Vaccine Safety Datalink Publications
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Yih WK, Daley MF, Duffy J, Fireman B, McClure D, Nelson J, Qian L, Smith N, Vazquez-Benitez G, Weintraub E, Williams JTB, Xu S, Maro JC. A broad assessment of covid-19 vaccine safety using tree-based data-mining in the vaccine safety datalink. Vaccine. 2023 Jan 16; https://doi.org/10.1016/j.vaccine.2022.12.026. Online ahead of print.
Xu S, Huang R, Sy LS, Hong V, Glenn SC, Ryan DS, Morrissette K, Vazquez-Benitez G, Glanz JM, Klein NP, Fireman B, McClure D, Liles EG, Weintraub ES, Tseng HF, Qian L. A safety study evaluating non-COVID-19 mortality risk following COVID-19 vaccination. Vaccine. 2023 Jan 16; https://doi.org/10.1016/j.vaccine.2022.12.036. Online ahead of print.
Yih WK, Daley MF, Duffy J, Fireman B, McClure D, Nelson J, Qian L, Smith N, Vazquez-Benitez G, Weintraub E, Williams JTB, Xu S, Maro JC. Tree-based data mining for safety assessment of first COVID-19 booster doses in the Vaccine Safety Datalink. Vaccine. 2023 Jan 9; https://doi.org/10.1016/j.vaccine.2022.11.053. Online ahead of print.
Malden DE, Gee J, Glenn S, Li Z, Mercado C, Ogun OA, Kim S, Lewin BJ, Ackerson BK, Jazwa A, Weintraub ES, McNeil MM, Tartof S. Reactions following Pfizer-BioNTech COVID-19 mRNA vaccination and related healthcare encounters among 7,077 children aged 5-11 years within an integrated healthcare system. Vaccine. 2023 Jan 9; https://doi.org/10.1016/j.vaccine.2022.10.079. Online ahead of print.
Goddard K, Hanson KE, Lewis N, Weintraub E, Fireman B, Klein NP. Incidence of Myocarditis/Pericarditis Following mRNA COVID-19 Vaccination Among Children and Younger Adults in the United States. Annals of Internal Medicine. 2022 Oct 4. doi.org/10.7326/M22-2274.
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. doi: 10.1093/aje/kwac170. Online ahead of print.
Daley MF, Reifler LM, Glanz JM, Hambidge SJ, Getahun D, Irving SA, Nordin JD, McClure DL, Klein NP, Jackson ML, Duffy J, DeStefano F. Association Between Aluminum Exposure from Vaccines Before Age 24 Months and Persistent Asthma at Age 24-59 Months [PDF – 10 Pages]. Academic Pediatrics. 2022 Sept 27. Online ahead of print
This observational study suggests a possible association between exposure to aluminum in some childhood vaccines and development of persistent asthma in children. The study consisted of 326,991 children and found that cumulative exposure to aluminum from vaccines during the first two years of life was associated with a small increased risk of persistent asthma in children ages 2-5 years. There is overwhelming evidence of the benefits of vaccines. CDC is not changing the current routine childhood vaccination recommendations based on this single study. Small amounts of aluminum are included in many routine childhood vaccines to help the body build a stronger immunity from diseases. Further investigation is needed to explore the potential risk of aluminum exposure from routine childhood vaccines on the development of persistent asthma in children; efforts are underway.
Tartof SY, Malden DE, Liu ILA, Sy LS, Lewin BJ, Williams JTB, Hambidge SJ, Alpern JD, Daley MF, Nelson JC, McClure D, Zerbo O, Henninger ML, Fuller C, Weintraub E, Saydeh S, Qian L. Health Care Utilization in the 6 Months Following SARS-CoV-2 Infection. JAMA Network. 2022 Aug 12 ;5(8):e2225657. doi:10.1001/jamanetworkopen.2022.25657.
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, Yih WK, Klein NP. Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination. Vaccine. 2022 Aug 19; 40(35):5153-5159. Epub 2022 Jul 12.
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 United States Children Ages 5 to 11 Years. Pediatrics. 2022 Jul 14. https://doi.org/10.1542/peds.2022-057313.
Weintraub ES, Oster ME, Klein NP. Myocarditis or Pericarditis Following mRNA COVID-19 Vaccination. JAMA. 2022 Jun 24; 5(6):e2218512. doi:10.1001/jamanetworkopen.2022.18512
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. Epub ahead of print.
Xu S, Hong V, Sy LS, Glenn SC, Ryan DS, Morrissette KL, 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 May 20;40(23):3150-3158. Epub 2022 Apr 18.
Kenigsberg TA, Hause AM, McNeil MM, Nelson JC, Shoup JA, Goddard K, Lou Y, Hanson KE, Glenn SC, Weintraub ES. Dashboard development for near real-time visualization of COVID-19 vaccine safety surveillance data in the vaccine safety datalink. Vaccine. 2022 May 11; 40(22):3064-3071. Epub 2022 Apr 8.
The Vaccine Safety Datalink (VSD) is one of several systems that CDC uses to monitor vaccine safety. The VSD is a network of nine integrated health systems that uses electronic health records to conduct near-real time surveillance. Since the start of the COVID-19 vaccination program, the VSD has conducted weekly safety surveillance of COVID-19 vaccines. In February 2021, VSD investigators developed a new VSD COVID-19 Vaccine Dashboard to help quickly analyze and disseminate safety findings. This report describes how the dashboard provides safety experts with access to over 1,000 statistical analyses conducted weekly, with interactive features to filter and visualize the data. Dashboard visualizations of safety data have been used during Advisory Committee on Immunization Practices meetings to inform the public on COVID-19 vaccine safety and assist with policy makers’ decision making.
Hanson KE, Goddard K, Lewis N, Fireman B, Myers TR, Bakshi N, Weintraub E, Donahue JG, Nelson JC, Xu S, Glanz JM, Williams JTB, Alpern JD, Klein NP. Incidence of Guillain-Barré Syndrome After COVID-19 Vaccination in the Vaccine Safety Datalink. JAMA Netw Open. 2022 Apr 26; 5(4):e228879. doi: 10.1001/jamanetworkopen.2022.8879.
Guillain-Barré syndrome (GBS) is a rare neurological disorder where the body’s immune system damages the nerves. Most people fully recover from GBS, but some can have permanent nerve damage. In July 2021, data from the Vaccine Adverse Event Reporting System (VAERS) indicated that the GBS reporting rate was higher after Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 vaccination than after mRNA (Pfizer-BioNTech and Moderna) COVID-19 vaccinations. To investigate this further, researchers used data from the Vaccine Safety Datalink and analyzed the rate of GBS following COVID-19 vaccination. During the analytic period of December 13, 2020, through November 13, 2021, over 14.7 million doses of COVID-19 vaccines were administered. Of those, J&J/Janssen accounted for 467,126 doses and researchers confirmed 11 cases of GBS following vaccination. More than 14.2 million doses of mRNA vaccines were administered and 34 confirmed GBS cases following vaccination. In the head-to-head comparison, researchers found those who received J&J/Janssen vaccine were diagnosed with confirmed GBS at a rate 20x higher than recipients of the mRNA vaccine in the 21 days following vaccination. This analysis is consistent with the VAERS data and COVID-19 vaccine safety surveillance is ongoing.
Razzaghi H, Meghani M, Crane B, Ellington S, Naleway AL, Irving SA, Patel SA. Receipt of COVID-19 Booster Dose Among Fully Vaccinated Pregnant Individuals Aged 18 to 49 Years by Key Demographics. JAMA. 2022 Apr 22;327(23):2351-2354. doi:10.1001/jama.2022.6834.
Zerbo O, Modaressi S, Goddard K, Lewis E, Fireman B, Daley MF, Irving SA, Jackson LA, Donahue JG, Qian L, Getahun D, DeStefano F, McNeil MM, Klein NP. Safety of measles and pertussis-containing vaccines in children with autism spectrum disorders. Vaccine. 2022 Apr 20; 40(18):2568-2573. Epub 2022 Mar 18.
Sokolow AG, Stallings AP, Kercsmar C, Harrington T, Jimenez-Truque N, Zhu Y, Sokolow K, Moody MA, Schlaudecker EP, Walter EB, Allen Staat M, Broder KR, Creech CB. Safety of Live Attenuated Influenza Vaccine in Children With Asthma. Pediatrics. 2022 Apr 1; 149(4):e2021055432.
Moro PL, McNeil MM. Successes of the CDC monitoring systems in evaluating post-authorization safety of COVID-19 vaccines [Editorial]. Expert Rev Vaccines. 2022 Mar;21(3):281-284. Epub 2022 Jan 5.
Irving SA, Groom HC, Dandamudi P, Daley MF, Donahue JG, Gee J, Hechter R, Jackson LA, Klein NP, Liles E, Myers TR, Stokley S. A decade of data: Adolescent vaccination in the vaccine safety datalink, 2007 through 2016. Vaccine. 2022 Feb 23; 40(9):1246-1252. Epub 2022 Feb 4.
Navarro RA, Lin CC, Colli B, Qian L, Liu ILA, Sy LS, Jacobsen SJ, Tartof SY. Safety of Influenza Vaccination During Orthopaedic Surgery Hospitalizations. J Am Acad Orthop Surg. 2022 Jan 15; 30(2):e155-e1.
Lipkind HS, Vazquez-Benitez G, DeSilva M, Vesco KK, Ackerman-Banks C, Zhu J, Boyce TG, Daley MF, Fuller CC, Getahun D, Irving SA, Jackson LA, Williams JTB, Zerbo O, McNeil MM, Olson CK, Weintraub E, Kharbanda KO. Receipt of COVID-19 Vaccine During Pregnancy and Preterm or Small-for-Gestational-Age at Birth — Eight Integrated Health Care Oragnizations, United States, December 15, 2020-July 22, 2021. MMWR Morb Mort Wkly Rep. 2022 Jan 4:71 Early release
Evidence has shown that pregnant people are at higher risk for severe illness from COVID-19 infection. Additionally, COVID-19 infection can cause serious problems during pregnancy such as preterm birth and stillbirth. Due to the increased risk of severe illness that the virus poses for pregnant people, CDC strongly recommends COVID-19 vaccination for people who are pregnant, breastfeeding, trying to conceive, or who may become pregnant in the future. In this report, researchers with the Vaccine Safety Datalink specifically looked at reports of preterm birth (delivering before 37 weeks) and delivering an infant small for its gestational age (SGA) among both vaccinated and unvaccinated people ages 16 to 49 years. Among the more than 40,000 pregnancies included in the study, people who received a COVID-19 vaccine during pregnancy were not at greater risk for having a baby born preterm or SGA compared with those who did not receive a vaccine. The data also showed no association with trimester of vaccination or number of COVID-19 vaccine doses received. These data add to the existing evidence supporting the safety of COVID-19 vaccination in pregnancy and reinforce CDC’s recommendation to get vaccinated as soon as possible.
DeSilva MB, Haapal J, Vazquez-Benitez G, Daley MF, Nordin JD, Klein NP, Henninger ML, Williams JTB, Hambidge SJ, Jackson ML, Donahue JG, Qian L, Lindley MC, Gee J, Weintraub ES, Kharbanda EO. Association of the COVID-19 Pandemic with Routine Childhood Vaccination Rates and Proportion Up to Date with Vaccinations Across 8 US Health Systems in the Vaccine Safety Datalink. JAMA Pediatr. 2022 Jan 1;176(1):68-77. Doi: 10.1001/jamapediatrics.2021.4251
To better understand how the COVID-19 pandemic has affected routine vaccination in children, researchers compared the number of children who were up to date (UTD) on vaccinations before the pandemic with children who were UTD during the pandemic. Researchers collected data from eight healthcare systems in the Vaccine Safety Datalink (VSD) in 2019 and 2020. They evaluated the vaccination status of children who reached ages 7 months, 18 months, 6 years, 13 years and 18 years in 2019 and in 2020. In September 2020, 74% of infants turning 7 months and 57% of infants turning 18 months of age were UTD, compared to 81% and 61% of the same age groups in September 2019. Researchers also found that, across most age groups in this study during all time periods, Black children had the lowest rate of being UTD on vaccinations. Although this disparity existed before the COVID-19 pandemic, this study suggests that it became more pronounced during the pandemic. Based on this research, CDC recommends intervention efforts to promote catch-up vaccination among children, particularly children who are at greater risk for low immunization.
