{"id":78541,"date":"2022-03-10T12:16:33","date_gmt":"2022-03-10T18:16:33","guid":{"rendered":"https:\/\/milesfortis.com\/?p=78541"},"modified":"2022-03-10T12:16:33","modified_gmt":"2022-03-10T18:16:33","slug":"78541","status":"publish","type":"post","link":"https:\/\/milesfortis.com\/?p=78541","title":{"rendered":""},"content":{"rendered":"<p>Oh to those people pushing the vaxx because it &#8216;safe&#8217; or something? This is from <em>The Lancet<\/em>, which\u00a0is a weekly <strong>peer-reviewed<\/strong> general medical journal.<\/p>\n<hr \/>\n<p>Comment O&#8217; The Day (from a GP MD)<\/p>\n<p>1% of those who had a reaction to the vaccine are dead.<br \/>\nSorry if that was not made clear. But remember the cut off at the CDC for pulling a vaccine or medicine from the market is 50 deaths. Hit that magic number and it is off the market.<\/p>\n<p>The jabs in all their glory are far above that. And this is all being done under a EUA for a disease that is not that lethal. <strong>So you get a reaction to the jab, depending on the type of one given, you stand a 1% chance of dying.<\/strong> Remember, the VAERS data is skewed to make those numbers lower.\u00a0The vaccine is not safe given the usual definition per the CDC.<\/p>\n<p>My biggest problem is they had this data and it was not disclosed to people in terms of informed consent. How many people would have taken the jab if they were told: <em>\u201cThe vaccine is considered safe, but 1% of those who get a reaction are dead.\u201d<\/em><\/p>\n<p>Mind you, the vaccine failed to contain the disease and was considered not effective in preventing morbidity after 6 months. Why was this data not discussed earlier?\u00a0<span style=\"color: #333333;\">Well that is pretty clear in that when it came to consent time, most would have said <em>\u201cI\u2019ll just take my chances.\u201d<\/em><\/span><\/p>\n<hr \/>\n<p><a href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#%20\" target=\"_blank\" rel=\"noopener\">Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe<\/a><\/p>\n<section>\n<p tabindex=\"0\" data-left-hand-nav=\"Summary\"><a href=\"https:\/\/www.thelancet.com\/action\/showPdf?pii=S1473-3099%2822%2900054-8\" target=\"_blank\" rel=\"noopener\">PDF download<\/a><\/p>\n<div class=\"inline-table__head\"><span class=\"inline-table__label\">Table 1 <\/span><span class=\"inline-table__title\">Characteristics of reports received and processed by VAERS for mRNA COVID-19 vaccines<\/span><\/div>\n<div class=\"table-with-References\">\n<table class=\"scrollable bordered\" border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"0\">\n<thead>\n<tr>\n<th class=\"rowsep\"><\/th>\n<th class=\"rowsep\"><\/th>\n<th class=\"rowsep\"><strong>Both mRNA vaccines (n=340\u2008522)<\/strong><\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl1fn1\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl1fn1-d5011977e44\" aria-expanded=\"false\" aria-controls=\"tbl1fn1\">*<\/a><\/div>\n<\/th>\n<th class=\"rowsep\"><strong>BNT162b2 vaccine (n=164\u2008669)<\/strong><\/th>\n<th class=\"rowsep\"><strong>mRNA-1273 vaccine (n=175\u2008816)<\/strong><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td colspan=\"5\"><strong>Category<\/strong><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Non-serious<\/td>\n<td>313\u2008499 (92\u00b71%)<\/td>\n<td>150\u2008486 (91\u00b74%)<\/td>\n<td>162\u2008977 (92\u00b77%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Serious, including death<\/td>\n<td>27\u2008023 (7\u00b79%)<\/td>\n<td>14\u2008183 (8\u00b76%)<\/td>\n<td>12\u2008839 (7\u00b73%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Serious, excluding death<\/td>\n<td>22\u2008527 (6\u00b76%)<\/td>\n<td>12\u2008078 (7\u00b73%)<\/td>\n<td>10\u2008448 (5\u00b79%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><strong>Death<\/strong><\/td>\n<td><strong>4496 (1\u00b73%)<\/strong><\/td>\n<td><strong>2105 (1\u00b73%)<\/strong><\/td>\n<td><strong>2391 (1\u00b74%)<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<h2 id=\"seccestitle10\" class=\"top\" tabindex=\"0\" data-left-hand-nav=\"Summary\"><span class=\"top__text\">Summary<\/span><\/h2>\n<div class=\"section-paragraph\">\n<h3>Background<\/h3>\n<div class=\"section-paragraph\">In December, 2020, two mRNA-based COVID-19 vaccines were authorised for use in the USA.<br \/>\nWe 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.<\/div>\n<\/div>\n<\/section>\n<div><\/div>\n<p><!--more--><\/p>\n<div><span style=\"font-size: 23px; font-weight: 900;\">Methods<\/span><\/div>\n<section>\n<div class=\"section-paragraph\">\n<div class=\"section-paragraph\">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\u20137 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).<\/div>\n<h3>Findings<\/h3>\n<div class=\"section-paragraph\">During the study period, 298\u2009792\u2009852 doses of mRNA vaccines were administered in the USA. VAERS processed 340\u2009522 reports: 313\u2009499 (92\u00b71%) were non-serious, 22\u2009527 (6\u00b76%) were serious (non-death), and 4496 (1\u00b73%) were deaths. Over half of 7\u2009914\u2009583 v-safe participants self-reported local and systemic reactogenicity, more frequently after dose two (4\u2009068\u2009447 [71\u00b77%] of 5\u2009674\u2009420 participants for local reactogenicity and 4\u2009018\u2009920 [70\u00b78%] for systemic) than after dose one (4\u2009644\u2009989 [68\u00b76%] of 6\u2009775\u2009515 participants for local reactogenicity and 3\u2009573\u2009429 [52\u00b77%] for systemic). Injection-site pain (4\u2009488\u2009402 [66\u00b72%] of 6\u2009775\u2009515 participants after dose one and 3\u2009890\u2009848 [68\u00b76%] of 5\u2009674\u2009420 participants after dose two), fatigue (2\u2009295\u2009205 [33\u00b79%] participants after dose one and 3\u2009158\u2009299 participants [55\u00b77%] after dose two), and headache (1\u2009831\u2009471 [27\u00b70%] participants after dose one and 2\u2009623\u2009721 [46\u00b72%] participants after dose two) were commonly reported during days 0\u20137 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\u2009821\u2009421 [32\u00b71%]) than after dose one (808\u2009963 [11\u00b79%]); less than 1% of participants reported seeking medical care after vaccination (56\u2009647 [0\u00b78%] after dose one and 53\u2009077 [0\u00b79%] after dose two).<\/div>\n<h3>Interpretation<\/h3>\n<div class=\"section-paragraph\">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.<\/div>\n<h3>Funding<\/h3>\n<div class=\"section-paragraph\">US Centers for Disease Control and Prevention.<\/div>\n<\/div>\n<\/section>\n<div class=\"relatedItems-dropzone pb-dropzone\" data-pb-dropzone=\"relatedItems-dropzone\">\n<div data-widget-id=\"6211e606-91ef-4fed-96eb-a6bff90d54e7\" data-widget-name=\"UX3HTMLWidget\">\n<div id=\"related-links-container\">\n<section id=\"related-section\">\n<div id=\"related-message-box\" class=\"section-paragraph\">\n<p id=\"related-message-text\">\u2022\u00a0<a id=\"related-message-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#coronavirus-linkback-header\">View related content for this article<\/a><\/p>\n<\/div>\n<\/section>\n<\/div>\n<\/div>\n<\/div>\n<section id=\"cesec10\" tabindex=\"0\" data-locator=\"cesec10\">\n<h2 id=\"seccestitle70\" class=\"top\" tabindex=\"0\" data-left-hand-nav=\"Introduction\"><span class=\"top__text\">Introduction<\/span><\/h2>\n<div class=\"section-paragraph\">\n<p>In December, 2020, two mRNA COVID-19 vaccines (BNT162b2 [Pfizer-BioNTech]; and mRNA-1273 [Moderna]) were granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) as two-dose series and recommended for use by the Advisory Committee on Immunization Practices (ACIP).\u00a0<sup><a id=\"back-bib1\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib1-d5011977e2353\" aria-expanded=\"false\" aria-controls=\"bib1\">1,\u00a0<\/a><\/sup><sup><a id=\"back-bib2\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib2-d5011977e2353\" aria-expanded=\"false\" aria-controls=\"bib2\">2<\/a><\/sup><\/p>\n<p>In clinical trials, both mRNA COVID-19 vaccines showed acceptable safety profiles;<sup><a id=\"back-bib3\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib3-d5011977e2357\" aria-expanded=\"false\" aria-controls=\"bib3\">3<\/a><\/sup><sup>,\u00a0<\/sup><sup><a id=\"back-bib4\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib4-d5011977e2357\" aria-expanded=\"false\" aria-controls=\"bib4\">4<\/a><\/sup><\/p>\n<p>the most frequently reported local and systemic symptoms were injection-site pain, fatigue, and headache. Reactogenicity was more frequently reported after dose two than after dose one and among participants younger than 65 years than among older participants.<sup><a id=\"back-bib3\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib3-d5011977e2361\" aria-expanded=\"false\" aria-controls=\"bib3\">3,\u00a0<\/a><\/sup><sup><a id=\"back-bib4\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib4-d5011977e2361\" aria-expanded=\"false\" aria-controls=\"bib4\">4, <\/a><\/sup><sup><a id=\"back-bib5\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib5-d5011977e2361\" aria-expanded=\"false\" aria-controls=\"bib5\">5<\/a><\/sup><\/p>\n<\/div>\n<div class=\"section-paragraph\">\n<p>Post-authorisation safety monitoring can characterise the safety profiles of mRNA-based COVID-19 vaccines in large and heterogeneous populations.\u00a0<sup><a id=\"back-bib6\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib6\" data-db-target-for=\"bib6-d5011977e2366\" aria-expanded=\"false\" aria-controls=\"bib6\">6<\/a><\/sup><\/p>\n<p>Phased administration of COVID-19 vaccines in the USA began with health-care workers and long-term care-facility residents and was expanded to the general population during spring 2021; however, implementation plans varied by state.<sup><a id=\"back-bib7\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib7\" data-db-target-for=\"bib7-d5011977e2370\" aria-expanded=\"false\" aria-controls=\"bib7\">7<\/a><\/sup><\/p>\n<p>The major sources of initial US safety data were the Vaccine Adverse Event Reporting System (VAERS), a spontaneous, passive reporting system;<sup><a id=\"back-bib8\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib8\" data-db-target-for=\"bib8-d5011977e2374\" aria-expanded=\"false\" aria-controls=\"bib8\">8<\/a><\/sup><\/p>\n<p>and v-safe,<sup><a id=\"back-bib9\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib9\" data-db-target-for=\"bib9-d5011977e2378\" aria-expanded=\"false\" aria-controls=\"bib9\">9<\/a><\/sup><\/p>\n<p>a new active monitoring system. VAERS was established in 1990 as the US early warning system to rapidly detect adverse events that might occur following vaccinations. V-safe was established in 2020 specifically for monitoring COVID-19 vaccine safety in the USA and collects information on reactogenicity and effects on health following COVID-19 vaccination.<\/p>\n<\/div>\n<div class=\"section-paragraph\">\n<div class=\"accordion--textbox\">\n<div id=\"cetextbox10\" class=\"accordion\" tabindex=\"0\">\n<div class=\"accordion__content\">\n<p><b>Research in context<\/b><\/p>\n<div class=\"section-paragraph\"><strong>Evidence before this study<\/strong><\/div>\n<div class=\"section-paragraph\">We searched PubMed for articles published up to Dec 29, 2021, using the terms (\u201cBNT162b2\u201d OR \u201cmRNA-1273\u201d OR \u201cmRNA COVID-19 vaccine\u201d) AND (\u201creactogenicity\u201d OR \u201cside-effects\u201d OR \u201cadverse effects\u201d OR \u201chealth impact\u201d), not restricted by language or type of publication. Among 429 results, few publications described health impacts following vaccination by BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna). Available literature included reports of manufacturer-sponsored phase 1\u20133 clinical trials, observational and cross-sectional studies among specific groups (eg, transplant recipients or employees of a specific health-care system), and reviews or society recommendations that discussed reactogenicity and adverse events following mRNA vaccination.<\/div>\n<div class=\"section-paragraph\"><strong>Added value of this study<\/strong><\/div>\n<div class=\"section-paragraph\">In this large, observational study, we assessed reactogenicity, health impacts, and adverse events reported following mRNA COVID-19 vaccination during the first 6 months of the US vaccination programme to one active (v-safe) and one passive (Vaccine Adverse Event Reporting System) surveillance system. We found that reported reactions to mRNA vaccination were mostly mild in severity and transient in duration, and most reports were non-serious. Reactions and health impacts were reported more frequently in female than in male recipients, and in individuals younger than 65 years than in older individuals. Information on health impacts for individuals from v-safe is presented here for the first time.<\/div>\n<div class=\"section-paragraph\"><strong>Implications of all the available evidence<\/strong><\/div>\n<div class=\"section-paragraph\">The findings from two complementary surveillance systems from the first 6 months of mRNA vaccine administration in the USA are consistent with pre-authorisation clinical trials and early post-authorisation reports. On the basis of our findings, mild-to-moderate transient reactogenicity should be anticipated, particularly among younger and female vaccine recipients. Vaccine safety data collected by the US monitoring systems will be used to update the benefit\u2013risk assessments for COVID-19 vaccine recommendations.<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"section-paragraph\">\n<p>Previous reports from these systems have been issued<a id=\"back-bib14\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib14-d5011977e2404\" aria-expanded=\"false\" aria-controls=\"bib14\"><\/a><\/p>\n<p>We aimed to review VAERS and v-safe data during the first 6 months of the US vaccination programme, when more than 298 million doses of mRNA COVID-19 vaccines were administered, to better characterise the safety profile of mRNA vaccines.<\/p>\n<\/div>\n<\/section>\n<section id=\"cesec20\" tabindex=\"0\" data-locator=\"cesec20\">\n<h2 id=\"seccestitle80\" class=\"top\" tabindex=\"0\" data-left-hand-nav=\"Methods\"><span class=\"top__text\">Methods<\/span><\/h2>\n<section id=\"cesec30\" tabindex=\"0\" data-locator=\"cesec30\">\n<h3 class=\"sectionTitle\"><span class=\"top__sub\">\u00a0<\/span><span class=\"top__text\">VAERS<\/span><\/h3>\n<div class=\"section-paragraph\">\n<p>VAERS is a national spontaneous reporting system for detecting potential adverse events for authorised or licensed US vaccines.<sup><a id=\"back-bib8\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib8\" data-db-target-for=\"bib8-d5011977e2416\" aria-expanded=\"false\" aria-controls=\"bib8\">8<\/a><\/sup><\/p>\n<p>VAERS is co-administered by the US Centers for Disease Control and Prevention (CDC) and the US FDA. VAERS accepts reports from health-care providers and other members of the public primarily through online submissions and from vaccine manufacturers through electronic transmissions. The volume of mail, fax, and telephone reports is trivial compared with public online and manufacturer electronic submissions. Reports include information about the vaccinated person, type of vaccine administered, and adverse events experienced. A VAERS report can be submitted for any event experienced following receipt of a vaccine. We included all VAERS reports that were submitted for US residents who received mRNA vaccines and processed from Dec 14, 2020, to June 14, 2021, including any interval from vaccination to event report. Processed reports were quality checked, and submitted text on the adverse event was coded using Medical Dictionary for Regulatory Activities (MedDRA) terminology.<sup><a id=\"back-bib8\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib8\" data-db-target-for=\"bib8-d5011977e2420\" aria-expanded=\"false\" aria-controls=\"bib8\">8<\/a><\/sup><\/p>\n<p>Each VAERS report was assigned at least one and possibly more than one MedDRA preferred term; preferred terms do not necessarily indicate medically confirmed diagnoses and they include signs and symptoms of illness and the ordering and results of diagnostic tests.<\/p>\n<\/div>\n<div class=\"section-paragraph\">\n<p>Based on the Code of Federal Regulations,<sup><a id=\"back-bib15\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib15\" data-db-target-for=\"bib15-d5011977e2426\" aria-expanded=\"false\" aria-controls=\"bib15\">15<\/a><\/sup><\/p>\n<p>VAERS reports were classified as serious if any of the following outcomes were documented: inpatient hospitalisation, prolongation of hospitalisation, permanent disability, life-threatening illness, congenital anomaly or birth defect, or death. Prespecified adverse events of special interest were selected for enhanced monitoring of COVID-19 vaccine safety on the basis of biological plausibility, previous vaccine safety experience, and theoretical concerns related to COVID-19, such as vaccine-mediated enhanced disease.<sup><a id=\"back-bib16\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib16\" data-db-target-for=\"bib16-d5011977e2430\" aria-expanded=\"false\" aria-controls=\"bib16\">16<\/a><\/sup><\/p>\n<p>VAERS staff requested death certificates and autopsy reports for reports of death. CDC physicians reviewed VAERS reports and available death certificates for each death to form an impression about cause of death. Impressions were assigned to one of the following categories: one of the 15 most common diagnostic categories from the International Classification of Disease, Tenth Revision, reported on US death certificates,<sup><a id=\"back-bib17\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib17\" data-db-target-for=\"bib17-d5011977e2434\" aria-expanded=\"false\" aria-controls=\"bib17\">17<\/a><\/sup><\/p>\n<p>COVID-19 related, other (ie, impression was not included in prespecified categories), or unknown or unclear if not enough information were available to determine a cause of death.<\/p>\n<\/div>\n<\/section>\n<section id=\"cesec40\" tabindex=\"0\" data-locator=\"cesec40\">\n<h3 class=\"sectionTitle\"><span class=\"top__sub\">\u00a0<\/span><span class=\"top__text\">V-safe<\/span><\/h3>\n<div class=\"section-paragraph\">\n<p>V-safe is a voluntary smartphone-based system that uses text messaging and secure web-based surveys to actively monitor COVID-19 vaccine safety for common local injection-site and systemic reactions.<sup><a id=\"back-bib9\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib9\" data-db-target-for=\"bib9-d5011977e2443\" aria-expanded=\"false\" aria-controls=\"bib9\">9<\/a><\/sup><\/p>\n<p>V-safe participants receive text messages that link to web-based health check-in surveys following vaccination, initially daily (days 0\u20137), then at longer intervals after vaccination. The system resets to the initial survey frequency after entry of another dose. We analysed survey reports from days 0\u20137 for reactogenicity, severity (mild, moderate, or severe),<sup><a id=\"back-bib9\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib9\" data-db-target-for=\"bib9-d5011977e2447\" aria-expanded=\"false\" aria-controls=\"bib9\">9<\/a><\/sup><\/p>\n<p>and health impacts (ie, unable to perform normal daily activities, unable to work, or received care from a medical professional) that were submitted to v-safe between Dec 14, 2020, and June 14, 2021. Participants who reported receiving medical care were contacted and VAERS reports were completed, if clinically indicated.<\/p>\n<\/div>\n<\/section>\n<section id=\"cesec50\" tabindex=\"0\" data-locator=\"cesec50\">\n<h3 class=\"sectionTitle\"><span class=\"top__sub\">\u00a0<\/span><span class=\"top__text\">Data analysis<\/span><\/h3>\n<div class=\"section-paragraph\">\n<p>We conducted descriptive analyses of available VAERS and v-safe data following dose one and dose two of BNT162b2 and mRNA-1273 vaccines among individuals aged at least 16 years. We stratified analyses by sex, age group, race and ethnicity, serious versus non-serious reports, and vaccine manufacturer; and for death reports, by time from vaccination to death (ie, onset interval) and cause of death. Reporting rates to VAERS were calculated for adverse events using the number of doses of mRNA vaccines administered during the 6-month period as the denominator. COVID-19 vaccine administration data were provided through CDC&#8217;s COVID-19 Data Tracker.