Now that COVID-19 vaccines are approved for emergency use authorization by the Federal Drug Administration (FDA), researchers are continuing to monitor the vaccine to make sure nothing changes.
Now that COVID-19 vaccines have been deemed safe and are approved for emergency use authorization by the Federal Drug Administration (FDA), researchers are continuing to monitor the vaccine to make sure nothing changes.
This important research will add to the data from the clinical trials that have already deemed the COVID-19 vaccines safe after being provided to more than 30,000 participants.
There have been reports of rare, but serious allergic reactions occurring immediately after receiving the vaccine. These cases are being investigated. CDC currently recommends that people with a past history of severe allergic reaction after vaccination or injectable medication should talk to their doctor before getting the vaccine.
In the clinical trials, no additional safety concerns were found eight weeks after completing vaccination, providing a high level of confidence in vaccine safety.
Pain at the injection site is common and many people develop symptoms such as fatigue, headache, chills and muscle aches. These are mild to moderate in most people and typically resolve after 1-2 days. Lymph nodes may also become swollen and tender on the same side as the injection. These side effects occur because the immune system is responding normally to the vaccine. In general, these side effects are more severe after the second dose, and they may be less severe in older adults.
“It is possible that a rare vaccine-related problem could occur with longer follow-up in larger groups, and there are several monitoring systems in place to make sure any safety issues are quickly found and investigated,” said Dr. Edward Belongia, center director for the Center for Clinical Epidemiology and Population Health at Marshfield Clinic Research Institute.
Monitoring the vaccines for safety
The Immunization Safety Office of the Centers for Disease Control and Prevention (CDC) oversees four vaccine safety activities including the:
- Clinical Immunization Safety Assessment, which is a partnership between CDC and several U.S. medical centers that conduct clinical research on vaccine-associated health risks.
- Emergency Preparedness for Vaccine Safety, which is activated by the CDC in the event of a disease outbreak, to ensure that vaccines remain safe in the outbreak setting and during mass distribution.
- Vaccine Adverse Event Reporting System (VAERS), which is an early warning system that helps CDC and FDA monitor problems following vaccination. Anyone can report suspected vaccine reactions and issues to VAERS.
- Vaccine Safety Datalink (VSD), which is a collaboration between CDC and several health care organizations that allows for ongoing monitoring and pro-active searches of vaccine-related data. VSD will monitor both the effectiveness and safety of approved COVID-19 vaccines.
“These networks have been doing this research for many years, so they are accustomed to delivering answers to the public about the safety and effectiveness of vaccines quickly and efficiently,” said Dr. Thomas Boyce, pediatric infectious disease doctor at Marshfield Children’s and clinician researcher at Marshfield Clinic Research Institute. “This method was created to provide confidence to the public that the vaccines they receive are safe and that they work.”
Tracking COVID-19 vaccine safety
Some doctors call this type of research phase IV trials, but these large studies will be conducted on the newly-approved COVID-19 vaccines to look for rare side effects in specific populations.
The Vaccine Safety Datalink uses electronic health data from each participating site to conduct vaccine safety research after a vaccine is licensed or authorized for emergency use. In addition to CDC, the Vaccine Safety Datalink includes Harvard Pilgrim, Marshfield Clinic Research Institute, Health Partners Minnesota and five Kaiser Permanente sites (Colorado, Southern and Northern California, Oregon and Washington).
“This group of health care organizations brings together data from more than 12 million children and adults in the U.S.,” Dr. Boyce said. “We use the Datalink to monitor vaccine safety over time as well as with rapid cycle analysis to find safety issues in near-real time. Data used by the Datalink include outpatient, inpatient, emergency department and immunization data. It can find new safety concerns and confirm safety concerns from other sources such as the Vaccine Adverse Event Reporting System.”
For more information about the safety of the COVID-19 vaccine, talk to your doctor or visit this resource from the CDC.
