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 other health care professional. This case involves a 12-year-old female patient who was administered 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, and concomitant medications were not provided. Concomitant medication(s) included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Tdap) and Human papilloma virus vaccine (HPV). On 17-Mar-2026, the patient received a 0.5 mL once dose 1 of meningococcal A-C-Y-W135 (T CONJ) vaccine solution for injection (batch number: U8574AA, expiry date: 30-Sep-2028) (strength: unknown) via intramuscular route in left deltoid for immunization post excursion with no adverse event (Poor quality product administered, and latency: same day). It was reported that, Reason of the excursion: Malfunction with refrigerator. Human Error: No. Temperature reached (max/low): 48.9F (9.389C). Duration of excursion: March 5th - April 1st (712 hours). Products still suitable for use after the excursion- No. 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 medication 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.
Tdap; HPV vaccine