Johnson & Johnson

Constant pinching headache, ears clogged, chills and sweats for two days. From waist down: leg weakness, nerve pain (like sciatica pain), diarrhea and couldn?t control pee twice on the night of the shot. Took Tylenol pm to be able to deal with pain and sleep a bit Feeling better today but leg pain is still strong

Stabbing pain sensation ALL OVER BODY in random places each time - legs, chest, head, neck, feet, arms, hands, toes, fingers, inside mouth - everywhere. It?s like someone is stabbing me inside my veins. Nothing helps it. Also loss of bladder control. Pectoral muscle on left side is extremely swollen and painful, my neck hurts so badly at night that I have to sleek sitting up. Please help. My doctor doesn?t know what to do.

--Days 2-3 after vaccine: fever, chills, nausea, loss of appetite, felt like skin on fire; --Days 4 after vaccine: slight reprieve, no fever, still loss of appetite, skin no longer felt on fire --Days 5-6: extreme nausea, vomiting, diarrhea -- Taken by ambulance to hospital on 4/13/21; admitted due to acute renal failure --10 day hospital stay: First 7 days with extremely low potassium and magnesium levels, put on telemetry due to low electrolytes. BP fluctuated up and down. Lactic acid & hemoglobin extremely high upon admission. I have all lab reports if necessary to provide. In fact, discharged with potassium at bare minimum of safety. Released with 3.5 potassium level. --Unable to control nausea: Zofran & Phenergan ineffective. Eventually put on IV Phenergan piggy back through IV with oral Diclegis given every 8 hours, eventually change to every 6 hours. Pain felt in upper right quadrant and lower abdomen due to multiple bowel movements (extreme diarrhea). --Tests performed in hospital showed nothing abnormal: CT Scan, Ultrasound, Endoscopy, MRI with and without contrast --Immediate follow-up with GI doctor on 4/23/21.

Fine the day of the shot (5/6/2021), woke up the next day (5/7/2021) with headache, joint pain, muscle aches, fever, nausea, dizziness and what felt like severe heartburn, frequent urination and stomach pain. As of 5/8/2021 all symptoms have subsided except for let arm still being a little tender, a little sore in left neck and that's it. Everything seems to be fine now

11pm: Fever, chills and muscle aches 3am: Chills and muscle aches worsen 6am: Weak and short of breath 7:30am: Body begins to tingle, cant really feel hands or feet, trouble breathing, shaking, eyesight worsens, chest tightens, headache 7:43am: Call husband for help, begin sweating a lot 8am: Call 911, begin convulsing, trouble talking, cant see well, trouble breathing, urinate on myself Continue to have convulsions. Taken by ambulance to hospital. Continue to have involuntary contractions, tightening of chest, trouble breathing, bad eyesight, headache. etc. Diagnosed with Dystonic Reaction and Neurologic Problem because of a vaccine complication

Increased chest pain & pressure; Increased shortness of breath; increased kidney/flank pain; brief episode of tremors, severe chills

About 9 pm I felt fatigue, I went to bed. I took 800 mg of ibuprofen and 1000 mg Tylenol as a pain medication. I drank a bunch of water and took an Emergen-C. I fell asleep by 10:00. I slept and I woke up - shocked awake around 04:30 am - I was super thirsty. My whole body was really sore and stiff and I had a headache. It was uncomfortable but not unmanageable. I decided to take more Tylenol and Ibuprofen and drink more water again. I got back in bed and was feeling a lot of symptoms - I was really sore in my thigh muscles, lower back, knees and forearms. I had slight chills; I was pretty uncomfortable. I couldn't get back to sleep - I couldn't sleep on my arm with the injection site. This was about 5 pm. I never actually had a fever. But just a lot of fatigue and body aches. For the next day or two - I took 800 mg of ibuprofen and 1000 mg Tylenol every 6 hours. Within 48 hours, the body aches started to subside. I still felt a bit fatigued and I still do feel fatigued to this day. Into the next week, I started feeling like (towards the middle of the week - about the 7th) I was having an urinary urgency feeling. It was a sensation in my lower back like a UTI was coming on. I haven't gotten one in a long time ( I use to). On Friday or Saturday, when I wiped, I was seeing a slight pinkish hue - a trace of blood - in my urine. Decided to take probiotics and Vit C. and I started to feel better. But Sunday morning, I was back to feeling pretty bad. I visited the Urgent Care on Sunday, the 11th. In the visit, they took a urine specimen. Dr. saw blood in my urine from the test. And an absence of nitrates in the urine and she said it wasn't a typical UTI. They decided to culture the urine specimen. Macrobid - 2 times a day for 7 days - antibiotics was prescribed. I felt a little better the second day of taking it, I thought, but it was up and down. Culture showed there was no UTI. Friday, the 16th, I had my annual visit with my PCP, I was feeling okay by this time. But I still had a sensation in my lower back - not a pain but a sensation and I still feel this sensation now (on my left side). She asked me to come back after the antibiotics to take another urine sample. Lab test. I feel some fatigue but I'm doing normal daily life.

Tingly/numbness in right arm immediately with injection. Lasted about an hour. Fatigue and achiness the following day. 4/17-4/19 tingly and soreness in neck and shoulders. Virtual visit with doctor on 4/19 to discuss if symptoms were related to blood clots and/or vaccine. Week of 4/25 extremely swollen and sore lymph nodes. 5/4 -5/6 fever (101). COVID test 5/5 and negative result received 5/7. Fever returned higher (102.9) on 5/8. Virtual visit with doctor 5/10 to discuss fever and fatigue symptoms. 5/13 UTI test. No infection but blood in urine. Off and on fever and extreme fatigue continue along with loss of appetite and weight loss. 5/18 in person doctor visit to check symptoms, another UTI test and bloodwork. Blood work came back normal, UTI normal, still blood in urine. 5/20 X-ray to check for pneumonia (none found) and ultrasound on kidneys and bladder to check for infection, kidneys stones (none found). Also had more blood work done that day to check for mono (had as a teen with similar symptoms). 5/24 confirmed reactivated mono. Symptoms have slowly improved since 5/23. Another test is scheduled for the future to check the blood in urine again.

Quick onset of flu like symptoms, progressed to altered mental state, unable to close her eyes. Unable to eat or drink. Her face was frozen with her open eyes fixed to the top of her head, jaw dropped. Unresponsive, unable to verbalize. I have cared for her over 15 years and have never seen anything like this . ER visit.

notes: times are approximate. I got the vaccine on day two of my period. I moved my arm a lot after getting the vaccine. My arm did not hurt, even though the rest of my body ached. 4-27-21 2:45pm: got the vaccine in my left arm. 4pm: felt fine. slightly more energy, clearer head than usual. this good mood and clear head only lasted a few hours. it ended before other symptoms began. 9pm: minor body aches, but not in arm where I got the vaccine. minor chills, shivering. 10pm: began to feel worse. moderate body aches, chills, dizzy. 10:40pm: suddenly felt much worse. severe chills, shaking, dizzy, then felt very hot, nausea. vasovagal syncope. sudden low blood pressure. did not actually faint since I know how to prevent fainting. took ginger, drank a lot of water, got ready for bed. lying in bed. felt nauseas for a few hours. this was the most uncomfortable symptom. frequent peeing. thirsty, but water went right through me. sweating. could not really sleep, not totally awake either. felt horrible. after a few hours, still lying in bed. nausea mostly went away. headache, muscle pain in jaw and face were the worse symptoms at this time. frequent peeing. thirsty, but water went right through me. sweating. felt like someone had turned the heat up. when I checked, the heat was off. felt like I had a fever for a few hours. 4-28-21 1:45pm: got out of bed. feel better than the previous night, but generally unwell. short of breath when moving. fatigue. 6pm: dizzy, weak. 4-29-21: 3pm: mild headache, feel mildly hot. 4-30-21: 10pm: tense muscles, especially in my face and head. 5-1-21: sore breasts. 5-4-21: hormones feel unbalanced. PMS symptoms, but it is a few days after my period ended. intense negative moods, spotting, sore breasts.

At 11pm I started feeling chills and was having cold sweats. Around 1 am I went to the next room to check my temperature and almost fainted. I sat on the floor and started vomiting. I kept gagging nonstop for several minutes. During that time I urinated on myself, I felt strong stomach aches, headache, and my body felt extremely fatigued. I was dizzy and sweating. All these symptoms came back again a few minutes later. I do not remember how long everything lasted. I woke up the next day with a slightly upset stomach and headache.

Pt received vaccine 4/1/2021, started to feel ill 4/11/2021 thought it was allergies. Continued to current date 5/6/2021. Had 3 different occurrences where she passed out. Dates were 4/30/2021, 5/5/2021, and today 5/6/2021 which lead to current admission. Came to ER found to have saddle PE from CTA scan. Went to Cath Lab and had INARI procedur to remove clot. Sent to ICU afterwards, was found to have DVT in left leg from ultrasound, started on argatroban. Currently is still in ICU, was admitted to ICU from cath lab today.

Kidney nephritis. After 6 weeks, I am still currently being treated for this and no ETA has been given on how long the inflammation will last. I start another high dose of steroids tomorrow to help with the inflammation. So far the following medication have been prescribed for the pain in my right side from my paraspinal near my T4 around to the front of my ribcage are: Cipro, Macrobid, 60mg Prednisone, anti-nausea medications, Flexeril, Naproxen ER, and Tramadol.

Acute bacterial bronchitis, acute urinary infection, bladder infection, dehydration, fever, headache, migraine, Viral syndrome

The patient received the vaccine on April 7, 2021. Almost immediately after the vaccine, the patient developed some nonspecific complaints of headache, myalgias, arthralgias, fever and chills. The symptoms lasted for several days and then seemed to resolve. She was then at her baseline until approximately April 15, 2021 when she noted that she was becoming bruised. She had multiple ecchymoses on her lower extremities and this has never happened to her before. She apparently began taking aspirin at that time. According to the patient, she took 325 mg of aspirin on April 15th, 16th, and 17th. She did not take any aspirin on April 18th but then on April 19th, she took 650 mg of aspirin. On April 19, she had a telehealth visit. They recommended that she go to an urgent care. She went to an urgent care on the afternoon of April 19. They told her that they were ill equipped to take care of her and then sent her to the emergency department. On arrival in the ED on 04/20/21 she was afebrile. O2 saturation was 99% on room air. Her other vital signs were unremarkable. Her initial laboratory studies were notable for white count of 6.6 with a hemoglobin 15.2. Her initial platelet count was 5,000. Initial chemistry panel was completely unremarkable. She was not having any headache, dizziness, nausea, vomiting, blurred vision or any neurologic symptoms. She thinks that her lower extremities are swollen. She was not having any myalgias or arthralgias. Not having any abdominal pain, nausea vomiting, diarrhea, dysuria, urgency, frequency. . The patient has no other specific complaints.The patient was admitted on 04/20/21.

