Reporte zur Charge UJ620AA

Symptomtext

staff member gave the liquid portion of PENTACEL to a 4 month old with no reported AE; Initial information received on 16-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old patient of unknown gender to whom staff member gave the liquid portion of Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (VERO) Vaccine [Pentacle] portion and not HIB (PRP/T) Vaccine[ACT-HIB] portion 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 a staff member gave DTAP/IPV portion of the vaccine (lot - U7130AA) (strength, dose, route, formulation, expiry date not reported) via unknown route at unknown administration site for Immunization and not the ACTHIB portion to a 4 month old with no reported adverse event (Product preparation error) (unknown latency). 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.