Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Crohn's disease, Hypertension
Clinical narrative: CROHNS DISEASE GOT WORSE; BLOOD PRESSURE WENT UP DUE TO MODERNA VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (CROHNS DISEASE GOT WORSE) in an adult 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.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CROHN'S DISEASE (CROHNS DISEASE GOT WORSE) (seriousness criterion medically significant) and HYPERTENSION (BLOOD PRESSURE WENT UP DUE TO MODERNA VACCINE). At the time of the report, CROHN'S DISEASE (CROHNS DISEASE GOT WORSE) and HYPERTENSION (BLOOD PRESSURE WENT UP DUE TO MODERNA VACCINE) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high/went up.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   Moderna vaccine taken one in once.   No treatment information was provided.  The reporter's causality with Humira (Adalimumab) for the events of crohns disease got worse and blood pressure went up due to moderna vaccine was not provided.  Company comment: This spontaneous case concerns an adult male patient of an unknown age, with concurrent medical history of Crohn's disease, who experienced the unexpected serious (medically significant) event of Crohn's disease after receiving 1st dose of mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date and onset date of event was not reported. Patient reported that Crohn's disease got worse and blood pressure elevated. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. Concurrent Crohn's disease and co-suspect Adalimumab could be confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient of an unknown age, with concurrent medical history of Crohn's disease, who experienced the unexpected serious (medically significant) event of Crohn's disease after receiving 1st dose of mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date and onset date of event was not reported. Patient reported that Crohn's disease got worse and blood pressure elevated. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. Concurrent Crohn's disease and co-suspect Adalimumab could be confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.