Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colon cancer, Colonoscopy, Diabetes mellitus, Inappropriate schedule of product administration, Laboratory test
Clinical narrative: Malignant neoplasm of colon; Malignant neoplasm of small intestine, unspecified; Diabetic; 2nd dose On 13 May 2021 and booster dose 19 Aug 2021; Shaking VIOLENTLY; This spontaneous case was reported by a consumer and describes the occurrence of COLON CANCER (Malignant neoplasm of colon), SMALL INTESTINE CARCINOMA (Malignant neoplasm of small intestine, unspecified) and DIABETES MELLITUS (Diabetic) in a 62-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 Rheumatoid arthritis.    The patient's past medical history included Hysterectomy. Concurrent medical conditions included Breast cancer in 1984 and Rheumatoid arthritis.   In June 2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, Solution for injection in pre-filled pen. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-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 August 2021, the patient experienced TREMOR (Shaking VIOLENTLY). On an unknown date, the patient experienced COLON CANCER (Malignant neoplasm of colon) (seriousness criterion medically significant), SMALL INTESTINE CARCINOMA (Malignant neoplasm of small intestine, unspecified) (seriousness criterion medically significant), DIABETES MELLITUS (Diabetic) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose On 13 May 2021 and booster dose 19 Aug 2021). At the time of the report, COLON CANCER (Malignant neoplasm of colon), SMALL INTESTINE CARCINOMA (Malignant neoplasm of small intestine, unspecified), DIABETES MELLITUS (Diabetic), TREMOR (Shaking VIOLENTLY) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose On 13 May 2021 and booster dose 19 Aug 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: showed malignancy. On an unknown date, Laboratory test: second malignancy in small intestine.         Patient was told to stop HUMIRA. Patient had chemotherapy done for malignancy. Patient had two colon resections found since she had second malignancy in small intestine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient had Hysterectomy for which outcome was unknown. Concomitant medications were not reported.  No treatment information was provided by the reporter.  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 is a Spontaneous case reported by a consumer, concerning a 62-year-old female patient, with relevant medical history of breast cancer, and relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to medically significant) events of Colon cancer, Small intestine carcinoma and Diabetes mellitus, which occurred on an unknown date related to the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab for rheumatoid arthritis. Colonoscopy was performed and showed malignancy, and laboratory test showed second malignancy in small intestine. Hysterectomy was performed for unknown indication. No information disclosed about clinical course or treatments received. Medical history of breast cancer can be a confounding factor for Colon cancer and Small intestine carcinoma, and underlying rheumatoid arthritis can be a confounding factor for Diabetes mellitus. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Follow-up received include : No new information.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 62-year-old female patient, with relevant medical history of breast cancer, and relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to medically significant) events of Colon cancer, Small intestine carcinoma and Diabetes mellitus, which occurred on an unknown date related to the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab for rheumatoid arthritis. Colonoscopy was performed and showed malignancy, and laboratory test showed second malignancy in small intestine. Hysterectomy was performed for unknown indication. No information disclosed about clinical course or treatments received. Medical history of breast cancer can be a confounding factor for Colon cancer and Small intestine carcinoma, and underlying rheumatoid arthritis can be a confounding factor for Diabetes mellitus. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.