key: cord-0889604-wzxanpqs authors: Robinson, Lacey B.; Landman, Adam B.; Shenoy, Erica S.; Hashimoto, Dean; Fu, Xiaoqing; Camargo, Carlos A.; Wickner, Paige; Blumenthal, Kimberly G. title: Allergic symptoms after mRNA COVID-19 vaccination and risk of incomplete vaccination date: 2021-06-11 journal: J Allergy Clin Immunol Pract DOI: 10.1016/j.jaip.2021.05.031 sha: 34a08e29248fafedff3eedc95b0b7f28cac9a53e doc_id: 889604 cord_uid: wzxanpqs nan vaccination. Anaphylaxis to the first dose is a contraindication to subsequent mRNA vaccination; 72 however, many mild or nonimmediate allergic symptoms are not. 1, 2 We sought to determine if 73 self-reported allergic symptoms were associated with incomplete vaccination. 74 We prospectively studied Mass General Brigham (MGB) employees who received their first 76 dose of mRNA COVID-19 vaccine between (12/16/2020 and 2/1/2021, with follow-up through 77 03/15/2021, eMethods). For the 3 days after vaccination, which was captured in the electronic 78 health record, employees completed symptom surveys through e-mail, text, phone, or employee 79 smartphone application links. Self-reported allergic symptoms included: itching or rash (other 80 than at the injection site), hives, swelling and/or respiratory symptoms (Repository Text). MGB 81 allergists were available to assess any employees who self-reported a symptom more severe than 82 itching and rash between doses. 83 84 We determined the frequency of self-reported allergic symptoms using the number of dose one 85 survey respondents as the denominator. We compared frequencies using chi-squared tests, 86 considering a 2-sided p-value <0.05 statistically significant. The primary outcome was 87 incomplete mRNA COVID-19 vaccination (i.e., did not receive dose two). We used a 88 multivariable logistic regression model to assess the association of self-reported allergic 89 symptoms and incomplete vaccination. We adjusted for age, sex, race, vaccine manufacturer, 90 MGB site and eligibility group. We also considered the exposure of severe allergic symptoms 91 (respiratory symptoms plus one of the following: itching or rash other than injection site, hives or 92 swelling total of 348 (0.7%) employees: 43 (3%) who self-reported allergic symptoms after dose one 103 versus 305 (0.6%) who did not. Incomplete vaccination was more common among women and 104 differed by MGB site, but not by race or eligibility group (Table 1) . 105 106 Self-reported allergic symptoms after dose one was associated with an increased odds of 107 incomplete vaccination (adjusted odds ratio (OR) 5.15, 95%CI: 3.75,7.06, p <0.001, Table 2 ). 108 Self-reported severe allergic symptoms were rare and associated with a markedly increased odds were 146 (17%) with recurrent allergic symptoms but none were severe. 114 In a prospective cohort of employees receiving mRNA COVID-19 vaccination, self-reported 117 allergic symptoms (reported by 2.5% after dose one) were associated with 5-fold increased odds 118 of incomplete vaccination. The vast majority of individuals (97%) with self-reported allergic 119 symptoms safely completed the vaccination series. 120 The two currently authorized mRNA COVID-19 vaccines require a two-dose vaccination 122 series. 3,4 The implications of incomplete vaccination remain unclear, but decreased vaccine 123 efficacy and/or durability are the primary public health concern. 124 125 Study limitations include the use of self-reported data, although the cohort included healthcare 126 workers, and therefore data reliability may be high. Hospital employees had direct access to 127 MGB allergists and allergy protocols for dose two administration, a level of specialist access 128 unlikely to be reproduced on a population level. As such, these findings likely represent a "best 129 care scenario," biasing results towards the null and likely to be a larger factor in other US 130 populations that are not healthcare employees and do not have easy access to specialist care. United 158 States Acute allergic reactions to mRNA COVID-19 vaccines Safety and 164 efficacy of the BNT162b2 mRNA Covid-19 vaccine Efficacy and safety of 167 the mRNA-1273 SARS-CoV-2 vaccine Delayed large local reactions to mRNA-1273 vaccine against SARS-CoV-2 Adverse 173 reactions to vaccines practice parameter: 2012 update