Anne M. Hause's research while affiliated with Centers for Disease Control and Prevention and other places

... The increased probability of local injection-site symptoms in female compared to male sex after any type of vaccination in this pediatric population is in accordance with previous reports on various vaccines (22,23). The current BNT162b2 assessment in young children is important as previous reports on safety of BNT162b2 administration in this age group either did not stratify for sex (18,24,25) or found no sex differences (26). ...

... Rare symptomatic myocarditis and pericarditis cases have been reported following immunization with messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccines (e.g., 17.7 cases per million second mRNA COVID-19 vaccine doses administered in US adolescents and 22.6 cases per million doses in a meta-analysis of data from [ 290 million mRNA COVID-19 vaccine doses) [7][8][9][10]. Typically, these have occurred more often in young males, after the second dose, and within days after vaccination [7,[9][10][11][12]. ...

... V-safe is a voluntary smartphone-based vaccine safety surveillance system established by CDC in December 2020 to collect data on reactions and health impacts for registrants reporting COVID-19 vaccination. 5 through November 21, 2021. On November 22, 2021, V-safe began prospectively collecting the type of vaccine administered during the same visit. ...

... This elevated risk of mRNA vaccination-associated myocarditis has also been reported in adolescent males, although these cases have generally been mild and the long-term prognosis is favourable [23][24][25][26][27][28][29][30][31][32] . No serious safety concerns have yet been raised in younger children; however, population-based studies assessing the risk of adverse events following vaccination compared with an unvaccinated group are lacking [33][34][35] . ...

... The LVRNA012 vaccine has 53.4% (95% CI, 33.7% to 67.2%) efficacy in preventing symptomatic SARS-CoV-2 infections 7 days after vaccination, while protection against more than moderate symptoms could not be definitively assessed because of the small number of cases. Although the protective efficacy of the vaccine against COVID-19 attenuates as the strain mutates and the neutralizing antibody titer decreases (18), it is encouraging to note that we found that the LVRNA012 vaccine maintained a high protective efficacy (63.6 [30.6, 80.9]) up to three months, in which the predominant strain prevalent in China was BA.5. Neutralising antibodies against SARS-CoV-2 XBB.1.5 ...

... The vaccines against SARS-CoV-2 have saved many lives, but adverse events have been reported. [1][2][3][4][5][6][7][8] The Centers for Disease Control and Prevention notes the possibility of rare complications, including anaphylaxis, thrombosis with thrombocytopenia syndrome (specifically after viral vector vaccines), Guillain-Barré Syndrome (specifically after viral vector vaccines), and myocarditis and pericarditis. 9-13 These complications were not reported in the vaccine clinical trials, emphasizing the limitations of these studies in capturing rare adverse events and highlighting the critical role of post-market surveillance. ...

... 9 According to the July 2022 KFF Vaccine Monitor poll, 81% of parents of unvaccinated children ages six months to four years also were concerned about serious side effects and a lack of knowledge existing about "long-term effects of the COVID-19 vaccine in children." 10 Despite these parental concerns, clinical trials have demonstrated that serious adverse events are rare. 11 Most adverse events in preauthorization trials were reported as being mild to moderate in severity and zero severe adverse events were reported for the Pfizer-BioNTech COVID-19 vaccine in children six months to four years and for the Moderna COVID-19 vaccine in children six months to five years. 11 Furthermore, while infection with COVID-19 could transiently affect fertility in males, fertility is not impaired in males or females after COVID-19 vaccination. ...

... Other countries that investigated the safety profile and AEs of the BNT162b2 vaccine in healthy children aged 5-11 years reported pain at the injection site, fatigue, headache, myalgia, and fever as commonly observed and occurring more frequently following the second dose than following the first dose [18][19][20][21]. Our study showed a similar trend. ...

... [17] Wang et al. reported that among [18] In contrast, a large study of 5.9 million women from a vaccine safety surveillance system called v-safe in the US reported a 1 % prevalence of menstrual irregularity or bleeding. [19] The variations in rates may be due to differences in study designs, lack of uniformity in the definition of menstrual outcomes, confounding, type of vaccine, and sampling, selection or recall bias leading to enriched samples. For example, registry-based studies with participants enrolled through routine presentation in clinics may report lower prevalence of menstrual disturbance whereas surveys designed to actively enroll participants can report higher prevalence. ...

... BNT162b2 in COVID-19 vaccine-experienced individuals ≥12 years of age had a safety and tolerability profile similar to that seen with original and the BA.5/BA.5-adapted and BA.1-adapted BNT162b2 vaccines [28][29][30][31] and induced substantial increases in neutralizing responses against Omicron XBB.1.5, EG.5.1, and BA.2.86. ...