Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
terribly sick; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female 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. Vaccination history included: Comirnaty (2024-2025 formula) (DOSE 1, SINGLE), administration date: Nov2024, for COVID-19 immunization, reaction(s): "IgM number really goes up", "nose bleeds/bleeding disorder", "nose bleeds", "She has some kind of unknown bleeding disorder". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "terribly sick". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.