Johnson & Johnson

Loss of consciousness Client was said to have  passed out while sitting at the waiting area about 5 minutes after vaccination. He was brought to the First Aid area  on a wheelchair. Client was noted to having urinary incontinence immediately he arrived at the First Aid area. His head was repositioned and ice pack applied to his forehead and client  recuperated and started talking. Duration of witnessed episode lasted for 15 seconds . Patient claimed having similar episodes with last episode occurring 6 years ago while at work. Vital signs was taken, monitored for  additional 30 minutes and was driven home by his significant other. Vital signs recorded Temp: 96.9deg. F; BP: 102/62 MAP: 76; H.Rate: 78; Oxygen sat: 97%.  (Vasovagal syncope). Neurologic: Loss of consciousness (Comment: Patient had Vasovagal reaction with patient having urinary incontinence, lasting for 15 seconds 5 minutes after vaccination. Patient claimed having similar episodes 6 years ago. )

Experienced moderate debilitating flu symptoms day after vaccination and recovered the following day. Over one week later (3/25) developed skin sensitivity on the neck which later spread to back, torso, and legs. Skin sensitivity persists still one week after onset, is a severe chafing feeling when skin comes into contact with clothing. No rash or any visual signs. Along with the skin sensitivity, mild to moderate chills from day to day as well as muscle fatigue and upper/lower back pain. Symptoms varied in severity day to day; used ibuprofen and it seemed to offer limited, temporary relief. Concurrent with second onset of symptoms, noticed gradual abdominal inflammation and developed sensation similar to UTI but urine dip and lab test results were all normal. Doctor concluded immune reaction to vaccine as no other allergies or changes in routine as well as no prior medical history of any of these symptoms. Prescribed daily prednisone for three days to calm immune response; after one day symptoms were greatly improved. Abdominal inflammation has improved and UTI sensation improved. Still experiencing slight chills and skin sensitivity unchanged.

Patient was vaccinated at a pharmacy around 9AM in the morning. An hour later, he was driving on a highway, had a syncopal event and was involved in a single-vehicle MVC where his vehicle struck a guardrail and rolled twice. Patient was brought to the ED at Hospital where he was evaluated by me in the ED. Patient had a normal mental status (GCS 15) and was alert and oriented on exam. He did have some bruising to his forehead from the airbag. Patient denies feeling ill or lightheaded after receiving the vaccine and reports the syncopal event came on very suddenly.

Upon wakening this morning pt reports L arm numbness, tingling and flaccidity. pt walked to kitchen and he began feeling sweaty and hot, the next thing he awoke laying in the floor after passing out . Pt was incontinent of urine during event. He now reports some mild shortness of breath but no acute distress or known injuries from syncope episode. pt advised to go to the ER. Pt's states his wife is on her way home and will drive him to the ER.

Fever of 102, body chills, nausea, headache, body aches, pain in lower back/kidneys, frequent nighttime urination. Headache and body/ kidney aches persisted until 1pm the following day, chills, fever frequent urination, nausea persisted until 7am the following day.

Headache and shooting kidney pain two hours after injection. By that evening, I had severe chills and shivered all night. The next day, the kidney pain turned into a constant ache. Headache worsened. Severe joint pain. Arm/injection site was horribly sore. By 5:00PM I had a 101.2 fever. That (Thursday/next night) evening, I felt much better. Friday morning, I woke up feeling completely normal with only minor pain at injection site.

On April 2, 2021 around 8:00 p.m. I begin having chills, body aches, fever ,nausea, etc. This continued until Monday April 5, 2021, minus the chills. My urine became very dark brown for a few days, then changed to a light pink color.

Patient became pale, diaphoretic, and experienced a syncopal episode, laid flat and then had simple partial seizure lasting 10 seconds, became incontinent, IV started, A and O x4 , transported to hospital via ambulance

Approximately 2 weeks after vaccination, patient diagnosed with UTI. Was prescribed a course of Cephalexin. Patient did not take full course but symptoms resolved one day after initiation. Approximately one week later, he began to experience a metallic taste for about 1.5 days, followed by right sided facial palsy. As of date of this report, facial palsy has not resolved.

Janssen COVID-19 Vaccine EUA I received the dose yesterday in the late morning (around 11:25am PDT), last evening my urine color was changed dramatically to include obvious brown/red. This has continued today, when I urinated this morning, and at approximately the same visible saturation. I have not changed my diet in any significant way. I haven't had any alcohol, if that's relevant, since 04/07.

Received vaccine 3.24.21. Had been incarcerated / in prison system until 4.7.21. Complex past medical history. 4.10.21: Went to ED on 4.10.21 - for hematuria. CHIEF COMPLAINT: BLOOD IN URINE (patient reports hematuria an hour prior to arrival along with spitting up a large clot (hemoptysis). denies rectal bleeding at this time. denies being on a blood thinner. c/o back pain starting a few hours ago. HX aortic aneurysm and scheduled to get surgery in a few weeks. )Urinalysis returned showing moderate amount of blood was 73 RBCs. Patient did not have frank hematuria on specimen. Patient's laboratory work otherwise remains unremarkable. Electrolytes within normal limits. Patient has a stable hemoglobin of 13.8. CT scan showed evidence of acute aortic dissection. There were scattered faint ground-glass opacities along the right upper lobe as well as left upper lobe. COVID-19 testing was added on after results. At this time I do not have a great explanation for the patient's hematuria. I did instructed to follow up with Urology for further evaluation of this. He is hemodynamically stable I do not believe further testing is warranted at this time. Return precautions were discussed including urinary retention, large volume bleeding or any other concerning symptoms. He voiced understanding of this and was discharged stable condition. He was provided a work note as he is on probation and it is for her of his hospitalization at this time. 4.13.21: Went to ED on 4.13.21: CHIEF COMPLAINT: LEG PAIN (pt c.o. right leg swelling/pain that started 3 days ago; had johnson&johnson vaccine on 3/24 and is concerned for blood clots; supposed to have surgery at the end of the month; recently seen for blood in urine; c.o. generalized body aches)42-year-old male presents with right calf pain and reported swelling. On presentation patient is well-appearing and nontoxic, afebrile, hypertensive 134/113 with otherwise normal vital signs. On exam, the patient has no swelling in the bilateral lower extremities, he does have very mild tenderness to palpation in the right posterior proximal calf just below the knee. Remainder of physical examination is otherwise unremarkable. Given history of blood clot and reported right calf pain, right lower extremity duplex venous ultrasound ordered to evaluate for DVT. EKG was obtained on arrival, and showed normal sinus rhythm with no evidence of ST segment elevated for depression, no dysrhythmia, no comparison when compared with prior EKG from July 2019. Right lower extremity ultrasound showed no evidence of DVT. I shared results of the workup with the patient and told him that there is no indication for further workup or treatment at this time. I recommended Tylenol or Motrin as needed for right leg pain. I recommended compression stockings as needed for right leg swelling. I encouraged him to follow up with all specialists physicians as previously scheduled and with his primary care physician as needed. Office visit 4.14.21: Subjective: a 42 yr.. male evaluated with a video visit on 4/14/2021 Currently he complains of headache, hot/cold flashes (no fever), nasal congestion, and Bilat ear pain. R leg is swollen. The symptoms have been present for 2 day(s). Was incarcerated - has been out for about week. He denies a history of chills and fevers He has tried acetaminophen, Flonase for his symptoms. Sick Contacts: none known History is provided by patient There is history of asthma or recurrent respiratory infections. Went to the ER yesterday and 4/10 Had his J&J vaccine: 3/24 COVID19: negative 4/10

Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: patient was given jassen vaccine. during 15 minutes observation. patients appeared to black out for 3 seconds. patient can breath ok. no epipen injection was given. after 30 min. patient is coherent. BP 117/75. normal sinus rythm. 911 was called. Patient stated that he doesnt want to go to the hospital and doing fine. Patient had pee himself.

Cold hands and feet, blood pooling in hands, blurred vision, loss of appetite, palpitations, excessive urination, and pain around left shoulder blade area of back.

