Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Dizziness, Loss of consciousness, Malaise
Clinical narrative: OCCASIONALLY PASSES OUT; LIKE CROHN'S DISEASE FLARE OF BODY/TIRED; FELT SICK; DIZZY; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (OCCASIONALLY PASSES OUT) and CROHN'S DISEASE (LIKE CROHN'S DISEASE FLARE OF BODY/TIRED) in an adult female patient who received mRNA-1273 (Spikevax) 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 (MODERATE TO SEVERE ADULT CROHN'S DISEASE).   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (OCCASIONALLY PASSES OUT) (seriousness criterion medically significant), CROHN'S DISEASE (LIKE CROHN'S DISEASE FLARE OF BODY/TIRED) (seriousness criterion medically significant), MALAISE (FELT SICK) and DIZZINESS (DIZZY). At the time of the report, LOSS OF CONSCIOUSNESS (OCCASIONALLY PASSES OUT), CROHN'S DISEASE (LIKE CROHN'S DISEASE FLARE OF BODY/TIRED), MALAISE (FELT SICK) and DIZZINESS (DIZZY) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  It was reported that the patient was usually after injection got dizzy, and occasionally passed out. The Covid vaccinations were made the patient felt sick, like a flare of the body.  The reporter causality for the events of occasionally passes out, dizzy, felt sick, like Crohn's disease flare of body, felt sick, like Crohn's disease flare of body and tired was not provided.  But reporter opinion was that there was a reasonable possibility that the events of occasionally passes out and dizzy are related to Humira (Adalimumab) and that there was no reasonable possibility that the events of felt sick, like Crohn's disease flare of body, felt sick, like Crohn's disease flare of body and tired are related to Humira (Adalimumab).  No treatment information was provided by the reporter.  Company Comment: This spontaneous case concerns an adult female patient (age not specified) with a medical history of Crohn's disease treated with co-suspect drug Adalimumab, who experienced the unexpected serious (medically significant) events of Loss of consciousness and Crohn's disease (Crohn's disease aggravated), that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Patients medical history of Crohn's disease remains as a confounder for the event Crohn's disease (Crohn's disease aggravated). The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient (age not specified) with a medical history of Crohn's disease treated with co-suspect drug Adalimumab, who experienced the unexpected serious (medically significant) events of Loss of consciousness and Crohn's disease (Crohn's disease aggravated), that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Patients medical history of Crohn's disease remains as a confounder for the event Crohn's disease (Crohn's disease aggravated). The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.