Reporte zur Charge U6827BD

Symptomtext

accidentally gave a expired Menactra four days after the expiration date with no reported adverse event; Initial information received on 25-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 35 years old female patient who experienced accidentally gave a expired menactra four days after the expiration date with no reported 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 medications included Measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination. On 22-Feb-2022, the patient received a suspect Meningococcal a-c-y-w135 (D Conj) vaccine at a dose of 0.5 mg (strength; not reported) lot U6827BD via intramuscular route in unknown administration site for immunization. On 22-FEB-2022 the patient developed a non-serious accidentally gave a expired menactra four days after the expiration date with no reported adverse event (latency :same day) (expired product administered). Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (accidentally gave a expired Menactra four days after the expiration date with no reported adverse event). At time of reporting, the outcome was Unknown for the event accidentally gave a expired menactra four days after the expiration date with no reported adverse 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 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.