Evidence map›Paper›PMID 36404170›Full record

ArticleVaccine2023

Background rates of adverse events of special interest for COVID-19 vaccine safety monitoring in the United States, 2019-2020.

Keran Moll, Bradley Lufkin, Kathryn R Fingar, Cindy Ke Zhou, Ellen Tworkoski, Chianti Shi, Shayan Hobbi, Mao Hu, Minya Sheng, Jillian McCarty and 26 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed.

  1. Review
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  6. Observational
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  16. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

36 authors.

Keran MollIBM Consulting, Bethesda, MD, USA.
Bradley LufkinAcumen LLC, Burlingame, CA, USA.
Kathryn R FingarIBM Consulting, Bethesda, MD, USA.
Cindy Ke ZhouU.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
Ellen TworkoskiAcumen LLC, Burlingame, CA, USA.
Chianti ShiAcumen LLC, Burlingame, CA, USA.
Shayan HobbiIBM Consulting, Bethesda, MD, USA.
Mao HuAcumen LLC, Burlingame, CA, USA.
Minya ShengIBM Consulting, Bethesda, MD, USA.
Jillian McCartyIBM Consulting, Bethesda, MD, USA.
Shanlai ShangguanAcumen LLC, Burlingame, CA, USA.
Timothy BurrellIBM Consulting, Bethesda, MD, USA.
Yoganand ChillarigeAcumen LLC, Burlingame, CA, USA.
Jeff BeersIBM Consulting, Bethesda, MD, USA.
Patrick Saunders-HastingsGevity Inc, an Accenture Company, Ottawa, Canada.
Stella MuthuriIBM Consulting, Bethesda, MD, USA.
Kathryn EdwardsIBM Consulting, Bethesda, MD, USA.
Steven BlackIBM Consulting, Bethesda, MD, USA.
Jeff KelmanCenters for Medicare & Medicaid Services, Baltimore, MD, USA.
Christian ReichIQVIA, Falls Church, VA, USA.
Kandace L AmendOptum Epidemiology, Boston, MA, USA.
Djeneba Audrey DjiboAetna, Blue Bell, PA, USA.
Daniel BeachlerHealthCore, Inc, Wilmington, DE, USA.
Rachel P OgilvieOptum Epidemiology, Boston, MA, USA.
Alex SecoraIQVIA, Falls Church, VA, USA.
Cheryl N McMahill-WalravenAetna, Blue Bell, PA, USA.
John D SeegerOptum Epidemiology, Boston, MA, USA.
Patricia LloydU.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
Deborah ThompsonU.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
Rositsa DimovaU.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
Thomas MaCurdyAcumen LLC, Burlingame, CA, USA; Department of Economics, Stanford University, Stanford, CA, USA.
Joyce ObidiU.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
Steve AndersonU.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
Richard ForsheeU.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
Hui-Lee WongU.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
Azadeh ShoaibiU.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA. Electronic address: Azadeh.Shoaibi@fda.hhs.gov.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe U.S. Food and Drug Administration (FDA) Biologics Effectiveness and Safety (BEST) Initiative conducts active surveillance of adverse events of special interest (AESI) after COVID-19 vaccination. Historical incidence rates (IRs) of AESI are comparators to evaluate safety.

methodsWe estimated IRs of 17 AESI in six administrative claims databases from January 1, 2019, to December 11, 2020: Medicare claims for adults ≥ 65 years and commercial claims (Blue Health Intelligence®, CVS Health, HealthCore Integrated Research Database, IBM® MarketScan® Commercial Database, Optum pre-adjudicated claims) for adults < 65 years. IRs were estimated by sex, age, race/ethnicity (Medicare), and nursing home residency (Medicare) in 2019 and for specific periods in 2020.

resultsThe study included >100 million enrollees annually. In 2019, rates of most AESI increased with age. However, compared with commercially insured adults, Medicare enrollees had lower IRs of anaphylaxis (11 vs 12-19 per 100,000 person-years), appendicitis (80 vs 117-155), and narcolepsy (38 vs 41-53). Rates were higher in males than females for most AESI across databases and varied by race/ethnicity and nursing home status (Medicare). Acute myocardial infarction (Medicare) and anaphylaxis (all databases) IRs varied by season. IRs of most AESI were lower during March-May 2020 compared with March-May 2019 but returned to pre-pandemic levels after May 2020. However, rates of Bell's palsy, Guillain-Barré syndrome, narcolepsy, and hemorrhagic/non-hemorrhagic stroke remained lower in multiple databases after May 2020, whereas some AESI (e.g., disseminated intravascular coagulation) exhibited higher rates after May 2020 compared with 2019.

conclusionAESI background rates varied by database and demographics and fluctuated in March-December 2020, but most returned to pre-pandemic levels after May 2020. It is critical to standardize demographics and consider seasonal and other trends when comparing historical rates with post-vaccination AESI rates in the same database to evaluate COVID-19 vaccine safety.

Indexed as

AnaphylaxisCOVID-19NarcolepsyAdultAgedCOVID-19 VaccinesFemaleHumansMaleMedicareUnited StatesCOVID-19 VaccinesAdverse eventsBackground ratesCOVID-19Vaccine safety surveillance

Identifiers

PMID36404170
PMCPMC9640387

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.