Received Feb 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | RA |
severe headaches; made her feel like she had the flu; sick; This is a spontaneous report received from a Nurse from medical information team. A 50-year-old female patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing), notes: diagnosed at least 15 years ago. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (medically significant) with onset 19Jan2021, outcome "recovered" (20Jan2021), described as "sick"; HEADACHE (non-serious), outcome "recovered", described as "severe headaches"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "made her feel like she had the flu". Clinical course: The patient informed that she had both of Pfizer's Covid vaccines in the past and they made her very sick for several days. She informed that the doctor was not involved. Her symptoms occurred the day after she received the injections. The second dose made her sicker than the first. With both of them, she had a reaction and clarified that she had severe headaches, and it made her feel like she had the flu. The first shot she was sick for 2 days and with the 2nd shot she was sick in bed for 4 days. She has completely recovered from this. The event very sick was reported as serious as other medically important condition. The reporter relatedness of drug to reaction/events was yes. The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: Based on the close temporal relationship, the association between the event sick with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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-202500039829 same reporter/patient/events, different dose;
Hypothyroidism (diagnosed at least 15 years ago)