<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-2025-411
Date of Submission: 2025-03-12

This report was submitted by a Nurse from Terry-Cook Medical Center concerning patient ANON-PX-5671. The subject is an adult female with a significant medical history including seasonal allergies, migraines, type 2 diabetes. 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): Warfarin administered via the Topical route at a dosage of 413mg, initiated on 2025-01-16 for Thromboembolism prevention and discontinued on 2025-02-26; Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 392mg, initiated on 2025-01-16 for Pain and inflammation and discontinued on 2025-02-26.

On approximately 2025-02-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Anaphylaxis, Pruritus, Angioedema, Somnolence. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed standard and advised chair. 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 'Unknown'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed nearly and advised five. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 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. 

</data>
report_id: ADR-2025-411
report_date: '2025-03-12'
patient_details:
  patient_id: ANON-PX-5671
  gender: Female
  relevant_history:
  - seasonal allergies
  - migraines
  - type 2 diabetes
suspected_drugs:
- drug_name: Warfarin
  dosage: 413mg
  route_of_administration: Topical
  start_date: '2025-01-16'
  indication_for_use: Thromboembolism prevention
  end_date: '2025-02-26'
- drug_name: Ibuprofen
  dosage: 392mg
  route_of_administration: Subcutaneous
  start_date: '2025-01-16'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-02-26'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2025-02-17'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-02-17'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-02-17'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed standard and advised chair.
- symptom_name: Angioedema
  onset_date: '2025-02-17'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-02-17'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed nearly and advised five.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 10
reporting_facility: Terry-Cook Medical Center
reporter_type: Nurse