In the beginning, my feet and hands had poor circulation and became discolored, cold, and painful (like Reynaud's syndrome). I was able to get the circulation going by exercising. This lasted for a couple of weeks. I had cold sweats and chest discomfort, which I thought were symptoms of WPW. I went to the cardiologist. An EKG was done and I was put on a 2-week halter monitor. Everything checked out as not being a heart issue. Blood tests were done, and the results were normal. After the cold hands symptom, I developed palmar erythema. I also developed a lot of abdominal pain. I became really gassy, and my bowel movements became a light yellow. I had frequent urination. My weight dropped from 191 to 180, and I lost my appetite completely; the appetite loss happened for a week and a half. I had to force myself to eat. My hunger is now back, and I currently weigh 187. The gassiness, yellow stools, abdominal pains, and the frequent have all largely subsided. The stools are now a normal color. The palmar erythema is still present, though.

April 24 rush to ER because of urine retention then april 28 he started with facial paralisis wich the doctor said it was bellpalsy but 1 week after all that he lost all the strenght on his legs he was using Foley cateter sin april 24 thrue may 21 and now he could barely move he has limited balance i have to take him out of bed hold him he could not be seat because he feel sever pain on his legs an feets and sever cramps and tingling

Patient has history of MS well controlled with Cosentix injections. Patient reports approximately one week after taking vaccine he began experiencing pain in his feet and ankles. Reports the pain has ascended to lower back and reports he can no longer lift heavy objects and cannot perform required duties for his occupation. Denies numbness, tingling, burning. Difficulty with walking, especially distances or stairs. Reports pervasive fatigue and sleeping until late in the day but waking up exhausted.

Fever, chills, significant aches in lower back and lower body, weakness, and worst of all, intense headache that dulled after about 24 hours, but has persisted for 4 + days at this point. It is now day 5, and I still feel quite weak and my headache, though getting better, persists. I experienced dizziness on days 1 and 2 that has also dulled, but has not quite fully resolved. Frequent urination on days 1, 2, and 3.

BLOOD CLOTS IN URINE; URINATING BLOOD; FELT ACHY; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25-MAY-2021) dose was not reported, administered, 1 total, to left arm on 19-MAR-2021 around 06:00 PM for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, 12 hours after vaccination patient felt achy which had resolved in 24 hours. On 20-APR-2021, patient experienced blood clots in urine and had urinating blood lasted till evening of same day. The patient visited emergency room for same symptoms and admitted on 20-APR-2021, discharged around noon on same day. The patient was given with IV fluids and no other medications were administered. The patient had undergone blood test, urine analysis, computerized tomography (CT) scan and results were nothing urgent to consult. The patient had planned to do follow-up with urologist on 28-APR-2021. Laboratory data included: Blood test (NR: not provided) negative, computerized tomography (CT) scan (NR: not provided) negative, and Urinalysis (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots in urine, and urinating blood on 20-APR-2021, and felt achy on 21-MAR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: - Covid-19 vaccine .Ad26.Cov2.S- Blood clots in urine . 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).

"Janssen COVID-19 Vaccine EUA" Seven minutes after recieving the vaccination I started to feel light headed so I sat on the floor and notified medical personnel. I then passed out for an unknown amount of time but long enough to urinate on myself. Medical staff put me on a bed and started taking vitals. My Blood pressure was low but had a high heart rate. Medical Personnel called the ER to see if I needed to be transfered but it was reccommended to continue observation. After an hour or two I was released to go home. I felt weak for over a week after the vaccination.

patient received covid vaccine and went to sit out in waiting area. about 5 min later patients eyes rolled back, became unresponsive, was grunting, stiff muscles, and had uncontrolled urination. this continued for a few minutes. was able to get patient on the floor and in doing that he became responsive and alert. patient almost immediately felt fine. paramedics were called and they did check him out but he left without going to the hospital

Felt a little warm for first 30 minutes after receiving the shot at 1015am but then felt fine until about 6pm that same day. At that point, started getting chills, which progressed into mix of chills and hot spells, fever, headache, and frequent urination throughout the night (though was also hydrating a lot). Had fever the next morning still and Diarrhea. Still feel modest headache and chills the next evening (before bed where I had felt the worst overnight the first night of the vaccine) but feeling better than the first night. Per the form I received, I was told to include Janssen COVID-19 Vaccine EUA in this section of the form. I am reporting this on the day after the vaccination, so don't yet know final outcome, but again, improving and don't feel like I need medical attention.

CHRONIC KIDNEY STONES; FEVER; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and smoker, and the patient does not have any no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient did not have any no known previous medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZ1A expiry: not reported) dose was not reported,1 total, administered on 04-JUN-2021 15:00 to left arm as prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021,at 9 PM after 6 hours of vaccination ,patient was feeling sick, he got fever and steadily got worse over 3 days. Patient went back to the normal before fever broke .On 5-JUN-2021 afternoon, he experienced the abdominal pain and pain steadily got worse. Patient experienced the pain in lower abdomen ,groin and shooting down his legs. Pain got worse and spread a little further. On 11-JUN-2021,following week patient went to the doctor. Patient reported that he was going to the doctor 6 to 8 times. Patient went to the hospital to get the ultrasound (NR: not provided) on lower abdomen, groin and chest. Ultrasound test results were normal. Patient had done a CAT scan (computerised tomogram) (NR: not provided) and found the Chronic kidney stone. Patient had the chronic kidney stones and was hospitalized. Patient reported that he was not having kidney stones before the vaccination. Patient did not remember when he went to the hospital. Patient told that he was prescribed with steroid. Patient reported that he had done with first round and at the time of reporting he was on the fourth day of second round. Patient told that, steroid not helped to his symptoms. Patient was also prescribed with muscle relaxer and Percocet as per need. Patient took only 3 pills of Percocet since 3 weeks ago because patient not like to take medicine. On 09-JUL-2021 the patient received the call from hospital to request a MRI on him. Patient reported that he was healthy like a horse before and now he felt like he was ready to die. Patient stated that pain had not recovered . Number of days of hospitalization were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from chronic kidney stones. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210722902-COVID-19 VACCINE AD26.COV2.S-Chronic kidney stones. 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).

Acute saddle pulmonary embolus with acute cor pulmonale diagnosed 4/14/2021. Treated with anticoagulation, now on Eliquis for 6 months.

Stomach pain, extreme diarrhea, nausea. Got so dehydrated they put me an IV fluid at doctor's urgent care walk-in on 6/11/2021. My kidneys were hurting. Ciprofloxacin 500 mg 10 days, 1 tablet by mouth twice a day. Could have been a stomach virus. I still don't feel back to 100%. I still feel a little queasy every now and then. She wanted a stool sample, but I was too dehydrated for that.

Headache, Fever, Chills, Joint Pain, Kidney Region Soreness, Lethargy, Confusion and Difficulty in Expressing Thoughts Very similar to Malaria "type" symptoms without ringing in the ears. (Had malaria in 1997) Symptoms tempered by 40% day two.

Transferred from Hospital on 4/1/21 for fever and altered mental status, suspecting adverse reaction from Janssen COVID vaccine given 3/30/21, symptom onset 3/31/21 morning. Sepsis with unknown source of infection: This is evidenced by leukopenia, tachycardia and fever. Acute metabolic encephalopathy, likely secondary to possible sepsis versus effects of COVID vaccine. Encephalitis and meningitis ruled out. Acute nontraumatic rhabdomyolysis: evidenced by elevated CK levels 1700 on admission, likely secondary to sepsis. Acute renal failure, hypothyroidism, transaminitis, elevated troponin likely associated with rhabdo. On sepsis protocol (vancomycin, meropenem and acyclovir) Disc

My full list of symptoms were: Pins and needle feeling as well as hypersensitivity all over my skin that originated in my lower legs but traveled up my body to include my entire legs, hips, and arms. It was more severe on the left side of my body which is the side I received the vaccine. I did not notice it on my head, face, and upper torso. I had full muscle control but I did have problems with my bladder and bowels. I'm not sure if I could not control them or did not feel them because the sensitivity was high in my hip area but I could not control them fully. No treatment was administered except to wait and see. Three days later and I am improving but not fully recovered yet.

