Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Nephrolithiasis, Ovarian cyst
Clinical narrative: two very large cyst (size of base ball and the other one was oblong like two golf balls put together)/ovaries could barely be seen because the cyst was so big/vaccine spiked proteins and activated them and made the cyst grow; kidney stones; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (kidney stones) and OVARIAN CYST (two very large cyst (size of base ball and the other one was oblong like two golf balls put together)/ovaries could barely be seen because the cyst was so big/vaccine spiked proteins and activated them and made the cyst grow) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 031B21A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Past medical history of partial hysterectomy's in 2018/2019 and went into menopause in 2002/2003. Known penicillin allergy.  The patient's past medical history included Menopause (menopause in 2002/2003) and Partial hysterectomy (partial hysterectomy's in 2018/2019). Concurrent medical conditions included Penicillin allergy.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NEPHROLITHIASIS (kidney stones) (seriousness criterion medically significant). On an unknown date, the patient experienced OVARIAN CYST (two very large cyst (size of base ball and the other one was oblong like two golf balls put together)/ovaries could barely be seen because the cyst was so big/vaccine spiked proteins and activated them and made the cyst grow) (seriousness criterion medically significant). At the time of the report, NEPHROLITHIASIS (kidney stones) had resolved and OVARIAN CYST (two very large cyst (size of base ball and the other one was oblong like two golf balls put together)/ovaries could barely be seen because the cyst was so big/vaccine spiked proteins and activated them and made the cyst grow) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: she had two very large cyst (size of base ball and the other one was oblong like two golf balls put together). / ovaries could barely be seen because the cyst was so big.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. The doctor thought she had kidney stones but after a CT they said she had two very large cyst (size of base ball and the other one was oblong like two golf balls put together). Patient went into surgery because they were not sure if it was malignant or not. One of the ovaries could barely be seen because the cyst was so big. Caller believed the vaccine spiked proteins and activated them and made the cyst grow.  Company comment: This spontaneous case concerns a 65-year-old female patient , with relevant medical history of Partial hysterectomy and in menopause, who experienced the unexpected serious (medically significant) events of Ovarian cyst and Nephrolithiasis. The event ovarian cyst occurred on an unknown date, Nephrolithiasis occurred approximately 2.5 months after receiving the second dose of mRNA-1273 vaccine in COVID-19 vaccination series. It was reported that, the doctor thought she had kidney stones but Computerized tomogram showed two large ovarian cysts, (size of baseball and the other one was oblong like two golf balls put together), ovaries could barely be seen because the cyst was too big. Patient went into surgery because they were not sure if it was malignant or not.  Patient had received first and second dose of Moderna vaccine at an interval of 35days. No further information on additional risk factors, medical history, concurrent conditions, additional investigations and outcome of surgery were provided. The outcome of the event Ovarian cyst was unknown, Nephrolithiasis was recovered. Patients' medical history could be a risk factor for the event ovarian cyst. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65-year-old female patient , with relevant medical history of Partial hysterectomy and in menopause, who experienced the unexpected serious (medically significant) events of Ovarian cyst and Nephrolithiasis. The event ovarian cyst occurred on an unknown date, Nephrolithiasis occurred approximately 2.5 months after receiving the second dose of mRNA-1273 vaccine in COVID-19 vaccination series. It was reported that, the doctor thought she had kidney stones but Computerized tomogram showed two large ovarian cysts, (size of baseball and the other one was oblong like two golf balls put together), ovaries could barely be seen because the cyst was too big. Patient went into surgery because they were not sure if it was malignant or not.  Patient had received first and second dose of Moderna vaccine at an interval of 35days. No further information on additional risk factors, medical history, concurrent conditions, additional investigations and outcome of surgery were provided. The outcome of the event Ovarian cyst was unknown, Nephrolithiasis was recovered. Patients' medical history could be a risk factor for the event ovarian cyst. The benefit-risk relationship of mRNA-1273 is not affected by this report.