Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Serious blood clots on his lungs; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Serious blood clots on his lungs) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 002A21A and 5Feb2022) for COVID-19 vaccination.     The patient's past medical history included Sickness (Got very sick, but weren't diagnosed covid positive.) in February 2020. Concurrent medical conditions included Diabetes (30 years ago) and Blood pressure high (30 years ago). Concomitant products included INFLUENZA VACCINE (FLU), INSULIN ASPART, INSULIN ASPART PROTAMINE (NOVOLOG MIX), LIRAGLUTIDE (VICTOZA), ATORVASTATIN CALCIUM (LIPITOR), FENOFIBRATE (TRICOR [FENOFIBRATE]), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR), SULFASALAZINE (AZULFIDINE), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), POTASSIUM CITRATE (UROCIT K), ALLOPURINOL (ZYLOPRIM) and ACETYLSALICYLIC ACID (ASA EC) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY EMBOLISM (Serious blood clots on his lungs) (seriousness criterion hospitalization). The patient was hospitalized from 10-Feb-2022 to 12-Feb-2022 due to PULMONARY EMBOLISM. The patient was treated with OXYGEN at an unspecified dose and frequency; APIXABAN (ELIQUIS) from 11-Feb-2022 to 17-Feb-2022 for Clot blood, at a dose of 10 milligram twice a day and APIXABAN (ELIQUIS) ongoing from 18-Feb-2022 for Clot blood, at a dose of 5 milligram twice a day. At the time of the report, PULMONARY EMBOLISM (Serious blood clots on his lungs) had not resolved.            Patient took booster shot on 17-Nov-2021. Patient did not experience any symptoms right after any of the injections. This symptom was still ongoing, patient remains critical, under oxygen, even though he was now receiving care at home under doctor's care. This will have to be treated for months. Both acute and chronic illnesses at the time of vaccination. Patient's wife did not know what caused blood clots on her husband, but they were thinking about the possibility it could be due to COVID-19 vaccine.  Company comment:  This regulatory authority case concerns a 76-year-old male with no relevant medical history who experienced the serious (life threatening), unexpected event of pulmonary embolism 86 days after the third dose of mRNA-1273. No treatment or testing reported and the event is ongoing. The risk-benefit relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2022: Concomitant drugs were added.; Sender's Comments: Company comment:  This regulatory authority case concerns a 76-year-old male with no relevant medical history who experienced the serious (life threatening), unexpected event of pulmonary embolism 86 days after the third dose of mRNA-1273. No treatment or testing reported and the event is ongoing. The risk-benefit relationship of mRNA-1273 is not affected by this report.