Safety profile of human papilloma virus vaccines: an analysis of the US Vaccine Adverse Event Reporting System from 2007 to 2017
Aims Human papilloma virus (HPV) is the cause of different types of carcinoma. Despite the remarkable effectiveness of the HPV vaccines, there have been many complaints about their risk–benefit profile due to adverse events following immunization (AEFI). The purpose of this study is to analyse the s...
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| Veröffentlicht in: | British journal of clinical pharmacology 2019-03, Vol.85 (3), p.634-643 |
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| creator | Bonaldo, Giulia Vaccheri, Alberto D'Annibali, Ottavio Motola, Domenico |
| description | Aims
Human papilloma virus (HPV) is the cause of different types of carcinoma. Despite the remarkable effectiveness of the HPV vaccines, there have been many complaints about their risk–benefit profile due to adverse events following immunization (AEFI). The purpose of this study is to analyse the safety profile of the HPV vaccine basing on real‐life data derived from reports of suspected AEFIs collected in the US Vaccine Adverse Events Reporting System (VAERS) and assess if the searches on Google overlap with spontaneous reporting.
Methods
We collected all the reports in VAERS between January 2007 to December 2017 related to the HPV vaccines. A disproportionality analysis using reporting odds ratio (ROR) with 95% confidence interval was performed.
Results
Over the 10‐year period, 55 356 reports of AEFI related to HPV vaccines were retrieved in VAERS, corresponding to 224 863 vaccine‐event pairs. The highest number of reports was related to Gardasil (n = 42 244). The two events more frequently reported and statistically significant for HPV vaccines were dizziness (n = 6259; ROR = 2.60; 95% confidence interval 2.53–2.66) and syncope (n = 6004; ROR = 6.28; 95% confidence interval 6.12–6.44). The trends of spontaneous reporting and Google searches overlap.
Conclusion
The AEFI analysis showed that the events most frequently reported were non‐serious and listed in the corresponding summary of product characteristics. Potential safety signals arose regarding less frequent AEFIs that would deserve further investigation. It is extremely important to disseminate correct and evidence‐based scientific information. |
| doi_str_mv | 10.1111/bcp.13841 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6379209</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2159319850</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4151-92e420d3ab9398aef7b5859476681b779f0a547f85c4c782b6e9343262f29a9f3</originalsourceid><addsrcrecordid>eNp1kU1v1DAQhi0EokvhwB9APsIhrT_iOOaAVFYtIFUCsZSr5XjHXaMkTu0kKLf-dFxSKjgwlzm8j94Z6UHoJSUnNM9pY4cTyuuSPkIbyitRMMrEY7QhnFSFYIIeoWcp_SCEclqJp-iIE1GpsqYbdLszDsYFDzE43wIODh-mzvR4MINv29AZPPs4JTwba30P6S3OoelNuySf7vDxAPhqh7-vOT7bzxAT4PMZ-hF_hSHE0ffXeLekETrsYugwI0TiMeRN5XP0xJk2wYv7fYyuLs6_bT8Wl58_fNqeXRa2pIIWikHJyJ6bRnFVG3CyEbVQpayqmjZSKkeMKKWrhS2trFlTgeIlZxVzTBnl-DF6t_YOU9PB3ubvomn1EH1n4qKD8frfpPcHfR1mXXGpGFG54PV9QQw3E6RRdz5ZaFvTQ5iSZlQoTlUtSEbfrKiNIaUI7uEMJfrOmM7G9G9jmX31918P5B9FGThdgZ_Zz_L_Jv1--2Wt_AV1LJ-P</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2159319850</pqid></control><display><type>article</type><title>Safety profile of human papilloma virus vaccines: an analysis of the US Vaccine Adverse Event Reporting System from 2007 to 2017</title><source>MEDLINE</source><source>Wiley Free Content</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Wiley Online Library All Journals</source><creator>Bonaldo, Giulia ; Vaccheri, Alberto ; D'Annibali, Ottavio ; Motola, Domenico</creator><creatorcontrib>Bonaldo, Giulia ; Vaccheri, Alberto ; D'Annibali, Ottavio ; Motola, Domenico</creatorcontrib><description>Aims
Human papilloma virus (HPV) is the cause of different types of carcinoma. Despite the remarkable effectiveness of the HPV vaccines, there have been many complaints about their risk–benefit profile due to adverse events following immunization (AEFI). The purpose of this study is to analyse the safety profile of the HPV vaccine basing on real‐life data derived from reports of suspected AEFIs collected in the US Vaccine Adverse Events Reporting System (VAERS) and assess if the searches on Google overlap with spontaneous reporting.
