Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: CROHNS FLARE UP AFTER EACH COVID VACCINE with HUMIRA; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (CROHNS FLARE UP AFTER EACH COVID VACCINE with HUMIRA) in a 59-year-old 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.    The patient's past medical history included Crohn's disease and Shingles (Herpes Zoster (Shingles)  as this event occurred in Dec2020 assumed to be prior to mRNA-1273 vaccination. Even though the date of dose 1 mRNA-1273 vaccine was not known, dose 2 was given in April 2021, and if schedule was followed, Dose 1 would at least be sometime in March 2021. Although the outcome for Herpes zoster was reported as resolving, the clinical course usually lasts between 2 to 6 weeks, it would have been resolved already by the time Dose 1 was given and also it was unlikely that  Dose 1 was administered during an active Herpes Zoster infection.) in December 2020.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced CROHN'S DISEASE (CROHNS FLARE UP AFTER EACH COVID VACCINE with HUMIRA) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (CROHNS FLARE UP AFTER EACH COVID VACCINE with HUMIRA) was resolving.            No concomitant products were reported.  In December 2020, the patient experienced shingles. in 2021, the patient experienced crohns flare up after each covid vaccine. covid-19 vaccine moderna (covid-19 vaccine mrna (mrna 1273)) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. In 2021, patient received first dose covid-19 vaccine manufactured by moderna. In apr 2021, he received second dose of covid-19 vaccine manufactured by moderna.  The reporter's causality for the event(s) of shingles and crohns flare up after each covid vaccine was not  provided.  No treatment information was reported by the reporter.  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 a 59-year-old female patient with relevant medical history of Crohn's disease on treatment with Adalimumab, who experienced the unexpected, serious  (medically significant) event of Crohn's disease (reported as Crohns flare up after each COVID vaccine with Humira) in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as vaccination date and onset date of the event were not provided. Outcome of the event was reported as resolving. Patient received 2 doses of mRNA-1273 vaccine on unspecified dates and at unknown interval. It was also noted that Crohns flare up occurred after each COVID-19 vaccine but information on recovery outcome after each episode was lacking. The relevant medical history of Crohn's disease remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 59-year-old female patient with relevant medical history of Crohn's disease on treatment with Adalimumab, who experienced the unexpected, serious  (medically significant) event of Crohn's disease (reported as Crohns flare up after each COVID vaccine with Humira) in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as vaccination date and onset date of the event were not provided. Outcome of the event was reported as resolving. Patient received 2 doses of mRNA-1273 vaccine on unspecified dates and at unknown interval. It was also noted that Crohns flare up occurred after each COVID-19 vaccine but information on recovery outcome after each episode was lacking. The relevant medical history of Crohn's disease remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.