Reporte zur Charge U78388A

Symptomtext

2-year-old who accidently received quadracel and they were supposed to receive daptacel with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received via other health professional. This case involves 2-year-old male patient who accidently received diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [quadracel (VERO)] and they were supposed to receive diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml total dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine, Solution for injection (strength, expiry date: unknown) (lot: U78388A) via intramuscular route in the left vastus lateralis for Immunization and 2-year-old who accidently received quadracel and they were supposed to receive daptacel with no reported adverse event (wrong product administered) (latency: same day) Reportedly, medical assistant calling on behalf of a 2-year-old who accidently received Quadracel and they were supposed to receive Daptacel. She would like to know if it counted for the patient's DTaP. She would also like to know what they should look out for in terms of potential side effects. She states that the patient previously received two Pentacel injections and one Vaxelis injection. 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.