Received Apr 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | NG9E2 | — |
Use of the One-vial Presentation of Menveo Outside the Approved Age Range; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number NG9E2, expiry date 30-JUN-2025) for prophylaxis. On 26-MAR-2025, the patient received Menveo. On 26-MAR-2025, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Use of the One-vial Presentation of Menveo Outside the Approved Age Range). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 10-JUN-2025 The clinical operations manager reported that Menveo 1-vial was administered to a 4 year-old male child which led to inappropriate age at vaccine administration. Upon internal review the case was updated on 14-APR-2026. The case was incorrectly assessed as invalid by Intake. Upon reassessment, the case was routed to Valid; however, no additional tracking memo documenting the error correction was created to maintain case validity initially. Therefore, new tracking memo had been added in order for report scheduler to run. Summary of changes: General tab and narrative tab were updated.