Johnson & Johnson

Received COVID-19 Vaccine on 03/08/2021. About 7:00 am the next morning began having N/V x4 past 12 hrs, diarrhea x 6, headache and blood in urine. Chronic illness of stage 4 kidney disease with bilateral nephrostomy and acute bloody discharge, ulcerative colitis with colostomy and acute high output, CAD with 7 cardiac stents and 2 CABG. A&Ox4, Malaise, tachycardia and hypotension, afebrile. Patient reports chronic abdominal pain unchanged today. Denies back pain, chest pain, cough, or SHOB. Afebrile. Patient has new diagnosis of UTI. IV fluids administered, IV Zofran, Meropenem, and po Hydrocodone/APAP. Transferred due to creatinine of 4.3, bloody urine, and UTI. T: 98.1 HR 91, R-14 BP 106/71, O2 sat 97%

PAIN ON RIGHT KIDNEY AREA; MUSCLE CRAMPS ON RIGHT FOOT AND LEFT UPPER THIGH; HOT FLASHES; BACK PAIN; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced hot flashes. On 08-APR-2021, the subject experienced back pain. On 09-APR-2021, the subject experienced pain on right kidney area. On 09-APR-2021, the subject experienced muscle cramps on right foot and left upper thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain on 09-APR-2021, and had not recovered from hot flashes, pain on right kidney area, and muscle cramps on right foot and left upper thigh. This report was non-serious.

2 days post vaccine patient developed lower extremity edema which over the next 3 weeks progressed to anasarca and renal failure requiring hospitalization, renal biopsy and eventual hemodialysis.

Reported by mid Sunday am inability to void or have BM. Stated with temp, chills and feeling clammy that same day. Temp running 101.5. Taking Tylenol. States followed up with PCP on Wednesday 4-7-21 and reported had COVID test done that was negative. Pt's wife called back today and reported still taking Tylenol every 4-6 hours and temps spiking up to 100.9 with clammy skin. Pt reported feeling some better today.

HOT FLUSHES IN THE FACE; A LITTLE DIZZINESS; A LITTLE KIDNEY PAIN ON HIS RIGHT SIDE; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included back fusion, rheumatoid arthritis, and mild high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included etanercept for rheumatoid arthritis. On 06-MAR-2021, the subject experienced hot flushes in the face. On 06-MAR-2021, the subject experienced a little dizziness. On 06-MAR-2021, the subject experienced a little kidney pain on his right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flushes in the face, and a little dizziness on 06-MAR-2021, and a little kidney pain on his right side on 12-MAR-2021. This report was non-serious.

Patient was admitted on 4/9 to hospital with left facial, upper and lower extremity numbness that last 5 min and resolved. In ED had similar symptoms. CT head, MRI brain, MRA head and neck unremarkable. Hgb 6.6 and Plt 13. Transferred to Medical Center on 4/10 for more care. Diagnosed with TIA and possible TTP (ADAMTS13 pending, meets other criteria). Started on high dose methylprednisolone 1000 mg IV x 3 doses on 4/11, plasmapheresis on 4/11, and weekly rituximab on 4/11. Status/outcomes pending

The patient first exhibited diaphoresis, then was thirsty. He was then unresponsive and started seizing, and lost control of his bladder. The seizure lasted approximately 1 minute. Emergency services were contacted, and they assessed the patient after the event. He was released from their care back into the community.

1st day, and 2nd day, slight hearing loss particularly to mens speaking voice on TV. Now gone. 1st night frquent night time urination, now gone.

Flu-like symptoms chills fever up and down shortness of breath itchy skin dry cough shaky hands restless urinating frequently urination blood clotting in calves

In May patient noticed progressive painful lower extremity edema (left greater than right). On June 11, patient came to the hospital with sudden onset dyspnea, palpitations, lightheadedness and dizziness while refereeing a basketball game. Ultrasound of lower extremities found non-occlusive thrombus in the left common and profunda femoral veins/occlusive thrombus throughout the left femoral vein/popliteal vein, and tibioperoneal trunk. Patient started on heparin drip and admitted to stepdown unit for concern of submassive PE given elevated BNP, DVTs, and dyspnea, and confirmed via VQ scan. Patient was transitioned to oral anticoagulation (apixaban). Swelling of legs greatly improved, and dyspnea improved though cough persistent by the time of discharge. Of note, patient also has a history of elevated PSA (to 80s), but patient has not seen urology for follow-up for possible malignancy. Patient also found to have UTI (klebsiella) secondary to his chronic urinary retention.

