Johnson & Johnson

3/22/21: Vaccine administered 4:45 pm. Burning sensation on arms and legs began about 2 hrs later. Achy and feeling cold about 2 hrs after that. Then headache, shaking, muscles quivering, fever, weakness, some itchy spots, increased urination throughout next several hours. Fitbit showed elevated heart rate for several hours. 3/23/21: Nausea and vomiting. Could not keep water down. Very weak/shaky. That night, went to ED. Treated for dehydration and allergic reaction. 3/24/21: Able to tolerate clear liquids. Still weak. 3/26/21: Woke up with rash on both legs (small bumps, not itchy). Added bread to diet. Still weak. 3/29/21: Low grade fever, strong pain in right side of lower back.

The patient had burning sensations and increased urination symptoms consistent with a possible urinary tract infection prior to the vaccination that took place on 2 April 2021. A urinary culture was negative on 31 March 2021. A few days after the vaccination, the burning pain and urgency subsided but was replaced by increasing lower abdominal pressure and pain. The patient will see a doctor on 14 April 2021. Other effects observed following the vaccination on 2 April 2021 include: headaches, muscle pain, injection site arm pain, sore throat. These effects resolved within 24 hours after the vaccination with exception of the sore throat which is ongoing.

1ST DAY=Heachache, Dizzines, High blood pressure, Inflamation of hands. 2ND DAY= High blood pressure, headache, chills 3RD Day: Headache, kidney pain 4th Day: Headache, body ache. 5th day: Heachache, leg pain, can't sleep.

Patient presented to the ER on 4/16/21 for dyspnea and wheezing, diagnosed with acute COPD exacerbation/chronic bronchitis and discharged home. Pt presented to ER 4/22/21 with worsening symptoms and was admitted to the hospital for acute kidney injury, dehydration and COPD exacerbation.

BLOODY STOOL; INFLAMED BURSA OF LEFT HIP, RADIATING TOWARDS SPINE; ARTHRALGIA; MYALGIA; SLIGHTLY LOW KIDNEY FUNCTION; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism. The patient had no known allergies. The patient was previously treated with cortisone in shoulder joint. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 on right arm for prophylactic vaccination. Concomitant medications included ascorbic acid, calcium, chondroitin sulfate/glucosamine hydrochloride, colecalciferol, levothyroxine sodium, and magnesium. In the morning of 17-MAR-2021, the patient felt some fatigue, stayed in bed until noon and fatigue disappeared in the afternoon. On 07-APR-2021, the patient started experiencing pain and soreness in hamstring, behind knees and in hips. The pain and soreness gradually progressed upwards towards spine. The symptoms were worse in the morning and evening, with the period between noon and 8 PM saw some improvement. Since pain and soreness started, the patient had been taking painkillers like candy, Tylenol (paracetamol), Advil (ibuprofen) and Aleve (naproxen sodium) and had no effect on symptoms. On 21-APR-2021, the patient had some bloody stool and saw primary care physician that week. The blood tests, bone density and thyroid function were done. Only finding of note was slightly low kidney function and diagnosis of myalgia and arthralgia. The patient was told to discontinue painkiller use. On 12-JUN-2021, the patient saw orthopedist, was diagnosed with inflamed bursa on the left hip, radiating towards spine and was prescribed a 5 days tapering course of prednisone. The symptoms disappeared starting on the second day of prednisone. The symptoms reappeared with same severity 2 days after stopping prednisone (19-JUN-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bloody stool on 21-APR-2021, and fatigue on 17-MAR-2021, had not recovered from inflamed bursa of left hip, radiating towards spine, myalgia, and arthralgia, and the outcome of slightly low kidney function was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210660357-covid-19 vaccine ad26.cov2.s- bloody stool, slightly low kidney function. 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).

Felt crippled unable to walk excruciating pain (bone next to tailbone on left side) Shortness of breath Couldn't hold urine Felt perfectly fine until the morning of 3/20/21 (lasted 2 weeks-until I begged DR. to provide anti-inflammatory, 5% lidocaine patch to treat this, and I did not want continue to take my Percocet (from previous facture event) that the Dr. recommended.

Traveled and reported to family that she was disoriented and having some confusion. Was evaluated at ED, had some electrolyte imbalance and UTI. Once resolved, she continued to have neurological symptoms and was diagnosed with a stroke, including early onset dementia per telephone interview with daughter.

ACUTE KIDNEY INJURY; UNCONTROLLED HYPERTENSION; ELEVATED SEDIMENTATION RATE; ELEVATED C REACTIVE PROTEIN; ELEVATED LIVER FUNCTION TESTS; DAILY PERSISTENT HEADACHE; This spontaneous report received from a pharmacist concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was reported that, the patient received care at the clinic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) 1 total, dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient had acute kidney injury, uncontrolled hypertension, elevated sedimentation rate, elevated c reactive protein, elevated liver function tests, and daily persistent headache. The patient visited doctor/healthcare professional office for the events. The patient's laboratory data included blood pressure (not reported), C-reactive protein elevated, erythrocyte sedimentation rate elevated, and Liver function tests elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from uncontrolled hypertension, elevated sedimentation rate, elevated c reactive protein, daily persistent headache, elevated liver function tests, and acute kidney injury. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210537406-COVID-19 VACCINE AD26.COV2.S-Acute Kidney Injury. 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).

I started getting symptoms of UTI - I was treated with an antibiotic starting on 4/28/2021 - for five days. And then a few days later, it came back after I finished the antibiotic. I started on another antibiotic on May 8th. That took care of it. But after I finished with it, on May 19th, I had a fever that continued until May 24th. A urinalysis showed it wasn't UTI. No treatment.

Shortness of breath, difficulty breathing, difficulty speaking, chills, violent shaking, left kidney pain , headache, Coughing body aches, fatigue, confusion, difficulty sleeping ,loss of appetite, weakness , burning in my lungs

N17.9 - AKI (acute kidney injury) R19.5 - Occult blood positive stool E87.6 - Hypokalemia R55 - Syncope

DIVERTICULITIS ATTACKS; FLU- LIKE SYMPTOMS; FREQUENT URINATION; NOT SLEEPING WELL; DIARRHEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 95.5 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received Selexipag (form of admin and route of admin were not reported, batch number: UNKNOWN expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for drug used for unknown indication; and Macitentan (tablet, route of admin not reported, batch number: ZE019B0101 expiry: 31-JUL-2024) 10 mg, 1 time every 1 day, therapy dates were not reported for primary pulmonary hypertension. 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, the patient had diarrhea, flu- like symptoms, body aches, nausea, fatigue, short of breath frequent urination and was not sleeping well. She was unsure if this was due to the vaccine or a combination of the Uptravi and the vaccine. The patient also had short of breath when she took her garbage out and that she had occasional diverticulitis attacks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diverticulitis attacks, diarrhea, flu- like symptoms, frequent urination and not sleeping well was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210414881-Covid-19 vaccine ad26.cov2.s-Diverticulitis . This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. V0:20210414881-UPTRAVI-Diverticulitis. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. V0:20210414881-OPSUMIT-Diverticulitis. This event is considered unassessable. The event 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.

colonic necrosis 62 yo woman history of prior L occipital CVA and DVT on Xarelto presented to Hospital on April 6 with mental status changes. Patient was noted to be in severe metabolic acidosis, renal failure and shock. Chest x-ray showed interstitial infiltrates and she tested positive for SARS-CoV2. She required intubation and mechanical ventilation. CT brain showed encephalomalacia and atrophy, no new changes. She was transferred on April 8. She was given IV bicarb for persistent metabolic acidosis. Initially she was only treated with steroids, then antibiotics were added for fever and persistent hypotension. She started to spike fevers up to 40. Abdominal CXR ordered prior to MRI, showed possible pneumatosis. A follow up CT April 13 abdomen/pelvis was done which shows colonic pneumatosis, with air in the SMV, portal vein, air in the liver. No thrombocytopenia; platelets on April 13 were 310k, as low as 260 on April 8.

