Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Feeling abnormal, Haemorrhage urinary tract, Pyrexia
Clinical narrative: felt bad; mild burning with urination; low grade fever of about 100; started passing clots in my urine; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (started passing clots in my urine), FEELING ABNORMAL (felt bad), BURNING SENSATION (mild burning with urination) and PYREXIA (low grade fever of about 100) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 037A21B and 043B21A) for COVID-19 vaccination.     No medical history were reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced HAEMORRHAGE URINARY TRACT (started passing clots in my urine). On an unknown date, the patient experienced FEELING ABNORMAL (felt bad), BURNING SENSATION (mild burning with urination) and PYREXIA (low grade fever of about 100). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, HAEMORRHAGE URINARY TRACT (started passing clots in my urine), FEELING ABNORMAL (felt bad), BURNING SENSATION (mild burning with urination) and PYREXIA (low grade fever of about 100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low grade fever of about 100 (abnormal) low grade fever of about 100.         Company Comment- This case concerns a female patient of unknown age with no previous relevant medical history reported, who experienced the unexpected event of haemorrhage urinary tract. The events occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was not applicable since the event happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.  The case was downgraded to non-serious due the patient did not seek medical attention or meet the criteria to be medically significant.   Patient stated that the urine was slightly pink tinged but has actual small clots in it. She has no medical history of urinary tract infection or urinary stones.  She has noticed some mild burning with urination. She caller her primary care MD this am, and although they are out of the office today, they called something into the pharmacy but she was unsure as to what that medication was , as she has not yet picked it up. Sender's Comments: This case concerns a female patient of unknown age with no previous relevant medical history reported, who experienced the unexpected event of haemorrhage urinary tract. The events occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was not applicable since the event happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.  The case was downgraded to non-serious due the patient did not seek medical attention or meet the criteria to be medically significant.