Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 4 | UK305AB | OT / LL |
administration of only the DTap-IPV component of the PENTACEL, without reconstituting the ACT-HIB component with it with no adverse event; Initial information received on 03-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old male patient with administration of only the dtap-ipv component of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (VERO)], without reconstituting the act-hib component with it with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Oct-2025, the patient received dose 4 of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Powder and suspension for suspension for injection (strength standard) dose 0.5 ml 1x(once) lot UK305AB expiry date-30-Sep-2026 via intramuscular route in the left thigh for Immunization only the dtap-ipv component of the pentacel, without reconstituting the act-hib component with it with no adverse event (single component of a two-component product administered) (latency same day). Reportedly, No other vaccines given Action taken- 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.