Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Coagulation test, Computerised tomogram, Pulmonary thrombosis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Pulmonary thrombosis) and THROMBOSIS (Thrombosis leg) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 004D21A) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. The patient's past medical history included Hiatal hernia, Shoulder operation, Spinal laminectomy & removal of disc, Bone spur removal and Gallbladder removal. Family history included Clot blood (Patient's mother had a history of blood clots). Concurrent medical conditions included Non-tobacco user and Abstains from alcohol. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HYDROCHLOROTHIAZIDE), AMLODIPINE and LABETALOL for Blood pressure management, CELECOXIB (CELEBREX) for Inflammation, PREGABALIN (LYRICA) for Joint disorder and Nerve damage, TRAMADOL for Pain, SULFASALAZINE for Prophylaxis. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced PULMONARY THROMBOSIS (Pulmonary thrombosis) (seriousness criteria hospitalization and medically significant) and THROMBOSIS (Thrombosis leg) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 23-Aug-2021 to 26-Aug-2021 due to PULMONARY THROMBOSIS and THROMBOSIS. The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. At the time of the report, PULMONARY THROMBOSIS (Pulmonary thrombosis) was resolving and THROMBOSIS (Thrombosis leg) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Blood test: normal. On 23-Aug-2021, Blood test: Blood clot in lungs. On 23-Aug-2021, Chest X-ray: not reported. On 23-Aug-2021, Computerised tomogram: Blood clot in lungs. On an unknown date, Coagulation test: not reported. On an unknown date, SARS-CoV-2 test: (Negative) Negative. On an unknown date, Ultrasound scan: not reported. Formulation of Humira was reported as Solution for injection in pre-filled pen. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. He was admitted in intensive care unit for blood clots in leg and lungs. He discontinued Humira because his physician advised him that the medication had tendency to cause more clotting. He took unknown fiber supplement and unknown multivitamins. The alternative etiology for blood clot in lungs and difficulty breathing was Moderna vaccine. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case reported by a consumer, concerns a 41 year old male patient, with relevant medical history of multiple surgeries in past and family history of having blood clots, who experienced the unexpected, serious, (hospitalization, medically significant) AESI events of pulmonary thrombosis and thrombosis (thrombosis leg) in the same month, unknown days after receiving the 2 dose of mRNA-1273 vaccine in the Covid 19 vaccination series. The patient was hospitalized and on the same day, CT scan showed blood clot in lungs, results of ultra sound scan, x-ray and coagulation tests were not reported. SARS-cov-2 test was negative. the patient was treated with apixaban at an unspecified dose and frequency. concomitant products included hydrochlorothiazide, losartan potassium, amlodipine and labetalol for blood pressure. He also received Humira for rheumatoid arthritis, which is a confounder, family history of blood clotting, is a risk factor. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Added patient demographics, medical history, events, suspect drug information, concomitant medication, treatment drug and lab data. Sender's Comments: This spontaneous case reported by a consumer, concerns a 41 year old male patient, with relevant medical history of multiple surgeries in past and family history of having blood clots, who experienced the unexpected, serious, (hospitalization, medically significant) AESI events of pulmonary thrombosis and thrombosis (thrombosis leg) in the same month, unknown days after receiving the 2 dose of mRNA-1273 vaccine in the Covid 19 vaccination series. The patient was hospitalized and on the same day, CT scan showed blood clot in lungs, results of ultra sound scan, x-ray and coagulation tests were not reported. SARS-cov-2 test was negative. the patient was treated with apixaban at an unspecified dose and frequency. concomitant products included hydrochlorothiazide, losartan potassium, amlodipine and labetalol for blood pressure. He also received Humira for rheumatoid arthritis, which is a confounder, family history of blood clotting, is a risk factor. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.