<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-2025-205
Date of Submission: 2025-01-13

This report was submitted by a Nurse from Cook-Brown Medical Center concerning patient ANON-PX-8345. The subject is an adult female with a significant medical history including chronic kidney disease, 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 Intravenous route at a dosage of 337mg, initiated on 2024-12-14 for Major depressive disorder with the course ongoing.

On approximately 2025-01-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Headache, Pruritus. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly 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: According around base western president hundred money. Direction often phone cost young bed middle. Wife allow real story economic.</data>
report_id: ADR-2025-205
report_date: '2025-01-13'
patient_details:
  patient_id: ANON-PX-8345
  gender: Female
  relevant_history:
  - chronic kidney disease
  - anxiety
suspected_drugs:
- drug_name: Sertraline
  dosage: 337mg
  route_of_administration: Intravenous
  start_date: '2024-12-14'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2025-01-09'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-01-09'
  severity: Severe
  outcome: Recovering
  intervention_required: true
- symptom_name: Pruritus
  onset_date: '2025-01-09'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 9
reporting_facility: Cook-Brown Medical Center
reporter_type: Nurse
notes: According around base western president hundred money. Direction often phone
  cost young bed middle. Wife allow real story economic.
