Sex: F
Vaccine: COVID19
Symptoms: Renal cyst, Ultrasound kidney, Urinary tract infection, Vaginal infection
Clinical narrative: She had kidney stone; Renal cell carcinoma; pain; Urinary tract infection; Vaginitis; Thrush; never felt quite right after; she had a small cyst; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (She had kidney stone) and RENAL CELL CARCINOMA (Renal cell carcinoma) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis.    Concurrent medical conditions included Panuveitis.   On 12-Mar-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced RENAL CYST (she had a small cyst). On an unknown date, the patient experienced NEPHROLITHIASIS (She had kidney stone) (seriousness criterion medically significant), RENAL CELL CARCINOMA (Renal cell carcinoma) (seriousness criterion medically significant), PAIN (pain), URINARY TRACT INFECTION (Urinary tract infection), VAGINAL INFECTION (Vaginitis), CANDIDA INFECTION (Thrush) and FEELING ABNORMAL (never felt quite right after). At the time of the report, NEPHROLITHIASIS (She had kidney stone), RENAL CELL CARCINOMA (Renal cell carcinoma), PAIN (pain), RENAL CYST (she had a small cyst) and FEELING ABNORMAL (never felt quite right after) outcome was unknown and URINARY TRACT INFECTION (Urinary tract infection), VAGINAL INFECTION (Vaginitis) and CANDIDA INFECTION (Thrush) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Ultrasound kidney: Small kidney cyst.. On an unknown date, Ultrasound kidney: Kidney mass 4.7 cm.         No concomitant and treatment medications were reported.  It was reported that patient wondered that COVID-19 vaccine might had played a part because she had the Moderna COVID-19 vaccine in Nov 2021 and never felt quite right after. Reporters causality for event Urinary tract infection, vaginitis and thrush was probable and for all other events was not reported with respect to Humira drug.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment  This is a spontaneous case reported by a consumer, concerning an adult female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, medically significant event of POSSIBLE RENAL CELL CARCINOMA (Renal cell carninoma), and Nephrolithiasis, unknown days after receiving the 3 dose of mRNA-1273 Vaccine in the covid 19 vaccination series, along with other non serious events of Renal cyst, pain, Urinary Tract Infection. Vaginal Infection, Candida Infection, and feeling abnormal.Patient received the primary 2 doses of m RNA1273 vaccine at an interval of about 01 month between the 2 doses, with the 2 dose given about 6 months prior to the 3 dose. Concurrent medical conditions included Panuveitis. The patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) injection about 1 month prior to the 1 dose of Moderna vaccine, for Panuveitis. Ultrasound kidney showed Small kidney cyst and a Kidney mass of 4.7 cm on an unknown date, which was suspected to be a Renal cell carcinoma. Details of clinical course, concomitant medications, labs and further diagnostics,  and treatment details were not reported. The outcome of Nephrolithiasis was unknown and that of renal cell carcinoma was not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer, concerning an adult female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, medically significant event of POSSIBLE RENAL CELL CARCINOMA (Renal cell carninoma), and Nephrolithiasis, unknown days after receiving the 3 dose of mRNA-1273 Vaccine in the covid 19 vaccination series, along with other non serious events of Renal cyst, pain, Urinary Tract Infection. Vaginal Infection, Candida Infection, and feeling abnormal. Patient received the primary 2 doses of m RNA1273 vaccine at an interval of about 01 month between the 2 doses, with the 2 dose given about 6 months prior to the 3 dose. Concurrent medical conditions included Panuveitis. The patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) injection about 1 month prior to the 1 dose of Moderna vaccine, for Panuveitis. Ultrasound kidney showed Small kidney cyst and a Kidney mass of 4.7 cm on an unknown date, which was suspected to be a Renal cell carcinoma. Details of clinical course, concomitant medications, labs and further diagnostics,  and treatment details were not reported. The outcome of Nephrolithiasis was unknown and that of renal cell carcinoma was not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.