Vaccine Adverse Event Reporting System (VAERS) Publications

Hause Am, Baggs J, Marquez P, Myers TR, Gee J, Su JR, Zhang B, Thompson D, Shimabukuro TT, Shay DK. COVID-19 Vaccine Safety in Children Ages 5-11 years — United States, November 3-December 19, 2021.MMWR Morb Mort Wkly Rep. 2021 April 20. Epub ahead of print2021 Dec 31:70(5152);1755-1760.

On October 29, 2021, the FDA expanded emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include children ages 5-11 years. Once the EUA was in place, researchers began reviewing vaccine safety data for this age group, collected through the Vaccine Adverse Event Reporting System (VAERS) and v-safe. From November 3 through December 19, 2021, around 8.7 million doses of Pfizer vaccine were administered to children ages 5-11 years. During that time, VAERS received 4,249 reports of adverse events following vaccination for children in that age group, 98% of which were non-serious. There were 11 verified cases of myocarditis. Of the over 42,000 children enrolled in v-safe, 70% recorded a second dose. Local reactions (symptoms around the injection site) and systemic reactions (fever, headache, fatigue) following dose 2 of Pfizer vaccination among this age group were reported less frequently than reactions reported among children ages 12-15 years. The initial safety findings showed no unusual patterns of adverse events and that the benefits of COVID-19 vaccination continue to outweigh the risks. CDC and FDA will continue to monitor COVID-19 vaccine safety, communicate findings, and use vaccine safety data to inform vaccination recommendations.

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Moro PL, McNeil MM. Successes of the CDC monitoring systems in evaluating post-authorization safety of COVID-19 vaccines [Editorial]. Expert Rev Vaccines. 2021 Dec 27. Online ahead of print

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Belay ED, Godfred Cato S, Rao AK, Abrams J, Wilson WW, Lim S, Newton-Cheh C, Melgar M, DeCuir J, Webb B, Marquez P, Su JR, Meng L, Grome HN, Schlaudecker E, Talaat K, Edwards K, Barnett E, Campbell AP, Broder KR, Bamrah Morris S. Multisystem Inflammatory Syndrome in Adults after SARS-CoV-2 infection and COVID-19 vaccination. Clin Infect Dis. 2021 Nov 28;cia963. Online ahead of print.

Multisystem inflammatory syndrome in adults (MIS-A) is a rare but serious complication of COVID-19 disease. Because of the association with COVID-19 illness, MIS-A was included in the list of adverse events to monitor following COVID-19 vaccination. Researchers reviewed reports of MIS-A from December 14, 2020, to April 30, 2021. These MIS-A reports came from different sources, including treating clinicians, state health departments and as well as the Vaccine Adverse Event Reporting System (VAERS). During the analysis period, there were 20 patients who met the CDC case definition for MIS-A. All 20 patients had confirmed past or current COVID-19 infection. Most patients reported gastrointestinal and cardiac issues, low blood pressure, and shock. Seven patients received a COVID-19 vaccine before MIS-A onset, typically 10 days before MIS-A symptoms began; 3 patients received a second COVID-19 vaccine dose 4, 17, and 22 days before MIS-A onset. All vaccinated patients had underlying COVID-19 infection prior to MIS-A onset. MIS-A has not been reported following vaccination alone. Clinicians should report suspected MIS-A cases following COVID-19 vaccination to VAERS.

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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

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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.

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Hause AM, Baggs J, Gee J, Marquez P, Myers TR, Shimabukuro TT, Shay DK. Safety Monitoring of an Additional Dose of COVID-19 Vaccine — United States, August 12-September 19, 2021 MMWR Morb Mortal Wkly Rep. epub 2021 Sep 28.

On August 12, 2021, the Food and Drug Administration (FDA) expanded the Emergency Use Authorizations for Pfizer-BioNTech and Moderna (mRNA) COVID-19 vaccines to include an additional dose following the 2-dose vaccination series to those with compromised immune systems. From August 12 through September 19, over 22,000 v-safe enrollees reported an additional COVID-19 dose after completing the primary 2-dose mRNA vaccination series, most with the same vaccine. Among those who completed surveys for all 3 doses, local reactions (like pain or swelling where the shot was given) were reported slightly more after dose 3 compared with after dose 2 (79% vs. 78%), while reported systemic reactions (tiredness, headache) were slightly less common after dose 3 (74% vs. 77%). These side effects were mostly mild to moderate and short-lived. These findings did not show unexpected patterns of adverse events following an additional dose of COVID-19 vaccines. CDC will continue to monitor the safety of additional doses of COVID-19 vaccines and provide data to guide recommendations and protect the public’s health.

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Rosenblum HG, Hadler SC, Moulia D, Shimabukuro TT, Su JR, Tepper NK, Ess KC, Woo EJ, Mba-Jonas A, Alimchandani M, Nair N, Klein NP, Hanson KE, Markowitz LE, Wharton M, McNally VV, Romero JR, Talbot K, Lee GM, Daley MF, Mbaeyi SA, Oliver SE. Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices — United States, July 2021. MMWR Morb Mortal Wkly Rep. 2021 Aug 10.

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Hause AM, Gee J, Baggs J, Abara WE, Marquez P, Thompson D, Su JR, Licata C, Rosenblum HG, Myers TR, Shimabukuro TT, Shay DK. COVID-19 Vaccine Safety in Adolescents—United States, December 14, 2020—July 16, 2021. MMWR Morb Mortal Wkly Rep. 2021 Jul 30.

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Gargano JW, Wallace M, Hadler SC, Langley G, Su JR, Oster ME, Broder KR, Gee J, Weintraub E, Shimabukuro T, Scobie HM, Moulia D, Markowitz LE, Wharton M, McNally VV, Romero JR, Keipp Talbot H, Lee GM, Daley MF, Oliver SE. Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021. MMWR Morb Mortal Wkly Rep. 2021 Jul 9;70:977-982.

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Shay DK, Gee J, Su JR, Myers TR, Marquez P, Liu R, Zhang B, Licata C, Clark TA, Shimabukuro TT. Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine — United States, March—April 2021. MMWR Morb Mortal Wkly Rep. 2021 April 30. Epub ahead of print.

Johnson & Johnson’s Janssen COVID-19 vaccine was authorized by FDA for emergency use on February 27, 2021. By April 21, nearly 8 million doses of the Janssen COVID-19 vaccine had been administered. CDC researchers reviewed safety monitoring data from VAERS and the v-safe after-vaccination health checker, and found 97% of reported reactions after vaccination, such as headache, fever, chills, injection site pain, and fatigue, were nonserious and consistent with clinical trials data. CDC and FDA issued a pause of the Janssen vaccine April 12–23, 2021, after 6 cases of cerebral venous sinus thrombosis (CVST), a serious condition that involves blood clots in the brain, were identified in VAERS. By April 25, a total of 17 thrombotic (blood clots) events with thrombocytopenia (low platelet counts) were reported to VAERS, including 3 thrombotic events not occurring in the brain. CDC and FDA continue to monitor the safety of COVID-19 vaccines, analyzing the risks and benefits of continued use.

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MacNeil JR, Su JR, Broder KR, Guh AY, Gargano JW, Wallace M, Hadler SC, Scobie HM, Blain AE, Moulia D, Daley MF, McNally VV, Romero JR, Keipp Talbot H, Lee GM, Bell BP, Oliver SE. Updated Recommendations from the Advisory Committee on Immunization Practices for Use of Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients — United States, April 2021. MMWR Morb Mortal Wkly Rep. 2021 Apr 30;70:651-656.

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Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, Marquez PL, Olson CK, Liu T, Chang KT, Ellington SR, Burke VK, Smoots AN, Green CJ, Licata C, Zhang BC, Alimchandani M, Mba-Jonas A, Martin SW, Gee JM, Meaney-Delman DM. Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. N Engl J Med. 2021 April 21. DOI: 10.1056/NEJMoa2104983 Epub ahead of print.

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Hause AM, Gee J, Johnson T, Jazwa A, Marquez P, Miller E, Su J, Shimabukuro TT, Shay DK. Anxiety-Related Adverse Event Cluster After Janssen COVID-19 Vaccination — Five U.S. Mass Vaccination Sites, April 2021 MMWR Morb Mortal Wkly Rep. 2021 April 20. Epub ahead of print.

From April 7-9, 2021, 5 weeks after the J&J/Janssen COVID-19 vaccine was authorized by FDA for emergency use, clusters of anxiety-related events after Janssen vaccination were reported to CDC. The reports came from 5 mass vaccination sites in different states; 4 closed temporarily to investigate the cases. Of the 8,624 Janssen vaccine recipients, there were 64 reports of anxiety-related events, including 17 reports of fainting. Commonly reported symptoms were light-headedness/dizziness (56%), excessive sweating (31%), fainting (27%), nausea or vomiting (25%) and low blood pressure (16%). Additionally, CDC reviewed all reports to VAERS of fainting after Janssen vaccine between March 2 through April 11, 2021 and identified 653 reports out of 8 million doses administered. Review of reports found that fainting occurs in 8 per 100,000 doses administered. Vaccine providers should observe individuals for 15 minutes after COVID-19 vaccination for signs of immediate anxiety-related reactions or fainting.

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See I, Su JR, Lale A, Woo EJ, Guh AY, Shimabukuro TT, Streiff MB, Rao AK, Wheeler AP, Beavers SF, Durbin AP, Edwards K, Miller E, Harrington TA, Mba-Jonas A, Nair N, Nguyen DT, Talaat KR, Urrutia VC, Walker SC, Creech B, Clark TA, DeStefano F, Broder KR. US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021 JAMA 2021 April 30. Doi:10.1001/jama.2021.7517 Epub ahead of print.

Around 7 million doses of Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 vaccine were given between March 2–April 12, 2021. During this time, VAERS received reports following J&J/Janssen vaccination of cerebral venous sinus thrombosis (CVST) with thrombocytopenia, which involves blood clots in the brain with low platelet counts. By April 21, there were 12 reports of CVST and thrombocytopenia. This serious condition was reported in women between 18 and under 60 years. All were hospitalized; 10 were admitted to intensive care units (ICU). As of April 21, 4 patients were sent home, 2 were moved to hospital units outside of ICU, 3 continued ICU care, and 3 died. The review shows that U.S. cases of CVST and thrombocytopenia after J&J/Janssen vaccination were clinically similar to CVST cases in Europe after Oxford/AstraZeneca COVID-19 vaccination. Investigation of the potential relationship between J&J/Janssen vaccine and CVST with thrombocytopenia is ongoing.