J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified R56.9 - Unspecified convulsions

Finding of microhematuria on a routine urine dipstick. Repeat urine test confirmed microhemtutria and CBC showed 30,000 platelets. WAs admitted to hospital. No purpura or other signs of bleeding. Was diagnosed as Idiopathic Thrombocytopenic Purpura. Started on steroids with good response.

I exp shaking and headache lasted few hours . I went to the doctor on 3/17 had a UTI(which is not normal for me).

EXCESSIVE URINATION; VOMITING; INCREASED HEART RATE; CHILLS; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 134 pounds, and height was 176.78 centimeters. The patient's concurrent conditions included supraventricular tachycardia, high cholesterol, thinning bones, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no no allergies/no history of drug abuse/no past history of similar event/no adverse event after any previous vaccinations/ no history of allergy to vaccine, drug or food/ no history of hospitalization in last 30 days, with cause/no family history of any disease (relevant to vaccination) or allergy. the patient was not pregnant at the time of event. the patient was not currently breastfeeding.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered to the left deltoid, on 07-MAR-2021 16:30 for prophylactic vaccination. The batch number was not provided and has been requested. Concomitant medications included fish oil for heart health, pravastatin for high cholesterol, metoprolol succinate for supraventricular tachycardia, and calcium carbonate/colecalciferol for thinning bones. On 07-MAR-2021, the subject experienced excessive urination. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced increased heart rate. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced fatigue. Laboratory data included: Heart rate (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excessive urination, vomiting, increased heart rate, nausea, and fatigue on 08-MAR-2021, and chills on 07-MAR-2021. This report was non-serious.; Sender's Comments: V0 : Medical assessment comment is not required as per standard procedure as the case is non serious

BURNING SENSATION DURING URINATION; REALLY BAD TINNITUS; GENERAL MUSCLE ACHES; This spontaneous report received from a patient concerned a 63 year old female. 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 was not reported) dose was not reported, administered on 06-APR-2021 to Right Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced really bad tinnitus. On APR-2021, the subject experienced general muscle aches. On 07-APR-2021, the subject experienced burning sensation during urination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation during urination, and general muscle aches, and the outcome of really bad tinnitus was not reported. This report was non-serious.

Extreme Diarrhea, Fever 103 degrees, Chills, Sweating, Muscle Weakness, Fatigue, Muscle Pain, Nausea, Uncontrollable Diarrhea, Incontiness, headache, injection site welt, swelling, shoulder pain, unable to lift arm due to shoulder. Lasted 72 hrs for most extreme symptoms: headache, ongoing fever, extreme weakness (unable to walk without help). Did not return to regular strength until 8 days after administration of vaccine. Liquid Diet, Bedrest (4 days), Pain medication, Tylenol

FAINTING; ABNORMAL HEART BEAT; DIZZINESS; BLADDER CONTROL LOST/URINATED ON HERSELF; COULDN'T STAND UP; NAUSEA; CHILLS; DIDN'T HAVE APPETITE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included little asthma, cardiac resynchronization therapy (CRTS), and allergic to red tide. The patient was previously treated with gabapentin. 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, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in 2020, Laboratory data included: COVID-19 antigen test (NR: not provided) negative (units unspecified). On an unspecified date in MAR-2021, the subject didn't have appetite. On 13-MAR-2021, the patient experienced chills at night. On 14-MAR-2021, morning the patient experienced dizziness, nausea, she couldn't stand up and fainted (dead weight) and she reported that she was a dead weight and she didn't have control of bladder and urinated on herself (she was lying in a pool of urine. Also her heart rate went up to 84 b/p per min after she fainted and lasted for the whole day, next day it came down to 74 b/p. Her normal heart beat were 64 b/m. She was nauseous and dizzy for the past 3 weeks. Laboratory data included: Heart rate (NR: not provided) 84 (units unspecified). On 15-MAR-2021, Laboratory data included: Heart rate (NR: not provided) 72 (units unspecified). Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 64 b/p. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abnormal heart beat on MAR-2021, and bladder control lost/urinated on herself, chills, and nausea, and the outcome of dizziness, fainting, didn't have appetite and couldn't stand up was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210420179-COVID-19 VACCINE AD26.COV2.S-Fainted. This event is considered unassessable. The event 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.

The injection did hurt quite a bit more than other injections I have had in the past but it began to feel better and I sat in a chair and was on my phone to send a message, spoke to a stranger who was looking for where to go, and was ok until the feeling of fainting began 10 minutes after the shot. I put my head between my knees but it did not help so I called for help and eventually was helped onto the floor to lie down which began to help. I had vision trouble and hearing trouble and could not speak. I was told my neck became bright red as my face grew white and my hands twitched and my eyes rolled around. I found out later that I had also peed my pants. I have fainted only once before in 1989, and found this reaction pretty frightening although I do not believe it happened as a result of anxiety or fear, the adverse effect itself was frightening and unexpected- not listed on any paperwork I received and was not aware it could occur.

I had no regular symptoms, but a few days later I sat down in my chair and it felt like someone shot me in the stomach, I took oxycodone, it kept getting worse and I dealt with it for a week. I started getting pain in my kidney and went to the ER because of the pain and the pain level on a scale of 1-10 was a 8-9 at all times. I couldn't' breathe and was rushed to the hospital. I have portal vein thrombosis and have three blood clots in my stomach. I tried to figure out what to do to relieve the pain, I couldn't eat or during and was on IV's. I was in so much pain to even eat a cracker, they kept me at the hospital. While in the hospital they did a CAT scan to see if it was diverticulitis and found out that I had 3 blood clots, they also did the dye or contrast. I spent days in the hospital and was transferred to the hospitals skilled nursing facility so that they can watch me because of the clots. I was told that the blood clots could burst in the vein.

Began my yearly physical two days after the vaccine, as did my husband. Both of our urine tests showed blood in our urine. Had a second urine test a month later. Still had blood in urine. Also had 3 weeks of diarrhea. That was followed by a vaginal yeast infection. Given a prescription to clear that up. Then my breasts became swollen and painful. It has been ten weeks since the vaccination. Saw a urologist this week there is still blood in my urine. The amount of blood has decreased, but still showing up.

extreme shortness of breathe, irregular heartbeat, fatigue, loss of bladder control, shooting pains, muscle ache, tightness in chest

It began with being light-headed and difficulty walking on March 25th. On April 14 I had my first "seizure like" event as I was going to teach school. I had Upper arm tremors and difficulty speaking and walking. Sent by ambulance to the emergency room. Released later that day and given meds for UTI which was later deemed a misdiagnosis by Dr. Didn't go to work as I continued to have difficulty walking and had headaches and overall weakness. Saw Dr. on April 20th. Had to use wheelchair to attend the office visit and was given blood tests to see what was causing my condition. Had high blood pressure. She also advised me to see a neurologist and heart doctor. ON April 20th had to go back to ER as I had the smae seizure like event!On April 22nd I visited Dr. office (heart doctor). Blood pressure was off on this day as well and I stayed at clinic until it was better. Was given a heart monitor to wear for 24 hours. Heart was fine after wearing the monitor. Visited Neurologist and was given EEG and CT CTA tests. All came back fine.

