312 results match your criteria system vaers


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

View Article and Full-Text PDF

Mortality Rate and Characteristics of Deaths Following COVID-19 Vaccination.

Front Med (Lausanne) 2021 14;8:670370. Epub 2021 May 14.

Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center, Memphis, TN, United States.

The emergency use authorization for coronavirus disease 2019 (COVID-19) vaccines brought both hopes and concerns to the Americans and others. We aimed to estimate the mortality rate of COVID-19 vaccination and presented characteristics of deaths following COVID-19 vaccination. Data on deaths following COVID-19 vaccination were obtained from the Vaccine Adverse Event Reporting System (VAERS) from December 11, 2020 through January 8, 2021. Read More

View Article and Full-Text PDF

Thrombocytopenia including immune thrombocytopenia after receipt of mRNA COVID-19 vaccines reported to the Vaccine Adverse Event Reporting System (VAERS).

Vaccine 2021 06 30;39(25):3329-3332. Epub 2021 Apr 30.

Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, United States. Electronic address:

Background: The objective of this study is to assess cases of thrombocytopenia, including immune thrombocytopenia (ITP), reported to the Vaccine Adverse Event Reporting System (VAERS) following vaccination with mRNA COVID-19 vaccines.

Methods: This case-series study analyzed VAERS reports of thrombocytopenia after vaccination with Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine.

Results: Fifteen cases of thrombocytopenia were identified among 18,841,309 doses of Pfizer-BioNTech COVID-19 Vaccine and 13 cases among 16,260,102 doses of Moderna COVID-19 Vaccine. Read More

View Article and Full-Text PDF

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

View Article and Full-Text PDF

Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine - United States, March-April 2021.

MMWR Morb Mortal Wkly Rep 2021 May 7;70(18):680-684. Epub 2021 May 7.

CDC COVID-19 Response Team.

On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Janssen (Ad.26.COV2. Read More

View Article and Full-Text PDF

Anxiety-Related Adverse Event Clusters After Janssen COVID-19 Vaccination - Five U.S. Mass Vaccination Sites, April 2021.

MMWR Morb Mortal Wkly Rep 2021 May 7;70(18):685-688. Epub 2021 May 7.

CDC COVID-19 Response Team.

On April 7, 2021, after 5 weeks' use of the Janssen COVID-19 vaccine under the Food and Drug Administration (FDA) Emergency Use Authorization (EUA), CDC received reports of clusters of anxiety-related events after administration of Janssen COVID-19 vaccine from five mass vaccination sites, all in different states. To further investigate these cases, CDC interviewed vaccination site staff members to gather additional information about the reported events and vaccination site practices. Four of the five sites temporarily closed while an investigation took place. Read More

View Article and Full-Text PDF

US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021.

JAMA 2021 06;325(24):2448-2456

Centers for Disease Control and Prevention COVID-19 Response Team, Atlanta, Georgia.

Importance: Cerebral venous sinus thrombosis (CVST) with thrombocytopenia, a rare and serious condition, has been described in Europe following receipt of the ChAdOx1 nCoV-19 vaccine (Oxford/AstraZeneca), which uses a chimpanzee adenoviral vector. A mechanism similar to autoimmune heparin-induced thrombocytopenia (HIT) has been proposed. In the US, the Ad26. Read More

View Article and Full-Text PDF

Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons.

N Engl J Med 2021 06 21;384(24):2273-2282. Epub 2021 Apr 21.

From the Immunization Safety Office, Division of Healthcare Quality Promotion (T.T.S., T.R.M., P.L. Moro, L.P., P.L. Marquez, C.K.O., C.L., B.C.Z., J.M.G.), and the Arboviral Diseases Branch, Division of Vector-Borne Diseases (S.W.M.), National Center for Emerging and Zoonotic Infectious Diseases, the Division of Birth Defects and Infant Disorders, National Center on Birth Defects and Developmental Disabilities (S.Y.K., V.K.B., C.J.G., D.M.M.-D.), the Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion (T.O., K.T.C., S.R.E., A.N.S.), the World Trade Center Health Program, National Institute for Occupational Safety and Health (R.L.), and the Epidemic Intelligence Service (K.T.C.) - all at the Centers for Disease Control and Prevention, Atlanta; and the Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD (M.A., A.M.-J.).