<sup><a id=\"back-bib18\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib18\" data-db-target-for=\"bib18-d5011977e2456\" aria-expanded=\"false\" aria-controls=\"bib18\">18<\/a><\/sup><\/p>\n<\/div>\n<div class=\"section-paragraph\">V-safe participants who responded to at least one health check-in survey during days 0\u20137 after vaccination were included in analyses. Descriptive statistics were calculated for participants&#8217; characteristics (sex, age, and race and ethnicity), reaction (type and severity) and health impact by manufacturer, dose number, and number of days following vaccination.<\/div>\n<div class=\"section-paragraph\">Analyses were done using SAS (version 9.4). Both VAERS and v-safe conduct surveillance as a public health function and are exempt from institutional review board review. Activities were reviewed by the CDC and done in accordance with applicable\u00a0<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\" target=\"_blank\" rel=\"noopener\">federal law and CDC policy<\/a>.<\/div>\n<\/section>\n<section id=\"cesec60\" tabindex=\"0\" data-locator=\"cesec60\">\n<h3 class=\"sectionTitle\"><span class=\"top__sub\">\u00a0<\/span><span class=\"top__text\">Role of the funding source<\/span><\/h3>\n<div class=\"section-paragraph\">Authors from the CDC, the funder, were responsible for study design, data analysis, data interpretation, and writing of the report.<\/div>\n<\/section>\n<\/section>\n<section id=\"cesec70\" tabindex=\"0\" data-locator=\"cesec70\">\n<h2 id=\"seccestitle130\" class=\"top\" tabindex=\"0\" data-left-hand-nav=\"Results\"><span class=\"top__text\">Results<\/span><\/h2>\n<div class=\"section-paragraph\">From Dec 14, 2020, to June 14, 2021, 298\u2009792\u2009852 doses of mRNA COVID-19 vaccines were administered in the USA: 167\u2009177\u2009332 were BNT162b2 and 131\u2009639\u2009515 were mRNA-1273 (<a class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#sec1\">appendix p 2<\/a>). A greater proportion of vaccines was administered to females (155\u2009969\u2009573 [53\u00b72%]) than to males (134\u2009373\u2009958 [45\u00b78%]). The median age at vaccination was 50 years (IQR 33\u201365) for BNT162b2 and 56 years (39\u201368) for mRNA-1273. 112\u2009698\u2009875 (38\u00b74%) recipients were non-Hispanic White. Race and ethnicity was unknown for 102\u2009227\u2009532 (34\u00b79%) of all vaccine recipients.<\/div>\n<div class=\"section-paragraph\">\n<p>During the study period, VAERS received and processed 340\u2009522 reports: 164\u2009669 following BNT162b2 and 175\u2009816 following mRNA-1273 vaccination (<a id=\"back-tbl1\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl1\">table 1<\/a>). Of these reports, 313\u2009499 (92\u00b71%) were classified as non-serious; 22\u2009527 (6\u00b76%) were serious, not resulting in death; and 4496 (1\u00b73%) were deaths (<a id=\"back-tbl1\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl1\">table 1<\/a>). 246\u2009085 (72\u00b73%) reports were among female participants and 154\u2009171 (45\u00b73%) reports were among those aged 18\u201349 years; median age was 50 years (IQR 36\u201364;\u00a0<a id=\"back-tbl1\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl1\">table 1<\/a>). 169\u2009877 (49\u00b79%) of those reporting race or ethnicity identified as non-Hispanic White, and for 75\u2009334 (22\u00b71%) race and ethnicity were unknown (<a id=\"back-tbl1\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl1\">table 1<\/a>). The most common MedDRA preferred terms assigned to non-serious reports were headache (64\u2009064 [20\u00b74%] of 313\u2009499), fatigue (52\u2009048 [16\u00b76%]), pyrexia (51\u2009023 [16\u00b73%]), chills (49\u2009234 [15\u00b77%]), and pain (47\u2009745 [15\u00b72%];\u00a0<a id=\"back-tbl1\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl1\">table 1<\/a>). The most common MedDRA preferred terms assigned to serious reports were dyspnoea (4175 [15\u00b74%] of 27\u2009023), death (3802 [14\u00b71%]), pyrexia (2986 [11\u00b70%]), fatigue (2608 [9\u00b77%]), and headache (2567 [9\u00b75%];\u00a0<a id=\"back-tbl1\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl1\">table 1<\/a>).<\/p>\n<div class=\"floatDisplay\">\n<div id=\"tbl1\" class=\"inline-table\" tabindex=\"0\">\n<div class=\"inline-table__head\"><span class=\"inline-table__label\">Table 1<\/span><span class=\"inline-table__title\">Characteristics of reports received and processed by VAERS for mRNA COVID-19 vaccines<\/span><\/div>\n<div class=\"table-with-References\">\n<table class=\"scrollable bordered\" border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"0\">\n<thead>\n<tr>\n<th class=\"rowsep\"><\/th>\n<th class=\"rowsep\"><\/th>\n<th class=\"rowsep\"><strong>Both mRNA vaccines (n=340\u2008522)<\/strong><\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl1fn1\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl1fn1-d5011977e44\" aria-expanded=\"false\" aria-controls=\"tbl1fn1\">*<\/a><\/div>\n<\/th>\n<th class=\"rowsep\"><strong>BNT162b2 vaccine (n=164\u2008669)<\/strong><\/th>\n<th class=\"rowsep\"><strong>mRNA-1273 vaccine (n=175\u2008816)<\/strong><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td colspan=\"5\"><strong>Category<\/strong><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Non-serious<\/td>\n<td>313\u2008499 (92\u00b71%)<\/td>\n<td>150\u2008486 (91\u00b74%)<\/td>\n<td>162\u2008977 (92\u00b77%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Serious, including death<\/td>\n<td>27\u2008023 (7\u00b79%)<\/td>\n<td>14\u2008183 (8\u00b76%)<\/td>\n<td>12\u2008839 (7\u00b73%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Serious, excluding death<\/td>\n<td>22\u2008527 (6\u00b76%)<\/td>\n<td>12\u2008078 (7\u00b73%)<\/td>\n<td>10\u2008448 (5\u00b79%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Death<\/td>\n<td>4496 (1\u00b73%)<\/td>\n<td>2105 (1\u00b73%)<\/td>\n<td>2391 (1\u00b74%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"5\"><strong>Sex<\/strong><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Female<\/td>\n<td>246\u2008085 (72\u00b73%)<\/td>\n<td>116\u2008587 (70\u00b78%)<\/td>\n<td>129\u2008475 (73\u00b76%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Male<\/td>\n<td>88\u2008311 (25\u00b79%)<\/td>\n<td>45\u2008157 (27\u00b74%)<\/td>\n<td>43\u2008140 (24\u00b75%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Unknown<\/td>\n<td>6126 (1\u00b78%)<\/td>\n<td>2925 (1\u00b78%)<\/td>\n<td>3201 (1\u00b78%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"5\"><strong>Age, years<\/strong><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">16\u201317<\/td>\n<td>6874 (2\u00b70%)<\/td>\n<td>3283 (2\u00b70%)<\/td>\n<td>3591 (2\u00b70%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">18\u201349<\/td>\n<td>154\u2008171 (45\u00b73%)<\/td>\n<td>76\u2008385 (46\u00b74%)<\/td>\n<td>77\u2008773 (44\u00b72%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">50\u201364<\/td>\n<td>84\u2008949 (24\u00b79%)<\/td>\n<td>40\u2008367 (24\u00b75%)<\/td>\n<td>44\u2008572 (25\u00b74%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">65\u201374<\/td>\n<td>49\u2008755 (14\u00b76%)<\/td>\n<td>20\u2008048 (12\u00b72%)<\/td>\n<td>29\u2008702 (16\u00b79%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">75\u201384<\/td>\n<td>21\u2008418 (6\u00b73%)<\/td>\n<td>9021 (5\u00b75%)<\/td>\n<td>12\u2008392 (7\u00b71%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">\u226585<\/td>\n<td>7595 (2\u00b72%)<\/td>\n<td>3564 (2\u00b72%)<\/td>\n<td>4027 (2\u00b73%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Unknown<\/td>\n<td>15\u2008760 (4\u00b76%)<\/td>\n<td>12\u2008001 (7\u00b73%)<\/td>\n<td>3759 (2\u00b71%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"5\"><strong>Race or ethnicity<\/strong><\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl1fn2\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl1fn2-d5011977e190\" aria-expanded=\"false\" aria-controls=\"tbl1fn2\"><sup>\u2020<\/sup><\/a><\/div>\n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Hispanic or Latino<\/td>\n<td>23\u2008480 (6\u00b79%)<\/td>\n<td>11\u2008217 (6\u00b78%)<\/td>\n<td>12\u2008260 (7\u00b70%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"5\">Non-Hispanic<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>White<\/td>\n<td>169\u2008877 (49\u00b79%)<\/td>\n<td>73\u2008398 (44\u00b76%)<\/td>\n<td>96\u2008469 (54\u00b79%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Black<\/td>\n<td>10\u2008446 (3\u00b71%)<\/td>\n<td>5104 (3\u00b71%)<\/td>\n<td>5342 (3\u00b70%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Asian<\/td>\n<td>10\u2008172 (3\u00b70%)<\/td>\n<td>5038 (3\u00b71%)<\/td>\n<td>5131 (2\u00b79%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>American Indian or Alaska Native<\/td>\n<td>1414 (0\u00b74%)<\/td>\n<td>615 (0\u00b74%)<\/td>\n<td>799 (0\u00b75%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Native Hawaiian or other Pacific Islander<\/td>\n<td>441 (0\u00b71%)<\/td>\n<td>209 (0\u00b71%)<\/td>\n<td>232 (0\u00b71%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Multiple races<\/td>\n<td>3542 (1\u00b70%)<\/td>\n<td>1578 (1\u00b70%)<\/td>\n<td>1964 (1\u00b71%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Other race<\/td>\n<td>1684 (0\u00b75%)<\/td>\n<td>808 (0\u00b75%)<\/td>\n<td>876 (0\u00b75%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Unknown race<\/td>\n<td>2593 (0\u00b78%)<\/td>\n<td>1422 (0\u00b79%)<\/td>\n<td>1171 (0\u00b77%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"5\">Unknown ethnicity<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>White<\/td>\n<td>28\u2008787 (8\u00b75%)<\/td>\n<td>15\u2008497 (9\u00b74%)<\/td>\n<td>13\u2008289 (7\u00b76%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Black<\/td>\n<td>4189 (1\u00b72%)<\/td>\n<td>2524 (1\u00b75%)<\/td>\n<td>1662 (1\u00b70%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Asian<\/td>\n<td>2435 (0\u00b77%)<\/td>\n<td>1396 (0\u00b79%)<\/td>\n<td>1039 (0\u00b76%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>American Indian or Alaska Native<\/td>\n<td>724 (0\u00b72%)<\/td>\n<td>348 (0\u00b72%)<\/td>\n<td>375 (0\u00b72%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Native Hawaiian or other Pacific Islander<\/td>\n<td>105 (&lt;0\u00b71%)<\/td>\n<td>56 (&lt;0\u00b71%)<\/td>\n<td>49 (&lt;0\u00b71%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Multiple races<\/td>\n<td>590 (0\u00b72%)<\/td>\n<td>301 (0\u00b72%)<\/td>\n<td>289 (0\u00b72%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Other race<\/td>\n<td>4709 (1\u00b74%)<\/td>\n<td>2838 (1\u00b77%)<\/td>\n<td>1870 (1\u00b71%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Unknown race and ethnicity<\/td>\n<td>75\u2008334 (22\u00b71%)<\/td>\n<td>42\u2008320 (25\u00b77%)<\/td>\n<td>32\u2008999 (18\u00b78%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"5\"><strong>Signs or symptoms most frequently reported, non-serious<\/strong><\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl1fn3\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl1fn3-d5011977e372\" aria-expanded=\"false\" aria-controls=\"tbl1fn3\"><sup>\u2021<\/sup><\/a><\/div>\n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Total<\/td>\n<td>313\u2008499<\/td>\n<td>150\u2008486<\/td>\n<td>162\u2008977<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Headache<\/td>\n<td>64\u2008064 (20\u00b74%)<\/td>\n<td>30\u2008907 (20\u00b75%)<\/td>\n<td>33\u2008154 (20\u00b73%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Fatigue<\/td>\n<td>52\u2008048 (16\u00b76%)<\/td>\n<td>24\u2008805 (16\u00b75%)<\/td>\n<td>27\u2008241 (16\u00b77%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Pyrexia<\/td>\n<td>51\u2008023 (16\u00b73%)<\/td>\n<td>22\u2008185 (14\u00b77%)<\/td>\n<td>28\u2008837 (17\u00b77%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Chills<\/td>\n<td>49\u2008234 (15\u00b77%)<\/td>\n<td>21\u2008638 (14\u00b74%)<\/td>\n<td>27\u2008595 (16\u00b79%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Pain<\/td>\n<td>47\u2008745 (15\u00b72%)<\/td>\n<td>21\u2008506 (14\u00b73%)<\/td>\n<td>26\u2008238 (16\u00b71%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Nausea<\/td>\n<td>37\u2008333 (11\u00b79%)<\/td>\n<td>18\u2008066 (12\u00b70%)<\/td>\n<td>19\u2008267 (11\u00b78%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Dizziness<\/td>\n<td>37\u2008257 (11\u00b79%)<\/td>\n<td>20\u2008307 (13\u00b75%)<\/td>\n<td>16\u2008950 (10\u00b74%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Pain in extremity<\/td>\n<td>31\u2008753 (10\u00b71%)<\/td>\n<td>14\u2008098 (9\u00b74%)<\/td>\n<td>17\u2008653 (10\u00b78%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Injection-site pain<\/td>\n<td>28\u2008949 (9\u00b72%)<\/td>\n<td>10\u2008462 (7\u00b70%)<\/td>\n<td>18\u2008487 (11\u00b73%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Injection-site erythema<\/td>\n<td>22\u2008351 (7\u00b71%)<\/td>\n<td>2991 (2\u00b70%)<\/td>\n<td>19\u2008360 (11\u00b79%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"5\"><strong>Signs or symptoms most frequently reported, serious<\/strong><\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl1fn3\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl1fn3-d5011977e478\" aria-expanded=\"false\" aria-controls=\"tbl1fn3\"><sup>\u2021<\/sup><\/a><\/div>\n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Total<\/td>\n<td>27\u2008023<\/td>\n<td>14\u2008183<\/td>\n<td>12\u2008839<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Dyspnoea<\/td>\n<td>4175 (15\u00b74%)<\/td>\n<td>2210 (15\u00b76%)<\/td>\n<td>1965 (15\u00b73%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Death<\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl1fn4\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl1fn4-d5011977e502\" aria-expanded=\"false\" aria-controls=\"tbl1fn4\"><sup>\u00a7<\/sup><\/a><\/div>\n<\/td>\n<td>3802 (14\u00b71%)<\/td>\n<td>1753 (12\u00b74%)<\/td>\n<td>2039 (15\u00b79%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Pyrexia<\/td>\n<td>2986 (11\u00b70%)<\/td>\n<td>1469 (10\u00b74%)<\/td>\n<td>1517 (11\u00b78%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Fatigue<\/td>\n<td>2608 (9\u00b77%)<\/td>\n<td>1395 (9\u00b78%)<\/td>\n<td>1213 (9\u00b74%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Headache<\/td>\n<td>2567 (9\u00b75%)<\/td>\n<td>1360 (9\u00b76%)<\/td>\n<td>1207 (9\u00b74%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Chest pain<\/td>\n<td>2300 (8\u00b75%)<\/td>\n<td>1310 (9\u00b72%)<\/td>\n<td>990 (7\u00b77%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Nausea<\/td>\n<td>2228 (8\u00b72%)<\/td>\n<td>1160 (8\u00b72%)<\/td>\n<td>1068 (8\u00b73%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Pain<\/td>\n<td>2222 (8\u00b72%)<\/td>\n<td>1195 (8\u00b74%)<\/td>\n<td>1027 (8\u00b70%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Asthenia<\/td>\n<td>2194 (8\u00b71%)<\/td>\n<td>1084 (7\u00b76%)<\/td>\n<td>1110 (8\u00b76%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Dizziness<\/td>\n<td>2069 (7\u00b77%)<\/td>\n<td>1111 (7\u00b78%)<\/td>\n<td>958 (7\u00b75%)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<div class=\"inline-table__tail\">\n<div class=\"section-paragraph\">Data are n or n (%). Includes vaccines administered from Dec 14, 2020, to June 14, 2021. VAERS=Vaccine Adverse Event Reporting System. MedDRA=Medical Dictionary for Regulatory Activities.<\/div>\n<div class=\"inline-table__footnote\">*\u00a0Total includes reports without a vaccine manufacturer listed.<\/div>\n<div class=\"inline-table__footnote\">\u2020\u00a0Race is not reported for individuals who identify as Hispanic or Latino, but it is reported for individuals with unknown ethnicity or non-Hispanic ethnicity.<\/div>\n<div class=\"inline-table__footnote\">\u2021\u00a0Signs or symptoms refer to MedDRA preferred terms and are ordered by most frequently reported for both vaccines; MedDRA preferred terms are not mutually exclusive.<\/div>\n<div class=\"inline-table__footnote\">\u00a7\u00a0Not all reports of death were coded with the MedDRA preferred term of death.<\/div>\n<\/div>\n<ul class=\"rlist--inline separator download-links\">\n<li><a class=\"table__open__ctrl\" title=\"Open Full Table\" href=\"https:\/\/www.thelancet.com\/action\/showFullTableHTML?isHtml=true&amp;tableId=tbl1&amp;pii=S1473-3099%2822%2900054-8\" target=\"_blank\" rel=\"noopener\">Open table in a new tab<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"section-paragraph\">\n<p>The reporting rate to VAERS was 1049\u00b72 non-serious reports per million vaccine doses, and 90\u00b74 serious reports per million doses (<a id=\"back-tbl2\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl2\">table 2<\/a>). Among the prespecified adverse events of special interest, reporting rates ranged from 0\u00b71 narcolepsy reports per million doses administered to 31\u00b73 reports of COVID-19 disease per million doses administered (<a id=\"back-tbl2\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl2\">table 2<\/a>). 4496 reports of death were made to VAERS following receipt of an mRNA COVID-19 vaccine (<a id=\"back-tbl3\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl3\">table 3<\/a>). After review by clinical staff, 25 reports were excluded because of miscoding of death or duplicate reporting. Of the 4471 reports of deaths analysed, 2086 (46\u00b77%) were reported following BNT162b2 and 2385 (53\u00b73%) following mRNA-1273. 1906 (42\u00b76%) deaths were in female vaccine recipients and 2485 (55\u00b76%) were in male recipients; the median age of participants who died was 76 years (IQR 66\u201386;\u00a0<a id=\"back-tbl3\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl3\">table 3<\/a>). 3647 (81\u00b76%) deaths were reported among individuals aged 60 years or older (<a id=\"back-tbl3\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl3\">table 3<\/a>). 821 (18\u00b74%) deaths were identified as being in long-term care-facility residents. Time to death following vaccination was available for 4118 (92\u00b71%) reports; median time was 10\u00b70 days (IQR 3\u201325). The greatest number of death reports occurred on day 1 (470 [11\u00b74%] of 4118) and day 2 (312 [7\u00b76%] 4118) following vaccination (<a class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#sec1\">appendix p 10<\/a>).<\/p>\n<div class=\"floatDisplay\">\n<div id=\"tbl2\" class=\"inline-table\" tabindex=\"0\">\n<div class=\"inline-table__head\"><span class=\"inline-table__label\">Table 2<\/span><span class=\"inline-table__title\">Frequency and rates of adverse events of special interest reported to VAERS by recipients of mRNA COVID-19 vaccines<\/span><\/div>\n<div class=\"table-with-References\">\n<table class=\"scrollable bordered\" border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"0\">\n<thead>\n<tr>\n<th><\/th>\n<th><\/th>\n<th class=\"rowsep\" colspan=\"2\"><strong>Both mRNA vaccines (n=298\u2008792\u2008852)<\/strong><\/th>\n<th class=\"rowsep\" colspan=\"2\"><strong>BNT162b2 vaccine (n=167\u2008177\u2008332)<\/strong><\/th>\n<th class=\"rowsep\" colspan=\"2\"><strong>mRNA-1273 vaccine (n=131\u2008639\u2008515)<\/strong><\/th>\n<\/tr>\n<tr>\n<th class=\"rowsep\"><\/th>\n<th class=\"rowsep\"><\/th>\n<th class=\"rowsep\">n<\/th>\n<th class=\"rowsep\">Reports per million doses administered<\/th>\n<th class=\"rowsep\">n<\/th>\n<th class=\"rowsep\">Reports per million doses administered<\/th>\n<th class=\"rowsep\">n<\/th>\n<th class=\"rowsep\">Reports per million doses administered<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td colspan=\"2\">Non-serious adverse event reports<\/td>\n<td>313\u2008499<\/td>\n<td>1049\u00b72<\/td>\n<td>150\u2008486<\/td>\n<td>900\u00b72<\/td>\n<td>162\u2008977<\/td>\n<td>1238\u00b71<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Serious reports, including death<\/td>\n<td>27\u2008023<\/td>\n<td>90\u00b74<\/td>\n<td>14\u2008183<\/td>\n<td>84\u00b78<\/td>\n<td>12\u2008839<\/td>\n<td>97\u00b75<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Serious reports, excluding death<\/td>\n<td>22\u2008527<\/td>\n<td>75\u00b74<\/td>\n<td>12\u2008078<\/td>\n<td>72\u00b72<\/td>\n<td>10\u2008448<\/td>\n<td>79\u00b74<\/td>\n<\/tr>\n<tr>\n<td colspan=\"8\">Reports of adverse events of special interest<\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl2fn1\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl2fn1-d5011977e691\" aria-expanded=\"false\" aria-controls=\"tbl2fn1\">*<\/a><\/div>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl2fn2\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl2fn2-d5011977e693\" aria-expanded=\"false\" aria-controls=\"tbl2fn2\"><sup>\u2020<\/sup><\/a><\/div>\n<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>COVID-19<\/td>\n<td>9344<\/td>\n<td>31\u00b73<\/td>\n<td>7184<\/td>\n<td>43\u00b70<\/td>\n<td>2160<\/td>\n<td>16\u00b74<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Coagulopathy<\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl2fn3\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl2fn3-d5011977e716\" aria-expanded=\"false\" aria-controls=\"tbl2fn3\"><sup>\u2021<\/sup><\/a><\/div>\n<\/td>\n<td>4320<\/td>\n<td>14\u00b75<\/td>\n<td>2343<\/td>\n<td>14\u00b70<\/td>\n<td>1977<\/td>\n<td>15\u00b70<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Seizure<\/td>\n<td>2733<\/td>\n<td>9\u00b71<\/td>\n<td>1478<\/td>\n<td>8\u00b78<\/td>\n<td>1255<\/td>\n<td>9\u00b75<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Stroke<\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl2fn4\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl2fn4-d5011977e751\" aria-expanded=\"false\" aria-controls=\"tbl2fn4\"><sup>\u00a7<\/sup><\/a><\/div>\n<\/td>\n<td>1937<\/td>\n<td>6\u00b75<\/td>\n<td>981<\/td>\n<td>5\u00b79<\/td>\n<td>955<\/td>\n<td>7\u00b73<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Bells&#8217; palsy<\/td>\n<td>1918<\/td>\n<td>6\u00b74<\/td>\n<td>1057<\/td>\n<td>6\u00b73<\/td>\n<td>861<\/td>\n<td>6\u00b75<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Anaphylaxis<\/td>\n<td>1639<\/td>\n<td>5\u00b75<\/td>\n<td>972<\/td>\n<td>5\u00b78<\/td>\n<td>667<\/td>\n<td>5\u00b71<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Myopericarditis<\/td>\n<td>1307<\/td>\n<td>4\u00b74<\/td>\n<td>813<\/td>\n<td>4\u00b79<\/td>\n<td>494<\/td>\n<td>3\u00b78<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Acute myocardial infarction<\/td>\n<td>1118<\/td>\n<td>3\u00b77<\/td>\n<td>610<\/td>\n<td>3\u00b76<\/td>\n<td>508<\/td>\n<td>3\u00b79<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Appendicitis<\/td>\n<td>383<\/td>\n<td>1\u00b73<\/td>\n<td>258<\/td>\n<td>1\u00b75<\/td>\n<td>125<\/td>\n<td>1\u00b70<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Guillain-Barr\u00e9 syndrome<\/td>\n<td>293<\/td>\n<td>1\u00b70<\/td>\n<td>154<\/td>\n<td>0\u00b79<\/td>\n<td>139<\/td>\n<td>1\u00b71<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Multisystem inflammatory syndrome in adults<\/td>\n<td>119<\/td>\n<td>0\u00b74<\/td>\n<td>60<\/td>\n<td>0\u00b74<\/td>\n<td>59<\/td>\n<td>0\u00b74<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Transverse myelitis<\/td>\n<td>98<\/td>\n<td>0\u00b73<\/td>\n<td>55<\/td>\n<td>0\u00b73<\/td>\n<td>43<\/td>\n<td>0\u00b73<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Narcolepsy<\/td>\n<td>21<\/td>\n<td>0\u00b71<\/td>\n<td>12<\/td>\n<td>0\u00b71<\/td>\n<td>9<\/td>\n<td>0\u00b71<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<div class=\"inline-table__tail\">\n<div class=\"section-paragraph\">Includes vaccines administered from Dec 14, 2020, to June 14, 2021. VAERS=Vaccine Adverse Event Reporting System.<\/div>\n<div class=\"inline-table__footnote\">*\u00a0Represents reports, not confirmed by case definition. Events are not mutually exclusive.<\/div>\n<div class=\"inline-table__footnote\">\u2020\u00a0Reported death is an adverse event of special interest but counts appear in\u00a0<a id=\"back-tbl1\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl1\">Table 1<\/a>,\u00a0<a id=\"back-tbl3\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl3\">Table 3<\/a>.<\/div>\n<div class=\"inline-table__footnote\">\u2021\u00a0Coagulopathy is an aggregate term capturing three specific adverse events: thrombocytopenia, deep venous thrombosis or pulmonary embolism, and disseminated intravascular coagulopathy.<\/div>\n<div class=\"inline-table__footnote\">\u00a7\u00a0No vaccine manufacturer was provided for one report of stroke.<\/div>\n<\/div>\n<ul class=\"rlist--inline separator download-links\">\n<li><a class=\"table__open__ctrl\" title=\"Open Full Table\" href=\"https:\/\/www.thelancet.com\/action\/showFullTableHTML?isHtml=true&amp;tableId=tbl2&amp;pii=S1473-3099%2822%2900054-8\" target=\"_blank\" rel=\"noopener\">Open table in a new tab<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"floatDisplay\">\n<div id=\"tbl3\" class=\"inline-table\" tabindex=\"0\">\n<div class=\"inline-table__head\"><span class=\"inline-table__label\">Table 3<\/span><span class=\"inline-table__title\">Frequency and rates of death reported to VAERS by recipients of mRNA COVID-19 vaccines, by sex and age group<\/span><\/div>\n<div class=\"table-with-References\">\n<table class=\"scrollable bordered\" border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"0\">\n<thead>\n<tr>\n<th><\/th>\n<th class=\"rowsep\" colspan=\"2\"><strong>Both mRNA vaccines (n=4471<\/strong><\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl3fn1\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl3fn1-d5011977e951\" aria-expanded=\"false\" aria-controls=\"tbl3fn1\">*<\/a><\/div>\n<p><strong>)<\/strong><\/th>\n<th class=\"rowsep\" colspan=\"2\"><strong>BNT162b2 vaccine (n=2086)<\/strong><\/th>\n<th class=\"rowsep\" colspan=\"2\"><strong>mRNA-1273 vaccine (n=2385)<\/strong><\/th>\n<\/tr>\n<tr>\n<th class=\"rowsep\"><\/th>\n<th class=\"rowsep\">n (%)<\/th>\n<th class=\"rowsep\">Reports per million doses administered<\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl3fn2\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl3fn2-d5011977e964\" aria-expanded=\"false\" aria-controls=\"tbl3fn2\"><sup>\u2020<\/sup><\/a><\/div>\n<\/th>\n<th class=\"rowsep\">n (%)<\/th>\n<th class=\"rowsep\">Reports per million doses administered<\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl3fn2\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl3fn2-d5011977e971\" aria-expanded=\"false\" aria-controls=\"tbl3fn2\"><sup>\u2020<\/sup><\/a><\/div>\n<\/th>\n<th class=\"rowsep\">n (%)<\/th>\n<th class=\"rowsep\">Reports per million doses administered<\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl3fn2\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl3fn2-d5011977e978\" aria-expanded=\"false\" aria-controls=\"tbl3fn2\"><sup>\u2020<\/sup><\/a><\/div>\n<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td colspan=\"7\"><strong>Sex<\/strong><\/td>\n<\/tr>\n<tr>\n<td>Female<\/td>\n<td>1906 (42\u00b76%)<\/td>\n<td>12\u00b72<\/td>\n<td>918 (44\u00b70%)<\/td>\n<td>10\u00b76<\/td>\n<td>988 (41\u00b74%)<\/td>\n<td>14\u00b72<\/td>\n<\/tr>\n<tr>\n<td>Male<\/td>\n<td>2485 (55\u00b76%)<\/td>\n<td>18\u00b75<\/td>\n<td>1116 (53\u00b75%)<\/td>\n<td>15\u00b71<\/td>\n<td>1369 (57\u00b74%)<\/td>\n<td>22\u00b76<\/td>\n<\/tr>\n<tr>\n<td>Unknown<\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl3fn3\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl3fn3-d5011977e1018\" aria-expanded=\"false\" aria-controls=\"tbl3fn3\"><sup>\u2021<\/sup><\/a><\/div>\n<\/td>\n<td>80 (1\u00b78%)<\/td>\n<td>..<\/td>\n<td>52 (2\u00b75%)<\/td>\n<td>..<\/td>\n<td>28 (1\u00b72%)<\/td>\n<td>..-<\/td>\n<\/tr>\n<tr>\n<td colspan=\"7\"><strong>Age, years<\/strong><\/td>\n<\/tr>\n<tr>\n<td>16\u201317<\/td>\n<td>6 (0\u00b71%)<\/td>\n<td>1\u00b71<\/td>\n<td>6 (0\u00b73%)<\/td>\n<td>1\u00b71<\/td>\n<td>..<\/td>\n<td>..<\/td>\n<\/tr>\n<tr>\n<td>18\u201329<\/td>\n<td>51 (1\u00b71%)<\/td>\n<td>1\u00b73<\/td>\n<td>27 (1\u00b73%)<\/td>\n<td>1\u00b71<\/td>\n<td>24 (1\u00b70%)<\/td>\n<td>1\u00b76<\/td>\n<\/tr>\n<tr>\n<td>30\u201339<\/td>\n<td>94 (2\u00b71%)<\/td>\n<td>2\u00b74<\/td>\n<td>50 (2\u00b74%)<\/td>\n<td>2\u00b72<\/td>\n<td>44 (1\u00b78%)<\/td>\n<td>2\u00b78<\/td>\n<\/tr>\n<tr>\n<td>40\u201349<\/td>\n<td>151 (3\u00b74%)<\/td>\n<td>3\u00b78<\/td>\n<td>74 (3\u00b75%)<\/td>\n<td>3\u00b72<\/td>\n<td>77 (3\u00b72%)<\/td>\n<td>4\u00b76<\/td>\n<\/tr>\n<tr>\n<td>50\u201359<\/td>\n<td>328 (7\u00b73%)<\/td>\n<td>6\u00b79<\/td>\n<td>132 (6\u00b73%)<\/td>\n<td>5\u00b70<\/td>\n<td>196 (8\u00b72%)<\/td>\n<td>9\u00b73<\/td>\n<\/tr>\n<tr>\n<td>60\u201369<\/td>\n<td>765 (17\u00b71%)<\/td>\n<td>14\u00b74<\/td>\n<td>354 (17\u00b70%)<\/td>\n<td>13\u00b70<\/td>\n<td>411 (17\u00b72%)<\/td>\n<td>16\u00b70<\/td>\n<\/tr>\n<tr>\n<td>70\u201379<\/td>\n<td>1117 (25\u00b70%)<\/td>\n<td>28\u00b75<\/td>\n<td>496 (23\u00b78%)<\/td>\n<td>25\u00b79<\/td>\n<td>621 (26\u00b70%)<\/td>\n<td>31\u00b70<\/td>\n<\/tr>\n<tr>\n<td>80\u201389<\/td>\n<td>1128 (25\u00b72%)<\/td>\n<td>75\u00b74<\/td>\n<td>529 (25\u00b74%)<\/td>\n<td>72\u00b71<\/td>\n<td>599 (25\u00b71%)<\/td>\n<td>78\u00b76<\/td>\n<\/tr>\n<tr>\n<td>\u226590<\/td>\n<td>637 (14\u00b72%)<\/td>\n<td>207\u00b77<\/td>\n<td>302 (14\u00b75%)<\/td>\n<td>188\u00b71<\/td>\n<td>335 (14\u00b70%)<\/td>\n<td>229\u00b73<\/td>\n<\/tr>\n<tr>\n<td>Unknown<\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl3fn3\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl3fn3-d5011977e1175\" aria-expanded=\"false\" aria-controls=\"tbl3fn3\"><sup>\u2021<\/sup><\/a><\/div>\n<\/td>\n<td>194 (4\u00b73%)<\/td>\n<td>..<\/td>\n<td>116 (5\u00b76%)<\/td>\n<td>..<\/td>\n<td>78 (3\u00b73%)<\/td>\n<td>..<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<div class=\"inline-table__tail\">\n<div class=\"section-paragraph\">Includes reports made and vaccines administered from Dec 14, 2020, to June 14, 2021. VAERS=Vaccine Adverse Event Reporting System.<\/div>\n<div class=\"inline-table__footnote\">*\u00a0Of 4496 deaths, 25 were excluded as they could not be confirmed or were duplicate reports upon review.<\/div>\n<div class=\"inline-table__footnote\">\u2020\u00a0Doses of vaccine administered in the study period were used for denominators in each age group; does not include doses administered in Texas because data for Texas were reported to the US Centers for Disease Control and Prevention in aggregate.<\/div>\n<div class=\"inline-table__footnote\">\u2021\u00a0Reporting rates not shown for unknown categories because of unreliable dose denominators.<\/div>\n<\/div>\n<ul class=\"rlist--inline separator download-links\">\n<li><a class=\"table__open__ctrl\" title=\"Open Full Table\" href=\"https:\/\/www.thelancet.com\/action\/showFullTableHTML?isHtml=true&amp;tableId=tbl3&amp;pii=S1473-3099%2822%2900054-8\" target=\"_blank\" rel=\"noopener\">Open table in a new tab<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"section-paragraph\">Death certificates or autopsy reports were available for clinical review for 808 (18\u00b71%) of 4471 reports of deaths. Among these, causes of death were most commonly diseases of the heart (376 [46\u00b75%]) and COVID-19 (102 [12\u00b76%];\u00a0<a class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#sec1\">appendix pp 3\u20134<\/a>). Among the 3663 reports of death without a death certificate or autopsy, causes of death were most commonly unknown or unclear (1984 [54\u00b72%]), diseases of the heart (621 [17\u00b70<strong>%<\/strong>]), and COVID-19 (317 [8\u00b77%];\u00a0<a class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#sec1\">appendix pp 3\u20134<\/a>). Causes of death among reports with death certificate or autopsy reports available are shown by age in appendix p 5.<\/div>\n<div class=\"section-paragraph\">\n<p>During the study period, 7\u2009914\u2009583 mRNA COVID-19 vaccine recipients enrolled in v-safe after dose one or dose two and completed at least one post-vaccination health survey during days 0\u20137 (<a id=\"back-tbl4\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl4\">table 4<\/a>). The median age of v-safe participants was 50 years (IQR 36\u201363), 4\u2009975\u2009209 (62\u00b79%) were female, 2\u2009860\u2009738 (36\u00b71%) were male, and 4\u2009701\u2009715 (59\u00b74%) identified as non-Hispanic White (<a id=\"back-tbl4\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl4\">table 4<\/a>). 6\u2009775\u2009515 participants completed at least one survey during days 0\u20137 after dose one (<a id=\"back-tbl5\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl5\">table 5<\/a>). Of these participants, 4\u2009644\u2009989 (68\u00b76%) reported a local injection-site reaction and 3\u2009573\u2009429 (52\u00b77%) reported a systemic reaction (<a id=\"back-tbl5\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl5\">table 5<\/a>). Of the 5\u2009674\u2009420 participants who completed surveys after dose two, 4\u2009068\u2009447 (71\u00b77%) reported an injection-site reaction and 4\u2009018\u2009920 (70\u00b78%) a systemic reaction (<a id=\"back-tbl5\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl5\">table 5<\/a>). Local injection-site reactions were reported more frequently after mRNA-1273 than after BNT162b2 (<a id=\"back-tbl5\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl5\">table 5<\/a>). A similar pattern was found for systemic reactions after mRNA-1273 versus BNT162b2 (<a id=\"back-tbl5\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl5\">table 5<\/a>). The most frequently reported events after dose one of either mRNA vaccine included injection-site pain, fatigue, and headache, which were also more frequent after dose two than after dose one (<a id=\"back-tbl5\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl5\">table 5<\/a>). Differences in proportions of reactogenicity by dose number were similar after stratifying by age (&lt;65\u00a0<em>vs<\/em>\u00a0\u226565 years) and sex (<a class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#sec1\">appendix p 6<\/a>). More reactogenicity was reported among participants younger than 65 years than older participants and by female participants than male participants (<a class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#sec1\">appendix p 6<\/a>).<\/p>\n<div class=\"floatDisplay\">\n<div id=\"tbl4\" class=\"inline-table\" tabindex=\"0\">\n<div class=\"inline-table__head\"><span class=\"inline-table__label\">Table 4<\/span><span class=\"inline-table__title\">Demographic characteristics of v-safe participants reporting receipt of an mRNA COVID-19 vaccine and completing at least one health survey 0\u20137 days after vaccination<\/span><\/div>\n<div class=\"table-with-References\">\n<table class=\"scrollable bordered\" border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"0\">\n<thead>\n<tr>\n<th><\/th>\n<th><\/th>\n<th><\/th>\n<th><strong>Both mRNA vaccines (n=7\u2008914\u2008583)<\/strong><\/th>\n<th class=\"rowsep\" colspan=\"2\"><strong>BNT162b2 vaccine<\/strong><\/th>\n<th class=\"rowsep\" colspan=\"2\"><strong>mRNA-1273 vaccine<\/strong><\/th>\n<\/tr>\n<tr>\n<th class=\"rowsep\"><\/th>\n<th class=\"rowsep\"><\/th>\n<th class=\"rowsep\"><\/th>\n<th class=\"rowsep\"><\/th>\n<th class=\"rowsep\">Dose one (n=3\u2008455\u2008778)<\/th>\n<th class=\"rowsep\">Dose two (n=2\u2008920\u2008526)<\/th>\n<th class=\"rowsep\">Dose one (n=3\u2008319\u2008737)<\/th>\n<th class=\"rowsep\">Dose two (n=2\u2008753\u2008894)<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td colspan=\"8\">Sex<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td colspan=\"2\">Female<\/td>\n<td>4\u2008975\u2008209 (62\u00b79%)<\/td>\n<td>2\u2008150\u2008068 (62\u00b72%)<\/td>\n<td>1\u2008861\u2008599 (63\u00b77%)<\/td>\n<td>2\u2008073\u2008542 (62\u00b75%)<\/td>\n<td>1\u2008779\u2008200 (64\u00b76%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td colspan=\"2\">Male<\/td>\n<td>2\u2008860\u2008738 (36\u00b71%)<\/td>\n<td>1\u2008272\u2008011 (36\u00b78%)<\/td>\n<td>1\u2008032\u2008941 (35\u00b74%)<\/td>\n<td>1\u2008210\u2008622 (36\u00b75%)<\/td>\n<td>947\u2008612 (34\u00b74%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td colspan=\"2\">Other<\/td>\n<td>8872 (0\u00b71%)<\/td>\n<td>4027 (0\u00b71%)<\/td>\n<td>3464 (0\u00b71%)<\/td>\n<td>3443 (0\u00b71%)<\/td>\n<td>2947 (0\u00b71%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td colspan=\"2\">Prefer not to say<\/td>\n<td>69\u2008764 (0\u00b79%)<\/td>\n<td>29\u2008672 (0\u00b79%)<\/td>\n<td>22\u2008522 (0\u00b78%)<\/td>\n<td>32\u2008130 (1\u00b70%)<\/td>\n<td>24\u2008135 (0\u00b79%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"8\">Age, years<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td colspan=\"2\">16\u201317<\/td>\n<td>73\u2008347 (0\u00b79%)<\/td>\n<td>63\u2008865 (1\u00b78%)<\/td>\n<td>38\u2008530 (1\u00b73%)<\/td>\n<td>946 (0\u00b703%)<\/td>\n<td>473 (0\u00b702%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td colspan=\"2\">18\u201349<\/td>\n<td>3\u2008791\u2008839 (47\u00b79%)<\/td>\n<td>1\u2008726\u2008465 (50\u00b70%)<\/td>\n<td>1\u2008431\u2008627 (49\u00b70%)<\/td>\n<td>1\u2008505\u2008760 (45\u00b74%)<\/td>\n<td>1\u2008219\u2008210 (44\u00b73%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td colspan=\"2\">50\u201359<\/td>\n<td>1\u2008500\u2008981 (19\u00b70%)<\/td>\n<td>653\u2008799 (18\u00b79%)<\/td>\n<td>574\u2008422 (19\u00b77%)<\/td>\n<td>627\u2008214 (18\u00b79%)<\/td>\n<td>531\u2008200 (19\u00b73%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td colspan=\"2\">60\u201364<\/td>\n<td>739\u2008381 (9\u00b73%)<\/td>\n<td>315\u2008404 (9\u00b71%)<\/td>\n<td>279\u2008350 (9\u00b76%)<\/td>\n<td>316\u2008768 (9\u00b75%)<\/td>\n<td>270\u2008831 (9\u00b78%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td colspan=\"2\">65\u201374<\/td>\n<td>1\u2008344\u2008721 (17\u00b70%)<\/td>\n<td>516\u2008227 (14\u00b79%)<\/td>\n<td>452\u2008928 (15\u00b75%)<\/td>\n<td>643\u2008663 (19\u00b74%)<\/td>\n<td>557\u2008279 (20\u00b72%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td colspan=\"2\">\u226575<\/td>\n<td>464\u2008314 (5\u00b79%)<\/td>\n<td>180\u2008018 (5\u00b72%)<\/td>\n<td>143\u2008669 (4\u00b79%)<\/td>\n<td>225\u2008386 (6\u00b78%)<\/td>\n<td>174\u2008901 (6\u00b74%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"8\">Race or ethnicity<\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl4fn1\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl4fn1-d5011977e1394\" aria-expanded=\"false\" aria-controls=\"tbl4fn1\">*<\/a><\/div>\n<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td colspan=\"2\">Hispanic<\/td>\n<td>782\u2008301 (9\u00b79%)<\/td>\n<td>346\u2008197 (10\u00b70%)<\/td>\n<td>288\u2008263 (9\u00b79%)<\/td>\n<td>316\u2008460 (9\u00b75%)<\/td>\n<td>256\u2008185 (9\u00b73%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td colspan=\"7\">Non-Hispanic<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>White<\/td>\n<td>4\u2008701\u2008715 (59\u00b74%)<\/td>\n<td>2\u2008059\u2008560 (59\u00b76%)<\/td>\n<td>1\u2008896\u2008823 (64\u00b79%)<\/td>\n<td>1\u2008979\u2008056 (59\u00b76%)<\/td>\n<td>1\u2008830\u2008413 (66\u00b75%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>Black<\/td>\n<td>443\u2008938 (5\u00b76%)<\/td>\n<td>202\u2008598 (5\u00b79%)<\/td>\n<td>176\u2008164 (6\u00b70%)<\/td>\n<td>178\u2008981 (5\u00b74%)<\/td>\n<td>153\u2008667 (5\u00b76%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>Asian<\/td>\n<td>467\u2008932 (5\u00b79%)<\/td>\n<td>215\u2008713 (6\u00b72%)<\/td>\n<td>196\u2008173 (6\u00b77%)<\/td>\n<td>154\u2008498 (4\u00b77%)<\/td>\n<td>138\u2008793 (5\u00b70%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>American Indian or Alaska Native<\/td>\n<td>27\u2008899 (0\u00b74%)<\/td>\n<td>11\u2008161 (0\u00b73%)<\/td>\n<td>9\u2008194 (0\u00b73%)<\/td>\n<td>13\u2008486 (0\u00b74%)<\/td>\n<td>11\u2008410 (0\u00b74%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>Native Hawaiian or other Pacific Islander<\/td>\n<td>19\u2008393 (0\u00b72%)<\/td>\n<td>8\u2008500 (0\u00b72%)<\/td>\n<td>7\u2008373 (0\u00b73%)<\/td>\n<td>7\u2008689 (0\u00b72%)<\/td>\n<td>6\u2008664 (0\u00b72%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>Multiple races<\/td>\n<td>110\u2008326 (1\u00b74%)<\/td>\n<td>50\u2008954 (1\u00b75%)<\/td>\n<td>46\u2008129 (1\u00b76%)<\/td>\n<td>41\u2008977 (1\u00b73%)<\/td>\n<td>38\u2008772 (1\u00b74%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>Other race<\/td>\n<td>42\u2008230 (0\u00b75%)<\/td>\n<td>19\u2008252 (0\u00b76%)<\/td>\n<td>16\u2008757 (0\u00b76%)<\/td>\n<td>15\u2008885 (0\u00b75%)<\/td>\n<td>13\u2008880 (0\u00b75%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>Unknown race<\/td>\n<td>23\u2008420 (0\u00b73%)<\/td>\n<td>10\u2008249 (0\u00b73%)<\/td>\n<td>9\u2008090 (0\u00b73%)<\/td>\n<td>9502 (0\u00b73%)<\/td>\n<td>8270 (0\u00b73%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td colspan=\"7\">Unknown