Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
I developed a 4in wheel of redness and swelling at the injection site; I developed a 4in wheel of redness and swelling at the injection site; This is a spontaneous report received from a Physician. A 65-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 13Nov2025 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 14Nov2025, outcome "recovered" (19Nov2025) and all described as "I developed a 4in wheel of redness and swelling at the injection site". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling. Additional information: Patient did not received any other vaccines on the same date as the vaccines for which you are reporting. Patient did not received any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. Patient was not taking any other medications within 2 weeks of the event starting. Within 24 hours patient developed a 4in wheel of redness and swelling at the injection site and treatment received for the adverse event included topical steroids. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none