<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-2025-856
Date of Submission: 2025-01-28

This report was submitted by a Patient from Alvarez, Hamilton and Martin Medical Center concerning patient ANON-PX-7050. The subject is an adult male with a significant medical history including atrial fibrillation, type 2 diabetes, 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): Omeprazole administered via the Intramuscular route at a dosage of 9mg, initiated on 2024-12-28 for Gastroesophageal reflux disease with the course ongoing; Levothyroxine administered via the Intramuscular route at a dosage of 419mg, initiated on 2024-12-28 for Hypothyroidism with the course ongoing.

On approximately 2025-01-13, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Diarrhea, Stevens-Johnson syndrome, Somnolence. The Diarrhea was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Stevens-Johnson syndrome was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. The Somnolence 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. A Naranjo score of 2 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: Cost benefit reality decide involve. Message enough PM most PM responsibility option sell. Shoulder film market course knowledge with.</data>
report_id: ADR-2025-856
report_date: '2025-01-28'
patient_details:
  patient_id: ANON-PX-7050
  gender: Male
  relevant_history:
  - atrial fibrillation
  - type 2 diabetes
  - migraines
suspected_drugs:
- drug_name: Omeprazole
  dosage: 9mg
  route_of_administration: Intramuscular
  start_date: '2024-12-28'
  indication_for_use: Gastroesophageal reflux disease
- drug_name: Levothyroxine
  dosage: 419mg
  route_of_administration: Intramuscular
  start_date: '2024-12-28'
  indication_for_use: Hypothyroidism
adverse_reactions:
- symptom_name: Diarrhea
  onset_date: '2025-01-13'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2025-01-13'
  severity: Mild
  outcome: Recovered
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2025-01-13'
  severity: Severe
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Positive rechallenge
  naranjo_score: 2
reporting_facility: Alvarez, Hamilton and Martin Medical Center
reporter_type: Patient
notes: Cost benefit reality decide involve. Message enough PM most PM responsibility
  option sell. Shoulder film market course knowledge with.
