The California Immunization Coalition and our partners with CDC, CDPH and other health leaders are committed to safety, transparency and the sharing of information as it is available.
With the broad approval of COVID-19 vaccinations for children 5 years-11 years and previous recommendations for adolescents and adults, CIC wants to remind all of our partners and the public about the existing vaccine safety surveillance systems that have been in place for many years and emphasize the importance of sharing this information with all patients and providers.
Information about benefits and risks of each vaccine along with information about the disease(s) if prevents, is shared on every Vaccine Information Statement (VIS) of every vaccine, and mentioned at the end of Fact Sheets for Patients and Caregivers
for each COVID vaccine.
Reminder that it is Federal Law that providers administering vaccinations must make sure patients receive a VIS or other FDA approved document.
Patients must be reminded and encouraged to read this information and know what to do if they experience or witness an adverse event.
See below to learn more about our nation’s Vaccine Adverse Evernts Reporting System (VAERS) and V-safe surveillance system for COVID-19 vaccine and share broadly.
VAERS (Vaccine Adverse Event Reporting System) - Background
Established in 1990, the Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.
VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern. More about VAERS…
VAERS - The Facts
VAERS is a database that anyone can report any adverse event after a vaccine. It’s important to understand the difference between a vaccine adverse event and a vaccine adverse reaction; a vaccine adverse reaction is something that happens because of the vaccine, but an adverse event is something that simply happens after – there’s not necessarily a causal relationship between being vaccinated and what happened after.
Some events may in fact be causal, but just because they are listed in VAERS doesn’t mean the vaccine caused the event. For example, a broken arm occurring some time after a vaccine could be listed as an adverse event, but is not something that can be caused by a vaccine. Additionally, anyone can post anything to VAERS at any time – for the longest time there was an entry by someone claiming a vaccine turned them into the incredible hulk – nothing is verified.
VAERS exists as a sentinel program only. When people add events to the database, researchers can see if there are any patterns of new reactions occurring after vaccines, and if they see something, they can investigate it further to see if there actually is any causal link of that specific reaction to the vaccine.
In the case of deaths after COVID vaccine, (yes, they are adverse events – just like a car accident would be, but just because they are listed in VAERS, simply means that someone logged a death into the system. Not that the death was caused by the vaccine.
VAERS reports are monitored carefully by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).
Anyone can submit a report to VAERS including health care professionals, vaccine manufacturers, vaccine recipients, and parents or family members of people who have received a vaccine
For more information – Understanding the Vaccine Adverse Event Reporting System (VAERS)
V-Safe After Vaccination Health Checker
V-safe is a smartphone-based tool that uses text messaging and web surveys to give personalized health check-ins after you receive a COVID-19 vaccine. Through v-safe, you can quickly tell CDC if you have any side effects after getting a COVID-19 vaccine. This information helps CDC monitor the safety of COVID-19 vaccines in near real time. Depending on your answers to the v-safe questions, someone from CDC may call to check on you and get more information. V-safe will also remind you to get additional COVID-19 vaccine doses if you need one.
Parents and guardians can enroll their child in v-safe and complete health check-ins on their behalf after they have been vaccinated for COVID-19. Parents and guardians should use their smartphone to complete a separate v-safe registration for each child. All v-safe communications will be sent to the parent’s or guardian’s smartphone.