Reporte zur Charge U6990AA

Symptomtext

consumer only receiving the dtap-ipv portion and not the hib portion due to the staff member not knowing to mix the two parts with no reported adverse event; Initial information received on 31-May-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 years old female patient, consumer only receiving the dtap-ipv portion and not the hib portion due to the staff member not knowing to mix the two parts with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis b vaccine (hepatitis b vaccine) for prophylactic vaccination; and measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (proquad) for prophylactic vaccination. On 19-May-2022, the patient received a dose of suspect vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine suspension for injection (lot U6990AA, expiry date: 07-Au-2022; strength: unknown) total one day at a dose of 0.5 ml via intramuscular route in the left deltoid as prophylactic vaccination. On 19-MAY-2022, the consumer only receiving the dtap-ipv portion and not the hib portion due to the staff member not knowing to mix the two parts with no reported adverse event (product preparation error) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine. 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 guidelines. 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.