Received Apr 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | UNK | IM |
Aplisol was mistaken as diluent and mixed with the Menveo vaccine was given to the patient; Aplisol was mistaken as diluent and mixed with the Menveo vaccine was given to the patient; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of wrong solution used in drug reconstitution in a 73-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Co-suspect products included tuberculin ppd (Aplisol) for product used for unknown indication. On 06-MAR-2025 11:30, the patient received Menveo (intramuscular, unknown deltoid) and Aplisol (intramuscular) .1 ml. On 06-MAR-2025 11:30, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Aplisol was mistaken as diluent and mixed with the Menveo vaccine was given to the patient) and inappropriate dose of vaccine administered (Verbatim: Aplisol was mistaken as diluent and mixed with the Menveo vaccine was given to the patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 01-APR-2025 A spontaneous report was received from a nurse practitioner, concerning a 73 year old patient of an unknown gender, who experienced product preparation error, product administration error and incorrect route of product administration while using Aplisol for an unknown indication. Medical history and concomitant medications were not reported. On 06th March 2025 at 11:30 hour, the patient started Aplisol single dose via an intramuscular (IM) route in the deltoid (unknown dose). Co suspect medication included Menveo (meningococcal vaccine) via the IM route in the deltoid at an unknown dose and frequency, which was initiated on 06th March 2025 at 11:30 hour. It was reported that Aplisol was mistaken as diluent and mixed with the Menveo vaccine was given to the patient. At the time of this report, the action taken with Aplisol and Menveo was not applicable. The outcome of the events of product preparation error, product administration error and incorrect route of product administration was recovered.
APLISOL