<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-2025-278
Date of Submission: 2025-04-28

This report was submitted by a Pharmacist from Rodriguez, Cuevas and Walker Medical Center concerning patient ANON-PX-9518. The subject is a 50-year-old female with a significant medical history including type 2 diabetes, chronic kidney disease, asthma. 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 (Proton-pump inhibitor) administered via the Topical route at a dosage of 96mg, initiated on 2025-02-24 for Gastroesophageal reflux disease and discontinued on 2025-04-25; Metformin (Biguanide) administered via the Subcutaneous route at a dosage of 76mg, initiated on 2025-02-24 for Type 2 diabetes and discontinued on 2025-04-25.

On approximately 2025-04-06, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Diarrhea, Headache, Anaphylaxis. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed put and advised figure. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed beautiful and advised official. The current patient status regarding this symptom is 'Unknown'. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed its and advised computer. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Relate officer mention state memory outside. Contain anyone mother natural everyone enough.</data>
report_id: ADR-2025-278
report_date: '2025-04-28'
patient_details:
  patient_id: ANON-PX-9518
  gender: Female
  relevant_history:
  - type 2 diabetes
  - chronic kidney disease
  - asthma
  age_at_reaction: 50
suspected_drugs:
- drug_name: Omeprazole
  dosage: 96mg
  route_of_administration: Topical
  start_date: '2025-02-24'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-04-25'
- drug_name: Metformin
  dosage: 76mg
  route_of_administration: Subcutaneous
  start_date: '2025-02-24'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2025-04-25'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-04-06'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed put and advised figure.
- symptom_name: Diarrhea
  onset_date: '2025-04-06'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed beautiful and advised official.
- symptom_name: Headache
  onset_date: '2025-04-06'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed its and advised computer.
- symptom_name: Anaphylaxis
  onset_date: '2025-04-06'
  severity: Severe
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 6
reporting_facility: Rodriguez, Cuevas and Walker Medical Center
reporter_type: Pharmacist
notes: Relate officer mention state memory outside. Contain anyone mother natural
  everyone enough.
