Received Jan 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
The girl's husband died.; PATIENT SUPPORT PROGRAM This is a solicited report received from a Nurse, Program ID. A male patient in his 50's received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; Manufacturer unknown), for Covid-19 immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "The girl's husband died.". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: reporter has two friends that both took the shot and the booster. The girl's husband died. They both took the COVID shot and the booster. One of them died, and he wasn't a real elderly person. According to reporter's guess, maybe in his 50's. Reporter stated the patient died pretty young. He was healthy, he was very active, he was healthy. Reporter doesn't know what happened. The reporter's assessment of the causal relationship of "the girl's husband died." with the suspect product(s) BNT162b2 omicron (lp.8.1) 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. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event death 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: Unknown cause of death