Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; had that 3 times; 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. The patient's past medical history included covid-19. 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: had that 3 times). 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: 08-MAY-2025 The case was received from the patient via interactive digital media. The reporter got an RSV vaccine. The reporter got it when he/she was 67 from his/her great granddaughters. The reporter reported that it was way worse than Covid and he/she had that 3 times. Plus the reporter lost his/her mother, brother and sister in law within 21 days to Covid. RSV was the last vaccine the reporter got but he/she glad he/she did. There were a few times the reporter thought he/she was going to die when he/she had RSV. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection and laboratory confirmation regarding shingles 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK RSV vaccine."
Medical History/Concurrent Conditions: COVID-19