| Literature DB >> 35428497 |
Tat'Yana A Kenigsberg1, Anne M Hause2, Michael M McNeil2, Jennifer C Nelson3, Jo Ann Shoup4, Kristin Goddard5, Yingbo Lou6, Kayla E Hanson7, Sungching C Glenn8, Eric S Weintraub2.
Abstract
The Vaccine Safety Datalink (VSD) conducts active surveillance and vaccine safety research studies. Since the start of the U.S. COVID-19 vaccination program, the VSD has conducted near real-time safety surveillance of COVID-19 vaccines using Rapid Cycle Analysis. VSD investigators developed an internal dashboard to facilitate visualization and rapid reviews of large weekly automated vaccine safety surveillance data. Dashboard development and maintenance was informed by vaccine surveillance data users and vaccine safety partners. Key metrics include population demographics, vaccine uptake, pre-specified safety outcomes, sequential analyses results, and descriptive data on potential vaccine safety signals. Dashboard visualizations are used to provide situational awareness on dynamic vaccination coverage and the status of multiple safety analyses conducted among the VSD population. This report describes the development and implementation of the internal VSD COVID-19 Vaccine Dashboard, including metrics used to develop the dashboard, which may have application across various other public health settings. Published by Elsevier Ltd.Entities:
Keywords: Data visualization; Public health surveillance; Vaccines
Mesh:
Substances:
Year: 2022 PMID: 35428497 PMCID: PMC8989890 DOI: 10.1016/j.vaccine.2022.04.010
Source DB: PubMed Journal: Vaccine ISSN: 0264-410X Impact factor: 4.169
Vaccine Safety Datalink COVID-19 Rapid Cycle Analysis surveillance pre-specified outcomes displayed in the VSD COVID-19 Vaccine Dashboard.
| # | VSD Outcomes | Abbreviation | Settings | Risk Window (Days) | Exclude if COVID 19 in X prior days | Monitoring Only | Chart Review |
|---|---|---|---|---|---|---|---|
| 1 | Acute disseminated encephalomyelitis | ADEM | E, I | 1–21, 1–42 | Yes | ||
| 2 | Acute myocardial infarction | AMI | E, I | 1–21, 1–42 | 30 days | ||
| 3 | Acute respiratory distress syndrome | ARDS | E, I | 1–21, 1–42 | 42 days | Yes | |
| 4 | Anaphylaxis | ANAPH | E, I | 0–1 | Yes | Yes | |
| 5 | Appendicitis | APPND | E, I | 1–21, 1–42 | |||
| 6 | Bell's palsy | BP | E, I, O | 1–21, 1–42 | 30 days | ||
| 7 | Cerebral venous sinus thrombosis | CVST | E, I | 1–21, 1–42 | 30 days | Yes | |
| 8 | Convulsions / seizures | SZ | E, I | 1–21, 1–42 | 30 days | ||
| 9 | Disseminated intravascular coagulation | DIC | E, I | 1–21, 1–42 | 42 days | ||
| 10 | Encephalitis / myelitis / encephalomyelitis / encephalopathy | ENCEPH | E, I | 1–21, 1–42 | 30 days | ||
| 11 | Guillain-Barré syndrome | GBS | E, I | 1–21, 1–42 | Yes | ||
| 12 | Immune thrombocytopenia | ITP | E, I, O | 1–21, 1–42 | 30 days | ||
| 13 | Kawasaki disease | KD | E, I | 1–21, 1–42 | |||
| 14 | Multisystem Inflammatory Syndrome in Children & Adults | MISC, MISA | E, I | Yes | |||
| 15 | Myocarditis / pericarditis | MYOC | E, I | 1–21, 1–42 | 30 days | Yes, under 40 years of age | |
| 16 | Narcolepsy and cataplexy | NARC | E, I, O | Yes | |||
| 17 | Pulmonary embolism | PE | E, I | 1–21, 1–42 | 30 days | ||
| 18 | Stroke, hemorrhagic | HSTK | E, I | 1–21, 1–42 | 30 days | ||
| 19 | Stroke, ischemic | ISTK | E, I | 1–21, 1–42 | 30 days | ||
| 20 | Thrombosis with Thrombocytopenia Syndrome | TTS | E, I | 1–21, 1–42 | Yes | ||
| 21 | Thrombotic thrombocytopenic purpura | TTP | E, I | 1–21, 1–42 | 30 days | ||
| 22 | Transverse myelitis | TM | E, I | 1–21, 1–42 | Yes | ||
| 23 | Venous thromboembolism | VTE | E, I, O | 1–21, 1–42 | 30 days | ||
E = Emergency Department, I = Inpatient, O = Outpatient.
