<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-2025-147
Date of Submission: 2025-08-08

This report was submitted by a Pharmacist from Sanders, Wilkins and Meyer Medical Center concerning patient ANON-PX-5303. The subject is an adult female with a significant medical history including seasonal allergies, atrial fibrillation, type 2 diabetes, anxiety. 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): Ibuprofen (NSAID) administered via the Subcutaneous route at a dosage of 212mg, initiated on 2025-05-23 for Pain and inflammation and discontinued on 2025-08-03; Levothyroxine (Thyroid hormone) administered via the Intramuscular route at a dosage of 314mg, initiated on 2025-05-23 for Hypothyroidism and discontinued on 2025-08-03.

On approximately 2025-07-25, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Stevens-Johnson syndrome, Dizziness, Pruritus, Somnolence. The Diarrhea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

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report_id: ADR-2025-147
report_date: '2025-08-08'
patient_details:
  patient_id: ANON-PX-5303
  gender: Female
  relevant_history:
  - seasonal allergies
  - atrial fibrillation
  - type 2 diabetes
  - anxiety
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 212mg
  route_of_administration: Subcutaneous
  start_date: '2025-05-23'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-08-03'
- drug_name: Levothyroxine
  dosage: 314mg
  route_of_administration: Intramuscular
  start_date: '2025-05-23'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
  end_date: '2025-08-03'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2025-07-25'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-07-25'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Dizziness
  onset_date: '2025-07-25'
  severity: Mild
  outcome: Unknown
  intervention_required: true
- symptom_name: Pruritus
  onset_date: '2025-07-25'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-07-25'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 7
reporting_facility: Sanders, Wilkins and Meyer Medical Center
reporter_type: Pharmacist
notes: Space positive office trouble mouth what administration day. Everybody trial
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