Many people think that VAERS is the only way that we can monitor the safety of vaccines in the United States.
They are clearly unaware of the Vaccine Safety Datalink (VSD) and of the Clinical Immunization Safety Assessment (CISA) Project.
Clinical Immunization Safety Assessment (CISA) Project
CISA is a network of vaccine safety experts that can help health care providers evaluate their patients who may have had a reaction to a vaccine or a suspected vaccine injury.
“CISA is a national network of vaccine safety experts from the CDC’s Immunization Safety Office (ISO), seven medical research centers, and other partners, which provides a comprehensive vaccine safety public health service to the nation.”
Clinical Immunization Safety Assessment (CISA) Project
They can help health care providers and their patients figure out if it it would be safe to get another vaccine, when necessary, after a possible reaction to a previous dose.
- Fever After Influenza, Diphtheria-Tetanus-Acellular Pertussis, and Pneumococcal Vaccinations
- Primary ovarian insufficiency and human papilloma virus vaccines: a review of the current evidence
- Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women
- Case Report of Subcutaneous Nodules and Sterile Abscesses Due to Delayed Type Hypersensitivity to Aluminum-Containing Vaccines
- Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
CISA experts also do research about vaccine safety.
COVID-19 CISA Clinical Consultation
CISA consults have become particularly important as more and more people have been getting their COVID-19 vaccines.
Remember, our COVID-19 vaccines are rather reactogenic, meaning that they are a little more likely to cause minor side effects, like pain, fever, headache, and fatigue, etc., than many other vaccines.
And they are a little more likely to cause anaphylactic reactions, although at a much lower rate than most people likely think – at a rate of about 2.8 to 5 per million doses.
Combine all of that with some other reactions that have gotten a lot of media attention, like COVID arm, a delayed-injection site reaction, and inflammatory unilateral axillary adenopathy, swollen glands some folks get in their armpit, and you might see why some health care providers might need a little extra help when their patients have a possible reaction.
Fortunately, except for those who have had a severe allergic reaction or an immediate allergic reaction of any severity after a previous dose or known (diagnosed) allergy to a component of the vaccine, which are contraindications to COVID-19 vaccination, most others can be safely vaccinated and protected.
Still, knowing that CISA COVIDvax consults are available if your patient has a reaction and you are unsure if they should get a second dose to complete the series is reassuring.
A CISA COVIDvax consult might also be helpful if you are unsure if your patient has a contraindication before getting their first dose.
More on CISA:
- COVID-19 Vaccine Safety Monitoring Systems
- Side Effects After the Second Dose of the COVID-19 Vaccine
- I’m Not Anti-Vaccine, I Just Don’t Believe in the COVID-19 Vaccine
- COVID-19 Vaccination Questions and Answers
- The Truth About COVID-19 Vaccines
- COVID-19 Vaccines for the Immunocompromised
- COVID-19 Vaccine Safety Update
- Clinical Immunization Safety Assessment (CISA) Project
- CISA History
- Requesting a CISA Evaluation
- CISA Resources – includes an algorithm for the management of suspected allergic reactions to vaccines and an algorithm to assess causality after individual adverse events following immunizations.
- CDC – Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States