Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Chromaturia, Extra dose administered, Haemorrhage urinary tract, Somnolence
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (Little bit of blood, and blood clots in urine), SOMNOLENCE (Feeling groggier than normal), BLOOD URINE PRESENT (A little bit of blood in their urine), CHROMATURIA (Their urine was brown and black) and EXTRA DOSE ADMINISTERED (patient received a 3rd dose of the Moderna COVID-19 vaccine on 17Aug2021 in the left arm.) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Ureteral catheterisation.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced BLOOD URINE PRESENT (A little bit of blood in their urine) and EXTRA DOSE ADMINISTERED (patient received a 3rd dose of the Moderna COVID-19 vaccine on 17Aug2021 in the left arm.). On 18-Aug-2021, the patient experienced HAEMORRHAGE URINARY TRACT (Little bit of blood, and blood clots in urine) and CHROMATURIA (Their urine was brown and black). On an unknown date, the patient experienced SOMNOLENCE (Feeling groggier than normal). On 19-Aug-2021, HAEMORRHAGE URINARY TRACT (Little bit of blood, and blood clots in urine), BLOOD URINE PRESENT (A little bit of blood in their urine) and CHROMATURIA (Their urine was brown and black) had resolved. At the time of the report, SOMNOLENCE (Feeling groggier than normal) had not resolved and EXTRA DOSE ADMINISTERED (patient received a 3rd dose of the Moderna COVID-19 vaccine on 17Aug2021 in the left arm.) had resolved.            Concomitant product was not provided by the reporter. Treatment information was not provided.  Patient reported that self catheterize four times a day.  Patient had not taken anything to help with the symptoms.  Company Comment: This report refers to a case of Extra dose administered for mRNA-1273 (lot # 037K20A) with associated adverse events reported as BLOOD URINE PRESENT, HAEMORRHAGE URINARY TRACT, CHROMATURIA and SOMNOLENCE.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, current history of Ureteral catheterisation may be a confounding factor for the case. Event HAEMORRHAGE URINARY TRACT was automatically upgraded as serious as per IME list. However, based on information available and as per medical judgement was assessed as non-serious. No further contact is possible.   This case was linked to MOD-2021-292294, MOD-2021-292304 (Patient Link).; Sender's Comments: This report refers to a case of Extra dose administered for mRNA-1273 (lot # 037K20A) with associated adverse events reported as BLOOD URINE PRESENT, HAEMORRHAGE URINARY TRACT, CHROMATURIA and SOMNOLENCE.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, current history of Ureteral catheterisation may be a confounding factor for the case. Event HAEMORRHAGE URINARY TRACT was automatically upgraded as serious as per IME list. However, based on information available and as per medical judgement was assessed as non-serious. No further contact is possible.