<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-2024-958
Date of Submission: 2024-09-22

This report was submitted by a Patient from Nicholson, Johnson and Flynn Medical Center concerning patient ANON-PX-1780. The subject is an adult female with a significant medical history including migraines, hypertension. 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 (Anticoagulant) administered via the Intravenous route at a dosage of 394mg, initiated on 2024-08-18 for Thromboembolism prevention and discontinued on 2024-09-11.

On approximately 2024-08-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Somnolence, Nausea, Maculopapular Rash, Vomiting. The Headache was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed I and advised gas. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed dream and advised partner. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. 

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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-958
report_date: '2024-09-22'
patient_details:
  patient_id: ANON-PX-1780
  gender: Female
  relevant_history:
  - migraines
  - hypertension
suspected_drugs:
- drug_name: Warfarin
  dosage: 394mg
  route_of_administration: Intravenous
  start_date: '2024-08-18'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2024-09-11'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2024-08-28'
  severity: Mild
  outcome: Recovered
  intervention_required: true
- symptom_name: Somnolence
  onset_date: '2024-08-28'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed I and advised gas.
- symptom_name: Nausea
  onset_date: '2024-08-28'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Maculopapular Rash
  onset_date: '2024-08-28'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed dream and advised partner.
- symptom_name: Vomiting
  onset_date: '2024-08-28'
  severity: Mild
  outcome: Fatal
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 5
reporting_facility: Nicholson, Johnson and Flynn Medical Center
reporter_type: Patient
