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
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 vacc...
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Veröffentlicht in: | The Lancet infectious diseases 2022-06, Vol.22 (6), p.802-812 |
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creator | 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 |
description | 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.
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).
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).
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.
US Centers for Disease Co |
doi_str_mv | 10.1016/S1473-3099(22)00054-8 |
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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).
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).
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.
US Centers for Disease Control and Prevention.</description><identifier>ISSN: 1473-3099</identifier><identifier>EISSN: 1474-4457</identifier><identifier>DOI: 10.1016/S1473-3099(22)00054-8</identifier><identifier>PMID: 35271805</identifier><language>eng</language><publisher>United States: Elsevier Ltd</publisher><subject>Adverse Drug Reaction Reporting Systems ; Adverse events ; Clinical trials ; Coronaviruses ; COVID-19 ; COVID-19 - prevention & control ; COVID-19 vaccines ; COVID-19 Vaccines - adverse effects ; Data analysis ; Disease control ; Emergency communications systems ; Ethnicity ; Females ; Headache ; Headaches ; Health care ; Health services ; Humans ; Immunization ; Infectious diseases ; Medical personnel ; mRNA ; mRNA Vaccines ; Observational studies ; RNA, Messenger ; Safety ; Surveillance ; Text messaging ; United States - epidemiology ; Vaccination - adverse effects ; Vaccines ; Vaccines, Synthetic</subject><ispartof>The Lancet infectious diseases, 2022-06, Vol.22 (6), p.802-812</ispartof><rights>2022 Elsevier Ltd</rights><rights>Copyright © 2022 Elsevier Ltd. All rights reserved.</rights><rights>2022. Elsevier Ltd</rights><rights>Published by Elsevier Ltd. 2022 Elsevier Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c495t-b909964187e54b90d1c1b1c838ed18bb464ae95d92ac6b805ebc2f4b873c0b9d3</citedby><cites>FETCH-LOGICAL-c495t-b909964187e54b90d1c1b1c838ed18bb464ae95d92ac6b805ebc2f4b873c0b9d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1473309922000548$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35271805$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rosenblum, Hannah G</creatorcontrib><creatorcontrib>Gee, Julianne</creatorcontrib><creatorcontrib>Liu, Ruiling</creatorcontrib><creatorcontrib>Marquez, Paige L</creatorcontrib><creatorcontrib>Zhang, Bicheng</creatorcontrib><creatorcontrib>Strid, Penelope</creatorcontrib><creatorcontrib>Abara, Winston E</creatorcontrib><creatorcontrib>McNeil, Michael M</creatorcontrib><creatorcontrib>Myers, Tanya R</creatorcontrib><creatorcontrib>Hause, Anne M</creatorcontrib><creatorcontrib>Su, John R</creatorcontrib><creatorcontrib>Markowitz, Lauri E</creatorcontrib><creatorcontrib>Shimabukuro, Tom T</creatorcontrib><creatorcontrib>Shay, David K</creatorcontrib><title>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</title><title>The Lancet infectious diseases</title><addtitle>Lancet Infect Dis</addtitle><description>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.
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).
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).
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.
US Centers for Disease Control and Prevention.</description><subject>Adverse Drug Reaction Reporting Systems</subject><subject>Adverse events</subject><subject>Clinical trials</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>COVID-19 - prevention & control</subject><subject>COVID-19 vaccines</subject><subject>COVID-19 Vaccines - adverse effects</subject><subject>Data analysis</subject><subject>Disease control</subject><subject>Emergency communications systems</subject><subject>Ethnicity</subject><subject>Females</subject><subject>Headache</subject><subject>Headaches</subject><subject>Health care</subject><subject>Health services</subject><subject>Humans</subject><subject>Immunization</subject><subject>Infectious diseases</subject><subject>Medical personnel</subject><subject>mRNA</subject><subject>mRNA Vaccines</subject><subject>Observational studies</subject><subject>RNA, Messenger</subject><subject>Safety</subject><subject>Surveillance</subject><subject>Text messaging</subject><subject>United States - epidemiology</subject><subject>Vaccination - adverse