<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-2025-913
Date of Submission: 2025-08-09

This report was submitted by a Physician from Campbell and Sons Medical Center concerning patient ANON-PX-3680. The subject is a 27-year-old male with a significant medical history including type 2 diabetes, coronary artery disease. 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): Levothyroxine administered via the Oral route at a dosage of 251mg, initiated on 2025-05-24 for Hypothyroidism with the course ongoing.

On approximately 2025-06-24, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Diarrhea, Angioedema. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed top and advised hard. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Member brother unit boy. Show against throughout less do face. Wife social senior return group.</data>
report_id: ADR-2025-913
report_date: '2025-08-09'
patient_details:
  patient_id: ANON-PX-3680
  gender: Male
  relevant_history:
  - type 2 diabetes
  - coronary artery disease
  age_at_reaction: 27
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 251mg
  route_of_administration: Oral
  start_date: '2025-05-24'
  indication_for_use: Hypothyroidism
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-06-24'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-06-24'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed top and advised hard.
- symptom_name: Angioedema
  onset_date: '2025-06-24'
  severity: Mild
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 1
reporting_facility: Campbell and Sons Medical Center
reporter_type: Physician
notes: Member brother unit boy. Show against throughout less do face. Wife social
  senior return group.
