<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-2025-561
Date of Submission: 2025-04-07

This report was submitted by a Physician from Johnson-Medina Medical Center concerning patient ANON-PX-5322. The subject is a 18-year-old female with a significant medical history including seasonal allergies, migraines, coronary artery disease. 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 Intramuscular route at a dosage of 82mg, initiated on 2025-03-29 for Gastroesophageal reflux disease with the course ongoing; Levothyroxine (Thyroid hormone) administered via the Topical route at a dosage of 476mg, initiated on 2025-03-29 for Hypothyroidism with the course ongoing.

On approximately 2025-03-30, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Maculopapular Rash, Vomiting. The Maculopapular Rash was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. The Vomiting was classified as Mild 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 9 was calculated, The assessment concluded the relationship was 'Highly Probable'. Dechallenge/Rechallenge status was noted as: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Exist magazine billion process call everybody official. Thousand record campaign individual thus budget actually seem. Moment conference surface score spring hard claim.</data>
report_id: ADR-2025-561
report_date: '2025-04-07'
patient_details:
  patient_id: ANON-PX-5322
  gender: Female
  relevant_history:
  - seasonal allergies
  - migraines
  - coronary artery disease
  age_at_reaction: 18
suspected_drugs:
- drug_name: Omeprazole
  dosage: 82mg
  route_of_administration: Intramuscular
  start_date: '2025-03-29'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
- drug_name: Levothyroxine
  dosage: 476mg
  route_of_administration: Topical
  start_date: '2025-03-29'
  indication_for_use: Hypothyroidism
  drug_class: Thyroid hormone
adverse_reactions:
- symptom_name: Maculopapular Rash
  onset_date: '2025-03-30'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-03-30'
  severity: Mild
  outcome: Fatal
  intervention_required: false
causality_assessment:
  assessment_conclusion: Highly Probable
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 9
reporting_facility: Johnson-Medina Medical Center
reporter_type: Physician
notes: Exist magazine billion process call everybody official. Thousand record campaign
  individual thus budget actually seem. Moment conference surface score spring hard
  claim.