Pt received the J&J vaccine on Monday 4/12 around 10 am. Reports onset of diarrhea mon night, frequent episodes. Then Tuesday 4/13 developed dysuria, fever/chills, headache, nausea, vomiting. Presented to ED 4/14 and admitted to hospital medicine with acute kidney injury.

Client left message on immunization nurses line 04/13/2021 stating he received J&J vaccine on Friday, and is having a severe reaction, can't eat, drink, breathing problems, hasn't been able to pee for 4-5 days, throwing up and severe diarrhea, and he can't stand. I returned his call and he verbalized all issues above and also said his legs, arms and hands were cramping up and having ringing in the ears. I recommended him to go to the ER now, he said he had called his PCP and was told the same thing. He stated he is single and lives alone and does not drive. I told him to call 911 and he verbalized he is too embarrassed to do that and states he will wait for his daughter to call him. I offered to call his daughter for him and he declined. Addendum: Created by RN. 04/16/2021 02:01 PM 04/16/2021 Client called reporting the same symptoms as in 4/13 message -- I told him to go to the ER immediately. He stated he could not drive due to muscle spasms and feet and leg pain. Asked if he would please call 911 and stated that was not necessary. He verbalized he understood my directions and stated he would go to urgent Care. Called Sheriff office to make a well person check.

LEFT KIDNEY PAIN; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-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 kidney pain. This report was non-serious.

DIARRHEA; CHILLS; UNBREAKABLE FEVER OF 104F; CARDIOGENIC SHOCK; KIDNEY FAILURE; IMPAIRED LIVER FUNCTION; HIGH BLOOD PRESSURE (200/100); ABNORMAL WHITE BLOOD CELL COUNT (16000); BLISTERS ON CONJUNCTIVA OF BOTH EYES; This spontaneous report received from a physician concerned a 63 year old white 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 administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The physician reported that one day after receiving vaccine, on 08-MAY-2021, the patient experienced nausea, vomiting, shortness of breath, diarrhea, fever, chills, sweats, and severe chest pain. The patient was admitted to hospital for suspicion of heart attack. He was checked and no blockages were found. Laboratory data included: Scan (NR: not provided) No blockages were found. On 10-MAY-2021, he was transferred to another hospital where he was currently on a ventilator. The doctor reported that he had had fever of 104 f that was unbreakable. His blood pressure was 200/100 mmHg and his pulse oxygen was not good. His white blood cell count was 16000 and he was tested negative for covid-19. The doctor also reported that patient was in cardiogenic shock and was in kidney failure. He reported that the patient's liver function was getting better and patient's face and chest was very red. The patient also had blisters on conjunctiva of both eyes. It was unknown where patient received the vaccine as of this time. No further information was available since doctor had patients to see. Laboratory data included: Blood pressure (NR: not provided) 200/100 mmHg, Covid-19 virus test (NR: not provided) Negative, Body temperature increased (NR: not provided) 104 f, Pulse Oxygen (NR: not provided) Not good, and White blood cell count (NR: not provided) 16000. The patient was admitted to the hospital on 08-MAY-2021 and the duration of hospitalization was 6 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from impaired liver function, had not recovered from blisters on conjunctiva of both eyes, kidney failure, abnormal white blood cell count (16000), high blood pressure (200/100), cardiogenic shock, and unbreakable fever of 104f, and the outcome of diarrhea and chills was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening).; Sender's Comments: V0: 20210525538-covid-19 vaccine ad26.cov2.s-cardiogenic shock, kidney failure, impaired liver function, high blood pressure (200/100), abnormal white blood cell count (16000), blisters on conjunctiva of both eyes, diarrhea, chills, unbreakable fever of 104f. 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).

Desorientation while working at design work in computer Sudden weight loss -muscle mass Tiredness Extremely often urination Demotivation

Chills, fever 100.1 deg F, headache, stiff neck, loss of appetite, joint and bone pain, sciatica, throbbing kidneys, unable to sleep

Heart rate 186, shortness of breath, profuse sweating. Successfully treated with IV adenosine [ADENOCARD]. Diagnosed as SVT (supra ventricular tachycardia), AKI (acute kidney injury), and dehydration.

