Reporte zur Charge UJ326AAA

Symptomtext

The patient was administered an expired Pentacel/no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Medical Information (Reference number- 00642478 and 00645476) and transmitted to Sanofi on 15-Jun-2021. This case involves a 2 months old male patient who was administered 0.5 ml first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ326AAA, expiry date: 13-Jun-2021) via unknown route in the right thigh for prophylactic vaccination on 15-Jun-2021 (Expired product administered) The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE for prophylactic vaccination. It was a case of an actual medication error due to Expired vaccine used (latency same day) At the time of report, no adverse event was reported. The caller was calling back to report they had administered an expired Pentacel and asked what should be done regarding the expired dose that was given. 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.