Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pain, Pain in extremity
Clinical narrative: Chills; Body aches; Haematochezia; Frequent bowel movements; Pain in extremity; Pain; Chills; Fatigue; Headache; Injection site pain; This case was received via another Manufacturer on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. The license partner had received the report from FDA VAERS.    This regulatory authority case was reported by an other health care professional and describes the occurrence of HAEMATOCHEZIA (Haematochezia) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Irritable bowel syndrome. Concomitant products included ALBUMIN HUMAN (ALBUTEIN), CLONAZEPAM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced HAEMATOCHEZIA (Haematochezia) (seriousness criterion medically significant), FREQUENT BOWEL MOVEMENTS (Frequent bowel movements), PAIN IN EXTREMITY (Pain in extremity), PAIN (Pain), the first episode of CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache) and INJECTION SITE PAIN (Injection site pain). On an unknown date, the patient experienced the second episode of CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, HAEMATOCHEZIA (Haematochezia), FREQUENT BOWEL MOVEMENTS (Frequent bowel movements), PAIN IN EXTREMITY (Pain in extremity), PAIN (Pain), FATIGUE (Fatigue), HEADACHE (Headache) and INJECTION SITE PAIN (Injection site pain) had not resolved and last episode of CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Additional concomitant medications include Neotironine.  On the day of the vaccination, arm hurt pretty badly. It lasted about 3 days. pretty much had the same symptoms as the first dose: chills, body aches. headache, pain at the injection site, fatigue. It lasted for about 3-4 days. Now, He experienced bloody stools with first dose and it never really resolved before. He got the second dose and noticed increased the frequency, made it a little worse after the second dose. They were not so frequent anymore. Patient still have blood in stool at least 2 times a week.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  a discrepancy on onset date of PT haematochezia exists in the SD.  Concomitant medical condition could be potentially confounder for the events; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  a discrepancy on onset date of PT haematochezia exists in the SD.  Concomitant medical condition could be potentially confounder for the events