ethnicity<\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl4fn2\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl4fn2-d5011977e1539\" aria-expanded=\"false\" aria-controls=\"tbl4fn2\"><sup>\u2020<\/sup><\/a><\/div>\n<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>White<\/td>\n<td>115\u2008766 (1\u00b75%)<\/td>\n<td>48\u2008084 (1\u00b74%)<\/td>\n<td>38\u2008674 (1\u00b73%)<\/td>\n<td>52\u2008143 (1\u00b76%)<\/td>\n<td>42\u2008070 (1\u00b75%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>Black<\/td>\n<td>26\u2008865 (0\u00b73%)<\/td>\n<td>11\u2008602 (0\u00b73%)<\/td>\n<td>8570 (0\u00b73%)<\/td>\n<td>11\u2008993 (0\u00b74%)<\/td>\n<td>8406 (0\u00b73%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>Asian<\/td>\n<td>33\u2008146 (0\u00b74%)<\/td>\n<td>14\u2008134 (0\u00b74%)<\/td>\n<td>11\u2008844 (0\u00b74%)<\/td>\n<td>11\u2008356 (0\u00b73%)<\/td>\n<td>9153 (0\u00b73%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>American Indian or Alaska Native<\/td>\n<td>3142 (&lt;0\u00b71%)<\/td>\n<td>1206 (&lt;0\u00b71%)<\/td>\n<td>848 (&lt;0\u00b71%)<\/td>\n<td>1582 (&lt;0\u00b71%)<\/td>\n<td>1151 (&lt;0\u00b71%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>Native Hawaiian or other Pacific Islander<\/td>\n<td>1945 (&lt;0\u00b71%)<\/td>\n<td>815 (&lt;0\u00b71%)<\/td>\n<td>659 (&lt;0\u00b71%)<\/td>\n<td>800 (&lt;0\u00b71%)<\/td>\n<td>613 (&lt;0\u00b71%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>Multiple races<\/td>\n<td>6,370 (0\u00b71%)<\/td>\n<td>2902 (0\u00b71%)<\/td>\n<td>2408 (0\u00b71%)<\/td>\n<td>2478 (0\u00b71%)<\/td>\n<td>2041 (0\u00b71%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>Other race<\/td>\n<td>13\u2008148 (0\u00b72%)<\/td>\n<td>5681 (0\u00b72%)<\/td>\n<td>4528 (0\u00b72%)<\/td>\n<td>5414 (0\u00b72%)<\/td>\n<td>4263 (0\u00b72%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td colspan=\"2\">Unknown race and ethnicity<\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl4fn2\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl4fn2-d5011977e1651\" aria-expanded=\"false\" aria-controls=\"tbl4fn2\"><sup>\u2020<\/sup><\/a><\/div>\n<\/td>\n<td>129\u2008647 (1\u00b76%)<\/td>\n<td>56\u2008481 (1\u00b76%)<\/td>\n<td>45\u2008410 (1\u00b76%)<\/td>\n<td>54\u2008969 (1\u00b77%)<\/td>\n<td>44\u2008340 (1\u00b76%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td colspan=\"2\">Unavailable<\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl4fn3\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl4fn3-d5011977e1668\" aria-expanded=\"false\" aria-controls=\"tbl4fn3\"><sup>\u2021<\/sup><\/a><\/div>\n<\/td>\n<td>965\u2008400 (12\u00b72%)<\/td>\n<td>390\u2008689 (11\u00b73%)<\/td>\n<td>161\u2008619 (5\u00b75%)<\/td>\n<td>461\u2008468 (13\u00b79%)<\/td>\n<td>183\u2008803 (6\u00b77%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\">Pregnant at time of vaccination<\/td>\n<td>86\u2008801 (1\u00b71%)<\/td>\n<td>39\u2008884 (1\u00b72%)<\/td>\n<td>39\u2008163 (1\u00b73%)<\/td>\n<td>25\u2008255 (0\u00b78%)<\/td>\n<td>25\u2008428 (0\u00b79%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\">Pregnancy test positive after vaccination<\/td>\n<td>27\u2008370 (0\u00b73%)<\/td>\n<td>1548 (&lt;0\u00b71%)<\/td>\n<td>11\u2008677 (0\u00b74%)<\/td>\n<td>4009 (0\u00b71%)<\/td>\n<td>10\u2008199 (0\u00b74%)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<div class=\"inline-table__tail\">\n<div class=\"section-paragraph\">Data are n (%). Includes vaccines administered from Dec 14, 2020, to June 14, 2021.<\/div>\n<div class=\"inline-table__footnote\">*\u00a0Race is not reported for individuals who identify as Hispanic or Latino, but it is reported for individuals with unknown ethnicity or non-Hispanic ethnicity.<\/div>\n<div class=\"inline-table__footnote\">\u2020\u00a0Unknown indicates that v-safe participants selected unknown or preferred not to say.<\/div>\n<div class=\"inline-table__footnote\">\u2021\u00a0Unavailable refers to information that was not collected or was missing in v-safe.<\/div>\n<\/div>\n<ul class=\"rlist--inline separator download-links\">\n<li><a class=\"table__open__ctrl\" title=\"Open Full Table\" href=\"https:\/\/www.thelancet.com\/action\/showFullTableHTML?isHtml=true&amp;tableId=tbl4&amp;pii=S1473-3099%2822%2900054-8\" target=\"_blank\" rel=\"noopener\">Open table in a new tab<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"floatDisplay\">\n<div id=\"tbl5\" class=\"inline-table\" tabindex=\"0\">\n<div class=\"inline-table__head\"><span class=\"inline-table__label\">Table 5<\/span><span class=\"inline-table__title\">Local and systemic reactions and health impacts following mRNA COVID-19 vaccines reported during days 0\u20137 after vaccination to v-safe, by manufacturer and dose<\/span><\/div>\n<div class=\"table-with-References\">\n<table class=\"scrollable bordered\" border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"0\">\n<thead>\n<tr>\n<th><\/th>\n<th><\/th>\n<th class=\"rowsep\" colspan=\"2\"><strong>Both mRNA vaccines<\/strong><\/th>\n<th class=\"rowsep\" colspan=\"2\"><strong>BNT162b2 vaccine<\/strong><\/th>\n<th class=\"rowsep\" colspan=\"2\"><strong>mRNA-1273 vaccine<\/strong><\/th>\n<\/tr>\n<tr>\n<th class=\"rowsep\"><\/th>\n<th class=\"rowsep\"><\/th>\n<th class=\"rowsep\">Dose one (n=6\u2008775\u2008515)<\/th>\n<th class=\"rowsep\">Dose two (n=5\u2008674\u2008420)<\/th>\n<th class=\"rowsep\">Dose one (n=3\u2008455\u2008778)<\/th>\n<th class=\"rowsep\">Dose two (n=2\u2008920\u2008526)<\/th>\n<th class=\"rowsep\">Dose one (n=3\u2008319\u2008737)<\/th>\n<th class=\"rowsep\">Dose two (n=2\u2008753\u2008894)<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td colspan=\"2\">Any injection-site reaction<\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl5fn1\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl5fn1-d5011977e1766\" aria-expanded=\"false\" aria-controls=\"tbl5fn1\">*<\/a><\/div>\n<\/td>\n<td>4\u2008644\u2008989 (68\u00b76%)<\/td>\n<td>4\u2008068\u2008447 (71\u00b77%)<\/td>\n<td>2\u2008212\u2008051 (64\u00b70%)<\/td>\n<td>1\u2008908\u2008124 (65\u00b73%)<\/td>\n<td>2\u2008432\u2008938 (73\u00b73%)<\/td>\n<td>2\u2008160\u2008323 (78\u00b74%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Injection-site pain<\/td>\n<td>4\u2008488\u2008402 (66\u00b72%)<\/td>\n<td>3\u2008890\u2008848 (68\u00b76%)<\/td>\n<td>2\u2008140\u2008843 (61\u00b79%)<\/td>\n<td>1\u2008835\u2008398 (62\u00b78%)<\/td>\n<td>2\u2008347\u2008559 (70\u00b77%)<\/td>\n<td>2\u2008055\u2008450 (74\u00b76%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Swelling<\/td>\n<td>703\u2008790 (10\u00b74%)<\/td>\n<td>976\u2008946 (17\u00b72%)<\/td>\n<td>246\u2008230 (7\u00b71%)<\/td>\n<td>309\u2008718 (10\u00b76%)<\/td>\n<td>457\u2008560 (13\u00b78%)<\/td>\n<td>667\u2008228 (24\u00b72%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Redness<\/td>\n<td>353\u2008788 (5\u00b72%)<\/td>\n<td>640\u2008739 (11\u00b73%)<\/td>\n<td>116\u2008108 (3\u00b74%)<\/td>\n<td>167\u2008127 (5\u00b77%)<\/td>\n<td>237\u2008680 (7\u00b72%)<\/td>\n<td>473\u2008612 (17\u00b72%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Itching<\/td>\n<td>376\u2008076 (5\u00b76%)<\/td>\n<td>605\u2008633 (10\u00b77%)<\/td>\n<td>145\u2008596 (4\u00b72%)<\/td>\n<td>191\u2008132 (6\u00b75%)<\/td>\n<td>230\u2008480 (6\u00b79%)<\/td>\n<td>414\u2008501 (15\u00b71%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">Any systemic reaction<\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl5fn1\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl5fn1-d5011977e1847\" aria-expanded=\"false\" aria-controls=\"tbl5fn1\">*<\/a><\/div>\n<\/td>\n<td>3\u2008573\u2008429 (52\u00b77%)<\/td>\n<td>4\u2008018\u2008920 (70\u00b78%)<\/td>\n<td>1\u2008771\u2008509 (51\u00b73%)<\/td>\n<td>1\u2008931\u2008643 (66\u00b71%)<\/td>\n<td>1\u2008801\u2008920 (54\u00b73%)<\/td>\n<td>2\u2008087\u2008277 (75\u00b78%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Fatigue<\/td>\n<td>2\u2008295\u2008205 (33\u00b79%)<\/td>\n<td>3\u2008158\u2008299 (55\u00b77%)<\/td>\n<td>1\u2008127\u2008904 (32\u00b76%)<\/td>\n<td>1\u2008475\u2008646 (50\u00b75%)<\/td>\n<td>1\u2008167\u2008301 (35\u00b72%)<\/td>\n<td>1\u2008682\u2008653 (61\u00b71%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Headache<\/td>\n<td>1\u2008831\u2008471 (27\u00b70%)<\/td>\n<td>2\u2008623\u2008721 (46\u00b72%)<\/td>\n<td>893\u2008992 (25\u00b79%)<\/td>\n<td>1\u2008189\u2008444 (40\u00b77%)<\/td>\n<td>937\u2008479 (28\u00b72%)<\/td>\n<td>1\u2008434\u2008277 (52\u00b71%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Myalgia<\/td>\n<td>1\u2008423\u2008336 (21\u00b70%)<\/td>\n<td>2\u2008478\u2008170 (43\u00b77%)<\/td>\n<td>653\u2008821 (18\u00b79%)<\/td>\n<td>1\u2008085\u2008365 (37\u00b72%)<\/td>\n<td>769\u2008515 (23\u00b72%)<\/td>\n<td>1\u2008392\u2008805 (50\u00b76%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Chills<\/td>\n<td>631\u2008546 (9\u00b73%)<\/td>\n<td>1\u2008680\u2008185 (29\u00b76%)<\/td>\n<td>263\u2008617 (7\u00b76%)<\/td>\n<td>642\u2008856 (22\u00b70%)<\/td>\n<td>367\u2008929 (11\u00b71%)<\/td>\n<td>1\u2008037\u2008329 (37\u00b77%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Fever<\/td>\n<td>642\u2008092 (9\u00b75%)<\/td>\n<td>1\u2008679\u2008577 (29\u00b76%)<\/td>\n<td>274\u2008650 (7\u00b79%)<\/td>\n<td>656\u2008454 (22\u00b75%)<\/td>\n<td>367\u2008442 (11\u00b71%)<\/td>\n<td>1\u2008023\u2008123 (37\u00b72%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Joint pain<\/td>\n<td>642\u2008006 (9\u00b75%)<\/td>\n<td>1\u2008440\u2008927 (25\u00b74%)<\/td>\n<td>285\u2008812 (8\u00b73%)<\/td>\n<td>591\u2008877 (20\u00b73%)<\/td>\n<td>356\u2008194 (10\u00b77%)<\/td>\n<td>849\u2008050 (30\u00b78%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Nausea<\/td>\n<td>562\u2008273 (8\u00b73%)<\/td>\n<td>901\u2008103 (15\u00b79%)<\/td>\n<td>267\u2008160 (7\u00b77%)<\/td>\n<td>384\u2008525 (13\u00b72%)<\/td>\n<td>295\u2008113 (8\u00b79%)<\/td>\n<td>516\u2008578 (18\u00b78%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Diarrhoea<\/td>\n<td>383\u2008576 (5\u00b77%)<\/td>\n<td>419\u2008044 (7\u00b74%)<\/td>\n<td>190\u2008542 (5\u00b75%)<\/td>\n<td>198\u2008618 (6\u00b78%)<\/td>\n<td>193\u2008034 (5\u00b78%)<\/td>\n<td>220\u2008426 (8\u00b70%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Abdominal pain<\/td>\n<td>233\u2008511 (3\u00b74%)<\/td>\n<td>359\u2008107 (6\u00b73%)<\/td>\n<td>113\u2008872 (3\u00b73%)<\/td>\n<td>158\u2008251 (5\u00b74%)<\/td>\n<td>119\u2008639 (3\u00b76%)<\/td>\n<td>200\u2008856 (7\u00b73%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Rash<\/td>\n<td>85\u2008766 (1\u00b73%)<\/td>\n<td>99\u2008878 (1\u00b78%)<\/td>\n<td>41\u2008565 (1\u00b72%)<\/td>\n<td>42\u2008662 (1\u00b75%)<\/td>\n<td>44\u2008201 (1\u00b73%)<\/td>\n<td>57\u2008216 (2\u00b71%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Vomiting<\/td>\n<td>55\u2008710 (0\u00b78%)<\/td>\n<td>91\u2008727 (1\u00b76%)<\/td>\n<td>25\u2008336 (0\u00b77%)<\/td>\n<td>36\u2008761 (1\u00b73%)<\/td>\n<td>30\u2008374 (0\u00b79%)<\/td>\n<td>54\u2008966 (2\u00b70%)<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\">With reported health impacts<\/p>\n<div class=\"dropBlock reference-citations\"><a id=\"back-tbl5fn1\" class=\"reference-citations__ctrl scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"tbl5fn1-d5011977e2041\" aria-expanded=\"false\" aria-controls=\"tbl5fn1\">*<\/a><\/div>\n<\/td>\n<td>808\u2008963 (11\u00b79%)<\/td>\n<td>1\u2008821\u2008421 (32\u00b71%)<\/td>\n<td>361\u2008834 (10\u00b75%)<\/td>\n<td>740\u2008529 (25\u00b74%)<\/td>\n<td>447\u2008129 (13\u00b75%)<\/td>\n<td>1\u2008080\u2008892 (39\u00b72%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Unable to do normal activity<\/td>\n<td>658\u2008330 (9\u00b77%)<\/td>\n<td>1\u2008501\u2008679 (26\u00b75%)<\/td>\n<td>290\u2008207 (8\u00b74%)<\/td>\n<td>598\u2008584 (20\u00b75%)<\/td>\n<td>368\u2008123 (11\u00b71%)<\/td>\n<td>903\u2008095 (32\u00b78%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Unable to work<\/td>\n<td>305\u2008709 (4\u00b75%)<\/td>\n<td>911\u2008366 (16\u00b71%)<\/td>\n<td>135\u2008063 (3\u00b79%)<\/td>\n<td>360\u2008411 (12\u00b73%)<\/td>\n<td>170\u2008646 (5\u00b71%)<\/td>\n<td>550\u2008955 (20\u00b70%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Reported medical care<\/td>\n<td>56\u2008647 (0\u00b78%)<\/td>\n<td>53\u2008077 (0\u00b79%)<\/td>\n<td>27\u2008358 (0\u00b78%)<\/td>\n<td>25\u2008568 (0\u00b79%)<\/td>\n<td>29\u2008289 (0\u00b79%)<\/td>\n<td>27\u2008509 (1\u00b70%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Telehealth consultation<\/td>\n<td>19\u2008562 (0\u00b73%)<\/td>\n<td>19\u2008770 (0\u00b73%)<\/td>\n<td>9318 (0\u00b73%)<\/td>\n<td>9238 (0\u00b73%)<\/td>\n<td>10\u2008244 (0\u00b73%)<\/td>\n<td>10\u2008532 (0\u00b74%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Clinic attendance<\/td>\n<td>18\u2008671 (0\u00b73%)<\/td>\n<td>16\u2008793 (0\u00b73%)<\/td>\n<td>9109 (0\u00b73%)<\/td>\n<td>8487 (0\u00b73%)<\/td>\n<td>9562 (0\u00b73%)<\/td>\n<td>8306 (0\u00b73%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Emergency room visit<\/td>\n<td>9907 (0\u00b71%)<\/td>\n<td>8907 (0\u00b72%)<\/td>\n<td>5087 (0\u00b71%)<\/td>\n<td>4494 (0\u00b72%)<\/td>\n<td>4820 (0\u00b71%)<\/td>\n<td>4413 (0\u00b72%)<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td>Hospitalisation<\/td>\n<td>1896 (&lt;0\u00b71%)<\/td>\n<td>2053 (&lt;0\u00b71%)<\/td>\n<td>915 (&lt;0\u00b71%)<\/td>\n<td>1001 (&lt;0\u00b71%)<\/td>\n<td>981 (&lt;0\u00b71%)<\/td>\n<td>1052 (&lt;0\u00b71%)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<div class=\"inline-table__tail\">\n<div class=\"section-paragraph\">Data are n (%). Includes health check-in surveys made and vaccines administered from Dec 14, 2020, to June 14, 2021.<\/div>\n<div class=\"inline-table__footnote\">*\u00a0Reports of local and systemic reactions and reported health impacts are not mutually exclusive.<\/div>\n<\/div>\n<ul class=\"rlist--inline separator download-links\">\n<li><a class=\"table__open__ctrl\" title=\"Open Full Table\" href=\"https:\/\/www.thelancet.com\/action\/showFullTableHTML?isHtml=true&amp;tableId=tbl5&amp;pii=S1473-3099%2822%2900054-8\" target=\"_blank\" rel=\"noopener\">Open table in a new tab<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"section-paragraph\">\n<p>Local and systemic reactions stratified by manufacturer, dose, days after vaccination, and severity are shown in the\u00a0<a id=\"back-gr1\" class=\"figure-link scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#fig1\" data-link=\"modal\" data-target=\"#image-S1473-3099(22)00054-8gr1\" data-locator=\"fig1\">figure<\/a>. Most reported symptoms were mild (<a id=\"back-gr1\" class=\"figure-link scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#fig1\" data-link=\"modal\" data-target=\"#image-S1473-3099(22)00054-8gr1\" data-locator=\"fig1\">figure<\/a>). Participants reported moderate and severe reactogenicity most commonly on day 1 after dose two of either mRNA vaccine (<a id=\"back-gr1\" class=\"figure-link scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#fig1\" data-link=\"modal\" data-target=\"#image-S1473-3099(22)00054-8gr1\" data-locator=\"fig1\">figure<\/a>). The proportion of participants who reported symptoms was greatest on day 1 and then decreased subsequently (<a id=\"back-gr1\" class=\"figure-link scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#fig1\" data-link=\"modal\" data-target=\"#image-S1473-3099(22)00054-8gr1\" data-locator=\"fig1\">figure<\/a>). The highest proportions of participants reporting severe symptoms occurred on day 1 following dose two of mRNA-1273 (<a class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#sec1\">appendix p 8<\/a>). On all other days, proportions of participants reporting severe symptoms did not exceed 3\u00b70% for any individual symptom (<a class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#sec1\">appendix pp 7\u20138<\/a>).<\/p>\n<div class=\"floatDisplay\">\n<figure id=\"fig1\" class=\"\" tabindex=\"0\"><img decoding=\"async\" class=\"b-lazy b-loaded ux-lazyloaded wide img-aspect-ratio-checked\" src=\"https:\/\/els-jbs-prod-cdn.jbs.elsevierhealth.com\/cms\/attachment\/dac7128f-0e51-4d7e-bc25-92ff270be37b\/gr1.jpg\" alt=\"Figure thumbnail gr1\" data-locator=\"fig1\" data-high-res=\"\/\/els-jbs-prod-cdn.jbs.elsevierhealth.com\/cms\/attachment\/36127908-3671-412d-b425-95e49b77a654\/gr1_lrg.jpg\" data-large-image=\"\/\/els-jbs-prod-cdn.jbs.elsevierhealth.com\/cms\/attachment\/dac7128f-0e51-4d7e-bc25-92ff270be37b\/gr1.jpg\" \/><figcaption>\n<div class=\"figure__caption__body\">\n<div class=\"figure__title\"><span class=\"label figure__label\" data-fv-label=\"Fig. \">Figure<\/span><span class=\"figure__title__text\">Local and systemic reactions to mRNA COVID-19 vaccines reported to v-safe, by manufacturer, dose, days after vaccination, and severity<\/span><\/div>\n<div class=\"accordion\"><a class=\"accordion__control\" title=\"Expand\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" aria-expanded=\"false\"><i class=\"icon-section_arrow_d\"><\/i>Show full caption<\/a><\/div>\n<ul class=\"rlist--inline separator download-links\">\n<li><a title=\"View Large Image in a new tab\" href=\"https:\/\/els-jbs-prod-cdn.jbs.elsevierhealth.com\/cms\/attachment\/dac7128f-0e51-4d7e-bc25-92ff270be37b\/gr1.jpg\" target=\"_blank\" rel=\"noopener\">View Large Image<\/a><\/li>\n<li class=\"download-links__figureViewer\"><a class=\"figure__open__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\">Figure Viewer<\/a><\/li>\n<li><a class=\"download-links__download-Hi-res\" href=\"https:\/\/els-jbs-prod-cdn.jbs.elsevierhealth.com\/cms\/attachment\/36127908-3671-412d-b425-95e49b77a654\/gr1_lrg.jpg\" target=\"_blank\" rel=\"noopener\" download=\"\">Download Hi-res image<\/a><\/li>\n<li class=\"hidden-xs\"><a class=\"download-links__download-This\" href=\"https:\/\/www.thelancet.com\/action\/downloadFigures?pii=S1473-3099(22)00054-8&amp;id=gr1.jpg\">Download (PPT)<\/a><\/li>\n<\/ul>\n<\/div>\n<\/figcaption><\/figure>\n<\/div>\n<\/div>\n<div class=\"section-paragraph\">Reported health impacts were greater following dose two of either vaccine than dose one, and after mRNA-1273 than after BNT162b2 (<a id=\"back-tbl5\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl5\">table 5<\/a>). After dose two of BNT162b2, 598\u2009584 (20\u00b75%) of 2\u2009920\u2009526 participants were unable to do normal activities, and 360\u2009411 (12\u00b73%) were unable to work (<a id=\"back-tbl5\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl5\">table 5<\/a>). After dose two of mRNA-1273, 903\u2009095 (32\u00b78%) of 2\u2009753\u2009894 participants were unable to do normal activities, and 550\u2009955 (20\u00b70%) were unable to work (<a id=\"back-tbl5\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl5\">table 5<\/a>). Less than 1\u00b70% reported receiving medical care after receiving either dose of either vaccine (<a id=\"back-tbl5\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl5\">table 5<\/a>). A very small proportion reported an emergency room visit or hospitalisation (<a id=\"back-tbl5\" class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#tbl5\">table 5<\/a>).<\/div>\n<div class=\"section-paragraph\">When stratified by sex, female participants reported a health impact more frequently than did male participants, peaking on day 1 after vaccination (<a class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#sec1\">appendix p 11<\/a>). Following dose two of mRNA-1273 vaccine, 522\u2009192 (41\u00b74%) of 1\u2009262\u2009711 female participants reported an inability to do normal activities in the day 1 survey, and 296\u2009178 (23\u00b75%) reported an inability to work (<a class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#sec1\">appendix pp 9, 11<\/a>). Among male recipients of dose two of mRNA-1273, on the day 1 survey 167\u2009957 (25\u00b76%) of 655\u2009688 were unable to do normal activity and 110\u2009868 (16\u00b79%) were unable to work (<a class=\"scroll-into-link\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#sec1\">appendix pp 9, 11<\/a>).<\/div>\n<\/section>\n<section id=\"cesec80\" tabindex=\"0\" data-locator=\"cesec80\">\n<h2 id=\"seccestitle140\" class=\"top\" tabindex=\"0\" data-left-hand-nav=\"Discussion\"><span class=\"top__text\">Discussion<\/span><\/h2>\n<div class=\"section-paragraph\">\n<p>In this analysis of VAERS and v-safe data from the first 6 months of COVID-19 vaccination rollout in the USA, when over 298 million doses of mRNA vaccines were administered, we found that reactogenicity was similar to what was reported from clinical trials and from early post-authorisation monitoring.