RESUMO
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.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Vacinas contra COVID-19 , COVID-19 , Pós-Menopausa , Hemorragia Uterina , Humanos , Feminino , Pessoa de Meia-Idade , Vacinas contra COVID-19/efeitos adversos , Idoso , Hemorragia Uterina/etiologia , Hemorragia Uterina/induzido quimicamente , COVID-19/prevenção & controle , COVID-19/epidemiologia , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Estados Unidos/epidemiologia , SARS-CoV-2 , Vacinação/efeitos adversosAssuntos
Infecções por Vírus Respiratório Sincicial , Vacinas contra Vírus Sincicial Respiratório , Humanos , Estados Unidos/epidemiologia , Idoso , Vacinas contra Vírus Sincicial Respiratório/administração & dosagem , Pessoa de Meia-Idade , Infecções por Vírus Respiratório Sincicial/prevenção & controle , Infecções por Vírus Respiratório Sincicial/epidemiologia , Feminino , Masculino , Idoso de 80 Anos ou mais , Sistemas de Notificação de Reações Adversas a MedicamentosRESUMO
BACKGROUND: In response to the 2022 mpox outbreak in the United States, people with higher potential for exposure to mpox were recommended to receive 2 doses of the JYNNEOS vaccine. Vaccine safety was monitored using 2 complementary systems. METHODS: The Vaccine Adverse Event Reporting System (VAERS) is a passive surveillance system that accepts reports of adverse events after vaccination. VAERS is capable of rapidly identifying rare adverse events and unusual reporting patterns. Medical records were requested and reviewed for adverse events of special interest, including myocarditis. Adverse event reporting rates were calculated as the number of verified adverse event cases divided by the number of JYNNEOS doses administered. V-safe for mpox was a voluntary smartphone-based vaccine safety surveillance system that sent enrolled persons text messages linked to health surveys asking about reactions and health impact events occurring after vaccination. RESULTS: There were 1,207,056 JYNNEOS doses administered in the United States. VAERS received 1927 reports for JYNNEOS. The myocarditis reporting rate per million doses was 2.69 after dose 1 and 8.64 after dose 2. V-safe had 213 participants complete at least one health survey. Rates of injection site and systemic reactions were similar in the first week after dose 1 and dose 2. CONCLUSIONS: JYNNEOS vaccine safety surveillance findings from VAERS and v-safe did not identify any unexpected safety concerns. The VAERS reporting rate for myocarditis was similar to previously published population background rates.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Surtos de Doenças , Mpox , Vacina Antivariólica , Adolescente , Adulto , Idoso , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Adulto Jovem , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Surtos de Doenças/prevenção & controle , Miocardite/epidemiologia , Miocardite/induzido quimicamente , Smartphone , Envio de Mensagens de Texto , Estados Unidos/epidemiologia , Vacinação/efeitos adversos , Vacina Antivariólica/administração & dosagem , Vacina Antivariólica/efeitos adversos , Mpox/prevenção & controleRESUMO
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.
Assuntos
COVID-19 , Vacinas , Feminino , Humanos , Recém-Nascido , Gravidez , Sistemas de Notificação de Reações Adversas a Medicamentos , Vacina BNT162 , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Estados Unidos/epidemiologiaRESUMO
The GSK and Pfizer respiratory syncytial virus (RSV) vaccines are both indicated for adults aged 60 years and older, but only the Pfizer product is approved for use in pregnancy to prevent RSV-associated lower respiratory tract disease in infants aged younger than 6 months. To assess for vaccine administration errors (ie, administration of the GSK RSV vaccine to pregnant persons) VAERS (Vaccine Adverse Event Reporting System), a U.S. passive reporting system, was searched for the time period from August 2023 to January 2024. A total of 113 reports of these administration errors were identified. Most reports (103, 91.2%) did not describe an adverse event. These administration errors are preventable with proper education and training and other preventive measures.
