Reporte zur Charge U6401AA

Symptomtext

patient was given an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 17-Aug-2021 from a Physician via Global Medical Information (GMI) (Reference number- 00728357) and transmitted to Sanofi on 16-Aug-2021. This case involves an 11-year-old male patient who was administered with an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine with no adverse event (Expired product administered). The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided. On an unknown date, the patient received a 0.5ml (total) (once) dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number: U6401AA and expiry date: 26-Jul-2021] via intramuscular route in the left deltoid (also reported as left arm) for prophylactic vaccination. It was reported that, "she gave an expired ADACEL vaccine. She states that the vaccine was expired and she gave it to the patient intramuscularly in the left arm, she asked how soon the patient could be revaccinated". Emergency Room/Dr. visit and date 17Aug2021. First time product used: No. Still using product : Yes. Was Device Used : No. It was case of an actual medication error due to expired vaccine used (latency was on the same day). 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 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 liable for the occurrence of this medication error.