Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UC107AA | OT |
Hib component was not reconstituted with the DTaP-IPV component, resulting in the four-month-old patient receiving only the DTaP-IPV component, with no reported adverse event; Initial information received on 17-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient where hib component was not reconstituted with the dtap-ipv component, resulting patient receiving only the dtap-ipv component, of vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Feb-2025, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot- UC107AA and expiry date- 30-SEP-2025) via intramuscular route in the left leg (dose and strength: not provided) for Immunization and hib component was not reconstituted with the dtap-ipv component, resulting in the patient receiving only the dtap-ipv component, with no reported adverse event (single component of a two-component product administered) (latency- same day). Action taken- not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. 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.