Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose
Introduction COVID-19 vaccines were rapidly authorised, thus requiring intense post-marketing re-evaluation of their benefit-risk profile. A multi-national European collaboration was established with the aim to prospectively monitor safety of the COVID-19 vaccines through web-based survey of vaccine...
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Veröffentlicht in: | Drug safety 2023-04, Vol.46 (4), p.391-404 |
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creator | Raethke, Monika van Hunsel, Florence Thurin, Nicolas H. Dureau-Pournin, Caroline Mentzer, Dirk Kovačić, Barbara Mirošević Skvrce, Nikica De Clercq, Evelien Sabbe, Martine Trifirò, Gianluca Luxi, Nicoletta Giovanazzi, Alexia Shakir, Saad Klungel, Olaf H. Schmikli, Sandor Sturkenboom, Miriam |
description | Introduction
COVID-19 vaccines were rapidly authorised, thus requiring intense post-marketing re-evaluation of their benefit-risk profile. A multi-national European collaboration was established with the aim to prospectively monitor safety of the COVID-19 vaccines through web-based survey of vaccinees.
Methods
A prospective cohort event monitoring study was conducted with primary consented data collection in seven European countries. Through the web applications, participants received and completed baseline and up to six follow-up questionnaires on self-reported adverse reactions for at least 6 months following the first dose of COVID-19 vaccine (Netherlands, France, Belgium, UK, Italy) and baseline and up to ten follow-up questionnaires for one year in Germany and Croatia. Rates of adverse reactions have been described by type (solicited, non-solicited; serious/non-serious; and adverse events of special interest) and stratified by vaccine brand. We calculated the frequency of adverse reaction after dose 1 and prior to dose 2 among all vaccinees who completed at least one follow-up questionnaire.
Results
Overall, 117,791 participants were included and completed the first questionnaire in addition to the baseline: 88,196 (74.9%) from Germany, 27,588 (23.4%) from Netherlands, 984 (0.8%) from France, 570 (0.5%) from Italy, 326 (0.3%) from Croatia, 89 (0.1%) from the UK and 38 (0.03%) from Belgium. There were 89,377 (75.9%) respondents who had received AstraZeneca vaccines, 14,658 (12.4%) BioNTech/Pfizer, 11,266 (9.6%) Moderna and 2490 (2.1%) Janssen vaccines as a first dose. Median age category was 40–49 years for all vaccines except for Pfizer where median age was 70–79 years. Most vaccinees were female with a female-to-male ratio of 1.34, 1.96 and 2.50 for AstraZeneca, Moderna and Janssen, respectively. BioNtech/Pfizer had slightly more men with a ratio of 0.82. Fatigue and headache were the most commonly reported solicited systemic adverse reactions and injection-site pain was the most common solicited local reaction. The rates of adverse events of special interest (AESIs) were 0.1–0.2% across all vaccine brands.
Conclusion
This large-scale prospective study of COVID-19 vaccine recipients showed, for all the studied vaccines, a high frequency of systemic reactions, related to the immunogenic response, and local reactions at the injection site, while serious reactions or AESIs were uncommon, consistent with those reported on product labels. This study demon |
doi_str_mv | 10.1007/s40264-023-01281-9 |
format | Article |
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COVID-19 vaccines were rapidly authorised, thus requiring intense post-marketing re-evaluation of their benefit-risk profile. A multi-national European collaboration was established with the aim to prospectively monitor safety of the COVID-19 vaccines through web-based survey of vaccinees.
Methods
A prospective cohort event monitoring study was conducted with primary consented data collection in seven European countries. Through the web applications, participants received and completed baseline and up to six follow-up questionnaires on self-reported adverse reactions for at least 6 months following the first dose of COVID-19 vaccine (Netherlands, France, Belgium, UK, Italy) and baseline and up to ten follow-up questionnaires for one year in Germany and Croatia. Rates of adverse reactions have been described by type (solicited, non-solicited; serious/non-serious; and adverse events of special interest) and stratified by vaccine brand. We calculated the frequency of adverse reaction after dose 1 and prior to dose 2 among all vaccinees who completed at least one follow-up questionnaire.
Results
Overall, 117,791 participants were included and completed the first questionnaire in addition to the baseline: 88,196 (74.9%) from Germany, 27,588 (23.4%) from Netherlands, 984 (0.8%) from France, 570 (0.5%) from Italy, 326 (0.3%) from Croatia, 89 (0.1%) from the UK and 38 (0.03%) from Belgium. There were 89,377 (75.9%) respondents who had received AstraZeneca vaccines, 14,658 (12.4%) BioNTech/Pfizer, 11,266 (9.6%) Moderna and 2490 (2.1%) Janssen vaccines as a first dose. Median age category was 40–49 years for all vaccines except for Pfizer where median age was 70–79 years. Most vaccinees were female with a female-to-male ratio of 1.34, 1.96 and 2.50 for AstraZeneca, Moderna and Janssen, respectively. BioNtech/Pfizer had slightly more men with a ratio of 0.82. Fatigue and headache were the most commonly reported solicited systemic adverse reactions and injection-site pain was the most common solicited local reaction. The rates of adverse events of special interest (AESIs) were 0.1–0.2% across all vaccine brands.
Conclusion
This large-scale prospective study of COVID-19 vaccine recipients showed, for all the studied vaccines, a high frequency of systemic reactions, related to the immunogenic response, and local reactions at the injection site, while serious reactions or AESIs were uncommon, consistent with those reported on product labels. This study demonstrated the feasibility of setting up and conducting cohort event monitoring across multiple European countries to collect safety data on novel vaccines that are rolled out at scale in populations which may not have been included in pivotal trials.</description><identifier>ISSN: 0114-5916</identifier><identifier>EISSN: 1179-1942</identifier><identifier>DOI: 10.1007/s40264-023-01281-9</identifier><identifier>PMID: 37024736</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Adult ; Adverse events ; Aged ; Alliances ; Applications programs ; Belgium ; COVID-19 - epidemiology ; COVID-19 - prevention & control ; COVID-19 vaccines ; COVID-19 Vaccines - adverse effects ; Data collection ; Drug dosages ; Drug Safety and Pharmacovigilance ; Europe - epidemiology ; Feasibility studies ; Female ; Females ; Headache ; Humans ; Immunization ; Immunogenicity ; Injection ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Monitoring ; Original Research Article ; Pain ; Pharmacology/Toxicology ; Prospective Studies ; Questionnaires ; Risk assessment ; Safety ; Side effects ; Vaccines</subject><ispartof>Drug safety, 2023-04, Vol.46 (4), p.391-404</ispartof><rights>The Author(s), under exclusive licence to Springer Nature Switzerland AG 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.</rights><rights>Copyright Springer Nature B.V. Apr 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c419t-a1c1127abb021462e801d8ab141b6be95263f84d17207107a68d906dfb7ad0af3</citedby><cites>FETCH-LOGICAL-c419t-a1c1127abb021462e801d8ab141b6be95263f84d17207107a68d906dfb7ad0af3</cites><orcidid>0000-0003-2824-1087 ; 0000-0003-1147-7296 ; 0000-0003-1360-2388 ; 0000-0002-3643-683X ; 0000-0002-5334-1840 ; 0000-0001-8965-3224 ; 0000-0003-3589-0819</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s40264-023-01281-9$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40264-023-01281-9$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37024736$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Raethke, Monika</creatorcontrib><creatorcontrib>van Hunsel, Florence</creatorcontrib><creatorcontrib>Thurin, Nicolas H.</creatorcontrib><creatorcontrib>Dureau-Pournin, Caroline</creatorcontrib><creatorcontrib>Mentzer, Dirk</creatorcontrib><creatorcontrib>Kovačić, Barbara</creatorcontrib><creatorcontrib>Mirošević Skvrce, Nikica</creatorcontrib><creatorcontrib>De Clercq, Evelien</creatorcontrib><creatorcontrib>Sabbe, Martine</creatorcontrib><creatorcontrib>Trifirò, Gianluca</creatorcontrib><creatorcontrib>Luxi, Nicoletta</creatorcontrib><creatorcontrib>Giovanazzi, Alexia</creatorcontrib><creatorcontrib>Shakir, Saad</creatorcontrib><creatorcontrib>Klungel, Olaf H.</creatorcontrib><creatorcontrib>Schmikli, Sandor</creatorcontrib><creatorcontrib>Sturkenboom, Miriam</creatorcontrib><title>Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose</title><title>Drug safety</title><addtitle>Drug Saf</addtitle><addtitle>Drug Saf</addtitle><description>Introduction
COVID-19 vaccines were rapidly authorised, thus requiring intense post-marketing re-evaluation of their benefit-risk profile. A multi-national European collaboration was established with the aim to prospectively monitor safety of the COVID-19 vaccines through web-based survey of vaccinees.
