Received Nov 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
headache off and on; This is a spontaneous report received from a Consumer or other non HCP. An 82-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 31Oct2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2025, outcome "not recovered", described as "headache off and on". No follow-up attempts are possible. Additional information: Reporter stated, reporter had a 82 year old mother that on Friday had the COVID booster shot (Clarified as Pfizer COVID-19 Vaccine) and she had been experiencing a headache off and on ever since she took the booster on Friday so reporter is calling to find out if that was a side effect and what the reporter need to know. Batch/lot number is not provided, and it cannot be obtained.