Received Jul 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
only the ACTHIB component of PENTACEL was administered with no reported adverse event; Initial information received on 09-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who ronly eceived the Act-Hib component 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 Act-Hib component suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, (Unknown formulation, strength and expiry date) lot number not reported via unknown route in unknown administration site for immunization with no reported adverse event (single component of a two-component product administered) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence was requested. Reportedly, Nurse verified that they administered powdered part with sterile water diluent. She reported that and would now like to know what to do with the DTAP 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.