<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-2025-382
Date of Submission: 2025-06-10

This report was submitted by a Physician from Robertson, Bush and Palmer Medical Center concerning patient ANON-PX-2671. The subject is a 46-year-old female with a significant medical history including atrial fibrillation, migraines, osteoarthritis, chronic kidney 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 29mg, initiated on 2025-04-28 for Major depressive disorder and discontinued on 2025-06-08; Amoxicillin (Penicillin antibiotic) administered via the Subcutaneous route at a dosage of 208mg, initiated on 2025-04-28 for Bacterial infection and discontinued on 2025-06-08.

On approximately 2025-06-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Somnolence, Hepatotoxicity, Vomiting, Anaphylaxis. The Stevens-Johnson syndrome was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Hepatotoxicity was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed big and advised camera. The current patient status regarding this symptom is 'Unknown'. The Vomiting was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Anaphylaxis 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 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. 

Reporter's Narrative Summary: Travel entire grow human war response side. Business say site toward provide chair idea.</data>
report_id: ADR-2025-382
report_date: '2025-06-10'
patient_details:
  patient_id: ANON-PX-2671
  gender: Female
  relevant_history:
  - atrial fibrillation
  - migraines
  - osteoarthritis
  - chronic kidney disease
  age_at_reaction: 46
suspected_drugs:
- drug_name: Sertraline
  dosage: 29mg
  route_of_administration: Intravenous
  start_date: '2025-04-28'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-06-08'
- drug_name: Amoxicillin
  dosage: 208mg
  route_of_administration: Subcutaneous
  start_date: '2025-04-28'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2025-06-08'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-06-08'
  severity: Mild
  outcome: Unknown
  intervention_required: true
- symptom_name: Somnolence
  onset_date: '2025-06-08'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Hepatotoxicity
  onset_date: '2025-06-08'
  severity: Mild
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed big and advised camera.
- symptom_name: Vomiting
  onset_date: '2025-06-08'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-06-08'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
  naranjo_score: 7
reporting_facility: Robertson, Bush and Palmer Medical Center
reporter_type: Physician
notes: Travel entire grow human war response side. Business say site toward provide
  chair idea.
