<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-2025-192
Date of Submission: 2025-05-02

This report was submitted by a Pharmacist from Garcia, Clayton and Torres Medical Center concerning patient ANON-PX-4934. The subject is an adult other with a significant medical history including migraines, 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 (SSRI) administered via the Topical route at a dosage of 269mg, initiated on 2025-03-23 for Major depressive disorder and discontinued on 2025-04-21; Lisinopril (ACE inhibitor) administered via the Topical route at a dosage of 132mg, initiated on 2025-03-23 for Hypertension and discontinued on 2025-04-21.

On approximately 2025-03-31, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Stevens-Johnson syndrome. The Headache was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed live and advised me. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed exist and advised environment. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 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-2025-192
report_date: '2025-05-02'
patient_details:
  patient_id: ANON-PX-4934
  gender: Other
  relevant_history:
  - migraines
  - anxiety
suspected_drugs:
- drug_name: Sertraline
  dosage: 269mg
  route_of_administration: Topical
  start_date: '2025-03-23'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-04-21'
- drug_name: Lisinopril
  dosage: 132mg
  route_of_administration: Topical
  start_date: '2025-03-23'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
  end_date: '2025-04-21'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2025-03-31'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed live and advised me.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-03-31'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed exist and advised environment.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 6
reporting_facility: Garcia, Clayton and Torres Medical Center
reporter_type: Pharmacist
