Symptomtext
Expired Tenvac vaccine administered to patient/no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse (other health professional) via Medical Information (Reference number- 00422567) and transmitted to Sanofi on 08-Jan-2021. This case involves a 34 year old male patient who received an expired dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] [lot U6101AA, expiry date: 23-Oct-2020] via an intramuscular route at an unknown administration site for prophylactic vaccination on 08-Jan-2021 (expired product administered). (latency: on the same day) Medical history, medical treatments, vaccinations, list of concomitant medication and family history were not provided. Patient received no other vaccines. It was a case of actual medication error due to expired vaccine used (Latency-same day). It was reported that, nurse did not have the site Event Information also wanted to know how to proceed further. 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 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.