Symptomtext
child received an extra dose of pentacle with no reported adverse event; Initial information received on 27-Apr-2022 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 1-year-old male patient who received an extra dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with no reported adverse event. The patient's past vaccination(s) included IPV on 21-Apr-2021, HIB VACCINE on 22-Nov-2021, DTAP VACCINE on 22-Nov-2021. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination. On 26-Apr-2022, the patient received 0.5ml total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation: unknown) (lot: UJ622AA and Expiration Date: 07-Dec-2022) via intramuscular route in the left thigh for Immunization. On 26-Apr-2022 the patient developed a non-serious event; child received an extra dose of pentacle with no reported adverse event (extra dose administered) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Reportedly, Additional Description of event Adverse events: HCP states a patient was given a 5th dose of Pentacel. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. It was not reported if the patient received a corrective treatment for the event (child received an extra dose of pentacle with no reported adverse event). At time of reporting, the outcome was Unknown for the event child received an extra dose of pentacle with no reported adverse 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.