Reporte zur Charge U654343AA

Symptomtext

17 year old male patient received expired dose of Menactra with no reported adverse event; Initial information received on 26-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 year old male patient who was vaccinated with an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered). Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 23-Mar-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U654343AA and expiry date: 23-Feb-2021) (Frequency once) via an intramuscular route in the left deltoid for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency on same day). It was also reported that the description: Office manager states that staff gave expired dose within a month of expiration date and asks if there is potential harm, how potent the vaccine is, and should another injection be given. Reporter relationship: health care professional (HCP) Product used: used Still using product: no At the time of report, 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 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.