Vaccine Safety

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.

As we await additional information about the Johnson & Johnson Covid-19 vaccine, we want 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 the importance of sharing this information with all patients and providers.

This information is shared on every Vaccine Information Statement of every vaccine, and mentioned at the end of Fact Sheets for Patients and Caregivers
for each COVID vaccine – but patients must be reminded and encouraged to read this information and know what to do if they experience or witness an adverse event.

Learn more about VAERS and V-safe 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)