Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U82718C | OT |
Menquadfi was given to a patient after the excursion with no ae; Initial information received on 08-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an elderly and unknown gender patient who was administered with Meningococcal A-C-Y-W135 (T CONJ) vaccine [MenquadfI] after the excursion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength-unknown) (lot U82718C, expiry date- 31-Jan-2028) via unknown route in unknown administration site for Immunization after excursion (poor quality product administered) (latency-same day). Reportedly- Caller states that one their providers called previously to report a temperature excursion and some of the vaccines were not viable. She is calling to get information if they need to re-vaccinate the patient if the vaccine that was given were not viable. MENQUADFI that was no longer viable was given to a patient after temperature 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.