Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Colon cancer stage IV, Fatigue, Rash, Somnolence
Clinical narrative: Stage 4 cancer now; Left arm rash / got a rash on his right arm; Tired; Took a nap; This spontaneous case was reported by a consumer and describes the occurrence of COLON CANCER STAGE IV (Stage 4 cancer now) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Colon cancer (He reported that he had 7 months of treatment.) since March 2018 and Metastatic colon cancer since November 2019. Concomitant products included REGORAFENIB (STIVARGA) for Colon cancer and Metastatic colon cancer, POTASSIUM, VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS], VITAMIN B COMPLEX and POLYCARBOPHIL CALCIUM (FIBER) for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced SOMNOLENCE (Took a nap) and FATIGUE (Tired). In May 2021, the patient experienced RASH (Left arm rash / got a rash on his right arm). On an unknown date, the patient experienced COLON CANCER STAGE IV (Stage 4 cancer now) (seriousness criterion medically significant). At the time of the report, COLON CANCER STAGE IV (Stage 4 cancer now) had not resolved, SOMNOLENCE (Took a nap) and FATIGUE (Tired) outcome was unknown and RASH (Left arm rash / got a rash on his right arm) had resolved.            Concomitant product also included statins.  Treatment information was not provided.  Patient felt tired after the second dose and took a nap. He also reported he developed a left arm rash a week or two after receiving the second dose. He stated the left arm rash lasted a month or so and then went away on its own and then he got a rash on his right arm that eventually resolved on its own. The caller stated he was on a new medication at the time stivarga, so the rash may be related to the pill but it was unknown. The caller stated he was diagnosed with colon cancer in ??-Mar-2018. He reported that he had seven months of treatment. He stated one year later in ??-Nov-2019, metastatic colon cancer was diagnosed. He stated that there is no cure, but the tumors were shrinking. He reported recently that his cancer marker went up 1%. He reported the cancer as Stage 4 now. The caller stated he has no known drug or food allergies.  Company Comment : This case concerns a  58-year-old, male patient with relevant medical history colon cancer, metastatic colon cancer, and chemotherapy, who experienced the unexpected event of Colon Cancer Stage IV . The event occurred at unspecified interval after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as events occurred after second dose. This patient's underlying medical condition remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19) is not affected by this report.; Sender's Comments: This case concerns a  58-year-old, male patient with relevant medical history colon cancer, metastatic colon cancer, and chemotherapy, who experienced the unexpected event of Colon Cancer Stage IV . The event occurred at unspecified interval after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as events occurred after second dose. This patient's underlying medical condition remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19) is not affected by this report.