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Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, Marquez PL, Olson CK, Liu T, Chang KT, Ellington SR, Burke VK, Smoots AN, Green CJ, Licata C, Zhang BC, Alimchandani M, Mba-Jonas A, Martin SW, Gee JM, Meaney-Delman DM. Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons N Engl J Med 2021 April 21. DOI: 10.1056/NEJMoa2104983 Epub ahead of print.

Pregnant people were not included in the messenger RNA (mRNA) COVID-19 vaccine clinical trials. Because of the increased risk of severe illness from COVID-19, CDC has provided guidance to pregnant people who may want to get a COVID-19 vaccine. The safety of mRNA vaccines in pregnant people is monitored through 3 systems: v-safe after vaccination health checker, the v-safe pregnancy registry and VAERS. From December 14, 2020 through February 28, 2021, 35,691 v-safe participants ages 16 to 54 identified as pregnant. Injection site pain was commonly reported. Of those, 3,958 enrolled in the v-safe pregnancy registry: 827 completed pregnancy; 712 (86.1%) had live births, with most vaccinations completed in the 3rd trimester. In the VAERS reports following mRNA vaccinations, 155 (70.1%) were nonpregnancy specific; 66 (29.9%) were pregnancy and neonatal specific events. The analysis of v-safe and VAERS data did not show any safety concerns among pregnant persons who received mRNA COVID-19 vaccines.

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Woo EK, Moro PL. Postmarketing safety surveillance of quadrivalent recombinant influenza vaccine: Reports to the vaccine adverse event reporting system. Vaccine. 2021 Mar 4;S0264-410X(21)00232-2. Epub ahead of print.

The recombinant hemagglutinin quadrivalent influenza vaccine (Flublok Quadrivalent; RIV4) was approved by FDA in October 2016 for persons 18 years and older to reduce the risk from flu and flu-related complications. To analyze the safety profile of RIV4 since its approval, researchers reviewed adverse events reported to VAERS. From July 1, 2017 through June 30, 2020, VAERS received 849 reports after RIV4 vaccination. A majority of reports (810; 95%) were non-serious; injection site reactions were reported most often. There were 131 reports of allergic reactions. A majority of allergic reactions (127) were reported as non-serious, but required immediate medical care. Reports of allergic reactions do not necessarily suggest that RIV4 is particularly allergenic; some individuals may have a hypersensitivity to drug or vaccine exposure. Among serious adverse event reports, there were 10 cases of Guillain-Barré syndrome. Overall, the analysis did not identify any new safety concerns of RIV4

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Shimabukuro T, Nair N. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine JAMA 2021 Feb 23;325(8):780-781 doi: 10.1001/jama.2021.0600.

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Gee J, Marquez P, Su J, Calvert GM, Liu R, Myers T, Nair N, Martin S, Clark T, Markowitz L, Lindsey N, Zhang B, Licata C, Jazwa A, Sotir M, Shimabukuro T. First Month of COVID-19 Vaccine Safety Monitoring — United States, December 14, 2020-January 13, 2021 MMWR Morb Mortal Wkly Rep. 2021 Feb 26;70;283-288.

The U.S. FDA authorized two COVID-19 vaccines for emergency use in December 2020: Pfizer-BioNTech and Moderna. During clinical trials, there were reports of local reactions where the shot was given, and systemic reactions affecting other parts of the body. Safety monitoring for these vaccines has been the most intense and comprehensive in U.S. history. From December 14, 2020 through January 13, 2021, almost 14 million vaccine doses were distributed. During that time, over 1.6 million vaccine recipients enrolled in v-safe, and VAERS received 6,994 reports of adverse events following vaccination.  About 91% of VAERS reports were non-serious; commonly reported symptoms included headache (22.4%), fatigue (16.5%) and dizziness (16.5%). V-safe enrollees reported similar local and systemic reactions. While deaths were reported to VAERS, available documentation did not suggest a causal link between the vaccine and death. Overall, no unusual or unexpected reporting patterns were detected.

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Shimabukuro T, Cole M, Su JR. Reports of Anaphylaxis After Receipt of mRNA COVID-19 Vaccines in the US—December 14, 2020-January 18, 2021. JAMA 2021 Feb 12; doi:10.1001/jama.2021.1967. Epub ahead of print.

In December 2020, FDA issued Emergency Use Authorizations for two mRNA-based vaccines for prevention of COVID-19 disease: Pfizer-BioNTech COVID-19 vaccine (December 11) and Moderna COVID-19 vaccine (December 18). After implementation of the vaccines, cases of anaphylaxis following both vaccines were reported. Anaphylaxis is a severe, life-threatening allergic reaction that can occur after vaccination. During December 14, 2020 through January 18, 2021, over 9.9 million doses of Pfizer-BioNTech vaccine and over 7.5 million doses of Moderna vaccine were administered.  In this same time, CDC identified 66 anaphylaxis cases reported to VAERS: 47 following Pfizer-BioNTech vaccine (rate of 4.7 cases per million doses) and 19 following Moderna vaccine (rate of 2.5 cases per million doses). There were no deaths from anaphylaxis reported after either vaccine. Continued safety monitoring of mRNA COVID-19 vaccines has confirmed anaphylaxis following vaccination is a rare event.

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CDC COVID-19 Response Team Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine— United States, December 21, 2020-January 10, 2021 MMWR Morb Mortal Wkly Rep. 2021 Jan 22:70(4);125-129.

On December 18, 2020, FDA issued an Emergency Use Authorization for Moderna COVID-19 vaccine to prevent COVID-19. As of January 10, 2021, over 4 million first doses of the vaccine had been administered. Many people did not have any side effects after COVID-19 vaccination. However, some serious adverse reactions were reported, such as the life-threatening allergic reaction, anaphylaxis. From December 21, 20201 through January 10, 2021, VAERS received 108 reports following Moderna vaccine identified as possible allergic reaction, including anaphylaxis. Through case review of medical reports, 10 cases were determined to be anaphylaxis (a rate of 2.5 cases of anaphylaxis per million doses). Of the 10 cases, 9 had a history of allergies or allergic reaction, including 5 who had a history of anaphylaxis. Anaphylaxis following Moderna vaccine appears to be a rare event. CDC and FDA will continue to monitor for anaphylaxis following COVID-19 vaccines.

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CDC COVID-19 Response Team Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14-23, 2020 MMWR Morb Mortal Wkly Rep. 2021 Jan 15:70(2);46-51.

On December 11, 2020, FDA issued an Emergency Use Authorization for Pfizer-BioNTech COVID-19 vaccine to prevent COVID-19. As of December 23, 2020, over 1.8 million first doses of the vaccine had been administered. During this time, CDC and FDA were notified through multiple channels of suspected cases of anaphylaxis following vaccination. Anaphylaxis is a severe, life-threatening allergic reaction that occurs rarely after vaccination.  From December 14-23, 2020, VAERS received 175 reports identified as possible allergic reaction, including anaphylaxis. Through case review of medical reports, 21 cases were determined to be anaphylaxis (a rate of 11.1 cases of anaphylaxis per million doses). Most anaphylaxis cases (81%) occurred in persons with a history of allergies or allergic reactions. Anaphylaxis following Pfizer-BioNTech vaccine appears to be a rare event. CDC and FDA will continue to monitor for anaphylaxis following COVID-19 vaccines.

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Su JR, McNeil MM, Welsh KJ, Marquez PL, Ng C, Yan M, Cano MV. Myopericarditis after vaccination, Vaccine Adverse Event Reporting System (VAERS), 1990-2018. Vaccine. 2021 Jan 29; 39(5):839-845. Epub 2021 Jan 6.

Myopericarditis, an inflammation of the heart muscle and tissue around the heart, has many causes including viral infections. While not confirmed as a cause, myopericarditis after vaccination has been periodically reported. Researchers identified reports of myopericarditis following vaccination submitted to the Vaccine Adverse Event Reporting System (VAERS) from 1990–2018. During 1990–2018, VAERS received a total 620,195 reports: 708 (0.1%) met the case definition or were physician-diagnosed as myopericarditis. Most (79%) reports described males, 69% were serious, and 72% had symptom onset within 2 weeks of vaccination. Overall, smallpox (59%) and anthrax (23%) vaccines were most commonly reported, with higher reporting rates only after smallpox vaccine. Myopericarditis remains rarely reported after vaccines licensed for use in the United States. In this analysis, myopericarditis was most commonly reported after smallpox vaccine, and less commonly after other vaccines.

Moro PL, Marquez P. Reports of cell-based influenza vaccine administered during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2013-2020. Vaccine. 2021 Jan 22;39(4):678-681. Epub 2020 Dec 25.

Flucelvax (ccIIV3 or ccIIV4; ccIIV) was approved by FDA for use in persons aged 18 years and older. There are limited data on the safety of ccIIV in pregnant women or their infants. To assess the safety of ccIIV given during pregnancy, researchers searched VAERS for reports of adverse events (AEs) from July 1, 2013 through May 31, 2020. During that time, VAERS received 4,852 reports following ccIIV, and 391 reports included pregnant women (8%). Of those, 24 (6.1%) were classified as serious. Two neonatal deaths were reported; no maternal deaths occurred. Among the 340 reports with trimester information, ccIIV was administered during the second trimester in 170 (50%). The most frequently reported pregnancy-specific AE was premature delivery (85; 21.7%). There were 62 reports (15.9%) of low birth weight of infants and 15 report of birth defects. While these results are different than previous pregnancy reviews after inactivated influenza vaccines (IIV), no safety concerns were identified.

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Haber P, Tate J, Marquez PL, Moro PL, Parashar U. Safety Profile of rotavirus vaccines among individuals aged ≥8 months of age, United States, vaccine adverse event reporting system (VAERS), 2006-2019. Vaccine. 2020 Nov 29;S0264-410X(20)31466-3. Online ahead of print.

