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We identified U.S. reports of postmenopausal bleeding in the VAERS (Vaccine Adverse Event Reporting System) between December 13, 2020, and December 13, 2021. Among 711,224 VAERS reports after coronavirus disease 2019 (COVID-19) vaccination, during our study period, we identified 554 presumptive postmenopausal bleeding reports; 434 were further classified as verified based on data abstracted from reports and medical records, when available. In the United States, by December 14, 2021, 58.8 million women aged 50 years or older had received at least one dose of a COVID-19 vaccine, corresponding to approximately seven verified VAERS postmenopausal bleeding reports per 1 million women aged 50 years or older who received a COVID-19 vaccine. Reports of postmenopausal bleeding after COVID-19 vaccination in VAERS were rare, and causes of postmenopausal bleeding based on medical record review were consistent with known causes of postmenopausal bleeding., Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: Pregnant persons are at increased risk of severe COVID-19 illness. Bivalent mRNA COVID-19 vaccination is recommended for everyone, including pregnant persons. However, data are limited on the safety of bivalent mRNA COVID-19 vaccination during pregnancy., Objective: To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system, among pregnant persons who received bivalent mRNA COVID-19 vaccine., Methods: VAERS U.S. reports of adverse events (AEs) in pregnant persons who received the bivalent mRNA COVID-19 vaccine from 9/1/2022-03/31/2023 were identified. Clinicians reviewed all reports and available medical records. AEs of these reports were compared with AEs reported to VAERS following monovalent mRNA COVID-19 booster vaccination in pregnancy., Results: VAERS received 136 reports for pregnant persons who received bivalent mRNA COVID-19 vaccine; 87 (64 %) after BNT162b2 (Pfizer-BioNTech), and 48 (35 %) after mRNA-1273 (Moderna); 28 (20.6 %) reports were classified as serious. The most common pregnancy-specific outcomes reported included 12 (8.8 %) spontaneous abortions (<20 weeks gestation), 6 (4.4 %) episodes of preterm delivery, and 5 (3.7 %) reports of preeclampsia. One stillbirth (≥20 weeks gestation) was reported. No maternal or infant deaths were reported. There were 6 reports of AEs in infants, which included 3 reports of admissions to the neonatal intensive care unit: two infants with low birth weight, and one infant with a patent ductus arteriosus and patent foramen ovale. Non-pregnancy-specific adverse events were mostly COVID-19 infection and systemic reactions (e.g., headache, fatigue). Pregnancy-specific conditions were reported less frequently after bivalent mRNA COVID-19 vaccination compared to monovalent mRNA COVID-19 booster vaccination (3rd and 4th dose)., Conclusions: Based on this review of reports to VAERS, the safety profile of bivalent mRNA COVID-19 vaccination in pregnant persons was comparable to that observed for monovalent mRNA COVID-19 booster vaccination (3rd and 4th dose) in pregnant persons., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Published by Elsevier Ltd.)

The objective of this analysis was to assess the associations between pandemic-related stressors and feeling more anxious/depressed, among women with a live birth. We analyzed data from the Pregnancy Risk Assessment Monitoring System (PRAMS) COVID-19 maternal experiences supplement, implemented in 29 U.S. jurisdictions from October 2020-June 2021, among women with a live birth during April-December 2020. We examined stressors by type (economic, housing, childcare, food insecurity, partner, COVID-19 illness) and score (number of stressor types experienced [none, 1-2, 3-4, or 5-6]). Outcomes were feeling 1) more anxious and 2) more depressed than usual due to the pandemic. We calculated adjusted prevalence ratios estimating associations between stressors and outcomes. Among 12,525 respondents, half reported feeling more anxious and 28% more depressed than usual. The prevalence of stressor types was 50% economic, 41% childcare, 18% partner, 17% food insecurity, 12% housing, and 10% COVID-19 illness. Respondents who experienced partner stressors (anxious aPR: 1.81, 95% CI: 1.73-1.90; depressed aPR: 3.01, 95% CI: 2.78-3.25) and food insecurity (anxious aPR: 1.79, 95% CI: 1.71-1.88; depressed aPR: 2.32, 95% CI: 2.13-2.53) had the largest associations with feeling more anxious and depressed than usual. As stressor scores increased, so did the aPRs for feeling more anxious and more depressed due to the pandemic. COVID-19 stressors, not COVID-19 illness, were found to be significantly associated with feeling more anxious and depressed. Pregnant and postpartum women might benefit from access to supports and services to address pandemic-related stressors/social-determinants and feelings of anxiety and depression., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Background: Information on the severity of coronavirus disease 2019 (COVID-19) attributable to the Delta variant in the United States among pregnant people is limited. We assessed the risk for severe COVID-19 