Received Mar 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | UNK | IM |
| FLU3 | INFLUENZA (SEASONAL) (FLUARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
pulmonary embolism; my heart also then went into Afib; (I developed what turned out to be a DVT blood clot in my left calf/deep vein thrombosis (DVT) in the left calf; This serious case was reported by a consumer via other manufacturer and described the occurrence of pulmonary embolism in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) for prophylaxis. Co-suspect products included Elasomeran (Spikevax) for prophylaxis. Previously administered products included Covid 19 vaccine with an associated reaction of no adverse event (Pfizer vaccine). Concomitant products included other lipid modifying agents. On 15-NOV-2024, the patient received the 1st dose of Fluarix 2024-2025 season and Spikevax (intramuscular). In NOV-2024, 1 week after receiving Fluarix 2024-2025 season, the patient experienced dvt of calf (Verbatim: (I developed what turned out to be a DVT blood clot in my left calf/deep vein thrombosis (DVT) in the left calf) (serious criteria hospitalization, GSK medically significant and other: Serious as per reporter). In JAN-2025, the patient experienced atrial fibrillation (Verbatim: my heart also then went into Afib) (serious criteria hospitalization, GSK medically significant and other: Serious as per reporter). On 17-JAN-2025, the patient experienced pulmonary embolism (Verbatim: pulmonary embolism) (serious criteria hospitalization, GSK medically significant and other: Serious as per reporter). The outcome of the pulmonary embolism, dvt of calf and atrial fibrillation were not resolved. It was unknown if the reporter considered the pulmonary embolism, dvt of calf and atrial fibrillation to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. The company considered the pulmonary embolism, dvt of calf and atrial fibrillation to be unrelated to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-MAR-2025 Approximately one-week later post vaccination of Fluarix and Spikevax 2024-2025, 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 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. The 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. 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 booster dose.; Sender's Comments: Pulmonary embolism, Deep vein trombosis and Atrial fibrillation are unlisted events which are considered unrelated to GSK vaccine Fluarix 2024-2025 season and Fluarix PRE-FILLED SYRINGE DEVICE.
OTHER LIPID MODIFYING AGENTS