PMID- 33422381
OWN - NLM
STAT- MEDLINE
DCOM- 20210521
LR  - 20210521
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 39
IP  - 5
DP  - 2021 Jan 29
TI  - Myopericarditis after vaccination, Vaccine Adverse Event Reporting System 
      (VAERS), 1990-2018.
PG  - 839-845
LID - S0264-410X(20)31614-5 [pii]
LID - 10.1016/j.vaccine.2020.12.046 [doi]
AB  - BACKGROUND: Myopericarditis after vaccination has been sporadically reported in 
      the medical literature. Here, we present a thorough descriptive analysis of 
      reports to a national passive vaccine safety surveillance system (VAERS) of 
      myopericarditis after vaccines licensed for use in the United States. METHODS: We 
      identified U.S. reports of myopericarditis received by VAERS during 1990-2018 
      that met a published case definition for myopericarditis or were 
      physician-diagnosed. We stratified analysis by age group (<19, 19-49, >/=50 years), 
      describing reports by serious/non-serious status, sex, time to symptom onset 
      after vaccination, vaccine(s) administered, and exposure to other known causes of 
      myopericarditis. We used Empirical Bayesian data mining to detect 
      disproportionate reporting of myopericarditis after vaccination. RESULTS: VAERS 
      received 620,195 reports during 1990-2018: 708 (0.1%) met the case definition or 
      were physician-diagnosed as myopericarditis. Most (79%) myopericarditis reports 
      described males; 69% were serious; 72% had symptom onset </= 2 weeks 
      postvaccination. Overall, smallpox (59%) and anthrax (23%) vaccines were most 
      commonly reported. By age, among persons aged < 19 years, Haemophilus influenzae 
      type b (22, 22%) and hepatitis B (18, 18%); among persons aged 19-49 years 
      smallpox (387, 79%); among persons aged >/= 50 years inactivated influenza (31, 
      36%) and live attenuated zoster (19, 22%) vaccines were most commonly reported. 
      The vaccines most commonly reported remained unchanged when excluding 138 reports 
      describing other known causes of myopericarditis. Data mining revealed 
      disproportionate reporting of myopericarditis only after smallpox vaccine. 
      CONCLUSIONS: Despite the introduction of new vaccines over the years, 
      myopericarditis remains rarely reported after vaccines licensed for use in the 
      United States. In this analysis, myopericarditis was most commonly reported after 
      smallpox vaccine, and less commonly after other vaccines.
CI  - Published by Elsevier Ltd.
FAU - Su, John R
AU  - Su JR
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, GA, United States. Electronic address: ezu2@cdc.gov.
FAU - McNeil, Michael M
AU  - McNeil MM
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, GA, United States.
FAU - Welsh, Kerry J
AU  - Welsh KJ
AD  - Center for Biologicals Evaluation and Research, Food and Drug Administration 
      (FDA), United States.
FAU - Marquez, Paige L
AU  - Marquez PL
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, GA, United States.
FAU - Ng, Carmen
AU  - Ng C
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, GA, United States.
FAU - Yan, Ming
AU  - Yan M
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, GA, United States.
FAU - Cano, Maria V
AU  - Cano MV
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, GA, United States.
LA  - eng
PT  - Journal Article
DEP - 20210106
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Influenza Vaccines)
SB  - IM
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Bayes Theorem
MH  - Humans
MH  - *Influenza Vaccines
MH  - *Influenza, Human
MH  - Male
MH  - Middle Aged
MH  - United States/epidemiology
MH  - Vaccination/adverse effects
MH  - Young Adult
OTO - NOTNLM
OT  - Adverse event
OT  - Myopericarditis
OT  - Surveillance
OT  - VAERS
OT  - Vaccine
COIS- Declaration of Competing Interest The authors declare that they have no known 
      competing financial interests or personal relationships that could have appeared 
      to influence the work reported in this paper.
EDAT- 2021/01/11 06:00
MHDA- 2021/05/22 06:00
CRDT- 2021/01/10 20:29
PHST- 2020/09/10 00:00 [received]
PHST- 2020/12/11 00:00 [revised]
PHST- 2020/12/12 00:00 [accepted]
PHST- 2021/01/11 06:00 [pubmed]
PHST- 2021/05/22 06:00 [medline]
PHST- 2021/01/10 20:29 [entrez]
AID - S0264-410X(20)31614-5 [pii]
AID - 10.1016/j.vaccine.2020.12.046 [doi]
PST - ppublish
SO  - Vaccine. 2021 Jan 29;39(5):839-845. doi: 10.1016/j.vaccine.2020.12.046. Epub 2021 
      Jan 6.