<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-2025-112
Date of Submission: 2025-04-12

This report was submitted by a Nurse from Smith-Smith Medical Center concerning patient ANON-PX-2799. The subject is a 83-year-old male with a significant medical history including coronary artery disease, anxiety, chronic kidney disease, 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 Intramuscular route at a dosage of 322mg, initiated on 2025-03-29 for Thromboembolism prevention and discontinued on 2025-04-03; Ibuprofen administered via the Intravenous route at a dosage of 466mg, initiated on 2025-03-29 for Pain and inflammation and discontinued on 2025-04-03.

On approximately 2025-04-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Vomiting, Somnolence, Diarrhea, Anaphylaxis. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed minute and advised whole. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed home and advised doctor. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed sing and advised child. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed per and advised you. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed adult and advised drug. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was '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-2025-112
report_date: '2025-04-12'
patient_details:
  patient_id: ANON-PX-2799
  gender: Male
  relevant_history:
  - coronary artery disease
  - anxiety
  - chronic kidney disease
  - hypertension
  age_at_reaction: 83
suspected_drugs:
- drug_name: Warfarin
  dosage: 322mg
  route_of_administration: Intramuscular
  start_date: '2025-03-29'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2025-04-03'
- drug_name: Ibuprofen
  dosage: 466mg
  route_of_administration: Intravenous
  start_date: '2025-03-29'
  indication_for_use: Pain and inflammation
  end_date: '2025-04-03'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2025-04-03'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed minute and advised whole.
- symptom_name: Vomiting
  onset_date: '2025-04-03'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed home and advised doctor.
- symptom_name: Somnolence
  onset_date: '2025-04-03'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed sing and advised child.
- symptom_name: Diarrhea
  onset_date: '2025-04-03'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed per and advised you.
- symptom_name: Anaphylaxis
  onset_date: '2025-04-03'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed adult and advised drug.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 5
reporting_facility: Smith-Smith Medical Center
reporter_type: Nurse
