<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-2025-138
Date of Submission: 2025-01-19

This report was submitted by a Other Healthcare Professional from Evans LLC Medical Center concerning patient ANON-PX-6411. The subject is an adult female with a significant medical history including anxiety, migraines, coronary artery disease, 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 (Thyroid hormone) administered via the Topical route at a dosage of 362mg, initiated on 2024-12-25 for Hypothyroidism and discontinued on 2025-01-16; Amoxicillin administered via the Topical route at a dosage of 427mg, initiated on 2024-12-25 for Bacterial infection and discontinued on 2025-01-16.

On approximately 2025-01-09, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Somnolence, Dizziness, Vomiting, Diarrhea. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed per and advised catch. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Dizziness was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed paper and advised herself. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed recent and advised you. The current patient status regarding this symptom is 'Not Recovered'. The Diarrhea was classified as Severe 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. 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. 

Reporter's Narrative Summary: Cultural employee learn before. Term enough feeling institution save.</data>
report_id: ADR-2025-138
report_date: '2025-01-19'
patient_details:
  patient_id: ANON-PX-6411
  gender: Female
  relevant_history:
  - anxiety
  - migraines
  - coronary artery disease
  - seasonal allergies
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 362mg
  route_of_administration: Topical
  start_date: '2024-12-25'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
  end_date: '2025-01-16'
- drug_name: Amoxicillin
  dosage: 427mg
  route_of_administration: Topical
  start_date: '2024-12-25'
  indication_for_use: Bacterial infection
  end_date: '2025-01-16'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-01-09'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed per and advised catch.
- symptom_name: Somnolence
  onset_date: '2025-01-09'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2025-01-09'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed paper and advised herself.
- symptom_name: Vomiting
  onset_date: '2025-01-09'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed recent and advised you.
- symptom_name: Diarrhea
  onset_date: '2025-01-09'
  severity: Severe
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
reporting_facility: Evans LLC Medical Center
reporter_type: Other Healthcare Professional
notes: Cultural employee learn before. Term enough feeling institution save.
