Three participants in the Moderna COVID-19 vaccine clinical trial experienced facial or lip swelling due to a suspected reaction with cosmetic fillers that they had received before getting the vaccine. When the FDA reviewed the efficacy and safety of the Moderna vaccine for emergency use authorization, two of these reactions were resolved as Serious Adverse Events (SAEs), meaning that the swelling caused by the reaction went away and did not cause harm.
How much concern are these reactions to the health of patients, and what does it mean when the FDA marks an SAE as “resolved”? Dr. Beth Lertzman, board-certified dermatologist for Rochester Regional Health, discusses the Moderna COVID-19 vaccine and how it impacts patients with cosmetic fillers.
When a reaction causes damage or disruption to the normal body structure or function, the FDA deems it a Serious Adverse Event. The reaction that the Moderna COVID-19 vaccine may cause with cosmetic fillers creates a disruption to normal body structure, which is why the FDA considered it a serious adverse event.
“The FDA marked the reaction as resolved, meaning it is confirmed that the swelling caused by the reaction does go away,” said Dr. Lertzman.
Serious Adverse Event reporting guidelines consider an SAE to be resolved when “the subject’s health has returned to his/her baseline status or all variables have returned to normal.”
“The potential reaction in patients with cosmetic fillers is not a serious concern to the health of the patient.”
“For patients with cosmetic fillers, reactions such as swelling have been reported from a variety of causes,” said Dr. Lertzman. “Swelling may occur after other vaccinations, viral infections, dental procedures, and more.”
Although the possibility of reactions exists, it is uncommon and treatable.
“Swelling at the site of cosmetic filler injections is usually completely resolved after treatment. It’s recommended that you make an appointment with the doctor who performed your procedure to discuss treatment of the swelling.”
Before getting cosmetic fillers, it’s important to note that some types of fillers are more prone to reactions than others. Talk with your dermatologist about your current health and discuss options before deciding on a procedure.
“Patients with cosmetic fillers should get the COVID-19 vaccine,” said Dr. Lertzman.
For patients planning on getting cosmetic fillers in the near future, it may be best to wait until after receiving the vaccine, Dr. Lertzman advises.
“Speak with your doctor before getting cosmetic fillers. It may be best to wait to receive the fillers until after receiving the COVID-19 vaccine to avoid the possibility of a reaction.”
Limited vaccine supply doesn’t currently allow for people to choose which brand of vaccine they receive. However, choosing becomes an option in the future, Dr. Lertzman recommends weighing the decision based on the type of cosmetic filler you have.
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