Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA4457 | — |
syringe break when putting needle on it; This is a spontaneous report received from a Pharmacist and an Other HCP from product quality group. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Lot number: NA4457, Expiration Date: 23Jul2026) for covid-19 immunisation, Device Lot Number: NA4457, Device Expiration Date: 23Jul2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "syringe break when putting needle on it". Causality for "syringe break when putting needle on it" was determined associated to device constituent of BNT162b2 omicron (lp.8.1) (malfunction). Additional information: There was a syringe break when putting needle on it, it snapped off. NDC Number was 0069252801.