<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-2025-133
Date of Submission: 2025-03-18

This report was submitted by a Patient from Nichols-Pitts Medical Center concerning patient ANON-PX-4336. The subject is a 41-year-old female with a significant medical history including anxiety, 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): Sertraline (SSRI) administered via the Intramuscular route at a dosage of 138mg, initiated on 2025-02-14 for Major depressive disorder with the course ongoing; Omeprazole (Proton-pump inhibitor) administered via the Intramuscular route at a dosage of 194mg, initiated on 2025-02-14 for Gastroesophageal reflux disease with the course ongoing.

On approximately 2025-02-26, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Anaphylaxis, Diarrhea, Vomiting. The Angioedema was classified as Severe in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Anaphylaxis was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Recovered'. The Diarrhea was classified as Moderate in severity. This necessitated clinical intervention. The documented action was: Prescribed in and advised hotel. The current patient status regarding this symptom is 'Recovered'. The Vomiting was classified as Mild in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Not Recovered'. 

CAUSALITY ASSESSMENT:
An evaluation of causality was performed. A Naranjo score of 2 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: Material expect responsibility level only.</data>
report_id: ADR-2025-133
report_date: '2025-03-18'
patient_details:
  patient_id: ANON-PX-4336
  gender: Female
  relevant_history:
  - anxiety
  - seasonal allergies
  age_at_reaction: 41
suspected_drugs:
- drug_name: Sertraline
  dosage: 138mg
  route_of_administration: Intramuscular
  start_date: '2025-02-14'
  indication_for_use: Major depressive disorder
  drug_class: SSRI
- drug_name: Omeprazole
  dosage: 194mg
  route_of_administration: Intramuscular
  start_date: '2025-02-14'
  indication_for_use: Gastroesophageal reflux disease
  drug_class: Proton-pump inhibitor
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2025-02-26'
  severity: Severe
  outcome: Recovering
  intervention_required: false
- symptom_name: Anaphylaxis
  onset_date: '2025-02-26'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
- symptom_name: Diarrhea
  onset_date: '2025-02-26'
  severity: Moderate
  outcome: Recovered
  intervention_required: true
  intervention_details: Prescribed in and advised hotel.
- symptom_name: Vomiting
  onset_date: '2025-02-26'
  severity: Mild
  outcome: Not Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Possible
  dechallenge_rechallenge: Negative dechallenge
  naranjo_score: 2
reporting_facility: Nichols-Pitts Medical Center
reporter_type: Patient
notes: Material expect responsibility level only.
