Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
he had blood clots in his lungs/he couldn't breathe; get numerous vaccines a year and they get sick after it every time/" it feels like they're getting sick"; nausea; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (he had blood clots in his lungs/he couldn't breathe) in an elderly male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (he had blood clots in his lungs/he couldn't breathe) (seriousness criterion medically significant), ILLNESS (get numerous vaccines a year and they get sick after it every time/" it feels like they're getting sick"), NAUSEA (nausea) and DIZZINESS (dizziness). At the time of the report, PULMONARY EMBOLISM (he had blood clots in his lungs/he couldn't breathe), ILLNESS (get numerous vaccines a year and they get sick after it every time/" it feels like they're getting sick"), NAUSEA (nausea) and DIZZINESS (dizziness) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. Patient had not taken any vaccines in the past 4 weeks. It was stated that patient who was over 65 years old get a COVID vaccine every 3 months, it was asked for it and got it every time patient travel. It was stated that patient got numerous vaccines a year and got sick after it every time. It was stated that patient got it because wanted to get it, patient was not being recommended by anyone and was just continuing to take it. Patient got the symptoms what listed on there as the nausea, dizziness, general queasiness, " it felt like patient was getting sick. Patient had a terrible incident where he had blood clots in his lungs, it was several years ago, so were not going to connect it, nothing was ever connected to a COVID vaccine, it was very serious. He was still on blood thinners because would never take him off them because he was 77 years old. This happened 2 or 3 days after he got his 17th COVID vaccine. It was stated that before the blood clots, there has never been any issues that was aware of, he might have had something, but it was never diagnosed by a doctor, when he went to the doctor it was surprising. It was said the blood clots only happened once and it was a whole incident because he had to go to the ER, it was painful and he couldn't breathe, it was a very severe reaction. Patient was going to the doctor again because he was sick. it was not unusual; it was the listed side effects. It was stated not to the severity patient has ever had. It was unknown if the patient experienced any additional symptoms/events. No specific treatment drug was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790351 (E2B Linked Report). This case was linked to MOD-2025-790352 (Patient Link).; Reporter's Comments: The serious adverse event of pulmonary embolism was assessed s possibly related to suspected vaccine, however missing information regarding medical history and type of vaccine as ell as advance age were all assessed as confounding factors. All other non-serious events were assessed s related as all of them are in safety profile of suspected vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790351:mother case