Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Intestinal obstruction, Rash
Clinical narrative: Blockage where bowel and colon connect; Rash under both arms started a little after getting booster shot for COVID with Humira(Adalimumab); This spontaneous case was reported by a consumer and describes the occurrence of INTESTINAL OBSTRUCTION (Blockage where bowel and colon connect) in a 59-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INTESTINAL OBSTRUCTION (Blockage where bowel and colon connect) (seriousness criterion medically significant) and RASH (Rash under both arms started a little after getting booster shot for COVID with Humira(Adalimumab)). At the time of the report, INTESTINAL OBSTRUCTION (Blockage where bowel and colon connect) was resolving and RASH (Rash under both arms started a little after getting booster shot for COVID with Humira(Adalimumab)) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.  Causality for Moderna COVID-19 Vaccine was reported as Not reported for Intestinal obstruction and possible for Localized rash.  Causality for HUMIRA (ADALIMUMAB) The reporter's causality for the event(s) of BLOCKAGE WHERE BOWEL AND COLON CONNECT with HUMIRA (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of RASH UNDER BOTH ARMS STARTED A LITTLE AFTER GETTING BOOSTER SHOT FOR COVID was not provided. Company's opinion is that there is no reasonable possibility that the events of BLOCKAGE WHERE BOWEL AND COLON CONNECT and RASH UNDER BOTH ARMS STARTED A LITTLE AFTER GETTING BOOSTER SHOT FOR COVID are related to HUMIRA (ADALIMUMAB) .  Company comment: This case concerns a 59-year-old male patient with medical history of moderate to severe Crohn's disease, who experienced the unexpected, serious (medically significant) event of intestinal obstruction an unknown time after the booster dose of mRNA-1273. The medical history of Crohn's disease is a confounder. The patient experience blockage where the bowel and colon connect. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 59-year-old male patient with medical history of moderate to severe Crohn's disease, who experienced the unexpected, serious (medically significant) event of intestinal obstruction an unknown time after the booster dose of mRNA-1273. The medical history of Crohn's disease is a confounder. The patient experience blockage where the bowel and colon connect. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.