Received Sep 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspected vaccination failure; RSV; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: RSV). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy. The company considered the vaccination failure to be unrelated to Arexvy. It was unknown if the company considered the respiratory syncytial virus infection to be related to Arexvy. Additional Information: GSK receipt date: 01-SEP-2025 Reporter's husband and reporter had the RSV vaccine and did get RSV. Reporter asked if they should get an RSV booster. This case was considered as suspected vaccination failure as details regarding time to onset for RSV and laboratory confirmation regarding RSV were unknown at the time of reporting. This case was linked with US2025AMR114320 reported by same reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving unknown dose of Arexvy, in a male patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. GSK-US2025AMR114320:same reporter /different patient