Methods
A prospective cohort event monitoring study was conducted with primary consented data collection in seven European countries. Through the web applications, participants received and completed baseline and up to six follow-up questionnaires on self-reported adverse reactions for at least 6 months following the first dose of COVID-19 vaccine (Netherlands, France, Belgium, UK, Italy) and baseline and up to ten follow-up questionnaires for one year in Germany and Croatia. Rates of adverse reactions have been described by type (solicited, non-solicited; serious/non-serious; and adverse events of special interest) and stratified by vaccine brand. We calculated the frequency of adverse reaction after dose 1 and prior to dose 2 among all vaccinees who completed at least one follow-up questionnaire.
Results
Overall, 117,791 participants were included and completed the first questionnaire in addition to the baseline: 88,196 (74.9%) from Germany, 27,588 (23.4%) from Netherlands, 984 (0.8%) from France, 570 (0.5%) from Italy, 326 (0.3%) from Croatia, 89 (0.1%) from the UK and 38 (0.03%) from Belgium. There were 89,377 (75.9%) respondents who had received AstraZeneca vaccines, 14,658 (12.4%) BioNTech/Pfizer, 11,266 (9.6%) Moderna and 2490 (2.1%) Janssen vaccines as a first dose. Median age category was 40–49 years for all vaccines except for Pfizer where median age was 70–79 years. Most vaccinees were female with a female-to-male ratio of 1.34, 1.96 and 2.50 for AstraZeneca, Moderna and Janssen, respectively. BioNtech/Pfizer had slightly more men with a ratio of 0.82. Fatigue and headache were the most commonly reported solicited systemic adverse reactions and injection-site pain was the most common solicited local reaction. The rates of adverse events of special interest (AESIs) were 0.1–0.2% across all vaccine brands.
