Breast Cancer Related LymphedemaLymphVAXNCT04872738

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

An observational study of Breast Cancer Related Lymphedema and Covid19, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer Related Lymphedema, Covid19
What is being tested?: Survey
Type of treatment: Vaccines
How many people: 714 participants
Where: 1 siteUnited States
Study dates: 7 May 2021to 17 Mar 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Study population: Women with a history of breast cancer

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114

Other trials in United States

About this study

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.

Read the 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

Conditions: Breast Cancer Related Lymphedema, Covid19
Being tested: Survey
Keywords: Breast Cancer, Vaccination, Lymphadenopathy
Medical subject headings: Breast Cancer Lymphedema, COVID-19, Breast Neoplasms, Lymphadenopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SurveyOther
Patients in all groups will complete surveys about their experience with the vaccination and any side effects they may have experienced.

Study groups in NCT04872738
Study group	Role	What they receive
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). Receives: Other: Survey
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). Receives: Other: Survey

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 May 202117 Mar 2023

First posted4 May 2021
Study start7 May 2021
Primary completion17 Mar 2023
Study completion17 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast Cancer Related LymphedemaStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 714 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04872738
Sponsor's protocol ID: 21-528
Acronym: LymphVAX
Status last verified: Oct 2025
First submitted: 2 May 2021
Last updated: 6 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 37031282

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Recruiting
The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
Lymphedema, Breast Cancer
Recruiting
EFFECT OF ESWT ON BREAST-CANCER RELATED LYMPHEDEMA
Breast Cancer Related Lymphedema

All Breast Cancer Related Lymphedema trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Experiences With the COVID-19 Vaccination After Breast Cancer Treatment
ClinicalTrials.gov ID: NCT04872738
Acronym / sponsor ID: LymphVAX / 21-528
Conditions: Breast Cancer Related Lymphedema, Covid19
Keywords: Breast Cancer, Vaccination, Lymphadenopathy
Study type: Observational
Recruitment status: Completed
Enrolment: 714 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 7 May 2021 (actual)
Primary completion: 17 Mar 2023 (actual)
Study completion: 17 Mar 2023 (actual)
First posted: 4 May 2021 (actual)
Results: Posted 6 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Vaccinated Breast Cancer Patients [mRNA vaccine - Moderna, Pfizer]	–	Other: SurveyPatients 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).
Vaccinated Breast Cancer Patients [non-mRNA vaccine - Johnson & Johnson]	–	Other: SurveyPatients 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).

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Women with a history of breast cancer

Key inclusion criteria (5 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SurveyPatients in all groups will complete surveys about their experience with the vaccination and any side effects they may have experienced.	Other	Vaccinated Breast Cancer Patients [mRNA vaccine - Moderna, Pfizer], Vaccinated Breast Cancer Patients [non-mRNA vaccine - Johnson & Johnson]

Primary outcome

COVID-19 Vaccination on Contralateral vs Ipsilateral Arm
Time frame: 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.
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.
Lymph Node (LN) Swelling After COVID-19 Vaccine
Time frame: 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.
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.
Duration of Lymph Node Swelling as a Side Effect of mRNA and Non-mRNA Vaccines
Time frame: 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.
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.
Reported Side Effects of the mRNA and Non-mRNA Vaccines
Time frame: 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.
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.
Duration of Side Effects of mRNA and Non-mRNA Vaccines
Time frame: 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.
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.

Results and safety

Results posted to the registry on 6 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vaccinated Breast Cancer Patients [mRNA Vaccine - Moderna, Pfizer]	621	621
Vaccinated Breast Cancer Patients [Non-mRNA Vaccine - Johnson & Johnson]	49	49

Primary outcome: COVID-19 Vaccination on Contralateral vs Ipsilateral Arm

Measure	Vaccinated Breast Cancer Patients Dose 1 [mRNA vaccine - Moderna, Pfizer] n = 554	Vaccinated Breast Cancer Patients Dose 2 [mRNA vaccine - Moderna, Pfizer] n = 554	Vaccinated Breast Cancer Patients Booster [mRNA vaccine - Moderna, Pfizer] n = 405	Vaccinated Breast Cancer Patients [non-mRNA vaccine - Johnson & Johnson] n = 0
Patients who received the vaccine contralateral to breast cancer treatment	432	435	331	–
Patients who received the vaccine ipsilateral to breast cancer treatment	122	119	74	–

Population analysed: The cohort of patients who received a non-mRNA vaccine was not included in the analysis, as only a small proportion of the population received this vaccine type. Consequently, data on this group were not collected.

Primary outcome: Lymph Node (LN) Swelling After COVID-19 Vaccine

Measure	Vaccinated Breast Cancer Patients Dose 1 [mRNA vaccine - Moderna, Pfizer] n = 621	Vaccinated Breast Cancer Patients Dose 2 [mRNA vaccine - Moderna, Pfizer] n = 621	Vaccinated Breast Cancer Patients Booster [mRNA vaccine - Moderna, Pfizer] n = 469	Vaccinated Breast Cancer Patients Dose 1 [non-mRNA vaccine - Johnson & Johnson] n = 49	Vaccinated Breast Cancer Patients Booster [non-mRNA vaccine - Johnson & Johnson] n = 34
Lymph node (LN) swelling, general	61	80	53	4	1
LN swelling: Supraclavicular, Contralateral to Vaccine	11	16	5	0	0
LN swelling: Supraclavicular, Ipsilateral to Vaccine	18	21	17	1	0
LN swelling: Axillary, Contralateral to Vaccine	28	36	13	0	1
LN swelling: Axillary, Ipsilateral to Vaccine	33	50	38	3	0
LN swelling ipsilateral to vaccine, contralat. to BC (among pts who received dose contralat. to BC)	33	48	40	–	–
LN swelling contralat. to vaccine, ipsilateral to BC (among pts who received dose contralat. to BC)	30	42	12	–	–
Ipsilateral to vaccine and to BC (among pts who received dose ipsilateral to BC)	14	17	10	–	–

