Reporte zur Charge U6842DA

Symptomtext

pediatric patient was given Pentacel with only diluent with no adverse event; Initial information regarding an unsolicited valid non-serious case received from the other healthcare professional via phone at a call center as a Medication Inquiry on 11-Jan-2021. This case involved a 9-month old female patient who was given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (PENTACEL) with only diluent with no adverse event (Product preparation issue). It was an actual medication error due to inappropriate reconstitution technique. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis B vaccine for prophylactic vaccination. On 28-Dec-2020, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE 0.5 mL (lot number: U6842DA, expiry date: 05-Jul-2021) via intramuscular route in the right thigh for prophylactic vaccination. On 28-Dec-2020, it was reported that pediatric patient was given Pentacel with only diluent with no adverse event (Product preparation issue). At the time of reporting, the patient did not experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.