<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-2025-904
Date of Submission: 2025-06-09

This report was submitted by a Nurse from Harrington, Frost and Jones Medical Center concerning patient ANON-PX-8021. The subject is an adult male with a significant medical history including anxiety, asthma, migraines. 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 Topical route at a dosage of 284mg, initiated on 2025-04-29 for Major depressive disorder and discontinued on 2025-05-26.

On approximately 2025-05-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Angioedema, Stevens-Johnson syndrome. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Sign show only church wrong certain. Because almost different young fish process second. Hot grow night chair western anyone issue Democrat.</data>
report_id: ADR-2025-904
report_date: '2025-06-09'
patient_details:
  patient_id: ANON-PX-8021
  gender: Male
  relevant_history:
  - anxiety
  - asthma
  - migraines
suspected_drugs:
- drug_name: Sertraline
  dosage: 284mg
  route_of_administration: Topical
  start_date: '2025-04-29'
  indication_for_use: Major depressive disorder
  end_date: '2025-05-26'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2025-05-11'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-05-11'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-05-11'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Harrington, Frost and Jones Medical Center
reporter_type: Nurse
notes: Sign show only church wrong certain. Because almost different young fish process
  second. Hot grow night chair western anyone issue Democrat.
