Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Intestinal ischaemia, Product dose omission issue, Small intestinal obstruction, Thrombosis
Clinical narrative: small intestine got blocked and due to blockage blood supply stopped; started having blood clot thrombosis both in his right leg as well as left leg; Missed the 2nd dose; Blocked small intestine; This spontaneous case was reported by a nurse and describes the occurrence of SMALL INTESTINAL OBSTRUCTION (Blocked small intestine), INTESTINAL ISCHAEMIA (small intestine got blocked and due to blockage blood supply stopped) and THROMBOSIS (started having blood clot thrombosis both in his right leg as well as left leg) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse effect (No relevant medical history reported) and Surgery. Concomitant products included thyroid medication  for an unknown indication, cholesterol medication.    On 13-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced SMALL INTESTINAL OBSTRUCTION (Blocked small intestine) (seriousness criterion medically significant). On 13-Mar-2021, the patient experienced INTESTINAL ISCHAEMIA (small intestine got blocked and due to blockage blood supply stopped) (seriousness criterion medically significant), THROMBOSIS (started having blood clot thrombosis both in his right leg as well as left leg) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose). On 13-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose) had resolved. At the time of the report, SMALL INTESTINAL OBSTRUCTION (Blocked small intestine), INTESTINAL ISCHAEMIA (small intestine got blocked and due to blockage blood supply stopped) and THROMBOSIS (started having blood clot thrombosis both in his right leg as well as left leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included thyroid medication and cholesterol medication. Patient called in to report that he received his 1st dose of Moderna vaccine on 13Feb2021 in left arm at 10.30 am and his 2nd dose of Moderna vaccine was scheduled on 13Mar2021. On 13Mar2021he went to Emergency Room (ER) and he had major surgery on  small intestine, patient mentioned that his small intestine got blocked and due to blockage the blood supply was stopped and the intestine started to die. On that day, the patient underwent a surgical procedure which the  doctor had to take out 12 inches of small intestine and stapled back. He was hospitalized for five  days. Five to seven days after his surgery,  he developed blood clot thrombosis in his right and left legs. Treatment for the event included blood thinner, which he has been on for 45 days. It was reported that the second dose of Moderna vaccine was missed due to hospitalization for the events and the blood thinner that he was on.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: reporter added, product indication added, event added(missed dose), event assessment done, additional info added( Source Document and mail document added); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.