Methods
We collected all the reports in VAERS between January 2007 to December 2017 related to the HPV vaccines. A disproportionality analysis using reporting odds ratio (ROR) with 95% confidence interval was performed.
Results
Over the 10‐year period, 55 356 reports of AEFI related to HPV vaccines were retrieved in VAERS, corresponding to 224 863 vaccine‐event pairs. The highest number of reports was related to Gardasil (n = 42 244). The two events more frequently reported and statistically significant for HPV vaccines were dizziness (n = 6259; ROR = 2.60; 95% confidence interval 2.53–2.66) and syncope (n = 6004; ROR = 6.28; 95% confidence interval 6.12–6.44). The trends of spontaneous reporting and Google searches overlap.
Conclusion
The AEFI analysis showed that the events most frequently reported were non‐serious and listed in the corresponding summary of product characteristics. Potential safety signals arose regarding less frequent AEFIs that would deserve further investigation. It is extremely important to disseminate correct and evidence‐based scientific information.</description><identifier>ISSN: 0306-5251</identifier><identifier>ISSN: 1365-2125</identifier><identifier>EISSN: 1365-2125</identifier><identifier>DOI: 10.1111/bcp.13841</identifier><identifier>PMID: 30569481</identifier><language>eng</language><publisher>England: John Wiley and Sons Inc</publisher><subject><![CDATA[Adolescent ; Adult ; Adverse Drug Reaction Reporting Systems - statistics & numerical data ; adverse events following immunization ; Child ; Child, Preschool ; Data Mining ; Dizziness - chemically induced ; Dizziness - epidemiology ; Female ; human papilloma virus ; Humans ; Infant ; Internet - statistics & numerical data ; Male ; Middle Aged ; Original ; Papillomavirus Infections - prevention & control ; Papillomavirus Vaccines - administration & dosage ; Papillomavirus Vaccines - adverse effects ; safety ; Self Report - statistics & numerical data ; Syncope - chemically induced ; Syncope - epidemiology ; United States - epidemiology ; Uterine Cervical Neoplasms - prevention & control ; Vaccination - adverse effects ; Vaccination - statistics & numerical data ; vaccine ; vaccine adverse event reporting system ; vaccinovigilance ; Young Adult]]></subject><ispartof>British journal of clinical pharmacology, 2019-03, Vol.85 (3), p.634-643</ispartof><rights>2018 The British Pharmacological Society</rights><rights>2018 The British Pharmacological Society.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4151-92e420d3ab9398aef7b5859476681b779f0a547f85c4c782b6e9343262f29a9f3</citedby><cites>FETCH-LOGICAL-c4151-92e420d3ab9398aef7b5859476681b779f0a547f85c4c782b6e9343262f29a9f3</cites><orcidid>0000-0001-6253-4014</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fbcp.13841$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbcp.13841$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,780,784,885,1416,1432,27922,27923,45572,45573,46407,46831</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30569481$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bonaldo, Giulia</creatorcontrib><creatorcontrib>Vaccheri, Alberto</creatorcontrib><creatorcontrib>D'Annibali, Ottavio</creatorcontrib><creatorcontrib>Motola, Domenico</creatorcontrib><title>Safety profile of human papilloma virus vaccines: an analysis of the US Vaccine Adverse Event Reporting System from 2007 to 2017</title><title>British journal of clinical pharmacology</title><addtitle>Br J Clin Pharmacol</addtitle><description>Aims
Human papilloma virus (HPV) is the cause of different types of carcinoma. Despite the remarkable effectiveness of the HPV vaccines, there have been many complaints about their risk–benefit profile due to adverse events following immunization (AEFI). The purpose of this study is to analyse the safety profile of the HPV vaccine basing on real‐life data derived from reports of suspected AEFIs collected in the US Vaccine Adverse Events Reporting System (VAERS) and assess if the searches on Google overlap with spontaneous reporting.
