Vaccinations during pregnancy are generally recommended because
pregnant women are at high risk for the most adverse effects of many
78 Immunization during pregnancy provides
maternal benefit and may have the added benefit of infant protection through
79 Children under the age of 2 months may not be able to
receive a particular vaccine, which means they are dependent upon antibodies
received from their mothers.
Under this system, it is the phase IV surveillance studies that are
particularly attentive to rare reactions, increases in known reactions, and
signals for risks to pregnant women or their unborn children.
81 The Vaccine
Adverse Event Reporting System (“VAERS”) is a safety surveillance project
administered by the CDC and the FDA.
82 VAERS collects information about
adverse events associated with the administration of vaccines.
provides a mechanism by which adverse events following immunization may
be reported, analyzed, and made available to the public.
84 Providers must
report adverse events for specific routine childhood immunizations, and are
under professional obligations to report other health events.
85 Patients and
other caregivers also submit reports through the system, which receives up to
30,000 reports per year.
86 Through VAERS, researchers detect new or rare
events, increases in rates of known side effects, and enhance understanding
of patient risk factors.
87 VAERS can facilitate studies analyzing the
association, if any, between vaccination of pregnant women, and pregnancy
The Vaccine Safety Datalink (“VSD”) is another CDC immunization
safety analysis project that partners with nine health care organizations.
Since 1990, the VSD has monitored the safety of vaccines and undertaken
80. See U.S. DEP’T HEALTH & HUMAN SERVS., RECOMMENDED IMMUNIZATION SCHEDULE
FOR PERSONS AGED 0 THROUGH
https://www.vaccines.gov/who_and_when/infants_to_teens/ (last updated Feb. 1, 2016).
81. See U.S. NAT’L LIBRARY OF MED., supra note
82. U.S. DEP’T HEALTH & HUMAN SERVS., ABOUT THE VAERS PROGRAM,
https://vaers.hhs.gov/about/index (last visited Apr. 17, 2016).
88. See, e.g., GS Goldman, Comparison of VAERS Fetal-Loss Reports during Three
Consecutive Influenza Seasons, 32( 5) HUM. & EXPERIMENTAL TOXICOLOGY 464, 464 (2013).
89. CTRS. FOR DISEASE CONTROL & PREVENTION, VACCINE SAFETY DATALINK (VSD),
https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/ (last updated May 13,