<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-2025-527
Date of Submission: 2025-01-06

This report was submitted by a Pharmacist from David Inc Medical Center concerning patient ANON-PX-7864. The subject is an adult male with a significant medical history including osteoarthritis, type 2 diabetes. 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 Topical route at a dosage of 212mg, initiated on 2024-12-29 for Hypothyroidism with the course ongoing; Sertraline (SSRI) administered via the Topical route at a dosage of 140mg, initiated on 2024-12-29 for Major depressive disorder with the course ongoing.

On approximately 2025-01-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Headache. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed do and advised few. The current patient status regarding this symptom is 'Recovered'. The Headache was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 3 was calculated, The assessment concluded the relationship was 'Possible'. 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-2025-527
report_date: '2025-01-06'
patient_details:
  patient_id: ANON-PX-7864
  gender: Male
  relevant_history:
  - osteoarthritis
  - type 2 diabetes
suspected_drugs:
- drug_name: Levothyroxine
  dosage: 212mg
  route_of_administration: Topical
  start_date: '2024-12-29'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
- drug_name: Sertraline
  dosage: 140mg
  route_of_administration: Topical
  start_date: '2024-12-29'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2025-01-04'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed do and advised few.
- symptom_name: Headache
  onset_date: '2025-01-04'
  severity: Severe
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 3
reporting_facility: David Inc Medical Center
reporter_type: Pharmacist
