<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-2024-918
Date of Submission: 2024-10-22

This report was submitted by a Patient from Martin-Navarro Medical Center concerning patient ANON-PX-5159. The subject is an adult female with a significant medical history including asthma, atrial fibrillation, coronary artery 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): Sertraline (SSRI) administered via the Subcutaneous route at a dosage of 147mg, initiated on 2024-08-10 for Major depressive disorder and discontinued on 2024-10-20; Metformin (Biguanide) administered via the Oral route at a dosage of 462mg, initiated on 2024-08-10 for Type 2 diabetes and discontinued on 2024-10-20.

On approximately 2024-10-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Diarrhea, Hepatotoxicity, Vomiting. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed somebody and advised real. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed place and advised author. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed prove and advised site. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. 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. 

</data>
report_id: ADR-2024-918
report_date: '2024-10-22'
patient_details:
  patient_id: ANON-PX-5159
  gender: Female
  relevant_history:
  - asthma
  - atrial fibrillation
  - coronary artery disease
suspected_drugs:
- drug_name: Sertraline
  dosage: 147mg
  route_of_administration: Subcutaneous
  start_date: '2024-08-10'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-10-20'
- drug_name: Metformin
  dosage: 462mg
  route_of_administration: Oral
  start_date: '2024-08-10'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-10-20'
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2024-10-13'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed somebody and advised real.
- symptom_name: Diarrhea
  onset_date: '2024-10-13'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed place and advised author.
- symptom_name: Hepatotoxicity
  onset_date: '2024-10-13'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed prove and advised site.
- symptom_name: Vomiting
  onset_date: '2024-10-13'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Martin-Navarro Medical Center
reporter_type: Patient
