Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Influenza like illness, Investigation, Nephrolithiasis, Pyrexia
Clinical narrative: Kidney stone; Urinary tract infection; Urinary tract disorder; Cyst of kidney; patient received two doses of moderna vaccine 40 days apart; Flu like symptoms; Fever; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stone) in a 66-year-old 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In September 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever) and VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stone) (seriousness criterion medically significant), URINARY TRACT INFECTION (Urinary tract infection), URINARY TRACT DISORDER (Urinary tract disorder), RENAL CYST (Cyst of kidney) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received two doses of moderna vaccine 40 days apart). At the time of the report, NEPHROLITHIASIS (Kidney stone), URINARY TRACT INFECTION (Urinary tract infection), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received two doses of moderna vaccine 40 days apart) outcome was unknown and URINARY TRACT DISORDER (Urinary tract disorder), RENAL CYST (Cyst of kidney), INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Vaccination site pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: not reported not reported.         No concomitant medication was reported.  In September 2021, the patient had second dose of covid vaccine and had injection site soreness on arm, flu like symptoms and fever. The patient had a few cysts on kidneys and possible a stone. She got up just about every hour at night and had to go to the bathroom. She had urinary issue and she had done tests. She had done covid-19 vaccines, first vaccine was fine and second vaccine, she had flu like symptoms, slight fever and injection site soreness on arm. She took antibiotic every night to make sure that the urinary tract infection does not come back. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Company comment: This spontaneous case concerns 66-year-old female patient, with no relevant medical history, who experienced the unexpected, serious (due to medically significant) event of NEPHROLITHIASIS, among other non-serious events. The event was reported with no onset date; hence, latency to the first or the second dose of mRNA-1273 vaccine cannot be assessed. Inappropriate schedule of vaccine administered case: since the reported doses (1st and 2nd) were administered 40 days apart. As per source document, patient also reported (non-serious) a few cysts on kidneys, a possible a kidney stone and that she took antibiotic every night due to a urinary tract infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2022: Added event and updated event outcome.; Sender's Comments: This spontaneous case concerns 66-year-old female patient, with no relevant medical history, who experienced the unexpected, serious (due to medically significant) event of NEPHROLITHIASIS, among other non-serious events. The event was reported with no onset date; hence, latency to the first or the second dose of mRNA-1273 vaccine cannot be assessed. Inappropriate schedule of vaccine administered case: since the reported doses (1st and 2nd) were administered 40 days apart. As per source document, patient also reported (non-serious) a few cysts on kidneys, a possible a kidney stone and that she took antibiotic every night due to a urinary tract infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.