Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body mass index, Computerised tomogram, Fatigue, Pulmonary embolism, Pyrexia
Clinical narrative: BLOOD CLOTS IN LEFT LUNG; TIRED; FEVERISH; This spontaneous report received from a consumer concerned a 34 year old male. The patient's weight was 175 pounds, height was 67 inches and Body mass index (NR: not provided) 27.4. The patient's concurrent conditions included non smoker, no personal or family history of clotting disorders and no recent trauma or travel. The patient was active and ran for 30 mins every day. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 043AZ1A or 043A21A) frequency one total, dose was not reported, administered on 05-APR-2021 at 10:15 hours in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-APR-2021 in the evening, the patient experienced "normal side effects", specifically tiredness and fever (temperature was not taken) and he took 2 Advil and went to bed. On 06-APR-2021 in the morning, he felt back to his normal baseline. On an unspecified date of APR-2021 (08-APR-2021 or 09-APR-2021), he felt pain and tightness in his chest and difficulty breathing. He noticed that he had to work harder to do his daily run. On 13-APR-2021, when the symptoms did not improve, he went to the emergency room. The patient had blood was taken (results not reported). A computerised tomography (CT) scan showed 2 blood clots in the left lung and duplex scans of both legs did not reveal a clot. A chest x-ray was done but results not provided. The patient's COVID-19 test was negative, and he was admitted to the hospital and treated with intravenous heparin. It was reported that no oxygen was given. On 14-APR-2021, he was discharged with Eliquis which he should continue for 6 months.  On 16-APR-2021, the chest pain was gone, and his breathing was better in the morning but still difficult later in the day. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, and feverish, and was recovering from blood clots in left lung. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This 34 year-old overweight male (BMI 27.4) was hospitalized for 2 blood clots in his left lung 8 days after receiving vaccination with Janssen Covid-19 vaccine. He had no chronic medical conditions, was a nonsmoker, no personal or family history of clotting disorders, no recent trauma or travel, and exercised every day. On the evening of his vaccination, he felt tired and fever (temperature not taken) and took 2 ibuprofen and went to bed. The following morning, he felt back to normal. Two or three days later, he felt pain/tightness in his chest and difficulty breathing; he found it more difficult to perform his daily exercise. Eight days after vaccination, when his symptoms did not improve, he went to the emergency department where a CT scan showed 2 blood clots in his left lung. Covid-19 testing and duplex scans of his legs were negative. Blood tests were performed but results were unknown. He was hospitalized for 1 night, treated with IV heparin, and discharged the following day with apixaban. As of the time of this report, the chest pain had resolved and breathing was improved in the morning but still difficult later in the day. Based on the limited information (e.g. absence of blood test results), the relationship with Janssen Covid-19 vaccine is considered indeterminant.