Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Feeling abnormal, Pulmonary embolism, Venous thrombosis limb
Clinical narrative: They were not feeling all that great; fell; pulmonary blood clots; blood clot in their right leg; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (pulmonary blood clots) and VENOUS THROMBOSIS LIMB (blood clot in their right leg) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes (20 years ago had DBT (Diabetes)) in 2001.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VENOUS THROMBOSIS LIMB (blood clot in their right leg) (seriousness criterion medically significant). In September 2021, the patient experienced PULMONARY EMBOLISM (pulmonary blood clots) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (They were not feeling all that great) and FALL (fell). At the time of the report, PULMONARY EMBOLISM (pulmonary blood clots), VENOUS THROMBOSIS LIMB (blood clot in their right leg), FEELING ABNORMAL (They were not feeling all that great) and FALL (fell) outcome was unknown.      Concomitant products not reported. The case pertains to one of the patients the caller mentioned.   It was reported that two weeks ago (as reported) diagnosed with a blood clot in the right leg. The patient was not feeling all that great and then fell and noticed a vein on the right leg above the knee was hard and purple and had  a massive swelling on the right leg. The patient went to a health care professional, vein specialist, who prescribed to take daily shots of blood thinners for six weeks. She does not take any medication regularly. She got pulmonary blood clots around six months after getting their second dose of the Moderna vaccine.  Company Comment: This case concerns a 68 year-old, female subject with a history of, who experienced the  unexpected events of PULMONARY EMBOLISM and VENOUS THROMBOSIS LIMB. The event of pulmonary embolism occurred approximately 6 months after the second dose of Spikevax, even though specific date of occurrence was not provided for any of the reported events. The rechallenge was unknown as there is missing information on dates of events. Patient's age remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report. Further information is expected.   This case was linked to US-MODERNATX, INC.-MOD-2021-317609, US-MODERNATX, INC.-MOD-2021-317836, US-MODERNATX, INC.-MOD-2021-317918, US-MODERNATX, INC.-MOD-2021-318381 (E2B Linked Report).; Sender's Comments: This case concerns a 68 year-old, female subject with a history of, who experienced the  unexpected events of PULMONARY EMBOLISM and VENOUS THROMBOSIS LIMB. The event of pulmonary embolism occurred approximately 6 months after the second dose of Spikevax, even though specific date of occurrence was not provided for any of the reported events. The rechallenge was unknown as there is missing information on dates of events. Patient's age remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report. Further information is expected. US-MODERNATX, INC.-MOD-2021-317609:Same reporter US-MODERNATX, INC.-MOD-2021-317836:Same reporter US-MODERNATX, INC.-MOD-2021-317918:Same reporter US-MODERNATX, INC.-MOD-2021-318381:Same reporter