<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: 2025-05-04

This report was submitted by a Other Healthcare Professional from Lee, Miller and Carter Medical Center concerning patient ANON-PX-9086. The subject is a 71-year-old other with a significant medical history including atrial fibrillation, seasonal allergies, osteoarthritis. 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 Oral route at a dosage of 175mg, initiated on 2025-03-10 for Hypertension and discontinued on 2025-05-02.

On approximately 2025-05-02, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Hepatotoxicity, Headache, Vomiting, Somnolence. The Anaphylaxis was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed night and advised customer. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-133
report_date: '2025-05-04'
patient_details:
  patient_id: ANON-PX-9086
  gender: Other
  relevant_history:
  - atrial fibrillation
  - seasonal allergies
  - osteoarthritis
  age_at_reaction: 71
suspected_drugs:
- drug_name: Lisinopril
  dosage: 175mg
  route_of_administration: Oral
  start_date: '2025-03-10'
  indication_for_use: Hypertension
  end_date: '2025-05-02'
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2025-05-02'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-05-02'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed night and advised customer.
- symptom_name: Headache
  onset_date: '2025-05-02'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-05-02'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-05-02'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 6
reporting_facility: Lee, Miller and Carter Medical Center
reporter_type: Other Healthcare Professional
