Received Feb 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspected vaccination failure; Development of RSV; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in an unspecified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. 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: Development of RSV). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was unknown. It was unknown if 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. It was unknown if the company considered the respiratory syncytial virus infection to be related to Arexvy. Additional Information: GSK Receipt Date: 18-FEB-2025 The nurse practitioner did not know which dose of the vaccine this was. The infectious diseases nurse practitioner mentioned that they were surprised that the patients in her skilled nursing facilities (SNF) had developed respiratory Syncytial Virus this season despite vaccination. She did not say whether they had received GSK or Pfizer product, but she did say that she had reviewed these patients with their research MD and may look at them more closely because they were surprised to see several cases. It was unexpected to them, so it might have been more than mild illness. there were multiple patients. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Arexvy.