Jennifer Clark Nelson, PhD

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“As national statistical leaders, we promote the use of rigorous methods that enhance drug and vaccine safety monitoring in the United States.”

Jennifer Clark Nelson, PhD

Director, Biostatistics; Senior Investigator, Kaiser Permanente Washington Health Research Institute

Jen.Nelson@kp.org
206-287-2004

Biography

Jennifer Clark Nelson, PhD, is a senior investigator and biostatistician with expertise in methods to assess drug and vaccine safety and effectiveness for studies that use large electronic health care data. Dr. Nelson provides national statistical leadership as a methods core lead for the Food and Drug Administration (FDA)’s Sentinel Initiative, an active surveillance system for monitoring the safety of all FDA-regulated medical products after they have reached the market. She also leads methodological research within the Centers for Disease Control and Prevention-sponsored Vaccine Safety Datalink (VSD), a national collaboration involving seven managed care organizations that has monitored immunization safety in the United States since 1990.

As part of both the VSD and Sentinel projects, Dr. Nelson works with her Kaiser Permanente Washington Health Research Institute (KPWHRI) colleagues Andrea Cook, PhD, and David Carrell, PhD, to pilot and scale up innovative sequential monitoring, machine learning, and natural language processing approaches that rapidly and accurately identify adverse events not detected in pre-licensure studies. Her 2013 study of the safety of a pentavalent combination DTaP-IPV-Hib (Pentacel) childhood vaccine put some of these ideas into practice and was selected as one of the American Journal of Epidemiology’s 10 best articles of the year. She and her clinical KPWHRI research partner, Lisa Jackson, MD, MPH, lead the CDC’s surveillance effort to proactively monitor the safety of the new herpes zoster vaccine for adults (Shingrix).      

Dr. Nelson is an affiliate professor in biostatistics at the University of Washington (UW) and has been KPWHRI’s director of biostatistics since 2014. In collaboration with the UW, she and Dr. Cook co-founded the Seattle Symposium on Health Care Data Analytics, a conference designed to confront challenges and promote learning from electronic health record data to advance health and health care. In 2009, Dr. Nelson earned the VSD’s Margarette Kolczak Award for outstanding contributions in biostatistics and epidemiology in vaccine safety.

Research interests and experience

  • Biostatistics

    Post-marketing drug and vaccine safety study design and analysis; secondary use and misuse of large electronic health care databases for medical research; vaccine effectiveness study methods; sequential testing in observational data settings; methods to assess interrater variability

  • Vaccines & Infectious Diseases

    Biostatistics; post-marketing vaccine safety study design and analysis; influenza vaccine effectiveness in the elderly; methodological issues in large multi-site health care database studies

  • Medication Use & Patient Safety

    Biostatistics; post-marketing drug and vaccine safety study design and analysis; safety signal detection methods; methodological issues in large, multi-site health care database studies

  • Aging & Dementia

    Biostatistics; statistical issues in longitudinal observational cohort studies

  • Cardiovascular Health

Recent publications

Carrell DS, Gruber S, Floyd JS, Bann MA, Cushing-Haugen KL, Johnson RL, Graham V, Cronkite DJ, Hazlehurst BL, Felcher AH, Bejan CA, Kennedy A, Shinde M, Karami S, Ma Y, Stojanovic D, Zhao Y, Ball R, Nelson J. Improving methods of identifying anaphylaxis for medical product safety surveillance using natural language processing and machine learning. Am J Epidemiol. 2022 Nov 4:kwac182. doi: 10.1093/aje/kwac182. [Epub ahead of print]. PubMed

Nelson JC, Ulloa-Perez E, Yu O, Cook AJ, Jackson ML, Belongia EA, Daley MF, Harpaz R, Kharbanda EO, Klein NP, Naleway AL, Tseng HF, Weintraub ES, Duffy J, Yih WK, Jackson LA. Active post-licensure safety surveillance for recombinant zoster vaccine using electronic health record data. Am J Epidemiol. 2022 Oct 4:kwac170. doi: 10.1093/aje/kwac170. [Epub ahead of print]. PubMed

Floyd JS, Bann MA, Felcher AH, Sapp D, Nguyen MD, Ajao A, Ball R, Carrell DS, Nelson JC, Hazlehurst B. Validation of acute pancreatitis among adults in an integrated healthcare system. Epidemiology. 2022 Aug 22. doi: 10.1097/EDE.0000000000001541. Online ahead of print. PubMed

