<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-2024-500
Date of Submission: 2024-08-17

This report was submitted by a Other Healthcare Professional from Marshall-Bernard Medical Center concerning patient ANON-PX-2485. The subject is a 59-year-old male with a significant medical history including type 2 diabetes, anxiety, chronic kidney 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 administered via the Topical route at a dosage of 372mg, initiated on 2024-07-29 for Pain and inflammation and discontinued on 2024-08-15.

On approximately 2024-08-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Somnolence, Vomiting, Pruritus. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed later and advised force. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed another and advised sit. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Ever student travel thing crime because word pretty. Long green ten. Size investment across agree friend almost.</data>
report_id: ADR-2024-500
report_date: '2024-08-17'
patient_details:
  patient_id: ANON-PX-2485
  gender: Male
  relevant_history:
  - type 2 diabetes
  - anxiety
  - chronic kidney disease
  age_at_reaction: 59
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 372mg
  route_of_administration: Topical
  start_date: '2024-07-29'
  indication_for_use: Pain and inflammation
  end_date: '2024-08-15'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2024-08-12'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-08-12'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2024-08-12'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed later and advised force.
- symptom_name: Pruritus
  onset_date: '2024-08-12'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed another and advised sit.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 6
reporting_facility: Marshall-Bernard Medical Center
reporter_type: Other Healthcare Professional
notes: Ever student travel thing crime because word pretty. Long green ten. Size investment
  across agree friend almost.
