<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-2025-858
Date of Submission: 2025-06-11

This report was submitted by a Patient from Durham-Flores Medical Center concerning patient ANON-PX-2206. The subject is a 31-year-old female with a significant medical history including asthma, migraines, coronary artery disease, hypertension. 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 Topical route at a dosage of 446mg, initiated on 2025-04-01 for Hypertension with the course ongoing.

On approximately 2025-04-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Nausea. The Pruritus was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-858
report_date: '2025-06-11'
patient_details:
  patient_id: ANON-PX-2206
  gender: Female
  relevant_history:
  - asthma
  - migraines
  - coronary artery disease
  - hypertension
  age_at_reaction: 31
suspected_drugs:
- drug_name: Lisinopril
  dosage: 446mg
  route_of_administration: Topical
  start_date: '2025-04-01'
  indication_for_use: Hypertension
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2025-04-24'
  severity: Severe
  outcome: Recovering
  intervention_required: true
- symptom_name: Nausea
  onset_date: '2025-04-24'
  severity: Mild
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 4
reporting_facility: Durham-Flores Medical Center
reporter_type: Patient
