National Center for Immunization & Respiratory Diseases

COVID-19 vaccine safety update

Advisory Committee on Immunization Practices (ACIP)

January 27, 2021

Tom Shimabukuro, MD, MPH, MBA

CDC COVID-19 Vaccine Task Force 

Vaccine Safety Team
Disclaimer

▪ The findings and conclusions in this report are those of the authors and 

do not necessarily represent the official position of the Centers for 

Disease Control and Prevention (CDC) or the U.S. Food and Drug 

Administration (FDA)

▪ Mention of a product or company name is for identification purposes 

only and does not constitute endorsement by the CDC or FDA
Topics 

▪ V-safe update

▪ Vaccine Adverse Event Reporting System (VAERS) surveillance update

▪ Clinical Immunization Safety Assessment (CISA) Project update

▪ Vaccine Safety Datalink (VSD) surveillance update

▪ Update on anaphylaxis following COVID-19 vaccination

▪ Reports of deaths and mortality following COVID-19 vaccination

3

This Photo by Unknown Author is licensed under CC BY-SA

Call center

This Photo by Unknown Author is licensed under CC BY-SA

Vaccine recipient 

1. Text message check-ins from CDC (daily 1st week; 

weekly thru 6 weeks; then 3, 6, and 12 mo.)

Vaccine recipient completes web survey

2. Clinically 

important 

event(s) 

reported

3. A VAERS customer service representative 

conducts active telephone follow-up on a 

medically attended health impact event 

and takes a report if appropriate

✓ Received 

medical care
Summary of v-safe data

Pfizer-BioNTech Moderna All COVID-19 

vaccines 

People receiving 1 or more 

doses in the United States* 12,153,536 9,689,497 21,843,033

Registrants completing at least 

1 v-safe health check-in† 997,042 1,083,174 2,080,216

Pregnancies reported to v-safe 8,633 6,498 15,131

* COVID Data Tracker data as of 1/24/2021

† v-safe data as of 1/20/2021, 5:00 AM ET

6
Reactogenicity reported to v-safe

Local and systemic 

reactions, day 0-7*,†

All vaccines

%

Pfizer- BioNTech

dose 1 %

Pfizer-BioNtech

dose 2 %

Moderna

dose 1 %

Pain 70.7 67.7 74.8 70.1

Fatigue 33.4 28.6 50.0 29.7

Headache 29.4 25.6 41.9 26.0

Myalgia 22.8 17.2 41.6 19.6

Chills 11.5 7.0 26.7 9.3

Fever 11.4 7.4 25.2 9.1

Swelling 11.0 6.8 26.7 13.4

Joint pain 10.4 7.1 21.2 8.6

Nausea 8.9 7.0 13.9 7.7

* v-safe data lock point 1/14/2021, 5:00 AM ET

† Reported on at least one health check-in completed on days 0-7 after receipt of vaccine

7
Reactogenicity reported to v-safe

Local and systemic 

reactions, day 0-7*,†

All vaccines

%

Pfizer-BioNTech

dose 1 %

Pfizer-BioNtech

dose 2 %

Moderna

dose 1 %

Pain 70.7 67.7 74.8 70.1

Fatigue 33.4 28.6 50.0 29.7

Headache 29.4 25.6 41.9 26.0

Myalgia 22.8 17.2 41.6 19.6

Chills 11.5 7.0 26.7 9.3

Fever 11.4 7.4 25.2 9.1

Swelling 11.0 6.8 26.7 13.4

Joint pain 10.4 7.1 21.2 8.6

Nausea 8.9 7.0 13.9 7.7

* v-safe data lock point 1/14/2021, 5:00 AM ET

† Reported on at least one health check-in completed on days 0-7 after receipt of vaccine

