Reporte zur Charge U6877BC

Symptomtext

patient was administered a dose of MENACTRA, today, from an expired MENACTRA vial with no reported adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 16 years old male patient who was administered a dose of meningococcal A-C-Y-W135 (D conj) vaccine [Menactra], today, from an expired menactra vial with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Aug-2022, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (D conj) vaccine (formulation and strength not reported; lot U6877BC, expiry date: 28-Feb-2022) via intramuscular route in the left deltoid for immunization. On 12-Aug-2022, the patient was administered a dose of meningococcal A-C-Y-W135 (D conj) vaccine [Menactra], today, from an expired menactra vial with no reported adverse event (expired product administered) (latency : same day). It was reported, "stated a 16 year old male patient was administered a dose of MENACTRA, today, from an expired MENACTRA vial. Caller asked, about the efficacy the dose that was administered from an expired MENACTRA vial that was administered to the patient". Action taken was not applicable. At time of reporting, the outcome was Unknown for the 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 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.