Blood in the urine - hematuria - I saw the Urologist 3/30/21 - Had to determine what caused it; was put on Kephlex for a possible UTI initially. I passed a kidney stone as pain in the area was relieved. It appeared that it was caused by a kidney stone.

2021-04-23 Patient presents to the ED with right-sided mid-back pain and shortness of breath starting 2021-04-22 evening. Pain is sharp and worsens with coughing and deep inspiration; she feels that she is taking shallow breaths. On ED presentation, no shortness of breath, chest pain, dizziness, fevers, dysuria, or abdominal pain. She does have reproducible pain on her right mid-back area. There is some mild diffuse tenderness in her abdomen, but reports that she always has a tender abdomen due to Crohn's disease. No peritoneal signs. No recent travel. Patient was found to have pulmonary embolism. Hematology/Oncology specialist was consulted and recommended initiation of argatroban for treatment of pulmonary embolism. Patient was admitted to inpatient.

Janssen COVID-19 Vaccine EUA: patient presented to outside facility one day after vaccination reporting confusion, vomiting,and abdominal pain. Found to be hypotensive (blood pressure 70/40 mmHg) in DKA with electrolyte abnormalities and ventricular arrhythmias requiring shocks. Patient initiated on blood pressure support, airway protection, insulin, intravenous fluids, antimicrobials, electrolyte management and transferred to this facility for a higher level of care. Patient improved, DKA and shock resolved, electrolytes normalized, and was discharged five days later medically stable.

HEART BEATING FAST; HEART "SKIPPING BEATS"; ACHING JOINTS/JOINTS HURTING; NAUSEATED; HURTING ALL OVER; DIZZY; COULDN'T SLEEP; STOMACH FELT "BLOWN UP"; NO APPETITE; HURTING "DOWN REAL LOW" IN ABDOMEN; HAD TO URINATE ALOT; SHAKINESS; ITCHING ARM; FATIGUE; WEAKNESS/NO ENERGY; SORE ARM; DID NOT FEEL WELL; CHILLS; BREASTS SORE; SEVERE HEADACHE/SORE SPOTS ON HEAD; UNDER ARMS SORE; SUSPECTED COVID; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dental surgery, and left arm broken. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced suspected covid. On MAY-2021, the subject experienced breasts sore. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced did not feel well. On MAY-2021, the subject experienced sore spots on head. On MAY-2021, the subject experienced under arms sore. On 11-MAY-2021, the subject experienced shakiness. On 11-MAY-2021, the subject experienced itching arm. On 11-MAY-2021, the subject experienced weakness/no energy. On 11-MAY-2021, the subject experienced sore arm. On 11-MAY-2021, the subject experienced fatigue. On 11-MAY-2021, the subject experienced severe headache. On 12-MAY-2021, the subject experienced hurting all over. On 12-MAY-2021, the subject experienced dizzy. On 12-MAY-2021, the subject experienced couldn't sleep. On 12-MAY-2021, the subject experienced stomach felt "blown up". On 12-MAY-2021, the subject experienced no appetite. On 12-MAY-2021, the subject experienced hurting "down real low" in abdomen. On 12-MAY-2021, the subject experienced had to urinate alot. On 12-MAY-2021, the subject experienced aching joints/joints hurting. On 12-MAY-2021, the subject experienced nauseated. On 18-MAY-2021, the subject experienced heart beating fast. On 18-MAY-2021, the subject experienced heart "skipping beats". Treatment medications (dates unspecified) included: ibuprofen, naproxen sodium, and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate. The action taken with covid-19 vaccine was not applicable. The outcome of the severe headache, shakiness, weakness/no energy, fatigue, sore arm, itching arm, did not feel well, hurting all over, hurting "down real low" in abdomen, nauseated, dizzy, chills, couldn't sleep, stomach felt "blown up", no appetite, had to urinate alot, heart beating fast, heart "skipping beats", breasts sore, aching joints/joints hurting, sore spots on head and suspected covid was not reported. This report was non-serious.

5/3/21 Pt presented to ED with a 3 day history of feer to 103.5, sore throat, SOB and N/V. She had a known exposure to a household member(s) with COVID. NP swab was positive for SARS-CoV-2, Otherwise her labs were unremarkable. CXR showed subtle streaky opacities in left lung base. She had no oxygen requirement and was discharged to home with a referral for monoclonal antibody. 5/6/21 Patient received infusion of BAM+E. During the infusion she was noted to be SOB and O2 sat was 90%. She was sent directly from the infusion center to the ED. HOSPITAL COURSE: patient is a 64 y.o. female with shortness of breath from infusion clinic after getting antibody for covid. Pt was found hypoxia. Pt has been treated with Remdesivir, decadron and supportive care. Pt recovered very well Pneumonia due to COVID-19 virus Acute hypoxic respite failure secondary to above. -Was admitted on May 6, SP remdesivir and IV diuretics -05/11 improving respiratory failure, current on 6 L NC, continue supportive care, ID continue following up -05/12 pt is on 3 L NC without shortness of breath. Pt's CRP trending down 18.3. Pt will be discharged home with home oxygen. She will continue taking 4 days of decadron. Follow up with primary care physician. Return to ER for worsening symptoms or other concerns.

Patient received vaccine on 3/16/21. At 24 hours, she started having flu-like symptoms, along with diarrhea and vomiting that persisted for 48 hours. She continued to feel nauseous, congested, fatigue and rigors. Labs were ordered when she was seen in clinic on 3/25/21. Her creatinine reported on 3/26/21 was 7.19. She was admitted to local hospital for acute kidney injury, "probably" due to acute tubular necrosis from ischemic ATN per nephrologist. She was treated with IVF and bicarb drip.

Woke up during the night ( 2 am) and was unable to stand due to dizziness. Had to crawl to the bathroom; then realized I had lost bladder control when trying to stand up while I was still in the bedroom. No previous history of urinary incontinence. I also experienced significant chills prior to going to bed; about 10 pm but I don't consider it an adverse reaction.

Patient vaccinated by EMS on 3/29/21, EMS notified clinic that patient was taken to the Hospital for a stroke on 4/1/21

Patient admitted 4/12/21 with fatigue and abdominal pain. Found to have UTI but no definite sepsis, and acute renal failure. Treated with iv antibiotics and iv fluids. Over next 48 hours developed worsening encephalopathy and thrombocytopenia. MRI/MRA/MRV showed no acute findings. Hyperammonemia noted, with no known Hx of cirrhosis; US did not show portal vein or hepatic vein thrombosis. Encephalopathy worsened, no clear etiology; EEG just showed generalized encephalopathy. Renal function worsened. Patient became obtunded and was intubated 4/16/19. Platelet nadir of 31k. Dialysis started. Left common femoral DVT developed. Patient had DIC type picture. Respiratory failure worsened, hypotension developed, patient passed away 4/20/21. No clear etiology of encephalopathy and thrombocytopenia identified, unclear if related to J&J vaccine received 2 weeks prior.

