Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; Got RSV; Flu; 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. Co-suspect products included Influenza vaccine for prophylaxis. On an unknown date, the patient received RSV vaccine and Influenza 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: Got RSV) and influenza (Verbatim: Flu). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection and influenza were resolved (duration 1 week). It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and influenza to be related to RSV vaccine. The company considered the vaccination failure, respiratory syncytial virus infection and influenza to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 07-FEB-2025 This case was reported by a patient via interactive digital media. The patient got the Flu and RSV vaccine and still got RSV (respiratory syncytial virus infection), very congested, fevers, no appetite, ache bones was lasting a week. The patient did not know if it was RSV or the flu. It was unknown if the reporter considered the adverse events to be related to Flu (Influenza) vaccine. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding respiratory syncytial virus infection 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 the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. Respiratory syncytial virus infection and Influenza are unlisted events which are considered unrelated to GSK vaccine RSV vaccine.