Received Apr 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Tenderness/ her arm was tender to the touch; Redness; Skin warm/ her arm was warm to the touch; had a rash around the area; her temperature increased by 1 degree; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 84-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 05-APR-2025, the patient received Arexvy. On 06-APR-2025, 1 days after receiving Arexvy, the patient experienced pain in arm (Verbatim: Tenderness/ her arm was tender to the touch), erythema (Verbatim: Redness), skin warm (Verbatim: Skin warm/ her arm was warm to the touch) and rash (Verbatim: had a rash around the area). In APR-2025, the patient experienced body temperature increased (Verbatim: her temperature increased by 1 degree). The outcome of the pain in arm, erythema and skin warm were not resolved and the outcome of the rash and body temperature increased were not reported. It was unknown if the reporter considered the pain in arm, erythema, skin warm, rash and body temperature increased to be related to Arexvy. It was unknown if the company considered the pain in arm, erythema, skin warm, rash and body temperature increased to be related to Arexvy. Additional Information: GSK Receipt Date: 07-APR-2025 The patient self reported this case for herself. The patient had taken the Arexvy vaccine on Saturday, 5th April 2025, at the pharmacy. She had noticed the following day, on Sunday, 6th April 2025, that her arm was tender to the touch, warm to the touch, and had developed a rash around the area. She had been planning to follow up with her doctor and had wanted to report the events. She had mentioned that her temperature had increased by 1 degree.
Test Date: 202504; Test Name: Body temperature increased; Result Unstructured Data: (Test Result:increased by 1 degree,Unit:degree C,Normal Low:,Normal High:)