<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-2025-838
Date of Submission: 2025-01-14

This report was submitted by a Other Healthcare Professional from Harris, Garcia and Castillo Medical Center concerning patient ANON-PX-5975. The subject is an adult male with a significant medical history including osteoarthritis, seasonal allergies, type 2 diabetes, coronary artery 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 Intravenous route at a dosage of 487mg, initiated on 2024-10-21 for Major depressive disorder and discontinued on 2025-01-02; Metformin (Biguanide) administered via the Oral route at a dosage of 156mg, initiated on 2024-10-21 for Type 2 diabetes and discontinued on 2025-01-02.

On approximately 2024-10-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Nausea, Vomiting, Stevens-Johnson syndrome. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed my and advised must. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Moderate 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. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-838
report_date: '2025-01-14'
patient_details:
  patient_id: ANON-PX-5975
  gender: Male
  relevant_history:
  - osteoarthritis
  - seasonal allergies
  - type 2 diabetes
  - coronary artery disease
suspected_drugs:
- drug_name: Sertraline
  dosage: 487mg
  route_of_administration: Intravenous
  start_date: '2024-10-21'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-01-02'
- drug_name: Metformin
  dosage: 156mg
  route_of_administration: Oral
  start_date: '2024-10-21'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2025-01-02'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2024-10-30'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
- symptom_name: Nausea
  onset_date: '2024-10-30'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed my and advised must.
- symptom_name: Vomiting
  onset_date: '2024-10-30'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-10-30'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
reporting_facility: Harris, Garcia and Castillo Medical Center
reporter_type: Other Healthcare Professional
