<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-2025-790
Date of Submission: 2025-01-16

This report was submitted by a Patient from Sloan Ltd Medical Center concerning patient ANON-PX-3645. The subject is a 18-year-old other with a significant medical history including osteoarthritis, asthma. 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 (NSAID) administered via the Intravenous route at a dosage of 468mg, initiated on 2024-11-16 for Pain and inflammation with the course ongoing.

On approximately 2025-01-10, 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. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-790
report_date: '2025-01-16'
patient_details:
  patient_id: ANON-PX-3645
  gender: Other
  relevant_history:
  - osteoarthritis
  - asthma
  age_at_reaction: 18
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 468mg
  route_of_administration: Intravenous
  start_date: '2024-11-16'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2025-01-10'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
- symptom_name: Maculopapular Rash
  onset_date: '2025-01-10'
  severity: Mild
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 2
reporting_facility: Sloan Ltd Medical Center
reporter_type: Patient
