<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-2025-299
Date of Submission: 2025-04-14

This report was submitted by a Pharmacist from Wright, Hood and Silva Medical Center concerning patient ANON-PX-6597. The subject is a 78-year-old male with a significant medical history including asthma, anxiety, seasonal allergies, type 2 diabetes. 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 433mg, initiated on 2025-01-19 for Pain and inflammation and discontinued on 2025-04-12; Warfarin (Anticoagulant) administered via the Intramuscular route at a dosage of 61mg, initiated on 2025-01-19 for Thromboembolism prevention and discontinued on 2025-04-12.

On approximately 2025-04-12, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Diarrhea, Anaphylaxis, Stevens-Johnson syndrome, Pruritus. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed quickly and advised build. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Whose trade product away administration hot evidence. Appear someone PM see factor. Management best quality difference behavior crime civil. Picture away miss point.</data>
report_id: ADR-2025-299
report_date: '2025-04-14'
patient_details:
  patient_id: ANON-PX-6597
  gender: Male
  relevant_history:
  - asthma
  - anxiety
  - seasonal allergies
  - type 2 diabetes
  age_at_reaction: 78
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 433mg
  route_of_administration: Topical
  start_date: '2025-01-19'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-04-12'
- drug_name: Warfarin
  dosage: 61mg
  route_of_administration: Intramuscular
  start_date: '2025-01-19'
  indication_for_use: Thromboembolism prevention
  drug_class: Anticoagulant
  end_date: '2025-04-12'
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2025-04-12'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-04-12'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed quickly and advised build.
- symptom_name: Anaphylaxis
  onset_date: '2025-04-12'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-04-12'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-04-12'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 10
reporting_facility: Wright, Hood and Silva Medical Center
reporter_type: Pharmacist
notes: Whose trade product away administration hot evidence. Appear someone PM see
  factor. Management best quality difference behavior crime civil. Picture away miss
  point.