HEART ATTACK; COVID-19 PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; ELEVATED CREATININE; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included congestive heart failure. He was sick two weeks prior to hospitalization due to congestive heart failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, 1 total, administered in the beginning of MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included blood pressure and cholesterol medications. On 07-APR-2021, the patient went to the emergency room (ER) and was admitted to the hospital and was diagnosed with COVID-19 pneumonia and heart attack. He had suspected clinical vaccination failure. She reported of a positive COVID-19 test that was taken in the hospital and lab values showed everything as elevated. The reporter (daughter) also stated that her father had no issues with kidneys before but during hospitalization, he had elevated creatinine. During hospitalization, the patient received remdesevir, dexamethasone and was on heparin drip for first 4 days and was on bilevel positive airway pressure (BiPAP) machine and oxygen. He was stable and was going to be discharged from hospital later this afternoon on 13-APR-2021. He was hospitalized for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart attack, and covid-19 pneumonia, and the outcome of elevated creatinine and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused).; Sender's Comments: 20210424651-covid-19 vaccine ad26.cov2.s-Heart attack. This event(s) is considered not related. 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: MEDICAL HISTORY 20210424651-covid-19 vaccine ad26.cov2.s- Covid19 Pneumonia. 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). 20210424651-covid-19 vaccine ad26.cov2.s-Suspected 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

DEHYDRATED; URINARY INCONTINENCE; PLEURISY; CHEST PAIN; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included neck surgery, back surgery, left knee replacement, and covid-19 infection, and concurrent conditions included alcohol consumer, non smoker, and heart patient, and other pre-existing medical conditions included the patient has no known drug allergies and drug illicit use. the patient also had 29 surgeries. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included alprazolam for drug used for unknown indication, apixaban, clopidogrel, lisinopril, metoprolol, ranolazine, rosuvastatin calcium, and . On 31-MAR-2021, the subject experienced pleurisy. On 31-MAR-2021, the subject experienced chest pain. On 01-APR-2021, the subject experienced urinary incontinence. On an unspecified date, the subject experienced dehydrated. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Pleurisy on left lung, and Diagnostic ultrasound (NR: not provided) No abnormal finding. The action taken with covid-19 vaccine was not applicable. The patient recovered from pleurisy, chest pain on APR-2021, and urinary incontinence on 04-MAY-2021, and the outcome of dehydrated was not reported. This report was non-serious.

Approximately ten minutes following vaccination patient decided to check his blood pressure at the automated machine because he didn't feel well. Patient passed out sitting at the machine and lost control of his bladder. Patient's eyes were open and he was making snoring noises. Upon checking pulse, it was faint. Patient was breathing. Team moved patient to lying position on the floor. Pulse became more prominent and patient woke up. EMS arrived and took patient to local hospital for precautionary testing. Patient discharge home 2 hours later.

By 10:00 pm that evening I got Chills, fever, muscle aches, headache, nausea and low back pain. Stayed home from work for 1 or 2 days. Felt better in all ways except my low back got very, very painful. I asked my wife to buy me a walker to take to work because I had difficulty walking the distance from the parking lot to inside my office. Also used the walker at work. My boss said to go home, it looks like you're in pain. Saw Dr. on Monday March 15 because the low back was getting worse. He prescribed muscle relaxors and anti-inflammatory medicine. Called the next day asked for something stronger for pain because worse. Nurse responded to continue on existing meds. Went to Chiropractor on both March 16 and 18 without back pain relief. On March 19 went to urgent care, got X-ray and pain meds. MRI done 2 days later on March 21st which revealed a spinal abcess. Admitted to Hospital, surgery done to remove spinal abcess on March 22. Bacteremia, laminectomies in L3,4,5 S1 to relive spinal cord pressure. Puss had the filled spinal epidural cavity, cultured out as Strep bacteria. Remained hospitalized until April 2nd. Sent home for 1 night then returned to hospital via ambulence the next day April 3rd with 103 degree fever. Discharged April 8th. Readmitted to hospital for 3rd time on April 17 where I remain today with Kidney and liver function problems likely reactions to meds. Continue to have excruciating low back back which is why continues to be hospitalized at the time of this report.

pt says on 4/8/21 he got chills and dry cough. On 4/9/21 day he got body aches and pain w/chills. He had loss of appetite and had no taste. On 4/10 he developed night sweats. By 4/11/21 he was not able to control his bladder. On 4/12/21 he had diarhea. He went to Urgent Care. They did Covid Test, blood work and X-ray w/ negative. He was given a shot of penicillin. He was prescribed Cefuroxime Axetil 200mg. He feels like he is getting better but still has no taste. Pt says he has never felt like this bad in his life.

veins leaking blood under the skin on mt left and right arms the come and go / blood in urine for 3 hours with no stomach or back pains the leaking veins started 2 days after the shot on April 12th continuing to today on different parts of my body / the blood in urine occurred on June 11th

Patient woke up on May 26th being unable to urinate, was urinating blood. Patient was found to have a blood clot in his bladder.

Fever, chills, sore achy joints, night sweats, excessive urination, insomnia. Got some temporary relief with Acetaminophen. Symptoms lasted about 14 hours.

