- Staat
- ME
- Alter
- 64,0
- Geschlecht
- M
- Eingang
- 18.10.2022
- Impfdatum
- 19.09.2022
- Beginn
- 25.09.2022
- Tage bis Beginn
- 6,0
- Dosis
- UNK
- Route/Site
- IM / UN
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: ja
ER: unbekannt
Erholt: nein
Abdominal discomfort
Diarrhoea
Electromyogram abnormal
Guillain-Barre syndrome
Hypoaesthesia
Hypoaesthesia oral
Immunoglobulin therapy
Lumbar puncture
Magnetic resonance imaging head
Magnetic resonance imaging spinal
Muscular weakness
Paraesthesia
Pyrexia
Symptomtext
Stomach upset, diarrhea feverish started 9/25/2022. Developed numbness, tingling in fingertips and feet on 9/26/2022. Symptoms worsened w numbness in mouth on 9/27 and weakness in lower legs w progressive numbness 9/28/22. Evaluation by Dr of Neurology 9/29 w admission to hospital and EMG confirmed dx of Guillain Barre Syndrome. Weakness worsened despite treatment w IVIG and pt was transferred to Medical Center for further treatment.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Guillain-Barre syndrome
- Hospital-Tage
- 19,0
- Labordaten
- EMG, Spinal tap, Brain and spine MRI
- Aktuelle Erkrankungen
- presumed tick borne illness w myalgias, fever 08/25/2022 with reported tick bite one month prior. Started on Doxycycline 100mg BID 08/25/2022 w improvement in sx within 3 days. Pt completed 14 day course of Doxy w resolution of symptoms.
- Vorgeschichte
- Obesity, Hypertension, Hyperlipidemia, Insulin resistence, GERD, Osteoarthritis, Nephrolithiasis, B12 deficiency
- Andere Medikamente
- Crestor, Aspirin, Lisinopril, Tamsulosin, Zetia, Mutlivitamin
- Allergien
- Some statin medication causes myalgias Vicodin causes sedation
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 02.06.2021
- Impfdatum
- 02.06.2021
- Beginn
- 02.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- 6
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Arthralgia
Fall
Fatigue
Head injury
Headache
Pain in extremity
Pallor
Syncope
Symptomtext
Administered vaccines at 0947. Observed client after vaccination. Client alert, oriented x 4, and responding appropriately to questions. Skin warm, dry, and pink. Asked client if lightheaded or dizzy; client denied and stated felt fine. Mother asked if could go over to the administrative section of the department for business. Nurse - seeing no issues - allowed. At 0950, while client and mother in the lobby, client suddenly fainted and fell from standing to the floor. Administrative secretary called for nursing support. Client returned to consciousness without intervention as nurse arrived to scene. Client alert and oriented x 4. Client's color became pale while lying. Elevated client's legs on chair while client lying on back on floor. Water and graham crackers provided, able to tolerate. Asked client if hit head; client doesn't remember falling but stated posterior of head hurt as well as intermittent sharp pain in right posterior shoulder and medial left arm from mid-arm to upper forearm focused primarily in crook of elbow; rated pain 4/10. Applied ice to the back of the head. Asked mother if client had passed out from vaccines before; mother stated client never fainted from vaccination before but has had 3 prior syncopal episodes. Mother stated mother and client's brother also are prone to syncopal episodes. Asked mother and client if client had breakfast before coming. Mother stated client had a banana on the way to the immunization clinic, did not have any other intake this morning. Mother also stated that client exercised this morning by riding bicycle. At 0956, checked vitals. Heart rate 89, automatic wrist blood pressure right arm 84/45 lying, manual blood pressure right arm 100/50 lying, O2 SAT 98% room air, eyes PERRLA bilaterally. Skin color pink, warm and dry. Client attempted to sit up but color paled from face and unable to tolerate so returned to lying with legs elevated. Skin color returned to pink. At 0959, client wanted to try sitting, moved to sitting. Color paled from face and unable to tolerate so returned to lying with legs elevated. Skin color returned to pink. At 1002, client wanted to try sitting, moved to sitting. Skin color remained pink and client able to tolerate. Client stated feeling tired and posterior head as only location of pain. At 1006, assisted client to standing, able to tolerate. Nurse and mother escort client from clinic lobby to private vehicle. Instructed mother to not have client fall asleep until evaluated by physician.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- History of three syncopal episodes not correlated with vaccination
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 29.04.2021
- Impfdatum
- 28.04.2021
- Beginn
- 28.04.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Syncope
Symptomtext
Syncope after second vaccine was administered
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- N/A
- Vorgeschichte
- N/A
- Andere Medikamente
- N/A
- Allergien
- N/A
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 33,0
- Geschlecht
- M
- Eingang
- 25.06.2021
- Impfdatum
- 25.06.2021
- Beginn
- 25.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Chest discomfort
Chest pain
Hypoaesthesia
Investigation normal
Painful respiration
Symptomtext
c/o having numbness to right forearm , mid chest pressure, chest pain, and increase pain with respirations
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Chest pain
- Hospital-Tage
- -
- Labordaten
- Employee was referred to ED 6/25/21 and discharged same day. He stated they told him all his tests were normal.