by pregnancy status in the period of Delta variant predominance compared with the pre-Delta period., Methods: Laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections among symptomatic women of reproductive age (WRA) were assessed. We calculated adjusted risk ratios for severe disease including intensive care unit (ICU) admission, receipt of invasive ventilation or extracorporeal membrane oxygenation (ECMO), and death comparing the pre-Delta period (1 January 2020-26 June 2021) and the Delta period (27 June 2021-25 December 2021) for pregnant and nonpregnant WRA., Results: Compared with the pre-Delta period, the risk of ICU admission during the Delta period was 41% higher (adjusted risk ratio [aRR], 1.41 [95% confidence interval {CI}, 1.17-1.69]) for pregnant WRA and 9% higher (aRR, 1.09 [95% CI, 1.00-1.18]) for nonpregnant WRA. The risk of invasive ventilation or ECMO was higher for pregnant (aRR, 1.83 [95% CI, 1.26-2.65]) and nonpregnant (aRR, 1.34 [95% CI, 1.17-1.54]) WRA in the Delta period. During the Delta period, the risk of death was 3.33 (95% CI, 2.48-4.46) times the risk in the pre-Delta period among pregnant WRA and 1.62 (95% CI, 1.49-1.77) among nonpregnant WRA., Conclusions: Compared with the pre-Delta period, pregnant and nonpregnant WRA were at increased risk for severe COVID-19 in the Delta period., Competing Interests: Potential conflicts of interest. The authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2022.)

Objective: To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system, in pregnant people who received a booster dose of mRNA coronavirus disease 2019 (COVID-19) vaccine., Methods: We searched VAERS for U.S. reports of adverse events in pregnant people who received a booster dose of an mRNA COVID-19 vaccine from September 22, 2021, to March 24, 2022. Clinicians reviewed reports and available medical records., Results: The Vaccine Adverse Event Reporting System received 323 reports of adverse events in pregnant people who received a booster dose of COVID-19 vaccine; 178 (55.1%) after BNT162b2 from Pfizer-BioNTech and 145 (44.9%) after mRNA-1273 from Moderna. Seventy-two (22.3%) reports were coded as serious. One neonatal death was reported, but no maternal deaths occurred. Pregnancy-specific outcomes included 56 (17.3%) spontaneous abortions (before 20 weeks of gestation), eight (2.5%) episodes of vaginal bleeding, five (1.5%) stillbirths (at or after 20 weeks of gestation), four (1.2%) episodes of preeclampsia, and two (0.6%) preterm deliveries. Reporting rates for stillbirth and preterm delivery were below background rates. Ten instances of adverse events in neonates were reported, which included two reports of birth defects. Non-pregnancy-specific adverse events (n=207; 64.1%) were mostly systemic (eg, headache, fatigue) and local reactions and occurred in proportions comparable with those seen in pregnant people who received the primary COVID-19 vaccination series and reported to VAERS during the same period., Conclusion: Review of reports after a booster dose of mRNA COVID-19 vaccine in pregnant people in VAERS found their safety profile was comparable with that of published reports after primary COVID-19 vaccination in pregnant people., Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest., (Copyright © 2022 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: Anecdotal reports of menstrual irregularities after receiving COVID-19 vaccines have been observed in post-authorisation and post-licensure monitoring. We aimed to identify and classify reports of menstrual irregularities and vaginal bleeding after COVID-19 vaccination submitted to a voluntary active surveillance system., Methods: This observational cohort study included recipients of a COVID-19 vaccine who were aged 18 years and older and reported their health experiences to v-safe, a voluntary smartphone-based active surveillance system for monitoring COVID-19 vaccine safety in the USA, from Dec 14, 2020, to Jan 9, 2022. Responses to survey questions on reactions after vaccination were extracted, and a pre-trained natural language inference model was used to identify and classify free-text comments related to menstruation and vaginal bleeding in response to an open-ended prompt about any symptoms at intervals after vaccination. Related responses were further categorised into themes of timing, severity, perimenopausal and postmenopausal bleeding, resumption of menses, and other responses. We examined associations between symptom theme and respondent characteristics, including vaccine type and dose number received, solicited local and systemic reactions reported, and health care sought., Findings: 63 815 respondents reported on menstrual irregularities or vaginal bleeding, which included 62 679 female respondents (1·0% of 5 975 363 female respondents aged ≥18 years). Common themes identified included timing of menstruation (70 981 [83·6%] responses) and severity of menstrual symptoms (56 890 [67·0%] responses). Other themes included menopausal bleeding (3439 [4·0%] responses) and resumption of menses (2378 [2·8%] responses). Respondents submitting reports related to menopausal bleeding were