<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-2025-239
Date of Submission: 2025-05-02

This report was submitted by a Nurse from Martinez-Knight Medical Center concerning patient ANON-PX-7000. The subject is a 47-year-old male with a significant medical history including osteoarthritis, seasonal allergies. 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 333mg, initiated on 2025-03-17 for Pain and inflammation and discontinued on 2025-04-27; Sertraline (SSRI) administered via the Oral route at a dosage of 330mg, initiated on 2025-03-17 for Major depressive disorder and discontinued on 2025-04-27.

On approximately 2025-04-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Maculopapular Rash, Hepatotoxicity, Stevens-Johnson syndrome, Anaphylaxis. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed along and advised care. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed artist and advised off. The current patient status regarding this symptom is 'Fatal'. 

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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Call style government ten action above clear. Than certain yard school certain society theory own.</data>
report_id: ADR-2025-239
report_date: '2025-05-02'
patient_details:
  patient_id: ANON-PX-7000
  gender: Male
  relevant_history:
  - osteoarthritis
  - seasonal allergies
  age_at_reaction: 47
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 333mg
  route_of_administration: Topical
  start_date: '2025-03-17'
  indication_for_use: Pain and inflammation
  end_date: '2025-04-27'
- drug_name: Sertraline
  dosage: 330mg
  route_of_administration: Oral
  start_date: '2025-03-17'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-04-27'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2025-04-24'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2025-04-24'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-04-24'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed along and advised care.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-04-24'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-04-24'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed artist and advised off.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 6
reporting_facility: Martinez-Knight Medical Center
reporter_type: Nurse
notes: Call style government ten action above clear. Than certain yard school certain
  society theory own.
