Reporte zur Charge U6940AA

Symptomtext

Patient received only the liquid DTaP/IPV portion of PENTACEL with no reported adverse event; Initial information received on 12-Jan-2022 regarding an unsolicited valid non-serious case from was received from the health professional. This case involves a 7 months old male patient who received only the liquid dtap/ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with no reported adverse event. The patient's past medical history, medical treatment(s), and family history were not provided. Concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination. On 29-Dec-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (dosage: 0.5 ml once (Third in the series); lot number: U6940AA and expiry date: 21-May-2022) via intramuscular route in the left leg for Immunisation. On 29-Dec-2021, the patient developed a non-serious event "patient received only the liquid dtap/ipv portion of pentacel with no reported adverse event" (incorrect dose administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. It was reported "Caller states that a patient received only the DTaP/IPV portion of the product and would like to know how to proceed? Additional Description of event Adverse events : Patient received only the liquid DTaP/IPV portion of PENTACEL. Dosage Information o Frequency = once o Therapy Date: 29Dec2021 o Route = IM Left Leg o Dose = 0.5mL o Strength = standard o Indications = Immunization Event Information - Treatment - Dose: Third in the series " Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. At time of reporting, the outcome was Unknown for the event patient received only the liquid dtap/ipv portion of pentacel with no reported adverse 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.