Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder, Insomnia, Lung disorder, Malaise, Peripheral swelling
Clinical narrative: HIGH BLOOD PRESSURE; TIRED IN LUNGS; TROUBLE SLEEPING; BELLY FELT STIFF; AFFECTED APPETITE; SWELLING IN FOOT; DISCOMFORT; GOING TO PASS OUT; SHOTS CREATED A LOT OF MESS IN MY IMMUNE SYSTEM; VOMITED ALL NIGHT SEVEN TIMES; HIGH FEVER; BLEEDING THROUGH RECTUM; DIABETES; BLEEDING THROUGH NOSE; RINGING IN EARS; FEELS LIKE HE MIGHT DIE, HIS BODY DOES NOT HAVE ANYTHING LEFT FOR HIM; NOT FEELING WELL AFTER TAKING THE SHOT; WEAKNESS FOR EIGHT MONTHS; VACCINE DID NOT WORK; This spontaneous report received from a patient via a company representative concerned a 54 year old male of unspecified race and ethnic origin. Initial information was processed along with additional information on 16-AUG-2022. The patient's height, and weight were not reported. The patient's past medical history included: patient had motorcycle accident, broke leg in 32 places and lost eye in 1996, and other pre-existing medical conditions included: Patient was never sick. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 29-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 54 years old. No concomitant medications were reported.  On an unspecified date in MAR-2021 about 1.5 years ago, the patient experienced bleeding through nose and ringing in ears. On an unspecified date, the patient experienced high fever that lasted for 4-5 days, vomited all night in room for 7 times that lasted 12 hours, belly felt stiff, trouble regaining strengths and after 6 weeks, patient recovered his strength. Patient was not feeling well after taking the shot. Patient had trouble sleeping, a lot of bleeding through rectum, so sad, shots created a lot of mess in my immune system, affected appetite, weak for 8 months. Patient was so sad and stated that shots created a lot of mess in his immune system. Patient felt like he might die, his body did not have anything left for him, patient reported that on an unspecified date he was going to pass out because his blood was draining from his nose. Patient experienced high blood pressure, diabetes, swelling in foot, discomfort and tired lungs and was hospitalized. The patient was bleeding through nose and rectum daily. Patient stated that, the vaccine damaged me and my body/physical, lost good jobs (at the fire department), bleeding through nose and rectum daily. The patient did not know if he will make it next month. Every time tried to get my strength he could not get his strength. He was dead, he was not feeling well. The vaccine didn't work. On an unspecified date in JUL-2022, three weeks ago, the patient was admitted for 12 or 13 days. Patient was admitted to the hospital at the time of reporting. Patient was still experiencing the symptoms and stated that symptoms had worsened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomited all night seven times, high fever, and weakness for eight months, had not recovered from bleeding through nose, ringing in ears, trouble sleeping, belly felt stiff, bleeding through rectum, affected appetite, high blood pressure, diabetes, swelling in foot, discomfort, and tired in lungs, and the outcome of vaccine did not work, going to pass out, not feeling well after taking the shot, feels like he might die, his body does not have anything left for him and shots created a lot of mess in my immune system was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20220830199. This report was associated with a product quality complaint.; Sender's Comments: V0: 20220830167-covid-19 vaccine ad26.cov2.s- ringing in ears, vomited all night seven times, high fever. This event(s) is labeled per Database and is therefore considered potentially related.  20220830167-covid-19 vaccine ad26.cov2.s-bleeding through rectum, diabetes, bleeding through nose,  high blood pressure,  tired in lungs, trouble sleeping, belly felt stiff, affected appetite, swelling in foot, discomfort, going to pass out, shots created a lot of mess in my immune system. The event(s) has an unknown/unclear 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.  20220830167-covid-19 vaccine ad26.cov2.s-vaccine did not work. The event(s) has an unknown/unclear 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. Therefore, this event(s) is considered not related.