<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-2025-615
Date of Submission: 2025-08-12

This report was submitted by a Pharmacist from Ashley-Gallagher Medical Center concerning patient ANON-PX-4668. The subject is an adult female with a significant medical history including asthma, seasonal allergies, type 2 diabetes. 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): Ibuprofen (NSAID) administered via the Intravenous route at a dosage of 231mg, initiated on 2025-06-13 for Pain and inflammation and discontinued on 2025-08-10.

On approximately 2025-07-20, the patient began to manifest an adverse event. The primary symptoms noted in the clinical log were Angioedema, Pruritus, Headache. The Angioedema was classified as Moderate in severity. This necessitated clinical intervention. The current patient status regarding this symptom is 'Not Recovered'. The Pruritus was classified as Moderate in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovering'. The Headache was classified as Life-threatening in severity. No specific therapeutic intervention was required. The current patient status regarding this symptom is 'Recovered'. 

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: Upon five call anyone identify. Even along window fear its. Generation go cover hold response.</data>
report_id: ADR-2025-615
report_date: '2025-08-12'
patient_details:
  patient_id: ANON-PX-4668
  gender: Female
  relevant_history:
  - asthma
  - seasonal allergies
  - type 2 diabetes
suspected_drugs:
- drug_name: Ibuprofen
  dosage: 231mg
  route_of_administration: Intravenous
  start_date: '2025-06-13'
  indication_for_use: Pain and inflammation
  drug_class: NSAID
  end_date: '2025-08-10'
adverse_reactions:
- symptom_name: Angioedema
  onset_date: '2025-07-20'
  severity: Moderate
  outcome: Not Recovered
  intervention_required: true
- symptom_name: Pruritus
  onset_date: '2025-07-20'
  severity: Moderate
  outcome: Recovering
  intervention_required: false
- symptom_name: Headache
  onset_date: '2025-07-20'
  severity: Life-threatening
  outcome: Recovered
  intervention_required: false
causality_assessment:
  assessment_conclusion: Probable
  dechallenge_rechallenge: Positive rechallenge
reporting_facility: Ashley-Gallagher Medical Center
reporter_type: Pharmacist
notes: Upon five call anyone identify. Even along window fear its. Generation go cover
  hold response.
