Anxiety-related Adverse Event Clusters After Janssen COVID-19 Vaccination — Five U.S. Mass Vaccination Sites, April 2021

Details

• Personal Author:
  Hause, Anne M. ; Gee, Julianne ; Johnson, Tara ; Jazwa, Amelia ; Marquez, Paige ; Miller, Elaine ; Su, John ; Shimabukuro, Tom T. ; Shay, David K.
• Corporate Authors:
  CDC COVID-19 Response Team.
• Description:
  What is already known about this topic? Syncope and other anxiety-related events can occur after vaccination and have been reported to the Vaccine Adverse Events Reporting System (VAERS) for other vaccines.
  
  What is added by this report? Five mass vaccination sites reported 64 anxiety-related events, including 17 events of syncope (fainting) after receipt of Janssen COVID-19 vaccine. The reporting rates of syncope to VAERS after Janssen COVID-19 and influenza vaccines (2019–20) were 8.2 and 0.05 per 100,000 doses, respectively.
  
  What are the implications for public health practice? Vaccine providers should be aware of anxiety-related events after vaccination and observe all COVID-19 vaccine recipients for any adverse reactions for at least 15 minutes after vaccine administration.
  
  On April 7, 2021, after 5 weeks’ use of the Janssen COVID-19 vaccine under the Food and Drug Administration (FDA) Emergency Use Authorization (EUA), CDC received reports of clusters of anxiety-related events after administration of Janssen COVID-19 vaccine from five mass vaccination sites, all in different states. To further investigate these cases, CDC interviewed vaccination site staff members to gather additional information about the reported events and vaccination site practices. Four of the five sites temporarily closed while an investigation took place. Overall, 64 anxiety-related events, including 17 reports of syncope (fainting), an anxiety-related event, among 8,624 Janssen COVID-19 vaccine recipients, were reported from these sites for vaccines administered during April 7–9. As a follow-up to these interviews, CDC analyzed reports of syncope shortly after receipt of Janssen COVID-19 vaccine to the Vaccine Adverse Event Reporting System (VAERS), the vaccine safety monitoring program managed by CDC and FDA. To compare the occurrence of these events with those reported after receipt of other vaccines, reports of syncopal events after influenza vaccine administered in the 2019–20 influenza season were also reviewed. Syncope after Janssen COVID-19 vaccination was reported to VAERS (8.2 episodes per 100,000 doses). By comparison, after influenza vaccination, the reporting rate of syncope was 0.05 episodes per 100,000 doses. Anxiety-related events can occur after any vaccination. It is important that vaccination providers are aware that anxiety-related adverse events might be reported more frequently after receipt of the Janssen COVID-19 vaccine than after influenza vaccination and observe all COVID-19 vaccine recipients for any adverse reactions for at least 15 minutes after vaccine administration.
  
  Suggested citation for this article: Hause AM, Gee J, Johnson T, et al. Anxiety-Related Adverse Event Clusters After Janssen COVID-19 Vaccination — Five U.S. Mass Vaccination Sites, April 2021. MMWR Morb Mortal Wkly Rep. ePub: 30 April 2021.
  
  mm7018e3.htm?s_cid=mm7018e3_w
  
  mm7018e3-H.pdf
  
  
• Subjects:
  Adolescent Adverse Drug Reaction Reporting Systems Adverse Event Anxiety Anxiety-related Reaction CoronaVirus Infections/Prevention & Control COVID-19 Vaccines/adverse Reactions COVID-19/Prevention & Control Immunization Mass Vaccination Mass Vaccination/Psychology Vaccine Safety

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• Source:
  MMWR: Morbidity and Mortality Weekly Report 2021; v. 70 Early Release
• Series:
  Weekly Report: Morbidity and Mortality Weekly Report (MMWR)
• ISSN:
  0149-2195 (print) ; 1545-861X (digital)
• Document Type:
  Journal Article
• Name as Subject:
  Janssen COVID-19 Vaccine
• Place as Subject:
  United States
• Pages in Document:
  4 pdf pages
• Volume:
  70
• Collection(s):
  Morbidity and Mortality Weekly Report (MMWR)
• Main Document Checksum:
  urn:sha-512:fdd14b2f88b752e8490bdf44ef64c147a14ffcd4a279a7186cd6f157c3d78bfee125dcb04d3de5cfb00d1fd1e049f31f8e0c4c222cb9d04db1f4229e1edbbbca
• Download URL:
  https://stacks.cdc.gov/view/cdc/105683/cdc_105683_DS1.pdf
• File Type:
  [PDF - 116.93 KB ]