Reporte zur Charge U6141AB

Symptomtext

had given an expired Tdap to a patient, with no ae; Initial information received on 28-Dec-2020 regarding an unsolicited valid non-serious case from a nurse. This case involves unknown age male patient who had given an expired tdap to a patient (expired product administered), while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patients medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided. On 21-Dec-2020, the patient was vaccinated with 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6141AB and expiration date: 15-Dec-2020) via unknown route in the right deltoid for prophylactic vaccination. On an unknown date December-2020, (unknown latency) after initiation suspect medication, patient had given an expired tdap to a patient (expired product administered). No adverse event reported at the time of reporting. 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 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.