- Aktuelle Erkrankungen
- Denies
- Vorgeschichte
- Denies
- Andere Medikamente
- None
- Allergien
- Strawberries
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 23.05.2022
- Impfdatum
- 14.05.2021
- Beginn
- 15.05.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: ja
Hospital: ja
Disable: ja
ER: ja
Erholt: nein
Blood glucose increased
Diabetic ketoacidosis
Fatigue
Glucose urine present
Glycosylated haemoglobin increased
Type 1 diabetes mellitus
Vomiting
Symptomtext
Patient received his two vaccines, 1 TDAP (ADACEL) and Menactra (MCV4P) on 5-14-2021. This was on a Friday after school. He had just tested NEGATIVE for glucose and ketones minutes PRIOR to the 2 vaccines. The next day walking around the house asking us to feel his pulse under his chin and what a heart attack feels like. 16 days from shots he was throwing up, tired, etc. 43 days from shots he was in DKA in an ambulance with a 12.4 A1C. Spent 3 days in hospital. Diagnosed a Type 1 Diabetic.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- 3,0
- Labordaten
- Fresh urine test done minutes PRIOR to both vaccines and he was 100% negative for everything including glucose and ketones he was a 12.4 A1C 6 weeks later he would have had an average 309 blood glucose, therefore, testing a +3 on the glucose urine test but he was 100% negative for both glucose and ketones minutes PRIOR to the vaccines.
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- DC
- Alter
- 7,0
- Geschlecht
- M
- Eingang
- 19.10.2021
- Impfdatum
- 25.08.2021
- Beginn
- 27.08.2021
- Tage bis Beginn
- 2,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Rash
Rash papular
Skin hypopigmentation
Vaccination site rash
Symptomtext
Pt with rash to right arm appearing 2 days post vaccination. Rash started just below vaccine site and spread down arm towards hand. Eventually spread to trunk and back. Trunk and back rashes have since resolved, but rash to arm persists 2 months later. Rash appears raised with some hypopigmentation. Pt seen via virtual visit, and scheduled to be seen in person to better visualize and diagnose rash. No treatments given at this time.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 06.08.2021
- Impfdatum
- 28.07.2021
- Beginn
- 29.07.2021
- Tage bis Beginn
- 1,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dysphonia
Lip swelling
Oropharyngeal discomfort
Rash
Tongue pruritus
Symptomtext
Rash on face and neck, swollen lips, itchy tongue, voice alteration and throat discomfort.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- RI
- Alter
- 76,0
- Geschlecht
- F
- Eingang
- 25.06.2021
- Impfdatum
- 18.06.2021
- Beginn
- 23.06.2021
- Tage bis Beginn
- 5,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site discomfort
Injection site erythema
Injection site pain
Injection site pruritus
Injection site warmth
Symptomtext
Patient received Tdap on 6/18/21. Patient called our office on 6/24/21, reporting five days after receiving the vaccine she developed increased pruritus and redness to her left arm that has not resolved. Pt states erythema has expanded to the back of her upper arm, does not go below her elbow. Patient applied Benadryl ointment and has been taking Ibuprofen. She states site is warm to touch and throbs at times. She states site is sensitive, especially when her sleeve touches the area; feels similar to a sunburn. Pt reports full ROM in her arm. She denies any fevers, tongue swelling, difficulty swallowing, or sob. Pt was seen in our office for cellulitis and prescribed cephalexin and prednisone.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site discomfort
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- DM Type 1, Htn, Osteoporosis, Hx of Breast Cancer
- Andere Medikamente
- atorvastatin, irbesartan, metformin, methimazole, Novolog Mix
- Allergien
- codeine, penicillin, latex
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 56,0
- Geschlecht
- F
- Eingang
- 17.06.2021
- Impfdatum
- 16.06.2021
- Beginn
