<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-2025-704
Date of Submission: 2025-07-26

This report was submitted by a Physician from Morgan-Clark Medical Center concerning patient ANON-PX-3617. The subject is an adult male with a significant medical history including asthma, seasonal allergies, chronic kidney disease, migraines. 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 82mg, initiated on 2025-06-04 for Pain and inflammation and discontinued on 2025-07-05.

On approximately 2025-06-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Angioedema, Vomiting. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed own and advised ask. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: New bad medical more ability south treat piece.</data>
report_id: ADR-2025-704
report_date: '2025-07-26'
patient_details:
  patient_id: ANON-PX-3617
  gender: Male
  relevant_history:
  - asthma
  - seasonal allergies
  - chronic kidney disease
  - migraines
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 82mg
  route_of_administration: Topical
  start_date: '2025-06-04'
  indication_for_use: Pain and inflammation
  end_date: '2025-07-05'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-06-07'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-06-07'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
- symptom_name: Vomiting
  onset_date: '2025-06-07'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed own and advised ask.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 9
reporting_facility: Morgan-Clark Medical Center
reporter_type: Physician
notes: New bad medical more ability south treat piece.
