Symptomtext
patient received their 3rd dose of PENTACEL 2 weeks after their 2nd dose with no reported adverse event; Initial information received on 03-Mar-2022 regarding an unsolicited valid non-serious case received from a physician via call center. This case involves a 6 months old female patient who had experienced patient received their 3rd dose of pentacel 2 weeks after their 2nd dose with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel]. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar); and rotavirus vaccine (Rotavirus Vaccine) both for Prophylactic vaccination. On 29-Oct-2021, the patient received a 0.5 ml third dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine (frequency: once, Strength: standard) (formulation: unknown) lot UJ494AAA via intramuscular route in the right thigh. On 29-OCT-202, the patient developed a non-serious event patient received their 3rd dose of pentacel 2 weeks after their 2nd dose with no reported adverse event (inappropriate schedule of product administration) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the event (inappropriate schedule of product administration). At time of reporting, the outcome was Unknown for the event inappropriate schedule of product administration. 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.