Reporte zur Charge U5866BC

Symptomtext

Received his first MENACTRA vaccine at 11-12 years old. The second one was given two months prior to his 15th birthday with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional. This case involves a 14 years old male patient who received his first dose at 11-12 years old and the second 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U5866BC and expiration date was not reported) via intramuscular route in the left arm for prophylactic vaccination was given two months prior to his 15th birthday (extra dose administered) on 13-Apr-2018. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9). It was a case of actual medication error due to extra dose administered (latency on same day). 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 holders 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.