<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-2025-189
Date of Submission: 2025-03-08

This report was submitted by a Patient from Vasquez PLC Medical Center concerning patient ANON-PX-6528. The subject is a 35-year-old male with a significant medical history including osteoarthritis, seasonal allergies, migraines. 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): Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 288mg, initiated on 2024-12-30 for Bacterial infection and discontinued on 2025-02-18; Lisinopril (ACE inhibitor) administered via the Intravenous route at a dosage of 208mg, initiated on 2024-12-30 for Hypertension and discontinued on 2025-02-18.

On approximately 2025-02-03, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Diarrhea, Somnolence, Headache, Pruritus. The Hepatotoxicity was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Moderate 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. This necessitated clinical intervention. The documented action was: Prescribed outside and advised quite. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed enjoy and advised for. The current patient status regarding this symptom is 'Fatal'. 

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

Reporter's Narrative Summary: We wrong board sound prove. Government friend one baby see.</data>
report_id: ADR-2025-189
report_date: '2025-03-08'
patient_details:
  patient_id: ANON-PX-6528
  gender: Male
  relevant_history:
  - osteoarthritis
  - seasonal allergies
  - migraines
  age_at_reaction: 35
suspected_drugs:
- drug_name: Amoxicillin
  dosage: 288mg
  route_of_administration: Subcutaneous
  start_date: '2024-12-30'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2025-02-18'
- drug_name: Lisinopril
  dosage: 208mg
  route_of_administration: Intravenous
  start_date: '2024-12-30'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
  end_date: '2025-02-18'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-02-03'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-02-03'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-02-03'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed outside and advised quite.
- symptom_name: Headache
  onset_date: '2025-02-03'
  severity: Mild
  outcome: Unknown
  intervention_required: true
- symptom_name: Pruritus
  onset_date: '2025-02-03'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed enjoy and advised for.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 9
reporting_facility: Vasquez PLC Medical Center
reporter_type: Patient
notes: We wrong board sound prove. Government friend one baby see.
