Age: 39.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Laboratory test, Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM IN CHEST; TIREDNESS; This spontaneous report received from the patient's mother concerned a 39 year old. The patient's weight was 251 pounds, and height was 66 inches. The patient's past medical history included a previous pulmonary embolism on 12-JUL-2012, which the reporter said the physician attributed to the patient being "obese and lays on her bed and doesn't exercise".  Concurrent conditions included irregular menstruation, schizoaffective disorder, panic attacks, anxiety attacks, depression, incontinence, gastritis, constipation, sciatica nerve pain, asthma, obese, and doesn't comprehend well.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, 1 in total administered on 06-MAR-2021 at left arm for prophylactic vaccination. Non-Company suspect included ethinylestradiol/ferrous fumarate/norethisterone acetate, "for two months" for irregular menstruation.  On 17-MAR-2021, the patient's physician ordered the patient to stop taking.  Concomitant medications included salbutamol, lactulose for constipation, clozapine, gabapentin (noted as the doctor was trying to wean patient off medication), oxybutynin hydrochloride, pantoprazole, risperidone, valproate semisodium, vilazodone hydrochloride, and unspecified breathing treatments. In MAR-2021, the patient's mother stated that the first few days after vaccination the patient was fine. After a few days, patient was more tired than usual. On 16-MAR-2021, the patients mother noticed the patient's right leg was swollen and decided to take the patient to the Emergency Room. She was diagnosed with pulmonary embolism in the chest verified with radiology tests of chest and many other tests. Treatment included Eliquis 5 mg 2 times a day to treat the pulmonary embolism in her chest.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism in chest was not reported.  The patient had not recovered from tiredness.   This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 39-year-old obese (BMI 40.5 kg/m2) female patient was diagnosed with pulmonary embolism 10 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection.  Concurrent conditions includes  irregular menstruation, schizoaffective disorder, panic attacks, anxiety attacks, depression, incontinence, gastritis, constipation, sciatica nerve pain, asthma, obese, difficulty in comprehension.  Concurrent medications includes ethinylestradiol/ferrous fumarate/norethisterone acetate, salbutamol, lactulose, clozapine, gabapentin, oxybutynin hydrochloride, pantoprazole, risperidone, valproate semisodium, vilazodone hydrochloride, and unspecified breathing treatments.  There was prior history of pulmonary embolism (PE) 9 years prior to vaccination and was advised to be due to obesity and lack of physical activity.  Emergency room consult for leg swelling 10 days after vaccination; diagnosed with PE with radiology and many other unspecified tests; treated with Eliquis.  Th event is confounded by increased risk with prior history of pulmonary embolism, obesity, OCP, and risperidone (class effect).  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information was requested.