Received Dec 5, 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 69-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Stage 4; "High BP" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "allergy to statins" (unspecified if ongoing); "Heart attack" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC taken for diabetes mellitus; REPATHA taken for blood cholesterol abnormal; SERTRALINE taken for anxiety; AMLODIPINE taken for hypertension; EXEMESTANE taken for breast cancer female; CARVEDILOL taken for hypertension; ASPIRIN [ACETYLSALICYLIC ACID] taken for myocardial infarction. Vaccination history included: BNT162b2 (Dose 1, single), administration date: 25Feb2021, for Covid-19 immunization; BNT162b2 (Dose 2, single), administration date: 19Mar2021, for Covid-19 immunization; BNT162b2 (Dose 3 (booster), single), administration date: 15Dec2021, for Covid-19 immunization; BNT162b2 (Dose 4 (booster), single), administration date: 16Apr2022, for Covid-19 immunization; comirnaty (2023-2024 formula) (Dose 5 (booster), single), administration date: 30Nov2023, for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Anxiety; Blood cholesterol abnormal; Breast cancer female (Stage 4); Diabetes; Drug allergy; Heart attack; Hypertension
OZEMPIC; REPATHA; SERTRALINE; AMLODIPINE; EXEMESTANE; CARVEDILOL; ASPIRIN [ACETYLSALICYLIC ACID]