Assuntos
Infecções por Vírus Respiratório Sincicial , Vacinas contra Vírus Sincicial Respiratório , Adulto , Feminino , Humanos , Gravidez , Infecções por Vírus Respiratório Sincicial/prevenção & controle , Infecções por Vírus Respiratório Sincicial/induzido quimicamente , Vacinas contra Vírus Sincicial Respiratório/efeitos adversos , Vacinação , Erros MédicosRESUMO
INTRODUCTION: Bivalent mRNA coronavirus disease 2019 (COVID-19) vaccines may be simultaneously administered with other recommended vaccines, including seasonal influenza vaccines. However, few studies have evaluated the safety of co-administration of bivalent mRNA COVID-19 and seasonal influenza vaccines. OBJECTIVE: The aim was to describe reports to the Vaccine Adverse Event Reporting System (VAERS) after co-administration of bivalent mRNA COVID-19 and seasonal influenza vaccines. METHODS: We searched the VAERS database for reports of adverse events (AEs) following co-administration of bivalent mRNA COVID-19 and seasonal influenza vaccines during the period of September 1, 2022-March 31, 2023. We assessed the characteristics of these reports and described the most frequently reported AEs. Clinicians reviewed available medical records for reports of serious AEs and adverse events of special interest (AESI). RESULTS: During the period of 1 September 2022 through 31 March 2023, VAERS received 3689 reports of AEs following co-administration of bivalent mRNA COVID-19 and seasonal influenza vaccines. The median age of vaccinees was 59 years (interquartile range 39, 70 years); 342 reports (9.3%) were classified as serious. The most common AEs among non-serious reports were severe-acute-respiratory-syndrome-related coronavirus (SARS-CoV-2) infection (785, 23.5%), cough (592, 17.7%), and fatigue (568, 17.0%). The most common AEs among serious reports were Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection (88, 25.7%), dyspnea (81, 23.7%), and condition aggravated (55, 16.1%). DISCUSSION: Reports of AEs following co-administration of bivalent mRNA COVID-19 and seasonal influenza vaccines did not reveal any unusual or unexpected patterns of AEs. Increased reporting of certain events (e.g., COVID-19) was expected due to Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) reporting requirements. CDC and FDA will continue to monitor the safety of co-administration of mRNA COVID-19 and seasonal influenza vaccines.
Assuntos
COVID-19 , Vacinas contra Influenza , Humanos , Sistemas de Notificação de Reações Adversas a Medicamentos , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Vacinas contra Influenza/efeitos adversos , RNA Mensageiro , SARS-CoV-2 , Estados Unidos , Adulto , Pessoa de Meia-Idade , IdosoRESUMO
We assessed the safety of hexavalent vaccine diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, hepatitis b, and haemophilus influenzae b conjugate vaccine in the Vaccine Adverse Event Reporting System. Five hundred-one reports of adverse events (AEs) were identified; 21 (4.2%) were serious. Most frequently reported AEs were fever (10.2%) and injection site erythema (5.4%). AEs reported were consistent with findings from prelicensure studies.
Assuntos
Vacina contra Difteria, Tétano e Coqueluche , Vacinas Anti-Haemophilus , Humanos , Vacina contra Difteria, Tétano e Coqueluche/efeitos adversos , Vacinas Anti-Haemophilus/efeitos adversos , Vacinas contra Hepatite B/efeitos adversos , Vacina Antipólio de Vírus Inativado/efeitos adversos , Vacinas Combinadas/efeitos adversos , Vacinas ConjugadasRESUMO
As of May 7, 2023, CDC's Advisory Committee on Immunization Practices (ACIP) recommends that all children aged 6 months-5 years receive at least 1 age-appropriate bivalent mRNA COVID-19 vaccine dose. Depending on their COVID-19 vaccination history and history of immunocompromise, these children might also need additional doses* (1-3). Initial vaccine safety findings after primary series vaccination among children aged 6 months-5 years showed that transient local and systemic reactions were common whereas serious adverse events were rare (4). To characterize the safety of a third mRNA COVID-19 vaccine dose among children aged 6 months-5 years, CDC reviewed adverse events and health surveys reported to v-safe, a voluntary smartphone-based U.S. safety surveillance system established by CDC to monitor health after COVID-19 vaccination (https://vsafe.cdc.gov/en/) and the Vaccine Adverse Event Reporting System (VAERS), a U.S. passive vaccine safety surveillance system co-managed by CDC and the Food and Drug Administration (FDA) (https://vaers.hhs.gov/) (5). During June 17, 2022-May 7, 2023, approximately 495,576 children aged 6 months-4 years received a third dose (monovalent or bivalent) of Pfizer-BioNTech vaccine and 63,919 children aged 6 months-5 years received a third dose of Moderna vaccine. A third mRNA COVID-19 vaccination was recorded for 2,969 children in v-safe; approximately 37.7% had no reported reactions, and among those for whom reactions were reported, most reactions were mild and transient. VAERS received 536 reports after a third dose of mRNA COVID-19 vaccine for children in these age groups; 98.5% of reports were nonserious and most (78.4%) were classified as a vaccination error.§ No new safety concerns were identified. Preliminary safety findings after a third dose of COVID-19 vaccine for children aged 6 months-5 years are similar to those after other doses. Health care providers can counsel parents and guardians of young children that most reactions reported after vaccination with Pfizer-BioNTech or Moderna vaccine were mild and transient and that serious adverse events are rare.
