<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-2025-505
Date of Submission: 2025-07-31

This report was submitted by a Patient from Brown, Lee and Gardner Medical Center concerning patient ANON-PX-9083. The subject is an adult other with a significant medical history including type 2 diabetes, hypertension. 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 115mg, initiated on 2025-06-29 for Thromboembolism prevention and discontinued on 2025-07-20; Lisinopril administered via the Intravenous route at a dosage of 243mg, initiated on 2025-06-29 for Hypertension and discontinued on 2025-07-20.

On approximately 2025-07-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Anaphylaxis, Angioedema. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed important and advised exactly. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed four and advised staff. The current patient status regarding this symptom is 'Fatal'. 

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. 

</data>
report_id: ADR-2025-505
report_date: '2025-07-31'
patient_details:
  patient_id: ANON-PX-9083
  gender: Other
  relevant_history:
  - type 2 diabetes
  - hypertension
suspected_drugs:
- drug_name: Warfarin
  dosage: 115mg
  route_of_administration: Oral
  start_date: '2025-06-29'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2025-07-20'
- drug_name: Lisinopril
  dosage: 243mg
  route_of_administration: Intravenous
  start_date: '2025-06-29'
  indication_for_use: Hypertension
  end_date: '2025-07-20'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-07-11'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-07-11'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed important and advised exactly.
- symptom_name: Angioedema
  onset_date: '2025-07-11'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed four and advised staff.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 2
reporting_facility: Brown, Lee and Gardner Medical Center
reporter_type: Patient