On Sunday night, 04/11/2021 around 7:00pm, patient stated she started getting sick to her stomach. She complained of headaches and fatigue. At midnight she vomited, couldn't lay down and symptoms lasted all night. She complained of back pain too. she noticed blood in her urine with a clot of blood in it and had shortness of breath. She vomited twice. In contact by phone with her daughter at the time. Patient refused to go the the emergency room or call her physician. She has a cardiologist who is her primary care physician.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Additional Details: LOSS OF URINARY CONTROL

66 y.o. female who presents with DIZZINESS LIKE ROOM IS SPINNING. PT STATES IMPROVES WITH CLOSING EYES AND LAYING STILL. PT STATES HAS HAD SEVERAL TIMES BEFORE AND LAST TIME WAS ONE WEEK AGO AND TOOK A MOTION SICKNESS OVER THE COUNTER PILL AND DIZZINESS WAS RELIEVED. TODAY PT WAS AT WORK WHEN BECAME DIZZY AND NAUSEOUS AND VOMITED. PT DENIES CHEST PAIN BUT HAS PAST HISTORY OF CAD WITH PACEMAKER PLACEMENT.

My symptoms i had sever headache! Once April 1st Hit! Thats Was the day I Had a Heart stroke at store, i don?t remember anything and once i woke up i was at the hospital, and they told me that i had a heart stroke because i had lots of blood clots in my body. And they told me i vomit and peed myself durong the whole situation i went in store

1-2 weeks after dose of vaccine, developed nausea, chills, diarrhea. Presented 1 month after vaccine to ED with embolic strokes and new renal failure.

A PINECONE SHOVED DOWN HER THROAT; SEVERE HIVES; RECURRENT URINARY TRACT INFECTION; CHEST PAINS/HEART PAINS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylactic shock, anaphylaxis, and urinary tract infection, and concurrent conditions included penicillin allergy, and sulfa allergy, and other pre-existing medical conditions included allergy to 20 unspecified drugs. The patient was previously treated with doxycycline for urinary tract infection. 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 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced chest pains/heart pains. On APR-2021, the subject experienced recurrent urinary tract infection. Treatment medications included: doxycycline. On an unspecified date, the subject experienced a pinecone shoved down her throat, and severe hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pains/heart pains, a pinecone shoved down her throat, and severe hives, and the outcome of recurrent urinary tract infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.

67 yo female with PMH of HTN, DM who has two days of left sided numbness that has progressed to left hemiparesis and dysarthria in the setting of having received the Johnson and Johnson vaccine on Wednesday(48hours prior). Patient was found to have a right parietal multifocal parenchymal hemorrhage measuring 19x36x37mm and small right temporal lobe SAH. Subsequent CTA showed thrombosis of the superior sagittal sinus and the right frontoparietal cortical veins as well has nonocclusive thrombus of right transverse and sigmoid sinus. The patient was also noted to have focal seizure of mouth and tongue and was loaded with phosphenytoin. After discussing case with neurology, nuero IR, NSGY and family it was decided to transfer the patient to sunrise for close monitoring and consideration of cerebral venous sinus thrombectomy if she worsens. I had a long discussion with multiple sisters about the risks of anticoagulation with argatroban given the IPH but the necessity given the cerebral venous thrombosis. I also discussed that argatroban is not readily reversible and that heparin is contraindicated if there is concern about vaccine induced thrombotic thrombocytopenia due to possible PF4 ab related to HIT. The patients VITT modified 4T score is 4 and she is intermediate risk for this being VITT. #Right parietal IPH, right temporal SAH and Superior saggital sinus thrombosis with nonocclusive thrombus of right transverse and sigmoid sinus -concern for vaccine induced thrombotic thrombocytopenia given johnson and johnson vaccine 2 days prior -modified VITT 4T score of 4- intermediate -send fibrinogen, d dimer, consider IVIG 1gm/kg per day for two days if high dimer, low fibrinogen and falling platelets -will start argatroban, avoid heparin until HIT ab (PF4) is resulted, if HIT positive avoid heparin -neuro IR consulted for possible IR intervention if worsens -transfer accepted by sunrise ICU, appreciate transfer for IR evaluation -continue phosphenytoin -SBP goal <150 with nicardipine and esmolol gtts -monitor daily fibrinogen, dimer, coags #AKI- monitoring uop and cr, consider renal US if worsens #DM- ISS #HTN- nicardipine and esmolol gtts for SBP <150, target 140 Patient seen, examined, labs and imaging reviewed, agree with resident note

SORE THROAT; SHORTNESS OF BREATH; MYALGIA; FATIGUE; HORRIFIC HEADACHE; HORRIBLE PAIN IN CHEST LIKE HEART ATTACK; BONE WRACKING DRY COUGH; METALLIC TASTE IN MOUTH; FELT DIZZY; FELT LIKE HIT BY DUMP TRUCK; BODYACHE; NOT FEELING WELL; AGITATED; URINATING A LOT; BILATERAL EARACHE; WAS TOO SICK; HEART RATE WENT UP TO MORE THAN 80 BPM; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 66.7 kilograms, and height was not reported. The patient's past medical history included tachycardia, atrial fibrillation, left periorbital ecchymosis, dry eyes, trouble focusing, headache, nausea on right side of chest, felt like gas bubble and emesis, possible post concussion symptoms, voice hoarse/raspy voice, chronic laryngitis, flare up of hemorrhoid, constipated over a weekend, increased heart rate, nontoxic uninodular thyroid goiter, atherosclerosis of aorta, fatigue, papillary thyroid cancer, right thyroid lobectomy, deep vein thrombosis, gerd, melanoma of skin, dyspnea, deep vein thrombosis, sinus pain, tooth pain, treatment non compliance, pharyngitis, stroke, vertigo, and influenza like illness, and concurrent conditions included non-smoker, no alcohol use, asthma, cerebral palsy, qt prolonged, chest pain when tired, diabetes mellitus, chronic kidney disease stage 3, hypertension, congenital nystagmus, hearing loss, hypothyroidism, and diabetes, and other pre-existing medical conditions included the patient had no history of abuse or illicit drug usage. The patient was previously treated with phenoxymethylpenicillin, guaifenesin for sore throat, calcium carbonate, famotidine, simeticone, promethazine, cefalexin, diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid for prophylactic vaccination, salbutamol, ciclesonide, and polymyxin for red eyes; and experienced drug allergy when treated with atenolol, ciprofloxacin, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 04-APR-2021 11:15 for prophylactic vaccination. Concomitant medications included disopyramide phosphate. On 10-MAR-2014, Laboratory data included: Factor V Leiden mutation (NR: not provided) negative, and Prothrombin mutation G20210A (NR: not provided) HET Abnormal, coagulation. On APR-2021, the subject experienced heart rate went up to more than 80 bpm. On APR-2021, the subject experienced agitated. On APR-2021, the subject experienced urinating a lot. On APR-2021, the subject experienced bilateral earache. On APR-2021, the subject experienced was too sick. On APR-2021, the subject experienced bodyache. On APR-2021, the subject experienced not feeling well. On 04-APR-2021, the subject experienced metallic taste in mouth. On 04-APR-2021, the subject experienced felt dizzy. On 04-APR-2021, the subject experienced felt like hit by dump truck. On 05-APR-2021, the subject experienced horrible pain in chest like heart attack. On 05-APR-2021, the subject experienced bone wracking dry cough. On 05-APR-2021, the subject experienced horrific headache. On 09-APR-2021, the subject experienced fatigue. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 20-APR-2021, the subject experienced sore throat. On 20-APR-2021, the subject experienced shortness of breath. On 20-APR-2021, the subject experienced myalgia. Laboratory data included: Anion gap (NR: not provided) 10 mEq/L, B-type natriuretic peptide (NR: not provided) 64 pg/dL, BUN (NR: not provided) 26 mg/dL, Blood pressure (NR: not provided) 214/91 mm Hg, Body temperature (NR: not provided) 97.8 F, CO2 (NR: not provided) 26 mEq/L, Chloride (NR: not provided) 102 mEq/L, Creatinine (NR: not provided) 0.92 mg/dL, Differential white blood cell count (NR: not provided) Normal, Glomerular filtration rate (NR: not provided) more than 60 mL/min, Glucose (NR: not provided) 328 mg/dL, Hematocrit (NR: not provided) 42.9 %, Hemoglobin (NR: not provided) 14.9 g/dL, Lab test (NR: not provided) Normal (no blood clots/thrombocytopenia), MCV (NR: not provided) 91 fL, Nucleated red cells (NR: not provided) 0 kilo per microliter, Oxygen saturation (NR: not provided) 98 %, Pain scale (NR: not provided) 1 (units unspecified), Platelet count (NR: not provided) 190 kilo per microliter, Potassium (NR: not provided) 4 mEq/L, Pulse rate (NR: not provided) 81 beats per minute, RBC count (NR: not provided) 4.73 million per microliter, Respiratory rate (NR: not provided) 18 (units unspecified), Sodium (NR: not provided) 138 mEq/L, Troponin I (NR: not provided) more than 0.02 ng/dL, WBC count (NR: not provided) 7.3 kilo per microliter, and X-ray (NR: not provided) Aortic atherosclerosis. Treatment medications included: hydralazine. On 20-APR-2021 17:34, Laboratory data included: Blood pressure (NR: not provided) 190/100 mm Hg, Body temperature (NR: not provided) 36.6 degree celsius, Glasgow coma scale (NR: not provided) Eye opening:4, Verbal response:5, Motor Response: 6, Total Coma Score:15, Oxygen saturation (NR: not provided) 97 %, Pulse rate (NR: not provided) 74 bpm, and Respiratory rate (NR: not provided) 16 (units unspecified). On 28-APR-2021, treatment medications included: prednisone. Additional treatment medications (dates unspecified) included: estradiol, levothyroxine, paracetamol, verapamil hydrochloride, salbutamol, diphenhydramine hydrochloride/lidocaine/nystatin, budesonide/formoterol, guaifenesin, benzonatate, chlorhexidine gluconate, ipratropium, aciclovir, fluticasone, montelukast, hydralazine hydrochloride, fluticasone propionate/salmeterol xinafoate, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste in mouth on 05-APR-2021, felt dizzy on 20-APR-2021, felt like hit by dump truck on 16-APR-2021, was too sick, and shortness of breath, and horrific headache on 19-APR-2021, had not recovered from bone wracking dry cough, horrible pain in chest like heart attack, sore throat, and bilateral earache, and the outcome of heart rate went up to more than 80 bpm, myalgia, not feeling well, fatigue, urinating a lot, agitated and bodyache 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