At three AM I woke up with the room spinning, I couldn't focus, felt like I was falling. I had horrible pain in my back. I was sweating and vomiting. My husband carried me to the car and brought me to the ER. At the Er I was given a patch for my back pain, medicine for the dizziness and nausea. The dizziness didn't subside. I couldn't walk. I told them I had gotten the vaccine two weeks before and they said it wasn't related. I was diagnosed with a bladder infection, high blood sugar, and vertigo. I was discharged in the evening but with no improvement. I was not able to focus or walk for days. I saw my OBGYN, he was the only doctor I could see right away and he referred me to an ENT. The ENT can't see me until the end of June. I wasn't able to drive for weeks. I am slowly regaining my balance but still feel waves of dizziness and my eyes can't focus well when I am reading. The back pain is gone. My OBGYN also doesn't feel the dizziness is related.

3/13 vaccination. 3-4 hours later, I started having symptoms to include tickle in throat, post nasal drip. By 11:40 I had a HA, I was very tired, quite a bit of secretion. I continued taking Benadryl every 3 hours. At 2 :30 PM, heart palpitations and angina. My BP was 98/69. I took more Benadryl, drank some fluids. By 4:15, I was getting drowsy and tired, having pain in multiple joints through my body; 8/10 scale, especially in my hands in feet. I took something for pain. My arm was very sore. I had mild to moderate slight cough. By 7:40 PM I took my regular medication. I was having a sudden intense HA and pain in joints was 9/10. I was having stiffness, chest congestion, feeling 'flu like' symptoms, brain fog, and weird pains / electro shock pains on extremities. By 830, my symptoms increased to almost a really bad allergic reaction. I couldn't think well, dizzy, cough, chest congestion and my lungs started to hurt. By 10:30pm, I started to have a low grade fever, pain 9/10, I took Ibuprofen and Benadryl every 3 hours. 3/14 Ibuprofen, slight fever, slight HA, joints were swollen and stiff; 8/10 on pain and stiffness. I had muscle pain and brain fog, could not say words. Dull pain back of head. My kidney area, I felt like it hurt, severe anaphylactic reaction it felt like. I still had photophobia. It continued into the evening. I continued taking the Benadryl and ibuprofen. Around 6pm, I had 101.5 temperature, nauseated, crying, chest congestion. By 10:45, my temp was going up again. Monday I had low grade fever, continued medication. Symptoms continued for a few more days with palpitations, brain fog, pain in lungs and kidneys. I couldn't do anything. By the end of the week, I started to recover. *My PCM knew before I got the vaccine they were on board and knew what was going to happen in regards to my reaction, EKG, I had epi pen, didn't pass out, I decided I was going to stay home. *It took me a good couple weeks to recover to my baseline. But it was pretty tough.

I received the vaccine on March 27, 2021. Seconds after the injection was completed my vision went blurry, but it only lasted a few seconds. On March 28, 2021 I felt like my body was going to explode. My blood in the back of my head was thumping. I tried to take a nap to calm my body down but my body felt comp!eye unrest and thumping. My urine made the whole inside of the toilet water look like a white thick cloud. I have never seen my urine look like that in my life. I used my husbands blood pressure monitor and my blood pressure was 152/104! I arrived at urgent care about 5:30 PM. They gave me a blood pressure pill. I have never had a blood pressure pill my entire life. They also took a urine sample since I told them about the my very strange looking urine. They found protein and blood in my urine. The culture days later showed no infection. I am still having issues with the high blood pressure.

Painful injection. Arm immediately went numb. 15 mins later feeling restored. 6 hours later got chills fever muscle aches frequent urination twitching from muscle spasms. Face felt like it was on fire, sweating, headache however body pain was so so bad. My heart rate stayed around 128-130 bpm for 6 hours. Tight chest heard to breathe

Fever, Body ache with tremendous pain in legs. Experiencing early symptoms of periods with mild blood while urinating

Patient is a 46 year old female who was admitted on 4/27/2021 for ACUTE DVT, UNSPECIFIED VEIN. 46 year old female with past medical history of POTS and on chronic hormonal oral contraceptive medication, and reported history of recurrent renal stones. Patient presented to ED after several days of left upper quadrant pain and tenderness, that worsened and became associated with nausea and vomiting. Initial evaluation by imaging demonstrated left renal stone in left renal pelvis with associated mild hydronephrosis. Incidentally on imaging, patient had DVT noted in right illiac vein with continuation into IVC. Subsequently admitted and started on heparin drip and pain control.

Exhaustion Headache Dizziness Watery eyes Feels like bronchitis Muscle aches Arm discomfort Radiating pain all Over body Double vision Hazy vision Easily get out of breath Bright yellow urine output Insomnia

Had vaginal ulcers and pain/burning upon urination. Went to a medical facility to be evaluated. The physician was convinced I had genital herpes. Symptoms lasted about 7 days

Hi I had been given vaccine at 12:30 pm Had very unusual burping non stop till Later that day around 8 pm I got chills Fir about few hours I got tightness of the head Then my body started to hurt , like my bones where braking , kidney very fast filled up with urine I had to pee very often Then I felt like every molecule of my body was burning that was for few hours I couldn?t sleep The burning was all over body Though I didn?t take temperature I didn?t sweat Was unusual burning not topical of high fever It?s all stored by 2:30 am I have noticed that I got skin allergy Rash on my fingers And also they are swollen Like as if my body has holding liquid

Symptoms include: vaginal spotting (blood) (not on period at the time), headache, urinary tract infection

When I woke up, I was shaking really bad. I was freezing. I had the chills. It was 101. I kept going to the bathroom that night - 7 times. My hands went completely numb - both of them. I felt like I was going to throw up but didn't at that time. I couldn't breathe. My chest was heavy and hurting. I had tons of blankets on but couldn't get warm and was up all night sick. I felt like I couldn't walk - I had no strength to do anything. I had to hold on to things to get to the bathroom. I did throw up the next couple of days and I couldn't eat the next couple of days. I tried to call my doctor - and they told me take Advil/Tylenol for pain. They told to me to keep drinking even though I was throwing. I was throwing up for four days. My arm was sore for a week at least. My hands are still numb. This hasn't gone away since I've gotten the shot. My bladder - I'm in more pain from it - it's worse pain than my normal - it exacerbated it. I think something from the shot did something to make my immune system not work. I had a migraine for a month - really bad headaches for a month after. I had to keep taking migraine medicine and lay down. It knocked me off my feet. I am still having the bladder issues and the numbness in my hands. I had called the doctor a second time but they didn't know what to do and only advised ER which I didn't do.

Noticed a strange smell to my urine the day after the shot and a week later had pain upon urination and blood in my urine. I was diagnosed with a UTI.

FAINTED; PUKE/ VOMITING; RETCHING; CONFUSED OR COULD NOT FIGURE OUT; FELT HOT; SWEATING PROFUSELY; COULD NOT HOLD BODY WEIGHT; COULD NOT OPEN EYES; URINATED; LETHARGIC; LOW BLOOD PRESSURE; FELT FREEZING COLD; FELT SICK AND DID NOT FEEL GOOD; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 155 pounds, and height was 62 inches. The patient's concurrent conditions included little alcohol user, and non-smoker. The patient had no known allergies. She was not pregnant at the time of report. She had no drug abuse or illicit drug usage. The patient was healthy and not taking any medication regularly. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202/ZA21A, expiry: unknown) dose was not reported, 1 total, administered on 28-JUN-2021 at left arm for prophylactic vaccination. (The patient was not sure about 3rd letter of batch number as ‘2' or ‘Z'). No concomitant medications were reported. On 28-JUN-2021, within 30 second after receiving vaccine the patient did not feel good. She asked for water to her son while waiting she fainted. She urinated. She woke up after a while, felt confused or could not figure out what was going on. She was lethargic. She felt ‘so hot' for 30 minutes. She was sweating profusely. She sat down on the floor and felt sick, retching several times and finally vomiting/ puke. She could not hold her body weight and could not open eyes. Patient was taken to the hospital via ambulance. In ambulance patient received IV anti-nausea medication. In emergency room (ER) bloodwork up and electrocardiogram (ECG) was done and both were normal and she had really low blood pressure (did not recall the exact measurements). She felt freezing cold and needed warm blankets until her body temperature finally regulated, an hour later. After 3-4 hours she felt better and went home. She has not sought any further medical care after this occurrence. She was hospitalized for 3 hours. She was feeling better at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, puke/ vomiting, retching, confused or could not figure out, felt hot, sweating profusely, could not hold body weight, could not open eyes, urinated, low blood pressure, felt freezing cold, and felt sick and did not feel good on 28-JUN-2021, and lethargic on 29-JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210708856-COVID-19 VACCINE AD26.COV2.S-Fainted, Puke / vomiting, Retching. 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).

On 03-23-2021, 5pm. my symptoms started with chills and lethargic by 530p had chest pain and i felt burning my body and felt restless. The next day i had pain in my kidney area nd rib cage, was nauseous, my body was still aching, had a bead headaches, had a temperature of 99.87 and my body was so sore. I still had the kidney pain. My fever had jumped to 101.7F. The next day I had fever, chills, dizziness, kidney pain on one side, strange pain under my rib cage and sore teeth and gums. My glands were swelled up in my neck, my taste was a little off. On 3-25-2021, had two large lymph node and my felt I had a ball in my throat. the pain on my right side, I might had a right kidney stone. an ultrasound of the right kidney was performed but I do not have the results yet.

PT DEVELOPED CHILLS AT 9:15 PM ON 4/7/2021, 4/8/2021 3:17 AM, PT DEVELOPED FEVER 102, SEVERE DRY COUGH, FELT LIKE CHEST WAS SQUEEZING, BREATHING ISSUES, CHILLS, URINARY URGENCY WITH LEAKAGE EVERY 10 MINUTES AND SEVERE HEADACHE, WORSE SHE EVER HAD. AROUND 7:15 PM ON 4/8/2021 COUGH PERSISTED BUT ALL OTHER SYMPTOMS RESOLVED. PT STILL HAS A DRY COUGH OFF AND ON AS OF 4/14/2021.

Strong dizziness till lose the control of the left side of my body, headache, nausea, urgency to evacuate, couldn't control my bladder, left side of the face deformity, was unable to swallow even saliva

I experienced first day of the evening, had a hard time standing, my legs were hurting really bad. As I was driving my left leg was getting stiff, got a spasm. No side effects on my left arm. I also had a bad headache at night. I drank plenty of fluids, I do massages to relieve the pain. I also did peppermint oil and my back upper back was hurting bad on Sunday morning and by the afternoon my right arm was swollen, my joints in my hands hurt and could feel and was having pain opening and closing my hand. The rest of the week, I had constant headaches. My headaches are more intense behind my right eyeball. As the days went by I started to feel tingling sensation to my right side of my face and jaw which lasts about 6 seconds. I've had it also on my left side of my face. My legs feel very heavy and weak and I feel my les feel like they will give out. I also feel my joints hurt, on my right foot, where my joints start fusing together, my doctor prescribed a cream for my joint pain to my feet. The pain I feel on my arms, back and legs is still present. On my left shoulder I feel pain to my collar bone. I also get this pain on my back on my shoulder blade, right side as well, like a pricking, poking sensation, this pain comes and goes. I also started to have bladder issues, where I've lost muscle control and will be seen by an urologist on 06-04-2021. These are pain that I did not experience before. My right knee also got inflamed, to the inside part of my knee and pain to my right calf that comes and goes. I had an U/S of the right calf which are still pending. I also did an anti body test; i do not have the virus for covid.