TRANSPARENT URINE; MILD HEADACHE; This spontaneous report received from a consumer concerned a 47 year old male. The patient's concurrent conditions included weight loss, and high blood pressure. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. Concomitant medications included amlodipine/telmisartan for high blood pressure, and empagliflozin/metformin hydrochloride for weight loss. On MAY-2021, the subject experienced mild headache. On 22-MAY-2021, the subject experienced transparent urine. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from transparent urine, and the outcome of mild headache was not reported. This report was non-serious. This case, from the same reporter is linked.

Back inflammation 04/12/2021- present , UTI 04/12/2021- 04/18/2021Bladder infection 04/12/2021-04/18/2021, blurred vision 04/12/2021- present.

Patient said he had a seizure at home in his sleep. He said he wetted his pants and his wife told him he had a seizure. He sought medical attention after and his doctor changed his seizure medications. He is now asked by his doctor not to drive for 2 months

14 days after the injection developed severe headache and fever. Went to ER. More symptoms developed: Severe Numbness from the waste down Severe pins and needles sensation from the waste down Severe Burning sensation from the waste down Severe coldness on feet that has moved up past ankles Unable to urinate Unable to have a bowel moment Blurry vision

The patient is a 49 year old male who has a past medical history significant for bipolar disorder with manic episodes, OSA on CPAP, morbid obesity, HLD, and relapsing remitting MS. Per chart review, patient's MS was initially diagnosed in 2012 on MRI and LP and was on Copaxone for several years but stopped taking in 2017. Symptoms and imaging remained stable through 2019 then patient was lost to follow up until he was seen by Dr. on 4/12/21 who ordered an outpt MRI. Patient had COVID vaccine with Jansen vaccine on 4/10/21. He developed bilateral upper and lower exremity weakness and urinary retention on 4/21/21 which prompted presentation. He came into ED 4/21/21 and had foley placed but removed foley and decided to leave AMA. Returned on 4/22/21 with worsening symptoms and was subsequently admitted. Patient was seen by neurology and started on high dose steroid x5d for MS exacerbation. Initial MRI of the brain obtained on 4/22/21 was notably stable without change in previously described white matter disease. No new lesions to suggest active demyelination. New plaques were noted on MRI C and T spine (4/22/21). It is noted that patient received COVID19 vaccination with J&J vaccine on 4/10/21 and temporal relationship between his acute presentation and recent vaccination was questioned. On 4/30/21, patient developed severe bilateral facial weakness and he additionally was reported to have had an episode of aspiration. Repeat MRI brain on 4/30/21 showed new bilateral facial nerve enhancement. Etiologies could include: GBS, Lyme disease, botulism, neurosarcoidosis, less likely myasthenia gravis. LP was pursued on 5/1/21 which was significant for tube 4 with 136 WBC, 88% lymphocytes, glucose 89, protein 632. Meningitis/encephalitis panel was negative. Lyme CSF was negative, Lyme antibody panel was positive. MuSK antibody negative. ACE blood level normal. Ganglioside antibody panel and myasthenia graivs adult panel pending. He is being treated for Lyme disease with Ceftriaxone 2g IV daily since 5/1/21 with plan for 2-4 week course to cover for Lyme disease. He is still admitted and is still having symptoms of facial palsy as of today (5/4/21)

initially no symptoms until on day 8 after vaccine (1 Jun 2021), rapid onset progressive severe muscular pains in calves, thighs, buttocks and then upper arms. Within 24 hours unable to walk easily. No other symptoms and no physical signs of infection. Urine became dark brown at 24 hours and clinically has myositis with suspected rhabdomyolysis - was admitted for iv fluids and analgesia and is improving clinically but gait still disturbed. No demonstrable weakness and no neuro deficit or symptoms. no other obvious cause for acute myositis so consider ?vaccine related.

Persisted for three days: Arm soreness Headaches Body Aches Tiredness/fatigue These faded and on 4/7/2020, liver began to feel enlarged for two days. This was followed by UTI; pain in kidneys and groin; rigidity, discoloration, and extreme swelling in right testicle; inability to urinate; 100-degree fever. Remains on antibiotic (Keflex 500mg 4/pd) and Flomax. Testicle rigidity & some swelling remain.

starting have shortness of breath/difficulty breathing and back and chest pain. light headed, pain unbearable. Saturday April 23rd Went to er was treated for kidney stones but they could only find one small one, Was sent home with pain medication. Shortness of breath persisted as did bloody cough and pain in chest and all over. Went back to the er on 4/28 as pain was unbearable (chest pain) once given a cat scan and diagnosed with blood clots in my lungs and then an ultra sound and found a blood clot in my leg (just above knee). It is thought that I was mis-diagnosed on the original trip to the er with kidney stones. I have been put on blood thinners and pain medication and will be following up with my doctor.

Acute back pain leading to numbness in both legs causing paralysis in both legs, facial paralysis, blurred and double vision, trouble urinating and having bowel movements. Has been diagnosed with GBS/ Miller-fisher disease.

Patient experience loss of consciousness, diaphoresis, and urinary incontinence within approximately 10 minutes of receiving vaccine. This resolved within minutes of drinking juice and eating snacks.

Patient presented on 4/21 with 2 weeks of generalized fatigue, abdominal pain, and weight loss with multiple lab derangements concerning for acute liver failure. Patient on 4/22 is tachycardic and change in mental status. Acute liver failure likely due alcoholic hepatitis. Cholestatic etiologies will be considered. Acetaminophen toxicity treated with acetylcysteine. Started on methylprednisolone 32 mg daily. RUQ: biliary sludge within gallbladder. No sonographic evidence of acute cholecystitis. Acute respiratory failure secondary to COVID pneumonia. Chest pain and elevated troponins. Alcohol withdrawal on treatment protocol. Sepsis and Community acquired pneumonia. Thrombocytopenia and elevated INR. Macrocytic anemia and AKI.

Patient states that he received Janssen Covid-19 vaccine on 3/31/2021 and was exposed to a covid-19 positive co-worker on 4/2/2021 and tested positive for Covid-19 on 4-10-2021. The patient came to the hospital emergency room via EMS on 4/21/2021 at 0912 complaining of shortness of breath. According to EMS the patient had an O2 saturation of 57% on room air and was place on CPAP, 15 liters, and transported to the ER.

Exactly 11 days after receiving the J&J vaccine my husband developed leg pain in his right lower inner leg, he was taken to the hospital on 04/20/2021 which a ultrasound was completed but resulted no blood clots, no other labs or treatment was performed that day, the next day he developed severe diarrhea and flu like symptoms with continued leg pain and difficulty breathing, He was then rushed to the hospital by ambulance where he was suffering from very low BP 41/31 was the lowest, a line was placed and he was put on pressors to increase his BP. He was transferred to the hospital where he was diagnosed with a flesh eating bacteria in the right leg where the pain was at and Sepsis. He was taken to surgery to debride the right leg and was started on CVVHD because his new kidney was now failing, he eventually was started back on Hemodialysis and taken to surgery 2 more times where he cardiac arrested on the table in surgery and died. A private autopsy is being performed but the preliminary results shows he had multi-system organ failure, including his liver which was NEVER a problem in the past.

Patient was admitted to the hospital on 4/5/2021 for severe AKI with hyperkalemia. Patient had a prolonged hospital course due to kidney failure and AIDS. The patient developed acute respiratory failure on 5/1/21 and was transferred to the ICU, where he was found to be in septic shock. Patient passed away on 5/4/21 at 9:59am

Patient with extensive PMH- rectal adenocarcinoma with colostomy, sacral ulcers, cardiomyopathy, from Nursing Home. Sent from nursing home due to persistent hypotension for 2 days which did not respond to IV fluids, sepsis since patient was tachycardic and hypotensive. Urinalysis positive, sepsis possibly due to urinary tract infection, patient also with bacteremia- gram-negative. Patient still hospitalized on antibiotics.