Two live oral rotavirus vaccines, RotaTeq (RV5) and Rotarix (RV1), were introduced into the routine vaccination program in 2006 and 2008, respectively. RV1 is administered at ages 2 and 4 months and RV5 is administered at ages 2, 4, and 6 months. The series is recommended prior to 8 months of age to decrease the risk of intussusception (IS), an intestinal obstruction common in younger children. However, there is limited safety data on the vaccines when given to children older than 8 months. Researchers in the Vaccine Adverse Event Reporting System (VAERS) analyzed reports of adverse events (AEs) following rotavirus vaccination submitted January 2006 through December 2019. A total 344 reports were submitted: 309 reports included children 8 months to 5 years of age, and 35 reports included children 6 years and older. While known AEs were identified – diarrhea, fever and vomiting – no new or unexpected safety concerns were identified for those vaccinated beyond the recommended age.

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Duffy J, Marquez P, Dores GM, Ng C, Su J, Cano J, Perez-Vilar S. Safety Surveillance of bivalent meningococcal group B vaccine, Vaccine Adverse Event Reporting System, 2014-2018. Open Forum Infec Dis.2020 Oct 27. Online ahead of print.

Licensed in October 2014, MenB-FHbp was the first meningococcal group B vaccine approved for use in the United States. The Advisory Committee on Immunization Practices recommends the 3-dose series for individuals aged 10-25 years who are at an increased risk of meningococcal B disease. Researchers reviewed reports of adverse events (AEs) following MenB-FHbp submitted to the Vaccine Adverse Event Reporting System (VAERS) from October 2014 through December 2018. During this time period, VAERS received 2,106 reports involving MenB-FHbp, representing 698 reports per million doses distributed (over 3 million doses were distributed in this analysis period). The most common AEs reported were fever (27%), headache (25%), and pain (16%). Overall, the review did not identify any new safety issues. The most commonly reported AEs following MenB-FHbp were consistent with those identified in clinical trials as described in the package insert.

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Miller ER, McNeil MM, Moro PL, Duffy J, Su JR. The reporting sensitivity of the Vaccine Adverse Event Reporting System (VAERS) for anaphylaxis and for Guillain-Barré syndrome. Vaccine. 2020 Nov 3;38(47)7458-7463. Epub 2020 Oct 7.

Underreporting is an important limitation that is common to passive surveillance systems. The number of adverse events (AEs) that occur after vaccination and the percentage of those that get reported to the Vaccine Adverse Event Reporting System (VAERS) is unknown. To determine the sensitivity of VAERS in capturing AE reports, researchers analyzed pre-specified outcomes – anaphylaxis and Guillain-Barré syndrome (GBS) – reported to VAERS and determined if they are similar to previous estimates for other severe AEs. These estimates used were obtained from published studies of the Vaccine Safety Datalink of anaphylaxis and GBS following vaccination.  VAERS sensitivity for capturing anaphylaxis after seven different vaccines ranged from 13-76%; sensitivity for capturing GBS after three different vaccines ranged from 12-64%. For anaphylaxis and GBS, VAERS sensitivity is comparable to previous estimates for detecting important AEs following vaccination.

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Myers TR, McNeil MM, NG CS, Li R, Marquez PL, Moro PL, Omer SB, Cano MV. Adverse Events Following Quadrivalent Meningococcal Diphtheria Toxoid Conjugate Vaccine (Menactra ®) Reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2016. Vaccine. 2020 Sep 11;38(40):6291-6298 Epub 2020 Jul 31.

Licensed in January 2005, Menactra was the first quadrivalent meningococcal conjugate vaccine approved to provide protection against invasive meningococcal disease. It is licensed for use in individuals aged 9 months through 55 years. Researchers reviewed reports of adverse events (AEs) after Menactra to the Vaccine Adverse Event Reporting System (VAERS) from 2005-2016, including serious reports, selected pre-specified outcomes, and use during pregnancy. From January 2005 thought June 2019, VAERS received 13,075 reports of AEs following Menactra vaccination. Most reports (94%) were classified as non-serious; commonly reported AEs included injection site redness and swelling, fever, headache, and dizziness. There were 36 reports of death following Menactra; researchers did not find any evidence to suggest the vaccine caused the deaths. This review did not reveal any new safety concerns and provides further reassurance regarding the safety of Menactra.

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Moro PL, Woo EL, Marquez P, Cano M. Monitoring the safety of high-dose, trivalent inactivated influenza vaccine in the vaccine adverse event reporting system (VAERS), 2011-2019. Vaccine. 2020 Aug 18;38(37):5923-5926. Epub 2020 Jul 21.

Older adults are at higher risk of developing serious complications from flu. In December 2009, the high-dose trivalent influenza vaccine (IIV3-HD) was licensed for adults 65 years and older. Using the Vaccine Adverse Event Reporting System, researchers analyzed the 12,320 reports submitted after IIV3-HD vaccination from 2011-2019. Of the total, there were 61 reports of GBS and 13 of anaphylaxis. Nearly 6% of all reports were classified as serious (723). The most commonly reported serious events were fever (30.2%), weakness (28.9%), and shortness of breath (24.9%). There were 55 reports of death following IIV3-HD, and cause of deaths reported were typical for those in this age group with no evidence to suggest the vaccine caused the deaths. There were reports of 13 pregnant women and 59 children who inadvertently received IIV3-HD. Overall, this review of IIV3-HD did not reveal any new safety concerns among individual adults 65 years and older.

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Suragh TA, Hibbs B, Marquez P, McNeil MM. Age inappropriate influenza vaccination in infants less than 6 months old, 2010-2018 Vaccine. 2020 May 6;38(21):3747-3751. Epub Apr 6.

Annual influenza (flu) vaccination is recommended for everyone 6 months or older, and vaccination in infants less than 6 months old is a vaccine error. There are few safety studies in this population. Researchers searched the Vaccine Adverse Event Reporting System (VAERS) for reports of adverse events (AEs) following flu vaccination in infants less than 6 months old from 2010-2018. A total of 114 reports were found; 21 reported a specific AE. Fever, irritability, crying and diarrhea were the most common symptoms. Researchers identified several risk factors: 1) individuals getting vaccinated together resulting in patient mix-ups, 2) healthcare provider not verifying the patient’s information, and 3) provider confusion due to similarities in vaccines’ packaging and names of vaccines that sound alike. This study adds valuable information about the general absence of serious AEs in infants vaccinated with flu vaccine; yet, providers should be vigilant to avoid these preventable errors.

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Hause AM, Hesse EM, Ng C, Marquez P, McNeil MM, Omer SB. Association Between Vaccine Exemption Policy Change in California and Adverse Event Reporting. Pediatr Infec Dis J., 2020 May; 39(5):369-373. Epub 2020 Mar 5.

California Senate Bill 277 (SB277) eliminated non-medical immunization exemptions starting February 19, 2015. Since the bill’s introduction, the rate of medical exemptions in the state has increased. There is a perception that filing a report to the Vaccine Adverse Event Reporting System (VAERS) may aid in applying for a medical exemption. Researchers wanted to describe trends of reporting to VAERS after SB277. From June 2011-July 2018, 6,703 VAERS reports were submitted from California. Parent-submitted reports increased after SB277, from 14% to 23%. The median reporting time by parents increased from 9 days post-vaccination in 2013-2014 to 31 days in 2016-2017. Overall, there was an increase in reports submitted more than 6 months post-vaccination and reports describing behavioral and developmental symptoms. These changes in reporting patterns after SB277’s implementation may indicate more parents are using VAERS to assist in applying for a medical exemption for their child.

Haber P, Moro PL, Ng C, Dores GM, Perez-Vilar S, Marquez PL, Cano M. Safety review of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccines (Tdap) in adults aged ≥ 65 years, Vaccine Adverse Event Reporting System (VAERS), United States, September 2010 – December 2018. Vaccine. 2020 Feb 5;38(6):1476-1480. Epub 2019 Dec 28.

The Advisory Committee on Immunization Practices recommends vaccination in adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap). To date, few studies have assessed the safety of Tdap in this age group. Using the Vaccine Adverse Event Reporting System (VAERS), researchers analyzed reports of adverse events (AEs) following Tdap in adults 65 years and older. From September 2010 to December 2018, VAERS received 1,798 reports; 94% were classified as non-serious. The most common AEs were injection site redness (26%), pain (19%), and swelling (18%). Of 104 serious reports, 7 deaths were reported; none had evidence to suggest the vaccine caused the deaths. Serious non-death reports included nervous system disorders (35.1%; n=34) and infections (18.6%; n=18). Overall, the analysis did not identify any new safety concerns and is consistent with prior post-marketing observations and pre-licensure studies.

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Su JR, Haber P, Ng CS, Marquez PL, Dores GM, Perez-Vilar S, Cano MV. Erythema multiforme, Stevens Johnson syndrome, and toxic epidermal necrolysis reported after vaccination, 1999-2017. Vaccine. 2020 Feb 11;38(7): 1746-1752. Epub 2019 Dec 20.

While some dermatologic adverse events are common after vaccination (i.e. redness at the injection site), erythema multiforme (EM), Stevens Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and SJS/TEN are rare. Since the last review of VAERS data for these conditions, over 37 new vaccines were approved for use in the United States. Of the 466,027 reports to VAERS during 1999–2017, researchers identified and reviewed 984 reports of EM, 89 of SJS, 6 of SJS/TEN, and 7 of TEN. Most reports of EM (91%) were non-serious; 52% of SJS and all reports of SJS/TEN and TEN were serious. Most reports (58%) occurred within 7 days after vaccination. Childhood vaccines were reported most often; 48% of reports were of children younger than 4 years. Of 6 reported deaths, 5 were exposed or potentially exposed to medications known to cause these conditions, and 1 had severe dehydration. Overall, reporting of these conditions after vaccination remained rare, with no new safety concerns identified.

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Hibbs BF, Ng CS, Museru O, Moro PL, Marquez P, Woo EJ, Cano MV, Shimabukuro TT. Reports of atypical shoulder pain and dysfunction following inactivated influenza vaccine, Vaccine Adverse Event Reporting System (VAERS), 2010-2017. Vaccine. 2020 Jan 29;38(5):1137-1143. Epub 2019 Nov 26.

Some case reports have suggested that if inactivated influenza vaccine (IIV) is improperly administered, shoulder dysfunction may occur. Researchers reviewed reports of adverse events (AEs) made to the Vaccine Adverse Event Reporting System (VAERS) following IIV from July 2010 to June 2017. During this time, approximately 996 million flu vaccine doses were distributed in the United States. Of the 59,230 reports submitted, 1,220 met analysis criteria of atypical shoulder pain and dysfunction starting within 48 hours following IIV and continuing for more than 1 week. The analysis suggests these reports were not common, averaging 2% of flu vaccine AEs reported each year; most were females (82.6%), median age was 52 years. While the cause of these cases is unknown, vaccines given improperly might be a factor. Proper vaccine administration education and training are preventive measures.

