Symptomtext
pentacel was not mixed before administration with no reported adverse event; patient was administered with just the liquid portion of the Pentacel without the Hib component with no reported adverse event; Initial information received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 month old male patient who was administered with just the liquid portion of the diphtheria/tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] without the hib component with no reported adverse event and was not mixed before administration. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13), Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) And Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Vaxelis) for Prophylactic vaccination. On 19-Jul-2023, the patient received a Dose 2 at a dose of 0.5 ml of suspect /tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (expiry date: 19-Oct-2023; lot UJ785AA) via intramuscular route in the right thigh for immunization and administered with just the liquid portion of the pentacel without the hib component with no reported adverse event (single component of a two-component product administered) (latency: same day). On an unknown date the pentacel was not mixed before administration with no reported adverse event (product preparation error) (latency: same day). It was reported "she called in together with the doctor to report that they have a patient who was administered with just the liquid portion of the PENTACEL; they have the patient back today to administer the Hib component and they ask which diluent is appropriate to prepare the dose; provided information to the practice manager and the doctor." Action taken: not applicable. At time of reporting, the outcome was Unknown for the events. 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.