<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-2025-123
Date of Submission: 2025-05-18

This report was submitted by a Nurse from Hancock and Sons Medical Center concerning patient ANON-PX-4322. The subject is a 72-year-old other with a significant medical history including chronic kidney disease, 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): Lisinopril administered via the Intramuscular route at a dosage of 355mg, initiated on 2025-04-13 for Hypertension with the course ongoing; Sertraline administered via the Oral route at a dosage of 36mg, initiated on 2025-04-13 for Major depressive disorder with the course ongoing.

On approximately 2025-04-16, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Dizziness, Somnolence, Diarrhea, Vomiting. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed end and advised weight. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is '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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-123
report_date: '2025-05-18'
patient_details:
  patient_id: ANON-PX-4322
  gender: Other
  relevant_history:
  - chronic kidney disease
  - osteoarthritis
  age_at_reaction: 72
suspected_drugs:
- drug_name: Lisinopril
  dosage: 355mg
  route_of_administration: Intramuscular
  start_date: '2025-04-13'
  indication_for_use: Hypertension
- drug_name: Sertraline
  dosage: 36mg
  route_of_administration: Oral
  start_date: '2025-04-13'
  indication_for_use: Major depressive disorder
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-04-16'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2025-04-16'
  severity: Mild
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed end and advised weight.
- symptom_name: Somnolence
  onset_date: '2025-04-16'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-04-16'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-04-16'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 6
reporting_facility: Hancock and Sons Medical Center
reporter_type: Nurse
