Adverse Events In Pregnant Women Research Articles

Pregnancy outcomes and risk factors of serious cardiovascular adverse events in pregnant women with pulmonary hypertension.

Pregnancy outcomes and risk factors of serious cardiovascular adverse events in pregnant women with pulmonary hypertension.

Association between antenatal corticosteroid treatment and severe adverse events in pregnant women

BackgroundAntenatal corticosteroids are considered the standard of care for pregnant women at risk for preterm birth, but studies examining their potential risks are scarce. We aimed to estimate the associations of antenatal corticosteroids with three severe adverse events: sepsis, heart failure, and gastrointestinal bleeding, in pregnant women.MethodsOf 2,157,321 pregnant women, 52,119 at 24 weeks 0/7 days to 36 weeks 6/7 days of gestation were included in this self-controlled case series study during the study period of 2009–2018. We estimated incidence rates of three severe adverse events: sepsis, heart failure, and gastrointestinal bleeding. Conditional Poisson regression was used to calculate incidence rate ratios (IRRs) for comparing incidence rates of the adverse events in each post-treatment period compared to those during the baseline period among pregnant women exposed to a single course of antenatal corticosteroid treatment.ResultsAmong 52,119 eligible participants who received antenatal corticosteroid treatment, the estimated incidence rates per 1000 person-years were 0.76 (95% confidence interval (CI): 0.69–0.83) for sepsis, 0.31 (95% CI: 0.27–0.36) for heart failure, and 11.57 (95% CI: 11.27–11.87) for gastrointestinal bleeding. The IRRs at 5 ~ 60 days after administration of antenatal corticosteroids were 5.91 (95% CI: 3.10–11.30) for sepsis and 4.45 (95% CI: 2.63–7.55) for heart failure, and 1.26 (95% CI: 1.02–1.55) for gastrointestinal bleeding; and the IRRs for days 61 ~ 180 were 2.00 (95% CI: 1.01–3.96) for sepsis, 3.65 (95% CI: 2.14–6.22) for heart failure, and 1.81 (95% CI: 1.56–2.10) for gastrointestinal bleeding.ConclusionsThis nationwide population-based study suggests that a single course of antenatal corticosteroids is significantly associated with a 1.3- to 5.9-fold increased risk of sepsis, heart failure, and gastrointestinal bleeding in pregnant women. Maternal health considerations, including recommendations for adverse event monitoring, should be included in future guidelines for antenatal corticosteroid treatment.

To evaluate the efficacy and safety of intravenous ferrous carboxymaltose compared with Iron sucrose in treating iron deficiency anemia in postpartum period

Background: Iron deficiency anemia continues to be a serious problem in developing countries resulting in spectrum of adverse events in pregnant women. The first choice for prophylaxis and treatment of mild IDA in pregnancy is oral iron therapy. However, in patients with moderate and severe anemia, oral therapy takes very long time and compliance could be a big issue in our country. Thus, pregnant women with moderate anemia should be better treated with parenteral iron therapy. Postpartum women were eligible for the study with hemoglobin level <10 g/dl, while those with sickle cell anemia, aplastic anemia, megaloblastic anemia, etc., or having allergy to parental iron were considered not eligible for this study. The eligible women were randomly categorized to receive intravenous iron sucrose and intravenous ferrous carboxymaltose. Aims and Objectives: (1) To Compare ferrous carboxymaltose with iron sucrose in treating iron deficiency anemia in postpartum period (2) To assess the adverse effects and patient compliance. Materials and Methods: A comparative, prospective, and randomized distributed in 50 patients within the Department of Obstetrics and Gynecology, MGM Medical College and Hospital, Navi Mumbai. The subjects were randomized into two group, first group receiving iron sucrose, whereas second group receiving ferrous carboxymaltose. Results: Study, 25 women received iron sucrose and 25 women received ferrous carboxymaltose. There was significant higher increase in hemoglobin levels at 6 weeks in ferric carboxymaltose (FCM) group as compared iron sucrose group hemoglobin levels. There was significant higher increase in ferritin levels at 2 and 6 weeks in FCM group as compared iron sucrose group hemoglobin levels. There was significant higher increase in reticulocyte count at 6 week in FCM group as compared iron sucrose group reticulocyte count. Conclusion: Ferric carboxymaltose is safe and efficient in treatment of iron deficiency anemia in postpartum women as compared to iron sucrose with lesser adverse effect and better patient compliance.

