<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-2025-384
Date of Submission: 2025-01-28

This report was submitted by a Physician from Simmons-Mitchell Medical Center concerning patient ANON-PX-5226. The subject is a 67-year-old male with a significant medical history including chronic kidney disease, hypertension, atrial fibrillation, coronary artery 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): Ibuprofen (NSAID) administered via the Intramuscular route at a dosage of 483mg, initiated on 2024-11-10 for Pain and inflammation with the course ongoing; Amoxicillin (Penicillin antibiotic) administered via the Topical route at a dosage of 492mg, initiated on 2024-11-10 for Bacterial infection with the course ongoing.

On approximately 2024-12-04, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Somnolence, Maculopapular Rash, Anaphylaxis, Angioedema. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed resource and advised service. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 8 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: Relationship if them ok team visit begin score. Move somebody anything receive soon catch share. Provide discover account play field pattern.</data>
report_id: ADR-2025-384
report_date: '2025-01-28'
patient_details:
  patient_id: ANON-PX-5226
  gender: Male
  relevant_history:
  - chronic kidney disease
  - hypertension
  - atrial fibrillation
  - coronary artery disease
  age_at_reaction: 67
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 483mg
  route_of_administration: Intramuscular
  start_date: '2024-11-10'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
- drug_name: Amoxicillin
  dosage: 492mg
  route_of_administration: Topical
  start_date: '2024-11-10'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
adverse_reactions:
- symptom_name: Somnolence
  onset_date: '2024-12-04'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed resource and advised service.
- symptom_name: Maculopapular Rash
  onset_date: '2024-12-04'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2024-12-04'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-12-04'
  severity: Severe
  outcome: Recovering
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 8
reporting_facility: Simmons-Mitchell Medical Center
reporter_type: Physician
notes: Relationship if them ok team visit begin score. Move somebody anything receive
  soon catch share. Provide discover account play field pattern.
