<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-2024-697
Date of Submission: 2024-11-02

This report was submitted by a Patient from Bradley-Wells Medical Center concerning patient ANON-PX-8536. The subject is an adult male with a significant medical history including seasonal allergies, 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 administered via the Topical route at a dosage of 364mg, initiated on 2024-10-25 for Thromboembolism prevention and discontinued on 2024-10-31.

On approximately 2024-10-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Diarrhea. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed PM and advised east. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-697
report_date: '2024-11-02'
patient_details:
  patient_id: ANON-PX-8536
  gender: Male
  relevant_history:
  - seasonal allergies
  - hypertension
suspected_drugs:
- drug_name: Warfarin
  dosage: 364mg
  route_of_administration: Topical
  start_date: '2024-10-25'
  indication_for_use: Thromboembolism prevention
  end_date: '2024-10-31'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2024-10-29'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Diarrhea
  onset_date: '2024-10-29'
  severity: Mild
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed PM and advised east.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 7
reporting_facility: Bradley-Wells Medical Center
reporter_type: Patient
