Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Ear haemorrhage, Pyrexia, Systemic lupus erythematosus
Clinical narrative: Two weeks later her hair started coming out, now has lupus; her ears rupture every other week & blood pours out of them; 4 hours after getting the dose she had a 102.7F fever; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Two weeks later her hair started coming out, now has lupus) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced PYREXIA (4 hours after getting the dose she had a 102.7F fever). On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Two weeks later her hair started coming out, now has lupus) (seriousness criterion medically significant) and EAR HAEMORRHAGE (her ears rupture every other week & blood pours out of them). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Two weeks later her hair started coming out, now has lupus), EAR HAEMORRHAGE (her ears rupture every other week & blood pours out of them) and PYREXIA (4 hours after getting the dose she had a 102.7F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Body temperature: 102.7 (High) she had a 102.7F fever..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant were reported. Patient said that got the shot from a store. Patient had been sick as a dog and she had 2 small children that she could no longer care for and most days she stays on the couch. No treatment were reported.  Company Comment:  This spontaneous case concerns a 44-year-old female patient with no medical history reported, who experienced the unexpected serious (Medically significant) event of Systemic lupus erythematosus, that occurred on an unknown date after receiving first dose of mRNA-1273 Vaccine (latency between vaccine and event cannot be established).  Patient initially presented with fever 4 hours post vaccination followed by hair loss 2 weeks later. Patient reportedly developed lupus and has been sick noting rupture and bleeding from her ears every other week. Outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 44-year-old female patient with no medical history reported, who experienced the unexpected serious (Medically significant) event of Systemic lupus erythematosus, that occurred on an unknown date after receiving first dose of mRNA-1273 Vaccine (latency between vaccine and event cannot be established).  Patient initially presented with fever 4 hours post vaccination followed by hair loss 2 weeks later. Patient reportedly developed lupus and has been sick noting rupture and bleeding from her ears every other week. Outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.