Received May 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; rsv three weeks later; 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, 3 weeks after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: rsv three weeks later). 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 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: 26-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that took the rsv shot and came down with rsv (respiratory syncytial virus infection) three weeks later. This case was considered as suspected vaccination failure as 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 the completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine