<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-2025-599
Date of Submission: 2025-06-23

This report was submitted by a Pharmacist from Knight-Ellison Medical Center concerning patient ANON-PX-3031. The subject is a 31-year-old male with a significant medical history including migraines, osteoarthritis, atrial fibrillation. 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): Sertraline administered via the Topical route at a dosage of 70mg, initiated on 2025-05-11 for Major depressive disorder with the course ongoing; Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 291mg, initiated on 2025-05-11 for Hypothyroidism with the course ongoing.

On approximately 2025-05-22, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Vomiting, Angioedema, Dizziness, Anaphylaxis. The Headache was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed paper and advised family. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed raise and advised somebody. The current patient status regarding this symptom is 'Unknown'. The Dizziness was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed Mr and advised million. The current patient status regarding this symptom is 'Not 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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Truth boy pay job. Girl rather school accept response education well. News material itself against.</data>
report_id: ADR-2025-599
report_date: '2025-06-23'
patient_details:
  patient_id: ANON-PX-3031
  gender: Male
  relevant_history:
  - migraines
  - osteoarthritis
  - atrial fibrillation
  age_at_reaction: 31
suspected_drugs:
- drug_name: Sertraline
  dosage: 70mg
  route_of_administration: Topical
  start_date: '2025-05-11'
  indication_for_use: Major depressive disorder
- drug_name: Levothyroxine
  dosage: 291mg
  route_of_administration: Topical
  start_date: '2025-05-11'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Headache
  onset_date: '2025-05-22'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-05-22'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed paper and advised family.
- symptom_name: Angioedema
  onset_date: '2025-05-22'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed raise and advised somebody.
- symptom_name: Dizziness
  onset_date: '2025-05-22'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-05-22'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed Mr and advised million.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 6
reporting_facility: Knight-Ellison Medical Center
reporter_type: Pharmacist
notes: Truth boy pay job. Girl rather school accept response education well. News
  material itself against.
