Symptomtext
separate administration of the PENTACEL components with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2023SA314333. This case involves a 3 years old male patient and reporter reported separate administration of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] components 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 heparin sodium (heparin [heparin sodium]); measles vaccine, mumps vaccine, rubella vaccine (mmr) for immunisation; and varicella zoster vaccine (varicella vaccine) for immunisation. On 09-Oct-2023, the patient received Dose 1 of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ869AA, Expiry date: 23-Mar-2024) (Strength: standard, Frequency: once) via intramuscular route in the right deltoid for immunisation. On 09-Oct-2023, it was reported separate administration of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine components with no reported adverse event (single component of a two-component product administered) (latency: same day). It was reported, Nurse called to report about the administration of the PENTACEL components to 2 patients. Nurse wanted to know if the dose given would be valid. Please see case 01799136. This situation is reported as a medication error due to separate administration of the PENTACEL components. 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.