<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-2025-834
Date of Submission: 2025-06-20

This report was submitted by a Patient from Kennedy-Weber Medical Center concerning patient ANON-PX-7683. The subject is a 61-year-old male with a significant medical history including atrial fibrillation, coronary artery disease, 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 (Thyroid hormone) administered via the Topical route at a dosage of 226mg, initiated on 2025-04-07 for Hypothyroidism and discontinued on 2025-06-16.

On approximately 2025-04-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Dizziness, Maculopapular Rash, Diarrhea, Nausea. The Headache was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed available and advised culture. The current patient status regarding this symptom is 'Not Recovered'. The Maculopapular Rash was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed morning and advised sell. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Drive music appear present away one. Various especially fine military even gas eight.</data>
report_id: ADR-2025-834
report_date: '2025-06-20'
patient_details:
  patient_id: ANON-PX-7683
  gender: Male
  relevant_history:
  - atrial fibrillation
  - coronary artery disease
  - asthma
  age_at_reaction: 61
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 226mg
  route_of_administration: Topical
  start_date: '2025-04-07'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
  end_date: '2025-06-16'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2025-04-20'
  severity: Mild
  outcome: Recovering
  intervention_required: true
- symptom_name: Dizziness
  onset_date: '2025-04-20'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed available and advised culture.
- symptom_name: Maculopapular Rash
  onset_date: '2025-04-20'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2025-04-20'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed morning and advised sell.
- symptom_name: Nausea
  onset_date: '2025-04-20'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 10
reporting_facility: Kennedy-Weber Medical Center
reporter_type: Patient
notes: Drive music appear present away one. Various especially fine military even
  gas eight.
