post-injection reaction Injection site urticaria Malaise Nausea Oesophageal oedema Pharyngeal oedema Weight decreased

Symptomtext

Have edema in his throat/Have swelling his throat; Have edema in his esophagus/Have swelling esophagus; he has not been able to eat or drink normally; Not been able to eat or drink normally has lost 40 pound; Developed a welt at the injection site the size of a baseball; Feeling very nauseous; Feeling sick; This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 3454N, expiry date 23rd August 2022) for prophylaxis. Concurrent medical conditions included tooth infection. Concomitant products included amoxicillin + clavulanic acid (Augmentin). On 2nd August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd August 2021, immediately after receiving Shingrix, the patient experienced injection site wheal, nausea and feeling unwell. In August 2021, the patient experienced throat edema, esophageal edema, swallowing difficult and weight loss. On an unknown date, the outcome of the injection site wheal, nausea and feeling unwell were recovered/resolved and the outcome of the throat edema and esophageal edema were not recovered/not resolved and the outcome of the swallowing difficult and weight loss were unknown. It was unknown if the reporter considered the injection site wheal, nausea, feeling unwell, throat edema, esophageal edema, swallowing difficult and weight loss to be related to Shingrix. Additional details were provided as follows: The case was reported by the patient. The patient received Shingrix in his left arm. Soon after receiving the injection, he reported feeling very nauseous and sick, and he developed a welt at the injection site the size of a baseball. These symptoms last 3 days before resolving. The reporter then stated that about one week after the vaccine, he began to had swelling and edema in his throat and esophagus and described his throat as a riverbed of rocks. He stated he had not been able to eat or drink normally since then and has lost 40 pounds. The patient had an appointment for a GI (gastro-intestinal) exam later this week. The reporter stated at the time of the Shingrix vaccine he was also suffering from a tooth infection and was being treated with the antibiotic Augmentin. The patient reported the swelling of his throat and esophagus were the worst from the months of October through December and are still unresolved. The patient stated that he would not be taking the second dose of Shingrix due to the adverse events experienced. The reporter consented to follow up.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site urticaria
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Tooth infection
Vorgeschichte: -
Andere Medikamente: AUGMENTIN
Allergien: -
Vorherige Impfungen: -

VAERS 920844

GLAXOSMITHKLINE BIOLOGICALS · ZOSTER (SHINGRIX) · Charge 3454N

mild

Staat: PA
Alter: 64,0
Geschlecht: F
Eingang: 02.01.2021
Impfdatum: 06.11.2020
Beginn: 13.11.2020
Tage bis Beginn: 7,0
Dosis: UNK
Route/Site: IM / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: unbekannt Erholt: unbekannt

Aphasia Fatigue Feeling abnormal Hemiparesis Herpes zoster meningitis Meningitis viral Rash

Symptomtext

Healthy 64 year old received her initial dose of shingrix vaccine on 11/06/2020 in our primary care office. 1 week later, she began to feel symptoms of fatigue and brain fog. 1 week after onset of symptoms, she developed aphasia and hemiparesis of her right side. She was hospitalized and after a detailed work up, was diagnosed with a viral meningitis, determined to be likely a zoster meningitis, and developed a rash the following week. She is now on IV medication daily acyclovir and rocephin by PICC and following with infectious disease and only ongoing symptom is fatigue.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Fatigue
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: Pmhx included hypertension, hyperlipidemia, and benign thyroid nodules. NKDA. No history of previous vaccine reactions. No tobacco use history.
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1966590

GLAXOSMITHKLINE BIOLOGICALS · ZOSTER (SHINGRIX) · Charge 3454n

gering

Staat: PA
Alter: -
Geschlecht: F
Eingang: 21.12.2021
Impfdatum: 01.10.2020
Beginn: 26.12.2020
Tage bis Beginn: 86,0
Dosis: 2
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Herpes zoster Vaccination failure

Symptomtext

Shingles after completing the schedule/ Suspected vaccination failure; Shingles; This case was reported by a pharmacist and described the occurrence of suspected vaccination failure in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number 3454n, expiry date 23rd August 2022) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In October 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On 26th December 2020, between 1 and 3 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. 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 Shingrix and Shingrix. Additional details were provided are as follows: The age at vaccination was not reported. The patient had received immunosuppressive therapy in November 2020. The health care professional reported that the patient suffered a case of shingles after completing the schedule of Shingrix vaccine. No further events were reported. The reporter agreed to be contacted for follow-up. This case was considered as suspected vaccination failure since the detail regarding the laboratory confirmation for shingles was not reported.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Herpes zoster
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -