Received Sep 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK341AA | OT |
inappropriate use due to administering only the dtap-ipv component of the pentacel to a patient, without reconstituting the act-hib component with no reported adverse event; Initial information received on 02-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received only the DTAP-IPV component of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)], without reconstituting the ACT-HIB component with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Sep-2025, the patient received only the DTAP-IPV component of the Unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection of standard strength, frequency once with lot UK341AA and expiry date 31-Aug-2026 via unknown route in unknown administration site for immunization, without reconstituting the ACT-HIB component with no reported adverse event (single component of a two-component product administered) (Latency same day). Reportedly, Reporter stated that one of the nurses administered pentacel to a patient, but they did not make the two vials. The nurse only administered the DTaP and IPV component, and not the Hib component. 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.