Only the first event of an outcome that occurred during the risk interval will be counted, to avoid double counting the same outcome.
Exclusion for outcomes of interest for comparative analyses.
Outcomes monitored only; not included in comparative analyses.
Chart review of outcomes shortly after case detection to confirm possible cases and collect additional data.
Categories and metrics included in the internal Vaccine Safety Datalink COVID-19 Vaccine Dashboard.
| Category | Metrics |
|---|---|
| COVID-19 vaccine administration | Number of total doses administered Number of total doses administered per 100,000 persons Number of persons who received at least one dose Number of persons fully vaccinated Change in number doses administered since last week (total doses, total doses per 100,000 persons, persons who received at least one dose, persons fully vaccinated) Number of persons who received at least one dose and number persons fully vaccinated over time, by week Number of doses administered by vaccine manufacturer and dose number, where applicable Number of persons who received at least one dose and number persons fully vaccinated by demographics (i.e., sex, age group, race/ethnicity, VSD site, high-risk for COVID-19 disease status, and COVID-19 disease history status) and by week |
| COVID-19 vaccine coverage | Number and proportion of VSD population who received at least one dose Number and proportion of VSD population fully vaccinated Number and proportion of VSD population who received vaccine, by vaccine manufacturer and dose number Number and proportion of VSD population who received dose 1 and number and proportion of VSD population who received dose 2, by vaccine manufacturer and demographics Number and proportion of VSD population who received at least one dose and number and proportion of VSD population fully vaccinated by demographics and by week |
| Descriptive summaries of outcomes following COVID-19 vaccination | Number of pre-specified outcomes that occurred by outcome type, vaccine manufacturer and dose number Number of pre-specified outcomes that occurred by outcome type, vaccine manufacturer and dose number, average days to onset/diagnosis, sex, pregnancy status, and history of COVID-19 disease status Outcome-specific visualizations that show number of outcomes by vaccine manufacturer and dose number, demographics, pregnancy status, and days to outcome diagnosis Number of pre-specified outcomes by days since onset and rate per one million person-days, by pre-specified outcome |
| Statistical analyses of COVID-19 vaccine outcomes | Cumulative incidence of pre-specified outcomes during pre-specified post-vaccination risk intervals Rate ratios to estimate the ratio of outcome incidence in the risk interval to the outcome incidence in the comparison interval with 95% confidence intervals Sequential analyses results of the one-sided null hypothesis that the vaccine does not increase risk of outcome during the risk interval |
| COVID-19 disease hospitalization counts | Number of total COVID-19 hospitalizations among VSD population over time, by month Number of total COVID-19 hospitalizations among VSD population over time (by month), compared to total number of dose 1 and dose 2 COVID-19 vaccine doses administered over time (by month) Number of total COVID-19 hospitalizations among VSD population over time (by month), by demographics Number of total lab-positive COVID-19 hospitalizations among VSD population over time (by month), by demographics Number and proportion of deceased lab-positive COVID-19 hospitalized persons by sex and age group (denominator = all lab-positive COVID-19 hospitalized persons) |
| Descriptive summaries of simultaneous vaccine administration with COVID-19 vaccine (i.e., administration of a non-COVID-19 vaccine on same day as a COVID-19 vaccine) | Number of persons who received simultaneous vaccines with any dose of COVID-19 vaccine compared to number persons who initiated COVID-19 vaccine Number of persons who received simultaneous vaccinations with COVID-19 vaccine, by COVID-19 vaccine manufacturer, dose number, and demographics Number of persons who received simultaneous vaccines, by simultaneous vaccine name Number of persons who received simultaneous vaccines, by simultaneous vaccine name and by week |
| Descriptive summaries of COVID-19 disease and COVID-19 vaccination during pregnancy | |
All COVID-19 vaccine doses are those administered to patients enrolled at participating VSD sites.
Fig. 1Vaccine Safety Datalink COVID-19 Vaccine Dashboard “Home” page.
Fig. 2COVID-19 Outcomes Summary dashboard of automated Bell’s Palsy cases following Moderna dose 1. HR = High Risk for COVID-19 disease; HX = History; NH = Non-Hispanic.
Fig. 3Example of COVID-19 Vaccine Dashboard visualization used in a June 23, 2021 Advisory Committee on Immunization Practices presentation on COVID-19 vaccine safety updates.