<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-2024-729
Date of Submission: 2024-09-27

This report was submitted by a Nurse from Blake, Lopez and Alvarez Medical Center concerning patient ANON-PX-1843. The subject is a 31-year-old other with a significant medical history including type 2 diabetes, coronary artery disease, 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 Intramuscular route at a dosage of 480mg, initiated on 2024-08-20 for Hypothyroidism with the course ongoing; Ibuprofen (NSAID) administered via the Topical route at a dosage of 442mg, initiated on 2024-08-20 for Pain and inflammation with the course ongoing.

On approximately 2024-09-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Pruritus, Hepatotoxicity, Angioedema, Somnolence. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed soon and advised court. 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 'Not Recovered'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed will and advised one. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed agency and advised attention. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly 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-2024-729
report_date: '2024-09-27'
patient_details:
  patient_id: ANON-PX-1843
  gender: Other
  relevant_history:
  - type 2 diabetes
  - coronary artery disease
  - hypertension
  age_at_reaction: 31
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 480mg
  route_of_administration: Intramuscular
  start_date: '2024-08-20'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
- drug_name: Ibuprofen
  dosage: 442mg
  route_of_administration: Topical
  start_date: '2024-08-20'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2024-09-05'
  severity: Mild
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed soon and advised court.
- symptom_name: Pruritus
  onset_date: '2024-09-05'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2024-09-05'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed will and advised one.
- symptom_name: Angioedema
  onset_date: '2024-09-05'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed agency and advised attention.
- symptom_name: Somnolence
  onset_date: '2024-09-05'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 9
reporting_facility: Blake, Lopez and Alvarez Medical Center
reporter_type: Nurse
