Received Aug 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK232AB | OT |
inappropriate use due to patient not receiving a full dose with no reported adverse event; Initial information received on 22-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient with unknown age and gender who did not receive full dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] 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 did not receive a full dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot UK232AB, expiry date 31-Aug-2026, strength not reported) via unknown route in unknown administration site for Immunisation, with no reported adverse event (incorrect dose administered) (latency same day). Reportedly, nurse stated that they had patient that was administered with Pentacel but the patient moved and was not able to get the full dose. Nurse was not sure of if the patient was able to get at least half the dose but the needle punctured the patient's skin. 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.