Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal pain, Pain in extremity, Pyrexia
Clinical narrative: THOUGHT HAD CROHN'S DISEASE FLARE UP; AN INTESTINAL INFECTION; Intestinal cramps; Back pain; Constipation; ARM SORE; Fever; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (THOUGHT HAD CROHN'S DISEASE FLARE UP) in a 36-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) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, received third 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,Solution for injection in pre-filled pen. In 2021, the patient experienced DIARRHOEA (Diarrhea). In September 2021, the patient experienced CROHN'S DISEASE (THOUGHT HAD CROHN'S DISEASE FLARE UP) (seriousness criterion medically significant), GASTROINTESTINAL INFECTION (AN INTESTINAL INFECTION), GASTROINTESTINAL PAIN (Intestinal cramps), BACK PAIN (Back pain), CONSTIPATION (Constipation), PAIN IN EXTREMITY (ARM SORE) and PYREXIA (Fever). In September 2021, PAIN IN EXTREMITY (ARM SORE) and PYREXIA (Fever) had resolved. At the time of the report, CROHN'S DISEASE (THOUGHT HAD CROHN'S DISEASE FLARE UP), GASTROINTESTINAL INFECTION (AN INTESTINAL INFECTION), GASTROINTESTINAL PAIN (Intestinal cramps), BACK PAIN (Back pain), CONSTIPATION (Constipation) and DIARRHOEA (Diarrhea) was resolving.            Concomitant drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of THOUGHT HAD CROHN'S DISEASE FLARE UP OR AN INTESTINAL INFECTION onset in September 2021, INTESTINE CRAMPS, BACK PAIN, CONSTIPATION and DIARRHEA with HUMIRA was not provided.  The reporter's causality for the events of ARM SORE and FEVER with HUMIRA was no reasonable possibility.  Treatment details were not given.  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 36-year-old, male patient with medical history of Moderate-to-severe Crohn's disease treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) event of Crohn's disease (Crohn's disease aggravated) and other unexpected and expected, non-serious events. The event Crohn's disease and the non-serious events gastrointestinal infection, gastrointestinal pain, back pain, constipation, pain in extremity (pain in arm) and pyrexia occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was not provided and the event onset dates were reported as unspecified dates in Sep2021, hence, the onset latency could not be assessed. These events occurred unknown number of days after receiving the third (booster) dose of the mRNA-1273 vaccine. Since the event onset dates were reported as unspecified dates in Sep2021, hence, the onset latency could not be assessed. The start date of the event diarrhoea was reported as unspecified date in 2021, hence, the onset latency also could not be assessed. It was reported that the patient thought he had Crohn's disease flare-up or an intestinal infection. No additional details were provided. Treatment information was also not provided. The medical history of Crohn's disease remains a confounder for the event Crohn's disease aggravated since waxing and waning of symptoms is part of the natural course of the disease. The history of co-suspect administration of Humira also remains a confounder for the events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 36-year-old, male patient with medical history of Moderate-to-severe Crohn's disease treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) event of Crohn's disease (Crohn's disease aggravated) and other unexpected and expected, non-serious events. The event Crohn's disease and the non-serious events gastrointestinal infection, gastrointestinal pain, back pain, constipation, pain in extremity (pain in arm) and pyrexia occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was not provided and the event onset dates were reported as unspecified dates in Sep2021, hence, the onset latency could not be assessed. These events occurred unknown number of days after receiving the third (booster) dose of the mRNA-1273 vaccine. Since the event onset dates were reported as unspecified dates in Sep2021, hence, the onset latency could not be assessed. The start date of the event diarrhoea was reported as unspecified date in 2021, hence, the onset latency also could not be assessed. It was reported that the patient thought he had Crohn's disease flare-up or an intestinal infection. No additional details were provided. Treatment information was also not provided. The medical history of Crohn's disease remains a confounder for the event Crohn's disease aggravated since waxing and waning of symptoms is part of the natural course of the disease. The history of co-suspect administration of Humira also remains a confounder for the events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.