Received Jul 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Died in sleep; started getting blood clots; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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 "Died in sleep"; THROMBOSIS (medically significant), outcome "unknown", described as "started getting blood clots". The patient date of death was unknown. Reported cause of death: "Died in sleep". It was not reported if an autopsy was performed. Clinical course: The patient got the vaccine for COVID-19 from Pfizer. The patient started getting blood clots and she died in her sleep. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: Died in sleep