BLOOD IN THE URINE; SHINGLES; RASH LOOKING LIKE SHINGLES; FATIGUE/FEELING TIRED; BAD HEADACHE; LOSS OF APPETITE; FOOD DOES NOT TASTE QUITE WELL; NUMB AREA; ITCHING; FELT LIKE ELECTRIC CURRENT GOING THROUGH; PAIN 24/7; BUMP AND IT SPREAD TO SHOULDER AND IT SEEMED TO AFFECT THE NERVE; DISCHARGE FROM RASH; This spontaneous report received from a patient concerned a 68 year old white, not Hispanic or Latino male. Initial information was processed along with the additional information received on 10-MAY-2021. The patient's height, and weight were not reported. The patient's past medical history included ruptured pancreas for which he had a major surgery, eczema, femoral by pass of the right leg to increase blood flow, and blood in urine (which had occurred due to unspecified medical conditions and was cured), and concurrent conditions included prostate cancer, home bound (got vaccinated at home), and the patient was on foley catheter. The other pre-existing medical conditions included the patient had no known allergies, no history of mumps or chickenpox when he was a child and had not been in contact with anyone having chickenpox. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 06-APR-2021 for prophylactic vaccination. Concomitant medications included triamcinolone for eczema. On an unspecified date in 2020, 6 months ago at the time of reporting, laboratory data included: Blood cholesterol (NR: not provided) unknown, and Lipids (NR: not provided) unknown. On 06-APR-2021, after vaccination the patient experienced bad headache for a couple of days, fatigue/feeling tired, loss of appetite that was still lingering. Per patient the food wasn't tasting quite well. on an unspecified date the patient experienced rash like shingles. On 27-APR-2021, the nurse said that the patient experienced a kind of rash that looked like shingles on left shoulder and left neck and had dark colored urine which indicated blood in urine (patient was on foley catheter). On an unspecified date in 2021, the patient experienced a small bump ( injection site lump) at the site of shot on the left arm which spread to the shoulder and it seemed to affect the nerve, the area was generally numb, itching and electric current going through (electric shock sensation), the pain was 24/7 and discharge from rash. The bumps ruptured easily and the patient was advised not to spread the discharge from rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad headache on 08-APR-2021, was recovering from fatigue/feeling tired, had not recovered from rash looking like shingles on left shoulder and left neck, loss of appetite, blood in the urine, and pain 24/7, and the outcome of numb area, food does not taste quite well, injection site bump spreading to shoulder and affecting the nerve, itching, discharge from rash and felt like electric current going through was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516869-COVID-19 VACCINE AD26.COV2.S-Blood in the urine . 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

Extremely large amounts of bleeding into bladder during the release of kidney stone. Taken to OR for insertion of urethra tube. Follow-up Fragmentation procedure on 6/7/2021 caused large amounts of blood loss and blood clots the size of quarters into the urine. Blood loss and excessive clotting lasted for 5+ days.

Patient developed symptomatic COVID infection with symptoms starting 3/13, was admitted to the hospital for respiratory failure on 3/16 and expired on 3/18/21

- The following message was transmitted to my PCP on Sunday, 04/11/2021, about 11 PM. - Hello, yesterday, Saturday, April 10th, 2021, I received the Janssen (O42A21A) single-dose vaccine around 10 AM. About an hour after arriving home, i started having some of the most common symptoms reported, as in the following: Low-grade fever 99.3', Marked fatigue, mild muscle aches, some dizziness and generalized weakness. Took one 800mg Ibuprofen and rested. Last night, at around 10 PM, I had one episode of hematuria with some visible small-to-medium sized red clots, with no pain or discomfort on urination. Today, in the AM, I took another 800m Additional information for Item 18: 800mg Ibuprofen tablet, and by 12 noon, there was less fatigue and weakness, as I moved on in the day, the other symptoms improved or sub-sided, Except, for some, small clots, in a otherwise normal-appearing colored urine, around 1 PM. My B/P was 148/78, pulse 70, which is normal range for me. Additional information for Item 18: On Monday, 04/12/2021, during the day-time, I again experienced severe-to-moderate fatigue, and some dizziness, and then, last night, at around 7 PM, and 10 PM, I had two separate episode's of hematuria with some visible small-to-medium sized, Dark red clots this time, with no pain or discomfort on urination.

WEAKNESS, ALLERGIES, SICK, COULD NOT SLEEP FOR DAYS, BODY PAIN, THEN I HAVE TO GO TO THE HOSPITAL WITH AN INFECTION. VISITED THE ER.

Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29.

