<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-2024-331
Date of Submission: 2024-11-26

This report was submitted by a Other Healthcare Professional from Frost-Torres Medical Center concerning patient ANON-PX-2992. The subject is a 46-year-old other with a significant medical history including chronic kidney 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 Subcutaneous route at a dosage of 300mg, initiated on 2024-09-04 for Pain and inflammation and discontinued on 2024-10-05.

On approximately 2024-09-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Nausea, Maculopapular Rash, Dizziness, Stevens-Johnson syndrome. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed such and advised nearly. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Severe in severity. No specific therapeutic intervention was required. 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 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 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-2024-331
report_date: '2024-11-26'
patient_details:
  patient_id: ANON-PX-2992
  gender: Other
  relevant_history:
  - chronic kidney disease
  - osteoarthritis
  age_at_reaction: 46
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 300mg
  route_of_administration: Subcutaneous
  start_date: '2024-09-04'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2024-10-05'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2024-09-07'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-09-07'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Maculopapular Rash
  onset_date: '2024-09-07'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed such and advised nearly.
- symptom_name: Dizziness
  onset_date: '2024-09-07'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-09-07'
  severity: Severe
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 1
reporting_facility: Frost-Torres Medical Center
reporter_type: Other Healthcare Professional
