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Anxiety-Related Adverse Event Clusters After Janssen COVID-19 Vaccination - Five U.S. Mass Vaccination Sites, April 2021.
MMWR Morb Mortal Wkly Rep. 2021 May 07; 70(18):685-688.MM

Abstract

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.

Authors+Show Affiliations

CDC COVID-19 Response Team.CDC COVID-19 Response Team.CDC COVID-19 Response Team.CDC COVID-19 Response Team.CDC COVID-19 Response Team.CDC COVID-19 Response Team.CDC COVID-19 Response Team.CDC COVID-19 Response Team.CDC COVID-19 Response Team.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

33956781

Citation

Hause, Anne M., et al. "Anxiety-Related Adverse Event Clusters After Janssen COVID-19 Vaccination - Five U.S. Mass Vaccination Sites, April 2021." MMWR. Morbidity and Mortality Weekly Report, vol. 70, no. 18, 2021, pp. 685-688.
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. 2021;70(18):685-688.
Hause, A. M., Gee, J., Johnson, T., Jazwa, A., Marquez, P., Miller, E., Su, J., Shimabukuro, T. T., & Shay, D. K. (2021). Anxiety-Related Adverse Event Clusters After Janssen COVID-19 Vaccination - Five U.S. Mass Vaccination Sites, April 2021. MMWR. Morbidity and Mortality Weekly Report, 70(18), 685-688. https://doi.org/10.15585/mmwr.mm7018e3
Hause AM, 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. 2021 May 7;70(18):685-688. PubMed PMID: 33956781.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Anxiety-Related Adverse Event Clusters After Janssen COVID-19 Vaccination - Five U.S. Mass Vaccination Sites, April 2021. AU - Hause,Anne M, AU - Gee,Julianne, AU - Johnson,Tara, AU - Jazwa,Amelia, AU - Marquez,Paige, AU - Miller,Elaine, AU - Su,John, AU - Shimabukuro,Tom T, AU - Shay,David K, Y1 - 2021/05/07/ PY - 2021/5/6/entrez PY - 2021/5/7/pubmed PY - 2021/5/8/medline SP - 685 EP - 688 JF - MMWR. Morbidity and mortality weekly report JO - MMWR Morb Mortal Wkly Rep VL - 70 IS - 18 N2 - 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. SN - 1545-861X UR - https://www.unboundmedicine.com/medline/citation/33956781/Anxiety_Related_Adverse_Event_Clusters_After_Janssen_COVID_19_Vaccination___Five_U_S__Mass_Vaccination_Sites_April_2021_ L2 - https://doi.org/10.15585/mmwr.mm7018e3 DB - PRIME DP - Unbound Medicine ER -