Received Jan 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
shot did not work/ suspected vaccination failure; Respiratory syncytial virus infection; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient received RSV vaccine. The patient experienced vaccination failure (Verbatim: shot did not work/ suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Respiratory syncytial virus infection). 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: 11-JAN-2026 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection 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.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving RSV vaccine, in a adult 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.