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      Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine — United States, December 21, 2020–January 10, 2021

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      CDC COVID-19 Response Team, Food and Drug Administration
      Morbidity and Mortality Weekly Report
      Centers for Disease Control and Prevention

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          Abstract

          As of January 20, 2021, a total of 24,135,690 cases of coronavirus disease 2019 (COVID-19) and 400,306 associated deaths had been reported in the United States (https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days). On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Moderna COVID-19 vaccine administered as 2 doses, 1 month apart to prevent COVID-19. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of Moderna COVID-19 vaccine ( 1 ). As of January 10, 2021, a reported 4,041,396 first doses of Moderna COVID-19 vaccine had been administered in the United States, and reports of 1,266 (0.03%) adverse events after receipt of Moderna COVID-19 vaccine were submitted to the Vaccine Adverse Event Reporting System (VAERS). Among these, 108 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that occurs rarely after vaccination, with onset typically within minutes to hours ( 2 ). Among these case reports, 10 cases were determined to be anaphylaxis (a rate of 2.5 anaphylaxis cases per million Moderna COVID-19 vaccine doses administered), including nine in persons with a documented history of allergies or allergic reactions, five of whom had a previous history of anaphylaxis. The median interval from vaccine receipt to symptom onset was 7.5 minutes (range = 1–45 minutes). Among eight persons with follow-up information available, all had recovered or been discharged home. Among the remaining case reports that were determined not to be anaphylaxis, 47 were assessed to be nonanaphylaxis allergic reactions, and 47 were considered nonallergic adverse events. For four case reports, investigators have been unable to obtain sufficient information to assess the likelihood of anaphylaxis. This report summarizes the clinical and epidemiologic characteristics of case reports of allergic reactions, including anaphylaxis and nonanaphylaxis allergic reactions, after receipt of the first dose of Moderna COVID-19 vaccine during December 21, 2020–January 10, 2021, in the United States. CDC has issued updated interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States ( 3 ) and interim considerations for preparing for the potential management of anaphylaxis ( 4 ). Using methods previously described ( 5 ), CDC and FDA identified reports of suspected anaphylaxis in VAERS, the national passive surveillance (i.e., spontaneous reporting) system for monitoring adverse events after immunization ( 6 ). CDC physicians screened VAERS reports describing suspected severe allergic reactions and anaphylaxis and applied Brighton Collaboration case definition criteria for anaphylaxis* ( 7 ). After initial screening, reports with sufficient evidence to suggest anaphylaxis were followed up by collecting information from medical records and through direct outreach to health care facilities and treating health care providers, and, in some cases, vaccine recipients. Physician reviewers classified all initially identified case reports as anaphylaxis or not anaphylaxis and used clinical judgment to further categorize reports that were considered not anaphylaxis as nonanaphylaxis allergic reactions or nonallergic adverse events. Nonallergic adverse events, mostly vasovagal (e.g., fainting or the sensation of fainting) or suspected anxiety-related, were excluded from the final analyses. Anaphylaxis and nonanaphylaxis allergic reaction cases with symptom onset occurring later than the day after vaccination (i.e., outside the 0–1-day risk window) were also excluded because of the difficulty in clearly attributing allergic reactions with onset later than this to vaccination. † During December 21, 2020–January 10, 2021, the administration of 4,041,396 first doses of Moderna COVID-19 vaccine (2,465,411 to females [61%], 1,450,966 to males [36%], and 125,019 to persons whose sex was not recorded [3%]) was reported to CDC. During the same period, reports of 1,266 (0.03%) adverse events after receipt of the first dose of Moderna COVID-19 vaccine had been submitted to VAERS. Among these, 108 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis, based on descriptions of signs and symptoms; 10 of these reports, all describing events in females, met the Brighton Collaboration case definition criteria for anaphylaxis (Table 1), corresponding to an initial estimated rate of 2.5 anaphylaxis cases per million first Moderna COVID-19 vaccine doses administered. The median age of persons with anaphylaxis was 47 years (range = 31–63 years). The median interval from vaccine receipt to symptom onset was 7.5 minutes (range = 1–45 minutes); nine patients had onset within 15 minutes, and one had onset after 30 minutes (Figure). In all 10 reports, patients received epinephrine as part of initial emergency treatment; the route of administration was confirmed or presumed to be intramuscular based on the description of treatment and the clinical course of the event as documented in the VAERS report. Six patients were hospitalized (including five in intensive care, four of whom required endotracheal intubation), and four were treated in an emergency department; eight patients with follow-up information available are known to have been discharged home or had recovered at the time of report to VAERS. No deaths from anaphylaxis were reported after receipt of Moderna COVID-19 vaccine. Nine of the 10 anaphylaxis case reports included a patient history of allergies or allergic reactions, including to drugs (six), contrast media (two), and foods (one); five patients had experienced an episode of anaphylaxis in the past, none of which was associated with receipt of a vaccine (Table 2). No geographic clustering of anaphylaxis cases was observed, and the cases occurred after receipt of doses from multiple vaccine lots. At the time of this publication, despite follow-up efforts, investigators have been unable to obtain sufficient information to assess the likelihood of anaphylaxis in four of the initial 