<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-2024-427
Date of Submission: 2024-09-20

This report was submitted by a Patient from Hodge Ltd Medical Center concerning patient ANON-PX-4486. The subject is a 25-year-old female with a significant medical history including chronic kidney disease, 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): Ibuprofen (NSAID) administered via the Topical route at a dosage of 464mg, initiated on 2024-07-17 for Pain and inflammation and discontinued on 2024-08-26; Warfarin administered via the Intramuscular route at a dosage of 61mg, initiated on 2024-07-17 for Thromboembolism prevention and discontinued on 2024-08-26.

On approximately 2024-08-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Maculopapular Rash, Anaphylaxis. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 was calculated, The assessment concluded the relationship was 'Possible'. 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-2024-427
report_date: '2024-09-20'
patient_details:
  patient_id: ANON-PX-4486
  gender: Female
  relevant_history:
  - chronic kidney disease
  - coronary artery disease
  age_at_reaction: 25
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 464mg
  route_of_administration: Topical
  start_date: '2024-07-17'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2024-08-26'
- drug_name: Warfarin
  dosage: 61mg
  route_of_administration: Intramuscular
  start_date: '2024-07-17'
  indication_for_use: Thromboembolism prevention
  end_date: '2024-08-26'
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2024-08-17'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-08-17'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-08-17'
  severity: Mild
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 2
reporting_facility: Hodge Ltd Medical Center
reporter_type: Patient
