Reporte zur Charge U693588

Symptomtext

A 12 year old patient was vaccinated with Quadracel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Global Medical Information (GMI) (Reference number- 00718133) and transmitted to Sanofi on 10-Aug-2020. This case involves a 12-year-old female patient who was administrated DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] [Product administered to patient of inappropriate age]. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylactic vaccination. On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot U693588 and expiry date: 26-May-2023) via unknown route in the right deltoid for prophylactic vaccination. It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day). It was reported, "I gave a Quadracel injection to a 12 year old who didn't need it. Are there any concerns?" 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 holder's compliance with the requirements set out by the regulatory authority. 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