8
Reactogenicity reported to v-safe

Local and systemic 

reactions, day 0-7

*,†

All vaccines

%

Pfizer-BioNTech

dose 1 %

Pfizer-BioNtech

dose 2 %

Moderna

dose 1 %

Pain 70.7 67.7 74.8 70.1

Fatigue 33.4 28.6 50.0 29.7

Headache 29.4 25.6 41.9 26.0

Myalgia 22.8 17.2 41.6 19.6

Chills 11.5 7.0 26.7 9.3

Fever 11.4 7.4 25.2 9.1

Swelling 11.0 6.8 26.7 13.4

Joint pain 10.4 7.1 21.2 8.6

Nausea 8.9 7.0 13.9 7.7

* v-safe data lock point 1/14/2021, 5 AM ET

† Reported on at least one health check-in completed on days 0-7 after receipt of vaccine

9
Active COVID-19 vaccine safety surveillance in v-safe

▪ Follow-up phone calls ongoing to v-safe participants who 

report medically attended health impact events 

▪ Pregnancy registry

– 227 pregnancies enrolled as of January 22, 2021
+

co-managed by

CDC and FDA

Vaccine Adverse Event 

Reporting System

http://vaers.hhs.gov

VAERS is the nation’s early warning system for vaccine safety
Vaccine Adverse Event Reporting System (VAERS)

Strengths

▪

▪

▪

▪

National data 

Rapidly detects safety signals 

Can detect rare adverse events

Data available to public

Limitations

▪

▪

▪

▪

Reporting bias 

Inconsistent data quality and 

completeness of information

Lack of unvaccinated comparison group

Not designed to assess causality

‒

‒

VAERS accepts all reports from everyone regardless of the plausibility of the 

vaccine causing the event or the clinical seriousness of the event

As a hypothesis generating system, VAERS identifies potential vaccine safety 

concerns that can be studied in more robust data systems
Reports to VAERS after COVID-19 vaccines*

Vaccine N

Non-serious 

AEs (%)

Serious 

AEs†(%)

Median age in 

years (range) Female (%)

Moderna 1,786 1,396 (78) 390 (22) 43 (15–102) 1,361 (76)

Pfizer-BioNTech 7,307 6,719 (92) 588 (8) 43 (17–104) 5,628 (77)

Unknown vaccine 3 2 (67) 1 (33) 58 (49–93) 3 (100)

Total 9,096 8,117 (89) 979 (11) 43 (15–104) 6,992 (77)

* Reports received through January 18, 2021

† Based on the Code of Federal Regulations if one of the following is reported: death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, congenital anomaly or birth defect

▪ Reporting rates: Non-serious AEs 372 reports per million doses administered

Serious AEs 45 reports per million doses administered
Most commonly reported adverse events to VAERS 

after COVID-19 vaccines*

Pfizer-BioNTech COVID-19 vaccine (N = 7,307)

* Reports received through January 18, 2021; †Adverse events are not mutually exclusive

Adverse event† N (%)

Headache 1,550 (21.2)

Fatigue 1,192 (16.3)

Dizziness 1,113 (15.2)

Nausea 1,014 (13.9)

Chills 983 (13.5)

Pyrexia 962 (13.2)

Pain 958 (13.1)

Injection Site Pain 716 (9.8)

Pain In Extremity 610 (8.4)

Dyspnoea 536 (7.3)

Adverse event† N (%)

Headache 430 (24.1)

Pyrexia 333 (18.6)

Chills 315 (17.6) 

Pain 290 (16.2) 

Dizziness 289 (16.2) 

Fatigue 287 (16.1) 

Nausea 281 (15.7) 

Injection Site Pain 208 (11.6) 

Pain In Extremity 189 (10.6) 

Dyspnoea 172 (9.6) 

Moderna COVID-19 vaccine (N = 1,786)
Empirical Bayesian data mining in VAERS 

▪ FDA uses data mining to identify disproportional adverse event reporting for 

vaccines, including COVID-19 vaccines

–

–

Identifies, with a high degree of confidence, adverse event-vaccine pairs reported 

at least twice as frequently as expected for a COVID-19 vaccine compared to the 

VAERS database

i.e., lower bound of the 90% confidence interval surrounding the empirical 

Bayesian geometric mean (EB05 ≥2) compared to all other U.S.-licensed vaccines

▪ No empirical Bayesian data mining alerts (EB05 ≥2) detected for any adverse 

event-COVID-19 vaccine pairs (most recent [January 22, 2021] weekly results)
7 participating medical 

research centers with 

vaccine safety experts

†More information about clinical consults available at: 

http://www.cdc.gov/vaccinesafety/Activities/CISA.html

CISA 

Clinical

Immunization

Safety

Assessment 

(CISA) Project 

▪ clinical consult services†

▪ clinical research
CISA Project COVIDvax

▪ Extension of CDC’s CISA* Project’s clinical consultation service for U.S. 

