Symptomtext
gave PENTACEL to a child without the powder, the diluent only, liquid component of PENTACEL was administered but not the lyophilized powder,with no reported adverse event; Pentacel once for TB skin test with no reported adverse event; gave PENTACEL to a child without the powder, the diluent only, liquid component of PENTACEL was administered but not the lyophilized powder,with no reported adverse event; Initial information received on 19-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves unknown gender Child Patient of age <1 year who received Pentacel without the powder, the diluent only, liquid component of pentacel was administered but not the lyophilized powder once for TB skin test with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTOTECH for Immunisation On an unknown date, the patient received a (0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.25 mL) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ737AA) (Expiry date: 18-Sep-2023) (Frequency: once) (Strength: standard) Via unknown route in site UTR for Immunization or TB skin test. On an unknown date the patient received pentacel without the powder, the diluent only, liquid component of pentacel was administered but not the lyophilized powder once for tb skin test with no reported adverse event (product use in unapproved indication) (product preparation error) (Single component of a two-component product administered) (unknown latency). It was reported that patient had Emergency Room /Dr. visit and date UTR (Abbreviation unspecified) (estimates around: 4-Jan-2023) Relevant laboratory test results included: Tuberculin test - On an unknown date: [Unknown] Action taken: was not applicable. At time of reporting, the outcome was Unknown for all the events. 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.