We were vaccinated on April 2 in the morning. On April 12, 2021 we came home from work in the morning and he complained of numbness in his left. We thought it was related to the weather getting warm and we work the night shift, so he rested and increased his water intake. He was able to go to work on Monday night and return home and continued to rest on Tuesday. On Tuesday, there was no numbness, but there was weakness in both his legs. On Wednesday, he felt weakness throughout his body, especially in his legs. On Thursday, he collapsed. He did not lose consciences but his legs gave out under him and he was not able to get up up. He was taken to the hospital. He was diagnosed with a stroke, increased sugars (diabetes he has never had before), acute kidney injury, and uncontrolled increased blood pressure. He was hospitalized and discharged April 19, 2021. He was readmitted 04/24/2021 for another stroke.

Patient presented to the ED with complaint of abdominal pain and dysuria. Experiencing suprapubic pressure when trying to urinate, only minimal urine would come out. Patient was found to be COVID positive upon admission on 4/24/2021.

Neuropathy, painful burning sensation in feet, restless leg has gotten worse and is all day long. Painful electric shock type pains from feet up calf muscles. Sensation of no circulation in legs when elevated in recliner. Stumbling/tripping, lack of coordination and balance issues. Lack of mental clarity at times. Heart palpitations or PVC sensations. Difficulty urinating, in that the flow stops and starts as if I'm involuntarily doing Koegle exercises.

7/18/2021 Patent presemted to ED with a chief complaint of chest pain for the last 3 days associated with shortness of breath. Refers has been using ibuprofen achieving minimal relief. Received COVID 19 vaccinate in April (Johnson & Johnson). Upon initial evaluation on ED VS: stable. Laboratories revealed elevated creatinine and COVID 19 TEST Positive. EKG: Sinus rhythm, T wave abnormalities. A chest x ray: IMPRESSION: Left lower lung airspace disease. CT angio showed Acute pulmonary embolism, left lower lobe, nonocclusive. COVID-19 infection considered asymptomatic and no treatment required for this. Discharged home on 7/19/21.

LEFT TESTICULAR PAIN; SPINAL PAIN; LEFT KIDNEY PAIN; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes type 2, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043AZA expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced left testicular pain. On 11-APR-2021, the subject experienced spinal pain. On 11-APR-2021, the subject experienced left kidney pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left testicular pain, spinal pain, and left kidney pain. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard operating procedures.

PAIN IN JOINTS; WEAKNESS IN ARMS; BUMPY RASH; SWELLING IN LEFT FOOT AND RIGHT FOOT; ITCHINESS THROUGHOUT BODY; SWELLING OF LEFT AND RIGHT KNEE; FLUCTUATING FEVER; NIGHT SWEATS; HEADACHE; SORE THROAT; UNABLE TO WALK; BREAKOUT ON BACK OF HEAD; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight was 90.71 kilograms, and height was 179.832 centimeters. The patient's pre-existing medical conditions included the patient had no coughing, no nasal conjunction and no upper respiratory symptoms. The patient experienced drug allergy when treated with morphine, and sickness when treated with Demerol (pethidine hydrochloride). The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and cetirizine hydrochloride. On MAY-2021, the subject experienced breakout on back of head. On MAY-2021, the subject experienced sore throat. On MAY-2021, the subject experienced unable to walk. On 21-MAY-2021, the subject experienced night sweats. On 21-MAY-2021, the subject experienced headache. On 23-MAY-2021, the subject experienced swelling in left foot and right foot. On 23-MAY-2021, the subject experienced itchiness throughout body. On 23-MAY-2021, the subject experienced swelling of left and right knee. On 23-MAY-2021, the subject experienced bumpy rash. On 23-MAY-2021, the subject experienced fluctuating fever. Laboratory data included: Body temperature (NR: not provided) 97F to 101 F. On 24-MAY-2021, the subject experienced pain in joints. On 24-MAY-2021, the subject experienced weakness in arms. On 25-MAY-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and Recurrent urinary tract infection (NR: not provided) Negative. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, ibuprofen, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from swelling in left foot and right foot, itchiness throughout body, fluctuating fever, and bumpy rash, and the outcome of headache, night sweats, weakness in arms, pain in joints, swelling of left and right knee, sore throat, unable to walk and breakout on back of head was not reported. This report was non-serious.

For about 14+ hours after, my urine was thicker and a dark yellow in color, most of the time, a lot liker "the first one of the day." Even with good hydration, there was still a light yellow color, not clear, as it should have been. No pain, it smelled a little and I mention this as I've not seen it as a side-effect listed anywhere else.

pt received vaccine on 5/5/2021, shortly thereafter had severe diarrhea/vomiting. came to ER and was admitted on 5/6 @0104. Pt receiving fluids, Zofran, morphine and potassium. Admitted on observation status. Lot number for vaccine 1808980

To begin, I have always been a healthy, middle-aged male, with no history at all of neurological problems. What follows is a comprehensive summary of all that happened to me shortly (7 days) after getting the Janssen COVID vaccine and the supporting documentation to support the diagnosis of my having developed Guillian-Barre' Syndrome (GBS) as a direct and obvious consequence of the vaccine. THURSDAY, 5/13/21: Received the J&J vaccine at 10:00 AM (LOT NUMBER 205A21A). FRIDAY - THURSDAY, 5/13 - 5/20/21: No obvious reaction to the vaccine, at all. FRIDAY, 5/21/21: During the day, I noticed deep-muscle pain/soreness in both shoulders (deltoid muscles) that increased throughout the day. It felt as if I had been doing heavy-weight presses with the resulting soreness. I attributed it to a delayed reaction from the vaccine (as I'd heard muscle pain, particularly in the shoulders, is a common reaction symptom), as I had no injury or other possible cause and chose to ignore it. It may have even started a day or two before Friday, but wasn't of such consequence as for me to recall it; the only vivid memory I have is the discomfort on Friday, 5/21/21. SATURDAY - SUNDAY, 5/22 - 5/23/21: I had continued shoulder pains, but ignored them because they were not acute and just attributed them to a short-term vaccine reaction. MONDAY, 5/24/21: In the evening, while sitting in the bleachers attending a sporting event, I noticed my buttocks was pretty sore. The bleachers are not normally comfortable, but this was a dull, serious ache across my entire buttocks. I didn't know to what to attribute it (not yet at that time associating it with the shoulder pain), so ignored it. In retrospect, I realized later that the soreness I was feeling at that time was similar to the shoulder pain and was the pain felt from a deep numbness across the buttocks, akin to when a body part (hand, foot, etc) "falls asleep" so deeply that it's numb, but is still very, very sore. Later that night, my upper back began to feel sore, from shoulder to shoulder, down to my mid-back. As the night progressed, this pain increased exponentially to a "Level 10", leaving me unable to sleep but in 15-minute increments, wandering the house to find a spot -- sofa, chair, floor, anywhere -- to give me some comfort to sleep; I slept 2 hours, total, that night. The pain across my back felt equivalent to someone beating me with a baseball bat all over my upper back -- it wasn't an acute, localized pain, but very deep and broad across the area. Normally, Aleve quickly resolves any pain issues I have, but overnight, it did nothing to reduce the pain. TUESDAY, 5/25/21: I began to piggyback Aleve and Extra Strength Tylenol, and that seemed to help abate a little of the most intense pain, but it was still painful and precluded sleep and much of my working. I think it was at this time that I began to notice the pain and numbness going beyond my buttocks, down the backs of my legs, and into my feet, leaving my feet (and toes, in particular) numb and tingling. I also began to notice a problem with balance and gross motor controls (stumbling when walking, nearly falling several times in the shower) -- all symptoms I have never experienced in any capacity. Additionally, I had considerable pain down the backs of my legs, leading me to feel as if my calves and hamstrings had been through a heavy workout the day before and desperately needed stretching -- however, any attempts to do so led to excruciating, stabbing pains in those muscles. I also noticed that the pain in my upper back was becoming more acute and localized in my cervical vertebrae area. Having taken care of a father who has had many back surgeries and suspecting I have my own degenerative cervical disc issues (I've had past neck pains), I began to believe that all the pain and numbness throughout my body might be due to a cervical issue (e.g., bulging disc, stenosis, etc), and so tried to treat the area as such, with hot shower, heating pad, better neck support, etc. I continued to piggyback the two pain meds that day, but the upper back and neck pain and numbness and gross motor issues came back in full that night, again leaving me no relief for sleep -- I could only doze in 15-minute increments and found no position or place to sleep that was comfortable; I was in tremendous pain 10) across my entire back and down my legs. By 2:00 AM, I knew there was going to be no relief, and I couldn't wait until the morning; I drove myself to the nearby ER, again still believing/expecting at the time that this was a spinal issue. In the ER, I was met by a PA who reviewed my situation, determined that cervical imaging was unnecessary, and prescribed Percocet. My blood pressure was recorded at 160/94. I was released after two hours and returned home. Despite the meds, I was still in considerable pain that night and found myself unable to sleep in more than 10- to 15-minute increments. WEDNESDAY, 5/26/21: During the day, the Percocet seemed to abate the pain, somewhat, although it tended to flare up much more at night during the prior 2 nights, anyway. However, I noticed I had an upset stomach by midday, and as the day progressed, the pain in my abdomen grew considerably. By the evening, the pain across my abdomen was unbearable, as bad as it was in my back and legs. Late in the evening, I researched Percocet and saw that abdominal pain and nausea are two prominent side effects. I stopped taking the pain medication immediately, knowing that my back pain would return in full through the night; again, I slept in 15-minute increments in considerable back and abdominal pain for a total of about 3 hours. It was also during the day Wednesday that I noticed considerably worse gross motor skills (e.g., walking, ascending/descending stairs, standing up straight, writing), balance, and increased numbness and tingling in my legs, feet, and hands. At one point, I tried to walk by my daughter in a hallway in the house, and in trying to go around her, I fell against the wall. She thought I was joking; I wasn't. It happened several more times that week. Also, this day or the next, I started noticing additional problems with urinating and defecating. It felt as though I had no control over my abdominal muscles, so could not strain or push when going to the bathroom. When trying to have a bowel movement -- and I knew needed to -- I felt as though I had no control to push; when urinating, I had no muscle support for pushing out the urine. THURSDAY, 5/27/21: Still believing these pain, numbness, and other neurological, problems to be related to cervical vertebrae/disc issues, I had an appointment with a spine orthopedist. He ordered cervical X-Rays and confirmed that I do have disc compression/degeneration, but not excessive and nothing that could explain the pain and numbness persisting all over my back, down to my hands, across my buttocks, and down my legs to my feet. The message: the cervical discs were not the problem. This is when I reconsidered all I had been through, tying back to the initial pain I felt in my shoulders the prior Friday. This is when I realized that my body had been reacting to the vaccine. Never before in my life had I had neurological problem. Never before had I experienced pain, numbness, and tingling across my entire body that way, so until that moment, I hadn't considered the vaccine to be a possible vector for all that was going on with me. The coincidence of these events was FAR too great to be anything but a causal relationship. The likelihood of these symptoms arising on their own is infinitesimal in comparison to a causal effect. The vaccine had triggered a serious and painful neurological response in my body. The orthopedist, knowing I had responded poorly to the Percocet, prescribed oxycodone. I took that pain medicine that day and into the evening, but once again, my stomach and abdomen began to bother me and the abdominal pain returned. Once again, I looked at the side effects of the medicine, and the first two I saw were stomach pain and nausea. I stopped taking the pain medicine immediately. That night, I slept a total of 2.5 hours. FRIDAY, 5/28/21: I was still in considerable pain, and that combined with very little sleep (and none of it good) for 4 days led me to having trouble thinking clearly. My wife insisted I needed to go back to the ER in the morning to see what could be going on. My blood pressure upon being seen was initially approximately 185/140, but what was finally recorded after a second test was 191/112. I waited to be seen for about 2 hours, but I finally met with the ER physician and described my history of problems that week, including my then-belief that this was a vaccine reaction. She ordered full bloodwork, chest X-Ray and CT scans (without contrast) of lumbar and thoracic spine and CT scan with contrast of chest/abdomen. Nothing strikingly abnormal was found in these scans, but doctors (ER physician and neurologist) noted bliteral weakness in lower and upper body. The doctors wanted to order MRIs, but I am unable to have an MRI due to a piece of metal in my left eye. The morphine I was administered helped reduce my pain and my blood pressure upon leaving had abated, somewhat (don't recall my final BP). Both doctors seemed not to believe that these symptoms could be the result of an adverse vaccine reaction, but they were unable to explain a cause. On my inquiry, at my friend's recommendation I ask to verify, the neurologist disagreed that these were symptoms of a presentation of Guillian-Barre' Syndrome (GBS). The ER doctor asked if I was interested in being admitted, but I felt some of my more extreme symptoms (blood pressure and pain -- thanks to the morphine) had abated sufficiently to allow me to leave. After 8 hours in the ER, I left and returned home. My numbness, tingling, some pain, balance, and motor skills issues persisted, but were blunted somewhat (probably from the morphine?). It was either this day or the next, that I was standing outside, and knowing I had problems walking and with balance, I decided to try to run a few steps to see how weak my legs were and bad my motor skills and balance were. Immediately, it was clear that things were worse than I had considered. I had very poor control of my legs -- they flew off to the sides, out of control, as I tried to step; I stumbled a couple times and almost fell; and I couldn't proceed in a straight line, veering off at an angle. I earnestly tried several times, with the same results each time. That night, while the pain was still there, it was tolerable enough that I was able to sleep for a total of about 5 hours. SATURDAY, 5/29/21: Early in the AM, I noticed I was unable to smile. Having a friend who had had Bell's Palsy, I recognized the signs immediately. The left side of my face sagged, I was unable to smile (left side of my mouth sagged), and I was unable to close my left eye. My wife took me to the ER, and we were met by the same ER physician who had seen me the day before. She was shocked about my return so soon after my prior visit. My blood pressure, on being admitted, was 151/102, but as with my other visits, asymptomatic other than the problems described before (pain, numbness, and tingling, in my back, arms, legs, and abdomen; gross motor movement; lack of coordination; and lack of clarity in thinking); no other signs of infection or illness. The Dr ordered a CT scan (without contrast) of my head and other bloodwork. Of note, the CK came back at 712 U/L. The CT scan came back normal. Again, I was administered morphine, which abated my pain and allowed me to relax. After 3 hours, I was released, with prescriptions for Amlodipine for the high blood pressure and Prednisone and Valtrex (Valacyclovir) for the Bell's Palsy. The morphine helped reduce my back and abdominal pain and give me some comfort, such that I could sleep another 5 hours that night, although all other symptoms persisted. SUNDAY - WEDNESDAY, 5/30/21 - 6/2/21: I continued to experience the numbness and tingling in my back (primarily), abdomen, legs/feet, and arms/hands, but my severe pain began to abate, such that I could sleep a bit more easily. I taped my eye shut at night, as my Bell's Palsy eyelid would not close fully, and it teared constantly. WEDNESDAY, 6/2/21: Not having a GP, I finally found an Internist to review my case and symptoms, but primarily to extend my meds (Blood Pressure and antiviral and steroid for the Bell's Palsy), as the ER doctor had only given me a 5-day prescription. The doctor review my situation and continued the meds. Having been prompted regularly by my friend to confirm a GBS diagnosis, I asked this doctor about a possible GBS-vaccine link and after a cursory review, he said he did not think so. THURSDAY, 6/3/21: With the weakness in my left eyelid, my desire to find a resolution to it, and my concerns about its effect on my vision, I had an appointment with my opthamologist, who recommended eye drops until the eye improved and instructed me to stop taping the eye shut. She noted no other problems with my vision. FRIDAY - MONDAY, 6/4/21 - 6/7/21: During this time, the medicines for my Bell's Palsy seemed to take effect, and the paralysis symptoms abated mostly (with some residual weakness in my left eyelid). I continued to experience the other neurological symptoms, however. TUESDAY, 6/8/21: Having been unable to get a timely appointment with a trusted neurologist, a friend with a contact at medical school head of neurology was able to get me an appointment with a neurology faculty member. I met with Dr. that afternoon, and he was the first to really listen to the symptoms I had and understand some of the possible triggers and consequences of them. I started the conversation explaining that I'm a reasonable, rational, and science-based person, an engineer by training and career, and that I firmly believed all the symptoms I was presenting were a direct consequence of my getting the vaccine. Additionally, at my friend's continued urging, I asked if these symptoms could point to a Guillian-Barre' diagnosis. He was at first skeptical of my proposition of the vaccine cause, but was quick to say he was glad I had raised the question of GBS, because he had that diagnosis in mind, as I discussed my symptoms. He believed that the symptoms I had and the way and speed with which they had progressed pointed to a likely GBS diagnosis. He scheduled a follow-on appointment to have an Electromyogram (EMG) and Nerve Conduction Study to assess the extent of the neurological damage and prognosis for resolution, as I am unable to get an MRI and he seemed to feel a lumbar puncture was unnecessary. FRIDAY, 6/11/21: I had my scheduled EMG and Nerve Conduction Study with Dr. The results showed some abnormal neuropathy, but mostly normal in my extremities and indicative of some recovery from symptoms. Although I still had considerable numbness, tingling, and some pain down my legs into my feet and down my arms into my hands, my most prevalent issues at that point were numbness and tingling across my entire upper back and abdomen, but the doctor indicated these tests don't identify issues very well, that they are better designed for testing neurological issues in the extremities. We agreed to reconvene over the phone in several weeks, unless problems worsened. TUESDAY, 6/29/21: During a follow-up appointment with the doctor, I indicated that some of my neurological issues were abating and that my blood pressure had returned to near-normal range. My energy was returning to a degree and my motor skills and balance and control had improved. However, I continued to have significant numbness and tingling across my back and abdomen, and of greater concern, I had increasing tingling and pain going down my left arm to my index finger when I stretched out my arm. This was a new symptom and increased in pain in frequency in the following days and raises the question of what other symptoms might arise. AS OF 7/8/21: CURRENT STATUS: I have continued numbness and tingling in my feet and hands and back and abdomen, although they are reduced from their earlier state. However, I have increased shooting pain in my left index finger when stretching out my left arm. Additionally, I have a mild increase in weakness in my left eyelid, after prior improvement from the Bell's Palsy. My dangerously high blood pressure at the early onset of these symptoms has returned to near-normal levels, although my GP continues to keep on blood pressure medicine (Amlodopine) for now. Finally, a lot of the issues I had thinking clearly and regularly making mental mistakes, all noticeable and commented on by my family, have lessened, although I still find myself making mental mistakes and forgetting information that would have been MUCH less likely prior to this adverse GBS event caused by the J&J vaccine.

