{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T07:36:59Z","timestamp":1791877019742,"version":"4.3.4"},"reference-count":26,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2021,11,8]],"date-time":"2021-11-08T00:00:00Z","timestamp":1636329600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Two messenger RNA (mRNA) vaccines developed by Pfizer\u2010BioNTech and Moderna are being rolled out. Despite the high volume of emerging evidence regarding adverse events (AEs) associated with the COVID\u201019 mRNA vaccines, previous studies have thus far been largely based on the comparison between vaccinated and unvaccinated control, possibly highlighting\u00a0the AE risks with COVID\u201019 mRNA vaccination. Comparing the safety profile of mRNA vaccinated individuals with otherwise vaccinated individuals would enable a more relevant assessment for the safety of mRNA vaccination. We designed a comparative safety study between 18\u2009755 and 27\u2009895 individuals who reported to VigiBase for adverse events following immunization (AEFI) with mRNA COVID\u201019 and influenza vaccines, respectively, from January 1, 2020, to January 17, 2021. We employed disproportionality analysis to rapidly detect relevant safety signals and compared comparative risks of a diverse span of AEFIs for the vaccines. The safety profile of novel mRNA vaccines was divergent from that of influenza vaccines. The overall pattern suggested that systematic reactions like chill, myalgia, fatigue were more noticeable with the mRNA COVID\u201019 vaccine, while injection site reactogenicity events were more prevalent with the influenza vaccine. Compared to the influenza vaccine, mRNA COVID\u201019 vaccines demonstrated a significantly higher risk for a few manageable cardiovascular complications, such as hypertensive crisis (adjusted reporting odds ratio [ROR], 12.72; 95% confidence interval [CI], 2.47\u201365.54), and supraventricular tachycardia (adjusted ROR, 7.94; 95% CI, 2.62\u201324.00), but lower risk of neurological complications such as syncope, neuralgia, loss of consciousness, Guillain\u2010Barre syndrome, gait disturbance, visual impairment, and dyskinesia. This study has not identified significant safety concerns regarding mRNA vaccination in real\u2010world settings. The overall safety profile patterned a lower risk of serious AEFI following mRNA vaccines compared to influenza vaccines.<\/jats:p>","DOI":"10.1002\/jmv.27424","type":"journal-article","created":{"date-parts":[[2021,10,28]],"date-time":"2021-10-28T10:24:46Z","timestamp":1635416686000},"page":"1085-1095","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":59,"title":["Comparative safety of mRNA COVID\u201019 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO international database"],"prefix":"10.1002","volume":"94","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2115-7835","authenticated-orcid":false,"given":"Min Seo","family":"Kim","sequence":"first","affiliation":[{"name":"College of Medicine Korea University  Seoul Republic of Korea"},{"name":"Samsung Advanced Institute for Health Sciences and Technology (SAIHST) Sungkyunkwan University, Samsung Medical Center  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1337-563X","authenticated-orcid":false,"given":"Se Yong","family":"Jung","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Yonsei University College of Medicine  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jong Gyun","family":"Ahn","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Severance Children's Hospital, Yonsei University College of Medicine  South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Se Jin","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Eulji University School of Medicine  Daejeon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yehuda","family":"Shoenfeld","sequence":"additional","affiliation":[{"name":"Laboratory of the Mosaics of Autoimmunity Saint Petersburg State University  Saint\u2010Petersburg Russian Federation"},{"name":"Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center Affiliated to Tel\u2010Aviv University School of Medicine  Tel\u2010Hashomer Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Kronbichler","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine IV Medical University Innsbruck  Innsbruck Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ai","family":"Koyanagi","sequence":"additional","affiliation":[{"name":"Research and Development Unit, Parc Sanitari Sant Joan de D\u00e9u Universitat de Barcelona, Fundaci\u00f3 Sant Joan de D\u00e9u, CIBERSAM  Barcelona Spain"},{"name":"ICREA, Pg. Lluis Companys 23  Barcelona Spain"},{"name":"Instituto de Salud Carlos III Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Salud Mental, CIBERSAM  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Dragioti","sequence":"additional","affiliation":[{"name":"Pain and Rehabilitation Centre, and Department of Health, Medicine and Caring Sciences Link\u00f6ping University  Link\u00f6ping Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8524-6058","authenticated-orcid":false,"given":"Kalthoum","family":"Tizaoui","sequence":"additional","affiliation":[{"name":"Laboratory of Microorganismes and Active Biomolecules, Sciences Faculty of Tunis University Tunis El Manar  Tunis Tunisia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sung Hwi","family":"Hong","sequence":"additional","affiliation":[{"name":"Yonsei University College of Medicine  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1071-1239","authenticated-orcid":false,"given":"Louis","family":"Jacob","sequence":"additional","affiliation":[{"name":"Research and Development Unit, Parc Sanitari Sant Joan de D\u00e9u Universitat de Barcelona, Fundaci\u00f3 Sant Joan de D\u00e9u, CIBERSAM  Barcelona Spain"},{"name":"Faculty of Medicine University of Versailles Saint\u2010Quentin\u2010en\u2010Yvelines  Montigny\u2010le\u2010Bretonneux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joe\u2010Elie","family":"Salem","sequence":"additional","affiliation":[{"name":"Sorbonne Universit\u00e9, INSERM, CIC\u20101901 Paris\u2010Est, CLIP\u00b2 Galil\u00e9e, UNICO\u2010GRECO Cardio\u2010oncology Program, and Department of Pharmacology Piti\u00e9\u2010Salp\u00eatri\u00e8re Hospital, Assistance Publique\u2013H\u00f4pitaux de Paris  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1628-9948","authenticated-orcid":false,"given":"Dong Keon","family":"Yon","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Seoul National University Children's Hospital, Seoul National University College of Medicine  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5632-5208","authenticated-orcid":false,"given":"Seung Won","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Data Science Sejong University College of Software Convergence  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3909-2323","authenticated-orcid":false,"given":"Shuji","family":"Ogino","sequence":"additional","affiliation":[{"name":"Cancer Immunology and Cancer Epidemiology Programs Dana\u2010Farber Harvard Cancer Center  Boston Massachusetts USA"},{"name":"Department of Epidemiology Harvard TH Chan School of Public Health  Boston Massachusetts USA"},{"name":"Program in MPE Molecular Pathological Epidemiology, Department of Pathology, Brigham and Women's Hospital Harvard Medical School  Boston Massachusetts USA"},{"name":"Broad Institute of Massachusetts Institute of Technology and Harvard  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanna","family":"Kim","sequence":"additional","affiliation":[{"name":"College of Medicine, Ewha Womans University  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jerome H.","family":"Kim","sequence":"additional","affiliation":[{"name":"International Vaccine Institute  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Louis","family":"Excler","sequence":"additional","affiliation":[{"name":"International Vaccine Institute  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florian","family":"Marks","sequence":"additional","affiliation":[{"name":"International Vaccine Institute  Seoul Republic of Korea"},{"name":"Cambridge Institute of Therapeutic Immunology and Infectious Disease University of Cambridge School of Clinical Medicine  Cambridge UK"},{"name":"University of Antananarivo  Antananarivo Madagascar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John D.","family":"Clemens","sequence":"additional","affiliation":[{"name":"International Vaccine Institute  Seoul Republic of Korea"},{"name":"International Centre for Diarrheal Diseases Research  Dhaka Dhaka Bangladesh"},{"name":"UCLA Fielding School of Public Health  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Eisenhut","sequence":"additional","affiliation":[{"name":"Luton &amp; 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