Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Respiratory syncytial virus infection; suspected vaccination failure; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 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: Respiratory syncytial virus infection) (serious criteria hospitalization). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was unknown. 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 and respiratory syncytial virus infection to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 10-SEP-2025 The patient who received Arexvy approximately two years ago, in 2023. The patient was recently hospitalized for respiratory syncytial virus infection. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding respiratory syncytial virus were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Respiratory syncytial virus infection, unknown time after receiving Arexvy, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.