Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3032264 | IM |
saddle pulmonary embolism/she couldn't step up and she couldn't stand; very tired; felt weird after; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (saddle pulmonary embolism/she couldn't step up and she couldn't stand) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032264) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. In October 2023, the patient experienced PULMONARY EMBOLISM (saddle pulmonary embolism/she couldn't step up and she couldn't stand) (seriousness criteria hospitalization, medically significant and life threatening) and FEELING ABNORMAL (felt weird after). On an unknown date, the patient experienced FATIGUE (very tired). The patient was hospitalized on sometime in 2023 due to PULMONARY EMBOLISM. The patient was treated with Surgery (Operation for a saddle pulmonary embolism) for Pulmonary embolism. At the time of the report, PULMONARY EMBOLISM (saddle pulmonary embolism/she couldn't step up and she couldn't stand) and FATIGUE (very tired) was resolving and FEELING ABNORMAL (felt weird after) outcome was unknown. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown. Concomitant medications were not reported. Patient felt weird after the vaccine administration, but the pharmacy said that it was normal. Patient ended up going by ambulance to the hospital to have an operation for a saddle pulmonary embolism. Patient was in the ICU for quite a while. On 01-Nov-2023 patient had the big surgery at hospital. It was reported that patient had done a lot of tests and exams to exclude that the side effects are from blood disease or cancer, so she was sure that the AE was because of the Moderna vaccine. Patient started feeling weird a couple of days after she got the vaccine, it was probably like flu. Patient got scared as she felt very tired, she couldn't step up and she couldn't stand. Patient got a surgery, and she was told that was the biggest embolism that the doctors had seen. Patient was better now, she can walk and people can understand her when she talks. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790097 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 10-Oct-2025: Live follow-up received contains significant information. New events were added, narrative was updated and reference was added.; Reporter's Comments: All events have been assessed as related to suspected vaccine due to close temporal association, however additional information has been requested. The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790097:Other patient case