Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Skin disorder
Clinical narrative: Crohns flare up; Bump on right leg; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohns flare up) and SKIN DISORDER (Bump on right leg) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced CROHN'S DISEASE (Crohns flare up) (seriousness criteria hospitalization and medically significant) and SKIN DISORDER (Bump on right leg) (seriousness criterion hospitalization). At the time of the report, CROHN'S DISEASE (Crohns flare up) had resolved and SKIN DISORDER (Bump on right leg) had not resolved.            Concomitant medications were not reported.  Patient reported events of Crohn's flare-up and bump on right leg and patient had some good and bad days with HUMIRA (ADALIMUMAB). On unknown dates, the patient experienced crohns flare up, bump on right leg and patient had some good and bad days. MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered suspect.  After Covid 19 vaccine the patient was admitted for two nights at the hospital, patient had really bad Crohn's flare-up. She had small bump on her right leg and was unsure if it had to do with taking the Humira. She was concerned about Covid booster.    It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  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 an adult female patient of unknown age with medical history of Crohn's disease, who experienced the unexpected, serious (hospitalization) events of Crohn's disease and skin disorder an unknown time after the second dose of mRNA-1273. The patient experienced a flare up of Crohn's disease and a bump on his right leg for which he was hospitalized for two days. Crohn's disease can present relapses as part of the natural history of disease, so that as well as fluctuating effect of Adalimumab, could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Live follow up received is significant. Narrative description was updated. Current condition added.; Sender's Comments: This spontaneous case concerns an adult female patient of unknown age with medical history of Crohn's disease, who experienced the unexpected, serious (hospitalization) events of Crohn's disease and skin disorder an unknown time after the second dose of mRNA-1273. The patient experienced a flare up of Crohn's disease and a bump on his right leg for which he was hospitalized for two days. Crohn's disease can present relapses as part of the natural history of disease, so that as well as fluctuating effect of Adalimumab, could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.