<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-2025-791
Date of Submission: 2025-07-26

This report was submitted by a Physician from Barton, Brown and Dennis Medical Center concerning patient ANON-PX-1617. The subject is a 42-year-old female with a significant medical history including asthma, type 2 diabetes, atrial fibrillation. 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): Sertraline (SSRI) administered via the Intravenous route at a dosage of 407mg, initiated on 2025-05-10 for Major depressive disorder and discontinued on 2025-06-30; Ibuprofen administered via the Intramuscular route at a dosage of 333mg, initiated on 2025-05-10 for Pain and inflammation and discontinued on 2025-06-30.

On approximately 2025-06-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Angioedema, Dizziness. The Diarrhea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed poor and advised future. The current patient status regarding this symptom is 'Recovering'. 

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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-791
report_date: '2025-07-26'
patient_details:
  patient_id: ANON-PX-1617
  gender: Female
  relevant_history:
  - asthma
  - type 2 diabetes
  - atrial fibrillation
  age_at_reaction: 42
suspected_drugs:
- drug_name: Sertraline
  dosage: 407mg
  route_of_administration: Intravenous
  start_date: '2025-05-10'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-06-30'
- drug_name: Ibuprofen
  dosage: 333mg
  route_of_administration: Intramuscular
  start_date: '2025-05-10'
  indication_for_use: Pain and inflammation
  end_date: '2025-06-30'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2025-06-10'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-06-10'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2025-06-10'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed poor and advised future.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 4
reporting_facility: Barton, Brown and Dennis Medical Center
reporter_type: Physician
