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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.
Rosenblum, Hannah G; Gee, Julianne; Liu, Ruiling; Marquez, Paige L; Zhang, Bicheng; Strid, Penelope; Abara, Winston E; McNeil, Michael M; Myers, Tanya R; Hause, Anne M; Su, John R; Markowitz, Lauri E; Shimabukuro, Tom T; Shay, David K.
  • Rosenblum HG; CDC 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.
  • Gee J; CDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: eocevent416@cdc.gov.
  • Liu R; CDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Marquez PL; CDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Zhang B; CDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Strid P; CDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Abara WE; CDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • McNeil MM; CDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Myers TR; CDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Hause AM; CDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Su JR; CDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Markowitz LE; CDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Shimabukuro TT; CDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
  • Shay DK; CDC COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Lancet Infect Dis ; 22(6): 802-812, 2022 06.
Article in English | MEDLINE | ID: covidwho-1730170
ABSTRACT

BACKGROUND:

In 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.

METHODS:

In 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).

FINDINGS:

During 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).

INTERPRETATION:

Safety 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.

FUNDING:

US Centers for Disease Control and Prevention.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Topics: Vaccines Limits: Humans Country/Region as subject: North America Language: English Journal: Lancet Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article Affiliation country: S1473-3099(22)00054-8

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Topics: Vaccines Limits: Humans Country/Region as subject: North America Language: English Journal: Lancet Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article Affiliation country: S1473-3099(22)00054-8