The U.S. CDC and the FDA use ‘VAERS’ to track adverse reactions. Patient submissions and evidence of some underreporting show it doesn’t reveal a full picture.
BRUNSWICK, Maine — Since COVID-19 vaccinations first became available, the Center for Disease Control (CDC) warned the public about common side effects of the vaccine: soreness or swelling at the injection site– or fever, chills, tiredness, and/or a headache in the days following vaccination.
Occasionally, there are more serious reactions or “adverse reactions” to the vaccine. Federal authorities are tracking those reactions through an online database.
The database is called “VAERS,” or the “Vaccine Adverse Event Reporting System.” It’s not new. VAERS was established more than two decades ago and is co-managed by the U.S. Center for Disease Control and Prevention and the Food and Drug Administration (FDA).
VAERS is used to monitor adverse reactions to all approved vaccines, most recently, the COVID-19 vaccines.
Mid Coast Hospital Chief Medical Officer Chris Bowe said, “It’s really set up so information can be obtained if there’s an unusual or unexpected reaction.”
Bowe continues, “It’s a nice system in that individuals can report it themselves. Anyone can report.”
While patients can report any reaction, health care systems are required to report serious reactions.
According to the VAERS website, healthcare providers are required to report to VAERS when the following adverse events after vaccinations occur:
- Death
- A life-threatening event
- Inpatient hospitalization or prolongation of existing hospitalization
- A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
- A congenital anomaly/birth defect
- An important medical event that based on appropriate medical judgment may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.
Furthermore, healthcare providers are encouraged to report to VAERS any additional clinically significant AEs following vaccination, even if they are not sure if vaccination caused the event.
The FDA and the CDC use the data to spot concerning trends and determine how often and how widely they happen.
Maine CDC Director Dr. Nirav Shah said, “There have been a few instances of allergic reactions reported with the vaccines. Beyond that, there haven’t been new concerning signs.”
As of Monday, the database shows 100 adverse reactions to COVID-19 vaccines in Maine. Nine of them are characterized as ‘serious’ either by the health professional or patient who submitted the report.
However, VAERS data doesn’t tell a complete story.
Associate VP of Northern Light Pharmacy Matt Marston said, “With any reporting system, it’s only as good as the people who report the data.”
Because patients can submit reports, information may be incomplete, inaccurate, coincidental, or unverifiable.
The VAERS website underscores the challenges it faces in collecting accurate data, saying:
“VAERS is a passive reporting system, meaning that reports about adverse events are not automatically collected, but require a report to be filed to VAERS. VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. Reports vary in quality and completeness. They often lack details and sometimes can have information that contains errors.”
Furthermore, the protocol for VAERS use varies from hospital to hospital in Maine.
While there are just four reported cases of patients receiving epinephrine, or an ‘epi-pen’, following vaccination, a source working inside the Brunswick Recreation Center vaccination site, run by Mid Coast Hospital, tells NEWS CENTER Maine there have been five instances, just at that site, of epinephrine-pen use and emergency room visits.
Mid Coast Hospital’s Chris Bowe says this report is likely accurate, saying the Brunswick site has “probably” used epinephrine on vaccination patients five times.
Bowe says, following CDC guidance, the site has been liberal in epinephrine-pen use, particularly for patients who have used one in the past.
“We would err on the side of giving someone epinephrine rather than letting their condition worsen.”
In terms of the events not being logged into VAERS, Bowe says he will work to get to the bottom of it.
“I’ll go right to our log and we’ll verify everyone we called 911 on and re-check that those make it to VAERS,” Bowe said, “because it’s critical that it is.”
Bowe said any instance where medical personnel intervene should be reported.
“The more we report the better, no question about that.”
During the interviews, both Bowe and Marston underscored that adverse reactions are still rare.
At the Brunswick site where there were five uses of epinephrine-pens, that’s out of more than 10,000 vaccinations, comprising 0.05 percent.
Additionally, they all say the data shows your chances of getting COVID-19 and being severely ill far outweigh your chances of having an adverse reaction to the vaccine.
To ensure those with more severe reactions to a COVID-19 vaccine are properly cared for, folks are asked to wait in a monitoring area for at least 15 minutes following vaccination. Those with a history of allergic reactions will be asked to wait 30 minutes.
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