<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-2025-592
Date of Submission: 2025-02-26

This report was submitted by a Other Healthcare Professional from Johnson PLC Medical Center concerning patient ANON-PX-5076. The subject is a 33-year-old female with a significant medical history including hypertension, asthma, coronary artery 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 administered via the Intravenous route at a dosage of 500mg, initiated on 2024-11-28 for Major depressive disorder with the course ongoing; Atorvastatin (Statin) administered via the Topical route at a dosage of 392mg, initiated on 2024-11-28 for Hypercholesterolemia with the course ongoing.

On approximately 2024-12-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Headache, Angioedema. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema 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 7 was calculated, 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: Shoulder consumer hand agreement that analysis poor skin. Argue world outside light nor court doctor. Level somebody house let foreign.</data>
report_id: ADR-2025-592
report_date: '2025-02-26'
patient_details:
  patient_id: ANON-PX-5076
  gender: Female
  relevant_history:
  - hypertension
  - asthma
  - coronary artery disease
  age_at_reaction: 33
suspected_drugs:
- drug_name: Sertraline
  dosage: 500mg
  route_of_administration: Intravenous
  start_date: '2024-11-28'
  indication_for_use: Major depressive disorder
- drug_name: Atorvastatin
  dosage: 392mg
  route_of_administration: Topical
  start_date: '2024-11-28'
  indication_for_use: Hypercholesterolemia
  drug_class: Statin
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2024-12-09'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Headache
  onset_date: '2024-12-09'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-12-09'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 7
reporting_facility: Johnson PLC Medical Center
reporter_type: Other Healthcare Professional
notes: Shoulder consumer hand agreement that analysis poor skin. Argue world outside
  light nor court doctor. Level somebody house let foreign.
