Received Jun 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | 7+ | UNK | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; RSV; Flu; 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 Influenza vaccine for prophylaxis and COVID-19 vaccine for prophylaxis. Previously administered products included Covid-19 vaccine (received 8 doses on an unknown date). On an unknown date, the patient received RSV vaccine, Influenza vaccine and the 9th dose of COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, Influenza vaccine and COVID-19 vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: RSV) and influenza (Verbatim: Flu). The outcome of the vaccination failure, respiratory syncytial virus infection and influenza were not reported. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and influenza to be related to RSV vaccine, Influenza vaccine and COVID-19 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 and influenza to be related to RSV vaccine, Influenza vaccine and COVID-19 vaccine. It was unknown if the company considered the vaccination failure to be related to Influenza vaccine and COVID-19 vaccine. Additional Information: GSK Receipt Date: 19-JUN-2025 This case was reported by a patient via interactive digital media. The patient had a flu shot, an RSV shot, and 9th Covid shot in last fall but still got the Flu and respiratory syncytial virus before February. The patient spent some time in the hospital and then they brought nurses to saws the patient in the house for another few days four times a day. If patient not had insurance he/she would have been billed for over 16,000 dollars. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine.