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Reporting rates for VAERS death reports following COVID-19 vaccination, December 14, 2020-November 17, 2021.

Day, B ; Menschik, D ; et al.
In: Pharmacoepidemiology and drug safety, Jg. 32 (2023-07-01), Heft 7, S. 763-772
Online academicJournal

Titel:
Reporting rates for VAERS death reports following COVID-19 vaccination, December 14, 2020-November 17, 2021.
Autor/in / Beteiligte Person: Day, B ; Menschik, D ; Thompson, D ; Jankosky, C ; Su, J ; Moro, P ; Zinderman, C ; Welsh, K ; Dimova, RB ; Nair, N
Link:
Zeitschrift: Pharmacoepidemiology and drug safety, Jg. 32 (2023-07-01), Heft 7, S. 763-772
Veröffentlichung: Chichester, West Sussex : Wiley, 1992-, 2023
Medientyp: academicJournal
ISSN: 1099-1557 (electronic)
DOI: 10.1002/pds.5605
Schlagwort:
  • Female
  • Humans
  • Male
  • Ad26COVS1
  • Adverse Drug Reaction Reporting Systems
  • United States epidemiology
  • Vaccination adverse effects
  • COVID-19 epidemiology
  • COVID-19 prevention & control
  • COVID-19 Vaccines adverse effects
  • Vaccines adverse effects
Sonstiges:
  • Nachgewiesen in: MEDLINE
  • Sprachen: English
  • Publication Type: Journal Article
  • Language: English
  • [Pharmacoepidemiol Drug Saf] 2023 Jul; Vol. 32 (7), pp. 763-772. <i>Date of Electronic Publication: </i>2023 Mar 07.
  • MeSH Terms: COVID-19* / epidemiology ; COVID-19* / prevention & control ; COVID-19 Vaccines* / adverse effects ; Vaccines* / adverse effects ; Female ; Humans ; Male ; Ad26COVS1 ; Adverse Drug Reaction Reporting Systems ; United States / epidemiology ; Vaccination / adverse effects
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Fact Check: Vaccine Adverse Reporting System Isn't Proof of COVID-19 Vaccine Deaths. USA Today; 2021. https://www.usatoday.com/story/news/factcheck/2021/06/28/fact-check-covid-19-vaers-death-reports-not-verified/7587577002/. ; Reuters Fact Check. Fact Check-VAERS Data Does Not Suggest COVID-19 Vaccines Killed 150,000 People, As Analysis Claims. Reuters; 2021. https://www.reuters.com/article/factcheck-coronavirus-usa/fact-check-vaers-data-does-not-suggest-covid-19-vaccines-killed-150000-people-as-analysis-claims-idUSL1N2R00KP. ; Jaramillo C. Viral Posts Misuse VAERS Data to Make False Claims About COVID-19 Vaccines. FactCheck.org; 2021. https://www.factcheck.org/2021/03/scicheck-viral-posts-misuse-vaers-data-to-make-false-claims-about-covid-19-vaccines/. ; Kertscher T. No Truth That VAERS System Shows 6,000 “Died Because of” COVID-19 Vaccines. Politifact - The Poynter Institute; 2021. https://www.politifact.com/factchecks/2021/aug/09/tiktok-posts/no-truth-vaers-system-shows-6000-died-because-covi/. ; US Food and Drug Administration. Vaccine Adverse Event Reporting System (VAERS) Questions and Answers. 2021. https://www.fda.gov/vaccines-blood-biologics/vaccine-adverse-events/vaccine-adverse-event-reporting-system-vaers-questions-and-answers. ; Centers for Disease Control and Prevention. Vaccine Safety: Vaccine Adverse Event Reporting System (VAERS). 2021. https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index.html#anchor_1616772579977. ; Centers for Disease Control and Prevention. CDC WONDER: Vaccine Adverse Event Reporting Systems (VAERS). 2021. https://wonder.cdc.gov/wonder/help/vaers.html. ; US Department of Health and Human Services. VAERS Home: Frequently Asked Questions (FAQs). 2021. https://vaers.hhs.gov/faq.html. ; US Department of Health and Human Services. Guide to Interpreting VAERS Data. 2021. https://vaers.hhs.gov/data/dataguide.html. ; Centers for Disease Control and Prevention. CDC COVID-19 Vaccination Program Provider Requirements and Support 2022. 2022. https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html. ; US Food and Drug Administration. Janssen COVID-19 Vaccine: Fact Sheet for Healthcare Providers Administering Vaccine 2022. 2022. https://www.fda.gov/media/146304/download. ; US Food and Drug Administration. Moderna COVID-19 Vaccine: Fact Sheet for Healthcare Providers Administering Vaccine 2022. 2022. https://www.fda.gov/media/144637/download. ; US Food and Drug Administration. Pfizer-BioNTech COVID-19 Vaccine: Fact Sheet for Healthcare Providers Administering Vaccine 2022. 2022. https://www.fda.gov/media/153713/download. ; Shimabukuro T, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2015;33(36):4398-4405. doi:10.1016/j.vaccine.2015.07.035. ; US Department of Health and Human Services. Report an Adverse Event with a Writable PDF Form 2021. 2021. https://vaers.hhs.gov/uploadFile/index.jsp. ; Centers for Disease Control and Prevention. Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19 (as of 29 January 2021). 