Received Dec 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | UNK | IM / LA |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | UNK | IM / RA |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | IM / LA |
latex allergy; she developed a large, baseball sized localized redness on her arm; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of erythema of extremities in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included Tozinameran (Pfizer BioNTech COVID-19 vaccine) for prophylaxis and Tozinameran (Pfizer BioNTech COVID-19 vaccine) for prophylaxis. On 22-OCT-2024, the patient received Arexvy (intramuscular, left arm). On an unknown date, the patient received the 2nd dose of Pfizer BioNTech COVID-19 vaccine (intramuscular, left arm). On 22-OCT-2024, the patient received the 1st dose of Pfizer BioNTech COVID-19 vaccine (intramuscular, right arm). On 22-OCT-2024, less than a day after receiving Arexvy and an unknown time after receiving Pfizer BioNTech COVID-19 vaccine and Pfizer BioNTech COVID-19 vaccine, the patient experienced erythema of extremities (Verbatim: she developed a large, baseball sized localized redness on her arm) and latex allergy (Verbatim: latex allergy). The outcome of the erythema of extremities was resolved (duration 1 month) and the outcome of the latex allergy was not reported. It was unknown if the reporter considered the erythema of extremities and latex allergy to be related to Arexvy, Pfizer BioNTech COVID-19 vaccine and Pfizer BioNTech COVID-19 vaccine. It was unknown if the company considered the erythema of extremities and latex allergy to be related to Arexvy, Pfizer BioNTech COVID-19 vaccine and Pfizer BioNTech COVID-19 vaccine. Additional Information: GSK Receipt Date: 26-DEC-2025 The patient reported that for two consecutive years (2023 to 2024 and 2024 to 2025), after receiving her COVID vaccinations she had developed a large, baseball sized localized redness on her arm at the injection site. The redness had lasted about a month in 2024 and had persisted for a similar duration in 2023. The patient mentioned that she had a latex allergy and wondered whether the vial stopper had contained latex. The patient stated that she had not taken any medications nor sought medical treatment but had decided not to receive the COVID vaccine anymore. The batch number was not provided and follow up was denied.