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Shimabukuro TT, Su JR, Marquez PL, Mba-Jonas A, Arana JE, Cano MV. Safety of the 9-Valent Human Papillomavirus Vaccine. Pediatrics 2019 Dec; 144(6). pii: e20191791. 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. Researchers analyzed reports of adverse events (AEs) after 9vHPV to the Vaccine Adverse Event Reporting System (VAERS) from December 2014 to December 2017. During that time, approximately 28 million 9vHPV doses were distributed in the United States. Of the 7,244 reports received, 31% were female, nearly 22% were male, and 47% of reports did not identify gender. Over 97% of reports were classified as non-serious. There were 2 deaths reported; no information in the reports or medical records suggested the deaths were related to vaccination. Overall, the analysis revealed no new or unexpected safety concerns. The 9vHPV safety profile is consistent with pre-licensure clinical trial data, and with the post-marketing safety data of Gardasil, the earlier quadrivalent HPV vaccine.

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Moro PL, McNeil MM. Challenges in evaluating post-licensure vaccine safety: observations from the Center for Disease Control and Prevention. Expert Rev Vaccines. 2019 Oct; 18(10): 1091-1101 Epub 2019 Oct 19.

There is overwhelming scientific evidence that supports the safety of vaccines and their proven ability to prevent illness and death caused by infectious diseases. Yet like any medicine, no vaccine can be considered completely safe and completely effective. Prior to licensure, vaccines undergo extensive safety and efficacy evaluations. After licensure, they require follow up studies and continuous monitoring to investigate any new or unexpected adverse events (AEs). This article presents challenges in monitoring U.S. vaccines for AEs after licensure and describes CDC’s post-licensure safety surveillance infrastructure, including the Vaccine Adverse Event Reporting System, the Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment project. The authors describe each system’s unique strengths and limitations, and the harmonized approach they provide in meeting vaccine safety monitoring challenges.

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McNeil MM, Paradowska-Stankiewicz I, Miller ER, Marquez PL, Seshadri S, Collins LC Jr, Cano MV. Adverse events following adenovirus type 4 and type 7 vaccine, live, oral in the Vaccine Adverse Event Reporting System (VAERS), United States, October 2011-July 2018. Vaccine. 2019 Oct 16; 37(44): 6760-6767 Epub 2019 Sep 20.

Adenovirus vaccine (adenovirus type 4 and type 7, live, oral) was licensed by FDA in March 2011 for use in U.S. military personnel ages 17-50 years. The vaccine was first routinely given to recruits in October 2011. Researchers reviewed reports of adverse events (AEs) following the adenovirus vaccine from October 2011 to July 2018 using the Vaccine Adverse Event Reporting System (VAERS). VAERS received 100 adverse event reports; 39 were considered serious. While the reporting rate for serious AEs was higher than with other vaccines given in a comparison recruit population (39% versus 18%), no unexpected or concerning pattern of adenovirus vaccine AEs were identified. Reports showed multiple other vaccines (95%) and penicillin G (50%) were given at the same time, and these exposures may have contributed to the higher reporting rate for serious AEs observed with the adenovirus vaccine. Future studies without these exposures would be helpful in clarifying the vaccine’s safety profile.

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McNeil MM. Vaccine-Associated Anaphylaxis. Curr Treat Options Allergy. 2019 Sep; 6(3): 297-308. Epub 2019 Jul 16

Anaphylaxis is a rare, serious hypersensitivity reaction, which can happen within minutes and is characterized by multisystem involvement. Although anaphylaxis may occur after any vaccine, the risk following flu vaccines is important to understand due to the large number of persons vaccinated annually. This review looks at two recent CDC studies that confirm its rarity. In a 25-year review of data from the Vaccine Adverse Event Reporting System, reports in children most commonly followed childhood vaccinations, and in adults most often followed influenza vaccine. In a Vaccine Safety Datalink study, the estimated incidence of anaphylaxis was 1.3 per million vaccine doses administered for all vaccines and 1.6 per million doses for IIV3 (trivalent) influenza vaccine. Despite its rarity, the rapid onset and potentially lethal nature of anaphylaxis requires that all personnel and facilities providing vaccinations have procedures in place to treat it.

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Hesse EM, Hibbs BF, Cano MV. Notes from the Field: Administration of Expired Injectable Influenza Vaccines Reported to the Vaccine Adverse Event Reporting System — United States, July 2018–March 2019. MMWR Morb Mortal Wkly Rep. 2019; 68: 529–530. 2019 June 14.

During the 2018-2019 flu season, the Vaccine Adverse Event Reporting System received 125 reports (totaling 192 patients) of people receiving expired inactivated influenza vaccine (IIV). During that time, 169.1 million doses of seasonal flu vaccine were distributed. Of those who received the expired IIV, 70% were in high-risks group for influenza (under the age of 5, over the age of 50 and pregnant women). Researchers found the reported adverse events were consistent with adverse events following administration of non-expired seasonal IIV, suggesting no additional safety issues associated with receipt of expired IIV. To avoid inadvertent administration of expired IIV, CDC recommends facilities that administer vaccines follow the guidance in the Vaccine Storage and Handling Toolkit, and make plans for the safe disposal or return of any remaining IIV after the expiration date of June 30 each year.

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Moro PL, Arana J, Marquez PL, Ng C, Barash F, Hibbs BF, Cano M. Is there any harm in administering extra-doses of vaccine to a person? Excess doses of vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2007-2017. Vaccine. 2019 Jun 19; 37(28): 3730-3734. Epub 2019 May 30.

The administration of an extra dose of a vaccine may occur due to a vaccination error or when there is need to provide immunization in a person with uncertain vaccination histories (e.g., refugees). There is little data available on the safety of an extra dose of vaccine. Researchers searched for adverse events following the administration of excess doses of vaccines using the Vaccine Adverse Events Reporting System from January 2007 through the end of July 2017. Of 366,815 total reports received, over 5,000 (1.4%) reported an excess dose of vaccine was administered and less than 4,000 (76.9%) did not describe an AE. The top two vaccines reported were trivalent inactivated influenza (15.4%), and varicella (13.9%). The most common events were fever (12.8%), and injection site reaction (9.7%). Among reports where an AE was reported, researchers did not observe any unexpected conditions or clustering of AEs.

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Kochhar S, Edwards KM, Ropero Alvarez AM, Moro PL, Ortiz JR. Introduction of new vaccines for immunization in pregnancy – Programmatic, regulatory, safety and ethical considerations. Vaccine. 2019 May 31; 37(25): 3267-3277. Epub  2019 May 6.

Women are encouraged to get immunizations when they are pregnant; but in certain areas of the world, there are no programs to implement vaccine recommendations. Maternal immunization is a promising strategy to reduce infectious disease-related illness and death in pregnant women and their infants. Pre-requisites for introducing immunization during pregnancy include: (1) political commitment and adequate financial resources, (2) healthcare workers to deliver vaccines, (3) combining immunization programs with prenatal care and maternal/child health services, and (4) access to prenatal care for pregnant women in low and middle-income countries where births occur in healthcare facilities. A system to advance a vaccine program from product licensure to successful country-level implementation needs to include evidence of anticipated vaccine program impact, developing supportive policies, and translating policies into local action.

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Su JR, Moro PL, Ng CS, Lewis PW, Said MA, Cano MV. Anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System, 1990-2016. J  Allergy Clin Immunol. 2019 Apr;143(4):1465-1473. Epub 2019 Jan 14.

Anaphylaxis is a rare, potentially life-threatening hypersensitivity reaction that can occur after vaccination. During 1990–2016, the Vaccine Adverse Event Reporting System (VAERS) received a total of 467,960 reports. Researchers identified 828 reports describing persons who were physician-diagnosed with or met the Brighton Collaboration case definition for anaphylaxis. Of reports in people aged 18 years or younger, 65% were male; childhood vaccines were most commonly reported. Of reports in people aged 19 years and older, 80% were female, and influenza vaccines were most commonly reported. Over 40% of the 828 reports described persons with no history of hypersensitivity. Of 8 reported deaths, 4 had no history of hypersensitivity. Anaphylaxis after vaccination is rare, but can occur, including among persons with no history of hypersensitivity. Providers who administer vaccines should be prepared to manage severe hypersensitivity reactions.

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Haber P, Moro PL, Ng C, Dores GM, Lewis P, Cano M. Post-licensure surveillance of trivalent adjuvanted influenza vaccine (aIIV3; Fluad), Vaccine Adverse Event Reporting System (VAERS), United States, July 2016-June 2018. Vaccine. 2019 Mar 7;37(11):1516-1520. Epub 2019 Feb 7.

Trivalent adjuvanted influenza vaccine (aIIV3; Fluad®) was approved in the U.S. in 2015 for adults aged 65 years and older, and has been in use since the 2016-2017 influenza season. Using the Vaccine Adverse Event Reporting System, researchers analyzed U.S. reports for aIIV3 submitted from July 2016 to June 2018, totaling 630 reports. Of note, there were 79 reports of people under the age of 65 who received the vaccine. The most commonly reported adverse events were consistent with pre-licensure studies, and included injection site pain and redness. Researchers did not identify any new safety concerns associated with aIIV3 among individuals indicated for the vaccine (65 years of age or older). Importantly, vaccine providers should be aware of and follow the prescribing information for the vaccine and administer it only to patients in the recommended age range.

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Hesse EM, Shimabukuro TT, Su JR, et al. Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) — United States, October 2017–June 2018. MMWR Morb Mortal Wkly Rep 2019;68:91–94.

This is the first report covering post-licensure safety monitoring of the recombinant zoster vaccine (RZV; Shingrix, GSK) in the Vaccine Adverse Event Reporting System (VAERS) during the initial 8 months of use in the United States. From October 2017 to June 2018, VAERS received 4,381 adverse event reports related to Shingrix; 4,251 (97%) were classified as non-serious. During that timeframe, about 3.2 million doses of Shingrix were distributed in the United States. The most common symptoms reported were fever, and injection site pain and redness. These findings are consistent with pre-licensure clinical trial data, and no unexpected patterns were detected. Clinicians should counsel patients to expect common reactions such as pain, swelling, and redness at the injection site, along with possible body aches, fever, and chills. These reactions usually resolve on their own in 2 to 3 days.

