Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
suspected vaccination failure; RSV; This serious case was reported by a other health professional via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of RSV vaccine. On an unknown date, less than a year after receiving RSV vaccine, 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 RSV vaccine. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 23-OCT-2025 This case was reported by a patient via interactive digital media. Patient took the vaccine last year in 2024 for the first time and got RSV (respiratory syncytial virus infection) that year for the first time and it was not a fun. Patient stated that he/she was in medical field for 30 years but never got either. The patient thought he/she would sit it out this year (2025). The batch number was not provided, and unable to contact the reporter. This case was considered as suspected vaccination failure as details of laboratory confirmation regarding respiratory syncytial virus infection was unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, less than a year after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received