<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-2025-184
Date of Submission: 2025-04-06

This report was submitted by a Other Healthcare Professional from Roberson-Davis Medical Center concerning patient ANON-PX-1746. The subject is a 77-year-old male with a significant medical history including chronic kidney disease, migraines. 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): Metformin (Biguanide) administered via the Topical route at a dosage of 379mg, initiated on 2025-03-26 for Type 2 diabetes and discontinued on 2025-04-04; Atorvastatin (Statin) administered via the Topical route at a dosage of 23mg, initiated on 2025-03-26 for Hypercholesterolemia and discontinued on 2025-04-04.

On approximately 2025-04-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Stevens-Johnson syndrome, Somnolence, Maculopapular Rash, Nausea. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed general and advised statement. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed clearly and advised summer. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed affect and advised of. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Business table left affect sometimes. Thought base former need. Claim laugh since. We receive political call sound home.</data>
report_id: ADR-2025-184
report_date: '2025-04-06'
patient_details:
  patient_id: ANON-PX-1746
  gender: Male
  relevant_history:
  - chronic kidney disease
  - migraines
  age_at_reaction: 77
suspected_drugs:
- drug_name: Metformin
  dosage: 379mg
  route_of_administration: Topical
  start_date: '2025-03-26'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2025-04-04'
- drug_name: Atorvastatin
  dosage: 23mg
  route_of_administration: Topical
  start_date: '2025-03-26'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2025-04-04'
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2025-04-04'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed general and advised statement.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-04-04'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-04-04'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed clearly and advised summer.
- symptom_name: Maculopapular Rash
  onset_date: '2025-04-04'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-04-04'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed affect and advised of.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Roberson-Davis Medical Center
reporter_type: Other Healthcare Professional
notes: Business table left affect sometimes. Thought base former need. Claim laugh
  since. We receive political call sound home.
