Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK235AC | OT |
patient only received the liquid dtap-IPV portion. The patient did not receive the hib component since it was not reconstituted with the liquid portion of pentacel with no reported adverse event; Initial information received on 04-Nov-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who only received the liquid dtap-ipv portion and did not receive the hib component since it was not reconstituted with the liquid portion 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 received only the liquid Dtap-Ipv portion and did not receive the Hib component since it was not reconstituted with the liquid portion of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, (unknown strength and formulation) lot UK235AC and expiry date via unknown route in unknown administration site for immunisation, with no reported adverse event (single component of a two-component product administered) (latency 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.