Symptomtext
A patient received an expired Adacel vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (Reference number- 00672539) and transmitted to Sanofi on 07-Jul-2021. This case involves a 33-year-old male patient who received an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 07-Jul-2021, the patient received 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6378AA and expiry date: 04-Jul-2021) via an intramuscular route in the right deltoid for prophylactic vaccination (expired product administered). It was reported that "Caller states that she gave an Adacel vaccine to a male patient because the patient stepped on a nail. She states that over the weekend the expired vaccines were not pulled out due to the holiday and she did not pay attention to the expiration date before vaccinating the patient. The nurse states that the patient did not experience any other AE's (adverse event) as a result of this. Pasteur AE Reporting." There were no lab data/results available. It was a case of actual medication error due to expired vaccine used (latency same day). At time of reporting, no adverse events were 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.