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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey | Other | Patients in all groups will complete surveys about their experience with the vaccination and any side effects they may have experienced. |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Women with a history of breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Alphonse G Taghian, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37031282 | Derived | 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. |
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We excluded 44 incomplete surveys or surveys from patients who received the first vaccine prior to breast cancer treatment, resulting in data from 670 patients for analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose 1/Primary Series Survey |
| |||||||||||||
| Booster Survey |
|
Demographic and breast cancer-related characteristics for the 621 patients receiving an mRNA primary vaccine series and the 49 patients receiving a non-mRNA primary vaccine series were presented.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 (Moderna, Pfizer) and Cohort 2 being those who received a non-mRNA vaccination (Johnson & Johnson). Demographic data for Cohort 2 is not included, as this cohort was not included in the primary analysis and therefore its data was not pulled. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | 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 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.
This was a non-interventional cross-sectional survey study. There were no adverse events reported as there was no study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vaccinated Breast Cancer Patients [mRNA Vaccine Dose 1- 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). Side effects were reported separately for each vaccine dose and booster. The data presented here represent Dose 1 of the mRNA vaccine cohort. Survey: Patients in all groups will complete surveys about their experience with the vaccination and any side effects they may have experienced. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Soreness | General disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Lymphedema Research Program | Massachusetts General Hospital | 617-724-0127 | cbrunelle@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2023 | Jul 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072656 | Breast Cancer Lymphedema |
| D000086382 | COVID-19 |
| D001943 | Breast Neoplasms |
| D000072281 | Lymphadenopathy |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 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. |
| NOT COMPLETED |
|
|
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI, Continuous | There was missing data for 2 participants in regards to BMI for the mRNA vaccine cohort and missing data for 3 participants in regards to BMI for the non-mRNA vaccine cohort. | Median | Full Range | kg/m² |
|
| BMI > 25 | There was missing data for 2 participants in regards to BMI for the mRNA vaccine cohort and missing data for 3 participants in regards to BMI for the non-mRNA vaccine cohort. | Count of Participants | Participants |
|
| Mastectomy with Reconstruction | Count of Participants | Participants |
|
| Mastectomy without Reconstruction | Count of Participants | Participants |
|
| Lumpectomy | Count of Participants | Participants |
|
| Axillary Lymph Node Dissection | Count of Participants | Participants |
|
| Sentinel Lymph Node Biopsy | Count of Participants | Participants |
|
| No Nodal Surgery | Count of Participants | Participants |
|
| Regional Lymph Node Radiation | Count of Participants | Participants |
|
| Neoadjuvant +/- adjuvant chemotherapy | Count of Participants | Participants |
|
| Adjuvant chemotherapy, only | Count of Participants | Participants |
|
| Time between breast surgery and first dose | There was missing data for 3 participants in regards to date of surgery for the non-mRNA vaccine cohort. | Median | Full Range | months |
|
| OG000 |
| Vaccinated Breast Cancer Patients Dose 1 [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). |
| OG001 | Vaccinated Breast Cancer Patients Dose 2 [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). |
| OG002 | Vaccinated Breast Cancer Patients Booster [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). |
| OG003 | 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). |
|
|
| Primary | 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. | 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). | Posted | Count of Participants | Participants | 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. |
|
|
|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | 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. |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 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. |
|
|
|
| Primary | 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. | Participants are represented in multiple rows for the duration of separate side effects, so they can be accounted for in more than one row. The discrepancy for the "[mRNA vaccine Dose 1 - Moderna, Pfizer] reported side effects" Arm/Group is due to three participants who did not respond to the side effects question for Dose 1, resulting in a total of 529 responses out of 532 participants. | Posted | Count of Participants | Participants | 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. |
|
|
|
| 9 |
| 621 |
| 0 |
| 621 |
| 532 |
| 621 |
| EG001 | Vaccinated Breast Cancer Patients [mRNA Vaccine Dose 2- 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). Side effects were reported separately for each vaccine dose and booster. The data presented here represent Dose 2 of the mRNA vaccine cohort. Survey: Patients in all groups will complete surveys about their experience with the vaccination and any side effects they may have experienced. | 3 | 621 | 0 | 621 | 546 | 621 |
| EG002 | Vaccinated Breast Cancer Patients [mRNA Vaccine Booster - 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). Side effects were reported separately for each vaccine dose and booster. The data presented here represents patients who received the mRNA vaccine booster. Survey: Patients in all groups will complete surveys about their experience with the vaccination and any side effects they may have experienced. | 0 | 469 | 0 | 469 | 397 | 469 |
| EG003 | Vaccinated Breast Cancer Patients [Non-mRNA Vaccine Dose 1 - 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). Side effects were reported separately for each vaccine dose and booster. The data presented here represents the non-mRNA vaccine cohort. Survey: Patients in all groups will complete surveys about their experience with the vaccination and any side effects they may have experienced. | 0 | 49 | 0 | 49 | 36 | 49 |
| EG004 | Vaccinated Breast Cancer Patients [Non-mRNA Vaccine Booster - 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). Side effects were reported separately for each vaccine dose and booster. The data presented here represents patients who received the non-mRNA vaccine booster. Survey: Patients in all groups will complete surveys about their experience with the vaccination and any side effects they may have experienced. | 0 | 34 | 0 | 34 | 24 | 34 |
