Received Dec 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
swelling and itching in arm; itching in arm that extended down to elbow and up the arm; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP, Program ID. An 82-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 10Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 82 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 10Sep2024, outcome "recovered", described as "itching in arm that extended down to elbow and up the arm"; PERIPHERAL SWELLING (non-serious) with onset 10Sep2024, outcome "recovered", described as "swelling and itching in arm". The events "swelling and itching in arm" and "itching in arm that extended down to elbow and up the arm" required physician office visit. Additional information: Patient reports reaction after getting COMIRNATY 12+ (COVID 2024-25) with swelling and itching in arm that extended down to elbow and up the arm. This reaction lasted for two weeks. After discussing with provider, decision was made to not get any other vaccinations as this has occurred with other vaccinations in the past as well. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.