Received Aug 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK342AA | OT / LL |
medication error/an inappropriate use due to the reconstituting the ACTHIB component PENTACEL with sterile water with no reported adverse event; Initial information received on 12-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient and there was inappropriate use due to the reconstituting the acthib component Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Caller reported that 0.5mL of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot UK342AA, expiry date 31-Aug-2026) via intramuscular route in the left thigh for Immunisation and on 11-Aug-2025, an inappropriate use due to the reconstituting the acthib component pentacel with sterile water with no reported adverse event (product preparation error). 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.