Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Biopsy, Lymphoid tissue hyperplasia, Ultrasound Doppler, Ultrasound scan
Clinical narrative: Reactive follicular hyperplasia; palpable lump in the left axilla; This literature-non-study case was reported in a literature article and describes the occurrence of LYMPHOID TISSUE HYPERPLASIA (Reactive follicular hyperplasia) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:   The patient's past medical history included Breast ductal carcinoma and Mastectomy (for invasive ductal carcinoma) in 2006. Concurrent medical conditions included BRCA2 gene mutation.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHOID TISSUE HYPERPLASIA (Reactive follicular hyperplasia) (seriousness criterion medically significant). an unknown date, the patient experienced AXILLARY MASS (palpable lump in the left axilla). At the time of the report, LYMPHOID TISSUE HYPERPLASIA (Reactive follicular hyperplasia) and AXILLARY MASS (palpable lump in the left axilla) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: guided core biopsy yielded reactive follicular hyperplasia. On an unknown date, Ultrasound Doppler: type 5 lymph node, which had associated hyperemia on a power Doppler image Breast Imaging Reporting and Data System (BI-RADS 4). On an unknown date, Ultrasound scan: Ultrasound image showed a type 5 lymph node (focally lobulated hypoechoic cortex).     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  In the patients with persistent concerns, axillary ultra sound is performed and a final BI-RADS (Breast Imaging advise clinical management and benign classification) assessment is rendered on the basis of careful consideration of the imaging findings, including cortical-hilar lymph node morphology, clinical presentation, site and timing of vaccinations, and personal risk factors for nodal metastasis. Company comment: This is a literature non study case concerning a BRCA2 mutation Carrier 63-year-old female patient, with medical history of invasive ductal carcinoma treated with left mastectomy in the past, who experienced the unexpected and serious (due to medically significant) event of lymphoid tissue hyperplasia. She had a palpable lump in the left axilla 9 days after the first dose of mRNA-1273 vaccine, which ultrasound showed a focally lobulated hypoechoic cortex lymph node, associated with hyperemia on power Doppler and a ultrasound core biopsy yielded reactive follicular hyperplasia. No further information was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MODERNATX, INC.-MOD-2022-668768, MODERNATX, INC.-MOD-2022-668779, MODERNATX, INC.-MOD-2022-668780 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2022: Live follow-up received by safety on 03-Nov-2022 has email with full text article and contains significant information. Reporter information, literature information, medical history, laboratory data, and event details were updated. Sender's Comments: This is a literature non study case concerning a BRCA2 mutation Carrier 63-year-old female patient, with medical history of invasive ductal carcinoma treated with left mastectomy in the past, who experienced the unexpected and serious (due to medically significant) event of lymphoid tissue hyperplasia. She had a palpable lump in the left axilla 9 days after the first dose of mRNA-1273 vaccine, which ultrasound showed a focally lobulated hypoechoic cortex lymph node, associated with hyperemia on power Doppler and a ultrasound core biopsy yielded reactive follicular hyperplasia. No further information was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. MODERNATX, INC.-MOD-2022-668779:62-year-old woman, same article MODERNATX, INC.-MOD-2022-668780:46-year-old woman, same article MODERNATX, INC.-MOD-2022-668768:70-year-old woman, same article