Received Nov 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | OT |
administration of menquadfi to a 12-year-old patient less than three months after their last menquadfi dose with no reported adverse event; Initial information received on 21-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old male patient who was administered to Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] which was less than three months after their last menquadfi dose with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Sep-2025, the patient received an unknown dose (dose 1) of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (lot number not reported) via unknown route in the unknown site and on 21-Nov-2025, he also received 0.5mL (dose 1) (lot U8599AA, expiry date 31-Oct-2028, frequency once and strength standard) via intramuscular route in the left deltoid for Immunisation, 12-year-old patient less than three months after their last menquadfi dose with no reported adverse event (product administered to patient of inappropriate age) (latency same day). It was reported 'nurse leader called to seek guidance following the administration of Menquadfi to a12-year-old patient less than three months after their last Menquadfi dose. They explained that a patient had just received Menquadfi in their facility on 21-Nov-2025. Only after the vaccination were they able to confirm that they received their first Menquadfi dose on 09-Sep-2025.' 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.