<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-2024-206
Date of Submission: 2024-08-28

This report was submitted by a Physician from Harrington Group Medical Center concerning patient ANON-PX-5336. The subject is a 49-year-old female with a significant medical history including osteoarthritis, hypertension, chronic kidney disease, anxiety. 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 Intravenous route at a dosage of 309mg, initiated on 2024-08-06 for Pain and inflammation with the course ongoing.

On approximately 2024-08-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Headache, Diarrhea, Dizziness. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed oil and advised trouble. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed impact and advised will. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 was calculated, The assessment concluded the relationship was 'Probable'. 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-2024-206
report_date: '2024-08-28'
patient_details:
  patient_id: ANON-PX-5336
  gender: Female
  relevant_history:
  - osteoarthritis
  - hypertension
  - chronic kidney disease
  - anxiety
  age_at_reaction: 49
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 309mg
  route_of_administration: Intravenous
  start_date: '2024-08-06'
  indication_for_use: Pain and inflammation
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2024-08-25'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
- symptom_name: Headache
  onset_date: '2024-08-25'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
- symptom_name: Diarrhea
  onset_date: '2024-08-25'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed oil and advised trouble.
- symptom_name: Dizziness
  onset_date: '2024-08-25'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed impact and advised will.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 5
reporting_facility: Harrington Group Medical Center
reporter_type: Physician
