Johnson & Johnson

Fever (101 F), muscle ache, slight headache/sinus pressure in front nasal cavity. Woke from sleeping after feeling feverish and achy at 2:30 AM. Ate a small bite and took 1 500mg Tylenol.

swollen ankles and toes, toe swelling resolved after 3 days, patient still had some ankle swelling on day 4 but was muchimproved

3/09/21 - Took 2 regular strength Ibuprofen at 4:00 PM, as a precaution of swelling/inflammation or other adverse effects. At approximately 11:00 PM, severe chills set in. No fever at that time. Took 2 regular strength Tylenol. Started running fever at approximately midnight (approximately 100 F). 3/10/21 - By 1:00 AM, fever had spiked to 101.7F. Chills still ongoing. Headache and joint aches/pains as well. Fever reduced to around 100F by approximately 2:00 AM. Fever completed subsided by 4:00 AM. Took 2 regular strength Ibuprofen around 3:00 AM. Aches /soreness/pain lasted until around noon on 3/10/21. Continued alternating Ibuprofen and Tylenol throughout 3/10/21, stopped at approximately 10:00 PM. Extreme fatigue persisted all day on 3/10/21. 3/11/21 - Upon waking, all adverse effects subsided. Energy levels normal.

Headache, Myalgia & Fever Narrative: 3/18/21 1500: Myalgia, headache, fever 100.5, fatigue; taking Tylenol. Other Relevant History:

Tingling sensation in left hand and on left side of head. Sore neck muscles and very sore joints all within 2 hours of the shot. Late that night (day of shot) I had a low grade fever. The first day after the shot I felt very sick and had very sore joints and stiff/painful muscles. By the second day I felt better but again had sickness and soreness in the evening.

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

Employee did not have immediate post-vaccination reaction within 15-30 minutes. Employee reported that his wife found him wondering in the street at 2 AM on 3/27/21, confused with high fever of 104. Also reported nausea, vomiting, diarrhea, chills, myalgia, fatigue, headaches.

Significant leg pain in the thighs of both legs. Including stiffness and hard to move them. This lasted for 2 days at the same pain level. On the third day the stiffness, pain, hard to move went down to about 5% of what it was.

Developed a fever 6 hours after vaccine administered, had chills, muscle aches, and severe headache, around 10 hours after vaccine, fever peaked at 101.4 then subsided, about 12 hours after shot woke up in night with cramping in my feet, severe headache continued 18 hrs after vaccine and took two Tylenol, headache subsided and went away, fever was reduced to below 99 degrees about 16 hrs after vaccine. After 24hrs from vaccine all symptoms were gone and has not return to date.

Injection administered on a Wednesday, by Saturday severe pain and inflammation on forearm below injection location. Not at injection- but on same arm. Forearm stayed swollen and stay in severe pain with no ability to grip. Feels like internal grinding at joints, muscle and wrist. Resting has minimized pain, but has not improved much since Saturday.

BACK ACHE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201a21a, and 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 fever. On 09-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced back ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and headache on 10-APR-2021, and had not recovered from back ache. This report was non-serious.

Patient reports he had chills and headaches the day after his vaccine. He is reporting SOB at rest that worsens on exertion since having had his vaccine. Pt also reports back pain and chest pressure since the day he got his vaccine

Starting from 04/07/21, Sudden waist and back pain, cannot straighten up the body. When straighten up the body feels breathing difficulties . After 3-4 days there?s a continuous pain in both thigh and the calf, and red marks are spawning on the legs.

Pain in chest and back began on Wednesday 4/14. What started out feeling like an uncomfortable pulled muscle in my back/chest area on Wednesday escalated rapidly to very sharp stabbing pains in my chest and back by Thursday afternoon 4/15. After discussing my symptoms with the office of my PCP Thursday afternoon, I was told to go to the Emergency Room for evaluation. I checked into the ER at approx 6pm that Thursday evening on 4/15. While there I underwent a blood test, EKG and a chest Xray. Upon evaluating the results of each test the Dr on assignment stated that there were no problems with major organs but could not diagnose. Small red marks began developing on the right side of my chest that same day and progressively expanded in quantity across the right side of my chest and back. A follow-up visit with my PCP was completed on Tuesday 4/20 and the diagnosis of Shingles was confirmed. Pain has not subsided and has only gotten worse as of 4/21. Prescription treatments began the evening of 4/20.

I got a cough two weeks after my vaccine. It's a dry cough that is constant and hard to control. I tried taking cold and flu medicine before bed so that I could sleep. I developed a cough and I damaged my ribs as a result of the coughing. My ribs on the right side hurt when I cough. I was prescribed a cough suppressant Benzonatate 100. I also got a steroid and the cough has gotten better after six weeks. It is still present but seems to be happening less often.

Pain developed early on and persisted till ~ 3 weeks remains persistent. Went to internist following tests Positive ANA, Elevated RO-SSA >200, Elevated sed rate, Elevated crp, change in hgb from 14.9 to 12.7, low iron, muscle pain, bilateral leg swelling, joint pain, tightness, rash on both legs, ankle up to knee over 3-4 days, at four weeks out continued pain, weakness, and swelling. Persistent soaking night sweats and low grade fever in the evenings. Purple rash on arms and legs with nodules. Referral made to rheumatologist for further work up.

CHILLS; MUSCLE PAIN/ACHE; FEVER; FATIGUE/ TIREDNESS; HEADACHE; This spontaneous report received from a consumer concerned a 40 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23/JUN/2021) .5 ml, administered on 07-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced muscle pain/ache. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced fatigue/ tiredness. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, muscle pain/ache, fatigue/ tiredness, and headache on 09-APR-2021, and fever on 08-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210435796.

Mild aches and joint pain all day. Didn't think anything of it. Then at 830 pm I very suddenly got the chills. Chills turned into shakes. My temp read 99.1. Normal is 97.4-97.7. Took Tylenol and went to bed. Woke up a few hours later sweating profusely. Took temp again, was 101.6. Was very unpleasant. Fever broke a few hours later, though it went up and down throughout the next day, but not nearly as high. This was easily the sickest I've been in 10-15 years.

Very ill feeling started on the following morning from the vaccination. Joint and muscle ache, chills, headache, stomach ache and fever. The symptoms were severe on the first day, and they were gradually fainting during the next two days. Was unable to work on the next day following the vaccination.

Headache, fatigue, muscle ache (mainly in back), joint ache (legs), soreness at injection site. All of these started within 6 hours of having been vaccinated. Alternating ibuprofen and acetaminophen provided good relief for muscle/joint ache. This also reduced the severity of the headache, but did not relieve it. Headache, muscle ache, and joint ache resolved by 40 hours post-vaccination. Mild fatigue/tiring more easily gradually improved over the next 48 hours. I took one day of sick leave from my job to rest.

Neck/muscle pain. From back, bottom, right base of neck, up the neck, to the hairline of head. Barely able to turn my neck to the right. A lot of pain and discomfort. Limited mobility of neck.

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

Patient received single dose vaccine of Janssen / Johnson and Johnson Covid-19 vaccine to R deltoid on 15 MAR 2021 and presented to clinic here on 18 MAR 2021 with excess left shoulder pain (2/10 rest but increased with active range of motion) and slight limitation in range of motion to R shoulder due to pain

Felt tired at 2:15pm, stayed awake a bit longer than napped for a couple hours. At about 10:30pm I started feeling sick, fever of 99.6, muscle and joint pain, chills, dizziness, weakness. Left arm where I got injected also felt like it was falling asleep at some point when it shouldn't have been based on how I was positioned. I finally took an ibuprofen so I could sleep around 2:30am, and felt better a couple hours later or so. Today so far I feel fine but my resting heart rate is about 30 beats higher than normal so I'm still responding to vaccine. I think overall my symptoms aren't out of the ordinary, just way stronger than I was expecting. I felt miserable.

I started a low-grade fever about 7 hours after the injection (99.5-100.0 degrees when I'm normally in the 97s) that lasted for about 24 hours. Also I had headaches and achy muscles for that same 24 hours. Still had some fatigue and achyness after that. All symptoms had dissipated after about 48 hours.

Neck pain, back pain, fatigue, weakness, muscle soreness in back, injection shot pain, headache, out of sorts - all lasted from 3-4 hours after shot for approximately 48-72 hours

Severe Axillary Lymphadenapathy shown in left side, with pain radiating into back and chest. Slight Axillary Lymphadenapathy shown in right side, tender to touch. Moderate headache treated with ibuprofen.

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

I got the vaccine at about 12:55pm. About ten minutes after getting the vaccine, while sitting in a chair, I began to get tunnel vision and felt extremely tired. I broke out in a cold sweat all over my body. I began to lose my vision like I was fainting and I momentarily blacked out or dozed off, then came back awake. I started to get tunnel vision again for a minute, then it faded away. Then I continued sweating for a minute and then it faded away. After a couple minutes I felt fine again. I sat for another several minutes then left at 1:15 feeling ok with just a sore shoulder.

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

DEEP , SHARP BILATERAL BACK PAIN; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's past medical history included previous accident causing herniated discs ( unknown when ).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 06-APR-2021, the subject experienced deep, sharp bilateral back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep , sharp bilateral back pain. This report was non-serious.

I started get chills and sweating around 6pm when I woke up from a nap. I was still tired so I went back to sleep after a hour or two. I woke up again in a few hours with worse chills, minor headache, and minor joint pain. I took over the counter medication, felt a little better and went back to sleep after a few hours. I woke up around 4am to use the bathroom and still had the worse chills, sweats, minor headache and was very dizzy. I decided to lay down on a rug rather than try to make it back to my bed and laid awake for a few hours again I woke up again in a few hours a little better and repeated everything until Sunday night when all my symptoms were very mild. I eat and drank water regularly and took over the counter acetaminophen a few times.

On March 20th I received the J&J covid-19 vaccine shot. Starting on March 21st I begin to experience symptom such as fever, chills and body aches. That lasted for about 2 weeks. The week of April 5th- I been to experience struggling the ability to breathe. I was having serious pain in my left side of my chest and in the lower left side in my back. It was so severe, I went to the hospital on April 8th and at the hospital the Doctors discovered I had blood clots in my lung. I was in the hospital for 2 days. Iam currently on blood thinners inhaler and and oxygen.

CHILLS, LOWER BACK PAIN, TIREDNESS AT THE FIRST DAY BUMPS ON MY HEAD AN MY MOUTH, MY GUMS ARE DAMAGED 2 DAYS AFTER.

4/13-Adverse events experienced and are they still occurring now: experiencing anterior inferior rib pain that is worse with touching/palpation. They started 4/9/21 in the evening and have been constant. Unrelieved with NSAIDs. constant in nature. Specifically denies dyspnea.

11 days after vaccination patient had the onset of generalized myalgias, headaches. This was followed by the onset of unilateral facial weakness 17 days after vaccination. On examination, he had ataxia and facial weakness. He had MRI's, LP and EMG/NCS which confirmed demyelinating polyradiculoneuropathy, presumably Miller Fisher variant of Guillain Barre Syndrome.

Very Extreme headache for about 18 hours starting at 11:30 PM 4/1/21, the same day as recieving the vaccine. Chills, fever, fatigue, and joint soreness all accompanied the severe headache as well.

Night of vaccination approx. 10pm, very painful body aches with fever and chills; especially in lower legs, felt like a deep muscular ache that could not be stretched out; I would relate this feeling to "growing pains" experienced as an adolescent. Fatigue lasted for 3 days after this event

4-12-21 Patient reported to sick call with soreness under right arm. Not relieved by cool compresses or hydrocortisone cr. came to clinic for c/o allergy to possibly wool blanket- Wool test performed 4-22 wool test negative, but several zosters noted. Dx Shingles- started on Acyclovir

CRAMPING SENSATION; BAD LEFT LEG PAIN; HEADACHE DAILY; LEFT LEG MUSCLE PULLED; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced left leg muscle pulled. On 10-APR-2021, the subject experienced headache daily. On 21-APR-2021, the subject experienced cramping sensation. On 21-APR-2021, the subject experienced bad left leg pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad left leg pain, headache daily, and cramping sensation, and the outcome of left leg muscle pulled was not reported. This report was non-serious.

I was vaccinated with J and J for COVID-19 I developed Pneumonia, Blood Clot on right calf (hospital diagnosis- acute deep vein thrombosis (DVT) of lower extremity), lower back pain

Patient reported adverse effect after receiving J&J vaccine on the 4/6/21. Pain inner elbow intermittently. Fever 103.2F on the evening of the date of vaccine, but has not had another fever since. Patient reported headache that comes and go. Pt was scheduled for UC visit

DIAGNOSIS OF BRANCH RETINAL VEIN OCCLUSION VIA BLOOD CLOT; LETHARGIC; CHILLS; MUSCLE ACHE; HEADACHE; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 210 pounds, and height was 72 inches. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on left deltoid on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021,he reported blurred vision in left eye. Then he experienced lethargic, chills, muscle ache, headache. On 14-APR-2021, he experienced diagnosis of branch retinal vein occlusion via blood clot in the eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, chills, and muscle ache, and the outcome of diagnosis of branch retinal vein occlusion via blood clot and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a report of a 41 year old male patient, who was noted to have branch retinal vein occlusion via blood clot in the eye 7 days after receiving the covid-19 vaccine ad26.cov.2. Patient is 210 pounds and 72 inches. No pre existing medical conditions. No known allergies. Patient is a non smoker and did not have any drug abuse/illicit drug use. On the day of the vaccination, patient reported blurred vision on the left eye. He also experienced lethargy, chills, muscle ache and headache. Seven (7) days after receiving the vaccine, a blood clot was noted leading to branch retinal vein occlusion. The information provided precludes a meaningful medical assessment. Additional information requested.

continuous muscle pain on the left shoulder/neck area. identical feeling to having a crick in the neck

STROKE; LITTLE BIT OF JOINT PAIN ON LEGS; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, and psoriasis. The patient received guselkumab (solution for injection, subcutaneous, batch number was not reported) 100 mg, 1 time every 8 weeks, strength 100 milligram per milliliter from 2020 for psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included vedolizumab for ulcerative colitis. On an unspecified date, (13 days after vaccination), the patient had stroke. In APR-2021 (recent to this report), the patient had a little bit of joint pain on legs especially after exercising. The action taken with covid-19 vaccine ad26.cov2.s, and guselkumab was not applicable. The outcome of the stroke and little bit of joint pain on legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210438989-covid-19 vaccine ad26.cov2.s-stroke. 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). 20210438989-guselkumab-stroke. 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).

12 hours after injection, experienced normal side effects (e.g., muscle aches, chills, headache, fatigue) Within 1 week of receiving the vaccine, I began to experience blurriness in my left eye. After conferring with my primary care facility, it was recommended that I see an ophthalmologist. Confirmed that I had a Branch Retinal Vein Occlusion (BRVO) and recommended I meet with a retinal specialist. Dr. confirmed the BRVO was caused by a blood clot and commenced treatment via eye injection. I then met with my primary physician to discuss the situation. He recommend further tests to determine whether I had other clotting. In addition to blood work, he order MRIs of my brain, head and neck region and also recommended that I meet with a thrombosis specialist. I met with a Dr. who ordered additional blood work for additional testing. All tests performed to determine if I had additional clotting have come back negative.

