<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-2024-319
Date of Submission: 2024-09-25

This report was submitted by a Patient from Gomez-Guerrero Medical Center concerning patient ANON-PX-3952. The subject is a 84-year-old female with a significant medical history including migraines, type 2 diabetes. 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 373mg, initiated on 2024-08-19 for Hypertension and discontinued on 2024-08-31.

On approximately 2024-08-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Pruritus, Somnolence, Dizziness. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Dizziness was classified as Moderate 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. 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-2024-319
report_date: '2024-09-25'
patient_details:
  patient_id: ANON-PX-3952
  gender: Female
  relevant_history:
  - migraines
  - type 2 diabetes
  age_at_reaction: 84
suspected_drugs:
- drug_name: Lisinopril
  dosage: 373mg
  route_of_administration: Topical
  start_date: '2024-08-19'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
  end_date: '2024-08-31'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2024-08-28'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2024-08-28'
  severity: Severe
  outcome: Fatal
  intervention_required: true
- symptom_name: Somnolence
  onset_date: '2024-08-28'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
- symptom_name: Dizziness
  onset_date: '2024-08-28'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Gomez-Guerrero Medical Center
reporter_type: Patient