healthcare providers and health departments for complex COVID-19 vaccine 

safety questions/issues that are** 

– (1) about an individual patient(s) residing in the United States

– (2) not readily addressed by CDC or ACIP guidelines 

▪ Vaccine safety subject matter expertise in multiple specialties (e.g., infectious 

diseases, allergy/immunology, neurology, OB/GYN, pediatrics, geriatrics) 

▪ Requests for a CISA consult about COVID-19 vaccine safety:

– Contact CDC-INFO: 800-CDC-INFO (800-232-4636) or webform 

– Indicate the request is for a “CDC CISA”* consult (no patient identifiers)

* https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html

**Advice from CDC and CISA is meant to assist in decision-making, rather than provide direct patient management 17
CISA Project contributions

▪ Responded to 143 clinical inquiries or consultation requests about COVID-19 

vaccine safety*

▪ Assisted state health departments with evaluation of complex medical 

issues pertaining to COVID-19 vaccines safety 

▪ Convened CISA Project workgroup with allergy/immunology specialists

– Provided input for CDC’s guidance on clinical considerations for use of the mRNA COVID-19 

vaccines and how to prepare for managing anaphylaxis after vaccination

– Contributed to MMWRs on anaphylaxis/allergic reactions after 1st dose of Pfizer-BioNTech

and Moderna COVID-19 vaccines

– Ongoing work to investigate possible mechanism for anaphylaxis, in collaboration with 

FDA, NIH and other partners 

*Since December 14, 2020 – January 24, 2021 18
VSD

Vaccine

Safety

Datalink

9 participating integrated healthcare organizations

data on over 12 million persons per year
Types of information in VSD

Images created by Wilson Joseph, Megan Mitchell, Ananth, and Iga from the noun project

birth and death 

certificate 

information & 

family linkage

immunization 

enrollment and records

demographics

linked by 

study IDs

outpatient and 

clinic visits

emergency room 

visits

procedure codes hospital discharge 

diagnosis codes

charts and 

electronic 

health records
VSD Rapid Cycle Analysis (RCA) aims

▪ Monitor the safety of COVID-19 vaccines weekly using 

pre-specified outcomes of interest among VSD members

▪ Assess each pre-specified outcome for a 1-21 and 1-42 

day risk interval

▪ Describe the uptake of COVID-19 vaccines over time 

among eligible VSD members
VSD COVID-19 vaccine totals through Jan 16, 2021
VSD COVID-19 vaccine totals through Jan 16, 2021
VSD RCA outcomes for COVID-19 vaccines Concurrent 

comparator

Risk 

interval

Events in

vaccinated

Events in

unvaccinated

Signal

(Y/N)

