Received Dec 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
sore arm; This is a spontaneous report received from a Consumer or other non HCP. A 68-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Stage 4 breast cancer" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "High BP" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Allergy to all statins" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Heart attack" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC taken for diabetes mellitus; REPATHA taken for blood cholesterol; SERTRALINE taken for anxiety; EXEMESTANE taken for breast cancer; AMLODIPINE taken for hypertension; CARVEDILOL taken for hypertension; ASPIRIN [ACETYLSALICYLIC ACID] taken for myocardial infarction. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 16Apr2022, when the patient was 66-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 15Dec2021, when the patient was 66-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 19Mar2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1, SINGLE), administration date: 25Feb2021, when the patient was 65-year-old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Nov2023, outcome "unknown", described as "sore arm". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Anxiety; Blood pressure high; Breast cancer stage IV; Diabetes; Drug allergy; Heart attack; High cholesterol
OZEMPIC; REPATHA; SERTRALINE; EXEMESTANE; AMLODIPINE; CARVEDILOL; ASPIRIN [ACETYLSALICYLIC ACID]