Woke up with shoulder pain the next day. Pain has now persisted for 6 weeks. In the last week has slowly migrated into chest and neck. No shortness of breath or any other symptoms. Somewhat relieved by ibuprofen. Ongoing

Patient is 41 year old who presented with right sided upper and lower extremities weakness with facial drip , call as code stroke level 1 -CTbrain, CTA showed right basilar ganglia hemorrhage with small volume subarachnoid hemorrhage, left middle cerebral artery thrombosis with left basilar ganglia infarct and right basilar ganglia infarcts. TEE was negative for LV thrombus /vegetation .

Felt severe burning/stinging pain in injection site upon injection. Left pinky and ring finger were pretty numb shortly thereafter for about a day or two. Numbness still comes and goes, but not as bad as after the initial injection. After about day 2 started to have severe pain in joint of left shoulder along with impingement, popping. Uncomfortable to sleep on left shoulder as it starts to hurt and "feels" as if it will pop out. Range of motion seems pretty normal, but still getting some pain, popping, and impingement with certain movements/actions throughout the day. I believe it to be SIRVA.

5/21/21 10:00pm shortness breath, chest pain, shoulder pain, jaw pain, metallic taste, fatigue ?mini heart attack? symptoms 5/26-5/27 trouble breathing, fatigue, light headed 5/29 pain in left arm 5/30 night - second ?mini heart attack? symptoms General fatigue, hard to breath, overall feeling bad 6/2 - bruise on arm and lump Extreme headache, fatigue, chest pain, arm pain Emergency room visit = blood clots

Pain started at elbow and shot down to the wrist and hand. Worsened with time. Could not lift anything, had to wear a sling to avoid movement and pain has not fully gone away until now. It's lessened, but I have to avoid doing many things with my left arm now. Diagnosed with Compression of right radial nerve, left lateral epicondylitis, left ulnar nerve irritation on Friday April 23, 2021.

SHAKY HANDS AND LEGS; CANNOT WORK; CANNOT EXERCISE; MUSCLE PAIN ON FEET AND LEGS; MUSCLE WEAKNESS/WEAKNESS ON FEET AND LEGS; NUMBNESS ON NECK, CHEST, ARMS, FEET AND LEGS; STOMACH PAIN/BURNING SENSATION; COLD SENSATION COMING FROM INSIDE OF BODY LEADING TO HEART; PAIN AROUND HEART, SHOWING UP INTERMITTENTLY; DIZZINESS; HOT SENSATION OVER FEET AND BODY; BACK PAIN ON KIDNEY AND LUNGS AREA; PAIN ON FEET AND HANDS/ PAINS WORSEN AT NIGHT ON FEET, HANDS, LOWER PAIN, AND UNDER ARMPITS; BURNING SENSATION ON FEET AND HANDS; MUSCLES SPASMS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 134 pounds, and height was 155 centimeters. The patient's past medical history included covid-19, and covid-19 like symptoms, and concurrent conditions included tomato allergy, alcohol use, non smoker, and gum infection, and other pre-existing medical conditions included the patient has no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced muscles spasms. On 17-APR-2021, the subject experienced pain on feet and hands/ pains worsen at night on feet, hands, lower pain, and under armpits. On 17-APR-2021, the subject experienced burning sensation on feet and hands. On 18-APR-2021, the subject experienced stomach pain/burning sensation. On 18-APR-2021, the subject experienced pain around heart, showing up intermittently. On 18-APR-2021, the subject experienced dizziness. On 18-APR-2021, the subject experienced hot sensation over feet and body. On 18-APR-2021, the subject experienced back pain on kidney and lungs area. On 18-APR-2021, the subject experienced cold sensation coming from inside of body leading to heart. On JUL-2021, the subject experienced numbness on neck, chest, arms, feet and legs. On 01-JUL-2021, the subject experienced muscle weakness/weakness on feet and legs. On an unspecified date, the subject experienced shaky hands and legs, cannot work, cannot exercise, and muscle pain on feet and legs. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, Stool culture (NR: not provided) Unknown, Tuberculosis test (NR: not provided) False-positive, and Urine culture (NR: not provided) Unknown. Treatment medications (dates unspecified) included: omeprazole, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness on neck, chest, arms, feet and legs on JUL-2021, dizziness on 19-APR-2021, headache on 13-APR-2021, and fever on APR-2021, had not recovered from stomach pain/burning sensation, pain on feet and hands/ pains worsen at night on feet, hands, lower pain, and under armpits, muscle weakness/weakness on feet and legs, pain around heart, showing up intermittently, muscles spasms, hot sensation over feet and body, back pain on kidney and lungs area, shaky hands and legs, burning sensation on feet and hands, and muscle pain on feet and legs, and the outcome of cannot work, cold sensation coming from inside of body leading to heart and cannot exercise was not reported. This report was non-serious.

When I got the vaccine I got an instant pain in my arm and into my neck, then an intense headache between my eyes above my nose, I was flush and sweaty, nauseous. Then had a bad headache on the top of my head, then soon I had left side facial numbness . Light sensitivity

Moderate soreness at site of injection. Headache Mild fever (99-99.6) Body wide muscle ache Skin touch sensitivity Tiredness Treated with 2 tablets of Extra strength Tylenol

have been extremely fatigued, headaches, muscle aches, swelling in my fingers (joints), weak, dizzy, weird feeling in my chest

(Janssen COVID-19 vaccine EUA) Day of vaccine - soreness in shoulder at the site of the injection. Day 2 - continuing soreness of shoulder, along with general aches, chills, and sleepiness. Day 3 - continuing soreness in shoulder, but no aches, chills, or sleepiness. Began feeling nauseous, but still had appetite. Day 4 - continuing soreness in shoulder, as well as nausea, but both are somewhat diminished.

About 8 hours after the injection I felt chills, night sweats, headache, lethargy, dizziness, muscle aches, pain in my entire right arm and loss of appetite. Lasted about 36 hours.

I had the vaccine at 4:00 PM. I woke up at 12:05 AM with severe chills that turned into uncontrollable shaking for the next hour and twenty minutes. The shaking stopped at that time and my temperature went from 101.1 to 102.5. My skin was warm and I began to be very clammy. Around 3:45 AM, the fever broke and I was down to 99.5. I?ve subsequently had muscle aches and the feeling of being fatigued.

Around 8pm I became very cold and tired. I took a bath, which is out of character, and tried to sleep. By 9 pm I was alternating between hot and cold sweats. By 10 pm I was vomiting and defeating uncontrollably while still alternating between hot and cold sweats. I dry heaved until around 3 am and then finally passed out. My fever never exceeded right about 100 degrees. For the next 2 days I was incredibly exhausted with muscle aches and a minor headache. I didn?t return to baseline for approximately 6 days after the shot.

Brain Fog /confusion since shot.. Arm (left) the shot was administered is still lacking in strength (just holding a cell phone wears it out). 2 weeks to the date, after the shot, I experienced extreme pain in all joints in left arm ( elbow, wrist, finger joints) The pain extruded to the middle of my rib cage from the left side. Shot site still mildly sore.. Brain fog still continues.

After the initial 12 hour period, I experienced night-time chills followed then by being too warm and night sweats. This happened both the first and second night. During the day I was taking Tylenol every 6 hours for aches and pain. Mainly my neck and back have been what hurts, although my knees, elbows, hips, etc. also were achy. The third and fourth days I still continued to have chills, no fever throughout as far as I am aware (took my temp 2-3 times). The fourth day I was very faint and somewhat unbalanced, felt shaky and light headed and I ended up having an anxiety attack. I mention the last symptom as I have never had an episode like this previously in my life. Today is day 5, still feel tired, slightly nauseous, neck and back pain, headache, difficulty focusing.

3/13/2021 began having right forearm wrist was sensitive to touch and skin clammy. 3/14/2021 still clammy in both hands. 3/15/2021 whole body clammy and sticky. Both shins and ankles had burning sensation. 3/17/2021 both ankles painful mostly at night. 3/18/2021 both ankles, shins and legs painful all day. Unable to sleep at night. 3/19/2021 left work early due to nauseated, headache and pain and burning both legs. Blood pressure elevated. 3/20/2021 head pounding and elevated rate and nauseated. Went to ER for continued leg/shins burning and pain. ABI was normal. Diagnosed with neuropathy. 3/23/2021 blood pressure elevated due to pain 3/24/2021 pain to legs and shins continue below know. pain scale 5. 3/26/2021 pain to legs and shins pain scale 7 3/27/2021 pain to legs and shins pain scale 3 3/29/2021 burning and sensitive legs. Sensitivity now present in both arms. 3/30/2021 burning to forearms and legs 4/1/2021 pain scale 3 burning pain to forearms and legs. 4/4/2021 improved pain 4/5/2021 tingling resumed to legs and calves. Pain scale 4. 4/6/2021 sensitive/burning bilateral forearm and wrist and bilateral legs. 4/7/2021 left leg burning more and feels warm. Back ache began 4/8/2021 both legs still burning and tingling. Heart rate elevated. Back pain continues.

About 45 minutes after, my left arm started to feel like there was pins and needles all the way down to my finger tips, and I started to feel very lethargic on and off for 2 days and I also had a few rounds of tachycardia. As of Monday I have developed severe lower back pain

Started feeling dizzy and started to respond slowly to things and felt weak around 8pm. Shortly after these symptoms I begin to have uncontrollable chills followed by a fever and Nausea. The whole time starting around 8pm I had pretty bad muscle aches as well. I took a warm shower and bundled up the whole night because I had a fever, aches, chills, and nausea. It was impossible to sleep because of this and sometimes my heart was beating fast as well. The next morning I had a headache that would not go away until I took Tylenol. The whole next day I felt exhausted as well and very weak. I began to feel better on day 3 but still feel somewhat foggy from the shot. I would not recommend this vaccine to anyone and would never get it again and hopefully the foggy sensation goes away.

Flu like symptoms, joint pain, lungs heavy, pain in lungs, headaches - went to ED and PE was found - admitted to ICU - DC'd 5 days later

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

About 2-4 hours after shot husband had body aches and was sleepy. 12-14 hours post vaccination husbands vision would go blurry for about 10-20 seconds, happened about a dozen times over the course of the next 5-6 hours then stopped. At 30ish hours post vaccine woke up drenched in sweat, all bedding had to be washed, but said he felt better aside from mild Muscle pain/body aches that remained for about 48 hours from initial time of injection but was about return to work without issue on Wednesday. Still has mild soreness at injection site on Thursday 4/15.

SORE ARM; CHILLS; FATIGUE; NAUSEA; FEVER; TOTAL BODY MUSCLE ACHES; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) UNKNOWN. On 08-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced total body muscle aches. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, nausea, fever, and total body muscle aches on 10-APR-2021, and had not recovered from fatigue, and sore arm. This report was non-serious.

Arm pain, excessive fatigue, nausea, confusion, dizziness, sweats, cold, pain in joints. started Monday and continues today, 5 days later

1st Adverse Event 4/13/2021, Left posterior lower leg(calve) pain, lasted 2 days, no treatment 2nd Adverse Event 4/16/2021 Left posterior knee pain, pain is still present but pain level has decreased, no treatment 3rd Adverse Event 4/16/2021 Left supraclavicular tender and enlarged lymph node for 2 days, no longer tender but lymph node is currently slightly enlarged, no treatment.

HEART PALPITATIONS; FAST HEART RATE; SHORTNESS OF BREATH; SHAKINESS; WEAK FEET; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980,expiry: 20/JUN/2021) dose was not reported, administered on 07-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced heart palpitations. On 07-APR-2021, the subject experienced fast heart rate. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced shakiness. On 07-APR-2021, the subject experienced weak feet. Treatment medications included: paracetamol. On 08-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart palpitations, shakiness, shortness of breath, and fast heart rate, and the outcome of weak feet 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.

Leg pain, Back pain , Developed shingles 5-6 days after the leg and back pain started. (April 11-12th.)

On 4/10 I started feeling tired with muscle aches. A few days later my skin started to hurt. Clothing was uncomfortable when it moved across my skin. Those symptoms lasted about a week. Then as they started to lessen I had some back pain (Sciatic) and a sore throat. Also the muscles behind my eyes were slightly painful and bright lights were uncomfortable. Then about 4/21 most of the symptoms reduced and I was feeling close to normal. Then on 4/22 I was brushing my teeth and noticed that I couldn?t spit water like normal. I called my GP doc and she recommended I head to the ER. After thinking about it I also remember on 4/21 while drinking something I had some water squirt out of my lips. At the time I thought I was just being clumsy but in hindsight the muscle weakness in my face started on 4/20. I checked into the ER on 4/22. When I checked into the hospital my facial weakness was very difficult to notice. By the evening of 4/22 it was noticeable if I tried to ?show my teeth? or make a big smile. By the morning of 4/23 it was very noticeable. The morning of 4/24 I couldn?t move my lips, nose or eyebrows. My tongue, jaw and throat were not impacted at all. I was started on plasmapheresis on 4/24. I had another treatment on 4/25. I noticed facial weakness was very slightly recovering the evening of 4/25. By 4/27 my facial weakness is still healing with noticeable improvement day to day.

Right side tingling past 10 days. Reports tingling to right face and right arm feels like intermittent pins and needles. Received Janssen COVID vaccine on 4/12/21 at an outside facility. Diagnostic workup revealed Cerebral Vascular Accident (CVA).

Right toe began hurting on May 8. 3 out of 10 pain. No redness or warmth. Fever (103 F), body aches, and fatigue on May 8. Took Tylenol 500 mg TID that day. No fever, body aches on May 9 but fatigue remained. Fatigue remains mild to moderate. Right toe continues with discomfort.

Patient is a 42 y/o male residing. At approximately 4: 40PM received a Johnson and Johnson Janssen vaccine in the left from . Client approached this nurse at 5:37PM complaining of pain in his left arm. Client described pain as ?pressure? in his left upper and lower arm and the pain radiated to the left side of his neck and left jaw. Client was alert and oriented; client was had no diaphoresis and client color was within normal limited; reparations deep even and unlabored; heart rate 70 bmp and pulse were strong and regular. Explained to client the need to call 911 and client refused.5:40PM Client remained alert and oriented without change in physical appearance; heart rate 80 bmp and pulse remained strong and regular. Resident denies any routine medications. Reports he had ibuprofen twice during the day from the staff. Client reports he had been clean from cocaine use for the last 6 weeks. 5:40PM Had Program Assistant/Counselor summoned to the room and explained to Patient client's refusal for 911 assistance. Patient was able to get client to agree to a 911 call. At 5:45PM 911 was called. 5:55PM Paramedics arrived and assessed client. According to paramedics? EKG and vital signs ?looked good?. Paramedics suggested client go to the emergency room for further evaluation; client declined. Paramedics explained to client the risk involved in refusing additional assessment by the emergency room. Client verbalized he understood the risks he was taking by refusing transportation to the emergency room. 5/21/2021 approximately 11AM Called to follow up with client; was not in but spoke with Manager. According to has no residual effects and was ?up and about? as usual.

