Received Feb 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK377AA | OT / LA |
negative disposition and product used/unsuitable product administered with no AE; Initial information received on 19-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3-year-old male patient who received unsuitable HIB (PRP/T) VACCINE [ACT-HIB] with no ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel) for Immunisation. On 30-Jan-2026, the patient received an unsuitable dose of 0.5ml of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (lot UK377AA and expiry date-31-DEC-2026) via intramuscular route in the left arm for Immunization with no ae (poor quality product administered) (latency-same day). It was reported that Refrigerator malfunction Max/Low Temperature reached: negative 1.6? Duration out of labelled range: 56 minutes; there was no previous excursion; the vaccine was administered post excursion; human error was not involved. Action taken was 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.
Daptacel