Symptomtext
nurse administered the DTAP-IPV component to the patient without reconstituting the HIB component with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 18 months old female patient who experienced nurse administered the diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] component to the patient without reconstituting 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 an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection lot UJ849AA via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (poor quality product administered) (latency- same day). Reportedly, only the DTAP-IPV component was given and not the HIB component. As per caller one of their nurses was rushing and did not realize there is a 2nd vial. The nurse administered the DTAP-IPV component to the patient without reconstituting the HIB component Action taken- not applicable. 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.