Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | MY9550 | IM / LA |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
It affected my face - my right leg - both feet swelled - etc.; It affected my face - my right leg - both feet swelled - etc.; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 81-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 19Sep2025 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: BNT162b2 (DOSE 1, SINGLE; Lot: ER8729; Anatomical Location: Arm left; Vaccination time: 08:30), administration date: 29Apr2021, for COVID-19 immunization, reaction(s): "Burning sensation", "burning sensation under the skin", "very sore and warm", "very sore and warm", "swelling in throat area", "roof of her mouth became sore/ pain in the area on the left side of her upper cheek", "Overwhelming exhaustion"; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), SWELLING FACE (non-serious) all with onset 2025, outcome "unknown" and all described as "It affected my face - my right leg - both feet swelled - etc.". The event "it affected my face - my right leg - both feet swelled - etc." required physician office visit and emergency room visit. Additional information: The patient reported she got the Covid Vaccine booster on 19Sep2025 and experienced adverse reactions she is 81 - and wants to know more about those adverse reactions others have experienced. She stated that do you have a department that can discuss this with her. She has been seen by urgent care - dermatologist - internist and the pharmacists has reported it to Vars. Has it affected the heart in any way? It affected her face - her right leg - both feet swelled - etc. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.