Patient Experiences With the COVID-19 Vaccination After Breast Cancer Treatment (LymphVAX)

This study aims to elicit patient experiences, choices, and side effects associated with the COVID-19 vaccine after breast cancer surgery. Lymph node swelling is a known and common side effect of both the Moderna and Pfizer COVID-19 vaccines. This is the body's normal reaction to the vaccine. It is worrisome that lymph node swelling after the vaccine mimics that found in breast cancer which has spread to the lymph nodes. This side effect will cause worry and anxiety amongst patients as a result. For patients who have had lymph node removal (axillary lymph node dissection or sentinel lymph node biopsy) and are at risk of lymphedema, the investigators are concerned that the lymph node swelling may tax the lymphatic system and incite lymphedema in those at risk or worsen it in those with BCRL. Fear of lymphedema is high in this population and the investigators need to better understand what risk, if any, lymph node swelling after the COVID-19 vaccine imparts to BCRL risk.

Study Overview

• Status: Completed
• Conditions: Covid19; Breast Cancer Related Lymphedema
• Intervention / Treatment: Other: Survey

Detailed Description

• Hypothesis 1: Patients will choose to receive the vaccine on the arm contralateral to axillary lymph node removal, or in the lower extremity if they have had bilateral axillary lymph node removal
• Hypothesis 2: Patients with a history of breast cancer will experience axillary lymph node swelling after receiving the COVID-19 vaccine at the same rate as the general population
• Hypothesis 3: Patients with axillary surgery who develop lymph nodes swelling in the ipsilateral side might be at increased risk of developing lymphedema

• Study Type: Observational
• Enrollment (Actual): 714

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women with a history of breast cancer

Description

Inclusion Criteria:

• Female patients who are
• ≥18 years of age and have a
• History of breast cancer For the MGH site, patients must have
• Received some breast cancer treatment at MGH or its affiliates
• Received perometry measurements to measure arm volume at MGH

