<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-2025-161
Date of Submission: 2025-02-23

This report was submitted by a Physician from Lopez-Sanchez Medical Center concerning patient ANON-PX-4176. The subject is a 84-year-old other with a significant medical history including coronary artery disease, 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): Omeprazole administered via the Subcutaneous route at a dosage of 134mg, initiated on 2024-12-12 for Gastroesophageal reflux disease and discontinued on 2025-02-12; Sertraline (SSRI) administered via the Intramuscular route at a dosage of 110mg, initiated on 2024-12-12 for Major depressive disorder and discontinued on 2025-02-12.

On approximately 2025-02-11, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Vomiting, Nausea, Stevens-Johnson syndrome, Maculopapular Rash. The Anaphylaxis was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Nausea was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 10 was calculated, The assessment concluded the relationship was 'Highly 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-2025-161
report_date: '2025-02-23'
patient_details:
  patient_id: ANON-PX-4176
  gender: Other
  relevant_history:
  - coronary artery disease
  - chronic kidney disease
  age_at_reaction: 84
suspected_drugs:
- drug_name: Omeprazole
  dosage: 134mg
  route_of_administration: Subcutaneous
  start_date: '2024-12-12'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2025-02-12'
- drug_name: Sertraline
  dosage: 110mg
  route_of_administration: Intramuscular
  start_date: '2024-12-12'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2025-02-12'
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2025-02-11'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-02-11'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2025-02-11'
  severity: Moderate
  outcome: Fatal
  intervention_required: true
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-02-11'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
- symptom_name: Maculopapular Rash
  onset_date: '2025-02-11'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 10
reporting_facility: Lopez-Sanchez Medical Center
reporter_type: Physician