Population analysed: The first row, 'Lymph node (LN) swelling, general', reports the number of subjects who reported LN swelling. We then analyzed, of the subjects who indicated that they experienced LN swelling, the laterality in which this swelling occurred. These data are represented in rows 2 through 5. In the analysis of LN swelling laterality related to both vaccine and BC laterality, the population size was the number of participants vaccinated on the specified side (only conducted for mRNA vaccines).

Primary outcome: Duration of Lymph Node Swelling as a Side Effect of mRNA and Non-mRNA Vaccines

Measure	Vaccinated Breast Cancer Patients Dose 1 [mRNA vaccine - Moderna, Pfizer] n = 61	Vaccinated Breast Cancer Patients Dose 2 [mRNA vaccine - Moderna, Pfizer] n = 80	Vaccinated Breast Cancer Patients Booster [mRNA vaccine - Moderna, Pfizer] n = 53
Duration of LN swelling - Supraclavicular, Contralateral to Vaccine: 24 hours or less	2	2	0
Duration of LN swelling - Supraclavicular, Contralateral to Vaccine: 48 hours or less	3	0	1
Duration of LN swelling - Supraclavicular, Contralateral to Vaccine: 1 week or less	2	4	2
Duration of LN swelling - Supraclavicular, Contralateral to Vaccine: 2 weeks or less	0	0	0
Duration of LN swelling - Supraclavicular, Contralateral to Vaccine: 3 weeks or less	0	0	0
Duration of LN swelling - Supraclavicular, Contralateral to Vaccine: 4 weeks or less	0	2	0
Duration of LN swelling-Supraclavicular, Contralateral to Vaccine: > than 4 weeks/still experiencing	2	4	2
Duration of LN swelling - Supraclavicular, Contralateral to Vaccine: I don't know	2	3	0

Population analysed: The number analyzed reflects participants who experienced swelling at the specified location (axilla or supraclavicular) and the side relative to vaccine administration. For example, "Duration of LN swelling - Supraclavicular, Contralateral to Vaccine: 24 hours or less" for Dose 1 included 11 patients, as 11 of 61 reported swelling in the supraclavicular region contralateral to the side they received the vaccine.

Primary outcome: Reported Side Effects of the mRNA and Non-mRNA Vaccines

Measure	[mRNA vaccine Dose 1- Moderna, Pfizer] reported side effects n = 621	[mRNA vaccine Dose 2- Moderna, Pfizer] reported side effects n = 621	[mRNA vaccine Booster - Moderna, Pfizer] reported side effects n = 469	[non-mRNA vaccine Dose 1 - Johnson & Johnson] reported side effects n = 49	[non-mRNA vaccine Booster - Johnson & Johnson] reported side effects n = 34
Symptom: Injection Site Soreness	472	473	328	31	19
Symptom: Fatigue	265	368	208	21	10
Symptom: Generalized Muscle Soreness	143	198	115	9	5
Symptom: Headache	114	201	101	15	8
Symptom: Chills	59	147	90	10	5
Symptom: Joint Pain	58	108	59	8	4
Symptom: Fever	31	104	52	7	5
Symptom: Injection Site Swelling	84	119	63	5	2

Adverse events

Time frame: 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. This was a non-interventional cross-sectional survey study. There were no adverse events reported as there was no study intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vaccinated Breast Cancer Patients [mRNA Vaccine Dose 1- Moderna, Pfizer]	0 of 621 (0%)	532 of 621 (85.7%)	9 of 621
Vaccinated Breast Cancer Patients [mRNA Vaccine Dose 2- Moderna, Pfizer]	0 of 621 (0%)	546 of 621 (87.9%)	3 of 621
Vaccinated Breast Cancer Patients [mRNA Vaccine Booster - Moderna, Pfizer]	0 of 469 (0%)	397 of 469 (84.6%)	0 of 469
Vaccinated Breast Cancer Patients [Non-mRNA Vaccine Dose 1 - Johnson & Johnson]	0 of 49 (0%)	36 of 49 (73.5%)	0 of 49
Vaccinated Breast Cancer Patients [Non-mRNA Vaccine Booster - Johnson & Johnson]	0 of 34 (0%)	24 of 34 (70.6%)	0 of 34

Limitations and caveats (from the sponsor): It is difficult to determine the exact response rate as surveys were sent when many patients hadn't yet received the vaccine; recall bias may have played a role. Questions regarding LN swelling relied on self-report. The surveys do not include questions regarding the severity of the side effects reported; therefore, conclusions about severity cannot be drawn. Methodological limitations prevent statistical comparisons with studies of the general population.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37031282Juhel 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alphonse G Taghian, MD, PhD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer Related Lymphedema and Covid19, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COVID-19 Vaccination on Contralateral vs Ipsilateral Arm (time frame: 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04872738, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.