| Injection site swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Injection site redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Arm swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Arm numbness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Arm heaviness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Generalized muscle soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Joint Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Bell's Palsy | Nervous system disorders | Systematic Assessment |
|
| LN Swelling | Blood and lymphatic system disorders | Systematic Assessment |
|
Not provided
Not provided
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
|
| LN swelling: Supraclavicular, Contralateral to Vaccine |
|
|
| LN swelling: Supraclavicular, Ipsilateral to Vaccine |
|
|
| LN swelling: Axillary, Contralateral to Vaccine |
|
|
| LN swelling: Axillary, Ipsilateral to Vaccine |
|
|
| LN swelling ipsilateral to vaccine, contralat. to BC (among pts who received dose contralat. to BC) |
|
|
| LN swelling contralat. to vaccine, ipsilateral to BC (among pts who received dose contralat. to BC) |
|
|
| Ipsilateral to vaccine and to BC (among pts who received dose ipsilateral to BC) |
|
|
| Contralateral to vaccine and to BC (among pts who received dose ipsilateral to BC) |
|
|
|
| Duration of LN swelling - Supraclavicular, Contralateral to Vaccine: 48 hours or less |
|
|
| Duration of LN swelling - Supraclavicular, Contralateral to Vaccine: 1 week or less |
|
|
| Duration of LN swelling - Supraclavicular, Contralateral to Vaccine: 2 weeks or less |
|
|
| Duration of LN swelling - Supraclavicular, Contralateral to Vaccine: 3 weeks or less |
|
|
| Duration of LN swelling - Supraclavicular, Contralateral to Vaccine: 4 weeks or less |
|
|
| Duration of LN swelling-Supraclavicular, Contralateral to Vaccine: > than 4 weeks/still experiencing |
|
|
| Duration of LN swelling - Supraclavicular, Contralateral to Vaccine: I don't know |
|
|
| Duration of LN swelling - Supraclavicular, Contralateral to Vaccine: Missing |
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| Duration of LN swelling - Supraclavicular, Ipsilateral to Vaccine: 24 hours or less |
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| Duration of LN swelling - Supraclavicular, Ipsilateral to Vaccine: 48 hours or less |
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| Duration of LN swelling - Supraclavicular, Ipsilateral to Vaccine: 1 week or less |
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| Duration of LN swelling - Supraclavicular, Ipsilateral to Vaccine: 2 weeks or less |
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| Duration of LN swelling - Supraclavicular, Ipsilateral to Vaccine: 3 weeks or less |
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| Duration of LN swelling - Supraclavicular, Ipsilateral to Vaccine: 4 weeks or less |
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| Duration of LN swelling - Supraclavicular, Ipsilateral to Vaccine: > than 4 weeks/still experiencing |
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| Duration of LN swelling - Supraclavicular, Ipsilateral to Vaccine: I don't know |
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| Duration of LN swelling - Axilla, Ipsilateral to Vaccine: 24 hours or less |
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| Duration of LN swelling - Axilla, Ipsilateral to Vaccine: 48 hours or less |
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| Duration of LN swelling - Axilla, Ipsilateral to Vaccine: 1 week or less |
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| Duration of LN swelling - Axilla, Ipsilateral to Vaccine: 2 weeks or less |
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| Duration of LN swelling - Axilla, Ipsilateral to Vaccine: 3 weeks or less |
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| Duration of LN swelling - Axilla, Ipsilateral to Vaccine: 4 weeks or less |
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| Duration of LN swelling - Axilla, Ipsilateral to Vaccine: More than 4 weeks/still experiencing |
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| Duration of LN swelling - Axilla, Ipsilateral to Vaccine: I don't know |
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| Duration of LN swelling - Axilla, Ipsilateral to Vaccine: Missing |
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| Duration of LN swelling - Axilla, Contralateral to Vaccine: 24 hours or less |
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| Duration of LN swelling - Axilla, Contralateral to Vaccine: 48 hours or less |
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| Duration of LN swelling - Axilla, Contralateral to Vaccine: 1 week or less |
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| Duration of LN swelling - Axilla, Contralateral to Vaccine: 2 weeks or less |
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| Duration of LN swelling - Axilla, Contralateral to Vaccine: 3 weeks or less |
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| Duration of LN swelling - Axilla, Contralateral to Vaccine: 4 weeks or less |
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| Duration of LN swelling - Axilla, Contralateral to Vaccine: More than 4 weeks/still experiencing |
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| Duration of LN swelling - Axilla, Contralateral to Vaccine: I don't know |
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| Symptom: Fatigue |
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| Symptom: Generalized Muscle Soreness |
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| Symptom: Headache |
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| Symptom: Chills |
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| Symptom: Joint Pain |
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| Symptom: Fever |
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| Symptom: Injection Site Swelling |
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| Symptom: Arm Heaviness |
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| Symptom: Arm Swelling |
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| Symptom: Vomiting |
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| Symptom: Arm numbness |
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| Symptom: Bell's Palsy |
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| Symptom: Other |
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| Symptom: None |
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| 48 hours or less |
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| 1 week or less |
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| 2 weeks or less |
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| 3 weeks or less |
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| 4 weeks or less |
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| More than 4 weeks/still experiencing |
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| I don't know |
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