108 suspected cases reported. TABLE 1 Characteristics of reported cases of anaphylaxis (n = 10) after receipt of the first dose of Moderna COVID-19 vaccine — Vaccine Adverse Events Reporting System (VAERS), United States, December 21, 2020–January 10, 2021 Age, yrs Sex Past history Onset after receipt (mins) Signs and symptoms Treatment setting† Epi received Brighton level§ Outcome or disposition¶ Allergies or allergic reactions* Previous anaphylaxis episode 37 F Penicillin, phenytoin, ibuprofen No 1 Respiratory failure, vomiting Inpatient Yes 2 Discharged home 39 F Penicillin, aloe Yes, penicillin 2 Decreased peripheral perfusion, persistent dry cough, nausea Inpatient Yes 3 Discharged home 63 F Acetaminophen, azithromycin No 4 Periorbital edema, nausea ED Yes 2 Not specified 55 F Multiple unspecified environmental and food allergies Yes, unspecified 5 Hypotension, wheezing Inpatient Yes 2 Not specified 31 F No No 5 Diffuse erythematous rash, throat swelling ED Yes 1 Discharged home 49 F Gadolinium, iodine Yes, gadolinium, iodine 10 Diffuse erythematous rash, tongue swelling, wheezing ED Yes 1 Recovered at time of report 37 F Unspecified intravenous contrast dye, penicillin Yes, intravenous contrast dye 11 Generalized urticarial rash, tongue swelling Inpatient Yes 1 Discharged home 50 F Unspecified allergies or allergic reactions Yes, unspecified 12 Diffuse erythematous rash, wheezing Inpatient Yes 1 Discharged home 57 F Multiple drugs including penicillin and sulfa No 13 Periorbital edema, tongue swelling ED Yes 1 Recovered at time of report 44 F Morphine, codeine No 45 Diffuse erythematous rash, marked tongue swelling Inpatient Yes 1 Discharged home Abbreviations: COVID-19 = coronavirus disease 2019; ED = emergency department; Epi = epinephrine; F = female. * As documented in the VAERS report or medical records, or through confirmation with the treating health care provider or the patients themselves. † Inpatient hospitalization. § The Brighton Collaboration case definition uses combinations of symptoms to define levels of diagnostic certainty. Brighton level 1 represents the highest level of diagnostic certainty that a reported case is indeed a case of anaphylaxis; levels 2 and 3 are successively lower levels of diagnostic certainty. Level 4 is a case reported as anaphylaxis but that does not meet the Brighton Collaboration case definition. Level 5 is a case that was neither reported as anaphylaxis nor meets the case definition (https://doi.org/10.1016/j.vaccine.2007.02.064). ¶ As documented in the description of the adverse event in the VAERS report in Box 18 or as documented in recovery status in Box 20. FIGURE Minutes from vaccine receipt to onset of anaphylaxis (A)* and nonanaphylaxis allergic reactions (B) † after receipt of the first dose of Moderna COVID-19 vaccine — Vaccine Adverse Events Reporting System (VAERS), United States, December 21, 2020–January 10, 2021 Abbreviation: COVID-19 = coronavirus disease 2019. * The interval from vaccine receipt to symptom onset was >30 minutes for one anaphylaxis case (45 minutes). † The interval from vaccine receipt to symptom onset was ≥60 minutes for three nonanaphylaxis patients who had a documented history of allergies or allergic reactions at 60, 90, and 98 minutes and for four who did not have a documented history of allergies or allergic reactions (60 minutes, 10 hours, 20 hours, and 24 hours). The interval from vaccine receipt to symptom onset was missing in two case reports, both of which documented a history of allergies or allergic reactions. Four cases of nonanaphylaxis allergic reactions with symptom onset occurring later than the day after vaccination (i.e., outside of the 0–1-day risk window) were excluded from the final analysis. The figure is two histograms showing minutes from vaccine receipt to onset of anaphylaxis (A) and nonanaphylaxis allergic reactions (B) after receipt of the first dose of Moderna COVID-19 vaccine, using data from the Vaccine Adverse Events Reporting System, in the United States, during December 21, 2020–January 10, 2021. TABLE 2 Characteristics of patients with reported anaphylaxis and nonanaphylaxis allergic reactions after receipt of the first dose of Moderna COVID-19 vaccine — Vaccine Adverse Events Reporting System (VAERS), United States, December 21, 2020–January 10, 2021 Characteristic Type of reported reaction, no. (%) Anaphylaxis (n = 10) Nonanaphylaxis allergic reactions (n = 43)* Median age, yrs (range) 47 (31–63) 43 (22–96) Female 10 (100) 39 (91) Minutes to symptom onset, median (range) 7.5 (1–45) 15 (<1–1,440 [24 hrs]) Symptom onset ≤15 mins 9 (90) 21 (51)† Symptom onset ≤30 mins 9 (90) 30 (73)† Documented history of allergies or allergic reactions 9 (90)§ 26 (60) Abbreviation: COVID-19 = coronavirus disease 2019. * Four of the initial 47 nonanaphylaxis allergic reaction reports were excluded from the final analysis because symptom onset occurred later than the day after vaccination (i.e., outside the 0–1-day risk window). † Two nonanaphylaxis allergic reaction reports were missing information on time of symptom onset; percentage calculated among 41 case reports with onset documented. § Five anaphylaxis reports included a patient history of a previous anaphylaxis episode. Among the 43 cases of nonanaphylaxis allergic reaction after receipt of Moderna COVID-19 vaccination with symptom onset within the 0–1-day risk window, 26 (60%) were classified as nonserious. § Commonly reported symptoms included pruritus, rash, itchy sensations in the mouth and throat, sensations of throat closure, and respiratory symptoms. The median patient age was 43 years (range = 22–96 years), and 39 (91%) of the reported reactions occurred in women. The median interval from vaccine receipt to symptom onset was 15 minutes (range = <1 minute–24 hours); in 30 (73%) cases, onset occurred within 30 minutes, in 11 cases, onset occurred after 30 minutes, and for two cases, time of onset was missing. For 26 (60%) case reports, a past history of allergies or allergic reactions, mostly to foods and drugs, was documented (Figure). Discussion Early safety monitoring of Moderna COVID-19 vaccine detected 10 cases of anaphylaxis after reported administration of 4,041,396 first doses of Moderna COVID-19 vaccine (2.5 cases per million Moderna COVID-19 vaccine doses administered) as well as cases of less severe nonanaphylaxis