Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood pressure measurement, Blood test, Headache, Hypertension
Clinical narrative: Wound up in the ER with High Blood Pressure/Back in the ER with the same; Collapsed; Lupus in his kidneys; Kidney Malfunction/ hospitalized for 3 weeks now with kidney failure and is on dialysis; Stomach Issues after second dose; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Collapsed), LUPUS NEPHRITIS (Lupus in his kidneys), RENAL DISORDER (Kidney Malfunction/ hospitalized for 3 weeks now with kidney failure and is on dialysis), ABDOMINAL DISCOMFORT (Stomach Issues after second dose), HYPERTENSION (Wound up in the ER with High Blood Pressure/Back in the ER with the same) and HEADACHE (Headache) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A. and M20A) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach Issues after second dose) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). On 06-Jun-2021, the patient experienced SYNCOPE (Collapsed) (seriousness criteria hospitalization and medically significant), LUPUS NEPHRITIS (Lupus in his kidneys) (seriousness criteria hospitalization and medically significant) and RENAL DISORDER (Kidney Malfunction/ hospitalized for 3 weeks now with kidney failure and is on dialysis) (seriousness criterion hospitalization). On an unknown date, the patient experienced HYPERTENSION (Wound up in the ER with High Blood Pressure/Back in the ER with the same) (seriousness criterion hospitalization). At the time of the report, SYNCOPE (Collapsed), LUPUS NEPHRITIS (Lupus in his kidneys) and RENAL DISORDER (Kidney Malfunction/ hospitalized for 3 weeks now with kidney failure and is on dialysis) outcome was unknown and ABDOMINAL DISCOMFORT (Stomach Issues after second dose), HYPERTENSION (Wound up in the ER with High Blood Pressure/Back in the ER with the same) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) Increased. On an unknown date, Blood test: abnormal (abnormal) Diagnosed kidney malfunction.         Concomitant product use was not provided by the reporter.  Patient reported that he had hospitalized for 3 weeks with kidney failure and he was on dialysis. he also reported that his son diagnosed with lupus in his kidney.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.