Acute disseminated encephalomyelitis Unvaccinated 1-21 days 0 0 N

Acute myocardial infarction Unvaccinated 1-21 days 1 179 N

Acute respiratory distress syndrome Unvaccinated 1-21 days 0 4 N

Anaphylaxis Unvaccinated 0-1 days 0 8 N

Appendicitis Unvaccinated 1-21 days 5 267 N

Bell’s palsy Unvaccinated 1-21 days 4 358 N

Convulsions / seizures Unvaccinated 1-21 days 0 39 N

Disseminated intravascular coagulation Unvaccinated 1-21 days 0 14 N

Encephalitis / myelitis / encephalomyelitis Unvaccinated 1-21 days 0 6 N

Guillain-Barré syndrome Unvaccinated 1-21 days 0 4 N

Thrombotic thrombocytopenic purpura Unvaccinated 1-21 days 0 4 N

Immune thrombocytopenia Unvaccinated 1-21 days 0 21 N

Kawasaki disease Unvaccinated 1-21 days 0 1 N

MIS-C and MIS-A Unvaccinated NA 0 NA N

Myocarditis / pericarditis Unvaccinated 1-21 days 0 12 N

Narcolepsy and cataplexy Unvaccinated N/A 0 8 N

Stroke, hemorrhagic Unvaccinated 1-21 days 1 85 N

Stroke, ischemic Unvaccinated 1-21 days 0 197 N

Transverse myelitis Unvaccinated 1-21 days 0 0 N

Venous thromboembolism Unvaccinated 1-21 days 3 408 N

Pulmonary embolism (subset of VTE) Unvaccinated 1-21 days 0 132 N

▪ Preliminary results 

of VSD unvaccinated 

concurrent 

comparator analyses 

for COVID-19 

vaccine safety

▪ No signals as of 

January 16
VSD RCA next steps – next analyses

▪ Vaccinated concurrent comparator analysis

ꟷ Start when informative comparator follow-up available (expected within a week)

▪ Dose 1, Dose 2 analysis for each vaccine

ꟷ Both the 1-21 and 1-42 day risk intervals

▪ Historical comparator analysis

ꟷ General age comparable background rates

ꟷ Rates following well care visits among those that received influenza vaccine in 

the past 18 months

ꟷ Planning to start in mid-March
Update on anaphylaxis following 

COVID-19 vaccine
Anaphylaxis reports to VAERS following COVID-19 vaccines

▪ Suspected anaphylaxis reports to VAERS through January 18, 2021 

– Detected through early screening to identify suspected anaphylaxis reports 

prior to formal processing and MedDRA coding

– Detected through a MedDRA code search strategy after formal processing 

and coding

▪ Suspected anaphylaxis reports were assessed by physicians at CDC who 

conducted medical record review and additional follow-up if necessary

▪ Cases were classified according to the Brighton Collaboration case 

definition criteria*(Brighton Levels 1, 2, and 3 are cases, 4 and 5 are not)

▪ CDC and FDA met to discuss and further adjudicate cases if necessary

* Rüggeberg et al.; Brighton Collaboration Anaphylaxis Working Group. Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation 

of immunization safety data. Vaccine. 2007;25(31):5675-84. 
Anaphylaxis reports to VAERS following COVID-19 vaccines*

Characteristics

Pfizer-BioNTech

(N = 50)

Moderna

(N = 21)

Median age, years (range) 38.5 (26–63) 39 (24–63)

Female (%) 47 (94) 21 (100)

Minutes to symptom onset, median (range) 10 (<1–1200 [20 hr])† 10 (<1-45)

Symptom onset ≤15 minutes (%) 37 (74) 18 (86)

Symptom onset ≤30 minutes (%) 45 (90) 19 (90)

Documented h/o of allergies or allergic rxns (%) 40 (80) 18 (86)

Documented h/o of prior anaphylaxis (%) 12 (24) 5 (24)

Dose number (1st, 2nd, unknown) 42, 3, 5 19, 1, 1

* Reports received through January 18, 2021; Includes case reports that met Brighton Collaboration case definition criteria for anaphylaxis at Levels 1, 2, or 3

†20 hour onset was an outlier, the remaining onset for cases with onset >30 minutes were 34, 54, 90, and 150 minutes

▪ Common allergies and allergic reactions included to drugs and foods

▪ Anaphylaxis cases occurred following drugs, foods, contrast media, vaccines, insect stings, unspecified
Data through January 18, 2021
Estimated anaphylaxis reporting rates following COVID-19 vaccines 

based on VAERS reports and reported doses administered*

Reported vaccine doses 

administered

Anaphylaxis 

cases

Reporting rate 

(analytic period Dec 14-Jan 18)

Pfizer-BioNTech: 9,943,247 50 5.0 per million doses admin.

Moderna: 7,581,429 21 2.8 per million doses admin.