Hanson KE, Goddard K, Lewis N, Fireman B, Myers TR, Bakshi N, Weintraub E, Donahue JG, Nelson JC, Xu S, Glanz JM, Williams JTB, Alpern JD, Klein NP. Guillain-Barré Syndrome after COVID-19 Vaccination in the Vaccine Safety Datalink medRxiv – the preprint server for health sciences 2021 Dec 5 http://doi.org/10.1101.2021.12.03.21266419.
Glanz JM, Clarke CL, Daley MF, Shoup JA, Hambidge SJ, Williams JTB, Groom HC, Kharbanda EO, Klein NP, Jackson LA, Lewin BJ, McClure DL, Xu S, DeStefano F. The Childhood Vaccination Schedule and the Lack of Association with Type 1 Diabetes. Pediatrics. 2021 Dec 1;148(6):e2021051910. Doi: 10.1542/peds.2021-051910 Online ahead of print.
Goud R, Lufkin B, Duffy J, Whitaker B, Wong HL, Liao J, Lo AC, Weintraub E, Kelman JA, Forshee RA. Risk of Guillain-Barré Syndrome Following Recombinant Zoster Vaccine in Medicare Beneficiaries. JAMA Intern Med. 2021 Dec 1;181(12):1623-1630. Doi: 10.1001/jamainternmed.2021.6227. Online ahead of print.
Moro PL, Panagiotakopoulos L, Oduyebo T, Olson CK, Myers T. Monitoring the safety of COVID-19 vaccines in pregnancy in the US. Human Vaccines & Immunotherapies. 2021 Nov 10. doi.org/10.1080/21645515.2021.1984132.
Xu S, Huang R, Sy LS, Glenn SC, Ryan DS, Morrissette K, Shay DS, Vazquez-Benitez G, Glanz JM, Klein NP, McClure D, Liles EG, Weintraub ES, Tseng HF, Qian L. COVID-19 Vaccination and Non-COVID-19 Mortality Risk — Seven Integrated Health Care Organizations, United States, December 14, 2020-July 31, 2021 MMWR Morb Mortal Wkly Rep. epub 2021 Oct 22.
Since COVID-19 vaccinations have become available in December 2020, an estimated 182 million people in the United States were fully vaccinated against COVID-19 by September 21, 2021. However, since April 2021, the number of people starting to get COVID-19 vaccines has decreased. People have cited vaccine safety concerns as deterrents to getting a COVID-19 vaccine, concerns that include deaths following COVID-19 vaccination. Although deaths after COVID-19 vaccination have been reported to VAERS, there have been few studies done to evaluate the mortality not associated with COVID-19 among vaccinated and unvaccinated groups. To analyze this, researchers conducted a study using the Vaccine Safety Datalink, comparing those who received COVID-19 vaccines and those who did not between December 2020 through July 2021. This study included data from 11 million people; 6.4 million received either Pfizer-BioNTech, Moderna or Janssen COVID-19 vaccine and 4.6 were unvaccinated. The analysis showed that those who received COVID-19 vaccinations had lower rates of mortality for non-COVID-19 causes than those unvaccinated. These findings provide evidence that COVID-19 vaccines are safe and support current vaccination recommendations.
Abara WE, Gee J, Mu Y, Deloray M, Ye T, Shay DK, Shimabukuro T. Expected Rates of Select Adverse Events Following Immunization for COVID-19 Vaccine Safety Monitoring. medRxiv – the preprint server for health sciences 2021 Sept 5 https://doi.org/10.1101/2021.08.31.21262919
Kharbanda EO, Haapala J, DeSilva M, Vazquez-Benitez G, Vesco KK, Naleway AL, Lipkind HS. Spontaneous Abortion Following COVID-19 Vaccination During Pregnancy JAMA. 2021 Sep 8. Doi:10.1001/jama.2021.15494
Although pregnant people are at increased risk for severe illness from COVID-19, the COVID-19 vaccination rate among pregnant people has been much lower than that of the general U.S. population. Data about vaccination during pregnancy was initially limited because pregnant participants were excluded from vaccine clinical trials. Researchers within the Vaccine Safety Datalink, a collaboration between CDC and 9 health systems, representing approximately 3% of the U.S. population, analyzed data from 8 health systems from December 15, 2020 through June 28, 2021 to evaluate whether there’s an association between COVID-19 vaccine and miscarriage (pregnancy loss that occurs before 20 weeks of pregnancy). This analysis included over 105,000 pregnancies. About 14% received one or more doses of one of the 3 available COVID-19 vaccines during pregnancy before 20 weeks’ gestational age. The analysis found that people who were currently pregnant at the time of COVID-19 vaccination and those who became pregnant after vaccination did not have an increased risk of miscarriage. Research will continue on the safety of COVID-19 vaccines in pregnant people.
Klein NP, Lewis N, Goddard K, Fireman B, Zerbo Q, Hanson KE, Donahue JG, Kharbanda EO, Naleway A, Clark Nelson J, Xu S, Yih WK, Glanz JM, Williams JTB, Hambridge SJ, Lewin BJ, Shimabukuro TT, DeStefano F, Weintraub ES. Surveillance for Adverse Events After COVID-19 mRNA Vaccination JAMA 2021 Sept 3. Doi:10.1001/jama.2021.15072.
The Vaccine Safety Datalink (VSD) has conducted weekly near real-time monitoring, or Rapid Cycle Analysis (RCA), of Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines since those vaccines received emergency use authorization from the Food and Drug Administration in December 2020. Between December 14, 2020 through June 25, 2021, over 11.8 million doses of mRNA were administered to 6.2 million people in the VSD network; 57% received Pfizer-BioNTech and 43% received Moderna. During that time period, VSD monitored 23 pre-specified health outcomes, including myocarditis/pericarditis and anaphylaxis. Researchers identified 34 cases of myocarditis/pericarditis in people ages 12 to 39 years; a majority (85%) were males. Among this age group, there is an increased risk of 6.3 additional myocarditis cases per million mRNA vaccinations administered in the first week following vaccination. The rate of anaphylaxis following vaccination was 4.8 cases per million doses of Pfizer-BioNTech and 5.1 per million doses of Moderna vaccination. VSD monitoring did not detect safety signals for any other pre-specified outcomes. Additional research is ongoing. Getting vaccinated remains the best way to protect against COVID-19 infection.
Pingali C, Meghani M, Razzaghi H, , Lamias MJ, Weintraub E, Kenigsberg TA, Klein NP, Lewis N, Fireman B, Zerbo O, Bartlett J, Goddard K, Donahue J, Hanson K, Naleway A, Kharbanda EO, Yih K, Clark Nelson J, Lewin BJ, Williams JTB, Glanz JM, Singletom JA, Patel SA. COVID-19 Vaccination Coverage Among Insured Persons Aged ≥ 16 years, by Race/Ethnicity and Other Selected Characteristics — Eight Integrated Health Care Organizations, United States, December 14, 2020-May 15, 2021. MMWR Morb Mortal Wkly Rep. 2021 Jul 16;70(28):985-990.
Data has shown that non-Hispanic Black and Hispanic people have experienced higher COVID-19–associated deaths and serious outcomes; however, COVID-19 vaccination coverage has been lower in these groups. To look into these disparities further, researchers from CDC analyzed data collected from the Vaccine Safety Datalink (VSD) from December 14, 2020, through May 15, 2021. During that time, over 9.6 million people ages 16 years and older were enrolled in the VSD; 48.3% of the population had received at least one vaccine dose and 38.3% were considered fully vaccinated. In non-Hispanic Black and Hispanic populations, only 40.7% and 41.1% had received at least one COVID-19 vaccine dose, respectively. By comparison, non-Hispanic White people and non-Hispanic Asian people had higher coverage rates (54.6% and 57.4%, respectively). CDC will continue its ongoing efforts to improve vaccination coverage in all populations, especially among populations that are most greatly affected by COVID-19.
Razzaghi H, Meghani M, Pingali C, Crane B, Naleway A, Weintraub E, Kenigsberg TA, Lamias MJ, Irving SA, Kauffman TL, Vesco KK, Daley MF, DeSilva M, Donahue J, Getahun D, Glee S, Hambidge SJ, Jackson LJ, Lipkind HS, Nelson J, Zerbo O, Oduyebo T, Singleton JA, Patel SA. COVID-19 Vaccination Coverage Among Pregnant Women During Pregnancy — Eight Integrated Health Care Organizations, United States, December 14, 2020-May 8, 2021. MMWR Morb Mortal Wkly Rep. 2021 Jun 18;70(24):895-899.
Pregnant people are at increased risk for severe illness and death from COVID-19; however, current data about vaccination coverage and safety in pregnant people are limited. Researchers reviewed safety data collected from the Vaccine Safety Datalink (VSD) on COVID-19 vaccination among pregnant people. From December 14, 2020 to May 8, 2021, 135,968 pregnant people were identified in the VSD network. Of those, only 16.3% received at least one dose of a COVID-19 vaccine. Researchers identified Hispanic (11.9%) and non-Hispanic Black women (6%) ages 18 to 24 years old as among the groups of pregnant people with the lowest vaccination rate. Non-Hispanic Asian women were the group with the highest vaccination rate (24.7%). Overall, pregnant women ages 35 to 49 years had a high vaccination rate (22.7%). CDC recommends COVID-19 vaccination for anyone who is pregnant or considering becoming pregnant to prevent serious outcomes from COVID-19 illness. Additional outreach, especially for younger pregnant individuals and those from racial and ethnic minority groups, could increase vaccine confidence and COVID-19 vaccination in these populations.
Salmon DA, Lamber PH, Nohynek HM, Gee J, Parashar UD, Tate JE, Wilder-Smith A, Hartigan-Go KY, Smith PG, Zuber PLF. Novel vaccine safety issues and areas that would benefit from further research BMJ Glob Health. 2021 May;6(Suppl 2):e003814. Epub ahead of print.
Vaccines are held to very high safety standards. After licensure, vaccines are continually monitored to ensure the benefits outweigh the risks. Any potential safety issues that arise are quickly identified and investigated. Researchers conducted a literature review of 5 vaccine safety case studies to develop lessons learned on addressing potential safety issues. The case reviews included: 1) dengue vaccine and enhanced dengue disease, 2) pandemic influenza vaccine and narcolepsy, 3) rotavirus vaccine and intussusception, 4) human papillomavirus (HPV) vaccine and postural orthostatic syndrome and complex regional pain syndrome, and 5) RTS,S/AS01 malaria vaccine and serious adverse events. Overall, these reviews show that vaccine safety science should be proactive and timely, and information should be transparent. It is advisable for vaccine safety science to inform the public’s view, rather than try to change the views that have already been formed.
Panagiotakopoulos L, McCarthy NL, Tepper NK, Kharbanda NK, Lipkind HS, Vazquez-Benitez G, McClure DL, Greenberg V, Getahun D, Glanz JM, Naleway AL, Klein NP, Nelson JC, Weintraub ES. Evaluating the Association of Stillbirths After Maternal Vaccination in the Vaccine Safety Datalink. Obstet Gynecol. 2020 Dec;136(6):1086-1094.