Methods
We collected all the reports in VAERS between January 2007 to December 2017 related to the HPV vaccines. A disproportionality analysis using reporting odds ratio (ROR) with 95% confidence interval was performed.
Results
Over the 10‐year period, 55 356 reports of AEFI related to HPV vaccines were retrieved in VAERS, corresponding to 224 863 vaccine‐event pairs. The highest number of reports was related to Gardasil (n = 42 244). The two events more frequently reported and statistically significant for HPV vaccines were dizziness (n = 6259; ROR = 2.60; 95% confidence interval 2.53–2.66) and syncope (n = 6004; ROR = 6.28; 95% confidence interval 6.12–6.44). The trends of spontaneous reporting and Google searches overlap.
Conclusion
The AEFI analysis showed that the events most frequently reported were non‐serious and listed in the corresponding summary of product characteristics. Potential safety signals arose regarding less frequent AEFIs that would deserve further investigation. It is extremely important to disseminate correct and evidence‐based scientific information.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Adverse Drug Reaction Reporting Systems - statistics & numerical data</subject><subject>adverse events following immunization</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Data Mining</subject><subject>Dizziness - chemically induced</subject><subject>Dizziness - epidemiology</subject><subject>Female</subject><subject>human papilloma virus</subject><subject>Humans</subject><subject>Infant</subject><subject>Internet - statistics & numerical data</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Original</subject><subject>Papillomavirus Infections - prevention & control</subject><subject>Papillomavirus Vaccines - administration & dosage</subject><subject>Papillomavirus Vaccines - adverse effects</subject><subject>safety</subject><subject>Self Report - statistics & numerical data</subject><subject>Syncope - chemically induced</subject><subject>Syncope - epidemiology</subject><subject>United States - epidemiology</subject><subject>Uterine Cervical Neoplasms - prevention & control</subject><subject>Vaccination - adverse effects</subject><subject>Vaccination - statistics & numerical data</subject><subject>vaccine</subject><subject>vaccine adverse event reporting system</subject><subject>vaccinovigilance</subject><subject>Young Adult</subject><issn>0306-5251</issn><issn>1365-2125</issn><issn>1365-2125</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kU1v1DAQhi0EokvhwB9APsIhrT_iOOaAVFYtIFUCsZSr5XjHXaMkTu0kKLf-dFxSKjgwlzm8j94Z6UHoJSUnNM9pY4cTyuuSPkIbyitRMMrEY7QhnFSFYIIeoWcp_SCEclqJp-iIE1GpsqYbdLszDsYFDzE43wIODh-mzvR4MINv29AZPPs4JTwba30P6S3OoelNuySf7vDxAPhqh7-vOT7bzxAT4PMZ-hF_hSHE0ffXeLekETrsYugwI0TiMeRN5XP0xJk2wYv7fYyuLs6_bT8Wl58_fNqeXRa2pIIWikHJyJ6bRnFVG3CyEbVQpayqmjZSKkeMKKWrhS2trFlTgeIlZxVzTBnl-DF6t_YOU9PB3ubvomn1EH1n4qKD8frfpPcHfR1mXXGpGFG54PV9QQw3E6RRdz5ZaFvTQ5iSZlQoTlUtSEbfrKiNIaUI7uEMJfrOmM7G9G9jmX31918P5B9FGThdgZ_Zz_L_Jv1--2Wt_AV1LJ-P</recordid><startdate>201903</startdate><enddate>201903</enddate><creator>Bonaldo, Giulia</creator><creator>Vaccheri, Alberto</creator><creator>D'Annibali, Ottavio</creator><creator>Motola, Domenico</creator><general>John Wiley and Sons Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6253-4014</orcidid></search><sort><creationdate>201903</creationdate><title>Safety profile of human papilloma virus vaccines: an analysis of the US Vaccine Adverse Event Reporting System from 2007 to 2017</title><author>Bonaldo, Giulia ; Vaccheri, Alberto ; D'Annibali, Ottavio ; Motola, Domenico</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4151-92e420d3ab9398aef7b5859476681b779f0a547f85c4c782b6e9343262f29a9f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Adverse Drug Reaction Reporting Systems - statistics & numerical data</topic><topic>adverse events following immunization</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Data Mining</topic><topic>Dizziness - chemically induced</topic><topic>Dizziness - epidemiology</topic><topic>Female</topic><topic>human papilloma virus</topic><topic>Humans</topic><topic>Infant</topic><topic>Internet - statistics & numerical data</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Original</topic><topic>Papillomavirus Infections - prevention & control</topic><topic>Papillomavirus Vaccines - administration & dosage</topic><topic>Papillomavirus Vaccines - adverse effects</topic><topic>safety</topic><topic>Self Report - statistics & numerical data</topic><topic>Syncope - chemically induced</topic><topic>Syncope - epidemiology</topic><topic>United States - epidemiology</topic><topic>Uterine Cervical Neoplasms - prevention & control</topic><topic>Vaccination - adverse effects</topic><topic>Vaccination - statistics & numerical data</topic><topic>vaccine</topic><topic>vaccine adverse event reporting system</topic><topic>vaccinovigilance</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bonaldo, Giulia</creatorcontrib><creatorcontrib>Vaccheri, Alberto</creatorcontrib><creatorcontrib>D'Annibali, Ottavio</creatorcontrib><creatorcontrib>Motola, Domenico</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bonaldo, Giulia</au><au>Vaccheri, Alberto</au><au>D'Annibali, Ottavio</au><au>Motola, Domenico</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety profile of human papilloma virus vaccines: an analysis of the US Vaccine Adverse Event Reporting System from 2007 to 2017</atitle><jtitle>British journal of clinical pharmacology</jtitle><addtitle>Br J Clin Pharmacol</addtitle><date>2019-03</date><risdate>2019</risdate><volume>85</volume><issue>3</issue><spage>634</spage><epage>643</epage><pages>634-643</pages><issn>0306-5251</issn><issn>1365-2125</issn><eissn>1365-2125</eissn><abstract>Aims
Human papilloma virus (HPV) is the cause of different types of carcinoma. Despite the remarkable effectiveness of the HPV vaccines, there have been many complaints about their risk–benefit profile due to adverse events following immunization (AEFI). The purpose of this study is to analyse the safety profile of the HPV vaccine basing on real‐life data derived from reports of suspected AEFIs collected in the US Vaccine Adverse Events Reporting System (VAERS) and assess if the searches on Google overlap with spontaneous reporting.
Methods
We collected all the reports in VAERS between January 2007 to December 2017 related to the HPV vaccines. A disproportionality analysis using reporting odds ratio (ROR) with 95% confidence interval was performed.
Results
Over the 10‐year period, 55 356 reports of AEFI related to HPV vaccines were retrieved in VAERS, corresponding to 224 863 vaccine‐event pairs. The highest number of reports was related to Gardasil (n = 42 244). The two events more frequently reported and statistically significant for HPV vaccines were dizziness (n = 6259; ROR = 2.60; 95% confidence interval 2.53–2.66) and syncope (n = 6004; ROR = 6.28; 95% confidence interval 6.12–6.44). The trends of spontaneous reporting and Google searches overlap.
Conclusion
The AEFI analysis showed that the events most frequently reported were non‐serious and listed in the corresponding summary of product characteristics. Potential safety signals arose regarding less frequent AEFIs that would deserve further investigation. It is extremely important to disseminate correct and evidence‐based scientific information.</abstract><cop>England</cop><pub>John Wiley and Sons Inc</pub><pmid>30569481</pmid><doi>10.1111/bcp.13841</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-6253-4014</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adult Adverse Drug Reaction Reporting Systems - statistics & numerical data adverse events following immunization Child Child, Preschool Data Mining Dizziness - chemically induced Dizziness - epidemiology Female human papilloma virus Humans Infant Internet - statistics & numerical data Male Middle Aged Original Papillomavirus Infections - prevention & control Papillomavirus Vaccines - administration & dosage Papillomavirus Vaccines - adverse effects safety Self Report - statistics & numerical data Syncope - chemically induced Syncope - epidemiology United States - epidemiology Uterine Cervical Neoplasms - prevention & control Vaccination - adverse effects Vaccination - statistics & numerical data vaccine vaccine adverse event reporting system vaccinovigilance Young Adult |
| title | Safety profile of human papilloma virus vaccines: an analysis of the US Vaccine Adverse Event Reporting System from 2007 to 2017 |
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