<format type="yaml">{report_id: string, report_date: date, patient_details: {patient_id: string, age_at_reaction: number optional, gender: string, relevant_history: list[string]}, suspected_drugs: list[{drug_name: string, drug_class: string optional, dosage: string, route_of_administration: string, start_date: date, end_date: date optional, indication_for_use: string}], adverse_reactions: list[{symptom_name: string, onset_date: date, severity: string, outcome: string, intervention_required: boolean, intervention_details: string optional}], causality_assessment: {naranjo_score: number optional, assessment_conclusion: string, dechallenge_rechallenge: string}, reporting_facility: string, reporter_type: string, notes: string optional}</format> <data>PHARMACOVIGILANCE CASE REPORT - CONFIDENTIAL
Report Identifier: ADR-2025-880
Date of Submission: 2025-08-06

This report was submitted by a Other Healthcare Professional from Harper, Kane and Caldwell Medical Center concerning patient ANON-PX-7904. The subject is an adult female with a significant medical history including coronary artery disease, chronic kidney disease. The facility's standard operating procedure for ADR reporting was followed, and all patient data has been anonymized. The patient chart was reviewed for comorbidities. 

Current medication review revealed the following suspected agent(s): Warfarin (Anticoagulant) administered via the Oral route at a dosage of 113mg, initiated on 2025-06-05 for Thromboembolism prevention and discontinued on 2025-07-16; Ibuprofen (NSAID) administered via the Topical route at a dosage of 213mg, initiated on 2025-06-05 for Pain and inflammation and discontinued on 2025-07-16.

On approximately 2025-07-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Vomiting, Pruritus, Angioedema. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Pruritus was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-880
report_date: '2025-08-06'
patient_details:
  patient_id: ANON-PX-7904
  gender: Female
  relevant_history:
  - coronary artery disease
  - chronic kidney disease
suspected_drugs:
- drug_name: Warfarin
  dosage: 113mg
  route_of_administration: Oral
  start_date: '2025-06-05'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2025-07-16'
- drug_name: Ibuprofen
  dosage: 213mg
  route_of_administration: Topical
  start_date: '2025-06-05'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-07-16'
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2025-07-03'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-07-03'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-07-03'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-07-03'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 8
reporting_facility: Harper, Kane and Caldwell Medical Center
reporter_type: Other Healthcare Professional
