Received Feb 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
stroke; PSP-ELIQ-IQVIACSMS-US: ELIQUIS (APIXABAN) PSP / PSP-ELIQ-IQVIACSMS- This is a solicited report received from a Consumer or other non HCP and an Other HCP. A 69-year-old female patient received BNT162b2 (BNT162B2), in Feb2022 as dose number unknown(booster), single (Batch/Lot number: unknown) at the age of 69 years for immunisation. The patient's relevant medical history included: "Fecal incontinence" (unknown if ongoing); "Heart murmur" (unknown if ongoing), notes: at birth; "Heartburn" (unknown if ongoing); "UTI" (ongoing); "Menopause" (unspecified if ongoing), notes: at 48 years; "COVID-19" (unspecified if ongoing); "fibroids" (unspecified if ongoing); "D & C" (unspecified if ongoing); "Arthritis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset Feb2022, 3 days after the suspect product(s) administration, outcome "unknown", described as "stroke". Therapeutic measures were taken as a result of cerebrovascular accident. Clinical course: The patient experienced a sudden stroke in February 2022. The patient was hospitalized in a stroke ward for five or six days and underwent extensive testing. The stroke team (doctors, cardiologists, and neurologists) concluded that the stroke was directly caused by a reaction to the Pfizer COVID booster shot received three days prior. Upon discharge, the patient was started on clopidogrel (Plavix) and aspirin (81mg daily). The patient had no history of arrhythmias or atrial fibrillation prior to this stroke, a status confirmed by a cardiologist over 30 years of care. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the available information and implied temporal association, the company considers that there was a reasonable possibility that the event Stroke was related to BNT162b2. however underlying medical condition could be a confounding factor for causality assessment along with old age. 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.
Arthritis; UTI
Medical History/Concurrent Conditions: COVID-19; D & C; Fecal incontinence; Fibroids; Heart murmur (at birth); Heartburn; Menopause (at 48 years)