Reporte zur Charge U69445AA

Symptomtext

only received the DTap-IPV diluent portion of PENTACEL and that it was not reconstituted with lyophilized Hib component prior to injection/ no AE; Initial information was received on 21-Sep-2021 regarding an unsolicited valid non-serious case from other healthcare professional and consumer/non-healthcare professional via call center via Medical Information (Reference number- 00778581). This case involves a 3-month-old male patient who received only received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] which DTaP-IPV diluent was not reconstituted with lyophilized HIB component (product preparation issue). The patient's medical history, past medical treatments, vaccinations and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination. On 20-Sep-2021, the patient received a first dose of 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: U69445AA and expiry date: 22-Jul-2022) via an intramuscular route in the right quadricep for prophylactic vaccination. It was an actual medication error case due to inappropriate reconstitution technique (latency: same day). It was reported "Nurse states that a patient on 20SEP2021 only received the DTaP-IPV diluent portion of PENTACEL and that it was not reconstituted with lyophilized HIB component prior to injection. Nurse asked for information on how to proceed and whether or not the patient would need to receive the entire PENTACEL injection over again." 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 guidelines. 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.