Received Feb 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | 1 | 4CA34C1 | OT / LL |
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 1 | UK377AA | OT / RL |
negative disposition and product used/unsuitable product administered with no reported adverse event; Initial information received on 19-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1-year-old female patient and reported negative disposition and HIB (PRP/T) VACCINE [ACT-HIB] product used/unsuitable product administered with no reported 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 a 0.5 ml (dose 1) of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection of lot UK377AA and expiry date: 31-DEC-2026 via intramuscular route in the right thigh for Immunization and negative disposition and product used/unsuitable product administered with no reported adverse event (poor quality product administered) (latency: on same day). It was reported, Cause: Refrigerator malfunction Max/Low Temperature reached: negative 1.6? Duration out of labelled range: 56 minutes Previous excursion: None Administered post-excursion: Yes Suitable for use after the excursion: No Human Error: No 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