Reporte zur Charge UJ317AAA

Symptomtext

medication error with Pentacel described as receiving only the liquid DTAP-IPV portion and not the powder HIB component with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a nurse via phone at a call center as a Medication Inquiry on 11-Jan-2021. This case involved a 4 month old male patient for whom medication error was reported with Pentacel described as receiving only the liquid DTaP-IPV portion and not the powder HiB component with no adverse event (Product preparation issue), after receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (PENTACEL). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine 13V for prophylactic vaccination. On 11-Jan-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE 0.5 mL (lot number: UJ317AAA, expiry date: 04-Jun-2021) via intramuscular route in the left thigh for prophylactic vaccination. On 11-Jan-2021, medication error was reported with Pentacel described as receiving only the liquid DTaP-IPV portion and not the powder HiB component with no adverse event (Product preparation issue). At the time of reporting, the patient did not involve 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.