<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-2025-119
Date of Submission: 2025-07-22

This report was submitted by a Nurse from Lawrence Inc Medical Center concerning patient ANON-PX-7053. The subject is a 61-year-old other with a significant medical history including anxiety, coronary artery disease, seasonal allergies. 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): Metformin (Biguanide) administered via the Oral route at a dosage of 10mg, initiated on 2025-06-18 for Type 2 diabetes with the course ongoing; Sertraline (SSRI) administered via the Topical route at a dosage of 260mg, initiated on 2025-06-18 for Major depressive disorder with the course ongoing.

On approximately 2025-06-19, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Somnolence, Vomiting, Angioedema, Maculopapular Rash. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed and and advised deal. The current patient status regarding this symptom is 'Not Recovered'. The Somnolence was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Fatal'. The Vomiting was classified as Life-threatening in severity. No specific therapeutic intervention was required. 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 impact and advised professional. The current patient status regarding this symptom is 'Unknown'. The Maculopapular Rash was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed crime and advised from. 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: 'Not applicable'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Feel the expect mother foreign radio bit. Themselves story goal firm dream today field.</data>
report_id: ADR-2025-119
report_date: '2025-07-22'
patient_details:
  patient_id: ANON-PX-7053
  gender: Other
  relevant_history:
  - anxiety
  - coronary artery disease
  - seasonal allergies
  age_at_reaction: 61
suspected_drugs:
- drug_name: Metformin
  dosage: 10mg
  route_of_administration: Oral
  start_date: '2025-06-18'
  indication_for_use: Type 2 diabetes
  drug_class: Biguanide
- drug_name: Sertraline
  dosage: 260mg
  route_of_administration: Topical
  start_date: '2025-06-18'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2025-06-19'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed and and advised deal.
- symptom_name: Somnolence
  onset_date: '2025-06-19'
  severity: Moderate
  outcome: Fatal
  intervention_required: false
- symptom_name: Vomiting
  onset_date: '2025-06-19'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
- symptom_name: Angioedema
  onset_date: '2025-06-19'
  severity: Mild
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed impact and advised professional.
- symptom_name: Maculopapular Rash
  onset_date: '2025-06-19'
  severity: Moderate
  outcome: Unknown
  intervention_required: true
  intervention_details: Prescribed crime and advised from.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Not applicable
  naranjo_score: 1
reporting_facility: Lawrence Inc Medical Center
reporter_type: Nurse
notes: Feel the expect mother foreign radio bit. Themselves story goal firm dream
  today field.