Conclusion
This large-scale prospective study of COVID-19 vaccine recipients showed, for all the studied vaccines, a high frequency of systemic reactions, related to the immunogenic response, and local reactions at the injection site, while serious reactions or AESIs were uncommon, consistent with those reported on product labels. This study demonstrated the feasibility of setting up and conducting cohort event monitoring across multiple European countries to collect safety data on novel vaccines that are rolled out at scale in populations which may not have been included in pivotal trials.</description><subject>Adult</subject><subject>Adverse events</subject><subject>Aged</subject><subject>Alliances</subject><subject>Applications programs</subject><subject>Belgium</subject><subject>COVID-19 - epidemiology</subject><subject>COVID-19 - prevention & control</subject><subject>COVID-19 vaccines</subject><subject>COVID-19 Vaccines - adverse effects</subject><subject>Data collection</subject><subject>Drug dosages</subject><subject>Drug Safety and Pharmacovigilance</subject><subject>Europe - epidemiology</subject><subject>Feasibility studies</subject><subject>Female</subject><subject>Females</subject><subject>Headache</subject><subject>Humans</subject><subject>Immunization</subject><subject>Immunogenicity</subject><subject>Injection</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Monitoring</subject><subject>Original Research Article</subject><subject>Pain</subject><subject>Pharmacology/Toxicology</subject><subject>Prospective Studies</subject><subject>Questionnaires</subject><subject>Risk assessment</subject><subject>Safety</subject><subject>Side 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H.</creator><creator>Dureau-Pournin, Caroline</creator><creator>Mentzer, Dirk</creator><creator>Kovačić, Barbara</creator><creator>Mirošević Skvrce, Nikica</creator><creator>De Clercq, Evelien</creator><creator>Sabbe, Martine</creator><creator>Trifirò, Gianluca</creator><creator>Luxi, Nicoletta</creator><creator>Giovanazzi, Alexia</creator><creator>Shakir, Saad</creator><creator>Klungel, Olaf H.</creator><creator>Schmikli, Sandor</creator><creator>Sturkenboom, Miriam</creator><general>Springer International Publishing</general><general>Springer Nature 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Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose</title><author>Raethke, Monika ; van Hunsel, Florence ; Thurin, Nicolas H. ; Dureau-Pournin, Caroline ; Mentzer, Dirk ; Kovačić, Barbara ; Mirošević Skvrce, Nikica ; De Clercq, Evelien ; Sabbe, Martine ; Trifirò, Gianluca ; Luxi, Nicoletta ; Giovanazzi, Alexia ; Shakir, Saad ; Klungel, Olaf H. ; Schmikli, Sandor ; Sturkenboom, Miriam</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c419t-a1c1127abb021462e801d8ab141b6be95263f84d17207107a68d906dfb7ad0af3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adult</topic><topic>Adverse events</topic><topic>Aged</topic><topic>Alliances</topic><topic>Applications programs</topic><topic>Belgium</topic><topic>COVID-19 - epidemiology</topic><topic>COVID-19 - prevention & control</topic><topic>COVID-19 vaccines</topic><topic>COVID-19 Vaccines - adverse effects</topic><topic>Data collection</topic><topic>Drug dosages</topic><topic>Drug Safety and Pharmacovigilance</topic><topic>Europe - epidemiology</topic><topic>Feasibility studies</topic><topic>Female</topic><topic>Females</topic><topic>Headache</topic><topic>Humans</topic><topic>Immunization</topic><topic>Immunogenicity</topic><topic>Injection</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Monitoring</topic><topic>Original Research Article</topic><topic>Pain</topic><topic>Pharmacology/Toxicology</topic><topic>Prospective Studies</topic><topic>Questionnaires</topic><topic>Risk assessment</topic><topic>Safety</topic><topic>Side effects</topic><topic>Vaccines</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Raethke, Monika</creatorcontrib><creatorcontrib>van Hunsel, Florence</creatorcontrib><creatorcontrib>Thurin, 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Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</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>ProQuest Central China</collection><jtitle>Drug safety</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Raethke, Monika</au><au>van Hunsel, Florence</au><au>Thurin, Nicolas H.</au><au>Dureau-Pournin, Caroline</au><au>Mentzer, Dirk</au><au>Kovačić, Barbara</au><au>Mirošević Skvrce, Nikica</au><au>De Clercq, Evelien</au><au>Sabbe, Martine</au><au>Trifirò, Gianluca</au><au>Luxi, Nicoletta</au><au>Giovanazzi, Alexia</au><au>Shakir, Saad</au><au>Klungel, Olaf H.</au><au>Schmikli, Sandor</au><au>Sturkenboom, Miriam</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose</atitle><jtitle>Drug safety</jtitle><stitle>Drug Saf</stitle><addtitle>Drug Saf</addtitle><date>2023-04-01</date><risdate>2023</risdate><volume>46</volume><issue>4</issue><spage>391</spage><epage>404</epage><pages>391-404</pages><issn>0114-5916</issn><eissn>1179-1942</eissn><abstract>Introduction
COVID-19 vaccines were rapidly authorised, thus requiring intense post-marketing re-evaluation of their benefit-risk profile. A multi-national European collaboration was established with the aim to prospectively monitor safety of the COVID-19 vaccines through web-based survey of vaccinees.
