Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Autoimmune disorder, Feeling abnormal
Clinical narrative: Positive for Antinuclear antibody test indicator of autoimmune diseases/sometime the shot will bring up autoimmune diseases; Another person did not feel good after second shot; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Positive for Antinuclear antibody test indicator of autoimmune diseases/sometime the shot will bring up autoimmune diseases) in a 34-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Positive for Antinuclear antibody test indicator of autoimmune diseases/sometime the shot will bring up autoimmune diseases) (seriousness criterion medically significant) and FEELING ABNORMAL (Another person did not feel good after second shot). At the time of the report, AUTOIMMUNE DISORDER (Positive for Antinuclear antibody test indicator of autoimmune diseases/sometime the shot will bring up autoimmune diseases) and FEELING ABNORMAL (Another person did not feel good after second shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: (Positive) Positive.         No concomitant medications were provided. No treatment medications were reported.  Company comment-This spontaneous case concerns an adult male patient aged 34 years with no medical history reported, who experienced the unexpected serious (medically significant) event of Autoimmune disorder on unknown date after receiving second dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient also experienced non serious event of Feeling abnormal. Antinuclear antibody test done on unknown date was positive. His doctor said that sometimes the shot will bring up autoimmune diseases. No further clinical course, lab reports or treatment details were reported. Outcome of the event was resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns an adult male patient aged 34 years with no medical history reported, who experienced the unexpected serious (medically significant) event of Autoimmune disorder on unknown date after receiving second dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient also experienced non serious event of Feeling abnormal. Antinuclear antibody test done on unknown date was positive. His doctor said that sometimes the shot will bring up autoimmune diseases. No further clinical course, lab reports or treatment details were reported. Outcome of the event was resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.