<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-2024-558
Date of Submission: 2024-12-29

This report was submitted by a Nurse from Miller, Garcia and Ramirez Medical Center concerning patient ANON-PX-8120. The subject is an adult male with a significant medical history including osteoarthritis, chronic kidney disease, migraines. 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 administered via the Subcutaneous route at a dosage of 13mg, initiated on 2024-11-08 for Major depressive disorder and discontinued on 2024-12-25; Ibuprofen (NSAID) administered via the Oral route at a dosage of 156mg, initiated on 2024-11-08 for Pain and inflammation and discontinued on 2024-12-25.

On approximately 2024-12-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Hepatotoxicity, Nausea, Maculopapular Rash. The Headache was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Hepatotoxicity was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed field and advised else. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed hotel and advised others. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, 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-2024-558
report_date: '2024-12-29'
patient_details:
  patient_id: ANON-PX-8120
  gender: Male
  relevant_history:
  - osteoarthritis
  - chronic kidney disease
  - migraines
suspected_drugs:
- drug_name: Sertraline
  dosage: 13mg
  route_of_administration: Subcutaneous
  start_date: '2024-11-08'
  indication_for_use: Major depressive disorder
  end_date: '2024-12-25'
- drug_name: Ibuprofen
  dosage: 156mg
  route_of_administration: Oral
  start_date: '2024-11-08'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2024-12-25'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2024-12-19'
  severity: Severe
  outcome: Unknown
  intervention_required: true
- symptom_name: Hepatotoxicity
  onset_date: '2024-12-19'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed field and advised else.
- symptom_name: Nausea
  onset_date: '2024-12-19'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-12-19'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed hotel and advised others.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 6
reporting_facility: Miller, Garcia and Ramirez Medical Center
reporter_type: Nurse
