Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK205A | OT / LA |
hcp's mixed the powder of pentacel with water instead of the diluent that is provided with no reported ae; Initial information received on 29-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 month old female patient who was administered with Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] that was mixed with water instead of the diluent that was provided with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included chicken pox vaccine (administered in right arm). On 28-Jul-2025, the patient received a dose of 0.5ml of suspect Diphtheria/Tetanus/5 hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UK205A and expiry date-30-Sep-2026) (strength-unknown) via intramuscular route in the left arm for Immunization that was mixed with water instead of the diluent that was provided with no reported ae (product preparation error) (latency-same day). Reportedly- Pentacel was mixed with saline instead of the prescribed diluent. 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.