Adverse events in pregnant women with the tetravalent influenza vaccine obtained from cell cultures

Influenza vaccination in pregnant women shows a clear benefit/risk ratio. Influenza vaccines are currently being developed using new platforms. It is essential to analyse the safety of these new vaccines in this population group, underrepresented in clinical trials.In the 2019–2020 season, a vaccine obtained in cell culture was recommended to pregnant women in two autonomous communities. Information is collected from the vaccination and pharmacovigilance centres of both communities.The reporting rate of adverse events (AEs) after vaccination in pregnant women was 4.02/100,000 doses administered, and in non-pregnant women aged 18–64 years it was 5.9/100,000 doses administered. The rate of AE reported was 8.04 and 17.74 respectively. No spontaneous abortions, prematurity or foetal malformations were reported.This analysis suggests the safety in pregnant women of the influenza vaccine obtained from cell cultures.

Effects of COVID-19 infection during pregnancy

Women develop important changes in their cardiovascular and respiratory systems during pregnancy. They also have important changes in their immune system which are necessary to tolerate foreign fetal tissue. These expected alterations can increase the likelihood of poor outcomes with certain respiratory infections, especially viral infection. There is extensive literature describing COVID-19 in pregnant women, and there is evidence that this virus can infect the placenta, raising implications for maternal-fetal transmission. Women who contract COVID-19 during pregnancy are at increased risk of preterm labor and other perinatal complications when compared to non-pregnant women. Trials on the safety and efficacy of the COVID-19 vaccines during pregnancy are in progress; several reproductive societies have recommended that women who are planning to get pregnant or are pregnant should get vaccination since there are few reports of adverse events in pregnant women who have received vaccines. Healthcare providers will need to address concerns of infertility, the possibility of vertical transmission, and neonatal infection with women regarding timely vaccination against this disease and other necessary precautions.
 Keywords: coronavirus, COVID-19, pregnancy, placental pathology, vertical transmission

Predicting the Risk of Adverse Events in Pregnant Women With Congenital Heart Disease.

BackgroundWomen with congenital heart disease are considered at high risk for adverse events. Therefore, we aim to establish 2 prediction models for mothers and their offspring, which can predict the risk of adverse events occurred in pregnant women with congenital heart disease.Methods and ResultsA total of 318 pregnant women with congenital heart disease were included; 213 women were divided into the development cohort, and 105 women were divided into the validation cohort. Least absolute shrinkage and selection operator was used for predictor selection. After validation, multivariate logistic regression analysis was used to develop the model. Machine learning algorithms (support vector machine, random forest, AdaBoost, decision tree, k‐nearest neighbor, naïve Bayes, and multilayer perceptron) were used to further verify the predictive ability of the model. Forty‐one (12.9%) women experienced adverse maternal events, and 93 (29.2%) neonates experienced adverse neonatal events. Seven high‐risk factors were discovered in the maternal model, including New York Heart Association class, Eisenmenger syndrome, pulmonary hypertension, left ventricular ejection fraction, sinus tachycardia, arterial blood oxygen saturation, and pregnancy duration. The machine learning–based algorithms showed that the maternal model had an accuracy of 0.76 to 0.86 (area under the receiver operating characteristic curve=0.74–0.87) in the development cohort, and 0.72 to 0.86 (area under the receiver operating characteristic curve=0.68–0.80) in the validation cohort. Three high‐risk factors were discovered in the neonatal model, including Eisenmenger syndrome, preeclampsia, and arterial blood oxygen saturation. The machine learning–based algorithms showed that the neonatal model had an accuracy of 0.75 to 0.80 (area under the receiver operating characteristic curve=0.71–0.77) in the development cohort, and 0.72 to 0.79 (area under the receiver operating characteristic curve=0.69–0.76) in the validation cohort.ConclusionsTwo prenatal risk assessment models for both adverse maternal and neonatal events were established, which might assist clinicians in tailoring precise management and therapy in pregnant women with congenital heart disease.