2 events : 1st-4/15- Hives on both arms. Just watched them and kept an eye on them and used Benadryl and anti-itch cream, postponed allergy shots from Friday 4-16 until Monday 4/19. Hives went away in the next day or two. 2nd event-Lower right back pain achy off and on and eventually wrapping around to the right side. Went to urgent care on 4/29. They did a CT with contrast and found a large kidney stone that I would not be able to pass without surgery, referred to neurologist. Saw neurologist on 5/3, kidney X-ray confirmed an 18 mm kidney stone in my right renal pelvis. Scheduled lithotripsy with stent placement on 5/10. Had that done on 5/10. Had follow up kidney X-ray and stent removed on 5/17. Then on 5/24 another follow up kidney X-ray. Results weren?t easy to see due to gaseous distention but he thought I had passed most of the larger particles. Will see him in 6 months. May see him sooner because I?m still experiencing achy pain in the same areas off and on that same side.

I experienced a week later after receiving my J&J vaccine, inflammation to my legs and hands, I have water retention, feel very sick, have kidney pain which I did not have before getting the J&J vaccine. When I was getting my vaccine, I told the nurse that was putting the injection, that I have history of high blood pressure but I do not take any medicine, the nurse said it was fine that I should be okay. I also experienced swollenness to my face. I went to the ER on 05-27-2021 due to how I was feeling. AT the ER they performed lab work and did an echocardiogram. I recently got a type of medical insurance. I am also not working at this time due to my symptoms of retaining water in my body, where I get so inflamed to my legs and hands and face. At the ER I was told I needed to see a PCP but I do not have one at the moment since I did not have insurance when I received my J&J vaccine. I feel my quality of life has decreased since receiving the J&J vaccine. I do not have my lot# to provide at this time..

I peed some blood clots for 2 days, it was sporadic, not every time I went to the restroom. My urine turned orange.

I received my vaccine at 5;35pm on Thursday 4/8/21. I started feeling arm soreness in both arms and developed a headache, I took Tylenol at 10pm. I woke up at 3am Friday morning with body aches and still had the headache. I took more Tylenol. By 9am Friday morning I had severe adverse reactions. I still had a severe headache and body aches with muscle soreness and extreme fatigue. I also experienced chills, light sensitivity and brain fog. Around 4:30 pm I developed chest pains that lasted about one hour. My headache, body aches and fatigue have not subsided as of today. I have had a televisit with my physicians office on may 10 where bloodwork. Some of my headaches rk was requested. The results showed elevated kidney function due to the amount of Advil I had taken to control the headache and muscle soreness. The recommended Tylenol did not alleviate my headache or muscle soreness so I have not taken either medicine. Some of my headaches have been accompanied with nausea and light sensitivity. I went for a physical exam on 5/18/21 and more bloodwork was requested. It has been 6 weeks and these adverse effects have not subsided.

Patient got her vaccination on Monday morning, called on Wednesday 03/17 around 12:20 and reported that she saw Blood in Urine started wedneday, Has fever after vaccination and red spot at injection site.

High fever, 102.7 F; high pulse 160 bpm, ranged for first 36-48 hours 122-140 bpm resting rate; severe abdominal pain, kidney pain right side, constipation, severe headache, rash underarm, cold chills, and hot spells

TINGLING IN THE FEET AND FINGERS; LEFT SIDE SENSITIVE TO TOUCH; CRAMPING IN THE ABDOMEN; DIARRHEA; FREQUENT URINATION; ACHY JOINTS; SORE MUSCLES; HEADACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, dust mite allergy, and intravenous pyelogram dye allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 11:15 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced tingling in the feet and fingers. On 09-APR-2021, the subject experienced left side sensitive to touch. On 09-APR-2021, the subject experienced cramping in the abdomen. On 09-APR-2021, the subject experienced diarrhea. On 09-APR-2021, the subject experienced frequent urination. On 09-APR-2021, the subject experienced achy joints. On 09-APR-2021, the subject experienced sore muscles. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in the feet and fingers, diarrhea, and nausea on 09-APR-2021, and left side sensitive to touch on 10-APR-2021, was recovering from headache, and had not recovered from fatigue, cramping in the abdomen, frequent urination, sore muscles, and achy joints. This report was non-serious.

INJECTION SITE PAIN; BLOOD IN URINE; ARM REDNESS; This spontaneous report received from a pharmacist concerned a 50 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, intramuscular, batch number: 1805031, expiry: 26-MAY-2021) 0.5 ml, administered on left arm on 15-MAR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced blood in urine. On MAR-2021, the subject experienced arm redness. On 15-MAR-2021, the subject experienced injection site pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/zinc oxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood in urine, and the outcome of injection site pain and arm redness was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Within 5 minutes from receiving my J&J vaccine, I went to sit down and I started feeling very hot in my body. My heart started to race, had chest discomfort and had trouble breathing, my trachea closed up, had blurry vision and pain in my chest. I felt like I could not breathe and when the nurse came over to ask me I could not speak to her, I went into a shock and I was placed on the floor and I could not hear anything nor could open my eyes, from my hips down to my feet I could not feel anything, my legs went completely numb and I had a syncope. What I was told from the nurse that I was given an Epi-pen to help with my reaction. When I came back my body was having convulsions, felt my head spinning, had pain in my chest that so very intense and the nurse got me up and took me to a nearby ambulance and the EMT staff placed like a heart monitor because my heart was racing super fast. I also felt heaviness in my chest and inside the ambulance I was given two injections on my left arm and when I slowly started coming back, I was already at the hospital. I was at the hospital from 2pm to 4:30pm more less being monitored. At the hospital x-ray of the chest was performed as well as lab work and I was discharged home. When I got home, I still did not feel good, I felt heaviness to my chest, still have trouble breathing and get chills during the night. I also could not stand up and have a nerve sensation to my body and the chest pain to my left side is still very present. I have blurry vision, dizziness, headaches, and my heart-beat continues to race very fast. I get headaches, have abdominal pain and I peed blood few times then that's when I was able to pee, my abdominal pain was painful like having a baby. On Friday 04-08-2021, I again went to the hospital because I had fallen to the floor on my kitchen floor and my daughter took me to the hospital. I let the nurse staff know that I still have continued chest pain and pressure, difficulty breathing and headaches, dizziness and they monitored and gave me three pills as medication. I was discharged home about 5pm with a referral to see a neurologist due to my chest pain, blurry vision, dizziness and fever which I had these past three weeks. I do not know why I felt all these symptoms after my J&J vaccine.

fulminant liver failure (INR 3.0, AST and ALT > 2600, Tbili 2.0) without identifiable autoantibodies expected for autoimmune hepatitis, course complicated by retiform purpura and digital/acral lower extremity necrosis, dermatologic biopsy confirmed thromboembolic vaso-occlusion throughout the superficial and mid-dermal vessels without evidence for vasculitis, rheumatologic evaluation without cause, hereditary and acquired thrombophilia evaluation without cause

MEDICATION INDUCED COLITIS; RECTAL BLEEDING; RENAL INSUFFICIENCY; MUSCLE TENDERNESS; HEADACHE; NAUSEA; REDNESS AT INJECTION SITE; FEVER; GENERALIZED ITCHY RASH; SWELLING AT INJECTION SITE; DIZZINESS; RINGING IN THE RIGHT EAR; INTENSE MUSCLE/JOINT CRAMPING; JOINT TIGHTNESS; LUMP AT INJECTION SITE; BLOATING; UNABLE TO EAT OR DRINK; HAD POLYP; SMALL INTERNAL HEMMORRHOID; This spontaneous report received from a patient concerned a 50 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, and batch number: 1805029 expiry: unknown) dose was not reported, 1 total administered to left deltoid on 14-MAR-2021 for prophylactic vaccination. The patient received Benadryl unspecified (form of admin and route of admin were not reported, batch number: unknown expiry: unknown) dose and frequency were not reported from MAR-2021 for itchy rash. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, after eight hours of vaccination, the patient woke up with intense muscle cramping which she had anticipated but also had joint cramp. The patient had temperature of 103.5 (unit unspecified) and the patient's right side of face was itching down into under her ears which also started to swell. The patient had a rash on her legs, arms, face and everything was itchy for her. The patient took a diphenhydramine (Benadryl) and then she had headache, dizziness, ringing in the right ear, nausea, and her fever jumped to 104. The patient laid down her head into floor because the dizziness was so bad and she ended up in more muscle cramping. The patient's fever never went away but went down and did not go for about a week and three days; the fever was just hanging out at 100 (unit unspecified) the whole time. The patient's dizziness and ringing was going on and also had GI (gastrointestinal) problems and really bad headache. The patient called a healthcare company and ordered meclizine (Meclizine) but did not specified she administered it or not. On 26-MAR-2021, the patient could not take the stomach pain, cramping, diarrhea, high fever, rectal bleeding and mucusy and bloody stool. The patient had intense abdominal pain and GI (gastrointestinal) issues after three days of her fever and was taken to ER (emergency room) and was confirmed that the patient had renal insufficiency and medication induced colitis. The patient had colitis and was given with metronidazole (Flagyl), however she had low grade fever, dizziness, ringing in ears, really bad headache and was admitted to hospital on 28-MAR-2021. The patient's CRP (C-reactive protein) was up, lactic acid was elevated, hemoglobin went from 14 down to 12, WBC count elevated, occult blood was positive and also had rectal bleeding, a foggy headache and dizziness feeling. The patient felt something was way off in her body at the side, also had a small orange halo on arm at the injection site which got resolved after four days. The patient had undergone unspecified tests and the results was negative. The patient liver enzymes were too off which was hand in hand with medication induced colitis. The patient had a small internal hemorrhoid and removed a polyp. The patient's heart rate experienced some issues as well. The patient was hospitalized for 6 days. The patient was discharged on 02-APR-2021.The patient had a follow-up with her physician on the next day of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with Benadryl unspecified was not reported. The patient recovered from had polyp on MAR-2021, generalized itchy rash on 16-MAR-2021, muscle tenderness on 06-APR-2021, and redness at injection site on 18-MAR-2021, was recovering from ringing in the right ear, rectal bleeding, medication induced colitis, joint tightness, lump at injection site, bloating, swelling at injection site, and small internal hemorrhoid, had not recovered from fever, headache, and dizziness, and the outcome of intense muscle/joint cramping, nausea, unable to eat or drink and renal insufficiency was not reported. This report was serious (Hospitalization Caused/Prolonged, and Other Medically Important Condition). This case is associated with the product quality complaint number 90000176228. This case is a duplicate of 20210429754. Additional information was received from patient on 13-APR-2021. It was determined that Manufacturer Case Number 20210429754 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20210427282.; Sender's Comments: V0: 20210427282-covid-19 vaccine ad26.cov2.s- rectal bleeding, medication induced colitis, renal insufficiency and had polyp. 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: CONMEDS-OTHER SUSPECT DRUGS

Hour or so after the vaccine experienced rapid heart rate and onset of headache and fatigue, injection site pain. 8-10 hours after vaccine symptoms increased to include headache, body aches, fever, chills, muscle and joint pain as well as continued injection site pain. Inability to sleep first night frequent urge to urinate. Symptoms lasted 48 hours.

