Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Moaning, Weight
Clinical narrative: Crohn's disease/ Flare with groan; Flare with groans; This spontaneous case was reported by a patient and describes the occurrence of CROHN'S DISEASE (Crohn's disease/ Flare with groan) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID19 vaccine (The second one. she had high fever) and Moderna COVID19 vaccine (She had a severe reaction to the first one). Past adverse reactions to the above products included Fever with Moderna COVID19 vaccine; and Vaccination adverse reaction with Moderna COVID19 vaccine. Concurrent medical conditions included Crohn's disease.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's disease/ Flare with groan) (seriousness criterion medically significant) and MOANING (Flare with groans). At the time of the report, CROHN'S DISEASE (Crohn's disease/ Flare with groan) and MOANING (Flare with groans) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: Lost a significant amount of weight. Weight was very, very low.   No concomitant medication was reported.  After the third dose (booster), patient did not had a reaction. But patient had a flare with groans and had lost a significant amount of weight. Patient's weight was very low. Patient was not sure about what to do in terms of the vaccine.  Patient asked if it was safe to receive another booster.  No treatment medication was reported.  Company Comment: This spontaneous case concerns a female patient, of unknown age, with relevant medical history of Crohn's disease and past drug history of administration of two doses of the mRNA-1273 original vaccine, 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 the third (booster) dose of the mRNA-1273 original vaccine. Of note, the vaccination date and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that patient experienced a severe reaction (unspecified) to the first dose of the mRNA-1273 original vaccine and had high fever after the second dose of the mRNA-1273 original vaccine. After receiving the third dose of the mRNA-1273 original vaccine, it was reported that the patient experienced a flare with groans, and had lost a significant amount of weight described as 'My weight is very, very low'. Of note, the patient's baseline body weight was not provided as well as the amount of weight that was reportedly lost. Treatment information was not provided. The outcomes of the events were unknown at the time of the report. 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 benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report.   This case was linked to MOD-2022-677886, MOD-2022-675945 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with relevant medical history of Crohn's disease and past drug history of administration of two doses of the mRNA-1273 original vaccine, 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 the third (booster) dose of the mRNA-1273 original vaccine. Of note, the vaccination date and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that patient experienced a severe reaction (unspecified) to the first dose of the mRNA-1273 original vaccine and had high fever after the second dose of the mRNA-1273 original vaccine. After receiving the third dose of the mRNA-1273 original vaccine, it was reported that the patient experienced a flare with groans, and had lost a significant amount of weight described as 'My weight is very, very low'. Of note, the patient's baseline body weight was not provided as well as the amount of weight that was reportedly lost. Treatment information was not provided. The outcomes of the events were unknown at the time of the report. 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 benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report.