The Advisory Committee on Immunization Practices recommends women receive vaccinations against flu and tetanus, diphtheria, and acellular pertussis (Tdap) during each pregnancy. Despite reassuring safety data, pregnant women often have concerns about the safety of vaccines for them and their babies. Researchers used the Vaccine Safety Datalink to evaluate whether vaccinations given during pregnancy were associated with stillbirth (fetal death occurring on or after 20 weeks gestation). The study compared 795 stillbirths (confirmed with medical record review) and 3,180 live birth controls between September 30, 2015 and January 1, 2020. Researchers found 51.7% of stillbirth cases and 52.9% live birth controls were exposed to vaccines during pregnancy, including flu and Tdap vaccines. The findings show that vaccination during pregnancy did not increase the risk of stillbirth, including recommended, non-recommended, and contraindicated vaccines. Overall, the study results support the safety of ACIP recommendations during pregnancy.
Kharbanda EO, Vazquez-Benitez G, DeSilva MB, Spaulding AB, Daley MF, Naleway AL, Irving SA, Klein NP, Tseng HF, Jackson LA, Hambridge SJ, Olaiya O, Panozzo CA, Myers TR, Romitti PA. Developing Algorithms for Identifying Major Structural Birth Defects Using Automated Electronic Health Data. Pharmacoepidemiol Drug Saf. 2021 Feb;30(2):266-274. Epub 2020 Dec 3.
Vaccine Safety Datalink (VSD) researchers often rely on electronic health records when conducting observational studies. To improve case identification, researchers use algorithms to accurately identify diagnoses for particular conditions or diseases. Algorithms used in previous studies for selected birth defects were based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes. In October 2015, the United States transitioned to the 10th edition (ICD-10-CM). In this study, researchers updated, validated, and refined algorithms for use with ICD-10-CM codes. Final algorithms were applied to a group of live births delivered between Oct. 2015 through Sept. 2017 at 8 VSD sites and were compared to the original ICD-9-CM algorithms applied to a group of live births in 2004-2013. Results demonstrated that the new ICD-10-CM algorithms can be used for future studies of maternal vaccine safety.
Perez-Vilar S, Hu M, Weintraub E, Arya D, Lufkin B, Myers T, Woo EJ, Lo A, Chu S, Swarr M, Liao J, Wernecke M, MaCurdy T, Kelman J, Anderson S, Duffy J, Forshee RA. Guillain-Barré Syndrome After High-Dose Influenza Vaccine Administration in the United States, 2018–2019 Season J Infect Dis. 2020 Nov 2; jiaa543. Online ahead of print
While an association between influenza vaccination and Guillain-Barré syndrome (GBS) was first noticed in 1976, studies in subsequent flu seasons have assessed the risk and found either no or small risk of GBS following influenza vaccination. Early during the 2018-2019 flu season, the Vaccine Safety Datalink (VSD) identified a statistical signal for an increased risk of GBS in days 1–42 following high-dose influenza vaccine (IIV3-HD) administration. The signal was rapidly evaluated using Medicare data by conducting early- and end-of-season analyses. The Medicare analyses, which included more than 7 million IIV3-HD vaccinations, did not detect a statistically significant increased GBS risk. The VSD end-of-season analysis also did not find an increased GBS risk among more than 600,000 IIV3-HD vaccinations. These analyses determined that if a GBS risk existed, it was similar to that from prior seasons.
Panagiotakopoulos L, Myers TR, Gee J, Lipkind HS, Kharbanda EO, Ryan DO, Williams, JTB, Naleway AL, Klein NP, Hambridge SJ, Jacobsen SJ, Glanz JM, Jackson LA, Shimabukuro TT, Weintraub ES. SARS-CoV-2 Infection Among Hospitalized Pregnant Women: Reasons for Admission and Pregnancy Characteristics – Eight U.S. Health Care Centers, March 1-May 30, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1355-1359. 2020 Sept 25.
As part of CDC surveillance of COVID-19 hospitalizations, Vaccine Safety Datalink researchers identified 105 pregnant women with SARS-CoV-2 infection from March 1 – May 30, 2020. Of those, 43 (41%) were admitted for COVID-19 illness (e.g., worsening respiratory status) and 62 (59%) were admitted for pregnancy-related treatment or procedures (e.g, delivery) and identified with SARS-CoV-2 infection. More pregnant women with prepregnancy obesity and gestational diabetes were hospitalized for the treatment of COVID-19 illness than pregnant women admitted for pregnancy-related reasons. Intensive care was required in 30% (13/43) of pregnant women admitted for COVID-19 illness, and one pregnant woman died from COVID-19. Adverse birth outcomes, such as preterm delivery and stillbirth, were more common among pregnant women with SARS-CoV-2 infection, regardless of symptoms. Pregnant women should take preventive measures to protect themselves against SARS-CoV-2 infection.
Wang SV, Stefanini K, Lewis E, Newcomer SR, Fireman B, Daley MF, Glanz JM, Duffy J, Weintraub E, Kulldorf M. Determining Which of Several Simultaneously Administered Vaccines Increase Risk of an Adverse Event Drug Saf. 2020 Oct;43(10):1057-1065. Epub 2020 Jul 1
The CDC childhood immunization schedule recommends all children get vaccinated. Children may get multiple vaccinations on the same day. If a child has an adverse event after getting multiple vaccinations, it would be difficult to determine which vaccine, if any, caused the event. Using observed data from two Vaccine Safety Datalink sites, researchers developed a systematic process to determine which of the simultaneously administered vaccine(s) are most likely to have caused an observed increase in risk of an adverse event. From the five scenarios simulated, the process determined which of the vaccines contributed to the simulated excess risk. This process could be used again in the future to provide valuable information on the potential risk of adverse events following individual and simultaneous vaccinations.
Hesse EM, Navarro RA, Daley MF, Getahun D, Henninger ML, Jackson LA, Nordin J, Olson SC, Zerbo O, Zheng C, Duffy J. Risk for Subdeltoid Bursitis After Influenza Vaccination: A Population-Based Cohort Study Ann Intern Med. 2020 Aug 18;173(4):253-261. Epub 2020 Jun 23.
Subdeltoid bursitis, characterized by pain or loss of motion in the shoulder, has been reported as an adverse event following intramuscular vaccination in the upper arm, and most case reports involved the influenza vaccine. With over 160 million U.S. doses distributed annually and recommended to everyone over 6 months of age, researchers wanted to estimate the risk of subdeltoid bursitis following influenza vaccination. In this cohort study using data from 7 Vaccine Safety Datalink sites, researchers included people who received an inactivated influenza vaccine during the 2016–2017 flu season, totaling 2.9 million people. The analysis to calculate risk of bursitis compared cases that appeared 3 days following vaccination to a control period 30-60 days following vaccination. There were an estimated 7.78 (95% CI 2.19-13.38) additional cases of bursitis per one million people vaccinated. While an increased risk of bursitis following vaccination was present, the overall risk was small.
Hause AM, Panagiotakopoulos L, Weintraub E, Sy LS, Glenn SC, Tseng HF, McNeil MM. Adverse Outcomes in Pregnant Women Hospitalized with Respiratory Syncytial Virus Infection: A Case-Series Clin Infect Dis. 2020 Jun 2; ciaa668. Online ahead of print.
Respiratory syncytial virus (RSV) is a common respiratory virus that usually causes mild, cold-like symptoms and can be serious for infants and older adults. RSV infection in pregnant women has not been well described and can be clinically severe and result in hospitalization. CDC has emphasized the need to characterize RSV infection during pregnancy, including burden of the illness, risk factors for severe disease, and pregnancy and neonatal outcomes. In this study, researchers identified 25 pregnant women at Kaiser Permanente Southern California who tested positive for RSV. Ten of those women (40%) were hospitalized: five were diagnosed with pneumonia/atelectasis, two with respiratory failure (one requiring mechanical ventilation), and two with sepsis. Six women had a pregnancy complication during hospitalization, including one induced preterm birth. The information from this study may inform the benefits of maternal vaccination for an RSV vaccine intended to protect infants.
Glanz JM, Clarke CL, Xu S, Daley MF, Shoup JA, Schroeder EB, Lewin BL, McClure DL, Kharbanda E, Klein NP, DeStefano F. Association between Rotavirus Vaccine and Type 1 Diabetes in Children. JAMA Pediatr. 2020 May 1;174(5):455-462. Epub 2020 Mar 9.
Type 1 diabetes mellitus (T1DM) is an autoimmune disease that tends to occur in genetically susceptible individuals and is primarily diagnosed during childhood. Previous research suggests that a live attenuated rotavirus vaccine could either increase or decrease the risk of T1DM in early childhood. Researchers conducted a study of children enrolled in 7 integrated healthcare organizations in the Vaccine Safety Datalink. There were 386,937 children enrolled born between 2006 and 2014. During their infancy, 360,169 children were exposed to the full series of rotavirus vaccination, 15,765 partially exposed and 11,003 unexposed. By the end of 2017, 464 children had developed T1DM. The incidence of T1DM was not significantly different across the vaccination groups, indicating that rotavirus vaccination is not associated with T1DM in children.
Newcomer SR, Daley MF, Marwaney KJ, Xu S, DeStefano F, Groom HC, Jackson ML, Lewin BJ, McLean HQ, Nordin JD, Zerbo O, Glanz JM. Order of Live and Inactivated Vaccines and Risk of Non-vaccine-targeted Infections in US Children 11-23 Months of Age. Pediatr Infect Dis J., 2020 Mar:39(3);247-253.
Children in the United States receive up to 28 vaccine doses against 14 diseases before their 2nd birthday and 3 are live vaccines. Some observational studies suggest that receiving live vaccines may be associated with decreased non-vaccine targeted infection (NVTI) risk. Researchers conducted a retrospective study within the Vaccine Safety Datalink to estimate the risk of NVTIs based on most recent vaccine type received in children 11-23 months of age. Electronic health records and immunization data were reviewed from children born between 2003-2013. Among 428,608 children, 4.9% had more than 1 immunization visit with live vaccines only and 10.3% had a NVTI. Researchers observed modest associations between live vaccine receipt and a decreased risk of NVTIs, which may have been influenced by multiple factors, including healthcare-seeking behavior. In total, the results support the current sequence of live and inactivated vaccines in the U.S. vaccine schedule with respect to NVTI.
Li R, Stewart B, Rose C. A Bayesian approach to sequential analysis in post-licensure vaccine safety surveillance. Pharm Stat. 2020 May;19(3):291-302 Epub 2019 Dec 22.
Bayesian statistics is an approach for learning from evidence as it accumulates. While this analytic method is used in other areas of public health with acknowledged practical benefits, its potential application in vaccine safety monitoring analysis has not been fully realized. In this study, researchers compare the use of a traditional (frequentist) sequential method and a Bayesian method, with simulations and a real-world vaccine safety example. The performance was evaluated using 3 metrics: false positive rate, false negative rate, and average earliest detection time. The authors found that depending on the background rate of adverse events, the Bayesian sequential method could significantly improve performance in terms of the false negative rate and decrease the earliest time to producing a safety signal for further analysis. Overall, the Bayesian sequential approach was found to show promise as an alternative for vaccine safety monitoring.
Yu W, Zheng C, Xie F, Chen W, Mercado C, Sy LS, Qian L, Glenn S, Tseng HF, Lee G, Duffy J, McNeil MM, Daley MF, Crane B, McLean HQ, Jackson LA, Jacobsen SJ. The use of natural language processing to identify vaccine-related anaphylaxis at five health care systems in the Vaccine Safety Datalink. Pharmacoepidemiolo Drug Saf. 2020 Feb;29(2): 182-188 Epub 2019 Dec 3.
