<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-2025-731
Date of Submission: 2025-08-11

This report was submitted by a Other Healthcare Professional from Sullivan Group Medical Center concerning patient ANON-PX-7243. The subject is a 31-year-old female with a significant medical history including atrial fibrillation, type 2 diabetes, asthma, hypertension. 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 Subcutaneous route at a dosage of 411mg, initiated on 2025-05-21 for Pain and inflammation and discontinued on 2025-07-16.

On approximately 2025-06-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Stevens-Johnson syndrome, Diarrhea. The Nausea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed particularly and advised last. The current patient status regarding this symptom is '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 'Not Recovered'. The Diarrhea was classified as Severe 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 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-731
report_date: '2025-08-11'
patient_details:
  patient_id: ANON-PX-7243
  gender: Female
  relevant_history:
  - atrial fibrillation
  - type 2 diabetes
  - asthma
  - hypertension
  age_at_reaction: 31
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 411mg
  route_of_administration: Subcutaneous
  start_date: '2025-05-21'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-07-16'
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2025-06-16'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed particularly and advised last.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-06-16'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-06-16'
  severity: Severe
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 4
reporting_facility: Sullivan Group Medical Center
reporter_type: Other Healthcare Professional
