Symptomtext
4-month-old receiving PENTACEL described as the liquid portion was not administered, with no reported adverse event; 4-month-old receiving PENTACEL described as the liquid portion was not administered and the powder portion was mixed with the wrong diluent of 0.5 % NaCl, with no reported adverse event; Initial information received on 18-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] described as the liquid portion was not administered and the powder portion was mixed with the wrong diluent of 0.5 % nacl, 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 Rotavirus Vaccine (Rotavirus Vaccine) for Prophylactic vaccination. On 18-Sep-2023, the patient received 0.5 ml total (1x) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ853AB, Expiry date: 13-Apr-2024) (Strength: standard) (Frequency: once) via intramuscular route in the left thigh for Immunization. On 18-Sep-2023, the patient received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine described as the liquid portion was not administered and the powder portion was mixed with the wrong diluent of 0.5 % nacl, with no reported adverse event (single component of a two-component product administered) (product preparation error) (latency: same day). It was reported, A Clinic wanting to know how to proceed after a Medication error with a 4-month -old receiving PENTACEL described as the liquid portion was not administered and the powder portion was mixed with the wrong diluent of 0.5 % NaCl. Action taken: not applicable. Outcome: Unknown 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.