Methods
A prospective cohort event monitoring study was conducted with primary consented data collection in seven European countries. Through the web applications, participants received and completed baseline and up to six follow-up questionnaires on self-reported adverse reactions for at least 6 months following the first dose of COVID-19 vaccine (Netherlands, France, Belgium, UK, Italy) and baseline and up to ten follow-up questionnaires for one year in Germany and Croatia. Rates of adverse reactions have been described by type (solicited, non-solicited; serious/non-serious; and adverse events of special interest) and stratified by vaccine brand. We calculated the frequency of adverse reaction after dose 1 and prior to dose 2 among all vaccinees who completed at least one follow-up questionnaire.
Results
Overall, 117,791 participants were included and completed the first questionnaire in addition to the baseline: 88,196 (74.9%) from Germany, 27,588 (23.4%) from Netherlands, 984 (0.8%) from France, 570 (0.5%) from Italy, 326 (0.3%) from Croatia, 89 (0.1%) from the UK and 38 (0.03%) from Belgium. There were 89,377 (75.9%) respondents who had received AstraZeneca vaccines, 14,658 (12.4%) BioNTech/Pfizer, 11,266 (9.6%) Moderna and 2490 (2.1%) Janssen vaccines as a first dose. Median age category was 40–49 years for all vaccines except for Pfizer where median age was 70–79 years. Most vaccinees were female with a female-to-male ratio of 1.34, 1.96 and 2.50 for AstraZeneca, Moderna and Janssen, respectively. BioNtech/Pfizer had slightly more men with a ratio of 0.82. Fatigue and headache were the most commonly reported solicited systemic adverse reactions and injection-site pain was the most common solicited local reaction. The rates of adverse events of special interest (AESIs) were 0.1–0.2% across all vaccine brands.
Conclusion
This large-scale prospective study of COVID-19 vaccine recipients showed, for all the studied vaccines, a high frequency of systemic reactions, related to the immunogenic response, and local reactions at the injection site, while serious reactions or AESIs were uncommon, consistent with those reported on product labels. This study demonstrated the feasibility of setting up and conducting cohort event monitoring across multiple European countries to collect safety data on novel vaccines that are rolled out at scale in populations which may not have been included in pivotal trials.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>37024736</pmid><doi>10.1007/s40264-023-01281-9</doi><tpages>14</tpages><orcidid>https://orcid.org/0000-0003-2824-1087</orcidid><orcidid>https://orcid.org/0000-0003-1147-7296</orcidid><orcidid>https://orcid.org/0000-0003-1360-2388</orcidid><orcidid>https://orcid.org/0000-0002-3643-683X</orcidid><orcidid>https://orcid.org/0000-0002-5334-1840</orcidid><orcidid>https://orcid.org/0000-0001-8965-3224</orcidid><orcidid>https://orcid.org/0000-0003-3589-0819</orcidid><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 0114-5916 |
ispartof | Drug safety, 2023-04, Vol.46 (4), p.391-404 |
issn | 0114-5916 1179-1942 |
language | eng |
recordid | cdi_proquest_journals_2805226061 |
source | MEDLINE; SpringerNature Journals |
subjects | Adult Adverse events Aged Alliances Applications programs Belgium COVID-19 - epidemiology COVID-19 - prevention & control COVID-19 vaccines COVID-19 Vaccines - adverse effects Data collection Drug dosages Drug Safety and Pharmacovigilance Europe - epidemiology Feasibility studies Female Females Headache Humans Immunization Immunogenicity Injection Male Medicine Medicine & Public Health Middle Aged Monitoring Original Research Article Pain Pharmacology/Toxicology Prospective Studies Questionnaires Risk assessment Safety Side effects Vaccines |
title | Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose |
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