Document text
cdc.gov/coronavirusMyocarditis Outcomes Following mRNA
COVID -19 Vaccination
Preliminary Data: data are subject to change
Advisory Committee on Immunization Practices
February 4, 2022
Ian Kracalik PhD MPH
Vaccine Safety Team
CDC COVID-19 Vaccine Task Force
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)
Mention of a product or company name is for identification purposes only does not constitute endorsement by CDC or FDA
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Myocarditis following mRNA COVID -19 vaccination
Evidence from safety monitoring systems in multiple countries supports the
finding of an increased, but still rare, risk of myocarditis following mRNA COVID -
19 vaccination*
•Risk:
‒Highest in adolescents and young adults
‒Males > females
‒Following dose 2 > dose 1
•Onset within a few days of vaccination, mostly within a week
•Severity of cases varies; most who presented to medical care have responded
well to medications and rest
•Assessment of myocarditis health effects after COVID -19 vaccination in
progress 3 * https://www.who.int/news/item/09 -07-2021- gacvs -guidance -myocarditis -pericarditis -covid -19-mrna -vaccines
CDC enhanced surveillance for myocarditis outcomes after
mRNA COVID- 19 vaccination in Vaccine Adverse Event
Reporting System (VAERS) case reports*
4Purpose: Assess functional status and clinical outcomes among individuals
reported to have developed myocarditis after mRNA COVID -19 vaccination
Methods: A two -component survey conducted at least 90 days after the onset
of myocarditis symptoms
•Patient survey: Focused on 12 –29 years of age, ascertain functional status, clinical
symptoms, quality of life, and need for medication or other medical treatment
•Healthcare provider (e.g., cardiologist): Gather data on cardiac health and
functional status
Timeline: Data collection August 2021–January 2022
* https://www.cdc.gov/coronavirus/2019- ncov/vaccines/safety/myo -outcomes.html
Preliminary data from surveys of patients at least
90 days post myocarditis diagnosis
6Outreach focusing on myocarditis patients 12 –29 years of age
As of November 2021, VAERS had received ~989 reports of myocarditis or
myopericarditis after COVID -19 vaccination that met CDC case definition*
Of these, ~850 patient ages 12–29 years had reached 90 days post -myocarditis
diagnosis
•Of ~850 patients 90 days post diagnosis, 648 (81%) had a phone number listed
‒Of the ~648 patients who were called, ~360 (56%) completed the survey;
~270 (42%) were unreachable and 18 (3%) declined to participate
‒For the 360 patients interviewed, time from myocarditis onset to interview was 143 days (IQR: 131, 162)
* https://www.cdc.gov/mmwr/volumes/70/wr/mm7027e2.htm
020406080100120
M F M F M F M F
12 to 14 15 to 19 20 to 24 25 to 29Number of patients
Sex and age group7Most patients diagnosed with myocarditis were young males
Median patient age was 18 years (IQR: 15 –22);
Of the 360 patients 90 days post myocarditis diagnosis, 86% (308) were male
17%
2%38%
6%21%
3%11%
2%Male patients
Female patients
8Race and ethnicity of myocarditis patients (N=360)
0 50 100 150 200 250
White,
non-Hispanic
Hispanic
Asian,
non-Hispanic
Black,
non-Hispanic
Multi-racial,
non-Hispanic
Other,
non Hispanic
American Indian orAlaskan Native,
non-HispanicNumber of patients
62%
20%
5%
4%
4%
3%
<1%
*4 patients did not provide a response
987% (314/360) received two doses of a COVID -19 vaccine
•Of those who received two doses, 98% (307/314) reported receiving
both doses before they were diagnosed with myocarditis
•9%(31/360) had a positive COVID -19 test before their
myocarditis diagnosisPrior to their myocarditis diagnosis, most patients received
two doses of a COVID- 19 vaccine
10Self reported previous medical history among patients with
myocarditis after mRNA COVID -19 vaccination (N=360)
60 (17%) had any condition
•11(3%) had an arrhythmia
•6(2%) had congenital heart disease
•6 (2%) had a history of myocarditis
•2(<1%) had Kawasaki disease
•1(<1%) had previous heart failure•32 (9%) had a history of asthma
•7 (2%) had an autoimmune disorder
•5(1%) genetic or chromosomal condition
•4 (1%) were immunosuppressed
•1 (<1%) had a history of Leukemia
•1(<1%) had type 1 diabetes
11Most patients with myocarditis after vaccination reported being
hospitalized at the time of myocarditis diagnosis (n=360)
92% (324) were hospitalized
•4% (13) were readmitted following myocarditis; 8 of 13 (62%) were
readmitted because of a concern with the heart
•20% (71) were prescribed medication for their heart as of their last
appointment with the provider
12Missed school or work within the 2 weeks prior to the date of
the interview reported among patients with myocarditis after
vaccination (N=360)
46 (8%) reported missing school
•Of these, 10 (37%) believed it was due to their myocarditis
19(5%) missed work
•Of these, 7 (37%) believed it was due to their myocarditis
Self-reported symptoms within 2 weeks prior to the date of the
interview among myocarditis patients (n=360)
•About half (49%)
reported
experiencing at
least 1 symptom in
the prior two
weeks
0 50 100 150 200 250 300noyesnoyesnoyesnoyesFatigue Palpitations SOB Chest pain
Number of patients 1378%
25%78%
22%
75%32%
68%
22%Shortness
of breathChest
pain
Palpitations
Fatigue
14EuroQol -5D-5L measurement of health status among patients
who developed myocarditis after vaccination (n=242)
Preliminary data from completed cardiologist or
other healthcare provider surveys
16Outreach to cardiologists or other healthcare providers