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

I, am reporting this VAER on behalf of my brother who is currently incarcerated in a state correctional facility in PA. During a phone call a few days following his vaccine, he told me that his continues to experience shoulder pain and issues with range of motion following administration of the J&J COVID vaccine. When he first informed me, I asked him if the discomfort he was feeling was expected pain and discomfort at the injection site, to which he responded no. He reports that a couple days following administration upon stretching when waking he experienced shooting left upper arm/shoulder pain and reduced ROM the arm in which he received the vaccine. I am reporting this adverse event as he is still having this issue.

I had general soreness and stiffness. I took a bath before I went to bed because I noticed a fever. I had a fever of 103 F. I also realized I lost my motor skills. I was not able to do normal functions. Around 3:00am I experienced shakiness, and I experienced the worst headache in my life. I also have bumps that have appeared on my face. My right arm where I did not receive the shot I saw bruises down my arm. April 25,2021 is when I was in the hospital my blood pressure dropped and my pulse because very low. My blood pressure has been very high since I have gotten the vaccine.

Soreness in feet, ankles and calves starting on March 24th, then soreness started progressing up the body with numbness and tingling within my trunk, skull, arms, hands, legs and feet. Lightning Strikes throughout my whole body

11 days following the single shot I developed severe pain in my right calf muscle that felt like a charlie horse and on my leg from knee to my ankle felt a squeezing sensation like I was wearing a very tight sock that I couldn't take off. After a few days the pain subsided and the similar pain began in my left leg however not as severe. The pain would seemingly move around and come and go. Some days it was so bad I couldn't walk or balance. I believed I had a muscular issue. I then began having swelling on the top of my left foot and around the ankle of my left foot. After about a week, my right leg began to swell from the knee to ankle fairly significantly. New veins appeared on the front of my right leg and other veins on the back of my right leg began to bulge. Pain on both legs started to subside on the evening of 5/23, however swelling continued. On the evening of 5/25 I was experiencing severe squeezing sensation and bulging veins in my right leg.

BEGINNING ABOUT 1 WEEK AFTER VACCINATION PATIENT BEGAN EXPERIENCING MUSCLE WEAKNESS AND TINGLING IN THE LEFT ARM, HAS PROGRESSIVELY GOTTEN WORSE AND HAS IMPACTED DAY TO DAY ACTIVITY

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

5/17/21 - general body soreness, didn't leave bed 5/18/21 - Extreme abdominal pain, couldn't eat, didn't leave bed 6/9/21 - Severe side pains and bloating below rib cage 6/16/21 - Woke up to 10/10 pain in my abdominal region, felt like knives were being stuck directly under my rib cage, around this same time, I noticed that both of my inner legs, from roughly my ankles up was going numb to the touch, severe stomach bloating as well 7/6/21 - Everything described for 6/16/21 progressively getting worse to the point where my legs were so sore that I can barely climb up stairs, can't eat much so went to the ER. During the visit they didn't address my leg issues, released me with diuretics to deal with bloating (which have not helped). My stomach is generally bloated anywhere from 50-75% and I have pain in my stomach , legs, and shoulders and seem to be losing muscle and a rapid rate. I'm a healthy eater so all of this is very unusual and extremely concerning. I cannot work as well.

Was having normal side effects including headache, fever, muscle aches which started about 6 hours after injections. Roughly 14-16 hours after the injection (8:30-9am) started getting chest pain and slight shortness of breath. Called my PCP and they told me to go to the ER as the chest pain is not normal. At the ER they did an EKG which came back abnormal and I was rushed into a procedure to check my heart including a catheter, ultrasound, and a few more I will provide below. Outcome after all the test was inflammation which I asked if it could have been in other areas of my body but doctor said it was my chest. My C-Reactive Protein level was double the normal level. They put me on 3 medications, Ibuprofen, one for Gout and Prilosec.

Janssen COVID-19 Vaccine EUA - Tingling started on left side of face, left arm and left leg. Paresthesia worsened to both sides of my face and has not gone away; have experienced this for 10 weeks now. Also experiencing sporadic parethesia in right forearm down to fingers, and right calf down to toes. I have also experienced intermittent bouts of muscle fatigue/weakness in arms and legs, as well as lightheadedness.

Developed muscle pain in left leg. No swelling, tenderness, or visible signs of issue. Other symptoms from vaccine have resolved, but this area is still sore. States it feels like a pulled muscle. Patient was advised to seek medical care if symptoms have not resolved soon.

Patient began to have metallic taste in mouth - felf like "he had braces on again." Also felt slight tightness in his cheeks. Dispensed 1 loratadine per patient request (his allergist told him to take one when he has signs of reaction), and shortly after administered 50mg benadryl liquid to the patient. Sat with patient for 45 minutes after administration, to which all symptoms resolved and patient stated they were ready to go, and they left.

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

Fever of 104, heart rate in 160's, rigor, severe back pain. 911 called and ambulance brought to Hospital at 1am. Took 3 bags of fluids, Ativan, Tylenol and Toradol to get the heart to the 110's over the 3 hours there. It is now 12:30 on the following day (3/7) and the fever, shakes, and elevated heart is starting up again but not to the extreme of last night

- severe chills - lasted about 4 hrs - severe headache - lasted about 24hs - body ache - joint pain - nausea - lasted about 18hrs

About 12hours after dose fever chills and joint pain with side of headache lasting untill Saturday Mar 13th.

Had a sudden onset fever which reached 103 the evening of the injection. There was muscle soreness, fatigue, my pulse was above 80 all night and reached 100 during the peak of the fever. By the next morning, the fever had dropped to 100, fatigue remained and a slight headache appeared. The headache was gone by noon, the fatigue remained all day. The evening after the injection, a slight fever returned and then stopped. Two days after the injection, there were no further averse reactions other than slight soreness in the injection site. I am no longer fatigued and feel fine. Hope this information helps.

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

Fever increased to 102 from Friday evening and finally broke Sunday around noon (rotated Tylenol and Ibruprofen). Muscle and joint pain that is still ongoing. Not near as painful as the first 72 hours after vaccine, but still ache all over. Chills Headache - Different than cluster headaches and migraines. Began a few hours after receiving vaccine.

For 1 hour post injection, metallic taste in mouth. Beginning 6 hours later: myalgias, fatigue, fever -> resolved at 30 hours post vaccine.

Started feeling heavy chills, deep dull pain in legs (joints, especially knees) for about 12 hours. Headache. Ran low-grade fever of 100.

Strong heart palpitations for 2-3 hours starting about 8 hours after injection. As soon as the palpitations passed I got an onslaught of symptoms including fever, chills, sore muscles, weakness, headache, and light headed.

Metal taste in mouth with soda, water, coffee. 26 hours after vaccine and still have the metal taste. It started right away. I also had a sore shoulder that has turned into a sore arm.

PATIENT RECEIVED VACCINE ON 4/4/21. ON 4/7/21, WAS AWAKENED DURING SLEEP WITH SHARP, STABBING PAIN IN LEFT LEG CALF MUSCLE. PAIN LASTED FOR 30-40 SECONDS. FOR THE NEXT 2 DAYS, PAIN IN THIS AREA REMAINED SORE, IRRITATED, AND TENDER. RATED PAIN 1-2/10 IF NOT TOUCHING THE AREA, BUT UP TO A 3/10 WITH TOUCHING THE AREA. IN ADDITION, FELT BREATHING HAS BEEN HEAVIER AND LITTLE WORSE THAN HIS NORMAL BASELINE (BASELINE DUE TO HISTORY OF ANEMIA/LOW IRON), AS WELL AS FEELING BRAIN FOGGY SINCE RECEIVING THE SHOT.

MUSCLE ACHE; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced muscle ache. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, muscle ache, and chills. This report was non-serious. This case, from the same reporter is linked to 20210411696.

COULDN'T SLEEP LAST NIGHT; TINY HEADACHE; LEFT ARM HURTING; LEFT SHOULDER HURTING; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 at 14.30 to left deltoid at 14:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced couldn't sleep last night. On 07-APR-2021, the patient experienced tiny headache. On 07-APR-2021, the patient experienced left arm hurting. On 07-APR-2021, the patient experienced left shoulder hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiny headache, left arm hurting, and left shoulder hurting, and the outcome of couldn't sleep last night was not reported. This report was non-serious.

(1) Fever 2 days 100.3 - 101.1 (took tylenol every 6-8 hours). (2) Fatigue (slept most of day after injection). (3) Heart rate elevated (woke up 7hrs after injection with feeling of heart pounding in my chest; heart rate over 90 while trying to sleep; believe reducing fever with tylenol helped settle heart rate). (4) Muscle aches 2 days (previously injured muscles/joints became very sore 1-2 day after injection [left hip, right foot, left quad, lower back] - believe tylenol reduced inflammation) --symptoms ended 3-4 days after injection; slight fatigue remains 7 days later.

SHAKING; CHILLS; HEADACHE; FEVER; LOWER BACK HURT; NOT FEELING WELL; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight was 183 pounds, and height was 69 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies. patient had no history of 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: Unknown) dose was not reported, administered on 08-APR-2021 13:30 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced not feeling well. On 09-APR-2021, the subject experienced lower back hurt. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Low grade fever 100. On 09-APR-2021 02:00, the subject experienced shaking. On 09-APR-2021 02:00, the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, and not feeling well, and chills on 09-APR-2021, and was recovering from fever, lower back hurt, and headache. This report was non-serious.

SHAKING; STIFF BODY; SHIVERING; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic breathing problems .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 09-APR-2021 10:00 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 shaking. On 09-APR-2021, the subject experienced stiff body. On 09-APR-2021, the subject experienced shivering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shaking, shivering and stiff body was not reported. This report was non-serious.

Began to develop extreme exhaustion throughout day following shot. At approximately 5:00pm, began to develop a headache, severe joint pain throughout body. Approximately 2 hours later, began to develop a fever that rose to 102.5. Immediately took Tylenol. Fever last for approximately 24 hours as did joint pain. tiredness and washed out feeling lasted approximately 5 days.

Body chills. Joint's ached. Fatigue. All mild. Lasted just the Friday after. No symptoms on Saturday. Just rested all day. and hydrated.

I received the shot on 4/10. First 24 hours I had a slight fever and headache. Treated with Acetaninophhen. Since that time, I had relatively mild symptoms 4/11 - 4/13. Mostly fatigue. On 4/14, I had a sudden increase in heart rate, dizziness, tingling sensation in all arms and legs and weakness in my limbs/grip. This prompted me to visit the ER. They ran numerous blood tests amd scans on me but found no abnormalities. Various unusual symptoms have continued to persist since 4/14. For brief moments I feel fine. At other times I have experience fatigue, diziness/vertigo, rapid heart rate, pins and needles feeling in my left hand and left leg. Left leg numbness/tightness and heaviness. The fingers on my left hand sometimes move involuntarily. And my anxiety has also gone up during this time. Tonight it has migratee to my left foot, where I have numbness in several of my toes. I'm looking for advice. Should I be concerned? Should these symptoms still be occurring 11 days after receiving my shot? It has been very distressing and there seem to be very few people who have knowledge on this subject. My care providers keep saying to self monitor and contact them if symptoms worsen. The problem is symptoms don't necessarily worsen, they just migrate from one area of my body to another. The numbness comes and goes in maybe 1-2 hour intervals.

Patient states he was doing well until 419 when he had abdominal pain. Patient says abdominal pain started in the middle of his belly and radiated to his back. Pain is worse when he tries to eat and 8 out of 10. Pain is sharp. Patient has not had pain like this before. Pain improved when not eating. Patient has had watery non-bloody diarrhea for the past 2 days. Patient denies any fevers or chills.

MUSCLE PAIN THROUGHOUT THE BODY; This spontaneous report received from a consumer concerned a 43 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced muscle pain throughout the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain throughout the body. This report was non-serious.

I thought I was going to get the first shot of the Moderna vaccine, it wasn't until the needle was in my arm that I was told I had received the Janssen vaccine. At approximately 4:46pm I developed a strong pain at the injection site. At approximately 8pm I began to run a fever and feel extremely fatigued. My back and all my joints started to ache, I was sweating but also freezing cold. I had a dull, throbbing pain in my testes. I had pain in my scalp, my eyebrows, my ear lobes, my fingernails, my toes and toenails, the soles of my feet hurt. Least of all I also had a headache. I took 500mg Ibuprofen for the pain. Now, almost 48 hours later I still have a low grade fever, still have considerable pain at the injection site, still have a headache. The remaining symptoms dissipated on 5/2/21 at about 12pm. Took another 500mg Ibuprofen for breakfast, but otherwise have had no appetite since receiving the vaccine.

Severe pain in bones and joints for 3 days extruciating pain the worse pain imaginable unable to even get up from bed. Extreme fatigue and weakess

TENDERNESS IN THE CHEST; LUNG INFLAMMATION; COUGHING; SORENESS; TROUBLE BREATHING; THROAT SWELLING; CHEST TIGHTNESS; GENERAL SWELLING; DETERIORATION; DID NOT FEEL WELL; TIRED/FATIGUE; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced tired/fatigue. On MAY-2021, the subject experienced deterioration. On MAY-2021, the subject experienced did not feel well. On 07-MAY-2021, the subject experienced soreness. On 07-MAY-2021, the subject experienced trouble breathing. On 07-MAY-2021, the subject experienced throat swelling. On 07-MAY-2021, the subject experienced chest tightness. On 07-MAY-2021, the subject experienced general swelling. On 07-MAY-2021, the subject experienced coughing. On 08-MAY-2021, the subject experienced tenderness in the chest. On 08-MAY-2021, the subject experienced lung inflammation. The action taken with covid-19 vaccine was not applicable. The patient was recovering from tired/fatigue, had not recovered from soreness, trouble breathing, throat swelling, chest tightness, general swelling, lung inflammation, and coughing, and the outcome of tenderness in the chest, did not feel well and deterioration was not reported. This report was non-serious.

Initial extreme fatigue 1 day following the vaccine, which resolved after overnight rest Five (5) days after vaccine, extreme fatigue and chills, and several hours later a temperature of 103.5, as well as some muscle soreness Night sweats first night; next morning temperature returned to normal. Fatigue continued with some daytime sweating for 2-3 days. Saw primary care doctor 5 days after symptom onset; mostly cleared up, normal temperature Patient suspected a flare-up of mononucleosis / Epstein Barr as cause.

