Received Apr 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Caller said that he took the shot before and he almost died; SUPPORT This is a solicited report received from a Consumer or other non HCP, Program ID. A male patient 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. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "Caller said that he took the shot before and he almost died". Clinical course: caller said that he took the shot before and he almost died. caller did not mentioned the covid vaccine he took but it was from Pfizer. The reporter's assessment of the causal relationship of "caller said that he took the shot before and he almost 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: Although it is difficult to establish temporal association between the reported event NEAR DEATH EXPERIENCE and suspect drug BNT162b2 omicron based on the limited information provided in the case, the causal association between the reported events and the suspect drug cannot be excluded as there is no concrete evidence available to eliminate the causal association. 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.