Evidence map›Paper›PMID 35271805›Full record

Observational studyThe Lancet. Infectious diseases2022

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.

Hannah G Rosenblum, Julianne Gee, Ruiling Liu, Paige L Marquez, Bicheng Zhang, Penelope Strid, Winston E Abara, Michael M McNeil, Tanya R Myers, Anne M Hause and 4 more

Abstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in The Lancet. Infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 112 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
112citing papers in PubMed, 6 pooled it
–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

112 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  4. COVID-19 vaccine induced myocarditis in young males: A systematic review.European journal of clinical investigation · 2023
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52 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Hannah G RosenblumCDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA; Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Julianne GeeCDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: eocevent416@cdc.gov.
Ruiling LiuCDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Paige L MarquezCDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Bicheng ZhangCDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Penelope StridCDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Winston E AbaraCDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Michael M McNeilCDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Tanya R MyersCDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Anne M HauseCDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
John R SuCDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Lauri E MarkowitzCDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Tom T ShimabukuroCDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
David K ShayCDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn December, 2020, two mRNA-based COVID-19 vaccines were authorised for use in the USA. We aimed to describe US surveillance data collected through the Vaccine Adverse Event Reporting System (VAERS), a passive system, and v-safe, a new active system, during the first 6 months of the US COVID-19 vaccination programme.

methodsIn this observational study, we analysed data reported to VAERS and v-safe during Dec 14, 2020, to June 14, 2021. VAERS reports were categorised as non-serious, serious, or death. Reporting rates were calculated using numbers of COVID-19 doses administered as the denominator. We analysed v-safe survey reports from days 0-7 after vaccination for reactogenicity, severity (mild, moderate, or severe), and health impacts (ie, unable to perform normal daily activities, unable to work, or received care from a medical professional).

findingsDuring the study period, 298 792 852 doses of mRNA vaccines were administered in the USA. VAERS processed 340 522 reports: 313 499 (92·1%) were non-serious, 22 527 (6·6%) were serious (non-death), and 4496 (1·3%) were deaths. Over half of 7 914 583 v-safe participants self-reported local and systemic reactogenicity, more frequently after dose two (4 068 447 [71·7%] of 5 674 420 participants for local reactogenicity and 4 018 920 [70·8%] for systemic) than after dose one (4 644 989 [68·6%] of 6 775 515 participants for local reactogenicity and 3 573 429 [52·7%] for systemic). Injection-site pain (4 488 402 [66·2%] of 6 775 515 participants after dose one and 3 890 848 [68·6%] of 5 674 420 participants after dose two), fatigue (2 295 205 [33·9%] participants after dose one and 3 158 299 participants [55·7%] after dose two), and headache (1 831 471 [27·0%] participants after dose one and 2 623 721 [46·2%] participants after dose two) were commonly reported during days 0-7 following vaccination. Reactogenicity was reported most frequently the day after vaccination; most reactions were mild. More reports of being unable to work, do normal activities, or of seeking medical care occurred after dose two (1 821 421 [32·1%]) than after dose one (808 963 [11·9%]); less than 1% of participants reported seeking medical care after vaccination (56 647 [0·8%] after dose one and 53 077 [0·9%] after dose two).

interpretationSafety data from more than 298 million doses of mRNA COVID-19 vaccine administered in the first 6 months of the US vaccination programme show that most reported adverse events were mild and short in duration.

fundingUS Centers for Disease Control and Prevention.

Indexed as

COVID-19COVID-19 VaccinesAdverse Drug Reaction Reporting SystemsHumansmRNA VaccinesRNA, MessengerUnited StatesVaccinationVaccines, SyntheticCOVID-19 VaccinesmRNA VaccinesRNA, MessengerVaccines, Synthetic

Identifiers

PMID35271805
PMCPMC8901181

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.