<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-2025-949
Date of Submission: 2025-01-15

This report was submitted by a Nurse from Grimes-Simpson Medical Center concerning patient ANON-PX-4802. The subject is an adult male with a significant medical history including migraines, osteoarthritis, type 2 diabetes, 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): Warfarin administered via the Subcutaneous route at a dosage of 81mg, initiated on 2024-10-25 for Thromboembolism prevention and discontinued on 2025-01-05; Gabapentin (Anticonvulsant) administered via the Topical route at a dosage of 491mg, initiated on 2024-10-25 for Neuropathic pain and discontinued on 2025-01-05.

On approximately 2024-11-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Pruritus, Diarrhea, Nausea. 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 Pruritus was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-949
report_date: '2025-01-15'
patient_details:
  patient_id: ANON-PX-4802
  gender: Male
  relevant_history:
  - migraines
  - osteoarthritis
  - type 2 diabetes
  - anxiety
suspected_drugs:
- drug_name: Warfarin
  dosage: 81mg
  route_of_administration: Subcutaneous
  start_date: '2024-10-25'
  indication_for_use: Thromboembolism prevention
  end_date: '2025-01-05'
- drug_name: Gabapentin
  dosage: 491mg
  route_of_administration: Topical
  start_date: '2024-10-25'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-01-05'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2024-11-09'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2024-11-09'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-11-09'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-11-09'
  severity: Severe
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 4
reporting_facility: Grimes-Simpson Medical Center
reporter_type: Nurse
