Received Sep 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; we got RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a unspecified number of patients who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patients received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patients experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: we got RSV). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was resolved (duration 1 month). 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: 30-AUG-2025 This case was reported by a patient via interactive digital media. Patient stated that when he/she read said that the vaccine will not prevent you from getting it; but it was 86 percent effective at kept from being in the hospital with pneumonia. Patient did not got pneumonia. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding respiratory syncytial infection were unknown at the time of reporting.; 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.