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Comparative safety ...
Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO international database
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- Kim, Min Seo (författare)
- Korea Univ, South Korea; Sungkyunkwan Univ, South Korea
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- Jung, Se Yong (författare)
- Yonsei Univ, South Korea
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- Ahn, Jong Gyun (författare)
- Yonsei Univ, South Korea
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- Park, Se Jin (författare)
- Eulji Univ, South Korea
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- Shoenfeld, Yehuda (författare)
- St Petersburg State Univ, Russia; Tel Aviv Univ, Israel
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- Kronbichler, Andreas (författare)
- Med Univ Innsbruck, Austria
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- Koyanagi, Ai (författare)
- Univ Barcelona, Spain; ICREA, Spain; CIBERSAM, Spain
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- Dragioti, Elena (författare)
- Linköpings universitet,Avdelningen för prevention, rehabilitering och nära vård,Medicinska fakulteten,Region Östergötland, Smärt och rehabiliteringscentrum
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- Tizaoui, Kalthoum (författare)
- Univ Tunis El Manar, Tunisia
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- Hong, Sung Hwi (författare)
- Yonsei Univ, South Korea
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- Jacob, Louis (författare)
- Univ Barcelona, Spain; Univ Versailles St Quentin Yvelines, France
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- Salem, Joe-Elie (författare)
- Sorbonne Univ, France; Hop La Pitie Salpetriere, France
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- Yon, Dong Keon (författare)
- Seoul Natl Univ, South Korea
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- Lee, Seung Won (författare)
- Sejong Univ, South Korea
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- Ogino, Shuji (författare)
- Dana Farber Harvard Canc Ctr, MA USA; Harvard TH Chan Sch Publ Hlth, MA USA; Harvard Med Sch, MA 02115 USA; Broad Inst MIT & Harvard, MA 02142 USA
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- Kim, Hanna (författare)
- Ewha Womans Univ, South Korea
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- Kim, Jerome H. (författare)
- Int Vaccine Inst, South Korea
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- Excler, Jean-Louis (författare)
- Int Vaccine Inst, South Korea
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- Marks, Florian (författare)
- Int Vaccine Inst, South Korea; Univ Cambridge, England; Univ Antananarivo, Madagascar
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- Clemens, John D. (författare)
- Int Vaccine Inst, South Korea; Int Ctr Diarrheal Dis Res, Bangladesh; UCLA Fielding Sch Publ Hlth, CA USA
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- Eisenhut, Michael (författare)
- Luton & Dunstable Univ Hosp, England
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- Barnett, Yvonne (författare)
- Anglia Ruskin Univ, England
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- Butler, Laurie (författare)
- Anglia Ruskin Univ, England
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- Ilie, Cristian Petre (författare)
- Queen Elizabeth Hosp Fdn Trust, England
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- Shin, Eui-Cheol (författare)
- Korea Adv Inst Sci & Technol, South Korea; Korea Adv Inst Sci & Technol, South Korea
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- Shin, Jae Il (författare)
- Yonsei Univ, South Korea
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- Smith, Lee (författare)
- Anglia Ruskin Univ, England
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(creator_code:org_t)
- 2021-11-08
- 2022
- Engelska.
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Ingår i: Journal of Medical Virology. - : WILEY. - 0146-6615 .- 1096-9071. ; 94:3, s. 1085-1095
- Relaterad länk:
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https://onlinelibrar...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Two messenger RNA (mRNA) vaccines developed by Pfizer-BioNTech and Moderna are being rolled out. Despite the high volume of emerging evidence regarding adverse events (AEs) associated with the COVID-19 mRNA vaccines, previous studies have thus far been largely based on the comparison between vaccinated and unvaccinated control, possibly highlighting the AE risks with COVID-19 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 18 755 and 27 895 individuals who reported to VigiBase for adverse events following immunization (AEFI) with mRNA COVID-19 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-19 vaccine, while injection site reactogenicity events were more prevalent with the influenza vaccine. Compared to the influenza vaccine, mRNA COVID-19 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], 2.47-65.54), and supraventricular tachycardia (adjusted ROR, 7.94; 95% CI, 2.62-24.00), but lower risk of neurological complications such as syncope, neuralgia, loss of consciousness, Guillain-Barre syndrome, gait disturbance, visual impairment, and dyskinesia. This study has not identified significant safety concerns regarding mRNA vaccination in real-world settings. The overall safety profile patterned a lower risk of serious AEFI following mRNA vaccines compared to influenza vaccines.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
Nyckelord
- COVID-19; influenza vaccine; mRNA vaccine; post-implementation surveillance; safety; VigiBase
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Kim, Min Seo
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Jung, Se Yong
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Ahn, Jong Gyun
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Park, Se Jin
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Shoenfeld, Yehud ...
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Kronbichler, And ...
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visa fler...
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Koyanagi, Ai
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Dragioti, Elena
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Tizaoui, Kalthou ...
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Hong, Sung Hwi
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Jacob, Louis
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Salem, Joe-Elie
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Yon, Dong Keon
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Lee, Seung Won
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Ogino, Shuji
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Kim, Hanna
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Kim, Jerome H.
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Excler, Jean-Lou ...
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Marks, Florian
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Clemens, John D.
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Eisenhut, Michae ...
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Barnett, Yvonne
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Butler, Laurie
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Ilie, Cristian P ...
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Shin, Eui-Cheol
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Shin, Jae Il
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Smith, Lee
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