- 16.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Injection site swelling
Lymphadenopathy
Swelling
Symptomtext
Patient reported swelling at injection site and swelling extending up to left side of her neck. Patient also reported a small movable lumps located next to her left collarbone. Patients reaction was reported on the VAERS website. Patient will be coming in for a follow up visit with provider if reaction is not resolved.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site swelling
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- TYPE 2 DIABETES ESSENTIAL HYPERTENSION CHRONIC KNEE PAIN
- Andere Medikamente
- ATORVASTSTIN 10 MG BUSPIRONE 5 MG JARDIANCE 25 MG LISINOPRIL 10 MG MELOXICAM 15 MG METFORRMIN 1,000 MG OMEPRAZOLE 40 MG TRAMADOL 50 MG TRAZODONE 50 MG
- Allergien
- NO KNOWN ALLERGIES
- Vorherige Impfungen
- -
- Staat
- ID
- Alter
- 59,0
- Geschlecht
- F
- Eingang
- 09.06.2021
- Impfdatum
- 19.05.2021
- Beginn
- 24.05.2021
- Tage bis Beginn
- 5,0
- Dosis
- N/A
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Injection site pain
Joint noise
Joint range of motion decreased
Pain
Pain in extremity
Symptomtext
Patient with left shoulder, arm and torso pain with limited ROM and feeling of crepitus in joint. Treated with NSAIDS with minimal relief, prednisone with some improvement and now referral placed for PT and accupuncture.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Injection site pain
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- Menopause Hypothyroid Scoliosis Low back pain Varicose Veins
- Andere Medikamente
- Progesterone compounded Multivitamin Imitrex prn Armour thyroid Compounded Estradiol, estriol Other supplments
- Allergien
- None known
- Vorherige Impfungen
- -
- Staat
- MN
- Alter
- 11,0
- Geschlecht
- F
- Eingang
- 24.05.2021
- Impfdatum
- 24.05.2021
- Beginn
- 24.05.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Dizziness
Hyperhidrosis
Pain in extremity
Pallor
Symptomtext
Patient received all three vaccines. We remained in the room for approximately 3-5 minutes after the vaccines were complete visiting and finishing up questions. There were no signs of distress, lightheadedness or dizziness. Patient left the room and stated to mom that her legs hurt and she was dizzy. Mom was able to get patient to the floor safely by sliding her down the wall and laying her on the floor. Mom stated that the patient did not hit anything on her way down nor when she was laid out on the floor. A pillow was brought to put under the patients head and mom put patients feet above her heart. I grabbed juice for the patient and we let her lay for a few minutes. The team manager Dr. was brought to the patient and we then moved her to a patient room out of the hallway to assess further. she remained with us for another 15 minutes and was able to complete a juice while sitting with mom. She had stopped sweating, had color back to her face and no longer felt dizzy or lightheaded so the patient and mom where let go from the office.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dizziness
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- Attention Deficit Disorder Combined Type
- Andere Medikamente
- Tylenol, Vitamin C oral, atropine 0.1mg/ml in BSS ophthalmic solution, Flonase, Ibuprofen, levothyroxine, loratadine, Ritalin LA, multivitamin with iron, Patanol 0.1% ophthalmic solution, OCEAN nasal spray. (none of these were taken at the
- Allergien
- Amoxicillin, Pollen Extracts
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 50,0
- Geschlecht
- F
- Eingang
- 02.05.2021
- Impfdatum
- 28.04.2021
- Beginn
- 28.04.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- SYR / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Chills
Injection site nodule
Injection site swelling
Pyrexia
Symptomtext
golf ball sized knot, fevers and chills
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Chills
- Hospital-Tage
- -
- Labordaten
- n/a
- Aktuelle Erkrankungen
