Publications by authors named "Paige Marquez"

20 Publications

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Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine - United States, March-April 2021.

MMWR Morb Mortal Wkly Rep 2021 May 7;70(18):680-684. Epub 2021 May 7.

CDC COVID-19 Response Team.

On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Janssen (Ad.26.COV2.S) COVID-19 vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson) (1). The Janssen COVID-19 vaccine, the third COVID-19 vaccine authorized for use in the United States, uses a replication-incompetent human adenoviral type 26 vector platform* (2) and is administered as a single intramuscular dose, whereas the first two authorized vaccines use an mRNA platform and require 2 doses. On February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for use of Janssen COVID-19 vaccine among persons aged ≥18 years (3). During April 13-23, CDC and FDA recommended a pause in use of Janssen vaccine after reports of six cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia (platelet count <150,000/μL of blood) among Janssen vaccine recipients (4). Similar thrombotic events, primarily among women aged <60 years, have been described in Europe after receipt of the AstraZeneca COVID-19 vaccine, which uses a replication-incompetent chimpanzee adenoviral vector (5-7). The U.S. CVST cases that prompted the pause in Janssen vaccination, as well as subsequently detected CVST cases, are described elsewhere (8). This report summarizes adverse events among Janssen vaccine recipients, including non-CVST cases of thrombosis with thrombocytopenia syndrome (TTS), reported to the Vaccine Adverse Events Reporting System (VAERS), a passive surveillance system, and through v-safe, an active monitoring system. As of April 21, 2021, 7.98 million doses of the Janssen COVID-19 vaccine had been administered. Among 13,725 VAERS reports reviewed, 97% were classified as nonserious and 3% as serious, including three reports among women of cases of thrombosis in large arteries or veins accompanied by thrombocytopenia during the second week after vaccination. These three cases and the previously detected CVST cases are consistent with 17 cases of TTS, a newly defined condition. Approximately 338,700 Janssen COVID-19 vaccine recipients completed at least one v-safe survey during the week after vaccination; 76% reported a systemic reaction, 61% reported a local reaction, and 34% reported a health impact. Fatigue and pain were commonly reported symptoms in both VAERS and v-safe. The overall safety profile is consistent with preauthorization clinical trials data. Prompt review of U.S. vaccine safety data detected three additional cases of non-CVST TTS, in addition to the previously recognized CVST cases that initiated the pause in use of the Janssen COVID-19 vaccine. Ongoing monitoring of adverse events after COVID-19 vaccination, including vaccination with the Janssen single-dose vaccine, is essential for evaluating the risks and benefits of each vaccine.
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http://dx.doi.org/10.15585/mmwr.mm7018e2DOI Listing
May 2021

Anxiety-Related Adverse Event Clusters After Janssen COVID-19 Vaccination - Five U.S. Mass Vaccination Sites, April 2021.

MMWR Morb Mortal Wkly Rep 2021 May 7;70(18):685-688. Epub 2021 May 7.

CDC COVID-19 Response Team.

On April 7, 2021, after 5 weeks' use of the Janssen COVID-19 vaccine under the Food and Drug Administration (FDA) Emergency Use Authorization (EUA), CDC received reports of clusters of anxiety-related events after administration of Janssen COVID-19 vaccine from five mass vaccination sites, all in different states. To further investigate these cases, CDC interviewed vaccination site staff members to gather additional information about the reported events and vaccination site practices. Four of the five sites temporarily closed while an investigation took place. Overall, 64 anxiety-related events, including 17 reports of syncope (fainting), an anxiety-related event, among 8,624 Janssen COVID-19 vaccine recipients, were reported from these sites for vaccines administered during April 7-9. As a follow-up to these interviews, CDC analyzed reports of syncope shortly after receipt of Janssen COVID-19 vaccine to the Vaccine Adverse Event Reporting System (VAERS), the vaccine safety monitoring program managed by CDC and FDA. To compare the occurrence of these events with those reported after receipt of other vaccines, reports of syncopal events after influenza vaccine administered in the 2019-20 influenza season were also reviewed. Syncope after Janssen COVID-19 vaccination was reported to VAERS (8.2 episodes per 100,000 doses). By comparison, after influenza vaccination, the reporting rate of syncope was 0.05 episodes per 100,000 doses. Anxiety-related events can occur after any vaccination. It is important that vaccination providers are aware that anxiety-related adverse events might be reported more frequently after receipt of the Janssen COVID-19 vaccine than after influenza vaccination and observe all COVID-19 vaccine recipients for any adverse reactions for at least 15 minutes after vaccine administration.
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http://dx.doi.org/10.15585/mmwr.mm7018e3DOI Listing
May 2021

Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons.

N Engl J Med 2021 06 21;384(24):2273-2282. Epub 2021 Apr 21.