Around 4:30 pm April 6 I became very cold and my fingertips went numb and fingernails turned purple-ish. This lasted for 2 hours until I could soak in a warm bath April 6 5:00pm- April 7 8:00 pm Slight loss of urinary control; leaking urine on the way to use toilet and very frequent trips to toilet April 7. 12:30 am 103.8 fever. Reduced when I took 2 extra strength Tylenol

Aprox 2 hours after Vaccine, I started having TMJ pain (left jaw) , Headache, Gerd pain (chest and back pain), kidney pain (lower back pain) and extreme fatigue. This lasted for a couple hours straight. By morning it was dull pains. 2 days after, I had 2 instances where I had lower back spasms (kidney area) and strong urine odor. 3rd day and beyond, I am back to normal.

COVID-19 Vaccine Johnson and Johnson Covid vaccine yesterday 1330 Chest hurts, nasal congestion, chills last night after the vaccine Pt had negative covid test 5 days ago pt had screening while in the hospital for chest pain pt had normal ekg then Pt has achy and tingling in chest and body aches denies fever states does have chills also c/o diarrhea one to two episodes last night and not today is drinking water well Pt states was very tired last night Since yesterday patient has worsening symptoms, Today she has increased her oxygen use and continues to feel that she cannot breathe, she presents with chest pain, fatigue, nose is running, chills, cold sweats, cough, abdominal pain and dizziness. She received the Johnson Covid vaccination four days ago and is concerned this is related to her blood clotting disorder. She needs transportation to the ED. Hospital admission on 4/16/21 - remains inpt. Diagnosis patient iss is a 51 y.o. female with complex past medical history. Including chronic obstructive pulmonary disease currently on 4 L nasal cannula at night. Active tobacco use, remote history of alcohol and polysubstance abuse she has been in remission for 20-25 years from crack cocaine and alcohol. She used methamphetamine 6 months ago. Benign essential hypertension and insulin dependant diabetes mellitus, gastroparesis, bipolar disorder, schizoaffective disorder, psychogenic nonepileptic seizure. Presented to the emergency department with chief complain of worsening shortness of breath along with right side lower abdominal pain and urinary symptoms including dysuria and burning sensation. Upon arrival to the emergency department patient was hypertensive and her oxygen saturation was 87 on room air, with moderate respiratory distress. Initial ABG showed pH of 7.25 with pCO2 of 98 following ABG showed 7.1 and pCO2 of 104 she was placed on BiPAP which has improved her breathing and respiration follow-up ABG showed pH of 7.3 with pCO2 of 73. CT angiogram was negative for pulmonary embolism, showed finding of acute bronchitis/aspiration, CT of the abdomen and pelvis was unremarkable. Urinalysis was negative. Patient was giving 125 mg Solu-Medrol along with magnesium and DuoNeb breathing treatment, and admitted for further management.

Patient had noticed some mild bruising 1 month ago and had recently received Janssen vaccine on 5/21/2021. She developed severe bruising to the site of injection on left arm. Later she developed more bruising on abdomen, wrist and arms. She presented to the hospital with right flank pain with kidney stone and found to be severely thrombocytopenic of which likely was ITP. Received IVIG and steriods with improvement in her platelet response. Thankfully no bleeding. Patient has been in hospital for 4 days and still hospitalized at the time of this report.

01APR - Vaccine 02APR - Chills, 2 hours 12APR - Onset hot/cold flashes, paresthesia 23APR - Onset bilateral Bell's Palsy, loss of taste, pain in kidney area; continuation of hot/cold flashes and paresthesia in arms, legs, mouth area, esophagus and lungs 23APR - Antivirals, prednisone, 1 week + XS Tylenol for pain 23APR-02MAY - severe pain, over time moving up the spine and into the shoulders and neck. Stopped after 02MAY. 01MAY - Suspect Lyme, begin 3 weeks antibiotics; hot/cold flashes cease. 01MAY-09JUL - gradual improvement of paresthesia, return of taste, and facial paralysis 09JUL - partial loss of vision in left eye 21-24JUL - hospitalization

Patient awoken by joint pain, primarily of hip and knees, progression to wide spread neuralgias, focal kidney pain, temp 99.9 degrees, emesis x 12, loss of appetite, paresthesia of hands and feet, headache and sinus headache (worst headache pain of life, pain scale 9), sinus drainage, photosensitivity, inability to focus eyes to read, extreme fatigue lasting 30 hours. headache and paresthesia unresolved at time of this report. UC worsened.

Severe headache Extreme urgency for urination, pain (abdominal near bladder, and left back), bladder pressure, weakness, also loss of control of bladder. Received diagnostic test for UTI on 3/29/21 - no infection found, referral was made by doctor to urologist possible link to vaccine.

Already had hip pain, side pain and abdomen pain weeks before taking the Janssen shot. Only had a severe headache and fatigue for 2 days after taking the shot , started on 3-25-2021 and ended by the end of the day on 3-26-2021. Chest tightness started on 3-27-2021 and still on going today. I didn't think anything of the chest pain or the headache because I suffer with migraine headaches and occasional shortness of breath due to (CHF)

NO APPETITE; NO TASTE; PAIN IN KIDNEY REGION; CHILLS; SEVERE HEADACHE; FEVER; This spontaneous report received from a patient concerned a 52 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: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced no appetite. On 09-APR-2021, the subject experienced no taste. On 09-APR-2021, the subject experienced pain in kidney region. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced severe headache. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) over 100 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, fever, chills, no appetite, no taste, and pain in kidney region. This report was non-serious.

- Symptoms: - nausea, headache, unable to eat due to nausea - liver HBV elevated reported from blood tests - yellow urine - yellow skin all over body - chill Treatment: - livery biopsy on 6/14 at hospital - No clear treatment, patient 's condition is not improving at this time when reporting this form.

POSSIBLE BLOOD CLOT ISSUE; ELEVATED HEART RATE (OVER 100 AT REST); KIDNEY PAIN; NO APPETITE; FLU LIKE SYMPTOMS; SWOLLEN GLANDS IN NECK; SERIOUS BRAIN FOG; DIARRHEA; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to contrast dye. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: unknown) dose was not reported, 1 total, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021 after getting vaccination, the patient experienced elevated heart rate of over 100 at rest for four days. On an unspecified date in JUN-2021 after vaccination, the patient also experienced shortness of breath, headache, kidney pain, diarrhea, no appetite, flu-like symptoms, swollen glands in neck, aches and pains and had severe fatigue. On 14-JUN-2021, after four days of vaccination, the patient heart rate decreased to a healthier range but shortness of breath, headache, swollen glands, extreme fatigue and diarrhea continued. The patient also had serious brain fog. On 21-JUN-2021, after 11 days of vaccination, the patient had a severe shortness of breath and the patient's PCP (primary care physician) directed patient to visit an emergency room in a hospital. The patient took blood test and showed an elevated d-dimer indicating possible blood clot issue. The patient could not perform lung CT (computed tomography) or angiography due to a severe allergy to contrast dye. The patient also had an MRI (magnetic resonance imaging) of brain and ultra sound of the legs and the results were normal. The patient was on day 16 post vaccination at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated heart rate (over 100 at rest) on 14-JUN-2021, had not recovered from flu like symptoms, swollen glands in neck, possible blood clot issue, serious brain fog, and diarrhea, and the outcome of shortness of breath, kidney pain and no appetite was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210660381-Covid 19 Vaccine ad26.cov2.s-Possible blood Clot. 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).

NON-ISCHEMIC CARDIOMYOPATHY; CONGESTIVE HEART FAILURE (TROUBLE BREATHING, FLUID RETENTION, SWOLLEN HANDS, ABDOMEN EXTREMELY DISTENDED, ACUTE SYSTOLIC HEART FAILURE, HEART WAS EXTREMELY ENLARGED); PREMATURE HEARTBEAT; BLOOD CLOT; KIDNEY STONES; SORENESS IN THE LEFT ARM; PAROXYSMAL ATRIAL FIBRILLATION (SYNCOPE, COLLAPSE); This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 240 pounds and height was 174 centimeters. The patient had no known allergies and no heart condition before the vaccine administration. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 42A21A and expiry: unknown) dose was not reported, 1 total administered on 06-APR-2021 around 11:30 on the left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, right after the administration, the patient experienced soreness in the left arm, but nothing patient could not handle. Since 06-APR-2021, the patient experienced syncope/ collapse episode and was in detox several times, had to have a loop monitor inserted into her chest. Patient was diagnosed with paroxysmal atrial fibrillation. On 17-APR-2021, around 09:00 patient had trouble breathing, abdomen was getting distended, by 15:00 patient was looking like 9 months pregnant, patient's hands were very swollen, abdomen extremely distended. Patient was admitted to the emergency room (ER) and was made stabilized. Patient had a computerised tomogram (CAT) scan and all sort of testing and it was determined that patient had fluid retention. Patient was treated with Lasix (furosemide) to get the fluid off. On 19-APR-2021, patient underwent an echocardiogram and was diagnosed with congestive heart failure, non-ischemic cardiomyopathy, acute systolic heart failure (with ejection fraction= 25%). Patient was sent to another hospital with a cardiac center, where was told that arteries were clean but heart was extremely enlarged. Then patient was hospitalized for 4 more days and sent back home. Cardiac team put patient on high blood pressure medicine because they wanted patient's blood pressure to be around 90/60. Treatment medications were started which included metoprolol 25 mg 3 times a day, then lowered to 25 mg twice a day. Patient was also started with Xarelto (rivaroxaban) 20 mg once a day. On MAY-2021, the patient had kidney stones. On 28-JUN-2021, the patient had first blood clot under the blood thinner. Patient had shortness of breath (extremely painful, like someone was stabbing). From that patient was taking Lovenox 110 U twice a day and was told that would need to take that for the rest of her life. Patient had second blood clot six days after the first one, it was smaller than the first one but extremely painful too. On an unspecified date, the patient had premature heartbeat. Laboratory data showed elevated troponins. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness in the left arm, blood clot, paroxysmal atrial fibrillation (syncope, collapse), premature heartbeat, kidney stones, congestive heart failure (trouble breathing, fluid retention, swollen hands, abdomen extremely distended, acute systolic heart failure, heart was extremely enlarged) and non-ischemic cardiomyopathy was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210730842-covid-19 vaccine ad26.cov2.s-blood clot, congestive heart failure (trouble breathing, fluid retention, swollen hands, abdomen extremely distended, acute systolic heart failure, heart was extremely enlarged), non-ischemic cardiomyopathy, paroxysmal atrial fibrillation (syncope, collapse), kidney stones. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Chills and shaking until 4:00 AM. Along with chills, symptoms of head cold. Slight runny nose, slight pain in both ears and throat. Feverish feeling, ears, face, and feet hot. By 4:00AM chills subsided and headache began. Also, urinated a lot during the night, but was not drinking. Very uncomfortable and couldn?t sleep. Symptoms as of 5:00 PM: slight headache, post nasal drip, stuffy feeling head. Much better than last night.