UNABLE TO URINATE AT ALL; BLOOD CLOTS THAT WERE BLOCKING CATHETER; PROSTATE INFLAMMATION/ ENLARGED PROSTATE; This spontaneous report received from a consumer concerned a 71 year old male. The patient's weight was 212 pounds, and height was 182 centimeters. The patient's past medical history included urinary tract infection (UTI), enlarged prostate,. The patient's past medication included shingles vaccine for alpha gal syndrome. Concurrent conditions included kidney stones, alcohol user, non smoker, polyethylene glycol allergy, sulfa allergy, alpha gal syndrome and high uric acid. The patient previously experienced drug allergy when treated with polyethylene glycol for unspecified indication.The patient had no illness at the time of vaccination, no history of drug abuse. Because of the inflammation the stones caused when in the process of being passed, the patient also had occasional issues with an enlarged prostate as well as UTIs as a result of the stones. However, the patient never had his prostate enlarged to the point where he could not urinate as a result of passing stone. The patient has passed a small stone unannounced without symptoms approximately 10 days prior to receiving the COVID vaccine. The patient had no side effects after passing the stone, there was no pain, no dis colouration and no trouble urinating. The patient felt 100% with no after effects that would be attributed to passing the small stone. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and 1805029 expiry: not reported) dose was not reported, administered on 09-MAR-2021 09:30 in left deltoid for prophylactic vaccination. Expiry date was not reported and has been requested. Concomitant medications included allopurinol for high uric acid, and prevention of stones On 10-MAR-2021, 1:00 AM, approximately 15 hours post vaccination the patient experienced pain and trouble urinating. Subsequently, the patient went to urgent care where he was diagnosed with enlarged prostate and sent home. By mid morning, he was unable to urinate at all and went to see the physician. Patient has undergone a bladder scan and catheter was placed. On 10-MAR-2021 01:00, the patient also experienced prostate inflammation/ enlarged prostate On 13-Mar-2021, the patient returned to the emergency room twice for blood clots that were blocking the catheter due to overextension of the bladder. On 18-Mar-2021, the patient returned to the physician, got the catheter removed and scope was performed. The patient was noted to have greatly enlarged prostate gland and the physician allowed him to leave the office without catheter. Several hours later, the patient was unable to urinate once again and went to physician's office and the catheter was put back in for additional two weeks, at the end of that time the patient will be reassessed. Laboratory data included: Prostate examination (NR: not provided) Enlarged prostate. On 18-MAR-2021, Laboratory data included: Ureteroscopy (NR: not provided) prostate greatly enlarged. Treatment medications (dates unspecified) included: finasteride to help with urine flow. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from prostate inflammation/ enlarged prostate, had not recovered from unable to urinate at all, and the outcome of blood clots that were blocking catheter was not reported. This report was serious (Other Medically Important Condition) Additional information was received from consumer on 31-MAR-2021 following information was updated and incorporated into case narrative: Patient demographic details (height, weight, date of birth), patient's past medical history ( urinary tract infection (UTI), enlarged prostate), past medication (shingles vaccine for alpha gal syndrome), concurrent conditions (kidney stones, alcohol user, non smoker, polyethylene glycol allergy, sulfa allergy, alpha gal syndrome and high uric acid), COVID-19 vaccine therapy details (vaccination time), additional event of enlarged prostate, reporter details, lab details were added.; Sender's Comments: V2. Follow up information received regarding Patient demographic details, past medical history, past medication, concurrent conditions, vaccine therapy details, additional events , reporter details, lab details were added . 20210323574-COVID-19 VACCINE AD26.COV2.S- Unable to urinate at all, Prostate inflammation. Follow-up received regarding Clinical Details. 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 .

Two weeks after the shot, he noticed bloody noses, hematuria, ecchymoses all over his abdomen, bruises on the top of his mouth. Fatigue

BACK PAIN IN KIDNEY AREA, BRUISING THAT LOOKS LIKE LIVER SPOTS. REPORTS THAT THIS BEGAN RIGHT AFTER VACCINE.

Starting on 04/13/2021 noticed very easy bruising seems to be improving. Starting 04/16/2021 backache right side near kidney area, still on-going. Starting 04/18/2021 sore on tongue and right inside of mouth.

