Received Feb 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA0739 | — |
Patient died after Comirnaty administered assumed was a stoke; This is a spontaneous report received from a Pharmacist from a sales representative. A 69-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 13Oct2025 as dose 1, single (Lot number: NA0739), in arm (deltoid) for covid-19 immunisation. The patient's relevant medical history included: "Dementia" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "high cholesterol levels" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (death, medically significant) with onset 2025, outcome "fatal", described as "Patient died after Comirnaty administered assumed was a stoke". Therapeutic measures were not taken as a result of cerebrovascular accident. The patient date of death was 30Nov2025. Reported cause of death: "Patient died after Comirnaty administered assumed was a stoke". No autopsy was performed. No follow-up attempts are possible.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cerebrovascular accident and the suspect drug BNT162B2 OMICRON (LP.8.1) cannot be excluded. The case will be reassessed once new information is 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.; Reported Cause(s) of Death: Patient died after Comirnaty administered assumed was a stoke
Medical History/Concurrent Conditions: Dementia; Diabetes; High cholesterol; Hypertension