Shot burned severely going in and for about 30 minutes after. Developed low grade fever that night and arm was very sore. Some mild body aches. The next day, I felt fine other than my arm was sore. I had a very large, firm lump at the injection site for about 8 days.

3 days fever, chills, muscle aches & pains, Migraine Headaches, Nausea, Diarrhea, UTI, Dizziness, lethargic, sore throat

SEVERE DIARRHEA; BURNING RASH; NAUSEA; FLU-LIKE SYMPTOMS; SEVERE BODY ACHES; BURNING SENSATION WHEN URINATING; 4 FALLS; FELLS LIKE SOMETHING IN THROAT; BEDRIDDEN; REDUCED ABILITY TO PERFORM DAILY ACTIVITY; MEMORY PROBLEMS; TINNITUS; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included cancer.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 on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced burning sensation when urinating. On 2021, the subject experienced 4 falls. On 2021, the subject experienced fells like something in throat. On 2021, the subject experienced bedridden. On 2021, the subject experienced reduced ability to perform daily activity. On 2021, the subject experienced memory problems. On 2021, the subject experienced tinnitus. On 12-MAR-2021, the subject experienced severe body aches. On 12-MAR-2021, the subject experienced nausea. On 12-MAR-2021, the subject experienced extreme fatigue. On 13-MAR-2021, the subject experienced severe diarrhea. On 13-MAR-2021, the subject experienced flu-like symptoms. On 13-MAR-2021, the subject experienced burning rash. Treatment medications (dates unspecified) included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhea on 22-APR-2021, was recovering from burning rash, and nausea, had not recovered from extreme fatigue, memory problems, flu-like symptoms, and severe body aches, and the outcome of 4 falls, burning sensation when urinating, bedridden, reduced ability to perform daily activity, fells like something in throat and tinnitus was not reported. This report was non-serious.

5/10/21 - I began to urinate uncontrollably for 20 minutes and off an on during the night and early morning. 5/11/21 - At 1:45 p.m., I noticed a rash on my left upper thigh (quadracept). This rash disappeared within 30 minutes of discovery. 5/11/21 - From 2:00 p.m. to 2:15 p.m. I had a fever. I had the shot at the pharmacy on 05/10/21.

URINARY TRACT INFECTION SYMPTOMS (URGENCY TO URINATE AND BURNING)/ ELEVATED WBC AND NITRATES; UPSET STOMACH; INCREASED FREQUENCY OF BOWEL MOVEMENTS/NUMBER 2 MORE OFTEN; STIFF NECK; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 235 pounds, and height was 64 inches. The patient's past medical history included hysterectomy, gall bladder removal, lost voice, urinary tract infections, factor v leiden, and biceps tenodesis, and concurrent conditions included high blood pressure, seasonal allergies, and environmental allergies ( cannot use cleaners wheeze and headache with bleach, perfume).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included salbutamol for allergies, amlodipine for high blood pressure, lisinopril for high blood pressure, and epinephrine for stings. On 09-APR-2021, the subject experienced stiff neck. On JUN-2021, the subject experienced upset stomach. On JUN-2021, the subject experienced increased frequency of bowel movements/number 2 more often. On 16-JUN-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Enlarged liver, but her bladder was emptying properly, and Urine analysis (NR: not provided) Not reported. On an unspecified date, the subject experienced urinary tract infection symptoms (urgency to urinate and burning) / elevated wbc and nitrates. Laboratory data (dates unspecified) included: Urinalysis (NR: not provided) positive for increased WBC, nitrates and negative for infection, positive urinary tract infections. Treatment medications (dates unspecified) included: ibuprofen, nitrofurantoin, azithromycin, phenazopyridine, and phenazopyridine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from urinary tract infection symptoms (urgency to urinate and burning)/ elevated wbc and nitrates, and increased frequency of bowel movements/number 2 more often, and had not recovered from stiff neck, and upset stomach. This report was non-serious.

Sudden intense pain in neck, chest, head area (so intense that I had a root canal tooth removed hoping this was the cause, although my dentist could not see anything, and it didn't help). Pain and tingling in my arms. In addition a few weeks into it pain in my inner thighs and strange bruising patterns down my thighs, and tingling legs. severe bladder pain, and constant feeling that I need to go to bathroom (bladder infection was ruled out). Pain is usually much worse at night. Sleep has become very difficult. Throat issues to a degree that I constantly have to clear my throat before I'm able to talk Massages, acupuncture helps, also tried PT for jaw area. IV immunity drips (does not help) Saw 2 general practitioners, one osteopath, one gynecologist, and dentist. There are days which are better and then days where I can't work and need to cancel my patients.

low grade fever, chills, body aches, headache so bad that meds would not help, dizziness, frequent urination the day after, blurred vision and fatigue.

Severe relentless shivering, high fever, explosive vomiting, excessive urination and deffication - about 36 hours. Took pepto bismol to lessen symptoms after 6 hours to 36 hours, as directed. Severe headache, muscle cramping, joint pain, weakness, instability, sleepy, nausea, moderate fever, chills, sweats, difficulty keeping water, bone broth, salt cracker, pedialyte down - 3 days, now subsiding. Took Tylenol, showers, rest.

Pt received J&J covid vaccine on 3/15/21 in.presented to the ED on 3/29 for few days of progressive weakness and urinary difficulty. Recently took a trip and returned Thursday evening. That night, she noticed mild sensitivity to her left forearm. On Friday she developed an achy feeling under both arms and across her breasts. Her eyes felt painful as well. Overnight Friday into Saturday her feet began feeling cold and numb and she developed a generalized sensitivity over her entire body that she describes almost as a burning sensation. Also had trouble urinating -. presented with pain, paresthesias and weakness below mid-chest level and urinary retention. MRI brain, C and T spi ~C and T spine c/w demyelination. Neuro consulted and impression = acute demyelinating disease, unclear etiology but may be acute disseminated encephalomyelitis (ADEM) 2/2 COVID vaccine vs. 1st presentation of multiple sclerosis. Sx gradually improved s/p solumedrol IV bid x 5d in hospital -- > transitioned to PO prednisone taper per neuro (60 mg x2 days then go down by 10 mg every 2 days until off) for discharge. Pt to f/u with neuro post discharge. For neurogenic bladder PT had temporary foley, removed 4/2 and will require CIC QID (teaching done prior to discharge) at home. Outpt f/u Urology.

Started with sore arm. During the day following the shot I developed a very low grade fever not going above 99.9. Had severe headache from the left ear to the right ear and going up around my forehead, as if my head was in a vise - all day. Heart was racing all day and night, couldn't sleep on my side because of it. around 24 hours after the shot I felt chest heaviness, which went away after a few minutes. Face was flushed, and I felt clammy. Went to the bathroom more than normal. Aches and joint pain, which weren't too bad. When I woke up the next day, symptoms were gone, except my arm was still sore and had slight fatigue.

Chills Extreme fatigue Lower back pain Pain in left shouder blade Painful/burning urination Fever Headache

I received the Jannsen Covid Vaccine on April 05, 2021 at 08:50 am. On April 09,2021 at around 04:30 am I woke up with vaginal spotting. I had a full hysterectomy in 1999, 21 years ago. Alarmed. I took myself to urgent care. I was tested for a Urinary Tract Infection and a Yeast Infection by pelvic examination. Both tests were NEGATIVE. I was prescribed Diflucan 2 doses 150mg each to take 3 days apart. I discontinued the Diflucan upon learning of the negative result for yeast. April 10, 2021 I was still experiencing Vaginal bleeding upon waking up. April 11, 2021 the spotting had ceased.

*5 hours after injection: 7:30 pm. extreme shivering/chills. Fever 101.4 major body aches and a moderate headache. I Took exedrin migraine 200 mg at 10 pm and 250 Ibuprohren tablet at midnight. Fever hovered around in 99.4 to 100 range, throughout night. Took another Ibuprohren 2:30am. Took another exedrin migraine tablet around 9am morning after injection. Frequent urination, throughout first night. I was up every hour to hour and half. 24 hours after injection. Temp back to normal. Fatigued. Butcher body aches and headache have abated. Loss of appetite, lasted several days after injection.

I woke up at approximately 9:30 AM the morning of Sunday May 2nd 2021 the day after getting my covid vaccine and had to rush to the bathroom. I proceeded to have blood and blood clots come out my urethra very urgently. I had abdominal pain and pressure. I proceeded to need to urinate blood and blood clots for approximately 4 hours urgently. I could not go far from the bathroom without having to return quickly to the toilet. I wet myself several times. The clots stopped coming around 1:30 PM. I proceeded to have to have no control over urination urge and could not leave the bathroom. Around approximately 2:00 PM I could leave the bathroom without fear of wetting myself. I continued to have a small amount of a mix of blood and normal urine passing for another hour or so. I have a picture of the blood and clots that came out of my urethra. I continue to have dull pain and pressure in my abdomen.

Patient received J&J Covid-19 vaccine on 4/9/21. Patient developed upper respiratory symptoms, fever, chills, nausea, vomiting, diarrhea, anorexia on 4/15/21. Patient tested positive for Covid-19 rapid test on 4/19/21. Patient presented to emergency department on 5/2 with continued symptoms. Patient found to be in acute renal failure with serum creatinine 23.7, BUN 179, and potassium 5.4. As of 5/7/21, patient's renal function has improved following daily hemodialysis and will be monitored for further renal recovery.