On 6/7/2021- UTI, had to get antibiotics On 6/10/2021- CT scan, diverticulitis, antibiotics again On 6/26/2021-throat and ear infection, antibiotics

Severe exacerbation of idiopathic capillary leak syndrome 48 hours following administeration of Janssen vaccine leading to profound vasodilatory shock, renal failure and DIC and death

HYPOCHROMIA; HIGH WHITE BLOOD CELLS; DVT WITH INFLAMMATION AND SWELLING OF RIGHT LOWER LEG; RUNNY NOSE; BILATERAL WATERY EYES; LEFT ARM TENDERNESS POST IMMUNIZATION; URINARY TRACT INFECTION; LOWER BACK PAIN; This spontaneous report received from a patient concerned a 68-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included baker's cyst, and reflux sympathetic dystrophy. The patient experienced drug allergy when treated with gabapentin, and prednisone, drug intolerance when treated with codeine, and ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) once a total dose was not reported, administered on 10-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced urinary tract infection. On MAR-2021, the subject experienced lower back pain. On 10-MAR-2021, the subject experienced left arm tenderness post immunization. On 11-MAR-2021, the subject experienced runny nose. On 11-MAR-2021, the subject experienced bilateral watery eyes. On 14-MAR-2021, the subject experienced deep vein thrombosis with inflammation and swelling of right lower leg. On 23-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) confirmed DVT right lower leg, Urinalysis (NR: not provided) Unknown, and White blood cell count high (NR: not provided) 10.35 increased and was previously 9.23 not reported. Treatment medications included: ciprofloxacin for urinary tract infection. On 24-MAR-2021, the subject experienced hypochromia. On 24-MAR-2021, the subject experienced high white blood cells. Additional treatment medications (dates unspecified) included: rivaroxaban for deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, and bilateral watery eyes on 12-MAR-2021, and left arm tenderness post immunization on 11-MAR-2021, had not recovered from deep vein thrombosis with inflammation and swelling of right lower leg, high white blood cells, and hypochromia, and the outcome of urinary tract infection and lower back pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210348648-Covid-19 vaccine ad26.cov2.s-Deep vein thrombosis. 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).

FEELING INTENSE DEBILITATING PAIN AROUND LOWER STOMACH AND GROIN AREA ON RIGHT SIDE; NEW TREMOR IN HANDS; THOUGHTS JUMBLING; INTERRUPT SLEEP; UNABLE TO EXERCISE; TERRIBLE HEADACHE; TERRIBLE VOMITING; COULD TAKE NO FOOD OR MEDICATION AT ALL; INTENSE VOMITING IT CAUSED TO LOSE CONTROL OF BLADDER; This spontaneous report received from a patient via a company representative concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included dental implants, and concurrent conditions included malignant neoplasm of right kidney except renal pelvis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included axitinib, and ondansetron. On MAR-2021, the subject experienced intense vomiting it caused to lose control of bladder. On 10-MAR-2021, the subject experienced terrible vomiting. On 10-MAR-2021, the subject experienced could take no food or medication at all. On an unspecified date, the subject experienced feeling intense debilitating pain around lower stomach and groin area on right side, new tremor in hands, thoughts jumbling, interrupt sleep, unable to exercise, and terrible headache. Treatment medications (dates unspecified) included: naproxen, and codeine phosphate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible vomiting, could take no food or medication at all, and intense vomiting it caused to lose control of bladder on 2021, and the outcome of feeling intense debilitating pain around lower stomach and groin area on right side, new tremor in hands, terrible headache, thoughts jumbling, interrupt sleep and unable to exercise was not reported. This report was non-serious.

(Noted Auto-Immune Disease) Pt. states after receiving the dose of J&J vaccine 05/11/2021, started to experiencing symptoms 05/16/2021 a pulling pain in the right thigh, broken blood vessels through the leg (right), uncomfortable sensations going from groin to feet (both), pain beneath the fingernails, abdominal bloating, and chronic UTIs. Nerve sensations running through the facial area and (pinching) back of the head.

