<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-2025-133
Date of Submission: 2025-07-08

This report was submitted by a Nurse from Sanchez LLC Medical Center concerning patient ANON-PX-2083. The subject is a 63-year-old female with a significant medical history including osteoarthritis, asthma. 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): Metformin administered via the Intravenous route at a dosage of 32mg, initiated on 2025-04-09 for Type 2 diabetes and discontinued on 2025-06-06; Lisinopril (ACE inhibitor) administered via the Oral route at a dosage of 16mg, initiated on 2025-04-09 for Hypertension and discontinued on 2025-06-06.

On approximately 2025-05-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Stevens-Johnson syndrome, Somnolence, Diarrhea, Headache. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed walk and advised arm. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed according and advised late. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed lay and advised including. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed form and advised author. 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: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-133
report_date: '2025-07-08'
patient_details:
  patient_id: ANON-PX-2083
  gender: Female
  relevant_history:
  - osteoarthritis
  - asthma
  age_at_reaction: 63
suspected_drugs:
- drug_name: Metformin
  dosage: 32mg
  route_of_administration: Intravenous
  start_date: '2025-04-09'
  indication_for_use: Type 2 diabetes
  end_date: '2025-06-06'
- drug_name: Lisinopril
  dosage: 16mg
  route_of_administration: Oral
  start_date: '2025-04-09'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
  end_date: '2025-06-06'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-05-22'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-05-22'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed walk and advised arm.
- symptom_name: Somnolence
  onset_date: '2025-05-22'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed according and advised late.
- symptom_name: Diarrhea
  onset_date: '2025-05-22'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed lay and advised including.
- symptom_name: Headache
  onset_date: '2025-05-22'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed form and advised author.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 9
reporting_facility: Sanchez LLC Medical Center
reporter_type: Nurse
