Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: crohns disease flare up; Endometriosis; cysts in left breast; chest bone pain on left side; bone pain after vaccination; muscle pain/soreness after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (crohns disease flare up) in a 45-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.    No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-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. In 2021, the patient experienced BONE PAIN (bone pain after vaccination) and MYALGIA (muscle pain/soreness after vaccination). On an unknown date, the patient experienced CROHN'S DISEASE (crohns disease flare up) (seriousness criterion medically significant), ENDOMETRIOSIS (Endometriosis), BREAST CYST (cysts in left breast) and CHEST PAIN (chest bone pain on left side). At the time of the report, CROHN'S DISEASE (crohns disease flare up), ENDOMETRIOSIS (Endometriosis), BREAST CYST (cysts in left breast) and CHEST PAIN (chest bone pain on left side) had not resolved and BONE PAIN (bone pain after vaccination) and MYALGIA (muscle pain/soreness after vaccination) outcome was unknown.            No concomitant medications were reported.  The reporter causality for the events of endometriosis, cysts in left breast, Crohn's disease flare up, chest bone pain on left side, muscle pain and soreness after vaccination and bone pain after vaccination with Humira(adalimumab) was no reasonable possibility.  No treatment medications were reported.  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 reported by a consumer, concerns a 45 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious, event of CROHN'S DISEASE (crohns disease flare up) unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events. Patient had previously received the 1 dose with Moderna vaccine about 1 month prior to the 2 dose, with no adverse events reported. On an unknown date, the patient had received ADALIMUMAB (Humira) for Chron's Disease, which could be considered as a confounder. No further clinical information on comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event had not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 45 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious, event of CROHN'S DISEASE (crohns disease flare up) unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events. Patient had previously received the 1 dose with Moderna vaccine about 1 month prior to the 2 dose, with no adverse events reported. On an unknown date, the patient had received ADALIMUMAB (Humira) for Chron's Disease, which could be considered as a confounder. No further clinical information on comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event had not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.