Received Oct 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; ill with RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: ill with 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 RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 10-OCT-2025 This case was reported by a reporter who knew the patient via interactive digital media. The patient was ill with respiratory syncytial virus infection (RSV) despite vaccination was scary. This case was considered as suspected vaccination failure as details of time to onset and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter. This case was linked with US2025AMR131395, reported by same reporter for different patient.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving RSV vaccine, 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. US-GSK-US2025AMR131395:Case for Another girl