Received Dec 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | LA |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | LA |
Injection site scab; two-inch area of redness; injection site pain - left arm; left arm pain; open wound at injection site; Fatigue; Headache; Cannot use left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis. On 11-OCT-2025, the patient received Arexvy (left arm) and Influenza vaccine (left arm). On 11-OCT-2025, less than a day after receiving Arexvy and Influenza vaccine, the patient experienced injection site pain (Verbatim: injection site pain - left arm) and pain in arm (Verbatim: left arm pain). On 12-OCT-2025, the patient experienced injection site erythema (Verbatim: two-inch area of redness). In OCT-2025, the patient experienced injection site injury (Verbatim: open wound at injection site), fatigue (Verbatim: Fatigue), headache (Verbatim: Headache) and injected limb mobility decreased (Verbatim: Cannot use left arm). On an unknown date, the patient experienced injection site scab (Verbatim: Injection site scab). The patient was treated with prednisone and mupirocin. The outcome of the injection site pain, pain in arm, injection site erythema, fatigue, headache and injected limb mobility decreased were not resolved and the outcome of the injection site injury was resolving and the outcome of the injection site scab was not reported. It was unknown if the reporter considered the injection site pain, pain in arm, injection site erythema, injection site injury, injection site scab, fatigue, headache and injected limb mobility decreased to be related to Arexvy and Influenza vaccine. It was unknown if the company considered the injection site pain, pain in arm, injection site erythema, injection site injury, injection site scab, fatigue, headache and injected limb mobility decreased to be related to Arexvy and Influenza vaccine. Additional Information: GSK receipt date: 12-DEC-2025 The patient received Arexvy in the left arm on 11th October 2025 at a pharmacy, along with a flu vaccine administered in the same arm above the Arexvy site. The flu injection site remained clear. Later in October, the redness progressed to an open wound that eventually formed a scab. About two and a half weeks after vaccination, the patient consulted a primary care physician and was prescribed prednisone for seven days without improvement. In November 2025, a dermatologist prescribed mupirocin cream QID, which also did not improve the local reaction. The batch number was not provided, and we are unable to contact the reporter.