Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | U7447AC | OT / RA |
administration of extra doses of MENQUADFI to a patient with no reported adverse event; Initial information received on 01-Dec-2025 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case- US-SA-2025SA362380 This case involves a 12 years old male patient reporter reported administration of extra doses of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 16-Jun-2023 the patient received dose 1 of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection dose 0.5 ml Frequency = once (strength standard) batch U7447AC, expiry date-20-Sep-2024 via intramuscular route in the right deltoid for immunization. On 17-Jul-2024 (Patient age: 12 years old) he also received dose 2 (dose 0.5 ml once)of same vaccine batch U7986AA expiry date-31-Mar-2026 via intramuscular route in the right deltoid for immunization extra doses of menquadfi to a patient with no reported adverse event (extra dose administered) following (latency same day). On 12-Sep-2025 (13 years old), the patient received a dose 3 of same vaccine (0.5 ml once) lot U8508AA expiry date-31Jul-2028 via intramuscular route in the left deltoid for immunization. It was reported "The only dose that was necessary was the dose the patient received on 16-JUN-2023. The state website for schools, health departments and healthcare professionals, did not show that the patient had previously received any doses, so the patient received both products three years in a row." Action taken- 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.; Sender's Comments: US-SA-2025SA362380: