Received May 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNQ | MENINGOCOCCAL CONJUGATE (MENQUADFI) | SANOFI PASTEUR | 1 | u8369AA | IM / LA |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8369AA | OT / LA |
inappropriate use due to dilution of menquadfi with sterile saline with no reported adverse event; Initial information received on 28-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old male patient for who inappropriate use due to dilution of meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] with sterile saline 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 and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) both for Immunisation. On 27-May-2025, the patient received an unknown dose (1.2ml) 1X (once) inappropriate use due to dilution of meningococcal a-c-y-w135 (t conj) vaccine; Solution for injection (Strength = standard) (lot U8369AA with expiry date 01-MAR-2028) via intramuscular route in the left deltoid for Immunization; with sterile saline with no reported adverse event (product preparation error) (latency: same day). Reportedly: he needs to readminister a menquadfi dose. She stated she thought it was a powder that needed to be reconstituted, so they added 0.7 ml of sterile saline to the 0.5 ml dose, diluting it to a volume of 1.2 ml total. 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.
HPV VACCINE; TDAP