Anaphylaxis is a rare but serious allergic reaction that can be caused by various triggers, including vaccine components. Natural language processing (NLP) uses computers to analyze large amounts of text. Vaccine Safety Datalink (VSD) researchers developed an NLP application to identify vaccine-related anaphylaxis cases from electronic medical record notes and implemented the method at 5 VSD sites. The NLP system was trained on a dataset of 311 potential anaphylaxis cases and validated on another 731 potential cases. NLP was then applied to the notes of 6.4 million vaccinated patients, and it captured 8 additional true cases confirmed by manual chart review. This study demonstrated the potential to apply NLP to clinical notes to identify anaphylaxis cases and its use to improve sensitivity and efficiency in future vaccine safety studies.
Hesse EM, Stanasoff S, Hibbs BF, Adegoke OJ, Ng C, Marquez P, Osborn M, Su JR, Moro PL, Shimbukuro T, Nai N. Shoulder Injury Related to Vaccine Administration (SIRVA): Petitioner Claims to the National Vaccine Injury Compensation Program, 2010-2016. Vaccine. 2020 Jan 29;38(5): 1076-1083. Epub 2019 Nov 22.
Petitioner claims for shoulder injury related to vaccine administration (SIRVA) to the National Vaccine Injury Compensation Program (VICP) increased substantially from 2010 to 2016. The Health Resources and Services Administration and the Centers for Disease Control and Prevention initiated a joint scientific review of clinical characteristics of SIRVA petitions to VICP. Researchers queried VICP’s Injury Compensation System database for alleged SIRVA and SIRVA-like injuries and conducted a descriptive analysis of claims recommended by VICP for concession as SIRVA injuries; 476 claims were identified and 400 of them involved influenza vaccine. Of the 476 claims, 227 reported a suspected administration error; 172 reported ‘injection too high’ on the arm. Injection too high on the arm could be a factor due to the risk of injecting into underlying non-muscular tissues. Healthcare providers should be aware of proper injection technique and anatomical landmarks when administering vaccines.
Donahue JG, Kieke BA, Lewis EM, Weintraub ES, Hanson KE, McClure DL, Vickers ER, Gee J, Daley MF, Destefano F, Hechter RC, Jackson LA, Klein NP, Naleway AL, Nelson JC, Belongia EA. Near Real-Time Surveillance to Assess the Safety of the 9-valent Human Papillomavirus Vaccine. Pediatrics. 2019 Dec; 144(6): e20191808. Epub 2019 Nov 18.
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant; 9vHPV) was approved in 2014 for females and males to protect against 9 types of human papillomavirus infections that can cause cancer. CDC’s Vaccine Safety Datalink (VSD) conducted near real-time post-licensure safety monitoring following 9vHPV for 11 pre-specified adverse events (AEs), including anaphylaxis, allergic reaction, appendicitis, certain neurological disorders, pancreatitis, and stroke. From October 2015 to October 2017, 838,991 9vHPV doses were administered to people aged 9-26 years at 6 VSD sites. Statistical signals were detected for 2 expected AEs: injection site reactions and syncope. Signals were also detected for appendicitis, pancreatitis, and allergic reaction; however, evaluation and medical record reviews did not confirm these to be true associations. Overall, no new safety concerns were identified. The results are consistent with pre-licensure clinical trial data and support the favorable safety profile of 9vHPV.
Groom HC, Smith N, Irving SA, Koppolu P, Vazquez-Benitez G, Kharbanda EO, Daley MF, Donahue JG, Getahun D, Jackson LA, Klein NP, McCarthy NL, Nordin JD, Panagiotakopoulos L, Naleway AL. Uptake and safety of hepatitis A vaccination during pregnancy: A Vaccine Safety Datalink study. Vaccine. 2019 Oct 16;37(44):6648-6655. Epub 2019 Sep 20.
Although uncommon, infection with hepatitis A virus during pregnancy is associated with gestational complications and pre-term labor. CDC recommends that pregnant women who are at an increased risk of contracting hepatitis A get the Hepatitis A vaccine (HepA). Current safety data, however, are limited on maternal HepA vaccination. Researchers used the Vaccine Safety Datalink to compare pregnancies with HepA exposure to other vaccine exposures, and those with no exposure, from 2004-2015. Of nearly 667,000 pregnancies, 1,140 had HepA exposure. The rate of maternal HepA vaccination was low, and rarely due to documented risk factors. The results did not show an increased risk of adverse events for HepA vaccination during pregnancy. There was an identified association of maternal HepA exposure and small-for-gestational age (SGA) infants, however, the difference in rates were small (4%), and likely due to other factors. Further research may be needed to further explore this association.
Donahue JG, Kieke BA, King JP, Mascola MA, Shimabukuro TT, DeStefano F, Hanson KE, McClure DL, Olaiya O, Glanz JM, Hechter RC, Irving SA, Jackson LA, Klein NP, Naleway AL, Weintraub ES, Belongia EA. Inactivated influenza vaccine and spontaneous abortion in the Vaccine Safety Datalink in 2012-13, 2013-14, and 2014-15. Vaccine. 2019 Oct 16;37(44):6673-6681. Epub 2019 Sep 17.
A prior study in the Vaccine Safety Datalink (VSD) covering the two influenza seasons from 2010-2012 reported an association between inactivated influenza vaccine (IIV) and spontaneous abortion (SAB), but only among women who had also been vaccinated in the previous influenza season. In follow-up, VSD researchers conducted a larger case-control study over three more recent influenza seasons (2012-2015). Women with SAB were matched with women who had live births according to VSD site, influenza vaccination status in the previous influenza season, and other factors. The main analysis included 1,236 women. During the three influenza seasons, researchers found no association between IIV and SAB, including among women vaccinated in the previous season. These findings lend support to current recommendations for influenza vaccination at any time during pregnancy, including the first trimester.
Weinmann S, Naleway AL, Koppolu P, Baxter R, Belongia EA, Hambidge SJ, Irving SA, Jackson ML, Lewin B, Liles E, Marin M, Smith N, Weintraub E, Chun C. Incidence of Herpes Zoster Among Children: 2003-2014. Pediatrics. 2019 Jul; 144(1). Pii: e20182917. Epub 2019 Jun 10.
After the 1996 introduction of routine varicella (chickenpox) vaccination in the U.S., most studies evaluating the incidence of pediatric herpes zoster (HZ), also known as shingles, reported lower incidence over time, with varying degrees of decline. Researchers used data from 6 integrated health care organizations surveyed by the Vaccine Safety Datalink to examine HZ incidence rate in children from 2003-2014. Using electronic medical records from children aged 0 to 17 years, researchers identified HZ cases and calculated HZ incidence rates for all children and children who were vaccinated versus unvaccinated. Researchers then calculated rates for the 12-year period, examined temporal trends, and compared HZ rates by month and year of age at vaccination. This population-based study confirms the decline in pediatric HZ incidence and the significantly lower incidence among children who are vaccinated, and reinforces the benefit of routine varicella vaccination to prevent pediatric HZ.
Zheng C, Yu W, Xie F, Chen W, Mercado C, Sy LS, Qian L, Glenn S, Lee G, Tseng HF, Duffy J, Jackson LA, Daley MF, Crane B, McLean HQ, Jacobsen SJ. The use of natural language processing to identify Tdap-related local reactions at five health care systems in the Vaccine Safety Datalink, International Journal of Medical Informatics, 2019 Jul; 127(1386-5056): 27-34. Epub 2018 Jun 3.
The Vaccine Safety Datalink (VSD) plays a critical role in monitoring adverse events after vaccinations by using the electronic health records. Most studies performed in the VSD rely on diagnosis codes and manual chart review for outcome identification and confirmation. A natural language processing (NLP) system was developed, then deployed and executed at multiple institutions. The system achieved reasonable accuracy in identifying a specific vaccine-related adverse event. This study demonstrates the feasibility of using NLP to reduce the potential burden of conducting manual chart review in future vaccine safety studies. “False negatives” of diagnosis codes are not commonly investigated in vaccine safety studies. NLP can identify cases missed by diagnosis codes. NLP has many potential applications in future vaccine safety studies based on the considerations of the pros and cons of NLP and the specific requirements of the study.
Hanson KE, McLean HQ, Belongia EA, Stokley S, McNeil MM, Gee J, VanWormer JJ. Sociodemographic and clinical correlates of human papillomavirus vaccine attitudes and receipt among Wisconsin adolescents. Papillomavirus Res. 2019 Dec;8:100168. Epub 2019 May 25.
Few studies have assessed adolescent human papillomavirus (HPV) vaccine attitudes and whether they are associated with vaccination uptake. The Vaccine Safety Datalink conducted an HPV vaccine study in an integrated healthcare system to identify factors associated with adolescents’ attitude changes and their link to vaccine receipt. Adolescents who had not completed the HPV vaccine series were surveyed using a modified version of the Carolina HPV Immunization Attitudes and Beliefs Scale before and during a campaign to improve HPV vaccination rates. Adolescents’ attitudes to HPV slightly improved during the period of the campaign. However, attitude changes were not associated with receipt of HPV vaccines and adolescents identified as opposed to HPV vaccine before the campaign began were less likely to receive a HPV vaccine dose afterwards. More research is needed to learn how HPV vaccine attitudes form in parents and children, and how best to address concerns about vaccine harms.
Hechter RC, Qian L, Tartof SY, Sy LS, Klein NP, Weintraub E, Mercado C, Naleway A, McLean HQ, Jacobsen SJ. Vaccine safety in HIV-infected adults within the Vaccine Safety Datalink Project. Vaccine. 2019 May 31; 37(25): 3296-3302. Epub 2019 May 4.
Despite the increased risk of vaccine-preventable infectious diseases in adults with HIV, vaccine coverage among this risk group remains low; safety concerns around side effects or impact on HIV disease may be a factor. Using data from 5 U.S. integrated healthcare sites in the Vaccine Safety Datalink, researchers evaluated the safety of recommended vaccinations among HIV-infected adults. They evaluated 20,417 HIV-infected adults from 2002-2013 and found an elevated risk of cellulitis and infection, particularly among patients with high viral load and those who received bacterial vaccines. These findings were consistent with prior reports in the literature. The analysis did not find an increased risk of other adverse events of interest. Patients with HIV with very high viral load might have elevated risk for stroke and cerebrovascular diseases; future research should examine further. Overall, this study reassures that vaccines currently recommended for HIV-infected adults are safe.
Cook AJ, Wellman RD, Marsh T, Shoaibi A, Tiwari R, Nguyen M, Boudreau D, Weintraub ES, Jackson L, Nelson JS. Applying sequential surveillance methods that use regression adjustment or weighting to control confounding in a multisite, rare-event, distributed setting: Part 2 in-depth example of a reanalysis of the measles-mumps-rubella-varicella combination vaccine and seizure risk. J Clin Epidemiol. 2019 Sep; 113: 114-122. Epub 2019 May 2.
Safety surveillance of newly marketed vaccines is a public health priority. National systems have linked vast amounts of electronic health record (EHR) data across multiple health care organizations and insurers. This allows monitoring of large patient groups for potential safety concerns. Group sequential methods (methods of evaluating data as it is entered) involve routine estimation and testing of vaccine-outcome associations over time. This method can lead to earlier identification of excess risk compared with one-time analysis. Researchers assessed the use of two different sequential methods for safety monitoring: analysis-based confounder adjustment (influential variables) and weighting (the number items or events). Both methods were applied to the FDA’s Sentinel network, that already positively paired the outcome to the vaccine. The estimates from both methods were similar and comparable to prior studies of different designs and are viable alternatives for safety monitoring.
