Received Dec 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Red spot at the injection site that was the size of a dime/red spot increased to the size of a baseball, was hot to the touch, sore and felt hard around the area - diagnosed with an infection; This is a spontaneous report received from an Other HCP, Program ID. A 79-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUAD taken for influenza immunisation, on 16Oct2024 as dose number unknown, single. The following information was reported: VACCINATION SITE INFECTION (non-serious) with onset 15Nov2024, outcome "recovered", described as "Red spot at the injection site that was the size of a dime/red spot increased to the size of a baseball, was hot to the touch, sore and felt hard around the area - diagnosed with an infection". The events "red spot at the injection site that was the size of a dime/red spot increased to the size of a baseball, was hot to the touch, sore and felt hard around the area - diagnosed with an infection" required physician office visit. Therapeutic measures were taken as a result of vaccination site infection. Additional Information: Age was reported as 79 years 2 months.The night following the vaccine patient noticed a red spot at the injection site that was the size of a dime. The following morning the red spot increased to the size of a baseball, was hot to the touch, sore and felt hard around the area. Patient went to a walk in clinic the same day and was diagnosed with an infection and provided antibiotics for treatment. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.