Background: Many pregnant persons in the United States are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy.

Methods: From December 14, 2020, to February 28, 2021, we used data from the "v-safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons.

Results: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Read More

View Article and Full-Text PDF

Ocular adverse events following vaccination: overview and update.

Surv Ophthalmol 2021 Apr 16. Epub 2021 Apr 16.

Departments of Ophthalmology, Pathology and Molecular Biology, Morsani College of Medicine, University of South Florida, Tampa, FL, USA. Electronic address:

The Food and Drug Administration has licensed, approved, and expanded guidelines for dozens of vaccines since 2010. Although advancements in biotechnology have made vaccines more effective and safer, none are completely free from adverse effects. Many vaccines have been implicated in causing ocular adverse events based on the temporal association of exposure and putative complication. Read More

View Article and Full-Text PDF

Low Rates of Urologic Side Effects Following Coronavirus Disease Vaccination: An Analysis of the Food and Drug Administration Vaccine Adverse Event Reporting System.

Urology 2021 Apr 20. Epub 2021 Apr 20.

Division of Urology, Cedars-Sinai Medical Center, Los Angeles, CA. Electronic address:

Objective: To quantify and describe urologic adverse events and symptoms after vaccination with the Pfizer-BioNTech and Moderna COVID-19 vaccines.

Methods And Materials: We queried the FDA Vaccine Adverse Event Reporting System (VAERS) for all reported symptoms following the Pfizer-BioNTech and Moderna vaccines as of February 12th, 2021. All urologic symptoms were isolated and the reported adverse events associated with each symptom were reviewed. Read More

View Article and Full-Text PDF

Severe, Refractory Immune Thrombocytopenia Occurring After SARS-CoV-2 Vaccine.

J Blood Med 2021 6;12:221-224. Epub 2021 Apr 6.

The Bleeding and Clotting Disorders Institute, Peoria, IL, USA.

The rollout of the SARS-CoV-2 vaccine is underway, and millions have already been vaccinated. At least 25 reports of "immune thrombocytopenia" (ITP) or "thrombocytopenia" following the Moderna or Pfizer vaccine have been added to the Vaccine Adverse Event Reporting System (VAERS) in the US. ITP is a rare but known complication of several vaccinations. Read More

View Article and Full-Text PDF

Postmarketing safety surveillance of quadrivalent recombinant influenza vaccine: Reports to the vaccine adverse event reporting system.

Vaccine 2021 03 5;39(13):1812-1817. Epub 2021 Mar 5.

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

On October 7, 2016, the Food and Drug Administration approved recombinant hemagglutinin quadrivalent influenza vaccine (RIV4) (Spodoptera frugiperda cell line; Flublok Quadrivalent) for active immunization for the prevention of influenza disease in individuals 18 years of age and older. Clinical trials did not reveal any major differences in adverse events or serious adverse events following Flublok Quadrivalent versus standard-dose quadrivalent inactivated influenza vaccine. To improve our understanding of the safety profile of this vaccine, we reviewed and summarized adverse event reports after Flublok Quadrivalent administration to the Vaccine Adverse Event Reporting System (VAERS). Read More

View Article and Full-Text PDF

Extracting postmarketing adverse events from safety reports in the vaccine adverse event reporting system (VAERS) using deep learning.

J Am Med Inform Assoc 2021 Feb 27. Epub 2021 Feb 27.

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

Objective: Automated analysis of vaccine postmarketing surveillance narrative reports is important to understand the progression of rare but severe vaccine adverse events (AEs). This study implemented and evaluated state-of-the-art deep learning algorithms for named entity recognition to extract nervous system disorder-related events from vaccine safety reports.

Materials And Methods: We collected Guillain-Barré syndrome (GBS) related influenza vaccine safety reports from the Vaccine Adverse Event Reporting System (VAERS) from 1990 to 2016. Read More

View Article and Full-Text PDF
February 2021

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(8):283-288. Epub 2021 Feb 26.

