Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan, Venous thrombosis, Weight increased
Clinical narrative: THROMBOSIS OF THE RIGHT FEMORAL VEIN; PULMONARY EMBOLISM; PAIN ON RIGHT SIDE OF UPPER ABDOMEN UNDER RIB CAGE WHICH THEN APPEARED ON LEFT SIDE; STOMACH GROWLING; WEIGHT GAIN ABOUT 10 POUNDS; CONSTANT BLOATING; This spontaneous report received from a consumer concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (On DEC-2019 patient quit but started drinking again when COVID hit), smoker (1.5 pack (around 30) cigarettes per day), and asthma. The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, 1 total administered on 23-MAY-2021 to left arm for prophylactic vaccination. Concomitant medications included epinephrine (Primatene Mist) for asthma relief, apixaban (Eliquis), fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (Trilegy Ellipta), and lovastatin. On 28-MAY-2021, the patient experienced difficulty breathing, constant bloating and pain on right side of upper abdomen under rib cage which made his stomach hurt much, but that subsided It was also reported that, the patient had pain at the upper right side of his abdomen, under his rib cage, that started going away but then appeared on his left side. On 01-JUN-2021, the patient had gone cold turkey thinking that his breathing problems were due to that fact that he was smoking. On 08-JUN-2021, one to two weeks after quitting to smoke, the patient experienced weight gain of about 10 pounds. On 12-JUN-2021, the patient was taken to the accident and emergency (A&E) department, was hospitalized and was diagnosed for pulmonary embolism after being seen by a cardiologist, pulmonologist and hematologist. The patient was treated with heparin. On 14-JUN-2021, the patient experienced thrombosis of the right femoral vein. Laboratory data included: Ultrasound scan (Doppler) (NR: not provided) thrombosis of right femoral vein (despite no swollen ankles) and no deep vein thrombosis (DVT) of left leg. On an unspecified date, the patient's upper right abdominal pain had gone away but had appeared on the left side. On 15-JUN-2021, the patient was discharged. The patient hospitalized for 3 days. On 24-SEP-2021, Laboratory data included: Blood test ordered by hematologist, showed presence of protein factor V. On an unspecified date in 2021, the patient was put on anti-reflux medication, even though he had no heartburn. On DEC-2021, the patient had stopped taking the anti-reflux medication. On 15-MAR-2022, the patient experienced stomach growling, which people could hear it from about 10 feet away. The patient stated that he would find it easier to breathe when laying down and that his breathing had not gotten any better. The patient further stated that he believed he was ineligible for the vaccine as he had protein factor 5, and also that his physician thought he had COPD (chronic obstructive pulmonary disease) due to him being an ex-smoker. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach growling, constant bloating, and pulmonary embolism, and the outcome of weight gain about 10 pounds, pain on right side of upper abdomen under rib cage which then appeared on left side and thrombosis of the right femoral vein was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220513847-Covid-19 vaccine ad26.cov2.s-pulmonary embolism, thrombosis of the right femoral vein, pain on right side of upper abdomen under rib cage which then appeared on left side. 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.