Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
hospitalized with rsv; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, less than a month after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: hospitalized with rsv) (serious criteria hospitalization). 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 and respiratory syncytial virus infection to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 01-OCT-2025 This case was reported by a consumer via interactive digital media. The reporter reported that the patient got RSV vaccine and 3 weeks later he was hospitalized with respiratory syncytial virus infection. The reporter said that please avoid this vaccine. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of respiratory syncytial virus infection was unknown at the time of reporting. The batch number was not provided and we and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure and Respiratory syncytial virus infection, Less than a month after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.