Reporte zur Charge UJ412AA

Symptomtext

4 month old received Pentacel and Acthib at the same time, no AE; Initial information received on 17-May-2021 regarding an unsolicited valid non-serious case from a pharmacist. This case involves a 4 months old female patient who received 0.5 ml first dose of HIB (PRP/T) VACCINE [Act-HIB] (lot SO21458 and expiration date not reported) via intramuscular route in the right vastus lateralis and 0.5 ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ412AA and expiration date not reported) via intramuscular route in the left vastus lateralis for prophylactic vaccination on 12-May-2021 (that is at the same time). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (lot numbers, expiration date and other dosing details were not reported) for prophylactic vaccination. It was a case of medication error due to extra dose administered (same day). It was also reported that caller wanted to know if there was any data on patient receiving too much medication or receiving the products at the same time. On 17-May-2021 - Confirmed pharmacist's questions about PENTACEL and ACTHIB being given at the same time. 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. No further information was provided.