<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-2024-897
Date of Submission: 2024-12-01

This report was submitted by a Pharmacist from Douglas-Webb Medical Center concerning patient ANON-PX-1277. The subject is an adult female with a significant medical history including atrial fibrillation, seasonal allergies, 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): Sertraline (SSRI) administered via the Topical route at a dosage of 420mg, initiated on 2024-09-23 for Major depressive disorder and discontinued on 2024-10-22.

On approximately 2024-10-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Pruritus, Headache, Somnolence, Stevens-Johnson syndrome. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed guy and advised himself. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed popular and advised receive. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Mild 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. A Naranjo score of 7 was calculated, 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. 

</data>
report_id: ADR-2024-897
report_date: '2024-12-01'
patient_details:
  patient_id: ANON-PX-1277
  gender: Female
  relevant_history:
  - atrial fibrillation
  - seasonal allergies
  - osteoarthritis
suspected_drugs:
- drug_name: Sertraline
  dosage: 420mg
  route_of_administration: Topical
  start_date: '2024-09-23'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-10-22'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-10-04'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed guy and advised himself.
- symptom_name: Pruritus
  onset_date: '2024-10-04'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Headache
  onset_date: '2024-10-04'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed popular and advised receive.
- symptom_name: Somnolence
  onset_date: '2024-10-04'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-10-04'
  severity: Mild
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 7
reporting_facility: Douglas-Webb Medical Center
reporter_type: Pharmacist
