Symptomtext
was administered with PENTACEL for the supposed to be 5th dose of the DTaP vaccination series instead of QUADRACEL with no reported adverse event; Initial information received on 08-Dec-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old female patient who was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] for the supposed to be 5th dose of the dtap vaccination series instead of Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel] 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) for Prophylactic vaccination. On 08-Dec-2023, the patient received 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ957AB) (Expiry date: 01-Jun-2024) (Strength: standard) (Frequency: once) via intramuscular route in the right thigh for immunization. On 08-Dec-2023, the patient was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] for the supposed to be 5th dose of the dtap vaccination series instead of Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel] with no reported adverse event (wrong product administered) (latency: same day). It was reported, Caller calls in to inform that they have a 4-year-old patient that was administered with PENTACEL for the supposed to be 5th dose of the DTaP vaccination series instead of quadracel. They are calling to ask whether the DTaP-IPV component is valid or the patient needs to be revaccinated. See transfer screen for more details. This situation is pre-assessed as a medication error/an inappropriate use due to administration of pentacel instead of quadracel for dtap-ipv 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.