URINARY TRACT INFECTION; EXTREMELY LOW BLOOD PRESSURE; POSITIVE DIAGNOSTIC TEST FOR COVID; This spontaneous report received from a consumer concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included gastrointestinal infection, and concurrent conditions included dialysis. The patient was hospitalized on an unspecified date in MAR-2021, (a week before vaccination) due to gastrointestinal infection and was discharged approximately on 29-MAR-2021 or 30-MAR-2021. On 31-MAR-2021, the patient had dialysis and was administered the vaccine as well in the dialysis center. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered to left arm on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the patient experienced extremely low blood pressure and was taken to the emergency room. On the same day, the patient was admitted to the hospital and was diagnosed with a urinary tract infection. The patient took the quick COVID-19 test which was negative. The patient took another unspecified diagnostic test for COVID-19 on the same day which was positive. It was reported that, the patient did not have COVID-19 related symptoms (or previous symptoms) and was asymptomatic. Laboratory data included: Blood pressure (NR: not provided) Extremely low, COVID-19 antigen test (NR: not provided) Negative, and COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the urinary tract infection, extremely low blood pressure and positive diagnostic test for COVID was not reported. This report was serious (Hospitalization Caused / Prolonged). The case is associated with Product Quality Complaint number # 90000175206. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210407177 -covid-19 vaccine ad26.cov2.s-extremely low blood pressure, urinary tract infection. 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).

pt says on the 6th day she woke up w/ a headache and nauseated. She started vomiting and took Medizine which seem to help. On 4/11/21 she started having cramps in her stomachs like a spasm and SOB. She went to hospital ER. They did blood work and Chest X-Ray which came back negative results. She was told she did not have the same blood disorder as the other people who have had blood clots after taking the vax. She was told she had blood in her urine but had no infection. She will FU w/ PCP in June. Pt says her only symptoms now are some nausea and still does not feel normal.

FOGGY FEELING IN HEAD; BURNING IN THE HEART MUSCLE; EVERY BONE WAS HURT; HEADACHE; CHILLS; FEVER; SWOLLEN HEART MUSCLE; CHEST PAIN; URINE COLORING YELLOW ORANGE; BODY ACHE; VOICE WAS HOARSE; This spontaneous report received from a patient concerned a 69 year old female. 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced voice was hoarse. On APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced swollen heart muscle. On 07-APR-2021, the subject experienced chest pain. On 07-APR-2021, the subject experienced urine coloring yellow orange. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced foggy feeling in head. On 08-APR-2021, the subject experienced burning in the heart muscle. On 08-APR-2021, the subject experienced every bone was hurt. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, foggy feeling in head, voice was hoarse, fever, chills, and headache on 11-APR-2021, burning in the heart muscle, and every bone was hurt on 09-APR-2021, urine coloring yellow orange on 10-APR-2021, and body ache on APR-2021, and was recovering from swollen heart muscle. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.

Intense UTI and urgency to urinate, no control of it. Fatigue/sleeping, brain confusion, aches, headaches everyday, old injuries became active again i.e. my broken hand 7 years ago began hurting and couldn't use it, my knee would not hold me up to stand and kept going out on me (from 2010 broken tibia and torn knee ligaments). Began a sinus infection, cough and eye pain with awful bouts of constant sneezing. Third round of antibiotics for the UTI and my bladder is still not right with leakage and urgency. Liver enzymes are high chart.

Intense UTI and urgency to urinate, no control of it. Fatigue/sleeping, brain confusion, aches, headaches everyday, old injuries became active again i.e. my broken hand 7 years ago began hurting and couldn't use it, my knee would not hold me up to stand and kept going out on me (from 2010 broken tibia and torn knee ligaments). Began a sinus infection, cough and eye pain with awful bouts of constant sneezing. Third round of antibiotics for the UTI and my bladder is still not right with leakage and urgency. Liver enzymes are high chart.

69 YO female received one dose of J&J vaccination on 3/12/21. 4/8: Patient complaint of epigastric abdominal pain almost nightly since March 12 (coincided with her COVID vaccination) described as 10/10, crampy and without radiation. CT abdominal and pelvis with contrast showed infiltrating mass in the left hepatic lobe concerning for intrahepatic cholangiocarcinoma with reactive adenopathy. Additionally, left mid ovarian vein thrombus found. No thrombus in the renal veins or IVC. 4/28: Venous duplex demonstrated bilateral leg acute DVT. Eliquis was started. 5/7: Pt underwent laparoscopic biopsy/paracentesis. Eliquis was held 2 days prior to laparoscope...5/11: Pt presented to hospital with complaints of generalized weakness, fatigue and leg pain. CTPA showed bilateral PE. Pt received heparin drip and was switched back to Eliquis on discharge. Echocardiogram on 5/12 noted mobile round mass in RV junction, right atrial mass; presumed to be a thrombus. Pt additionally with elevated troponin, determined to likely demand ischemia related to PE; EKG without any acute changes. Discharged on 5/24. 5/27: Patient started on chemotherapy with gemcitabine/cisplatin for metastatic intrahepatic cholangiocarcinoma. 6/4: Presented to the ED again due to worsening dyspnea and home pulse ox readings in the 70s. CT chest showed moderate burden of bilateral obstructive pulmonary emboli with no overt RV strain. EKOS and clot retrieval was contraindicated d/t thrombocytopenia. Was noted to have demand ischemia, and transitioned from eliquis to heparin gtt. Vascular was consulted for eval of her ischemic right foot, and deemed that it needed amputation, but would be a high risk surgery. 6/8: Patient was transferred to this reporting institution for second opinion requested by the family. Upon arrival, patient was found to be obtunded and hypotensive requiring heated high flow nasal cannula and vasopressor with norepinephrine. Code status was deemed DNRCCA/Do not intubate per family. Bedside ultrasound was concerning for an LV mass. Cardiology and Vascular surgery were consulted and recommended that the foot be amputated as well, but requested further workup with ECHO and CTA chest/abdomen/pelvis to further evaluate the LV mass. During admission workup, she was incidentally found to be COVID PCR positive. She was started on DEXA-ARDS prednisone dosing, remdesivir, and placed in enhanced droplet isolation. Her hospital course was complicated by acute hypoxemic respiratory failure due to pulmonary emboli, COVID-19 infection, and underlying malignancy requiring heated high flow nasal cannula. Empiric cefepime was started to treat any underlying superimposed pneumonia. Due to extensive clot burden with limb ischemia, as well as + COVID, she was systemically anticoagulated with a heparin drip despite her thrombocytopenia. She was intermittently given platelet transfusions in order to keep platelet count >30. TTE was obtained on 6/11 which showed large masses in right ventricle and right atrium, vegetations on mitral valve, aortic valve, and tricuspid valve, and probable mass in IVC. She also developed AKI with oliguria related to shock and critical illness. Medical oncology was consulted and she unfortunately was not a candidate for further chemotherapy at the time due to critical illness, as well as ischemic limb. (If further treatment was pursued, she would need a left leg amputation, then would require 4-6 weeks of recovery before additional chemotherapy could be given.) She slowly became more encephalopathic and had increased oxygen requirements, requiring continuous heated high flow nasal cannula. Goals of care were discussed with her family. Given her advanced cancer, it was decided to transition to comfort-focused care. Her code status was changed to DNRCC. Symptoms were controlled with IV pain and anxiety medication. She expired on 6/13/2021 at 0225.

I noticed when I urinated about 09:15 am on 17th, the toilet paper looked pink after I wiped myself. I went again an hour later and I was experiencing irritation and issue with not urinating. This time there was a trickle of blood down the toilet. This is very unusual for me - have not experienced it before. The pink color on the toilet paper continued for about 4 hours. I was having to go to the bathroom frequently. I upped my fluid intake knowing that it may be a bladder infection. I made an appt with doctor - on the 17th - by the time I got to see her in the afternoon I saw a physician in the same office as my normal doctor - I saw Dr. - the pink on the toilet paper wasn't happening anymore. Was prescribed Cephalexin -500 mg - twice a day for 5 days. It took until yesterday before I didn't have urgency and irritation and an issue with urinating - at this point - it feels like it may be almost back to normal. We are watching now to make sure if I have any more blood or pink staining, I will get an appt with an urologist.

Patient described kidney pain for a few hours and she was freezing and her teeth were chattering for 2 hours. She stated that adverse effects resolved and she stated she has an upcoming appointment with her nephrologist.

