Reporte zur Charge U5472AA

Symptomtext

Patient was given an Adacel at the age of 8, no adverse event; Initial information regarding an unsolicited non-valid non-serious case was from a pharmacist via Global Medical Information (GMI) (Reference number- 00517032) and transmitted to Sanofi on 12-Mar-2021. This case involves a 8 years old female patient who was given 0.5 ml total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number- U5472AA, expiration date- 15-Oct-2018) via unknown route in unknown administration site for prophylactic vaccination on an unknown date at the minute clinic (Product administered to patient of inappropriate age). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was given to the patient. It was an actual medication error due to inappropriate age at vaccine administration (same day latency). Also stated that she was 12 now but she got the dose when she was 8 years old and reporter was asking if it was safe for her daughter to get an Adacel injection at age 12. No laboratory data was reported It was not reported whether the patient had 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 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.