Reporte zur Charge UJ684AAA, U7331

Symptomtext

a dose of PENTACEL was administered and only the liquid component was administered, with no reported adverse event; whether the powdered portion consist of only the HIB portion of the vaccine and what diluent it now needs to be reconstituted with, wit no reported adverse event; Initial information received on 17-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who received a dose of pentacel was administered and only the liquid component was administered, with no reported adverse event and whether the powdered portion consist of only the hib portion of the vaccine and what diluent it now needs to be reconstituted with, wit 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 A VACCINE (HEPATITIS A VACCINE) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation. On 06-Jan-2023, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ684AAA, U7331AA (DILUENT) via unknown route in unknown administration site. On an unknown date the patient recieved a dose of pentacel was administered and only the liquid component was administered, with no reported adverse event (single component of a two-component product administered) and whether the powdered portion consist of only the hib portion of the vaccine and what diluent it now needs to be reconstituted with, wit no reported adverse event (product preparation error) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. At time of reporting, the outcome was Unknown for both the events. 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.