Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Crohn's disease, Injection site reaction, Rheumatoid arthritis
Clinical narrative: Crohn's aggravated / CROHN'S FLARE UP; Injection site reaction; JOINT PAIN WAS SO BAD/COULD NOT OPEN HAND; Rheumatoid arthritis; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's aggravated / CROHN'S FLARE UP) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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.    The patient's past medical history included Rectal bleeding. Concurrent medical conditions included Crohn's disease.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second 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) at an unspecified dose. On 24-Apr-2021, the patient experienced INJECTION SITE REACTION (Injection site reaction). In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant) and ARTHRALGIA (JOINT PAIN WAS SO BAD/COULD NOT OPEN HAND). On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's aggravated / CROHN'S FLARE UP) (seriousness criterion medically significant). The patient was treated with KETOROLAC TROMETHAMINE (TORADOL) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In April 2021, INJECTION SITE REACTION (Injection site reaction) had resolved. At the time of the report, CROHN'S DISEASE (Crohn's aggravated / CROHN'S FLARE UP) was resolving and RHEUMATOID ARTHRITIS (Rheumatoid arthritis) and ARTHRALGIA (JOINT PAIN WAS SO BAD/COULD NOT OPEN HAND) outcome was unknown.            Patient had no known allergies. The symptom of Rheumatoid arthritis include joint range of motion decreased and symptom of Crohn's aggravated include Fistula was bleeding. Humira was so far not helping rheumatoid arthritis symptoms (LOE). Concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 57-year-old female patient with relevant medical history of Crohn's disease on Adalimumab and history of rectal bleeding, who experienced the unexpected, serious  (medically significant) event of Crohn's disease (reported as Crohn's aggravated / Crohn's flare up), and adverse event of special interest Rheumatoid arthritis that occurred in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as the date of vaccination and the date of onset of events were not reported. Patient presented with fistula bleeding which could be in association with the event Crohn's aggravated. The patient was treated with Ketorolac tromethamine (Toradol) and Paracetamol (Tylenol) possibly for the event of Rheumatoid arthritis. Patient received a 2-dose primary series of mRNA-1273 vaccine given at unknown interval and on unspecified dates. Relevant medical history of Crohn's disease remains a confounder as the disease itself is known to result in flares with a more complicated clinical course such as the development of fistula and bleeding while Adalimumab may cause gastrointestinal hemorrhage as a serious adverse reaction.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 57-year-old female patient with relevant medical history of Crohn's disease on Adalimumab and history of rectal bleeding, who experienced the unexpected, serious  (medically significant) event of Crohn's disease (reported as Crohn's aggravated / Crohn's flare up), and adverse event of special interest Rheumatoid arthritis that occurred in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as the date of vaccination and the date of onset of events were not reported. Patient presented with fistula bleeding which could be in association with the event Crohn's aggravated. The patient was treated with Ketorolac tromethamine (Toradol) and Paracetamol (Tylenol) possibly for the event of Rheumatoid arthritis. Patient received a 2-dose primary series of mRNA-1273 vaccine given at unknown interval and on unspecified dates. Relevant medical history of Crohn's disease remains a confounder as the disease itself is known to result in flares with a more complicated clinical course such as the development of fistula and bleeding while Adalimumab may cause gastrointestinal hemorrhage as a serious adverse reaction.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.