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Report #2836493

Received Apr 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
Female
Age
11 yrs
State
PA
Recovered
Unknown
Vaccinated
Apr 1, 2025
Onset
Apr 1, 2025
Days to onset
0
Hospital days
—

Vaccines (1)

TypeNameManufacturerDoseLotRoute / Site
MNQMENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSUNKAMVB056A—

Symptoms (1)

Product preparation error

Symptom narrative

powder portion was drowning up with normal saline; powder portion was drowning up with normal saline; 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 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB056A, expiry date 31-AUG-2025) for prophylaxis. On 01-APR-2025, the patient received Menveo. On 01-APR-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: powder portion was drowning up with normal saline) and inappropriate dose of vaccine administered (Verbatim: powder portion was drowning up with normal saline). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 07-APR-2025 Other HCP reported that they received a box with 2 vials presentation (Menveo), one the powder one the liquid, and when drowning up to give to a patient, powder portion was drowning up with normal saline and the liquid was completely not given. Menveo reconstituted with normal saline instead of the supplied CYW-135 liquid conjugate, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.