<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-2025-453
Date of Submission: 2025-06-25

This report was submitted by a Nurse from Johnson-Thomas Medical Center concerning patient ANON-PX-1385. The subject is a 72-year-old female with a significant medical history including asthma, anxiety, atrial fibrillation. 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 Intravenous route at a dosage of 252mg, initiated on 2025-05-17 for Major depressive disorder and discontinued on 2025-06-23.

On approximately 2025-06-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Stevens-Johnson syndrome, Anaphylaxis, Headache, Diarrhea. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed yourself and advised card. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed against and advised cost. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed middle and advised relate. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. 

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

Reporter's Narrative Summary: Magazine lot talk open parent.</data>
report_id: ADR-2025-453
report_date: '2025-06-25'
patient_details:
  patient_id: ANON-PX-1385
  gender: Female
  relevant_history:
  - asthma
  - anxiety
  - atrial fibrillation
  age_at_reaction: 72
suspected_drugs:
- drug_name: Sertraline
  dosage: 252mg
  route_of_administration: Intravenous
  start_date: '2025-05-17'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-06-23'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-06-06'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed yourself and advised card.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-06-06'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-06-06'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed against and advised cost.
- symptom_name: Headache
  onset_date: '2025-06-06'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed middle and advised relate.
- symptom_name: Diarrhea
  onset_date: '2025-06-06'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Johnson-Thomas Medical Center
reporter_type: Nurse
notes: Magazine lot talk open parent.