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Landazabal CS, Moro PL, Lewis P, Omer SB. Safety of 9-valent human papillomavirus vaccine administration among pregnant women: Adverse event reports in the Vaccine Adverse Event Reporting System (VAERS), 2014-2017. Vaccine. 2019 Feb 21;37(9):1229-1234. Epub 2019 Jan 16.

9-valent human papillomavirus vaccine (9vHPV) was approved by FDA in December 2014. 9vHPV is not recommended during pregnancy but some women of childbearing age may be inadvertently exposed. This study assessed reports to Vaccine Adverse Event Reporting System (VAERS) of pregnant women vaccinated with 9vHPV in the United States between December 2014-December 2017. Disproportionate reporting of adverse events (AEs) was assessed using proportional reporting ratios. A total of 82 pregnancy reports were identified. Sixty reports (73.2%) did not describe an AE. The most frequently reported AEs were miscarriage and injection site reactions (both n=3; 3.7%). Of note, miscarriage may occur in up to one-third of pregnancies; the observed reports in this study were not unusual or unexpected. No disproportional reporting for any AE was found. Overall, no unexpected AEs were observed among these pregnancy reports.

Suragh TA, Lewis P, Arana J, Mba-Jonas A, Li R, Stewart B, Shimabukuro TT, Cano M. Safety of bivalent human papillomavirus vaccine in the US vaccine adverse event reporting system (VAERS), 2009-2017. Br J Clin Pharmacol. 2018 Dec;84(12):2928-2932. Epub 2018 Sep 21.

In 2009, bivalent human papillomavirus vaccine (2vHPV, Cervarix) was licensed for use in the United States. Due to low use in the marketplace, the manufacturer stopped supplying 2vHPV in the United States in 2016 and withdrew it from the U.S. market completely in late 2017. The vaccine is currently licensed and used in at least 134 other countries worldwide. In this review, reports submitted to the Vaccine Adverse Event Reporting Systems (VAERS) following 2vHPV vaccination during 2009-2017 were analyzed. During this period, over 720,000 2vHPV doses were distributed in the U.S.; VAERS received 241 adverse event reports. Researchers did not identify any new or unexpected safety concerns in their review.

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Moro PL, Lewis P, Cano M Adverse events following purified chick embryo cell rabies vaccine in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 2006-2017 – Correspondence Travel Medicine and Infectious Disease 2018 Oct. ISSN 1477-8939.

Rabies is a viral disease of mammals most often transmitted through the bite of a rabid animal and is life threatening. For those exposed to the virus, the benefits of vaccination outweigh the risks. There are two cell cultures rabies vaccines available in the United States: human diploid cell vaccine (HDCV – licensed in 1980) and purified chick embryo cell vaccine (PCECV – licensed in 1997). A safety study on PCECV has not been done since 2005. Researchers re-assessed the safety of the vaccine in the Vaccine Adverse Event Reporting System (VAERS) from January 2006 through June 2017. Excluding non-U.S. reports and duplicate records, VAERS received 604 reports involving PCECV during the 10 year time frame. Of those, 42 were coded as serious reports. No deaths were reported. Data mining analysis did not reveal disproportional reporting for any adverse event. Adverse events reported were consistent with previous post-licensure study and no new or unexpected adverse events were observed.

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Shimabukuro TT, Miller ER, Strikas RA, Hibbs BF, Dooling K, Goud R, Cano MV Notes from the Field: Vaccine Administration Errors Involving Recombinant Zoster Vaccine — United States, 2017–2018. MMWR Morb Mortal Wkly Rep 2018;67:585–586.

During the first four months of RZV (Shingrix®) monitoring (October 20, 2017-February 20, 2018), Vaccine Adverse Event Reporting System received a total of 155 reports, of which 13 (8%) documented an administration error, some with more than one type of error. Vaccine providers may be confusing administration procedures and storage requirements between the older ZVL (Zostavax®) vaccine and the newly licensed RZV. Prior experience indicates that reports of administration errors are highest shortly after licensure and recommendation, likely due to lack of familiarity with a new vaccine. To prevent RZV administration errors, vaccine providers should be aware of prescribing information, storage requirements, preparation guidelines, and Advisory Committee on Immunization Practices recommendations for herpes zoster vaccines.

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Moro PL, Perez-Vilar S, Lewis P, Bryant-Geneview M, Kamiya H, Cano M  Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccines Pediatrics Jul 2018, 142 (1)e20174171.

Diphtheria, tetanus toxoids and acellular pertussis (DTaP) vaccines were first licensed by the Food and Drug Administration in 1991. To assess the post-licensure safety of DTaP vaccines, researchers reviewed reports of adverse events following vaccination submitted to the Vaccine Adverse Event Reporting System (VAERS). From January 1991 to December 2016, 50,157 reports were submitted to VAERS following DTaP vaccination. The most frequently reported adverse events were injection site redness (25.3%), fever (19.8%), and injection site swelling (15.0%). This assessment did not identify any new or unexpected safety issues and supports the favorable safety profile from pre-clinical trials. Reports of non-serious vaccination errors, such as incorrect vaccine administered or wrong site, call for better education of providers on the specific indications for each of the DTaP vaccines.

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Haber P, Amin M, Ng C, Weintraub E, McNeil MM Reports of lower respiratory tract infection following dose 1 of RotaTeq and Rotarix vaccines to the Vaccine Adverse Event Reporting System (VAERS), 2008–2016, Human Vaccines & Immunotherapeutics, 2018 Jul 11;14(11); 2755-2759.

A recent GlaxoSmithKline post-marketing study found a possible association between the administration of the first dose of the rotavirus vaccine Rotarix and lower respiratory tract infections (LRTI) in infants 0-6 days after vaccination. Using Vaccine Adverse Event Reporting System data, this study examined reports of LRTIs in infants 6-15 weeks old who received one of two rotavirus vaccines, Rotarix or RotaTeq, in addition to either the 7-valent (PCV7) or 13-valent (PCV13) pneumococcal conjugate vaccine. Reports of LRTIs occurring in the 0-29 day window following the first dose of the rotavirus vaccination were analyzed between January 2008 and December 2016. Researchers found LRTI rates were not different in those infants from rates of LRTIs in infants receiving other recommended childhood vaccines.

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Walker WL, Hills SL, Miller ER, Fischer M, Rabe IB. Adverse events following vaccination with an inactivated, Vero cell culture-derived Japanese encephalitis vaccine in the United States, 2012-2016.  Vaccine. 2018 Jul 5;36(29):4369-4374. Epub 2018 Jun 8.

Inactivated Vero cell culture-derived vaccine (JE-VC; IXIARO) was licensed by Food and Drug Administration in 2009 and has a generally favorable safety profile. In this review of adverse events (AEs) following JE-VC reported to Vaccine Adverse Event Reporting System during May 1, 2012 through April 30, 2016, researchers found reporting rates of AEs were similar to those of the previous analysis (2009-2012). Although reporting rates of AEs in children could not be calculated, there were low numbers of reported events in this age group. Safety surveillance for this relatively new vaccine continues to be important to monitor AE reporting rates and identify possible rare serious events.

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Su JR, Ng C, Lewis PW, Cano MV. Adverse events after vaccination among HIV-positive persons, 1990-2016. PLoS One. 2018 Jun 19:13(6); e0199229. eCollection 2018.

Vaccines are especially critical for people with chronic health conditions such as HIV infection, and are recommended by Advisory Committee on Immunization Practices and CDC based on a person’s immune status. Through this study, researchers looked at U.S. reports to Vaccine Adverse Event Reporting System during 1990-2016 to investigate if people living with HIV experienced unexpected adverse events (AEs) or unusual patterns of AEs after vaccination. The analysis found no unexpected or unusual patterns of AEs. These results support the safety of recommended vaccines in people with HIV. Of note, 2 people with HIV with severely compromised immune systems died from widespread infection after receiving live virus vaccines. Healthcare providers should be aware of a patient’s immune status prior to administration of live virus vaccines. Following ACIP best practices can help prevent rare, but life-threatening, AEs.

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Miller ER, Lewis P, Shimabukuro TT, Su J, Moro P, Woo EJ, Jankosky C, Cano M. Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015External. Hum Vaccin Immunother. 2018 May 18;14(8):1963-1969. Epub 2018 Mar 26.

Herpes zoster (HZ), or shingles, is caused by reactivation of varicella-zoster virus—the same virus that causes chickenpox. Live-attenuated HZ vaccine (zoster vaccine live, ZVL, Zostavax) was licensed by the Food and Drug Administration in 2006 to prevent shingles and is recommended by CDC for people 60 years and older. Researchers reviewed reports of adverse events following ZVL to the Vaccine Adverse Event Reporting System (VAERS) from May 1, 2006 through January 31, 2015. During this time, close to 22 million ZVL doses were distributed. VAERS received 23,092 reports; 96% were classified as non-serious. The most common adverse events reported included injection site pain (27%), HZ (17%), injection site swelling (17%) and rash (14%). This review did not detect new or unexpected safety signals.

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Arana JE, Harrington T, Cano M, Lewis P, Mba-Jonas A, Rongxia L, Stewart B, Markowitz LE, Shimabukuro TT. Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015External. Vaccine. 2018 Mar 20;36(13):1781-1788. Epub 2018 Feb 21.

This study reviewed adverse events reported to Vaccine Adverse Event Reporting Systems following Gardasil® (4vHPV) vaccination between January 2009 and December 2015. A previous review did not include males because they were not recommended for vaccination at the time; this study includes both males and females. The analysis found 94.2% of the 19,760 reported adverse events were non-serious, and included headache, nausea, and fatigue. More than 60 million 4vHPV doses were distributed in the United States at the time, making the crude adverse event reporting rate 327 reports per million 4vHPV doses distributed. No unexpected or new safety concerns or reporting patterns were found.

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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.

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Haber P, Moro PL, Ng C, Lewis PW, Hibbs B, Schillie SF, Nelson NP, Li R, Stewart B, Cano MV. Safety of Currently Licensed Hepatitis B Surface Antigen Vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015. Vaccine. 2018 Jan 25;26(4):559-564.

This study is based on a national vaccine safety data and reassures the public on the safety of Hepatitis B vaccine(s). Although it reveals increased reports of vaccine storage errors, and incorrect dose or wrong vaccine given to infants or adults, no adverse events are noted. The findings highlight the need for education and training of health providers on prevention of vaccine administration errors.

