Sex: F
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram, Cough, Headache, Malaise
Clinical narrative: BLOOD SPOTS UNDER THE SKIN ON FEET, LEGS, STOMACH, CHEST AND FACE; BAD COUGH; BODY ACHES; FELT VERY SICK; CHILLS; HORRIBLE HEADACHE; FEVER; SNEEZING; BLOOD CLOT IN RIGHT LUNG; This spontaneous report received from a patient concerned a 59 year old. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection (in 2020), cough, and chills (chills were from my spinal cord and was not hospitalized), and concurrent conditions included: non-smoker, non-alcohol consumer, and systemic lupus, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug usage. There was no history of blood clots in patient's family and she was one of nine children.  The patient was previously treated with belimumab for systemic lupus.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient experienced shortness of breath, and sneezing. On 07-APR-2021, the next day after receiving the vaccine, the patient experienced body aches, horrible headache, chills and fever. On 09-APR-2021, 3 days after receiving the vaccine the patient developed bad cough. The patient stated that she felt very sick with these symptoms during the first month after receiving the vaccine when the symptoms were the worst and all the symptoms did not resolved yet. The patient still had bad headache daily and was seeing a neurologist for the headache and he prescribed toradol injection for it, she felt occasional body aches, the cough would not go away and the fever and chills were on and off. The patient stated that she did not feel 100 percent up to this time. The patient described her cough as it did not go away, it was scary, sounded like she had bronchitis, sneezed like she had bronchitis, it was not the same cough that she had before, some days patient felt worse than others, her voice changed, she had horse voice because of coughing. She could not lay on her back because of shortness of breath, she felt like she was choking. The patient visited emergency room because of the shortness of breath countless number of visits and computed tomography scan was done and the patient was diagnosed with a blood clot in right lung on Feb 2022. The patient was put on xarelto for at least 2 years and the patient might need to continue to take it for the rest of her life if she will still have the blood clot. The patient stated that physician will prescribe antibiotics for her cough and will also refer her to pulmonologist and to a vascular surgeon because of the blood clots and for another condition which she could not remember. The patient stated that, the same time she was diagnosed with the blood clot, one morning she developed blood spots under the skin on her feet, legs, stomach, chest and face, all the spots were very small in size but the ones on the chest and stomach were relatively bigger and still have them on her leg, stomach and face, the ones on feet and chest were gone, she was chocked when she developed them and her husband took pictures. The patient stated the she visited the same emergency room multiple times, she stated that she could not remember that dates of all the visits but recalls only 3 visits on 11-Mar-2022, 12-Mar-2022 and 17-Mar-2022, however she confirmed twice that the diagnosis of blood clot in the right lung was in Feb-2022. The patient mentioned that she had all the paperwork from the emergency room visits. The patient described the adverse events as so horrific that she could not take a second shot, she also described them as being similar in nature to the symptoms she developed when she had the COVID-19 infection in 2020, when she also felt so sick, had a horrific cough that was scary, she was not hospitalized due to COVID but was prescribed steroids, antiviral and antibiotic for the COVID infection. Laboratory data included: CT scan (NR: not provided) Blood clot in the right lung. On FEB-2022, the patient experienced blood spots under the skin on feet, legs, stomach, chest and face. On 01-FEB-2022, the patient experienced blood clot in right lung. On an unspecified date, the patient experienced chocking. Treatment medications (dates unspecified) included: ketorolac tromethamine, and rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt very sick, blood clot in right lung, chills, body aches, horrible headache, bad cough, fever, and sneezing, and the outcome of blood spots under the skin on feet, legs, stomach, chest and face was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220538912-covid-19 vaccine ad26.cov2.s -BLOOD CLOT IN RIGHT LUNG. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.