* Data through January 18, 2021

▪ Total COVID-19 vaccine doses administered thru Jan 18 by sex: Female 61%, Male 36%, Unk 3%

▪ Previously reported rate for Pfizer-BioNTech vaccine: 11.1 per million doses admin (Dec 14-Dec 23) 

https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm

▪ Previously reported rate for Moderna vaccine: 2.5 per million doses admin (Dec 21-Jan 10) 

https://www.cdc.gov/mmwr/volumes/70/wr/mm7004e1.htm
Reports of deaths and mortality 

following COVID-19 vaccination
Processing and follow-up on reports of death to VAERS

▪ Upon receipt or notification of a reported death after COVID-19 vaccine,*the 

VAERS contractor:

– Expedites processing of the report (processed the day of report)

– Contacts the reporter for additional information (medical records, death 

certificate, autopsy report, etc.)

– Notifies state Vaccine Safety Coordinator (VSC) of the death and provides 

copy of the initial report to the VSC via Epi-X

▪ Physicians in the CDC’s Immunization Safety Office and at FDA review all reports 

of death following COVID-19 vaccination as soon as notified in the daily VAERS 

priority report and make an assessment if any immediate action is necessary

▪ Attempts (multiple if necessary) are made to obtain death certificates and 

autopsy reports, when an autopsy is conducted, to ascertain cause of death

* A similar process occurs for reports of death following influenza vaccine
Reports of deaths (due to any cause) following COVID-19 

vaccination to VAERS*(N = 196)

* Data through January 18, 2021

Characteristics

Reports of death

(N = 196)

Median age, years (range) 79 (25–104)

Age <65 years (%) 43 (22)

Female (%) 91 (46)

Long-term care facility (LTCF) resident (%) 129 (66)

Pfizer-BioNTech vaccine 113

Moderna vaccine 83

▪ These reports of death to VAERS involve temporally associated deaths following vaccination 

due to any cause; adverse event reports to VAERS, including deaths, should not be assumed to 

be causally related to vaccination 
Reports of death following COVID-19 vaccination: 

Background mortality in long-term care facility 

(LTCF) residents 
Estimated background mortality in LTCF residents

▪ Estimated 2 million COVID-19 vaccine doses administered in LTCFs through 

January 18, 2021 (CDC COVID Data Tracker)

– Assume 65% administered to LTCF residents (1.3 million residents)

– Assume a 22% annual mortality rate*(n = 286,000)

▪ Risk period

– Assume December 21 was when vaccinations commenced in LTCFs

– Therefore, risk period=29 days (December 21-January 18)

– Assume each resident contributes 14.5 person-days (~ mid-point of risk period)

– 14.5 days = 4% of a calendar year

* Thomas et al, J Gerontol A Biol Sci Med Sci, 2019, Vol. 74, 219–225
Estimated background mortality in LTCF residents (cont.)

▪ Among 1.3 million LTCF residents (2M x 65%) vaccinated over the 29-

day risk period (December 21-January 18)

– Expect 11,440 deaths among LTCF residents (= 286,000*4%) 

following vaccination

▪ By comparison, VAERS received 129 reports of deaths following COVID19 vaccination in LTCF residents through January 18, 2021

▪ Mortality in LTCF residents is high and substantial numbers of deaths in 

this population will occur following vaccination as temporallyassociated coincidental events
Genesis Healthcare analysis

This research was supported, in part, by a grant from the National Institute on Aging [5U54AG063546-02S5] with supplemental 

funding from the Centers for Disease Control and Prevention (CDC) under an inter-agency agreement.
Vaccine Safety Monitoring 

among Residents of 284 Genesis 

Skilled Nursing Facilities

On behalf of: Barbara Bardenheier, PhD, MPH, MA

Assistant Professor of Health Services, Policy, and Practice 

Assistant Professor of Epidemiology

Brown University School of Public Health
Background

▪ Genesis Healthcare is the largest nursing home company in the 

United States, spanning 24 states

– Analysis included Skilled Nursing Facilities (284 Facilities with about 

25,000 residents)