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib3\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib3-d5011977e2627\" aria-expanded=\"false\" aria-controls=\"bib3\">3<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib4\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib4-d5011977e2627\" aria-expanded=\"false\" aria-controls=\"bib4\">4<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib5\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib5-d5011977e2627\" aria-expanded=\"false\" aria-controls=\"bib5\">5<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib10\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib10-d5011977e2627\" aria-expanded=\"false\" aria-controls=\"bib10\">10<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib11\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib11-d5011977e2627\" aria-expanded=\"false\" aria-controls=\"bib11\">11<\/a><\/sup><\/div>\n<p>In both VAERS and v-safe, local injection-site and systemic reactions were commonly reported. V-safe participants more frequently reported transient reactions following mRNA-1273 than following BNT162b2, and more frequently following dose two of either vaccine compared with after dose one. Female participants and individuals younger than 65 years reported adverse events and reactions more frequently than male participants and those aged 65 years and older, respectively. Reporting rates for death were higher in older age groups, as expected on the basis of general age-specific mortality in the general adult population.<\/p>\n<\/div>\n<div class=\"section-paragraph\">\n<p>Safety monitoring of COVID-19 vaccines has been the most comprehensive in US history and has used established systems, including the Vaccine Safety Datalink (VSD),<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib20\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib20\" data-db-target-for=\"bib20-d5011977e2633\" aria-expanded=\"false\" aria-controls=\"bib20\">20<\/a><\/sup><\/div>\n<p>VAERS, and a new system, v-safe, developed specifically for monitoring COVID-19 vaccine safety. During the study period, all COVID-19 vaccines were administered under EUAs, which require vaccine providers to report all serious adverse events (including deaths) that occur after vaccination to VAERS, regardless of whether they were plausibly associated with vaccination. Heightened public awareness of the COVID-19 vaccination programme, outreach and education to health-care providers and hospitals about COVID-19 EUA reporting requirements for adverse events, and adherence to EUA reporting requirements by providers and health systems, probably all contributed to the high volume of VAERS reports received.<\/p>\n<\/div>\n<div class=\"section-paragraph\">\n<p>Data from US safety monitoring systems for all COVID-19 vaccines authorised or approved by the FDA have been reviewed regularly by the ACIP COVID-19 Vaccines Safety Technical Work Group<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib21\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib21\" data-db-target-for=\"bib21-d5011977e2639\" aria-expanded=\"false\" aria-controls=\"bib21\">21<\/a><\/sup><\/div>\n<p>and at public ACIP meetings.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib22\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib22\" data-db-target-for=\"bib22-d5011977e2643\" aria-expanded=\"false\" aria-controls=\"bib22\">22<\/a><\/sup><\/div>\n<p>Similar to reports following receipt of other vaccines routinely administered to adults, most VAERS reports following mRNA COVID-19 vaccination were non-serious.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib23\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib23-d5011977e2647\" aria-expanded=\"false\" aria-controls=\"bib23\">23<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib24\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib24-d5011977e2647\" aria-expanded=\"false\" aria-controls=\"bib24\">24<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib25\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib25-d5011977e2647\" aria-expanded=\"false\" aria-controls=\"bib25\">25<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib26\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib26-d5011977e2647\" aria-expanded=\"false\" aria-controls=\"bib26\">26<\/a><\/sup><\/div>\n<p>Serious adverse events detected in VAERS and VSD<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib27\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib27\" data-db-target-for=\"bib27-d5011977e2651\" aria-expanded=\"false\" aria-controls=\"bib27\">27<\/a><\/sup><\/div>\n<p>surveillance prompted specific safety evaluations for anaphylaxis,<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib14\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib14\" data-db-target-for=\"bib14-d5011977e2655\" aria-expanded=\"false\" aria-controls=\"bib14\">14<\/a><\/sup><\/div>\n<p>thrombosis with thrombocytopenia syndrome,<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib28\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib28\" data-db-target-for=\"bib28-d5011977e2660\" aria-expanded=\"false\" aria-controls=\"bib28\">28<\/a><\/sup><\/div>\n<p>myocarditis,<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib29\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib29\" data-db-target-for=\"bib29-d5011977e2664\" aria-expanded=\"false\" aria-controls=\"bib29\">29<\/a><\/sup><\/div>\n<p>and Guillain-Barr\u00e9 syndrome.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib30\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib30\" data-db-target-for=\"bib30-d5011977e2668\" aria-expanded=\"false\" aria-controls=\"bib30\">30<\/a><\/sup><\/div>\n<p>After reports of anaphylaxis following mRNA vaccination with both vaccines, clinical guidance and management recommendations were updated.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib31\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib31\" data-db-target-for=\"bib31-d5011977e2672\" aria-expanded=\"false\" aria-controls=\"bib31\">31<\/a><\/sup><\/div>\n<p>Also during this time period, a safety signal for myocarditis was identified and investigated further in VAERS and other US safety systems.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib32\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib32-d5011977e2676\" aria-expanded=\"false\" aria-controls=\"bib32\">32<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib33\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib33-d5011977e2676\" aria-expanded=\"false\" aria-controls=\"bib33\">33<\/a><\/sup><\/div>\n<p>Thrombosis with thrombocytopenia syndrome<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib28\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib28\" data-db-target-for=\"bib28-d5011977e2680\" aria-expanded=\"false\" aria-controls=\"bib28\">28<\/a><\/sup><\/div>\n<p>and Guillain-Barr\u00e9 syndrome<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib30\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib30\" data-db-target-for=\"bib30-d5011977e2685\" aria-expanded=\"false\" aria-controls=\"bib30\">30<\/a><\/sup><\/div>\n<p>have been associated with Janssen&#8217;s Ad26.COV2.S adenoviral vector COVID-19 vaccine but not with mRNA vaccines. ACIP has conducted several benefit\u2013risk assessments for each of the authorised or approved US COVID-19 vaccines;<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib22\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib22-d5011977e2689\" aria-expanded=\"false\" aria-controls=\"bib22\">22<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib28\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib28-d5011977e2689\" aria-expanded=\"false\" aria-controls=\"bib28\">28<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib29\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib29-d5011977e2689\" aria-expanded=\"false\" aria-controls=\"bib29\">29<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib30\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib30-d5011977e2689\" aria-expanded=\"false\" aria-controls=\"bib30\">30<\/a><\/sup><\/div>\n<p>these assessments have resulted in several modifications to clinical guidance and a preferential recommendation for mRNA vaccines.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib31\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib31\" data-db-target-for=\"bib31-d5011977e2693\" aria-expanded=\"false\" aria-controls=\"bib31\">31<\/a><\/sup><\/div>\n<\/div>\n<div class=\"section-paragraph\">\n<p>Reactogenicity findings following mRNA COVID-19 vaccination from VAERS and v-safe data are similar to those from a large study in the UK.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib34\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib34\" data-db-target-for=\"bib34-d5011977e2698\" aria-expanded=\"false\" aria-controls=\"bib34\">34<\/a><\/sup><\/div>\n<p>The observed patterns might be explained in part by host characteristics known to influence reactogenicity, including age, sex, and the presence of underlying medical conditions.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib35\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib35\" data-db-target-for=\"bib35-d5011977e2702\" aria-expanded=\"false\" aria-controls=\"bib35\">35<\/a><\/sup><\/div>\n<p>Female recipients have more vigorous antibody responses<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib36\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib36\" data-db-target-for=\"bib36-d5011977e2706\" aria-expanded=\"false\" aria-controls=\"bib36\">36<\/a><\/sup><\/div>\n<p>to certain vaccines and also tend to report more severe local and systemic reactions to influenza vaccine, compared with male recipients.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib37\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib37\" data-db-target-for=\"bib37-d5011977e2710\" aria-expanded=\"false\" aria-controls=\"bib37\">37<\/a><\/sup><\/div>\n<p>Female recipients might also be more likely than male recipients to respond to surveys.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib38\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib38-d5011977e2714\" aria-expanded=\"false\" aria-controls=\"bib38\">38<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib39\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib39-d5011977e2714\" aria-expanded=\"false\" aria-controls=\"bib39\">39<\/a><\/sup><\/div>\n<p>Younger people might be more comfortable with smartphone-based surveys and more likely to respond to surveys generally.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib40\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib40-d5011977e2719\" aria-expanded=\"false\" aria-controls=\"bib40\">40<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib41\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib41-d5011977e2719\" aria-expanded=\"false\" aria-controls=\"bib41\">41<\/a><\/sup><\/div>\n<\/div>\n<div class=\"section-paragraph\">\n<p>Using v-safe data, we were able to assess the effects of mRNA vaccination on daily-life activities among vaccine recipients for the first time for a vaccine administered in the USA. These effects were most frequently reported on day 1 after vaccination. Reports about the measures of health impacts used in v-safe, although self-assessed and subjective, correlate with reports about reactogenicity: more health impacts were reported by female than by male recipients, by participants younger than 65 years compared with older participants, after dose two compared with dose one, and by those who received mRNA-1273 versus BNT162b2. Reports of seeking medical care after mRNA vaccine were rare; v-safe surveys did not ask which symptoms prompted the participant to seek medical care. Reactogenicity and its associated health impacts, even if transient, might deter some from seeking vaccination. Surveys found that nearly half of unvaccinated adults younger than 50 years expressed concern about missing work because of vaccine side-effects and that employees who were given paid leave were more likely to get vaccinated than were those without paid leave;<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib42\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib42\" data-db-target-for=\"bib42-d5011977e2724\" aria-expanded=\"false\" aria-controls=\"bib42\">42<\/a><\/sup><\/div>\n<p>employer policies that accommodate such leave might increase vaccination coverage.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib43\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib43\" data-db-target-for=\"bib43-d5011977e2728\" aria-expanded=\"false\" aria-controls=\"bib43\">43<\/a><\/sup><\/div>\n<\/div>\n<div class=\"section-paragraph\">\n<p>In our review and analysis of death reports to VAERS following mRNA vaccination, we found no unusual patterns in cause of death among the death reports received. Under the COVID-19 vaccine EUA regulations, health-care providers are required to report deaths and life-threatening adverse health events after COVID-19 vaccinations to VAERS regardless of their potential association with vaccination. These requirements make comparing the number of reported deaths to VAERS for COVID-19 vaccines with reported deaths following other adult vaccines<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib44\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib44\" data-db-target-for=\"bib44-d5011977e2733\" aria-expanded=\"false\" aria-controls=\"bib44\">44<\/a><\/sup><\/div>\n<p>difficult because no other adult vaccines have been so widely administered under FDA EUAs. Initially, US COVID-19 vaccination was prioritised for individuals aged 65 years and older and those in long-term care facilities.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib7\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib7\" data-db-target-for=\"bib7-d5011977e2737\" aria-expanded=\"false\" aria-controls=\"bib7\">7<\/a><\/sup><\/div>\n<p>These populations have the highest baseline mortality risk, complicating comparisons with mortality reporting for other adult vaccines. Similar to general mortality in the adult population,<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib45\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib45\" data-db-target-for=\"bib45-d5011977e2741\" aria-expanded=\"false\" aria-controls=\"bib45\">45<\/a><\/sup><\/div>\n<p>reporting rates for deaths in this analysis increased with increasing age. The concentrated reporting of deaths on the first few days after vaccination follows patterns similar to those observed for other adult vaccinations.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib46\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib46\" data-db-target-for=\"bib46-d5011977e2745\" aria-expanded=\"false\" aria-controls=\"bib46\">46<\/a><\/sup><\/div>\n<p>This pattern might represent reporting bias because the likelihood to report a serious adverse event might increase when it occurs in close temporal proximity to vaccination.<\/p>\n<\/div>\n<div class=\"section-paragraph\">\n<p>There are limitations in any review of preliminary data concerning reports of death following vaccination. A comparison with national mortality data<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib45\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib45\" data-db-target-for=\"bib45-d5011977e2751\" aria-expanded=\"false\" aria-controls=\"bib45\">45<\/a><\/sup><\/div>\n<p>suggests that certain causes of death, such as accidents, suicides, or cancer, are less likely to be reported to VAERS. Underreporting to VAERS, in general, is expected.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib8\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib8\" data-db-target-for=\"bib8-d5011977e2755\" aria-expanded=\"false\" aria-controls=\"bib8\">8<\/a><\/sup><\/div>\n<p>The predominance of heart disease as a cause of death reported to VAERS warrants continued monitoring and assessment but might be driven by non-specific causes, such as cardiac arrest, that might be chosen as a terminal event if no immediate explanation for death was available. Death certificate or autopsy reports were available for only a small proportion of deaths reported to VAERS when our analyses were conducted. Finally, VAERS is designed as an early warning system to detect potential safety signals,<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib8\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib8\" data-db-target-for=\"bib8-d5011977e2759\" aria-expanded=\"false\" aria-controls=\"bib8\">8<\/a><\/sup><\/div>\n<p>and VAERS data alone generally cannot establish causal relationships between vaccination and adverse events. Another surveillance system, the VSD, showed no increased risk of non-COVID-19 mortality in vaccinated people.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib47\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib47\" data-db-target-for=\"bib47-d5011977e2763\" aria-expanded=\"false\" aria-controls=\"bib47\">47<\/a><\/sup><\/div>\n<\/div>\n<div class=\"section-paragraph\">\n<p>This study has several strengths, including the large population under surveillance and the comprehensive capture of national data from two complementary surveillance systems. Because the US Government purchased all COVID-19 doses and collected administration data, we were able to calculate VAERS reporting rates using the number of mRNA vaccine doses administered as denominators.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib18\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib18\" data-db-target-for=\"bib18-d5011977e2768\" aria-expanded=\"false\" aria-controls=\"bib18\">18<\/a><\/sup><\/div>\n<p>By contrast, VAERS analyses for non-COVID-19 vaccines rely on doses distributed, not administered. Because the number of doses distributed is greater than that of doses administered, these past VAERS analyses are likely to underestimate reporting rates of vaccine-related adverse events. Information from v-safe about how reactogenicity during the week after mRNA vaccination affects daily activities and work is novel and provides new insights.<\/p>\n<\/div>\n<div class=\"section-paragraph\">\n<p>An important limitation of this report is one shared by all VAERS analyses: we used data from a passive reporting system subject to underreporting and variable or incomplete reporting.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib8\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib8\" data-db-target-for=\"bib8-d5011977e2774\" aria-expanded=\"false\" aria-controls=\"bib8\">8<\/a><\/sup><\/div>\n<p>Although VAERS death reports were individually reviewed by CDC physicians and follow-up is ongoing to obtain additional and missing records, other reports of serious adverse events were not individually reviewed. Additionally, VAERS reports require interpretation to identify whether reports meet clinical case definitions.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib48\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib48\" data-db-target-for=\"bib48-d5011977e2778\" aria-expanded=\"false\" aria-controls=\"bib48\">48<\/a><\/sup><\/div>\n<p>A limitation of v-safe is the need for smartphone access. Because a subset of all vaccine recipients participated in v-safe, the results are unlikely to be generalisable to the entire vaccinated US population. Other differences might exist among participants who received mRNA-1273 or BNT162b2 vaccines that were unaccounted for; therefore, v-safe cannot be used to draw conclusions that one mRNA vaccine type is more reactogenic than the other. Additionally, participants in v-safe might be lost to follow-up because continuous enrolment is not required. Finally, this report only included v-safe responses received during the first week after vaccination.<\/p>\n<\/div>\n<div class=\"section-paragraph\">\n<p>During the first 6 months of the US COVID-19 vaccination programme, more than 50% of the eligible population received at least one vaccine dose.<sup>19<\/sup>\u00a0VAERS and v-safe data from this period show a post-authorisation safety profile for mRNA COVID-19 vaccines that is generally consistent with pre-authorisation trials<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib3\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib3-d5011977e2787\" aria-expanded=\"false\" aria-controls=\"bib3\">3<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib4\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib4-d5011977e2787\" aria-expanded=\"false\" aria-controls=\"bib4\">4<\/a><\/sup><\/div>\n<p>and early post-authorisation surveillance reports.