<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-2025-977
Date of Submission: 2025-08-06

This report was submitted by a Other Healthcare Professional from Brown-Mitchell Medical Center concerning patient ANON-PX-7097. The subject is an adult other with a significant medical history including migraines, chronic kidney disease. 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 325mg, initiated on 2025-07-29 for Major depressive disorder and discontinued on 2025-08-04; Atorvastatin (Statin) administered via the Subcutaneous route at a dosage of 374mg, initiated on 2025-07-29 for Hypercholesterolemia and discontinued on 2025-08-04.

On approximately 2025-08-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Maculopapular Rash, Anaphylaxis, Vomiting. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed community and advised foreign. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed contain and advised world. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed instead and advised whom. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-977
report_date: '2025-08-06'
patient_details:
  patient_id: ANON-PX-7097
  gender: Other
  relevant_history:
  - migraines
  - chronic kidney disease
suspected_drugs:
- drug_name: Sertraline
  dosage: 325mg
  route_of_administration: Topical
  start_date: '2025-07-29'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-08-04'
- drug_name: Atorvastatin
  dosage: 374mg
  route_of_administration: Subcutaneous
  start_date: '2025-07-29'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
  end_date: '2025-08-04'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-08-01'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed community and advised foreign.
- symptom_name: Maculopapular Rash
  onset_date: '2025-08-01'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed contain and advised world.
- symptom_name: Anaphylaxis
  onset_date: '2025-08-01'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-08-01'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed instead and advised whom.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 5
reporting_facility: Brown-Mitchell Medical Center
reporter_type: Other Healthcare Professional
