<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-2025-748
Date of Submission: 2025-03-20

This report was submitted by a Patient from Allen Ltd Medical Center concerning patient ANON-PX-3778. The subject is an adult other with a significant medical history including chronic kidney disease, asthma, seasonal allergies, osteoarthritis. 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 419mg, initiated on 2025-01-20 for Hypothyroidism with the course ongoing; Lisinopril (ACE inhibitor) administered via the Subcutaneous route at a dosage of 246mg, initiated on 2025-01-20 for Hypertension with the course ongoing.

On approximately 2025-01-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Nausea, Vomiting, Somnolence. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed too and advised nice. The current patient status regarding this symptom is 'Not Recovered'. 

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 rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-748
report_date: '2025-03-20'
patient_details:
  patient_id: ANON-PX-3778
  gender: Other
  relevant_history:
  - chronic kidney disease
  - asthma
  - seasonal allergies
  - osteoarthritis
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 419mg
  route_of_administration: Subcutaneous
  start_date: '2025-01-20'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
- drug_name: Lisinopril
  dosage: 246mg
  route_of_administration: Subcutaneous
  start_date: '2025-01-20'
  indication_for_use: Hypertension
  drug_class: ACE inhibitor
adverse_reactions:
- symptom_name: Nausea
  onset_date: '2025-01-30'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-01-30'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-01-30'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed too and advised nice.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 5
reporting_facility: Allen Ltd Medical Center
reporter_type: Patient
