Myopericarditis following COVID -19 vaccination: Updates ...

Myopericarditis following COVID-19 vaccination: Updates from the Vaccine Adverse Event Reporting System (VAERS)

Aug 30, 2021

John R. Su, MD, PhD, MPH Vaccine Safety Team CDC COVID-19 Vaccine Task Force

coronavirus

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 CDC or FDA

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Myopericarditis reports to VAERS

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Focusing analysis on reports of myocarditis and myocarditis with pericarditis (myopericarditis) following COVID-19 vaccination

As of August 18, 2021, total of 2,574 reports in all ages/age groups ? Myopericarditis: 1,903 reports ? Pericarditis alone: 671 reports

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Preliminary myopericarditis reports to VAERS following COVID-19 vaccination by dose number (data thru Aug 18, 2021)

Manufacturer

Reports after Reports after Reports after

dose 1

dose 2 unknown dose

Pfizer-BioNTech (n=1,282)

169

922

191

Moderna (n=557)

133

339

85

Janssen (n=49)

33

1

15

Not reported (n=15)

2

9

4

Total (N=1,903)

337

1,271

295

Includes total preliminary reports identified through VAERS database searches for reports with myopericarditis MedDRA* codes and pre-screened VAERS reports with signs and symptoms consistent with myopericarditis; excludes reports of solely pericarditis

? Follow-up, medical record review, application of CDC working case definition, and adjudication is ongoing or pending

* Medical Dictionary for Regulatory Activities

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Characteristics of preliminary* myopericarditis reports to VAERS following known mRNA COVID-19 vaccination (data thru Aug 18, 2021)

Characteristics

Dose 1 (mRNA only)

Dose 2

(n=302)

(n=1,261)

Median age, years (range) Median time to symptom onset, days (range)

26 (12?94) 3 (0?71)

20 (11?87) 2 (0?98)

Sex (%)

Male

218 (72%)

1,034 (82%)

Female

78 (26%)

220 (17%)

Not reported/not available

6 (2%)

7 (1%)

* Includes reports identified through VAERS database searches for reports with myopericarditis MedDRA codes, with signs and symptoms consistent with

myopericarditis, and with dose number documented; and pre-process VAERS reports with follow-up, medical record review, and application of CDC case definition

for myopericarditis

Excludes 33 reports after Janssen, and 2 reports that did not specify manufacturer after Dose 1; excludes 1 report after Janssen and 9 reports that did not specify

manufacturer after Dose 2 Four reports after Dose 1 had onset >71 days; five reports after Dose 2 had onset >98 days

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Expected vs. Observed reports after mRNA vaccination dose 2, 7-day risk period (N=765)*

Females

Males

Age group, years

Cases of myopericarditis,

expected

Cases of myopericarditis,

observed

Cases of myopericarditis,

expected

Cases of myopericarditis,

observed

12?15*

0?3

12

1?5

117

16?17*

0?2

15

0?3

121

18?24*

1?8

24

1?11

213

25?29*

1?6

16

1?9

56

30?39

2?21

10

2?19

72

40?49

2?22

22

2?19

45

50?64

4?40

15

4?35

13

65+

4?44

6

4?36

8

* As of Aug 18, 2021; assumes a 7-day observation window, with 765 of 897 reports after mRNA vaccines occurring during Days 0?6 after vaccination; counts among 12?29 years from reports meeting case definition for myopericarditis; expected estimates for females 12?29 years adjusted to reflect reduced incidence in this age group

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Expected vs. Observed reports after Pfizer-BioNTech dose 2, 7-day risk period (N=549)*

Females

Males

Age group, years

Cases of myopericarditis,

expected

Cases of myopericarditis,

observed

Cases of myopericarditis,

expected

Cases of myopericarditis,

observed

12?15*

0?3

12

1?5

116

16?17*

0?2

15

0?3

120

18?24*

0?5

11

1?7

134

25?29*

0?4

4

1?5

30

30?39

1?13

7

1?11

40

40?49

1?13

12

1?11

26

50?64

2?22

9

2?19

5

65+

2?22

4

2?18

4

8 * As of Aug 18, 2021; assumes a 7-day observation window, with 549 of 765 reports after mRNA vaccines occurring during Days 0?6 after vaccination; counts among 12?29 years

from reports meeting case definition for myopericarditis; expected estimates for females 12?29 years adjusted to reflect reduced incidence in this age group

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