Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Immunodeficiency, Nasopharyngitis, Positron emission tomogram, Sepsis
Clinical narrative: Immunodeficiency; Crohn's aggravated; Sepsis; Vomiting projectile; Cold; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immunodeficiency), CROHN'S DISEASE (Crohn's aggravated) and SEPSIS (Sepsis) in a 52-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease, Crohn's disease and Ulcerative colitis.    Concurrent medical conditions included Crohn's disease, Diabetes, Abstains from alcohol, Penicillin allergy and Allergy to antibiotic (CEPHALEXIN ALLERGY).   In 2004, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Sep-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 80 milligram. On 09-Dec-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) 160 milligram once a day. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 80 milligram and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On an unknown date, the patient experienced IMMUNODEFICIENCY (Immunodeficiency) (seriousness criteria hospitalization and medically significant), CROHN'S DISEASE (Crohn's aggravated) (seriousness criteria hospitalization and medically significant), SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant), VOMITING PROJECTILE (Vomiting projectile) and NASOPHARYNGITIS (Cold). The patient was hospitalized from 13-Mar-2022 to 23-Mar-2022 due to CROHN'S DISEASE, IMMUNODEFICIENCY and SEPSIS. The patient was treated with PREDNISONE for Crohn's disease, at an unspecified dose and frequency and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) at an unspecified dose and frequency. At the time of the report, IMMUNODEFICIENCY (Immunodeficiency), SEPSIS (Sepsis), VOMITING PROJECTILE (Vomiting projectile) and NASOPHARYNGITIS (Cold) outcome was unknown and CROHN'S DISEASE (Crohn's aggravated) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Positron emission tomogram: Compatible with Crohn's disease flare near distal ilium was observed..         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Patient experienced CROHN'S FLARE previously in September, October and then resolved. Patient received HUMIRA in 2004, when it was an infusion, and then went hospital for about every eight weeks to get it. It was been off of HUMIRA for years as of 03 Sep 2021 and was in a terrible Crohn's flare and had been flaring for a year and might have not been completed HUMIRA starter pack. Crohn's flare lasted fifteen months for the patient. Patient was extremely sick with a body temperature of 104, immune system down, severe crohns flare, and sepsis. Patient was hospitalized for about 11 days. Patient received all three doses of COVID vaccines and reported that vaccine knocked patient out. Patient was cold and was admitted to hospital on 13 Mar 2022 to 23 Mar 2022. Patient was given intravenous of Polymedrol when admitted to hospital. At time of discharge patient diarrhea condition already improved and continued to manage at home.  Company comment: This spontaneous case concerns a 52-year-old female patient, with relevant medical history of Diabetes mellitus and Crohn's disease that had been flaring for a year and treated with co-suspect Adalimumab for years, who experienced the unexpected serious (medically significant) events of Immunodeficiency, Crohn's disease (reported as Crohn's aggravated), and Sepsis on an unknown date after receiving the mRNA-1273 vaccine. Patient had severe Crohn's flare and sepsis along with projectile vomiting and diarrhea. Patient was hospitalized, treated with intravenous steroids, diarrhea improved, and was discharged after 11 days of hospitalization. Prednisone was given for home treatment. Positron emission tomogram result was compatible with Crohn's disease flare near distal ilium. Patient received 3 doses of mRNA-1273 vaccine, wherein 1st and 2nd doses were given 28 days apart, and 3rd dose was given approximately 6 months later. The medical history of diabetes mellitus could be considered as risk factor for immunodeficiency and sepsis. Crohn's disease and co-suspect Adalimumab as confounders for this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Live follow-up received by safety on 04-Apr-2022 has Email and contains Significant information: Event and lab data were updated.; Sender's Comments: This spontaneous case concerns a 52-year-old female patient, with relevant medical history of Diabetes mellitus and Crohn's disease that had been flaring for a year and treated with co-suspect Adalimumab for years, who experienced the unexpected serious (medically significant) events of Immunodeficiency, Crohn's disease (reported as Crohn's aggravated), and Sepsis on an unknown date after receiving the mRNA-1273 vaccine. Patient had severe Crohn's flare and sepsis along with projectile vomiting and diarrhea. Patient was hospitalized, treated with intravenous steroids, diarrhea improved, and was discharged after 11 days of hospitalization. Prednisone was given for home treatment. Positron emission tomogram result was compatible with Crohn's disease flare near distal ilium. Patient received 3 doses of mRNA-1273 vaccine, wherein 1st and 2nd doses were given 28 days apart, and 3rd dose was given approximately 6 months later. The medical history of diabetes mellitus could be considered as risk factor for immunodeficiency and sepsis. Crohn's disease and co-suspect Adalimumab as confounders for this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.