Safety of oral ivermectin during pregnancy: a systematic review and meta-analysis

BackgroundAbout 3·7 billion doses of ivermectin have been distributed in mass drug administration (MDA) campaigns globally over the past 30 years. At 10−100 times higher than current human doses, ivermectin is a known teratogen in mammals. During these campaigns with recommended doses, pregnant women might be inadvertently exposed. We therefore aimed to evaluate the existing evidence for serious and non-serious adverse events after ivermectin exposure in pregnant women.MethodsFor this systematic review and meta-analysis, we searched relevant databases and trial registry platforms on July 15, 2018, for randomised controlled trials (RCTs) and observational studies that reported adverse events in pregnant women. We did not use language or date restrictions. Outcomes of interest were spontaneous abortions, stillbirths, congenital anomalies, and neonatal death (serious adverse events), as well as maternal morbidity, preterm births, and low birthweight (adverse events). The risk of bias was assessed using the Newcastle-Ottawa Scale for observational studies and the Cochrane Risk of Bias Tool for RCTs. We did the meta-analysis of observational studies and RCTs separately. The quality of evidence was assessed using the GRADE approach. The study protocol is registered with PROSPERO, protocol CRD42016046914.FindingsWe identified 147 records, of which only five observational studies and one RCT were included for quantitative analysis; these studies were published between 1990 and 2008, and were done in six African countries. 893 women with 899 pregancy outcomes were included, of whom 496 pregnant women (500 pregnancy outcomes) received ivermectin inadvertently during MDA campaigns in the observational studies and 397 pregnant women (399 pregnancy outcomes) purposely received ivermectin as part of the open-label RCT. No study reported neonatal deaths, maternal morbidity, preterm births, or low birthweight. It is unclear whether exposure to ivermectin during pregnancy increases the risk of spontaneous abortions and stillbirths (odds ratio [OR] 1·15 [95% CI 0·75−1·78] with very low certainty of evidence for the four observational studies and 0·62 [0·18−2·14] with very low certainty of evidence for the RCT) or congenital anomalies (OR 1·69 [95% CI 0·83−3·41] with very low certainty of evidence for the five observational studies and 1·10 [0·07−17·65] with very low certainty of evidence for the RCT).InterpretationThere is insufficient evidence to conclude on the safety profile of ivermectin during pregnancy. Treatment campaigns should focus additional efforts on preventing inadvertent treatment of pregnant women.FundingUnitaid.

Characteristics of Adverse Events in Pregnant Women

Characteristics of Adverse Events in Pregnant Women

Outcomes After Nonobstetric Surgery in Pregnant Patients: A Nationwide Study

ObjectiveTo evaluate outcomes after nonobstetric surgical procedures in pregnant patients. MethodsWe conducted a retrospective cohort study of 5591 pregnant women who underwent nonobstetric surgical procedures using Taiwan's National Health Insurance Research Database 2008-2012 claims data. Using a propensity score matching procedure, 22,364 nonpregnant women were selected for comparison. Logistic regression was used to calculate the odds ratios (ORs) and 95% CIs of postoperative complications and in-hospital mortality associated with pregnancy. ResultsPregnant women had higher risks of postoperative septicemia (OR=1.75; 95% CI, 1.47-2.07), pneumonia (OR=1.47; 95% CI, 1.01-2.13), urinary tract infection (OR=1.29; 95% CI, 1.08-1.54), and in-hospital mortality (OR=3.94; 95% CI, 2.62-5.92) compared with nonpregnant women. Pregnant women also had longer hospital stays and higher medical expenditures after nonobstetric surgical procedures than controls. Higher rates of postoperative adverse events in pregnant women receiving nonobstetric surgery were noted in all age groups. ConclusionSurgical patients with pregnancy showed more adverse events, with a risk of in-hospital mortality approximately 4-fold higher after nonobstetric surgery compared with nonpregnant patients. These findings suggest the urgent need to revise the protocols for postoperative care for this population.

