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. 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.Īs 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.
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). 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. VAERS reports are accepted from health care providers, vaccine manufacturers, and the public. VAERS is a national passive surveillance system that monitors adverse events after all vaccinations ( 1). Each of the five sites reported all anxiety-related events to VAERS reports for each event were reviewed by CDC.
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.ĬDC 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. Anxiety-related events can occur after any vaccination. By comparison, after influenza vaccination, the reporting rate of syncope was 0.05 episodes per 100,000 doses. Syncope after Janssen COVID-19 vaccination was reported to VAERS (8.2 episodes per 100,000 doses). 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. 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. 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. Four of the five sites temporarily closed while an investigation took place. To further investigate these cases, CDC interviewed vaccination site staff members to gather additional information about the reported events and vaccination site practices.
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.
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