<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-2025-283
Date of Submission: 2025-03-01

This report was submitted by a Other Healthcare Professional from Perez Ltd Medical Center concerning patient ANON-PX-8040. The subject is an adult male with a significant medical history including 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): Sertraline (SSRI) administered via the Oral route at a dosage of 376mg, initiated on 2024-12-09 for Major depressive disorder and discontinued on 2025-02-26.

On approximately 2024-12-10, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Pruritus, Nausea. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 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-2025-283
report_date: '2025-03-01'
patient_details:
  patient_id: ANON-PX-8040
  gender: Male
  relevant_history:
  - seasonal allergies
  - osteoarthritis
suspected_drugs:
- drug_name: Sertraline
  dosage: 376mg
  route_of_administration: Oral
  start_date: '2024-12-09'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-02-26'
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2024-12-10'
  severity: Mild
  outcome: Unknown
  intervention_required: true
- symptom_name: Pruritus
  onset_date: '2024-12-10'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-12-10'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 4
reporting_facility: Perez Ltd Medical Center
reporter_type: Other Healthcare Professional
