Reporte zur Charge U669OAB

Symptomtext

patient received MENACTRA 2 days after expiration date/no AE; Initial information was received on 03-Sep-2021 regarding an unsolicited valid non-serious case from other healthcare professional. This case involves a 11-year-old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] 2 days after expiration date (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV VACCINE and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination. On 25-Aug-2021, the patient received first dose of 0.5 ml suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (solution for injection, lot U669OAB and expiry date 23-Aug-2021) via an intramuscular route in the left deltoid for prophylactic vaccination (expired product administered). It was reported, "caller reports that a patient was given expired MENACTRA; MENACTRA was administered 2 days after expiration date. Caller asks for recommendations following administration of expired product. " It was a case of an actual medication error due to expired vaccine administered (latency-same day). At 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 guidelines. 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.