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Report #2835164

Received Apr 9, 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
Male
Age
83 yrs
State
CA
Recovered
Unknown
Vaccinated
Mar 20, 2025
Onset
Mar 20, 2025
Days to onset
0
Hospital days
—

Vaccines (1)

TypeNameManufacturerDoseLotRoute / Site
RSVRSV (AREXVY)GLAXOSMITHKLINE BIOLOGICALSUNK52Z52—

Symptoms (2)

Incorrect dose administeredProduct preparation issue

Symptom narrative

Pharmacist realized that after vaccination one of the powder vials (diluent) was not mixed; one of those patients was given an incomplete dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 83-year-old male 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: Pharmacist realized that after vaccination one of the powder vials (diluent) was not mixed) and inappropriate dose of vaccine administered (Verbatim: one of those patients was given an incomplete dose). 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 asked about guidance on revaccination on two patient that was vaccinated, nevertheless after mixing doses, the pharmacist realized that after vaccination one of the powder vials (diluent) was not mixed and one of those patients was given an incomplete dose. The pharmacist did not know which of this patient was given the incomplete dose. Vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter.; Sender's Comments: US-GSK-US2025034229:same reporter different patient