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COVID-19 , Criança , Pré-Escolar , Humanos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Estados Unidos/epidemiologia , Vacinação , Vacinas/efeitos adversosRESUMO
BACKGROUND: Following the authorization and recommendations for use of the U.S. COVID-19 vaccines, the Centers for Disease Control and Prevention (CDC)'s Immunization Safety Office (ISO) responded to inquiries and questions from public health officials, healthcare providers, and the general public on COVID-19 vaccine safety. METHODS: We describe COVID-19 vaccine safety inquiries, by topic, received and addressed by ISO from December 1, 2020-August 31, 2022. RESULTS: Of the 1978 COVID-19 vaccine-related inquiries received, 1655 specifically involved vaccine safety topics. The most frequently asked-about topics included deaths following vaccination, myocarditis, pregnancy, and reproductive health outcomes, understanding or interpreting data from the Vaccine Adverse Event Reporting System (VAERS), and thrombosis with thrombocytopenia syndrome. CONCLUSIONS: Inquiries about vaccine safety generally reflect issues that receive media attention. ISO will continue to monitor vaccine safety inquiries and provide accurate and timely information to healthcare providers, public health officials, and the general public.
Assuntos
COVID-19 , Vacinas , Gravidez , Feminino , Estados Unidos , Humanos , Vacinas contra COVID-19/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos , COVID-19/prevenção & controle , Vacinação/efeitos adversos , Vacinas/efeitos adversos , Imunização/efeitos adversos , Centers for Disease Control and Prevention, U.S.RESUMO
BACKGROUND: Since 2012, reports of primary ovarian insufficiency (POI) temporally associated with receipt of human papillomavirus (HPV) vaccine have been published leading to questions about a potential causal association. A Vaccine Safety Datalink study did not find an increased risk for POI after vaccination. We reviewed the Vaccine Adverse Event Reporting System (VAERS) to describe POI reports. METHODS: We searched VAERS, a U.S. passive surveillance system, for domestic POI reports received from 01/01/1990 to 12/31/2017 after any vaccination. The search used both Medical Dictionary for Regulatory Activity Preferred Terms and a text-based search for POI and its symptoms. All reports were reviewed, and the American College of Obstetricians and Gynecologists (ACOG) guidelines for POI diagnosis were applied. Data mining for disproportionate reporting was conducted. RESULTS: Six hundred fifty-two reports met the search criteria and clinical review identified 19 POI reports. Most reports (n = 16) were received between 2013 and 2017. The median age at vaccination was 14.5 years (range 10-25 years) and the median interval between first dose of vaccination and reporting the event to VAERS was 43 months (range 4-132 months; mean 59.6 months). Four reports met ACOG diagnostic criteria; one with an underlying cause (47XXX chromosomal abnormality) reported. Eleven reports documented menstrual irregularity ≥ 3 months; 5 had ≥ 1 laboratory test result used to diagnose POI. Eighteen of 19 reports described receipt of HPV vaccine with or without other vaccines. Other vaccines reported were meningococcal conjugate vaccine, hepatitis A, varicella and tetanus toxoid, reduced diphtheria toxoid and acellular pertussis. Disproportionate reporting was found for three relevant coding terms after HPV vaccination. CONCLUSIONS: POI is rarely reported to VAERS. Most reports contained limited diagnostic information and were submitted after published cases of POI following HPV vaccination. Results of our review do not suggest a safety concern.
