87 results match your criteria vaers database


COVID-19 mRNA Vaccines Are Generally Safe in the Short Term: A Vaccine Vigilance Real-World Study Says.

Front Immunol 2021 21;12:669010. Epub 2021 May 21.

Nephrology Department, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.

Background: The prophylactic vaccination of COVID-19 mRNA vaccines is the first large-scale application of this kind in the human world. Over 1.8 million doses of the COVID-19 vaccine had been administered in the US until December 2020, and around 0. Read More

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Vaccine adverse event enrichment tests.

Stat Med 2021 May 9. Epub 2021 May 9.

Department of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA.

Vaccination safety is critical for individual and public health. Many existing methods have been used to conduct safety studies with the VAERS (Vaccine Adverse Event Reporting System) database. However, these methods frequently identify many adverse event (AE) signals and they are often hard to interpret in a biological context. Read More

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Vocal Fold Immobility Following Vaccination.

Ann Otol Rhinol Laryngol 2021 Jun 16;130(6):609-613. Epub 2020 Oct 16.

Department of Otolaryngology-Head and Neck Surgery, Rutgers New Jersey Medical School, Newark, NJ, USA.

Objective: Vocal fold immobility (VFI) may severely affect quality of life due to dysphonia and respiratory distress. Many etiologies of this disorder have been evaluated, however the relationship between VFI and vaccination has yet to be explored. The objective of this study was to identify the relationship between VFI and vaccine administration. Read More

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Adverse events following quadrivalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2016.

Vaccine 2020 09 31;38(40):6291-6298. Epub 2020 Jul 31.

Division of Healthcare Quality Promotion, Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA.

Background: Post marketing safety evaluations of quadrivalent meningococcal diphtheria-toxoid conjugate vaccine (MenACWY-D) have focused on post-vaccination risk of Guillain Barré syndrome (GBS), adverse events (AEs) after maternal vaccination, and comparative studies with the newer quadrivalent meningococcal CRM conjugate vaccine (MenACWY-CRM). To provide an updated general safety assessment, we reviewed reports of AEs following MenACWY-D submitted to the Vaccine Adverse Event Reporting System (VAERS).

Methods: VAERS is a national spontaneous reporting vaccine safety surveillance system co-administered by the Centers for Disease Control and Prevention and the U. Read More

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September 2020

Facial Paralysis Following Influenza Vaccination: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System Database.

Clin Drug Investig 2020 Sep;40(9):883-889

Department of General Medicine, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.

Background And Objective: Several cases of facial paralysis have been reported following influenza vaccination; however, recent surveillance studies have not shown an increased risk. In this study, we analyzed the vaccine adverse event reporting system (VAERS) data to determine whether the facial paralysis reporting rate is higher in those who received influenza vaccination compared with those who received other vaccines.

Methods: We evaluated reports of facial paralysis in people who received influenza vaccination during January 2015 to October 2019 using Medical Dictionary for Regulatory Activities Preferred Terms. Read More

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September 2020

Age inappropriate influenza vaccination in infants less than 6 months old, 2010-2018.

Vaccine 2020 05 6;38(21):3747-3751. Epub 2020 Apr 6.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.

Background: Annual influenza vaccination is recommended for persons 6 months or older and vaccination in infants less than 6 months old is a vaccine administration error. There are limited safety studies in this population, particularly among infants less than 6 weeks old.

Methods: We searched the U. Read More

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Postlicensure surveillance of human papillomavirus vaccine using the Vaccine Adverse Event Reporting System, 2006-2017.

Perspect Clin Res 2020 Jan-Mar;11(1):24-30. Epub 2019 Apr 26.

Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, Bangalore, India.

Background: The United States Food and Drug Administration (FDA) has licensed three HPV (Human papilloma virus) vaccines. The centers for disease control and prevention (CDC) and advisory committee on immunization practices (ACIP) recommends routine HPV vaccination at age 11 or 12 years. This study aimed to summarize and characterize adverse events following HPV vaccination reported to VAERS database from July 2006 to May 2017. Read More

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Improvement in the Analysis of Vaccine Adverse Event Reporting System Database.

Stat Biopharm Res 2020 8;12(3):303-310. Epub 2020 Jun 8.

Department of Pediatrics and Department of Health Management and Policy, University of Michigan, Ann Arbor, Michigan, USA.

