Received Jun 1, 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 other health care professional. This case involves an 11-year-old male patient who was administered with the suspect 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, were not provided. Concomitant medication(s) included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Tdap) and human papillomavirus (HPV) vaccine (HPV). On 10-Mar-2026, the patient received 0.5 ml (dose 1) of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine solution for injection (strength: standard and frequency: once), batch: U8574AA,expiry date:30-Sep-2028 via intramuscular route in the left deltoid for immunization, post excursion with no reported adverse event (Poor quality product administered) (latency: same day) It was reported "A medical assistant reported a temperature excursion and asked for guidance about it. The product involved was an unopened MENQUADFI. The reason for the excursion was malfunction with refrigerator. No human error was involved. The temperature reached (maximum/lowest) was 48.9degF (9.389degC). The duration of excursion was from March 5th to April 1st (712 hours)". 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