Received Mar 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
when attempting to inject, the Comirnaty Vaccine broke and was not able to utilize the product This is a solicited report received from a Pharmacist and a Consumer or other non 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 (Batch/Lot number: unknown) for covid-19 immunisation. 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 "when attempting to inject, the Comirnaty Vaccine broke and was not able to utilize the product". Additional information: The patient was given another dose. Causality for "when attempting to inject, the Comirnaty vaccine broke and was not able to utilize the product" was determined associated to device constituent of BNT162b2 omicron (lp.8.1) (malfunction). Batch/lot number is not provided, and it cannot be obtained.