<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-2025-927
Date of Submission: 2025-08-12

This report was submitted by a Patient from Phillips Ltd Medical Center concerning patient ANON-PX-4473. The subject is a 56-year-old male with a significant medical history including asthma, 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 489mg, initiated on 2025-07-15 for Hypertension and discontinued on 2025-07-25; Metformin (Biguanide) administered via the Topical route at a dosage of 364mg, initiated on 2025-07-15 for Type 2 diabetes and discontinued on 2025-07-25.

On approximately 2025-07-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Somnolence. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed thus and advised customer. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed nor and advised sign. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Nature contain civil these.</data>
report_id: ADR-2025-927
report_date: '2025-08-12'
patient_details:
  patient_id: ANON-PX-4473
  gender: Male
  relevant_history:
  - asthma
  - type 2 diabetes
  age_at_reaction: 56
suspected_drugs:
- drug_name: Lisinopril
  dosage: 489mg
  route_of_administration: Topical
  start_date: '2025-07-15'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
  end_date: '2025-07-25'
- drug_name: Metformin
  dosage: 364mg
  route_of_administration: Topical
  start_date: '2025-07-15'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2025-07-25'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2025-07-24'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed thus and advised customer.
- symptom_name: Somnolence
  onset_date: '2025-07-24'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed nor and advised sign.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 9
reporting_facility: Phillips Ltd Medical Center
reporter_type: Patient
notes: Nature contain civil these.
