Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Basophil count, Haematuria, International normalised ratio, Monocyte count, Nephrolithiasis
Clinical narrative: Urological work-up revealed a non-obstructing 9 mm stone in the proximal left ureter and a non-obstructing punctate right renal stone; wine-colored urine/Urine dipstick showed large blood; This literature-non-study case was reported in a literature article and describes the occurrence of NEPHROLITHIASIS (Urological work-up revealed a non-obstructing 9 mm stone in the proximal left ureter and a non-obstructing punctate right renal stone) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: (Privacy)    The patient's past medical history included Nephrolithiasis (remote history of nephrolithiasis (22 years ago)) in 1999, Atrial flutter (remote history of atrial flutter (22 years ago)), Ex-smoker (40-pack-year smoking history (quit 32 years prior to presentation)) and Cystoscopy (Hematuria resolved completely after cystoscopy with bladder irrigation and has not recurred to date.). Concurrent medical conditions included Penicillin allergy, Iodine allergy, Shellfish allergy, Drug allergy (Allergic to Cipro) and Atherosclerotic cardiovascular disease. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and RIVAROXABAN for Atherosclerotic cardiovascular disease and Atrial flutter.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HAEMATURIA (wine-colored urine/Urine dipstick showed large blood). On an unknown date, the patient experienced NEPHROLITHIASIS (Urological work-up revealed a non-obstructing 9 mm stone in the proximal left ureter and a non-obstructing punctate right renal stone) (seriousness criterion medically significant). The patient was treated with Surgery (Hematuria resolved completely after cystoscopy with bladder irrigation and has not recurred to-date.) for Haematuria. At the time of the report, NEPHROLITHIASIS (Urological work-up revealed a non-obstructing 9 mm stone in the proximal left ureter and a non-obstructing punctate right renal stone) outcome was unknown and HAEMATURIA (wine-colored urine/Urine dipstick showed large blood) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Basophil count (20-90): 110 cells/ul (High) 110 cells/UL. On an unknown date, International normalised ratio (0.8-1.1): 1.2 (High) 1.2. On an unknown date, Monocyte count (200-700): 740 cells/ul (High) 740 cells/UL. On an unknown date, Physical examination: abnormal (abnormal) physical exam only revealed tenderness to deep palpation in the suprapubic region.. On an unknown date, Urine analysis: abnormal (abnormal) Urine dipstick confirmed large blood. Urological work-up revealed a non-obstructing 9 mm stone in the proximal left ureter and a non-obstructing punctate right renal stone.. On an unknown date, Vital signs measurement: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.  This literature case concerns a 72 year-old, male patient with a history of Nephrolithiasis and concomitant use of acetylsalicylic acid and rivaroxaban, who experienced the serious unexpected event of Nephrolithiasis and the non serious unexpected event of haematuria. The event Nephrolithiasis occurred at an unknown date after the second dose of mRNA-1273 vaccine and the event haematuria on the same date after the second dose. The patient required a cystoscopy. The rechallenge was not applicable, as the events were reported exclusively after the second dose and no information on additional dosing is available. The medical history, of Nephrolithiasis and concomitant use of acetylsalicylic acid and rivaroxaban remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-380601 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Significant follow up appended - Events, Laboratory data, Relevant History and Batch number were updated; Sender's Comments: This literature case concerns a 72 year-old, male patient with a history of Nephrolithiasis and concomitant use of acetylsalicylic acid and rivaroxaban, who experienced the serious unexpected event of Nephrolithiasis and the non serious unexpected event of haematuria. The event Nephrolithiasis occurred at an unknown date after the second dose of mRNA-1273 vaccine and the event haematuria on the same date after the second dose. The patient required a cystoscopy. The rechallenge was not applicable, as the events were reported exclusively after the second dose and no information on additional dosing is available. The medical history, of Nephrolithiasis and concomitant use of acetylsalicylic acid and rivaroxaban remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.