J&J Dose 4/10/21 (042A21A) COVID Positive 5/10/21 5/10/21: This is a 71-year-old male with history of left CVA, right minimal hemiplegia, diabetes mellitus, hypertension, right lower extremity DVT, depression and obesity. The patient is saying he feels excessively weak and fatigued in the last 2 days for which he decided to come to the emergency room. He denies any shortness of breath, wheezing, cough, chest pain. He is a former smoker and does not know any history of COPD. He thinks he is passing urine regularly. He denies any polyuria, nocturia, difficulty passing urine or any history of BPH. His diabetes was poorly controlled for few years and patient does not know how much insulin he is taking at this time. He took covid 19 vacine on April 10. 5/15/21: Patient was admitted on the 10th with complaints of weakness, fatigue going on for at least 2 days. Patient was diagnosed with COVID-19 positivity. Chest x-ray showed bilateral airspace disease. Patient also had acute renal failure. Patient was given supplemental oxygen, started on IV remdesivir, IV dexamethasone, IV ceftriaxone, and IV Zithromax. The patient's oxygen use was attempted to wean down. Patient finished course of IV remdesivir, ceftriaxone, and Zithromax in the hospital. Renal function improved. Losartan was discontinued in the hospital. Home O2 walk was done today. Patient to finish oral dexamethasone. Home Health services were provided. Discharged home today. Advised to remain in isolation.

Patient had acute onset of low back pain 1.5 weeks prior to presentation on 6/3/2021. This pain and weakness progressed to complete bilateral lower extremity paralysis with loss of bowel and bladder function on 6/09/2021. Patient was seen emergently and found to have critical, bilateral lower extremity ischemia. imaging showed RIGHT RUNOFF: 1)There is abrupt vessel cut off suggestive of acute thrombotic occlusion of the proximal common femoral artery with propagation into the superficial femoral artery and the popliteal artery. On the delayed imaging, small amount of contrast is seen within the severely stenotic popliteal artery and very small amount of contrast is seen in the peroneal artery extending to the ankle suggesting proximal stenosis and extremely slow flow. LEFT IMPRESSION: 2)Abrupt cut off suggestive of acute thrombotic or embolic occlusion identified at the origin of the LEFT common iliac arteries with propagation throughout the LEFT lower extremity down to the popliteal artery. 3)On the delayed phase imaging, tiny wisp of contrast within the severely stenotic popliteal artery identified suggestive of very slow flow. The peroneal artery is also faintly patent on the delayed phase imaging with flow contrast extending to mid calf level. Due to severity of the ischemic limb, patient was offered bilateral above the knee amputations. He declined and will discharge to hospice on 6/12/2021. He is going to die.

DIPLEGIA; ANAL INCONTINENCE; URINARY INCONTINENCE; ASTHENIA; ILIAC ARTERY EMBOLISM; ILIAC ARTERY OCCLUSION; PERIPHERAL ARTERY OCCLUSION; PERIPHERAL ARTERY STENOSIS; PERIPHERAL ARTERIAL OCCLUSIVE DISEASE; PERIPHERAL ARTERY THROMBOSIS; POOR PERIPHERAL CIRCULATION; ANGIOGRAM PERIPHERAL ABNORMAL; COMPUTERISED TOMOGRAM ABDOMEN; COMPUTERISED TOMOGRAM PELVIS ABNORMAL; BACK PAIN; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Report System) concerned a 71 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes type II. The patient experienced drug allergy when treated with acetylsalicylic acid (aspirin), and ibuprofen. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: unknown) dose was not reported, 1 total administered to left arm, on 18-MAR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid/calcium/minerals NOS/retinol/tocopheryl acetate/vitamin B NOS/vitamins NOS/zinc (centrum silver), fish oil, glipizide and lisinopril, all for unknown indications. Patient had acute onset of low back pain 1.5 weeks prior to presentation on 03-JUN-2021. On 09-JUN-2021, this pain and weakness (asthenia) progressed to complete bilateral lower extremity paralysis (diplegia) with loss of bowel function (anal incontinence) and bladder function (urinary incontinence). He was seen emergently and was found to have critical, bilateral lower extremity ischemia. Computerised Tomogram angiography of the abdomen and pelvis revealed: 1. Right runoff: abrupt vessel cut off suggestive of acute thrombotic occlusion of the proximal common femoral artery with propagation into the superficial femoral artery and the popliteal artery. On the delayed imaging a small amount of contrast was seen within the severely stenotic popliteal artery and very small amount of contrast was seen in the peroneal artery extending to the ankle suggesting proximal stenosis and extremely slow flow. 2. Left impression: abrupt cut off suggestive of acute thrombotic or embolic occlusion identified at the origin of the left common iliac arteries (iliac artery embolism, iliac artery occlusion) with propagation throughout the left lower extremity down to the popliteal artery. 3. On the delayed phase imaging, tiny wisp of contrast within the severely stenotic popliteal artery (peripheral artery stenosis) identified suggestive of very slow flow. The peroneal artery is also faintly patent on the delayed phase imaging with flow contrast extending to mid-calf level. Additional events were reported which occurred on an unspecified date in JUN-2021: peripheral arterial occlusive disease, peripheral artery occlusion, peripheral artery stenosis, peripheral artery thrombosis, poor peripheral circulation. The patient was hospitalized for 6 days. Due to severity of the ischemic limbs, he was offered bilateral above the knee amputations. He declined and would discharge from the hospital to hospice on 12-JUN-2021. Report stated "He is going to die." The patient had also visited Emergency Room (ER) for the events anal incontinence, angiogram peripheral abnormal, asthenia, back pain, Computerised Tomogram abdomen, Computerised Tomogram pelvis abnormal, diplegia, iliac artery embolism, iliac artery occlusion, peripheral arterial occlusive disease, peripheral artery occlusion, peripheral artery stenosis, peripheral artery thrombosis, poor peripheral circulation, and urinary incontinence. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anal incontinence, angiogram peripheral abnormal, asthenia, back pain, Computerised Tomogram abdomen, Computerised Tomogram pelvis abnormal, diplegia, iliac artery embolism, iliac artery occlusion, peripheral arterial occlusive disease, peripheral artery occlusion, peripheral artery stenosis, peripheral artery thrombosis, poor peripheral circulation, and urinary incontinence. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). Version created to amend previously reported information on 25/Jun/2021. Upon review, following information was amended: In event tab, for Emergency Room (ER) ticked as 'yes' for all the events and updated same in narrative too.; Sender's Comments: V1 The follow up version updates the following information: In event tab, for Emergency Room (ER) ticked as 'yes' for all the events and updated same in narrative too.The updated information does not change the causality of previously reported events. This case, received from VAERS, concerns a 71 year-old male patient with diabetes, who presented with back pain, weakness, lower extremity paralysis and bowel/bladder incontinence, and was found to have critical lower extremity ischemia, 83 days after receiving the Janssen COVID-19 vaccine. Angiography revealed occlusion of the left iliac and bilateral femoral and popliteal arteries. Events included iliac artery occlusion and embolism, and peripheral artery occlusion, stenosis and thrombosis. No platelet counts were provided. The patient was offered amputations but declined; the events did not resolve and he was discharged to hospice. The vessel stenosis is longstanding in nature and most likely related to his age and diabetes; the embolism/thrombosis may also be related to his chronic condition, and the latency between the events and the vaccine is long. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.

