Received Jun 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Bone marrow transplant; This serious case was reported by a pharmacist via patient support programs and described the occurrence of bone marrow transplant in a 73-year-old male patient 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 bone marrow transplant (Verbatim: Bone marrow transplant) (serious criteria clinically significant/intervention required). The outcome of the bone marrow transplant was unknown. It was unknown if the reporter considered the bone marrow transplant to be related to Arexvy. The company considered the bone marrow transplant to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 17-APR-2025 The patient received Arexvy vaccine previously, but recently had a bone marrow transplant. Their doctor recommended to repeat vaccines. The patient tried to check to readminister Arexvy per doctor order but came back denied. The reporter asked about a prior authorization for this situation and would like a call back for assistance. The Quality Auditor located the note in this case from the email and advised that this was an adverse event that needs to be reported.; Sender's Comments: Bone marrow transplant is an unlisted event which is considered unrelated to GSK vaccine Arexvy.