BLOOD IN URINE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, high blood pressure, and high cholesterol, and other pre-existing medical conditions included patient has no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802025, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to Right Deltoid for prophylactic vaccination at noon.. No concomitant medications were reported. On 08-MAR-2021 16:15, the subject experienced blood in urine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood in urine. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

Face pain especially jaw bones, headache, sharp shooting pain in right abdomen, icy cold, foot cramps, extremely loud and fast heartbeat for about seven hours followed by moderately loud but still very fast heartbeat for several more hours, urination approximately every half hour throughout the night resulting dehydration.

severe chills, fever, fatigue, urinary tract infection (no symptoms before 5/02, more memory problems than previous ( normal aging, not dementia).

4/30/21: This patient comes in complaining of worsening low back pain. She has a history of severe degenerative disease in his had surgery. She was scheduled to see her neurosurgeon last year however it got canceled due to the COVID-19. Patient states she saw her neurologist on Tuesday and was given injections which significantly helped. She states that her pain has returned however. She has had no trauma. No footdrop. No difficulty with her bowel or bladder. Patient states she only uses Tylenol arthritis at home. 5/1/21:The patient is a 70-year-old female presenting to the emergency department for back pain. She has a history of chronic back pain and states that has been worsening. She was recently seen here for the same complaint. She currently rates her pain 10/10 intensity. She reports that she has chronic numbness and tingling of her bilateral arms/hands and legs/feet. She states that this is also worsening. She denies any changes in bowel or bladder function or perineal numbness. She states that she has been using a walker at home and that she has tried to make an appointment with her neurosurgeon who previously operated on her but that she has been unable to get through to their office. She reports that she only called 1 time on a Friday. She is taking Tylenol at home for her pain and reports minimal relief. She denies any fevers or associated concerns at this time. 5/2/21: This is actually her 3rd visit in less than a week with this complaint. She was seen 2 other times at a outside facility. She states that she had back surgery about 10 years ago at Beaumont. She states she was supposed to see her neurosurgeon last year but this did not occur secondary to COVID-19. Her primary care physician had referred her to a neurologist did some injections ahead some relief of her back pain for a week or 2 but this is since worsened. She states that over last several days she has had increasing numbness and tingling in her feet as well as increasing weakness of her lower extremities as well as some now some new incontinence of urine when she stands up. She today she also complains some chest pain she attributes more from just amount of pain he has from her back. She rates her back pain as a 10/10 intensity. She did have 1 episode of a week or 2 ago where she slipped down and fell on her knee but did not hit her back directly. She did not hit her head. She describes the chest discomfort in her upper abdomen lower chest area. She is nauseated but not vomiting here. She denies any exertional dyspnea or orthopnea prior to this. She has had no recent fever chills. 5/11/21: The patient is an 70 y old female admitted on 5/4/2021. The patient was originally seen by Neurology on 05/07/2021 when she presented with diffuse weakness. She has a history of hyperlipidemia, hypertension and diabetes. The patient at that time described the acute onset of weakness ascending from the feet, then involving the legs and arms also associated with sensory symptoms that started about 2 weeks prior to her presentation. She also had persistent neck and back pain radiating to her arm and legs limiting her ability to walk. On neurologic examination at that time the patient had absent deep tendon reflexes in the lower extremities and trace reflexes at the biceps. She had significant weakness in the lower extremities and mild weakness in the upper extremities. She also had a dysarthric speech. Given the patient's CSF analysis showing protein elevation to 266 with no pleocytosis, wbc's were only for, there was support for a clinical diagnosis of acute inflammatory demyelinating poly radicular neuropathy or such variant. The patient was started on plasmapheresis and has received her 2nd session of plasmapheresis on 05/09/2021. She will have a total of 5 sections, one every other day. The patient also has hyponatremia, this can be seen in about 5% of patients with Guillain-Barre syndrome, we also do see pseudohyponatremia but this is in patients that have received IVIG.

Pain down left arm, severe pain, to hand and hand was numb, up all night could not sleep. Went to ER because she thought it might be her heart, it wasn't. Diarrhea was uncontrollable, messed herself a few times, never had time to run to restroom. Had to take a leave from work. Has been out of work a month because of the diarrhea. Had a colonoscopy, endoscopy, has to go back for another endoscopy, was in the hospital. Had blood in stool. Never experienced diarrhea or pain like that before. Afraid to go back to work or leave her house because the diarrhea continues and starts without warning.

36 hours after vaccine: Pain in left side of abdomen, vomiting, diarrhea for approximately 5 hours. 1 week after: pain in left side of abdomen and vomiting approximately 4 hours 9 days after vaccine urinary tract infection

BLOOD IN URINE; TEMPERATURE WENT DOWN; This spontaneous report received from a patient concerned a 71 year old female. 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: 841A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced temperature went down. Laboratory data included: Body temperature (NR: not provided) 97.7 F, 96.4 F. On 03-APR-2021, the subject experienced blood in urine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood in urine, and the outcome of temperature went down was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

BLOOD CLOT INSIDE THE BUMP (INJECTION SITE); WHEEZING; HIVES ON NECK; BLADDER INFECTION/ABDOMINAL PAIN TO GROIN; BLADDER INFECTION/ ABDOMINAL PAIN TO GROIN; INJECTOR PULLED THE NEEDLE BACK AND PUT IT IN AGAIN; COULD HARDLY WALK; COULDN'T TOUCH THE ARM; REDNESS IS STILL AS BIG AS A BASEBALL; NAUSEA; VOMITING; HALLUCINATIONS; DIARRHEA; This spontaneous report received from a consumer concerned a 71 year old white (Hispanic/Latino) female. The patient's height, and weight were not reported. The patient's past medical history included bladder infection, and concurrent conditions included high blood pressure, high cholesterol, and asthma/ bronchitis/ get asthma attacks often. The patient's other pre-existing medical conditions included that she had no history of heart attack or pain. The patient's family history included that her mother had bladder infection and lady part infections. The patient was not pregnant at the time of reporting. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 23-JUN-2021) dose was not reported, 1 total administered on 10-APR-2021 around 10;00 AM for prophylactic vaccination on right arm. No concomitant medications were reported. On 10-APR-2021, the patient almost passed out after she got the shot (vaccination), they (vaccine facility) had to take her out to the car, and she could hardly walk. The patient reported that injector pulled the needle back and put it in again (Wrong injection technique). It was reported that right after injection when she turns around her arm was big as baseball, mushy, swollen and it was painful (injection site). The mushiness was going down, but it was still mushy. The patient's arm was hard as a marble, redness was still as big as a baseball and she could not touch her arm. On 20-APR-2021, the patient had bladder infection/abdominal pain to groin and had infection from lady's problem and further stated it as bladder infection. The patient think that the bladder infection was not because of the Janssen vaccine. On 21-APR-2021, the patient experienced hives on the neck and she applied Benadryl cream on it. The patient went to her physician on 22-APR-2021 (Thursday) and Nurse looked at her arm and said that it was perfusion and there was blood clot inside the bump. The patient's physician told her to take Benadryl and put ice and heating pad on it. The patient reported that she was already putting ice packs 3-4 times a day and heating pads 3 times a day. The patient also showed her hives to her physician and she was told to keep putting Benadryl on it. The patient had a follow up with her physician on 03-MAY-2021 for her arm checkup. On an unknown date in APR-2021 (reported as first night), she could see penguins walking around, marching up the stairs on first night (Hallucinations) and then no more penguins after the first night. On the same first night, the patient experienced nausea, diarrhea, and vomiting. On an unknown date, the patient experienced wheezing and she thinks that her wheezing was not related to the Janssen Covid-19 vaccine. According to patient her wheezing is related to her asthma. The patient did not have any trouble sleeping since she was taking the Benadryl. The patient stated that she could move her arm up and down, but she was scared to do so. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucinations, bladder infection/abdominal pain to groin, diarrhea, vomiting, and nausea, and the outcome of almost passed out, hives on neck, couldn't touch the arm, blood clot inside the bump (injection site), wheezing, could hardly walk, injector pulled the needle back and put it in again and redness is still as big as a baseball was not reported. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and wheezing, and bladder infection as not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210452551-covid-19 vaccine ad26.cov2.s- blood clot inside the bump (injection site), hallucinations. 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).

