Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / LA |
left arm got sore from the shot; fallen on her left knee; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP, Program ID: . A 75-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Aug2025 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years intravenous, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FALL (non-serious) with onset 19Aug2025 at 11:00, outcome "unknown", described as "fallen on her left knee"; VACCINATION SITE PAIN (non-serious) with onset 19Aug2025 at 11:00, outcome "unknown", described as "left arm got sore from the shot". The events "left arm got sore from the shot" and "fallen on her left knee" required physician office visit. Therapeutic measures were taken as a result of vaccination site pain, fall. Additional information: Patient was 75 years 6 months at the time of vaccination. The patient reported that her left arm got sore from the shot, but it is still hurting her now months later. She had also fallen on her left knee in an unrelated event, so has been doing therapy for both her leg and her arm. This is more a side effect than adverse event. The reporter considered "fallen on her left knee" not related to BNT162b2 omicron (kp.2). The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Based on available information in the case the reported event FALL assessed as unrelated to suspect drug and more likely related to external mechanical trauma