Assuntos
Infecções por Papillomavirus , Vacinas contra Papillomavirus , Insuficiência Ovariana Primária , Feminino , Humanos , Estados Unidos , Lactente , Pré-Escolar , Sistemas de Notificação de Reações Adversas a Medicamentos , Insuficiência Ovariana Primária/induzido quimicamente , Vacinação/efeitos adversos , Toxoide Tetânico , Vacinas contra Papillomavirus/efeitos adversosRESUMO
BACKGROUND: COVID-19 vaccines may be co-administered with other recommended vaccines, including seasonal influenza vaccines. However, few studies have evaluated the safety of co-administration of mRNA COVID-19 and seasonal influenza vaccines. OBJECTIVE: To describe reports to the Vaccine Adverse Event Reporting System (VAERS) after co-administration of mRNA COVID-19 and seasonal influenza vaccines. METHODS: We searched the VAERS database for reports of adverse events (AEs) following co-administration of mRNA COVID-19 and seasonal influenza vaccines and following a first booster dose mRNA COVID-19 vaccine alone, during July 1, 2021-June 30, 2022. We assessed the characteristics of these reports and described the most frequently reported MedDRA preferred terms (PTs). Clinicians reviewed available medical records for serious reports and reports of adverse events of special interest (AESI) and categorized the main diagnosis by system organ class. RESULTS: From July 1, 2021 through June 30, 2022, VAERS received 2,449 reports of adverse events following co-administration of mRNA COVID-19 and seasonal influenza vaccines. Median age of vaccinees was 48 years (IQR: 31, 66); 387 (15.8%) were classified as serious. Most reports (1,713; 69.3%) described co-administration of a first booster dose of an mRNA COVID-19 vaccine with seasonal influenza vaccine. The most common AEs among non-serious reports were injection site reactions (193; 14.5%), headache (181; 13.6%), and pain (171; 12.8%). The most common AEs among reports classified as serious were dyspnea (38; 14.9%), COVID-19 infection (32; 12.6%), and chest pain (27; 10.6%). DISCUSSION: This review of reports to VAERS following co-administration of mRNA COVID-19 and seasonal influenza vaccines did not reveal any unusual or unexpected patterns of AEs. Increased reporting of certain events (e.g., COVID-19 disease) was expected. CDC will continue to monitor the safety of co-administration of mRNA COVID-19 and seasonal influenza vaccines, including co-administration involving bivalent mRNA COVID-19 booster vaccines that have been recommended for people ages ≥ 6 months in the United States.
Assuntos
COVID-19 , Vacinas contra Influenza , Influenza Humana , Humanos , Estados Unidos/epidemiologia , Lactente , Vacinas contra Influenza/efeitos adversos , Vacinas contra COVID-19/efeitos adversos , Vacinas de Produtos Inativados , Sistemas de Notificação de Reações Adversas a Medicamentos , Estações do Ano , COVID-19/prevenção & controle , Influenza Humana/prevenção & controle , RNA MensageiroRESUMO
BACKGROUND: . The Vaccine Adverse Event Reporting System (VAERS) is the United States national passive vaccine safety surveillance system. We updated the data on the safety of single-antigen varicella vaccine (VAR) and assessed the safety of combination measles, mumps, rubella, and varicella vaccine (MMRV) licensed in the United States using VAERS data. METHODS: US VAERS reports received after administration of VAR and MMRV during 2006-2020 were identified. Reports were analyzed by vaccine type, age, seriousness, most common adverse events (AEs), and concomitant vaccines. We reviewed medical records of selected reports of AEs of special interest and conducted empirical Bayesian data mining to identify disproportionally reported AEs. RESULTS: During 2006-2020, approximately 132.8 million VAR doses were distributed; 40 684 reports were received in VAERS (30.6/100 000 doses distributed), with 4.1% classified as serious (1.3/100 000 doses distributed). Approximately 35.5 million MMRV doses were distributed; 13 325 reports were received (37.6/100 000 doses distributed) with 3.3% classified as serious (1.3/100 000 doses distributed). The most common adverse health events after both VAR and MMRV were injection site reactions (31% and 27%), rash (28% and 20%), and fever (12% and 14%), respectively. Vaccination errors accounted for 23% of reports after VAR administration and 41% after MMRV administration, but ≥95% of them did not describe an adverse health event. AEs associated with evidence of vaccine strain varicella-zoster virus (vVZV) infection included meningitis, encephalitis, herpes zoster, and 6 deaths (all in immunocompromised persons with contraindications for vaccination). No new or unexpected AE was disproportionally reported. CONCLUSIONS: No new or unexpected safety findings were detected for VAR and MMRV given as recommended, reinforcing the favorable safety profiles of these vaccines. Providers should obtain specimens for viral testing and strain-typing for serious AEs if they consider vVZV as the possible causative agent.
