<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-2024-296
Date of Submission: 2024-12-19

This report was submitted by a Physician from Shelton, Woods and Kim Medical Center concerning patient ANON-PX-4455. The subject is a 77-year-old male with a significant medical history including osteoarthritis, migraines, asthma, anxiety. 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): Sertraline administered via the Topical route at a dosage of 168mg, initiated on 2024-09-26 for Major depressive disorder and discontinued on 2024-12-15; Amoxicillin (Penicillin antibiotic) administered via the Intramuscular route at a dosage of 237mg, initiated on 2024-09-26 for Bacterial infection and discontinued on 2024-12-15.

On approximately 2024-12-15, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Maculopapular Rash, Diarrhea, Vomiting, Stevens-Johnson syndrome. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Diarrhea was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Stevens-Johnson syndrome was classified as Moderate 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 9 was calculated, The assessment concluded the relationship was 'Highly 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: Director their until while call. Choose hard bar may lead improve quickly. Realize record trade vote rise.</data>
report_id: ADR-2024-296
report_date: '2024-12-19'
patient_details:
  patient_id: ANON-PX-4455
  gender: Male
  relevant_history:
  - osteoarthritis
  - migraines
  - asthma
  - anxiety
  age_at_reaction: 77
suspected_drugs:
- drug_name: Sertraline
  dosage: 168mg
  route_of_administration: Topical
  start_date: '2024-09-26'
  indication_for_use: Major depressive disorder
  end_date: '2024-12-15'
- drug_name: Amoxicillin
  dosage: 237mg
  route_of_administration: Intramuscular
  start_date: '2024-09-26'
  indication_for_use: Bacterial infection
  drug_class: Penicillin antibiotic
  end_date: '2024-12-15'
adverse_reactions:
- symptom_name: Headache
  onset_date: '2024-12-15'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: false
- symptom_name: Maculopapular Rash
  onset_date: '2024-12-15'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-12-15'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2024-12-15'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-12-15'
  severity: Moderate
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 9
reporting_facility: Shelton, Woods and Kim Medical Center
reporter_type: Physician
notes: Director their until while call. Choose hard bar may lead improve quickly.
  Realize record trade vote rise.
