Incidence, Timing, and Long-Term Outcomes of COVID-19 Vaccine-Related Lymphadenopathy on Screening Mammography.

ABSTRACT

OBJECTIVE: To determine the incidence, timing, and long-term outcomes of unilateral axillary lymphadenopathy ipsilateral to vaccine site (UIAL) on screening mammography after COVID-19 vaccination. METHODS: This retrospective, multisite study included consecutive patients undergoing screening mammography February 8, 2021, to January 31, 2022, with at least 1 year of follow-up. UIAL was typically considered benign (BI-RADS 1 or 2) in the setting of recent (≤6 weeks) vaccination or BI-RADS 0 (ultrasound recommended) when accompanied by a breast finding or identified >6 weeks postvaccination. Vaccination status and manufacturer were obtained from regional registries. Lymphadenopathy rates in vaccinated patients with and without UIAL were compared using Pearson's χ2 test. RESULTS: There were 44,473 female patients (mean age 60.4 ± 11.4 years) who underwent screening mammography at five sites, and 40,029 (90.0%) received at least one vaccine dose. Ninety-four (0.2%) presented with UIAL, 1 to 191 days postvaccination (median 13.5 [interquartile range 5.0-31.0]). Incidence declined from 2.1% to 0.9% to ≤0.5% after 1, 2, and 3 weeks and persisted up to 36 weeks (P < .001). UIAL did not vary across manufacturer (P = .15). Of 94, 77 (81.9%) were BI-RADS 1 or 2 at screening. None were diagnosed with malignancy at 1-year follow-up. Seventeen (18.1%) were BI-RADS 0 at screening. At diagnostic workup, 13 (76.5%) were BI-RADS 1 or 2, 2 (11.8%) were BI-RADS 3, and 2 (11.8%) were BI-RADS 4. Both BI-RADS 4 patients had malignant status and ipsilateral breast malignancies. Of BI-RADS 3 patients, at follow-up, one was biopsied yielding benign etiology, and one was downgraded to BI-RADS 2. DISCUSSION: Isolated UIAL on screening mammography performed within 6 months of COVID-19 vaccination can be safely assessed as benign.