Reporte zur Charge U4648AA

Symptomtext

This case involves a 17-year old male patient who received 3 doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], not showing any adverse reactions (extra dose administered). Past vaccination(s) included MENACTRA (First dose at the age of 11 years and second dose at the age of 16 years). Medical history, past medical treatment(s), concomitant medication(s) and family history were not provided. On 01-Jul-2021, the patient received 0.5 ml third dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number: U4648AA and expiration date: 25-Apr-2015 and lot number: U6951AA and expiration date: 06-Jun-2022] via intramuscular route in the left deltoid for prophylactic vaccination. It was reported as " a nurse (RN) stated a male patient received 3 doses of MENACTRA and asked if there are any concerns or anything to be aware or on the lookout for. RN stated the first MENACTRA dose was administered at the age of 11 years old; the second was administered at 16 years old and the 3rd dose was administered at the age of 17 years old. Nurse stated the patient has not shown any symptoms of adverse reactions. Nurse provided the lot & exp. dates of the first and third Menactra doses; Nurse stated there is no record of the lot/exp. date of the second dose. MIA attempted to warm transfer the nurse to a HCP. However, no HCP was available. Nurse requested a call back or an email reply tomorrow; she will be available 08:00 - 16:30. Outbound call made on 08Jul2021, 10:26 Spoke with nurse who states they thought the patient needed the second dose and when the Menactra injection was given he then presented paperwork to show he had already had the second dose. Patient Information o Patient age <1 year enter as 2m, 4m, etc. Many pediatric vaccines need month for age.---SF male dob: Jul 24, 2003". It was a case of actual medication error due to extra dose administered (latency: same day). At the time of report, no adverse event 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.