Reporte zur Charge U75268A

Symptomtext

a child was administered Quadracel after they had turned 7 years of age with no reported adverse event; Initial information received on 23-Nov-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 7 years old female patient who was administered diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] after they had turned 7 years of age with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis A vaccine inact (Havrix) for Immunisation. On 21-Nov-2022, the patient received 0.5 mL total dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (formulation and strength not reported; lot U75268A and expiry date: 07-Sep-2024) via intramuscular route in unknown administration site for prophylactic immunization. On 21-Nov-2022, the patient who was a child was administered quadracel after they had turned 7 years of age with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). It was reported, a child was administered QUADRACEL after they had turned 7 years of age. This situation is reported as a medication error due to the patient not being in the age range of 4-6 years as stated on the label. 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.