<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-2024-360
Date of Submission: 2024-11-16

This report was submitted by a Physician from Sutton, Mora and Johnson Medical Center concerning patient ANON-PX-1049. The subject is a 35-year-old female with a significant medical history including asthma, 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): Ibuprofen administered via the Topical route at a dosage of 346mg, initiated on 2024-11-02 for Pain and inflammation with the course ongoing.

On approximately 2024-11-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Hepatotoxicity, Somnolence, Diarrhea. The Angioedema was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed body and advised nothing. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. 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-2024-360
report_date: '2024-11-16'
patient_details:
  patient_id: ANON-PX-1049
  gender: Female
  relevant_history:
  - asthma
  - atrial fibrillation
  age_at_reaction: 35
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 346mg
  route_of_administration: Topical
  start_date: '2024-11-02'
  indication_for_use: Pain and inflammation
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2024-11-12'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2024-11-12'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed body and advised nothing.
- symptom_name: Somnolence
  onset_date: '2024-11-12'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-11-12'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Sutton, Mora and Johnson Medical Center
reporter_type: Physician
