Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8193AA | OT |
Menquadfi was administered post-excursion, fridge malfunction, max/low temperature reached: negative 2.4 c duration: 13 hours and 30 minutes with no reported adverse event; Initial information received on 09-Sep-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 was administered with Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] that had temperature excursion due to, fridge malfunction, where max/low temperature reached: negative 2.4 c duration: 13 hours and 30 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2025, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot U8193AA and expiry date-30-Sep-2025) via unknown route in unknown administration site for Immunization that had temperature excursion due to, fridge malfunction, where max/low temperature reached: negative 2.4 c duration: 13 hours and 30 minutes with no reported adverse event (poor quality product administered) (latency- same day) Reportedly-There was no previous excursion. extended stability data does not cover the excursion, human error was not involved, The product was administered. 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.; Sender's Comments: US-SA-2025SA270817:menquadfi