Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | SC |
redness at injection site; swelling at injection site; improper injection; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 28-OCT-2025, the patient received Arexvy (subcutaneous, unknown arm). On 28-OCT-2025, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness at injection site), injection site swelling (Verbatim: swelling at injection site) and intramuscular formulation administered by other route (Verbatim: improper injection). The outcome of the injection site erythema and injection site swelling were not reported and the outcome of the intramuscular formulation administered by other route was not applicable. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Arexvy. It was unknown if the company considered the injection site erythema and injection site swelling to be related to Arexvy. Additional Information: GSK receipt date: 20-OCT-2025 The reporter stated that, gave the Arexvy injection on the back of the arm as a subcutaneous injection to several residents of the nursing home. (AE). The caller reported that the arms was red and swollen at the injection site of all patients involved.