Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer metastatic, SARS-CoV-2 antibody test
Clinical narrative: Metastatic Breast Cancer; This spontaneous case was reported by a patient and describes the occurrence of BREAST CANCER METASTATIC (Metastatic Breast Cancer) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A, 20SL210 and 025B21A) for COVID-19 prophylaxis.     Patient had no known allergies.  The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Breast tumor benign since 2014.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced BREAST CANCER METASTATIC (Metastatic Breast Cancer) (seriousness criterion medically significant). The patient was treated with LETROZOLE at an unspecified dose and frequency. At the time of the report, BREAST CANCER METASTATIC (Metastatic Breast Cancer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 antibody test: (Positive) Positive.         No concomitant medications were reported. On Dec 2020 the tumor was still benign and on July 2021 was diagnosed with metastatic breast cancer. She was reporting just in case it might have been caused by the Moderna Covid 19 vaccine. The patient did not experienced allergies medications, food and other products. Event all her bones broke subsumed under the event breast cancer metastatic.  Treatment: Breasenial 150 mg 2 tice day.  Company comment: This spontaneous case concerns 53 years old female with Concurrent medical conditions included Breast tumor benign, who experienced the unexpected serious (medically significant) event of breast cancer metastatic, which occurred approximately 3 months after second dose of mRNA-1273 vaccine. Patient was diagnosed with metastatic breast cancer after second primary dose of vaccination. Started on Tablet Breasenial 150 mg 2 times a day. At the time of reporting event outcome is unknown. Concurrent medical conditions included Breast tumor benign is confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns 53 years old female with Concurrent medical conditions included Breast tumor benign, who experienced the unexpected serious (medically significant) event of breast cancer metastatic, which occurred approximately 3 months after second dose of mRNA-1273 vaccine. Patient was diagnosed with metastatic breast cancer after second primary dose of vaccination. Started on Tablet Breasenial 150 mg 2 times a day. At the time of reporting event outcome is unknown. Concurrent medical conditions included Breast tumor benign is confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.