Blood clot in superficial vein behind right knee as well as vertigo and nausea. Currently on 30mg/day of XARELTO blood thinner (I've been taking since diagnosis on 5/5/21). Will continue to take 20mg/day for the next 30 days. Background: I started to notice my right calf get tight and sore approximately ~3 weeks following my vaccination. I had been doing a lot of running and hill training so I assumed it was a muscle strain/aggravation. After approximately 1-2 weeks I noticed the tightness worsen and also noticed significant swelling around my lower calf/ankle. I went to the doctor on 5/4/21 and was given a D Dimer blood test which came back 1.27 mcg/mL FEU (over the recommended 0.5 mcg/mL). The next day I had an ultrasound of my right leg where they discovered the SVT clot behind my right knee in a superficial vein (but near a major/deep vein intersection). I was immediately prescribed XARELTO blood thinner - to be taken for ~51 days. ~21 days of 30mg/day (15mg twice/day) followed by ~30 days of 20mg/day 1x per day. The morning of 5/20/21 around 6:30am I started to feel nausea and vertigo after returning home from walking my dog. I finished a low-intensity exercise routine at my home and around ~7:15am my symptoms worsened. I went upstairs to my bedroom to lay down on my bed and the room started spinning. I then went to the bathroom and vomited clear fluid. I started feeling a little better after vomiting but was still slightly dizzy and light-headed. I made an appointment and went to the doctor around 10:30am. The doctor suggested doing further bloodwork and a CT scan of my head. Both tests came back normal. The doctor suggested the vertigo and nausea were inner ear related and that I should continue taking XARELTO and to also start wearing a compression sock (especially during exercise/activity).

PAIN IN STOMACH; SWEATS; REDNESS ON BODY LOOKS LIKE SKIN IS DISCOLORED; CHILLS; FEVER; NAUSEA; BODY PAIN; MIGRAINE; EVERY BEAT OF HEART HURTS; HYPERVENTILATION; COULD NOT GET A FULL BREATH; PASSED OUT'; FINGERS WENT NUMB; GOT A CHARLIE HORSE ON LEG; EVERY SINGLE JOINT AND ANKLES HURTS FOR NO REASON; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight was 135 pounds, and height was 66 inches. No past medical history or concurrent conditions were reported. The patient's concurrent conditions included migraine The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered, 1 total to right deltoid on 19-MAY-2021 around 10 am for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, around 7 pm patient started experiencing side effects. After 1 hour of shot patient had his heart hurt at every beats, hyperventilation. It lasted for 1 -2 hours. The patient also had fever, chills, nausea, sweats and had not taken any medication, as he was afraid of another side effects, had redness on his body which looked like skin was discolored and was like hives. The patient also had body pain appeared suddenly. The patient also had pain in stomach which felt like nastiest gas cramp patient had ever and it was continuous like a rock blocking in stomach, he did not know if it is pain or gas but was hurting. Patient had migraine which lasted long time and was continuous than he ever had. The patient was fine as he was speaking at the time of reporting. On MAY-2021 (dates unspecified) the patient experienced Charlie on his leg (muscle spasm) for which he stood up and didn't do anything on leg, he was passed out and fingers went numb, felt every single joint and ankle hurt with sharp pain like a stuffed knife (intermittent pain for 3-5 minutes).He could not get a full breath of air, and was breathing really fast. Then patient tried to slow down breathing as he didn't want to be hyperventilated but it happened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body pain, hyperventilation, migraine, pain in stomach, chills, fever, nausea, and sweats, and the outcome of passed out, could not get a full breath, redness on body looks like skin is discolored, got a charlie horse on leg, every single joint and ankles hurts for no reason, fingers went numb and every beat of heart hurts was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210540430-COVID-19 VACCINE AD26.COV2.S --Every beat of heart hurts, Passed out. 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).

Extraordinary chills and body shakes, painful joints, burning sensation of skin all over, fever of 103.6, slight nausea - all lasting 12 hours and then subsiding.

Patient reported received his Johnson and Johnson COVID 19 vaccine 05/31/2021. Reported stated having generalized joint aches, HA and left axillary swelling. Reported symptoms stated 06/1/2021 at 8pm. patient reported did not take any medications for symptoms.

Intense shoulder soreness that day. The next morning woke up with extreme muscle cramps all over my entire body. Developed sore throat later in the day. Symptoms worsened over the course of the week, sore throat, headache, malaise, extreme sinus congestion, coughing, sneezing, excess saliva production. It was as if I contracted a sever cold. Today is June 3'rd and it is the first day I am feeling close back to 100%. I should note that I have a strong immune system and have not been sick in years.

Patient stated that starting 3 days after vaccine he started with pain in his left arm and chest, pain in his joints to his bones. He says he has trouble sleeping. He did go to the Emergency Room and was evaluated. He says he still currently has the pain.

High fever, muscle aches, shaking, nausea, shortness of breath. All of these lasted for 18 full hours, and slightly shortened breath is still present 5 days later.

after the vaccine I had a fever and was able to treat with Tylenol, and within two days my legs and knees were in pain and I had a cough. The pain is behind my knee on both legs and does up to my thigh and down to my ankle. When i sit it hurts realy bad behind the knee, especially when sitting on the toilet.

COLD; COUGH; FEVERISH; FEELING LIKE KNEES BENDING WHEN STANDS UP; CAN NOT SIT TOO LONG IN TOILET AND CHAIR; SEVERE PAIN IN LEGS BEHIND THE KNEES; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced feeling like knees bending when stands up. On JUN-2021, the subject experienced can not sit too long in toilet and chair. On JUN-2021, the subject experienced severe pain in legs behind the knees. Treatment medications included: paracetamol. On 16-JUN-2021, the subject experienced feverish. On 17-JUN-2021, the subject experienced cough. On 18-JUN-2021, the subject experienced cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, and feverish on JUN-2021, had not recovered from cough, feeling like knees bending when stands up, and severe pain in legs behind the knees, and the outcome of can not sit too long in toilet and chair was not reported. This report was non-serious.

A little over a month after receiving the vaccine I began to have weakness in my right hand that got worse over time. I could not use my hand to unscrew a lid on anything, Squeeze anything and hold certain things at certain times. I have also got weakness in my left hand now that is progressively worse. I have random pain of various types in certain places I had not previously. I drop things all the time.

INTENSE PAIN; DIFFICULTY THINKING STRAIGHT; INTERMITTENT, INVOLUNTARY MOVEMENT OF LEFT FINGERS; SPELLS OF STUTTERING; SLURRED SPEECH 2-3 TIMES A DAY; DIFFICULTY SEEING; MIGRAINE "WORST PAIN IN LIFE"; RINGING IN EARS; NON-CONTAGIOUS MENINGITIS / BRAIN SWELLING / UNABLE TO MOVE NECK TO THE LEFT / STIFF NECK RADIATED TO SHOULDERS AND LEFT ARM AT INJECTION SITE / STIFF NECK TO THE LEFT SIDE; LIME DISEASE / CHILLS / MUSCLE ACHE / MILD FLU LIKE SYMPTOMS; HEADACHE; TIRED/ FATIGUE; COULD NOT SLEEP ALL NIGHT; KNEE SWELLED UP; LEFT KNEE PAIN; SPINAL CORD SHIFTING FROM BASE OF SKULL TO TAILBONE- POPPING AND CRACKING; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and penicillin allergy at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: unknown) dose was not reported with frequency 1 total administered on 25-MAR-2021 at 16:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the patient did not have any side effects initially and he was fine after vaccination and suddenly he felt tired an hour after arriving home, also could not be to sleep all night, mild flu-like symptoms including chills, muscle aches, fatigue and a headache. He took ibuprofen 200 mg via oral route (frequency unknown) for headache or pain. On 26-MAR-2021, the patient experienced headache again. On 02-APR-2021, the patient experienced headache which continued to get worse, brain swelling, non-contagious meningitis, lime disease (Lyme disease), migraine "worst pain in his life", difficulty seeing, ringing in ears. Then, he took more ibuprofen (frequency unknown) as the migraine was unbearable for him and had mild relief. The patient went to the hospital and was admitted on 02-APR-2021. At hospital he received morphine (indication unknown). On the same day, the laboratory testing or data of patient included CT scan reported as brain swelling reduced in size and spinal tap reported as unknown chemical found, positive for lime disease and meningitis. Laboratory testing revealed the meningitis of patient was non-contagious. The patient started on blood thinners and antibiotics (drugs name unknown). The patient got followed-up with (Centers for Disease Control and Prevention) CDC disease specialist who said that it could not be clearly revealed whether it was related to the vaccine or not. On 05-APR-2021, the patient experienced difficulty thinking straight, intermittent, involuntary movement of left fingers, spells of stuttering, slurred speech. The patient hospitalized for 4 days and got discharged from hospital on 05-APR-2021 at 20:00. On the night of 06-APR-2021, it was reported that in the middle of the night the patient woke-up at 01:00 as his spinal cord was shifting from base of skull to the tailbone, it was popping and cracking, no pain, just moving. It was gone when he work-up that morning. On 08-APR-2021 at morning, the patient experienced stiff neck to the left side / stiff neck radiated to shoulders and left arm at injection site as unable to move neck to the left side and the stiff neck got progressively worse each day and by 09-APR-2021, the stiff neck was more severe and radiated to the shoulders and to the left arm where he received his vaccine, not the right side, unable to move neck to the left side. However, this lasted until 13-APR-2021. On 26-MAY-2021, the patient woke up with pain and swelling in the left knee. On an unspecified date, the patient experienced intense pain. Treatment medications (dates unspecified) included: ibuprofen several times, morphine, antibiotics and blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lime disease / chills / muscle ache / mild flu like symptoms, migraine "worst pain in life", difficulty seeing, and ringing in ears on 05-APR-2021, non-contagious meningitis / brain swelling / unable to move neck to the left / stiff neck radiated to shoulders and left arm at injection site / stiff neck to the left side, spinal cord shifting from base of skull to tailbone- popping and cracking on 07-APR-2021 and knee swelled up, and left knee pain on 30-JUN-2021, had not recovered from tired/ fatigue, headache, spells of stuttering, intermittent, involuntary movement of left fingers, difficulty thinking straight, and slurred speech 2-3 times a day, and the outcome of could not sleep all night and intense pain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210718928-covid-19 vaccine ad26.cov2.s-spinal cord shifting from base of skull to tailbone- popping and cracking ; non-contagious meningitis / brain swelling / unable to move neck to the left / stiff neck radiated to shoulders and left arm at injection site / stiff neck to the left side; lime disease / chills / muscle ache / mild flu like symptoms; difficulty thinking straight; migraine "worst pain in life"; ringing in ears; intermittent, involuntary movement of left fingers; spells of stuttering; slurred speech 2-3 times a day; difficulty seeing; intense pain; could not sleep all night. 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). 20210718928-covid-19 vaccine ad26.cov2.s-headache; tired/ fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.

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

pt stated that he got flu like symptoms including tight muscles, headache, body aches, chills, he was nauseated. He woke up feeling a little better but still has head ache, body aches and some nausea.

Myalgia, Arthralgia, Fever, Diarrhea, Fatigue Narrative: Reports fever on 3/5 at night into 3/6, diarrhea on 3/7. Myalgias, arthralgias, and fatigue on 3/5, 3/6, and 3/7. All resolved on 3/8.

Fever, muscle aches, extreme fatigue, nausea. Used Advil and rest...left work due to symptoms. Symptoms lasted about 36 hours. Resolved.

Three hours after the vaccine I had nausea and tiredness, slept for five hours. After waking up, I've had muscle ache, high fatigue and weakness, soreness all over the body, headache, head pressure, and pain in my muscles when an area of my body is pressed or grasped. Yesterday at 4pm, had chills and temperature for a total of 4 to five hours.

TENSION; SHIVERS; HEADACHE; VOMITING; LETHARGIC; SORE ARM; MYALGIA; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient experienced drug allergy when treated with ibuprofen. 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 27-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced lethargic. On 27-MAR-2021, the subject experienced sore arm. On 27-MAR-2021, the subject experienced myalgia. On 30-MAR-2021, the subject experienced vomiting. On 31-MAR-2021, the subject experienced tension. On 31-MAR-2021, the subject experienced shivers. On 31-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, vomiting, myalgia, sore arm, shivers, headache, and tension. This report was non-serious.

Rapid onset of nausea and dizzy / lightheaded feeling shortly after standing up from chair within 2 minutes after vaccination. Immediately sat back down to place my head between my knees, and completely blacked out, fallout out of the chair and hitting my head and knee on the floor and nearby fixtures. Regained consciousness on floor about 30 seconds after fainting and immediately felt much better. Pharmacy staff were on hand and promptly called 911, instructed me not to move and took my pulse and monitored me until EMS arrived within 5-10 minutes. Vital signs normal including BP 120/90, 100% o2 levels, normal blood sugar and EKG. EMS assisted in getting me back to seated position and monitored for another 10-15 minutes. Declined transport and had family member drive me home where I rested for a few hours and woke up feeling fine. Very minor bruising / bump on head with no lasting sign of concussion or other trauma. 24+ hours post vaccine no other notable vaccine reactions aside from sore arm / muscles on injection site.

I felt fine all day and went to bed at 9:30pm. I woke up to my body shaking uncontrollably and I was freezing at 10:30pm. My wife felt my skin and she said I was burning up. Unfortunately our thermometer wasn't working so I don't know my temperature, but I have never in my life shaken so badly with a fever. I couldn't control myself and I was shaking so hard that my muscles were sore from it, but I still couldn't stop. I then began vomiting every 45 minutes or so. This happened for nearly 4 hours until 2:18am. Then very suddenly everything just stopped. No more feeling cold (actually I then felt very warm and couldn't cool off. I was sweating quite a bit). No more shaking. No more vomiting. I did get a wicked headache, but I figured it was due to dehydration and took two Advil. The Advil didn't do anything and I was awake until 5:59am because my head hurt too badly to sleep. Finally I slept for about 4.5 hours. Then I just felt worn out for most of the day on the 10th, and couldn't shake the headache. Then on the evening if the 10th, I started getting a sore throat and a slightly runny nose. I went to bed that way. When I woke up on the 11th (today) I still had the sore throat and slight runny nose. The headache was gone, but I felt tightness in my chest. As I went throughout the day, I've noticed that I'm short of breath with doing most things. I have two young children, so even taking care of them I feel like at times I'm struggling for breath. I'm not in bad shape and am a runner, so my cardio isn't bad. So I was surprised by this.

Left arm felt thick and stiff; fingers on same side began to tingle; became dizzy; sweaty; got up to ask for help as instructed, fainted and hit the top on my head on the counter, I believe; came to; threw up; laid on the floor for a while; moved to a chair; wife came to pick me up; slept for 2 1/2 hours after that; felt better in the evening; typical sore arm

Symptoms: Extreme cold and shaking from cold. No fever. Was taken by ambulance to ER. They used heated blankets to warm me up and gave me a shot of Motrin. Symptoms began approximately 11 hours after shot was given. After returning home and sleeping, currently have a headache and muscle aches.

CHILLS; JOINT PAIN; SENSITIVITY AT THE INJECTION SITE; MUSCLE ACHES; HEADACHE; FEVER UP TO 101 FAHRENHEIT; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pernicious anemia, non smoker, and ketosis, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 10:00 for prophylactic vaccination. Concomitant medications included cyanocobalamin for pernicious anemia. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced joint pain. On 08-APR-2021, the subject experienced sensitivity at the injection site. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever up to 101 fahrenheit .Laboratory data included: Body temperature (NR: not provided) 98 F, 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, muscle aches, headache, and fever up to 101 fahrenheit ,on 10-APR-2021, and had not recovered from sensitivity at the injection site. This report was non-serious.

In sleep, on the night of vaccination, i thought I twisted my left leg ankle. It was not hurting if not moving but hurt when walking on uneven surface or when tried to move the ankle. I used bandage few days. its not completely gone, but much better and hurts when try to push the foot/toe downwards.

Tinnitus with continued buzzing sound starting 2 days after the injection. This continues at all times and seems constant. Shoulder Pain - Beyond initial pain following injection, I have experienced arthritis like pain developing in my right shoulder joint.

Patient reported to medical clinic 24 hours after COVID 19 injection (03/19/2021) with symptoms of visual hallucinations, myalgia, rigors, headache, nausea, vomiting and dehydration. At the time of arrival to the medical clinic, he had refractory nausea and vomiting after receiving Zofran earlier in the day at another clinical site. Medical treatment consisted of IV Fluid bolus with maintenance fluids, IV Phenergan for the nausea and vomiting, and IV Ketorolac for headache pain. His symptoms resolved and he started to feel better so a clinical decision was made to discharge him home in the care of a close friend. He planned to follow-up the next day. The patient returned to medical Clinic on 03/22/2021 with no specific symptoms. Previous symptoms from initial encounter resolved according to medical chart. Patient returned on 03/28/2021 with right upper arm DVT proven on U/S. He was seen at Primary Care Clinic beforehand where diagnosis of DVT was made. He was then started on anticoagulation therapy by MD in clinic after specialist phone consult, and will be closely followed. He was sent to Evacuation to home station due to the complexity of the condition, medications, etc.

Patient reported to medical clinic 24 hours after COVID 19 injection (03/19/2021) with symptoms of visual hallucinations, myalgia, rigors, headache, nausea, vomiting and dehydration. At the time of arrival to the medical clinic, he had refractory nausea and vomiting after receiving Zofran earlier in the day at another clinical site. Medical treatment consisted of IV Fluid bolus with maintenance fluids, IV Phenergan for the nausea and vomiting, and IV Ketorolac for headache pain. His symptoms resolved and he started to feel better so a clinical decision was made to discharge him home in the care of a close friend. He declined any other treatment modalities or medications at the time of the discharge. The patient returned on 03/28/2021 with a right arm DVT proven on U/S. He was then started on anticoagulation therapy after specialist phone consult and will be closely followed.

At injection muscle spasmed, nurse stated never seen that before. Within 1-2 hours had runny nose and felt stuffed up, thought it could be allergies or something and didn?t really attribute to vaccine. 4-5 hours after injection felt something across the top of my brain ... felt as though something had been stuck in a blood vessel and became unstuck allowing blood to shoot through. Was certainly freaked out by this, but was at an event and head of the ER department of the local hospital was also attending - so figured I had quicker access to medical care there if needed, than at home. 30-60 minutes later congestion completely cleared up. 9-12 hours after vaccination had extreme chills. Day after vaccination had pain below the injection site... injection was 2? above pain. Also neck pain. Day 2-8 since vaccination, on/off muscle pain or injection site pain. Today, day 9, have muscle pain in wrist of injection arm.

LOSS OF CONSCIOUSNESS(PATIENT WAS COMING IN AND OUT OF CONSCIOUSNESS); BRADYCARDIA; SEIZURE (EYES ROLLED BACK, HEAD WENT BACK); ARM WEAKNESS; PROFUSELY SWEATING; This spontaneous report received from a consumer concerned a 44-year-old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included patient did not have any known allergies. The patient did not have any reaction to vaccine before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, five minutes after vaccination, patient started profusely sweating and he had a seizure (eyes rolled back, head went back) and lost consciousness. Paramedics were on site came and they did a Electrocardiogram. He had bradycardia (heartrate was very low : 30 bpm). During all this time, he kept on coming in and out of consciousness. Patient also had arm weakness. Paramedics took him by ambulance to the emergency room; they administered some kind of medication because of his heart rate. Reporter thought it was atropine and took him to the hospital. In emergency room, they did a chest x-ray, Computerised tomogram scan and blood work, they did not see anything abnormal that would have caused the seizure. Emergency room Doctor determined that, it was the vaccine or a component of the vaccine that caused the reaction. Laboratory data included Blood test (NR: not provided) Normal, Computerised tomogram scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, and EKG (NR: not provided) 30 bpm. Treatment medications included atropine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure (eyes rolled back, head went back) on 09-APR-2021, and bradycardia on 10-APR-2021, and the outcome of arm weakness, loss of consciousness (patient was coming in and out of consciousness) and profusely sweating was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210422272- covid-19 vaccine ad26.cov2.s-loss of consciousness (patient was coming in and out of consciousness), bradycardia, seizure (eyes rolled back, head went back) . 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).

5 MINUTES AFTER INJECTION WHILE IN THE CAR, I FELT HOT, NAUSEUS THEN FOLLOWED A STRONG SURGE OF DIZZINESS. IT HAPPENED TWICE WITHIN 15 MINUTES. 12 HOURS LATER, I WOKE UP WITH HEAVY LEGS AND SLIGHTLY FEVERISH. MILD FATIGUE PERSISTED THROUGHOUT THE DAY EVENTUALLY GOING AWAY AFTER A DAY OF REST.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Within a few minutes, pt began to sweat/feel light headed/dizzy/ringing in the ears. Pt stated he felt like he was going to pass out. Pt reported no symptoms related to anaphylaxis. Pt did not lose consciousness and symptoms started improving within 10 minutes. Pt then noticed blurry vision which resolved. Pt's BP was checked: 120/90, pulse WNL. Pt. was feeling fine but per PCP guidance, went to ER for a follow up when I followed up via phone. Reported no further issues after leaving pharmacy

LEFT ELBOW PAIN AND PAIN FROM SHOULDER TO WRIST; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol use, and smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have 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: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021, the subject experienced left elbow pain and pain from shoulder to wrist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left elbow pain and pain from shoulder to wrist. This report was non-serious.

1 hour after shot started sweating along with blurred vision and light sensitivity from outdoor to indoor. 4 hours after chills and mild to medium headache with fever 101.5 along with joint and muscle aches. Also my chest felt heavy with no breathing problem. Headache lasted for about 24 hours. Fever and chills lasted for about 60 hours after shot. Joint and Muscle pain lasted 72 hours. Blurred vision last about 18 hours with sensitivity to light. Took tylenol fever reduces to 99.7 - 100.4 After 72 hours body felt normal

PAIN BEGAN TO MOVE TO BACK; SHOCK LIKE PAIN IN RIGHT PECTORALIS; This spontaneous report received from a patient concerned a 44 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced pain began to move to back, and shock like pain in right pectoralis. The action taken with covid-19 vaccine was not applicable. The outcome of the shock like pain in right pectoralis and pain began to move to back was not reported. This report was non-serious.

102 temperature. Strong involuntary shaking. Chills. Back pain. Elevated pulse. Muscle Weakness. Fever broke around 0600. Adverse reaction appeared to be resolved by 36 hours from time of administering vaccine.

HEAD PRESSURE; ABDOMINAL PAIN; STUCK THROAT; DIZZINESS FOR APPROXIMATE HALF A DAY BUT GONE ON THE NEXT DAY; NAUSEA; MILD HEADACHE; HALF OF MY HEAD TO THE NECK IS SO STIFF AND GIVING HEADACHES AND DIZZINESS; CHEST FELT LIKE A TIGHT SQUEEZE; HEAD FELT LIKE A TIGHT SQUEEZE, COMPRESSION AND GIVING ME HEADACHES; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced half of my head to the neck is so stiff and giving headaches and dizziness. On APR-2021, the subject experienced chest felt like a tight squeeze. On APR-2021, the subject experienced head felt like a tight squeeze, compression and giving me headaches. On 06-APR-2021, the subject experienced head pressure. On 06-APR-2021, the subject experienced abdominal pain. On 06-APR-2021, the subject experienced stuck throat. On 06-APR-2021, the subject experienced dizziness for approximate half a day but gone on the next day. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced mild headache. On 03-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not provided., Chest X-ray (NR: not provided) Not provided, EKG (NR: not provided) Not provided, and MRI (NR: not provided) Not provided. Treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine was not applicable. The patient recovered from dizziness for approximate half a day but gone on the next day on 07-APR-2021, had not recovered from head pressure, abdominal pain, stuck throat, nausea, head felt like a tight squeeze, compression and giving me headaches, and half of my head to the neck is so stiff and giving headaches and dizziness, and the outcome of mild headache and chest felt like a tight squeeze was not reported. This report was non-serious.

muscle aches...all over, the more he moves the more it hurts he has mental illness that makes him pace. he stated he feels a lot better after taking his anxiety med, a warm bath and some aspirin all his symptoms subsided.

It started with a pain around my spine and it proceeded through my hand. I thought it was a muscle strain. I had blotches in the crevice area of my arm.

Cold chills, cough, muscle aches, swelling at injection site, dizziness, body aches, headache, fatigue

The day of the vaccine, I have the normal regular arm pain. The following day, I had minor body aches and a lot of joint pain in my knees and legs. Those symptoms lasted a few days and resolved. My doctor prescribed a new medication called Cymbalta for my depression on 5/3/2021. I took the medication and developed tinnitus on 5/8/2021 and thought the tinnitus from the medication and stopped the medication. I called my doctor who advised that Cymbalta does not cause that reaction. The tinnitus went away and I was not taking Cymbalta. Around mid June, I developed tinnitus again. I consulted my doctor and was prescribed Dramamine. I did not take the medication since the tinnitus have resolve. I had only those 2 episodes of tinnitus and haven't had any other episode. I am going to follow up with a specialist ENT doctor.

Reporter started having weakness in the arms and legs. Reporter said that he lost strength in both sides and is having more weakness on the left side.

Flu like symptoms. Stuffy nose, cough, shortness of breath, muscle aches, chills. Numbness in the whole right arm from shoulder to fingertips.

On 4/23/2021 patient began having pain in his lower legs and feet. The pain then moved up to his upper legs. Patient states " I felt like I had a really bad sun burn on my arms and chest". These symptoms lasted about one week. Patient states then his lower legs/feet and hands feel "numb and tingly with nerve like pain". He states the rest of his body has a numb like feeling. He says his tongue, lips, and back of his throat are really numb. He continues to have these symptoms. He says he has decreased taste and due to this has lost 28 pounds.

Sharp stabbing pains weakness in my right hip, and tingling sensation in my right upper leg. Lower back tightness and pain. Recently my leg pain has turned to burning, ripping pain.

Fatigue, Muscle weakness, and soreness primarily in arms. Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.

Fever of 101°f. Joint pain, Fatigue, Muscle aches. Beginning about 10 hours after vaccination. Lasting about 16 hours. Vomiting and diarrhea with fever of 99°f about 60 hours after vaccination.

Initially Fever, Fatigue, Joint Pain. 2 days later pain in right abdomen, diagnosed with Appendicitis and had emergency appendectomy performed.

Vaccine at 11:30, at 12:30 he started feeling faint, light headed, heavy legs, little nausea. Monitored blood pressure from 12:40 to 1:50, ranged 142/93 to 163/113. Pt has high blood pressure. Had he sit and recline until he felt better.

At bedtime, felt chills. Overnight developed muscle aches and a headache. On 3/12 9:45am still feeling headache and body aches.

Severe chills, fever, and whole body muscle ache. Symptoms began approximately 8 hours after injection and continued at a high level for 12 hours (overnight). Muscle aches and skin sensitivity continued into the day following but chills and fever subsided completely.

Mach 24 1700-1730 feeling odd with some joint pain in knees. Injection shot pain normal as most injuections. 1900 achy 2000 chills started 2100 fever of 99.8 March 25 0015 sweaty and hot fever of 102.5 entire body aches, joint pains knees and arms. Musclar aches all over felt slight nausea 0700 aches continued fever down 100.2, fatigued slept most of the day. Injection site tender. Drank water ate toast. 1300 fever subsided 98.6 (my normal is 98.2) Took motrin for aches. Rest of day and night slightly achy stiff joints fatigued. March 26 Still achy and stiff. No fever. Took Motrin. By midday had more energy and able to get around and walk. Noticed taking deep breaths was hard to do with out slight pain. Was gone by the 28th.

Around 09:00 pm I started to feel muscle pain, hot breath, hot ears, headache and a slight fever 99 ° F. Approximately at 10:30 p.m., the fever increased to 104 ° F, muscle pain intensified all over the body, my teeth hurt, headache and chills. I took one (1) tablet of ACETAMINOPHEN 650MG, I took a cold bath and I put an ice pack on my head to lower my fever. I kept monitoring the temperature that at some point reached 104.9 ° F. Around 1:30 am I began to see that the temperature started to go down little by little. Around 2:30 am my temperature returned to 98 ° F and I no longer felt chills, no hot breath, neither hot ears, nor muscle pain was mild, I felt tired, headache was minimal. My last temperature was 97.5 ° F at 3:00 am. I got up around 10:30 am and I just felt tired and mild muscle pain.

After roughly 15 hours I woke up with a fever, which followed by severe chills, sweating, and muscle aches. Was not ale to sleep the rest of the night. After around 8 hours the symptoms subsided, but still feel flu-like and have a low fever more than 24 hours after the shot.

Onset Thursday, 4/08/21 at 03:00 am: Fever, Chills, Severe Body Aches and Joint Pain, Exhaustion. 09:00 am to 1:50 pm: Slept with profuse sweating. Friday 4/09/21 at 12 midnight: Fever with ears red and burning. Applied wet cold towels on body. Vomited once, followed by dry heaves. 10: 00 am Nauseous. Checked temperature with ear thermometer- afebrile. Checked oxygen saturation with pulse oximeter- 96% HR 35. Checked pulse manually with a range of 39-44 and irregular.

EMS dispatched to the Vaccine Clinic for the syncopal. Found male supine in vehicle ico event paramedic. Stated male received a Johnson and Johnson vaccine. Stated he drove his car to the medical monitoring location. Stated he had a syncopal episode with muscle rigidity. IV established. Fluids administered. Vitals noted to be hypotensive. Patient-stretcher-ambulance. Patient stated he felt dizzy. Muscle rigidity present. Patient stated he feels his whole body cramping. Stated he remember events that occurred. Denies chest pain. Denies SOB. Denies ABD pain. Denies N/V. Stated he felt healthy prior to the vaccine. No incident during transport. Muscle rigidity resolved PTA at the ER. Patient received 900cc NS. Transfer of care to ER nurse w/ report.

nausea, faint, migraine, chills, fever, muscle pain, shortness of breath, joint pain, weakness, fatigue, dizziness, heart acceleration, lots of sleep, anxiety, drowsy.

