Reporte zur Charge UJ267AA

Symptomtext

received a dose of Pentacel in error instead of prescribed Adacel, no adverse event; 66 years received a dose of Pentacel in error, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via Medical Information (Reference number- 00448734) and transmitted to Sanofi on 27-Jan-2021. This case involves a 66-year-old male patient who received a 0.5ml standard dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [lot UJ267AA, expiry date: 04-Jun-2021] once via an intramuscular route at left deltoid for prophylactic vaccination in error on 27-Jan-2021 instead of prescribed DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered, 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 other vaccine was given concomitantly. This was an actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration (latency same day). The reporter wanted to know if the dose would be valid At the time of reporting, 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 the guidelines. 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.