Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UKD43AA | OT |
only the DTap-IPV solution was given and the Hib component was not reconstituted with no reported adverse event; Initial information received on 25-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 8 weeks old female patient who experienced only the DTAP-IPV solution was given and the HIB component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was not reconstituted with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Feb-2025, the patient received only the DTAP-IPV solution with an unknown dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength- unknown, expiry date- 3-Aug-2025 and lot UKD43AA) via intramuscular route in unknown administration site for Immunization and the HIB component was not reconstituted 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.