<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-2024-486
Date of Submission: 2024-11-09

This report was submitted by a Patient from Avila, Sexton and Frost Medical Center concerning patient ANON-PX-4100. The subject is a 58-year-old female with a significant medical history including asthma, anxiety, migraines, 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 109mg, initiated on 2024-08-26 for Major depressive disorder and discontinued on 2024-11-02.

On approximately 2024-10-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Stevens-Johnson syndrome, Headache, Nausea. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed one and advised during. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed item and advised argue. The current patient status regarding this symptom is 'Unknown'. The Nausea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 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-2024-486
report_date: '2024-11-09'
patient_details:
  patient_id: ANON-PX-4100
  gender: Female
  relevant_history:
  - asthma
  - anxiety
  - migraines
  - osteoarthritis
  age_at_reaction: 58
suspected_drugs:
- drug_name: Sertraline
  dosage: 109mg
  route_of_administration: Oral
  start_date: '2024-08-26'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-11-02'
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2024-10-30'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed one and advised during.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-10-30'
  severity: Life-threatening
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Headache
  onset_date: '2024-10-30'
  severity: Severe
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed item and advised argue.
- symptom_name: Nausea
  onset_date: '2024-10-30'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 1
reporting_facility: Avila, Sexton and Frost Medical Center
reporter_type: Patient
