Age: 32.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Crohn's disease
Clinical narrative: Crohns disease aggravated; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohns disease aggravated) in a 32-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) for Crohn's disease.    The patient's past medical history included Crohn's disease.   On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, received second 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) UNK, Citrate Free. In 2021, the patient experienced ARTHRALGIA (Joint pain). On an unknown date, the patient experienced CROHN'S DISEASE (Crohns disease aggravated) (seriousness criterion medically significant). In 2021, ARTHRALGIA (Joint pain) had resolved. At the time of the report, CROHN'S DISEASE (Crohns disease aggravated) was resolving.            No concomitant medications were reported. Patient experienced non-serious events Crohn's disease flare up and after getting covid-19 vaccine had intense joint pain with HUMIRA (adalimumab). The reporter's causality of HUMIRA for the event(s) of Crohn's disease flare up and after getting covid-19 vaccine had intense joint pain was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications information were provided. 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  Company Comment:  This spontaneous case concerns a 32-year-old male patient with relevant medical history of Crohn's disease, who experienced the unexpected, serious  (medically significant) event of Crohn's disease (reported as Crohns disease aggravated) in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency between vaccine and event could not be determined as the date of event onset  was not reported. Outcome of the event was reported as resolving.    Patient received a 2-dose primary series of mRNA-1273 vaccine given 32 days apart. Relevant medical history of Crohn's disease remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 32-year-old male patient with relevant medical history of Crohn's disease, who experienced the unexpected, serious  (medically significant) event of Crohn's disease (reported as Crohns disease aggravated) in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency between vaccine and event could not be determined as the date of event onset  was not reported. Outcome of the event was reported as resolving.    Patient received a 2-dose primary series of mRNA-1273 vaccine given 32 days apart. Relevant medical history of Crohn's disease remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.