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. 2022 Jan 31;40(5):752-756.
doi: 10.1016/j.vaccine.2021.12.048. Epub 2021 Dec 31.

Monitoring vaccine safety using the vaccine safety Datalink: Assessing capacity to integrate data from Immunization Information systems

Holly C Groom  1 , Bradley Crane  1 , Allison L Naleway  1 , Eric Weintraub  2 , Matthew F Daley  3 , Kris Wain  3 , Mary Beth Kurilo  4 , Rachael Burganowski  5 , Malini B DeSilva  6 , James G Donahue  7 , Sungching C Glenn  8 , Kristin Goddard  7 , Michael L Jackson  5 , Elyse O Kharbanda  6 , Ned Lewis  7 , Yingbo Lou  8 , Marlene Lugg  9 , Erica Scotty  10 , Lina S Sy  9 , Joshua T B Williams  8 , Stephanie A Irving  1
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Monitoring vaccine safety using the vaccine safety Datalink: Assessing capacity to integrate data from Immunization Information systems

Holly C Groom et al. Vaccine. .

Abstract

Background: The Vaccine Safety Datalink (VSD) uses vaccination data from electronic health records (EHR) at eight integrated health systems to monitor vaccine safety. Accurate capture of data from vaccines administered outside of the health system is critical for vaccine safety research, especially for COVID-19 vaccines, where many are administered in non-traditional settings. However, timely access and inclusion of data from Immunization Information Systems (IIS) into VSD safety assessments is not well understood.

Methods: We surveyed the eight data-contributing VSD sites to assess: 1) status of sending data to IIS; 2) status of receiving data from IIS; and 3) integration of IIS data into the site EHR. Sites reported separately for COVID-19 vaccination to capture any differences in capacity to receive and integrate data on COVID-19 vaccines versus other vaccines.

Results: All VSD sites send data to and receive data from their state IIS. All eight sites (100%) routinely integrate IIS data for COVID-19 vaccines into VSD research studies. Six sites (75%) also routinely integrate all other vaccination data; two sites integrate data from IIS following a reconciliation process, which can result in delays to integration into VSD datasets.

Conclusions: COVID-19 vaccines are being administered in a variety of non-traditional settings, where IIS are commonly used as centralized reporting systems. All eight VSD sites receive and integrate COVID-19 vaccine data from IIS, which positions the VSD well for conducting quality assessments of vaccine safety. Efforts to improve the timely receipt of all vaccination data will improve capacity to conduct vaccine safety assessments within the VSD.

Keywords: Immunization Information Systems; Vaccine data completeness; Vaccine safety.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Michael Jackson reports a relationship with Sanofi Pasteur Inc that includes: funding grants. Allison Naleway reports a relationship with Pfizer that includes: funding grants. James Donahue reports a relationship with Janssen Inc that includes: funding grants. Lina Sy reports a relationship with Moderna that includes: funding grants. Lina Sy reports a relationship with GlaxoSmithKline that includes: funding grants. Lina Sy reports a relationship with Dynavax that includes: funding grants. Lina Sy reports a relationship with Seqirus Inc. that includes].

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