Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; got RSV in March of 2025; This serious case was reported by a consumer 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 RSV vaccine. In MAR-2025, less than 2 years after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: got RSV in March of 2025). 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: 23-OCT-2025 This case was reported by a patient via interactive digital media. The patient had the RSV shot in 2024 and got respiratory syncytial virus infection in March of 2025. The patient's doctor was stumped how he/she got them. The patient stated that worst experience. The batch number was not provided, and unable to contact the reporter. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, less than 2 years after receiving RSV vaccine, in a 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.