Received Nov 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | MY9547 | — |
syringe that broke when trying to uncap it; 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: MY9547, Expiration Date: 15Jun2026) for covid-19 immunisation, Device Lot Number: MY9547, Device Expiration Date: 15Jun2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MATERIAL ISSUE (non-serious), outcome "unknown", described as "syringe that broke when trying to uncap it". Causality for "syringe that broke when trying to uncap it" was determined associated to device constituent of BNT162b2 omicron (lp.8.1) (malfunction).