<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-2025-117
Date of Submission: 2025-01-06

This report was submitted by a Patient from Goodwin-Shaw Medical Center concerning patient ANON-PX-3871. The subject is a 22-year-old male with a significant medical history including anxiety, 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 Subcutaneous route at a dosage of 189mg, initiated on 2024-12-08 for Hypothyroidism and discontinued on 2025-01-05.

On approximately 2024-12-18, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Pruritus, Headache. The Angioedema was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Moderate 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 5 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-117
report_date: '2025-01-06'
patient_details:
  patient_id: ANON-PX-3871
  gender: Male
  relevant_history:
  - anxiety
  - coronary artery disease
  age_at_reaction: 22
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 189mg
  route_of_administration: Subcutaneous
  start_date: '2024-12-08'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
  end_date: '2025-01-05'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2024-12-18'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2024-12-18'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Headache
  onset_date: '2024-12-18'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 5
reporting_facility: Goodwin-Shaw Medical Center
reporter_type: Patient
