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Thrombocytopenia including immune thrombocytopenia after receipt of mRNA COVID-19 vaccines reported to the Vaccine Adverse Event Reporting System (VAERS).
Vaccine. 2021 06 08; 39(25):3329-3332.V

Abstract

BACKGROUND

The objective of this study is to assess cases of thrombocytopenia, including immune thrombocytopenia (ITP), reported to the Vaccine Adverse Event Reporting System (VAERS) following vaccination with mRNA COVID-19 vaccines.

METHODS

This case-series study analyzed VAERS reports of thrombocytopenia after vaccination with Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine.

RESULTS

Fifteen cases of thrombocytopenia were identified among 18,841,309 doses of Pfizer-BioNTech COVID-19 Vaccine and 13 cases among 16,260,102 doses of Moderna COVID-19 Vaccine. The reporting rate of thrombocytopenia was 0.80 per million doses for both vaccines. Based on an annual incidence rate of 3.3 ITP cases per 100,000 adults, the observed number of all thrombocytopenia cases, which includes ITP, following administration of mRNA COVID-19 vaccines is not greater than the number of ITP cases expected.

CONCLUSIONS

The number of thrombocytopenia cases reported to VAERS does not suggest a safety concern attributable to mRNA COVID-19 vaccines at this time.

Authors+Show Affiliations

Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, United States.Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, United States.Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, United States.Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, United States.Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, United States. Electronic address: Narayan.Nair@fda.hhs.gov.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

34006408

Citation

Welsh, Kerry J., et al. "Thrombocytopenia Including Immune Thrombocytopenia After Receipt of mRNA COVID-19 Vaccines Reported to the Vaccine Adverse Event Reporting System (VAERS)." Vaccine, vol. 39, no. 25, 2021, pp. 3329-3332.
Welsh KJ, Baumblatt J, Chege W, et al. Thrombocytopenia including immune thrombocytopenia after receipt of mRNA COVID-19 vaccines reported to the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2021;39(25):3329-3332.
Welsh, K. J., Baumblatt, J., Chege, W., Goud, R., & Nair, N. (2021). Thrombocytopenia including immune thrombocytopenia after receipt of mRNA COVID-19 vaccines reported to the Vaccine Adverse Event Reporting System (VAERS). Vaccine, 39(25), 3329-3332. https://doi.org/10.1016/j.vaccine.2021.04.054
Welsh KJ, et al. Thrombocytopenia Including Immune Thrombocytopenia After Receipt of mRNA COVID-19 Vaccines Reported to the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2021 06 8;39(25):3329-3332. PubMed PMID: 34006408.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Thrombocytopenia including immune thrombocytopenia after receipt of mRNA COVID-19 vaccines reported to the Vaccine Adverse Event Reporting System (VAERS). AU - Welsh,Kerry J, AU - Baumblatt,Jane, AU - Chege,Wambui, AU - Goud,Ravi, AU - Nair,Narayan, Y1 - 2021/04/30/ PY - 2021/03/04/received PY - 2021/04/22/revised PY - 2021/04/27/accepted PY - 2021/5/20/pubmed PY - 2021/6/10/medline PY - 2021/5/19/entrez KW - Immune thrombocytopenia KW - Thrombocytopenia KW - VAERS KW - mRNA COVID-19 vaccines SP - 3329 EP - 3332 JF - Vaccine JO - Vaccine VL - 39 IS - 25 N2 - BACKGROUND: The objective of this study is to assess cases of thrombocytopenia, including immune thrombocytopenia (ITP), reported to the Vaccine Adverse Event Reporting System (VAERS) following vaccination with mRNA COVID-19 vaccines. METHODS: This case-series study analyzed VAERS reports of thrombocytopenia after vaccination with Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine. RESULTS: Fifteen cases of thrombocytopenia were identified among 18,841,309 doses of Pfizer-BioNTech COVID-19 Vaccine and 13 cases among 16,260,102 doses of Moderna COVID-19 Vaccine. The reporting rate of thrombocytopenia was 0.80 per million doses for both vaccines. Based on an annual incidence rate of 3.3 ITP cases per 100,000 adults, the observed number of all thrombocytopenia cases, which includes ITP, following administration of mRNA COVID-19 vaccines is not greater than the number of ITP cases expected. CONCLUSIONS: The number of thrombocytopenia cases reported to VAERS does not suggest a safety concern attributable to mRNA COVID-19 vaccines at this time. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/34006408/Thrombocytopenia_including_immune_thrombocytopenia_after_receipt_of_mRNA_COVID_19_vaccines_reported_to_the_Vaccine_Adverse_Event_Reporting_System__VAERS__ DB - PRIME DP - Unbound Medicine ER -