▪ COVID-19 vaccination began on December 18, 2021

– By December 31, first dose of vaccine was administered in 118 facilities 

among 7,006 residents (61.4% in those facilities) 

▪ Assessed 7-day mortality rates among the vaccinated and 

unvaccinated residents in 118 facilities as well as 17,076 residents in 

the 166 facilities that started vaccinating after January 1, 2021

39
Results

▪ After excluding residents with a positive SARS-CoV-2 

diagnostic test within 20 days prior to their 7-day 

observation window

– Mortality was lower among vaccinated versus unvaccinated 

residents within the same facilities and compared to 

residents in not-yet-vaccinated facilities, with overlapping 

95% confidence intervals

40
Conclusions

▪ Findings suggest that short term mortality rates appear 

unrelated to vaccination for COVID-19 in skilled nursing 

facility residents

▪ This study underscores the value of having an analytic 

infrastructure to support near real-time monitoring of 

adverse events and safety during rapid vaccine 

deployment in this vulnerable population

41
ACKNOWLEDGMENTS

Vincent Mor

Richard Feifer

Carolyn Blackman

Stefan Gravenstein

Denine Hastings

Elizabeth White

Chris Santostefano

Neil Sarkar

Jeff Hiris

42
Reports of deaths following COVID-19 

vaccination in LTCF residents to VAERS
Reports of deaths in LTCF residents following COVID-19 

vaccination to VAERS*(N = 129) 

* Data through January 18, 2021; †Standard follow-up on reports of death includes attempts to collect and review death certificates and autopsy reports

Characteristics

Reports of death

(N = 129)

Median age, years (range) 84 (51–104)

Female (%) 65 (50)

Hospice, DNR, or DNI (%) 43 (33)

Autopsy conducted, results pending 2

Death certificate available 18

Death certificate unavailable or autopsy 

results pending†

112

▪ Initial assessment indicated that many case reports documented ill health and a history of multiple comorbidities and common age-related diseases (e.g., heart disease, type 2 diabetes, dementia, etc.) 
Reports of deaths in LTCF residents following COVID-19 vaccination to 

VAERS with death certificates available*(N = 18)

* Data through January 18, 2021

Cause of death from death certificate

Hypertension, leading to acute myocardial infarction, leading to anoxic brain injury

Atherosclerotic cardiovascular disease, acute myocardial infarction

Arteriosclerotic Disease

Cardiac arrest, cardiopulmonary arrest

Acute congestive heart failure, non-ischemic cardiomyopathy

Congestive heart failure, non-ischemic cardiomyopathy

Congestive heart failure

Congestive heart failure

Heart failure, hypertension

End stage chronic obstructive pulmonary disease

Acute kidney failure, resulting from acute liver failure, resulting from liver masses

Hypertension, hypothyroidism, bipolar disorder, peripheral vascular disease

Pneumonia, cardiac arrest and shock

Aspiration, frontotemporal dementia

Hypertension, mixed Alzheimer’s and vascular dementia

Dementia

Chronic alcohol abuse and severe malnutrition, alcohol withdrawal, electrolyte 

derangement, ventricular arrhythmia, cardiogenic shock

Failure to thrive
Impression on deaths and mortality in LTCF residents following 

COVID-19 vaccination

▪ Mortality in LTCF residents is high due to the underlying health status of 

the LTCF resident population

▪ The available evidence from VAERS monitoring and Genesis populationbased surveillance does not suggest a safety problem with respect to 

deaths in older adults residing in LTCFs 

▪ Case reports of deaths in LTCF residents following COVID-19 vaccination 

to VAERS include many persons:

– With multiple co-morbidities, including some with cognitive impairment

– In ill health and declining states health

– In hospice or DNR or DNI status (in one-third of reported deaths)

