Reporte zur Charge U6207AA

Symptomtext

patient was given the first dose of MENACTRA on 16JAN2019 then a second dose of MENACTRA on 19FEB2019, she should have gotten the first dose then 4-5 years later the second dose with no adverse event; patient was given the first dose of MENACTRA on 16JAN2019 then a second dose of MENACTRA on 19FEB2019, both were expired on 20-May-2020, no AE; Initial information received on 29-Jan-2021 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 14 years old female patient who was given 0.5 ml first and second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number lot U6207AA and expiration date 20-May-2020) via intramuscular route in the left deltoid for prophylactic vaccination on 16-Jan-2019 and 19-Feb-2019 respectively. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) (lot number: UJ041AB Expiration date: 30-Jun-2019) on 16-Jan-2019 and On 19-Feb-2019 no concomitant vaccines was given. Also reported that health professional was aware she should have gotten the first dose then 4-5 years later the second dose. The nurse and provider have been talked to. This happened two years ago so they cannot remember why this happened. And was now there with the question anything long term and they need to be on the look out for? Does the patient need a second vaccine? If a second vaccine was needed do they use the date of the first vaccine or second vaccine? Asking for the email of the CDC (Centers for Disease Control and Prevention) link to the missed dose information and the MENACTRA PI (Prescribing Information)? It was an actual medication error due to extra dose administered and expired vaccine used [extra dose administered, extra product administered (same day latency)]. It was not reported that the patient experienced any 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.