Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 7HZ93 | — |
Injection site pain; Red; swollen; very painful lasting over two days/ achy; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7HZ93) for prophylaxis. On 01-OCT-2025, the patient received Arexvy .5 ml. On 01-OCT-2025, less than a day after receiving Arexvy, the patient experienced injection site pain (Verbatim: Injection site pain). In OCT-2025, the patient experienced erythema (Verbatim: Red), swelling (Verbatim: swollen) and pain (Verbatim: very painful lasting over two days/ achy). The outcome of the injection site pain was not resolved and the outcome of the erythema, swelling and pain were resolved (duration 2 days). It was unknown if the reporter considered the injection site pain, erythema, swelling and pain to be related to Arexvy. It was unknown if the company considered the injection site pain, erythema, swelling and pain to be related to Arexvy. Additional Information: GSK Receipt Date: 03-OCT-2025 The patient self-reported this case for herself. The patient received the Arexvy vaccine and experienced injection site pain, red swollen and very painful lasting over two days which was also achy. The injection site pain symptom was not treated.