Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 35P2C | LA |
2 inches purple color around injection site below the skin; weakness; limiting the motion of patient's arm; sore arm/arm hurts during movements; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 35P2C, expiry date 30-NOV-2025) for prophylaxis. On 08-JAN-2025, the patient received the 1st dose of Arexvy (left arm). In JAN-2025, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: sore arm/arm hurts during movements). In MAR-2025, the patient experienced mobility decreased (Verbatim: limiting the motion of patient's arm). On an unknown date, the patient experienced injection site discoloration (Verbatim: 2 inches purple color around injection site below the skin) and weakness (Verbatim: weakness). The outcome of the injection site discoloration, pain in arm, mobility decreased and weakness were unknown. It was unknown if the reporter considered the injection site discoloration, pain in arm, mobility decreased and weakness to be related to Arexvy. It was unknown if the company considered the injection site discoloration, pain in arm, mobility decreased and weakness to be related to Arexvy. Additional Information: GSK Receipt Date: 18-MAR-2025 The reporter reported that a patient received Arexvy vaccine and two days later arm sored. A week later, the arm still sored, this was continued. Patient started using massages and it did help a little while but then it comes back right on patient's side, right where the needle went in, there was a purple 2 inches across like a very sore to touch below the skin. Also, when patient goes to left her arm up, because patient did yoga, it wants to stop and it hurts to go pass that high. It was like weakness. It was 2 months later and it was limiting the motion of patient arm. It was slowing getting better but patient can not find anything online talking about long term side effects with Arexvy.