Received Nov 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 7+ | 8080433 | IM |
Patient had blood clots in lungs/Patient had it for a while. It was in patient's leg, went to patient's lungs; Blood clot was in my leg/I'm sure I've had it for a while. It was in my leg; It could have been related to the COVID; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Patient had blood clots in lungs/Patient had it for a while. It was in patient's leg, went to patient's lungs) and THROMBOSIS (Blood clot was in my leg/I'm sure I've had it for a while. It was in my leg) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080433) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Suspect product included Pre-filled Syringe injection (batch no. 8080433) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Lot no: 031L20A, Dose no: 1, dosage: 999 mL) on 18-Feb-2021, Moderna COVID-19 Vaccine (Lot no: 040A21A, Dose no: 2, dosage: 999 mL) on 23-Mar-2021, Moderna COVID-19 Vaccine (Lot no:058H21A, Dose no: 3, dosage: 0.25 mL) on 02-Dec-2021, Spikevax (Lot no:013B22A, Dose no: 4, dosage: 0.25 mL) on 25-Jul-2022, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Lot no:010H22A, Dose no: 5, dosage: 0.5 mL) on 12-Dec-2022, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Lot no:AS7185B, Dose no: 6, dosage: 0.5 mL) on 03-Jun-2023, SPIKEVAX 2023-2024 (Lot no:3030592, Dose no: 7 and dosage: 0.5 mL) on 13-Nov-2023. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), SPIKEVAX 2023-2024 and Spikevax. Concomitant products included Apixaban (Eliquis) for Thrombosis. On 06-Sep-2024, the patient received eighth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 16-May-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PULMONARY EMBOLISM (Patient had blood clots in lungs/Patient had it for a while. It was in patient's leg, went to patient's lungs) (seriousness criteria hospitalization, medically significant and life threatening). On an unknown date, the patient experienced THROMBOSIS (Blood clot was in my leg/I'm sure I've had it for a while. It was in my leg) (seriousness criterion medically significant) and COVID-19 (It could have been related to the COVID). The patient was hospitalized on 16-May-2025 due to PULMONARY EMBOLISM. The patient was treated with Benzocaine, Benzyl nicotinate, Heparin sodium (Heparin) on 17-May-2025 for Thrombosis, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Patient had blood clots in lungs/Patient had it for a while. It was in patient's leg, went to patient's lungs) and THROMBOSIS (Blood clot was in my leg/I'm sure I've had it for a while. It was in my leg) was resolving and COVID-19 (It could have been related to the COVID) outcome was unknown. No concomitant medications were reported. In May 2025, patient was diagnosed with blood clots in her lungs. Doctors ran many tests but couldn't find a clear reason for the clots. She wondered if they might be related to COVID or the vaccines. She was frustrated because her doctors hadn't given her clear advice, and even her pharmacist couldn't help. She went to the emergency room on 16-May-2025, and was told the clot started in her leg and traveled to her lungs. After being treated with a heparin drip for a couple of days and started with Eliquis (5 mg twice daily), at night, possibly on May 18 or even May 19, but she was not certain of the exact date, which she now took permanently as advised by her hematologist Her last Moderna vaccine was given in 2024. She had received Moderna vaccines and had a record of 8 doses. She was still unsure if it's safe to get another booster and was looking for guidance. Patient had taken several Moderna vaccines, the original, and then 7 or 8 booster doses.; Reporter's Comments: Company comment: Concurrent COVID 19 is a confounder. Considering implausible temporal association with events occurring approx. 9 months after latest dose of Spikevax causality is assessed as not related for pulmonary embolism and thrombosis. The benefit-risk relationship of product is not affected by this report.
Eliquis