Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / LA |
Her arm was sore initially from the injection; Injection site turn quite red; Swelling around the injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 78-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 14Oct2025 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 78 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 22Oct2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history included: "Allergic to Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergic to Erythromycin"; Retinol, reaction(s): "Allergic to Retinol". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Oct2025, outcome "not recovered", described as "Her arm was sore initially from the injection"; VACCINATION SITE ERYTHEMA (non-serious) with onset 21Oct2025, outcome "not recovered", described as "Injection site turn quite red"; VACCINATION SITE SWELLING (non-serious) with onset 21Oct2025, outcome "not recovered", described as "Swelling around the injection site". Additional information: Her arm was sore initially from the injection, but nothing out of the ordinary. Today, after the flu shot yesterday, thought it was why her arm was so sore, but when she looked at her arm below where the flu injection was, it was very red and swollen and believes that is where the covid vaccine was injected. Feeling it, it is pretty swollen and is a large part of her arm. She does not know if it could be from the flu vaccine. It is well below where she got injected from the flu shot. The information sheet said that she could develop symptoms up to 14 days after receiving the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. No adverse events (AEs) required a visit to the Emergency Room and Physician's Office. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Penicillin allergy