<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-2025-863
Date of Submission: 2025-02-12

This report was submitted by a Patient from Smith Ltd Medical Center concerning patient ANON-PX-6231. The subject is an adult male with a significant medical history including migraines, 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): Levothyroxine (Thyroid hormone) administered via the Subcutaneous route at a dosage of 248mg, initiated on 2024-11-16 for Hypothyroidism and discontinued on 2025-02-06.

On approximately 2025-01-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Headache, Hepatotoxicity, Angioedema. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed radio and advised level. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed send and advised anything. The current patient status regarding this symptom is 'Not Recovered'. The Angioedema 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. 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-2025-863
report_date: '2025-02-12'
patient_details:
  patient_id: ANON-PX-6231
  gender: Male
  relevant_history:
  - migraines
  - osteoarthritis
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 248mg
  route_of_administration: Subcutaneous
  start_date: '2024-11-16'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
  end_date: '2025-02-06'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-01-15'
  severity: Mild
  outcome: Recovered
  intervention_required: true
- symptom_name: Headache
  onset_date: '2025-01-15'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed radio and advised level.
- symptom_name: Hepatotoxicity
  onset_date: '2025-01-15'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed send and advised anything.
- symptom_name: Angioedema
  onset_date: '2025-01-15'
  severity: Mild
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
reporting_facility: Smith Ltd Medical Center
reporter_type: Patient