Two coronavirus disease 2019 (COVID-19) vaccines are currently authorized for use in the United States. The Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020, and for the Moderna COVID-19 vaccine on December 18, 2020; each is administered as a 2-dose series. The Advisory Committee on Immunization Practices issued interim recommendations for Pfizer-BioNTech and Moderna COVID-19 vaccines on December 12, 2020 (1), and December 19, 2020 (2), respectively; initial doses were recommended for health care personnel and long-term care facility (LTCF) residents (3). Read More

View Article and Full-Text PDF
February 2021

Prediction of post-vaccination Guillain-Barré syndrome using data from a passive surveillance system.

Pharmacoepidemiol Drug Saf 2021 05 23;30(5):602-609. Epub 2021 Feb 23.

Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Purpose: Severe adverse events (AEs), such as Guillain-Barré syndrome (GBS) occur rarely after influenza vaccination. We identify highly associated AEs with GBS and develop prediction models for GBS using the US Vaccine Adverse Event Reporting System (VAERS) reports following trivalent influenza vaccination (FLU3).

Methods: This study analyzed 80 059 reports from the US VAERS between 1990 and 2017. Read More

View Article and Full-Text PDF

Evaluatıon of adverse events following immunization reported during national immunization programs (Between 2017-2019 in Ankara Province).

Hum Vaccin Immunother 2021 Jul 29;17(7):2145-2148. Epub 2021 Jan 29.

Ankara City Hospital, Ankara, Turkey.

Vaccination services are important in primary health-care service. The Expanded Programme on Immunization (EPI) began in 1981 in Turkey. Vaccines are generally safe products; although rare, undesirable effects may be observed after vaccination. Read More

View Article and Full-Text PDF

Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine - United States, December 21, 2020-January 10, 2021.

Authors:

MMWR Morb Mortal Wkly Rep 2021 Jan 29;70(4):125-129. Epub 2021 Jan 29.

As of January 20, 2021, a total of 24,135,690 cases of coronavirus disease 2019 (COVID-19) and 400,306 associated deaths had been reported in the United States (https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days). Read More

View Article and Full-Text PDF
January 2021

Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine - United States, December 14-23, 2020.

Authors:

MMWR Morb Mortal Wkly Rep 2021 Jan 15;70(2):46-51. Epub 2021 Jan 15.

As of January 3, 2021, a total of 20,346,372 cases of coronavirus disease 2019 (COVID-19) and 349,246 associated deaths have been reported in the United States. Long-term sequalae of COVID-19 over the course of a lifetime currently are unknown; however, persistent symptoms and serious complications are being reported among COVID-19 survivors, including persons who initially experience a mild acute illness.* On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 vaccine to prevent COVID-19, administered as 2 doses separated by 21 days. Read More

View Article and Full-Text PDF
January 2021

Myopericarditis after vaccination, Vaccine Adverse Event Reporting System (VAERS), 1990-2018.

Vaccine 2021 01 6;39(5):839-845. Epub 2021 Jan 6.

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

Background: Myopericarditis after vaccination has been sporadically reported in the medical literature. Here, we present a thorough descriptive analysis of reports to a national passive vaccine safety surveillance system (VAERS) of myopericarditis after vaccines licensed for use in the United States.

Methods: We identified U. Read More

View Article and Full-Text PDF
January 2021

Influenza Vaccination and Myo-Pericarditis in Patients Receiving Immune Checkpoint Inhibitors: Investigating the Likelihood of Interaction through the Vaccine Adverse Event Reporting System and VigiBase.

Vaccines (Basel) 2021 Jan 4;9(1). Epub 2021 Jan 4.

Cardiology Unit, Department of Experimental, Diagnostic and Specialty Medicine, Alma Mater Studiorum-University of Bologna, 40138 Bologna, Italy.

Background: Evidence on whether the influenza vaccine could exacerbate immune-related adverse events, including myopericarditis (MP), in patients treated with immune checkpoint inhibitors (ICIs), is still conflicting. We explored this issue through a global real-world approach.

Methods: We queried the Vaccine Adverse Event Reporting System (VAERS) and VigiBase to retrieve cases of MP in which the influenza vaccine and ICIs were recorded as suspect and were concomitantly reported. Read More

View Article and Full-Text PDF
January 2021

Reports of cell-based influenza vaccine administered during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2013-2020.

Vaccine 2021 01 25;39(4):678-681. Epub 2020 Dec 25.

