Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Came down with RSV, spent 19 days in the hospital; Suspected vaccination failure; 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) and respiratory syncytial virus infection (Verbatim: Came down with RSV, spent 19 days in the hospital) (serious criteria hospitalization). 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: 24-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that at the suggestion of his/her pulmonologist patient had the RSV vaccine last fall in 2024. The patient came down with RSV (respiratory syncytial virus infection), spent 19 days in the hospital, and was told that if he/she had not been vaccinated it could have been fatal. This case was considered as suspected vaccination failure as details regarding time to onset for RSV and laboratory confirmation regarding RSV were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine Respiratory syncytial virus infection is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine