Safety of the 9-Valent Human Papillomavirus Vaccine.

Abstract:

BACKGROUND:The 9-valent human papillomavirus vaccine (9vHPV) was approved for females and males aged 9 to 26 years in 2014. We analyzed postlicensure surveillance reports to the Vaccine Adverse Event Reporting System (VAERS). METHODS:We searched VAERS data for US reports of adverse events (AEs) after 9vHPV from December 2014 through December 2017. We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reporting. Physicians reviewed reports for selected prespecified conditions. RESULTS:VAERS received 7244 reports after 9vHPV: 31.2% among females, 21.6% among males, and for 47.2%, sex was not reported. Overall, 97.4% of reports were nonserious. Dizziness, syncope, headache, and injection site reactions were most commonly reported; the most commonly reported AEs were similar between females and males. Two reports of death after 9vHPV were verified; no information in autopsy reports or death certificates suggested a causal relationship with vaccination. Approximately 28 million 9vHPV doses were distributed during the study period; crude AE reporting rates were 259 reports per million 9vHPV doses distributed for all reports and 7 per million doses distributed for serious reports. Syncope (a known AE associated with human papillomavirus vaccination) and several types of vaccine administration errors (eg, administered at wrong age) exceeded the statistical threshold for empirical Bayesian data mining findings. CONCLUSIONS:No new or unexpected safety concerns or reporting patterns of 9vHPV with clinically important AEs were detected. The safety profile of 9vHPV is consistent with data from prelicensure trials and from postmarketing safety data of its predecessor, the quadrivalent human papillomavirus vaccine.

journal_name

Pediatrics

journal_title

Pediatrics

authors

Shimabukuro TT,Su JR,Marquez PL,Mba-Jonas A,Arana JE,Cano MV

doi

10.1542/peds.2019-1791

subject

Has Abstract

pub_date

2019-12-01 00:00:00

issue

6

eissn

0031-4005

issn

1098-4275

pii

peds.2019-1791

journal_volume

144

pub_type

杂志文章
  • Absorption of protein and protein fragments in the developing intestine: role in immunologic/allergic reactions.

    abstract::An important adaptation of the gastrointestinal tract to the extrauterine environment is its development of a mucosal barrier against the penetration of proteins and protein fragments. To combat the potential danger of invasion across the mucosal barrier the newborn infant must develop within the lumen and on the lumi...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Walker WA

    更新日期:1985-01-01 00:00:00

  • Guidelines for pediatric cancer centers.

    abstract::Since the American Academy of Pediatrics published guidelines for pediatric cancer centers in 1986 and 1997, significant changes in the delivery of health care have prompted a review of the role of tertiary medical centers in the care of pediatric patients. The potential effect of these changes on the treatment and su...

    journal_title:Pediatrics

    pub_type: 指南,杂志文章

    doi:10.1542/peds.113.6.1833

    authors: Corrigan JJ,Feig SA,American Academy of Pediatrics.

    更新日期:2004-06-01 00:00:00

  • Intima-media thickness and flow-mediated dilatation in the Helsinki study of very low birth weight adults.

    abstract:BACKGROUND:Adults born at a very low birth weight (VLBW) (< 1500 g), compared with those born at term, bear risk factors for cardiovascular disease, including higher blood pressure and insulin resistance. OBJECTIVE:We studied, in young adults born at a VLBW, early signs of an accelerated atherosclerotic process and th...

    journal_title:Pediatrics

    pub_type: 杂志文章,随机对照试验

    doi:10.1542/peds.2010-2199

    authors: Hovi P,Turanlahti M,Strang-Karlsson S,Wehkalampi K,Järvenpää AL,Eriksson JG,Kajantie E,Andersson S

    更新日期:2011-02-01 00:00:00

  • Neuroprotection with prolonged head cooling started before postischemic seizures in fetal sheep.

    abstract:OBJECTIVE:Cerebral hypothermia has been shown to reduce damage from experimental hy-poxia-ischemia if started shortly after reperfusion. However, in the newborn infant it may not be feasible to determine prognosis so soon after exposure to asphyxia. The aim of this study was to determine whether head cooling, delayed u...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.102.5.1098

    authors: Gunn AJ,Gunn TR,Gunning MI,Williams CE,Gluckman PD

    更新日期:1998-11-01 00:00:00

  • Can home visitation improve the health of women and children at environmental risk?

    abstract::We reviewed randomized trials of prenatal and infancy home-visitation programs for socially disadvantaged women and children. Some home-visitation programs were effective in improving women's health-related behaviors during pregnancy, the birth weight and length of gestation of babies born to smokers and young adolesc...

    journal_title:Pediatrics

    pub_type: 杂志文章,评审

    doi:

    authors: Olds DL,Kitzman H

    更新日期:1990-07-01 00:00:00

  • Diagnosis and treatment of acute otitis media: an assessment.

