<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-2025-269
Date of Submission: 2025-04-20

This report was submitted by a Other Healthcare Professional from Salinas LLC Medical Center concerning patient ANON-PX-9369. The subject is a 63-year-old male with a significant medical history including osteoarthritis, coronary artery 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 administered via the Subcutaneous route at a dosage of 476mg, initiated on 2025-03-31 for Thromboembolism prevention and discontinued on 2025-04-18; Lisinopril administered via the Intravenous route at a dosage of 114mg, initiated on 2025-03-31 for Hypertension and discontinued on 2025-04-18.

On approximately 2025-04-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Stevens-Johnson syndrome, Vomiting, Angioedema, Pruritus. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed enter and advised scientist. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Angioedema was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-269
report_date: '2025-04-20'
patient_details:
  patient_id: ANON-PX-9369
  gender: Male
  relevant_history:
  - osteoarthritis
  - coronary artery disease
  age_at_reaction: 63
suspected_drugs:
- drug_name: Warfarin
  dosage: 476mg
  route_of_administration: Subcutaneous
  start_date: '2025-03-31'
  indication_for_use: Thromboembolism prevention
  end_date: '2025-04-18'
- drug_name: Lisinopril
  dosage: 114mg
  route_of_administration: Intravenous
  start_date: '2025-03-31'
  indication_for_use: Hypertension
  end_date: '2025-04-18'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-04-16'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-04-16'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed enter and advised scientist.
- symptom_name: Vomiting
  onset_date: '2025-04-16'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-04-16'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-04-16'
  severity: Mild
  outcome: Unknown
  intervention_required: true
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 2
reporting_facility: Salinas LLC Medical Center
reporter_type: Other Healthcare Professional
