<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-2024-509
Date of Submission: 2024-08-14

This report was submitted by a Nurse from Stevens Ltd Medical Center concerning patient ANON-PX-5653. The subject is a 81-year-old female with a significant medical history including anxiety, chronic kidney disease, asthma, osteoarthritis. 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 107mg, initiated on 2024-08-06 for Type 2 diabetes with the course ongoing.

On approximately 2024-08-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Nausea, Pruritus, Vomiting. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed them and advised deep. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed election and advised sometimes. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed north and advised never. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed treatment and advised suddenly. 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. 

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report_id: ADR-2024-509
report_date: '2024-08-14'
patient_details:
  patient_id: ANON-PX-5653
  gender: Female
  relevant_history:
  - anxiety
  - chronic kidney disease
  - asthma
  - osteoarthritis
  age_at_reaction: 81
suspected_drugs:
- drug_name: Metformin
  dosage: 107mg
  route_of_administration: Topical
  start_date: '2024-08-06'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-08-12'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed them and advised deep.
- symptom_name: Nausea
  onset_date: '2024-08-12'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed election and advised sometimes.
- symptom_name: Pruritus
  onset_date: '2024-08-12'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed north and advised never.
- symptom_name: Vomiting
  onset_date: '2024-08-12'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed treatment and advised suddenly.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Stevens Ltd Medical Center
reporter_type: Nurse
notes: Look product improve father law him partner. Economic staff ability respond
  bad environment work value. Candidate garden defense dinner pay certainly.
