<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-2024-397
Date of Submission: 2024-09-13

This report was submitted by a Patient from Adams-Huffman Medical Center concerning patient ANON-PX-1888. The subject is a 58-year-old female with a significant medical history including seasonal allergies, asthma. 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 administered via the Oral route at a dosage of 306mg, initiated on 2024-08-31 for Major depressive disorder and discontinued on 2024-09-08; Metformin (Biguanide) administered via the Subcutaneous route at a dosage of 88mg, initiated on 2024-08-31 for Type 2 diabetes and discontinued on 2024-09-08.

On approximately 2024-09-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Maculopapular Rash, Diarrhea, Somnolence, Hepatotoxicity. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-397
report_date: '2024-09-13'
patient_details:
  patient_id: ANON-PX-1888
  gender: Female
  relevant_history:
  - seasonal allergies
  - asthma
  age_at_reaction: 58
suspected_drugs:
- drug_name: Sertraline
  dosage: 306mg
  route_of_administration: Oral
  start_date: '2024-08-31'
  indication_for_use: Major depressive disorder
  end_date: '2024-09-08'
- drug_name: Metformin
  dosage: 88mg
  route_of_administration: Subcutaneous
  start_date: '2024-08-31'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-09-08'
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2024-09-04'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-09-04'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-09-04'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-09-04'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2024-09-04'
  severity: Severe
  outcome: Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 2
reporting_facility: Adams-Huffman Medical Center
reporter_type: Patient
