<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-2025-246
Date of Submission: 2025-05-20

This report was submitted by a Patient from Roberts Ltd Medical Center concerning patient ANON-PX-1576. The subject is an adult other with a significant medical history including type 2 diabetes, seasonal allergies, atrial fibrillation, 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 Intramuscular route at a dosage of 277mg, initiated on 2025-04-05 for Pain and inflammation and discontinued on 2025-05-13.

On approximately 2025-04-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Stevens-Johnson syndrome, Somnolence. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed pull and advised various. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-246
report_date: '2025-05-20'
patient_details:
  patient_id: ANON-PX-1576
  gender: Other
  relevant_history:
  - type 2 diabetes
  - seasonal allergies
  - atrial fibrillation
  - osteoarthritis
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 277mg
  route_of_administration: Intramuscular
  start_date: '2025-04-05'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-05-13'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2025-04-27'
  severity: Severe
  outcome: Recovering
  intervention_required: true
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-04-27'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed pull and advised various.
- symptom_name: Somnolence
  onset_date: '2025-04-27'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 3
reporting_facility: Roberts Ltd Medical Center
reporter_type: Patient
