Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Echocardiogram, Insomnia, Pulmonary embolism, Vision blurred
Clinical narrative: diagnosed with a bilateral pulmonary embolism; diagnosed with DVT of the entire left arm; experienced "Foggy vision" since after the vaccination; Patient states he, "Cannot sleep; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (diagnosed with a bilateral pulmonary embolism) and DEEP VEIN THROMBOSIS (diagnosed with DVT of the entire left arm) in a 54-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031897) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: PFIZER BIONTECH COVID-19 VACCINE (First and second dose.) and Moderna (Dose 5). Past adverse reactions to the above products included No adverse event with Moderna and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Penicillin allergy and Eyeglasses wearer (using reading glasses to read "very tiny print" for "a couple of years now).    On 16-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 18-Mar-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced PULMONARY EMBOLISM (diagnosed with a bilateral pulmonary embolism) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (diagnosed with DVT of the entire left arm) (seriousness criterion medically significant), VISION BLURRED (experienced "Foggy vision" since after the vaccination) and INSOMNIA (Patient states he, "Cannot sleep). The patient was hospitalized from 18-Mar-2024 to 21-Mar-2024 due to PULMONARY EMBOLISM. The patient was treated with RIVAROXABAN (XARELTO) for DVT, at a dose of 15 milligram once a day and RIVAROXABAN (XARELTO) for DVT, at a dose of 20 milligram once a day. At the time of the report, PULMONARY EMBOLISM (diagnosed with a bilateral pulmonary embolism), DEEP VEIN THROMBOSIS (diagnosed with DVT of the entire left arm) and VISION BLURRED (experienced "Foggy vision" since after the vaccination) had not resolved and INSOMNIA (Patient states he, "Cannot sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: Echocardiogram showed "problem with lower two valves" after vaccination.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered PULMONARY EMBOLISM (diagnosed with a bilateral pulmonary embolism), DEEP VEIN THROMBOSIS (diagnosed with DVT of the entire left arm), VISION BLURRED (experienced "Foggy vision" since after the vaccination) and INSOMNIA (Patient states he, "Cannot sleep) to be related.    Concomitant medication use information was not provided by reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient stated that a couple of months later after receiving the vaccine, in late January or early February of 2024, patient started to feel hardening in his entire left arm. He just dealt with it for a couple of weeks, but it did not go away so, he became concerned, and he visited the ER. He was not hospitalized. Patient was diagnosed with DVT of the entire left arm up through the shoulder and was discharged from the ER. Then on 18MAR2024, patient had Chest pain and couldn't breathe and went to hospital, where he was diagnosed with a bilateral pulmonary embolism and hospitalized in the ICU for 4 days. Patient stated that he spits up really dark blood on a regular basis and he cannot sleep because he cannot breathe. Patient states he truly believes his symptoms are a result of taking the Moderna vaccine.  Company comment: This is a spontaneous case concerning a 54-year-old male patient using reading glasses for several years, who experienced the unexpected and serious (hospitalization and medically significant) AESI pulmonary embolism, the unexpected serious (medically significant) AESI deep vein thrombosis. The event pulmonary embolism occurred approximately 4 months after a dose of SPIKEVAX 2023-2024 vaccine, given as a sixth dose of COVID vaccine schedule, was administered. The event deep vein thrombosis occurred on un unknown date hence latency cannot be assessed. Two doses (first and second doses) of TOZINAMERAN vaccine were also given. It was reported that a couple of months after vaccination patient started to feel hardening in his entire left arm, he just dealt with it for a couple of weeks, but it did not go away so, he became concerned, and he visited the ER and was not hospitalized. He was diagnosed with deep vein thrombosis of the entire left arm up through the shoulder and was discharged from the ER and told to start 15mg of rivaroxaban twice a day for 30 days to be followed by 20 mg per day. Then approximately 4 months after vaccine was given patient had chest pain and couldn't breathe and went to hospital where he was diagnosed with a bilateral pulmonary embolism and hospitalized in the ICU for 4 days where he was treated. Patient states he did have an echocardiogram and he was told he has some valve trouble with the bottom to valves but, heart is otherwise not affected as the clots are only in his lungs. Patient states the bilateral pulmonary embolus is unresolved. He states he spits up dark blood on a regular basis. Patient states he, cannot sleep because he cannot breathe. Patient states he truly believes his symptoms are a result of taking the Moderna vaccine. Patient also mentioned needing reading glasses, he states that although he has been using reading glasses for several years to read "really tiny print," he has experienced foggy vision since after the vaccination as well. Medical history of using reading glasses for several years remains as a confounder for event blurry vision. The benefit-risk relationship of the SPIKEVAX 2023-2024 vaccine is not affected by this report.