From the Immunization Safety Office, Division of Healthcare Quality Promotion (T.T.S., T.R.M., P.L. Moro, L.P., P.L. Marquez, C.K.O., C.L., B.C.Z., J.M.G.), and the Arboviral Diseases Branch, Division of Vector-Borne Diseases (S.W.M.), National Center for Emerging and Zoonotic Infectious Diseases, the Division of Birth Defects and Infant Disorders, National Center on Birth Defects and Developmental Disabilities (S.Y.K., V.K.B., C.J.G., D.M.M.-D.), the Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion (T.O., K.T.C., S.R.E., A.N.S.), the World Trade Center Health Program, National Institute for Occupational Safety and Health (R.L.), and the Epidemic Intelligence Service (K.T.C.) - all at the Centers for Disease Control and Prevention, Atlanta; and the Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD (M.A., A.M.-J.).

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.
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http://dx.doi.org/10.1056/NEJMoa2104983DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8117969PMC
June 2021

First Month of COVID-19 Vaccine Safety Monitoring - United States, December 14, 2020-January 13, 2021.

MMWR Morb Mortal Wkly Rep 2021 Feb 26;70(8):283-288. Epub 2021 Feb 26.

Two coronavirus disease 2019 (COVID-19) vaccines are currently authorized for use in the United States. The Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020, and for the Moderna COVID-19 vaccine on December 18, 2020; each is administered as a 2-dose series. The Advisory Committee on Immunization Practices issued interim recommendations for Pfizer-BioNTech and Moderna COVID-19 vaccines on December 12, 2020 (1), and December 19, 2020 (2), respectively; initial doses were recommended for health care personnel and long-term care facility (LTCF) residents (3). Safety monitoring for these vaccines has been the most intense and comprehensive in U.S. history, using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system, and v-safe,* an active surveillance system, during the initial implementation phases of the COVID-19 national vaccination program (4). CDC conducted descriptive analyses of safety data from the first month of vaccination (December 14, 2020-January 13, 2021). During this period, 13,794,904 vaccine doses were administered, and VAERS received and processed 6,994 reports of adverse events after vaccination, including 6,354 (90.8%) that were classified as nonserious and 640 (9.2%) as serious. The symptoms most frequently reported to VAERS were headache (22.4%), fatigue (16.5%), and dizziness (16.5%). A total of 113 deaths were reported to VAERS, including 78 (65%) among LTCF residents; available information from death certificates, autopsy reports, medical records, and clinical descriptions from VAERS reports and health care providers did not suggest any causal relationship between COVID-19 vaccination and death. Rare cases of anaphylaxis after receipt of both vaccines were reported (4.5 reported cases per million doses administered). Among persons who received Pfizer-BioNTech vaccine, reactions reported to the v-safe system were more frequent after receipt of the second dose than after the first. The initial postauthorization safety profiles of the two COVID-19 vaccines in current use did not indicate evidence of unexpected serious adverse events. These data provide reassurance and helpful information regarding what health care providers and vaccine recipients might expect after vaccination.
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http://dx.doi.org/10.15585/mmwr.mm7008e3DOI Listing
February 2021

Myopericarditis after vaccination, Vaccine Adverse Event Reporting System (VAERS), 1990-2018.

Vaccine 2021 01 6;39(5):839-845. Epub 2021 Jan 6.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States.

Background: Myopericarditis after vaccination has been sporadically reported in the medical literature. Here, we present a thorough descriptive analysis of reports to a national passive vaccine safety surveillance system (VAERS) of myopericarditis after vaccines licensed for use in the United States.

Methods: We identified U.S. reports of myopericarditis received by VAERS during 1990-2018 that met a published case definition for myopericarditis or were physician-diagnosed. We stratified analysis by age group (<19, 19-49, ≥50 years), describing reports by serious/non-serious status, sex, time to symptom onset after vaccination, vaccine(s) administered, and exposure to other known causes of myopericarditis. We used Empirical Bayesian data mining to detect disproportionate reporting of myopericarditis after vaccination.

Results: VAERS received 620,195 reports during 1990-2018: 708 (0.1%) met the case definition or were physician-diagnosed as myopericarditis. Most (79%) myopericarditis reports described males; 69% were serious; 72% had symptom onset ≤ 2 weeks postvaccination. Overall, smallpox (59%) and anthrax (23%) vaccines were most commonly reported. By age, among persons aged < 19 years, Haemophilus influenzae type b (22, 22%) and hepatitis B (18, 18%); among persons aged 19-49 years smallpox (387, 79%); among persons aged ≥ 50 years inactivated influenza (31, 36%) and live attenuated zoster (19, 22%) vaccines were most commonly reported. The vaccines most commonly reported remained unchanged when excluding 138 reports describing other known causes of myopericarditis. Data mining revealed disproportionate reporting of myopericarditis only after smallpox vaccine.

Conclusions: Despite the introduction of new vaccines over the years, myopericarditis remains rarely reported after vaccines licensed for use in the United States. In this analysis, myopericarditis was most commonly reported after smallpox vaccine, and less commonly after other vaccines.
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http://dx.doi.org/10.1016/j.vaccine.2020.12.046DOI Listing
January 2021

Reports of cell-based influenza vaccine administered during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2013-2020.

