Received Jun 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | OT / LA |
pre-assessed as a medication error/an inappropriate use due to prescription of inappropriate vaccine and receiving unindicated extra dose of MENQUADFI with no reported adverse event; Initial information received on 13-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 year old female patient who received unindicated extra dose of Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Mar-2019, the patient received an unknown dose (dose 1) of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection and On 12-Jul-2024 she also received an unknown dose (dose 2) of vaccine both with (lot number and expiry date-unknown) via unknown route in unknown administration site. On 13-Jun-2025 she received an extra dosed 0.5ml (dose 3) standard strength of vaccine (lot-U8194AA) (expiry date-unknown) via intramuscular route in left deltoid for Immunization with no reported adverse event (extra dose administered). Reportedly- Nurse stated that the patient should have received MenB (Bexsero) but the provider mistakenly ordered Menquadfi instead. 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.