Myers TR, McCarthy NL, Panagiotakopoulos L, Omer SB. Estimation of the Incidence of Guillain-Barré Syndrome During Pregnancy in the United States, Open Forum Infectious Diseases, 2019 Mar 3; 6(3).
Guillain-Barré syndrome (GBS) is an adverse event of interest after vaccination, yet little is known about how frequently this rare neurologic disorder occurs during pregnancy. GBS may be an outcome of particular interest during Zika vaccine trials, because it has been associated with Zika virus infection. In this Vaccine Safety Datalink study, researchers identified potential GBS cases from January 1, 2004 through July 31, 2015 during pregnancy and the 42 days following birth. Of the 1.2 million pregnancies that met inclusion criteria, 35 potential cases of GBS were identified and 2 cases were confirmed as incident GBS during pregnancy. The resulting estimated incidence rate for GBS during pregnancy was 2.8 GBS cases per million person-years. These findings will help inform future safety assessments of Zika and other vaccines in pregnant populations.
Klein NP, Goddard K, Lewis E, Ross P, Gee J, DeStefano F, Baxter R. Long term risk of developing type 1 diabetes after HPV vaccination in males and females. Vaccine. 2019 Mar 28; 37(14):1938-1944. Epub 2019 Mar 1.
Despite scientific evidence, public concerns that the human papillomavirus (HPV) vaccine can cause autoimmune diseases persist. The Vaccine Safety Datalink evaluated whether HPV vaccine is associated with a long-term increased risk of type 1 diabetes at one participating site. This retrospective cohort study identified all potential type 1 diabetes cases from Kaiser Permanente Northern California members who were between 11 and 26 years old any time after June 2006 through December 2015 – over 900,000 individuals. Of the 2,613 cases of type 1 diabetes identified, 338 (123 vaccinated with HPV and 265 unvaccinated) remained in the analysis. Over the 10 years of the study period, comparing vaccinated with unvaccinated persons, researchers did not find an increased risk of type 1 diabetes associated with HPV vaccine receipt.
Tartof SY, Qian L, Liu IA, Tseng HF, Sy LS, Hechter RC, Lewin BJ, Jacobsen SJ. Safety of Influenza Vaccination Administered During Hospitalization. Mayo Clin Proc. 2019 Mar; 94(3):397-407. Epub 2019 Jan 8.
CDC recommends that hospitalized patients who are eligible to receive influenza vaccine be vaccinated before discharge; however, previous data suggest that rates of influenza immunization among hospitalized patients before discharge remain low. In a retrospective cohort study conducted at Kaiser Permanente Southern California, investigators analyzed whether influenza vaccination during hospitalization was associated with an increased risk of outpatient and emergency department visits, readmissions, fever, and clinical laboratory evaluations for infection in the 7 days following discharge. Investigators found no increased risk for these outcomes among those vaccination during hospitalization compared with those who were never vaccinated or were vaccinated at other times. These findings provide reassurance about the safety of influenza vaccination during hospitalization.
McClure DL, Jacobsen SJ, Klein NP, Naleway AL, Kharbanda EO, Glanz JM, Jackson LA, Weintraub ES, McLean HQ. Similar relative risks of seizures following measles containing vaccination in children born preterm compared to full-term without previous seizures or seizure-related disorders. Vaccine. 2019 Jan 3; 37(1):76-79. Epub 2018 Nov 23.
In the United States, measles-mumps-rubella (MMR) and measles-mumps-rubella-varicella (MMRV) vaccines are recommended to children at age 12 months and older. These vaccines are associated with a small increased risk of febrile seizures during the second week after vaccination. This Vaccine Safety Datalink study assessed the relative risk of febrile seizures after MMR/MMRV vaccination in children born preterm and children born full-term. Prior to this study, limited data were available on the safety of vaccinations given during the second year of life in preterm children. Researchers looked at 532,375 children (45,343 preterm and 487,032 full-term) who received their first dose of measles-containing vaccine at age 12 through 23 months. The data showed similar relative risk of seizure in both groups. The results support current Advisory Committee on Immunization Practices recommendations to administer the first dose of these vaccines at age 12 through 15 months for all children, including those born preterm.
Groom HC, Irving SA, Koppolu P, Smith N, Vazquez-Benitez G, Kharbanda EO, Daley MF, Donahue JG, Getahun D, Jackson LA, Tse Kawai A, Klein NP, McCarthy NL, Nordin JD, Sukumaran L, Naleway AL. Uptake and safety of Hepatitis B vaccination during pregnancy: A Vaccine Safety Datalink study. Vaccine. 2018 Oct 1; 36(41):6111-6116. Epub 2018 Sep 5.
Hepatitis B virus (HBV) infection acquired during pregnancy can pose a risk to the infant at birth that can lead to significant and lifelong morbidity. Hepatitis B vaccine (HepB) is recommended for anyone at increased risk for contracting HBV infection, including pregnant women. Prior to this study, limited data were available on the safety of HepB administration during pregnancy. In this Vaccine Safety Datalink retrospective cohort study, researchers assessed potential association between maternal HepB vaccinations and pre-specified maternal and infant safety outcomes, looking at pregnancies resulting in live births from 2004-2015. Women were continuously enrolled from 6 months pre-pregnancy to 6 weeks postpartum. Most women who received maternal HepB did not have high-risk indications for vaccination. The study found there was no increased risk for the examined adverse events in women who received maternal HepB or in their offspring.
Naleway AL, Mittendorf KF, Irving SA, Henninger ML, Crane B, Smith N, Daley MF, and Gee J. Incidence of Primary Ovarian Insufficiency and Adolescent Vaccination. Pediatrics 2018 Sep; 142(3). Epub 2018 Aug 21.
Published case series have suggested a potential association between human papillomavirus (HPV) vaccination and primary ovarian insufficiency (POI). But, no population-based epidemiological studies have been reported. To the authors’ knowledge, this new Vaccine Safety Datalink study – a population-based, retrospective cohort study of nearly 200,000 women – is a first, and overcomes some of the limitations of earlier post-licensure monitoring that relied on passive reporting. Researchers found there was no elevated risk of POI following HPV, Tdap, IIV, and MenACWY vaccination in women of reproductive age. These findings should lessen concern about potential impact on fertility from adolescent vaccination.
Kharbanda EO, Vazquez-Benitez G, Lipkind HS, Sheth SS, Zhu J, Naleway AL, Klein NP, Hechter R, Daley MF, Donahue JG, Jackson ML, Kawai AT, Sukumaran L, Nordin JD. Risk of Spontaneous Abortion After Inadvertent Human Papillomavirus Vaccination in Pregnancy. Obstet. Gynecol. 2018 Jul; 132(1): 35-44.
Quadrivalent human papillomavirus vaccine (4vHPV) is not recommended during pregnancy but may be given inadvertently when pregnancy status is not known. While data on HPV vaccine exposures during or around the time of pregnancy have not raised concerns, additional safety studies are needed. Using the Vaccine Safety Datalink, researchers conducted a retrospective observational cohort study that evaluated the risk of spontaneous abortion following 4vHPV before and during pregnancy. Between January 2008 and November 2014, 2,800 pregnancies were identified with 4vHPV exposure. The authors found the risk of spontaneous abortion did not increase among women who received 4vHPV before or during pregnancy. These findings are consistent with pre-licensures clinical trials and post-licensure safety studies.
Jackson ML, Yu O, Nelson JC, Nordin JD, Tartof SY, Klein NP, Donahue JG, Irving SA, Glanz JM, McNeil MM, Jackson LA. Safety of repeated doses of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine in adults and adolescents. Pharmacoepidemiol. Drug Saf. 2018 Aug; 27(8): 921-925. Epub 2018 Jun 3.
Because protective pertussis immunity may wane within 5 years of Tdap (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) vaccine receipt, maintaining protection may require repeated vaccination. A possible strategy would be to recommend Tdap in place of decennial Td (tetanus toxoid, reduced diphtheria) doses. This VSD study evaluated the safety of repeated doses of tetanus-containing vaccine at intervals <10 years between doses among a population of 68,915 non-pregnant adults and adolescents. Compared to 7,521 subjects who received a subsequent dose of Td vaccine, 61,394 subjects who received a subsequent dose of Tdap did not have significantly elevated risk of medical visits for seizure, cranial nerve disorders, limb swelling, pain in limb, cellulitis, paralytic syndromes, or encephalopathy/encephalitis/meningitis. These results suggest that repeated Tdap vaccination has acceptable safety relative to Tdap vaccination followed by subsequent Td vaccination.
Xu S, Clarke CL, Newcomer SR, Daley MF, Glanz JM. Analyzing self-controlled case series data when case confirmation rates are estimated from an internal validation sample. Biom. J. 2018 Jul; 60(4): 748-760. Epub 2018 May 16.
Vaccine safety studies are often observational studies using electronic health records (EHR), however, these studies face some challenges, including outside influences (confounding) and outcome misclassification. To handle the confounding effect, researchers use self-controlled case series (SCCS) study design and review of EHRs to validate cases. SCCS design is limited to those individuals who experienced the event during or outside of certain times. While SCCS can adjust for some factors, it cannot adjust for others. This review considered 4 approaches for analyzing SCCS data: observed cases, confirmed cases only, known confirmation rate, and multiple imputation. Researchers found through simulation that when misclassification of adverse events is present, multiple imputation analysis should be considered. When only a sample of presumptive cases can be validated, this approach can address the influence of false-positive cases in EHR data.
Tseng HF, Sy LS, Qian L, Liu IA, Mercado C, Lewin B, Tartof SY, Nelson J, Jackson LA, Daley MF, Weintraub E, Klein NP, Belongia E, Liles EG, Jacobsen SJ. Pneumococcal Conjugate Vaccine Safety in Elderly Adults. Open. Forum Infect. Dis. 2018 May 2; 5(6).
The 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) are both licensed vaccines recommended for use in adults 65 years of age and older to protect against pneumococcal disease. PPSV23 protects against 23 types of the approximately 90 types of pneumococcal bacteria and was first licensed in 1983; the newer PCV13 vaccine protects against 13 types of pneumococcal bacteria and was licensed in 2010. In this large cohort study using data from 6 Vaccine Safety Datalink sites, researchers compared the risk in adults 65 years of age and older for serious adverse events (AEs) following vaccination with either PCV13 or PPSV23. The analysis did not find an increased risk of adverse events following PCV13 administration compared to PPSV23, and should provide reassurance regarding use of PCV13.
Zerbo O, Modaressi S, Goddard K, Lewis E, Fireman BH, Daley MF, Irving SA, Jackson LA, Donahue JG, Qian L, Getahun D, DeStefano F, McNeil MM, Klein NP. Vaccination Patterns in Children After Autism Spectrum Disorder Diagnosis and in Their Younger Siblings. JAMA Pediatr. 2018 May 1; 172(5): 469-475.
Recently, several outbreaks of vaccine-preventable diseases generated concerns about the impact of increasing rates of undervaccination. This study investigates whether rates of vaccination in children with autism spectrum disorder (ASD) and their younger siblings differ from rates of vaccination in the general pediatric population. Results show that both children with ASD and their younger siblings are significantly less likely to be fully vaccinated than children in families without a child with ASD. Although the reasons for undervaccination are not fully explored in this study, results suggest that parental refusal of vaccination may play an important role.
Donahue J. Response to three Letters to the Editor regarding: Donahue JG, et al. Association of spontaneous abortion with receipt of inactivated influenza vaccine containing H1N1pdm09 in 2010-11 and 2011-12. Vaccine. 35 (2017) 5314-5322. Vaccine. 2018 Apr 19; 36(17): 2231-2232.
Summaries are not made for a response to a letter to the editor.
