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the patient was inadvertently administered a dose of Pentacel that had expired with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via medical information (Reference number- 00685292) and transmitted to Sanofi on 16-Jul-2021. This case involves a 15-month-old male patient who inadvertently received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that had expired (expired product administered). The patient had DTaP and polio vaccine doses as past vaccination. Medical history, medical treatment and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE, VARICELLA ZOSTER VACCINE (MMRV). On 15-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ337AAA, expiry date: 05-Jul-2021] via an intramuscular route at the right thigh for prophylactic vaccination. (expired product administered) (Latency: on the same day) It was a case of actual medication error due to expired vaccine used. It was reported that, "Upon transfer, physician (MD) asked how to proceed if a patient was administered an expired dose of Pentacel. MD also asked for any safety information on giving an expired vaccine or repeating the dose. MD did not have available the number dose in the series that this Pentacel dose was to have been, because the patient was born overseas and just came here in June". At the time of report, no adverse event reported. Outcome of event was unknown. 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.