<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-2025-443
Date of Submission: 2025-07-06

This report was submitted by a Other Healthcare Professional from Medina-Vega Medical Center concerning patient ANON-PX-2551. The subject is a 42-year-old female with a significant medical history including type 2 diabetes, coronary artery disease, anxiety, 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): Ibuprofen administered via the Topical route at a dosage of 192mg, initiated on 2025-06-09 for Pain and inflammation and discontinued on 2025-07-01.

On approximately 2025-06-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Maculopapular Rash. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. 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-2025-443
report_date: '2025-07-06'
patient_details:
  patient_id: ANON-PX-2551
  gender: Female
  relevant_history:
  - type 2 diabetes
  - coronary artery disease
  - anxiety
  - osteoarthritis
  age_at_reaction: 42
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 192mg
  route_of_administration: Topical
  start_date: '2025-06-09'
  indication_for_use: Pain and inflammation
  end_date: '2025-07-01'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2025-06-25'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-06-25'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 9
reporting_facility: Medina-Vega Medical Center
reporter_type: Other Healthcare Professional
