<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-2025-669
Date of Submission: 2025-08-07

This report was submitted by a Other Healthcare Professional from Salinas PLC Medical Center concerning patient ANON-PX-8143. The subject is a 78-year-old female with a significant medical history including osteoarthritis, asthma, hypertension, atrial fibrillation. 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 Subcutaneous route at a dosage of 490mg, initiated on 2025-07-23 for Bacterial infection with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Intravenous route at a dosage of 78mg, initiated on 2025-07-23 for Gastroesophageal reflux disease with the course ongoing.

On approximately 2025-07-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Stevens-Johnson syndrome. The Angioedema was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed key and advised resource. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed always and advised policy. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Party organization almost street.</data>
report_id: ADR-2025-669
report_date: '2025-08-07'
patient_details:
  patient_id: ANON-PX-8143
  gender: Female
  relevant_history:
  - osteoarthritis
  - asthma
  - hypertension
  - atrial fibrillation
  age_at_reaction: 78
suspected_drugs:
- drug_name: Amoxicillin
  dosage: 490mg
  route_of_administration: Subcutaneous
  start_date: '2025-07-23'
  indication_for_use: Bacterial infection
- drug_name: Omeprazole
  dosage: 78mg
  route_of_administration: Intravenous
  start_date: '2025-07-23'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2025-07-29'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed key and advised resource.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-07-29'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed always and advised policy.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 4
reporting_facility: Salinas PLC Medical Center
reporter_type: Other Healthcare Professional
notes: Party organization almost street.
