<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-2025-390
Date of Submission: 2025-08-01

This report was submitted by a Pharmacist from Holmes, Rodriguez and Doyle Medical Center concerning patient ANON-PX-8248. The subject is a 35-year-old male with a significant medical history including hypertension, seasonal allergies. 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 Topical route at a dosage of 411mg, initiated on 2025-07-18 for Hypothyroidism with the course ongoing.

On approximately 2025-07-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Somnolence, Nausea, Pruritus, Dizziness. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed west and advised road. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed response and advised behavior. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. 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. 

</data>
report_id: ADR-2025-390
report_date: '2025-08-01'
patient_details:
  patient_id: ANON-PX-8248
  gender: Male
  relevant_history:
  - hypertension
  - seasonal allergies
  age_at_reaction: 35
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 411mg
  route_of_administration: Topical
  start_date: '2025-07-18'
  indication_for_use: Hypothyroidism
adverse_reactions:
- symptom_name: Headache
  onset_date: '2025-07-23'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-07-23'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed west and advised road.
- symptom_name: Nausea
  onset_date: '2025-07-23'
  severity: Severe
  outcome: Unknown
  intervention_required: true
- symptom_name: Pruritus
  onset_date: '2025-07-23'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
- symptom_name: Dizziness
  onset_date: '2025-07-23'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed response and advised behavior.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
reporting_facility: Holmes, Rodriguez and Doyle Medical Center
reporter_type: Pharmacist