Vaccine 2021 01 25;39(4):678-681. Epub 2020 Dec 25.

Immunization Safety Office, Division of Healthcare Quality Promotion, United States.

Background: In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax(®), ccIIV3), was approved in the United States for adults aged ≥18 years. A quadrivalent version (ccIIV4) was later approved in 2016 and replaced ccIIV3. The safety of ccIIV3 or ccIIV4 (ccIIV) was not assessed for pregnant women or their infants during pre-licensure studies.

Objective: To assess the safety of ccIIV administered during pregnancy in pregnant women and their infants whose reports were submitted to VAERS during 2013-2020.

Material And Methods: We searched VAERS for United States reports of adverse events (AEs) in pregnant women who received ccIIV from 1 July 2013 through 31 May 2020. Clinicians reviewed reports and available medical records and assigned a primary clinical category for each report. Reports were coded as serious based on the Code of Federal Regulations definition.

Results: VAERS received 391 reports following ccIIV administered to pregnant women. Twenty-four (6.1%) were serious. Two neonatal deaths were reported. No maternal deaths occurred. Among reports with trimester information (n = 340), ccIIV was administered during the second trimester in 170 (50%). The most frequent pregnancy-specific AE was premature delivery in 85 (21.7%) reports, followed by dysmature placenta in 13 (3.3%) and pre-eclampsia/eclampsia in ten (2.3%). The most common non-pregnancy specific conditions were infectious conditions in 32 (8.2%). Among infant conditions, low birth weight was reported in 62 (15.9%) reports. Fifteen birth defects were reported; in 12 with gestational age information, administration of the vaccine occurred late in the second trimester or later.

Conclusions: Review of maternal ccIIV reports in VAERS was not unexpectedly different from other maternal influenza vaccine safety VAERS reviews.
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http://dx.doi.org/10.1016/j.vaccine.2020.12.045DOI Listing
January 2021

Safety Surveillance of Bivalent Meningococcal Group B Vaccine, Vaccine Adverse Event Reporting System, 2014-2018.

Open Forum Infect Dis 2020 Dec 27;7(12):ofaa516. Epub 2020 Oct 27.

Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Background: In October 2014, MenB-FHbp (Trumenba, Pfizer) became the first meningococcal group B vaccine licensed in the United States. It is approved for use in individuals aged 10-25 years. Our objective was to evaluate the safety of MenB-FHbp postlicensure.

Methods: The Vaccine Adverse Event Reporting System (VAERS) is a national passive vaccine safety surveillance system. We analyzed US VAERS reports for MenB-FHbp received from the date of licensure in October 2014 through December 2018. We described the characteristics of the persons and adverse events (AEs) reported and calculated reporting rates using the number of doses distributed. We used empirical Bayesian data mining to identify AEs reported at least twice as often as expected compared with all other vaccines.

Results: VAERS received 2106 reports involving MenB-FHbp, representing 698 reports per million doses distributed. The median age of vaccinees was 17 years, and 55% were female. MenB-FHbp was given simultaneously with other vaccines in 37% of reports. Most reports (57%) described AEs that started on the day of or day after vaccination. The most common AEs reported were pyrexia (27%), headache (25%), and pain (16%). There were 44 serious reports (2% of all reports), among which 42 reported a hospitalization. Data mining identified disproportional reporting of headache, pyrexia, chills, and myalgia.

Conclusions: The AEs most commonly or disproportionately reported following MenB-FHbp were consistent with those identified in clinical trials as described in the US package insert. We did not identify any new safety issues.
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http://dx.doi.org/10.1093/ofid/ofaa516DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7724509PMC
December 2020

Safety profile of rotavirus vaccines among individuals aged ≥8 months of age, United States, vaccine adverse event reporting system (VAERS), 2006-2019.

Vaccine 2021 01 29;39(4):746-750. Epub 2020 Nov 29.

Viral Gastroenteritis Branch, Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention USA.

Introduction: In 2006 and 2008, two live, oral rotavirus vaccines, RotaTeq (RV5) and Rotarix (RV1), were introduced into the routine immunization program in the United States. A previous rotavirus vaccine, RotaShield, was associated with an increased risk of intussusception, with data suggesting an age-dependent variation in risk. Advisory Committee on Immunization Practices (ACIP) currently recommends that RV5 or RV1 immunization be initiated by age 14 weeks and 6 days and completed by 8 months 0 days.

Methods: We searched for U.S. VAERS reports of RV5, RV1, or unknown rotavirus vaccine brand among individuals aged ≥8 months. We analyzed reports by 2 age groups (individuals aged ≥8 months-≤5 years and ≥6 years), vaccine brand name, adverse event (AE) reported, classification of seriousness (death, non-death serious, and non-serious) and mode of exposure (direct vs. indirect exposure). For serious reports we reviewed available medical records and assigned a primary diagnosis.

