<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-2025-828
Date of Submission: 2025-05-28

This report was submitted by a Nurse from Brewer and Sons Medical Center concerning patient ANON-PX-8238. The subject is a 78-year-old male with a significant medical history including asthma, seasonal allergies, migraines. 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 Oral route at a dosage of 141mg, initiated on 2025-03-30 for Major depressive disorder and discontinued on 2025-05-09.

On approximately 2025-05-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Vomiting, Nausea. The Pruritus was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Nausea 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 5 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. 

</data>
report_id: ADR-2025-828
report_date: '2025-05-28'
patient_details:
  patient_id: ANON-PX-8238
  gender: Male
  relevant_history:
  - asthma
  - seasonal allergies
  - migraines
  age_at_reaction: 78
suspected_drugs:
- drug_name: Sertraline
  dosage: 141mg
  route_of_administration: Oral
  start_date: '2025-03-30'
  indication_for_use: Major depressive disorder
  end_date: '2025-05-09'
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2025-05-08'
  severity: Severe
  outcome: Unknown
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-05-08'
  severity: Mild
  outcome: Fatal
  intervention_required: true
- symptom_name: Nausea
  onset_date: '2025-05-08'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 5
reporting_facility: Brewer and Sons Medical Center
reporter_type: Nurse
