Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Renal pain
Clinical narrative: Kidney stones the size of the kidneys; Diagnosed with chronic kidney disease; Infection in both kidneys; Got sick with multiple things; The kidney hurts; Couldn't complete the series; The patient also said that had COVID since it was Caring for the husband who was unvaccinated/very sick and symptomatic; This spontaneous case was reported by a nurse and describes the occurrence of NEPHROLITHIASIS (Kidney stones the size of the kidneys), CHRONIC KIDNEY DISEASE (Diagnosed with chronic kidney disease) and KIDNEY INFECTION (Infection in both kidneys) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced COVID-19 (The patient also said that had COVID since it was Caring for the husband who was unvaccinated/very sick and symptomatic). On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stones the size of the kidneys) (seriousness criterion medically significant), CHRONIC KIDNEY DISEASE (Diagnosed with chronic kidney disease) (seriousness criterion medically significant), KIDNEY INFECTION (Infection in both kidneys) (seriousness criterion medically significant), ILLNESS (Got sick with multiple things), RENAL PAIN (The kidney hurts) and PRODUCT DOSE OMISSION ISSUE (Couldn't complete the series). At the time of the report, NEPHROLITHIASIS (Kidney stones the size of the kidneys), CHRONIC KIDNEY DISEASE (Diagnosed with chronic kidney disease), KIDNEY INFECTION (Infection in both kidneys), ILLNESS (Got sick with multiple things), RENAL PAIN (The kidney hurts) and COVID-19 (The patient also said that had COVID since it was Caring for the husband who was unvaccinated/very sick and symptomatic) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Couldn't complete the series) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NEPHROLITHIASIS (Kidney stones the size of the kidneys), CHRONIC KIDNEY DISEASE (Diagnosed with chronic kidney disease) and KIDNEY INFECTION (Infection in both kidneys) to be not related. No further causality assessments were provided for ILLNESS (Got sick with multiple things), RENAL PAIN (The kidney hurts), COVID-19 (The patient also said that had COVID since it was Caring for the husband who was unvaccinated/very sick and symptomatic) and PRODUCT DOSE OMISSION ISSUE (Couldn't complete the series).    No concomitant medication was given. The patient reported that after vaccination she had four surgeries so cannot complete the vaccination series. No treatment medication was given.  Company comment: This case concerns a 47-year-old female patient, with no medical history provided, who experienced the serious unexpected events of NEPHROLITHIASIS, CHRONIC KIDNEY DISEASE and KIDNEY INFECTION, and the non-serious unexpected AESI of COVID 19. The event of COVID 19 occurred on an unknown date, approximately 7 months after receiving the first dose of Moderna COVID 19 vaccine. Second dose was missed. The events of nephrolithiasis, chronic kidney disease and kidney infection occurred on an unknown date after the first dose of COVID 19. The rechallenge is not applicable since the outcome of the events is unknown. The reporter considered the events of nephrolithiasis, chronic kidney disease and kidney infection as not related to the vaccine. The benefit-risk relation of Moderna COVID 19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 47-year-old female patient, with no medical history provided, who experienced the serious unexpected events of NEPHROLITHIASIS, CHRONIC KIDNEY DISEASE and KIDNEY INFECTION, and the non-serious unexpected AESI of COVID 19. The event of COVID 19 occurred on an unknown date, approximately 7 months after receiving the first dose of Moderna COVID 19 vaccine. Second dose was missed. The events of nephrolithiasis, chronic kidney disease and kidney infection occurred on an unknown date after the first dose of COVID 19. The rechallenge is not applicable since the outcome of the events is unknown. The reporter considered the events of nephrolithiasis, chronic kidney disease and kidney infection as not related to the vaccine. The benefit-risk relation of Moderna COVID 19 vaccine is not affected by this report.