Received Feb 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 255T2 | IM |
experienced soreness at the injection site; a small bump at the injection site; itching at the injection site; large red area surrounding the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 255T2, expiry date 05-DEC-2025) for prophylaxis. On 09-JAN-2025, the patient received Arexvy (intramuscular). On 09-JAN-2025, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: large red area surrounding the injection site) and injection site itching (Verbatim: itching at the injection site). On 10-JAN-2025, the patient experienced injection site pain (Verbatim: experienced soreness at the injection site) and injection site mass (Verbatim: a small bump at the injection site). The outcome of the injection site erythema and injection site itching were not resolved and the outcome of the injection site pain and injection site mass were resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site mass and injection site itching to be related to Arexvy. It was unknown if the company considered the injection site erythema, injection site pain, injection site mass and injection site itching to be related to Arexvy. Additional Information: GSK Receipt Date: 24-JAN-2025 The reporter reported that she received her Arexvy vaccine on 9th January 2025. Later the day of reporting she noticed a large red area surrounding the injection site that had faded somewhat but was still visible. She also experienced soreness, a small bump and itching at the injection site. The itching was milder but still present. The bump and soreness had resolved.