Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA0587 | — |
Hub of Comirnaty single dose syringe broke and vaccine leaked out as vaccine was provided; Hub of Comirnaty single dose syringe broke and vaccine leaked out as vaccine was provided; Hub of Comirnaty single dose syringe broke and vaccine leaked out as vaccine was provided; This is a spontaneous report received from a Pharmacist. An 80-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Sep2025 as dose 1, single (Lot number: NA0587) at the age of 80 years for covid-19 immunisation, Device Lot Number: NA0587. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: UNDERDOSE (non-serious), DEVICE LEAKAGE (non-serious), SYRINGE ISSUE (non-serious) all with onset 04Sep2025 and all described as "Hub of Comirnaty single dose syringe broke and vaccine leaked out as vaccine was provided". Therapeutic measures were not taken as a result of underdose, device leakage, syringe issue. Causality for "hub of comirnaty single dose syringe broke and vaccine leaked out as vaccine was provided" was determined associated to device constituent of BNT162b2 omi xbb.1.5 (malfunction). Additional information: the patient did not receive any other vaccine within 4 weeks prior to BNT162b2 omi xbb.1.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None