Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
heart attack couple of months after getting vaccinated; afib; ASSESSMENT PROGRAM This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. A 74-year-old female patient received BNT162b2 (BNT162B2), on 01Jun2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 01Aug2021, outcome "unknown", described as "afib"; MYOCARDIAL INFARCTION (medically significant) with onset 01Aug2021, outcome "unknown", described as "heart attack couple of months after getting vaccinated". The events "heart attack couple of months after getting vaccinated" and "afib" required physician office visit. Clinical course: The patient stated that she had developed atrial fibrillation and had a heart attack a couple of months after getting vaccinated. The reporter's assessment of the causal relationship of "heart attack couple of months after getting vaccinated" and "afib" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on plausible temporal association, there is reasonable possibility of causal association between the Reported events Heart attack, AFib and the suspect drug 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.