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib10\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib10-d5011977e2791\" aria-expanded=\"false\" aria-controls=\"bib10\">10<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib11\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib11-d5011977e2791\" aria-expanded=\"false\" aria-controls=\"bib11\">11<\/a><\/sup><\/div>\n<p>Serious adverse events, including myocarditis, have been identified following mRNA vaccinations; however, these events are rare. Vaccines are the most effective tool to prevent serious COVID-19 disease outcomes<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib49\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#bib49\" data-db-target-for=\"bib49-d5011977e2795\" aria-expanded=\"false\" aria-controls=\"bib49\">49<\/a><\/sup><\/div>\n<p>and the benefits of immunisation in preventing serious morbidity and mortality strongly favour vaccination.<\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib28\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib28-d5011977e2799\" aria-expanded=\"false\" aria-controls=\"bib28\">28<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib29\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib29-d5011977e2799\" aria-expanded=\"false\" aria-controls=\"bib29\">29<\/a><\/sup><\/div>\n<p><sup>,\u00a0<\/sup><\/p>\n<div class=\"dropBlock reference-citations\"><sup><a id=\"back-bib30\" class=\"reference-citations__ctrl\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#\" data-db-target-for=\"bib30-d5011977e2799\" aria-expanded=\"false\" aria-controls=\"bib30\">30<\/a><\/sup><\/div>\n<p>VAERS and v-safe, two complementary surveillance systems, will continue to provide data needed to inform policy makers, immunisation providers, other health-care professionals, and the public about the safety of COVID-19 vaccination.<\/p>\n<\/div>\n<\/section>\n<div class=\"section-paragraph\"><strong>Contributors<\/strong><\/div>\n<div class=\"section-paragraph\">HGR, JG, JRS, TRM, AMH, LEM, TTS, and DKS contributed to conceptualisation, data curation, formal analysis, investigation, methodology, project administration, visualisation, writing, and editing. JRS, TRM, TTS, DKS, JG, and LEM contributed to supervision. RL, PLM, and BZ contributed to data curation, formal analysis, validation, visualisation, writing, and editing, and have verified the underlying data. WEA and MMM contributed to data curation, analysis, writing, and editing. PS contributed to project administration, visualisation, writing, and editing. All authors had access to the underlying data of the study and were responsible for the decision to submit for publication.<\/div>\n<section id=\"cesec90\" tabindex=\"0\" data-locator=\"cesec90\">\n<h2 id=\"seccestitle150\" class=\"top\" tabindex=\"0\" data-left-hand-nav=\"Data sharing\"><span class=\"top__text\">Data sharing<\/span><\/h2>\n<div class=\"section-paragraph\">US COVID-19 vaccine administration data are available at\u00a0<a href=\"https:\/\/covid.cdc.gov\/covid-data-tracker\/#vaccinations_vacc-total-admin-rate-total\" target=\"_blank\" rel=\"noopener\">https:\/\/covid.cdc.gov\/covid-data-tracker\/#vaccinations_vacc-total-admin-rate-total<\/a>. VAERS data, redacted of personal identifying information and other sensitive information, can be accessed at\u00a0<a href=\"https:\/\/vaers.hhs.gov\/data.html\" target=\"_blank\" rel=\"noopener\">https:\/\/vaers.hhs.gov\/data.html<\/a>. Per-protocol (<a href=\"https:\/\/www.cdc.gov\/vaccinesafety\/pdf\/V-safe-Protocol-508.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/www.cdc.gov\/vaccinesafety\/pdf\/V-safe-Protocol-508.pdf<\/a>), final de-identified v-safe data will be made available at the end of the v-safe programme. Protocols and standard operating procedures for COVID-19 for both systems are available at\u00a0<a href=\"https:\/\/www.cdc.gov\/vaccinesafety\/ensuringsafety\/monitoring\/emergencypreparedness\/index.html\" target=\"_blank\" rel=\"noopener\">https:\/\/www.cdc.gov\/vaccinesafety\/ensuringsafety\/monitoring\/emergencypreparedness\/index.html<\/a>.<\/div>\n<\/section>\n<section class=\"conflict-of-interest\">\n<h2 id=\"cestitle160\" class=\"top\" tabindex=\"0\" data-left-hand-nav=\"Declaration of interests\">Declaration of interests<\/h2>\n<div class=\"section-paragraph\">We declare no competing interests.<\/div>\n<\/section>\n<section>\n<div class=\"section-paragraph\"><strong>Acknowledgments<\/strong><\/div>\n<div class=\"section-paragraph\">This work was supported by the CDC. We wish to acknowledge the following contributors: from the CDC, Amelia Jazwa, Tara Johnson, Charles Licata, Stacey Martin, Florence Lee, and Carla Black; from the FDA, David Menschik, Bethany Baer, Jane Baumblatt, Deborah Thompson, Kerry Welsh, Narayan Nair, and Kosal Nguon (Commonwealth Informatics); v-safe participants; and the Oracle v-safe development team. CDC received non-financial technical support to develop and maintain the v-safe infrastructure from Oracle Corporation (Austin, TX, USA). The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the CDC or the FDA. Mention of a product or company name is for identification purposes only and does not constitute endorsement by the CDC or the FDA.<\/div>\n<\/section>\n<section id=\"sec1\" tabindex=\"0\" data-locator=\"sec1\">\n<h2 id=\"supplementaryMaterial\" class=\"top\" tabindex=\"0\" data-left-hand-nav=\"Supplementary Material\"><span class=\"top__text\">Supplementary Material<\/span><\/h2>\n<div class=\"section-paragraph\">\n<ul class=\"rlist\">\n<li id=\"ecomp10\" class=\"supplemental-information__item\">\n<div class=\"supplemental-information__icon icon-gizmo-pdf-file2\"><\/div>\n<div class=\"supplemental-information__links clearfix\">\n<div class=\"col-sm-6 gutterless\"><a class=\"supplemental-information__download \" href=\"https:\/\/www.thelancet.com\/cms\/10.1016\/S1473-3099(22)00054-8\/attachment\/3893fc8d-deef-4d11-86ac-d48b32667da6\/mmc1.pdf\" target=\"_blank\" rel=\"noopener\">Download .pdf (.9 MB)<\/a><\/div>\n<div class=\"col-sm-6 gutterless\"><a class=\"supplemental-information__help \" href=\"https:\/\/service.elsevier.com\/app\/answers\/detail\/a_id\/19286\/supporthub\/sciencedirect\/\" target=\"_blank\" rel=\"noopener\">Help with pdf files<\/a><\/div>\n<\/div>\n<div class=\"supplemental-information__title\">Supplementary appendix<\/div>\n<\/li>\n<\/ul>\n<\/div>\n<\/section>\n<div class=\"extra-dropzone pb-dropzone\" data-pb-dropzone=\"extra-dropzone\"><\/div>\n<section class=\"refs\">\n<h2 id=\"seccestitle180\" class=\"top\" tabindex=\"0\" data-left-hand-nav=\"References\"><span class=\"top__text\">References<\/span><\/h2>\n<ol class=\"ref__wrapper\">\n<li class=\"ref\"><span class=\"refLabel\">1.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Oliver SE<\/li>\n<li class=\"ref__authors__name\">Gargano JW<\/li>\n<li class=\"ref__authors__name\">Marin M<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">The Advisory Committee on Immunization Practices&#8217; interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine\u2014United States, December 2020.<\/div>\n<p><span class=\"ref__series\"><i>Morb Mortal Wkly Rep.<\/i>\u00a0<span class=\"ref__seriesDate\">2020;\u00a0<\/span><span class=\"ref__seriesVolume\">69<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">1922-1924<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib1\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=69&amp;publication_year=2020&amp;pages=1922-1924&amp;journal=Morb+Mortal+Wkly+Rep&amp;author=Oliver+SE&amp;author=Gargano+JW&amp;author=Marin+M&amp;title=The+Advisory+Committee+on+Immunization+Practices%27+interim+recommendation+for+use+of+Pfizer-BioNTech+COVID-19+vaccine%E2%80%94United+States%2C+December+2020\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">2.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Oliver SE<\/li>\n<li class=\"ref__authors__name\">Gargano JW<\/li>\n<li class=\"ref__authors__name\">Marin M<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">The Advisory Committee on Immunization Practices&#8217; interim recommendation for use of Moderna COVID-19 vaccine\u2014United States, December 2020.<\/div>\n<p><span class=\"ref__series\"><i>Morb Mortal Wkly Rep.<\/i>\u00a0<span class=\"ref__seriesDate\">2021;\u00a0<\/span><span class=\"ref__seriesVolume\">69<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">1653-1656<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib2\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=69&amp;publication_year=2021&amp;pages=1653-1656&amp;journal=Morb+Mortal+Wkly+Rep&amp;author=Oliver+SE&amp;author=Gargano+JW&amp;author=Marin+M&amp;title=The+Advisory+Committee+on+Immunization+Practices%27+interim+recommendation+for+use+of+Moderna+COVID-19+vaccine%E2%80%94United+States%2C+December+2020\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">3.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Polack FP<\/li>\n<li class=\"ref__authors__name\">Thomas SJ<\/li>\n<li class=\"ref__authors__name\">Kitchin N<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine.<\/div>\n<p><span class=\"ref__series\"><i>N Engl J Med.<\/i>\u00a0<span class=\"ref__seriesDate\">2020;\u00a0<\/span><span class=\"ref__seriesVolume\">383<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">2603-2615<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib3\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=383&amp;publication_year=2020&amp;pages=2603-2615&amp;journal=N+Engl+J+Med&amp;author=Polack+FP&amp;author=Thomas+SJ&amp;author=Kitchin+N&amp;title=Safety+and+efficacy+of+the+BNT162b2+mRNA+COVID-19+vaccine\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">4.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Baden LR<\/li>\n<li class=\"ref__authors__name\">El Sahly HM<\/li>\n<li class=\"ref__authors__name\">Essink B<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine.<\/div>\n<p><span class=\"ref__series\"><i>N Engl J Med.<\/i>\u00a0<span class=\"ref__seriesDate\">2021;\u00a0<\/span><span class=\"ref__seriesVolume\">384<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">403-416<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib4\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=384&amp;publication_year=2021&amp;pages=403-416&amp;journal=N+Engl+J+Med&amp;author=Baden+LR&amp;author=El+Sahly+HM&amp;author=Essink+B&amp;title=Efficacy+and+safety+of+the+mRNA-1273+SARS-CoV-2+vaccine\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">5.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Anderson EJ<\/li>\n<li class=\"ref__authors__name\">Rouphael NG<\/li>\n<li class=\"ref__authors__name\">Widge AT<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">Safety and immunogenicity of SARS-CoV-2 mRNA-1273 vaccine in older adults.<\/div>\n<p><span class=\"ref__series\"><i>N Engl J Med.<\/i>\u00a0<span class=\"ref__seriesDate\">2020;\u00a0<\/span><span class=\"ref__seriesVolume\">383<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">2427-2438<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib5\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=383&amp;publication_year=2020&amp;pages=2427-2438&amp;journal=N+Engl+J+Med&amp;author=Anderson+EJ&amp;author=Rouphael+NG&amp;author=Widge+AT&amp;title=Safety+and+immunogenicity+of+SARS-CoV-2+mRNA-1273+vaccine+in+older+adults\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">6.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Chen RT<\/li>\n<li class=\"ref__authors__name\">Davis RL<\/li>\n<li class=\"ref__authors__name\">Rhodes PH<\/li>\n<\/ul>\n<div class=\"ref__title\">Special methodological issues in pharmacoepidemiology studies of vaccine safety.<\/div>\n<p>in:\u00a0<span class=\"editors\">Strom BL\u00a0<\/span>Pharmacoepidemiology.\u00a0<span class=\"refPublisherName\">John Wiley &amp; Sons<\/span>,\u00a0<span class=\"refPublisherLoc\">Sussex<\/span><span class=\"refDate\">2005<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib6\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar?hl=en&amp;q=Chen+RT+Davis+RL+Rhodes+PH+Special+methodological+issues+in+pharmacoepidemiology+studies+of+vaccine+safety.in%3A+Strom+BL+Pharmacoepidemiology.+John+Wiley+%26+Sons%2C%0A+Sussex2005\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">7.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Dooling K<\/li>\n<li class=\"ref__authors__name\">McClung N<\/li>\n<li class=\"ref__authors__name\">Chamberland M<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">The Advisory Committee on Immunization Practices&#8217; interim recommendation for allocating initial supplies of COVID-19 vaccine\u2014United States, 2020.<\/div>\n<p><span class=\"ref__series\"><i>Morb Mortal Wkly Rep.<\/i>\u00a0<span class=\"ref__seriesDate\">2020;\u00a0<\/span><span class=\"ref__seriesVolume\">69<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">1857-1859<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib7\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=69&amp;publication_year=2020&amp;pages=1857-1859&amp;journal=Morb+Mortal+Wkly+Rep&amp;author=Dooling+K&amp;author=McClung+N&amp;author=Chamberland+M&amp;title=The+Advisory+Committee+on+Immunization+Practices%27+interim+recommendation+for+allocating+initial+supplies+of+COVID-19+vaccine%E2%80%94United+States%2C+2020\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">8.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Shimabukuro TT<\/li>\n<li class=\"ref__authors__name\">Nguyen M<\/li>\n<li class=\"ref__authors__name\">Martin D<\/li>\n<li class=\"ref__authors__name\">DeStefano F<\/li>\n<\/ul>\n<div class=\"ref__title\">Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).<\/div>\n<p><span class=\"ref__series\"><i>Vaccine.<\/i>\u00a0<span class=\"ref__seriesDate\">2015;\u00a0<\/span><span class=\"ref__seriesVolume\">33<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">4398-4405<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib8\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=33&amp;publication_year=2015&amp;pages=4398-4405&amp;journal=Vaccine&amp;author=Shimabukuro+TT&amp;author=Nguyen+M&amp;author=Martin+D&amp;author=DeStefano+F&amp;title=Safety+monitoring+in+the+Vaccine+Adverse+Event+Reporting+System+%28VAERS%29\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">9.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li>US Centers for Disease Control and Prevention<\/li>\n<\/ul>\n<div class=\"ref__title\">V-safe after vaccination health checker.<\/div>\n<div class=\"citation-host\">\n<p><a href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/vaccines\/safety\/vsafe.html\" target=\"_blank\" rel=\"noopener\">https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/vaccines\/safety\/vsafe.html<\/a><\/p>\n<div>Date accessed:\u00a0July 14, 2021<\/div>\n<\/div>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib9\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar?hl=en&amp;q=US+Centers+for+Disease+Control+and+PreventionV-safe+after+vaccination+health+checker.https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvaccines%2Fsafety%2Fvsafe.htmlDate+accessed%3A+July+14%2C+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">10.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Gee J<\/li>\n<li class=\"ref__authors__name\">Marquez P<\/li>\n<li class=\"ref__authors__name\">Su J<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">First month of COVID-19 vaccine safety monitoring\u2014United States, December 14, 2020\u2013January 13, 2021.<\/div>\n<p><span class=\"ref__series\"><i>Morb Mortal Wkly Rep.<\/i>\u00a0<span class=\"ref__seriesDate\">2021;\u00a0<\/span><span class=\"ref__seriesVolume\">70<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">283-288<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib10\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=70&amp;publication_year=2021&amp;pages=283-288&amp;journal=Morb+Mortal+Wkly+Rep&amp;author=Gee+J&amp;author=Marquez+P&amp;author=Su+J&amp;title=First+month+of+COVID-19+vaccine+safety+monitoring%E2%80%94United+States%2C+December+14%2C+2020%E2%80%93January+13%2C+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">11.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Chapin-Bardales J<\/li>\n<li class=\"ref__authors__name\">Gee J<\/li>\n<li class=\"ref__authors__name\">Myers T<\/li>\n<\/ul>\n<div class=\"ref__title\">Reactogenicity following receipt of mRNA-based COVID-19 vaccines.<\/div>\n<p><span class=\"ref__series\"><i>JAMA.<\/i>\u00a0<span class=\"ref__seriesDate\">2021;\u00a0<\/span><span class=\"ref__seriesVolume\">325<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">2201-2202<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib11\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=325&amp;publication_year=2021&amp;pages=2201-2202&amp;journal=JAMA&amp;author=Chapin-Bardales+J&amp;author=Gee+J&amp;author=Myers+T&amp;title=Reactogenicity+following+receipt+of+mRNA-based+COVID-19+vaccines\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">12.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Shimabukuro TT<\/li>\n<li class=\"ref__authors__name\">Cole M<\/li>\n<li class=\"ref__authors__name\">Su JR<\/li>\n<\/ul>\n<div class=\"ref__title\">Reports of anaphylaxis after receipt of mRNA COVID-19 vaccines in the US\u2014December 14, 2020\u2013January 18, 2021.<\/div>\n<p><span class=\"ref__series\"><i>JAMA.<\/i>\u00a0<span class=\"ref__seriesDate\">2021;\u00a0<\/span><span class=\"ref__seriesVolume\">325<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">1101-1102<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib12\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=325&amp;publication_year=2021&amp;pages=1101-1102&amp;journal=JAMA&amp;author=Shimabukuro+TT&amp;author=Cole+M&amp;author=Su+JR&amp;title=Reports+of+anaphylaxis+after+receipt+of+mRNA+COVID-19+vaccines+in+the+US%E2%80%94December+14%2C+2020%E2%80%93January+18%2C+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">13.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Shay DK<\/li>\n<li class=\"ref__authors__name\">Gee J<\/li>\n<li class=\"ref__authors__name\">Su JR<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">Safety monitoring of the Janssen (Johnson &amp; Johnson) COVID-19 vaccine\u2014United States, March\u2013April 2021.<\/div>\n<p><span class=\"ref__series\"><i>Morb Mortal Wkly Rep.<\/i>\u00a0<span class=\"ref__seriesDate\">2021;\u00a0<\/span><span class=\"ref__seriesVolume\">70<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">680-684<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib13\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=70&amp;publication_year=2021&amp;pages=680-684&amp;journal=Morb+Mortal+Wkly+Rep&amp;author=Shay+DK&amp;author=Gee+J&amp;author=Su+JR&amp;title=Safety+monitoring+of+the+Janssen+%28Johnson+%26+Johnson%29+COVID-19+vaccine%E2%80%94United+States%2C+March%E2%80%93April+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">14.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li>US Centers for Disease Control and Prevention<\/li>\n<\/ul>\n<div class=\"ref__title\">Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine\u2014United States, December 14\u201323, 2020.<\/div>\n<p><span class=\"ref__series\"><i>MMWR Morb Mortal Wkly Rep.<\/i>\u00a0<span class=\"ref__seriesDate\">2021;\u00a0<\/span><span class=\"ref__seriesVolume\">70<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">46-51<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib14\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=70&amp;publication_year=2021&amp;pages=46-51&amp;journal=MMWR+Morb+Mortal+Wkly+Rep&amp;author=US+Centers+for+Disease+Control+and+Prevention&amp;title=Allergic+reactions+including+anaphylaxis+after+receipt+of+the+first+dose+of+Pfizer-BioNTech+COVID-19+vaccine%E2%80%94United+States%2C+December+14%E2%80%9323%2C+2020\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">15.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li>US Food and Drug Administration<\/li>\n<\/ul>\n<div class=\"ref__title\">Code of federal regulations title 21.