3/21 - Felt like a sinus infection/Ear infection. Swollen lymph nodes. No congestion. 3/27 - Went to urgent care. Was given antibiotic/steroid to combat sinus/ear infection type symptoms. Tested neg. for strep. 3/29 - Went to PCP for continues pain in head and starting to have pain in lower back and down both legs. Some pain in arms too. 3/31 - Went to PCP for increased pain, weakness and numbness in legs and arms. Took blood for tests. COvid test 4/3 - Went to ER with intense pain/numbness/weakness/ restlessness in legs and some in arms/hands. Head still hurts too. More blood work, given Hydrocodone/Ibuprofin to help manage pain. 4/5 - Returned to PCP. Was given Gabapentin to help with the pain. Was referred to neurologist. 4/8 - Initial exam at neurologist. Plan to complete MRI and Nerve Conduction studies. 4/9 - Had MRI completed of brain and upper spinal cord.

Spent 2.5 days off work feeling like a moderate severity stomach flu. Lower GI cramping, which moved higher on day 2, hot and cold flashes, sweating, extreme fatigue, upper back muscle aches (severe). Diarrhea, total loss of appetite.

Immediate intense internal heat with excessive sweating; nausea; light headed; faintish; severe dizziness. After 40 minutes, the lightheadedness, faintish and dizziness subsided. However, the intense heat, sweating and nausea continued. By the evening an intense migraine started and by 4/10/21 my sister vomited and started running a fever 100.5. Complete muscle aches, overall feeling extremely ill, totally bed ridden and a migraine that cannot be controlled at all.

Started with chills and muscle fatigue at 8pm. Once chill subsided felt feverish and could not fall asleep at about 1 am on 4/8. Sweating followed by better rest until waking at 6am for day, but felt fatigued from lack of restful sleep during night. Was able to nap during day (4/8) and felt much better by evening.

States that he got the J&J COVID vaccine Thursday 4/8/21 States that he had immediate muscle pain right away and a cough right away Upper chest is painful and he is having trouble breathing Chest pain has started yesterday- reports the pain has gotten worse States that he exercises every day and ran this AM States that today the chest pain has gotten worse and his breathing has gotten worse as well States that he works around chemicals in a woodworking shop but doesn't think that this is the cause of his chest pain Chest pain is located at the top of his sternum States that he feels queasy and unwell over all Advised that with current symptoms that he needs to be evaluated urgently and advised calling 911 if he did not have someone to bring him in. Patient refuses 911 but agrees to be seen in the ER. Will go to his closest ER now.

Beginning two days after getting the vaccine, I completely lost my appetite and developed severe abdominal pain, my blood pressure and heart rate were elevated and my stomach continued to hurt. I also had chest and back pain, muscle aches, insomnia and cramping. Finally went to the Emergency Room on the third night.

Chills and joint pain in the evenings from day 3 through day 7. Mild to moderate Headaches from day 3 through day 9. Shortness of breath, twice between day 5 and 7. Chest pain on the evening of day 6, lasted 3 to 4 minutes.

I had mild pain radiating in my arm within 2 minutes of the vaccine. 1-2 hours later I developed unusual and intermittent pain on the volar surface of my wrist. 8 hours after the vaccine I developed chills, severe fatigue, myalgias, loss of appetite, and a fever up to 101. I was bedridden for 36 hours and then the symptoms gradually subsided by day 3. I then developed a sense of chest tightness intermittently for the next 4 days usually at night. I did not have chest pain, but had tachypnea at times with a respiratory rate up to 22/min. At day 7 this resolved.

COUGH; BACK PAIN; CHILLS/SHIVERS; HEADACHE IN RIGHT TEMPLE, MALICIOUS HEADACHE; FEVER; LIGHT HEADEDNESS, DIZZINESS; VOMITING; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced light headedness, dizziness. On an unspecified date, the subject experienced cough, back pain, chills/shivers, headache in right temple, malicious headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: oxycodone hydrochloride/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headedness, dizziness on 12-APR-2021, had not recovered from headache in right temple, malicious headache, and back pain, and the outcome of vomiting, cough, chills/shivers and fever was not reported. This report was non-serious.

HYPOTHERMIA; LOSS OF TASTE; ARM WAS LIKE ROCK SOLID; RASH ON LEFT ARM AND WENT ALL OVER THE BODY; HURTING ARM; WEAKNESS; FEVER; FLUCTUATING BLOOD GLUCOSE LEVEL; LIGHT HEADED; DIARRHEA; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included sinus surgery, and spine surgery, and concurrent conditions included type 2 diabetes mellitus, allergy to pecan walnut, allergic to pollen, allergic to lobster/oyster, allergic to molds, allergic to dust, and allergic to cat hair. The patient experienced drug allergy when treated with doxycycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 16:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, within 1-2 hours after getting vaccinated the patient experienced a rash on left arm where he got the vaccine and it went all over the body. On the same day, his temperature was 95.1 F On 05-APR-2021, he also experienced weakness that lasted for a week. His arm was hurting and was like rock solid for almost ten days. The patient was feeling light headed that started on the same day of vaccination and could be due to low glucose level. The patient had diarrhea that started the same day as vaccination and was still ongoing. The patient's blood glucose was going up and down since the vaccination. On 05-APR-2021 at 23:05, his blood glucose level was 249 mg/dl. On 05-APR-2021 around midnight the patient had a fever of 101.9F. The patient experienced fever for first three days after vaccination, for which he took Tylenol for three days as directed by his physician. The patient took Tylenol 500 mg for every four hours total he took 5 pills on day one. The next day he took 3 pills of Tylenol 500 mg. On 06-APR-2021 at 8:00, his blood glucose level was 349 mg/dl and then he took his medication and it went down to 169 mg/dl. The patient stated that since vaccination his blood glucose has been unstable and the blood glucose readings are between 47 to 389 mg/dl. On 06-APR-2021, his temperature reading was 94.3 F. The patient also experienced loss of taste on the day after vaccination which has resolved now. His taste came back about a week or 10 days. The patient was not sure if the loss of taste is due to his allergy or the vaccine. On 07-APR-2021, the patient's temperature was 99.7 F. On 07-APR-2021, he took 500 mg every 6 hours. The patient took Tylenol for only three days and fever stopped after three days. On 07-APR-2021 the patient experienced hypothermia of 94.3 F. On 18-APR-2021 at 6:30, his glucose level was 95 mg/dl. The patient said that he had such unstable blood glucose readings only when he had an infection going on. On Friday the patient was going to see his endocrinologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hypothermia, loss of taste, arm was like rock solid, hurting arm, and weakness on APR-2021, and fever on 07-APR-2021, had not recovered from diarrhea, and fluctuating blood glucose level, and the outcome of rash on left arm and went all over the body and light headed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210438172- COVID-19 VACCINE AD26.COV2.S- Hypothermia, Fluctuating blood glucose level. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.

12 hours after vaccine, 100.4 fever, chills, body aches. Fever broke after about 18 hours. General pain on injection arm, continuing through this day. General pain/discomfort in upper left arm and shoulder/back area.

Janssen COVID-19 Vaccine EUA Pain started in right shoulder joint, by next morning was in right hip joint. Went to ER, given oxy and toradol, next day, pain was diminished in right but migrated to left shoulder joint, and wrist joints and finger joints of both hands. Minimal swelling in hands. Went to PCP on day 5, prescribed prednisone that helped greatly, pain still present but markedly less. Joint pain now in knee joints also.

Patient felt unwell after administration. He complained of headache and muscle soreness in both arms

Started with nausea, then it followed. Migrane, unable to talk, unable been awake ,I even fainted I don't know for how long but when I woke up was on the floor and sweating, chills, fever, shortness of breath, tireness, muscle pain and cough. Did not go to the doctor or hospital, I have no insurance. Even until today I still have a light cough and shortness of breath. All this stopped me from going to work for 2 weeks, and unenployment did not pay.

Started in the middle of night- awoke to my arm I got injected in being completely numb. Moved my arm around, got circulation and feeling back went back to sleep. Then the next day all day my back was sore and all my joints felt sore including my ankles, wrist, neck, knuckles, elbows, knees. Just soreness - NO FLU LIKE SYMPTOMS - but sorness all over. I left message with Doc's office. Next day my joints felt better but I awoke with splitting headache. Took aspire and all improved.

Pain on side of torso of mid abdomem near lower last rib starting on Saturday, 5/8. Felt like a side stitch similar to a long run but much more intense. Pain steadily increased as to Monday, 5/17, in the AM went to urgent care. They misdiagnosed and said I must have twisted wrong. Went to primary care phisician Wednesday, 5/18, and was diagnosed with, Shingles, Herpes Zoster. Prescribed anti-viral Valacyclovir 1000mg 3x daily, Naproxen 500Mb 2x daily and lidocaine cream as needed.

MAGNETS ARE STICKING TO HIS LEFT SHOULDER; CHILLS; HEADACHE; MUSCLE ACHES; VERY TIRED; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included vitamins nos, and zinc. On 03-MAY-2021, the subject experienced chills. On 03-MAY-2021, the subject experienced headache. On 03-MAY-2021, the subject experienced muscle aches. On 03-MAY-2021, the subject experienced very tired. On 25-MAY-2021, the subject experienced magnets are sticking to his left shoulder. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, headache, muscle aches, and very tired on 04-MAY-2021, and had not recovered from magnets are sticking to his left shoulder. This report was non-serious.

MOTHER REPORTED HE HAD ADDITIONAL SEIZURES, VOMITING, EXTREME FATIGUE,STIFF ARM, SLURRED SPEECH, COULDN'T WALK WELL. MOSTLY AFFECTED RIGHT SIDE.

BONE PAIN IN RIGHT SOLE OF FEET AND BOTH ARMS, FINGERS AS WELL AS WRISTS ON BOTH HANDS; INTERMITTENT FEVER; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcohol user, and other pre-existing medical conditions included no known allergies and no 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: 1808986, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced bone pain in right sole of feet and both arms, fingers as well as wrists on both hands. On 02-JUN-2021, the subject experienced intermittent fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intermittent fever on 05-JUN-2021, and had not recovered from bone pain in right sole of feet and both arms, fingers as well as wrists on both hands. This report was non-serious.

Patient presented to ED on 6/14/21 with 4 day history of cough, malaise and 1 day history of right flank/pleuritic pain. He was found to have a left leg DVT and bilateral pulmonary emboli. He was started on a heparin drip which he tolerated well. He was transitioned from heparin to Eliquis. He has no family or personal history nor other risk factors for DVT or PE; no long travel, no surgery, no immobilization. Hypercoag workup was initiated. He continued to have right sided pleuritic chest pain which improved during his stay. There was some question of possible community-acquired pneumonia, which he was empirically treated with CTX and azithromycin. He had normal WBC, low procalcitonin, and no fever. Patient was discharged home on 6/15/21 on Eliquis with follow up scheduled with primary care provider.

dry mouth , shiver and difficulty breathing and tightness in arms complained (05.10 pm)by patient within 15 minutes of administration( 450pm) . Patient was laid down on floor with raised legs and cold packs applied to face and hands. Bp monitored and benadryl given ( 5.15 pm) . patient was still breathing . BP was high. next 10 minutes patient was feeling better. was seated with elevated legs. Drank water and Ems was called . Bp was at 178/112 pulse 83 Per EMS possibly syncope or initial reaction to the shot.

Superficial thrombophlebitis in left medial lower calf, along with edema in foot and ankle on same leg and pain in calf, foot, and ankle. No explicit treatment prescribed. Symptoms are ongoing as of 6/25/2021, but have reduced in intensity. The was the first blood clot I've ever experienced.

CHEST PAIN; NUMBNESS IN FINGERS ON LEFT HAND AND LEFT ARM; FELT WEIRD; PAIN; PAIN IN NECK; PAIN IN ARM; PAIN IN HEAD ON LEFT SIDE; LACK OF ENERGY WHEN WALKING OR WORKING; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight was 175 pounds, and height was not reported. The patient's concurrent conditions included glaucoma. The patient experienced does not feel good when treated with metoclopramide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced numbness in fingers on left hand and left arm. On 18-APR-2021, the subject experienced felt weird. On 18-APR-2021, the subject experienced pain. On 18-APR-2021, the subject experienced pain in neck. On 18-APR-2021, the subject experienced pain in arm. On 18-APR-2021, the subject experienced pain in head on left side. On 18-APR-2021, the subject experienced lack of energy when walking or working. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, numbness in fingers on left hand and left arm, lack of energy when walking or working, and pain in head on left side, and the outcome of felt weird, pain, pain in arm and pain in neck was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.

On Tuesday, June 8th, I'm driving a car on the highway and a dizzy spell hits me hard with no warning. I got the car pulled off the side of the road but my world was spinning for 2-3 minutes. It scared me enough to go the ER an hour later where I had blood drawn, EKG, CT scan of brain, overnight monitoring, and an echocardiogram. All were normal, but over the course of the next week, I felt the full force of the following symptoms: lightheadedness to the point of almost fainting, brain fog, nausea, neck tightness, headaches, anxiety, and fatigue. I had so many lightheaded moments where I felt I would pass out. My life was affected because I couldn't do anything without feeling like I would pass out. Driving more than a mile is out of the question. Fortunately, I'm a school teacher and all this started on the 2nd day of summer vacation. I certainly would not be able to teach if school were in session. How bad was my brain fog? I have kids who love to play board games like monopoly. I play 5 or more times a week. My brain fog prevented me from playing monopoly with him. It was too complicated for me to roll the dice, count the dice, move my piece the number of spaces, figure out money amounts, etc. . My family was really worried because they noticed how I couldn't think. I felt like a 90 year old man with dementia. As far as my lightheadedness, I never actually fainted, but there were many times I had the "sense of doom" feeling where I was going to die. I visited the ER again a week later and they did another EKG with normal readings again and ordered a holter monitor to be worn for 24 hours, which came back normal. When I finally got into my primary care physician on June 17th, he suspected something terminal, so he orders a brain MRA the very next day. That came back clean, so he orders me to see a neurologist. Once I received news that the brain MRA was normal, my anxiety went away for the most part--I was not going to die! The neurologist prescribed gabapentin 100 mg daily (which is anti-migraine/anti-seizure meds) and a carotid artery ultrasound, which came back clean. (Notice a pattern?) Because of the neck tightness/pain/uncomfortability, I visited a chiropractor thinking neck alignment was off. Chiro realigned me but I didn't feel any better or worse. I have had 2 visits at the chiropractor, specifically for the neck pain and seeking relief. Today, I am 6 weeks from the June 8th out-of-the-blue dizzy spell that changed my life. If I gave a percentage of how good I am today, I would give a 75%. During all this time, I've never had a fever and my blood pressure has been normal every time it's been taken. According to all these tests, I'm the healthiest man in the world--my heart, brain, bloodwork is all great. My episodes are less and less frequent, and I drove today for about 5 miles! Yay! I feel like there's light at the end of the tunnel. In the last week, I've been playing board games much better with less brain fog, but I have my moments with brain fog and lightheadedness. My neurologist and my primary care physician feel like there is no correlation to the vaccine, but the chiropractor I visited has said that he's treated multiple patients like me who are looking for relief from these symptoms in the past 4 months.

