Reporte zur Charge U66908AAA

Symptomtext

expired MENACTRA was administered to a patient with the expiration date of 23Aug2021 with no reportd adverse event; Initial information received on 24-Jun-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 14 years old patient of unknown gender to whom expired menactra was administered with the expiration date of 23aug2021 with no reportd adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation. On 24-JUN-2022, the patient received a 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, frequency, formulation was unknown, lot U66908AAA and expiry date: 23-Aug-2021) via unknown intramuscular route in right deltoid for Immunization. Patient was not taking it for the first time. On 24-JUN-2022 the patient developed a non-serious event of expired menactra was administered to a patient with the expiration date of 23aug2021 with no reported adverse event (expired product administered) (same day latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Action taken : not applicable. Outcome: unknown 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.