    abstract:OBJECTIVE:To assess compliance with the Centers for Disease Control and Prevention (CDC) evidence-based guidelines for the judicious use of antimicrobials in children with acute otitis media (AOM). METHODS:Compliance with CDC's recommended diagnostic criteria and antimicrobial treatments for management of AOM was asse...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.112.1.143

    authors: Garbutt J,Jeffe DB,Shackelford P

    更新日期:2003-07-01 00:00:00

  • Polyarticular Arthritis and Spinal Muscular Atrophy in Acid Ceramidase Deficiency.

    abstract::Survival of motor neuron 1-------negative spinal muscular atrophy (SMA) is heterogeneous and remains a diagnostic challenge. The clinical spectrum continues to expand and ∼33 genes have been identified to date. The present report describes a 9-year-old girl with novel clinical phenotype of a patient with polyarticular...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2016-1068

    authors: Teoh HL,Solyom A,Schuchman EH,Mowat D,Roscioli T,Farrar M,Sampaio H

    更新日期:2016-10-01 00:00:00

  • Intellectual development and familial dysautonomia.

    abstract::The study examined adaptive trends in cognitive development among individuals with familial dysautonomia and sought to establish new base rates of intelligence for the dysautonomic population. Fifty-two subjects, aged 6 to 28 years, were administered the Wechsler scales of intelligence. The results indicate that there...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Welton W,Clayson D,Axelrod FB,Levine DB

    更新日期:1979-05-01 00:00:00

  • Mortality risk in children with epilepsy: the Dutch study of epilepsy in childhood.

    abstract:OBJECTIVE:Long-term follow-up studies of patients with epilepsy have revealed an increased mortality risk compared with the general population. Mortality of children who have epilepsy in modern times is as yet unknown. Therefore, the objective of this study was to determine mortality of children who have epilepsy in co...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.107.6.1259

    authors: Callenbach PM,Westendorp RG,Geerts AT,Arts WF,Peeters EA,van Donselaar CA,Peters AC,Stroink H,Brouwer OF

    更新日期:2001-06-01 00:00:00

  • Nutritional practices in the neonatal intensive care unit: analysis of a 2006 neonatal nutrition survey.

    abstract:OBJECTIVE:The goal of this investigation was to determine how current parenteral nutrition and enteral nutrition practice intentions for preterm infants compare with published recommendations and previous feeding practices. METHODS:A survey of feeding strategies for 3 preterm infant weight groups was sent to NICU dire...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2007-3644

    authors: Hans DM,Pylipow M,Long JD,Thureen PJ,Georgieff MK

    更新日期:2009-01-01 00:00:00

  • Skin lesions in association with beta-hemolytic Streptococcus group B.

    abstract::A full-term male infant delivered by caesarean section following a prolonged rupture of the amniotic membranes of 30 hours' duration manifested peculiar skin lesions at the time of birth consistent with the healing phase of bullous impetigo. He was colonized with beta-hemolytic Streptococcus group B that was also cult...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Lopez JB,Gross P,Boggs TR

    更新日期:1976-12-01 00:00:00

  • Improving early literacy promotion: a quality-improvement project for Reach Out and Read.

    abstract:BACKGROUND:The Reach Out and Read (ROR) program promotes early literacy as part of pediatric primary care through the distribution of children's books and anticipatory guidance during early childhood. OBJECTIVES:To improve the rates of age-appropriate book-giving during well-child care and the delivery of ROR-recommen...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2010-2290

    authors: Khandekar AA,Augustyn M,Sanders L,Zuckerman B

    更新日期:2011-04-01 00:00:00

  • Evidence from proton magnetic resonance spectroscopy for a metabolic cascade of neuronal damage in shaken baby syndrome.

    abstract:OBJECTIVE:The purpose of this study was to use proton magnetic resonance spectroscopy (MRS) as a metabolic assay to describe biochemical changes during the evolution of neuronal injury in infants after shaken baby syndrome (SBS), that explain the disparity between apparent physical injury and the neurological deficit a...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.99.1.4

    authors: Haseler LJ,Arcinue E,Danielsen ER,Bluml S,Ross BD

    更新日期:1997-01-01 00:00:00

  • Survival after neonatal myocardial infarction.

    abstract::These are case reports of two children with structurally normal hearts and with normal coronary arteries, who survived myocardial infarction in the early neonatal period. They are only the third and fourth reported survivors of neonatal myocardial infarction and the first in which hypercholesterolemia is postulated to...

    journal_title:Pediatrics

    pub_type: 杂志文章,评审

    doi:

    authors: Boulton J,Henry R,Roddick LG,Rogers D,Thompson L,Warner G

    更新日期:1991-07-01 00:00:00

  • Diabetes in Pregnancy and Childhood Cognitive Development: A Systematic Review.

