Age: 72.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Crohn's disease, Hypertension
Clinical narrative: CROHN'S DISEASE FLARE UP FROM EATING TO MUCH; SINCE GOT THE COVID VACCINE HAD HIGHLY BLOOD; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (CROHN'S DISEASE FLARE UP FROM EATING TO MUCH) in a 72-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.    Concurrent medical conditions included Crohn's disease.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-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) Citrate Free. In 2021, the patient experienced HYPERTENSION (SINCE GOT THE COVID VACCINE HAD HIGHLY BLOOD). On 25-Nov-2021, the patient experienced CROHN'S DISEASE (CROHN'S DISEASE FLARE UP FROM EATING TO MUCH) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (CROHN'S DISEASE FLARE UP FROM EATING TO MUCH) had resolved and HYPERTENSION (SINCE GOT THE COVID VACCINE HAD HIGHLY BLOOD) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: High.         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.  No concomitant medication information was provided.  In November 2021, the CROHN'S DISEASE FLARE UP FROM EATING TO MUCH resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No treatment medication was provided.  CC: This spontaneous case concerns a 72-year-old, male patient with a concurrent condition of Crohn's disease treated with adalimumab, who experienced an unexpected, medically significant event of Crohn's disease aggravated approximately 7 months after receiving a 2nd dose of mRNA-1273 vaccine. Reportedly, the patient experienced Crohn's disease flare-up from eating too much. Patient also had high blood pressure since his vaccination. Outcome of the event Crohn's disease aggravated was reported as resolved. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine, given 31 days apart. Patient's elderly age and underlying Crohn's disease remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a 72-year-old, male patient with a concurrent condition of Crohn's disease treated with adalimumab, who experienced an unexpected, medically significant event of Crohn's disease aggravated approximately 7 months after receiving a 2nd dose of mRNA-1273 vaccine. Reportedly, the patient experienced Crohn's disease flare-up from eating too much. Patient also had high blood pressure since his vaccination. Outcome of the event Crohn's disease aggravated was reported as resolved. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine, given 31 days apart. Patient's elderly age and underlying Crohn's disease remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.