Symptomtext
Medical Assist reconstituted the Hib component of PENTACEL with normal saline, administered it to a patient/DTaP-IPV portion of PENTACEL was not given to the patient, this is how they discovered that only the Hib portion was given with no reported ae; Initial information received on 02-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old female patient whose medical assist (assistant) reconstituted the hib component of pentacel with normal saline, administered it to a patient/dtap-ipv portion of pentacel was not given to the patient, this is how they discovered that only the hib portion was given with no reported ae (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 Sodium Chloride (Normal Saline). On 06-Jan-2022, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE , once, (formulation, strength: unknown) lot UJ502AA via intramuscular route in unknown administration site as Immunisation. On 06-JAN-2022 the medical assist reconstituted the hib component of pentacel with normal saline, administered it to a patient/dtap-ipv portion of pentacel was not given to the patient, this is how they discovered that only the hib portion was given with no reported ae (product preparation error) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken was 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.