Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 3 | UK226AA | OT / LL |
pentacel was administered too early so the dose for IPV was given too early as well with no adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 18 months old male patient who received diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] too early so the dose for IPV was given too early as well with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis a vaccine for Immunisation. On 15-Jul-2025, the patient received 0.5 ml of dose 3 of diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection (strength- Standard, expiry date- 31-AUG-2026 and lot UK226AA) once via intramuscular route in the left vastus lateralis for Immunization and the dose was administered too early so the dose for IPV was given too early as well with no adverse event (inappropriate schedule of product administration) (latency- same day). Reportedly, Treatment: No reaction, no treatment 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.
Hepatitis A