I was at work and feeling sluggish and couldn't hardly breathe. I went to the hospital and was told my kidneys were failing and my blood pressure was dropping lower and lower. My kidneys were dehydrated and I needed to get fluids.

patient received J&J vaccine during the day on 6/16. reports to ED on 6/18 for evaluation of Nausea and vomiting. She reported feeling ill on same day as vaccination with one vomiting episode same day, also reports generalize malaise and body aches. 3 additional non bloody non bilious vomiting episodes 6/17 with inability to keep anything down with constant nausea. found to have acute emphysematous cystitis and admitted at observation to our hospital. Diagnosed with worsening AKI due to dehydration.

pain starting in legs, spreading through body. rec'd vaccine in May, believes she has Guillan-Barre. states she normally walks w/out a cane and has some episodes of urinary incontinence. 54 years old with past history of asthma came in for with lower extremity weakness and pain after she was given the Johnson & Johnson COVID-19 vaccine on May 7, 2021. Patient thinks this is related to the vaccine, she thought it was progressive pain and worsening of weakness which has become unsteady. Admitted to the hospital to rule out Gilliam Barré and other progressive post viral infection myelopathies. We will also worried about multiple sclerosis. She did have a spinal tap which is completely normal with no evidence of encephalitis, meningitis or evidence of Gilliam Barre, she did also have MRI of the brain, cervical, thoracic and lumbar spines which is also completely negative. Seen by neurology and think this is likely fibromyalgia because of the weakness and pain together not clinically fitting with any post viral infection neuropathy. Patient was put on Cymbalta but this will take at least about 1-2 weeks to get the effect of improvement. She was seen by PT and OT and has some improvement to her weakness and was able to walk with assistance and recommend that she'll go home with home health to continue therapy and she'll follow-up with neurology. She may also benefit from Tizanidine if Cymbalta is not making a lot of difference.?

First night severe chills, stomach ache, tiredness. 4 days later tiredness and kidneys ached continued left to right kidneys through 3/16/2021.

Low grade fever, vomiting and diarrhea multiple times over course of 3 days. Received 3 liters of IV fluids in ER and blood work was done.

Pt received the Johnson and Johnson COVID-19 vaccine on 4/1/21. Pt had fever (hot to touch) with delusions (talking to self as reported by husband) within 24 hours of vaccine. No further fevers nor delusions since then. Within 2 to 3 days after vaccine, she developed midback (right side) pain which radiated around to RUQ abdominal, pain was sharp. It hurt a lot to sneeze. She denies nausea, vomiting, diarrhea, constipation, hematochezia, melena, or dysuria. Pt reports she is getting stomach acid reflux in her month. RUQ abdominal pain was initially 10/10, now it is constant 4-5/10 pain, 14 d after vaccination. Food does not impact abd pain or reflux. She denies heartburn. She has frequency of bowel movements (6 to 8 per day) for the last 2 days.

I am reporting per recommendation of the V-safe system/conversation. I am reporting as the patient. I received the Jansen vaccine through a special monitored vaccine clinic due to a past severe reaction to a Shingrix vaccine. I did not have any immediate symptoms after the Jansen vaccine. The following day I developed aches/pains and fever to 103, but this resolved within 48 hours. I then noticed itching, swelling and pain at the site of the injection and developed a mild headache, called my primary doctor on 4/13/21 and was seen on 4/14/21 at which time a CBC was done. CBC including platelets-normal. However, within the next few days a more severe headache then developed, which was severe enough to limit my activities by 4/16/21. Because of the rare problem of thrombocytopenia associated with clotting, it was advised I not take aspirin or ibuprofen. I also was having some mild abdominal pain, low grade fever (to 100.7), malaise, dysuria and arthralgias. My headache continued to be limiting my daily activities and on 4/17/21, I went to a Urgent Care. However, they were unable to check and get results back on a CBC within that day, I had a normal neurological exam, my UA had some abnormal findings but not clearly indicative of a UTI and a culture is pending. A rapid Covid test was negative. It was recommended that if I was concerned I could proceed to a local ED for further testing. I decided to continue to try conservative treatment and monitoring at home. As of today 4/18/21, the headache has mostly resolved and I no longer have a fever. I am still having some dysuria and joint pains.

Vaccine reaction began day of injection: sore arm, difficulty sleeping next day: generalized malaise, fever, nausea, vomiting, diarrhea, body aches, cold sweats Transported by EMS to ED for chest pain but patient reports cocaine and beer the night before Admitted for chest pain work-up and patient only has a homeless shelter to return to. Diagnosed with GERD and UTI.

No immediate reaction day of vaccination. By evening had an increase in mast cell symptoms including, dizziness, nausea, severe headache, stomach pain, mild chest pain, fluish feeling, very fatigued. Also severe left leg pain in calf (not a normal mast cell symptom for me). Symptoms still very prevalent by April 13, leg pain was worse, now in both legs. Saw primary physician Dr. He saw no swelling in legs and no treatment done at this time. April 18th headaches and leg pain was so severe went to ER. They ran a D Dimer test to test for blood clots and it was normal. Spoke with my mast cell specialist, Dr. by phone on April 19th and he prescribed 40 mg Prednisone daily for 5 days. Started prednisone on April 24th. When treatment course was finished my mast cell symptoms came back even worse than before, Had throat swelling, in addition to above symptoms. Went to Urgent Care on May 2nd, and they prescribed 60 mg Prednisone for 5 days. After this course of treatment, same thing happened,symptoms returned. Dr. suggested I follow up with my primary physician to make sure there wasn't something else going on besides mast cell symptoms. Dr. ran blood tests on May 14th, including another D Dimer which was negative. Since tests were normal Dr. prescribed a long term taper of Prednisone which I am currently on as of June 9, 2021. Saw Dr on June 1st for follow up. Continuing prednisone taper for an additional 3 weeks. Symptoms as of June 9, 2021-still very sick. I still can't eat foods I was eating prior to vaccination, worsening of mast cell symptoms and leg pain is now mild and intermittent which is better. Still have headaches but they are not as severe as they were.

The next day after vaccine, about 4:00pm - pain hit me and it was so severe I started to throw up from the pain. Short term memory/brain fog has been an issue. I've had massive migraines. Complete body aches - even my bones hurt. The worse one was on both of my arms - above the wrist - and it was horrible (mostly on the right). One big blur of pain - I'm in a lot of pain all the time. I have a constant headache. I keep losing consciousness and that started after the vaccine. It use to hit every three hours. Now it's more than that. I have been two ERs in the couple of weeks. I've been to the doctor, too. I am referred to a neurologist - can't get me in until middle of July. I pass out and when I wake up from it I am in excruciating pain - my whole body hurts. I can only take Tylenol because I'm on Warfarin. I use Tylenol as needed and ice pack and heating pad for the pain. I started to almost lose consciousness when I have been completing this but I'm okay - it is like a blanking out of the moment.

DEATH; COMPUTERISED TOMOGRAM HEAD ABNORMAL; MULTIPLE ORGAN DYSFUNCTION SYNDROME; HYPOXIA; HYPOTENSION; CONTINUOUS HAEMODIAFILTRATION; ENDOTRACHEAL INTUBATION; DEEP VEIN THROMBOSIS; ULTRASOUND DOPPLER ABNORMAL; LUNG ASSIST DEVICE THERAPY; DYSPNOEA; PAIN IN EXTREMITY; PERIPHERAL SWELLING; HYPOXIC-ISCHAEMIC ENCEPHALOPATHY; BRAIN INJURY; BRAIN OEDEMA; ACUTE KIDNEY INJURY; MENTAL IMPAIRMENT; HEPATIC STEATOSIS; THROMBECTOMY; PULMONARY EMBOLISM; PULMONARY INFARCTION; RIGHT VENTRICULAR DYSFUNCTION; ANGIOGRAM PULMONARY ABNORMAL; WITHDRAWAL OF LIFE SUPPORT; This spontaneous report received from a health care professional via a Regulatory Authority, VAERS (Vaccine Adverse Event Reporting System), concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included ethyl alcohol abuse, and concurrent conditions included hypertension. The patient had no known drug allergies. The patient had no known other illness at the time of vaccination. The patient was not pregnant at the time of vaccination. The patient had not taken any prescriptions, over the counter medications, dietary supplements or herbal remedies at the time of vaccination. The patient had no adverse event following any previous vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 21-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the patient's laboratory data included CT (computed tomography) angiography of chest showed severe burden of acute pulmonary embolism (PE) with severe right heart strain, small early infarct posteromedial left lower lobe (LLL), hepatic steatosis and interventional radiology (IR) thrombectomy procedure showed large bilateral pulmonary emboli. On 09-MAY-2021 (approximately 3 weeks after vaccination), the patient was presented to the emergency room due to progressively worsening shortness of breath. The patient also had pain and swelling in the left calf and leg. On the same day, the patient experienced brain injury, brain oedema, acute kidney injury, hypoxic-ischaemic encephalopathy, mental impairment, pain in extremity, peripheral swelling and had lung assist device therapy. The patient was hospitalized on an unspecified date. On 10-MAY-2021, the patient's ultrasound venous Doppler showed complete thrombosis left femoral, popliteal, posterior tibial, peroneal and anterior tibial veins, partial thrombosis of left common femoral vein. The patient underwent urgent thrombectomy, however, on 11-MAY-2021 (the next morning), she became more hypoxic and hypotensive and was intubated and was urgently placed on extracorporeal membrane oxygenation (ECMO). The patient developed multi-organ failure and was started on continuous veno-venous hemofiltration (CVVH) for oliguric renal failure. On 13-MAY-2021, CT computerised tomogram (CT) scan of the patient's head showed diffuse cerebral edema, which was most likely a result of hypoxic encephalopathy. With no improvement in her mental status over the course of the next few days, the patient was taken off life support and died on 15-MAY-2021 due to unknown cause. The patient was in hospital for 7 days. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death, multiple organ dysfunction syndrome, hypoxic-ischaemic encephalopathy, brain injury, brain oedema, acute kidney injury, mental impairment, deep vein thrombosis, pulmonary embolism, pulmonary infarction, hypoxia, dyspnoea, pain in extremity, peripheral swelling, hepatic steatosis, hypotension, right ventricular dysfunction, continuous haemodiafiltration, endotracheal intubation, thrombectomy, lung assist device therapy, withdrawal of life support, angiogram pulmonary abnormal, computerised tomogram head abnormal and ultrasound doppler abnormal on 15-MAY-2021. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210542597. Additional information was received from patient on 01-JUN-2021. The following information was updated and incorporated in to the case narrative: Patient demographics (race, ethnic origin), added patient history, added ethyl alcohol abuse in disease tab, added batch number, added facility type and other identification numbers updated.; Sender's Comments: V1: This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System), concerns a 55 year old female patient, who was noted to experience acute pulmonary embolism (PE), with severe right heart strain, 18 days after receiving the Janssen Covid-19 vaccine. The patient sought consult at the emergency room due to worsening of the shortness of breath. The patient also had pain and swelling in the left calf and leg. Computed Tomography Angiography (CTA) of chest showed acute pulmonary embolism (PE) with severe right heart strain, small early infarct posteromedial left lower lobe (LLL), hepatic steatosis. Venous doppler showed complete thrombosis left femoral, popliteal, posterior tibial, peroneal and anterior tibial veins, partial thrombosis of left common femoral vein. The patient underwent urgent thrombectomy. However, she became more hypoxic and hypotensive, was intubated and was urgently placed on extracorporeal membrane oxygenation (ECMO). Later, she developed multi-organ failure and was started on continuous veno-venous hemofiltration (CVVH) for renal failure. Nineteen (19) days after receiving the vaccine, Computerised tomogram (CT) scan of the patient's head showed diffuse cerebral edema, which was most likely a result of hypoxic encephalopathy. With no improvement in her mental status, life support was said to be taken off which resulted to death. It was unknown if autopsy was performed. Patient's height and weight were not reported. The patient's past medical history included ethyl alcohol abuse and concurrent conditions included hypertension. The patient had no known drug allergies. The patient was not pregnant at the time of vaccination. Information is limited in this case. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and the relationship is considered indeterminate. Additional information has been requested.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

