Received Feb 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | LA |
pain at injection site; dizzy; had syncope; This serious case was reported by a consumer via call center representative and described the occurrence of syncope in a 64-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 06-FEB-2025, the patient received the 1st dose of Arexvy (left arm). In FEB-2025, 3 hrs after receiving Arexvy, the patient experienced syncope (Verbatim: had syncope) (serious criteria GSK medically significant), injection site pain (Verbatim: pain at injection site) and dizziness (Verbatim: dizzy). In FEB-2025, the outcome of the injection site pain was resolved. The outcome of the syncope was unknown and the outcome of the dizziness was not resolved. It was unknown if the reporter considered the syncope, injection site pain and dizziness to be related to Arexvy. The company considered the syncope to be unrelated to Arexvy. It was unknown if the company considered the injection site pain and dizziness to be related to Arexvy. Additional Information: GSK Receipt Date: 10-FEB-2025 The patient self-reported this case himself. The patient stated he received Arexvy in left arm. 3 hours later the patient had pain at injection site and he was dizzy. The patient reported he read the side effects and warnings and stated he had syncope, but never lost consciousness. The patient's pain in harm had subsided but the dizziness has not.; Sender's Comments: Syncope is an unlisted event which is considered unrelated to GSK vaccine Arexvy.