MEMORY LOSS (SOMETIMES CAN'T REMEMBER THINGS); SORENESS THROUGHOUT THE BODY; INSOMNIA/CAN'T SLEEP; PAIN IN RIGHT ELBOW IS GETTING WORSE; CHILLS AFTER WIPING AWAY SWEAT AT NIGHT; HEAVY SWEATING AT NIGHT (DESCRIBING IT AS LITERALLY SWEATING BUCKETS, HAVE TO SLEEP ON TOWELS AND CAN'T SLEEP); This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no medical history, no known drug allergies and no 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: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUN-2021, the subject experienced heavy sweating at night (describing it as literally sweating buckets, have to sleep on towels and can't sleep). On 27-JUN-2021, the subject experienced soreness throughout the body. On 27-JUN-2021, the subject experienced insomnia/can't sleep. On 27-JUN-2021, the subject experienced pain in right elbow is getting worse. On 27-JUN-2021, the subject experienced chills after wiping away sweat at night. On 13-JUL-2021, the subject experienced memory loss (sometimes can't remember things). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy sweating at night (describing it as literally sweating buckets, have to sleep on towels and can't sleep), memory loss (sometimes can't remember things), soreness throughout the body, insomnia/can't sleep, chills after wiping away sweat at night, and pain in right elbow is getting worse. This report was non-serious.

Received vaccine at 9:00am, 9:15am light headache 10:30am felt light headed when walking. 12:00pm headache slightly stronger and discomfort in knees. 4:00pm joint aches specially in the knees, ankles and finger joints. 6:00pm tingling sensation on cheeks and headache persist. Walking uncomfortably because of joint aches.

Pt stated that he had experience side effect of Janssen Vaccine like Headache, Muscle aches, Fever , Pain

Sore and swollen at the shot site. 24 hours after shot I experienced chills, and a bad headache that lasted all day off and on even with use of Motrin. Headache went away but still had chills and a low grade fever next day. Was really tired and fatigued for 48 hours sore hips and aching joints. Now 3 days after just a swollen itchy shot site.

Symptoms began immediately. I felt an aching pain in my left arm immediately after the vaccination. It then moved to my scapula. It persisted the rest of the day and all day Tuesday. I also felt soreness of limbs (both arms and legs) intermittently for the 48 hours. I had shortness of breath for the next day. I felt extreme fatigue for the next 48 hours. I felt my heart racing off and on for 24 hours, I felt a loss of strength in both arms and legs for the next 48 hours. Monday Night I woke up sweating as I had a fever. The fever persisted off and on for about 24 hours. I was irritable (probably due to not feeling well) for about 48 hours. My wife had to drive me home.

24 hours later had all the side effects and feels like my rectum is swollen, and ears are burning, belly is swollen, feels like I have the flu, I feel hot but don't have fever, and I started feeling better and it all came back at one week later, is this normal and will it pass. Lymph nodes hurt from back of head down shoulders, constipation, voice different, smells are different, taste is different, and skin feels half numb.

Full body joint aches starting approx 10 hours after injection. lasting strongly until 27 hours after injection. Minor joint aches continuing at least 32 hours past injection. Treated with regular doses of acetaminophen or ibuprofen. Severe full body chills, starting approximately 11 hours after injection. Treated with multiple heavy blankets and heating pad while attempting to sleep.

Same day/evening: chills, severe headache, sleeplessness, chest pain Next morning/afternoon: fever, muscle soreness, worn down

I received the J&J shot after work on Friday around 5:30 p.m.. Around 3 a.m. Saturday morning, I woke up with a fever and chills. My head was hot. My body was cold. I had a pretty severe headache as well. My body ached all over. Muscle and joint pain. I took Tylenol, but it didn't seem to do much. I spent all day Saturday in bed or on the couch. I ran a fever of 100.9 to 101.6 all day Saturday. My body ached making it hard to go up or down stairs. I was weak feeling and I was exhausted just going to refrigerator to get juice or water. Not much of an appetite all day. Also, arm was sore and bruised at the shot location. That was the least of my issues. Today is Sunday and I am feeling better now. I feel like the worst is absolutely behind me, but I felt so terrible yesterday, I thought I should report my issues.

Blurred vision, sore body, stiff neck and swollen glands, size of a lemon. Flu like systems but no fever.

Immediate dizziness and nauseous. Took 20 minutes to resolve. After 12 hours had extreme fatigue and muscle aches that lasted for 2 days. Could still feel some mild symptoms 4 days after the injection.

Seizure-like episode. Patient was seated when his body went rigid and he lost postural control and started to slide sideways. His body was shaking slightly and his eyes were open but there was no cognitive awareness. This lasted no more than 90 seconds and then patient came to abruptly and reoriented himself on the chair before I had the opportunity to get him to the floor. Patient then stated that he was lightheaded, warm and sweaty. EMT had been called and upon assessment of the patient transported him to the ER.

CHILLS; FEVER; MUSCLE ACHE; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 at Right Arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced muscle ache. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from nausea on 05-APR-2021, was recovering from chills, and had not recovered from fever, muscle ache, and headache. This report was non-serious.

3AM woke up with high fever, headache, muscle ache from shoulders up. Treated with Tylenol to reduce fever, symptoms continued through the day. 2PM discovered large patch of hives on back from right shoulder to waist approximately 4 inches wide at the top and narrowing to 1 inch wide at the bottom. Treated with my go-to allergic reaction kit: Xyzal, Benadryl, Prednisone, and Pepcid. Hives started fading after 1 hour and were mostly gone within 3 hours, followed by 12 hours of sleep.

Severe Nausea, Some Vomit, Stomach Upset, Stomachache, Mild but continuous Dizziness, Severe Fatigue, Muscle Weakness

Since taking vaccine have had chills, slight fever, headaches, fatigued and tiredness with sore muscles for 13 days since vaccination on 4/1/2021

4/9/21 night, about 12hr post vaccination, developed low fever, slight pain in elbow and knees. Took Ibuprofen, recovered next day. 4/13/21 morning around 10am, 4 days post vaccination, mid-level abdominal pain lasted ~1hr, then turned into low level pain, persisted until 4/13 night. 4/14/21, feel normal. 4/15/21 about 7am, abdominal pain again, and persists. Visited family doctor at 11:00am, doctor checked, no lab work was done. Send home with prescription: Ciprofloxacin HCl 500mg Tablet, was instructed to take 1 tablet twice a day for 7 days. Took first tablet at 3pm. Abdominal pain still persists at night.

FEVER; MUSCLE ACHES (SHOULDERS UP); HEADACHE; LARGE PATCH OF HIVES (SHOULDERS TO WAIST); This spontaneous report received from a patient concerned a 46 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced muscle aches (shoulders up). On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced large patch of hives (shoulders to waist). Treatment medications (dates unspecified) included: prednisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, muscle aches (shoulders up), and headache on APR-2021, and large patch of hives (shoulders to waist) on 11-APR-2021. This report was non-serious.

Pain all over the body! Swelling in both feet ankles, fever, stomach pain, fatigue, chest pain and phlegm! Extreme tiredness, pain and swelling in the vaccinated arm, swollen of the shoulder of the vaccinated arm, severe headache

I have had sparatic stomach pains, fatigue , Severe Headache , Muscle pain, Nausea and Pain in joints. The fatigue, knee pain and chronic headache still remains constistent since vaccination.

Arm muscle pain, leg muscle pain, back pain, headaches, metallic taste in mouth : all lasting up to 2 weeks

SWELLING ON HIS KNEES; JOINT PAIN; HORRIBLE CHILLS; FEVER OF 105.9 F; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 135 pounds, and height was 173 centimeters. The patient's past medical history included marijuana use, and concurrent conditions included penicillin allergy, alcohol use, smoker, lactose intolerance, attention deficit hyperactivity disorder, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included clonazepam for ADHD, and anxiety, and hopantenate calcium for ADHD, and anxiety. On APR-2021, treatment medications included: ibuprofen. On 06-APR-2021, the subject experienced swelling on his knees, joint pain, horrible chills, fever of 105.9 f. Laboratory data included: Body temperature (NR: not provided) 105.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from horrible chills on 10-APR-2021, and fever of 105.9 f on 09-APR-2021, and was recovering from joint pain, and swelling on his knees. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious

BODY ACHES; SHOULDER PAIN/FELT SYMPTOMS OF SORE JOINTS; FELT FATIGUE/EXTREMELY TIRED; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's past medical history included exercise induced asthma, and concurrent conditions included occasional alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient was previously treated with salbutamol for exercise induced asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced shoulder pain/felt symptoms of sore joints. On 01-APR-2021, the subject experienced felt fatigue/extremely tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, shoulder pain/felt symptoms of sore joints, and felt fatigue/extremely tired on 03-APR-2021. This report was non-serious.

SHOULDER PAIN; MUSCLE ACHES; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced shoulder pain. On 01-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder pain, and muscle aches. This report was non-serious.

For about 36 hours after vaccine - I started getting headaches and I never get them. I had backaches and my legs were hurting too. My blood pressure was elevated as well. And that was not going away either. I went to doctor. My headaches have decreased. But for the last two to three days I have been getting chest pains. I have called the doctor this morning and I'm waiting to call me back. It's not ongoing pain - just every now and then - I'm not sure what it is.

Severe Muscle Aches began 7-8 hours after the shot Chills began 7-8 hours after the shot Elevated Heart Rate - 100BPM Resting - When i woke up the next morning Symptoms started going away roughly 24 hours after injection.

Localized rash to right shoulder (injection in right deltoid) and a slight increase in lower back pain since day after injection

Freezing (no chills) literally woke up freezing and shaking bad trying to get warm, fever, bad muscle and joint pain and bad fatigue

Vaccine administered at 12:30 pm. By 6:30 pm, a fever and chills started. I woke up at 11:00 pm and had a 104.7 fever with vomiting, nausea, join pains, weakness, fatigue, and headache, along sinus tachycardia. Went to the ER to be evaluated, it was determined that this was an adverse reaction. I was released from care around 2:30 am.

Patient received their J&J vaccination on 4/7/2021. The patient's wife tested positive on 4/12/2021. The patient tested positive on 4/23/2021. The patient presented to the ER with a severe progressive cough (starting one week prior), worsening shortness of breath, a high fever, chills, myalgias, and malaise. The patient was diagnosed with COVID pneumonia and ARDS with hypoxia and given Lovenox, remdesivir, and dexamethasone, tessalon, and Brovana. The patient was admitted on the 23rd and continued to decline until their eventual passing on 4/28/2021.

Woke up with COVID-like symptoms similar to when I had contracted COVID 5 months earlier. Headache, mild loss of taste, body pains all over body, extreme back pains not typical of back problem, fatigue, nausea, vomiting

Had the following events: muscle & joint pain, persistent tiredness for 4 days following the shot. On the 3rd day following the shot I started sneezing regularly and having a stuffy head & runny nose. This lasted about 4 days. After the sneezing started to subside I started experiencing a nasty head cold which then traveled to my chest and lasted for about 5 days. Was coughing all day long. Once those symptoms started to subside, about 2 and a half weeks after the shot, I broke out in a body rash which I'm still dealing with today and seems to be getting a little worse. I'm currently at a dermatologist in the waiting room filling out this report. The rash is very itchy & at times a tad painful.

On 6/4 patient (pt) reported to workplace clinic that he started experiencing shoulder pain approx. 2 weeks post injection. Pt stated he felt the vaccine was given to high in the arm and took a picture of where the vaccinator had placed his band-aid. If the vaccinator gave the vaccine at the site of band-aid vaccinator gave the vaccine to close to pts acromion process. On 6/10 pt. reported his pain is now extending down from his shoulder to his wrist. Nurse onsite informed pt. that he should see a physician.

PATIENT HAS EXPERIENCED MUSCLE PAIN FROM THE SHOULDER TO THE TOE OF THE LEFT SIDE OF HIS BODY FROM 06/04/2021 UNTIL NOW . THE PAIN HAS PERSISTED AND NOT GOTTEN ANY BETTER. HE WENT TO MASSAGE PARLOR ON JUNE 7,2021 FOR MASSAGE , THE PAIN WAS GETTING WORSE AFTER MASSAGE.

24 hour after vaccination patient experienced hot flashes and dizziness that lasted on and off for three consecutive days. On the third day patient experience bilateral lower leg cramps and muscle tightness in both calves, patient also experience the same cramps and muscles tightness lower left abdomen. Symptoms resolved after three day with slight residual tight experienced in lower left calf muscle

within 12 hours of vaccine develop viral arthritis symptoms ( ankle, knee, hip and cervical spine pain) subsided after 24 hours but a concertation of pain develop orally- oral pain, feels like a tooth ache across all teeth, extreme sensitivity to temperature. over several days decreased to dull pain along the maxilla mostly on right side. Some days are better than others ie. just sensitive to cold (liquids and food) others days full pain along the upper and lower, primarily on right side but radiates to left side. on day 8 and 13 was having extreme break though pain, Alieve and Tylenol were not helping. on 13th day almost unbearable. Currenly on day 16th and still taking tylenol daily to help with discomfort.

Got vaccine at 12:30am, was home asleep by 2:30. Head was insanely stuffy when I woke up around 8:30, my ears hurt on the inside and I couldn?t hear well. My lungs felt kind of funny, as if I?d taken too much asthma medication. By noon my lungs were burning with every breath, my eyes were hot and weepy, the fever and muscle/joint aches had gotten really bad, and I had pain in my neck under my jaw between chin and ears.

Chills/shivering (at normal room temperature), Muscle & Joint aches, headache, soreness at injection site. Symptoms (except soreness at injection site) remained for 12 hours after onset. Soreness at injection site reduced to very mild after 48 hours

Within 2 hours of receiving vaccination I had a very mild bout of diarrhea that lasted around 20 minutes, had to go to the restroom twice. The next morning at 4:45 am I woke with chills and moderate muscle , joint aches and random sharp muscle pains all over my hips, arms, and legs. Chills, aches, and fever continued until 8:30pm the same night. My fever would go to 102.8 as a high to 100.2 depending on how close I was to my next timeframe to take Tylenol. I took 4 extra strength Tylenol (2000 mg) every 4 hours, give or take 30 minutes. Around 8:30 pm my fever broke and I sweated mildly Until around 10:30pm

I am filling this this out to report similar symptoms and reactions for three of us in the same household (ages 47, 45, and 18). Flu-like symptoms: fever reaching as high as 101.2, night sweats, joint pain, chills, unable to get warm, exceedingly tired, loss of appetite, upset stomach. Missed work (two of us) and school (one of us) within a couple days of the shot.