Results: VAERS received a total of 344 U.S. reports following rotavirus vaccination among individuals ≥8 months of age, 32 (9.3%) were serious. In the younger age-group, 307 (99%) of 309 reports followed direct vaccination of the child. In contrast, in individuals aged ≥6 years, 21 (60%) of 35 reports were via potential indirect exposure to a vaccinated child. The frequently reported AEs in the younger age-group were inappropriate schedule of drug administration 104 (34%) and drug administered to patient of inappropriate age 45 (15%); in the older group these were accidental exposure 9 (26%) and eye irritation 7 (20%). No difference in the safety profile was observed between RV1 and RV5.

Conclusions: We did not identify any unexpected AEs for RV vaccines among individuals aged ≥8 months. Health care providers should adhere to the ACIP recommended schedule and older individuals should apply necessary precautions to prevent potential secondary exposure from vaccinated children.
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http://dx.doi.org/10.1016/j.vaccine.2020.11.026DOI Listing
January 2021

Adverse events following quadrivalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2016.

Vaccine 2020 09 31;38(40):6291-6298. Epub 2020 Jul 31.

Division of Healthcare Quality Promotion, Immunization Safety Office, National Center for Emerging Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA.

Background: Post marketing safety evaluations of quadrivalent meningococcal diphtheria-toxoid conjugate vaccine (MenACWY-D) have focused on post-vaccination risk of Guillain Barré syndrome (GBS), adverse events (AEs) after maternal vaccination, and comparative studies with the newer quadrivalent meningococcal CRM conjugate vaccine (MenACWY-CRM). To provide an updated general safety assessment, we reviewed reports of AEs following MenACWY-D submitted to the Vaccine Adverse Event Reporting System (VAERS).

Methods: VAERS is a national spontaneous reporting vaccine safety surveillance system co-administered by the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration. We searched the VAERS database for U.S. reports of AEs after administration of MenACWY-D from January 2005 through June 2016. We conducted clinical reviews of serious reports after MenACWY-D administered alone, reports of MenACWY-D use during pregnancy, and reports of selected pre-specified outcomes. We screened for disproportionate reporting of AEs after MenACWY-D using empirical Bayesian data mining.

Results: VAERS received 13,075 U.S. reports after receipt of MenACWY-D; most (86%) described vaccination in adolescents, were classified as non-serious (94%), and described AEs consistent with pre-licensure studies. We did not find any evidence that reported deaths were related to vaccination. In serious reports, GBS and meningococcal infection were the most commonly reported medical conditions. Many reports of MenACWY-D use during pregnancy described inadvertent vaccination; most (61%) did not report any AE.

Conclusions: Findings from our comprehensive review of reports to VAERS following MenACWY-D are consistent with data from pre-licensure studies and provide further reassurance on the safety of MenACWY-D.
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http://dx.doi.org/10.1016/j.vaccine.2020.07.039DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7495357PMC
September 2020

Monitoring the safety of high-dose, trivalent inactivated influenza vaccine in the vaccine adverse event reporting system (VAERS), 2011 - 2019.

Vaccine 2020 08 21;38(37):5923-5926. Epub 2020 Jul 21.

Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA, United States.

Background: On 12/23/2009 a new high-dose trivalent inactivated influenza vaccine (IIV3-HD) was licensed for adults aged ≥65 years. We assessed the post-licensure safety data for IIV3-HD in the Vaccine Adverse Event Reporting System (VAERS) during 2011-2019.

Methods: We searched VAERS for reports after IIV3-HD during 1/1/2011-06/30/2019 in persons aged ≥65 years. Medical records were reviewed for all death reports and for certain pre-specified conditions (e.g. Guillain Barré Syndrome [GBS], anaphylaxis). We also reviewed certain groups who received IIV3-HD erroneously (e.g. pregnant women, children). Empirical Bayesian data mining was used to identify disproportional reporting.

Results: VAERS received 12,320 reports after IIV3-HD;723 reports (5.9%) were serious. The most common adverse events (AEs) among serious reports were pyrexia (30.2%), asthenia (28.9%), and dyspnea (24.9%), and among non-serious reports were injection site erythema (16.8%), pain in extremity (15.8%), and injection site pain (14.2%). Among 55 death reports, the most common causes of death were diseases of the circulatory system (n = 23;41.8%). Based on medical record review, there were 61 reports of GBS and 13 of anaphylaxis. There were 13 reports of pregnant-women who inadvertently received IIV3-HD; three reports described arm pain or local reactions, and 10 did not report any AE. Among 59 reports of children who erroneously received IIV3-HD, 31 experienced an AE (most commonly injection site or constitutional reactions) and the remaining 28 reports did not describe any AE.

