Reporte zur Charge U6272AA

Symptomtext

Patient received a dose of ADACEL on 28Apr2021, that was expired on 26Apr2021 with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00582362) and transmitted to Sanofi on 29-Apr-2021. This case involves a 12 years old female patient who experienced patient received a 0.5 mL expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6272AA and expiry date: 26-Apr-2021) via intramuscular route in the left deltoid (expired product administered) for prophylactic vaccination on 28-Apr-2021. The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It was an actual medication error case due to expired vaccine used (latency: same day). It was reported that they administered expired vaccine. The vaccine expired on exp 4/26/2021 and was administered on yesterday. They wanted to know if they needed to redose the patient at some point or is okay since the time frame was so close. Reporter asked if it would be okay since it was just a few days past the expiration date. They stated that they had a plan to repeat the ADACEL dose in three months and is asking if that would be okay. They asked if it would be okay since it was just a few days past the expiration date. They stated that they had a plan to repeat the ADACEL dose in three months and is asking if that would be okay. At the time of reporting, the patient experienced no specific 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 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.