allergic reactions, based on U.S. data for December 21, 2020–January 10, 2021. Anaphylaxis is potentially life-threatening and requires immediate treatment ( 4 ). Based on this early monitoring, anaphylaxis after receipt of Moderna COVID-19 vaccine appears to be a rare event; however, comparisons of anaphylaxis risk with that associated with non–COVID-19 vaccines are constrained at this time by the limited data available this early in the COVID-19 vaccination program. A previous analysis of the Pfizer-BioNTech COVID-19 vaccine, also an mRNA vaccine, estimated an initial rate of 11.1 cases per million doses administered after receipt of the first dose of the Pfizer-BioNTech vaccine ( 5 ). CDC and FDA will continue enhanced monitoring for anaphylaxis among recipients of COVID-19 vaccines and will review case reports to VAERS. In nine of 10 cases of anaphylaxis after receipt of Moderna COVID-19 vaccine, patients had symptom onset within 30 minutes of vaccination, and nine anaphylaxis patients also had a history of allergies or allergic reactions, including some with previous anaphylaxis events; up to 30% of persons in the general population might have some type of allergy or history of allergic reactions. ¶ All 10 anaphylaxis cases reported after receipt of Moderna COVID-19 vaccine occurred in women. Whereas a previous review of anaphylaxis reports to VAERS found that 80% of cases reported in adults involved females ( 8 ), the current finding could be affected by the observation that more women than men had received a first dose of Moderna COVID-19 vaccine during the analytic period (61% of doses administered versus 36%, respectively). In a previous analysis of the Pfizer-BioNTech COVID-19 vaccine, two thirds of first doses were administered in women ( 5 ). The clinical and epidemiologic characteristics of anaphylaxis case reports after receipt of Moderna COVID-19 vaccine are similar to those reported after receipt of the Pfizer-BioNTech COVID-19 vaccine ( 5 ). For both vaccines, symptom onset after vaccination occurred quickly, usually within minutes. A strong female predominance of anaphylaxis case reports exists for both vaccines. Finally, many persons experiencing anaphylaxis after receiving either vaccine had a history of allergies or allergic reactions, with several having experienced an anaphylaxis episode in the past. Similar patient characteristics in case reports of nonanaphylaxis allergic reactions were observed among the two vaccines. The findings in this report are subject to at least two limitations. First, analyses of passive surveillance data include reporting biases, both underreporting because of lack of awareness or compliance with reporting requirements and reporting guidance, as well as stimulated reporting related to increased awareness from media or other public information sources. Second, incomplete information in reports and potential data lags because of processing times might result in an undercount of cases, and lags in reporting for vaccine doses administered might underestimate denominator data. However, reporting efficiency to VAERS for clinically severe adverse events is believed to be high ( 9 ). It is reasonable to expect that diagnosis and reporting of an acute and clinically severe condition such as anaphylaxis occurs relatively quickly, and VAERS is likely sensitive at capturing anaphylaxis cases occurring after COVID-19 vaccination. Mortality from COVID-19 in populations at increased risk for severe illness is substantial ( 10 ), and treatment options are limited. Widespread vaccination against COVID-19 with highly effective vaccines represents a critical tool in efforts to control the pandemic and save lives. CDC and FDA will continue to monitor for adverse events, including anaphylaxis, after administration of COVID-19 vaccines and will regularly assess the benefits and risks of vaccination in the context of the evolving epidemiology of the pandemic. Continued monitoring in VAERS and additional monitoring in population-based surveillance systems, such as the CDC’s Vaccine Safety Datalink (https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html), will help to further characterize the risk for anaphylaxis after administration of COVID-19 vaccines. CDC guidance on use of mRNA COVID-19 vaccines and management of anaphylaxis is available ( 3 , 4 ). Persons with an immediate allergic reaction to the first dose of an mRNA COVID-19 vaccine should not receive additional doses of either of the mRNA COVID-19 vaccines. In addition to screening for contraindications and precautions before administering COVID-19 vaccines, vaccine locations should have the necessary supplies and trained staff members available to manage anaphylaxis, implement postvaccination observation periods, immediately treat persons experiencing anaphylaxis signs and symptoms with intramuscular injection of epinephrine, and transport patients to facilities where they can receive advanced medical care. In addition, all patients should be instructed to seek immediate medical care if they develop signs or symptoms of an allergic reaction after their observation period ends and they have left the vaccination location. Health care providers can play an important role in vaccine safety monitoring by being vigilant in recognizing and reporting adverse events after immunization to VAERS at https://vaers.hhs.gov/reportevent.html. Summary What is already known about this topic? Anaphylaxis is a severe, life-threatening allergic reaction that occurs rarely after vaccination. What is added by this report? During December 21, 2020–January 10, 2021, monitoring by the Vaccine Adverse Event Reporting System detected 10 cases of anaphylaxis after administration of a reported 4,041,396 first doses of Moderna COVID-19 vaccine (2.5 cases per million doses administered). In nine cases, onset occurred within 15 minutes of vaccination. No anaphylaxis-related deaths were reported. What are the implications for public health practice? Locations administering COVID-19 vaccines should adhere to CDC guidance, including screening recipients for contraindications and precautions, having necessary supplies and staff members available to manage anaphylaxis, implementing recommended postvaccination observation periods, and immediately treating suspected anaphylaxis with intramuscular epinephrine injection.

