Received Feb 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
redness right deltoid injection site; itching right deltoid injection site; soreness right deltoid injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 06-FEB-2025, the patient received Arexvy .5 ml. On 06-FEB-2025, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness right deltoid injection site), injection site itching (Verbatim: itching right deltoid injection site) and injection site muscle pain (Verbatim: soreness right deltoid injection site). The outcome of the injection site erythema, injection site itching and injection site muscle pain were not resolved. It was unknown if the reporter considered the injection site erythema, injection site itching and injection site muscle pain to be related to Arexvy. It was unknown if the company considered the injection site erythema, injection site itching and injection site muscle pain to be related to Arexvy. Additional Information: GSK Receipt Date: 14-FEB-2025 The reporter reported there was no other conditions provided. Pharmacy did not provide lot number.