    abstract:CONTEXT:The effect of diabetes during pregnancy on the cognitive development of offspring is unclear because of inconsistent findings from limited studies. OBJECTIVE:This review was aimed to provide the best available scientific evidence on the associations between maternal pregnancy diabetes and the cognitive develop...

    journal_title:Pediatrics

    pub_type: 杂志文章,评审

    doi:10.1542/peds.2015-4234

    authors: Adane AA,Mishra GD,Tooth LR

    更新日期:2016-05-01 00:00:00

  • Maternal prenatal lifestyle factors and infectious disease in early childhood: a follow-up study of hospitalization within a Danish birth cohort.

    abstract:OBJECTIVES:To examine whether maternal prenatal lifestyle factors were associated with the risk of hospitalization with infectious disease during early childhood and whether a possible association was modified by fetal growth reduction. METHODS:The study was based on a birth cohort of 10 400 newborns whose mothers att...

    journal_title:Pediatrics

    pub_type: 杂志文章,多中心研究

    doi:10.1542/peds.107.2.357

    authors: Yuan W,Basso O,Sørensen HT,Olsen J

    更新日期:2001-02-01 00:00:00

  • Motor Abnormalities and Epilepsy in Infants and Children With Evidence of Congenital Zika Virus Infection.

    abstract::Initial reports of congenital Zika virus (ZIKV) infection focused on microcephaly at birth with severe brain anomalies; the phenotype has broadened to include microcephaly that develops after birth and neurodevelopmental sequelae. In this narrative review, we summarize medical literature describing motor abnormalities...

    journal_title:Pediatrics

    pub_type: 杂志文章,评审

    doi:10.1542/peds.2017-2038F

    authors: Pessoa A,van der Linden V,Yeargin-Allsopp M,Carvalho MDCG,Ribeiro EM,Van Naarden Braun K,Durkin MS,Pastula DM,Moore JT,Moore CA

    更新日期:2018-02-01 00:00:00

  • Neonatal Acute Kidney Injury.

    abstract::In recent years, there have been significant advancements in our understanding of acute kidney injury (AKI) and its impact on outcomes across medicine. Research based on single-center cohorts suggests that neonatal AKI is very common and associated with poor outcomes. In this state-of-the-art review on neonatal AKI, w...

    journal_title:Pediatrics

    pub_type: 杂志文章,评审

    doi:10.1542/peds.2014-3819

    authors: Selewski DT,Charlton JR,Jetton JG,Guillet R,Mhanna MJ,Askenazi DJ,Kent AL

    更新日期:2015-08-01 00:00:00

  • Calcium, dairy products, and bone health in children and young adults: a reevaluation of the evidence.

    abstract:OBJECTIVE:Numerous nutrition policy statements recommend the consumption of 800 to 1500 mg of calcium largely from dairy products for osteoporosis prevention; however, the findings of epidemiologic and prospective studies have raised questions about the efficacy of the use of dairy products for the promotion of bone he...

    journal_title:Pediatrics

    pub_type: 杂志文章,评审

    doi:10.1542/peds.2004-0548

    authors: Lanou AJ,Berkow SE,Barnard ND

    更新日期:2005-03-01 00:00:00

  • Fomepizole treatment of ethylene glycol poisoning in an infant.

    abstract::The enzyme alcohol dehydrogenase metabolizes ingested ethylene glycol (EG) to the toxic compounds glycolic and oxalic acids. Renal failure, acidosis, hypocalcemia, and death may follow. Traditional treatment of EG poisoning may require ethanol, a competitive substrate of alcohol dehydrogenase, and hemodialysis, that r...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.106.6.1489

    authors: Baum CR,Langman CB,Oker EE,Goldstein CA,Aviles SR,Makar JK

    更新日期:2000-12-01 00:00:00

  • Efficacy of bidirectional fiber-optic phototherapy for neonatal hyperbilirubinemia.

    abstract:OBJECTIVE:To evaluate the efficacy of fiber-optic phototherapy using the standard Ohmeda Biliblanket, a large version, double standard Biliblankets, and conventional phototherapy using daylight fluorescent lamps in full-term, healthy infants with nonhemolytic hyperbilirubinemia. METHODS:Full-term, healthy infants with...

    journal_title:Pediatrics

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1542/peds.99.5.e13

    authors: Tan KL

    更新日期:1997-05-01 00:00:00

  • Economic evaluation of the US Environmental Protection Agency's SunWise program: sun protection education for young children.

    abstract:OBJECTIVE:The SunWise School Program is a school-based sun safety education program that was developed by the US Environmental Protection Agency and aims to teach children how to protect themselves from overexposure to the sun. The objectives of this study were to assess the health benefits of the SunWise School Progra...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2007-1400

    authors: Kyle JW,Hammitt JK,Lim HW,Geller AC,Hall-Jordan LH,Maibach EW,De Fabo EC,Wagner MC