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          Excess Deaths Associated with COVID-19, by Age and Race and Ethnicity — United States, January 26–October 3, 2020

          As of October 15, 216,025 deaths from coronavirus disease 2019 (COVID-19) have been reported in the United States*; however, this number might underestimate the total impact of the pandemic on mortality. Measures of excess deaths have been used to estimate the impact of public health pandemics or disasters, particularly when there are questions about underascertainment of deaths directly attributable to a given event or cause ( 1 – 6 ). † Excess deaths are defined as the number of persons who have died from all causes, in excess of the expected number of deaths for a given place and time. This report describes trends and demographic patterns in excess deaths during January 26–October 3, 2020. Expected numbers of deaths were estimated using overdispersed Poisson regression models with spline terms to account for seasonal patterns, using provisional mortality data from CDC’s National Vital Statistics System (NVSS) ( 7 ). Weekly numbers of deaths by age group and race/ethnicity were assessed to examine the difference between the weekly number of deaths occurring in 2020 and the average number occurring in the same week during 2015–2019 and the percentage change in 2020. Overall, an estimated 299,028 excess deaths have occurred in the United States from late January through October 3, 2020, with two thirds of these attributed to COVID-19. The largest percentage increases were seen among adults aged 25–44 years and among Hispanic or Latino (Hispanic) persons. These results provide information about the degree to which COVID-19 deaths might be underascertained and inform efforts to prevent mortality directly or indirectly associated with the COVID-19 pandemic, such as efforts to minimize disruptions to health care. Estimates of excess deaths can provide a comprehensive account of mortality related to the COVID-19 pandemic, including deaths that are directly or indirectly attributable to COVID-19. Estimates of the numbers of deaths directly attributable to COVID-19 might be limited by factors such as the availability and use of diagnostic testing (including postmortem testing) and the accurate and complete reporting of cause of death information on the death certificate. Excess death analyses are not subject to these limitations because they examine historical trends in all-cause mortality to determine the degree to which observed numbers of deaths differ from historical norms. In April 2020, CDC’s National Center for Health Statistics (NCHS) began publishing data on excess deaths associated with the COVID-19 pandemic ( 7 , 8 ). This report describes trends and demographic patterns in the number of excess deaths occurring in the United States from January 26, 2020, through October 3, 2020, and differences by age and race/ethnicity using provisional mortality data from the NVSS. § Excess deaths are typically defined as the number of persons who have died from all causes, in excess of the expected number of deaths for a given place and time. A detailed description of the methodology for estimating excess deaths has been described previously ( 7 ). Briefly, expected numbers of deaths are estimated using overdispersed Poisson regression models with spline terms to account for seasonal patterns. The average expected number, as well as the upper bound of the 95% prediction interval (the range of values likely to contain the value of a single new observation), are used as thresholds to determine the number of excess deaths (i.e., observed numbers above each threshold) and percentage excess (excess deaths divided by average expected number of deaths). Estimates described here refer to the number or percentage above the average; estimates above the upper bound threshold have been published elsewhere ( 7 ). Observed numbers of deaths are weighted to account for incomplete reporting by jurisdictions (50 states and the District of Columbia [DC]) in the most recent weeks, where the weights were estimated based on completeness of provisional data in the past year ( 7 ). Weekly NVSS data on excess deaths occurring from January 26 (the week ending February 1), 2020, through October 3, 2020, were used to quantify the number of excess deaths and the percentage excess for deaths from all causes and deaths from all causes excluding COVID-19. ¶ Deaths attributed to COVID-19 have the International Classification of Diseases, Tenth Revision code U07.1 as an underlying or contributing cause of death. Weekly numbers of deaths by age group (0–24, 25–44, 45–64, 65–74, 75–84, and ≥85 years) and race/ethnicity (Hispanic or Latino [Hispanic], non-Hispanic White [White], non-Hispanic Black or African American [Black], non-Hispanic Asian [Asian], non-Hispanic American Indian or Alaska Native [AI/AN], and other/unknown race/ethnicity, which included non-Hispanic Native Hawaiian or other Pacific Islander, non-Hispanic multiracial, and unknown) were used to examine the difference between the weekly number of deaths occurring in 2020 and the average number occurring in the same week during 2015–2019. These values were used to calculate an average percentage change in 2020 (i.e., above or below average compared with past years), over the period of analysis, by age group and race and Hispanic ethnicity. NVSS data in this report include all deaths occurring in the 50 states and DC and are not limited to U.S. residents. Approximately 0.2% of decedents overall are foreign residents. R statistical software (version 3.5.0; The R Foundation) was used to conduct all analyses. From January 26, 2020, through October 3, 2020, an estimated 299,028 more persons than expected have died in the United States.** Excess deaths reached their highest points to date during the weeks ending April 11 (40.4% excess) and August 8, 2020 (23.5% excess) (Figure 1). Two thirds of excess deaths during the analysis period (66.2%; 198,081) were attributed to COVID-19 and the remaining third to other causes †† (Figure 1). FIGURE 1 Weekly numbers of deaths from all causes and from all causes excluding COVID-19 relative to the average expected number and the upper bound of the 95% prediction interval (A), and the weekly and total numbers of deaths from all causes and from all causes excluding COVID-19 above the average expected number and the upper bound of the 95% prediction interval (B) — National Vital Statistics System, United States, January–September 2020 Abbreviation: COVID-19 = coronavirus disease 2019. The figure is a histogram, an epidemiologic curve showing the weekly numbers of deaths from all causes and from all causes excluding COVID-19 relative to the average expected number and the upper bound of the 95% prediction interval (A), and the weekly and total numbers of deaths from all causes and from all causes excluding COVID-19 above the average expected number and the upper bound of the 95% prediction interval (B), using data from the National Vital Statistics System, in United States, during January–September 2020. The total number of excess deaths (deaths above average levels) from January 26 through October 3 ranged from a low of approximately 841 in the youngest age group (<25 years) to a high of 94,646 among adults aged 75–84 years. §§ However, the average percentage change in deaths over this period compared with previous years was largest for adults aged 25–44 years (26.5%) (Figure 2). Overall, numbers of deaths among