Symptomtext
pediatric patient given first dose of pentacel at the hospital at 2 months of age and given the 2nd dose at 3 months of age as mother did not disclose that first dose given at 2 months of age with no reported adverse event; Initial information received on 27-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center. This case involves a 3 months old male patient who given first dose of pentacel at the hospital at 2 months of age and given the 2nd dose at 3 months of age as mother did not disclose that first dose given at 2 months of age 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) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (VACCINE, HEPATITIS B) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunisation. On 23-Dec-2021, the patient received dose: 2, 0.5ml total, dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ577AAA exp: date: 10-Sep-2022 via intramuscular route in the left vastus lateralis for immunization. On 23-DEC-2021 the patient given first dose of pentacel at the hospital at 2 months of age and given the 2nd dose at 3 months of age as mother did not disclose that first dose given at 2 months of age with no reported adverse event (product administered to patient of inappropriate age) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken: was 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.