Adverse reaction to vaccines
Conditions
Interventions
None listed
Sponsors
National Hospital Oraganizationa, Mie National Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Patients who had an adverse reaction after COVID-19 vaccination and gave informed consent for this study. The criteria for anaphylaxis were based on the Brighton criteria. *Matched control subjects who have consented to have blood samples taken and who have not experienced allergic symptoms by vaccination.
Exclusion criteria
Exclusion criteria: *Those who did not give informed consent. *Those who are judged to be ineligible by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient factors associated with the vaccine adverse reactions *demographics *history of anaphylaxis *comorbid allergic diseases *other underlying diseases *use of polyethylene glycol-containing cosmetics, daily necessities, and drugs | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory investigation of culprit components of vaccines and mechanisms to cause the reaction. *in vitro and in vivo tests using vaccines, vaccine components and polyethylene glycols - skin test (prick and intradermal) - specific IgE and IgG antibodies - basophil activation test - other immunological tests | — |
Countries
Japan
Contacts
Public ContactMizuho Nagao
National Hospital Organization Mie National Hospital Institute for Clinical Research
Outcome results
None listed