Reporte zur Charge U65218A

Symptomtext

accidentally administered expired Menactra to 4 patients with no reported adverse event; Initial information received on 04-Aug-2021 regarding an unsolicited valid non-serious case from a nurse via Global Media information (under reference 00710627). This case involved 4 patients (unknown age and unknown gender) who accidentally received an expired dose of MENINGOCOCCAL VACCINE (MENACTRA) [expired product administered]. The past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patients received a 0.5 mL dose of suspect MENACTRA (lot U65218A, total, once and expiration date: 26-Jan-2021) via unknown route in an unknown administration site for prophylactic vaccination. It was an actual medication error due to expired vaccine used (same day latency). It was reported that "She said that they had read the expiration date wrong. She is looking for information on next steps. Outbound call placed on 04-Aug-2021 at 02:15 pm. the dates being entered into the system with the expiration date transposed with the year in the day spot and the day in the year spot. The caller reported that some of the patients recently received the expired Menactra and that at the time of this call the Patient Information and Administering physicians are unknown due to not having the information pulled up at the time of the call". At the time of reporting, it was unknown whether the patients had any adverse event or not. At time of reporting, the outcome was unknown for the reported 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.