Reporte zur Charge UJ057AAA

Symptomtext

expired PENTACEL given to an infant with no AE; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 3 months old female patient who received expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and IMMUNOGLOBULIN ANTIHEPATITIS B (HEPATITIS B) On 10-Nov-2020, the patient received 0.5 mL once daily dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE via intramuscular route in right vastus lateralis (lot number: UJ057AAA and expiry date: 07-Nov-2020) for prophylactic vaccination. This was an actual medication error due to expired vaccine used (PT: expired product administered) (latency was same day). No laboratory data reported. At the time of reporting, 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.