I experienced pain in my right side of my back. It was not back pain, it felt like my kidney. The intense pain began March 10, on a scale from 1-10, the pain was a 6. I was uncomfortable when I tried to sleep, lasting throughout the day time hours. and lasted until March 15, 2021. I was prescribed Metocabamol and Meloxican. Also, I applied heat which was not affective, ice, worked at 50%.and I used a portable muscle stem for 1-2 hours at a time. This treatment worked the best. doctor diagnosis was a sprain ligaments of lumbar spine.

Janssen COVID-19 Vaccine EUA Fever of 101.3 for over 24 hrs. Only could control with Tylenol. Once I stopped, fever would spike up. Severe joint pain Headache Severe pain at injection site for 48 hours Burning eyes Uncomfortable urination

SMELL OF COVID; TASTE WEIRD; HIP PAIN; MUSCLE ACHES; CHILLS; FEVER; BLOOD IN URINE; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and hyperlipidemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination in right arm. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2020, Laboratory data included: COVID-19 antigen test (NR: not provided) POSITIVE. On NOV-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE. On MAR-2021, the subject experienced blood in urine. On 22-MAR-2021, the subject experienced smell of covid. On 22-MAR-2021, the subject experienced taste weird. On 22-MAR-2021, the subject experienced hip pain. On 22-MAR-2021, the subject experienced muscle aches. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced fever. The patient was recovering from fever, muscle aches, smell of covid, taste weird, and hip pain, had not recovered from blood in urine, and the outcome of chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.

I tested positive for Covid after my J&J vaccine. I had blood in my urine before testing positive to Covid. I had a virtual telemedicine and was told it also probably a bacterial infection in the blood. On 03-14-2021 I was to have knee surgery but had to postponed it due to I having Covid. I tested positive for Covid on 04-01-2021. I was prescribed Doxycycline for ten days. Today I still have blood in my urine ad I have messaged my doctor for a call back.

Johnson & Johnson COVID Vaccine EUA J&J Dose 4/9/21 NOT COVID POSITIVE 5/25/21: The patient is a 55-year-old male presents to the emergency department via EMS today after calling 911 with acute shortness of breath and being found unresponsive and pulseless at home, subsequently requiring cardiopulmonary resuscitation on route to the ED. the patient has a past medical history significant for gout, which he takes indomethacin as needed, and recently went to another state in March. His significant other reports that COVID-19 infection went throughout the house in December, although he did test negative, they believe he had it due to his symptoms. He did have that Johnson and Johnson COVID-19 vaccination at the beginning of April of this year. Apparently the patient was speaking with the 1st responder right up until for minutes prior to EMS arrival and when fire department arrived on the scene the patient was found unresponsive, pulseless, and apneic, and subsequently they performed 1 round of CPR administering epinephrine and Narcan, when the patient regained a pulse. The patient lost a pulse again, requiring subsequent CPR and airway tube was placed. The patient arrived in the ED at 10:02 a.m., epinephrine was administered x7 rounds, patient was intubated with a 7.5 ET tube, Lucas device on patient, at 1053 the patient was awake, opening his eyes, squeezing nursing staff hand. At 10:59 a.m., nursing staff reported patient trying to pull his ET tube out. The patient received at least 1 hour 15 minutes CPR including time on scene, on route to ED, and in ED. At 11:10 a.m. patient's O2 saturation decreased to 79%, patient became diaphoretic with decreased responsiveness. At 11:13 a.m., cardiology was at the bedside. The patient's laboratory studies were significant for platelets 44, INR 1.2, CO2 16, AGAP 24, glucose 475, BUN 17, CR 1.55, ALT 248, AST 274, ALP 123, mg 2.9, lactate 15, troponin negative, 1st ABG: PH 7.11, pCO2 39.4, base excess -17, PO2 46, HC03 12.6, O2 saturation 100%. EKG showed right bundle-branch block with ST elevation in lead 3, V1, V2, V3, and V4 leads with ST depression in 1, aVL, and lead II. Limited stat bedside echo showed akinetic septum and hypokinetic right ventricle. The patient was taken to the cath lab. Dr. completed a pulmonary arteriogram and found bilateral massive emboli subsequently undergoing thrombectomy. Patient was on epinephrine, norepinephrine, IV fluids, heparin, and propofol. The patient was seen postprocedure in the intensive care unit while mechanically ventilated and sedated. The patient's sedation was stopped and the patient woke up, moved all extremities, and followed some commands. The patient's significant other was at the bedside. He is currently on norepinephrine at 20mcg/min, epinephrine 20mcg/min, heparin per PE protocol after receiving bolus in CCL, propofol 25mcg/kg/min, and IV NS fluids. The patient's wife reports that he has a history of chewing tobacco, but quit over 20 years ago. She believes that he has a family history of blood clots in his sister's and maybe his dad, but she is not completely sure about that. 6/8/21: 56-year-old man who called EMS with complaints of acute onset shortness breath, was found unresponsive, apneic and without a pulse on arrival of EMS. ACLS protocol was initiated, he was brought to the emergency department where CPR was continued with Lucas device. He was intubated, required administration of 7 rounds of epinephrine, a total of 1 arm 15 minutes of resuscitation was required prior to return of spontaneous CT circulation. Cardiology was emergently consulted, he was taken to the cath had last cath lab with only mild nonobstructive CAD noted. He then underwent pulmonary angiography with the finding of saddle pulmonary embolism as well as bilateral main pulmonary artery thrombosis. He underwent mechanical thrombectomy of the right and left main pulmonary trunk, right upper middle old and lower lobe pulmonary artery, left lower lobe pulmonary artery. Therapeutic anticoagulation was initiated with IV heparin then transition to oral Eliquis. He was treated with empiric antibiotic therapy for presumed aspiration pneumonia. Tunneled hemodialysis catheter was placed secondary to legal Rhea and acute kidney injury, renal replacement therapy was initiated with CRRT. Clinical response was favorable, he was subsequently extubated and transitioned to intermittent hemodialysis. He was assessed by Physical and Occupational therapy and recommended for acute rehabilitation placement. His been discharged today in stable medical condition to continue hemodialysis as scheduled per Nephrology at the acute rehabilitation unit.

