Received Mar 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | LA |
the blood clot moved to my lungs becoming a pulmonary embolism (my heart also then went into Afib)/blood clot moved to my lungs becoming a pulmonary embolism (my heart also then went into Afib)/the blood clot moved to the lungs, resulting in a pulmo; the blood clot moved to my lungs becoming a pulmonary embolism (my heart also then went into Afib)/blood clot moved to my lungs becoming a pulmonary embolism (my heart also then went into Afib)/the blood clot moved to the lungs, resulting in a pulmon; I developed what turned out to be a DVT blood clot in my left calf/deep vein thrombosis (DVT) in the left calf/one week later, they developed a deep vein thrombosis (DVT) in the left calf; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (the blood clot moved to my lungs becoming a pulmonary embolism (my heart also then went into Afib)/blood clot moved to my lungs becoming a pulmonary embolism (my heart also then went into Afib)/the blood clot moved to the lungs, resulting in a pulmo), DEEP VEIN THROMBOSIS (I developed what turned out to be a DVT blood clot in my left calf/deep vein thrombosis (DVT) in the left calf/one week later, they developed a deep vein thrombosis (DVT) in the left calf) and ATRIAL FIBRILLATION (the blood clot moved to my lungs becoming a pulmonary embolism (my heart also then went into Afib)/blood clot moved to my lungs becoming a pulmonary embolism (my heart also then went into Afib)/the blood clot moved to the lungs, resulting in a pulmon) in a 58-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine inact split 3v (Fluarix) for an unknown indication. Previously administered products included for Product used for unknown indication: Pfizer BioNTech COVID-19 vaccine (Patient previously always had Pfizer). Past adverse reactions to the above products included No adverse effect with Pfizer BioNTech COVID-19 vaccine. Concomitant products included Docosahexaenoic acid, Eicosapentaenoic acid (Omega-3) for an unknown indication. On 15-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine inact split 3v (Fluarix) (unknown route) 1 dosage form. In November 2024, the patient experienced DEEP VEIN THROMBOSIS (I developed what turned out to be a DVT blood clot in my left calf/deep vein thrombosis (DVT) in the left calf/one week later, they developed a deep vein thrombosis (DVT) in the left calf) (seriousness criteria hospitalization and medically significant). In January 2025, the patient experienced ATRIAL FIBRILLATION (the blood clot moved to my lungs becoming a pulmonary embolism (my heart also then went into Afib)/blood clot moved to my lungs becoming a pulmonary embolism (my heart also then went into Afib)/the blood clot moved to the lungs, resulting in a pulmon) (seriousness criteria hospitalization and medically significant). On 17-Jan-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PULMONARY EMBOLISM (the blood clot moved to my lungs becoming a pulmonary embolism (my heart also then went into Afib)/blood clot moved to my lungs becoming a pulmonary embolism (my heart also then went into Afib)/the blood clot moved to the lungs, resulting in a pulmo) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 22-Jan-2025 to 27-Jan-2025 due to ATRIAL FIBRILLATION, DEEP VEIN THROMBOSIS and PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (the blood clot moved to my lungs becoming a pulmonary embolism (my heart also then went into Afib)/blood clot moved to my lungs becoming a pulmonary embolism (my heart also then went into Afib)/the blood clot moved to the lungs, resulting in a pulmo), DEEP VEIN THROMBOSIS (I developed what turned out to be a DVT blood clot in my left calf/deep vein thrombosis (DVT) in the left calf/one week later, they developed a deep vein thrombosis (DVT) in the left calf) and ATRIAL FIBRILLATION (the blood clot moved to my lungs becoming a pulmonary embolism (my heart also then went into Afib)/blood clot moved to my lungs becoming a pulmonary embolism (my heart also then went into Afib)/the blood clot moved to the lungs, resulting in a pulmon) had not resolved. Patient was not allergic to any medications, food or other products. Patient treatment medication included M.E.E.S 50 plus once a day for product used for unknown indication. Patient was first time received Moderna Covid-19 vaccination as booter dose. Approximately one-week later post vaccination patient was developed a deep vein thrombosis (DVT) in the left calf. In January, the blood clot was moved to the lungs for patient, which caused a pulmonary embolism and atrial fibrillation for patient. Patient was developed a pulmonary embolism on 17-Jan-2025 in AM. Patient was hospitalized for five days from 22-Jan-2025 to 27-Jan-2025 and he went through a catheter-based clot removal, and since then patient was on unspecified blood thinners and beta blocker as a treatment medication. Due to symptom patient wear compression socks. Reporter was stated that blood clot and Covid booster felt like the only possibility as a cause. A hematology consultation was scheduled for further evaluation for patient. Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2025: Live Significant follow up added in which country of incident, Country in which Event Occurred, suspect drug coding, co-suspect drug coding, reported reaction, Reporter causality was updated. New reference number was added. On 18-Feb-2025: Live non-significant follow up was received and new reference number was added. On 27-Feb-2025: Significant follow-up received in which primary reporter detail was updated, and secondary reporter detail was added, patient demography was updated (Patient initial, age, height, weight, race, ethnic group, Suspect and co-suspect product vaccination site of administration was added, new concomitant medication was added nature made omega 3 and M.E.E.S 50 plus. Event outcome for the event of Deep vein thrombosis Atrial fibrillation and Pulmonary embolism was updated. For all the reported event seriousness was updated as Hospitalized and Medically Significant. Event onset date for the event Pulmonary embolism and Atrial fibrillation was updated. Case narrative was updated. On 28-Feb-2025: Live non-significant follow-up received in which other manufacturer Reference number was added.; Reporter's Comments: Concomitant Fluarix remains as a confounder. The benefit-risk relationship of mRNA-1273 (Spikevax) vaccine is not affected by this report.
Omega-3