Of the 360/648 patients interviewed, ~346 (96%) listed contact information for a
cardiologist or other healthcare provider
•Of the 346 providers with contact information listed, 229 completed a survey
•An additional 151 providers completed surveys they had submitted for multiple
patients in VAERS or provided contact information via the VAERS report
•We were unable to contact 268 providers
•In total, 380 providers completed the survey with a median of 191 days (IQR: 170, 216) from patient myocarditis onset to date of provider survey
17The proportion of myocarditis patients cleared for physical
activity by their cardiologist or healthcare provider has increased (n=380)
At time of myocarditis diagnosis, 83% of patients
had restrictions on their physical activity
83%
Restricted
At time of provider survey, at least 90 days post
diagnosis, only 39% had restrictions
*25 (7%) were unsure39%
Restricted
050100150200250
Same cardiac status as
at the initial
myocarditis diagnosisImproved, but not
fully recoveredProbably fully
recovered, awaiting
additional informationFully recoveredNumber of PatientsBased on the cardiologists/healthcare provider assessment,
most patients appear to have fully or probably recovered from their myocarditis (n=380)
81% (309) of cardiologists or healthcare providers indicated the patient was
fully or probably recovered
Patient Recovery66%
15% 15%
1%
*8 providers were unsure 18
Proportion of myocarditis patients deemed to be fully or
probably recovered by their healthcare provider (n=309)
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Results of the most recent cardiac function test (n=380)
53%
36%93%
77%
90%89%46%
64%
7%23%
10% 11%
050100150200250300350400
Troponin Cardiac MRI Echocardiogram Electrocardiogram Exercise stress test Ambulatory rhythm
monitoringNumber of patientsNormal or baseline Abnormal or elevated
20
121
68
231832
28
1 16383 592
53
17
920
030 14 3 514
020406080100120Late gadolinium enhancementInflamation or edemaWall motion abnormalitiesST segment elevationT wave abnormalitiesArrhythmiaConduction delays or blocksEctopic rhythymArrhythmiaOther cardiac concernOther non-cardiac concernArrhythmiaConduction delays or blocksEctopic rhythym
Cardiac MRI Electrocardiogram Exercise stress test Ambulatory rhythym
monitoringNumber of patientsAll patientsAbnormal findings from most recent cardiac function test
Patients fully or probably recovered
Overlap of abnormal findings among most recent cardiac
function tests
Troponin 51
EKG 26 22
Ambulatory rhythm 3 2 6
Exercise stress test 1 1 1 10
ECHO 9 7 31 20 060–80%
40–60%
20–40%
0–20%
22
Comparison of cardiac function tests at time of diagnosis and follow -up
14
127
239
248
57
75
36
340
4At �me of ini�al diagnosis At �me of follow -Up
68
79
233
253
17
174110
20
186
Number of myocardi�s pa�entsNumber of myocardi�s pa�ents
elevatedelevated
Comparison of cardiac function tests at time of diagnosis and follow -up
24Number of myocarditis patients Number of myocarditis patients 14
127
239At �me of ini�al diagnosis At �me of follow -Up
68
79
233
Comparison of cardiac function tests at time of diagnosis and follow -up
25248
57
75
253
17
110
At time of initial diagnosis At time of follow -upNumber of myocarditis patients Number of myocarditis patients
Comparison of cardiac function tests at time of diagnosis and follow -up
26At time of initial diagnosis At time of follow -up
36
340
4
174
20
186
elevatedelevatedNumber of myocarditis patients Number of myocarditis patients
Normal/Baseline function or absence of symptoms
Abnormal function or presence of symptoms
Unknown or no test results available
Patients deemed fully or probably fully recoveredPatients deemed not recovered
27Cardiac assessment and symptoms among patients deemed to be
recovered and not recovered from their myocarditis
Normal/Baseline function or absence of symptoms
Abnormal function or presence of symptoms
Unknown or no test results availablePatients deemed not recoveredCardiac assessment and symptoms among patients deemed to be
recovered and not recovered from their myocarditis
28Patients deemed fully or probably fully recovered
Normal/Baseline function or absence of symptoms
Abnormal function or presence of symptoms
Unknown or no test results availablePatients deemed not recovered
29Cardiac assessment and symptoms among patients deemed to be
recovered and not recovered from their myocarditis
Patients deemed fully or probably fully recovered
Summary
30At least 90 days after myocarditis diagnosis, most patients reported no impact
on their quality of life, and most did not report missing school or work
Only 13 (4%) were readmitted to the hospital
Most (81%) healthcare providers indicated the patient was probably fully or fully recovered
There did not appear to be a single test that was indicative of recovery
To our knowledge, there were no vaccine -associated myocarditis deaths in this
group
Ongoing efforts to continue patient follow- up and contact myocarditis patients
who were not yet recovered at time of survey
Surveys are being modified for children aged 5 -11 and follow -up to start in
February 2022
Acknowledgments
VAERS Team
•VAERS TTS abstraction team
•VAERS Myopericarditis abstraction team
•VAERS data team
Clinical Immunization Safety Assessment Project
COVID -19 Vaccine Task Force Data Monitoring and Reporting GroupThanks to the many people who made analysis of these data possible:
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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.
Thank you!
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