Received Sep 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
rigors; fatigue; This is a spontaneous report received from a Physician. An elderly female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 12Sep2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA), on 13Sep2025 for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 13Sep2025, outcome "recovered" (14Sep2025); CHILLS (non-serious) with onset 13Sep2025, outcome "recovered" (14Sep2025), described as "rigors". Therapeutic measures were not taken as a result of chills, fatigue. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.