Received Oct 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | AE435 | — |
about 1/3 of the dose was loosed in the process; vaccine did get in contact with patient skin; vaccine did get in contact with patient skin; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 56-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number AE435, expiry date 13-OCT-2025) for prophylaxis. On 09-SEP-2025, the patient received Arexvy. On 09-SEP-2025, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: about 1/3 of the dose was loosed in the process), exposure via skin contact (Verbatim: vaccine did get in contact with patient skin) and inadvertent exposure to vaccine (Verbatim: vaccine did get in contact with patient skin). The outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were not applicable. Additional Information: GSK Receipt Date: 09-SEP-2025 The Vaccine Administration Facility was the same as the Primary Reporter. The reporter mentioned they had attempted to administer an Arexvy vaccine to a patient, but the syringe was defective. The Health Care Professional informed that there had been a crack in the needle connector, so the quality issue was not from the Pre-Filled Syringe, and that the vaccine had come into contact with the patient's skin. The reporter had called to verify whether another dose should be administered to the patient.