<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-2025-715
Date of Submission: 2025-03-23

This report was submitted by a Physician from Higgins, Cruz and Cummings Medical Center concerning patient ANON-PX-5697. The subject is an adult other with a significant medical history including migraines, anxiety. 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 13mg, initiated on 2025-01-04 for Hypertension with the course ongoing.

On approximately 2025-01-27, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Angioedema, Somnolence, Hepatotoxicity, Headache. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed argue and advised base. The current patient status regarding this symptom is 'Unknown'. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Life-threatening 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 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-715
report_date: '2025-03-23'
patient_details:
  patient_id: ANON-PX-5697
  gender: Other
  relevant_history:
  - migraines
  - anxiety
suspected_drugs:
- drug_name: Lisinopril
  dosage: 13mg
  route_of_administration: Topical
  start_date: '2025-01-04'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-01-27'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed argue and advised base.
- symptom_name: Angioedema
  onset_date: '2025-01-27'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-01-27'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-01-27'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Headache
  onset_date: '2025-01-27'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 8
reporting_facility: Higgins, Cruz and Cummings Medical Center
reporter_type: Physician
