Reporte zur Charge C5666BNA

Symptomtext

Patient received an expired dose of Adacel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via Medical Information (MI) (Reference number- 00794447) and transmitted to Sanofi on 01-Oct-2021. This case involves Adult female patient who was received an expired dose DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Expired product administered). Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 30-Sep-2021, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5666BNA, expiry: 17-Sep-2021) via intramuscular route in the right arm for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency same day). It was reported "A Pharmacist reporting that a consumer received an expired dose of ADACEL, on 30Sep2021. The caller reported that the vaccine expired on 17Sep2021 and the dose was given on 30Sep2021 and that the consumer is between the age of 30 to 40 years old." No other adverse event was reported. 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.