Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Malaise
Clinical narrative: NOT FELT VERY WELL; Crohn's disease aggravated/Experienced blood/ Blood in stool/ Went bathroom a lot and experienced blood/ Diarrhea/Fever; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's disease aggravated/Experienced blood/ Blood in stool/ Went bathroom a lot and experienced blood/ Diarrhea/Fever) in a 53-year-old female 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.    The patient's past medical history included Post procedural inflammation (FISSURE SURGERY WHICH WAS INFLAMMED) and Surgery in 2017.   On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CROHN'S DISEASE (Crohn's disease aggravated/Experienced blood/ Blood in stool/ Went bathroom a lot and experienced blood/ Diarrhea/Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (NOT FELT VERY WELL). At the time of the report, CROHN'S DISEASE (Crohn's disease aggravated/Experienced blood/ Blood in stool/ Went bathroom a lot and experienced blood/ Diarrhea/Fever) and MALAISE (NOT FELT VERY WELL) had not resolved.            No concomitant medications were reported.  Patient was not feeling very well, went bathroom a lot and experienced blood/blood in stool and humira was not working. Patient had bad diarrhea, fever and blood in stool. Patient felt that her flare ups got worse since she got her covid booster shot on 26-Oct 2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  No treatment medications were reported.   Company comment:This spontaneous case concerns a 53-year-old, female patient with relevant 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 an unexpected, non-serious event. The events occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was not provided, hence, the onset latency could not be assessed. The event Crohn's disease occurred on the same day after receiving the third (booster) dose of the mRNA-1273 vaccine. The onset date of the non-serious event was not provided, hence, the onset latency could not be assessed. It was reported that Humira was not working and the patient experienced bad diarrhea, fever and blood in the stool. The patient felt that her Crohn's disease flare-ups got worse since receiving the booster dose of the mRNA-1273 vaccine. On an unknown date, the patient felt unwell, went to the bathroom frequently and experienced blood in the stool. Treatment information was 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.  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.   This case was linked to MOD-2022-624837 (Patient Link).; Sender's Comments: This spontaneous case concerns a 53-year-old, female patient with relevant 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 an unexpected, non-serious event. The events occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was not provided, hence, the onset latency could not be assessed. The event Crohn's disease occurred on the same day after receiving the third (booster) dose of the mRNA-1273 vaccine. The onset date of the non-serious event was not provided, hence, the onset latency could not be assessed. It was reported that Humira was not working and the patient experienced bad diarrhea, fever and blood in the stool. The patient felt that her Crohn's disease flare-ups got worse since receiving the booster dose of the mRNA-1273 vaccine. On an unknown date, the patient felt unwell, went to the bathroom frequently and experienced blood in the stool. Treatment information was 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.