<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-2025-662
Date of Submission: 2025-06-19

This report was submitted by a Physician from Sims Group Medical Center concerning patient ANON-PX-6801. The subject is an adult male with a significant medical history including seasonal allergies, coronary artery disease, osteoarthritis. 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 Subcutaneous route at a dosage of 438mg, initiated on 2025-05-23 for Thromboembolism prevention with the course ongoing.

On approximately 2025-06-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Somnolence, Angioedema, Maculopapular Rash, Anaphylaxis. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed where and advised education. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 

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 rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: About successful remain dark. Late of story. Half success state mouth.</data>
report_id: ADR-2025-662
report_date: '2025-06-19'
patient_details:
  patient_id: ANON-PX-6801
  gender: Male
  relevant_history:
  - seasonal allergies
  - coronary artery disease
  - osteoarthritis
suspected_drugs:
- drug_name: Warfarin
  dosage: 438mg
  route_of_administration: Subcutaneous
  start_date: '2025-05-23'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
adverse_reactions:
- symptom_name: Headache
  onset_date: '2025-06-17'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-06-17'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-06-17'
  severity: Severe
  outcome: Fatal
  intervention_required: true
- symptom_name: Maculopapular Rash
  onset_date: '2025-06-17'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed where and advised education.
- symptom_name: Anaphylaxis
  onset_date: '2025-06-17'
  severity: Mild
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 2
reporting_facility: Sims Group Medical Center
reporter_type: Physician
notes: About successful remain dark. Late of story. Half success state mouth.
