Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Subacute cutaneous lupus erythematosus, Thrombosis, Viral infection
Clinical narrative: After receiving the vaccine she started getting sick; She has been "going through hell"; the virus" 3 times; Blood clots; She has had symptoms from her lupus for the past 10 months; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) and SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS (She has had symptoms from her lupus for the past 10 months) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Subacute cutaneous lupus erythematosus (Patient was reading online that you should not receive the vaccine if you had lupus.).   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). In 2021, the patient experienced SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS (She has had symptoms from her lupus for the past 10 months) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (After receiving the vaccine she started getting sick), FEELING ABNORMAL (She has been "going through hell") and VIRAL INFECTION (the virus" 3 times). At the time of the report, THROMBOSIS (Blood clots) and SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS (She has had symptoms from her lupus for the past 10 months) had resolved and ILLNESS (After receiving the vaccine she started getting sick), FEELING ABNORMAL (She has been "going through hell") and VIRAL INFECTION (the virus" 3 times) outcome was unknown.            No concomitant medications were provided. No treatment medication was reported. The patient came down in April with blood clots, which were all gone. The patient has had symptoms from her lupus for the past 10 months, although the patient never had symptoms for more than 1 month in the past during her 31 years with this condition. She had spoke to he HCP and claims nobody could help her. She had the virus 3 times. She had been gone through hell.  Company comment: This spontaneous case concerns a female patient (age not specified) with relevant medical history of Subacute cutaneous lupus erythematosus, who experienced the unexpected serious (medically significant) events Thrombosis (AESI) and Subacute cutaneous lupus erythematosus, on an unspecified date after the second dose of mRNA-1273. The patient experienced blood clots and Subacute cutaneous lupus erythematosus. At the time of report thrombosis had resolved and outcome of Subacute cutaneous lupus erythematosus was recovered/resolved. It was not reported if the patient had similar events after first dose. Medical history of Subacute cutaneous lupus erythematosus could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient (age not specified) with relevant medical history of Subacute cutaneous lupus erythematosus, who experienced the unexpected serious (medically significant) events Thrombosis (AESI) and Subacute cutaneous lupus erythematosus, on an unspecified date after the second dose of mRNA-1273. The patient experienced blood clots and Subacute cutaneous lupus erythematosus. At the time of report thrombosis had resolved and outcome of Subacute cutaneous lupus erythematosus was recovered/resolved. It was not reported if the patient had similar events after first dose. Medical history of Subacute cutaneous lupus erythematosus could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.