<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-2024-921
Date of Submission: 2024-09-22

This report was submitted by a Other Healthcare Professional from Vasquez and Sons Medical Center concerning patient ANON-PX-4742. The subject is an adult female with a significant medical history including osteoarthritis, chronic kidney disease, 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): Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 172mg, initiated on 2024-07-01 for Gastroesophageal reflux disease and discontinued on 2024-09-08; Amoxicillin (Penicillin antibiotic) administered via the Oral route at a dosage of 36mg, initiated on 2024-07-01 for Bacterial infection and discontinued on 2024-09-08.

On approximately 2024-08-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Headache, Pruritus, Hepatotoxicity. The Stevens-Johnson syndrome was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Headache was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Moderate 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. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Listen sound gas room. Deep just room song.</data>
report_id: ADR-2024-921
report_date: '2024-09-22'
patient_details:
  patient_id: ANON-PX-4742
  gender: Female
  relevant_history:
  - osteoarthritis
  - chronic kidney disease
  - seasonal allergies
suspected_drugs:
- drug_name: Omeprazole
  dosage: 172mg
  route_of_administration: Topical
  start_date: '2024-07-01'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2024-09-08'
- drug_name: Amoxicillin
  dosage: 36mg
  route_of_administration: Oral
  start_date: '2024-07-01'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2024-09-08'
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-08-26'
  severity: Severe
  outcome: Fatal
  intervention_required: true
- symptom_name: Headache
  onset_date: '2024-08-26'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Pruritus
  onset_date: '2024-08-26'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
- symptom_name: Hepatotoxicity
  onset_date: '2024-08-26'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
reporting_facility: Vasquez and Sons Medical Center
reporter_type: Other Healthcare Professional
notes: Listen sound gas room. Deep just room song.
