Reporte zur Charge U791AA

Symptomtext

received the powder portion of PENTACEL diluted with sterile water with no reported adverse event; Initial information received on 25-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2022SA356995. This case involves a 3 months old male patient who had received the powder portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] diluted with WATER FOR INJECTION [STERILE WATER]with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE). On 24-Aug-2022 the patient developed a non-serious event of received the powder portion of pentacel (strength, formulation was unknown, dose: 0.5ml, once (1X), Batch number: U791AA and expiry date: 10-Oct-2023) diluted with sterile water with no reported adverse event (product preparation error,onset date: 24-Aug-2022, Latency: same day) for prophylactic vaccination. Action taken : not applicable. Outcome: Unknown 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.