Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | K4M4J | SC |
redness and swelling to the arms where the injections were administered; redness and swelling to the arms where the injections were administered; administered the Arexvy subcutaneous in the back of the arm to 7 patients; administered the Arexvy subcutaneous in the back of the arm to 7 patients; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of injection site swelling in an unspecified number of patients who received RSVPreF3 adjuvanted (Arexvy) (batch number K4M4J, expiry date 12-DEC-2026) for prophylaxis. On an unknown date, the patients received Arexvy (subcutaneous). On an unknown date, an unknown time after receiving Arexvy, the patients experienced injection site swelling (Verbatim: redness and swelling to the arms where the injections were administered), injection site erythema (Verbatim: redness and swelling to the arms where the injections were administered), intramuscular formulation administered by other route (Verbatim: administered the Arexvy subcutaneous in the back of the arm to 7 patients) and vaccine administered at inappropriate site (Verbatim: administered the Arexvy subcutaneous in the back of the arm to 7 patients). The outcome of the injection site swelling and injection site erythema were unknown and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were not applicable. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Arexvy. It was unknown if the company considered the injection site swelling and injection site erythema to be related to Arexvy. Additional Information: GSK Receipt Date: 28-OCT-2025 The reporter was calling about the medication Arexvy and reported that a nusre administered the Arexvy subcutaneous in the back of the arm to 7 patients. She was looking for what to do next. The reporter said that they have never seen anything like this before. The reporter stated that there were redness and swelling to the arms where the injections were administered.