<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-2025-646
Date of Submission: 2025-03-21

This report was submitted by a Nurse from Murillo-Ferguson Medical Center concerning patient ANON-PX-8371. The subject is a 43-year-old female with a significant medical history including asthma, 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 Oral route at a dosage of 459mg, initiated on 2025-01-03 for Pain and inflammation and discontinued on 2025-02-07; Sertraline (SSRI) administered via the Oral route at a dosage of 324mg, initiated on 2025-01-03 for Major depressive disorder and discontinued on 2025-02-07.

On approximately 2025-02-01, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Nausea. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed teacher and advised this. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-646
report_date: '2025-03-21'
patient_details:
  patient_id: ANON-PX-8371
  gender: Female
  relevant_history:
  - asthma
  - osteoarthritis
  age_at_reaction: 43
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 459mg
  route_of_administration: Oral
  start_date: '2025-01-03'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-02-07'
- drug_name: Sertraline
  dosage: 324mg
  route_of_administration: Oral
  start_date: '2025-01-03'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-02-07'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-02-01'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed teacher and advised this.
- symptom_name: Nausea
  onset_date: '2025-02-01'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
reporting_facility: Murillo-Ferguson Medical Center
reporter_type: Nurse
