Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Chills, Headache, Hepatic mass, Influenza like illness
Clinical narrative: Diagnosed with breast cancer; There is a spot on my liver; Flu like symptoms; Chills; Fever; Headache; Body Ache; This spontaneous case was reported by a patient and describes the occurrence of BREAST CANCER (Diagnosed with breast cancer), HEPATIC MASS (There is a spot on my liver), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and PYREXIA (Fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history information was reported.  Concomitant products included LOSARTAN, METFORMIN, EZETIMIBE (ZETIA) and CALCITRIOL for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body Ache). On an unknown date, the patient experienced BREAST CANCER (Diagnosed with breast cancer) and HEPATIC MASS (There is a spot on my liver). At the time of the report, BREAST CANCER (Diagnosed with breast cancer), HEPATIC MASS (There is a spot on my liver), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body Ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: abnormal (abnormal) diagnosed patient with breast cancer.. On an unknown date, Magnetic resonance imaging: mri (abnormal) tests performed on an unknown date  lead to the breast cancer diagnosis. On an unknown date, Mammogram: mammogram (abnormal) tests performed on an unknown date  lead to the breast cancer diagnosis. On an unknown date, Positron emission tomogram: pet scan (abnormal) tests performed on an unknown date  lead to the breast cancer diagnosis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included multivitamins.  The patient first experienced flu like symptoms as well as chills, fever and headache. The patient reports that 4 weeks after the second dose of the Moderna COVID-19 vaccine (middle of March, date not specified), she discovered lumps in her left breast. Six weeks after the second dose, she claims to have developed large lumps in her right breast as well. The patient has gone under a variety of exams and scans including MRI, PET scan, mammograms, and biopsies which diagnosed her with breast cancer. The patient reports that they are scheduled for a double mastectomy in a couple of weeks (date not specified). The patient also claims there is a spot on their liver and they are awaiting test results.   Company Comment Very limited information regarding these events has been provided at this time. Further information has been  requested. However, presented medical facts suggest that the patient has a previous undiagnosed breast cancer.   This case was linked to MOD-2021-228065 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been  requested. However, presented medical facts suggest that the patient has a previous undiagnosed breast cancer.