Reporte zur Charge U6543AB

Symptomtext

Menactra was administered two days after the expiration date, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via agency (Reference number- 00495741) and transmitted to Sanofi on 26-Feb-2021. This case involves a 24 years old female patient who was vaccinated 0.5 ml second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], solution for injection (lot number- U6543AB, expiration date- 23-FEB-2021) via intramuscular route in the right deltoid for prophylactic vaccination on 25-FEB-2021 and reported that Menactra was administered two days after the expiration date (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications were given to the patient. It was a case of actual medication error due to expired vaccine used (same day latency). Also reported that the caller would like to know how to proceed in caring for the patient. MIA (Manufacturing and/or importation activities) transferred Health Care Professional who asked for appropriate follow-up after expired Menactra was given. It was not reported whether the patient had any adverse 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 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.