persons aged <25 years were 2.0% below average, ¶¶ and among adults aged 45–64, 65–74 years, 75–84, and ≥85 years were 14.4%, 24.1%, 21.5%, and 14.7% above average, respectively. FIGURE 2 Percentage change in the weekly number of deaths in 2020 relative to average numbers in the same weeks during 2015–2019, by age group — United States, 2015–2019 and 2020 The figure is a histogram, an epidemiologic curve showing the percentage change in the weekly number of deaths in 2020 relative to average numbers during the same weeks in 2015–2019, by age group, in the United States, during 2015–2019 and 2020. When examined by race and ethnicity, the total numbers of excess deaths during the analysis period ranged from a low of approximately 3,412 among AI/AN persons to a high of 171,491 among White persons. For White persons, deaths were 11.9% higher when compared to average numbers during 2015–2019. However, some racial and ethnic subgroups experienced disproportionately higher percentage increases in deaths (Figure 3). Specifically, the average percentage increase over this period was largest for Hispanic persons (53.6%). Deaths were 28.9% above average for AI/AN persons, 32.9% above average for Black persons, 34.6% above average for those of other or unknown race or ethnicity, and 36.6% above average for Asian persons. FIGURE 3 Percentage change in the weekly number of deaths in 2020 relative to average numbers in the same weeks during 2015–2019, by race and Hispanic ethnicity — United States, 2015–2019 and 2020 The figure is a histogram, an epidemiologic curve showing the percentage change in the weekly number of deaths in 2020 relative to average numbers in the same weeks during 2015–2019, by race and Hispanic ethnicity, in the United States, during 2015–2019 and 2020. Discussion Based on NVSS data, excess deaths have occurred every week in the United States since March 2020. An estimated 299,028 more persons than expected have died since January 26, 2020; approximately two thirds of these deaths were attributed to COVID-19. A recent analysis of excess deaths from March through July reported very similar findings, but that study did not include more recent data through September ( 5 ). Although more excess deaths have occurred among older age groups, relative to past years, adults aged 25–44 years have experienced the largest average percentage increase in the number of deaths from all causes from late January through October 3, 2020. The age distribution of COVID-19 deaths shifted toward younger age groups from May through August ( 9 ); however, these disproportionate increases might also be related to underlying trends in other causes of death. Future analyses might shed light on the extent to which increases among younger age groups are driven by COVID-19 or by other causes of death. Among racial and ethnic groups, the smallest average percentage increase in numbers of deaths compared with previous years occurred among White persons (11.9%) and the largest for Hispanic persons (53.6%), with intermediate increases (28.9%–36.6%) among AI/AN, Black, and Asian persons. These disproportionate increases among certain racial and ethnic groups are consistent with noted disparities in COVID-19 mortality.*** The findings in this report are subject to at least five limitations. First, the weighting of provisional NVSS mortality data might not fully account for reporting lags, particularly in recent weeks. Estimated numbers of deaths in the most recent weeks are likely underestimated and will increase as more data become available. Second, there is uncertainty associated with the models used to generate the expected numbers of deaths in a given week. A range of values for excess death estimates is provided elsewhere ( 7 ), but these ranges might not reflect all of the sources of uncertainty, such as the completeness of provisional data. Third, different methods or models for estimating the expected numbers of deaths might lead to different results. Estimates of the number or percentage of deaths above average levels by race/ethnicity and age reported here might not sum to the total numbers of excess deaths reported elsewhere, which might have been estimated using different methodologies. Fourth, using the average numbers of deaths from past years might underestimate the total expected numbers because of population growth or aging, or because of increasing trends in certain causes such as drug overdose mortality. Finally, estimates of excess deaths attributed to COVID-19 might underestimate the actual number directly attributable to COVID-19, because deaths from other causes might represent misclassified COVID-19–related deaths or deaths indirectly caused by the pandemic. Specifically, deaths from circulatory diseases, Alzheimer disease and dementia, and respiratory diseases have increased in 2020 relative to past years ( 7 ), and it is unclear to what extent these represent misclassified COVID-19 deaths or deaths indirectly related to the pandemic (e.g., because of disruptions in health care access or utilization). Despite these limitations, however, this report demonstrates important trends and demographic patterns in excess deaths that occurred during the COVID-19 pandemic. These results provide more information about deaths during the COVID-19 pandemic and inform public health messaging and mitigation efforts focused on the prevention of infection and mortality directly or indirectly associated with the COVID-19 pandemic and the elimination of health inequities. CDC continues to recommend the use of masks, frequent handwashing, and maintenance of social distancing to prevent COVID-19. ††† Summary What is already known about this topic? As of October 15, 216,025 deaths from COVID-19 have been reported in the United States; however, this might underestimate the total impact of the pandemic on mortality. What is added by this report? Overall, an estimated 299,028 excess deaths occurred from late January through October 3, 2020, with 198,081 (66%) excess deaths attributed to COVID-19. The largest percentage increases were seen among adults aged 25–44 years and among Hispanic or Latino persons. What are the implications for public health practice? These results inform efforts to prevent mortality directly or indirectly associated with the COVID-19 pandemic, such as efforts to minimize disruptions to health care.
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            Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14–23, 2020

            (2021)
