Facial Dermal Filler Injection and Vaccination: A 12-Year Review of Adverse Event Reporting and Literature Review

Abstract

Background Following authorization of two COVID-19 vaccinations in December 2020, media attention increased towards post-vaccine adverse events (AEs) in patients with facial dermal filler injections. Objectives The purpose was to characterize vaccine-related facial dermal filler AEs using the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. Methods The MAUDE database was queried from January 1, 2011 to January 28, 2023 for facial dermal filler reports discussing vaccination-related AEs. A PubMed (National Institutes of Health, Bethesda, MD) literature review on dermal filler AEs was then conducted. Data were analyzed with descriptive statistics. Results Of 10,637 reports identified, 33 were included. There were 25 reports (75.8%) related to COVID-19 vaccination. Six reports (18.1%) were received before December 2020. There were 13 reports (39.4%) from February to June 2021 and 14 (42.4%) from September to December 2022. Hyaluronic acid-based fillers were described in 31 reports (93.9%). AEs were mostly reported within days post-injection (n=7, 21.2%), but ranged from immediately (n=2, 6.1%) to months (n=6, 18.2%) post-injection. Most AEs were reported post-vaccine (n=17, 51.5%) versus post-filler (n=14, 42.4%). In 26 reports (78.8%), AEs occurred at the site of filler injection. Most reports described inflammation/swelling (n=21, 28.0%). The literature review returned 302 articles, of which 14 were included. Only 1 article (7.1%) was published in a plastic surgery journal. Conclusions While the pandemic brought attention to COVID-19 vaccine-related facial dermal filler AEs, our study shows a low incidence compared to millions of vaccine and filler injections administered. The authors also document reactions with non-COVID-19 vaccines. Increased awareness may help providers counsel patients undergoing vaccination and dermal filler implantation.