Received Dec 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
patient suffered a stroke soon after first covid vaccination; This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. An 80-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 80 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant, life threatening) with onset 2021, outcome "unknown", described as "patient suffered a stroke soon after first covid vaccination". The event "patient suffered a stroke soon after first covid vaccination" required emergency room visit. Clinical information: Per patient spouse, patient suffered a stroke soon after first covid vaccination. Unable to dertmine exact date of vaccination - approximately 2021. The reporter's assessment of the causal relationship of "patient suffered a stroke soon after first covid vaccination" 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 the very limited information provided by the reporter (unknown patient history and concomitant drugs), considering the temporal relationship between the vaccination and the AE (reporter mentioned "soon after covid vaccination" however without further specification), the AE can conservatively be considered Related to the SD.