<\/div>\n<div class=\"citation-host\">\n<p><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/cfrsearch.cfm?fr\" target=\"_blank\" rel=\"noopener\">https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/cfrsearch.cfm?fr<\/a><\/p>\n<div>Date accessed:\u00a0July 14, 2021<\/div>\n<\/div>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib15\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar?hl=en&amp;q=US+Food+and+Drug+AdministrationCode+of+federal+regulations+title+21.https%3A%2F%2Fwww.accessdata.fda.gov%2Fscripts%2Fcdrh%2Fcfdocs%2Fcfcfr%2Fcfrsearch.cfm%3FfrDate+accessed%3A+July+14%2C+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">16.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li>US Centers for Disease Control and Prevention<\/li>\n<\/ul>\n<div class=\"ref__title\">Vaccine Adverse Event Reporting System (VAERS) standard operating procedures for COVID-19 (as of 29 January 2021).<\/div>\n<div class=\"citation-host\">\n<p><a href=\"https:\/\/www.cdc.gov\/vaccinesafety\/pdf\/VAERS-v2-SOP.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/www.cdc.gov\/vaccinesafety\/pdf\/VAERS-v2-SOP.pdf<\/a><\/p>\n<div>Date accessed:\u00a0July 14, 2021<\/div>\n<\/div>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib16\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar?hl=en&amp;q=US+Centers+for+Disease+Control+and+PreventionVaccine+Adverse+Event+Reporting+System+%28VAERS%29+standard+operating+procedures+for+COVID-19+%28as+of+29+January+2021%29.https%3A%2F%2Fwww.cdc.gov%2Fvaccinesafety%2Fpdf%2FVAERS-v2-SOP.pdfDate+accessed%3A+July+14%2C+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">17.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li>US Centers for Disease Control and Prevention<\/li>\n<\/ul>\n<div class=\"ref__title\">Leading causes of death.<\/div>\n<div class=\"citation-host\">\n<p><a href=\"https:\/\/www.cdc.gov\/nchs\/nvss\/leading-causes-of-death.htm\" target=\"_blank\" rel=\"noopener\">https:\/\/www.cdc.gov\/nchs\/nvss\/leading-causes-of-death.htm<\/a><\/p>\n<div>Date accessed:\u00a0September 9, 2021<\/div>\n<\/div>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib17\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar?hl=en&amp;q=US+Centers+for+Disease+Control+and+PreventionLeading+causes+of+death.https%3A%2F%2Fwww.cdc.gov%2Fnchs%2Fnvss%2Fleading-causes-of-death.htmDate+accessed%3A+September+9%2C+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">18.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li>US Centers for Disease Control and Prevention<\/li>\n<\/ul>\n<div class=\"ref__title\">COVID-19 vaccinations in the United States.<\/div>\n<div class=\"citation-host\">\n<p><a href=\"https:\/\/covid.cdc.gov\/covid-data-tracker\/#vaccinations_vacc-total-admin-rate-total\" target=\"_blank\" rel=\"noopener\">https:\/\/covid.cdc.gov\/covid-data-tracker\/#vaccinations_vacc-total-admin-rate-total<\/a><\/p>\n<div>Date accessed:\u00a0September 9, 2021<\/div>\n<\/div>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib18\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar?hl=en&amp;q=US+Centers+for+Disease+Control+and+PreventionCOVID-19+vaccinations+in+the+United+States.https%3A%2F%2Fcovid.cdc.gov%2Fcovid-data-tracker%2F%23vaccinations_vacc-total-admin-rate-totalDate+accessed%3A+September+9%2C+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">20.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li>US Centers for Disease Control and Prevention<\/li>\n<\/ul>\n<div class=\"ref__title\">Vaccine safety monitoring\u2014VSD.<\/div>\n<div class=\"citation-host\">\n<p><a href=\"https:\/\/www.cdc.gov\/vaccinesafety\/ensuringsafety\/monitoring\/vsd\/index.html\" target=\"_blank\" rel=\"noopener\">https:\/\/www.cdc.gov\/vaccinesafety\/ensuringsafety\/monitoring\/vsd\/index.html<\/a><\/p>\n<div>Date accessed:\u00a0September 9, 2021<\/div>\n<\/div>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib20\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar?hl=en&amp;q=US+Centers+for+Disease+Control+and+PreventionVaccine+safety+monitoring%E2%80%94VSD.https%3A%2F%2Fwww.cdc.gov%2Fvaccinesafety%2Fensuringsafety%2Fmonitoring%2Fvsd%2Findex.htmlDate+accessed%3A+September+9%2C+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">21.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li>US Centers for Disease Control and Prevention<\/li>\n<\/ul>\n<div class=\"ref__title\">Advisory Committee on Immunization Practices. VaST Reports.<\/div>\n<div class=\"citation-host\">\n<p><a href=\"https:\/\/www.cdc.gov\/vaccines\/acip\/work-groups-vast\/index.html\" target=\"_blank\" rel=\"noopener\">https:\/\/www.cdc.gov\/vaccines\/acip\/work-groups-vast\/index.html<\/a><\/p>\n<div>Date accessed:\u00a0September 9, 2021<\/div>\n<\/div>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib21\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar?hl=en&amp;q=US+Centers+for+Disease+Control+and+PreventionAdvisory+Committee+on+Immunization+Practices.+VaST+Reports.https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Facip%2Fwork-groups-vast%2Findex.htmlDate+accessed%3A+September+9%2C+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">22.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li>US Centers for Disease Control and Prevention<\/li>\n<\/ul>\n<div class=\"ref__title\">Advisory Committee on Immunization Practices. Meeting information.<\/div>\n<div class=\"citation-host\">\n<p><a href=\"https:\/\/www.cdc.gov\/vaccines\/acip\/meetings\/index.html\" target=\"_blank\" rel=\"noopener\">https:\/\/www.cdc.gov\/vaccines\/acip\/meetings\/index.html<\/a><\/p>\n<div>Date accessed:\u00a0July 14, 2021<\/div>\n<\/div>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib22\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar?hl=en&amp;q=US+Centers+for+Disease+Control+and+PreventionAdvisory+Committee+on+Immunization+Practices.+Meeting+information.https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Facip%2Fmeetings%2Findex.htmlDate+accessed%3A+July+14%2C+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">23.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Miller ER<\/li>\n<li class=\"ref__authors__name\">Lewis P<\/li>\n<li class=\"ref__authors__name\">Shimabukuro TT<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">Post-licensure safety surveillance of zoster vaccine live (Zostavax\u00ae) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006\u20132015.<\/div>\n<p><span class=\"ref__series\"><i>Hum Vaccin Immunother.<\/i>\u00a0<span class=\"ref__seriesDate\">2018;\u00a0<\/span><span class=\"ref__seriesVolume\">14<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">1963-1969<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib23\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=14&amp;publication_year=2018&amp;pages=1963-1969&amp;journal=Hum+Vaccin+Immunother&amp;author=Miller+ER&amp;author=Lewis+P&amp;author=Shimabukuro+TT&amp;title=Post-licensure+safety+surveillance+of+zoster+vaccine+live+%28Zostavax%C2%AE%29+in+the+United+States%2C+Vaccine+Adverse+Event+Reporting+System+%28VAERS%29%2C+2006%E2%80%932015\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">24.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Moro PL<\/li>\n<li class=\"ref__authors__name\">Haber P<\/li>\n<li class=\"ref__authors__name\">McNeil MM<\/li>\n<\/ul>\n<div class=\"ref__title\">Challenges in evaluating post-licensure vaccine safety: observations from the Centers for Disease Control and Prevention.<\/div>\n<p><span class=\"ref__series\"><i>Expert Rev Vaccines.<\/i>\u00a0<span class=\"ref__seriesDate\">2019;\u00a0<\/span><span class=\"ref__seriesVolume\">18<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">1091-1101<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib24\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=18&amp;publication_year=2019&amp;pages=1091-1101&amp;journal=Expert+Rev+Vaccines&amp;author=Moro+PL&amp;author=Haber+P&amp;author=McNeil+MM&amp;title=Challenges+in+evaluating+post-licensure+vaccine+safety%3A+observations+from+the+Centers+for+Disease+Control+and+Prevention\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">25.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Haber P<\/li>\n<li class=\"ref__authors__name\">Moro PL<\/li>\n<li class=\"ref__authors__name\">Ng C<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">Safety review of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccines (Tdap) in adults aged \u226565 years, Vaccine Adverse Event Reporting System (VAERS), United States, September 2010\u2013December 2018.<\/div>\n<p><span class=\"ref__series\"><i>Vaccine.<\/i>\u00a0<span class=\"ref__seriesDate\">2020;\u00a0<\/span><span class=\"ref__seriesVolume\">38<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">1476-1480<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib25\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=38&amp;publication_year=2020&amp;pages=1476-1480&amp;journal=Vaccine&amp;author=Haber+P&amp;author=Moro+PL&amp;author=Ng+C&amp;title=Safety+review+of+tetanus+toxoid%2C+reduced+diphtheria+toxoid%2C+acellular+pertussis+vaccines+%28Tdap%29+in+adults+aged+%E2%89%A565+years%2C+Vaccine+Adverse+Event+Reporting+System+%28VAERS%29%2C+United+States%2C+September+2010%E2%80%93December+2018\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">26.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Woo EJ<\/li>\n<li class=\"ref__authors__name\">Moro PL<\/li>\n<\/ul>\n<div class=\"ref__title\">Postmarketing safety surveillance of quadrivalent recombinant influenza vaccine: reports to the Vaccine Adverse Event Reporting System.<\/div>\n<p><span class=\"ref__series\"><i>Vaccine.<\/i>\u00a0<span class=\"ref__seriesDate\">2021;\u00a0<\/span><span class=\"ref__seriesVolume\">39<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">1812-1817<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib26\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=39&amp;publication_year=2021&amp;pages=1812-1817&amp;journal=Vaccine&amp;author=Woo+EJ&amp;author=Moro+PL&amp;title=Postmarketing+safety+surveillance+of+quadrivalent+recombinant+influenza+vaccine%3A+reports+to+the+Vaccine+Adverse+Event+Reporting+System\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">27.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Klein NP<\/li>\n<li class=\"ref__authors__name\">Lewis N<\/li>\n<li class=\"ref__authors__name\">Goddard K<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">Surveillance for adverse events after COVID-19 mRNA vaccination.<\/div>\n<p><span class=\"ref__series\"><i>JAMA.<\/i>\u00a0<span class=\"ref__seriesDate\">2021;\u00a0<\/span><span class=\"ref__seriesVolume\">326<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">1390-1399<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib27\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=326&amp;publication_year=2021&amp;pages=1390-1399&amp;journal=JAMA&amp;author=Klein+NP&amp;author=Lewis+N&amp;author=Goddard+K&amp;title=Surveillance+for+adverse+events+after+COVID-19+mRNA+vaccination\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">28.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">MacNeil JR<\/li>\n<li class=\"ref__authors__name\">Su JR<\/li>\n<li class=\"ref__authors__name\">Broder KR<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">Updated recommendations from the Advisory Committee on Immunization Practices for use of the Janssen (Johnson &amp; Johnson) COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome among vaccine recipients\u2014United States, April 2021.<\/div>\n<p><span class=\"ref__series\"><i>Morb Mortal Wkly Rep.<\/i>\u00a0<span class=\"ref__seriesDate\">2021;\u00a0<\/span><span class=\"ref__seriesVolume\">70<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">651-656<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib28\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=70&amp;publication_year=2021&amp;pages=651-656&amp;journal=Morb+Mortal+Wkly+Rep&amp;author=MacNeil+JR&amp;author=Su+JR&amp;author=Broder+KR&amp;title=Updated+recommendations+from+the+Advisory+Committee+on+Immunization+Practices+for+use+of+the+Janssen+%28Johnson+%26+Johnson%29+COVID-19+vaccine+after+reports+of+thrombosis+with+thrombocytopenia+syndrome+among+vaccine+recipients%E2%80%94United+States%2C+April+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">29.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Gargano JW<\/li>\n<li class=\"ref__authors__name\">Wallace M<\/li>\n<li class=\"ref__authors__name\">Hadler SC<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">Use of mRNA COVID-19 vaccine after reports of myocarditis among vaccine recipients: update from the Advisory Committee on Immunization Practices\u2014United States, June 2021.<\/div>\n<p><span class=\"ref__series\"><i>Morb Mortal Wkly Rep.<\/i>\u00a0<span class=\"ref__seriesDate\">2021;\u00a0<\/span><span class=\"ref__seriesVolume\">70<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">977-982<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib29\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=70&amp;publication_year=2021&amp;pages=977-982&amp;journal=Morb+Mortal+Wkly+Rep&amp;author=Gargano+JW&amp;author=Wallace+M&amp;author=Hadler+SC&amp;title=Use+of+mRNA+COVID-19+vaccine+after+reports+of+myocarditis+among+vaccine+recipients%3A+update+from+the+Advisory+Committee+on+Immunization+Practices%E2%80%94United+States%2C+June+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">30.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Rosenblum HG<\/li>\n<li class=\"ref__authors__name\">Hadler SC<\/li>\n<li class=\"ref__authors__name\">Moulia D<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">Use of COVID-19 vaccines after reports of adverse events among adult recipients of Janssen (Johnson &amp; Johnson) and mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna): update from the Advisory Committee on Immunization Practices\u2014United States, July 2021.<\/div>\n<p><span class=\"ref__series\"><i>Morb Mortal Wkly Rep.<\/i>\u00a0<span class=\"ref__seriesDate\">2021;\u00a0<\/span><span class=\"ref__seriesVolume\">70<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">1094-1099<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib30\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=70&amp;publication_year=2021&amp;pages=1094-1099&amp;journal=Morb+Mortal+Wkly+Rep&amp;author=Rosenblum+HG&amp;author=Hadler+SC&amp;author=Moulia+D&amp;title=Use+of+COVID-19+vaccines+after+reports+of+adverse+events+among+adult+recipients+of+Janssen+%28Johnson+%26+Johnson%29+and+mRNA+COVID-19+vaccines+%28Pfizer-BioNTech+and+Moderna%29%3A+update+from+the+Advisory+Committee+on+Immunization+Practices%E2%80%94United+States%2C+July+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">31.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li>US Centers for Disease Control and Prevention<\/li>\n<\/ul>\n<div class=\"ref__title\">Interim clinical considerations.<\/div>\n<div class=\"citation-host\">\n<p><a href=\"https:\/\/www.cdc.gov\/vaccines\/covid-19\/clinical-considerations\/covid-19-vaccines-us.html\" target=\"_blank\" rel=\"noopener\">https:\/\/www.cdc.gov\/vaccines\/covid-19\/clinical-considerations\/covid-19-vaccines-us.html<\/a><\/p>\n<div>Date accessed:\u00a0July 14, 2021<\/div>\n<\/div>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib31\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar?hl=en&amp;q=US+Centers+for+Disease+Control+and+PreventionInterim+clinical+considerations.https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fcovid-19%2Fclinical-considerations%2Fcovid-19-vaccines-us.htmlDate+accessed%3A+July+14%2C+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">32.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Oster ME<\/li>\n<li class=\"ref__authors__name\">Shay DK<\/li>\n<li class=\"ref__authors__name\">Su JR<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">Myocarditis cases reported after mRNA-based COVID-19 vaccination in the US from December 2020 to August 2021.<\/div>\n<p><span class=\"ref__series\"><i>JAMA.<\/i>\u00a0<span class=\"ref__seriesDate\">2022;\u00a0<\/span><span class=\"ref__seriesVolume\">327<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">331-340<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib32\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=327&amp;publication_year=2022&amp;pages=331-340&amp;journal=JAMA&amp;author=Oster+ME&amp;author=Shay+DK&amp;author=Su+JR&amp;title=Myocarditis+cases+reported+after+mRNA-based+COVID-19+vaccination+in+the+US+from+December+2020+to+August+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">33.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Shimabukuro T<\/li>\n<\/ul>\n<div class=\"ref__title\">COVID-19 vaccine safety updates. Advisory Committee on Immunization Practices.<\/div>\n<div class=\"citation-host\">\n<p><a href=\"https:\/\/www.cdc.gov\/vaccines\/acip\/meetings\/downloads\/slides-2021-10-20-21\/06-COVID-Shimabukuro-508.pdf\" target=\"_blank\" rel=\"noopener\">https:\/\/www.cdc.gov\/vaccines\/acip\/meetings\/downloads\/slides-2021-10-20-21\/06-COVID-Shimabukuro-508.pdf<\/a><\/p>\n<div>Date:\u00a0Oct 21, 2021<\/div>\n<div>Date accessed:\u00a0January 11, 2022<\/div>\n<\/div>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib33\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;publication_year=Oct+21%2C+2021&amp;author=Shimabukuro+T&amp;title=COVID-19+vaccine+safety+updates.+Advisory+Committee+on+Immunization+Practices\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">34.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Menni C<\/li>\n<li class=\"ref__authors__name\">Klaser K<\/li>\n<li class=\"ref__authors__name\">May A<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study.<\/div>\n<p><span class=\"ref__series\"><i>Lancet Infect Dis.<\/i>\u00a0<span class=\"ref__seriesDate\">2021;\u00a0<\/span><span class=\"ref__seriesVolume\">21<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">939-949<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib34\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=21&amp;publication_year=2021&amp;pages=939-949&amp;journal=Lancet+Infect+Dis&amp;author=Menni+C&amp;author=Klaser+K&amp;author=May+A&amp;title=Vaccine+side-effects+and+SARS-CoV-2+infection+after+vaccination+in+users+of+the+COVID+Symptom+Study+app+in+the+UK%3A+a+prospective+observational+study\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">35.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Herv\u00e9 C<\/li>\n<li class=\"ref__authors__name\">Laup\u00e8ze B<\/li>\n<li class=\"ref__authors__name\">Del Giudice G<\/li>\n<li class=\"ref__authors__name\">Didierlaurent AM<\/li>\n<li class=\"ref__authors__name\">Tavares Da Silva F<\/li>\n<\/ul>\n<div class=\"ref__title\">The how&#8217;s and what&#8217;s of vaccine reactogenicity.<\/div>\n<p><span class=\"ref__series\"><i>NPJ Vaccines.<\/i>\u00a0<span class=\"ref__seriesDate\">2019;\u00a0<\/span><span class=\"ref__seriesVolume\">4<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">39<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib35\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=4&amp;publication_year=2019&amp;pages=39&amp;journal=NPJ+Vaccines&amp;author=Herv%C3%A9+C&amp;author=Laup%C3%A8ze+B&amp;author=Del+Giudice+G&amp;author=Didierlaurent+AM&amp;author=Tavares+Da+Silva+F&amp;title=The+how%27s+and+what%27s+of+vaccine+reactogenicity\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">36.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Zimmermann P<\/li>\n<li class=\"ref__authors__name\">Curtis N<\/li>\n<\/ul>\n<div class=\"ref__title\">Factors that influence the immune response to vaccination.<\/div>\n<p><span class=\"ref__series\"><i>Clin Microbiol Rev.<\/i>\u00a0<span class=\"ref__seriesDate\">2019;\u00a0<\/span><span class=\"ref__seriesVolume\">32<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">e00084-e00118<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib36\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=32&amp;publication_year=2019&amp;pages=e00084-e00118&amp;journal=Clin+Microbiol+Rev&amp;author=Zimmermann+P&amp;author=Curtis+N&amp;title=Factors+that+influence+the+immune+response+to+vaccination\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">37.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Klein SL<\/li>\n<li class=\"ref__authors__name\">Jedlicka A<\/li>\n<li class=\"ref__authors__name\">Pekosz A<\/li>\n<\/ul>\n<div class=\"ref__title\">The Xs and Y of immune responses to viral vaccines.<\/div>\n<p><span class=\"ref__series\"><i>Lancet Infect Dis.