Received Jul 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
rsv's infections/suspected vaccination failure; rsv's infections; 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, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: rsv's infections/suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: rsv's infections). 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: 04-JUL-2025 This case was reported by a consumer via interactive digital media. After the RSV shot, he/she had stopped taking any vaccines. That's how bad rsv's infections were to his/her body that he/she had to check in emergency room and it was happened first time in his/her life. This case was considered as suspected vaccination failure as details regarding time to onset and 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine.