Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
body aches; arm soreness; headache; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 05Oct2025 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: PAIN IN EXTREMITY (non-serious) with onset 06Oct2025, outcome "recovered" (06Oct2025), described as "arm soreness"; PAIN (non-serious) with onset 06Oct2025, outcome "recovered" (06Oct2025), described as "body aches"; HEADACHE (non-serious) with onset 06Oct2025, outcome "recovered" (06Oct2025). Therapeutic measures were taken as a result of pain, pain in extremity, headache. Additional information: The patient received the new vaccine 05Oct2025 at a pharmacy and experienced body aches, arm soreness and headache by late morning on 06Oct2025. Symptoms resolved after taking Advil. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.