Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram, Thrombosis
Clinical narrative: hospitalized for blood clot; Abdominal pain; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (hospitalized for blood clot) and ABDOMINAL PAIN (Abdominal pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0083J21A, 939902, 037A21B and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Hypercholesterolemia and Kidney stones.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant). On an unknown date, the patient experienced THROMBOSIS (hospitalized for blood clot) (seriousness criteria hospitalization and medically significant). At the time of the report, THROMBOSIS (hospitalized for blood clot) and ABDOMINAL PAIN (Abdominal pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: to confirm the blood clot to confirm the blood clot.         No concomitant medications were provided by the reporter. On 07-Sep-2021, patient received first booster. On 15-Apr-2022, patient received second booster. It was reported that patient was experienced  abdomen pain, Patient stated due to kidney stone history he initially thought the pain was related to his kidney. However consumer visited ER shortly and hospitalized for blood clot, series of test taken as well as CT scan to confirm the blood clot. Patient never had blood clot before. Patient had received blood thinner.  Company Comment: This spontaneous case concerns a 66-year-old, male patient, with pre-existing conditions of blood pressure high, hypercholesterolaemia, & kidney stones, who experienced the unexpected, medically significant serious events of an AESI Thrombosis and Abdominal pain in association with a 2nd booster dose of mRNA-1273 vaccine. Event thrombosis resulted to patient's hospitalization. The exact onset latency of both events cannot be determined with unknown event onset dates. Patient has completed a 2-dose primary series and 2 subsequent booster doses with mRNA-1273 vaccine within the recommended dosage schedule. After 2 weeks of his 2nd booster vaccination, patient experienced abdomen pain which he initially attributed to his history of kidney stones. However, patient visited the ER shortly and was hospitalized for blood clot. A series of unspecified tests and a CT scan were done to confirm blood clot. Blood thinner medication was started. Further details on the medical history, clinical course, diagnostic data, and treatment were not reported. The risk of thrombosis is higher with increasing age as well as in patients with high blood pressure and hypercholesterolaemia. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a 66-year-old, male patient, with pre-existing conditions of blood pressure high, hypercholesterolaemia, & kidney stones, who experienced the unexpected, medically significant serious events of an AESI Thrombosis and Abdominal pain in association with a 2nd booster dose of mRNA-1273 vaccine. Event thrombosis resulted to patient's hospitalization. The exact onset latency of both events cannot be determined with unknown event onset dates. Patient has completed a 2-dose primary series and 2 subsequent booster doses with mRNA-1273 vaccine within the recommended dosage schedule. After 2 weeks of his 2nd booster vaccination, patient experienced abdomen pain which he initially attributed to his history of kidney stones. However, patient visited the ER shortly and was hospitalized for blood clot. A series of unspecified tests and a CT scan were done to confirm blood clot. Blood thinner medication was started. Further details on the medical history, clinical course, diagnostic data, and treatment were not reported. The risk of thrombosis is higher with increasing age as well as in patients with high blood pressure and hypercholesterolaemia. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.