Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: Crohn's attack after the first primary shot/ High Fever after the first primary shot/ Nausea after the first primary shot/ Vomiting after the first primary shot/ Diarrhea after the first primary shot; Dehydrated after the first primary shot; Chills after the first primary shot; This spontaneous case was reported by a nurse and describes the occurrence of CROHN'S DISEASE (Crohn's attack after the first primary shot/ High Fever after the first primary shot/ Nausea after the first primary shot/ Vomiting after the first primary shot/ Diarrhea after the first primary shot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Crohn's disease (For the past 2 years, it was under control prior to receiving the Moderna vaccine).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced CROHN'S DISEASE (Crohn's attack after the first primary shot/ High Fever after the first primary shot/ Nausea after the first primary shot/ Vomiting after the first primary shot/ Diarrhea after the first primary shot) (seriousness criterion medically significant), DEHYDRATION (Dehydrated after the first primary shot) and CHILLS (Chills after the first primary shot). The patient was treated with Manual therapy (Oral hydration) for Dehydration. At the time of the report, CROHN'S DISEASE (Crohn's attack after the first primary shot/ High Fever after the first primary shot/ Nausea after the first primary shot/ Vomiting after the first primary shot/ Diarrhea after the first primary shot), DEHYDRATION (Dehydrated after the first primary shot) and CHILLS (Chills after the first primary shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the physician did oral hydration on the patient and sent the patient back home.  Company comment: This is a spontaneous case concerning a 59-year-old, female patient with relevant concurrent medical condition of Crohn's disease. The patient experienced the unexpected serious (medically significant) event of Crohn's disease (Crohn's attack after the first primary shot) along with non-serious events of dehydration and chills. The events occurred the same day after the first dose of mRNA-1273 vaccine administration. Allegedly the events were described as, for the past 2 years the patient's Crohn's disease was under control and then after receiving the first dose of mRNA-1273 vaccine the patient experienced Crohn's attack with high fever, nausea, vomiting, diarrhea, chills and dehydration. The patient sought consult at the urgent care and was given oral hydration and was sent home. The concurrent medical condition of Crohn's disease remain confounder for the event Crohn's disease (Crohn's attack after the first primary shot). The symptom of diarrhea remain confounder for the event dehydration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-677449, MOD-2022-677451 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 59-year-old, female patient with relevant concurrent medical condition of Crohn's disease. The patient experienced the unexpected serious (medically significant) event of Crohn's disease (Crohn's attack after the first primary shot) along with non-serious events of dehydration and chills. The events occurred the same day after the first dose of mRNA-1273 vaccine administration. Allegedly the events were described as, for the past 2 years the patient's Crohn's disease was under control and then after receiving the first dose of mRNA-1273 vaccine the patient experienced Crohn's attack with high fever, nausea, vomiting, diarrhea, chills and dehydration. The patient sought consult at the urgent care and was given oral hydration and was sent home. The concurrent medical condition of Crohn's disease remain confounder for the event Crohn's disease (Crohn's attack after the first primary shot). The symptom of diarrhea remain confounder for the event dehydration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.