Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA0589 | — |
broken glass; This is a spontaneous report received from 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: NA0589, Expiration Date: 23Jun2026) for covid-19 immunisation, Device Lot Number: NA0589, Device Expiration Date: 23Jun2026. 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 "broken glass". Additional information: A pharmacist wanted to request a replacement for Comirnaty 2025-2026 because the plunger is broken. A broken syringe was observed during the evaluation of the returned complaint sample. Pictures shows broken glass. The reporter considered "broken glass" not related to BNT162b2 omicron (lp.8.1). Causality for "broken glass" was determined associated to device constituent of BNT162b2 omicron (lp.8.1) (malfunction).