| アブストラクト | 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. |
|---|
| ジャーナル名 | The Lancet. Infectious diseases |
|---|
| 投稿日 | 2022/3/11 |
|---|
| 投稿者 | 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 |
|---|
| 組織名 | 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.;GA, USA. Electronic address: eocevent416@cdc.gov.;GA, USA. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/35271805/ |
|---|