    更新日期:2008-05-01 00:00:00

  • Outcomes of extremely premature infants related to their peak serum bilirubin concentrations and exposure to phototherapy.

    abstract:OBJECTIVES:To analyze, in extremely low birth weight infants, associations between peak bilirubin concentration and evidence of brain damage, and between peak bilirubin concentration and blindness attributable to retinopathy of prematurity. METHODS:Retrospective study of 128 infants of

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.102.6.1426

    authors: Yeo KL,Perlman M,Hao Y,Mullaney P

    更新日期:1998-12-01 00:00:00

  • Regulation of growth of 7- to 36-month-old children by energy and fat intake in the prospective, randomized STRIP baby trial.

    abstract:OBJECTIVE:To study the fat and energy intakes of children between 7 and 36 months of age with different growth patterns. METHODS:In the Special Turku coronary Risk factor Intervention Project for Babies, children were randomized to intervention (n = 540) and control groups (n = 522) at age 7 months. The intervention w...

    journal_title:Pediatrics

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1542/peds.100.5.810

    authors: Niinikoski H,Viikari J,Rönnemaa T,Helenius H,Jokinen E,Lapinleimu H,Routi T,Lagström H,Seppänen R,Välimäki I,Simell O

    更新日期:1997-11-01 00:00:00

  • Health of children born as a result of in vitro fertilization.

    abstract:OBJECTIVE:The purpose of this study was to use nationwide registries to examine the health of children up to 4 years of age who were born as a result of in vitro fertilization. METHODS:Children born after in vitro fertilization (N = 4559) from 1996 to 1999 were monitored until 2003. Two control groups were selected fr...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2006-0735

    authors: Klemetti R,Sevón T,Gissler M,Hemminki E

    更新日期:2006-11-01 00:00:00

  • Pulse oxygen saturation levels and arterial oxygen tension values in newborns receiving oxygen therapy in the neonatal intensive care unit: is 85% to 93% an acceptable range?

    abstract:OBJECTIVE:Our aim was to define the relationship of PaO(2) and pulse oxygen saturation values during routine clinical practice and to evaluate whether pulse oxygen saturation values between 85% and 93% were associated with PaO(2) levels of <40 mmHg. METHODS:Prospective comparison of PaO(2) and pulse oxygen saturation ...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2007-0117

    authors: Castillo A,Sola A,Baquero H,Neira F,Alvis R,Deulofeut R,Critz A

    更新日期:2008-05-01 00:00:00

  • Diagnosing Infection in a Neonate Using Whole-Body Screening Magnetic Resonance Imaging.

    abstract::The location of invasive infections is difficult to detect in infants, in part due to their inability to localize signs and symptoms. However, identifying the location often significantly alters clinical management by extending the duration of antibiotic therapy or revealing a source requiring surgical intervention. C...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2016-0732

    authors: Fu TT,Kingma PS

    更新日期:2017-12-01 00:00:00

  • Bullying among young adolescents: the strong, the weak, and the troubled.

    abstract:OBJECTIVES:Bullying and being bullied have been recognized as health problems for children because of their association with adjustment problems, including poor mental health and more extreme violent behavior. It is therefore important to understand how bullying and being bullied affect the well-being and adaptive func...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.112.6.1231

    authors: Juvonen J,Graham S,Schuster MA

    更新日期:2003-12-01 00:00:00

  • Symptomatic congenital cytomegalovirus infection in infants born to mothers with preexisting immunity to cytomegalovirus.

    abstract:OBJECTIVES:To determine the frequency of symptomatic congenital cytomegalovirus (CMV) infection in the offspring of women with a recurrent maternal CMV infection and to characterize the demographic and newborn findings. METHODS:Study subjects consisted of infants with symptomatic congenital CMV infection identified by...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.104.1.55

    authors: Boppana SB,Fowler KB,Britt WJ,Stagno S,Pass RF

    更新日期:1999-07-01 00:00:00

  • Narrow vs broad-spectrum antimicrobial therapy for children hospitalized with pneumonia.

    abstract:BACKGROUND:The 2011 Pediatric Infectious Diseases Society/Infectious Diseases Society of America community-acquired pneumonia (CAP) guideline recommends narrow-spectrum antimicrobial therapy for most children hospitalized with CAP. However, few studies have assessed the effectiveness of this strategy. METHODS:Using da...

    journal_title:Pediatrics

    pub_type: 杂志文章,多中心研究

    doi:10.1542/peds.2013-1614

    authors: Williams DJ,Hall M,Shah SS,Parikh K,Tyler A,Neuman MI,Hersh AL,Brogan TV,Blaschke AJ,Grijalva CG

    更新日期:2013-11-01 00:00:00