<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-2024-424
Date of Submission: 2024-09-23

This report was submitted by a Other Healthcare Professional from Golden, Soto and Hernandez Medical Center concerning patient ANON-PX-6069. The subject is an adult female with a significant medical history including type 2 diabetes, 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 Intravenous route at a dosage of 91mg, initiated on 2024-07-01 for Major depressive disorder and discontinued on 2024-09-16.

On approximately 2024-07-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Diarrhea, Anaphylaxis, Stevens-Johnson syndrome. The Maculopapular Rash was classified as Severe 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 Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed citizen and advised probably. 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. 

</data>
report_id: ADR-2024-424
report_date: '2024-09-23'
patient_details:
  patient_id: ANON-PX-6069
  gender: Female
  relevant_history:
  - type 2 diabetes
  - anxiety
suspected_drugs:
- drug_name: Sertraline
  dosage: 91mg
  route_of_administration: Intravenous
  start_date: '2024-07-01'
  indication_for_use: Major depressive disorder
  end_date: '2024-09-16'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2024-07-24'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-07-24'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-07-24'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-07-24'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed citizen and advised probably.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
reporting_facility: Golden, Soto and Hernandez Medical Center
reporter_type: Other Healthcare Professional
