although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the covid-19 pandemic. descriptive analyses were performed with the use of v-safe survey data for persons who identified as pregnant through february 28, 2021 (35,691 persons); persons enrolled in the v-safe pregnancy registry who were vaccinated through february 28, 2021 (3958 persons); and vaers reports involving pregnant women received through february 28, 2021 (221 persons). as of march 30, 2021, the v-safe pregnancy registry call center attempted to contact 5230 persons who were vaccinated through february 28, 2021, and who identified during a v-safe survey as pregnant at or shortly after covid-19 vaccination. this u.s. surveillance review of the safety of mrna covid-19 vaccines during pregnancy and the periconception period indicates that some pregnant persons in the united states are choosing to be vaccinated against covid-19 in all trimesters of pregnancy. early data from the v-safe surveillance system, the v-safe pregnancy registry, and the vaers do not indicate any obvious safety signals with respect to pregnancy or neonatal outcomes associated with covid-19 vaccination in the third trimester of pregnancy.
the members of the cdc v-safe covid-19 pregnancy registry team are listed in the supplementary appendix, available at nejm.org. covid-19 vaccines: interim clinical considerations for use of covid-19 vaccines currently authorized in the united states. 17. practice committee of the american society for reproductive medicine. evaluating the association of stillbirths after maternal vaccination in the vaccine safety datalink. table 1. characteristics of persons who identified as pregnant in the v-safe surveillance system and received an mrna covid-19 vaccine. table 2. frequency of local and systemic reactions reported on the day after mrna covid-19 vaccination in pregnant persons.
the vaers database was searched for reports of fetal demise following administration of the influenza vaccine/vaccines to pregnant women. the rr of the fetal-loss report rate and cis for the two-dose 2009/2010 influenza season to the fetal-loss report rate in the adjacent seasons were similarly estimated. if no weber-like effect existed, that is there was no increased or enhanced ae reporting associated with the newly marketed pandemic a-h1n1 vaccine during the 2009/2010 influenza season, we would expect the number of vaers reports resulting from administration of the seasonal tiv and pandemic a-h1n1 vaccine to be approximately equal. the factor of increased reporting that might be potentially due to a weber-like effect in the 2009/2010 influenza season is quantified by computing the ratio of 7734 females reporting aes associated with a-h1n1 vaccine to the 4863 females reporting aes associated with seasonal tiv (table 5), yielding a 1.6-fold increase in the a-h1n1 ae reports.
moreover, the percentage of influenza vaccine–related reports to vaers for females was similar for each of the consecutive influenza seasons. this independent ae control group confirms that most of the observed 7.7-fold (170 a-h1n1 fetal-loss reports/22 tiv fetal-loss reports) increase in fetal-loss reports associated with the administration of the 2009 a-h1n1 vaccine appears to be attributable to some type of toxicity effect rather than a ‘new vaccine’ weber-like reporting effect. thus, the concomitant administration of the seasonal influenza and pandemic a-h1n1 vaccines during 2009/2010 suggests a synergistic toxicity and a statistically significant higher rate of fetal loss reporting relative to the single-dose seasons. determined 57.0 per million; however, the numerator of the rate calculation included case reports for only a partial influenza season and the denominator of the rate calculation included annual elective abortions.8 comparison of mean time from vaccination to fetal demise and mean gestational age at fetal demise for vaers reports and the ncow survey, 2009/2010 influenza season.
important: if you are experiencing a medical emergency, seek immediate assistance from a healthcare provider or call 9-1-1. cdc and fda do not provide vaers data is accessible by downloading raw data in comma-separated value (csv) files for import into a database, spreadsheet, or text editing program, monitoring covid-19 vaccine safety during pregnancy. cdc and the food and drug administration (fda) have safety monitoring systems in place to capture, .
abstract background many pregnant persons in the united states are receiving messenger rna (mrna) coronavirus disease 2019 (covid-19) the vaers database was searched for reports of fetal demise following administration of the influenza vaccine/vaccines to pregnant women. this report presents data captured by the vaccine adverse event reporting system (vaers) on the safety of covid-19 vaccination in pregnancy., .
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