Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Breast oedema, Recurrent cancer
Clinical narrative: breast cancer; Spot had increased in size/ Has the same type of cancer she had twenty years ago; Biopsy was all liquid; This spontaneous case was reported by a consumer and describes the occurrence of RECURRENT CANCER (Spot had increased in size/ Has the same type of cancer she had twenty years ago) and BREAST CANCER (breast cancer) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ovarian cancer (she had ovarian cancer 20 years ago).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced BREAST OEDEMA (Biopsy was all liquid). On 04-Oct-2021, the patient experienced RECURRENT CANCER (Spot had increased in size/ Has the same type of cancer she had twenty years ago) (seriousness criterion medically significant). On 11-Oct-2021, the patient experienced BREAST CANCER (breast cancer) (seriousness criterion medically significant). At the time of the report, RECURRENT CANCER (Spot had increased in size/ Has the same type of cancer she had twenty years ago), BREAST CANCER (breast cancer) and BREAST OEDEMA (Biopsy was all liquid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Mammogram: abnormal (abnormal) abnormal. On 04-Oct-2021, Ultrasound scan: abnormal (abnormal) spot had increased in size. On 06-Oct-2021, Biopsy: abnormal (abnormal) she had the same type of cancer that she had 20 years ago..   She went for a biopsy and they were unable to get a biopsy because it was "all liquid."  She believed it was due to the vaccine because the type of cancer she had does not return.  The vaccine was the only thing she had put into her body that would stimulate her immune system. She knew the vaccine can affect the lymph nodes and that was  exactly where her cancer was. Concomitant product use was not provided by reporter. Treatment information was not provided.  Company Comment: This spontaneous case concerns a 60 -year-old, female patient with medical history of Ovarian cancer who experienced  the serious unexpected events of Recurrent cancer and breast cancer approximately 8 months after the second dose of spikevax. About 2 months after the second dose patient reported that a mammography was abnormal, and in 6 month later she went to a breast biopsy and the results was a recurrent cancer. Because previous history is of ovarian cancer, additional event of breast cancer was added.  Rechallenge was not applicable. Patient´s medical history of previous ovarian cancer remains as a confounder for the events. Further information about diagnosis and details about medical history has been requested. The benefit-risk relationship of Spikevax in not affected by this report.   This case was linked to MOD-2021-353405 (Patient Link).; Sender's Comments: This spontaneous case concerns a 60 -year-old, female patient with medical history of Ovarian cancer who experienced  the serious unexpected events of Recurrent cancer and breast cancer approximately 8 months after the second dose of spikevax. About 2 months after the second dose patient reported that a mammography was abnormal, and in 6 month later she went to a breast biopsy and the results was a recurrent cancer. Because previous history is of ovarian cancer, additional event of breast cancer was added.  Rechallenge was not applicable. Patient´s medical history of previous ovarian cancer remains as a confounder for the events. Further information about diagnosis and details about medical history has been requested. The benefit-risk relationship of Spikevax in not affected by this report