Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
styrofoam container with the last few doses was covered in the blood; This is a spontaneous report received from a Consumer or other non HCP from product quality group. This report involves BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The following information was reported: PRODUCT CONTAMINATION WITH BODY FLUID (non-serious), outcome "unknown", described as "styrofoam container with the last few doses was covered in the blood". Additional information: The order they received of their Pfizer COVID-19 Vaccine they ordered 300 doses and the last package that they opened Styrofoam container with the last few doses was covered in the blood. Causality for "styrofoam container with the last few doses was covered in the blood" was determined associated to device constituent of BNT162b2 omicron (lp.8.1) (malfunction). Batch/lot number is not provided, and it cannot be obtained.