Reporte zur Charge UJ504AA

Symptomtext

Patient received PENTACEL and DAPTACEL this morning, no AE; Initial information was received on 19-May-2021 regarding an unsolicited valid non-serious case from a physician via other health care professional. This case involves a 15 months old female patient who received 0.5 ml fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ504AA) and 0.5 ml first dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5743AA) via intramuscular route in the left thigh for prophylactic vaccination on 19-May-2021 (Extra dose administered) Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of an actual medication error due to Extra dose administered (latency same day) At the time of report, no adverse event was reported. A 15-month-old patient received PENTACEL and DAPTACEL this morning, so patient was duplicated on the DTAP. They were calling to see what they needed to do and what to expect. They were suggested to be on a lookout for any adverse reaction or side effect. They were requesting a response as soon as possible, preferably within 24 hours 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. 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.