Received Sep 11, 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 female 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. Linked case(s) involving the same patient: US2025AMR114326 Additional Information: GSK Receipt Date: 01-SEP-2025 This case received from the patient via interactive digital media. The patient had received the RSV vaccine (Arexvy) but still contracted respiratory syncytial virus infection. She inquired whether she should receive an RSV booster. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting. This was 1 of the 2 linked cases reported by the same reporter for her husband.; Sender's Comments: A case of Vaccination failure,an unknown time after receiving Arexvy, in a female 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