            As of January 3, 2021, a total of 20,346,372 cases of coronavirus disease 2019 (COVID-19) and 349,246 associated deaths have been reported in the United States. Long-term sequalae of COVID-19 over the course of a lifetime currently are unknown; however, persistent symptoms and serious complications are being reported among COVID-19 survivors, including persons who initially experience a mild acute illness.* On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 vaccine to prevent COVID-19, administered as 2 doses separated by 21 days. On December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine ( 1 ); initial doses were recommended for health care personnel and long-term care facility residents ( 2 ). As of December 23, 2020, a reported 1,893,360 first doses of Pfizer-BioNTech COVID-19 vaccine had been administered in the United States, and reports of 4,393 (0.2%) adverse events after receipt of Pfizer BioNTech COVID-19 vaccine had been submitted to the Vaccine Adverse Event Reporting System (VAERS). Among these, 175 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that does occur rarely after vaccination, with onset typically within minutes to hours ( 3 ). Twenty-one cases were determined to be anaphylaxis (a rate of 11.1 per million doses administered), including 17 in persons with a documented history of allergies or allergic reactions, seven of whom had a history of anaphylaxis. The median interval from vaccine receipt to symptom onset was 13 minutes (range = 2–150 minutes). Among 20 persons with follow-up information available, all had recovered or been discharged home. Of the remaining case reports that were determined not to be anaphylaxis, 86 were judged to be nonanaphylaxis allergic reactions, and 61 were considered nonallergic adverse events. Seven case reports were still under investigation. This report summarizes the clinical and epidemiologic characteristics of case reports of allergic reactions, including anaphylaxis and nonanaphylaxis allergic reactions, after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine during December 14–23, 2020, in the United States. CDC has issued updated interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States ( 4 ) and interim considerations for preparing for the potential management of anaphylaxis ( 5 ). In addition to screening for contraindications and precautions before administering COVID-19 vaccines, vaccine locations should have the necessary supplies available to manage anaphylaxis, should implement postvaccination observation periods, and should immediately treat persons experiencing anaphylaxis signs and symptoms with intramuscular injection of epinephrine ( 4 , 5 ). CDC and FDA received notification of suspected anaphylaxis cases through multiple channels, including direct outreach by health care providers and public health officials and reports to VAERS, the national passive surveillance (spontaneous reporting) system for adverse events after immunization, which is jointly operated by CDC and FDA ( 6 ). All notifications of suspected anaphylaxis that came to the attention of CDC or FDA were also captured in VAERS. CDC physicians screened VAERS reports describing suspected severe allergic reactions and anaphylaxis and applied Brighton Collaboration case definition criteria ( 7 ), which use combinations of symptoms to define levels of diagnostic certainty to identify cases with sufficient evidence to warrant further assessment for anaphylaxis. Brighton level 1 represents the highest level of diagnostic certainty that a reported case is indeed a case of anaphylaxis; levels 2 and 3 represent successively lower levels of diagnostic certainty. Level 4 is a case reported as anaphylaxis but which does not meet the Brighton Collaboration case definition. Level 5 is a case that was neither reported as anaphylaxis nor meets the case definition. Reports with sufficient evidence to suggest anaphylaxis were followed up by direct outreach, including telephoning contacts listed in the VAERS report to gather additional clinical details (e.g., health care facilities and treating health care providers, and, in some cases, vaccine recipients) and collecting medical records. Physician reviewers also used their clinical judgment to categorize reports that were considered not anaphylaxis as nonanaphylaxis allergic reactions or nonallergic adverse events. Nonallergic adverse events, mostly vasovagal or anxiety-related, were excluded from the analysis. Anaphylaxis and nonanaphylaxis allergic reaction cases with symptom onset occurring later than the day after vaccination (i.e., outside of the 0–1-day risk window) were also excluded because of the difficulty in clearly attributing allergic reactions with onset later than this to vaccination. † CDC and FDA conducted joint review sessions to discuss and adjudicate cases. Because the FDA EUA for the Moderna COVID-19 vaccine was received 1 week later than that for the Pfizer-BioNTech vaccine (i.e., on December 18, 2020), and the Moderna vaccine was only available beginning December 21, this report focuses on the Pfizer-BioNTech COVID-19 vaccine. An assessment of adverse events reported after receipt of the Moderna COVID-19 vaccine will be forthcoming. During December 14–23, 2020, after administration of 1,893,360 first doses of Pfizer-BioNTech COVID-19 vaccine (1,177,527 doses in females, 648,327 doses in males, and 67,506 doses missing sex), reports of 4,393 (0.2%) adverse events after receipt of the vaccine had been submitted to VAERS. Among these, 175 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis, based on descriptions of signs and symptoms; 21 of these reports met the Brighton Collaboration case definition criteria for anaphylaxis, corresponding to an initial estimated rate of 11.1 cases per million doses administered. All reports were Brighton levels 1 or 2 (Table 1). The median age of persons with anaphylaxis was 40 years (range = 27–60 years), and 19 (90%) cases occurred in females. The median interval from vaccine receipt to symptom onset was 13 minutes (range = 2–150 minutes); 15 (71%) patients had onset within 15 minutes, three (14%) within 15 to 30 minutes, and three (14%) after 30 minutes (Figure). In 19 of 21 (90%) reports, patients were treated with epinephrine as part of therapy; one patient received subcutaneous epinephrine and the remaining 18 were confirmed or presumed to have received intramuscular epinephrine based on the report. Four (19%) patients were hospitalized (including three in intensive care), and 17 (81%) were treated in an emergency department; 20 (95%) are known to have been discharged home or had recovered at the time of report to VAERS. No deaths from anaphylaxis were reported after receipt of Pfizer-BioNTech COVID-19 vaccine. Seventeen (81%) of 21 patients with anaphylaxis had a documented history of allergies or allergic reactions, including to drugs or medical products, foods, and insect stings; seven (33%) patients had experienced an episode of anaphylaxis in the past, including one after receipt of a rabies vaccine and another after receipt of an influenza A(H1N1) vaccine (Table 2). No geographic clustering of anaphylaxis cases was observed, and the cases occurred after receipt of doses from multiple vaccine lots. At the time of this report, investigators have been unable to obtain sufficient information to confirm or rule out anaphylaxis in seven cases despite follow-up efforts; these cases remain under investigation. TABLE 1 Characteristics of reported cases of anaphylaxis (n = 21) after receipt of Pfizer-BioNTech COVID-19 vaccine — Vaccine Adverse Events Reporting System (VAERS), United States, December 14–23, 2020 Age (yrs) Sex Past history Onset after receipt (mins) Signs and symptoms Treatment setting† Epi received Brighton level§ Outcome or disposition¶ Allergies or allergic reactions* Anaphylaxis 27 F Tropical fruit No 2 Diffuse erythematous rash, sensation of throat closure ED Yes 2 Recovered at time of report 35 M No No 5 Diffuse erythematous rash, swollen tongue ED Yes 1 Discharged home 55 F Rabies vaccine Yes, rabies vaccine 5 Generalized urticaria, wheezing Inpatient Yes 1 Discharged home 52 F Sulfa drugs Yes, sulfa drugs 7 Wheezing, stridor, nausea Inpatient Yes 1 Discharged home 30 F Bee sting No 8 Generalized urticaria, wheezing Inpatient Yes 1 Recovered at time of report 32 F No No 10 Diffuse erythematous rash, difficulty breathing Inpatient Yes 2 Discharged home 60 F Eggs, milk, sulfa drugs, jellyfish sting Yes, jellyfish sting 10 Diffuse erythematous rash, hoarseness ED Yes 