<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-2024-388
Date of Submission: 2024-12-27

This report was submitted by a Other Healthcare Professional from Cook PLC Medical Center concerning patient ANON-PX-4483. The subject is a 87-year-old male with a significant medical history including chronic kidney disease, migraines, 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 Oral route at a dosage of 377mg, initiated on 2024-10-05 for Hypothyroidism and discontinued on 2024-11-29; Ibuprofen (NSAID) administered via the Topical route at a dosage of 261mg, initiated on 2024-10-05 for Pain and inflammation and discontinued on 2024-11-29.

On approximately 2024-10-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Pruritus, Stevens-Johnson syndrome. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed special and advised decade. 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 'Fatal'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed health and advised top. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 5 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-2024-388
report_date: '2024-12-27'
patient_details:
  patient_id: ANON-PX-4483
  gender: Male
  relevant_history:
  - chronic kidney disease
  - migraines
  - seasonal allergies
  age_at_reaction: 87
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 377mg
  route_of_administration: Oral
  start_date: '2024-10-05'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
  end_date: '2024-11-29'
- drug_name: Ibuprofen
  dosage: 261mg
  route_of_administration: Topical
  start_date: '2024-10-05'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2024-11-29'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2024-10-19'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed special and advised decade.
- symptom_name: Pruritus
  onset_date: '2024-10-19'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-10-19'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed health and advised top.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 5
reporting_facility: Cook PLC Medical Center
reporter_type: Other Healthcare Professional
