Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
catching the flu after taking the vaccine; Suspected vaccination failiure; Had my shot in September got RSV in January; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. In SEP-2024, the patient received RSV vaccine. In JAN-2025, between 3 and 5 months after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failiure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Had my shot in September got RSV in January). On an unknown date, the patient experienced influenza (Verbatim: catching the flu after taking the vaccine). The outcome of the vaccination failure and influenza were not reported and the outcome of the respiratory syncytial virus infection was unknown. 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: 14-MAR-2025 This case was reported by the patient via interactive digital media. The patient reported that she had shot in September got RSV in January. The patient did not mention a specific product name. However, they mentioned having taken an RSV vaccine and still contracting the flu. Based on this information, it seems the product in question could be the RSV vaccine. The patient did not explicitly mention any other specific side effects, other than still catching the flu after taking the vaccine, which might imply that the vaccine did not provide the expected protection. This case was considered as suspected vaccination failure as details regarding laboratory test confirming 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 RSV vaccine. Respiratory syncytial virus infection and Influenza are unlisted event which are considered unrelated to GSK RSV vaccine.