Adverse Event Reporting
| VAERS ID | 2486094 |
|---|---|
| Gender | Male |
| Age | 33 |
| StateCode | FL |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | FJ1620 |
| Number of vaccinations | 3 |
| Vaccinated | 2021-11-26 |
| Onset | 2021-11-26 |
| Condition | Permanent Disability Recovered |
Symptoms
- Urticaria
- Off label use
- Product use issue
- Interchange of vaccine products
Current Illness
Preexisting Conditions
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Other Conditions: No
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Pfizer Covid vaccine: hives everywhere; Had Moderna on 04Jan2021 and the second Moderna on 01Feb2021.
; Had flu shot on the same date as the Pfizer Covid vaccine.
; Had flu shot on the same date as the Pfizer Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).
The reporter is the patient.
A 33-year-old male patient received BNT162b2 (BNT162B2), on 26Nov2021 at 09:00 as dose 3 (initial pfizer dose), single (Lot number: FJ1620) at the age of 33 years intramuscular, in right deltoid for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 26Nov2021 as dose number unknown, single (Batch/Lot number: unknown) for immunisation.
The patient had no relevant medical history.
There were no concomitant medications.
Vaccination history included: moderna (Dose: 1, Route of Administration: Intramuscular, Dose: unknown), administration date: 04Jan2021, when the patient was 33-year-old, for COVID-19 immunization; moderna (Dose: 2, Route of Administration: Intramuscular, Dose: unknown), administration date: 01Feb2021, when the patient was 33-year-old, for COVID-19 immunization.
The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 26Nov2021, outcome "unknown", described as "Had Moderna on 04Jan2021 and the second Moderna on 01Feb2021.
"; OFF LABEL USE (disability) with onset 26Nov2021, outcome "unknown", described as "Had flu shot on the same date as the Pfizer Covid vaccine"; PRODUCT USE ISSUE (disability) with onset 26Nov2021, outcome "unknown", described as "Had flu shot on the same date as the Pfizer Covid vaccine.
"; URTICARIA (disability) with onset 2022, outcome "recovered" (2022), described as "Pfizer Covid vaccine: hives everywhere".
Therapeutic measures were taken as a result of urticaria.
Clinical course: Treatment: Put some Benadryl the first time he had hives.
Had Pepcid and put on Benadryl the second time he had hives.
Patient had flu shot on the same date as the Pfizer Covid vaccine.
Manufacturer, dosage and formulation not provided.
Wanted advice, to know if they had heard reports from other people and know what to do.
Wanted to know if people recommended to do other treatments or therapies.
The patient did not receive any other vaccines within four weeks prior to the vaccination.
Family medical history relevant to ae(s) were reported as none.
Relevant tests were reported as none.
; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Urticaria, Interchange of vaccine products, Product use issue, Off label use and the suspect drug cannot be excluded.
The case will be reassessed once new information is available.
The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
,Linked Report(s) : US-PFIZER INC-202201240311 same product, patient, different AEs, different dose;