Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Scan, Thrombosis, Vaccination site pain
Clinical narrative: discomfort in her back like she slept wrong; could not take a deep breath without pain; she felt like something was off/felt vaguely like she did in 2012 (when she had a pulmonary embolism); 3 blood clots in her lungs/clotting factors in the blood test were four times over a certain number of normal/she had two blood clots in her left lung and one blood clot in her right lung/clotting factors in the blood test were four times; pain if take a deep breath and sneeze; lethargy; slight tenderness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (3 blood clots in her lungs/clotting factors in the blood test were four times over a certain number of normal/she had two blood clots in her left lung and one blood clot in her right lung/clotting factors in the blood test were four times) and PAIN (pain if take a deep breath and sneeze) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pulmonary embolism in 2012, Legionnaire's disease in 2012 and Sprained ankle in 2012. Previously administered products included for Pulmonary embolism: Warfarin (She was placed on warfarin at that time along with an injection in her abdomen that she did not recall the name of the shot.) in 2012. Concurrent medical conditions included COPD.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced THROMBOSIS (3 blood clots in her lungs/clotting factors in the blood test were four times over a certain number of normal/she had two blood clots in her left lung and one blood clot in her right lung/clotting factors in the blood test were four times) (seriousness criteria medically significant and life threatening), PAIN (pain if take a deep breath and sneeze) (seriousness criterion medically significant), MUSCULOSKELETAL DISCOMFORT (discomfort in her back like she slept wrong), DYSPNOEA (could not take a deep breath without pain) and FEELING ABNORMAL (she felt like something was off/felt vaguely like she did in 2012 (when she had a pulmonary embolism)). In 2021, the patient experienced LETHARGY (lethargy) and VACCINATION SITE PAIN (slight tenderness in her arm). The patient was treated with APIXABAN ongoing from 14-Jun-2021 for Clot blood, at a dose of 10 mg twice a day and APIXABAN ongoing from 22-Jun-2021 for Clot blood, at a dose of 5 mg twice a day. In June 2021, PAIN (pain if take a deep breath and sneeze), MUSCULOSKELETAL DISCOMFORT (discomfort in her back like she slept wrong), DYSPNOEA (could not take a deep breath without pain) and FEELING ABNORMAL (she felt like something was off/felt vaguely like she did in 2012 (when she had a pulmonary embolism)) had resolved, LETHARGY (lethargy) and VACCINATION SITE PAIN (slight tenderness in her arm) had resolved. At the time of the report, THROMBOSIS (3 blood clots in her lungs/clotting factors in the blood test were four times over a certain number of normal/she had two blood clots in her left lung and one blood clot in her right lung/clotting factors in the blood test were four times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2021, Blood test: high clotting factor (abnormal) The clotting factors in the blood test were four times over a certain number of normal.. On 14-Jun-2021, Scan: blood clots (abnormal) Two blood clots in her left lung and one blood clot in her right lung.         The  concomitant medications on use were not provided.   On 13-Mar-2021, received second dose of Moderna COVID-19 Vaccine. On 14-Jun-2021, the patient experienced THROMBOSIS (3 blood clots in her lungs/clotting factors in the blood test were four times over a certain number of normal/she had two blood clots in her left lung and one blood clot in her right lung/clotting factors in the blood test were four times.   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.; Sender's Comments: 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.