Anxiety-Related Adverse Event Clusters After Janssen COVID-19 Vaccination

Five U.S. Mass Vaccination Sites, April 2021

Anne M. Hause, PhD; Julianne Gee, MPH; Tara Johnson, MPH, MS; Amelia Jazwa, MSPH; Paige Marquez, MSPH; Elaine Miller, MPH; John Su, MD, PhD; Tom T. Shimabukuro, MD; David K. Shay, MD

Disclosures

Morbidity and Mortality Weekly Report. 2021;70(18):685-688. 

In This Article

Abstract and Introduction

Introduction

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.

CDC interviewed staff members from the five mass COVID-19 vaccination sites that reported anxiety-related adverse event clusters after receipt of Janssen COVID-19 vaccine, focusing on site capacity and layout, vaccination processes, timeline of reported events, and clinical follow-up. Each of the five sites reported all anxiety-related events to VAERS; reports for each event were reviewed by CDC. VAERS is a national passive surveillance system that monitors adverse events after all vaccinations.[1] VAERS reports are accepted from health care providers, vaccine manufacturers, and the public. Signs and symptoms in VAERS reports are coded using the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms.* VAERS reports are classified as serious if any of the following are reported: hospitalization, prolongation of hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death. An anxiety-related event was defined as any of the following occurring in a person during the 15-minute postvaccination observation period at any of the five sites reporting these clusters: tachycardia (rapid heart rate), hyperventilation (rapid breathing), dyspnea (difficulty breathing), chest pain, paresthesia (numbness or tingling), light-headedness, hypotension (low blood pressure), headache, pallor, or syncope.[2] Six persons who received diphenhydramine or epinephrine at the vaccination visit were excluded because these events might have represented allergic reactions; none was classified as anaphylaxis.

As a follow-up to these interviews, CDC reviewed VAERS reports received during March 2–April 22, 2021, for adverse events associated with receipt of Janssen COVID-19 vaccine doses administered during March 2–April 12. Syncope, a common anxiety-related event reported by the five mass vaccination sites, has specific MedDRA preferred terms ("syncope" and "syncope vasovagal") and was the focus of this follow-up investigation. Syncopal events that occurred off-site or ≥1 hour after vaccine administration and those in 16 persons who received diphenhydramine or epinephrine were not included. VAERS reports of syncopal events occurring after receipt of any influenza vaccine administered to persons aged ≥18 years during the 2019–20 influenza season (i.e., July 1, 2019–June 30, 2020) served as a comparison, because influenza vaccine is similarly administered as a single dose and is available to all U.S. adults. Reporting rates were calculated using the approximate number of doses of each vaccine administered during the respective analysis periods. Descriptive analyses of VAERS data were stratified by vaccine type, sex, and age group. These activities were reviewed by CDC and were conducted consistent with applicable federal law and CDC policy.§

*Each VAERS report might be assigned more than one MedDRA preferred term. A MedDRA coded event does not indicate a medically confirmed diagnosis. https://www.meddra.org/how-to-use/basics/hierarchy
Influenza vaccine doses administered during the 2019–20 season were estimated based on coverage estimates. https://www.cdc.gov/flu/fluvaxview/coverage-1920estimates.htm
§45 C.F.R. part 46, 21 C.F.R. part 56; 42 U.S.C. Sect. 241(d); 5 U.S.C. Sect. 552a; 44 U.S.C. Sect. 3501 et seq.

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