Received May 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | U8369BA | OT / LA |
menquadfi was given twice to a patient 19 days apart with no reported adverse event; Initial information received on 21-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 12 years old male patient who has been administered Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] twice, 19 days apart with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV Vaccine for prophylactic vaccination. On 01-May-2025, the patient received a 0.5 ml 1x (once) (dose:1) of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine (batch number: U8369BA, expiry date: 31-Mar-2028) via intramuscular route in the left arm and on 20-May-2025 the patient had received a 0.5 ml 1x (dose:2) of same vaccine (batch number and expiry date) via intramuscular route in the left arm for immunization. On 20-MAY-2025 Meningococcal A-C-Y-W135 (T CONJ) Vaccine was given twice to a patient 19 days apart with no reported adverse event (Inappropriate schedule of product administration) (latency: 19 days). 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.
HPV VACCINE