Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Lacrimation increased, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: PULMONARY EMBOLISM IN RIGHT AND LEFT LUNG; CONFIRMED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; EXTREME WEIGHT LOSS; HALLUCINATING; ASTHMA LIKE SYMPTOMS; VARICOSE VEINS IN RIGHT AND LEFT CALVES; FEVER 104 F; BURNING SENSATION IN VEIN; This spontaneous report received from a patient concerned a 53 year old  The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, diabetic, high blood pressure, and gout, and other pre-existing medical conditions included: Patient had complications due to a flu vaccine in the past. The patient was previously treated with glipizide, empagliflozin, dulaglutide, carvedilol and allopurinol for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: unknown) dose was not reported, 1 total, administered on 07-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the after vaccination the patient had to be observed for the full 15 minutes and then was admitted to the emergency room for 30 minutes due to a burning sensation in his veins. On 08-APR-2021, patient had to get admitted to the emergency room again via ambulance ride for a fever of 104 F. Patient stated that in the emergency room he was given tylenol and other anti inflammatories which helped to bring the fever down. Patient reported that he might have been hallucinating because the police found him in the hospital parking lot wondering around. On 20-APR-2021, patient went to see a specialist who diagnosed him with varicose veins in his right and left calves and the patient was referred to his primary care physician. On unspecified date in JUL-2021, patient started experiencing asthma like symptoms, patient had to go to the emergency room due to the asthma like symptoms where they gave him an albuterol inhaler which he stated seemed to help with his symptoms. Patient stated that he started to experience extreme weight loss. On 06-AUG-2021, patient reported that he continued to have the difficulty breathing and continued to seek a prescription for an albuterol inhaler. On 13-AUG-2021, his oxygen saturation level dropped and he had to take an ambulance to the emergency room. Computed tomography (CAT) scan was performed and it was found that he had a pulmonary embolism in his left lung and repeated the Computed tomography (CAT) scan on the 18-AUG-2021 which revealed small clusters of clots in the right lung. On 13-AUG-2021, patient was started on Lovenox and then switched to Eliquis on 01-SEP-2021 by his pulmonologist. Patient stated that during his admission to the emergency room, nasal swabs was performed of both his nasal passages and also a blood work test confirmed that he was positive for the delta variant of Covid-19. Patient was not able to distinguish if it was antigen or antibody or polymerase chain reaction test based but did state that his doctors informed him he was positive for delta variant Covid-19 even though he received vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning sensation in vein, fever 104 F, hallucinating, varicose veins in right and left calves, asthma like symptoms, extreme weight loss, covid-19 infection, confirmed clinical vaccination failure, and pulmonary embolism in right and left lung was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000197999.; Sender's Comments: V0: 20211033738-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS  20211033738-covid-19 vaccine ad26.cov2.s-pulmonary embolism in right and left lung, covid-19 infection, Hallucinating. 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).