Received Nov 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | MY9547 | — |
Product defect, vial broke. when trying to uncap it, to place syringe/syringe break; This is a spontaneous report received from Nurses and Other HCPs from product quality group. This report involves 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 following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Product defect, vial broke. when trying to uncap it, to place syringe/syringe break". Additional information: Nurse clarified, there was no patient involvement with this broken vial of Comirnaty. It broke when nurse was trying to uncap it, to place syringe. Product defect, vial broke. when trying to uncap it, to place syringe. Has picture from email. Clarified, was 1 vial only, this occurred with. Other HCP reported "we have another syringe break at our pediatric location. I do not know if it was broken already, or if they broke it." related to this case syringe. Causality for "product defect, vial broke. when trying to uncap it, to place syringe/syringe break" was determined associated to device constituent of BNT162b2 omicron (lp.8.1) (malfunction). Product Quality Group provided investigational results on 25Nov2025 for bnt162b2 omicron (lp.8.1) (device constituent): Investigation Summary and Conclusion: The complaint for "vial broke. when trying to uncap it, to place syringe." of Comirnaty PFS was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the involved scope and Annual Product Review. A complaint sample was not returned. The complaint is not confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. The Issue Escalation (NTM) process determined that no regulatory notification was required. The final scope was determined to be the associated lot of the reported lot MY9547. The reported defect is not representative of the quality of the batch, and reported lot remains acceptable for further distribution.