<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-2024-496
Date of Submission: 2024-09-21

This report was submitted by a Other Healthcare Professional from Ellis, Allison and Page Medical Center concerning patient ANON-PX-6464. The subject is a 78-year-old other with a significant medical history including hypertension, 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): Amoxicillin administered via the Intravenous route at a dosage of 455mg, initiated on 2024-08-05 for Bacterial infection with the course ongoing.

On approximately 2024-08-08, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Anaphylaxis, Stevens-Johnson syndrome, Nausea, Vomiting. The Headache was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Fatal'. The Anaphylaxis was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome 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 Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Mild in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. 

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-2024-496
report_date: '2024-09-21'
patient_details:
  patient_id: ANON-PX-6464
  gender: Other
  relevant_history:
  - hypertension
  - asthma
  age_at_reaction: 78
suspected_drugs:
- drug_name: Amoxicillin
  dosage: 455mg
  route_of_administration: Intravenous
  start_date: '2024-08-05'
  indication_for_use: Bacterial infection
adverse_reactions:
- symptom_name: Headache
  onset_date: '2024-08-08'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
- symptom_name: Anaphylaxis
  onset_date: '2024-08-08'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-08-08'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Nausea
  onset_date: '2024-08-08'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2024-08-08'
  severity: Mild
  outcome: Recovered
  intervention_required: true
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive dechallenge
  naranjo_score: 10
reporting_facility: Ellis, Allison and Page Medical Center
reporter_type: Other Healthcare Professional
