Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
medication error/an inappropriate use due to administration of 3 doses of MENQUADFI; Initial information received on 07-Oct-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 16-year-old and unknown gender patient who received of 3 doses of Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received an unknown 3 doses of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection (lot number, strength, expiry date-unknown) via unknown route in unknown administration site for Immunization with no reported ae (adverse event) (extra dose administered). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.