Enhanced surveillance of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines in pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2011–2015

BackgroundIn October 2011, the Advisory Committee on Immunization Practices (ACIP) issued updated recommendations that all pregnant women routinely receive a dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine. ObjectivesWe characterized reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received Tdap after this updated recommendation (2011–2015) and compared the pattern of adverse events (AEs) with the period before the updated recommendation (2005–2010). MethodsWe searched the VAERS database for reports of AEs in pregnant women who received Tdap vaccine after the routine recommendation (11/01/2011–6/30/2015) and compared it to published data before the routine Tdap recommendation (01/01/2005–06/30/2010). We conducted clinical review of reports and available medical records. The clinical pattern of reports in the post-recommendation period was compared with the pattern before the routine Tdap recommendation. ResultsWe found 392 reports of Tdap vaccination after the routine recommendation. One neonatal death but no maternal deaths were reported. No maternal or neonatal deaths were reported before the recommendation. We observed an increase in proportion of reports for stillbirths (1.5–2.8%) and injection site reactions/arm pain (4.5–11.9%) after the recommendation compared to the period before the routine recommendation for Tdap during pregnancy. We noted a decrease in reports of spontaneous abortion (16.7–1%). After the 2011 Tdap recommendation, in most reports, vaccination (79%) occurred during the third trimester compared to 4% before the 2011 Tdap recommendation. Twenty-six reports of repeat Tdap were received in VAERS; 13 did not report an AE. One medical facility accounted for 27% of all submitted reports. ConclusionsNo new or unexpected vaccine AEs were noted among pregnant women who received Tdap after routine recommendations for maternal Tdap vaccination. Changes in reporting patterns would be expected, given the broader use of Tdap in pregnant women in the third trimester.

Maternal Tdap vaccination: Coverage and acute safety outcomes in the vaccine safety datalink, 2007–2013

IntroductionSince October 2012, the combined tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine (Tdap) has been recommended in the United States during every pregnancy. MethodsIn this observational study from the Vaccine Safety Datalink, we describe receipt of Tdap during pregnancy among insured women with live births across seven health systems. Using a retrospective matched cohort, we evaluated risks for selected medically attended adverse events in pregnant women, occurring within 42 days of vaccination. Using a generalized estimating equation, we calculated adjusted incident rate ratios (AIRR). ResultsOur vaccine coverage cohort included 438,487 live births between January 1, 2007 and November 15, 2013. Across the coverage cohort, 14% received Tdap during pregnancy. By 2013, Tdap was administered during pregnancy in 41.7% of live births, primarily in the 3rd trimester. Our vaccine safety cohort included 53,885 vaccinated and 109,253 matched unvaccinated pregnant women. There was no increased risk for a composite outcome of medically attended acute adverse events within 3 days of vaccination. Similarly, across the safety cohort, over a 42 day window, incident neurologic events, thrombotic events, and new onset proteinuria did not differ by maternal receipt of Tdap. Among women receiving Tdap at 20 weeks gestation or later, as compared to their matched controls, there was no increased risk for gestational diabetes or cardiac events while venous thromboembolic events and thrombocytopenia were diagnosed within 42 days of vaccination at slightly decreased rates. ConclusionTdap coverage during pregnancy increased from 2007 through 2013, but was still below 50%. No acute maternal safety signals were detected in this large cohort.

Abstract 9816: Placenta Characteristics in Women With Heart Disease and Possible Impact on Fetal Outcomes

