Received Dec 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | UNK | RA |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | LA |
developed a large, baseball sized localized redness on her arm where she received the vaccine; This non-serious case was reported by a pharmacist via other manufacturer and described the occurrence of injection site erythema in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included Tozinameran (Comirnaty) for prophylaxis. Concurrent medical conditions included latex allergy. On 08-NOV-2023, the patient received Arexvy (left arm) .5 ml and Comirnaty (right arm). On an unknown date, less than 2 months after receiving Arexvy and Comirnaty, the patient experienced injection site erythema (Verbatim: developed a large, baseball sized localized redness on her arm where she received the vaccine). The outcome of the injection site erythema was not reported. It was unknown if the reporter considered the injection site erythema to be related to Arexvy. The reporter considered the injection site erythema to be not reported if related to Comirnaty. It was unknown if the company considered the injection site erythema to be related to Arexvy. The company considered the injection site erythema to be not reported if related to Comirnaty. Additional Information: GSK receipt date:30-DEC-2025 The pharmacist reported that patient received covid vaccination for 2 consecutive year 2023-2024 and 2024-2025. The patient developed a large, baseball sized localized redness on her arm where the vaccine was received which lasted about a month in 2023. The patient did not take any medications. On 22-OCT-2024, the patient received covid-19 vaccine and experienced the same reaction on the same day, and it lasted a month i.e. 22-NOV-2024. The batch number was not provided, and we are unable to contact the reporter.
Latex allergy