<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-2024-211
Date of Submission: 2024-10-19

This report was submitted by a Physician from Schneider-Baker Medical Center concerning patient ANON-PX-7949. The subject is an adult other with a significant medical history including anxiety, 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): Gabapentin administered via the Subcutaneous route at a dosage of 293mg, initiated on 2024-09-25 for Neuropathic pain and discontinued on 2024-10-12; Sertraline (SSRI) administered via the Subcutaneous route at a dosage of 254mg, initiated on 2024-09-25 for Major depressive disorder and discontinued on 2024-10-12.

On approximately 2024-09-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Hepatotoxicity, Dizziness. The Hepatotoxicity was classified as Severe in severity. This necessitated clinical intervention. The documented action was: Prescribed sit and advised ability. The current patient status regarding this symptom is 'Recovering'. The Dizziness was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed despite and advised call. The current patient status regarding this symptom is 'Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 4 was calculated, The assessment concluded the relationship was 'Possible'. Dechallenge/Rechallenge status was noted as: 'Rechallenge not performed'. The on-site pharmacist concurred with the assessment during a routine case review. 

</data>
report_id: ADR-2024-211
report_date: '2024-10-19'
patient_details:
  patient_id: ANON-PX-7949
  gender: Other
  relevant_history:
  - anxiety
  - seasonal allergies
  - asthma
suspected_drugs:
- drug_name: Gabapentin
  dosage: 293mg
  route_of_administration: Subcutaneous
  start_date: '2024-09-25'
  indication_for_use: Neuropathic pain
  end_date: '2024-10-12'
- drug_name: Sertraline
  dosage: 254mg
  route_of_administration: Subcutaneous
  start_date: '2024-09-25'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-10-12'
adverse_reactions:
- symptom_name: Hepatotoxicity
  onset_date: '2024-09-26'
  severity: Severe
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed sit and advised ability.
- symptom_name: Dizziness
  onset_date: '2024-09-26'
  severity: Mild
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed despite and advised call.
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Rechallenge not performed
  naranjo_score: 4
reporting_facility: Schneider-Baker Medical Center
reporter_type: Physician
