Received Jan 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Itchy scab at injection site; There was an itchy spot at injection site along with a scab; There is a bump under the skin; the area looks dry with a scab in the center area; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site itching in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 09-DEC-2025, the patient received the 1st dose of Arexvy. In DEC-2025, an unknown time after receiving Arexvy, the patient experienced injection site itching (Verbatim: Itchy scab at injection site), injection site scab (Verbatim: There was an itchy spot at injection site along with a scab), injection site swelling (Verbatim: There is a bump under the skin) and injection site dryness (Verbatim: the area looks dry with a scab in the center area). The outcome of the injection site itching, injection site scab and injection site swelling were unknown and the outcome of the injection site dryness was not reported. It was unknown if the reporter considered the injection site itching, injection site scab, injection site swelling and injection site dryness to be related to Arexvy. It was unknown if the company considered the injection site itching, injection site scab, injection site swelling and injection site dryness to be related to Arexvy. Additional Information: GSK Receipt Date: 26-DEC-2025 The reporter stated that when the patient cleaned the area, the scab went away but then came back. The patient stated that it was itchy at one spot and not all over his body. No additional details were provided. The batch number was not provided upon follow- up with the reporter.