Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT / LA |
Significant increase in size of her left breast; This is a spontaneous report received from an Other HCP. An elderly female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Nov2024 at 10:03 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 12Nov2024 at 10:03 as dose number unknown, single intramuscular, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST ENLARGEMENT (non-serious), outcome "not recovered", described as "Significant increase in size of her left breast". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.