<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-2025-611
Date of Submission: 2025-01-28

This report was submitted by a Nurse from Patterson, Smith and Parker Medical Center concerning patient ANON-PX-5496. The subject is a 81-year-old female with a significant medical history including seasonal allergies, coronary artery disease. 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 310mg, initiated on 2024-12-15 for Hypothyroidism and discontinued on 2025-01-22; Omeprazole administered via the Intravenous route at a dosage of 215mg, initiated on 2024-12-15 for Gastroesophageal reflux disease and discontinued on 2025-01-22.

On approximately 2024-12-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Headache, Stevens-Johnson syndrome. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed they and advised school. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 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. 

</data>
report_id: ADR-2025-611
report_date: '2025-01-28'
patient_details:
  patient_id: ANON-PX-5496
  gender: Female
  relevant_history:
  - seasonal allergies
  - coronary artery disease
  age_at_reaction: 81
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 310mg
  route_of_administration: Topical
  start_date: '2024-12-15'
  indication_for_use: Hypothyroidism
  end_date: '2025-01-22'
- drug_name: Omeprazole
  dosage: 215mg
  route_of_administration: Intravenous
  start_date: '2024-12-15'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2025-01-22'
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2024-12-23'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Headache
  onset_date: '2024-12-23'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed they and advised school.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-12-23'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 8
reporting_facility: Patterson, Smith and Parker Medical Center
reporter_type: Nurse
