Received May 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
three individuals that died due to the Pfizer BioNTech vaccine.; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) 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: DEATH (death, medically significant), outcome "fatal", described as "three individuals that died due to the Pfizer BioNTech vaccine.". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: The reporter stated that they were calling because there were three individuals who had died due to the Pfizer BioNTech vaccine. Product Details: The reporter stated that they had the product information. It was the Comirnaty (later the name of vaccine was mentioned as Comirnaty; hence suspect captured the same). The reporter stated that they did not have the LOT number and only knew that these were BioNTech vaccines. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The event of death is assessed as unrelated to BNT162b2 Omicron (LP.8.1) based on the lack of supportive clinical information, absence of a reported temporal relationship, unknown cause of death, and absence of medical documentation or autopsy findings. Therefore, a causal association between the vaccine and the reported fatal outcome cannot be established.; Reported Cause(s) of Death: three individuals that died due to the Pfizer BioNTech vaccine.