Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Inappropriate schedule of product administration, Lupus-like syndrome
Clinical narrative: Drug-induced lupus erythematosus (develop antibodies to drugs); Crohn's disease aggravated; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of LUPUS-LIKE SYNDROME (Drug-induced lupus erythematosus (develop antibodies to drugs)) and CROHN'S DISEASE (Crohn's disease aggravated) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Hidradenitis suppurativa and Crohn's disease.    Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe hidradenitis suppurativa) and Crohn's disease (Moderate to severe adult Crohn's disease).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 02-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced LUPUS-LIKE SYNDROME (Drug-induced lupus erythematosus (develop antibodies to drugs)) (seriousness criterion medically significant) and CROHN'S DISEASE (Crohn's disease aggravated) (seriousness criterion medically significant). At the time of the report, LUPUS-LIKE SYNDROME (Drug-induced lupus erythematosus (develop antibodies to drugs)), CROHN'S DISEASE (Crohn's disease aggravated) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            Concomitant product use was not provided by the reporter.  Reported that on unknown date patient experienced events after each COVID-19 vaccine with Humira(Solution for injection in pre-filled pen)(ADALIMUMAB). The reporter's causality for suspect drug Humira was a reasonable possibility. Treatment information was not provided.  Company Comment: This spontaneous case concerns a 36-year-old, male patient with relevant current condition of Crohn's disease, Hidradenitis suppurativa and concomitant use of Adalimumab who experienced the unexpected, serious (medically significant) events of Lupus like syndrome and Crohn's disease aggravated which occurred on unknown interval after administration of third dose of mRNA-1273 vaccine. Inappropriate schedule of vaccine administered is noted in this case as the second dose was administered 8 days after the first dose of mRNA-1273 vaccine. Patient developed joint pains and flares after each COVID-19 vaccine administration. He was also diagnosed to have Drug-induced Lupus secondary to Adalimumab. The clinical course, diagnostic investigations and treatment details were not provided in the report. Crohn's disease can flare as part of the natural history of disease. Concomitant use of Adalimumab remains a confounder for Lupus like syndrome. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 36-year-old, male patient with relevant current condition of Crohn's disease, Hidradenitis suppurativa and concomitant use of Adalimumab who experienced the unexpected, serious (medically significant) events of Lupus like syndrome and Crohn's disease aggravated which occurred on unknown interval after administration of third dose of mRNA-1273 vaccine. Inappropriate schedule of vaccine administered is noted in this case as the second dose was administered 8 days after the first dose of mRNA-1273 vaccine. Patient developed joint pains and flares after each COVID-19 vaccine administration. He was also diagnosed to have Drug-induced Lupus secondary to Adalimumab. The clinical course, diagnostic investigations and treatment details were not provided in the report. Crohn's disease can flare as part of the natural history of disease. Concomitant use of Adalimumab remains a confounder for Lupus like syndrome. The benefit-risk relationship of mRNA-1273 is not affected by this report.