Reporte zur Charge UJ228AA/ UJ315A

Symptomtext

A patient received both IPOL and PENTACEL and they were both expired doses, no adverse event; Initial information received on 22-Jun-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional and physician via Information (under reference 00651487). This case involves a 3 years old male patient who was vaccinated with an expired dose of both 0.5 ml IPV (VERO) [IPOL] (lot number and expiration date not reported) and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (total, lot UJ228AA (HIB)/ UJ315AA and expiration date: 04-Apr-2021) via intramuscular route in an unknown administration site for prophylactic vaccination on 21-Jun-2021 (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included a dose of PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (lot number and expiration date not reported) via unknown route and site of administration for prophylactic vaccination on 21-Jun-2021. It was a case of an actual medication error due to expired vaccine used (same day latency). Reported that the caller was with a question on whether dose needs repeating and on adverse effects to expect due to patient receiving IPOL as well as PENTACEL. At time of reporting, the outcome was unknown for the reported event. 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. There will be no information on the batch number for IPOL.