Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of FIBROADENOMA OF BREAST (Lump in my breast/4 x 6 x 3 mm, shrunk/lump remained the same), COVID-19 (Got COVID-19) and VACCINATION FAILURE (Lack of drug effect) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L207 and 011J20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma (status: no change), Drug allergy (Sulfa), Drug allergy (Phenergan) and Drug allergy (codeine). On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced FIBROADENOMA OF BREAST (Lump in my breast/4 x 6 x 3 mm, shrunk/lump remained the same). On 18-Nov-2021, the patient experienced COVID-19 (Got COVID-19) and VACCINATION FAILURE (Lack of drug effect). At the time of the report, FIBROADENOMA OF BREAST (Lump in my breast/4 x 6 x 3 mm, shrunk/lump remained the same) had not resolved and COVID-19 (Got COVID-19) and VACCINATION FAILURE (Lack of drug effect) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Mammogram: found a lump in her breast. On 14-Apr-2021, Ultrasound breast: lump in her breast. It measured 0.5 x 0.8 x 0.3 cm.. On 18-Nov-2021, SARS-CoV-2 test: (Positive) Positive. No concomitant medications were reported. Patient followed up with an ultrasound on 14-Apr-2021. It measured 0.5 x 0.8 x 0.3 cm. On 15-Oct-2021, the lump had shrunk. It measured 4 x 6 x 3 mm. They told her it was fibroadenoma. Further it was stated that she considered getting a booster dose, but she got COVID in November 2021. Patient did not get any booster doses after that. At her follow-up on 20-Apr-2022, the lump remained the same. The patient denies any other symptoms to report. AE cause patient to seek office visit. Patient had not experienced a similar event in the past. Symptoms improved because it shrunk. Treatment information reported as none. No vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Company Comment: This spontaneous case concerns a 48-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 which occurred approximately 10 months after the second dose of mRNA-1273 vaccine. SARS-CoV-2 test was Positive approximately 10 months after the second dose of mRNA-1273 vaccine. Additionally, vaccination failure is also reported. Non-serious event of Fibroadenoma of breast occurred approximately 2 months after the second dose. Patient found a lump in her breast on a mammogram approximately 2 months after the vaccination. 21 days later upon follow up with an ultrasound where it measured 0.5 x 0.8 x 0.3 cm. 6 months later, the lump had shrunk. It measured 4 x 6 x 3 mm. Diagnosed as fibroadenoma. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event covid-19 and vaccination failure was reported as unknown and Fibroadenoma of breast as not resolved. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 48-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 which occurred approximately 10 months after the second dose of mRNA-1273 vaccine. SARS-CoV-2 test was Positive approximately 10 months after the second dose of mRNA-1273 vaccine. Additionally, vaccination failure is also reported. Non-serious event of Fibroadenoma of breast occurred approximately 2 months after the second dose. Patient found a lump in her breast on a mammogram approximately 2 months after the vaccination. 21 days later upon follow up with an ultrasound where it measured 0.5 x 0.8 x 0.3 cm. 6 months later, the lump had shrunk. It measured 4 x 6 x 3 mm. Diagnosed as fibroadenoma. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event covid-19 and vaccination failure was reported as unknown and Fibroadenoma of breast as not resolved. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.