Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
I had RSV a year ago. Was in the hospital 6 days; I really felt awful; 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. Concurrent medical conditions included allergy (Im allergic to the RSV vaccine). 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: I had RSV a year ago. Was in the hospital 6 days) (serious criteria hospitalization) and feels awful (Verbatim: I really felt awful). The outcome of the vaccination failure, respiratory syncytial virus infection and feels awful were not reported. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and feels awful to be related to RSV vaccine. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine. It was unknown if the company considered the feels awful to be related to RSV vaccine. Additional Information: GSK receipt date:27-OCT-2025 This case was reported by a patient via interactive digital media. Consumer reported that had respiratory syncytial virus infection year ago. The reporter mentioned was in the hospital 6 days. The reporter mentioned he/she was allergic to the RSV vaccine and was really felt awful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 and Respiratory syncytial virus infection, 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.
Allergy (Im allergic to the RSV vaccine)