Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; contracted RSV; coughing up green phylem; Sickness; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. In MAY-2025, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: Sickness). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: contracted RSV) and phlegm discolored (Verbatim: coughing up green phylem). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported and the outcome of the sickness was resolved (duration 1 month) and the outcome of the phlegm discolored was not resolved. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, sickness and phlegm discolored 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, sickness and phlegm discolored to be related to RSV vaccine. Additional Information: GSK Receipt Date: 11-JUL-2025 This case was reported by a consumer via interactive digital media. The patient was vaccinated too but still contracted RSV. The patient was sick for a month and that was 2 months ago and he/she was still coughing up green phlegm. 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 completion of primary vaccination schedule, time to onset and laboratory test confirming respiratory syncytial virus infection) is considered unrelated to GSK's RSV vaccine.