<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-2024-854
Date of Submission: 2024-10-25

This report was submitted by a Pharmacist from Banks-Ewing Medical Center concerning patient ANON-PX-8883. The subject is a 65-year-old female with a significant medical history including asthma, migraines, hypertension. 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): Sertraline (SSRI) administered via the Topical route at a dosage of 145mg, initiated on 2024-08-06 for Major depressive disorder and discontinued on 2024-10-13.

On approximately 2024-09-28, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Anaphylaxis, Nausea, Somnolence. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed race and advised measure. The current patient status regarding this symptom is 'Not Recovered'. The Nausea was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Somnolence was classified as Mild in severity. This necessitated clinical intervention. The documented action was: Prescribed real and advised soon. The current patient status regarding this symptom is 'Recovering'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. The assessment concluded the relationship was 'Probable'. 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: Piece society culture industry. Tend media charge data consider against pass. Do six available protect quality reason point.</data>
report_id: ADR-2024-854
report_date: '2024-10-25'
patient_details:
  patient_id: ANON-PX-8883
  gender: Female
  relevant_history:
  - asthma
  - migraines
  - hypertension
  age_at_reaction: 65
suspected_drugs:
- drug_name: Sertraline
  dosage: 145mg
  route_of_administration: Topical
  start_date: '2024-08-06'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
  end_date: '2024-10-13'
adverse_reactions:
- symptom_name: Anaphylaxis
  onset_date: '2024-09-28'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
  intervention_details: Prescribed race and advised measure.
- symptom_name: Nausea
  onset_date: '2024-09-28'
  severity: Mild
  outcome: Recovering
  intervention_required: false
- symptom_name: Somnolence
  onset_date: '2024-09-28'
  severity: Mild
  outcome: Recovering
  intervention_required: true
  intervention_details: Prescribed real and advised soon.
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Banks-Ewing Medical Center
reporter_type: Pharmacist
notes: Piece society culture industry. Tend media charge data consider against pass.
  Do six available protect quality reason point.
