<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-2025-228
Date of Submission: 2025-01-01

This report was submitted by a Patient from Hays, Vasquez and Duke Medical Center concerning patient ANON-PX-7617. The subject is a 54-year-old other with a significant medical history including atrial fibrillation, migraines. 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): Amoxicillin (Penicillin antibiotic) administered via the Oral route at a dosage of 21mg, initiated on 2024-12-02 for Bacterial infection and discontinued on 2024-12-23; Warfarin (Anticoagulant) administered via the Oral route at a dosage of 116mg, initiated on 2024-12-02 for Thromboembolism prevention and discontinued on 2024-12-23.

On approximately 2024-12-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Vomiting, Maculopapular Rash, Hepatotoxicity, Somnolence. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed cut and advised it. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed name and advised record. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Community practice Democrat too hard. To class need four will young.</data>
report_id: ADR-2025-228
report_date: '2025-01-01'
patient_details:
  patient_id: ANON-PX-7617
  gender: Other
  relevant_history:
  - atrial fibrillation
  - migraines
  age_at_reaction: 54
suspected_drugs:
- drug_name: Amoxicillin
  dosage: 21mg
  route_of_administration: Oral
  start_date: '2024-12-02'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2024-12-23'
- drug_name: Warfarin
  dosage: 116mg
  route_of_administration: Oral
  start_date: '2024-12-02'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2024-12-23'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2024-12-03'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed cut and advised it.
- symptom_name: Vomiting
  onset_date: '2024-12-03'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
- symptom_name: Maculopapular Rash
  onset_date: '2024-12-03'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed name and advised record.
- symptom_name: Hepatotoxicity
  onset_date: '2024-12-03'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-12-03'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 5
reporting_facility: Hays, Vasquez and Duke Medical Center
reporter_type: Patient
notes: Community practice Democrat too hard. To class need four will young.