Daley MF, Shoup JA, Newcomer SR, Jackson ML, Groom HC, Jacobsen SJ, McLean HQ, Klein NP, Weintraub ES, McNeil MM, Glanz JM. Assessing Potential Confounding and Misclassification Bias When Studying the Safety of the Childhood Immunization Schedule. Acad. Pediatr. 2018 Sep – Oct; 18(7): 754-762. Epub 2018 Mar 28.
Some parents are concerned the childhood immunization schedule could increase risk for allergic disorders, including asthma. This, along with the overall safety of the schedule, has parents delaying their children’s vaccinations. Researchers wanted to examine if there was a risk of vaccination status misclassification (between parent and health record) and if risk factors of asthma and other allergies varied by status. This survey was conducted among parents of children 19-35 months old at 8 Vaccine Safety Datalink sites. Among a sample of 2,043 parents, 1,209 (59.2%) responded. The observed agreement between parents and health record for no vaccines was 94% and 87.3 % for receiving all vaccines, no delay. Results showed that misclassification of vaccination status was uncommon, and parents’ reports of asthma risk factors generally did not vary by vaccination status. The data from this study will assist future observational studies with measurement and controlling disease risk.
Glanz JM, Newcomer SR, Daley MF, DeStefano F, Groom HC, Jackson ML, Lewin BJ, McCarthy NL, McClure DL, Narwaney KJ, Nordin JD, Zerbo O. Association Between Estimated Cumulative Vaccine Antigen Exposure Through the First 23 Months of Life and Non-Vaccine-Targeted Infections From 24 Through 47 Months of Age. JAMA. 2018 Mar 6; 319(9): 906-913.
Up to 15% of parents delay their children’s immunizations because of concerns that early childhood vaccines may overwhelm the immune system and cause children to be more susceptible to other infections. While a Danish study did not find evidence that multiple vaccine antigen exposure was associated with the risk for non-vaccine-targeted infectious diseases, this type of study has not been completed in the United States. In this case control study, data was collected from 6 Vaccine Safety Datalink sites to compare children with non-vaccine targeted infections to children without such infections. There were 944 children ages 24 through 47 months enrolled (193 cases, and 751 controls) and the results were not different between the two groups in their estimated cumulative vaccine antigen exposure during the first 23 months of life. In summary, exposure to multiple vaccines did not increase a child’s risk of non-vaccine targeted infections.
Irving SA, Groom HC, Stokley S, McNeil MM, Gee J, Smith N, Naleway AL. Human Papillomavirus Vaccine Coverage and Prevalence of Missed Opportunities for Vaccination in an Integrated Healthcare System. Acad. Pediatr. 2018 Mar; 18(2S): S85-S92.
Human papillomavirus (HPV) vaccination has been recommended in the United States for female and male adolescents since 2006 and 2011, respectively. However, vaccination rates for HPV compared to other childhood vaccines are lower. Researchers designed an assessment and provider-feedback intervention to increase HPV vaccine rate and identify missed opportunities for vaccination. The assessment and intervention occurred at 9 Oregon-based Kaiser Permanente Northwest outpatient clinics between April 2015 and June 2016. An average 29,021 adolescents ages 11-17 were included. Researchers collected baseline data four years prior to the intervention and found that vaccination rates were increasing; after intervention, there were no significant increases. Researchers did identify that missed opportunities decreased during the intervention for females 13-17 years old. Increasing HPV rates in large health systems is challenging, but other interventions are worth examining.
Newcomer SR, Kulldorff M, Xu S, Daley MF, Fireman B, Lewis E, Glanz JM. Bias From Outcome Misclassification in Immunization Schedule Safety Research. Pharmacoepidemiol Drug Saf. 2018 Feb;27(2):221-228.
The Institute of Medicine in 2013 recommended conducting observational studies of the childhood immunization schedule safety. However, these studies present a methodical challenge because of bias from misclassification of outcomes in electronic health record data. Using simulations, researchers evaluated the percent of valid diagnoses (positive predictive values, PPVs) as indicators of bias of an exposure-outcome association, and quantitative bias analyses methods used for bias correction. Overall outcome PPVs did not reflect the distribution of false positives by exposure and are poor indicators of bias in individual studies. Quantitative bias analysis was effective in correcting outcome misclassification bias and should be considered in immunization schedule research.
Sukumaran L, McCarthy NL, Kharbanda EO, Vazquez-Benitez G, Lipkind HS, Jackson L, Klein NP, Naleway AL, McClure DL, Hechter RC, Kawai AT, Glanz JM, Weintraub ES. Infant Hospitalizations and Mortality After Maternal Vaccination. Pediatrics. 2018 Mar; 141(3). Epub 2018 Feb 20.
Influenza and Tdap vaccines are recommended for pregnant women. However, there are limited data on long-term outcomes of infants born to mothers vaccinated during pregnancy. This case-control study found that influenza and Tdap vaccines in pregnancy are not associated with an increased risk of hospitalization or death in infants during the first six months of life. These findings contribute to the knowledge of the long-term safety of vaccination during pregnancy.
Kuntz J, Crane B, Weinmann S, Naleway AL. Myocarditis and pericarditis are rare following live viral vaccinations in adults. Vaccine. 2018 Mar 14; 36(12): 1524-1527. Epub 2018 Feb 15.
Cardiac complications including myocarditis, pericarditis, and arrhythmias following smallpox vaccination have been rarely reported in the United States. However, after 67 cases of myocarditis or pericarditis were reported after a vaccination campaign of military personnel, there was a need to assess these outcomes among adults after live-viral vaccinations. In this study using data from 4 Vaccine Safety Datalink sites from 1996-2007, researchers identified over 400,000 adults who received at least 1 live viral vaccine. Of those, there was only 1 probable case of pericarditis and no cases of myocarditis in 42 days following vaccination. Self-controlled risk interval analysis found there is no increased risk of myopericarditis in the 42 days following vaccination. The study findings suggest that the occurrence of myopericarditis following live viral vaccination is rare, not higher than the background rate, and much lower than rates following smallpox vaccination.
Li R, Weintraub E, McNeil MM, Kulldorff M, Lewis EM, Nelson J, Xu S, Qian L, Klein NP, DeStefano F. Meningococcal conjugate vaccine safety surveillance in the Vaccine Safety Datalink using a tree-temporal scan data mining method. Pharmacoepidemiol. Drug Saf. 2018 Apr; 27(4): 391-397. Epub 2018 Feb 15.
Traditional pharmacovigilance techniques used in vaccine safety are generally geared to detecting adverse events (AEs) based on pre‐defined sets of conditions or diagnoses. Using a newly developed tree‐temporal scan statistic data mining method, researchers performed a pilot study to evaluate the safety profile of the meningococcal conjugate vaccine Menactra®. The authors detected known AEs following the vaccine; no new safety concerns were raised. The study demonstrates that the tree‐temporal scan statistic data mining method can be successfully applied to screen broadly for a wide range of vaccine‐AE associations within a large health care data network.
Zhou H, Thompson WW, Belongia EA, Fowlkes A, Baxter R, Jacobsen SJ, Jackson ML, Glanz JM, Naleway AL, Ford DC, Weintraub E, Shay, DK. Estimated rates of influenza-associated outpatient visits during 2001-2010 in six US integrated health care delivery organizations. Influenza. Other Respir. Viruses. 2018 Jan; 12(1): 122-131. Epub 2018 Feb 15.
Influenza (flu) related illnesses are responsible for many morbidity cases during each flu season, but these illnesses are difficult to count: symptoms are non-specific, diagnostic codes for flu-related symptoms are broad, and lab testing is not routine. This makes population-based estimates of flu-related outpatient visits during flu epidemics or pandemics uncommon. In this study using data from 6 Vaccine Safety Datalink sites from 2001-2010, researchers estimated flu-related outpatient visits. Researchers modeled the rates of outpatient visits with diagnostic codes of pneumonia or acute respiratory visits. Of the nearly 7.7 million people enrolled, children had higher estimated flu-related outpatient rates than adults during pre-pandemic and pandemic seasons. Rates estimated with pneumonia visits plus flu-coded visits were similar to previous studies using confirmed flu cases. These numbers are crucial for measuring the potential benefits of flu prevention and treatment.
McNeil MM, DeStefano F. Vaccine-associated hypersensitivity. J. Allergy Clin. Immunol. 2018 Feb; 141(2): 463-472.
Vaccines are considered one of the most effective public health interventions – resulting in major reductions of vaccine preventable diseases and death. Vaccine-associated hypersensitivity reactions are not infrequent; however, serious acute-onset anaphylaxis reactions are extremely rare. Risk of anaphylaxis after all vaccines is estimated to be 1.31 per million vaccine doses administered. This review focuses on serious hypersensitivity reactions following flu vaccines, given the large number of people vaccinated yearly and the formulation changes the vaccines go through each year to match circulating flu viruses. Recent advances in vaccine technology, along with new vaccines and the universal flu vaccination recommendation (people 6 months of age and older), make continued safety monitoring for hypersensitivity reactions following flu vaccination particularly important.
McNeil MM, Hibbs BF, Miller ER, Cano MV. Notes from the Field: Errors in Administration of an Excess Dosage of Yellow Fever Vaccine – United States, 2017. MMWR Morb Mortal Wkly Rep. 2018 Jan 26; 67:109-110.
Following a March 2017 report to Vaccine Adverse Event Reporting System (VAERS) of four persons receiving incorrect dosages of yellow fever vaccine, CDC conducted a VAERS search and literature review for similar reported administration errors. Reports were few (15 in VAERS; 67 in literature) and most did not involve an adverse event. However, the error was costly in terms of medical follow-up and vaccine wastage. More distinctive single/multi-dose packaging and in-service training might prevent future errors.
Newcomer SR, Kulldorff M, Xu S, Daley MF, Fireman B, Lewis E, Glanz JM. Bias from outcome misclassification in immunization schedule safety research. Pharmacoepidemiol. Drug Saf. 2018 Feb; 27(2): 221-228. Epub 2018 Jan 2.
The Institute of Medicine in 2013 recommended conducting observational studies of the childhood immunization schedule safety. However, these studies present a methodical challenge because of bias from misclassification of outcomes in electronic health record data. Using simulations, researchers evaluated the percent of valid diagnoses (positive predictive values, PPVs) as indicators of bias of an exposure-outcome association, and quantitative bias analyses methods used for bias correction. Overall outcome PPVs did not reflect the distribution of false positives by exposure and are poor indicators of bias in individual studies. Quantitative bias analysis was effective in correcting outcome misclassification bias and should be considered in immunization schedule research.
Storms AD, Chen J, Jackson LA, Nordin JD, Naleway AL, Glanz, JM, Jacobsen SJ, Weintraub ES, Klein NP, Gargiullo PM, Fry AM. Rates and risk factors associated with hospitalization for pneumonia with ICU admission among adults. BMC. Pulm. Med. 2017 Dec 16; 17(1): 208.
Groom HC, Irving SA, Caldwell J, Larsen R, Beaudrault S, Luther LM, Naleway AL. Implementing a Multipartner HPV Vaccination Assessment and Feedback Intervention in an Integrated Health System. J. Public Health Manag. Pract. 2017 Nov/Dec; 23(6): 589-592.
Daley MF, Clarke CL, Glanz JM, Xu S, Hambidge SJ, Donahue JG, Nordin JD, Klein NP, Jacobsen SJ, Naleway AL, Jackson ML, Lee G, Duffy J,Weintraub E. The safety of live attenuated influenza vaccine in children and adolescents 2 through 17 years of age: A Vaccine Safety Datalink study. Pharmacoepidemiol Drug Saf. 2018 Jan; 27(1): 59-68. Epub 2017 Nov 17.
