Reporte zur Charge U6101

Symptomtext

administered 0.5 ml of Daptacel in the left deltoid by SS, the vaccine had expired prior to the administration with no AE; Initial information regarding this unsolicited valid non-serious case This case involves a 63 year old female patient who received a 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot: U6101, expiry date: 23-Oct-2020), via intramuscular route at left deltiod, on 19-Jan-2021 (expired product administered). The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided. It was an actual medication error due to the expired product administered. At the time of reporting, the patient had no 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.