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Hibbs BF, Miller E, Shi J, Smith K, Lewis P, Shimabukuro TT. Safety of Vaccines That Have Been Kept Outside of Recommended Temperatures: Reports to the Vaccine Adverse Event Reporting System (VAERS), 2008-2012. Vaccine. 2018 Jan 25;36(4):553-558.

This review does not indicate any substantial direct health risk from administration of vaccines kept outside of recommended temperatures. However, there are potential costs and risks, including vaccine wastage, possible decreased protection, and patient inconvenience related to revaccination. Maintaining high vigilance, proper staff training, regular equipment maintenance, and having adequate auxiliary power are important components of comprehensive vaccine cold chain management.

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Schillie S, Vellozzi C, Reingold A, Harris A, Haber P, Ward JW, Nelson NP. Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep 2018 Jan 12; 67(No. RR-1): 1–31.

Hepatitis B is a serious disease that affects the liver. The virus is highly infectious and can be transmitted in the absence of visible blood. As part of the recommended immunization schedule for infants and children, Hepatitis B vaccine should be given to children in three doses between birth and 18 months of age. In January 2018, the Advisory Committee on Immunization Practices (ACIP) published new recommendations for the vaccine. These include: 1) administration of the universal hepatitis B vaccination within 24 hours of birth of medically stable infants, 2) testing pregnant women for Hepatitis B, 3) post-vaccination serologic testing for infants whose mother has an unknown hepatitis B status, and 4) the removal of lenient language for delaying the birth dose until after hospital discharge. Vaccine safety information was updated to include data from the pre- and post-licensure studies and report information from the Vaccine Adverse Events Report System from 2005 to 2015.

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Moro PL, Zheteyeva WY, Barash F, Lewis P, Cano M. Assessing the Safety of Hepatitis B Vaccination During Pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 1990-2016. Vaccine. 2018 Jan 2;26(1):50-54.

Few studies have been done on the safety of hepatitis B vaccine in pregnant women. This review describes adverse events after Hepatitis B vaccination of pregnant women reported to the Vaccine Adverse Event Reporting System (VAERS). During the period from January 1, 1990 to June 30, 2016, VAERS received 192 reports involving pregnant women following Hepatitis B vaccination. No new or unexpected safety concerns were found.

Hibbs BF, Miller E, Shi J, Smith K, Lewis P, Shimabukuro TT. Safety of vaccines that have been kept outside of recommended temperatures: Reports to the Vaccine Adverse Event Reporting System (VAERS), 2008-2012. Vaccine. 2018 Jan 25;36(4):553-558. Epub 2017 Dec 14.

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Haber P, Moro PL, Ng C, Lewis PW, Hibbs B, Schillie SF, Nelson NP, Li R, Stewart B, Cano MV. Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015. Vaccine. 2018 Jan 25;36(4):559-564. Epub 2017 Dec 11.

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Loharikar A, Suragh TA, MacDonald NE, Balakrishnan MR, Benes O, Lamprianou S, Hyde TB, McNeil MM. Anxiety-related adverse events following immunization (AEFI): A systematic review of published clusters of illness. Vaccine. 2018 Jan 4;36(2):299-305. Epub 2017 Nov 29.

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Moro PL, Zheteyeva Y, Barash F, Lewis P, Cano M. Assessing the safety of hepatitis B vaccination during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 1990-2016. Vaccine. 2018 Jan 2;36(1):50-54. Epub 2017 Nov 27.

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Arana J, Mba-Jonas A, Jankosky C, Lewis P, Moro PL, Shimabukuro TT, Cano M. Reports of Postural Orthostatic Tachycardia Syndrome After Human Papillomavirus Vaccination in the Vaccine Adverse Event Reporting System. J Adolesc Health. 2017 Nov;61 (5) :577-582.

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Arana J, Mba-Jonas A, Jankosky C, Lewis P, Moro PL, Shimabukuro TT, Cano M. Reports of Postural Orthostatic Tachycardia Syndrome After Human Papillomavirus Vaccination in the Vaccine Adverse Event Reporting System. J Adolesc Health. 2017 Nov;61(5):577-582.

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Izurieta HS, Moro PL, Chen RT. Hospital-based collaboration for epidemiological investigation of vaccine safety: A potential solution for low and middle-income countries? Vaccine. 2018 Jan 8;36(3):345-346. Epub 2017 Oct 21.

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Woo EJ, Moro PL, Cano M, Jankosky C. Postmarketing safety surveillance of trivalent recombinant influenza vaccine: Reports to the Vaccine Adverse Event Reporting System. Vaccine. 2017 Oct 9;35(42):5618-5621. Epub 2017 Sep 5.

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Moro PL, Cragan J, Lewis P, Sukumaran L. Major Birth Defects after Vaccination Reported to the Vaccine Adverse Event Reporting System (VAERS), 1990 to 2014. Birth Defects Res. 2017 Jul 17;109(13):1057-1062.

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Moro PL, Cragan J, Lewis P, Sukumaran L. Major Birth Defects after Vaccination Reported to the Vaccine Adverse Event Reporting System (VAERS), 1990 to 2014. Birth Defects Res. 2017 Apr 11. [Epub ahead of print]

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Suragh TA, Miller ER, Hibbs BF, Winiecki SK, Zinderman C, Shimabukuro TT. Cognitive testing to evaluate revisions to the Vaccine Adverse Event Reporting System (VAERS) reporting form. Vaccine. 2017 Apr 25;35(18):2295-2297. Epub 2017 Mar 25.

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Myers TR, McNeil MM, Ng CS, Li R, Lewis PW, Cano MV. Adverse events following quadrivalent meningococcal CRM-conjugate vaccine (Menveo®) reported to the Vaccine Adverse Event Reporting system (VAERS), 2010-2015. Vaccine. 2017 Mar 27;35(14):1758-1763. Epub 2017 Mar 3.

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Su JR, Leroy Z, Lewis PW, Haber P, Marin M, Leung J, Woo EJ, Shimabukuro TT. Safety of Second-Dose Single-Antigen Varicella Vaccine. Pediatrics. 2017 Mar;139(3). Epub 2017 Feb 7.

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Moro PL, Sukumaran L. Cholera vaccination: pregnant women excluded no more. Lancet Infect Dis. 2017 May;17(5):469-470. Epub 2017 Feb 2. No abstract available.

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Moro P, Baumblatt J, Lewis P, Cragan J, Tepper N, Cano M. Surveillance of Adverse Events After Seasonal Influenza Vaccination in Pregnant Women and Their Infants in the Vaccine Adverse Event Reporting System, July 2010-May 2016. Drug Saf. 2017 Feb;40(2):145-152.

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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(3):109-110. No abstract available.

Haber P, Arana J, Pilishvili T, Lewis P, Moro PL, Cano M. Post-licensure surveillance of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ⩾19years old in the United States, Vaccine Adverse Event Reporting System (VAERS), June 1, 2012-December 31, 2015. Vaccine. 2016 Dec 7;34(50):6330-6334. Epub 2016 Nov 9.

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Chen RT, Moro PL, Bauwens J, Bonhoeffer J. Obstetrical and neonatal case definitions for immunization safety data. Vaccine. 2016 Dec 1;34(49):5991-5992. Epub 2016 Aug 20. No abstract available.

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Moro PL, Woo EJ, Paul W, Lewis P, Petersen BW, Cano M. Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015. PLoS Negl Trop Dis. 2016 Jul 13;10(7):e0004846. eCollection 2016 Jul.

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Moro PL, Li R, Haber P, Weintraub E, Cano M. Surveillance systems and methods for monitoring the post-marketing safety of influenza vaccines at the Centers for Disease Control and Prevention. Expert Opin Drug Saf. 2016 Sep;15(9):1175-83. Epub 2016 Jun 16. Review.

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Miller ER, Moro PL, Cano M, Lewis P, Bryant-Genevier M, Shimabukuro TT. Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013. Vaccine. 2016 May 27;34(25):2841-6. Epub 2016 Apr 15.

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Haber P, Moro PL, Lewis P, Woo EJ, Jankosky C, Cano M. Post-licensure surveillance of quadrivalent inactivated influenza (IIV4) vaccine in the United States, Vaccine Adverse Event Reporting System (VAERS), July 1, 2013-May 31, 2015. Vaccine. 2016 May 11;34(22):2507-12. Epub 2016 Mar 23. Review.

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Moro PL, Cragan J, Tepper N, Zheteyeva Y, Museru O, Lewis P, Broder K. Enhanced surveillance of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines in pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2011-2015. Vaccine. 2016 Apr 29;34(20):2349-53. Epub 2016 Mar 22.

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Haber P, Moro PL, Ng C, Lewis PW, Hibbs B, Schillie SF, Nelson NP, Li R, Stewart B, Cano MV. Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015. Vaccine. 2018 Jan 25;36(4):559-564. Epub 2017 Dec 11.

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Su JR, Leroy Z, Lewis PW, Haber P, Marin M, Leung J, Woo EJ, Shimabukuro TT. Safety of Second-Dose Single-Antigen Varicella Vaccine. Pediatrics. 2017 Mar;139(3). Epub 2017 Feb 7.

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Haber P, Arana J, Pilishvili T, Lewis P, Moro PL, Cano M. Post-licensure surveillance of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ⩾19years old in the United States, Vaccine Adverse Event Reporting System (VAERS), June 1, 2012-December 31, 2015. Vaccine. 2016 Dec 7;34(50):6330-6334. Epub 2016 Nov 9.

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Moro PL, Li R, Haber P, Weintraub E, Cano M. Surveillance systems and methods for monitoring the post-marketing safety of influenza vaccines at the Centers for Disease Control and Prevention. Expert Opin Drug Saf. 2016 Sep;15(9):1175-83. Epub 2016 Jun 16. Review.

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Su JR, Miller ER, Duffy J, Baer BM, Cano MV. Notes from the Field: Administration Error Involving a Meningococcal Conjugate Vaccine–United States, March 1, 2010-September 22, 2015. MMWR Morb Mortal Wkly Rep. 2016 Feb 19;65(6):161-2. Erratum in: Errata: Vol. 65, No. 6. [MMWR Morb Mortal Wkly Rep. 2016].

Baker MA, Kaelber DC, Bar-Shain DS, Moro PL, Zambarano B, Mazza M, et al. Advanced clinical decision support for vaccine adverse event detection and reporting. Clin Infect Dis. 2015 Sep 15;61(6):864-70. Epub 2015 Jun 9.