Acute gastro intestinal cramps for 12-18 hours Joint pain in kidney, bank and left hip joints Both reactions were acute on the first day experienced then on more modest basis 2 days later

About 2 weeks after receiving the J&J Covid-19 vaccination, I became ill with confusion, lethargy, and disorientation. Taken to hospital in town to rule out possible CVA. MRI, CT, Carotid sonograms, were all negative. While waiting on lab, the preliminary DX was metabolic Stroke. After all lab returned, the diagnosis was Hemolytic Uremic Syndrome (HUS). Transferred to ICU in different town for dialysis and plasmapheresis. Hospital in another town had closed their department for holiday. I spent about 2 weeks at hospital. My Hgb on admission was 7.0 and kidney function was 20% . the platelets were being destroyed in the glomeruli. Blood transfusion and platelets were contraindicated.

Shortly after vaccine, upper respiratory issue started. Fatigue, falling, soiling bed sheets and pants regularly. Then went to hospital on june 7th with abdominal pain. Low bloid pressure and hight white blood count. Had blood clot. Urinary Infection Possible sepsis. Still in hospital.

BLOOD CLOTS IN URINE; BLOOD IN URINE; STABBING BACKPAIN IN THE KIDNEY AREA ON THE RIGHT SIDE; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 09-JUL-2021) dose was not reported, frequency 1 total administered on 05-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 6-Jun-2021 the patient complaint of a severe headache at 2 am, followed by severe stabbing back pain in the kidney area on the right side and blood in urine. The blood started to clot after an hour. The patient went to the hospital emergency room (ER) twice once at night and the other in the evening. After four days due to persistent clotting, he visited a urologist where a catheter was inserted to help to empty the clots. On 18-Jun-2021, he was admitted to another hospital ER because the bleeding could not be stopped. He was hospitalized for 9 days. In order to stop the bleeding and clotting, a stent was placed in the kidney by a surgeon. On unspecified date in JUN-2021 Laboratory data included: Laboratory test COVID-19 virus test (NR: not provided) negative. The patient was discharged from hospital and came home on 26-Jun-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots in urine, and stabbing backpain in the kidney area on the right side on 26-JUN-2021, and was recovering from blood in urine, and severe headache. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210725558-covid-19 vaccine ad26.cov2.s-Blood clots in urine, Blood in Urine ,Stabbing back pain in the kidney area on the right side. 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).

