Reporte zur Charge UJ163AA

Symptomtext

07 month old female patient administered expired dose of Pentacel, no AE; Initial information received on 11-May-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old female patient (reported that 7 months, 1 week, and 3 days) who was administered expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered). Past vaccination included PEDIARIX. Medical history, medical treatment and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation. On 04-May-2021, the patient received a 0.5 ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ163AA and expiry date: 03-May-2021) (Frequency once) via an intramuscular route in the left thigh for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency on same day). It was also reported that the caller stated that PENTACEL was administered to a patient 1 day after the expiration date. The caller would like to know what the protocol is for this issue. Caller asking how to proceed if an expired Pentacel was given to a patient. 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 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.