Immunization Safety Office, Division of Healthcare Quality Promotion, United States.

Background: In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax(®), ccIIV3), was approved in the United States for adults aged ≥18 years. A quadrivalent version (ccIIV4) was later approved in 2016 and replaced ccIIV3. The safety of ccIIV3 or ccIIV4 (ccIIV) was not assessed for pregnant women or their infants during pre-licensure studies. Read More

View Article and Full-Text PDF
January 2021

Safety Surveillance of Bivalent Meningococcal Group B Vaccine, Vaccine Adverse Event Reporting System, 2014-2018.

Open Forum Infect Dis 2020 Dec 27;7(12):ofaa516. Epub 2020 Oct 27.

Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Background: In October 2014, MenB-FHbp (Trumenba, Pfizer) became the first meningococcal group B vaccine licensed in the United States. It is approved for use in individuals aged 10-25 years. Our objective was to evaluate the safety of MenB-FHbp postlicensure. Read More

View Article and Full-Text PDF
December 2020

Safety profile of rotavirus vaccines among individuals aged ≥8 months of age, United States, vaccine adverse event reporting system (VAERS), 2006-2019.

Vaccine 2021 01 29;39(4):746-750. Epub 2020 Nov 29.

Viral Gastroenteritis Branch, Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention USA.

Introduction: In 2006 and 2008, two live, oral rotavirus vaccines, RotaTeq (RV5) and Rotarix (RV1), were introduced into the routine immunization program in the United States. A previous rotavirus vaccine, RotaShield, was associated with an increased risk of intussusception, with data suggesting an age-dependent variation in risk. Advisory Committee on Immunization Practices (ACIP) currently recommends that RV5 or RV1 immunization be initiated by age 14 weeks and 6 days and completed by 8 months 0 days. Read More

View Article and Full-Text PDF
January 2021

Strategies to Reduce Errors Associated with 2-Component Vaccines.

Pharmaceut Med 2021 01 5;35(1):1-9. Epub 2020 Nov 5.

Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kentucky, College of Medicine and Chandler Medical Center, Lexington, KY, USA.

The high incidence of error reports received by the US Food and Drug Administration (FDA) involving 2-component vaccines led to collaboration between the United States Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). This collaborating group sought to further understand errors associated with all 2-component vaccines (i.e. Read More

View Article and Full-Text PDF
January 2021

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

View Article and Full-Text PDF

The reporting sensitivity of the Vaccine Adverse Event Reporting System (VAERS) for anaphylaxis and for Guillain-Barré syndrome.

Vaccine 2020 11 7;38(47):7458-7463. Epub 2020 Oct 7.

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: Underreporting is a limitation common to passive surveillance systems, including the Vaccine Adverse Event Reporting System (VAERS) that monitors the safety of U.S.-licensed vaccines. Read More

View Article and Full-Text PDF
November 2020

Evaluation of the safety profile of rotavirus vaccines: a pharmacovigilance analysis on American and European data.

Sci Rep 2020 08 12;10(1):13601. Epub 2020 Aug 12.

Unit of Pharmacology, Department of Medical and Surgical Sciences, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy.

Rotaviruses (RVs) are the most common cause of severe diarrheal disease. To date two rotavirus oral vaccines are licensed: Rotarix and Rotateq. Our aim was to contribute to the post-marketing evaluation of these vaccines safety profile. Read More

View Article and Full-Text PDF

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

View Article and Full-Text PDF
September 2020

Monitoring the safety of high-dose, trivalent inactivated influenza vaccine in the vaccine adverse event reporting system (VAERS), 2011 - 2019.

Vaccine 2020 08 21;38(37):5923-5926. Epub 2020 Jul 21.

Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA, United States.

Background: On 12/23/2009 a new high-dose trivalent inactivated influenza vaccine (IIV3-HD) was licensed for adults aged ≥65 years. We assessed the post-licensure safety data for IIV3-HD in the Vaccine Adverse Event Reporting System (VAERS) during 2011-2019.

Methods: We searched VAERS for reports after IIV3-HD during 1/1/2011-06/30/2019 in persons aged ≥65 years. Read More

View Article and Full-Text PDF

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

View Article and Full-Text PDF
September 2020