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 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 (Tdap) and HPV vaccine (HPV). On 12-Mar-2026, the patient received a 0.5 mL dose 1 of Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (batch/lot number: U8574AA, expiration date: 30-Sep-2028) (strength: standard) via intramuscular route in left deltoid for immunisation [Immunisation]. The patient was administered to Menquadfi post temperature excursion with no reported adverse event [Poor quality product administered, onset: 12-Mar-2026 and latency: same day]. A temperature excursion occurred due to a refrigerator malfunction, with the temperature reaching 48.9°F (9.389°C) for a duration of 712 hours (March 5th - April 1st). The products were determined to be unsuitable for use following this excursion. The reason of the excursion: Malfunction with refrigerator and not related to human error. 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