Age: 30.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Biopsy, Body temperature, Chills, Colitis, Colonoscopy
Clinical narrative: hands cracked and splitting due to weather had been cold and harsh; Active colitis worsening; sweats; Fever; Headache; overall drainage feeling of being tired/fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS (Active colitis worsening), SKIN FISSURES (hands cracked and splitting due to weather had been cold and harsh), HYPERHIDROSIS (sweats), PYREXIA (Fever) and HEADACHE (Headache) in a 30-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) injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe).   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-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 HYPERHIDROSIS (sweats), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (overall drainage feeling of being tired/fatigue) and CHILLS (Chills). On 04-Nov-2021, the patient experienced COLITIS (Active colitis worsening). On an unknown date, the patient experienced SKIN FISSURES (hands cracked and splitting due to weather had been cold and harsh). In 2021, PYREXIA (Fever) had resolved. At the time of the report, COLITIS (Active colitis worsening) had not resolved and SKIN FISSURES (hands cracked and splitting due to weather had been cold and harsh), HYPERHIDROSIS (sweats), HEADACHE (Headache), FATIGUE (overall drainage feeling of being tired/fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Colonoscopy: 3 of 6 areas of biopsy showed no dysplasia.. On an unknown date, Biopsy: No dysplasia, but other areas show active colitis worsening. On an unknown date, Body temperature: three days averaging 101.3 degrees Fahrenheit.         Concomitant drugs not reported.  The formulation for Humira was reported as Solution for injection in pre-filled pen. Patient had non-serious events active colitis worsening, hands cracked and splitting due to  weather had been cold and harse, overall drainage feeling of being tired/fatigue, Chills, sweats, HUMIRA no longer working, fever and headache with HUMIRA (ADALIMUMAB).  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of active colitis worsening and HUMIRA no longer working with  HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of hands cracked  and splitting due to weather had been cold and harse, overall drainage feeling of being tired/fatigue, chills, sweats, fever, and headache with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Treatment drugs not 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