<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-2024-460
Date of Submission: 2024-11-15

This report was submitted by a Nurse from Mccann and Sons Medical Center concerning patient ANON-PX-1444. The subject is a 89-year-old male with a significant medical history including coronary artery disease, atrial fibrillation, migraines, seasonal allergies. 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 Subcutaneous route at a dosage of 484mg, initiated on 2024-09-27 for Major depressive disorder and discontinued on 2024-10-28; Metformin administered via the Intravenous route at a dosage of 387mg, initiated on 2024-09-27 for Type 2 diabetes and discontinued on 2024-10-28.

On approximately 2024-10-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Dizziness, Maculopapular Rash, Anaphylaxis, Nausea, Stevens-Johnson syndrome. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed reality and advised identify. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed single and advised skin. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-460
report_date: '2024-11-15'
patient_details:
  patient_id: ANON-PX-1444
  gender: Male
  relevant_history:
  - coronary artery disease
  - atrial fibrillation
  - migraines
  - seasonal allergies
  age_at_reaction: 89
suspected_drugs:
- drug_name: Sertraline
  dosage: 484mg
  route_of_administration: Subcutaneous
  start_date: '2024-09-27'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-10-28'
- drug_name: Metformin
  dosage: 387mg
  route_of_administration: Intravenous
  start_date: '2024-09-27'
  indication_for_use: Type 2 diabetes
  end_date: '2024-10-28'
adverse_reactions:
- symptom_name: Dizziness
  onset_date: '2024-10-20'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed reality and advised identify.
- symptom_name: Maculopapular Rash
  onset_date: '2024-10-20'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-10-20'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-10-20'
  severity: Mild
  outcome: Unknown
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-10-20'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed single and advised skin.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 7
reporting_facility: Mccann and Sons Medical Center
reporter_type: Nurse
