<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-2024-875
Date of Submission: 2024-11-13

This report was submitted by a Nurse from Cooper-Vaughn Medical Center concerning patient ANON-PX-4205. The subject is a 44-year-old female with a significant medical history including atrial fibrillation, chronic kidney disease, anxiety. 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 Topical route at a dosage of 147mg, initiated on 2024-09-22 for Major depressive disorder and discontinued on 2024-11-09.

On approximately 2024-10-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Hepatotoxicity, Maculopapular Rash. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed put and advised good. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed front and advised direction. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, 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: May for ten difficult crime factor boy. Then claim say industry well realize American visit. Hot range physical must art already.</data>
report_id: ADR-2024-875
report_date: '2024-11-13'
patient_details:
  patient_id: ANON-PX-4205
  gender: Female
  relevant_history:
  - atrial fibrillation
  - chronic kidney disease
  - anxiety
  age_at_reaction: 44
suspected_drugs:
- drug_name: Sertraline
  dosage: 147mg
  route_of_administration: Topical
  start_date: '2024-09-22'
  indication_for_use: Major depressive disorder
  end_date: '2024-11-09'
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2024-10-25'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed put and advised good.
- symptom_name: Hepatotoxicity
  onset_date: '2024-10-25'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-10-25'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed front and advised direction.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 7
reporting_facility: Cooper-Vaughn Medical Center
reporter_type: Nurse
notes: May for ten difficult crime factor boy. Then claim say industry well realize
  American visit. Hot range physical must art already.
