Reporte zur Charge U6594AB

Symptomtext

patient received an expired dose of MENACTRA; Initial information was received on 01-Jun-2021 regarding an unsolicited valid non-serious case from a other health professional (Agency Inquiry number: 00623308). It was reported that a 57-year old female patient received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Suspension For Injection) (lot number: U6594AB, expiry date: 21-May-2021) on 28-May-2021 via intramuscular route at right arm for prophylactic vaccination (expired product administered). It was a case of actual medication error due to expired vaccine used. 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 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.