Reporte zur Charge UJ8068A

Symptomtext

patient was given an extra dose of DTaP via PENTACEL administration with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 years old female patient who was given an extra dose of dtap after receiving Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] And Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad) And Pneumococcal Vaccine 13v (Pneumococcal 13 Valent Vaccine) For Prophylactic Vaccination. On 28-Sep-2023, the patient received a dose 4 at a dose of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (strength: standard, frequency: once and lot UJ8068A) (expiry date: unknown) via intramuscular route in the left thigh, also received a unknown dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (strength, expiry date, and lot number not reported) via unknown route in unknown administration site as immunization and given an extra dose of dtap via pentacel administration with no reported adverse event (extra dose administered) (same day latency). Information on he batch number was requested. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event. 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 the 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.