Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Computerised tomogram, Dyspnoea, Thrombosis
Clinical narrative: CT Scan revealed blood clots / The blood clot has gone down to the size of the tip of the little finger; pain in lower left side just above where the spleen is; having a hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (CT Scan revealed blood clots / The blood clot has gone down to the size of the tip of the little finger), DYSPNOEA (having a hard time breathing) and ABDOMINAL PAIN LOWER (pain in lower left side just above where the spleen is) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     The patient's past medical history included Heart block in 2004, Bypass surgery in 2004 and Stent placement in 2006. Concurrent medical conditions included Asthma and Allergy (allergies to trees in her surroundings (pine, oak, etc)).    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced DYSPNOEA (having a hard time breathing) (seriousness criterion hospitalization). In July 2021, the patient experienced THROMBOSIS (CT Scan revealed blood clots / The blood clot has gone down to the size of the tip of the little finger) (seriousness criteria hospitalization and medically significant) and ABDOMINAL PAIN LOWER (pain in lower left side just above where the spleen is) (seriousness criterion hospitalization). The patient was hospitalized from 06-Jul-2021 to 14-Jul-2021 due to ABDOMINAL PAIN LOWER, DYSPNOEA and THROMBOSIS. The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. At the time of the report, THROMBOSIS (CT Scan revealed blood clots / The blood clot has gone down to the size of the tip of the little finger) was resolving and DYSPNOEA (having a hard time breathing) and ABDOMINAL PAIN LOWER (pain in lower left side just above where the spleen is) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Computerised tomogram: blood clots (abnormal) blood clots. On 13-Jan-2022, Computerised tomogram: blood thinner was doing its job. blood thinner was doing its job. The blood clot had gone down to the size of the tip of the little finger..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that in the CT scan of 13-JAN-2022 the blood clots are down to the size of the tip of the little finger. And patient was recommended by her doctor to get the 2nd dose  It was reported that symptoms starts on JUL 2021 and resolved on unspecified date after she was discharged from the hospital on 14Jul2022.   And also it was reported that patient was discharged on 14 JUL 2021 and a week later, her breathing problem was better by 100% and she mentioned that they were not sure if this had to do with the Moderna shot or not.    Patient was seen by a vascular surgeon in Aug2021 and another CT Scan was done with results not mentioned by the consumer.  Patient had asthma which have been present even before she got the vaccine so she goes to her pulmonary doctor every 6 months. She has not any history of Covid-19 infection. There were no history of Myocarditis/pericarditis.   Company comment: This spontaneous case concerns a 79-year-old female patient, with relevant medical history of asthma and bypass surgery (2004) and stent placement (2006), who experienced the serious unexpected events of Thrombosis (AESI), dyspnoea and abdominal pain lower after the first dose of mRNA1273.  20 days after receiving the first dose the patient experienced dyspnoea, then she reported abdominal lower pain so she was admitted to the hospital. CT scan was performed and found blood clots. No information provided regarding anatomical location of the blood clots or lab test. The event dyspnoea resolved a week later after being discharged. Began treatment with anticoagulation therapy and a CT scan performed 6 months later showed that the clots decreased in size. Patient history of asthma remains a confounder for the event dyspnea and cardiovascular disease could be considered contributing factor for the event thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 79-year-old female patient, with relevant medical history of asthma and bypass surgery (2004) and stent placement (2006), who experienced the serious unexpected events of Thrombosis (AESI), dyspnoea and abdominal pain lower after the first dose of mRNA1273.  20 days after receiving the first dose the patient experienced dyspnoea, then she reported abdominal lower pain so she was admitted to the hospital. CT scan was performed and found blood clots. No information provided regarding anatomical location of the blood clots or lab test. The event dyspnoea resolved a week later after being discharged. Began treatment with anticoagulation therapy and a CT scan performed 6 months later showed that the clots decreased in size. Patient history of asthma remains a confounder for the event dyspnea and cardiovascular disease could be considered contributing factor for the event thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.