assessing safety of coronavirus infection (covid-19) messenger rna (mrna) vaccine administration in the setting of a previous adverse reaction

Conditions: COVID-19; Corona Virus Infection

Summary: this study will evaluate the safety of administering an additional dose of an mrna covid-19 vaccine or mrna bivalent covid-19 booster vaccine to individuals who have had adverse reactions to a previous dose or administering an initial dose of an mrna covid-19 vaccine to individuals with a personal history of allergic reaction. in addition, this study will evaluate the safety of administering an initial or additional dose or bivalent booster of an mrna covid-19 vaccine to individuals experiencing an adverse reaction to a natural covid-19 infection ("long covid"). eligible participants enrolled in this trial will receive an initial or additional dose of either the pfizer-biontech covid-19 bivalent vaccine or the moderna covid-19 bivalent vaccine. participants will also be required to have 1-2 in person visits along with phone call follow up visits. we hypothesize that individuals who have had adverse reactions to a previous dose of an mrna covid-19 vaccine will tolerate an additional dose of the primary mrna vaccine or bivalent booster, as indicated, and those with a personal history of allergic reaction will tolerate an initial dose of an mrna covid-19 vaccine. we also hypothesize that those individuals experiencing an adverse reaction will tolerate an initial or additional dose of a primary mrna covid-19 bivalent vaccine, as indicated. the study hypothesizes that individuals that have had adverse reactions to a dose of an mrna covid-19 vaccine will tolerate an additional dose and those with a personal history of allergic reaction will tolerate vaccination with an mrna covid-19 vaccine.


Eligibility criteria:
inclusion criteria 1. age over 18. 2. participant must be able to understand and provide informed consent 3. no evidence of infectious illness (defined as fever \>38⁰c, vomiting, diarrhea, new cough, new shortness of breath, new congestion, new runny nose, new headache or sore throat) within 14 days of vaccine administration. 4. subjects must have a history of adverse reaction to either the pfizer-biontech mrna covid vaccination or the moderna mrna covid vaccination, a personal history of allergic reaction without prior mrna covid vaccination, or a history of adverse reaction to natural covid infection. 5. females of childbearing potential must have a negative pregnancy test prior to vaccination. exclusion criteria 1. under age 18 2. inability or unwillingness of a participant to give written informed consent 3. evidence of covid-19 infection within 21 days of vaccination visit 4. history of antibody agent or convalescent plasma for treatment or prevention of covid-19 within 90 days 5. individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech mrna covid-19 vaccination or the moderna mrna covid-19 vaccination. 6. history of underlying immune disorder. * pregnancy * immunocompromised * persons with primary or acquired immunodeficiency * persons on anti-rejection therapy following solid organ transplant or bone marrow transplant * persons on biologic therapeutic agents * persons with malignancy and ongoing or recent chemotherapy * persons receiving systemic immunosuppressive therapy, including corticosteroids equivalent to 20 mg/day of prednisone for 2 weeks * persons with chronic kidney disease stage 3 or higher * persons with history of significant pulmonary compromise

Keywords: mrna vaccine adverse reactions vaccine re-challenge allergic reactions long covid infection