- no acute illnesses
- Vorgeschichte
- low back pain elevated hemoglobin smoker
- Andere Medikamente
- Protonix Robaxin Neurontin
- Allergien
- amoxicillin PCN propoxyphene tramadol augmentin
- Vorherige Impfungen
- -
- Staat
- NC
- Alter
- 27,0
- Geschlecht
- M
- Eingang
- 28.06.2023
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Medication error
No adverse event
Symptomtext
expired vaccine given to a patient, with no reported adverse event; Initial information received on 23-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 27 years old male patient who used expired Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] vaccine, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot U6900AA, Expiry date: 18-Nov-2022) via unknown route in unknown administration site for prophylactic vaccination (immunization). On an unknown date the patient used expired Diphtheria-2/Tetanus/5 Ac Pertussis vaccine, with no reported adverse event (expired product administered) (latency: same day). It was reported, "Nurse called to inquire if there is an extension of expiration date for vaccines. She also wanted to know if an expired vaccine given to a patient is valid and if not when this should repeated. Nurse does not want to provide email address at the time of call. Please see transfer screen for details. Product used : Used." Action taken with Diphtheria, Tetanus and Acellular Pertussis Vaccine was not applicable. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NY
- Alter
- 11,0
- Geschlecht
- M
- Eingang
- 17.01.2023
- Impfdatum
- 12.01.2023
- Beginn
- 12.01.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Expired product administered
Medication error
No adverse event
Symptomtext
Received a dose of Adacel in the left deltoid, dose that was administered was expired with no reported adverse event; Initial information was received on 12-Jan-2023 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 11 years old male patient who received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in the left deltoid, dose that was administered was expired with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI). On 12-Jan-2023, the patient received Total 0.5 ml once dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6900AA, route, strength, formulation: Unknown) in the left deltoid for Immunization (Immunisation) that was administered was expired on 18-Nov-2022 with no reported adverse event (expired product administered) (Unknown latency) It was reported that " Today about 20 minutes ago a patient received a dose of Adacel in the left deltoid. The dose that was administered was expired on 18-Nov-2022. Treatment The caller stated they would plan to call the patient back as soon as possible to repeat the dose." No lab data reported. Action taken: not applicable. Outcome: Unknown for the event received a dose of adacel in the left deltoid, dose that was administered was expired with no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 17,0
- Geschlecht
- M
- Eingang
- 20.01.2022
- Impfdatum
- 18.01.2022
- Beginn
- 18.01.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
MMR II Lot T001213 Expiration date 1/12/2022 was administered on 1/18/2022. There were no adverse effects to patient. I contacted Merck & Company to discuss with representative if a re-vaccination was necessary. Merck stated that as long as there were no temperature excursions and with the vaccine storage, they stand behind their product with in-house data to still be potent beyond the 6 days usage (after expiration date).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- N/A
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- 37,0
- Geschlecht
- M
- Eingang
- 19.01.2022
- Impfdatum
- 18.01.2022
- Beginn
- 18.01.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Symptomtext
No symptoms or reactions
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- Lorazepam, Neurontin, Suboxone, Narcan, Zyprexa, Paxil, Buspirone.
