<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-2025-101
Date of Submission: 2025-08-09

This report was submitted by a Pharmacist from Boone-King Medical Center concerning patient ANON-PX-8249. The subject is a 77-year-old male with a significant medical history including hypertension, osteoarthritis, migraines. 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 Subcutaneous route at a dosage of 292mg, initiated on 2025-06-10 for Hypothyroidism and discontinued on 2025-08-01; Ibuprofen (NSAID) administered via the Oral route at a dosage of 451mg, initiated on 2025-06-10 for Pain and inflammation and discontinued on 2025-08-01.

On approximately 2025-07-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Stevens-Johnson syndrome, Maculopapular Rash, Somnolence. The Hepatotoxicity was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed yes and advised eight. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed box and advised find. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed trial and advised establish. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-101
report_date: '2025-08-09'
patient_details:
  patient_id: ANON-PX-8249
  gender: Male
  relevant_history:
  - hypertension
  - osteoarthritis
  - migraines
  age_at_reaction: 77
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 292mg
  route_of_administration: Subcutaneous
  start_date: '2025-06-10'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
  end_date: '2025-08-01'
- drug_name: Ibuprofen
  dosage: 451mg
  route_of_administration: Oral
  start_date: '2025-06-10'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-08-01'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2025-07-28'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-07-28'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed yes and advised eight.
- symptom_name: Maculopapular Rash
  onset_date: '2025-07-28'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed box and advised find.
- symptom_name: Somnolence
  onset_date: '2025-07-28'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed trial and advised establish.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 6
reporting_facility: Boone-King Medical Center
reporter_type: Pharmacist
