Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Muscle spasms, Pulmonary embolism
Clinical narrative: Deep Vein Thrombosis in right leg/The starting point was the right leg; bilateral pulmonary embolism/clot started traveling and ended up in lungs; cramp in right leg started, but went away in a day; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (Deep Vein Thrombosis in right leg/The starting point was the right leg) and PULMONARY EMBOLISM (bilateral pulmonary embolism/clot started traveling and ended up in lungs) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: pfizer (dose 1) on 09-Apr-2021 and pfizer (dose 2) on 30-Apr-2021. Past adverse reactions to the above products included No adverse event with pfizer and pfizer. Concurrent medical conditions included Non-smoker (Non-smoker for life.).    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2022, the patient experienced MUSCLE SPASMS (cramp in right leg started, but went away in a day). On 15-Jan-2022, the patient experienced DEEP VEIN THROMBOSIS (Deep Vein Thrombosis in right leg/The starting point was the right leg) (seriousness criteria hospitalization and medically significant) and PULMONARY EMBOLISM (bilateral pulmonary embolism/clot started traveling and ended up in lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 15-Jan-2022 to 18-Jan-2022 due to DEEP VEIN THROMBOSIS and PULMONARY EMBOLISM. The patient was treated with HEPARIN (intravenous) for Adverse event, at an unspecified dose and frequency and APIXABAN (oral) on 18-Jan-2022 for Adverse event, at a dose of blood thinner. At the time of the report, DEEP VEIN THROMBOSIS (Deep Vein Thrombosis in right leg/The starting point was the right leg) had resolved with sequelae and PULMONARY EMBOLISM (bilateral pulmonary embolism/clot started traveling and ended up in lungs) and MUSCLE SPASMS (cramp in right leg started, but went away in a day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. On 03Jan2021, patient was started experiencing cramp in right leg started, but went away in a day. However, the cramp came back on 12 January 2022 and it was growing. The cramp started in the right calf and went up to the right thigh. Patient was in excruciating pain and was short of breath, so went to the hospital and was admitted. Hospitalized at Mount Auburn Healthcare on Saturday morning 15 January 2022. Diagnosed with bilateral pulmonary embolism and Deep Vein Thrombosis in right leg. The starting point was the right leg and the clot started traveling and ended up in lungs. patient reports he feels completely okay. Not short of breath. Just when walking, leg still hurts a little bit. Does not travel. Patient was active before the DVT developed. Treatment included heparin IV for 4 days. On 18Jan2022. stopped heparin mid-day and put on oral blood thinner - apixaban (Eliquis).   Company comment: This case concerns a 47-year-old male patient, with no relevant medical history, previously vaccinated with two doses of Pfizer, as reported, who experienced the unexpected events of deep vein thrombosis and pulmonary embolism which required hospitalization and non serious event of muscle spasm. The events occurred approximately 25-28 days after the third dose of mRNA-1273. As reported, the patient experienced cramp in right leg 13 days after second dose and the event resolved. However the event returned 22 days after third dose with progression to right thigh and patient went to hospital, two day later due to excruciating pain and shortness of breath and was hospitalized and diagnosed with bilateral pulmonary embolism and Deep Vein Thrombosis in right leg. After treatment patient reported feeling completely okay, not short of breath, just when walking, leg still hurt a little bit. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 47-year-old male patient, with no relevant medical history, previously vaccinated with two doses of Pfizer, as reported, who experienced the unexpected events of deep vein thrombosis and pulmonary embolism which required hospitalization and non serious event of muscle spasm. The events occurred approximately 25-28 days after the third dose of mRNA-1273. As reported, the patient experienced cramp in right leg 13 days after second dose and the event resolved. However the event returned 22 days after third dose with progression to right thigh and patient went to hospital, two day later due to excruciating pain and shortness of breath and was hospitalized and diagnosed with bilateral pulmonary embolism and Deep Vein Thrombosis in right leg. After treatment patient reported feeling completely okay, not short of breath, just when walking, leg still hurt a little bit. The benefit-risk relationship of mRNA-1273 is not affected by this report.