Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK235AC | OT / LL |
medication error (unintentional)/an inappropriate use (unknown intention) due to administration error for PENTACEL/administered only the Hib component of the PENTACEL with no reported adverse event; Initial information received on 05-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 months old male patient who was administered with Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel] only the HIB component with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Nov-2025, the patient received a dose of 0.7ml suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (lot UK235AC and expiry date-31-Aug-2025) standard strength, frequency once via intramuscular route in the left vastus lateralis for Immunization only the HIB component 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.