more likely to seek health care than were those submitting reports related to other menstruation and vaginal bleeding themes., Interpretation: Reports of heterogeneous symptoms related to menstruation or vaginal bleeding after COVID-19 vaccination are being submitted to v-safe, although this study is unable to characterise the relationship of these symptoms to COVID-19 vaccination. Methods that leverage pretrained models to interpret and classify unsolicited signs and symptoms in free-text reports offer promise in the initial evaluation of unexpected adverse events potentially associated with use of newly authorised or licensed vaccines., Funding: Centers for Disease Control and Prevention., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: In December, 2020, two mRNA-based COVID-19 vaccines were authorised for use in the USA. We aimed to describe US surveillance data collected through the Vaccine Adverse Event Reporting System (VAERS), a passive system, and v-safe, a new active system, during the first 6 months of the US COVID-19 vaccination programme., Methods: In this observational study, we analysed data reported to VAERS and v-safe during Dec 14, 2020, to June 14, 2021. VAERS reports were categorised as non-serious, serious, or death. Reporting rates were calculated using numbers of COVID-19 doses administered as the denominator. We analysed v-safe survey reports from days 0-7 after vaccination for reactogenicity, severity (mild, moderate, or severe), and health impacts (ie, unable to perform normal daily activities, unable to work, or received care from a medical professional)., Findings: During the study period, 298 792 852 doses of mRNA vaccines were administered in the USA. VAERS processed 340 522 reports: 313 499 (92·1%) were non-serious, 22 527 (6·6%) were serious (non-death), and 4496 (1·3%) were deaths. Over half of 7 914 583 v-safe participants self-reported local and systemic reactogenicity, more frequently after dose two (4 068 447 [71·7%] of 5 674 420 participants for local reactogenicity and 4 018 920 [70·8%] for systemic) than after dose one (4 644 989 [68·6%] of 6 775 515 participants for local reactogenicity and 3 573 429 [52·7%] for systemic). Injection-site pain (4 488 402 [66·2%] of 6 775 515 participants after dose one and 3 890 848 [68·6%] of 5 674 420 participants after dose two), fatigue (2 295 205 [33·9%] participants after dose one and 3 158 299 participants [55·7%] after dose two), and headache (1 831 471 [27·0%] participants after dose one and 2 623 721 [46·2%] participants after dose two) were commonly reported during days 0-7 following vaccination. Reactogenicity was reported most frequently the day after vaccination; most reactions were mild. More reports of being unable to work, do normal activities, or of seeking medical care occurred after dose two (1 821 421 [32·1%]) than after dose one (808 963 [11·9%]); less than 1% of participants reported seeking medical care after vaccination (56 647 [0·8%] after dose one and 53 077 [0·9%] after dose two)., Interpretation: Safety data from more than 298 million doses of mRNA COVID-19 vaccine administered in the first 6 months of the US vaccination programme show that most reported adverse events were mild and short in duration., Funding: US Centers for Disease Control and Prevention., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: Pregnant persons are at increased risk of severe illness from COVID-19 infection, including intensive care unit admission, mechanical ventilation, and death compared with non-pregnant persons of reproductive age. Limited data are available on the safety of COVID-19 vaccines administered during and around the time of pregnancy., Objective: To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system, in pregnant persons who received a COVID-19 vaccine to assess for potential vaccine safety problems., Methods: We searched VAERS for US reports of adverse events (AEs) in pregnant persons who received a COVID-19 vaccine from 12/14/2020-10/31/2021. Clinicians reviewed reports and available medical records. Crude reporting rates for selected AEs were calculated, and disproportional reporting was assessed using data mining methods., Results: VAERS received 3,462 reports of AEs in pregnant persons who received a COVID-19 vaccine; 1,831 (52.9%) after BNT162b2, 1,350 (38.9%) after mRNA-1273, and 275 (7.9%) after Ad26.COV2.S. Eight maternal deaths and 12 neonatal deaths were reported. Six-hundred twenty-one (17.9%) reports were serious. Pregnancy-specific outcomes included: 878 spontaneous abortions (<20 weeks), 101 episodes of vaginal bleeding, 76 preterm deliveries (<37 weeks), 62 stillbirths (≥20 weeks), and 33 outcomes with birth defects. Crude reporting rates for preterm deliveries and stillbirths, as well as maternal and neonatal mortality rates were below background rates from published sources. No disproportional reporting for any AE was observed., Conclusions: Review of reports to VAERS following COVID-19 vaccines in pregnant persons did not identify any concerning patterns of maternal or infant-fetal outcomes., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Published by Elsevier Ltd.)

