Received Feb 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | LA |
sick; Vaccination failure; consumer reports he tested positive for RSV/lack of effect; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. In NOV-2024, the patient received RSV vaccine (left arm). On 02-JAN-2025, between 2 and 3 months after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: consumer reports he tested positive for RSV/lack of effect). On an unknown date, the patient experienced sickness (Verbatim: sick). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported and the outcome of the sickness was resolved. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and sickness to be related to RSV vaccine. The company considered the vaccination failure, respiratory syncytial virus infection and sickness to be unrelated to RSV vaccine. Additional Information: GSK receipt date: 24-FEB-2025 The patient was vaccinated with an RSV vaccine sometime in November of 2024. The consumer experienced coryza, excessive mucus production, cough and low-grade fever. Consumer stated he was sick for approximately one month but was not hospitalized. The consumer stated that he did not know which RSV vaccine he received in left arm. Consumer declined to provide any demographic information. No further information was provided including lot number, date of vaccination, vaccine name/manufacturer.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Respiratory syncytial virus infection and Illness are unlisted event which is considered unrelated to GSK RSV vaccine.
Test Date: 20250102; Test Name: Laboratory test; Test Result: Positive