Received Feb 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | LA |
intermittent sharp pain in left breast/Pain continued for one week, intermittently 4-5 times per day; This is a spontaneous report received from a Pharmacist from a sales representative. A 44-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 10Jan2025 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 10Jan2025 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST PAIN (non-serious) with onset 27Jan2025, outcome "recovering", described as "intermittent sharp pain in left breast/Pain continued for one week, intermittently 4-5 times per day". The event "intermittent sharp pain in left breast/pain continued for one week, intermittently 4-5 times per day" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the vaccine. Patient did not taking any other medications within 2 weeks of the event starting. Received comirnaty and flu vaccine in left arm on 10Jan2025. On 27Jan2025 began experiencing intermittent sharp pain in left breast. Pain continued for one week, intermittently 4-5 times per day. Went to breast surgeon for evaluation and ultrasound - nothing identified. Breast surgeon stated that this was likely related to the covid-19 vaccine and she has seen a handful of patients with similar symptoms described as "twingey" pain the breast on the side where vaccine was administered. She has not seen this with other vaccines, only Covid-19. Treatment received for the adverse event was Evaluation by breast surgeon. No drug allergy was reported. On 27Jan2025 when patient started to have symptoms patient did not at all associate them with the vaccine so patient did not report at that time. Only after seeing the surgeon did this association become clear. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Test Name: ultrasound; Result Unstructured Data: Test Result:nothing identified