Conclusions: Post-licensure safety data of IIV3-HD during 9 influenza seasons revealed no new or unexpected safety concerns among individuals ≥65 years. Inadvertent administration of IIV3-HD to children or pregnant women was observed, although with no serious AEs reported. Training and education of providers in vaccine recommendations and groups for whom the vaccine is indicated may help in preventing these vaccine administration errors. This review provides baseline information for future monitoring of the quadrivalent-high-dose influenza vaccine.
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http://dx.doi.org/10.1016/j.vaccine.2020.07.007DOI Listing
August 2020

Age inappropriate influenza vaccination in infants less than 6 months old, 2010-2018.

Vaccine 2020 05 6;38(21):3747-3751. Epub 2020 Apr 6.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.

Background: Annual influenza vaccination is recommended for persons 6 months or older and vaccination in infants less than 6 months old is a vaccine administration error. There are limited safety studies in this population, particularly among infants less than 6 weeks old.

Methods: We searched the U.S. Vaccine Adverse Event Reporting System (VAERS) database for reports of adverse events (AEs) following influenza vaccination in infants less than 6 months old for the 2010-2018 influenza seasons. We conducted a descriptive and qualitative analysis of reports to describe AEs and identify possible risk factors.

Results: In total, 114 reports were identified; only 21 reported a specific AE. Pyrexia, irritability, crying and diarrhea were the most common symptoms. There were 12 reports involving newborns; the most common circumstance cited was confusion with the birth dose of hepatitis B vaccine. The following risk factors were identified: (1) individuals getting vaccinated together resulting in patient mix-ups; (2) healthcare provider not verifying the patient's information; (3) individual provider confusion due to similarities in vaccines' packaging and names of vaccines that sound alike.

Conclusions: Reports identified of influenza vaccination in infants less than 6 months old indicate that vaccination errors in this age group are occurring and healthcare providers who vaccinate infants should be aware of how to prevent such events. Our study adds to the existing literature by providing valuable information regarding the general absence of serious adverse events in the case of vaccination errors associated with inadvertent influenza vaccine within this population.
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http://dx.doi.org/10.1016/j.vaccine.2020.03.039DOI Listing
May 2020

Association Between Vaccine Exemption Policy Change in California and Adverse Event Reporting.

Pediatr Infect Dis J 2020 05;39(5):369-373

Yale Institute for Global Health, Yale University, New Haven, Connecticut.

Background: California Senate Bill 277 (SB277) eliminated non-medical immunization exemptions. Since its introduction on February 19, 2015, the rate of medical exemptions in the state has increased. Filing a report to Vaccine Adverse Event Reporting System (VAERS) may be perceived as helpful in applying for a medical exemption. Our objective was to describe trends in reporting to VAERS from California coincident with introduction of SB277.

Methods: This was a retrospective study of Californian children <18 years for whom a VAERS report was submitted between June 1, 2011 and July 31, 2018. VAERS is a national, passive, vaccine safety surveillance program co-managed by Centers for Disease Control and Prevention and FDA. The main outcomes were the proportion of VAERS reports submitted by parents (vs. other reporter types), time from immunization to VAERS report (reporting time), and adverse event type. We also performed spatial analysis, mapping reports pre- and post-mandate by county.

Results: We identified 6703 VAERS reports from California during the study period. The proportion of reports received from parents increased after implementation of SB277, from 14% to 23%. The median reporting time by parents increased from 9 days in 2013-2014 to 31 days in 2016-2017. After the introduction of SB277, we observed an increase in reports describing behavioral and developmental symptoms among reports submitted >6 months after immunization.

Conclusions: These recent changes in reporting patterns coincident with the introduction of SB277 may indicate that more parents are using VAERS to assist in applying for a medical exemption for their child.
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http://dx.doi.org/10.1097/INF.0000000000002585DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7874304PMC
May 2020

Fever After Influenza, Diphtheria-Tetanus-Acellular Pertussis, and Pneumococcal Vaccinations.

Pediatrics 2020 03 6;145(3). Epub 2020 Feb 6.

Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.

Background: Administering inactivated influenza vaccine (IIV), 13-valent pneumococcal conjugate vaccine (PCV13), and diphtheria-tetanus-acellular pertussis (DTaP) vaccine together has been associated with increased risk for febrile seizure after vaccination. We assessed the effect of administering IIV at a separate visit from PCV13 and DTaP on postvaccination fever.

Methods: In 2017-2018, children aged 12 to 16 months were randomly assigned to receive study vaccines simultaneously or sequentially. They had 2 study visits 2 weeks apart; nonstudy vaccines were permitted at visit 1. The simultaneous group received PCV13, DTaP, and quadrivalent IIV (IIV4) at visit 1 and no vaccines at visit 2. The sequential group received PCV13 and DTaP at visit 1 and IIV4 at visit 2. Participants were monitored for fever (≥38°C) and antipyretic use during the 8 days after visits.

Results: There were 110 children randomly assigned to the simultaneous group and 111 children to the sequential group; 90% received ≥1 nonstudy vaccine at visit 1. Similar proportions of children experienced fever on days 1 to 2 after visits 1 and 2 combined (simultaneous [8.1%] versus sequential [9.3%]; adjusted relative risk = 0.87 [95% confidence interval 0.36-2.10]). During days 1 to 2 after visit 1, more children in the simultaneous group received antipyretics (37.4% vs 22.4%; = .020).