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vaccinated Breast Cancer Patients [mRNA vaccine - Moderna, Pfizer]; Patients who enroll in the trial and decided to get the COVID-19 vaccine will complete surveys to indicate their experiences, side effects, location of vaccination (i.e. right arm, left arm, or leg). This information will be analyzed in conjunction with their breast cancer treatment history and lymphedema measurements. Participants were separated into two different cohorts for analysis, Cohort 1 being those who received an mRNA vaccine for their primary vaccination series (two doses of Moderna or Pfizer) and Cohort 2 being those who received a non-mRNA vaccination for their primary vaccination series (one dose of Johnson & Johnson).	Other: Survey; Patients in all groups will complete surveys about their experience with the vaccination and any side effects they may have experienced.
Vaccinated Breast Cancer Patients [non-mRNA vaccine - Johnson & Johnson]; Patients who enroll in the trial and decided to get the COVID-19 vaccine will complete surveys to indicate their experiences, side effects, location of vaccination (i.e. right arm, left arm, or leg). This information will be analyzed in conjunction with their breast cancer treatment history and lymphedema measurements. Participants were separated into two different cohorts for analysis, Cohort 1 being those who received an mRNA vaccine for their primary vaccination series (two doses of Moderna or Pfizer) and Cohort 2 being those who received a non-mRNA vaccination for their primary vaccination series (one dose of Johnson & Johnson).	Other: Survey; Patients in all groups will complete surveys about their experience with the vaccination and any side effects they may have experienced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 Vaccination on Contralateral vs Ipsilateral Arm	The investigators expect 90% of participants to receive the COVID-19 vaccine on their contralateral (unaffected) arm. This outcome measure is looking at the number of participants who received the COVID-19 vaccine on the side of breast cancer treatment vs those who received the vaccine on the opposite side of breast cancer treatment. Patients with bilateral cancer were excluded from this analysis due to the nature of breast cancer laterality categorization.	This was a survey study of patients with breast surgery for breast cancer. Participants replied to the online survey up to 361.5 months post their breast surgery (median 69.0 months). This was the study's reported timeframe in the published manuscript.
Lymph Node (LN) Swelling After COVID-19 Vaccine	The investigators expect 10-15% of participants to experience lymph node swelling after receiving the Pfizer or Moderna vaccines. The outcome measure analyzes the number of participants who experienced LN swelling after receiving each dose of their COVID-19 vaccines. The analysis looked at what location on the body lymph node swelling occurred (axilla vs supraclavicular region), which side of the body this swelling occurred in relation to the side of the body that received the vaccine (ipsilateral vs contralateral), and which side of the body this swelling occurred in relation to the side of the body the patient has/had breast cancer (ipsilateral vs contralateral). Patients with bilateral cancer were excluded from the analysis of LN swelling in relation to both the vaccine and breast cancer laterality due to the nature of BC laterality categorization. Analysis on breast cancer laterality and LN swelling was not conducted for the non-mRNA vaccine (Johnson & Johnson) group.	This was a survey study of patients with breast surgery for breast cancer. Participants replied to the online survey up to 361.5 months post their breast surgery (median 69.0 months). This was the study's reported timeframe in the published manuscript.
Duration of Lymph Node Swelling as a Side Effect of mRNA and Non-mRNA Vaccines	The outcome measure will be analyzing the reported duration of lymph node swelling, categorized by the location at which lymph node swelling occurred (the axilla vs supraclavicular region) and which side of the body this swelling occurred in relation to the side of the body that received the vaccine injection (ipsilateral vs contralateral). The main aim of this paper was to report the side effects of the mRNA COVID-19 vaccines in patients treated for breast cancer.	This was a survey study of patients with breast surgery for breast cancer. Participants replied to the online survey up to 361.5 months post their breast surgery (median 69.0 months). This was the study's reported timeframe in the published manuscript.
Reported Side Effects of the mRNA and Non-mRNA Vaccines	Due to the inherent activity of mRNA vaccines and the immune system, as well as the role of the lymph nodes in breast cancer (BC) and in breast cancer-related lymphedema (BCRL), this study analyzed the side effect profile in patients treated for BC and who received up to three doses of the COVID-19 vaccinations [Moderna, Pfizer]. A separate analysis is presented on results from participants who received the Johnson & Johnson (J&J) vaccine as lymph node swelling is not a listed side effect of this non-mRNA vaccine and only a small proportion of the population received this vaccine.	This was a survey study of patients with breast surgery for breast cancer. Participants replied to the online survey up to 361.5 months post their breast surgery (median 69.0 months). This was the study's reported timeframe in the published manuscript.
Duration of Side Effects of mRNA and Non-mRNA Vaccines	Due to the inherent activity of mRNA vaccines and the immune system, as well as the role of the lymph nodes in breast cancer (BC) and in breast cancer-related lymphedema (BCRL), this study analyzed the side effect profile in patients treated for BC and who received up to three doses of the COVID-19 vaccinations [Moderna, Pfizer]. A separate analysis is presented on results from participants who received the Johnson & Johnson (J&J) vaccine as lymph node swelling is not a listed side effect of this non-mRNA vaccine and only a small proportion of the population received this vaccine. This outcome analyzes the duration of side effects associated with each dose of the vaccine.	This was a survey study of patients with breast surgery for breast cancer. Participants replied to the online survey up to 361.5 months post their breast surgery (median 69.0 months). This was the study's reported timeframe in the published manuscript.

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Alphonse G Taghian, MD, PhD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Juhel BC, Brunelle CL, Bernstein MC, Smith LH, Jung AW, Ababneh HS, Hausman EK, Bucci LK, Bernstein T, Naoum GE, Taghian AG. Side effects of COVID-19 vaccinations in patients treated for breast cancer. Clin Exp Med. 2023 Nov;23(7):3671-3680. doi: 10.1007/s10238-023-01050-z. Epub 2023 Apr 8.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2021
• Primary Completion (Actual): March 17, 2023
• Study Completion (Actual): March 17, 2023

Study Registration Dates

• First Submitted: May 2, 2021
• First Submitted That Met QC Criteria: May 2, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Breast Cancer; Vaccination; Lymphadenopathy
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Skin Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Breast Diseases; Lymphatic Diseases; Lymphedema; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; COVID-19; Lymphadenopathy; Breast Cancer Lymphedema; Breast Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 21-528

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No