Received Jun 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
I am vaccinated and had the booster shots but I got it anyway; had the booster shots; 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. Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine and RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine and RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: I am vaccinated and had the booster shots but I got it anyway) (serious criteria hospitalization) and extra dose administered (Verbatim: had the booster shots). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine and RSV vaccine. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine and RSV vaccine. Additional Information: GSK Receipt Date: 23 -MAY-2025 This case was reported by a patient via interactive digital media. The patient was vaccinated and had the booster shots but he/she got it anyway which led to extra dose administered. And the patient couldn't breathe, he/she had to go to the hospital. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine(Dose 1 & 2) Respiratory syncytial virus infection is an unlisted event which is considered unrelated to GSK RSV vaccine(Dose 1 & 2)