<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-2025-118
Date of Submission: 2025-04-15

This report was submitted by a Other Healthcare Professional from Madden, Brooks and Miller Medical Center concerning patient ANON-PX-4883. The subject is a 18-year-old female with a significant medical history including atrial fibrillation, hypertension, 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): Gabapentin (Anticonvulsant) administered via the Intramuscular route at a dosage of 122mg, initiated on 2025-03-23 for Neuropathic pain and discontinued on 2025-04-06; Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 174mg, initiated on 2025-03-23 for Gastroesophageal reflux disease and discontinued on 2025-04-06.

On approximately 2025-03-29, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Vomiting, Angioedema, Stevens-Johnson syndrome. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed health and advised important. The current patient status regarding this symptom is 'Recovered'. The Angioedema was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed prepare and advised item. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2025-118
report_date: '2025-04-15'
patient_details:
  patient_id: ANON-PX-4883
  gender: Female
  relevant_history:
  - atrial fibrillation
  - hypertension
  - migraines
  age_at_reaction: 18
suspected_drugs:
- drug_name: Gabapentin
  dosage: 122mg
  route_of_administration: Intramuscular
  start_date: '2025-03-23'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
  end_date: '2025-04-06'
- drug_name: Omeprazole
  dosage: 174mg
  route_of_administration: Topical
  start_date: '2025-03-23'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
  end_date: '2025-04-06'
adverse_reactions:
- symptom_name: Vomiting
  onset_date: '2025-03-29'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed health and advised important.
- symptom_name: Angioedema
  onset_date: '2025-03-29'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed prepare and advised item.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-03-29'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Madden, Brooks and Miller Medical Center
reporter_type: Other Healthcare Professional
