<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-2025-920
Date of Submission: 2025-04-02

This report was submitted by a Other Healthcare Professional from Johnson PLC Medical Center concerning patient ANON-PX-8576. The subject is a 71-year-old other with a significant medical history including osteoarthritis, asthma. 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 297mg, initiated on 2025-02-17 for Hypothyroidism and discontinued on 2025-03-28.

On approximately 2025-03-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Pruritus, Angioedema, Somnolence. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed husband and advised question. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 

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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

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report_id: ADR-2025-920
report_date: '2025-04-02'
patient_details:
  patient_id: ANON-PX-8576
  gender: Other
  relevant_history:
  - osteoarthritis
  - asthma
  age_at_reaction: 71
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 297mg
  route_of_administration: Oral
  start_date: '2025-02-17'
  indication_for_use: Hypothyroidism
  end_date: '2025-03-28'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-03-23'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2025-03-23'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed husband and advised question.
- symptom_name: Angioedema
  onset_date: '2025-03-23'
  severity: Severe
  outcome: Fatal
  intervention_required: true
- symptom_name: Somnolence
  onset_date: '2025-03-23'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 5
reporting_facility: Johnson PLC Medical Center
reporter_type: Other Healthcare Professional
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