Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Gastrointestinal obstruction
Clinical narrative: Gastrointestinal obstruction; Crohn's disease aggravated; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL OBSTRUCTION (Gastrointestinal obstruction) and CROHN'S DISEASE (Crohn's disease aggravated) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Patient had no known allergies.    On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 27-Aug-2021, the patient experienced GASTROINTESTINAL OBSTRUCTION (Gastrointestinal obstruction) (seriousness criterion medically significant) and CROHN'S DISEASE (Crohn's disease aggravated) (seriousness criterion medically significant). The patient was treated with BUDESONIDE at an unspecified dose and frequency. At the time of the report, GASTROINTESTINAL OBSTRUCTION (Gastrointestinal obstruction) and CROHN'S DISEASE (Crohn's disease aggravated) had not resolved.            The patient received third booster shot of COVID-19 on 26 Aug 2021. He did not pause HUMIRA as per physician and was due for HUMIRA shot the next week. patient went out to dinner the next day after booster shot on 27 Aug 2021 and ate foods he would normally not eat but had been able to tolerate while on HUMIRA but this time around patient ended up getting a flare and had to be on Budesonide. Symptoms included bloating, pain, blockage. He was continuing HUMIRA treatment but flare was still lingering as of 09 Sep 2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant 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.  Company comment: This spontaneous case concerns a 56-year-old male patient, with no reported medical history, treated with co-suspect drug Adalimumab for moderate to severe Crohn's disease (start date not provided), who experienced the unexpected serious (medically significant) events of Gastrointestinal obstruction and Crohn's disease (reported as Crohn's disease aggravated) that occurred 1 day after receiving the 3rd dose of mRNA-1273 vaccine. Patient reported the next day, after receiving booster dose, patient had a flare with symptoms of bloating, pain, and blockage, and had to be on Budesonide. Flares continue after fourteen days. Clinical course was not reported. The outcome of events was reported as not resolved. Co-suspect drug Adalimumab for Crohn's disease could be considered as a confounder as the disease can have flares. Patient received first 2 doses of mRNA-1273 vaccine on unknown dates. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 56-year-old male patient, with no reported medical history, treated with co-suspect drug Adalimumab for moderate to severe Crohn's disease (start date not provided), who experienced the unexpected serious (medically significant) events of Gastrointestinal obstruction and Crohn's disease (reported as Crohn's disease aggravated) that occurred 1 day after receiving the 3rd dose of mRNA-1273 vaccine. Patient reported the next day, after receiving booster dose, patient had a flare with symptoms of bloating, pain, and blockage, and had to be on Budesonide. Flares continue after fourteen days. Clinical course was not reported. The outcome of events was reported as not resolved. Co-suspect drug Adalimumab for Crohn's disease could be considered as a confounder as the disease can have flares. Patient received first 2 doses of mRNA-1273 vaccine on unknown dates. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.