Myers TR, McNeil MM, Current safety issues with quadrivalent meningococcal conjugate vaccines. Hum Vaccin Immunother, 2018 May 4; 14(5): 1175-1178; Epub 2017 Nov 8.
McCarthy NL, Sukumaran L, Newcomer S, Glanz J, Daley MF, McClure D, Klein NP, Irving S, Jackson ML, Lewin B, Weintraub E. Patterns of childhood immunization and all-cause mortality. Vaccine. 2017 Dec 4; 35(48 Pt B): 6643-6648. Epub 2017 Oct 20.
VanWormer JJ, Bendixsen CG, Vickers ER, Stokley S, McNeil MM, Gee J, Belongia EA, McLean HQ. Association between parent attitudes and receipt of human papillomavirus vaccine in adolescents. BMC. Public Health. 2017 Oct 2; 17(1): 766.
Donahue JG, Kieke BA, King JP, DeStefano F, Mascola MA, Irving SA, Cheetham TC, Glanz JM, Jackson LA, Klein NP, Naleway AL, Weintraub E, and Belongia EA. Association of spontaneous abortion with receipt of inactivated influenza vaccine containing H1N1pdm09 in 2010-11 and 2011-12. Vaccine. 2017 Sep 25; 35(40): 5314-5322.
Gee J, Sukumaran L, Weintraub E. Risk of Guillain-Barre Syndrome following quadrivalent human papillomavirus vaccine in the Vaccine Safety Datalink. Vaccine. 2017 Oct 13; 35(43): 5756-5758. Epub 2017 Sep 19.
Eaton A, Lewis N, Fireman B, Hansen J, Baxter R, Gee J, Klein, NP. Birth outcomes following immunization of pregnant women with pandemic H1N1 influenza vaccine 2009-2010. Vaccine 2018 May 3; 36(19): 2733-2739. Epub 2017 Sep 13.
Vickers ER, McClure DL, Naleway AL, Jacobsen SJ, Klein NP, Glanz JM, Weintraub ES, Belongia EA. Risk of venous thromboembolism following influenza vaccination in adults aged 50 years and older in the Vaccine Safety Datalink. Vaccine. 2017 Oct 13; 35(4); 5872-5877. Epub 2017 Sep 6.
Lipkind HS, Vazquez-Benitez G, Nordin JD, Romitti PA, Naleway AL, Klein NP, Hechter RC, Jackson ML, Hambidge SJ, Lee GM, Sukumaran L, Kharbanda EO. Maternal and Infant Outcomes After Human Papillomavirus Vaccination in the Periconceptional Period or During Pregnancy. Obstet. Gynecol. 2017 Sep; 130(3): 599-608.
Duffy J, Hambidge SJ, Jackson LA, Kharbanda EO, Klein NP, Naleway A, Omer SB, Weintraub E. Febrile Seizure Risk after Vaccination in Children One to Five Months of Age. Pediatr. Neurol. 2017 Nov; 76: 72-78. Epub 2017 Aug 23.
DeSilva M, Vazquez-Benitez G, Nordin JD, Lipkind HS, Klein NP, Cheetham TC, Naleway AL, Hambidge SJ, Lee GM, Jackson ML, McCarthy NL, Kharbanda EO. Maternal Tdap vaccination and risk of infant morbidity. Vaccine 2017 Jun 22; 35(29): 3655-3660. Epub 2017 May 25.
Kharbanda EO, Vazquez-Benitez G, Romitti PA, Naleway AL, Cheetham TC, Lipkind HS, Klein NP, Lee G, Jackson ML, Hambidge SJ, McCarthy N, DeStefano F, Nordin JD. First Trimester Influenza Vaccination and Risks for Major Structural Birth Defects in Offspring. J. Pediatr. 2017 Aug; 187: 234-239. Epub 2017 May 24.
McLean HQ, VanWormer JJ, Chow BDW, Birchmeier B, Vickers E, DeVries E, Meyer J, Moore J, McNeil MM, Stokley S, Gee J, Belongia EA. Improving Human Papillomavirus Vaccine Use in an Integrated Health System: Impact of a Provider and Staff Intervention. J. Adolesc. Health. 2017 Aug; 61(2): 252-258. Epub 2017 Apr 24.
Ray GT, Lewis N, Goddard K, Ross P, Duffy J, DeStefano F, Baxter R, Klein NP. Asthma exacerbations among asthmatic children receiving live attenuated versus inactivated influenza vaccines. Vaccine 2017 May 9; 35(20): 2668-2675. Epub 2017 Apr 9.
Duffy J, Lewis M, Harrington T, Baxter R, Belongia EA, Jackson LA, Jacobsen SJ, Lee GM, Naleway AL, Nordin J, Daley MF. Live attenuated influenza vaccine use and safety in children and adults with asthma. Ann. Allergy Asthma Immunol. 2017 Apr; 118(4): 439-444.
Daley MF, Glanz JM, Newcomer SR, Jackson ML, Groom HC, Lugg MM, McLean HQ, Klein NP, Weintraub ES, McNeil MM. Assessing misclassification of vaccination status: Implications for studies of the safety of the childhood immunization schedule. Vaccine. 2017 Apr 4; 35(15): 1873-1878. Epub 2017 Mar 9.
Klein NP, Lewis E, McDonald J, Fireman B, Naleway A, Glanz J, Jackson LA, Donahue, JG, Jacobsen SJ, Weintraub E, Baxter R. Risk factors and familial clustering for fever 7-10 days after the first dose of measles vaccines. Vaccine. 2017 Mar 14; 35(12): 1615-1621. Epub 2017 Feb 21.
Narwaney KJ, Breslin K, Ross CA, Shoup JA, Wain KF, Weintraub ES, McNeil MM, Hambidge SJ. Vaccine adverse events in a safety net healthcare system and a managed care organization. Vaccine. 2017 March 1; 35(9): 1335-1340. Epub 2017 Feb 6.
Hambidge SJ, Ross C, Shoup JA, Wain K, Narwaney K, Breslin K, Weintraub ES, McNeil MM. Integration of data from a safety net health care system into the Vaccine Safety Datalink. Vaccine. 2017 March 1; 35(9): 1329-1334. Epub 2017 Feb 1.
Kharbanda EO, Vazquez-Benitez G, Romitti PA, Naleway AL, Cheetham TC, Lipkind HS, Sivanandam S, Klein NP, Lee GM, Jackson ML, Hambidge SJ, Olsen A, McCarthy N, DeStefano F, Nordin JD. Identifying birth defects in automated data sources in the Vaccine Safety Datalink. Pharmacoepidemiol. Drug Saf 2017 Apr; 26(4): 412-420. Epub 2017 Jan 4.
Sukumaran L, Omer SB. Repeat Tdap Vaccination and Adverse Birth Outcomes–Reply. JAMA 2016;315:1286. https://www.ncbi.nlm.nih.gov/pubmed/27002457
Duffy J, Weintraub E, Hambidge SJ et al. Febrile Seizure Risk After Vaccination in Children 6 to 23 Months. Pediatrics 2016. https://www.ncbi.nlm.nih.gov/pubmed/27802536
Vazquez-Benitez G, Kharbanda EO, Naleway AL et al. Risk of Preterm or Small-for-Gestational-Age Birth After Influenza Vaccination During Pregnancy: Caveats When Conducting Retrospective Observational Studies. Am J Epidemiol 2016;184:176-186. https://www.ncbi.nlm.nih.gov/pubmed/27449414
Baxter R, Lewis E, Goddard K et al. Acute demyelinating events following vaccines – a case centered analysis. Clin Infect Dis 2016. https://www.ncbi.nlm.nih.gov/pubmed/27585798
DeSilva M, Vazquez-Benitez G, Nordin JD et al. Tdap Vaccination During Pregnancy and Microcephaly and Other Structural Birth Defects in Offspring. JAMA 2016;316:1823-1825. https://www.ncbi.nlm.nih.gov/pubmed/27802536
Glanz JM, Newcomer SR, Jackson ML, Omer SB, Bednarczyk RA, Shoup JA, Daley MF: Vaccine Safety Datalink. White Paper on Studying the Safety of the Childhood Immunization Schedule [PDF – 896K]
Kharbanda EO, Vazquez-Benitez G, Lipkind HS et al. Maternal Tdap vaccination: Coverage and acute safety outcomes in the vaccine safety datalink, 2007-2013. Vaccine 2016.
McCarthy NL, Gee J, Sukumaran L et al. Vaccination and 30-Day Mortality Risk in Children, Adolescents, and Young Adults. Pediatrics 2016;137:1-8.
Tartof SY, Qian L, Rieg GK et al. Safety of Seasonal Influenza Vaccination in Hospitalized Surgical Patients: A Cohort Study. Ann Intern Med 2016.
Li R, Stewart B, McNeil MM et al. Post licensure surveillance of influenza vaccines in the Vaccine Safety Datalink in the 2013-2014 and 2014-2015 seasons. Pharmacoepidemiol Drug Saf 2016.
Gee J, Weinbaum C, Sukumaran L, Markowitz LE. Quadrivalent HPV vaccine safety review and US safety monitoring plans for nine-valent HPV vaccine. Hum Vaccin Immunother 2016;0.
Baxter R, Lewis E, Fireman B, DeStefano F, Gee J, Klein NP. Case-centered analysis of Optic Neuritis following vaccines. Clin Infect Dis 2016.
Abrams JY, Weintraub ES, Baggs JM, McCarthy NL, Schonberger LB, Lee GM, et al. Childhood vaccines and Kawasaki disease, Vaccine Safety Datalink, 1996-2006. Vaccine. 2015 Jan 3;33(2):382-7.
Duffy J, Weintraub E, Vellozzi C, DeStefano F; Vaccine Safety Datalink. Narcolepsy and influenza A(H1N1) pandemic 2009 vaccination in the United States. Neurology. 2014 Nov 11;83(20):1823-30. Epub 2014 Oct 15.
Kharbanda EO, Vazquez-Benitez G, Lipkind HS, Klein NP, Cheetham TC, Naleway A, et al. Evaluation of the association of maternal pertussis vaccination with obstetric events and birth outcomes. JAMA. 2014 Nov 12;312(18):1897-904.
Klein NP, Lewis E, Fireman B, Hambidge SJ, Naleway A, Nelson JC, et al. Safety of measles-containing vaccines in 1-Year-Old children. Pediatrics. 2015 Feb;135(2):e321-9. Epub 2015 Jan 5.
McNamara LA, Shumate AM, Johnsen P, MacNeil JR, Patel M, Bhavsar T, et al. First use of a serogroup B meningococcal vaccine in the us in response to a university outbreak. Pediatrics. 2015 May;135(5):798-804.
McNeil MM, Weintraub E, Duffy J, Sukumaran L, Jacobsen SJ, Klein NP, et al. Risk of anaphylaxis following vaccination in children and adults. J Allergy Clin Immunol. Epub 2015 Sep 28.
Payne DC, Baggs J, Klein NP, Parashar UD. Does preventing rotavirus infections through vaccination also protect against naturally occurring intussusception over time? Clin Infect Dis. 2015 Jan 1;60(1):163-4.
Stratton KG, Cook AJ, Jackson LA, Nelson JC. Simulation study comparing exposure matching with regression adjustment in an observational safety setting with group sequential monitoring. Stat Med. 2015 Mar 30;34(7):1117-33.
Sukumaran L, McCarthy NL, Kharbanda EO, McNeil MM, Naleway AL, Klein NP, et al. Association of Tdap vaccination with acute events and adverse birth outcomes among pregnant women with prior tetanus-containing immunizations. JAMA. 2015 Oct 20;314(15):1581-1587.
