Reporte zur Charge UJ226AAA

Symptomtext

5-month patient was given diluent portion of the Pentacel and not the vaccine/ NO AE; Initial information received on 11-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional via call-center. This case involves a 5-months-old male patient who received only diluent portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] not the vaccine (frequency: once and strength: standard batch number: UJ226AAA and expiry date 04-Apr-2021) via an unknown route at an unknown administration site (product preparation issue) on 02-Mar-2021 for prophylactic vaccination. The patient's medical history, past medical treatment, and family history were not provided. List of concomitant was unknown and no other vaccines were reported. It was an actual medication error case due to inappropriate reconstitution technique (latency: same day) Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test. 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.