Symptomtext
got injected expired Adacel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00692200) and transmitted to Sanofi on 21-Jul-2021. This case involve a 31-year-old female patient who was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in context of got injected expired adacel (Expired product administered). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was reported as 05-Jan-2021. The estimated due date is 12-Oct-2021. The patient past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 19-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [prefilled syringes, lot U6273AA and expiry: 24-Apr-2021] via an intramuscular route in the left deltoid for prophylactic vaccination (Fetus prevention of whooping cough). It was reported that, "The patient was given the Adacel because she is 28 weeks pregnant to protect the fetus against Whooping cough". The expired box of Adacel, but is believed that one of the expired Adacel prefilled syringes got accidentally put in a new Adacel box. It was as actual medication error due to expired product administered (latency: on the same day) It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the event got injected expired adacel. Additionally, at time of reporting, the pregnancy is still ongoing. 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 holder's compliance with the requirements set out in the 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.