Reporte zur Charge U67028A

Symptomtext

received two-doses of ADACEL in 28-days without realizing already received injection with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Global Medical Information (Reference number- 00759955) and transmitted to Sanofi on 08-Sep-2021. This case involves a 50-year-old female patient who received two-doses of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (suspension for injection) 0.5 mL (total, once) [lot U67028A, expiry date 20-Jun-2022] via intramuscular route at an unknown administration site on 08-Sep-2021 for prophylactic vaccination in 28-days without realizing already received injection (extra dose administered). Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided. It was a case of actual medication error due to extra dose administered (latency was on same day). At the time of report, no adverse event 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.