Received May 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8124AA | OT |
patient received vaccine that was stored at -0, with no reported adverse event; Initial information received on 23-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and gender patient who was administered with meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] that was stored at -0 temperature with no reported adverse event. On an unknown date, the patient received an unknown dose of suspect meningococcal a-c-y-w135 (t conj) vaccine, Solution for injection, lot U8124AA,expiry date:30-Sep-2027, strength not reported via unknown route in unknown administration site for immunization post excursion with temperature -0, with no reported adverse event (poor quality product administered). Reportedly, product was administered post-excursion. 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.