Received Mar 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Respiratory syncytial virus infection; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 84-year-old 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: Respiratory syncytial virus infection) (serious criteria hospitalization and GSK medically significant). 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: 20-FEB-2025 This case was reported by a patient via interactive digital media. The patient had the RSV vaccine and a few months later was in the hospital with the RSV infection. The patient was 84 years old, and it was horrible. After going home 8 days later stayed in room for a month, exhausted and coughing all time. The patient would definitely get the shot. This case was considered as suspected vaccination failure as details regarding 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, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. Respiratory syncytial virus infection is an unlisted event which is considered unrelated to GSK RSV vaccine.