As a national public health surveillance resource, Vaccine Adverse Event Reporting System (VAERS) is a key component in ensuring the safety of vaccines. Numerous methods have been used to conduct safety studies with the VAERS database. These efforts focus on the downstream statistical analysis of the vaccine and adverse event associations. Read More

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Reports of atypical shoulder pain and dysfunction following inactivated influenza vaccine, Vaccine Adverse Event Reporting System (VAERS), 2010-2017.

Vaccine 2020 01 26;38(5):1137-1143. Epub 2019 Nov 26.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC), United States.

Background: Vaccines administered into or too close to underlying joint structures have the potential to cause shoulder injuries. Limited data exist on the epidemiology of such events.

Objective: To describe case reports of atypical shoulder pain and dysfunction following injection of inactivated influenza vaccine (IIV). Read More

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January 2020

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 10 20;37(44):6760-6767. Epub 2019 Sep 20.

Immunization Safety Office, Division of Healthcare Quality Promotion (DHQP), National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers for Disease Control and Prevention (CDC), Atlanta, GA 30329, USA.

Background: In March 2011, the U.S. Food and Drug Administration licensed adenovirus type 4 and type 7 vaccine, live, oral (Barr Labs, Inc. Read More

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October 2019

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 02 16;37(9):1229-1234. Epub 2019 Jan 16.

Emory University Rollins School of Public Health, Department of Epidemiology, 1518 Clifton Road, Atlanta, GA 30322, United States; Emory University Rollins School of Public Health, Hubert Department of Global Health, 1518 Clifton Road, Atlanta, GA 30322, United States; Emory Vaccine Center, 954 Gatewood Road, Atlanta, GA 30329, United States. Electronic address:

Introduction: 9-valent human papillomavirus vaccine (9vHPV) was approved by the Food and Drug Administration (FDA) in December 2014. 9vHPV is not recommended during pregnancy, but some women of childbearing age may be inadvertently exposed. This study aims to evaluate reports submitted to the Vaccine Adverse Event Reporting System (VAERS) of pregnant women exposed to 9vHPV. Read More

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February 2019

Authors' Reply to Cohen et al.'s Comment on "Central Demyelinating Diseases after Vaccination Against Hepatitis B Virus: A Disproportionality Analysis within the VAERS Database".

Drug Saf 2018 12;41(12):1429-1430

Inserm, Bordeaux Population Health Research Centre, Team Pharmacoepidemiology, UMR 1219, University of Bordeaux, 33000, Bordeaux, France.

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December 2018

Comment on "Central Demyelinating Diseases After Vaccination Against Hepatitis B Virus: A Disproportionality Analysis Within the VAERS Database".

Drug Saf 2018 12;41(12):1425-1427

Global Pharmacovigilance, Sanofi Pasteur, 14 Espace Henri Vallée, 19/23 Boulevard Jules Carteret, 69007, Lyon, France.

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December 2018

Smallpox Autoinoculation Via Tattoo in a Soldier.

Mil Med 2019 01;184(1-2):e275-e279

San Antonio Military Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, TX.

Since the National Smallpox Vaccination Program began in 2002, over 2.4 million military servicemembers have been inoculated. Use of bifurcated needles to introduce live vaccinia virus by repeated skin trauma is largely the same process that was first developed over 200 years ago, and is similar to that of tattoo administration. Read More

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January 2019

Central Demyelinating Diseases after Vaccination Against Hepatitis B Virus: A Disproportionality Analysis within the VAERS Database.

Drug Saf 2018 08;41(8):767-774

Inserm, Bordeaux Population Health Research Centre, Team Pharmacoepidemiology, UMR 1219, University Bordeaux, 33000, Bordeaux, France.

Introduction: Hepatitis B (HB) vaccination programs were set up worldwide in the early 1990s. Despite their major focus on reducing the burden of HB infection, they have seldom achieved the targeted population coverage in most countries, including the USA, with around 24.5% of adults being vaccinated against HB. Read More

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No signal of interactions between influenza vaccines and drugs used for chronic diseases: a case-by-case analysis of the vaccine adverse event reporting system and vigibase.

Expert Rev Vaccines 2018 04 9;17(4):363-381. Epub 2018 Mar 9.

a Unit of Clinical Pharmacology Department of Biomedical and Clinical Sciences L. Sacco , 'Luigi Sacco' University Hospital, Università di Milano , Milan , Italy.

Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated.