BLOOD PRESSURE INCREASED; BURNING LIVER; EXACERBATION OF REFLUX; SHARP PAIN IN STOMACH; FELT LIKE KIDNEYS WERE BURNING; SHARP PAIN IN CHEST; FELT THE VACCINE GO TO HEAD 10 MINUTES AFTER GETTING SHOT; RIGHT SHOULDER THROBBING; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy, alcohol use, non-smoker, and hypertension, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 14:10 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, Laboratory data included: Blood pressure (NR: not provided) 144/80 mmHg. On 18-JUN-2021, the subject experienced felt the vaccine go to head 10 minutes after getting shot. On 18-JUN-2021, the subject experienced right shoulder throbbing. On 19-JUN-2021, the subject experienced sharp pain in chest. On 19-JUN-2021, the subject experienced sharp pain in stomach. On 19-JUN-2021, the subject experienced felt like kidneys were burning. On 19-JUN-2021, the subject experienced exacerbation of reflux. On 19-JUL-2021, the subject experienced burning liver. On 20-JUL-2021, the subject experienced blood pressure increased. Laboratory data included: Blood pressure (NR: not provided) 165/105 mmHg. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 100/70 mmHg. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp pain in chest, sharp pain in stomach, felt like kidneys were burning, felt the vaccine go to head 10 minutes after getting shot, and right shoulder throbbing on 21-JUN-2021, and burning liver on 21-JUL-2021, was recovering from exacerbation of reflux, and the outcome of blood pressure increased was not reported. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Chills, fever, headache, tiredness, nausea and chest pain to the left side, frequent urination, sweats

4/9/2021 10:30 am - Received vaccination 6:30 pm - Body Aches 7:30 pm - Chills and Shaking 8:00 pm - Fever from 96.9 to 98.9 9:00 pm - Fever from 98.9 to 100.1 10:00 pm - Severe Headache 11:00 pm - Fever from 100.1 to 101.50 4/10/2021 1:00 am - Fever from 101.50 to 102 2:00 am - Pains in my kidneys Throughout day, very lethargic and headache continued 8pm - Rash developed on neck and chest 4/11/2021 7:00 am - Rash moved further up my neck and pasty my shoulders 10:00 am - Called Pharmacy they recommend I go to Urgent Care or Hospital 12:00 pm - Checked in to Hospital and was treated for allergic reaction to immuzation

presentation to the ED on 4/17 with intractable HA & dizziness x3 days. Pt with MS. Normal & nonfocal neurologic exam. Given her use of Coumadin with described severe headache, head CT was obtained. This did not reveal any acute pathology. Patient was treated with a combination of IV fluids, IV Reglan, IV Benadryl, oral Valium, scopolamine patch, IV Haldol, IV magnesium, IV Decadron for combined dizziness and headache. She reported complete resolution of headache thereafter. She was able to ambulate midway through her emergency department visit but later reported intractable dizziness for which she felt uncomfortable being discharged. As such, general medicine was contacted for observation admission to obtain MRI to rule out posterior infarct and continue treatment for her intractable dizziness. MRI obtained 4/18 with and without contrast showed no evidence of acute infarct and no evidence of active demyelinating lesions. Findings compatible with known history of multiple sclerosis with supratentorial demyelination. There was no of opacified right maxillary sinus for which she will continue Flonase. Patient was seen by physical therapy who felt she was safe for discharge as she was able to ambulate independently without persistent dizziness. PT and Care Management arranged for in-home physical therapy 3-5 times per week. Prescriptions for Antivert and Zofran provided for presumed peripheral vertigo. Did discuss the possibility of current symptoms being related to Janssen COVID 19 vaccination on March 25th, although I did convey this seemed unlikely to patient and her brother. Patient is to follow up with her primary care doctor and was provided strict return precautions. in 4/20/21 phone call f/u with RN Care Manager pt reports ongoing dizziness, headaches including new onset diarrhea. PCP informed

PEEING BLOOD; This spontaneous report received from a consumer concerned a 56 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: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 09-APR-2021, the subject experienced peeing blood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from peeing blood. 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.

Initially 1 day of flu-like sx's. Then on 4/26 she had "left kidney pain". On 4/17 a burning redness and swelling of her legs bilaterally which worsened and she became unable to walk secondary to pain and swelling. Also reported shortness of breath. The rash was initially wheals spreading up legs with pain, burning and allodyina to light touch. It then spread to arms bilaterally. She admitted to Medical Center and discharged with dx of urticarial rash with petechiae. I saw her 4/19 with painful palpable purpura, significant diffuse joint pain, puffiness on all 4 extremities and starting to appear on abdomen. Areas on legs where condition originally started had began clearing. Likely Henoch Shonlein Purpura.

4/14/2021- urine appears to be very dark in the morning & if it has been a couple of hours since last urination 4/16/2021- went to doctor who thought I might have a UTI but no UTI was found 4/18/2021- entire body started itching, rash on front & back torso area Somewhere in here, I was very nauseous and had trouble eating & drinking. sometimes vomited after eating. Lot 7 pounds in 2 weeks. 5/3/2021- went to doctor for the itching- she checked urine again since those symptoms were still present- she became very concerned. Bilirubin present in urine. Doctor drew blood for some tests.

56-year-old very pleasant female with a known history of alcohol dependence and cirrhosis along with tobacco dependence and underlying nonoxygen dependent COPD who presented to the ER on 6/16 with uncontrolled diarrhea that started suddenly 2 weeks after getting her johnson and johnson vaccine on 5/5/21 associated with significant weight loss and persistent nausea and acute renal failure. She initially presented to her PCP on 5/25 complaining of urinary urgency for the past few months. She denied any frequency or dysuria but reported that her urine had an odor and an orange color. During that visit urine was positive for nitrates and leukocyte esterase she also had bilirubin in her urine and was given a 7-day course of Macrobid. There was not enough urine to send to the lab for culture. She then went to the emergency room that evening because her PCP contacted her that her potassium was low and she was sent to the emergency room during that visit she reported developing diarrhea she was given potassium and discharged home. She followed up with her PCP on 6/1 to follow-up on her ER visit and reported that the antibiotic was helping her urinary tract infection she continued to complain of some urinary urgency and it was recommended she have a urine culture done again which showed pansensitive E. coli which despite being sensitive to Macrobid she did not respond so she was prescribed 5 more days of Cipro. She reported that she quit drinking alcohol on 5/19/21 but admitted to drinking a beer now and then. Patient had her Johnson & Johnson COVID-19 vaccination on 5/5 and reports she was tired for a day or 2 afterwards and then felt better but then 2 weeks thereafter she felt terrible with associated development of nausea, weight loss, new diarrhea which has continued to progress to developing significant diarrhea and weight loss and fatigue for which she presented back to the ER on 6/16 with acute renal failure, uncontrolled diarrhea, hyponatremia and hypokalemia and metabolic acidosis. Imaging showed pancolitis, colonoscopy performed show diffuse bowel wall edema. She remains hospitalized as of 6/23/21. Stool pathogens panel and stool C. difficile x2 are both negative but the diarrhea is persistent and severe. Pt reports gi symptoms bagan 2 weeks after receiving her J and J vaccine associated with nausea, abd pain and development of diarrhea. CT of the abdomen pelvis showed a pan colitis and enteritis. colonoscopy was normal other than showing sign mucosal edema. Pathology negative for malignancy but the terminal ileum shows prominent peyers patches which are the immune sensors of the intestine.. stool o and P neg. Lactoferrin/fecal leukocytes is neg. fecal fat pending. stool ob neg. esr and crp markedly elevated.- budesonide 9mg was started, Added imodium q6h and acidophilous qid. rheumatoid factor neg, antinuclear and antimitochondrial antibodies neg, antineutrophilic cytoplasmic antibodies neg, anti-Saccharomyces cerevisiae antibodies neg and antithyroid peroxidase antibodies neg ,celiac ds panel neg. stool ob neg.. renal failure is felt due to acute tubular necrosis from severe diarrhea and poor po intake. She remains hospitalized in serious condition as of 6/23/21.

High fever, delirium. Body aches, joint pain in every joint of body, headache, nausea, sore throat, cough. I am now suffering with kidney stones, water retention and gained 15 lbs since I had the injection. Puffiness, bloating. Puffiness in hands, ankles, stomach. I have shortness of breath with sever anxiety that wakes me up. My heart races over 120 beats per minute during these anxiety attacks.

16 hrs after vaccine (4:30 am Thursday) woke up needing to urinate, went to stand up, collapsed via legs folding in, fell into window, went to bathroom, realized I had nausea, headache, checked temp 101.1, felt beginning aches and pains all over, up all night with crazy frequent urination, every 15-20 minutes, freezing chills, burning up at the same time, disoriented, wobbly, runny nose, up and down all day and night urinating and diarrhea began, Friday 6 am fever 100.3 still aching all over, still frequent urination and diarrhea, freezing chills, Friday 7 pm fever 99.3, still feeling awful, started sneezing, Saturday am, sneezing attacks , low grade fever of 98.9- mine is usually 97.3 avg., started feeling better, started Pedialyte and Imodium, still have hardly any voice from sneezing attacks, still aching in back, feel wobbly and disoriented, Saturday afternoon 4 pm, woke up soaking wet, fever gone, still feeling nausea, disoriented, wobbly, Sunday, slowly getting better, back hurts really bad and I am still shaky

5 minutes after injection my forearm and hand began to tingle and have pressure, nerve type pain. No breathing issues so was sent home. Reported the continued arm pain the next day to the doctor and she ordered an ultrasound. Report negative on blood arm clot. Got a fever, body aches, headache, tired, triggered a migraine per doctor, localized reaction of 2 3/4" at injection site with redness, swelling, pain. Almost passed out at a store - Became dizzy, tingling hands and sweating and taken to ER by ambulance. ER ruled out blood clot but found I had a UTI without any symptoms-prescribed an antibiotic. Contiue to have minor headache and minor discomfort at injection site. Awful experience and adverse reactions!

patient had headache and pain at injection site , went to PCP and ER checked up they did ultra sound and cat scan on her head . The result is no head trauma. Instead patient report has Urinary tract infection

Seizure on 3.10.2021. Treated in ER on 3.10.2021. Bit tongue and experience insentience. Prescribe Keppra XR 500 mg Tablet. Take twice a day.

