<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-2024-458
Date of Submission: 2024-12-28

This report was submitted by a Pharmacist from Freeman-Clements Medical Center concerning patient ANON-PX-1797. The subject is a 34-year-old female with a significant medical history including anxiety, atrial fibrillation, osteoarthritis, asthma. 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): Lisinopril (ACE inhibitor) administered via the Topical route at a dosage of 402mg, initiated on 2024-10-07 for Hypertension and discontinued on 2024-12-12; Sertraline (SSRI) administered via the Intravenous route at a dosage of 268mg, initiated on 2024-10-07 for Major depressive disorder and discontinued on 2024-12-12.

On approximately 2024-11-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Hepatotoxicity, Vomiting, Nausea. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

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

</data>
report_id: ADR-2024-458
report_date: '2024-12-28'
patient_details:
  patient_id: ANON-PX-1797
  gender: Female
  relevant_history:
  - anxiety
  - atrial fibrillation
  - osteoarthritis
  - asthma
  age_at_reaction: 34
suspected_drugs:
- drug_name: Lisinopril
  dosage: 402mg
  route_of_administration: Topical
  start_date: '2024-10-07'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
  end_date: '2024-12-12'
- drug_name: Sertraline
  dosage: 268mg
  route_of_administration: Intravenous
  start_date: '2024-10-07'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-12-12'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2024-11-27'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2024-11-27'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2024-11-27'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Nausea
  onset_date: '2024-11-27'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Freeman-Clements Medical Center
reporter_type: Pharmacist
