Reporte zur Charge U6971AA

Symptomtext

18 month old got Pentacel, including the polio, that was not due with no reported adverse event; Initial information was received on 04-May-2022 regarding an unsolicited valid non-serious case received from a health professional. This case involves a 18 months old female patient who got pentacel, including the polio, that was not due 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: Pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination. On 03-May-2022, the patient received 4th dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [pentacel] 0.5 ml (Batch number: U6971AA, expiration date: 11-Sep-2022) via intramuscular route in the left thigh for prophylactic vaccination. On 03-May-2022 the patient got pentacel, including the polio, that was not due with no reported adverse event (wrong product administered) (latency: on the same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [pentacel]. Action taken: Not applicable. Corrective treatment: Not reported. Outcome: Unknown. 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.