Conclusions: In our study, delaying IIV4 administration by 2 weeks in children receiving DTaP and PCV13 did not reduce fever occurrence after vaccination. Reevaluating this strategy to prevent fever using an IIV4 with a different composition in a future influenza season may be considered.
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http://dx.doi.org/10.1542/peds.2019-1909DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7055925PMC
March 2020

Safety review of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccines (Tdap) in adults aged ≥65 years, Vaccine Adverse Event reporting System (VAERS), United States, September 2010-December 2018.

Vaccine 2020 02 26;38(6):1476-1480. Epub 2019 Dec 26.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.

Introduction: The Advisory Committee on Immunization Practices (ACIP) recommends vaccination with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in persons ≥65 years of age. To date, few studies have assessed the safety of Tdap in this population. We aimed to summarize reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following receipt of Tdap in this age group.

Methods: We searched for and analyzed U.S. VAERS reports of Tdap among individuals ≥65 years of age submitted from September 1, 2010 through December 31, 2018. We classified reports according to concurrent vaccination, seriousness, and outcome (death, non-death) and determined the frequency of reported adverse events (AEs). For serious reports, we reviewed available medical records. Data mining analyses were undertaken to detect disproportionality in reporting.

Results: VAERS received a total of 1,798 reports following Tdap, of which 104 (6%) were serious. The most common AEs were injection site erythema (26%; n = 468), injection site pain (19%; n = 335), injection site swelling (18%; n = 329), and erythema (18%; n = 321). We identified seven deaths; none were attributed to Tdap. Among serious non-death reports, nervous system disorders (35.1%; n = 34) and infections and infestations (n = 18.6%; n = 18) were most commonly reported. Data mining did not identify any vaccine-AE combination reported more frequently than expected.

Conclusions: We did not identify any new safety concern over nearly a decade of recommended Tdap use among adults ≥65 years of age. Findings from this post-marketing review are consistent with prior post-marketing observations and pre-licensure studies.
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http://dx.doi.org/10.1016/j.vaccine.2019.11.074DOI Listing
February 2020

Erythema multiforme, Stevens Johnson syndrome, and toxic epidermal necrolysis reported after vaccination, 1999-2017.

Vaccine 2020 02 20;38(7):1746-1752. Epub 2019 Dec 20.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States.

Background: Since the last review of vaccine safety surveillance data for erythema multiforme (EM), Stevens Johnson syndrome (SJS), SJS/TEN, and toxic epidermal necrolysis (TEN) (EM/SJS/TEN), over 37 new vaccines have been introduced in the United States. We sought to describe reported EM/SJS/TEN after vaccines during 1999-2017.

Methods: We identified U.S. reports of EM/SJS/TEN received by the Vaccine Adverse Event Reporting System (VAERS) during 1999-2017. We stratified analysis by condition (EM, SJS, or TEN), and analyzed reports by serious or non-serious status, sex, age group, time from vaccination to symptom onset, exposure to known causes of EM/SJS/TEN, and vaccines administered. We used Empirical Bayesian data mining to detect vaccine-AE pairs reported more frequently than expected.

Results: Of 466,027 reports to VAERS during 1999-2017, we identified 984 reports of EM, 89 reports of SJS, 6 reports of SJS/TEN, and 7 reports of TEN. Few reports of EM (9%), and most reports of SJS (52%), SJS/TEN (100%), and TEN (100%) were serious. Overall, 55% of reports described males, 48% described children aged < 4 years; 58% of EM/SJS/TEN occurred ≤ 7 days after vaccination. Few reports (≤5%) described exposure to known causes of EM/SJS/TEN. Overall, childhood vaccines (e.g., combined measles, mumps, and rubella vaccine) were most commonly reported. We identified 6 deaths; 4 were exposed to medications associated with EM/SJS/TEN. EM after smallpox vaccine was reported disproportionately among people aged 19-49 years.

Conclusions: EM/SJS/TEN were rarely reported after vaccination; data mining identified a known association between EM and smallpox vaccine.
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http://dx.doi.org/10.1016/j.vaccine.2019.12.028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008074PMC
February 2020

Reports of atypical shoulder pain and dysfunction following inactivated influenza vaccine, Vaccine Adverse Event Reporting System (VAERS), 2010-2017.

Vaccine 2020 01 26;38(5):1137-1143. Epub 2019 Nov 26.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC), United States.

Background: Vaccines administered into or too close to underlying joint structures have the potential to cause shoulder injuries. Limited data exist on the epidemiology of such events.

Objective: To describe case reports of atypical shoulder pain and dysfunction following injection of inactivated influenza vaccine (IIV).