CONSTANT URINATION; DEHYDRATION; SENSITIVE TO TOUCH; BODY IS BRUISED; SCALP AND HAIR HURTS; EXTREME ACHE LIKE HIT BY BUS AND RUN OVER BY BUS; MUSCLE ACHE ON INJECTION ARM OTHER ARM AND THE WHOLE BODY; FEVER; SEVERE HEADACHE FELT LIKE PRESSURE FROM THE INSIDE OUT; RUNNY NOSE; VOICE HOARSENESS; EARS RINGING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraine headaches, and allergy to mixed nuts, and other pre-existing medical conditions included no known previous medical conditions. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced runny nose. On MAY-2021, the subject experienced voice hoarseness. On MAY-2021, the subject experienced ears ringing. On 06-MAY-2021, the subject experienced severe headache felt like pressure from the inside out. Laboratory data included: Body temperature (NR: not provided) 100 F. On 06-MAY-2021 17:00, the subject experienced muscle ache on injection arm other arm and the whole body. On 06-MAY-2021 17:00, the subject experienced fever. On 06-MAY-2021 20:00, the subject experienced extreme ache like hit by bus and run over by bus. On 07-MAY-2021, the subject experienced constant urination. On 07-MAY-2021, the subject experienced dehydration. On 07-MAY-2021, the subject experienced sensitive to touch. On 07-MAY-2021, the subject experienced body is bruised. On 07-MAY-2021, the subject experienced scalp and hair hurts. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from muscle ache on injection arm other arm and the whole body, and severe headache felt like pressure from the inside out, and the outcome of fever, runny nose, voice hoarseness, ears ringing, constant urination, dehydration, sensitive to touch, body is bruised, scalp and hair hurts and extreme ache like hit by bus and run over by bus was not reported. This report was non-serious. This report was associated with product quality complaint: 90000178841 The suspected product quality complaint has been confirmed to be management approval - confirmed nothing was identified within the reported complaint reported. complaint is approved for void based on the evaluation/investigation performed..

A few hours after the vaccine, began having a headache. The next day had severe body aches and chills, which continued for another 4 days. I missed 4 days of work. I began feeling better a week after the vaccine. 24 days after the vaccine, I was awaken with excruciating pain in my left abdomen, and had severe diarrhea. The diarrhea lasted most of that day, the pain continued. I went to an Emergency Room on 4/1/21, and a CT scan revealed what appeared to be a stomach ulcer, a kidney stone and a post-menopausal ovarian cyst, all of which were causing the pain. I have been through many tests and seeing a variety of doctors, and currently am awaiting results and treatment plans for the stomach problem and the ovarian cyst. The cyst has grown and is causing continued pain. The stomach issue is being treated with Sucralfate 1 g 4 times per day and Pepcid 20 mg.

Violently Ill, bodyaches, brain fog, rash in the left groin to knee area. Raised D-dimer test. Muscle aches and weakness. Joint pain and frequent headaches. Bladder leakage and her blood pressure has been elevated since vaccine.

High fever 103 unrelieved by tylenol, explosive headache, piercing eye pain, blurry vision, double vision, heart pain, kidney pain, muscle and joint pain.

Bones ache eyes out of focus extremely Dizzy nausea cannot keep any food or water down cannot focus or remember very foggy cannot walk forward in a straight line have to hold onto the walls and doors or crawl head aches right kidney aches knees don?t work

Urinary tract infection 2 weeks after emergency department visit for backpain, nose ring removal, and COVID vaccination

About a month later I started having odd symptoms. I notice changes in my urinary and bowel functions. Having to void often and more wet bowels on a weekly basis. Shortly after I started to feel weakness in my thighs and periodically in my upper arms. Overall weakness and stamina are not normal. Also considerably fatigued. Not happening every day but multiple times within a week. Often 2 to three days feeling like above and 3 to 4 days of somewhat normal but stamina is slowly getting less than before. Typically I can walk 3 to 4 miles 5 times a week, lift bags for yard work, not get winded on stair.

LOWER BACK PAIN; KIDNEY PAIN IN THE KIDNEY AREA; PROFUSE SWEATING; BODY ACHES; FREEZING COLD; VICIOUS HERPES OUTBREAK (ANAL DISCOMFORT, PAINFUL BLISTERS ON LABIA, DISCOLORATION/PUFFY/YELLOW APPEARANCE OF ANAL AREA THAT GOT ITCHY/BURNY AND PAINFUL, HAD ANAL BUMPS, FEVER); DISRUPTED SLEEP (PAIN FROM THE BLISTER WAS KEEPING PATIENT FROM SLEEPING); This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included candida, and concurrent conditions included latex allergy, alcohol consumption, and non-smoker, and other pre-existing medical conditions included the patient had no history for drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced disrupted sleep (pain from the blister was keeping subject from sleeping). Treatment medications included: paracetamol. On 29-MAY-2021, the subject experienced vicious herpes outbreak (anal discomfort, painful blisters on labia, discoloration/puffy/yellow appearance of anal area that got itchy/burny and painful, had anal bumps, fever). On 01-JUN-2021, the subject experienced lower back pain. On 01-JUN-2021, the subject experienced kidney pain in the kidney area. On 01-JUN-2021, the subject experienced profuse sweating. On 01-JUN-2021, the subject experienced body aches. On 01-JUN-2021, the subject experienced freezing cold. On 02-JUN-2021, treatment medications included: fluconazole, and valaciclovir. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower back pain, kidney pain in the kidney area, profuse sweating, and body aches on 04-JUN-2021, had not recovered from vicious herpes outbreak (anal discomfort, painful blisters on labia, discoloration/puffy/yellow appearance of anal area that got itchy/burny and painful, had anal bumps, fever), and the outcome of disrupted sleep (pain from the blister was keeping patient from sleeping) and freezing cold was not reported. This report was non-serious. This case, involving the same patient is linked to 20210614700.

Significant amount of blood in urine from 23Jun2021 to 07Jul2021. Massive bleed in first few days with blood clots...over the duration the appearance slowly diminished. Soreness in right side, No urgency, pain or infection. No previous history of urinary or kidney issues. 09Jul2021 - UroScan and Scope of bladder - normal

Patient had 5 days of bruising and left leg swelling prior to presenting to the emergency department 3/26/21, where she was found to have an extensive occlusive DVT of left lower extremity as well as thrombocytopenia of 15,000. That evening she was taken to the Cath Lab and had an IVC filter placed. The next day patient began to have paresthesias and discoloration of the right lower extremity. Ultrasound showed high-grade occlusion of the right proximal superficial femoral artery. Patient was pre-treated with platelets and taken back to Cath Lab emergently. In addition to the right SFA there is also thrombotic occlusion of bilateral iliacs. Patient had bilateral thrombectomy and bilateral common iliac stent placement. The following day developed gross hematuria.

Severe kidney pain followed by severe chills for about 12 hours. Was ?exhausted and whole body sore? (like hit by a truck) most of the next day.

pt started with flank pain on 3-29-21, went to the ER on 3-29-21 diagnosed with UTI, developed shingles rash on right side on 4-1-21, diagnosed with shingles per provider on 4-1-21. prescribed Neurontin, Lidocaine patch and Valacyclovir.

Fever, chills, severe headache and fatigue. It was exhausting opening my eyes. Even after two weeks I would try to convince myself to pull over in my truck and take a nap! I am still extremely tired. My Heart was pounding, throbbing in ?my ears?. I could hear it so loudly . 2weeks of brain fog ? could not stay on task (due to dehydration?) I still can?t drink enough water and Gatorade to satisfy my thirst. Extreme Weakness, Nausea , especially when I would try to eat . Increased thirst/ urination . My ankles and feet swelled . My friend who is a pharmacist instructed me to take a Tylenol but I couldn?t even get out of bed to get one to take. ? any movement made my head swim and I felt like I would throw up. I slept most of that day and also the next day

After 5 days of nausea, fatigue, back, kidney and joint pain abated, strong eye and temple headache continued followed by worsening swelling of eye. Diagnosed by optometrist as uveitis and treated with indocin, post-treatment relapse and seen by eye specialist in uveitis. Abated as of April 15

Bad headache day after shot. Then headache came and went, not too bad until 4.21.21. Sharp pain behind right eye. Dr ran labs, and all look ok. But today, 2 weeks to the day of shot, my headache came roaring back ad bad as day 1. Most pain is behind forehead and eyes. Finally took advil...But pain is not gone. Worst pain is behind right eye. I've never had migraines before. I'm tired of the pain.

On 04-12-2021 at night, I noticed blood in my urine. I saw my PCP on 04-13-2021. On 04-14-2021, I again had blood in my urine. I called my urologist and was seen on 04-14-2021. My blood platelets were extremely low. I was then referred to see a hematologist who sent me to the hospital. I was admitted at Hospital where they performed lab work, MRI's and CT scans. I stayed two days at the hospital. The hematologist who saw me said I have thrombocytopenia. Other tests were also performed and they checked me for stroke and I did not have a stroke. I am concerned due to my thrombocytopenia, if I get cut, I will bleed a lot and this is interfering with my job and to carry out my daily functions. I am still not recovered and my platelets are low. I still have to follow-up with my PCP and my hematologist has to check my bone marrow as the next step of treatment.

Patient called us today at approximately 1:20pm to let us know after receiving the vaccine on stated date, she felt off all afternoon and had no appetite. Her stomach was upset and she wasn't right. That evening her friend drove her to the ER and she was hospitalized for 5 days. She was said to be dehydrated, put on dialysis and her Kidney function was 11 and creatinine was 95 according to patient. She stated MD told her she is lucky she went when she did. She just wanted to make us aware and I told her I would report the issue

4-08-2021 Frequent urination 4x during night vivid dreams 4-22-2021 Muscle weakness, loss of muscle tone , falling, red eyes, swollen wrist 5-1-2021 Went to Urgent care for adverse reactions was prescribed muscle relaxant 5-5-2021 Feel and broke wrist from muscle weakness

MI-had catherization 4/3-transferred to hospital for possible CABG but had acute renal failureso deferred. Underwent another cath 4/20 with stent placement

Severe UTI - Was tired and nauseous starting May 18th. Saw a doctor on May 21 when I had blood in the urine. Gave me Levofloxacin and it seemed to clear it up. June 24 I got a high fever of 101.5. Went to Immediate Care and another UTI. Due to the fact I started itching at the end of the last treatment, decided to try Myobic. Had a fever for 4 more days and it finally it cleared up.