<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-2025-320
Date of Submission: 2025-03-08

This report was submitted by a Physician from Rodriguez LLC Medical Center concerning patient ANON-PX-2940. The subject is a 84-year-old female with a significant medical history including coronary artery disease, migraines, seasonal allergies. 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 104mg, initiated on 2024-12-28 for Major depressive disorder with the course ongoing.

On approximately 2025-02-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Headache, Vomiting, Nausea, Stevens-Johnson syndrome. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed skin and advised beat. 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 'Recovering'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed form and advised weight. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed memory and advised high. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Happen news government measure himself home. Admit figure participant. Throw case five cell physical.</data>
report_id: ADR-2025-320
report_date: '2025-03-08'
patient_details:
  patient_id: ANON-PX-2940
  gender: Female
  relevant_history:
  - coronary artery disease
  - migraines
  - seasonal allergies
  age_at_reaction: 84
suspected_drugs:
- drug_name: Sertraline
  dosage: 104mg
  route_of_administration: Topical
  start_date: '2024-12-28'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-02-18'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-02-18'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed skin and advised beat.
- symptom_name: Vomiting
  onset_date: '2025-02-18'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-02-18'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed form and advised weight.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-02-18'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed memory and advised high.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 10
reporting_facility: Rodriguez LLC Medical Center
reporter_type: Physician
notes: Happen news government measure himself home. Admit figure participant. Throw
  case five cell physical.
