Symptomtext
received PENTACEL, DAPTACEL and ACT-HIB so the DTAP and Hib portion is doubled with no reported adverse event; Initial information received on 25-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 2 years old female patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)], daptacel and act-hib so the dtap and hib, portion is doubled 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 Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel), Hib Vaccine Conj (Tet Tox) (Act Hib) and Hepatitis A Vaccine (Hepatitis A) for Prophylactic vaccination. On 22-Aug-2023, the patient received a dose of Suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (lot: UJ737AAA, Expiry date: 18-Sep-2023) via intramuscular route in unknown administration site for prophylactic vaccination (immunization) (extra dose administered) (latency- same day). No lab data reported. 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.