Related links
Frequently asked questions about the COVID-19 vaccine
Vaccine development: A primer on the process and timeline
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Can I have a choice of which vaccine company I want the shot from. Example I would prefer the Johnson and Johnson one when it is available .
Hi Mary,
Most Marshfield Clinic Health System locations have the Pfizer vaccine at this time. Only one site has Moderna. We do not know if we will receive other COVID-19 vaccine products as they receive Emergency Use Authorization or FDA license. If you wish to receive a specific product, we recommend talking to your provider prior to scheduling to ensure they have the product on hand.
Thank you,
Jake
my husband has several allergies how will I kow if he can or should get the vaccine ?
Hi Mary,
We recommend that people with a history of severe allergies talk to their doctor prior to getting vaccinated. Due to the doctor's knowledge of your husband's medical history and past conditions, they should be able to best advise him.
If you'd like to read more about common questions related to the COVID vaccine, feel free to check out our following webpage: https://www.marshfieldclinic.org/specialties/infectious-diseases/covid-19-vaccine-faq
Thank you,
Jake
How is the data gathered after the vaccine is given? I think the information on these quickly developed meds is very important.
Within my family there are individuals who experience allergic reactions to meds and shots. How can they be protected?
Hi Ken,
Anyone can provide information about adverse effects of the vaccine to the Vaccine Adverse Event Reporting System found here: https://vaers.hhs.gov/. There are also many research studies going on throughout the U.S. that collect information from other sources. For instance, the Vaccine Safety Datalink uses information from electronic health records to determine if there are any adverse events.
You should talk to your doctor about the COVID-19 vaccine and these allergic reactions. There are certain precautions that can be taken to ensure your family is safe during vaccination.
Thanks,
Jake
I am wondering if everyone will be forced to get the vaccination or if it it will be our decision.
Hi Nancy.
You cannot currently be required to take the COVID-19 vaccine. However, certain employers may be able to require it in the future. For instance, many health care organizations throughout the U.S. require certain vaccinations. The COVID-19 vaccine may be included in the future.
Thanks,
Jake
Waiting to receive the vaccine. I'm 76 and a diabetic. My Dr. Is Haleem M.D. of Mfld., Clinic. I live close to the Steven's Point Center. Will to go to esther place.
Hi Dale,
Thank you for reaching out.
The COVID-19 vaccine is not available at this time for most patients. The Wisconsin Department of Health Services and CDC have prioritized front line health care workers, emergency responders and residents of long-term care facilities as the first to receive the vaccine. We are expecting further guidance from the state about the rollout of the vaccine beyond these groups in the coming weeks. We will communicate out to the community once the vaccine is available to additional groups.
For the latest updates, please feel free to check our online COVID hub: https://www.marshfieldclinic.org/coronavirus
We appreciate your patience,
Jake
This does not answer the question of how we can learn when it is available to those not front line workers, how to get on a list. I am 76 and have a chronic lung disorder.
Hi Carol,
Thank you for reaching out.
At this time, Marshfield Clinic Health System does not have waitlists. We are expecting further guidance from the state about the rollout of the vaccine beyond these groups in the coming weeks. We will communicate out to the community once the vaccine is available and if there is any update regarding waitlists.
We appreciate your patience as we continue to plan for mass vaccination in the coming months,
Jake
how will I know when I can sign up/make an appointment to get the vaccine and where do I sign up/make an appointment. I am a woman 76 years old? Regarding the covid=19caccine.
Hi Kathy,
The COVID-19 vaccine is not available at this time for most patients. The Wisconsin Department of Health Services and CDC have prioritized front line health care workers, first responders and residents of long-term care facilities as the first to receive the vaccine. We are expecting further guidance from the state about the rollout of the vaccine beyond these groups in the coming weeks. We will communicate out to the community once the vaccine is available. You can also watch our COVID-19 hub at marshfieldclinic.org/coronavirus for the latest updates. We appreciate your patience as we continue to plan for mass vaccination in the coming months.
Thank you,
Jake