Background: Pregnant women with cardiomyopathy (CM) have higher rates of major adverse cardiovascular events (MACE) and fetal adverse clinical events (FACE) than those with other heart disease (HD) (congenital, valvular, or arrhythmia) and no HD, per a prior cohort. 1 Fetuses of mothers with CM are at higher risk for death, premature delivery, underweight, respiratory distress, and lower APGAR scores compared to those with HD. We sought to identify whether pregnant women with known CM or HD demonstrate a pattern of placental changes. Hypothesis: We anticipate pregnant women with a history of CM will have higher rates of abnormal placental characteristics compared with those with HD. Methods and results: We studied 86 pregnancies in women with CM or HD. Of these, 52 (60%) had HD and 34 (40%) had CM. Pathologic analyses were performed on 53 HD and 37 CM placentas. Gestational age in the HD and CM groups were different (38.6 vs 35.5, p < 0.001), as was the incidence of gestational hypertension (21 vs 50%, p 0.003). Among the maternal HD group, 44% had history of congenital heart disease, 33% prior corrective cardiac surgery and 31% had history of arrhythmia. Placental and fetal weight were lower among CM patients compared to those with HD (396 vs. 478 grams, p 0.007; and 2443 versus 3181 grams, p<0.001, respectively). Placentas of those patients with CM compared to those with HD were also more likely to have ischemic changes (65% vs. 34%, p 0.005) and be immature (60% vs. 9%, p<0.001). Pathological villous vascular congestion, fetal membrane abnormalities, fetal surface coloration abnormalities, umbilical cord abnormalities and extent of subchorionic fibrin and placenta calcification were not significantly different between the two groups. Conclusion: Abnormal placental pathologic characteristics such as low weight, ischemic changes and immaturity may contribute to fetal adverse events in pregnant women with CM. 1 Koutrolou-Sotiropoulou P, Parikh PB, Miller C, Lima FV, Butler J, Stergiopoulos K. Impact of Heart Disease on Maternal and Fetal Outcomes in Pregnant Women. Am J Cardiol In Press 2015.

Association of Cardiomyopathy With Adverse Cardiac Events in Pregnant Women at the Time of Delivery

ObjectivesThe aim of this study was to determine the predictors of adverse events in pregnant women with cardiomyopathy (CDM) and CDM subtypes at the time of delivery. BackgroundInvestigation of patients’ characteristics and outcomes in women with CDM at the time of delivery has been limited. MethodsThe Healthcare Cost and Utilization Project’s National Inpatient Sample was screened for hospital admissions for delivery in pregnant women with CDM from 2006 to 2010. Clinical characteristics and maternal outcomes were identified in women with and without CDM and in CDM subtypes. The primary outcome of interest was major adverse clinical events (MACE), a composite of in-hospital death, acute myocardial infarction, heart failure, arrhythmia, cerebrovascular event, or embolic event. ResultsOur study population comprised 2,078 patients with CDM and 4,438,439 patients without CDM. Of those with CDM, 52 (2.5%) were hypertrophic, 1,039 (50.0%) were peripartum, and 987 (47.5%) were classified as other. Women with CDM were older, white, and insured by Medicaid. MACE rates were significantly higher in women with peripartum CDM (46%), compared with hypertrophic CDM (23%) and all others (39%) (p < 0.001). In multivariable analysis, the presence of peripartum cardiomyopathy (odds ratio [OR]: 2.2; 95% confidence interval [CI]: 1.1 to 4.6), valvular disease (OR: 2.11; 95% CI: 1.6 to 2.9), and eclampsia (OR: 5.0; 95% CI: 1.6 to 1.9) was independently associated with MACE. ConclusionsPresence of CDM is independently predictive of MACE during hospitalization for delivery. Patients with peripartum CDM had the highest likelihood of MACE compared with other CDM subtypes.

Reports to the Vaccine Adverse Event Reporting System after hepatitis A and hepatitis AB vaccines in pregnant women

To characterize adverse events (AEs) after hepatitis A vaccines (Hep A) and hepatitis A and hepatitis B combination vaccine (Hep AB) in pregnant women reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. We searched VAERS for AEs reports in pregnant women who received Hep A or Hep AB from Jan. 1, 1996-April 5, 2013. Clinicians reviewed all reports and available medical records. VAERS received 139 reports of AEs in pregnant women; 7(5.0%) were serious; no maternal or infant deaths were identified. Sixty-five (46.8%) did not describe any AEs. For those women whose gestational age was available, most were vaccinated during the first trimester, 50/60 (83.3%) for Hep A and 18/21 (85.7%) for Hep AB. The most common pregnancy-specific outcomes following Hep A orHep AB vaccinations were spontaneous abortion in 15 (10.8%) reports, elective termination in 10 (7.2%), and preterm delivery in 7(5.0%) reports. The most common nonpregnancy specific outcome was urinary tract infection and nausea/vomiting with 3 (2.2%) reports each. One case of amelia of the lower extremities was reported in an infant following maternal Hep A immunization. This review of VAERS reports did not identify any concerning pattern of AEs in pregnant women or their infants following maternal Hep A or Hep AB immunizations during pregnancy.