Assuntos
Sarampo , Caxumba , Rubéola (Sarampo Alemão) , Estados Unidos/epidemiologia , Humanos , Vacina contra Varicela , Teorema de Bayes , Caxumba/prevenção & controle , Rubéola (Sarampo Alemão)/prevenção & controle , Sarampo/prevenção & controle , Vacinas Atenuadas/efeitos adversos , Vacina contra Sarampo-Caxumba-Rubéola , Vacinas CombinadasRESUMO
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.
Assuntos
Vacinas contra COVID-19 , COVID-19 , Feminino , Humanos , Recém-Nascido , Gravidez , Sistemas de Notificação de Reações Adversas a Medicamentos , Vacina BNT162 , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , RNA Mensageiro , Estados Unidos/epidemiologia , VacinasRESUMO
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 (<20â¯weeks), 101 episodes of vaginal bleeding, 76 preterm deliveries (<37â¯weeks), 62 stillbirths (≥20â¯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.
Assuntos
COVID-19 , Vacinas , Ad26COVS1 , Sistemas de Notificação de Reações Adversas a Medicamentos , Vacina BNT162 , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Feminino , Humanos , Lactente , Recém-Nascido , Gravidez , Natimorto/epidemiologia , Estados Unidos/epidemiologiaRESUMO
On November 4, 2019, the Food and Drug Administration approved high-dose quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent; QIV-HD) for active immunization for the prevention of influenza disease in individuals 65 years of age and older. A prelicensure randomized, active-controlled, modified double-blind trial did not reveal any major differences in adverse events following QIV-HD versus Fluzone High-Dose (trivalent). To improve our understanding of the safety profile of QIV-HD, we reviewed and summarized reports of adverse events after QIV-HD to the Vaccine Adverse Event Reporting System (VAERS). From July 30, 2020 through June 30, 2021, VAERS received 2,122 reports after QIV-HD. The vast majority (2,018; 95.1%) were non-serious and included events that had been observed in the prelicensure clinical trial, such as injection site reactions, fever, headache, and nausea. The most common serious events included Guillain-Barré syndrome, cellulitis or other local reactions, constitutional signs/symptoms (e.g., fever), and cardiovascular events. Our review did not reveal any new safety concerns. This information may enable policy makers, health officials, clinicians, and patients to make a more informed decision regarding vaccination strategies.
Assuntos
Síndrome de Guillain-Barré , Vacinas contra Influenza , Influenza Humana , Síndrome de Guillain-Barré/epidemiologia , Humanos , Vacinas contra Influenza/efeitos adversos , Vigilância de Produtos Comercializados , Vacinação/efeitos adversos , Vacinas de Produtos InativadosRESUMO
Pregnant persons are at increased risk of severe illness from COVID-19. The first COVID-19 vaccines in the U.S. were authorized for emergency use in December 2020 and pregnant persons were eligible and could get vaccinated despite scarce safety data in this population. To monitor the safety of COVID-19 vaccination during pregnancy, four surveillance systems are used by the Centers for Disease Control and Prevention (CDC). The Vaccine Adverse Event Reporting System is a national, passive system that captures reports of potential adverse events. V-safe is a novel, active system that uses text messaging and web-based surveys to provide health check-ins after vaccination; and enrolls eligible v-safe participants in the v-safe pregnancy registry. The Vaccine Safety Datalink is a collaboration between the CDC and nine integrated health care organizations which performs near-real time surveillance and traditional epidemiologic studies on pregnant vaccine recipients. The CDC is committed to timely and comprehensive monitoring of COVID-19 vaccine safety in pregnancy.
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COVID-19 , Vacinas , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Feminino , Humanos , Gravidez , SARS-CoV-2 , VacinaçãoRESUMO
BACKGROUND: Many pregnant persons in the United States are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. METHODS: From December 14, 2020, to February 28, 2021, we used data from the "v-safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. RESULTS: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. 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. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). CONCLUSIONS: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.