The objective of the study was to evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system, in pregnant women who received influenza A (H1N1) 2009 monovalent vaccine to assess for potential vaccine safety problems. We reviewed reports of adverse events (AEs) in pregnant women who received 2009-H1N1 vaccines from Oct. 1, 2009, through Feb. 28, 2010. VAERS received 294 reports of AEs in pregnant women who received 2009-H1N1 vaccine: 288 after inactivated and 6 after the live attenuated vaccines. Two maternal deaths were reported. Fifty-nine women (20.1%) were hospitalized. We verified 131 pregnancy-specific outcomes: 95 spontaneous abortions (<20 weeks); 18 stillbirths (≥20 weeks); 7 preterm deliveries (<37 weeks); 3 threatened abortions; 2 preterm labor; 2 preeclampsia; and 1 each of fetal hydronephrosis, fetal tachycardia, intrauterine growth retardation, and cleft lip. Review of reports to VAERS following H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes.
Immunization during pregnancy against poliomyelitis and influenza in relation to childhood malignancy
From the Centers for Disease Control and Prevention. Intussusception among recipients of rotavirus vaccine--United States, 1998-1999
An analysis of rotavirus vaccine reports to the vaccine adverse event reporting system: more than intussusception alone?
Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration
Vaccine risk perception among reporters of autism after vaccination: vaccine adverse event reporting system 1990-2001
The development of standardized case definitions and guidelines for adverse events following immunization
Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data
Safety of varicella vaccine after licensure in the United States: experience from reports to the vaccine adverse event reporting system, 1995-2005
Safety of trivalent inactivated influenza vaccines in adults: background for pandemic influenza vaccine safety monitoring
Serious adverse events rarely reported after trivalent inactivated influenza vaccine (TIV) in children 6-23 months of age
Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines
Guillain-Barré syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data
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
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
Vaccination against pandemic A/H1N1 2009 influenza in pregnancy and risk of fetal death: cohort study in Denmark
Comparison of VAERS fetal-loss reports during three consecutive influenza seasons: was there a synergistic fetal toxicity associated with the two-vaccine 2009/2010 season?
Evaluating the hazard of foetal death following H1N1 influenza vaccination; a population based cohort study in the UK GPRD
Influenza vaccination during pregnancy: a qualitative study of the knowledge, attitudes, beliefs, and practices of general practitioners in Central and South-Western Sydney
Pharmacists' knowledge, attitudes, and practices regarding influenza vaccination and treatment of pregnant women
Recommendations of the Infectious Diseases Work Group (GTEI) of the Spanish Society of Intensive and Critical Care Medicine and Coronary Units (SEMICYUC) and the Infections in Critically Ill Patients Study Group (GEIPC) of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) for the diagnosis and treatment of influenza A/H1N1 in seriously ill adults admitted to the Intensive Care Unit
The Centers for Disease Control and Prevention's public health response to monitoring Tdap safety in pregnant women in the United States
A systematic review of adverse events following immunization during pregnancy and the newborn period
Reporting vaccine complications: what do obstetricians and gynecologists know about the Vaccine Adverse Event Reporting System?
Adverse event following immunization surveillance systems for pregnant women and their infants: a systematic review
Events supposedly attributable to vaccination or immunization during pandemic influenza A (H1N1) vaccination campaigns in Latin America and the Caribbean
The safety of adjuvants in influenza vaccines during pregnancy: what do we know and why do we need them?
Influenza vaccination during pregnancy: coverage rates and influencing factors in two urban districts in Sydney
Acceptance of vaccination during pregnancy: experience with 2009 influenza A (H1N1) in the Netherlands
Safety of influenza vaccination during pregnancy: a review of subsequent maternal obstetric events and findings from two recent cohort studies
Surveillance systems and methods for monitoring the post-marketing safety of influenza vaccines at the Centers for Disease Control and Prevention
Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women
Statistical and Ontological Analysis of Adverse Events Associated with Monovalent and Combination Vaccines against Hepatitis A and B Diseases
Health outcomes of young children born to mothers who received 2009 pandemic H1N1 influenza vaccination during pregnancy: retrospective cohort study
Does the availability of influenza vaccine at prenatal care visits and of immediate vaccination improve vaccination coverage of pregnant women?
Maternal tetanus, diphtheria, and acellular pertussis (Tdap) and influenza immunization: an overview
The National Vaccine Advisory Committee: reducing patient and provider barriers to maternal immunizations: approved by the National Vaccine Advisory Committee on June 11, 2014
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
To vaccinate or not to vaccinate? Women's perception of vaccination in pregnancy: a qualitative study
Reports of cell-based influenza vaccine administered during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2013-2020.
Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death.
Birth defects encompass structural and functional alterations that occur during embryonic or fetal development and are present since birth. The cause may be genetic, environmental or unknown and can result in physical and/or mental impairment. Here is the latest research on birth defects.