Symptomtext
patient was inadvertently given an expired dose of Pentacel, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician, other healthcare professional and consumer/non-health care professional via Medical Information (MI) (Reference number- 00830643) and transmitted to Sanofi on 27-Oct-2021. This case involved a two-month-old (2 months and 3 days) male patient who was inadvertently given an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [Expired product administered]. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On 27-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ393AA, expiry date: 12-OCT-2021, formulation: suspension for injection) via intramuscular route in the thigh NOS (not otherwise specified) for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency same day). It was reported "Nurse reported that a patient was inadvertently given an expired dose of Pentacel, today. She requested guidance on how to proceed." No other adverse event was reported. This suspected adverse reaction report was 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 was 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 had contributed to or was to be held liable for the occurrence of this medication error.