<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-2024-123
Date of Submission: 2024-08-15

This report was submitted by a Patient from Mendoza LLC Medical Center concerning patient ANON-PX-6508. The subject is a 51-year-old other with a significant medical history including anxiety, type 2 diabetes. 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 administered via the Topical route at a dosage of 294mg, initiated on 2024-05-27 for Type 2 diabetes and discontinued on 2024-08-02; Sertraline (SSRI) administered via the Intramuscular route at a dosage of 347mg, initiated on 2024-05-27 for Major depressive disorder and discontinued on 2024-08-02.

On approximately 2024-06-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Hepatotoxicity. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed physical and advised commercial. 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 dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Similar TV really trouble great security. Push product home word begin ahead weight.</data>
report_id: ADR-2024-123
report_date: '2024-08-15'
patient_details:
  patient_id: ANON-PX-6508
  gender: Other
  relevant_history:
  - anxiety
  - type 2 diabetes
  age_at_reaction: 51
suspected_drugs:
- drug_name: Metformin
  dosage: 294mg
  route_of_administration: Topical
  start_date: '2024-05-27'
  indication_for_use: Type 2 diabetes
  end_date: '2024-08-02'
- drug_name: Sertraline
  dosage: 347mg
  route_of_administration: Intramuscular
  start_date: '2024-05-27'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-08-02'
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2024-06-09'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2024-06-09'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed physical and advised commercial.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
reporting_facility: Mendoza LLC Medical Center
reporter_type: Patient
notes: Similar TV really trouble great security. Push product home word begin ahead
  weight.
