Received Feb 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
just have surgery to remove cancer; This serious case was reported by a pharmacist via call center representative and described the occurrence of cancer surgery in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included immunocompromised. On 18-SEP-2023, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cancer surgery (Verbatim: just have surgery to remove cancer) (serious criteria clinically significant/intervention required). The outcome of the cancer surgery was not reported. It was unknown if the reporter considered the cancer surgery to be related to Arexvy. The company considered the cancer surgery to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 03-FEB-2025 The registered pharmacist reported that they had a patient that was severely immunocompromised on radiation and chemotherapy and just had surgery to remove cancer and had her 1st dose for Arexvy back in 2023. The reporter asked could she get another dose and stated that she was not sure that at the moment of the 1st dose if the patient was already immunocompromised The reporter requested for the information to see if the patient was eligible for a 2nd dose. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments: Cancer surgery is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Immunocompromised