Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | NM99E | — |
Maladministration of diluent only ( Inappropriate Reconstitution Technique); Maladministration of diluent only ( Inappropriate Reconstitution Technique); This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) (batch number NM99E, expiry date 23-JAN-2027) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of diluent only ( Inappropriate Reconstitution Technique)) and inappropriate dose of vaccine administered (Verbatim: Maladministration of diluent only ( Inappropriate Reconstitution Technique)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 01-MAY-2026 The reporter reported that the patient that only received the sterile water(diluent) of the Arexvy vaccine. The reporter wanted to know how to proceed, do we revaccinate, any titers to obtain. The estimated suspect vaccine start date range from 03-DEC-2025 until 16-MAR-2026. The batch number was not provided upon follow- up with the reporter. This cases US2026060080 and US2026059875 reported by same reporter.; Sender's Comments: US-GSK-US2026060080:Same Reporter US-GSK-US2026059875:SAME REPORTER