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Chen RT, Shimabukuro TT, Martin DB, Zuber PL, Weibel DM, Sturkenboom M. Enhancing vaccine safety capacity globally: A lifecycle perspective. Vaccine. Epub 2015 Sep 30.

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Datwani H, Moro PL, Harrington T, Broder K. Chorioamnionitis following vaccination in the Vaccine Adverse Event Reporting System. Vaccine. 2015 Jun 17;33(27):3110-3. Epub 2015 May 11.

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Haber P, Parashar UD, Haber M, DeStefano F. Intussusception after monovalent rotavirus vaccine—United States, Vaccine Adverse Event Reporting System (VAERS), 2008–2014. Vaccine. 2015 Sep 11;33(38):4873-7. Epub 2015 Aug 11.

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Hibbs BF, Moro PL, Lewis P, Miller ER, Shimabukuro T. Vaccination errors reported to the Vaccine Adverse Event Reporting System, United States, 2000–2013. Vaccine. 2015 Jun 22;33(28):3171-8. Epub 2015 May 14.

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Iqbal S, Shi J, Seib K, Lewis P, Moro PL, Woo EJ, et al.  Preparation for global introduction of inactivated poliovirus vaccine: Safety evidence from the US Vaccine Adverse Event Reporting System, 2000-2012. Lancet Infect Dis. 2015 Oct;15(10):1175-82. Epub 2015 Aug 16.

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Miller ER, Moro PL, Cano M, Shimabukuro T. Deaths following vaccination: What does the evidence show? Vaccine. 2015 Jun 26;33(29):3288-92. Epub 2015 May 23.

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Miller ER, Shimabukuro T, Hibbs B, Moro P, Broder K, Vellozzi C. Vaccine safety resources for nurses. Am J Nurs. 2015 Aug; 115(8):55-58.

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Moro PL, Arana J, Cano M, Lewis P, Shimabukuro TT. Deaths reported to the Vaccine Adverse Event Reporting System, United States, 1997-2013. Clin Infect Dis. 2015 Sep 15;61(6):980-7. Epub 2015 May 28.

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Moro PL, Jankosky C, Menschik D, Lewis P, Duffy J, Stewart B, et al.  Adverse events following Haemophilus influenzae type b vaccines in the Vaccine Adverse Event Reporting System, 1990-2013. J Pediatr. 2015 Apr;166(4):992-7. Epub 2015 Jan 15.

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Moro PL, McNeil MM, Sukumaran L, Broder KR. The Centers for Disease Control and Prevention’s public health response to monitoring Tdap safety in pregnant women in the United States. Hum Vaccin Immunother. Epub 2015 Sep 17.

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Moro PL, Zheteyeva Y, Lewis P, Shi J, Yue X, Museru OI, et al. Safety of quadrivalent human papillomavirus vaccine (Gardasil®) in pregnancy: Adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006-2013. Vaccine. 2015 Jan 15;33(4):519-22.

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Rabe IB, Miller ER., Fischer M, Hills SL. Adverse events following vaccination with an inactivated, Vero cell culture-derived Japanese encephalitis vaccine in the United States, 2009-2012. Vaccine. 2015 Jan 29;33(5):708-12. Epub 2014 Dec 9.

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Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2015 Aug 26;33(36):4398-405. Epub 2015 Jul 22.

Briere EC, Rubin L, Moro PL, Cohn A, Clark T, Messonnier N. Prevention and control of haemophilus influenzae type b disease: Recommendations of the advisory committee on immunization practices (ACIP) [PDF – 20 pages]. MMWR. 2014 Feb 28;63(RR-01):1-14.

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Haber P, Moro PL, McNeil MM, Lewis P, Woo EJ, Hughes H, et al. Post-licensure surveillance of trivalent live attenuated influenza vaccine in adults, United States, Vaccine Adverse Event Reporting System (VAERS), July 2005-June 2013. Vaccine. 2014 Nov 12;32(48):6499-504.

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Haber P, Moro PL, McNeil MM, Lewis P, Woo EJ, Hughes H, et al. Post-licensure surveillance of trivalent live attenuated influenza vaccine in children aged 2-18 years, Vaccine Adverse Event Reporting System (VAERS), United States, July 2005-June 2012. J Ped Infect Dis. Epub 2014 May 7.

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Hibbs BF, Miller ER, Shimabukuro T. Notes from the field: Rotavirus vaccine administration errors-United States, 2006-2013. MMWR. 2014;63(4):81.

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McNeil MM, Cano M, Miller ER, Petersen BW, Engler RJ, Bryant-Genevier MG. Ischemic cardiac events and other adverse events following ACAM2000® smallpox vaccine in the Vaccine Adverse Event Reporting System. Vaccine. 2014 Aug 20;32(37):4758-65.

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Moro PL, Museru OI, Niu M, Lewis P, Broder K. Reports to the Vaccine Adverse Event Reporting System after hepatitis A and hepatitis AB vaccines in pregnant women. Am J Obstet Gynecol. 2014 Jun;210(6):561.e1-6.

Haber P, Patel M, Pan Y, Baggs J, Haber M, Museru O, et al. Intussusception after Rotavirus Vaccines—United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2012. Pediatrics. 2013 Jun;131(6):1042-9.

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Moro PL, Harrington T, Shimabukuro T, Cano M, Museru OI, Menschik D, et al. Adverse events after Fluzone® Intradermal vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2011-2013. Vaccine. 2013 Oct 9;31(43):4984-7.

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Zheteyeva Y, Moro PL, Yue X, Broder K. Safety of meningococcal polysaccharide-protein conjugate vaccine in pregnancy: A review of the Vaccine Adverse Event Reporting System. Am J Obstet Gynecol. 2013 Jun;208(6):478.e1-6.

Broder KR, Martin DB, Vellozzi C. In the heat of a signal: Responding to a vaccine safety signal for febrile seizures after 2010–11 influenza vaccine in young children, United States. Vaccine. 2012;30(11):2032-2034.

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Leroy Z, Broder K, Menschik D, Shimabukuro T, Martin D.  Febrile seizures after 2010–2011 influenza vaccine in young children, United States: A vaccine safety signal from the vaccine adverse event reporting system. Vaccine. 2012;30(11):2020-3.

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Moro PL, Tepper NK, Grohskopf LA, Vellozzi C, Broder K. Safety of seasonal influenza and influenza A (H1N1) 2009 monovalent vaccines in pregnancy. Expert Rev Vaccines. 2012 Aug;11(8):911-21.

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Moro PL, Arana J, Cano M, Menschik D, Yue Lewis P, Haber P, et al. Postlicensure safety surveillance for high-dose trivalent inactivated influenza vaccine in the Vaccine Adverse Event Reporting System, 1 July 2010–31 December 2010. Clin Infect Dis.2012; 54(11):1608-14. Epub 2012 Mar 22.

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Zheteyeva YA, Moro PL, Tepper NK, Rasmussen SA, Barash FE, Revzina NV, et al. Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women. Am J Obstet Gynecol. 2012 Jul; 207(1):59.e1-7. Epub 2012 May 14.

Haber P, Iskander J, Walton K, Campbell SR, Kohl KS.  Internet-Based Reporting to the Vaccine Adverse Event Reporting System: A More Timely and Complete Way for Providers to Support Vaccine Safety. Pediatrics. 2011; 127 Suppl 1: S39-44. Epub 2011 Apr 18.

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Moro PL, Broder K, Zheteyeva Y, Revzina N, Tepper N, Kissin D, et al. Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event Reporting System. Am J Obstet Gynecol. 2011; 205(5):473.e1-9. Epub 2011 Jun 21.

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Moro PL, Yue X, Lewis P, Haber P, Broder K. Adverse events after tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine administered to adults 65 years of age and older reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2010. Vaccine. 2011;29(50):9404-8. Epub 2011 Sep 13.

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Moro PL, Broder K, Zheteyeva Y, Walton K, Rohan P, Sutherland A, et al. Adverse events in pregnant women following administration of trivalent inactivated influenza vaccine and live attenuated influenza vaccine in the Vaccine Adverse Event Reporting System, 1990-2009. Am J Obstet Gynecol. 2011 Feb; 204(2):146.e1-7. Epub 2010 Oct 20.

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Slade BA, Gee J, Broder KR, Vellozzi C. Comment on the contribution by Souayah et al., “Guillain-Barré syndrome after Gardasil vaccination: data from Vaccine Adverse Event Reporting System 2006-2009”. Vaccine. 2011; 29(5):865-6. Epub 2010 Nov 25.

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Woo EJ, Wise RP, Menschik D, Shadomy SV, Iskander J, Beeler J, et al. Thrombocytopenia after vaccination: Case reports to the US Vaccine Adverse Event Reporting System, 1990-2008. Vaccine. 2011;29(6):1319-23. Epub 2010 Nov 30.

Huang WT, Chang S, Miller ER, Woo EJ, Hoffmaster AR, Gee JE, et al. Safety assessment of recalled Haemophilus influenzae type b (Hib) conjugate vaccines–United States, 2007-2008. Pharmacoepidemiol and Drug Saf. 2010;19(3):306-10.

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Lindsey NP, Staples JE, Jones JF, Sejvar JJ, Griggs A, Iskander J, et al. Adverse event reports following Japanese encephalitis vaccination in the United States, 1999-2009.Vaccine. 2010;29(1):58-64. Epub 2010 Nov 4.

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McNeil MM, Broder KR, Vellozzi C, DeStefano F. Risk of fatal adverse events after H1N1 influenza vaccine: Limitations of passive surveillance data. Clin Infect Dis. 2010;51(7):871-2; author reply 872-3.

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Muhammad RD, Haber P, Broder KR, Leroy Z, Ball R, Braun MM, et al. Adverse events following trivalent inactivated influenza vaccination in children: Analysis of the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J. 2010 Oct 29. [Epub ahead of print]

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Vellozzi C, Broder KR, Haber P, Guh A, Nguyen M, Cano M, Lewis P, McNeil MM, Bryant M, Singleton J, Martin D, DeStefano F.  Adverse events following influenza A (H1N1) 2009 monovalent vaccines reported to the Vaccine Adverse Event Reporting System, United States, October 1, 2009-January 31, 2010. Vaccine. 2010;28(45):7248-55. Epub 2010 Sep 16.

