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 an other healthcare professional (HCP). This case involves an 11-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). 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) via intramuscular route in left deltoid for immunization, post excursion with no reported adverse event (Poor quality product administered, and latency: same day) (batch: U8574AA, expiry date: 30-Sep-2028). It was reported "human error was not involved Medical assistant reported a temperature excursion and asked for guidance about it. # Product(s) involved: unopened MENQUADFI. Reason of the excursion: Malfunction with refrigerator; Temperature reached (maximum/lowest): 48.9F (9.389C) and Duration of excursion: 05-Mar-2026 ndash 01-Apr-2026 (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