Received May 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Nausea; whole body aches; headache; Coughing up phlegm; Painful arm; This non-serious case was reported by a consumer and described the occurrence of pain in arm in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included back disorder, arthritis, scoliosis and fibromyalgia. Concomitant products included hydrocodone and paracetamol (Tylenol). On 05-MAY-2026, the patient received Arexvy. On 19-MAY-2026, 14 days after receiving Arexvy, the patient experienced pain in arm (Verbatim: Painful arm). On an unknown date, the patient experienced nausea (Verbatim: Nausea), general body pain (Verbatim: whole body aches), headache (Verbatim: headache) and productive cough (Verbatim: Coughing up phlegm). The outcome of the pain in arm was not resolved and the outcome of the nausea, general body pain, headache and productive cough were not reported. It was unknown if the reporter considered the pain in arm, nausea, general body pain, headache and productive cough to be related to Arexvy. It was unknown if the company considered the pain in arm, nausea, general body pain, headache and productive cough to be related to Arexvy. Additional Information: GSK Receipt Date: 19-MAY-2026 The batch number was not provided upon follow- up with the reporter.
Arthritis; Back disorder; Fibromyalgia; Scoliosis
Hydrocodone; Tylenol