Reporte zur Charge U658BA

Symptomtext

A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00600408) and transmitted to Sanofi on 13-May-2021. This case involves a male patient (age not reported) who received 0.5 mL dose of an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U658BA and expiry date: 20-Apr-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 13-May-2021 (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. The medical assistant (MA) was calling to get more information in regards to expired MENACTRA had been administered. This was a case of actual medication error case due to expired vaccine used (latency same day). At the time of reporting, no 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.