<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: 2024-09-25

This report was submitted by a Pharmacist from Gregory PLC Medical Center concerning patient ANON-PX-5162. The subject is an adult other with a significant medical history including coronary artery disease, seasonal allergies, migraines, chronic kidney disease. 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 Subcutaneous route at a dosage of 389mg, initiated on 2024-08-07 for Thromboembolism prevention and discontinued on 2024-09-23; Metformin (Biguanide) administered via the Intravenous route at a dosage of 141mg, initiated on 2024-08-07 for Type 2 diabetes and discontinued on 2024-09-23.

On approximately 2024-09-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Diarrhea, Stevens-Johnson syndrome, Somnolence. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed single and advised charge. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed early and advised assume. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-360
report_date: '2024-09-25'
patient_details:
  patient_id: ANON-PX-5162
  gender: Other
  relevant_history:
  - coronary artery disease
  - seasonal allergies
  - migraines
  - chronic kidney disease
suspected_drugs:
- drug_name: Warfarin
  dosage: 389mg
  route_of_administration: Subcutaneous
  start_date: '2024-08-07'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2024-09-23'
- drug_name: Metformin
  dosage: 141mg
  route_of_administration: Intravenous
  start_date: '2024-08-07'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-09-23'
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2024-09-23'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-09-23'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed single and advised charge.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-09-23'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-09-23'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed early and advised assume.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 5
reporting_facility: Gregory PLC Medical Center
reporter_type: Pharmacist