Sukumaran L, McCarthy NL, Kharbanda EO, Weintraub ES, Vasquez-Benitez G, McNeil MM, et al. Safety of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis and influenza vaccinations in pregnancy. Obstet Gynecol. 2015 Nov;126(5):1069-74.
Sukumaran L, McCarthy NL, Li R, Weintraub ES, Jacobsen SJ, Hambidge SJ, et al. Demographic characteristics of members of the Vaccine Safety Datalink (VSD): A comparison with the United States population. Vaccine. 2015 Aug 26;33(36):4446-50. Epub 2015 Jul 23.
Daley MF, Yih WK, Glanz JM, Hambidge SJ, Narwaney KJ, Yin R, et al. Safety of diphtheria, tetanus, acellular pertussis and inactivated poliovirus (DTaP-IPV) vaccine. Vaccine. 2014;32(25):3019-3024.
Duffy J, Weintraub, E, Vellozzi, C, DeStefano F. Narcolepsy and influenza A(H1N1) pandemic 2009 vaccination in the United States. Neurology. 2014;83(20):1823-30.
Hambidge SJ, Newcomer SR, Narwaney KJ, Glanz JM, Daley MF, Xu S, et al. Timely versus delayed early childhood vaccination and seizures. Pediatrics. 2014;133(6):e1492-e1499.
Jackson ML, Peterson D, Nelson JC, Greene SK, Jacobsen SJ, Belongia EA, et al. Using winter 2009-2010 to assess the accuracy of methods which estimate influenza-related morbidity and mortality. Epidemiol Infect. 2014 Dec 12:1-9.
Kawai AT, Li L, Kulldorff M, Vellozzi C, Weintraub E, Baxter R, et al. Absence of associations between influenza vaccines and increased risks of seizures, Guillain-Barre syndrome, encephalitis, or anaphylaxis in the 2012-2013 season. Pharmacoepidemiol Drug Saf. 2014;23(5):548-553.
Kharbanda EO, Vazquez-Benitez G, Lipkind HS, Klein NP, Cheetham TC, Naleway A, et al. Evaluation of the Association of Maternal Pertussis Vaccination With Obstetric Events and Birth Outcomes. JAMA. 2014;312(18):1897-1904.
Kharbanda EO, Vazquez-Benitez G, Lipkind H, Naleway AL, Klein NP, Cheetham TC, et al. Receipt of pertussis vaccine during pregnancy across 7 Vaccine Safety Datalink sites. Prev Med. 2014 Oct;67:316-9.
Li R, Stewart B, Weintraub E, McNeil MM. Continuous sequential boundaries for vaccine safety surveillance. Stat Med. 2014 Aug 30;33(19):3387-3397.
McNeil MM, Gee J, Weintraub ES, Belongia EA, Lee GM, Glanz JM, et al. The Vaccine Safety Datalink: Successes and challenges monitoring vaccine safety. Vaccine. 2014 Sep 22;32(42):5390-5398.
Naleway AL, Irving SA, Henninger ML, Li DK, Shifflett P, Ball S, et al. Safety of influenza vaccination during pregnancy: A review of subsequent maternal obstetric events and findings from two recent cohort studies. Vaccine. 2014;32(26):3122-3127.
Naleway AL, Kurosky S, Henninger ML, Gold R, Nordin JD, Kharbanda EO, et al. Vaccinations given during pregnancy, 2002-2009: A descriptive study. Am J Prev Med. 2014;46(2):150-157.
Nelson JC, Shortreed SM, Yu O, Peterson D, Baxter R, Fireman B, et al. Integrating database knowledge and epidemiological design to improve the implementation of data mining methods to evaluate vaccine safety in large healthcare databases. Stat Analysis Data Mining. 2014 Oct;7(5):337–351.
Nordin JD, Kharbanda EO, Vazquez-Benitez G, Lipkind H, Lee GM, Naleway AL. Monovalent H1N1 influenza vaccine safety in pregnant women, risks for acute adverse events. Vaccine. 2014 Sep 3;32(39):4985-4992.
Nordin JD, Kharbanda EO, Vazquez Benitez G, Lipkind H, Vellozzi C, Destefano F, et al. Maternal influenza vaccine and risks for preterm or small for gestational age birth. J Pediatr. 2014;164(5):1051-1057.
Tartof SY, Tseng HF, Liu IL, Qian L, Sy LS, Hechter RC, et al. Inpatient admission for febrile seizure and subsequent outcomes do not differ in children with vaccine-associated versus non-vaccine associated febrile seizures. Vaccine. 2014;32(48):6408-14.
Tartof SY, Tseng HF, Liu AL, Qian L, Sy LS, Hechter RC, et al. Exploring the risk factors for vaccine-associated and non-vaccine associated febrile seizures in a large pediatric cohort. Vaccine. 2014;32(22):2574-2581.
Weintraub ES, Baggs J, Duffy J, Vellozzi C, Belongia EA, Irving S, et al. Risk of intussusception after monovalent rotavirus vaccination. N Engl J Med. 2014;370(6):513-519.
Xu S, Newcomer S, Nelson J, Qian L, McClure D, Pan Y, et al. Signal detection of adverse events with imperfect confirmation rates in vaccine safety studies using self-controlled case series design. Biom J. 2014;56(3):513-525.
Baxter R, Bakshi N, Fireman B, Lewis E, Ray P, et al. Lack of association of Guillain-Barré syndrome with vaccinations. Clin Infect Dis. 2013; 57(2):197-204.
DeStefano F, Price CS, Weintraub ES. Increasing exposure to antibody-stimulating proteins and polysaccharides in vaccines is not associated with risk of autism. J Pediatr. 2013;163(2):561-567.
Dodd CN, Romio SA, Black S, Vellozzi C, Andrews N, Sturkenboom M, et al. International collaboration to assess the risk of Guillain Barre Syndrome following Influenza A (H1N1) 2009 monovalent vaccines. Vaccine. 2013;31(40):4448-4458.
Glanz JM, Narwaney KJ, Newcomer SR, Daley MF, Hambidge SJ, Rowhani-Rahbar A, et al. Association between undervaccination with diphtheria, tetanus toxoids, and acellular pertussis (DTaP) vaccine and risk of pertussis infection in children 3 to 36 months of age. JAMA Pediatr. 2013;167(11):1060-1064.
Glanz JM, Newcomer SR, Narwaney KJ, Hambidge SJ, Daley MF, Wagner NM, et al. A population-based cohort study of undervaccination in 8 managed care organizations across the United States. JAMA Pediatr. 2013;167(3):274-281.
Gold R, Naleway A, Riedlinger K. Factors predicting completion of the human papillomavirus vaccine series. J Adolesc Health. 2013;52(4):427-432.
Greene SK, Li L, Shay DK, Fry AM, Lee GM, Jacobsen SJ, et al. Risk of adverse events following oseltamivir treatment in influenza outpatients, Vaccine Safety Datalink Project, 2007-2010. Pharmacoepidemiol Drug Saf. 2013;22(4):335-344.
Greene SK, Rett MD, Vellozzi C, Li L, Kulldorff M, Marcy SM,et al. Guillain-Barre syndrome, influenza vaccination, and antecedent respiratory and gastrointestinal infections: A case-centered analysis in the Vaccine Safety Datalink, 2009-2011. PLoS One. 2013;8(6):e67185.
Henninger M, Crane B, Naleway A. Trends in influenza vaccine coverage in pregnant women, 2008 to 2012. Perm J. 2013;17(2):31-36.
Henninger M, Naleway A, Crane B, Donahue J, Irving S. Predictors of seasonal influenza vaccination during pregnancy. Obstet Gynecol. 2013;121(4):741-749.
Iqbal S, Barile JP, Thompson WW, DeStefano F. Number of antigens in early childhood vaccines and neuropsychological outcomes at age 7-10 years. Pharmacoepidemiol Drug Saf. 2013;22(12):1263-1270.
Irving SA, Kieke BA, Donahue JG, Mascola MA, Baggs J, DeStefano F, et al. Trivalent inactivated influenza vaccine and spontaneous abortion. Obstet Gynecol. 2013;121(1):159-165.
Jackson ML, Yu O, Nelson JC, Naleway A, Belongia EA, Baxter R, et al. Further evidence for bias in observational studies of influenza vaccine effectiveness: The 2009 influenza A(H1N1) pandemic. Am J Epidemiol. 2013;178(8):1327-1336.
Jackson LA, Peterson D, Nelson JC, Marcy SM, Naleway AL, Nordin JD, et al. Vaccination site and risk of local reactions in children 1 through 6 years of age. Pediatrics. 2013;131(2):283-289.
Kharbanda EO, Vazquez-Benitez G, Lipkind H, Naleway A, Lee G, Nordin JD, et al. Inactivated influenza vaccine during pregnancy and risks for adverse obstetric events. Obstet Gynecol. 2013;122(3):659-667.
Kharbanda EO, Vazquez-Benitez G, Shi WX, Lipkind H, Naleway A, Molitor B, et al. Assessing the safety of influenza immunization during pregnancy: The Vaccine Safety Datalink. Am J Obstet Gynecol. 2012;207(3 Suppl):S47-S51.
McCarthy NL, Gee J, Lin ND, Thyagarajan V, Pan Y, Su S. Evaluating the safety of influenza vaccine using a claims-based health system. Vaccine. 2013;31(50):5975-5982.
McCarthy NL, Irving S, Donahue JG, Weintraub E, Gee J, Belongia E. Vaccination coverage levels among children enrolled in the Vaccine Safety Datalink. Vaccine. 2013;31(49):5822-5826.
McCarthy NL, Weintraub E, Vellozzi C, Duffy J, Gee J, Donahue JG. Mortality rates and cause-of-death patterns in a vaccinated population. Am J Prev Med. 2013;45(1):91-97.
Naleway AL, Gold R, Kurosky S, Riedlinger K, Henninger ML, Nordin JD, et al. Identifying pregnancy episodes, outcomes, and mother-infant pairs in the Vaccine Safety Datalink. Vaccine. 2013;31(27):2898-2903.
Nelson JC, Yu O, Dominguez-Islas CP, Cook AJ, Peterson D, Greene SK, et al. Adapting group sequential methods to observational postlicensure vaccine safety surveillance: Results of a pentavalent combination DTaP-IPV-Hib vaccine safety study. Am J Epidemiol. 2013;177(2):131-141.
Nelson JC, Marsh T, Lumley T, Larson EB, Jackson LA, Jackson M, et al. Validation sampling can reduce bias in health care database studies: An illustration using influenza vaccination effectiveness. J Clin Epidemiol. 2013;66(8 Suppl):S110-S121.
Newcomer SR, Hambidge SJ, McClure DL, Daley MF, Klein NP, Glanz JM. Factors that may explain observed associations between trivalent influenza vaccination and gastrointestinal illness in young children. Vaccine. 2013;31(37):3894-3898.
Nordin JD, Parker ED, Vazquez-Benitez G, Kharbanda EO, Naleway A, Marcy SM, et al. Safety of the yellow fever vaccine: A retrospective study. J Travel Med. 2013;20(6):368-373.
Nordin JD, Kharbanda EO, Benitez GV, Nichol K, Lipkind H, Naleway A, et al. Maternal safety of trivalent inactivated influenza vaccine in pregnant women. Obstet Gynecol. 2013;121(3):519-525.
Qian L, Tseng HF, Sy LS, Jacobsen SJ. Confounder adjustment in vaccine safety studies: Comparing three offset terms for case-centered approach. Vaccine. 2013;31(2):431-435.
Salmon DA, Proschan M, Forshee R, Gargiullo P, Bleser W, Burwen DR, et al. Association between Guillain-Barre syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: A meta-analysis. Lancet. 2013;381(9876):1461-1468.
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