Received May 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
patient was administered the liquid DTaP-IPV component of Pentacel without mixing it with the Hib component of the vaccine with no reported adverse event; Initial information received on 09-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old patient with unknown gender who was administered with the liquid dtap-ipv component of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] without mixing it with the hib component of the vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-May-2025, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization (Immunisation) and was administered the liquid dtap-ipv component of pentacel without mixing it with the hib component of the vaccine with no reported adverse event (single component of a two-component product administered). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, caller stated that she accidentally gave only the liquid DTaP-IPV component of the Pentacel vaccine to a 7-month-old baby, without first mixing it with the Hib component of the vaccine, and she is asking for information on that. 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.