Received Jun 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 4 | UNK | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
suspected vaccination failure; RSV; received 4 vaccines; 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, RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis and RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient's past medical history included respiratory syncytial virus infection. On an unknown date, the patient received the 4th dose of RSV vaccine, the 3rd dose of RSV vaccine, the 2nd dose of RSV vaccine and the 1st dose of RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, RSV vaccine, RSV vaccine and RSV vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: RSV) and extra dose administered (Verbatim: received 4 vaccines). 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, RSV vaccine, RSV vaccine and RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine, RSV vaccine, RSV vaccine and RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine, RSV vaccine, RSV vaccine and RSV vaccine. Additional Information: GSK Receipt Date: 09-JUN-2025 This case was reported by a patient via interactive digital media. Patient received 4 vaccines and became infected again and felt again like they did before had received any vaccinations, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding RSV 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine (Dose 1, 2, 3 and 4).
Medical History/Concurrent Conditions: Respiratory syncytial virus infection