USING WHEELCHAIR; FEEL LIKE COMPLETELY FULL BLADDER; URINATES 5 OR 6 TIMES IN THE LAST HOUR; SLUGGISH; MULTIPLE SCLEROSIS; PROBLEMS STANDING UP; This spontaneous report received from a consumer concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and no alcohol user, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. patient had no any side effect from a previous vaccine in the past. he had cold as a cucumber and temperature is in normal range. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 expiry: 04-AUG-2021) dose was not reported, administered on 24-JUN-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced multiple sclerosis, experienced problems standing up and sluggish. On 26-JUN-2021, the subject experienced feel like completely full bladder, urinates 5 or 6 times in the last hour, using wheelchair. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Normal. Treatment medications (dates unspecified) included: fampridine, and teriflunomide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sluggish, had not recovered from problems standing up, feel like completely full bladder, and urinates 5 or 6 times in the last hour, and the outcome of using wheelchair and multiple sclerosis was unknown. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210660422-COVID-19 VACCINE AD26.COV2.S-Multiple sclerosis. 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)

Adverse Events: Headache, Fever, Diarrhea, Nasal Congestion, Leg Pain, Weakness, Paralysis Dx. Guillain Barre Treatment: Immunoglobulin, Sodium Chloride 0.9%, Respiratory Bypass, Oxygen Outcomes: Patient actually in Intensive Care Unit at Hospital receiving treatment. Continue with oxygen by nasal cannula, whole body paralysis with urinary and feccal incontinence (foley and diaper). Symptoms begin since June 10,2021. Admission to Hospital on June 17, 2021 to present.

May 29, 2021 Kidney infection. Back pain, blood in urine. Hospitalized for three days treated with antibiotics. Continued antibiotics for three days after discharge.

Headache, 100 degree temp, aches, joint pain that includes neck, shoulders, knees, ankles and fingers. Cramps in legs. Skin sore to touch almost felt like sunburn. Gastrointestinal discomfort that included loose stools and gas. Frequent urination possibly due to water intake, but was unusual. Fever lasted about 24 hours. All symptoms starting to subside around the 24 hour mark.

Patient received his J&J vaccine on 3/19/21 at at outside location. Patient was admitted to the hospital for acute urinary retention on 4/7/21 and had a catheter placed via cystoscopy. He was discharged on 4/8/21. On 4/14/21 he presented to the ED with chest pressure/palpitations/dizziness. He stated that he has had chest pressure for 1 week prior to the this. CT revealed a saddle pulmonary embolism. he was admitted to the hospital for further work-up and treatment.

4/17/21 ER HPI: 56 y.o. male who presents with asymptomatic tachycardia. The patient purchased a home blood pressure monitoring device approximately 2 weeks ago and at that time he noted that the machine recorded his pulse at 150-160 beats per minute. The patient has repeatedly taking his blood pressure at home with this device and every time and has recorded his pulse in the same range. He denies fevers chills chest pain palpitations syncope lightheadedness peripheral edema or dyspnea. He presents today for evaluation of this as the machine again indicated that his pulse was 100 50-160 beats per minute

Patient received Jassen vaccine 4/10/21. 4/11/21 began with symptoms of fever, headache, chills, nausea, vomiting, and diarrhea, loss of taste and smell. 4/15/21 he presented to ED with symptoms of fever, chest pain and pressure, shortness o breath, myalgias, headache, tachypnea, tachycardia, hypoxia. Was given IV Decadron, DuoNeb and albuerol in ED. Inprovment seen, but patient continued with tachypnea and difficulty breathing. He was admitted to ED with a diagnosis of COVID 19 , asthma exacerbation and elevated Troponin at 31.52 (Ref Range 19) . During admission, glucose levels were labile, requiring adjustment to routine insulin regimen and Glucovance for hypoglycemia. An Echocardiogram was ordered due to elevated Troponin levels on admission. Echocardiogram 4/19/21 showed a density in the right atrium. Cardiology recommended a cardiac MRI. Patient was transfered to Hospital 4/19/21 for elevated care and evaluation, with diagnosis of

Tingling, thoracic sensory level loss, urinary retention. CSF protein elevated to 90. Started approximately 3 weeks from time of vaccine. Drug store provided vaccine 04/06/2021 Admitted to hospital 04/27/21

Fevers started on Wednesday evening, April 14th. Over the next three to four days, the fevers and chills continuously got worse. Patient experienced fatigue, congestion, headaches, sore throat, body aches, neck pain. Conducted a televisit on Sunday, April 18th, and then went into the doctor on Monday, April 19th. The day of the doctor appointment, the patient could not get out of bed and could not stand for longer than 15 minutes at a time before extreme fatigue set in. Blood tests were taken at the doctor, a Z-pack was prescribed. The evening of the 19th, the doctor called after hour to send patient to emergency room to be admitted to hospital. Patient went immediately to Medical Center at which point, the patient was admitted for the next 19 days. The patient was released from the hospital on Saturday, May 8th. While in the hospital, the patient saw almost every "category" of doctor possible. Patient experienced fevers every night for 15 days straight, and after release from the hospital and "fever free for 4-5 days, experienced fevers again for the next week. Doctors were unable for the first two and a half weeks of hospitalization to draw a conclusion about what was the cause of the sepsis (systemic). Patient received daily blood tests, MRIs, CAT scans, spinal tap, bone marrow biopsy, echocardiogram, etc. Patient spent the first two and a half weeks on an antibiotic, antifungal, and antiviral. The "final" diagnosis, which is still not confirmed, as histoplasmosis, which per the doctor would not have placed the patient in the hospital. Determined the fevers were officially "fevers of unknown origin" with a diagnosis of MIS-A and a vaccine contributing factor. Medication put patient in kidney failure and did not address the fevers (patient had fevers of 103+ for 25+ days in a row). On May 27th, doctors are conducing new fungal tests and patient is discontinuing antifungal medication because of severe liver damage. Patient was not and is not in a situation where histoplasmosis is a logical conclusion based on the patient's daily activities.

Extreme lower Extremity pain; like running a marathon; Red swollen lumps in legs; fever; chills and sweats This has been currently going on for 12 days with fever everyday up to 103

LEFT EYE TRAUMA/ CATARACT; RASH ALL OVER BODY ARM/ECZEMA; SHOULDER PAIN/SORENES/WOUND; BLOOD SUGAR ABNORMAL 319; URINATION PROBLEM; MALE GLAND (REALLY BIG) WAS SWOLLEN/ RED; FEELING OF PASSING; LIGHT HEADACHE; WEAKNESS; This spontaneous report received from a patient concerned a 57 years old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes (did not take any medication). Patient was assaulted before getting the Covid-19 vaccine and was cut in the neck and needed blood transfusion last OCT-2020. Patient got several vaccinations. Last vaccination he received was in 1980. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, 1 day after vaccination, patient experienced light headache, feeling of passing and weakness. On 11-APR-2021, after 2-3 days of vaccination, patient was suffering from urination problem which included swollen male gland/ redness (peeling of the skin /flesh is visible /getting worse) and pain during urination. He had pain upon pulling back his foreskin (he was not circumcised and never had such problems). On unspecified day, he had trouble in vision. He visited two doctors regarding the problem who stated that patient had left eye trauma (cataract). On unspecified date. he also had rashes all over the body (specifically arms) referred as eczema. On an unspecified date, he had shoulder pain/soreness/wound on both shoulders right as well left. Skin of the left shoulder was peeled and flesh was visible. He stated that peeling of the skin was moving towards the back of his shoulder and was getting worse. He had tattoos on his left and right shoulder/arm. As per patient, he was given a lot of shots in his right during his profession. Patient has abnormal blood sugar level. On 23-APR-2021, Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) 319. Treatment medications (dates unspecified) included: bismuth subsalicylate and took 7 up to alleviate symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left eye trauma/ cataract, urination problem, rash all over body arm/eczema, weakness, feeling of passing, light headache, and male gland (really big) was swollen/ red, and the outcome of shoulder pain/sorenes/wound and blood sugar abnormal 319 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210448488 - COVID-19 VACCINE AD26.COV2.S - left eye trauma / cataract . 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). 20210448488-COVID-19 VACCINE AD26.COV2.S-BLOOD SUGAR ABNORMAL 319 .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: MEDICAL HISTORY, UNDERLYING DISEASE

