Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Ultrasound scan
Clinical narrative: Left axillary lymphadenopathy; This literature-non-study case was reported in a literature article and describes the occurrence of LYMPHADENOPATHY (Left axillary lymphadenopathy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.        Concurrent medical conditions included BRCA2 gene mutation.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced LYMPHADENOPATHY (Left axillary lymphadenopathy) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Left axillary lymphadenopathy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Mammogram: 177 days after vaccination showed normalization of the lymph nodes. In 2021, Ultrasound scan: 177 days after vaccination showed normalization of the lymph nodes and 98 days after vaccination revealed a decrease in nodal size however, the lymph nodes were still morphologically abnormal (type 3).. On an unknown date, Ultrasound scan: performed on the same day, demonstrates multiple enlarged type 5 lymph nodes.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LYMPHADENOPATHY (Left axillary lymphadenopathy) to be related.    Concomitant and treatment medications were not reported.  Patient had vaccine 17 days prior to screening.  This was retrospective study of patients with imaging evidence of axillary lymphadenopathy who had received at least one dose of a COVID-19 vaccine and presented between January 1, 2021, and February 28, 2021.  The patient's lymphadenopathy persisted for at least 98 days after vaccination, with resolution at 177 days demonstrating the potential delay in lymph node normalization.   This case was linked to US-MODERNATX, INC.-MOD-2023-732122 (Linked Report).  Company Comment: This is a literature-non study case concerning a 70-year-old, female patient with concurrent medical condition of BRCA2 gene mutation, who experienced the serious (due to medically significant) unexpected event lymphadenopathy (reported as Left axillary lymphadenopathy). The event occurred 17 days after receiving the first dose of mRNA-1273 vaccine (event and dose dates were not specified, so exact latency could not be calculated). The patient's lymphadenopathy persisted for at least 98 days after vaccination, with resolution at 177 days demonstrating the potential delay in lymph node normalization. Relevant diagnostic tests included Mammogram performed 177 days after vaccination that showed normalization of the lymph nodes, Ultrasound scan performed on the same day that demonstrates multiple enlarged type 5 lymph nodes, follow up Ultrasound scan performed 98 days after vaccination revealed a decrease in nodal size however, the lymph nodes were still morphologically abnormal (type 3) and follow up Ultrasound scan performed 177 days after vaccination that showed normalization of the lymph nodes. Concomitant and treatment medications were not reported. At the time of the report, the event was reported as resolved.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2023: Follow up received by safety on 06-JUL-2023 has Email with Agency that contains significant information: Reporter information, literature information, lab data and suspect details were updated.; Sender's Comments: Company Comment: This is a literature-non study case concerning a 70-year-old, female patient with concurrent medical condition of BRCA2 gene mutation, who experienced the serious (due to medically significant) unexpected event lymphadenopathy (reported as Left axillary lymphadenopathy). The event occurred 17 days after receiving the first dose of mRNA-1273 vaccine (event and dose dates were not specified, so exact latency could not be calculated). The patient's lymphadenopathy persisted for at least 98 days after vaccination, with resolution at 177 days demonstrating the potential delay in lymph node normalization. Relevant diagnostic tests included Mammogram performed 177 days after vaccination that showed normalization of the lymph nodes, Ultrasound scan performed on the same day that demonstrates multiple enlarged type 5 lymph nodes, follow up Ultrasound scan performed 98 days after vaccination revealed a decrease in nodal size however, the lymph nodes were still morphologically abnormal (type 3) and follow up Ultrasound scan performed 177 days after vaccination that showed normalization of the lymph nodes. Concomitant and treatment medications were not reported. At the time of the report, the event was reported as resolved.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-732122:Master case