2 Recovered at time of report 29 F Shellfish, eggs No 10 Generalized urticaria, swollen lips and tongue ED Yes 1 Discharged home 52 F Metoprolol, clarithromycin No 10 Generalized urticaria, stridor, wheezing ED Yes 1 Recovered at time of report 49 F Iodinated contrast media No 13 Generalized urticaria, swollen throat ED Yes 1 Recovered at time of report 36 F No No 13 Generalized urticaria, nausea ED Yes 2 Not specified 40 F Sulfa drugs, walnuts Yes, walnuts 14 Generalized urticaria, nausea ED Yes 2 Discharged home 33 F Wasp sting No 15 Diffuse erythematous rash, swollen lip ED Yes 1 Recovered at time of report 41 F Prochlorperazine Yes, prochlorperazine 15 Diffuse erythematous rash, persistent dry cough ED No 2 Discharged home 57 F Penicillin, azithromycin Yes, unspecified 15 Diffuse pruritic rash, hoarseness ED Yes 2 Recovered at time of report 45 M No No 23 Generalized urticaria, swollen airway ED Yes 2 Discharged home 46 F Hydrocodone, nuts No 25 Diffuse erythematous rash, difficulty swallowing ED Yes 2 Discharged home 30 F Cats, dogs No 30 Generalized pruritis, wheezing ED No 2 Discharged home 44 F Influenza A(H1N1) vaccine Yes, influenza A(H1N1) vaccine 34 Generalized urticaria, swollen lips ED Yes 1 Discharged home 29 F Sulfa drugs No 54 Generalized urticaria, persistent cough ED Yes 2 Recovered at time of report 29 F Steroids No 150 Diffuse pruritic rash, swollen lip ED Yes 1 Discharged home Abbreviations: COVID-19 = coronavirus disease 2019; ED = emergency department; epi = epinephrine; F = female; M = male. * As documented in the VAERS report or medical records, or through confirmation with the treating health care provider or the patients themselves. † Inpatient = inpatient hospitalization. § The Brighton Collaboration case definition uses combinations of symptoms to define levels of diagnostic certainty. Brighton Level 1 represents the highest level of diagnostic certainty that a reported case is indeed a case of anaphylaxis; Levels 2 and 3 are successively lower levels of diagnostic certainty. Level 4 is a case reported as anaphylaxis but that does not meet the Brighton Collaboration case definition. Level 5 is a case that was neither reported as anaphylaxis nor meets the case definition (https://doi.org/10.1016/j.vaccine.2007.02.064). ¶ As documented in the description of the adverse event in the VAERS report in Box 18 or as document in recovery status in Box 20. FIGURE Interval (minutes) from vaccine receipt to onset of anaphylaxis (A)* and nonanaphylaxis allergic reactions (B) † after receipt of Pfizer-BioNTech COVID-19 vaccine — Vaccine Adverse Events Reporting System, United States, December 14–23, 2020 Abbreviation: COVID-19 = coronavirus disease 2019. * The interval from vaccine receipt to symptom onset was >30 minutes for three anaphylaxis cases (34, 54, and 150 minutes). † The interval from vaccine receipt to symptom onset was >60 minutes for three nonanaphylaxis patients who had a documented history of allergies or allergic reactions at 90, 96, and 180 minutes and for three who did not have a documented history of allergies or allergic reactions (105 minutes, 137 minutes, and 20 hours). Interval from vaccine receipt to symptom onset was missing for four patients with a history of allergies or allergic reactions and for seven without such history. Three cases of nonanaphylaxis allergic reactions with symptom onset occurring later than the day after vaccination (i.e., outside of the 0–1-day risk window) were excluded from the final analysis. The figure is a histogram showing the interval (minutes) from vaccine receipt to onset of anaphylaxis (A) and nonanaphylaxis allergic reactions (B) after receipt of Pfizer-BioNTech COVID-19 vaccine, using data from the Vaccine Adverse Events Reporting System, in the United States, during December 14–23, 2020. TABLE 2 Characteristics of patients with report of anaphylaxis and nonanaphylaxis allergic reactions after receipt of Pfizer-BioNTech COVID-19 vaccine — Vaccine Adverse Events Reporting System (VAERS), United States, December 14–23, 2020 Characteristic Type of reported reaction, no. (%) Anaphylaxis (n = 21) Nonanaphylaxis allergic reactions (n = 83)* Median age, yrs (range) 40 (27–60) 43 (18–65) Female 19 (90) 75 (90) Mins to symptom onset, median (range) 13 (2–150) 12 (<1–1,200 [20 hrs]) Symptom onset ≤15 mins 15 (71) 44 (61)† Symptom onset ≤30 mins 18 (86) 61 (85)† Documented history of allergies or allergic reactions 17 (81)§ 56 (67) Abbreviation: COVID-19 = coronavirus disease 2019. * Three of the initial 86 nonanaphylaxis allergic reaction reports were excluded from the final analysis because symptom onset occurred later than the day after vaccination (i.e., outside of the 0–1-day risk window). † Eleven reports were missing information on time of symptom onset; percentage calculated among 72 patients. § Seven anaphylaxis patients reported a history of a previous anaphylaxis episode, including one after receipt of rabies vaccine and one after receipt of influenza A(H1N1) vaccine. During the same period, VAERS identified 83 cases of nonanaphylaxis allergic reaction after Pfizer-BioNTech COVID-19 vaccination with symptom onset within the 0–1-day risk window, 72 (87%) of which were classified as nonserious. § Commonly reported symptoms included pruritus, rash, itchy and scratchy sensations in the throat, and mild respiratory symptoms. The median patient age was 43 years (range = 18–65 years), and 75 (90%) reported reactions occurred in women. The median interval from vaccine receipt to symptom onset was 12 minutes (range = <1 minute–20 hours); in 61 (85%) cases, onset occurred within 30 minutes, in 11 cases, onset occurred after 30 minutes, and for 11 cases, time of onset was missing. For 56 (67%) case reports, a past history of allergies or allergic reactions was documented (Table 2) (Figure). Discussion Early safety monitoring of the Pfizer-BioNTech COVID-19 vaccine has detected 21 cases of anaphylaxis after reported administration of 1,893,360 first doses of Pfizer-BioNTech COVID-19 vaccine (11.1 cases per million vaccine doses administered) as well as cases of less severe nonanaphylaxis allergic reactions, based on U.S. data for December 14–23, 2020. Most (86%) anaphylaxis cases had symptom onset within 30 minutes of vaccination, and most persons with anaphylaxis (81%) had a history of allergies or allergic reactions, including some with previous anaphylaxis events; up to 30% of persons in the general population might have some type of allergy or history of allergic reactions. ¶ Most (90%) reported anaphylaxis cases after receipt of Pfizer-BioNTech COVID-19 vaccine occurred in women, although 64% of the vaccine doses administered with sex of recipient recorded were given in women. Whereas a female predominance has been previously observed in a review of immediate hypersensitivity reports to VAERS after influenza A(H1N1) vaccine ( 8 ), the current finding could be impacted by the observation that more women than men had received a first dose of Pfizer-BioNTech COVID-19 vaccine during the analytic period. Anaphylaxis is potentially life-threatening and requires immediate treatment ( 5 ). Based on early safety monitoring, anaphylaxis after the Pfizer-BioNTech COVID-19 vaccine appears to be a rare event; however, comparisons of anaphylaxis risk with that associated with non-COVID-19 vaccines are constrained at this time by the limited data available this early in the COVID-19 vaccination program. CDC and FDA will continue enhanced monitoring for anaphylaxis among recipients of COVID-19 