Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Portal vein thrombosis, Product dose omission issue, Sepsis
Clinical narrative: My blood got septic; blood clot right outside of my liver; was causing pressure on my esophagus, & started bleeding; terrible chills,shivers; I had nausea; second dose missed; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (My blood got septic), PORTAL VEIN THROMBOSIS (blood clot right outside of my liver), VARICES OESOPHAGEAL (was causing pressure on my esophagus, & started bleeding), CHILLS (terrible chills, shivers) and NAUSEA (I had nausea) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Attention deficit disorder. Concomitant products included TRAMADOL, WARFARIN, METHYLPHENIDATE, LEVOTHYROXINE, LIOTHYRONINE (LEVOTHYROXINE AND LIOTHYRONINE [LEVOTHYROXINE;LIOTHYRONINE]), PANTOPRAZOLE and HYDROXYZINE EMBONATE (HYDROXYZINE PAM) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced SEPSIS (My blood got septic) (seriousness criteria hospitalization and medically significant), PORTAL VEIN THROMBOSIS (blood clot right outside of my liver) (seriousness criteria hospitalization and medically significant), VARICES OESOPHAGEAL (was causing pressure on my esophagus, & started bleeding) (seriousness criterion hospitalization), CHILLS (terrible chills,shivers) (seriousness criterion hospitalization) and NAUSEA (I had nausea) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose missed). At the time of the report, SEPSIS (My blood got septic), PORTAL VEIN THROMBOSIS (blood clot right outside of my liver), VARICES OESOPHAGEAL (was causing pressure on my esophagus, & started bleeding), CHILLS (terrible chills,shivers) and NAUSEA (I had nausea) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (second dose missed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided .  Reporter states that patient   experienced terrible chills at around 3a. patient  went to the hospital & they said he had a blood clot right outside of his liver, which was causing pressure on his esophagus, & subsequent esophageal bleeding. "patient  had esophageal varices."  Reports say's patient  blood got septic." Reports hospital stay of 33 days.   3 days after discharge, patient returned to the hospital, "due to the shivers." He was discharged to a convalescent facility, where he remained an additional 32 days.  Very limited information regarding this events has been provided at this time. 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. Further information can't be requested; Sender's Comments: Very limited information regarding this events has been provided at this time. 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. Further information can't be requested