<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-2024-701
Date of Submission: 2024-09-23

This report was submitted by a Physician from Miller-Wagner Medical Center concerning patient ANON-PX-2954. The subject is a 71-year-old male with a significant medical history including migraines, osteoarthritis. 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): Gabapentin (Anticonvulsant) administered via the Oral route at a dosage of 270mg, initiated on 2024-06-30 for Neuropathic pain with the course ongoing; Sertraline (SSRI) administered via the Topical route at a dosage of 319mg, initiated on 2024-06-30 for Major depressive disorder with the course ongoing.

On approximately 2024-09-17, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Pruritus, Headache, Somnolence, Maculopapular Rash, Stevens-Johnson syndrome. The Pruritus was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed reduce and advised room. The current patient status regarding this symptom is 'Not Recovered'. The Headache was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed hundred and advised environmental. The current patient status regarding this symptom is 'Recovered'. The Somnolence was classified as Severe in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovering'. The Maculopapular Rash was classified as Life-threatening in severity. No specific therapeutic intervention was required. 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 '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: 'Negative dechallenge'. The on-site pharmacist concurred with the assessment during a routine case review. 

Reporter's Narrative Summary: Grow true number kitchen could real which. Gas human product including Democrat.</data>
report_id: ADR-2024-701
report_date: '2024-09-23'
patient_details:
  patient_id: ANON-PX-2954
  gender: Male
  relevant_history:
  - migraines
  - osteoarthritis
  age_at_reaction: 71
suspected_drugs:
- drug_name: Gabapentin
  dosage: 270mg
  route_of_administration: Oral
  start_date: '2024-06-30'
  indication_for_use: Neuropathic pain
  drug_class: Anticonvulsant
- drug_name: Sertraline
  dosage: 319mg
  route_of_administration: Topical
  start_date: '2024-06-30'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
adverse_reactions:
- symptom_name: Pruritus
  onset_date: '2024-09-17'
  severity: Mild
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed reduce and advised room.
- symptom_name: Headache
  onset_date: '2024-09-17'
  severity: Severe
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed hundred and advised environmental.
- symptom_name: Somnolence
  onset_date: '2024-09-17'
  severity: Severe
  outcome: Recovering
  intervention_required: true
- symptom_name: Maculopapular Rash
  onset_date: '2024-09-17'
  severity: Life-threatening
  outcome: Fatal
  intervention_required: false
- symptom_name: Stevens-Johnson syndrome
  onset_date: '2024-09-17'
  severity: Mild
  outcome: Unknown
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 1
reporting_facility: Miller-Wagner Medical Center
reporter_type: Physician
notes: Grow true number kitchen could real which. Gas human product including Democrat.
