Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Inflammation
Clinical narrative: boosted her immune system very quickly and auto-immune disease; inflammation was boosted and it went crazy; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (boosted her immune system very quickly and auto-immune disease) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder. Concurrent medical conditions included Inflammation.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced AUTOIMMUNE DISORDER (boosted her immune system very quickly and auto-immune disease) (seriousness criterion medically significant) and INFLAMMATION (inflammation was boosted and it went crazy). At the time of the report, AUTOIMMUNE DISORDER (boosted her immune system very quickly and auto-immune disease) and INFLAMMATION (inflammation was boosted and it went crazy) outcome was unknown.            No concomitant medications were provided by the reporter.  It was reported the patient was told to stop all medications before first dose and she got very ill for a long time.  It was reported that a week after booster dose, patient had all her the auto-immune things kicked to high gear, boosted immune system very quickly, auto-immune disease and inflammation was boosted and it went crazy.  No treatment medications were provided by the reporter.  Company comment.  This spontaneous case concerns a 66  year  old female patient, with medical history of unspecified auto  immune disorder, who experienced the unexpected, serious (medically significant) event of autoimmune disorder. The event occurred one week after a dose of mRNA-1273 vaccine, reported as booster dose of her COVID  19 immunization schedules; the patient previously had one dose with mRNA  1273 vaccines (first dose of her schedules). Latency cannot be properly assessed since exact onset date was not provided. The report stated that before the first dose of COVID  19 vaccine the patient stopped all her medications and got "very ill for a long time". A week after the booster dose, her auto  immune disease and her inflammation were boosted. No further clinical details were provided for medical reviewing. Patient´s mentioned medical history remains as confounder for autoimmune disorder (autoimmune disease flare up). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 66  year  old female patient, with medical history of unspecified auto  immune disorder, who experienced the unexpected, serious (medically significant) event of autoimmune disorder. The event occurred one week after a dose of mRNA-1273 vaccine, reported as booster dose of her COVID  19 immunization schedules; the patient previously had one dose with mRNA  1273 vaccines (first dose of her schedules). Latency cannot be properly assessed since exact onset date was not provided. The report stated that before the first dose of COVID  19 vaccine the patient stopped all her medications and got "very ill for a long time". A week after the booster dose, her auto  immune disease and her inflammation were boosted. No further clinical details were provided for medical reviewing. Patient´s mentioned medical history remains as confounder for autoimmune disorder (autoimmune disease flare up). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.