Received Nov 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 2293B | — |
Product Complaint; The diluent is not coming out; I have tried with different syringes or needles.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in device usage process in a male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2293B, expiry date 05-DEC-2026) for prophylaxis. This case was associated with a product complaint. On 05-NOV-2025, the patient received the 1st dose of Arexvy. On 05-NOV-2025, an unknown time after receiving Arexvy, the patient experienced wrong technique in device usage process (Verbatim: The diluent is not coming out; I have tried with different syringes or needles.). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the wrong technique in device usage process and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the wrong technique in device usage process to be related to Arexvy. It was unknown if the company considered the wrong technique in device usage process to be related to Arexvy. Additional Information: GSK receipt date: 05-NOV-2025 and 11-NOV-2025 The reporter was consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.