Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Chronic lymphocytic leukaemia, Mammogram, Ultrasound scan
Clinical narrative: Chronic lymphocytic leukemia; This literature-non-study case was reported in a literature article and describes the occurrence of CHRONIC LYMPHOCYTIC LEUKAEMIA (Chronic lymphocytic leukemia) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.        No Medical History information was reported.    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 CHRONIC LYMPHOCYTIC LEUKAEMIA (Chronic lymphocytic leukemia) (seriousness criterion medically significant). At the time of the report, CHRONIC LYMPHOCYTIC LEUKAEMIA (Chronic lymphocytic leukemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: lymph node cortical thickness of 6 mm Maximum lymph node cortical thickness of 6 mm and biopsy findings exhibited symmetric cortical thickening with preservation of the fatty hilum. and chronic lymphocytic leukemia pathology test finding was chronic lymphocytic leukemia. On an unknown date, Mammogram: right unilateral axillary adenopathy Right unilateral axillary adenopathy was detected with annual screening mammography and BI RADS category was 3.. On an unknown date, Ultrasound scan: 2 abnormal lymph nodes Unilateral right side axillary adenopathy with 2 abnormal lymph nodes. and fatty hilum Sonographic findings was fatty hilum and focal hypoechoic cortical lobulation..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CHRONIC LYMPHOCYTIC LEUKAEMIA (Chronic lymphocytic leukemia) to be related.    Patient did not had any breast cancer history.  The time between second dose to initial ultrasound was 6.1 week and initial ultrasound to biopsy decision was reported as 7.1 week.  Biopsy was recommended from 12.3 to 13.1 weeks after second vaccine dose for malignant axillary adenopathy patient.  Delay between the initial ultrasound work-up and BI-RADS category 4 assessment occurred only in the patient with chronic lymphocytic leukemia (by 7.0 weeks) and was related  to atypical unilateral presentation and recent vaccination.  No concomitant and treatment medication information was provided.  Company comment: This is a literature-non-study case concerning a 59-year-old, female patient with no reported medical history except for no history of breast cancer, who experienced the unexpected serious (medically significant) event of Chronic lymphocytic leukaemia (CLL). The event occurrence was unknown with respect to the second dose of mRNA-1273 vaccine administration. Allegedly the event was described as, patient was administered with second dose of mRNA-1273 vaccine on her right side. On unknown date, patient underwent annual screening mammography with findings of right axillary adenopathy. Approximately 6 weeks after the second dose of mRNA-1273 vaccine administration, patient underwent unspecified ultrasound with findings of 2 abnormal unilateral right axillary lymph nodes with maximum lymph node cortical thickness of 6 mm, focal hypoechoic cortical lobulation and preserved fatty hilum, BI-RADS category 3. Patient underwent biopsy approximately 7 weeks after the initial ultrasound. Pathology reported is chronic lymphocytic leukemia (CLL). No reported treatment information. The outcome of the event was unknown. The patient's age remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-580131, US-MODERNATX, INC.-MOD-2022-580132 (Linked Report).; Sender's Comments: This is a literature-non-study case concerning a 59-year-old, female patient with no reported medical history except for no history of breast cancer, who experienced the unexpected serious (medically significant) event of Chronic lymphocytic leukaemia (CLL). The event occurrence was unknown with respect to the second dose of mRNA-1273 vaccine administration. Allegedly the event was described as, patient was administered with second dose of mRNA-1273 vaccine on her right side. On unknown date, patient underwent annual screening mammography with findings of right axillary adenopathy. Approximately 6 weeks after the second dose of mRNA-1273 vaccine administration, patient underwent unspecified ultrasound with findings of 2 abnormal unilateral right axillary lymph nodes with maximum lymph node cortical thickness of 6 mm, focal hypoechoic cortical lobulation and preserved fatty hilum, BI-RADS category 3. Patient underwent biopsy approximately 7 weeks after the initial ultrasound. Pathology reported is chronic lymphocytic leukemia (CLL). No reported treatment information. The outcome of the event was unknown. The patient's age remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-580131:Patient 2: 56 years old US-MODERNATX, INC.-MOD-2022-580132:Patient 3: 82 years old