Symptomtext
patient received PENTACEL at 4 months, at 6 months and at 9 months with no reported adverse event; Initial information received on 11-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 months old female patient and it was reported that patient received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] at 4 months, 6 months and at 9 months with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided. On 17-Jan-2023, the patient received 0.5 mL of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (batch/lot number: UJ754AB and expiry date: 26-Sep-2023; strength: standard) via intramuscular route in the left thigh for immunization. On 17-Oct-2022, she also received a dose of the same vaccine. On 29-Aug-2022 she also received a dose of the same vaccine (Product administered to patient of inappropriate age) (latency: same day). It was reported that patient was administered 4 DTAP components by the age of 9 months. Caller confirmed that they have a patient who received DAPTACEL at 2 months, PENTACEL at 4 months, 6 months, and 9 months. 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 guidelines. 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.