effects</subject><subject>Vaccines</subject><subject>Vaccines, Synthetic</subject><issn>1473-3099</issn><issn>1474-4457</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqFUU1v1DAUjBCIlsJPAFniAoeAndhJzAG02haoVFGpS3u1_PF219UmXmwn0v7A_i-cZKngxMn2e_PmjWey7DXBHwgm1ccVoXWZl5jzd0XxHmPMaN48yU5TmeaUsvrpdJ8hJ9mLEO4xJjXB9Hl2UrKiJg1mp9nDSq4hHpBbo_bmxwINUmvbQUDStLazIYIHg0zvbbdBcQsoFaOVO1Sh1nVxG8bJsX67Qsvru8vznPAjiYzWdWjv3cbLtoVPSHbIqQB-mDqJI8TeTKs97J2PAUU3cd3NItDCDOADoIsBuohuJtCoY3VIutrEZ9CQh_SBl9mztdwFeHU8z7Lbrxc_l9_zq-tvl8vFVa4pZzFXPHlRUdLUwGh6GKKJIropGzCkUYpWVAJnhhdSVyr5A0oXa6qautRYcVOeZZ9n3n2vWjA6yfJyJ_bettIfhJNW_Nvp7FZs3CAajglpSCJ4eyTw7lcPIYp71_vkRRBFVXHKCGFFQrEZpb0LwcP6cQPBYkxfTOmLMVpRFGJKXzRp7s3f8h6n_sSdAF9mACSTBgteBG2h02CsBx2FcfY_K34D4_PC1Q</recordid><startdate>20220601</startdate><enddate>20220601</enddate><creator>Rosenblum, Hannah G</creator><creator>Gee, Julianne</creator><creator>Liu, Ruiling</creator><creator>Marquez, Paige L</creator><creator>Zhang, Bicheng</creator><creator>Strid, Penelope</creator><creator>Abara, Winston E</creator><creator>McNeil, Michael M</creator><creator>Myers, Tanya R</creator><creator>Hause, Anne M</creator><creator>Su, John R</creator><creator>Markowitz, Lauri E</creator><creator>Shimabukuro, Tom T</creator><creator>Shay, David K</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><general>Elsevier Science ;, The Lancet Pub. 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prevention & control</topic><topic>COVID-19 vaccines</topic><topic>COVID-19 Vaccines - adverse effects</topic><topic>Data analysis</topic><topic>Disease control</topic><topic>Emergency communications systems</topic><topic>Ethnicity</topic><topic>Females</topic><topic>Headache</topic><topic>Headaches</topic><topic>Health care</topic><topic>Health services</topic><topic>Humans</topic><topic>Immunization</topic><topic>Infectious diseases</topic><topic>Medical personnel</topic><topic>mRNA</topic><topic>mRNA Vaccines</topic><topic>Observational studies</topic><topic>RNA, Messenger</topic><topic>Safety</topic><topic>Surveillance</topic><topic>Text messaging</topic><topic>United States - epidemiology</topic><topic>Vaccination - adverse effects</topic><topic>Vaccines</topic><topic>Vaccines, Synthetic</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rosenblum, Hannah G</creatorcontrib><creatorcontrib>Gee, Julianne</creatorcontrib><creatorcontrib>Liu, Ruiling</creatorcontrib><creatorcontrib>Marquez, Paige L</creatorcontrib><creatorcontrib>Zhang, Bicheng</creatorcontrib><creatorcontrib>Strid, Penelope</creatorcontrib><creatorcontrib>Abara, Winston E</creatorcontrib><creatorcontrib>McNeil, Michael M</creatorcontrib><creatorcontrib>Myers, Tanya R</creatorcontrib><creatorcontrib>Hause, Anne M</creatorcontrib><creatorcontrib>Su, John R</creatorcontrib><creatorcontrib>Markowitz, Lauri E</creatorcontrib><creatorcontrib>Shimabukuro, Tom T</creatorcontrib><creatorcontrib>Shay, David K</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Pharma and Biotech Premium PRO</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Nursing & Allied Health Database</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Lancet Titles</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The Lancet infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rosenblum, Hannah G</au><au>Gee, Julianne</au><au>Liu, Ruiling</au><au>Marquez, Paige L</au><au>Zhang, Bicheng</au><au>Strid, Penelope</au><au>Abara, Winston E</au><au>McNeil, Michael M</au><au>Myers, Tanya R</au><au>Hause, Anne M</au><au>Su, John R</au><au>Markowitz, Lauri E</au><au>Shimabukuro, Tom T</au><au>Shay, David K</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>The Lancet infectious diseases</jtitle><addtitle>Lancet Infect Dis</addtitle><date>2022-06-01</date><risdate>2022</risdate><volume>22</volume><issue>6</issue><spage>802</spage><epage>812</epage><pages>802-812</pages><issn>1473-3099</issn><eissn>1474-4457</eissn><abstract>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.
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).
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).
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.
US Centers for Disease Control and Prevention.</abstract><cop>United States</cop><pub>Elsevier Ltd</pub><pmid>35271805</pmid><doi>10.1016/S1473-3099(22)00054-8</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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source | MEDLINE; ScienceDirect Journals (5 years ago - present) |
subjects | Adverse Drug Reaction Reporting Systems Adverse events Clinical trials Coronaviruses COVID-19 COVID-19 - prevention & control COVID-19 vaccines COVID-19 Vaccines - adverse effects Data analysis Disease control Emergency communications systems Ethnicity Females Headache Headaches Health care Health services Humans Immunization Infectious diseases Medical personnel mRNA mRNA Vaccines Observational studies RNA, Messenger Safety Surveillance Text messaging United States - epidemiology Vaccination - adverse effects Vaccines Vaccines, Synthetic |
title | 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 |
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