Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
the needle came of and did not receive the full dose; the needle came of and did not receive the full dose; This is a spontaneous report received from a Pharmacist from medical information team. 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: UNDERDOSE (non-serious), DEVICE ISSUE (non-serious) and all described as "the needle came of and did not receive the full dose". Causality for "the needle came of and did not receive the full dose" was determined associated to device constituent of BNT162b2 omicron (lp.8.1) (malfunction). Additional information: a pharmacy was asking for additional information on what to do as they have a patient who got the Pfizer COVID-19 vaccine and the needle came of and did not receive the full dose. The patient who received an incomplete dose of Comirnaty 2025-2026 (12+). The needle came off when being administered.