Received Feb 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | RA |
sick; it made her feel like she had the flu; headaches; This is a spontaneous report received from a Nurse from medical information team. A 50-year-old female patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 2, 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. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 18Jan2021, when the patient was 50-year-old, for Covid-19 immunization, reaction(s): "headaches", "it made her feel like she had the flu", "sick". The following information was reported: HEADACHE (non-serious) with onset 09Feb2021, outcome "recovered", described as "headaches"; INFLUENZA LIKE ILLNESS (non-serious) with onset 09Feb2021, outcome "recovered", described as "it made her feel like she had the flu"; ILLNESS (medically significant) with onset 09Feb2021, outcome "recovered" (12Feb2021), described as "sick". The second dose made her sicker than the first. The event 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: Given the compatible time association, the reasonable possibility that the reported events are related to BNT162b2 (BNT162B2) administration cannot be excluded. This case will be reassessed should additional information become available. 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-202500039043 same reporter/patient/event, different dose;
Hypothyroidism (Diagnosed at least 15 years ago)