Received Jun 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8494AA | OT |
one of their providers mistakenly mixed sterile water diluent with MENQUADFI and a patient received it with no reported AE; Initial information received on 16-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who had received Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] which was mistakenly mixed with sterile water diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Jun-2025, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection, lot U8494AA,expiry date: 30-Jun-2028, Frequency = once, Strength = standard via unknown route in unknown administration site for immunization which was mistakenly mixed with sterile water diluent with no reported adverse event (product preparation error) (latency: same day). Reportedly, Vaccine program coordinator called saying that one of their providers mistakenly mixed sterile water diluent with MENQUADFI and a patient received it. They wanted to confirm if the patient should be revaccinated 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.