Received Mar 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected Vaccination failure; Going thru it now/Respiratory syncytial virus infection; it was contaminated; Got vaccine, but it was contaminated; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly female 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), respiratory syncytial virus infection (Verbatim: Going thru it now/Respiratory syncytial virus infection), product contamination (Verbatim: it was contaminated) and poor quality vaccine administered (Verbatim: Got vaccine, but it was contaminated). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was not resolved and the outcome of the product contamination and poor quality vaccine administered were not applicable. 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: 18-MAR-2025 This case was reported by a patient via interactive digital media. The patient received the RSV vaccine and was going through it (Respiratory syncytial virus infection) now. The patient received the contaminated vaccine and got letter 2 days before he/she got it. The patient reported it to be awful and requested to get vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for Respiratory syncytial virus infection 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine.