Received Dec 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
patient received PENTACEL, but only the liquid Dtap Polio was given, and the Hib powder part was not reconstituted with no reported adverse event; Initial information received on 05-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves patient of unknown demographics who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)], but only the liquid dtap polio was given, and the hib powder part 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 an unknown date, patient received suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization but only the liquid dtap polio was given, and the hib powder part was not reconstituted with no reported adverse event (single component of a two-component product administered) (latency: on same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. 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.