<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-2025-647
Date of Submission: 2025-07-14

This report was submitted by a Physician from Parker-Juarez Medical Center concerning patient ANON-PX-5114. The subject is a 80-year-old female with a significant medical history including migraines, 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 Subcutaneous route at a dosage of 462mg, initiated on 2025-07-04 for Major depressive disorder and discontinued on 2025-07-13; Omeprazole (Proton-pump inhibitor) administered via the Subcutaneous route at a dosage of 147mg, initiated on 2025-07-04 for Gastroesophageal reflux disease and discontinued on 2025-07-13.

On approximately 2025-07-07, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Vomiting. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Vomiting 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 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Player fire just indeed south whole. Age yes project take it by general.</data>
report_id: ADR-2025-647
report_date: '2025-07-14'
patient_details:
  patient_id: ANON-PX-5114
  gender: Female
  relevant_history:
  - migraines
  - atrial fibrillation
  age_at_reaction: 80
suspected_drugs:
- drug_name: Sertraline
  dosage: 462mg
  route_of_administration: Subcutaneous
  start_date: '2025-07-04'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-07-13'
- drug_name: Omeprazole
  dosage: 147mg
  route_of_administration: Subcutaneous
  start_date: '2025-07-04'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-07-13'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-07-07'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-07-07'
  severity: Severe
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 4
reporting_facility: Parker-Juarez Medical Center
reporter_type: Physician
notes: Player fire just indeed south whole. Age yes project take it by general.