Objective: To inform the current coronavirus disease 2019 (COVID-19) outbreak, we conducted a systematic literature review of case reports of Middle East respiratory syndrome coronavirus (MERS-CoV), severe acute respiratory syndrome coronavirus (SARS-CoV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, during pregnancy and summarized clinical presentation, course of illness, and pregnancy and neonatal outcomes.Data Sources: We searched MEDLINE and ClinicalTrials.gov from inception to April 23, 2020.Methods Of Study Selection: We included articles reporting case-level data on MERS-CoV, SARS-CoV, and SARS-CoV-2 infection in pregnant women. Course of illness, indicators of severe illness, maternal health outcomes, and pregnancy outcomes were abstracted from included articles.Tabulation, Integration, and Results: We identified 1,328 unique articles, and 1,253 articles were excluded by title and abstract review. We completed full-text review on 75, and 29 articles were excluded by full-text review. Among 46 publications reporting case-level data, eight described 12 cases of MERS-CoV infection, seven described 17 cases of SARS-CoV infection, and 31 described 98 cases of SARS-CoV-2 infection. Clinical presentation and course of illness ranged from asymptomatic to severe fatal disease, similar to the general population of patients. Severe morbidity and mortality among women with MERS-CoV, SARS-CoV, or SARS-CoV-2 infection in pregnancy and adverse pregnancy outcomes, including pregnancy loss, preterm delivery, and laboratory evidence of vertical transmission, were reported.Conclusion: Understanding whether pregnant women may be at risk for adverse maternal and neonatal outcomes from severe coronavirus infections is imperative. Data from case reports of SARS-CoV, MERS-CoV, and SAR-CoV-2 infections during pregnancy are limited, but they may guide early public health actions and clinical decision-making for COVID-19 until more rigorous and systematically collected data are available. The capture of critical data is needed to better define how this infection affects pregnant women and neonates. This review was not registered with PROSPERO. [ABSTRACT FROM AUTHOR]

Risk of experiencing a systemic adverse event (AE) after mRNA coronavirus disease 2019 (COVID-19) vaccination may be greater among persons with a history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection; data on serious events are limited. We assessed if adults reporting systemic AEs resulting in emergency department visits or hospitalizations during days 0–7 after mRNA COVID-19 vaccine dose 1 were more likely to have a history of prior SARS-CoV-2 infection compared with persons who reported no or non-severe systemic AEs. We conducted a nested case-control study using v-safe surveillance data. Participants were ≥ 18 years and received dose 1 during December 14, 2020─May 9, 2021. Cases reported severe systemic AEs 0–7 days after vaccination. Three controls were frequency matched per case by age, vaccination date, and days since vaccination. Follow-up surveys collected SARS-CoV-2 histories. Follow-up survey response rates were 38.6 % (potential cases) and 56.8 % (potential controls). In multivariable analyses including 3,862 case-patients and 11,586 controls, the odds of experiencing a severe systemic AE were 2.4 (Moderna, mRNA-1273; 95 % confidence interval [CI]: 1.89, 3.09) and 1.5 (Pfizer-BioNTech, BNT162b2; 95 % CI: 1.17, 2.02) times higher among participants with pre-vaccination SARS-CoV-2 histories compared with those without. Medical attention of any kind for symptoms during days 0–7 following dose 2 was not common among case-patients or controls. History of SARS-CoV-2 infection was significantly associated with severe systemic AEs following dose 1 of mRNA COVID-19 vaccine; the effect varied by vaccine received. Most participants who experienced severe systemic AEs following dose 1 did not require medical attention of any kind for symptoms following dose 2. Vaccine providers can use these findings to counsel patients who had pre-vaccination SARS-CoV-2 infection histories, experienced severe systemic AEs following dose 1, and are considering not receiving additional mRNA COVID-19 vaccine doses. [ABSTRACT FROM AUTHOR]