Methods: We searched the Vaccine Adverse Event Reporting System (VAERS) database from July 2010 to June 2017 for reports of atypical shoulder pain and dysfunction following IIV. When identifying reports, we made no assumptions about true incident injury or causality with respect to vaccination. Pain had to begin <48 h after vaccination and signs and symptoms had to continue for >7 days to differentiate from self-limited local reactions. We conducted descriptive analysis.

Results: We identified 1220 reports that met our case definition (2.0% of all IIV reports, range 1.5%-2.5% across influenza seasons). Median age was 52 years (range 16-94) and most patients (82.6%) were female. Shoulder pain (44.1%), injected limb mobility decreased (40.8%), joint range of motion decreased (21.2%), rotator cuff syndrome (9.2%), and bursitis (9.0%) were frequently reported. In 86.6% of reports, signs and symptoms had not resolved by the time of report submission. In reports that included descriptions suggesting contributing factors (n = 266), vaccination given "too high" on the arm was cited in 81.2%. Nearly half (n = 605, 49.6%) of reports described a healthcare provider evaluation. Treatments included non-narcotic analgesics, physical therapy, and corticosteroid injection. Vaccinations were most commonly administered in a pharmacy or retail store (41.0%) or doctor's office or hospital (31.6%).

Conclusions: Reports of atypical shoulder pain and dysfunction following IIV were uncommon, considering the amount of IIV use, and stable across influenza seasons. While specific etiology of cases is unknown, improperly administered vaccine, which is preventable, might be a factor. Prevention strategies include education, training, and adherence to best practices for vaccine administration.
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http://dx.doi.org/10.1016/j.vaccine.2019.11.023DOI Listing
January 2020

Shoulder Injury Related to Vaccine Administration (SIRVA): Petitioner claims to the National Vaccine Injury Compensation Program, 2010-2016.

Vaccine 2020 01 23;38(5):1076-1083. Epub 2019 Nov 23.

National Vaccine Injury Compensation Program, Health Resources and Services Administration, U.S. Department of Health and Human Services, 5600 Fishers Lane, Rockville, MD 20857, United States.

Background: Since 2010, petitioner claims of shoulder injury related to vaccine administration (SIRVA) to the National Vaccine Injury Compensation Program (VICP) have been increasing.

Objective: To conduct a scientific review of clinical characteristics of SIRVA petitions to the VICP.

Methods: We queried the VICP's Injury Compensation System database for medical reports of alleged SIRVA and SIRVA-like injuries. Medical reports are summaries of petitioner claims and supporting documentation along with a VICP clinician reviewer diagnosis and assessment of criteria for concession. We conducted a descriptive analysis of SIRVA petitioner claims recommended by the VICP for concession as SIRVA injuries.

Results: We identified 476 petitioner claims recommended for concession. Claims per year increased from two in 2011, the first full year in the analytic period, to 227 in 2016. Median age was 51 years, 82.8% were women, and median body mass index was 25.1 (range 17.0-48.9). Four hundred cases (84.0%) involved influenza vaccine. Pharmacy or store (n = 168; 35.3%) was the most common place of vaccination followed by doctor's office (n = 147; 30.9%). Fewer than half of cases reported a suspected administration error; 172 (36.1%) reported 'injection too high' on the arm. Shoulder pain, rotator cuff problems, and bursitis were common initial diagnoses. Most (80.0%) cases received physical or occupational therapy, 60.1% had at least one steroid injection, and 32.6% had surgery. Most (71.9%) healthcare providers who gave opinions on causality considered the injury was caused by vaccination. A minority (24.3%) of cases indicated that symptoms had resolved by the last visit available in medical records.

Conclusions: Most conceded claims for SIRVA were in women and involved influenza vaccines. Injection too high on the arm could be a factor due to the risk of injecting into underlying non-muscular tissues. Healthcare providers should be aware of proper injection technique and anatomical landmarks when administering vaccines.
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http://dx.doi.org/10.1016/j.vaccine.2019.11.032DOI Listing
January 2020

Safety of the 9-Valent Human Papillomavirus Vaccine.

Pediatrics 2019 12 18;144(6). Epub 2019 Nov 18.

Division of Healthcare Quality Promotion, Immunization Safety Office, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; and.

Background: The 9-valent human papillomavirus vaccine (9vHPV) was approved for females and males aged 9 to 26 years in 2014. We analyzed postlicensure surveillance reports to the Vaccine Adverse Event Reporting System (VAERS).

Methods: We searched VAERS data for US reports of adverse events (AEs) after 9vHPV from December 2014 through December 2017. We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reporting. Physicians reviewed reports for selected prespecified conditions.

Results: VAERS received 7244 reports after 9vHPV: 31.2% among females, 21.6% among males, and for 47.2%, sex was not reported. Overall, 97.4% of reports were nonserious. Dizziness, syncope, headache, and injection site reactions were most commonly reported; the most commonly reported AEs were similar between females and males. Two reports of death after 9vHPV were verified; no information in autopsy reports or death certificates suggested a causal relationship with vaccination. Approximately 28 million 9vHPV doses were distributed during the study period; crude AE reporting rates were 259 reports per million 9vHPV doses distributed for all reports and 7 per million doses distributed for serious reports. Syncope (a known AE associated with human papillomavirus vaccination) and several types of vaccine administration errors (eg, administered at wrong age) exceeded the statistical threshold for empirical Bayesian data mining findings.

