Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Candida infection, Gait disturbance, Laryngeal oedema, Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; BLOOD CLOT IN LUNGS; EDEMA IN HER VOCAL CORDS; ORAL THRUSH, THAT SPREAD TO ESOPHAGUS AND ALL OVER BODY AND INTO HER LUNGS; TROUBLE WALKING DOWN THE STAIRS/CAN NOT WALK; BODY IS WEAK; This spontaneous report received from a consumer concerned an adult white female of an unspecified ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: neck surgery, and concurrent conditions included: COPD (Chronic obstructive pulmonary disease), alcohol consumer, and smoker. The patient had no known drug allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, frequency time 1 total was administered on JUN-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Reporter stated that, the patient was fine at the first. On an unspecified date, (couple of weeks later) the patient had difficulty breathing and trouble walking down the stairs and patient's throat was swollen (edema in her vocal cords). Patient went to the emergency room (ER) few times at night. At the ER, patient was treated with the Medrol IV (intravenous)- (methylprednisolone) and sent back to home with steroid as they thought it was from the edema and they did not checked if she had blood clots. Within a month after getting the vaccine, patient had difficulty breathing again but she didn't go get checked. Patient started experiencing oral thrush, that spreads to her esophagus and all over her body. It went through her body, esophagus then into her lung. She went to the hospital and there she was diagnosed with the blood clot in her lungs and pulmonary embolism. She was on the ventilator and incubated in the hospital for 9 to 10 days. She was off ventilator now and was discharged from hospital to rehab. Her body became weak because she was on ventilator for longer time. She would be able to came home once she could walk again. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pulmonary embolism (difficulty breathing), and blood clot in lungs, had not recovered from trouble walking down the stairs/can not walk, and body became weak, and the outcome of oral thrush, that spread to esophagus and all over body and into her lungs and her throat was swollen (edema in her vocal cords) was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: 20210958344-covid-19 vaccine ad26.cov2.s-Pulmonary embolism, blood clot in lungs, edema in her vocal cords, oral thrush that spread to esophagus and all over body and into her lungs, trouble walking down the stairs/can not walk. This event(s) is considered unassessable. 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).  20210958344-covid-19 vaccine ad26.cov2.s- body is weak. This event(s) is labeled per RSI and is therefore considered potentially related.