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Report #2826461

Received Feb 17, 2025

A note on interpretation. VAERS reports are unverified and may be incomplete or coincidental. A report does not establish that a vaccine caused an event, and counts should not be used to calculate incidence or infer causation. Full disclaimer

Overview

Sex
Unknown
Age
Age unknown
State
MI
Recovered
Unknown
Vaccinated
—
Onset
—
Days to onset
—
Hospital days
—

Vaccines (2)

TypeNameManufacturerDoseLotRoute / Site
RSVRSV (AREXVY)GLAXOSMITHKLINE BIOLOGICALSUNK——
VARZOSZOSTER (SHINGRIX)GLAXOSMITHKLINE BIOLOGICALSUNK——

Symptoms (1)

Product preparation error

Symptom narrative

Arexvy reconstituted with a different diluent; Shingrix reconstituted with a different diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Arexvy and Shingrix. On an unknown date, an unknown time after receiving Arexvy and not applicable after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Arexvy reconstituted with a different diluent) and wrong solution used in drug reconstitution (Verbatim: Shingrix reconstituted with a different diluent). The outcome of the wrong solution used in drug reconstitution and wrong solution used in drug reconstitution were unknown. Additional Information: GSK Receipt Date: 07-FEB-2025 Nurse reported that she realized that her staff has been using other diluents to reconstitute Shingrix and Arexvy vaccines, probably sterile water, which led wrong solution used in drug reconstitution. At the moment of the call, there was no patient information available. The reporter consented to follow up.