- Allergien
- Codeine, Cefaclor
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- -
- Geschlecht
- U
- Eingang
- 10.01.2022
- Impfdatum
- -
- Beginn
- 03.01.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
The temperature range was from 37.5F to 48.2F; Initial information received on 03-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient with unknown demographics whos temperature range was from 37.5f to 48.2f while receiving vaccines DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], HIB (PRP/T) VACCINE [ActHIB], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and IPV (VERO) [IPOL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect IPV (VERO) lot U1C571M via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5774BA via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ414AAA via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UJ583ABA via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U7191AA via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6900AA via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot C5779AA via unknown route in unknown administration site. On 03-JAN-2022 the patient developed a non-serious the temperature range was from 37.5f to 48.2f (product storage error) (unknown latency) following the administration of IPV (VERO), , TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL), DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL), HAEMOPHILUS TYPE B (HIB) VACCINE (ActHIB), MENINGOCOCCAL VACCINE (MENACTRA), DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) and DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable. It was not reported if the patient received a corrective treatment for the event (The temperature range was from 37.5F to 48.2F). At time of reporting, the outcome was Unknown for the event the temperature range was from 37.5f to 48.2f. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 12,0
- Geschlecht
- M
- Eingang
- 04.09.2021
- Impfdatum
- 31.07.2021
- Beginn
- 31.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Wrong product administered
Symptomtext
2 patients inadvertently received DAPTACEL instead of ADACEL with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from a other health professional via Medical Information (Reference number- 00736452). This case is linked with the 2021SA282217 (same reporter). This case involves a 12-year-old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 31-Jul-2021, the patient received a first dose of 0.5 mL of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot U6900A, expiry date-18-Nove-2022) via an intramuscular route in the left deltoid for prophylactic vaccination (wrong product administered). It was a case of actual medication error due to wrong vaccine administered (latency same day). It was reported, "2 patients inadvertently received DAPTACEL instead of ADACEL. Caller with question on whether a dose of ADACEL now needs to be administered. Caller also with question on when the patients will be due for a booster dose of ADACEL". At the time of reporting, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 10,0
- Geschlecht
- F
- Eingang
- 31.08.2021
- Impfdatum
- 30.07.2021
- Beginn
- 30.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
patient inadvertently received DAPTACEL instead of ADACEL/ no AE; 10-year-old patient received DAPTACEL/ no AE; Initial information was received on 23-Aug-2021 regarding an unsolicited valid non-serious case from other healthcare professional and consumer/ non healthcare professional via call center via Medical Information (Reference number- 00736487). This case is linked to case 2021SA281773(CLUSTER). This case involves a 10-year-old female patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and Product administered to patient of inappropriate age). The patient's past medical history, medical treatments, vaccinations, concomitant medication and family history were not provided. On 30-Jul-2021, the patient received a first dose of 0.5 mL of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6900AA and expiry date: 18-Nov-2022) via an intramuscular route in the left deltoid for prophylactic vaccination. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day). It was reported, "2 patients inadvertently received DAPTACEL instead of ADACEL. Caller with question on whether a dose of ADACEL now needs to be administered. Caller also with question on when the patients will be due for a booster dose of ADACEL". At the time of reporting, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product administered to patient of inappropriate age
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 12,0
- Geschlecht
- F
- Eingang
- 24.07.2021
- Impfdatum
- 14.07.2021
- Beginn
- 14.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Inappropriate schedule of product administration
Symptomtext
