Can you safely get another COVID shot after a bad reaction? new study says maybe
NCT ID NCT05212610
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether it is safe to give another dose of a COVID-19 mRNA vaccine to people who had a bad reaction to a previous dose, or to people with a history of allergies. It also included people with long COVID. A total of 137 adults took part and received either the Pfizer or Moderna bivalent booster. The goal was to see how many had another allergic or non-allergic reaction after the shot.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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137 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Mar 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Michigan
Ann Arbor, Michigan, 48109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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