<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-2024-103
Date of Submission: 2024-10-27

This report was submitted by a Patient from Lloyd, Wells and Palmer Medical Center concerning patient ANON-PX-8629. The subject is a 32-year-old male with a significant medical history including hypertension, atrial fibrillation, 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): Amoxicillin administered via the Topical route at a dosage of 245mg, initiated on 2024-07-31 for Bacterial infection with the course ongoing.

On approximately 2024-09-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Hepatotoxicity, Pruritus, Somnolence. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed range and advised end. The current patient status regarding this symptom is 'Recovering'. The Hepatotoxicity was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed agree and advised wear. The current patient status regarding this symptom is 'Unknown'. The Pruritus was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed hair and advised happen. 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 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 7 was calculated, The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-103
report_date: '2024-10-27'
patient_details:
  patient_id: ANON-PX-8629
  gender: Male
  relevant_history:
  - hypertension
  - atrial fibrillation
  - migraines
  age_at_reaction: 32
suspected_drugs:
- drug_name: Amoxicillin
  dosage: 245mg
  route_of_administration: Topical
  start_date: '2024-07-31'
  indication_for_use: Bacterial infection
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2024-09-17'
  severity: Moderate
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed range and advised end.
- symptom_name: Hepatotoxicity
  onset_date: '2024-09-17'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed agree and advised wear.
- symptom_name: Pruritus
  onset_date: '2024-09-17'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed hair and advised happen.
- symptom_name: Somnolence
  onset_date: '2024-09-17'
  severity: Severe
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 7
reporting_facility: Lloyd, Wells and Palmer Medical Center
reporter_type: Patient
