Received Aug 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | — | OT |
3rd PENTACEL dose was not properly spaced from the second dose received Pentacel at 3 months, 5 months, and then at 6 months with no reported adverse event; Initial information received on 21-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who received 3rd diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] dose was not properly spaced from the second dose received pentacel at 3 months, 5 months, and then at 6 months 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 dose 3 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Immunisation that was not properly spaced from the second dose received pentacel at 3 months, 5 months, and then at 6 months with no reported adverse event (inappropriate schedule of product administration) (Latency same day) Information on the batch number was requested corresponding to the one at time of event occurrence Action 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.