<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-2024-216
Date of Submission: 2024-12-05

This report was submitted by a Patient from Wright, Ortiz and Parker Medical Center concerning patient ANON-PX-3527. The subject is an adult female with a significant medical history including migraines, hypertension, 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): Lisinopril administered via the Intramuscular route at a dosage of 181mg, initiated on 2024-09-06 for Hypertension with the course ongoing; Ibuprofen (NSAID) administered via the Oral route at a dosage of 463mg, initiated on 2024-09-06 for Pain and inflammation with the course ongoing.

On approximately 2024-10-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Stevens-Johnson syndrome, Diarrhea, Vomiting, Hepatotoxicity, Angioedema. The Stevens-Johnson syndrome was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. The Diarrhea was classified as Moderate 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. This necessitated clinical intervention. The documented action was: Prescribed end and advised concern. The current patient status regarding this symptom is 'Fatal'. The Hepatotoxicity was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Angioedema was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 6 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. 

</data>
report_id: ADR-2024-216
report_date: '2024-12-05'
patient_details:
  patient_id: ANON-PX-3527
  gender: Female
  relevant_history:
  - migraines
  - hypertension
  - anxiety
suspected_drugs:
- drug_name: Lisinopril
  dosage: 181mg
  route_of_administration: Intramuscular
  start_date: '2024-09-06'
  indication_for_use: Hypertension
- drug_name: Ibuprofen
  dosage: 463mg
  route_of_administration: Oral
  start_date: '2024-09-06'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
adverse_reactions:
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-10-26'
  severity: Moderate
  outcome: Unknown
  intervention_required: false
- symptom_name: Diarrhea
  onset_date: '2024-10-26'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2024-10-26'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed end and advised concern.
- symptom_name: Hepatotoxicity
  onset_date: '2024-10-26'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2024-10-26'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 6
reporting_facility: Wright, Ortiz and Parker Medical Center
reporter_type: Patient
