Background rates of adverse events of special interest for COVID-19 vaccine safety monitoring in the United States, 2019–2020
Vaccine·
- DOI
- 10.1016/j.vaccine.2022.11.003
- PMID
- 36404170
- PMCID
- PMC9640387
- OpenAlex
- —
- Study type
- Journal article
- Publisher
- Elsevier BV
- Article type
- journal-article
- Integrity
- current
Why this research matters now
The findings provide historical incidence-rate context for comparing post-vaccination adverse event rates within the same database. The abstract emphasizes the need to account for demographic and temporal variation when interpreting such comparisons.
Structured evidence summary
Research question
What were the incidence rates of 17 adverse events of special interest in U.S. administrative claims data during 2019-2020, for use as historical comparators in COVID-19 vaccine safety monitoring?
Study design
The study estimated incidence rates using six U.S. administrative claims databases covering January 1, 2019, through December 11, 2020. The data included Medicare claims for adults aged 65 years or older and commercial claims for adults.
Population and setting
The study included more than 100 million enrollees annually in U.S. Medicare and commercial insurance databases. The reported analyses considered age, sex, race or ethnicity, nursing home status in Medicare, and seasonal or pandemic-period variation.
Main findings
Incidence rates for most adverse events varied by database, age, sex, race or ethnicity, nursing home status, and season. Most rates were lower during March-May 2020 than during the same period in 2019 and later returned to pre-pandemic levels, although several events remained lower after May 2020 and some had higher rates.
Public-health relevance
The findings provide historical incidence-rate context for comparing post-vaccination adverse event rates within the same database. The abstract emphasizes the need to account for demographic and temporal variation when interpreting such comparisons.
Important limitations
The supplied abstract does not state specific study limitations. This summary is limited to the supplied single-article abstract and metadata; the original paper is required for decision-grade interpretation of data quality, case definitions, representativeness, and analytic methods.
GIDS interpretation
This article is discoverable as U.S.-based surveillance and vaccine-safety background evidence concerning adverse-event incidence rates. It supplies historical context only and does not establish or confirm a live surveillance signal.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 10 auditable classifier relationships to diseases, places, topics, and study design.