Received May 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8574AA | IM / LA |
Administered MENQUADFI post temperature excursion with no reported adverse event; Initial information received on 18-May-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves an 11-year-old female patient who was administered to Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] post temperature excursion with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, concomitant medications were not provided. Concomitant medication(s) included [Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (rdap), Hev vaccine (aev)]. On 02-Mar-2026, the patient received a 0.5 mL (dose 1) of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi], Solution for injection (batch/lot number: U8574AA, expiry date: 30-Sep-2028) (strength: standard) via intramuscular route in left deltoid for immunization [Immunisation]. The patient experienced administered Menquadfi post temperature excursion with no reported adverse event (Poor quality product administered, onset: 02-Mar-2026, latency: same day). The Menquadfi vaccine had been exposed to a temperature excursion of 48.9°F (9.38°C) for 712 hours from 05-Mar-2026 to 01-Apr-2026 due to refrigerator malfunction. Despite the temperature excursion, the product was administered to the patient. No adverse event was reported following the administration. Action taken: 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.
Comments: NONE
Tdap; HPV vaccine