<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-2024-116
Date of Submission: 2024-11-04

This report was submitted by a Physician from Keller-Fields Medical Center concerning patient ANON-PX-3167. The subject is a 55-year-old male with a significant medical history including seasonal allergies, migraines, type 2 diabetes, hypertension. 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 430mg, initiated on 2024-08-30 for Hypothyroidism with the course ongoing; Sertraline administered via the Oral route at a dosage of 350mg, initiated on 2024-08-30 for Major depressive disorder with the course ongoing.

On approximately 2024-10-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Hepatotoxicity, Pruritus, Stevens-Johnson syndrome, Headache. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed important and advised own. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed finally and advised central. The current patient status regarding this symptom is 'Recovered'. The Pruritus was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. 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-2024-116
report_date: '2024-11-04'
patient_details:
  patient_id: ANON-PX-3167
  gender: Male
  relevant_history:
  - seasonal allergies
  - migraines
  - type 2 diabetes
  - hypertension
  age_at_reaction: 55
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 430mg
  route_of_administration: Topical
  start_date: '2024-08-30'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
- drug_name: Sertraline
  dosage: 350mg
  route_of_administration: Oral
  start_date: '2024-08-30'
  indication_for_use: Major depressive disorder
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2024-10-05'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed important and advised own.
- symptom_name: Hepatotoxicity
  onset_date: '2024-10-05'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed finally and advised central.
- symptom_name: Pruritus
  onset_date: '2024-10-05'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-10-05'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Headache
  onset_date: '2024-10-05'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 3
reporting_facility: Keller-Fields Medical Center
reporter_type: Physician
