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Background rates of adverse events of special interest for COVID-19 vaccine safety monitoring in the United States, 2019-2020
CONCLUSION: AESI background rates varied by database and demographics and fluctuated in March-December 2020, but most returned to pre-pandemic levels after May 2020. It is critical to standardize demographics and consider seasonal and other trends when comparing historical rates with post-vaccination AESI rates in the same database to evaluate COVID-19 vaccine safety.PMID:36404170 | DOI:10.1016/j.vaccine.2022.11.003
Source: Vaccine - November 20, 2022 Category: Allergy & Immunology Authors: Keran Moll Bradley Lufkin Kathryn R Fingar Cindy Ke Zhou Ellen Tworkoski Chianti Shi Shayan Hobbi Mao Hu Minya Sheng Jillian McCarty Shanlai Shangguan Timothy Burrell Yoganand Chillarige Jeff Beers Patrick Saunders-Hastings Stella Muthuri Kathryn Edwards Source Type: research

A post-marketing safety assessment of COVID-19 mRNA vaccination for serious adverse outcomes using administrative claims data linked with vaccination registry in a city of Japan
CONCLUSION: The findings suggested that the COVID-19 mRNA vaccine was generally safe, whilst a signal of pulmonary embolism following the first dose of the COVID-19 mRNA vaccine was observed.PMID:36371366 | DOI:10.1016/j.vaccine.2022.10.088
Source: Vaccine - November 12, 2022 Category: Allergy & Immunology Authors: Yoshinori Takeuchi Masao Iwagami Sachiko Ono Nobuaki Michihata Kohei Uemura Hideo Yasunaga Source Type: research

Changes in incidence rates of outcomes of interest in vaccine safety studies during the COVID-19 pandemic
CONCLUSION: Rates of some clinical outcomes during the pandemic changed and should not be used as historical background rates in vaccine safety studies. Inclusion of telehealth visits should be considered for vaccine studies involving Bell's palsy, ITP, and narcolepsy/cataplexy.PMID:35465977 | DOI:10.1016/j.vaccine.2022.04.037
Source: Vaccine - April 25, 2022 Category: Allergy & Immunology Authors: Stanley Xu Vennis Hong Lina S Sy Sungching C Glenn Denison S Ryan Kerresa L Morrissette Jennifer C Nelson Simon J Hambidge Bradley Crane Ousseny Zerbo Malini B DeSilva Jason M Glanz James G Donahue Elizabeth Liles Jonathan Duffy Lei Qian Source Type: research