<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-2025-703
Date of Submission: 2025-03-06

This report was submitted by a Patient from Collins-Roberson Medical Center concerning patient ANON-PX-9493. The subject is a 51-year-old female with a significant medical history including seasonal allergies, type 2 diabetes, asthma. 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): Omeprazole (Proton-pump inhibitor) administered via the Topical route at a dosage of 312mg, initiated on 2025-02-24 for Gastroesophageal reflux disease with the course ongoing; Gabapentin (Anticonvulsant) administered via the Subcutaneous route at a dosage of 350mg, initiated on 2025-02-24 for Neuropathic pain with the course ongoing.

On approximately 2025-02-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Headache, Stevens-Johnson syndrome, Somnolence, Vomiting, Maculopapular Rash. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed have and advised coach. The current patient status regarding this symptom is 'Fatal'. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Somnolence was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Life-threatening in severity. This necessitated clinical intervention. The documented action was: Prescribed claim and advised expect. The current patient status regarding this symptom is 'Fatal'. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 1 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Positive rechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: One trip important top. Discover country late west same need.</data>
report_id: ADR-2025-703
report_date: '2025-03-06'
patient_details:
  patient_id: ANON-PX-9493
  gender: Female
  relevant_history:
  - seasonal allergies
  - type 2 diabetes
  - asthma
  age_at_reaction: 51
suspected_drugs:
- drug_name: Omeprazole
  dosage: 312mg
  route_of_administration: Topical
  start_date: '2025-02-24'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
- drug_name: Gabapentin
  dosage: 350mg
  route_of_administration: Subcutaneous
  start_date: '2025-02-24'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
adverse_reactions:
- symptom_name: Headache
  onset_date: '2025-02-26'
  severity: Severe
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed have and advised coach.
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-02-26'
  severity: Mild
  outcome: Fatal
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-02-26'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-02-26'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: true
  intervention_details: Prescribed claim and advised expect.
- symptom_name: Maculopapular Rash
  onset_date: '2025-02-26'
  severity: Mild
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 1
reporting_facility: Collins-Roberson Medical Center
reporter_type: Patient
notes: One trip important top. Discover country late west same need.
