Received Oct 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
suspected vaccination failure; just got over RSV; Sickness; 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. 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), respiratory syncytial virus infection (Verbatim: just got over RSV) and sickness (Verbatim: Sickness). The patient was treated with antibiotics. The outcome of the vaccination failure and sickness were not reported and the outcome of the respiratory syncytial virus infection was resolving. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and sickness 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 and sickness to be related to RSV vaccine. Additional Information: GSK Receipt Date: 01-OCT-2025 This case was reported by a patient via interactive digital media. The patient received RSV vaccine last year in 2024 and just got over RSV (respiratory syncytial virus infection). The patient had a temperature for four days and he/she was pretty sick, had to take antibiotics. The patient did not know that could get it (respiratory syncytial virus infection) being vaccinated. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of respiratory syncytial virus infection were unknown at the time of reporting. The batch number was not provided and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, unknown time 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.