<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-2025-382
Date of Submission: 2025-01-09

This report was submitted by a Physician from Moss, Ward and Peterson Medical Center concerning patient ANON-PX-2107. The subject is a 41-year-old other with a significant medical history including type 2 diabetes, 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): Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 334mg, initiated on 2024-11-14 for Hypertension and discontinued on 2025-01-03.

On approximately 2024-12-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Diarrhea, Nausea, Maculopapular Rash, Anaphylaxis. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Nausea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Mild 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 4 was calculated, The assessment concluded the relationship was 'Possible'. 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-2025-382
report_date: '2025-01-09'
patient_details:
  patient_id: ANON-PX-2107
  gender: Other
  relevant_history:
  - type 2 diabetes
  - migraines
  age_at_reaction: 41
suspected_drugs:
- drug_name: Lisinopril
  dosage: 334mg
  route_of_administration: Intravenous
  start_date: '2024-11-14'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
  end_date: '2025-01-03'
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2024-12-25'
  severity: Severe
  outcome: Unknown
  intervention_required: true
- symptom_name: Diarrhea
  onset_date: '2024-12-25'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-12-25'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-12-25'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-12-25'
  severity: Mild
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 4
reporting_facility: Moss, Ward and Peterson Medical Center
reporter_type: Physician
