Symptomtext
patient was given expired vaccine/ no AE; Initial information was received on 23-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Agency (Reference number- 00653450) and transmitted to Sanofi on 23-Jun-2021. This case involves a four-year-old female patient who was vaccinated with 0.5 mL (once) (total) dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].(injection) (lot number UJ325AAA, expiry date 13-Jun-2021) via intramuscular route in right arm on 22-Jun-2021 for prophylactic vaccination (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency was on same day). At the time of reporting, 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.