Reporte zur Charge U6346AA

Symptomtext

Patient was given an expired Menactra , with no adverse event; Initial information received on 19-Apr-2021 regarding an unsolicited valid non-serious case from a other health professionals This case involves a 22 years old female patient who received an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (0.5 ml, lot U6346AA and expiration date: 30-Aug-2020, frequency: once) via intramuscular route in the right deltoid for prophylactic vaccination on 19-Apr-2021 (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitants were administered to the patient. It was an actual medication error due to expired vaccine used (latency: same day). Reported that caller asked what to do if an expired Menactra was given to a patient. At the time of reporting, it was unknown 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 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.