Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Anorectal disorder, COVID-19, Musculoskeletal stiffness
Clinical narrative: Stiff fingers/Fingers stiff/Trouble turning pages with fingers; Rectal disorder/Rectum still healing; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), MUSCULOSKELETAL STIFFNESS (Stiff fingers/Fingers stiff/Trouble turning pages with fingers) and ANORECTAL DISORDER (Rectal disorder/Rectum still healing) in a 79-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) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff fingers/Fingers stiff/Trouble turning pages with fingers) and ANORECTAL DISORDER (Rectal disorder/Rectum still healing). The patient was treated with HYDROCORTISONE (HYDROCORTISONE ENEMA) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved, MUSCULOSKELETAL STIFFNESS (Stiff fingers/Fingers stiff/Trouble turning pages with fingers) outcome was unknown and ANORECTAL DISORDER (Rectal disorder/Rectum still healing) was resolving.            No concomitant medications were reported.  It was unknown if the patient was enrolled in COVID-19 vaccine trial.  Company comment: This is a spontaneous case concerning a 79-year-old, female patient with no reported medical history and with co-suspect medication of Adalimumab (Humira) for moderate to severe ulcerative colitis. The patient has vaccine history of receiving first and second dose of Covid-19 vaccine with appropriate dosage interval of 28 days. Patient experienced the unexpected non-serious AESI event of Covid-19 and the unexpected non-serious events of anorectal disorder and musculoskeletal stiffness. The event Covid-19 occurred approximately 4-5 months after the third dose of mRNA-1273 vaccine administration. The events anorectal disorder and musculoskeletal stiffness occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. It was reported that the patient was treated with hydrocortisone enema with no further details. No other information surrounding the events was reported. The outcome of the event Covid-19 was reported as not resolved, the event anorectal disorder the outcome was reported as resolving, while the event musculoskeletal stiffness the outcome was reported as unknown. The current Covid-19 pandemic remain confounder for the event Covid-19. The indication of moderate to severe ulcerative colitis for the co-suspect medication of Adalimumab (Humira) remain confounder for the event anorectal disorder. The patient's age remain confounder for the event musculoskeletal stiffness. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 79-year-old, female patient with no reported medical history and with co-suspect medication of Adalimumab (Humira) for moderate to severe ulcerative colitis. The patient has vaccine history of receiving first and second dose of Covid-19 vaccine with appropriate dosage interval of 28 days. Patient experienced the unexpected non-serious AESI event of Covid-19 and the unexpected non-serious events of anorectal disorder and musculoskeletal stiffness. The event Covid-19 occurred approximately 4-5 months after the third dose of mRNA-1273 vaccine administration. The events anorectal disorder and musculoskeletal stiffness occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. It was reported that the patient was treated with hydrocortisone enema with no further details. No other information surrounding the events was reported. The outcome of the event Covid-19 was reported as not resolved, the event anorectal disorder the outcome was reported as resolving, while the event musculoskeletal stiffness the outcome was reported as unknown. The current Covid-19 pandemic remain confounder for the event Covid-19. The indication of moderate to severe ulcerative colitis for the co-suspect medication of Adalimumab (Humira) remain confounder for the event anorectal disorder. The patient's age remain confounder for the event musculoskeletal stiffness. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.