<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-2025-225
Date of Submission: 2025-07-27

This report was submitted by a Patient from Johnston Inc Medical Center concerning patient ANON-PX-3699. The subject is an adult other with a significant medical history including migraines, coronary artery disease, seasonal allergies. 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 375mg, initiated on 2025-06-03 for Thromboembolism prevention and discontinued on 2025-07-10; Ibuprofen (NSAID) administered via the Topical route at a dosage of 362mg, initiated on 2025-06-03 for Pain and inflammation and discontinued on 2025-07-10.

On approximately 2025-06-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Angioedema, Headache. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed reflect and advised chance. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: To PM relationship. Hear organization purpose family arm arm.</data>
report_id: ADR-2025-225
report_date: '2025-07-27'
patient_details:
  patient_id: ANON-PX-3699
  gender: Other
  relevant_history:
  - migraines
  - coronary artery disease
  - seasonal allergies
suspected_drugs:
- drug_name: Warfarin
  dosage: 375mg
  route_of_administration: Intramuscular
  start_date: '2025-06-03'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2025-07-10'
- drug_name: Ibuprofen
  dosage: 362mg
  route_of_administration: Topical
  start_date: '2025-06-03'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-07-10'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-06-07'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-06-07'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-06-07'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed reflect and advised chance.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 1
reporting_facility: Johnston Inc Medical Center
reporter_type: Patient
notes: To PM relationship. Hear organization purpose family arm arm.
