Report #2901033

Overview

Sex

Unknown

Age

Age unknown

State

CA

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

Potential maladministration of only the adjuvant component of Arexvy; Potential maladministration of only the adjuvant component of Arexvy; 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) suspension for injection (batch number 29EH4 with expiry date 19-JAN-2027 and batch number 4C4J2 with expiry date 19-JAN-2027) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) suspension for injection in pre-filled syringe (batch number TL74Y with expiry date 19-MAY-2028) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Arexvy and Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Potential maladministration of only the adjuvant component of Arexvy) and inappropriate dose of vaccine administered (Verbatim: Potential maladministration of only the adjuvant component of Arexvy). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-JUN-2026 The reporter reported that a patient received Arexvy but may have only received the adjuvant component without the lyophilized component of the vaccine. The reporter was conducting an investigation to determine if there was an error in the administration of the vaccine and provided three different lot numbers and their expiration dates to further assess whether an error was made. Lot numbers 4C4J2 and 29EH4 were not found in the Medical Information database, but lot number TL74Y corresponded to Shingrix PFS. The reporter did not know if Arexvy was administered with any other diluent component but asked whether the patient effectively received the vaccine if only the adjuvant component of Arexvy was administered. It was unclear whether Shingrix was also involved in the maladministration error or if it was simply administered along with the intended Arexvy. The health care professional did not have a clear understanding of what had happened or whether an actual error occurred but did not provide any indication that Arexvy was reconstituted with Shingrix PFS.