Reporte zur Charge UJ21AAA

Symptomtext

the patient received an expired dose of vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00459652) and transmitted to Sanofi on 03-Feb-2021. This case is linked to case 2021SA045576 (same reporter). This case involves a 17 months old male patient who received 0.5 ml fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ21AAA, expiry date: 21-Oct-2020) via intramuscular route in the left deltoid for prophylactic vaccination on 26-Jan-2021 (Expired product administered) The patient's past vaccination(s) included PENTACEL on 30-Oct-2019 (first dose) for prophylactic vaccination. Medical history, medical treatment(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for prophylactic vaccination It was a case of an actual medication error due to Expired vaccine used (latency same day). The reporter stated that 2 patients have received expired doses of Pentacel and asked if they need to re-dose second patient who received expired Pentacel by mistake. 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.