{"description":"The definition does not differ.","eventGroups":[{"deathsNumAffected":5,"deathsNumAtRisk":81,"description":"Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine.\n\nFluzone High Dose Vaccine","id":"EG000","otherNumAffected":0,"otherNumAtRisk":81,"seriousNumAffected":8,"seriousNumAtRisk":81,"title":"Fluzone High Dose Vaccine Then Fluzone High Dose Booster"},{"deathsNumAffected":2,"deathsNumAtRisk":41,"description":"Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine.\n\nStandard of care/Placebo","id":"EG001","otherNumAffected":0,"otherNumAtRisk":41,"seriousNumAffected":1,"seriousNumAtRisk":41,"title":"Standard of Care"}],"frequencyThreshold":"5","seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTEP-AERS","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":81,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":41,"numEvents":0}],"term":"Intracranial hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTEP-AERS","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":81,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":41,"numEvents":0}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTEP-AERS","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":81,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":41,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTEP-AERS","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":81,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":41,"numEvents":1}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTEP-AERS","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":81,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":41,"numEvents":0}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTEP-AERS","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":81,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":41,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTEP-AERS","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":81,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":41,"numEvents":0}],"term":"Seizure"}],"timeFrame":"Adverse event data were collected up to 12 months after initial vaccination"}