Reporte zur Charge UJ389AAA

Symptomtext

Hib portion of PENTACEL was reconstituted with sterile water and not the DTaP-IPV portion/ no AE; Initial information was received on 23-Aug-2021 regarding an unsolicited valid non-serious case from other healthcare professional, consumer/non-healthcare professional and physician via call center via Global Medical Information (Reference number- 00632994). This case involves a 8-month-old male patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which HIB portion was reconstituted with sterile water and not the DTaP-IPV portion (Product preparation error). The patient's medical history, past medical treatments, vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) for prophylactic vaccination. On 20-Aug-2021, the patient received a second dose of 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (solution, lot number: UJ389AAA and expiry date: 12-Oct-2021) via an intramuscular route in the left vastus lateralis for prophylactic vaccination. It was an actual medication error case due to wrong solution used in drug reconstitution (latency: same day). It was reported "Caller asking if the whole dose is invalid. Caller also asks how soon PENTACEL can be re-administered; caller referred to healthcare provider. Caller also referred to PENTACEL Reconstitution video" 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.