Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal tenesmus, Red blood cell count, Stool analysis, Unevaluable event, White blood cell count
Clinical narrative: patient was having issues; not able to empty completely bowel movement; inflammation of colon; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (patient was having issues), RECTAL TENESMUS (not able to empty completely bowel movement) and COLITIS (inflammation of colon) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 31O20A, 048A421A and 088021A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included Smoker (started smoking at the age of 15 or 16. less than half pack of cigarette a day), Alcoholic (wine or vodka once a month very little), Fasciitis, Pancreatitis and Carpal tunnel release. Previously administered products included for Drug use for unknown indication: MERCAPTOPURINE. Past adverse reactions to the above products included Drug allergy with MERCAPTOPURINE. Concurrent medical conditions included Inflammatory bowel disease, Drug allergy (mercaptopurine allergy manifested by pancreatitis) and Vaginal yeast. Concomitant products included CLOBETASOL and ESTRADIOL (ESTRACE) for Vaginal yeast.   In December 2014, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose every two weeks. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced RECTAL TENESMUS (not able to empty completely bowel movement) and COLITIS (inflammation of colon). On an unknown date, the patient experienced UNEVALUABLE EVENT (patient was having issues). The patient was treated with MACROGOL 3350 (MIRALAX) at an unspecified dose and frequency. In October 2021, RECTAL TENESMUS (not able to empty completely bowel movement) and COLITIS (inflammation of colon) had resolved. At the time of the report, UNEVALUABLE EVENT (patient was having issues) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, Haematocrit: increased. On 25-Aug-2021, Haemoglobin: increased. On 25-Aug-2021, Neutrophil count: segmented neutrophils elevated. On 25-Aug-2021, Red blood cell count: increased. On 25-Aug-2021, Stool analysis: abnormal. On 25-Aug-2021, White blood cell count: increased. On an unknown date, Laboratory test: Normal.         In Aug 2021, Laboratory test included: computer tomography scan and magnetic resonance imaging. Discogram done in Oct 2021.  Patient was doing so well in Humira and she stated that she was on remission for crohn's disease.   On 30 Sep 2021, the segmented neutrophils elevated, white blood cells elevated, red blood cells elevated, hemoglobin elevated, hematocrit elevated, and stool study elevated resolved. 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.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Patient age, relevant medical history, laboratory test, concomitant medication, treatment drug and suspect dose details were added. Event outcome updated. New event added.