Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Headache, Myalgia, Pyrexia
Clinical narrative: Crohns disease aggravated; Fever; Headache; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohns disease aggravated/Crohn's disease flare ups) in a 46-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) solution for injection for Crohn's disease.  Concurrent medical conditions included Crohn's disease.  On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2022, received fourth 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 19-Jan-2022, the patient experienced MYALGIA (Generalized aching/body aches), PYREXIA (Fever) and HEADACHE (Headache). On an unknown date, the patient experienced CROHN'S DISEASE (Crohns disease aggravated/Crohn's disease flare ups) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (Crohns disease aggravated/Crohn's disease flare ups) had not resolved and MYALGIA (Generalized aching/body aches), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.     Company comment: This is a spontaneous case concerning a 46-year-old female patient with Chron´s disease on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event Chron´s disease flare up, on an unknown date on relation to mRNA-1273 four doses. Clinical course, diagnostic tests and treatment details were not provided. Pyrexia, headache and myalgia were reported as non-serious events on the same day of fourth dose. Adalimumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.  No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Humira (Solution for injection in pre-filled pen) was used for the indication of moderate to severe adult Crohn's disease.  The reporter's causality for the event of Crohn's disease was a reasonable possibility with HUMIRA(ADALIMUMAB). The reporter's causality for the events of pyrexia, headache and pain was no reasonable possibility with HUMIRA(ADALIMUMAB).  No treatment medications were reported.  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.  Sender's Comments: Company comment: This is a spontaneous case concerning a 46-year-old female patient with Chron´s disease on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event Chron´s disease flare up, on an unknown date on relation to mRNA-1273 four doses. Clinical course, diagnostic tests and treatment details were not provided. Pyrexia, headache and myalgia were reported as non-serious events on the same day of fourth dose. Adalimumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.