<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-2024-878
Date of Submission: 2024-08-24

This report was submitted by a Pharmacist from Paul, Berry and Terrell Medical Center concerning patient ANON-PX-8849. The subject is an adult female with a significant medical history including type 2 diabetes, migraines, 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): Ibuprofen (NSAID) administered via the Topical route at a dosage of 459mg, initiated on 2024-07-24 for Pain and inflammation and discontinued on 2024-08-23; Amoxicillin (Penicillin antibiotic) administered via the Oral route at a dosage of 380mg, initiated on 2024-07-24 for Bacterial infection and discontinued on 2024-08-23.

On approximately 2024-08-05, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Stevens-Johnson syndrome, Somnolence, Maculopapular Rash, Diarrhea. The Vomiting was classified as Life-threatening 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. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed water and advised story. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. 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: Side they American always.</data>
report_id: ADR-2024-878
report_date: '2024-08-24'
patient_details:
  patient_id: ANON-PX-8849
  gender: Female
  relevant_history:
  - type 2 diabetes
  - migraines
  - chronic kidney disease
  - asthma
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 459mg
  route_of_administration: Topical
  start_date: '2024-07-24'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2024-08-23'
- drug_name: Amoxicillin
  dosage: 380mg
  route_of_administration: Oral
  start_date: '2024-07-24'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2024-08-23'
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2024-08-05'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-08-05'
  severity: Severe
  outcome: Recovering
  intervention_required: true
- symptom_name: Somnolence
  onset_date: '2024-08-05'
  severity: Severe
  outcome: Fatal
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-08-05'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-08-05'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed water and advised story.
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 9
reporting_facility: Paul, Berry and Terrell Medical Center
reporter_type: Pharmacist
notes: Side they American always.
