Received Dec 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | IM |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
her face swelled; breaking out in an itchy rash; swelling at injection site; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP, Program ID. A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Jan2025 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH PRURITIC (non-serious) with onset 30Jan2025 at 17:00, outcome "recovered", described as "breaking out in an itchy rash"; SWELLING FACE (non-serious) with onset 30Jan2025 at 17:00, outcome "recovered", described as "her face swelled"; VACCINATION SITE SWELLING (non-serious) with onset 30Jan2025 at 17:00, outcome "recovered", described as "swelling at injection site". The events "her face swelled", "breaking out in an itchy rash" and "swelling at injection site" required physician office visit. Additional information: The patient reported that after receiving the vaccine, she later started breaking out in an itchy rash, had swelling at injection site, and believes that her face swelled but was not certain. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.