Are there any different side effects or safety concerns with the updated 2023-2024 formula mRNA vaccines?
No, the side effect and safety profile are the same as that of previous formulations.
The side effects have been similar to other routine vaccines- sore arm, redness, fatigue, fever, chills, headache, myalgia, and arthralgia. The side effects are temporary and mostly mild or moderate. Anaphylaxis has been observed following receipt of COVID-19 mRNA vaccines but this has been rare. Extremely rare cases of myocarditis or pericarditis have been reported – most often in males between 12-39 years of age. Additional information on common side effects and rare adverse reactions can be found here:
What is the safety testing that has been done on COVID-19 vaccines? How is vaccine safety monitored? How do we know it is safe long-term?
The safety follow-up for COVID-19 vaccines is essentially the same that it is for all vaccine trials. All vaccines are determined to be safe and effective before they are authorized or licensed.
Pediatric vaccine studies involve very close follow up and tracking of patient’s health status and medical care post vaccination (eg. monitoring side effects, medical visits, use of new medications or changes to previous medications, and other interactions post vaccination). All reported medical events are recorded and reviewed by the study team, sponsor, an independent safety monitoring board, an ethics committee, and the FDA. Children in these studies are often followed for one to two years post vaccination and their health status is monitored for vaccine safety.
Even after authorization or licensure, safety data are collected through Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), Clinical Immunization Safety Assessment (CISA), and pharmacovigilance. VAERS and VSD are specifically designed to monitor safety signals from simultaneous administration of multiple vaccines (ie co-administration). These programs collect information on an even larger number of persons who get vaccinated than can be collected during clinical studies.
Safety data beyond 2 years, is captured through studies performed post licensure. No licensed vaccines have been found to have an unexpected long-term safety problem, that was found only years or decades after introduction.
How do I report an adverse event related to administration of COVID-19 vaccine?
Healthcare providers are required by law to report to Vaccine Adverse Event Reporting System (VAERS):
Healthcare providers are strongly encouraged to report:
- Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether or not it is clear that a vaccine caused the adverse event
- Vaccine administration errors