<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-2025-521
Date of Submission: 2025-08-01

This report was submitted by a Other Healthcare Professional from Davis-Aguirre Medical Center concerning patient ANON-PX-5859. The subject is a 59-year-old female with a significant medical history including atrial fibrillation, asthma. 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 Intramuscular route at a dosage of 298mg, initiated on 2025-07-06 for Thromboembolism prevention with the course ongoing; Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 398mg, initiated on 2025-07-06 for Hypertension with the course ongoing.

On approximately 2025-07-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Angioedema, Somnolence, Diarrhea. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Next history clear theory practice. Why with push argue democratic store most. Building hotel carry anything.</data>
report_id: ADR-2025-521
report_date: '2025-08-01'
patient_details:
  patient_id: ANON-PX-5859
  gender: Female
  relevant_history:
  - atrial fibrillation
  - asthma
  age_at_reaction: 59
suspected_drugs:
- drug_name: Warfarin
  dosage: 298mg
  route_of_administration: Intramuscular
  start_date: '2025-07-06'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
- drug_name: Lisinopril
  dosage: 398mg
  route_of_administration: Intravenous
  start_date: '2025-07-06'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-07-11'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Angioedema
  onset_date: '2025-07-11'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-07-11'
  severity: Severe
  outcome: Unknown
  intervention_required: true
- symptom_name: Diarrhea
  onset_date: '2025-07-11'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Davis-Aguirre Medical Center
reporter_type: Other Healthcare Professional
notes: Next history clear theory practice. Why with push argue democratic store most.
  Building hotel carry anything.
