<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-2025-635
Date of Submission: 2025-03-30

This report was submitted by a Physician from Jarvis Group Medical Center concerning patient ANON-PX-7479. The subject is an adult male with a significant medical history including osteoarthritis, migraines, seasonal allergies, 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 administered via the Topical route at a dosage of 261mg, initiated on 2025-01-26 for Gastroesophageal reflux disease and discontinued on 2025-02-28.

On approximately 2025-02-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Anaphylaxis, Stevens-Johnson syndrome, Somnolence. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Stevens-Johnson syndrome was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed able and advised charge. The current patient status regarding this symptom is 'Unknown'. The Somnolence was classified as Life-threatening in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Unknown'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. Dechallenge/Rechallenge status was noted as: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Everyone risk wide western hand. Some oil work than. Clearly plant series interesting from different.</data>
report_id: ADR-2025-635
report_date: '2025-03-30'
patient_details:
  patient_id: ANON-PX-7479
  gender: Male
  relevant_history:
  - osteoarthritis
  - migraines
  - seasonal allergies
  - asthma
suspected_drugs:
- drug_name: Omeprazole
  dosage: 261mg
  route_of_administration: Topical
  start_date: '2025-01-26'
  indication_for_use: Gastroesophageal reflux disease
  end_date: '2025-02-28'
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-02-19'
  severity: Life-threatening
  outcome: Recovering
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-02-19'
  severity: Severe
  outcome: Recovered
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-02-19'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed able and advised charge.
- symptom_name: Somnolence
  onset_date: '2025-02-19'
  severity: Life-threatening
  outcome: Unknown
  intervention_required: true
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Not applicable
reporting_facility: Jarvis Group Medical Center
reporter_type: Physician
notes: Everyone risk wide western hand. Some oil work than. Clearly plant series interesting
  from different.
