<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-2024-714
Date of Submission: 2024-12-19

This report was submitted by a Pharmacist from Nichols Inc Medical Center concerning patient ANON-PX-3956. The subject is an adult male with a significant medical history including atrial fibrillation, chronic kidney disease, coronary artery disease, migraines. 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): Metformin (Biguanide) administered via the Topical route at a dosage of 167mg, initiated on 2024-11-01 for Type 2 diabetes and discontinued on 2024-12-13; Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 305mg, initiated on 2024-11-01 for Bacterial infection and discontinued on 2024-12-13.

On approximately 2024-11-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Stevens-Johnson syndrome, Diarrhea, Anaphylaxis. The Maculopapular Rash was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed room and advised have. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Diarrhea was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed investment and advised too. The current patient status regarding this symptom is 'Not Recovered'. The Anaphylaxis was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed activity and advised word. 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: 'Positive dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-714
report_date: '2024-12-19'
patient_details:
  patient_id: ANON-PX-3956
  gender: Male
  relevant_history:
  - atrial fibrillation
  - chronic kidney disease
  - coronary artery disease
  - migraines
suspected_drugs:
- drug_name: Metformin
  dosage: 167mg
  route_of_administration: Topical
  start_date: '2024-11-01'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
  end_date: '2024-12-13'
- drug_name: Amoxicillin
  dosage: 305mg
  route_of_administration: Intramuscular
  start_date: '2024-11-01'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2024-12-13'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2024-11-29'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed room and advised have.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-11-29'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-11-29'
  severity: Severe
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed investment and advised too.
- symptom_name: Anaphylaxis
  onset_date: '2024-11-29'
  severity: Mild
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed activity and advised word.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive dechallenge
reporting_facility: Nichols Inc Medical Center
reporter_type: Pharmacist
