Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Vaccination failure
Clinical narrative: Colitis ulcerative aggravated/intestinal malabsorption /rectal haemorrhage; Rheumatoid arthritis flare up; Pancreatitis; Pain; Vaccination failure; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Colitis ulcerative aggravated/intestinal malabsorption /rectal haemorrhage ), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and PANCREATITIS (Pancreatitis) in a 21-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 Ulcerative colitis, unspecified.    The patient's past medical history included Rheumatoid arthritis on 25-Jul-2019 and Appendectomy on 06-Dec-2021. Family history included Ulcerative colitis since an unknown date. Concurrent medical conditions included Abstains from alcohol, Non-tobacco user, Drug allergy (Patient had sulfa allergy.) and Ulcerative colitis. Concomitant products included VITAMIN D3 from 27-Nov-2019 to an unknown date, MESALAZINE (APRISO) from 03-Mar-2019 to an unknown date, SERTRALINE HYDROCHLORIDE (ZOLOFT) from 27-Nov-2019 to an unknown date, OMEPRAZOLE, METHOCARBAMOL (ROBAXIN) and PROBIOTIC 10 [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS BREVIS;LACTOBACILLUS BULGARICUS;LACTOBACILLUS CASEI;LACTOBACILLUS PARACASEI;LACTOBACILLUS PLANTARUM;LACTOBACILLUS RHAMNOSUS;LACTOBACILLUS SALIVARIUS] for an unknown indication.   In 2014, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 03-Mar-2019, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 07-Oct-2020, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 26-Dec-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced COLITIS ULCERATIVE (Colitis ulcerative aggravated/intestinal malabsorption /rectal haemorrhage ) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), PANCREATITIS (Pancreatitis) (seriousness criterion medically significant), PAIN (Pain) and VACCINATION FAILURE (Vaccination failure). At the time of the report, COLITIS ULCERATIVE (Colitis ulcerative aggravated/intestinal malabsorption /rectal haemorrhage ) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved and PANCREATITIS (Pancreatitis), PAIN (Pain), COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: Five out of ten.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On the scale of one to ten the pain scale was five. Patient stopped treatment to receive COVID vaccine and flare up of blood in stool and was tired. Patient was started therapy after his last COVID  vaccine dose. After the second dose of COVID vaccine patient was pouring blood from rectum. It was reported that on 04 OCT 2021 C reactive protein, complete blood count, Humira levels antibody and comprehensive metabolic panel with unknown result. On 06 Dec 2021, patient experienced appendix removed. Patient was placed on steroids for a month to reduce the flare up and was still not back to normal.  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 21-year-old male patient on Adalimumab (Humira) indicated for Ulcerative colitis, and with relevant medical history Rheumatoid arthritis, who experienced the unexpected, serious  (medically significant) event of Colitis ulcerative (Colitis ulcerative aggravated), and adverse events of special interest Rheumatoid arthritis (Rheumatoid arthritis flare up), and Pancreatitis, and unexpected, non-serious adverse event of special interest COVID-19.  The events Colitis ulcerative, Rheumatoid arthritis, and Pancreatitis occurred on unknown dates in the context of  receiving a dose of mRNA-1273 vaccine. The event COVID-19 occurred approximately 4 and a half months after  2nd dose of mRNA-1273 vaccine was administered. Additionally, Vaccination failure was noted as patient received 2 doses of mRNA-1273 vaccine as primary series given 31 days apart. Patient presented with rectal bleeding and malabsorption along with arthritis flares when Adalimumab was stopped to receive the mRNA-1273 vaccines. Patient was placed on steroids for a month to manage the flares. C reactive protein, complete blood count, metabolic panel were reported with undisclosed results while SARS-CoV-2 test was not reported. The relevant medical history of Ulcerative colitis remains a confounder for Colitis ulcerative and Pancreatitis, and Rheumatoid arthritis for the event Rheumatoid arthritis as it is known to result in flares. Adalimumab  is an immunosuppressant that may lower the immune system and response to mRNA-1273 vaccine predisposing to COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 21-year-old male patient on Adalimumab (Humira) indicated for Ulcerative colitis, and with relevant medical history Rheumatoid arthritis, who experienced the unexpected, serious  (medically significant) event of Colitis ulcerative (Colitis ulcerative aggravated), and adverse events of special interest Rheumatoid arthritis (Rheumatoid arthritis flare up), and Pancreatitis, and unexpected, non-serious adverse event of special interest COVID-19.  The events Colitis ulcerative, Rheumatoid arthritis, and Pancreatitis occurred on unknown dates in the context of  receiving a dose of mRNA-1273 vaccine. The event COVID-19 occurred approximately 4 and a half months after  2nd dose of mRNA-1273 vaccine was administered. Additionally, Vaccination failure was noted as patient received 2 doses of mRNA-1273 vaccine as primary series given 31 days apart. Patient presented with rectal bleeding and malabsorption along with arthritis flares when Adalimumab was stopped to receive the mRNA-1273 vaccines. Patient was placed on steroids for a month to manage the flares. C reactive protein, complete blood count, metabolic panel were reported with undisclosed results while SARS-CoV-2 test was not reported. The relevant medical history of Ulcerative colitis remains a confounder for Colitis ulcerative and Pancreatitis, and Rheumatoid arthritis for the event Rheumatoid arthritis as it is known to result in flares. Adalimumab  is an immunosuppressant that may lower the immune system and response to mRNA-1273 vaccine predisposing to COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.