Conclusions: No new or unexpected safety concerns or reporting patterns of 9vHPV with clinically important AEs were detected. The safety profile of 9vHPV is consistent with data from prelicensure trials and from postmarketing safety data of its predecessor, the quadrivalent human papillomavirus vaccine.
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http://dx.doi.org/10.1542/peds.2019-1791DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6935554PMC
December 2019

Adverse events following adenovirus type 4 and type 7 vaccine, live, oral in the Vaccine Adverse Event Reporting System (VAERS), United States, October 2011-July 2018.

Vaccine 2019 10 20;37(44):6760-6767. Epub 2019 Sep 20.

Immunization Safety Office, Division of Healthcare Quality Promotion (DHQP), National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers for Disease Control and Prevention (CDC), Atlanta, GA 30329, USA.

Background: In March 2011, the U.S. Food and Drug Administration licensed adenovirus type 4 and type 7 vaccine, live, oral (Barr Labs, Inc.) (adenovirus vaccine) for use in military personnel 17 through 50 years of age. The vaccine was first universally administered to U.S. military recruits in October 2011. We investigated adverse event (AE) reports following the adenovirus vaccine submitted to the Vaccine Adverse Event Reporting System (VAERS).

Methods: We searched the VAERS database for U.S. reports among persons who received adenovirus vaccine during October 2011 through July 2018 including participants in a military observational study. We reviewed all serious reports and accompanying medical records. We compared the proportion of serious reports in a proxy military recruit population and reviewed all reports of suspected allergic reactions following adenovirus vaccination.

Results: During the analytic period, VAERS received 100 reports following adenovirus vaccination; 39 (39%) were classified as serious and of these, 17 (44%) were from the observational study. One death was reported. Males accounted for 72% of reports. Median age of vaccinees was 19 years (range 17-32). The most frequently reported serious AEs were Guillain Barré syndrome (GBS) (n = 12) and anaphylaxis (n = 8); of these, two GBS and all the anaphylaxis reports were reported in the observational study. Reports documented concurrent receipt of multiple other vaccines (95%) and penicillin G (IM Pen G) or other antibiotics (50%).

Conclusions: The reporting rate for serious AEs was higher than with other vaccines administered in the comparison military recruit population (39% vs 18%); however, we identified no unexpected or concerning pattern of adenovirus vaccine AEs. Co-administration of vaccines and IM Pen G was commonly reported in this military population. These exposures may have contributed to the GBS and anaphylaxis outcomes observed with the adenovirus vaccine. Future adenovirus vaccine safety studies in a population without these co-administrations would be helpful in clarifying the vaccine's safety profile.
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http://dx.doi.org/10.1016/j.vaccine.2019.08.087DOI Listing
October 2019

Is there any harm in administering extra-doses of vaccine to a person? Excess doses of vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2007-2017.

Vaccine 2019 06 30;37(28):3730-3734. Epub 2019 May 30.

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control and Prevention, USA.

Background: The administration of an extra dose of a vaccine may occur due to a programmatic error (e.g., vaccination error) when there is need to provide one of the antigens of a combination vaccine not readily available as a single antigen, or when there is need to provide immunization in a person with uncertain vaccination histories (e.g., refugees). There is little data available on the safety of an extra dose of vaccine.

Objective: To assess for the presence of adverse events (AEs) most commonly reported following the administration of excess doses of vaccine in the Vaccine Adverse Event Reporting System (VAERS).

Methods: We searched VAERS for US reports where an excess dose of vaccine was administered to a person received from 1/1/2007 through 1/26/2018. We reviewed medical records for all serious reports and a random sample of non-serious reports. The most common AEs among reports of excess dose of vaccine administered were compared with the corresponding AEs for all vaccines reported to VAERS during the same period.

Results: Out of 366,815 total VAERS reports received, 5067 (1.4%) reported an excess dose of vaccine was administered; 3898 (76.9%) did not describe an adverse health event (AHE). The most common vaccines reported were trivalent inactivated influenza (15.4%), varicella (13.9%), hepatitis A (11.4%), and measles, mumps, rubella, varicella (11.1%). Among reports where only AHEs were reported, the most common were pyrexia (12.8%), injection site erythema (9.7%), injection site pain (8.9%), and headache (6.6%). The percentage of AHEs among these reports was comparable to all reports submitted to VAERS during the same study period.

Conclusion: More than three-fourths of reports of an excess dose of vaccine did not describe an AHE. Among reports where an AHE event was reported, we did not observe any unexpected conditions or clustering of AEs.
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http://dx.doi.org/10.1016/j.vaccine.2019.04.088DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6925972PMC
June 2019