Methods: From VAERS and VigiBase, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i. Read More

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Lichen planus and lichenoid drug eruption after vaccination.

Authors:
Yi C Lai Yik W Yew

Cutis 2017 Dec;100(6):E6-E20

Harvard School of Public Health, Boston, Massachusetts, USA; and National Skin Centre, Singapore.

Lichen planus (LP) and lichenoid drug eruptions (LDEs) uncommonly occur after vaccination, especially for hepatitis B and influenza. The key initiating event that leads to the development of postimmunization LP or LDE is not well understood. There have been prior reports of an association between several vaccines and LP. Read More

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December 2017

Safety of vaccines that have been kept outside of recommended temperatures: Reports to the Vaccine Adverse Event Reporting System (VAERS), 2008-2012.

Vaccine 2018 01 14;36(4):553-558. Epub 2017 Dec 14.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC), United States.

Background: Vaccines should be stored and handled according to manufacturer specifications. Inadequate cold chain management can affect potency; but, limited data exist on adverse events (AE) following administration of vaccines kept outside of recommended temperatures.

Objective: To describe reports to the Vaccine Adverse Event Reporting System (VAERS) involving vaccines inappropriately stored outside of recommended temperatures and/or exposed to temperatures outside of manufacturer specifications for inappropriate amounts of time. Read More

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January 2018

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

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.

Purpose: Human papillomavirus (HPV) vaccination prevents infections with HPV strains that cause certain cancers. Reports of postural orthostatic tachycardia syndrome (POTS) following HPV vaccination have raised safety concerns. We reviewed POTS reports submitted to the Vaccine Adverse Event Reporting System (VAERS). Read More

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November 2017

Ontology-Based Vaccine Adverse Event Representation and Analysis.

Adv Exp Med Biol 2017 ;1028:89-103

University of Michigan Medical School, 1301 Medical School Research Building III, 1150 W, Medical Center Dr, Ann Arbor, MI, 48109, USA.

Vaccine is the one of the greatest inventions of modern medicine that has contributed most to the relief of human misery and the exciting increase in life expectancy. In 1796, an English country physician, Edward Jenner, discovered that inoculating mankind with cowpox can protect them from smallpox (Riedel S, Edward Jenner and the history of smallpox and vaccination. Proceedings (Baylor University. Read More

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Major Birth Defects after Vaccination Reported to the Vaccine Adverse Event Reporting System (VAERS), 1990 to 2014.

Birth Defects Res 2017 Jul;109(13):1057-1062

Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention (CDC), Atlanta, Georgia.

Background: Major birth defects are important infant outcomes that have not been well studied in the postmarketing surveillance of vaccines given to pregnant women. We assessed the presence of major birth defects following vaccination in the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system used to monitor the safety of vaccines in the United States.

Methods: We searched VAERS for reports of major birth defects during January 1, 1990, through December 31, 2014. Read More

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A signal detection method for temporal variation of adverse effect with vaccine adverse event reporting system data.

BMC Med Inform Decis Mak 2017 Jul 5;17(Suppl 2):76. Epub 2017 Jul 5.

Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

Background: To identify safety signals by manual review of individual report in large surveillance databases is time consuming; such an approach is very unlikely to reveal complex relationships between medications and adverse events. Since the late 1990s, efforts have been made to develop data mining tools to systematically and automatically search for safety signals in surveillance databases. Influenza vaccines present special challenges to safety surveillance because the vaccine changes every year in response to the influenza strains predicted to be prevalent that year. Read More

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Adverse events following quadrivalent meningococcal CRM-conjugate vaccine (Menveo®) reported to the Vaccine Adverse Event Reporting system (VAERS), 2010-2015.

Vaccine 2017 03 3;35(14):1758-1763. Epub 2017 Mar 3.

Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA.

Background: Limited data are available describing the post-licensure safety of meningococcal vaccines, including Menveo®. We reviewed reports of adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS) to assess safety in all age groups.

Methods: VAERS is a national spontaneous vaccine safety surveillance system co-administered by the Centers for Disease Control and Prevention and the US Food and Drug Administration. Read More

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A Two-Phase Case-Control Study of Autism Risk Among Children Born From the Late 1990s Through the Early 2000s in the United States.

Med Sci Monit 2016 Dec 29;22:5196-5202. Epub 2016 Dec 29.

Department of Research, Institute of Chronic Illnesses, Inc., Silver Spring, MD, USA.