Patient received two doses of Adacel 13 months apart, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Global Medical Information (Reference number- 00683679) and transmitted to Sanofi on 15-Jul-2021. This case involves a 12 year old female patient who received two doses of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] 13 months apart (Inappropriate schedule of product administration) The patient's past vaccination(s) included ADACEL on 17-JUN-2020, MENACTRA in 2020 and GARDASIL in 2020 for prophylactic vaccination. Medical history, medical treatment(s) and family history were not provided. Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) (lot: U6920AB, expiry date:15-Apr-2022) for prophylactic vaccination. On 14-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6900AA, expiry date: 18-Nov-2022) via unknown route in the right arm for prophylactic vaccination. It was a case of an actual medication error due to Drug dose administration interval too short (latency: same day) No adverse event was reported. It was reported "Caller reports that a patient received ADACEL, MENACTRA & GARDASIL in 2020 and they received the same vaccines yesterday. Is there anything we should informed the parents about? Caller stated that she had to disconnected but will call us back. Health care professional (HCP) requested guidance on how to proceed when a patient received two doses of Adacel, approximately 13 months apart. She stated that the patient was vaccinated with Adacel on June 17, 2020, and received a dose of Adacel yesterday, July 14, 2021" This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- GARDASIL; MENACTRA
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- OH
- Alter
- 0,5
- Geschlecht
- F
- Eingang
- 16.06.2021
- Impfdatum
- 04.06.2021
- Beginn
- 04.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product administered to patient of inappropriate age
Wrong product administered
Symptomtext
wrong vaccine Adacel (Tdap) was administered to an infant, with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00630973) and transmitted to Sanofi on 07-Jun-2021. This case involves a 6 months old female patient who was administered with a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6900AA and expiry date was not reported) via unknown route at an unknown administration site (product administered to patient of inappropriate age) for prophylactic vaccination on 04-Jun-2021. The patient's medical history, past medical treatments, past vaccinations and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation. The reporter needed to know what she needs to do from here? She states that she administered the wrong vaccine (adacel) to an infant on Friday. what do we need to do? Is there anything to watch out for?" It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day). At the time of reporting, the patient experienced no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 66,0
- Geschlecht
- M
- Eingang
- 12.06.2021
- Impfdatum
- 25.05.2021
- Beginn
- 25.05.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Off label use
Product administered to patient of inappropriate age
Symptomtext
66 year-old was administered Adacel/no AE; Initial information was received on 25-May-2021 regarding an unsolicited valid non-serious case received from a Nurse Practitioner via Medical Information (Reference number- 00615161). This case involves a 66 year-old male patient who was vaccinated with 0.5 mL (once; standard) dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number: U6900AA and expiry date 18-Nov-2022) via an intramuscular route at left deltoid on 25-May-2021 for prophylactic vaccination (Off label use in unapproved age group). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was given. It was a case of off label use (latency was on same day). At the time of report, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- F
- Eingang
- 25.05.2021
- Impfdatum
- 03.05.2021
- Beginn
- 03.05.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Medication error
No adverse event
Product storage error
Product temperature excursion issue
Symptomtext
No additional adverse events reported; administration of improperly stored PNEUMOVAX 23; administration error; Inofrmation has been received from a registered nurse and an office administrator reporting on a 58-year-old female patient. The patient concurrent conditions included diabetes type II, hyperlipidemia, and fatty liver. The patient's allergies included cough with lisinopril (manufacturer unknown) (captured in MARRS# 2105USA004965), adverse reaction with merformin, and nausea with atorvastatin calcium (LIPITOR) and rosuvastatin calcium (CRESTOR). There was no information about the patient's concomitant medication or historical conditions. On 03-MAY-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular, lot # T035379, expiration date 31-MAY-2022 for prophylaxis (first dose). That same date, the patient was vaccinated with an improperly stored dose of diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL) intramuscular, lot # U6900AA, expiration date 18-NOV-2022 for an unknown indication (first dose). Both vaccines were administered in the right deltoid. The medication error occurred during the administration. No additional adverse events reported, and no prescription drug treatment was required. The vaccine after administered was placed into sharps. On an unknown date, pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) underwent a temperature excursion of 34.5 Celsius degrees for 31 hours and 36 minutes. The refrigerator was out of the temperature range and the health professional/medical assistant did not acknowledge the temperature. The medical assistant gave the vaccines without any regard to the temperature. The patient was made aware of this afterwards. There was no previous temperature excursion. The call was not placed due to a digital data logger. After verifying that the remaining vaccines were not viable, they were removed from the fridge and shipped. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2105USA004965:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Drug hypersensitivity; Hyperlipidaemia; Liver fatty; Type 2 diabetes mellitus
- Vorgeschichte
- Medical History/Concurrent Conditions: Adverse drug reaction; Drug-induced cough; Nausea
- Andere Medikamente
- PNEUMOVAX23 SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -