Received Jun 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Possible administration only of the adjuvant portion; Possible administration only of the adjuvant portion; 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) 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: Possible administration only of the adjuvant portion) and inappropriate dose of vaccine administered (Verbatim: Possible administration only of the adjuvant portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 05-JUN-2025 It was asked if its possible to use the Arexvy vaccine with another diluent, different that the one in the vaccine box. They reported that they cannot find the adjuvant portion for the Arexvy vaccine. They are not sure if they missed the diluent, if they drop the vial, if a patient received only the diluent, etc During the call, they mentioned that they did not administer the powder portion plus another diluent to any patient, however, we will report this as a possible AE in case that a patient received only the adjuvant portion. As they did not know what happened with the Arexvy diluent, HCP did not provide any patient nor vaccine details. They mentioned that they did not administer the powder portion plus another diluent to any patient, however, we will report this as a possible AE in case that a patient received only the adjuvant portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.