Pt had her J and J vaccine on 5/18/21. now hospitalized from home on 6/15 with a few days of chest pain and admitted with sepsis, UTI, dense rll pneumonia and new svt/tachycardia/NSTEMI, syncope, rhabdomyolysis. her hospital course was very protracted due to recurrent tachycarida/svt and she was eventually discharged to rehab on 6/23/21.

Starting on the 8th, I saw signs of blood in urine. It started being extensive and frequent. By Wednesday at 11:30 I had extremely red bloody urine with small clots. I went to ( on Wednesday) Hospital ER - they performed a handheld exam - Flomax - to see if I could expel clotting. Late afternoon the next morning, I started expelling clots in very large quantities in very large clots. It got so bad that I had my wife take me to ER but we were in the parking lot and we called the Urologist - and he said that was what it was aiming for so that it would stretch the Urethra to pass the clots. So I didn't go to the ER. That night my urine began clearing. It stayed clear until early morning. I had a little blood and then it went away again. Since Friday, after I saw my Primary care doctor, I haven't had any blood in my urine. but I did see the doctor the next morning. I will see the Urologist tomorrow.

KIDNEY STONE; WEAKNESS IN BOTH LEGS, LOWER BACK AND PELVIC AREA; MORE FATIGUE/TIRED; MORE WEAKNESS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included right hip replacement, and concurrent conditions included hypertension, penicillin allergy, and sulfur allergy, weakness and fatigue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: Unknown) dose was not reported, 1 total, administered on 27-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 2020, Laboratory data included: Arthroscopy (NR: not provided) Not reported. The patient stated that she had been experiencing more weakness and fatigue than usual since Apr-2021 three weeks after taking vaccine. Further, the patient reported that in APR-2021, the pain intensified along with the weakness in both legs, pelvic area, and lower back 2-3 weeks after vaccination. On 20-MAY-2021, she went to emergency room for kidney stone. The patient was referred to pain specialist and stated that she felt about the same and wanted her leg to work. The patient was tired and fatigued. Laboratory data included: CAT scan (NR: not provided) Kidney stone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from more fatigue/tired, weakness in both legs, lower back and pelvic area, and more weakness, and the outcome of kidney stone was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210727924-Ccovid-19 vaccine ad26.cov2.s-kidney stone. This event is considered unassessable. The event 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.

She is a 74-year female with history of morbid obesity, OA on chronic opioids, T2DM, CKD 3, HTN, and hypothyroidism who presents with 10 days of worsening fatigue and trouble ambulating. She reports that she started feeling unwell about 10 days ago with a sore throat and pain radiated to her left ear. She had trouble swallowing due to the pain and was generally tired, thinking she had strep infection or ear infection. Her sore throat resolved as did her ear pain, however her fatigue worsened and had trouble walking due to weakness. Felt like she had trouble functioning at home, soshe presented to the ED. In the ED, she is hemodynamically stable, satting low 90s on room air. Labs are significant for mild hyponatremia 133 and bump in creatinine 1.84 (previously 1.44). Found to be Covid positive, and CXR with possible right lower lobe infiltrate. Currently, reports feeling tired with poor appetite and body aches though no shortness of breath, chest pain, nausea. She has been eating foods that taste good to her, not following diabetic diet and sugars have stayed appropriate. Denies any sick contacts or leaving the house. Of note had her Covid vaccine (J&J) 3/22 in her house, and does not know where she contracted Covid.

Patient had JANSEN vaccine on 3/9/21 and developed symptoms of nephrotic syndrome and acute kidney injury 8 days later which remain unexplained.

Experienced pain within minutes in right kidney area and the right and left sides of her head. She then had a low blood sugar attack. For the following 3 days, she suffered from chills and many low blood sugar attacks. Also upset stomach and diarrhea for a few days, as well as headache and body aches. April 12th, left side of face was puffy and more headaches; continued into April 13th; also some sinus pressure/overall stuffiness June 4th- Vertigo attack; had another back in May Continues to have chills, body aches, and headaches, and tired with low energy

Patient was seen in our ER on 3/8. She stated that she had received her Johnson/Johnson COVID Vaccine on Thursday (3/4/21) and since then, had been experiencing body aches, chills, fever, fatigue, headache, n/v/d. She was admitted for treatment with IV fluids and supportive meds for the n/v/d. On 3/9, she was still feeling very ill. Fever and chills had improved but she was still not tolerating PO. BP was also elevated ranging from 142/82 to 206/80. She was also diagnosed with AKI. BUN was 51, Cr 3.26. By 3/11, she was feeling a little better but kidney function continued to deteriorate. BUN was 53, Cr 4.39. The physician decided she should be transferred to a higher level facility for her AKI on CKD. However, there were no beds available. So she remained at our facility awaiting transfer. Around 1900 that night, she experienced a bout of hypotension and decreased urine output. Chest xray was normal. EKG was NSR. She was eventually transferred to another hospital on 3/12 at 1300.

DIFFICULTY BREATHING; SWOLLEN ANKLES ON BOTH SIDES (MORE NOTICEABLY AFTER THE VACCINE); LEAKAGE/GOING TO THE BATHROOM CONSISTENTLY; HEADACHE; TIRED; HARDLY SLEPT; DEHYDRATED (THIRSTY/DRY MOUTH); DRY RIGHT DOWN IN THE THROAT; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's past medical history included lung cancer, kidney infection, headache, swollen ankles, difficulty breathing, and leakage, and concurrent conditions included neuropathy, diabetic, and high blood pressure, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient's all medications were held at the time of vaccination. The patient was previously treated with oxygen for difficulty in breathing; and experienced drug allergy when treated with influenza vaccine for prophylactic vaccination, and drug allergy when treated with naproxen sodium, chlortalidone, carvedilol, lisinopril, losartan, morphine, prednisone, tiotropium bromide, and rashes when treated with cobalt. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included paracetamol for headache. On MAY-2021, Laboratory data included: Allergy test (NR: not provided) Not reported. On 09-JUL-2021, the subject experienced dehydrated (thirsty/dry mouth). On 09-JUL-2021, the subject experienced dry right down in the throat. On 09-JUL-2021, the subject experienced hardly slept. On 10-JUL-2021, the subject experienced difficulty breathing. On 10-JUL-2021, the subject experienced swollen ankles on both sides (more noticeably after the vaccine). On 10-JUL-2021, the subject experienced leakage/going to the bathroom consistently. On 10-JUL-2021, the subject experienced headache. On 10-JUL-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dehydrated (thirsty/dry mouth), swollen ankles on both sides (more noticeably after the vaccine), leakage/going to the bathroom consistently, difficulty breathing, hardly slept, headache, tired, and dry right down in the throat. This report was non-serious.