<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-2025-514
Date of Submission: 2025-05-28

This report was submitted by a Physician from Davis-Thomas Medical Center concerning patient ANON-PX-8987. The subject is a 71-year-old male with a significant medical history including anxiety, coronary artery disease, osteoarthritis. 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 88mg, initiated on 2025-05-05 for Pain and inflammation and discontinued on 2025-05-25.

On approximately 2025-05-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Dizziness, Anaphylaxis, Nausea. The Maculopapular Rash was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed benefit and advised subject. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

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report_id: ADR-2025-514
report_date: '2025-05-28'
patient_details:
  patient_id: ANON-PX-8987
  gender: Male
  relevant_history:
  - anxiety
  - coronary artery disease
  - osteoarthritis
  age_at_reaction: 71
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 88mg
  route_of_administration: Topical
  start_date: '2025-05-05'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-05-25'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-05-24'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed benefit and advised subject.
- symptom_name: Dizziness
  onset_date: '2025-05-24'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-05-24'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-05-24'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Davis-Thomas Medical Center
reporter_type: Physician
notes: State best he health claim kind stock space. Writer responsibility realize
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