73 y.o. male former smoker with PMH significant for coronary artery disease with history of CABG in 12/22/2020, hypertension, hyperlipidemia, type 2 diabetes mellitus, GERD, hypertension, non proliferative diabetic retinopathy, sleep apnea presents to emergency room complaining of generalized fatigue and body aches ongoing for 2 weeks. Patient received Johnson and Johnson COVID-19 vaccine 2 weeks ago. Patient denies any fever or chills. Denies any chest pain or shortness of breath. No nausea or vomiting. Poor appetite. Patient had is the cardiac catheterization rehab post CABG, last session was 1 week ago. Denies any sick contacts. ED vitals stable, afebrile. Patient on room air. Labs remarkable for lymphocytes 15.3, monocytes 10.9, glucose 190, BUN 21, creatinine 1.3, sodium 133, potassium 5.3, chloride 97. Lactate normal at 1.6, troponin 14, Last A1c 6.7 from 12/19/2020. EKG no acute ST wave changes EKG changes. CTA chest no pulmonary embolism seen. Patchy airspace disease of the lungs suspicious for mild to moderate bronchopneumonia. Ultrasound Dopplers of the lower extremity right negative for DVT. COVID-19 positive. Patient received Rocephin, Zithromax in ED, ER asked to admit patient the hospital for observation due to ongoing fatigue and body aches from COVID-19 pneumonia.

73 year old male, vaccinated with the Janssen Covid-19 vaccine at the time of hospital admission (5/31/21) for a type 3 odontoid fracture; C2 vertebral body fracture extending into bilateral transverse foramina and nasal bone fracture from a fall from standing. Admitted to the trauma service for pain control. Noted to be somnolent throughout admission. On 6/2, developed AKI, likely related to dehydration vs. contrast nephropathy. On the early morning of 6/3, found unresponsive. Given naloxone 0.02 mg x 3 with no documented response. Transferred to the ICU, intubated and had PEA arrest on induction for intubation. CPR was initiated and he received epi x 1 with ROSC within 3 minutes. Remained intubated and sedated in the ICU with labile pressures on 2 pressors throughout the day on 6/3. The patient expired following compassionate extubation 6/3 2211.

4/6/12 ER HPI: 74 y.o. male who presents with complaint of shortness of breath that is worse after eating for 3 weeks. Patient said he had received a his copied vaccine 3 weeks ago. No cough, no chest pain, no abdominal pain nausea vomiting, no palpitations and no fever or chills Shortness of Breath: Started 3 weeks ago and getting worse. Received covid vaccine 3 weeks ago and started then. No cough. Dyspnea on exertion. No fever. Early am he has had runny noses. No inhalers or nebs. Not smoker

13th of April. I had a blood clot in my hand. My index finger on my left hand was numb and black and blue all around the knuckle area and into my hand area. I went to my primary care - I went to the acute center there. She said the hand was cold and could see the black and blue. They put me on Plavix for 30 days and I haven't had any reoccurrence of that. I think it was the 21st, I couldn't sleep all night, I had a kidney stone - the pain was so bad I got nauseous - around my back and side and in my front. I didn't have a fever. I went to the doctor office and they checked urine - and said there was blood in the urine. I was prescribed - Tamsulosin HCL. They thought I had passed most of it by the time I got there.

74 y.o. male presented to the ER with complaints of right elbow pain and swelling. The nursing home did call the office yesterday requesting for x-ray of the right elbow. Bed x-ray did show an impression of: Unremarkable limited view left elbow without evidence definite fracture or dislocation this was read by the radiologist. Patient did have CT scan right elbow today showed an impression of: Diffuse soft tissue edema prominence subcutaneous soft tissue gas along the dorsum forearm proximally, in no acute pathology or CT evidence of acute osteomyelitis, no vascular pathology. It is noted that patient has swelling, redness pain, and erythema to the right elbow. Upon examination the patient does grimace pain movement of the right level. Patient does have a large pocket of fluid noted to the right medial epicondyle region and to the medial right upper forearm. Skin is hot to touch, but patient's pulses were noted at 2+ 2+, and CMS is less than 3 sec. Patient did also have lab work a white blood count noted of 5 point, hemoglobin is 10.4, hematocrit was 31, platelet count is 201. BMP showed a nonfasting glucose of 107, sodium was 135, calcium 8 1, and his GFR is 84. Patient's sed rate is elevated at 45. Patient's lactic acid noted at 0 4. Patient did also have blood culture in the emergency room and that result is pending. Patient's procalcitonin level is noted at less than 0.00. The patient was started on vancomycin 1 g IV piggyback every 12 hr. Patient was admitted to medical inpatient as it deemed that he will need longer than a 2 midnight stay for monitoring and IV piggyback antibiotics.