<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-2025-305
Date of Submission: 2025-06-28

This report was submitted by a Other Healthcare Professional from Holmes, Avila and Long Medical Center concerning patient ANON-PX-8879. The subject is an adult male with a significant medical history including chronic kidney disease, 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 (Thyroid hormone) administered via the Oral route at a dosage of 299mg, initiated on 2025-05-15 for Hypothyroidism with the course ongoing.

On approximately 2025-06-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Anaphylaxis. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-305
report_date: '2025-06-28'
patient_details:
  patient_id: ANON-PX-8879
  gender: Male
  relevant_history:
  - chronic kidney disease
  - coronary artery disease
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 299mg
  route_of_administration: Oral
  start_date: '2025-05-15'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2025-06-09'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-06-09'
  severity: Mild
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 8
reporting_facility: Holmes, Avila and Long Medical Center
reporter_type: Other Healthcare Professional