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Wong C, Krashin J, Rue-Cover A, Saraiya M, Unger E, Calugar A, et al. Invasive and in situ cervical cancer reported to the vaccine adverse event reporting system (VAERS). J Womens Health (Larchmt). 2010 Mar;19(3):365-70.

Haber P, Sejvar J, Mikaeloff Y, DeStefano F. Vaccines and Guillain-Barré syndrome. Drug Saf.2009; 32(4):309-23.

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Hua W, Izurieta HS, Slade B, Belay ED, Haber P, Tiernan R, et al. Kawasaki disease after vaccination: Reports to the vaccine adverse event reporting system 1990-2007. Pediatr Infect Dis J. 2009;28(11):943-7.

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Niu MT, Ball R, Woo EJ, Burwen DR, Knippen M, Braun MM; et al. Adverse events after anthrax vaccination reported to the Vaccine Adverse Event Reporting System (VAERS), 1990-2007. Vaccine. 2009;27(2):290-7. Epub 2008 Nov 6.

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Patel MM, Haber P, Baggs J, Zuber P, Bines JE, Parashar UD. Intussusception and rotavirus vaccination: A review of the available evidence. Expert Rev Vaccines. 2009;8(11):1555-64.

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Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA. 2009;302(7):750-7.

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Vellozzi C, Burwen DR, Dobardzic A, Ball R, Walton K, Haber P. Safety of trivalent inactivated influenza vaccines in adults: Background for pandemic influenza vaccine safety monitoring. Vaccine. 2009 Mar 26; 27(15):2114-20. Epub 2009 Feb 6.

Asatryan A, Pool V, Chen RT, Kohl KS, Davis RL, Iskander JK; The VAERS team. Live attenuated measles and mumps viral strain-containing vaccines and hearing loss: Vaccine Adverse Event Reporting System (VAERS), United States, 1990–2003. Vaccine. 2008;26(9):1166-72. Epub 2008 Jan 22.

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Chaves SS, Haber P, Walton K, Wise RP, Izurieta HS, Schmid DS, et al. Safety of varicella vaccine after licensure in the United States: Experience from reports to the vaccine adverse event reporting system, 1995-2005. J Infect Dis. 2008;197 Suppl 2:S170-7.

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Haber P, Patel M, Izurieta HS, Baggs J, Gargiullo P, Weintraub E, et al. Postlicensure monitoring of intussusception after RotaTeq vaccination in the United States, February 1, 2006, to September 25, 2007. Pediatrics. 2008;121(6):1206-12.

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Lindsey NP, Schroeder BA, Miller ER, Braun MM, Hinckley AF, Marano N, et al. Adverse event reports following yellow fever vaccination. Vaccine. 2008;26(48):6077-82. Epub 2008 Sep 20.

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McMahon AW, Iskander JK, Haber P, Braun MM, Ball R. Inactivated influenza vaccine (IIV) in children <2 years of age: Examination of selected adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) after thimerosal-free or thimerosal-containing vaccine. Vaccine. 2008;26(3):427-9. Epub 2007 Nov 29.

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Sutherland A, Izurieta H, Ball R, Braun MM, Miller ER, Broder KR, et al. Syncope after vaccination–United States, January 2005-July 2007. MMWR. 2008 May 2;57(17):457-60.

Belongia E, Izurieta H, Braun MM, Ball R, Haber P, Baggs J, et al. Postmarketing monitoring of intussusception after RotaTeq vaccination–United States, February 1, 2006-February 15, 2007. MMWR. 2007 Mar 16;56(10):218-22.

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Haber P, Slade B, Iskander J. Guillain-Barré Syndrome (GBS) after vaccination reported to the United States Vaccine Adverse Event Reporting System (VAERS) in 2004 [Letter]. Vaccine. 2007;25(48):8101. Epub 2007 Oct 1.

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Woo EJ, Ball R, Landa R, Zimmerman AW, Braun MM; VAERS Working Group. Developmental regression and autism reported to the Vaccine Adverse Event Reporting System. Autism.2007; 11(4):301-10.

CDC. Update: Guillain-Barré syndrome among recipients of Menactra meningococcal conjugate vaccine–United States, October 2005-February 2006. MMWR. 2006 Apr 7;55(13):364-6.

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DiMiceli L, Pool V, Kelso JM, Shadomy SV, Iskander J; VAERS Team. Vaccination of yeast sensitive individuals: Review of safety data in the US vaccine adverse event reporting system (VAERS). Vaccine. 2006; 24(6):703-7. Epub 2005 Aug 9.

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Iskander J, Pool V, Zhou W, English-Bullard R; VAERS Team. Data mining in the US using the Vaccine Adverse Event Reporting System. Drug Saf. 2006;29(5):375-84.

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Miller ER, Woo EJ. Time to prevent injuries from postimmunization syncope. Nursing. 2006; 36(12 Pt.1):20.

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Varricchio F, Reed J; VAERS Working Group. Follow-up study of medication errors reported to the vaccine adverse event reporting system (VAERS). South Med J. 2006 May;99(5):486-9.

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Vellozzi C, Mitchell T, Miller E, Casey CG, Eidex RB, Hayes EB. Yellow fever vaccine-associated viscerotropic disease (YEL-AVD) and corticosteroid therapy: Eleven United States cases, 1996-2004. Am J Trop Med Hyg. 2006 Aug;75(2):333-6.

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Woo EJ, Ball R, Braun M, Clark T, Rosenstein Messonnier N, Wharton M, et al. Update: Guillain-Barré syndrome among recipients of Menactra meningococcal conjugate vaccine—United States, June 2005–September 2006. MMWR. 2006 Oct 20;55(41):1120-4.

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Woo EJ, Miller NB, Ball R; VAERS Working Group. Adverse events after hepatitis A B combination vaccine. Vaccine. 2006;24(14):2685-91. Epub 2005 Nov 9.

Izurieta HS, Haber P, Wise RP, Iskander J, Pratt D, Mink C, et al. Adverse events reported following live, cold-adapted, intranasal influenza vaccine. JAMA. 2005;294(21):2720-5. Erratum in: JAMA. 2005 Dec 28;294(24):3092.

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McMahon AW, Iskander J, Haber P, Chang S, Woo EJ, Braun MM, etc. Adverse events after inactivated influenza vaccination among children less than 2 years of age: Analysis of reports from the vaccine adverse event reporting system, 1990-2003. Pediatrics. 2005;115(2):453-60.

Begier EM, Burwen DR, Haber P, Ball R; Vaccine Adverse Event Reporting System Working Group. Postmarketing safety surveillance for typhoid fever vaccines from the Vaccine Adverse Event Reporting System, July 1990 through June 2002. Clin Infect Dis. 2004;38(6):771-9. Epub 2004 Feb 26.

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Begier EM, Langford CA, Sneller MC, Wise RP, Ball R; VAERS Working Group. Polyarteritis nodosa reports to the vaccine adverse event reporting system (VAERS): Implications for assessment of suspected vaccine-provoked vasculitis. J Rheumatol. 2004;31(11):2181-8.

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Haber P, DeStefano F, Angulo FJ, Iskander J, Shadomy SV, Weintraub E, et al. Guillain-Barré syndrome following influenza vaccination.  JAMA. 2004; 292(20):2478-81.

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Haber P, Chen RT, Zanardi LR, Mootrey GT, English R, Braun MM; VAERS Working Group. An analysis of rotavirus vaccine reports to the vaccine adverse event reporting system: More than intussusception alone? Pediatrics. 2004;113(4):e353-9.
Iskander JK, Miller ER, Chen RT. The role of the Vaccine Adverse Event Reporting system (VAERS) in monitoring vaccine safety. Pediatr Ann. 2004;33(9):599-606.

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Varricchio F, Iskander J, Destefano F, Ball R, Pless R, Braun MM, et al. Understanding vaccine safety information from the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J. 2004 Apr;23(4):287-94.

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Wise RP, Iskander J, Pratt RD, Campbell S, Ball R, Pless RP, et al. Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine. JAMA. 2004;292(14):1702-10.

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Zhou W, Pool V, DeStefano F, Iskander JK, Haber P, Chen RT; VAERS Working Group. A potential signal of Bell’s palsy after parenteral inactivated influenza vaccines: Reports to the Vaccine Adverse Event Reporting System (VAERS)–United States, 1991-2001.Pharmacoepidemiol Drug Saf. 2004;13(8):505-10.

Lloyd JC, Haber P, Mootrey GT, Braun MM, Rhodes PH, Chen RT. Adverse event reporting rates following tetanus-diphtheria and tetanus toxoid vaccinations: Data from the Vaccine Adverse Event Reporting System (VAERS), 1991-1997. Vaccine. 2003;21(25-26):3746-50.

Lathrop SL, Ball R, Haber P, Mootrey GT, Braun MM, Shadomy SV, et al. Adverse event reports following vaccination for Lyme disease: December 1998-July 2000. Vaccine. 2002;20(11-12):1603-8.

Verstraeten T, Baughman AL, Cadwell B, Zanardi L, Haber P, Chen RT; Vaccine Adverse Event Reporting System Team. Enhancing vaccine safety surveillance: A capture-recapture analysis of intussusception after rotavirus vaccination. Am J Epidemiol. 2001 Dec 1;154(11):1006-12.

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Zanardi LR, Haber P, Mootrey GT, Niu MT, Wharton M. Intussusception among recipients of rotavirus vaccine: Reports to the vaccine adverse event reporting system. Pediatrics. 2001;107(6):E97.

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Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, et al. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)–United States, 1991-2001. MMWR Surveill Summ.2003 Jan 24; 52(1):1-24. Erratum in: MMWR. 2003 Feb 14; 52(06):113.

Braun MM, Mootrey GT, Salive ME, Chen RT, Ellenberg SS, VAERS Working Group. Infant immunization with acellular pertussis vaccines in the United States: Assessment of the first two years’ data from the Vaccine Adverse Event Reporting System (VAERS). Pediatrics. 2000;106(4):E51.

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Takahashi H, Pool V, Tsai TF, Chen RT. Adverse events after Japanese Encephalitis vaccination: Review of post-marketing surveillance data from Japan and the United States. Vaccine. 2000;18(26):2963-9.

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Wise RP, Salive ME, Braun MM, Mootrey GT, Seward JF, Rider LG, et al. Post licensure safety surveillance for varicella vaccine. JAMA. 2000;284:1271-9.