Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | AS01E | — |
Maladministration of the AS01E Component of Arexvy (Without the Lyophilized Antigen Component); inappropriate preparation of medication; inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 91-year-old patient who received RSVPreF3 adjuvanted (Arexvy) (batch number AS01E) for prophylaxis. On 03-OCT-2025, the patient received Arexvy. On 03-OCT-2025, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: Maladministration of the AS01E Component of Arexvy (Without the Lyophilized Antigen Component)), inappropriate preparation of medication (Verbatim: inappropriate preparation of medication) and inappropriate dose of vaccine administered (Verbatim: inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution, inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 06-OCT-2025 A floating Pharmacist administered Arexvy without the adjuvant component. Pharmacist has used Merck sterile water. Additionally, Pharmacist has noticed that in the Arexvy box it was left only one vial and that the suspension vials was missing. There was a possibility that another floating pharmacist has administered Arexvy vaccine without the powder portion. This case was linked with case US2025127996 reported by the same reporter, for different patient.; Sender's Comments: US-GSK-US2025127996:Same reporter/Diffrent patient