Tartof SY, Malden DE, Liu IA, Sy LS, Lewin BJ, Williams JTB, Hambidge SJ, Alpern JD, Daley MF, Nelson JC, McClure D, Zerbo O, Henninger ML, Fuller C, Weintraub E, Saydah S, Qian L. Health care utilization in the 6 months following SARS-CoV-2 infection. JAMA Netw Open. 2022 Aug 1;5(8):e2225657. doi: 10.1001/jamanetworkopen.2022.25657. PubMed

Goddard K, Lewis N, Fireman B, Weintraub E, Shimabukuro T, Zerbo O, Boyce TG, Oster ME, Hanson KE, Donahue JG, Ross P, Naleway A, Nelson JC, Lewin B, Glanz JM, Williams JTB, Kharbanda EO, Katherine Yih W, Klein NP. Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination. Vaccine. 2022 Jul 12:S0264-410X(22)00860-X. doi: 10.1016/j.vaccine.2022.07.007. Online ahead of print. PubMed

DeSilva M, Haapala J, Vazquez-Benitez G, Vesco KK, Daley MF, Getahun D, Zerbo O, Naleway A, Nelson JC, Williams JTB, Hambidge SJ, Boyce TG, Fuller CC, Lipkind HS, Weintraub E, McNeil MM, Kharbanda EO. Evaluation of acute adverse events after COVID-19 vaccination during pregnancy. N Engl J Med. 2022 Jun 22. doi: 10.1056/NEJMc2205276. Online ahead of print. PubMed

Hause AM, Shay DK, Klein NP, Abara WE, Baggs J, Cortese MM, Fireman B, Gee J, Glanz JM, Goddard K, Hanson KE, Hugueley B, Kenigsberg T, Kharbanda EO, Lewin B, Lewis N, Marquez P, Myers T, Naleway A, Nelson JC, Su JR, Thompson D, Olubajo B, Oster ME, Weintraub ES, Williams JTB, Yousaf AR, Zerbo O, Zhang B, Shimabukuro TT. Safety of COVID-19 vaccination in US children ages 5-11 years. Pediatrics. 2022 May 18. doi: 10.1542/peds.2022-057313. Online ahead of print. PubMed

Xu S, Hong V, Sy LS, Glenn SC, Ryan DS, Morrissette K, Nelson JC, Hambidge SJ, Crane B, Zerbo O, DeSilva MB, Glanz JM, Donahue JG, Liles E, Duffy J, Qian L. Changes in incidence rates of outcomes of interest in vaccine safety studies during the COVID-19 pandemic. Vaccine. 2022 Apr 18:S0264-410X(22)00464-9. doi: 10.1016/j.vaccine.2022.04.037. Online ahead of print. PubMed

Kenigsberg TA, Hause AM, McNeil MM, Nelson JC, Ann Shoup J, Goddard K, Lou Y, Hanson KE, Glenn SC, Weintraub E. Dashboard development for near real-time visualization of COVID-19 vaccine safety surveillance data in the vaccine safety datalink. Vaccine. 2022 Apr 8:S0264-410X(22)00426-1. doi: 10.1016/j.vaccine.2022.04.010. Online ahead of print. PubMed

Hanson KE, Goddard K, Lewis E, Myers TR, Bakshi N, Weintraub E, Donahue JG, Glanz JM, Nelson JC, Williams JTB, Xu S, Klein NP. Incidence of Guillain-BarrĂ© syndrome after COVID-19 vaccination in the Vaccine Safety Datalink. JAMA Netw Open. 2022 Apr 1;5(4):e228879. doi: 10.1001/jamanetworkopen.2022.8879. PubMed

 

Research

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New study confirms safety of shingles vaccine

KPWHRI researchers analyzed data from more than 640,000 vaccine doses to understand risk of severe reactions.

Vaccine research

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COVID-19 vaccines safe for people who are pregnant

New study supports a growing body of data that shows the vaccines are safe during pregnancy.

News

HCSRN 2022 Awards-Portrait images of Julie Richards and Jen Nelson

Richards and Nelson earn research awards

Honors from the Health Care Systems Research Network for early career achievements and manuscript of the year

Vaccine safety

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COVID-19 vaccines and serious reactions: 3 questions answered

Jen Nelson, PhD, talks about monitoring reactions to the mRNA vaccines.

Vaccine Safety

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Biostatisticians track COVID-19 vaccine safety

Dr. Jennifer Nelson explains how KP scientists are helping the CDC and FDA keep an eye out for rare adverse events.