Reporte zur Charge UJ62AAA

Symptomtext

Patient only receiving the liquid component (DTAP-IPV) and not the ACTHIB component of the PENTACEL vaccine with no reported adverse event; Initial information was received on 28-Feb-2022 regarding an unsolicited valid non-serious case via call center received from physician. This case involves a 1 months old male patient who experienced patient only receiving the liquid component (dtap-ipv) and not the acthib component of the pentacel vaccine 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 pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) for Immunisation. On 27-Apr-2022, the patient received 0ne dosage form of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (lot UJ62AAA, expiry- 7-dec-22) (strength; unknown) via intramuscular route in the left thigh for immunization. On 27-APR-2022 the patient developed a non-serious patient only receiving the liquid component (dtap-ipv) and not the acthib component of the pentacel vaccine with no reported adverse event (product preparation error) (latency: same day) 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 patient only receiving the liquid component (dtap-ipv) and not the acthib component of the pentacel vaccine with no reported adverse 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.