Received Mar 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 52Z52 | — |
one of the powder vials (diluent) was not mixed; one of the powder vials (diluent) was not mixed; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 82-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52Z52, expiry date 16-OCT-2025) for prophylaxis. On 20-MAR-2025, the patient received Arexvy. On 20-MAR-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: one of the powder vials (diluent) was not mixed) and inappropriate dose of vaccine administered (Verbatim: one of the powder vials (diluent) was not mixed). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 20-MAR-2025 The pharmacist reported that after mixing doses, he/she realized that after vaccination one of the powder vials (diluent) was not mixed and the patient was given an incomplete dose which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist does not know which of these patients was given the incomplete dose. No further information was obtained The Vaccine Administration Facility was the same as Primary Reporter. This case was linked with US2025034231, reported by same reporter.; Sender's Comments: US-GSK-US2025034231:same reporter different patient