Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: B-cell lymphoma, Biopsy, Mammogram, Ultrasound scan
Clinical narrative: B-cell lymphoma; This literature-non-study case was reported in a literature article and describes the occurrence of B-CELL LYMPHOMA (B-cell lymphoma) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.        Concurrent medical conditions included Breast cancer (left side).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced B-CELL LYMPHOMA (B-cell lymphoma) (seriousness criterion medically significant). At the time of the report, B-CELL LYMPHOMA (B-cell lymphoma) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: b-cell lymphoma B-cell lymphoma. On an unknown date, Mammogram: left unilateral axillary adenopathy Left unilateral axillary adenopathy and mammography(ASM). On an unknown date, Ultrasound scan: 2 abnormal lymph nodes 2 abnormal lymph nodes with maximal cortical thickness of 7mm, hypoechoic node, complete loss of fatty hilum, BI-RADS category 4.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered B-CELL LYMPHOMA (B-cell lymphoma) to be related.    This patient belonged to a study which included patients with an axillary ultrasound performed between 11-Dec-2020, and 31-Aug-2021.   No concomitant and treatment medications were provided  There were no additional mammography findings. Second dose to initial ultrasound interval was 12.3 weeks. Initial ultrasound to biopsy decision interval was 0 weeks.  Company Comment: This a literature non-study case concerning a 56-year-old female patient with medical history of breast cancer in the left, who experienced the unexpected, serious (medically significant) event of B-cell lymphoma, approximately 12 weeks after receiving the second dose of mRNA-1273 vaccine. Ultrasound showed 2 abnormal lymph nodes with maximal cortical thickness of 7mm, hypoechoic node, complete loss of fatty hilum, BI-RADS category 4. Biopsy showed B-cell lymphoma. Clinical course and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of breast cancer remains a risk factor for the event. It should be noted that the dose was reported as second dose however, there was no information regarding the first dose of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-580126, US-MODERNATX, INC.-MOD-2022-580132 (Linked Report).; Sender's Comments: This a literature non-study case concerning a 56-year-old female patient with medical history of breast cancer in the left, who experienced the unexpected, serious (medically significant) event of B-cell lymphoma, approximately 12 weeks after receiving the second dose of mRNA-1273 vaccine. Ultrasound showed 2 abnormal lymph nodes with maximal cortical thickness of 7mm, hypoechoic node, complete loss of fatty hilum, BI-RADS category 4. Biopsy showed B-cell lymphoma. Clinical course and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of breast cancer remains a risk factor for the event. It should be noted that the dose was reported as second dose however, there was no information regarding the first dose of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-580132:Patient 3:82 years old US-MODERNATX, INC.-MOD-2022-580126:Patient 1:59 years old