<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-2025-434
Date of Submission: 2025-04-15

This report was submitted by a Patient from Lewis, Long and Carter Medical Center concerning patient ANON-PX-6365. The subject is a 66-year-old other with a significant medical history including osteoarthritis, hypertension, atrial fibrillation. 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 Intravenous route at a dosage of 93mg, initiated on 2025-01-26 for Thromboembolism prevention and discontinued on 2025-02-03; Sertraline (SSRI) administered via the Topical route at a dosage of 128mg, initiated on 2025-01-26 for Major depressive disorder and discontinued on 2025-02-03.

On approximately 2025-01-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Angioedema, Nausea, Vomiting. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. 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-2025-434
report_date: '2025-04-15'
patient_details:
  patient_id: ANON-PX-6365
  gender: Other
  relevant_history:
  - osteoarthritis
  - hypertension
  - atrial fibrillation
  age_at_reaction: 66
suspected_drugs:
- drug_name: Warfarin
  dosage: 93mg
  route_of_administration: Intravenous
  start_date: '2025-01-26'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2025-02-03'
- drug_name: Sertraline
  dosage: 128mg
  route_of_administration: Topical
  start_date: '2025-01-26'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-02-03'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2025-01-28'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-01-28'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-01-28'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-01-28'
  severity: Mild
  outcome: Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 10
reporting_facility: Lewis, Long and Carter Medical Center
reporter_type: Patient