▪ Deaths in LTCF residents following COVID-19 vaccination are consistent 

with expected all cause mortality in this population 
https://www.who.int/news/item/22-01-2021-gacvs-review-deaths-pfizer-biontech-covid-19-vaccine-bnt162b2
Reports of deaths following COVID-19 

vaccination in community dwelling 

adults aged <65 years
Background: Sudden cardiac death in community residents

▪ Rate of sudden cardiac death = 29.6 per 100,000 person-years

*

– Out-of-hospital cardiac arrest in people 18–90 years of age in San 

Francisco County

• Inclusion criteria: sudden unexpected death either within 1 hour 

of symptom onset (event witnessed), or within 24 hours of 

having been observed alive and symptom free (unwitnessed)

• Excludes: (1) subjects with chronic/terminal illness in which imminent death not 

unexpected; (2) hospice residents; (3) subjects with identifiable noncardiac 

etiology of death at presentation, including drug abuse/overdose, trauma, 

homicide, or suicide; (4) subjects with hospital admission within prior 30 days 

for noncardiac illness or surgical procedure.

* Tseng et al, Circulation. 2018;137:2689–2700
Background: Sudden cardiac death in community residents

▪ Estimate ~13.7 million community residents vaccinated December 14–

January 18, 2021 (CDC COVID Data Tracker)

▪ Risk period

– Risk period = 35 days (December 14–January 18)

– Assume each resident contributes 15 person-days (~ mid-point of risk period, 

adjusted downward to account for Moderna not used until December 21)

– Total person-years contributed = 566,650 ([13.7million*15 days]/365.25)

▪ Expected sudden cardiac death count: 168 deaths (29.6*5.66)

▪ Reported VAERS sudden cardiac death count following COVID vaccination: 18 deaths
Reports of deaths following COVID-19 vaccination to VAERS 

in community dwelling adults aged <65 years*(N = 28)

* Data through January 18, 2021

Characteristics

Reports of death

(N = 28)

Median age, years (range) 54 (25–63)

Female (%) 12 (43)

Median time from vaccination to death 

(range), days 5 (day of vax–25)

Pfizer-BioNTech 16

Moderna 12

Autopsy (completed, pending) 1, 4

Death certificate/autopsy report available 11
Reports of deaths following COVID-19 vaccination to VAERS in community dwelling 

adults aged <65 years with death certificate or autopsy report available*(N = 11)

* Data through January 18, 2021

Cause of death from death certificate or autopsy report

Atherosclerotic cardiovascular disease

Atherosclerotic cardiovascular heart disease, hypertension

Cardiac arrest, COVID-19

Cardiac arrest, hypertension, morbid obesity

Cardiopulmonary arrest, hypertensive heart disease, hypertension, DM type II

Hypertensive cardiovascular disease

Myocardial infarction, ventricular fibrillation

Drug overdose

Pulmonary hemorrhage from squamous cell cancer of the lung

Subarachnoid hemorrhage, intraparenchymal hemorrhage, intraventricular hemorrhage

COVID-19 stroke, COVID-19 acute respiratory failure
Closing
Closing thoughts

▪ 23.5 million COVID-19 vaccine doses have been administered in the United States

▪ During this time, the U.S. government has implemented the most intense and 

comprehensive vaccine safety monitoring program in history

▪ Overall, the safety profiles of COVID-19 vaccines are reassuring and consistent with 

that observed from the pre-authorization clinical trials

▪ Anaphylaxis has been observed following mRNA COVID-19 vaccines, though rarely

▪ The data do not suggest a signal with respect to overall safety or deaths following 

vaccination in older adult residents of LTCFs

▪ Additional population-based monitoring systems will continue to gather safety 

data safety as vaccination increases and the immunization program broadens

– CDC’s Vaccine Safety Datalink, FDA monitoring in CMS data, VA electronic health record
Acknowledgments

Centers for Disease Control and Prevention

COVID-19 Vaccine Task Force

COVID-19 Vaccine Task Force, Vaccine Safety Team

Immunization Safety Office

Division of Healthcare Quality Promotion

Vaccine Safety Datalink

Clinical Immunization Safety Assessment Project

V-safe Team

U.S. Food and Drug Administration

Office of Biostatistics and Epidemiology

National Institutes of Health 

National Institute on Aging 

Brown University School of Public Health

Genesis

We wish to acknowledge the contributions of investigators from the following organizations:
Questions