Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism), DEEP VEIN THROMBOSIS (blood clot complications/3 in left leg and several in right leg. Clots in left and right arm and pulmonary embolism/hospitalized repeatedly) and COVID-19 (diagnosed with COVID twice) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 6T036C21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Iodine allergy. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Yes - Jan 2022 first diagnosed -COVID). On 20-May-2022, the patient experienced DEEP VEIN THROMBOSIS (blood clot complications/3 in left leg and several in right leg. Clots in left and right arm and pulmonary embolism/hospitalized repeatedly) (seriousness criteria hospitalization and medically significant) and COVID-19 (diagnosed with COVID twice) (seriousness criterion medically significant). On an unknown date, the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria hospitalization and medically significant), PLANTAR FASCIITIS (plantar fasciitis), GAIT DISTURBANCE (hard time walking/Could not walk.) and DRUG INEFFECTIVE (lack of efficacy). The patient was treated with OXYGEN at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (pulmonary embolism), DEEP VEIN THROMBOSIS (blood clot complications/3 in left leg and several in right leg. Clots in left and right arm and pulmonary embolism/hospitalized repeatedly), COVID-19 (diagnosed with COVID twice), COVID-19 (Yes - Jan 2022 first diagnosed -COVID), GAIT DISTURBANCE (hard time walking/Could not walk.) and DRUG INEFFECTIVE (lack of efficacy) outcome was unknown and PLANTAR FASCIITIS (plantar fasciitis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) Positive. On 20-May-2022, SARS-CoV-2 test: positive (Positive) Positive. Loss of personal independence in daily activities, as it maps out to SOC of Social circumstances. Company comment: This spontaneous case concerns a 46-year-old female patient, with no relevant medical history, who experienced the unexpected serious (hospitalization and medically significant) AESIs of Pulmonary embolism, Deep vein thrombosis, and unexpected serious (medically significant) AESI COVID-19. Patient received 2 doses of mRNA-1273 vaccine as primary series and was given at an interval of 29 days. Approximately 6 months after receiving the 2nd dose of mRNA-1273 vaccine, patient reported of hard time walking which improved after she was put on blood thinners. Two months later, patient was diagnosed with COVID-19. Clinical course, treatment details and outcome were not reported. Approximately 1 year after receiving the 2nd dose of mRNA-1273 vaccine, patient reported worsening of status everyday (details not reported), and patient sought medical consult and was diagnosed again to have COVID-19, with complications of deep vein thrombosis with blood clots in bilateral upper and lower extremities and pulmonary embolism. Patient was hospitalized and was given supplemental oxygen, started on blood thinner, nebulizer, and antibiotics. The outcome of events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness was assessed based on medical judgment. No concomitant medication information was provided. The patient had a hard time walking and was diagnosed with plantar fasciitis  Nov 2021 and Dec 2021. The patient Could not walk. it improved once she got on blood thinners. The patient did not experience medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Recent change in status was worsening every day. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient did not experienced a similar event in the past. The patient was placed on a blood thinner, nebulizer/oxygen, antibiotics. The symptoms worsened. The patient had been hospitalized repeatedly since 20 May (for three days) then a week later (for a day). Caller states that she usually pretty healthy - used to run 5 miles every day. Reporter's Comments: No concomitant medication information was provided. The patient had a hard time walking and was diagnosed with plantar fasciitis  Nov 2021 and Dec 2021. The patient Could not walk. it improved once she got on blood thinners. The patient did not experience medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Recent change in status was worsening every day. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient did not experienced a similar event in the past. The patient was placed on a blood thinner, nebulizer/oxygen, antibiotics. The symptoms worsened. The patient had been hospitalized repeatedly since 20 May (for three days) then a week later (for a day). Caller states that she usually pretty healthy - used to run 5 miles every day. Sender's Comments: This spontaneous case concerns a 46-year-old female patient, with no relevant medical history, who experienced the unexpected serious (hospitalization and medically significant) AESIs of Pulmonary embolism, Deep vein thrombosis, and unexpected serious (medically significant) AESI COVID-19. Patient received 2 doses of mRNA-1273 vaccine as primary series and was given at an interval of 29 days. Approximately 6 months after receiving the 2nd dose of mRNA-1273 vaccine, patient reported of hard time walking which improved after she was put on blood thinners. Two months later, patient was diagnosed with COVID-19. Clinical course, treatment details and outcome were not reported. Approximately 1 year after receiving the 2nd dose of mRNA-1273 vaccine, patient reported worsening of status everyday (details not reported), and patient sought medical consult and was diagnosed again to have COVID-19, with complications of deep vein thrombosis with blood clots in bilateral upper and lower extremities and pulmonary embolism. Patient was hospitalized and was given supplemental oxygen, started on blood thinner, nebulizer, and antibiotics. The outcome of events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness was assessed based on medical judgment.