Received Feb 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspected Vaccination failure; Still developed respiratory syncytial virus infection; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. The patient's past medical history included covid-19 (patient had Covid 19 multiple times). On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Still developed respiratory syncytial virus infection). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was not resolved. The reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy. The company considered the vaccination failure to be unrelated to Arexvy. The company considered the respiratory syncytial virus infection to be related to Arexvy. Additional Information: GSK Receipt Date: 22-JAN-2025 This case was reported by a patient mother via interactive digital media. The patient mother reported that her daughter had received the Respiratory syncytial virus infection vaccination and still developed Respiratory syncytial virus infection. She said it was worse than having covid the times The patient works with disability needs. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection and laboratory confirmation regarding 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 vaccine Arexvy.
Medical History/Concurrent Conditions: COVID-19 (patient had Covid 19 multiple times)