<\/i>\u00a0<span class=\"ref__seriesDate\">2010;\u00a0<\/span><span class=\"ref__seriesVolume\">10<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">338-349<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib37\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=10&amp;publication_year=2010&amp;pages=338-349&amp;journal=Lancet+Infect+Dis&amp;author=Klein+SL&amp;author=Jedlicka+A&amp;author=Pekosz+A&amp;title=The+Xs+and+Y+of+immune+responses+to+viral+vaccines\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">38.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Pathiravasan CH<\/li>\n<li class=\"ref__authors__name\">Zhang Y<\/li>\n<li class=\"ref__authors__name\">Trinquart L<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">Adherence of mobile app-based surveys and comparison with traditional surveys: eCohort study.<\/div>\n<p><span class=\"ref__series\"><i>J Med Internet Res.<\/i>\u00a0<span class=\"ref__seriesDate\">2021;\u00a0<\/span><span class=\"ref__seriesVolume\">23<\/span><\/span>e24773<\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib38\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=23&amp;publication_year=2021&amp;journal=J+Med+Internet+Res&amp;author=Pathiravasan+CH&amp;author=Zhang+Y&amp;author=Trinquart+L&amp;title=Adherence+of+mobile+app-based+surveys+and+comparison+with+traditional+surveys%3A+eCohort+study\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">39.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Guo X<\/li>\n<li class=\"ref__authors__name\">Vittinghoff E<\/li>\n<li class=\"ref__authors__name\">Olgin JE<\/li>\n<li class=\"ref__authors__name\">Marcus GM<\/li>\n<li class=\"ref__authors__name\">Pletcher MJ<\/li>\n<\/ul>\n<div class=\"ref__title\">Volunteer participation in the Health eHeart study: a comparison with the US population.<\/div>\n<p><span class=\"ref__series\"><i>Sci Rep.<\/i>\u00a0<span class=\"ref__seriesDate\">2017;\u00a0<\/span><span class=\"ref__seriesVolume\">7<\/span><\/span>1956<\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib39\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=7&amp;publication_year=2017&amp;journal=Sci+Rep&amp;author=Guo+X&amp;author=Vittinghoff+E&amp;author=Olgin+JE&amp;author=Marcus+GM&amp;author=Pletcher+MJ&amp;title=Volunteer+participation+in+the+Health+eHeart+study%3A+a+comparison+with+the+US+population\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">40.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Millar MM<\/li>\n<li class=\"ref__authors__name\">Elena JW<\/li>\n<li class=\"ref__authors__name\">Gallicchio L<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">The feasibility of web surveys for obtaining patient-reported outcomes from cancer survivors: a randomized experiment comparing survey modes and brochure enclosures.<\/div>\n<p><span class=\"ref__series\"><i>BMC Med Res Methodol.<\/i>\u00a0<span class=\"ref__seriesDate\">2019;\u00a0<\/span><span class=\"ref__seriesVolume\">19<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">208<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib40\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=19&amp;publication_year=2019&amp;pages=208&amp;journal=BMC+Med+Res+Methodol&amp;author=Millar+MM&amp;author=Elena+JW&amp;author=Gallicchio+L&amp;title=The+feasibility+of+web+surveys+for+obtaining+patient-reported+outcomes+from+cancer+survivors%3A+a+randomized+experiment+comparing+survey+modes+and+brochure+enclosures\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">41.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Messer BL<\/li>\n<li class=\"ref__authors__name\">Dillman DA<\/li>\n<\/ul>\n<div class=\"ref__title\">Surveying the general public over the internet using address-based sampling and mail contact procedures.<\/div>\n<p><span class=\"ref__series\"><i>Public Opin Q.<\/i>\u00a0<span class=\"ref__seriesDate\">2011;\u00a0<\/span><span class=\"ref__seriesVolume\">75<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">429-457<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib41\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=75&amp;publication_year=2011&amp;pages=429-457&amp;journal=Public+Opin+Q&amp;author=Messer+BL&amp;author=Dillman+DA&amp;title=Surveying+the+general+public+over+the+internet+using+address-based+sampling+and+mail+contact+procedures\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">42.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Liz Hamel L<\/li>\n<li class=\"ref__authors__name\">Lopes L<\/li>\n<li class=\"ref__authors__name\">Kearney A<\/li>\n<li class=\"ref__authors__name\">Sparks G<\/li>\n<li class=\"ref__authors__name\">Stokes M<\/li>\n<li class=\"ref__authors__name\">Brodie M<\/li>\n<\/ul>\n<div class=\"ref__title\">KFF COVID-19 Vaccine Monitor: June 2021.<\/div>\n<div class=\"citation-host\"><a href=\"https:\/\/www.kff.org\/coronavirus-covid-19\/poll-finding\/kff-covid-19-vaccine-monitor-april-2021\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.kff.org\/coronavirus-covid-19\/poll-finding\/kff-covid-19-vaccine-monitor-april-2021\/<\/a><\/div>\n<div class=\"citation-host\">\n<p><a href=\"https:\/\/www.kff.org\/coronavirus-covid-19\/poll-finding\/kff-covid-19-vaccine-monitor-june-2021\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.kff.org\/coronavirus-covid-19\/poll-finding\/kff-covid-19-vaccine-monitor-june-2021\/<\/a><\/p>\n<div>Date:\u00a0June 30, 2021<\/div>\n<div>Date accessed:\u00a0July 14, 2021<\/div>\n<\/div>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib42\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar?hl=en&amp;q=Liz+Hamel+L+Lopes+L+Kearney+A+Sparks+G+Stokes+M+Brodie+M+KFF+COVID-19+Vaccine+Monitor%3A+June+2021.https%3A%2F%2Fwww.kff.org%2Fcoronavirus-covid-19%2Fpoll-finding%2Fkff-covid-19-vaccine-monitor-april-2021%2Fhttps%3A%2F%2Fwww.kff.org%2Fcoronavirus-covid-19%2Fpoll-finding%2Fkff-covid-19-vaccine-monitor-june-2021%2FDate%3A+June+30%2C+2021Date+accessed%3A+July+14%2C+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">43.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li>The White House<\/li>\n<\/ul>\n<div class=\"ref__title\">FACT SHEET: President Biden to call on all employers to provide paid time off for employees to get vaccinated after meeting goal of 200 million shots in the first 100 days.<\/div>\n<div class=\"citation-host\">\n<p><a href=\"https:\/\/www.whitehouse.gov\/briefing-room\/statements-releases\/2021\/04\/21\/fact-sheet-president-biden-to-call-on-all-employers-to-provide-paid-time-off-for-employees-to-get-vaccinated-after-meeting-goal-of-200-million-shots-in-the-first-100-days\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.whitehouse.gov\/briefing-room\/statements-releases\/2021\/04\/21\/fact-sheet-president-biden-to-call-on-all-employers-to-provide-paid-time-off-for-employees-to-get-vaccinated-after-meeting-goal-of-200-million-shots-in-the-first-100-days\/<\/a><\/p>\n<div>Date:\u00a0April 21, 2021<\/div>\n<div>Date accessed:\u00a0May 1, 2021<\/div>\n<\/div>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib43\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;publication_year=April+21%2C+2021&amp;author=The+White+House&amp;title=FACT+SHEET%3A+President+Biden+to+call+on+all+employers+to+provide+paid+time+off+for+employees+to+get+vaccinated+after+meeting+goal+of+200+million+shots+in+the+first+100+days\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">44.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Moro PL<\/li>\n<li class=\"ref__authors__name\">Arana J<\/li>\n<li class=\"ref__authors__name\">Cano M<\/li>\n<li class=\"ref__authors__name\">Lewis P<\/li>\n<li class=\"ref__authors__name\">Shimabukuro TT<\/li>\n<\/ul>\n<div class=\"ref__title\">Deaths reported to the Vaccine Adverse Event Reporting System, United States, 1997\u20132013.<\/div>\n<p><span class=\"ref__series\"><i>Clin Infect Dis.<\/i>\u00a0<span class=\"ref__seriesDate\">2015;\u00a0<\/span><span class=\"ref__seriesVolume\">61<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">980-987<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib44\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=61&amp;publication_year=2015&amp;pages=980-987&amp;journal=Clin+Infect+Dis&amp;author=Moro+PL&amp;author=Arana+J&amp;author=Cano+M&amp;author=Lewis+P&amp;author=Shimabukuro+TT&amp;title=Deaths+reported+to+the+Vaccine+Adverse+Event+Reporting+System%2C+United+States%2C+1997%E2%80%932013\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">45.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Murphy SL<\/li>\n<li class=\"ref__authors__name\">Xu J<\/li>\n<li class=\"ref__authors__name\">Kochanek KD<\/li>\n<li class=\"ref__authors__name\">Arias E<\/li>\n<li class=\"ref__authors__name\">Tejada-Vera B<\/li>\n<\/ul>\n<div class=\"ref__title\">Deaths: final data for 2018.<\/div>\n<p><span class=\"ref__series\"><i>Natl Vital Stat Rep.<\/i>\u00a0<span class=\"ref__seriesDate\">2021;\u00a0<\/span><span class=\"ref__seriesVolume\">69<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">1-83<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib45\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=69&amp;publication_year=2021&amp;pages=1-83&amp;journal=Natl+Vital+Stat+Rep&amp;author=Murphy+SL&amp;author=Xu+J&amp;author=Kochanek+KD&amp;author=Arias+E&amp;author=Tejada-Vera+B&amp;title=Deaths%3A+final+data+for+2018\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">46.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li>US Centers for Disease Control and Prevention<\/li>\n<\/ul>\n<div class=\"ref__title\">About the Vaccine Adverse Event Reporting System (VAERS).<\/div>\n<div class=\"citation-host\">\n<p><a href=\"https:\/\/wonder.cdc.gov\/vaers.html\" target=\"_blank\" rel=\"noopener\">https:\/\/wonder.cdc.gov\/vaers.html<\/a><\/p>\n<div>Date accessed:\u00a0September 9, 2021<\/div>\n<\/div>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib46\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar?hl=en&amp;q=US+Centers+for+Disease+Control+and+PreventionAbout+the+Vaccine+Adverse+Event+Reporting+System+%28VAERS%29.https%3A%2F%2Fwonder.cdc.gov%2Fvaers.htmlDate+accessed%3A+September+9%2C+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">47.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li class=\"ref__authors__name\">Xu S<\/li>\n<li class=\"ref__authors__name\">Huang R<\/li>\n<li class=\"ref__authors__name\">Sy LS<\/li>\n<li>et al.<\/li>\n<\/ul>\n<div class=\"ref__title\">COVID-19 vaccination and non-COVID-19 mortality risk\u2014seven integrated health care organizations, United States, December 14, 2020\u2013July 31, 2021.<\/div>\n<p><span class=\"ref__series\"><i>Morb Mortal Wkly Rep.<\/i>\u00a0<span class=\"ref__seriesDate\">2021;\u00a0<\/span><span class=\"ref__seriesVolume\">70<\/span><\/span>:\u00a0<span class=\"ref__seriesPages\">1520-1524<\/span><\/p>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib47\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar_lookup?hl=en&amp;volume=70&amp;publication_year=2021&amp;pages=1520-1524&amp;journal=Morb+Mortal+Wkly+Rep&amp;author=Xu+S&amp;author=Huang+R&amp;author=Sy+LS&amp;title=COVID-19+vaccination+and+non-COVID-19+mortality+risk%E2%80%94seven+integrated+health+care+organizations%2C+United+States%2C+December+14%2C+2020%E2%80%93July+31%2C+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">48.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li>Vaccine Adverse Event Reporting System<\/li>\n<\/ul>\n<div class=\"ref__title\">Guide to interpreting VAERS data.<\/div>\n<div class=\"citation-host\">\n<p><a href=\"https:\/\/vaers.hhs.gov\/data\/dataguide.html\" target=\"_blank\" rel=\"noopener\">https:\/\/vaers.hhs.gov\/data\/dataguide.html<\/a><\/p>\n<div>Date accessed:\u00a0September 9, 2021<\/div>\n<\/div>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib48\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar?hl=en&amp;q=Vaccine+Adverse+Event+Reporting+SystemGuide+to+interpreting+VAERS+data.https%3A%2F%2Fvaers.hhs.gov%2Fdata%2Fdataguide.htmlDate+accessed%3A+September+9%2C+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li class=\"ref\"><span class=\"refLabel\">49.<\/span>\n<ul class=\"rlist inline-bullet-list ref__authors ref__inline-block\" title=\"list of authors\">\n<li>US Centers for Disease Control and Prevention<\/li>\n<\/ul>\n<div class=\"ref__title\">COVID-19 vaccines and vaccination.<\/div>\n<div class=\"citation-host\">\n<p><a href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/science\/science-briefs\/fully-vaccinated-people.html\" target=\"_blank\" rel=\"noopener\">https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/science\/science-briefs\/fully-vaccinated-people.html<\/a><\/p>\n<div>Date accessed:\u00a0September 9, 2021<\/div>\n<\/div>\n<div class=\"ref__controls\">\n<p><a class=\"ref__controls__viewInArticle scroll-into-link\" title=\"View in Article\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00054-8\/fulltext#back-bib49\">View in Article\u00a0<i class=\"icon-section_arrow_u\"><\/i><\/a><\/p>\n<ul class=\"rlist inline-bullet-list\">\n<li><a class=\"google-scholar\" href=\"http:\/\/scholar.google.com\/scholar?hl=en&amp;q=US+Centers+for+Disease+Control+and+PreventionCOVID-19+vaccines+and+vaccination.https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fscience%2Fscience-briefs%2Ffully-vaccinated-people.htmlDate+accessed%3A+September+9%2C+2021\">Google Scholar<\/a><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<\/ol>\n<\/section>\n<section class=\"article-info\">\n<h2 id=\"articleInformation\" class=\"top\">Article Info<\/h2>\n<section>\n<h3 class=\"publicationHistory__label\">Publication History<\/h3>\n<div class=\"article-info__dates\">\n<div class=\"article-info__date\">Published: March 07, 2022<\/div>\n<\/div>\n<\/section>\n<section>\n<h3>Identification<\/h3>\n<p>DOI:\u00a0<a href=\"https:\/\/doi.org\/10.1016\/S1473-3099(22)00054-8\">https:\/\/doi.org\/10.1016\/S1473-3099(22)00054-8<\/a><\/p>\n<\/section>\n<section>\n<h3>Copyright<\/h3>\n<div class=\"copyright\">Published by Elsevier Ltd.<\/div>\n<\/section>\n<section>\n<h3>ScienceDirect<\/h3>\n<p><a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S1473309922000548\">Access this article on ScienceDirect<\/a><\/p>\n<\/section>\n<\/section>\n<section>\n<h2 id=\"figures\" class=\"top\">Figures<\/h2>\n<ul class=\"figures rlist\">\n<li class=\"figures__thumbnail\">\n<div class=\"thumbnail__image thumbnail__image--img-ratio\">\n<div><img decoding=\"async\" class=\"b-lazy b-loaded ux-lazyloaded wide img-aspect-ratio-checked\" tabindex=\"0\" src=\"https:\/\/els-jbs-prod-cdn.jbs.elsevierhealth.com\/cms\/attachment\/dac7128f-0e51-4d7e-bc25-92ff270be37b\/gr1.jpg\" alt=\"Figure thumbnail gr1\" data-locator=\"fig1\" data-high-res=\"\/\/els-jbs-prod-cdn.jbs.elsevierhealth.com\/cms\/attachment\/36127908-3671-412d-b425-95e49b77a654\/gr1_lrg.jpg\" data-large-image=\"\/\/els-jbs-prod-cdn.jbs.elsevierhealth.com\/cms\/attachment\/dac7128f-0e51-4d7e-bc25-92ff270be37b\/gr1.jpg\" \/><\/div>\n<\/div>\n<div class=\"figure__title\"><span class=\"label figure__label\">Figure<\/span><span class=\"figure__title__text\">Local and systemic reactions to mRNA COVID-19 vaccines reported to v-safe, by manufacturer, dose, days after vaccination, and severity<\/span><\/div>\n<\/li>\n<\/ul>\n<\/section>\n<section class=\"table-list\">\n<h2 id=\"tables\" class=\"top\">Tables<\/h2>\n<ul class=\"tabels-list__wrapper rlist\">\n<li class=\"table-list__item\"><a href=\"https:\/\/www.thelancet.com\/action\/showFullTableHTML?isHtml=true&amp;tableId=tbl1&amp;pii=S1473-3099%2822%2900054-8\" target=\"_blank\" rel=\"noopener\"><span class=\"inline-table__label\">Table 1<\/span><span class=\"inline-table__title\">Characteristics of reports received and processed by VAERS for mRNA COVID-19 vaccines<\/span><\/a><\/li>\n<li class=\"table-list__item\"><a href=\"https:\/\/www.thelancet.com\/action\/showFullTableHTML?isHtml=true&amp;tableId=tbl2&amp;pii=S1473-3099%2822%2900054-8\" target=\"_blank\" rel=\"noopener\"><span class=\"inline-table__label\">Table 2<\/span><span class=\"inline-table__title\">Frequency and rates of adverse events of special interest reported to VAERS by recipients of mRNA COVID-19 vaccines<\/span><\/a><\/li>\n<li class=\"table-list__item\"><a href=\"https:\/\/www.thelancet.com\/action\/showFullTableHTML?isHtml=true&amp;tableId=tbl3&amp;pii=S1473-3099%2822%2900054-8\" target=\"_blank\" rel=\"noopener\"><span class=\"inline-table__label\">Table 3<\/span><span class=\"inline-table__title\">Frequency and rates of death reported to VAERS by recipients of mRNA COVID-19 vaccines, by sex and age group<\/span><\/a><\/li>\n<li class=\"table-list__item\"><a href=\"https:\/\/www.thelancet.com\/action\/showFullTableHTML?isHtml=true&amp;tableId=tbl4&amp;pii=S1473-3099%2822%2900054-8\" target=\"_blank\" rel=\"noopener\"><span class=\"inline-table__label\">Table 4<\/span><span class=\"inline-table__title\">Demographic characteristics of v-safe participants reporting receipt of an mRNA COVID-19 vaccine and completing at least one health survey 0\u20137 days after vaccination<\/span><\/a><\/li>\n<li class=\"table-list__item\"><a href=\"https:\/\/www.thelancet.com\/action\/showFullTableHTML?isHtml=true&amp;tableId=tbl5&amp;pii=S1473-3099%2822%2900054-8\" target=\"_blank\" rel=\"noopener\"><span class=\"inline-table__label\">Table 5<\/span><span class=\"inline-table__title\">Local and systemic reactions and health impacts following mRNA COVID-19 vaccines reported during days 0\u20137 after vaccination to v-safe, by manufacturer and dose<\/span><\/a><\/li>\n<\/ul>\n<\/section>\n<section data-widget-id=\"7c530872-6235-4433-899c-b3f276970189\" data-widget-name=\"UX3linkedContentList\">\n<h2 id=\"section-7c530872-6235-4433-899c-b3f276970189\" class=\"top\">Linked Articles<\/h2>\n<div class=\"section-paragraph linked-article\">\n<ul class=\"rlist\">\n<li class=\"linked-article__item\"><a class=\"linked-article__title link--underlined\" title=\"COVID-19 mRNA vaccine safety during the first 6 months of roll-out in the USA\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00123-2\/fulltext\">COVID-19 mRNA vaccine safety during the first 6 months of roll-out in the USA<\/a>\n<ul class=\"rlist rlist--inline linked-article__links clearfix\">\n<li class=\"bulleted preview-label\"><\/li>\n<li class=\"bulleted\"><a class=\"faded link--underlined\" title=\"Full-Text\" href=\"https:\/\/www.thelancet.com\/journals\/laninf\/article\/PIIS1473-3099(22)00123-2\/fulltext\">Full-Text\u00a0<\/a><\/li>\n<li class=\"bulleted\"><a class=\"link--underlined\" title=\"PDF\" href=\"https:\/\/www.thelancet.com\/pdfs\/journals\/laninf\/PIIS1473-3099(22)00123-2.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div>\n<\/section>\n","protected":false},"excerpt":{"rendered":"<p>Oh to those people pushing the vaxx because it &#8216;safe&#8217; or something? This is from The Lancet, which\u00a0is a weekly peer-reviewed general medical journal. Comment O&#8217; The Day (from a GP MD) 1% of those who had a reaction to the vaccine are dead. Sorry if that was not made clear. But remember the cut &hellip; <a href=\"https:\/\/milesfortis.com\/?p=78541\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;&#8221;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[62,64,41],"tags":[],"class_list":["post-78541","post","type-post","status-publish","format-standard","hentry","category-comment-o-the-day","category-deceit","category-health-medicine"],"_links":{"self":[{"href":"https:\/\/milesfortis.com\/index.php?rest_route=\/wp\/v2\/posts\/78541","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/milesfortis.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/milesfortis.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/milesfortis.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/milesfortis.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=78541"}],"version-history":[{"count":1,"href":"https:\/\/milesfortis.com\/index.php?rest_route=\/wp\/v2\/posts\/78541\/revisions"}],"predecessor-version":[{"id":78542,"href":"https:\/\/milesfortis.com\/index.php?rest_route=\/wp\/v2\/posts\/78541\/revisions\/78542"}],"wp:attachment":[{"href":"https:\/\/milesfortis.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=78541"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/milesfortis.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=78541"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/milesfortis.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=78541"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}