Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain, Weight
Clinical narrative: Kidney stone; ULCERATIVE COLITIS FLARE UP with HUMIRA; Depression; Fatigue; Chills; MODERNA COVID-19 VACCINE CAUSED ARM PAIN; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stone) and COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP with HUMIRA) in a female patient of an unknown age 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 Ulcerative colitis.    The patient's past medical history included Knee replacement in 2001 and Knee replacement in 2017. Concurrent medical conditions included Ulcerative colitis.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third 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 March 2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills) and VACCINATION SITE PAIN (MODERNA COVID-19 VACCINE CAUSED ARM PAIN). On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stone) (seriousness criterion medically significant), COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP with HUMIRA) (seriousness criterion medically significant) and DEPRESSION (Depression). At the time of the report, NEPHROLITHIASIS (Kidney stone), COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP with HUMIRA), DEPRESSION (Depression), FATIGUE (Fatigue), CHILLS (Chills) and VACCINATION SITE PAIN (MODERNA COVID-19 VACCINE CAUSED ARM PAIN) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: can not gain weight.         Concomitant Drugs Not Reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2001 and in 2017, the patient had knee replacement. The patient reported that levels of Humira were low and doctor took her off of Humira. She had reaction to Covid-19 vaccine and all three vaccines caused chills, fatigue, and arm pain. No treatment information was 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.  Weight gain poor subsumed under Colitis ulcerative aggravated.   CC: This spontaneous case concerns a female patient of unknown age with a concurrent condition of ulcerative colitis treated with adalimumab, who experienced the unexpected, medically significant events of Colitis ulcerative aggravated and Nephrolithiasis in association with a dose of mRNA-1273 vaccine. Exact latency of the events colitis ulcerative aggravated and kidney stones relative to vaccination cannot be determined with unknown events' onset dates. Patient also reported depression and poor weight gain on unknown dates. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine given 31 days apart. Reportedly, the events of chills, fatigue, and arm pain occurred after each dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying ulcerative colitis remains a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement. Sender's Comments: This spontaneous case concerns a female patient of unknown age with a concurrent condition of ulcerative colitis treated with adalimumab, who experienced the unexpected, medically significant events of Colitis ulcerative aggravated and Nephrolithiasis in association with a dose of mRNA-1273 vaccine. Exact latency of the events colitis ulcerative aggravated and kidney stones relative to vaccination cannot be determined with unknown events' onset dates. Patient also reported depression and poor weight gain on unknown dates. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine given 31 days apart. Reportedly, the events of chills, fatigue, and arm pain occurred after each dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying ulcerative colitis remains a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.