3/24/21 ER HPI: 58 y.o. male who presents with shortness of breath, palpitations, chest pressure, and hemoptysis. Patient has known history of atrial fibrillation and coronary artery disease. Patient reports he was out in his yard approximately 1 hour ago this evening picking up some items when he bent over and started feeling palpitations. Patient states the palpitations caused a pressure in the center of his chest. He then became short of breath. He then states he got into a coughing fit and coughed up some blood. Patient states he knew something was not right so he told his wife to bring him to the ER. Currently here in ER patient continues to complain of palpitations and trash pressure. Patient currently gives his pain as 6/10. It is nonradiating. Patient reports shortness of breath but denies any lightheadedness, dizziness, nausea, vomiting, or diaphoresis. Of note, patient reports he has been having acid reflux and belching tonight. He states his wife had given him two Pepcid earlier.

BLOOD IN URINE; ABDOMINAL PAIN; ACUTE,SHARP STOMACH PAIN; INDIGESTION; ARM SORENESS; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and other pre-existing medical conditions included had no medical history except back surgery in 1999 and no concurrent medications. no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 28-FEB-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced fatigue. On 29-MAR-2021, the subject experienced arm soreness. On 02-APR-2021, the subject experienced blood in urine. On 02-APR-2021, the subject experienced abdominal pain. On 02-APR-2021, the subject experienced acute, sharp stomach pain. On 02-APR-2021, the subject experienced indigestion. On 13-APR-2021, Laboratory data included: CT scan (NR: not provided) results came back clear., and Prostate examination (NR: not provided) results came back clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm soreness, chills, and fatigue, had not recovered from blood in urine, abdominal pain, and acute, sharp stomach pain, and the outcome of indigestion was not reported. This report was non-serious.

Johnson and Johnson Vaccine, shortness of breath, elevated blood pressure, elevated temperature, increased heart rate, decreased kidney functions, blood clots in both arms and jugular vein, slurred speech, severe pain in right side, fluid in right lung and around heart. Admitted to MICU from emergency room. Intubated for 12 days. Chest tubes both sides, central line, Hickman Catheter. Discharged and admitted to hospital. Currently home receiving outpatient therapy.

Injection recieved 4/10/21, a-fib started 5/16/21. Admitted to hospital 6/19/21 with sepsis syndrome in the mechanical cardiac valve, leukipenia, thrombocytopenia, encephalopaty, acute kidney injury, respiratory failure, tachycardia, new onset afib. Patient is currently still hospitalized and declining in status- on ventalator

severe ABD pain and chest pains that started 3-4 days after vaccine given, UA, CMP, CBC, US of ABD and CT ABD done, treated for mild UTI, s/sx did not improve,

No symptoms other than just a mild injection site pain. Didn't last long. On 5th of April I began to get: I had rigors (shaking, chills), sweats at night 3 or 4 times of night changes of bedding, acute Prostatitis and pain upon urination and pain from prostrate itself. fever spike as high as 102.2 and my blood cultures were positive for Staphauereus in my blood stream. Sepsis diagnosis. I was admitted to hospital on 7th April of Hospital I had a fever of 102. My prostate was enlarged to 131 grams and I was having difficulty urinating. The infection was Staphaureus Staphlicottis. I was initially treated at a walk-in clinic and they did a direct admit to the hospital for UT .and I stayed there for 7 days. They installed a PICC line for IV upper arm to vena cava up into my heart. I still have that in - for intravenous home infusions of antibiotic. Peripheral Inserted central Catheter. Up until Sunday, May 16, of this past week, I had extreme fatigue to the point of not being able to walk a normal amount for me - maybe 1/3 of the amount. I haven't been able to get back to my regular exercise. I was having headaches and brain fog and a lot of aches and pains throughout the body up until Sunday. Since then I have felt quite a bit better.

CONSTIPATION; LETHARGY; COLD; SWEATING; MUSCLE WEAKNESS; CHILLS; MUSCLE ACHES/MYALGIA; FEVER; DARKLY COLOURED URINE; TREMOR; TINNITUS; LOSS OF APPETITE; STUFFINESS; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included knee pain, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and he consumed alcohol no more than 2-3 drinks at any one time. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included celecoxib for knee pain, and minerals nos/vitamins nos. On 19-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 24-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE. On 30-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On MAY-2021, the subject experienced stuffiness. Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 F. Treatment medications included: paracetamol. On 06-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 09-MAY-2021, the subject experienced darkly coloured urine. On 09-MAY-2021, the subject experienced tremor. On 09-MAY-2021, the subject experienced tinnitus. On 09-MAY-2021, the subject experienced loss of appetite. On 09-MAY-2021, the subject experienced constipation. On 09-MAY-2021, the subject experienced lethargy. On 09-MAY-2021, the subject experienced cold. On 09-MAY-2021, the subject experienced sweating. On 09-MAY-2021, the subject experienced muscle weakness. On 09-MAY-2021, the subject experienced chills. On 09-MAY-2021, the subject experienced muscle aches/myalgia. On 09-MAY-2021, the subject experienced fever. On 12-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 13-MAY-2021, treatment medications included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from darkly coloured urine on 15-MAY-2021, tremor, tinnitus, loss of appetite, constipation, lethargy, cold, sweating, muscle weakness, chills, muscle aches/myalgia, and fever on 17-MAY-2021, and stuffiness on MAY-2021. This report was non-serious.

Pt was hospitalized from 6/3-6/7 for severe hypercalcemia and diagnosed with diffuse metastatic renal cell cancer. He received his J and J vaccine on 5/14/21 and reported "everything went to downhill" with development of nausea, constipation, weight loss, weakness, poor appetite resulting in hospitalization with new severe hypercalcemia and acute functional decline and dx with metastatic renal cell cancer. pt was dx with a bladder tumor 3/19, underwent TURP with bladder biopsy and fulguration and cyctoscopy on 5/19/21. Prostate bx reveals benign nodular hyperplasia, bladder bx revealed urothelial dysplasia felt to be pre neoplastic. Urine Cytology from 4/14/21 negative for high grade urothelial cardinoma. with pamidronate treatment, lasix and ivf and calcitonin his hypercalcemia improved and he was discharged to follow up with oncology and urology as out pt. He has since been readmitted on 6/22/21 with recurrent hypercalcemia and progressive decline. biopsy with I.R. of left renal mass confirmed RCC, biopsy of LN was non-diagnostic. per urology: Given the small size of the renal mass, it would be surprising if this was truly metastatic RCC, this could be metastatic urothelial carcinoma given his history of high grade T1 disease, although the primary site and the urinary tract has presumably been eradicated of disease, metastatic disease prior to initial tumor eradication in the bladder remains a possibility.

Other than mild flu-like symptoms a few hours after receiving the vaccine, on the following day and the next I was almost unable to urinate and ended up needing antibiotic for prostatitis which I am still dealing with 2 weeks later. I do have a prostate condition, but had been manageable on tamsulosin, and it was obvious the shot affected almost immediately my ability to urinate and I?m still recovering from it over two weeks later.