Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | LA |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Pain injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 13-MAR-2025, the patient received Arexvy. In MAR-2025, less than 2 weeks after receiving Arexvy, the patient experienced injection site pain (Verbatim: Pain injection site). The outcome of the injection site pain was not resolved. It was unknown if the reporter considered the injection site pain to be related to Arexvy. It was unknown if the company considered the injection site pain to be related to Arexvy. Additional Information: GSK Receipt Date: 26-MAR-2025 and 27-MAR-2025 The reporter reported that she received a dose of AREXVY on 13 MAR 2025. Consumer stated she did not experience injection site pain at the onset of the injection, however, states that later she began to feel injection site pain and it was persisting (onset of injection site pain unknown.) One had the side effects that she was having so that she just gave a three. Consumer stated she received the vaccination. Consumer declined to provide any additional information. Consumer stated she reported this adverse event to and to the pharmacy. No further information was obtained/provided.