<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-2025-494
Date of Submission: 2025-01-15

This report was submitted by a Patient from Allen, Shaw and Savage Medical Center concerning patient ANON-PX-8817. The subject is a 35-year-old female with a significant medical history including osteoarthritis, chronic kidney disease. 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 (SSRI) administered via the Topical route at a dosage of 171mg, initiated on 2024-12-19 for Major depressive disorder and discontinued on 2025-01-04; Ibuprofen administered via the Topical route at a dosage of 371mg, initiated on 2024-12-19 for Pain and inflammation and discontinued on 2025-01-04.

On approximately 2024-12-23, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Nausea. The Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed particularly and advised recently. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed on and advised use. The current patient status regarding this symptom is 'Recovering'. 

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

</data>
report_id: ADR-2025-494
report_date: '2025-01-15'
patient_details:
  patient_id: ANON-PX-8817
  gender: Female
  relevant_history:
  - osteoarthritis
  - chronic kidney disease
  age_at_reaction: 35
suspected_drugs:
- drug_name: Sertraline
  dosage: 171mg
  route_of_administration: Topical
  start_date: '2024-12-19'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-01-04'
- drug_name: Ibuprofen
  dosage: 371mg
  route_of_administration: Topical
  start_date: '2024-12-19'
  indication_for_use: Pain and inflammation
  end_date: '2025-01-04'
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2024-12-23'
  severity: Mild
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed particularly and advised recently.
- symptom_name: Nausea
  onset_date: '2024-12-23'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed on and advised use.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 3
reporting_facility: Allen, Shaw and Savage Medical Center
reporter_type: Patient
