Received Jan 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK232AB | OT |
PENTACEL's ACTHIB component, there is a possibility that it has been used with a different diluent/ACTHIB component was only given with no reported adverse event; Initial information received on 23-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves patient of unknown demographics and is reported diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel] acthib component, there is a possibility that it has been used with a different diluent/acthib component was only given with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection of lot UK232AB and expiry date: 31-Aug-2026 via unknown route in unknown administration site for Immunization and pentacel's acthib component, there is a possibility that it has been used with a different diluent/acthib component was only given with no reported adverse event (product preparation error) (latency: on same day). 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.