BACKGROUND This study evaluated the hypothesis that the 1999 recommendation by the American Academy of Pediatrics (AAP) and US Public Health Service (PHS) to reduce exposure to mercury (Hg) from Thimerosal in US vaccines would be associated with a reduction in the long-term risk of being diagnosed with autism. MATERIAL AND METHODS A two-phase assessment utilizing a case (n=73) -control (n=11,783) study in the Vaccine Adverse Event Reporting System (VAERS) database (for hypothesis generating) and a more rigorous, independent matched case (n=40) -control (n=40) study (hypothesis testing) was undertaken. RESULTS Analysis of the VAERS database using logistic regression revealed that the odds ratio (OR) for being an autism case in the VAERS database significantly decreased with a more recent year of vaccination in comparison to controls (OR=0. Read More

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December 2016

Differential Adverse Event Profiles Associated with BCG as a Preventive Tuberculosis Vaccine or Therapeutic Bladder Cancer Vaccine Identified by Comparative Ontology-Based VAERS and Literature Meta-Analysis.

PLoS One 2016 17;11(10):e0164792. Epub 2016 Oct 17.

Unit for Laboratory Animal Medicine, Department of Microbiology and Immunology, Center for Computational Medicine and Bioinformatics, University of Michigan Medical School, Ann Arbor, Michigan, United States of America.

M. bovis strain Bacillus Calmette-Guérin (BCG) has been the only licensed live attenuated vaccine against tuberculosis (TB) for nearly one century and has also been approved as a therapeutic vaccine for bladder cancer treatment since 1990. During its long time usage, different adverse events (AEs) have been reported. Read More

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Quadrivalent human papillomavirus vaccine and autoimmune adverse events: a case-control assessment of the vaccine adverse event reporting system (VAERS) database.

Immunol Res 2017 02;65(1):46-54

Institute of Chronic Illnesses, Inc, 14 Redgate Ct, Silver Spring, MD, 20905, USA.

Gardasil is a quadrivalent human papillomavirus (HPV4) vaccine that was approved for use by the US Food and Drug Administration in June 2006. HPV4 vaccine is routinely recommended for administration to women in the USA who are 11-12 years old by the Advisory Committee on Immunization Practices. Previous studies suggest HPV4 vaccine administration was associated with autoimmune diseases. Read More

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February 2017

Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013.

Vaccine 2016 05 15;34(25):2841-6. Epub 2016 Apr 15.

Immunization Safety Office, Centers for Disease Control and Prevention, United States.

Background: 23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax(®)23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted.

Objective: To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile. Read More

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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 22;34(20):2349-53. Epub 2016 Mar 22.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, MS D26, Atlanta, GA 30333, USA.

Background: In October 2011, the Advisory Committee on Immunization Practices (ACIP) issued updated recommendations that all pregnant women routinely receive a dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine.

Objectives: We characterized reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received Tdap after this updated recommendation (2011-2015) and compared the pattern of adverse events (AEs) with the period before the updated recommendation (2005-2010).

Methods: We searched the VAERS database for reports of AEs in pregnant women who received Tdap vaccine after the routine recommendation (11/01/2011-6/30/2015) and compared it to published data before the routine Tdap recommendation (01/01/2005-06/30/2010). Read More

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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. Epub 2016 Feb 19.

Menveo (GlaxoSmithKline, previously Novartis AG) is a conjugate vaccine that was recommended in October 2010 for routine use in adolescents (preferably aged 11 or 12 years, with a booster at 16 years), and among persons aged 2 through 54 years with certain immunosuppressive conditions, to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 (1). These recommendations have since been updated (2). Menveo is supplied in two vials that must be combined before administration. Read More

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February 2016

Identification of sex-associated network patterns in Vaccine-Adverse Event Association Network in VAERS.

J Biomed Semantics 2015 19;6:33. Epub 2015 Aug 19.

School of Biomedical Informatics, University of Texas Health Science Center at Houston, Houston, Texas USA.

Background: Vaccines are one of the most important public health successes in last century. Besides effectiveness in reducing the morbidity and mortality from many infectious diseases, a successful vaccine program also requires a rigorous assessment on their safety. Due to the limitations of adverse event (AE) data from clinical trials and post-approval surveillance systems, novel computational approaches are needed to organize, visualize, and analyze such high-dimensional complex data. Read More

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