vaccines. The findings in this report are subject to at least four limitations. First, the anaphylaxis and nonanaphylaxis allergic reaction case reports were gathered through passive surveillance based on spontaneous reports to VAERS. Spontaneous reporting is subject to reporting biases (including underreporting); however, the reporting efficiency to VAERS for clinically severe adverse events is believed to be high ( 9 ). A second potential source of bias arises from stimulated reporting related to increased public and health care provider awareness of a potential safety concern. Thus, it is possible that intense media attention around the national COVID-19 vaccination program and heightened awareness of reports of anaphylaxis have affected vaccine recipient and health care provider behavior and practices, including elevated concern and anxiety, higher index of suspicion for anaphylaxis, and lower threshold for early treatment of suspected cases, thereby resulting in an increase in diagnosis of suspected anaphylaxis and corresponding stimulated above-baseline reporting to VAERS. Third, it is possible that data lags and incomplete reporting of vaccine doses administered might underestimate the denominator (doses administered) relative to the numerator (anaphylaxis cases). If anaphylaxis cases after receipt of COVID-19 vaccine are identified and reported faster than vaccine doses administered are reported, the anaphylaxis rate associated with vaccination might be overestimated. Finally, the focus on the Pfizer-BioNTech COVID-19 vaccine is a function of the timing of product availability and doses administered. Data on the Moderna vaccine, which became available a week later, were limited. Vaccination with Moderna COVID-19 vaccine commenced on December 21, 2020, and through December 23, 2020, an estimated 224,322 first doses of the vaccine had been administered; one report that met the Brighton Collaboration case definition criteria for anaphylaxis had been submitted to VAERS. Mortality from COVID-19 in populations at high risk is substantial ( 10 ), and treatment options are limited. Widespread vaccination against COVID-19 with highly effective vaccines represents an important tool in efforts to control the pandemic. CDC and FDA will continue to monitor for adverse events, including anaphylaxis, after receipt of COVID-19 vaccines and will regularly assess the benefits and risks of vaccination in the context of the evolving epidemiology of the pandemic. Continued monitoring in VAERS and additional monitoring in population-based surveillance systems, such as the CDC’s Vaccine Safety Datalink (https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html), will help to further characterize the risk for anaphylaxis after administration of COVID-19 vaccines. CDC guidance on use of mRNA COVID-19 vaccines and management of anaphylaxis is available ( 4 , 5 ). Specifically, vaccination locations should 1) ensure that necessary supplies are available to manage anaphylaxis, especially sufficient quantities of epinephrine in prefilled syringes or autoinjectors; 2) screen potential vaccine recipients to identify persons with contraindications and precautions ( 4 ); 3) implement recommended postvaccination observation periods, either 15 or 30 minutes depending on each patient’s previous history of allergic reactions; 4) ensure that health care providers can recognize the signs and symptoms of anaphylaxis early; and 5) immediately treat suspected anaphylaxis with intramuscular epinephrine; because of the acute, life-threatening nature of anaphylaxis, there are no contraindications to epinephrine administration. Patients experiencing anaphylaxis should be transported to facilities where they can receive appropriate medical care ( 5 ). All patients should be instructed to seek immediate medical care if they develop signs or symptoms of an allergic reaction after their observation period ends and they have left the vaccination location. Health care providers can play an important role in vaccine safety by being vigilant in recognizing and reporting adverse events after immunization to VAERS at https://vaers.hhs.gov/reportevent.html. Summary What is already known about this topic? Anaphylaxis is a severe, life-threatening allergic reaction that occurs rarely after vaccination. What is added by this report? During December 14–23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine (11.1 cases per million doses); 71% of these occurred within 15 minutes of vaccination. What are the implications for public health practice? Locations administering COVID-19 vaccines should adhere to CDC guidance for use of COVID-19 vaccines, including screening recipients for contraindications and precautions, having the necessary supplies available to manage anaphylaxis, implementing the recommended postvaccination observation periods, and immediately treating suspected cases of anaphylaxis with intramuscular injection of epinephrine.
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              Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).

              The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) conduct post-licensure vaccine safety monitoring using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous (or passive) reporting system. This means that after a vaccine is approved, CDC and FDA continue to monitor safety while it is distributed in the marketplace for use by collecting and analyzing spontaneous reports of adverse events that occur in persons following vaccination. Various methods and statistical techniques are used to analyze VAERS data, which CDC and FDA use to guide further safety evaluations and inform decisions around vaccine recommendations and regulatory action. VAERS data must be interpreted with caution due to the inherent limitations of passive surveillance. VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination. CDC makes VAERS data available to the public and readily accessible online. We describe fundamental vaccine safety concepts, provide an overview of VAERS for healthcare professionals who provide vaccinations and might want to report or better understand a vaccine adverse event, and explain how CDC and FDA analyze VAERS data. We also describe strengths and limitations, and address common misconceptions about VAERS. Information in this review will be helpful for healthcare professionals counseling patients, parents, and others on vaccine safety and benefit-risk balance of vaccination.
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                Author and article information

                Journal
                MMWR Morb Mortal Wkly Rep
                MMWR Morb Mortal Wkly Rep
                WR
                Morbidity and Mortality Weekly Report
                Centers for Disease Control and Prevention
                0149-2195
                1545-861X
                29 January 2021
                29 January 2021
                : 70
                : 4
                : 125-129
                Author notes
                Corresponding author: Tom Shimabukuro, TShimabukuro@ 123456cdc.gov .
                Article
                mm7004e1
                10.15585/mmwr.mm7004e1
                7842812
                33507892
                d8ca92dd-0122-4e67-bcd6-ac4ef7832cd0

                All material in the MMWR Series is in the public domain and may be used and reprinted without permission; citation as to source, however, is appreciated.

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