Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Pulmonary thrombosis
Clinical narrative: 3 BLOOD CLOTS IN THE LOWER LUNG LOBE; COVID-19; HEADACHES; This spontaneous report received from a patient concerned a female of an unspecified age, race and ethnic origin. Initial information was processed along with the additional information received on 12-JUN-2023. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (blood thinners other than Xarelto), and other pre-existing medical conditions included: The patient was healthy person prior to the vaccine and was a runner. The patient did not have any medical history and had no family history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: unknown) dose was not reported, 1 in total, administered on an unspecified date in 2021 for covid-19 prophylaxis. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots, she was on rivaroxaban for 3 months. After she went off of rivaroxaban, they found another blood clot. She was on the same medication (rivaroxaban) for another 7 months because she was allergic to other blood thinners. 30 days after stopping rivaroxaban, a third blood clot appeared. All 3 blood clots appeared in the lung (lower lobe) but not sure which side. All clots were in the same area. The patient did not have any effect on her extremities until it gets to her lung. She stated that symptoms were started after the vaccine and it was related to vaccine. She stated that the vaccine did something to her DNA (Di-ribonucleic acid). The patient wanted to know if the vaccine changed her DNA and if she would go back to her normal healthy person or if clots would stay till the rest of her life. The patient also mentioned that one day she got a headache. The patient gets more headaches after the vaccine. She was really frustrated. The patient also stated that she had covid and that the vaccine was what injured her but the disease did not. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 3 blood clots in the lower lung lobe, and the outcome of covid-19 and headaches was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000285565 (covid-19 vaccine ad26.cov2.s vaccine), 90000285566 (Xarelto). The suspected product quality complaint has been confirmed to be voided for 90000285565 (covid-19 vaccine ad26.cov2.s vaccine) (this report describes medical adverse events in regards to covid-19 post vaccination. There is no product quality issue described and the case does not meet the definition for a product quality complaint (PQC) or explicitly allege a potency issue. This report also indicates the patient had covid-19 without a clear timeline indicating if the infection was before or after vaccination. There is no product quality issue described in regards to the covid-19 vaccine) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20230623176-3 blood clots in the lower lung lobe. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.