2021. https://www.cdc.gov/vaccinesafety/pdf/VAERS-v2-SOP.pdf. ; US Department of Health and Human Services. VAERS Table of Reportable Events Following Vaccination 2017. 2021. https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf. ; Centers for Disease Control and Prevention. Understanding the Vaccine Adverse Event Reporting System (VAERS) 2013. 2021. https://www.cdc.gov/vaccines/hcp/patient-ed/conversations/downloads/vacsafe-vaers-color-office.pdf. ; Abara WE, Gee J, Delorey M, et al. Expected rates of select adverse events after immunization for coronavirus disease 2019 vaccine safety monitoring. J Infect Dis. 2022;225(9):1569-1574. doi:10.1093/infdis/jiab628. ; Centers for Disease Control and Prevention. CDC WONDER: Multiple Cause of Death 1999-2020. 2022. https://wonder.cdc.gov/wonder/help/mcd.html. ; VAC4EU. COVID-19 vaccine monitoring 2019. 2022. https://vac4eu.org/covid-19-vaccine-monitoring/. ; World Health Organization. COVID-19 Vaccines: Safety Surveillance Manual, Geneva. 2020. https://www.who.int/docs/default-source/covid-19-vaccines-safety-surveillance-manual/covid19vaccines_manual_aefi_20210104.pdf. ; US Food and Drug Administration. Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. 2005. ; European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases. 2013. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-product-population-specific-considerations-i-vaccines_en.pdf. ; Black SB, Law B, Chen RT, et al. The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety. Vaccine. 2021;39(19):2712-2718. doi:10.1016/j.vaccine.2021.03.016. ; Gubernot D, Jazwa A, Niu M, et al. U.S. population-based background incidence rates of medical conditions for use in safety assessment of COVID-19 vaccines. Vaccine. 2021;39(28):3666-3677. doi:10.1016/j.vaccine.2021.05.016. ; Mahaux O, Bauchau V, Van Holle L. Pharmacoepidemiological considerations in observed-to-expected analyses for vaccines. Pharmacoepidemiol Drug Saf. 2016;25(2):215-222. doi:10.1002/pds.3918. ; Lin D-Y, Gu Y, Wheeler B, et al. Effectiveness of COVID-19 vaccines over a 9-month period in North Carolina. N Engl J Med. 2022;386:933-941. doi:10.1056/NEJMoa2117128. ; Self WH, Tenforde MW, Rhoads JP, Gaglani M, Ginde AA, Douin DJ. Comparative effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) vaccines in preventing COVID-19 hospitalizations among adults without immunocompromising conditions - United States, march-august 2021. MMWR Morb Mortal Wkly Rep. 2021;70(38):1337-1343. doi:10.15585/mmwr.mm7038e1. ; Centers for Disease Control and Prevention. Selected Adverse Events Reported after COVID-19 Vaccination. 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html. ; Miller ER, McNeil MM, Moro PL, Duffy J, Su JR. The reporting sensitivity of the vaccine adverse event reporting system (VAERS) for anaphylaxis and for Guillain-Barré syndrome. Vaccine. 2020;38(47):7458-7463. doi:10.1016/j.vaccine.2020.09.072. ; Verstraeten T, Baughman AL, Cadwell B, et al. Enhancing vaccine safety surveillance: a capture-recapture analysis of intussusception after rotavirus vaccination. Am J Epidemiol. 2001;154(11):1006-1012. doi:10.1093/aje/154.11.1006. ; Rosenthal S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health. 1995;85(12):1706-1709. doi:10.2105/ajph.85.12.1706. ; Remschmidt C, Wichmann O, Harder T. Frequency and impact of confounding by indication and healthy vaccinee bias in observational studies assessing influenza vaccine effectiveness: a systematic review. BMC Infect Dis. 2015;15(429). doi:10.1186/s12879-015-1154-y. ; Dooling K, Marin M, Wallace M, et al. The advisory committee on immunization Practices' updated interim recommendation for allocation of COVID-19 vaccine - United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69(5152):1657-1660. ; Xu S, Huang R, Sy LS, et al. COVID-19 vaccination and non-COVID-19 mortality risk - seven integrated health care organizations, United States, December 14, 2020-July 31, 2021. MMWR Morb Mortal Wkly Rep. 2021;70(43):1520-1524. doi:10.15585/mmwr.mm7043e2. ; Bardenheier BH, Gravenstein S, Blackman C, et al. Adverse events following mRNA SARS-CoV-2 vaccination among U.S. nursing home residents. Vaccine. 2021;39(29):3844-3851. doi:10.1016/j.vaccine.2021.05.088. ; Rosenblum HG, Gee J, Liu R, et al. Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe. Lancet Infect Dis. 2022;22(6):802-812. doi:10.1016/S1473-3099(22)00054-8.
  • Contributed Indexing: Keywords: COVID-19; VAERS; death; reports; safety; vaccine
  • Substance Nomenclature: JT2NS6183B (Ad26COVS1) ; 0 (COVID-19 Vaccines) ; 0 (Vaccines)
  • Entry Date(s): Date Created: 20230222 Date Completed: 20230613 Latest Revision: 20240510
  • Update Code: 20240511

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