Prevalence of thyrotoxicosis, antithyroid medication use, and complications among pregnant women in the United States.

Population-based estimates of the prevalence of thyrotoxicosis (TTX), the frequency of antithyroid drug (ATD) use, and risk of adverse events in pregnant women and their infants are lacking. Therefore, our objective was to obtain epidemiologic estimates of these parameters within a large population-based sample of pregnant women with TTX. A retrospective claims analysis was performed from the MarketScan Commercial Claims and Encounters health insurance database for the period 2005-2009. Women aged 15-44 years, enrolled for at least 2 years, and who had a pregnancy during the study period were included. Diagnosis of TTX was based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes using narrow (TTX-1=ICD 242.0) and broad (TTX-2=ICD 242.0 or 242.9) definitions. ATD use was based on prescriptions filled for propylthiouracil (PTU) or methimazole (MMI). Adverse events in mothers and infants were determined from the ICD-9-CM diagnosis codes recorded on submitted claims. The database contained 904,497 eligible women. The average yearly prevalence per 1000 pregnant women was 2.46 for TTX-1 and 5.88 for TTX-2. Thirty-nine percent used ATD at any time during the study period. Compared to women without a TTX diagnosis, there was more than a twofold increase for liver disease among women with TTX (odds ratio [OR]=2.08, p<0.001) and a 13% increased risk for congenital anomalies (OR=1.13, p=0.014), but no association was observed with ATD use. The rates of congenital defects (per 1000 infants) associated with ATD use were 55.6 for MMI, 72.1 for PTU, and 65.8 for untreated women with TTX, compared to 58.8 among women without TTX. There was some indication of an elevated risk of liver disease and congenital anomalies in women with TTX, but the risk did not appear to be related to the ATD use. There seems to be a higher pregnancy termination rate for women with TTX on MMI, which likely reflects elective pregnancy terminations.

Tdap vaccine should be discussed with pregnant patients, infant caregivers

Tdap vaccine should be discussed with pregnant patients, infant caregivers

The safety of yellow fever vaccine 17D or 17DD in children, pregnant women, HIV+ individuals, and older persons: systematic review.

Yellow fever vaccine provides long-lasting immunity. Rare serious adverse events after vaccination include neurologic or viscerotropic syndromes or anaphylaxis. We conducted a systematic review of adverse events associated with yellow fever vaccination in vulnerable populations. Nine electronic bibliographic databases and reference lists of included articles were searched. Electronic databases identified 2,415 abstracts for review, and 32 abstracts were included in this review. We identified nine studies of adverse events in infants and children, eight studies of adverse events in pregnant women, nine studies of adverse events in human immunodeficiency virus-positive patients, five studies of adverse events in persons 60 years and older, and one study of adverse events in individuals taking immunosuppressive medications. Two case studies of maternal-neonate transmission resulted in serious adverse events, and the five passive surveillance databases identified very small numbers of cases of yellow fever vaccine-associated viscerotropic disease, yellow fever vaccine-associated neurotropic disease, and anaphylaxis in persons ≥ 60 years. No other serious adverse events were identified in the other studies of vulnerable groups.

Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event Reporting System

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.

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

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

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

The objective of the study was to characterize reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received seasonal influenza vaccines to assess for potential vaccine safety concerns. We searched VAERS for reports of adverse events (AEs) in pregnant women who received trivalent inactivated influenza vaccine (TIV) from July 1, 1990 through June 30, 2009, or live attenuated influenza vaccine (LAIV) from July 1, 2003, through June 30, 2009. A total of 148 reports after TIV and 27 reports after LAIV were identified. Twenty TIV (13.5%) and 1 LAIV (4%) reports were classified as serious. No specific AEs were reported in 30 TIV (20.3%) and 16 LAIV (59%) reports. The most common pregnancy-specific AE was spontaneous abortion: 17 after TIV (11.5%) and 3 after LAIV (11%). The reporting rate of spontaneous abortion was 1.9 per million pregnant women vaccinated. No unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of TIV or LAIV.