Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hypoaesthesia, Nerve injury, Thrombosis
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOSIS (7cm blood clot at the bottom of the aorta, blocking completely blood circulation to the lower limb), HYPOAESTHESIA (Lost all feelings of legs, feet and toes) and NERVE INJURY (Permanent nerve damage on her feet and toes) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high (Started around 12 years ago; well controlled with medication). Concomitant products included LOSARTAN for Blood pressure high. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced THROMBOSIS (7cm blood clot at the bottom of the aorta, blocking completely blood circulation to the lower limb) (seriousness criteria hospitalization, medically significant and life threatening) and NERVE INJURY (Permanent nerve damage on her feet and toes) (seriousness criterion hospitalization). On 26-Mar-2021, the patient experienced HYPOAESTHESIA (Lost all feelings of legs, feet and toes) (seriousness criterion hospitalization). The patient was hospitalized from 26-Mar-2021 to 05-Apr-2021 due to HYPOAESTHESIA, NERVE INJURY and THROMBOSIS. At the time of the report, THROMBOSIS (7cm blood clot at the bottom of the aorta, blocking completely blood circulation to the lower limb) had resolved and HYPOAESTHESIA (Lost all feelings of legs, feet and toes) and NERVE INJURY (Permanent nerve damage on her feet and toes) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Blood test: abnormal (abnormal) A 7 cm blood clot at the bottom of the aorta, blocking completely blood circulation to the lower limb was found. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered THROMBOSIS (7cm blood clot at the bottom of the aorta, blocking completely blood circulation to the lower limb), HYPOAESTHESIA (Lost all feelings of legs, feet and toes) and NERVE INJURY (Permanent nerve damage on her feet and toes) to be related. Patient had no allergies to food or medication, never tested positive for COVID. Patient did not take any other vaccine. Patient never been diagnosed with myocarditis or pericarditis. A month after completing primary series of the Moderna COVID-19 vaccine, patient almost lost life due a blood clot that was blocking the aorta. On 26-Mar-2021, patient lost all feelings of legs, feet and toes. Ambulance rushed into the hospital and there find a 7cm blood clot at the bottom of the aorta, blocking completely blood circulation to the lower limb. Patient was intervened and hospitalized for 10 days, causing permanent nerve damage on feet and toes, also a hospital bill for more than 10 thousand dollars. Patient states that cardiologist and hematologist mention that there were no medical reason to explain what could cause this other than the vaccine. It took almost a year to recover from that situation. Patient also mention that will file a law suit. COMPANY COMMENT: This spontaneous case concerns a 47-year-old female patient, with no relevant medical history, who experienced unexpected serious AESI event of thrombosis (seriousness criteria hospitalization, medically significant and life threatening) and unexpected serious events of hypoaesthesia, nerve injury (seriousness criterion hospitalization), which occurred 1 month 17 days after second dose of mRNA-1273 vaccine, Blood test was abnormal, A 7 cm blood clot at the bottom of the aorta, blocking completely blood circulation to the lower limb was found on 26-MAR-2021.It is reported that patient went to hospital on On 26-Mar-2021 and Patient was intervened and hospitalized for 10 days ,it is reported that that cardiologist and hematologist mention that there were no medical reason to explain what could cause this other than the vaccine, It took almost a year to recover from the events. The benefit-risk relationship of the mRNA-1273 is not affected by this report. Company comment: This spontaneous case concerns a 47-year-old female patient, with no relevant medical history, who experienced unexpected serious AESI event of thrombosis (seriousness criteria hospitalization, medically significant and life threatening) and unexpected serious events of hypoaesthesia, nerve injury (seriousness criterion hospitalization), which occurred 1 month 17 days after second dose of mRNA-1273 vaccine, Blood test was abnormal, A 7 cm blood clot at the bottom of the aorta, blocking completely blood circulation to the lower limb was found on 26-MAR-2021.It is reported that patient went to hospital on On 26-Mar-2021 and Patient was intervened and hospitalized for 10 days ,it is reported that that cardiologist and hematologist mention that there were no medical reason to explain what could cause this other than the vaccine, It took almost a year to recover from the events. The benefit-risk relationship of the mRNA-1273 is not affected by this report. Sender's Comments: Company comment: This spontaneous case concerns a 47-year-old female patient, with no relevant medical history, who experienced unexpected serious AESI event of thrombosis (seriousness criteria hospitalization, medically significant and life threatening) and unexpected serious events of hypoaesthesia, nerve injury (seriousness criterion hospitalization), which occurred 1 month 17 days after second dose of mRNA-1273 vaccine, Blood test was abnormal, A 7 cm blood clot at the bottom of the aorta, blocking completely blood circulation to the lower limb was found on 26-MAR-2021.It is reported that patient went to hospital on On 26-Mar-2021 and Patient was intervened and hospitalized for 10 days ,it is reported that that cardiologist and hematologist mention that there were no medical reason to explain what could cause this other than the vaccine, It took almost a year to recover from the events. The benefit-risk relationship of the mRNA-1273 is not affected by this report.