Day 1: Saturday morning March 6 at 5:00am I was shaken out of my sleep with a nasty migraine, sour stomach, intense body aches, stuffy nose, fever (102f). Classic flu like symptoms. I was extremely sick all day Saturday (level of sick: 8/10). Day 2: Sunday morning March 7 I awoke again extremely sick, just as sick as Saturday. All same symptoms (level of sick: 7/10). Sunday night I was incredibly miserable, all flu symptoms, I did not sleep Sunday night, up all night and up all day the next day Monday. Day 3: Monday I continued to be sick, all same symptoms, all day long. This time the blood shot eyes & bloody nose came on, fever was steady at 101f (level of sick: 6/10). Day 4: Tuesday woke up still stick, same flu like symptoms. I feel the headache has gotten worse, in fact way worse. Fever steady at 101f all day. Overall I'm not as sick except the headache and fever (level of sick: 6/10). Day 5: Wednesday I was really hoping I'd make a full recovery but still still sick, fever dropped for a few hours then came back, fever peaks and bounces around at 101f. Headache is absolutely nasty, I feel intense pain in the back of my neck and head, hard to sleep or lay down. (level of sick: 5/10). Day 6: Thursday I feel like I'm just about kick this sickness, feeling way better. I dont have a fever today but I still have an incredibly nasty headache, really intense, my eyes hurt, back of my neck hurts. (level of sick: 3/10). Day 7: Friday, no flu symptoms, finally!! But the headache continues, really bad. It sort of disables my ability to function with the headache. Back of my neck and back of head hurts, inside my brain hurts. Ugh! Day 8: Saturday, no flu, no fever, although still bad headache. I've been taking Advil all week to help reduce the headache. It helps, but after about 6 hours later the headache returns. Late in the evening Saturday my head was pounding. Day 9: Sunday headache not that bad, mild headache lingered throughout the day, tolerable. Day 10: Monday no headache!! Today was the first full day of full happiness!! *NOTE*: In July 2020 I got COVID extremely bad, spent 4 days in the ICU, couldnt breathe!! I had a fever of 103 for 6 days straight before calling 911 to come and get me. I was in bad shape, lost 30 lbs, had respiratory breathing issue for about 2 months after hospital stay. Most sick I've ever been, total game changer, I will never be the same. To this day I feel my respiratory is at 90%, fatigue still comes around every so often.

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

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

1 hr after shot (tuesday 0831 hrs), right bicep was twitching. Next morning (wedenesday 0700 hrs) pain an redness in Right shoulder. Most importantly pain in the spine from middle to lower back.. (Thursday 0510 hrs) while brushing teeth, a sharp pain put me to my knees.. 1200 hrs pain was still there... Went to urgent care.. Doctor said it was back spasms.. Said he didn't know if it was related to the vaccine. Then also said nobody knows. I have not worked out nor have I lifted anything heavy in 2 weeks prior to receiving the covid vaccine.

Headache, treated with Tylenol for three days Nausea, treated with uncrystallized candied ginger for three days Muscle aches in calves and thighs, treated with rest and Tylenol for three days Fatigue, treated by take many naps over the course of three days. Fever, treated with Tylenol for 1 day Chills on and off for three days

Symptoms started around 4pm with muscle ache all over and the body chills. Severe muscle spasms followed in back and chest area, hard to relax. By 6pm, very high fevers - T-105.5, 105.6. interventions didn't drop temp unless stripped completely naked and temp would drop to 103.3 at lowest, Tylenol administered and temp and no clothes - just a sheet on temp is 101.9. and bad body aches currently.

SHORTNESS OF BREATH; FULL BODY ACHE; JOINTS HURT; SEVERE HEADACHE; NAUSEA; SENSITIVITY TO LIGHT; LETHARGIC; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 15:25 for prophylactic vaccination. Concomitant medications included benzylpenicillin for drug used for unknown indication. On APR-2021, the subject experienced lethargic. On 02-APR-2021, the subject experienced sensitivity to light. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021 01:15, the subject experienced shortness of breath. On 02-APR-2021 01:15, the subject experienced full body ache. On 02-APR-2021 01:15, the subject experienced joints hurt. On 02-APR-2021 01:15, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, full body ache, and severe headache on 03-APR-2021 09:35, had not recovered from lethargic, and the outcome of joints hurt, nausea and sensitivity to light was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Severe body pain all over body lasting for one day, alternating sweating and chills, weakness in left arm

On the day after the injection, a severe stiffness in both legs occurred. It was a soreness and stiffness similar to the day after running a marathon race . The soreness and stiffness would not change if I was sitting, walking, standing or kneeling. It was constant discomfort and irritation. It was not painful and therefore I originally did not go to medical. There was no discomfort in my left arm at the injection site. The discomfort increased for the rest of the day. A headache started in mid afternoon and kept increasing throughout the rest of day. I have not had a headache in years. Around 7:00 PM on Thursday, I had to sleep. I was extremely tired. My body had chills and I had to wear a sweatshirt and full set of clothes to bed just to stay warm. That is very unusual. I am usually throwing off covers every night throughout the entire year. I did not eat dinner because there was no appetite. I slept in bed for at least 12 hours. Typical night sleep = 8 hours. The next morning was no issue and therefore I did not go seek medical help because there are supposed to be side effects to vaccines. Now, I am reporting it because headache and the stiff muscles were identified on the news. However, it was around 24-36 hours and not the 6 days on the news.

102 fever for 48 hours beginning 5 hours after injection. Stiff neck for 3 days beginning 24 hours after injection. Rash on back, chest, and feet with itching and redness beginning 13 days after injection

04/09, ~11:15 a.m.: Received injection in left arm, released at 11:30 a.m. 04/09, ~1:00 p.m.: Mild headache, dizziness and fatigue, mild pain in left arm 04/09, ~7 p.m.: Moderate headache, dizziness and fatigue, mild nausea, spasms in muscle around injection site/itching/redness 04/09, ~8 p.m.: Went to bed and slept 04/10, ~2 a.m.: Awoke with severe headache, fatigue and dizziness, chills/fever, moderate nausea, sleeplessness, moderate pain in arm, moderate joint and muscle pain all over body 04/10, ~3 a.m.: Symptoms progressed to include delirium and hallucinations, rapid heart rate, itching in extremities, neuropathy and hyperesthesia 04/10, ~8 a.m.: Symptoms began reversing in order of occurrence over next 36 hours, starting with delirium and hallucinations; unable to concentrate or function properly 04/12: Lingering mild dizziness and headache, fatigue

PAIN; CHILLS; HEADACHE; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: /2023) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced pain. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.9. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, headache, muscle aches, fever, and pain. This report was non-serious.

Started sweating a lot and got very pale soon after injection. Hours after injection got chills, muscles aches, and a bad headache that lasted days. Lot appetite for days. Overall felt like I had the flu.

Mild Soreness at injection site, Sore,Achy muscles across upper back and shoulders. No Treatment required.

47-year old male c/o frontal headache since Friday, 4/9/2021. Received his Johnson & Johnson vaccine on Thursday, 4/8/2021. Still having his headache now. 9/10 pressure-like on the frontal head - constant States, "I never had this kind of headache before". 6/10 burning epigastric pain. Also has bodyaches. Has mild dizziness. Denies any photosensitivity, fever, flu-like sx, nausea/vomiting, chest pain, dyspnea, numbness, tingly sensation, slurred speech, back pain, rectal bleeding.

1st day: 2hours after the shot, felt dizzy for rest of the day, low grade fever. 2nd day: low grade fever, body aches, muscle weakness 3rd day : low grade fever, body aches, muscle weakness, right fore arm and lower right leg bottom half felt little stiff, moved leg around to avoid getting stiff. 4thday : general weakness , Headache started in the night. 5th day: Nausea, dizziness , head ache 6th day, head ache, dizziness, little stiff right leg bottom half ( as if muscle is become stiff ) 7th day: dizziness , as if I move head one side whole body moves that side ( dizziness still there as of this reporting day)

On 4/14/2021, right elbow started to hurt. This was a site of a removed gout-caused mass over a year ago. That subsided within a day. On 4/15/2021, left foot started to hurt. By 4/17/2021, the next to smallest toe and the large toe was swollen and very tender to any sort of touch. It was not warm. The pain was almost unbearable on 4/18/2021 and the suspicion that it might be gout was considered. On 4/19/2021, after a visit with his doctor, gout was confirmed as the likely cause of the pain/swelling. However, no blood tests were run to confirm. Treatment for gout was initiated.

Severe neck and arm pain started about 30 minutes after vaccination was given. Often times it is a tingle from the neck to my elbow and the pain lasts 24 hours a day.

Chief complaint of worsening lower leg pain. Initially the patient though that he had pulled a muscle however he had complaints of claudication upon ambulation. Patient reports having J&J COVID vaccination approx 2.5 weeks prior. Patient reported his friend informed him that he might potentially have a blood clot and that he should come to the emergency department. Imaging consistent with acute DVT and patient taken to IR for tPA direct catheter infusion.

About 1 week after vaccination, I noted sensations of fullness or bloatedness. It felt like gas trapped in my upper abdomen that could not be relieved by burping. Within 2 days, I began to have pain in lower, left rib cage akin to side cramps/stitch after strenuous running, but persisted the entire day. About 2-3 days later, the pain intensified and spread throughout my diaphragm region (left and right sides). Breathing was somewhat affected, after semi-strenuous activities, such as walking up/down stairs. So, I avoided physical exercise, and took Advil for a couple days to minimize the pain. After another 3-4 days, the pain in the diaphragm region subsided. I have not experienced further discomfort for the past week (today is 4/21/2021). No treatments were sought during this period. I self-researched the symptoms and hypothesize the pain stemmed from a swollen spleen, which might have been caused by an overactive immune system due to the vaccine.

RIGHT SHIN PAIN; ANXIETY; DIFFICULTY CONCENTRATING; HEAD FELLS FUZZY; POTENTIAL SHINGLES; SEVERE LEG PAIN IN RIGHT LEG/RIGHT THIGH PAIN; RIGHT HIP PAIN/RIGHT ANKLE PAIN; LOWER AND MID BACK PAIN; SENSATION IN HEAD AND NECK; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included inflammation, blood pressure, abstains from alcohol, and smoker (1 pack/day or a little less), and other pre-existing medical conditions included the patient had no known allergies and there was no 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: 1808978, and expiry: 13/JUN/2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included chlortalidone for blood pressure high, and ibuprofen for inflammation. On 26-MAR-2021, the subject experienced sensation in head and neck. On 27-MAR-2021, the subject experienced right hip pain/right ankle pain. On 27-MAR-2021, the subject experienced lower and mid back pain. On an unspecified date, the subject experienced right shin pain, anxiety, difficulty concentrating, head fells fuzzy, potential shingles, and severe leg pain in right leg/right thigh pain. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) 271 (units unspecified). Treatment medications (dates unspecified) included: cefalexin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe leg pain in right leg/right thigh pain, right shin pain, difficulty concentrating, head fells fuzzy, and lower and mid back pain, and the outcome of sensation in head and neck, right hip pain/right ankle pain, anxiety and potential shingles 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.

Hospitalist Discharge Summary Admission date/time Apr 23, 2021 at 00:19 Discharge date: Apr 26, 2021 Hospital course 47M pmh DMII, HTN, HLD, L basal ganglia stroke, pw right-sided weakness, gait imbalance, double vision and slurred speech beginning at 2:00 p.m. 4/22. on admission, double vision resolved; slurred speech, headache and right-sided weakness imbalance gait remain. 4/23am pt developed L pupil dilation and lethargy, MRI brain demonstrating acute stroke, allow permissive htn treat for sbp>220mmhg or DBP >120mmhg, cont asa/statin; US carotid nonacute/benign; TTE pending; ST/PT/OT. Tele benign. 4/24 BPs remain elevated, allow permissive htn to standards <220/120; cont st/pt/ot, a little improved participation today po intake etc. 4/25 cont to improve slowly, will be good candidate. cont allow permissive htn, no events on tele, cont asa/statin for significant stroke, add plavix. 4/26 pt cont improve clinically, BP stabilizing still permissive htn, recommend start home BP meds within 2-3 days once out of acute phase, pt accepted today, TTE benign doppler benign, but doesn't seem like bubble study done, recommend repeat as outpatient to ensure no positive bubble defer to pt's pcp f/u. double vision persists, pt currently w eye patch relief, recommend outpatient ophtho follow up closely after or during time. cont asa/plavix/statin, then transition to asa/statin as rx per guidelines. no afib on tele, consider zio patch on d/c to ensure no afib in young patient w x2 stroke. recommend hypercoag workup outpatient. Acute stroke, L lacunar -asa/plavix/statin -permissive htn -tele -PT/OT/ST -TTE benign, nml ef, no bobble done? -repeat tte outpatient w bubble to ensure no R>L shunt -US carotid nonacute -MRI Brain 4/23 1. Focal patchy restricted diffusion and FLAIR signal hyperintensity in the left medial thalamus/rostral midbrain compatible with acute lacunar type ischemic infarct. 2. No significant intracranial mass effect, midline shift or extra-axial collection. 3. Chronic left basal ganglia infarct approximating the anterior limb of the left internal capsule involving the head of the left caudate nucleus.

on the evening of the vaccination , had the expected effects, such as fever, muscle pains, stomach ache, nausea, headache, ..the nest day, my legs were so sore that I could barely stand & I had to wait for. while until I could walk. the headache lasted for a few days, the muscle pain is lessening but not gone until today, it makes my legs & feet grow sore & tired very quickly. last Sunday, April 18 2021, started around 5 pm, I started having nausea , then stomach pain so bad & vomitted many times until I was admitted to ER around midnight . the med staff at the ER did X-ray & citi scan, told me there was some bowel obstruction , gave me ivy, painkiller injection & some others then I was transferred to a medical center. they did another citi scan & found everything was ok, I asked what may cause it, they didn't really know beside probably not enough water etc .

In the weeks following my shot, I am feeling much discomfort and pain in my right shoulder blade, shoulder and neck.

Intense uncontrollable shaking, uncontrollable contraction of all muscles, inability to control breathing, intense very shallow hyperventilation, Inability to speak or answer questions, severe muscle aches, soreness.

FLUSHED; MINOR GOUT SWELLS; SORE ARM/THROBBING ARM; TIRED; SHORTNESS OF BREATH; ANXIETY; DIARRHEA WITH BLOOD; This spontaneous report received from a consumer concerned a 47 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic gout. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205ANA, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAY-2021 vaccination at left arm 16:30 for prophylactic vaccination. Concomitant medications included allopurinol for gout. On 08-May-2021, The patient experienced Shortness of breath shortly after vaccination, but this resolved in 15 minutes. He waited for 20 minutes after getting the vaccine. Patient noted that it could have been anxiety driven. On 08-May-2021 night (10 hours after), patient experienced diarrhea in the middle of the night and progressed to blood in the stool. The patient also very tired. Patient slept for almost 24 hours from Saturday to Sunday night, but now feels better. Patient felt very flushed, also experienced arm super sore for 1 day after vaccination, and throbbing for about an hour. The patient suffers from chronic gout and experienced minor gout swells (unsure if it is related to the vaccine or not) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and anxiety on 08-MAY-2021, and sore arm/throbbing arm, and tired on 09-MAY-2021, was recovering from diarrhea with blood, had not recovered from minor gout swells, and the outcome of flushed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210522256-COVID-19 VACCINE AD26.COV2.S-diarrhea with blood. 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; MUSCLE ACHES; NAUSEA; SORENESS AT INJECTION SITE; HEADACHES; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced chills. On 17-MAY-2021, the subject experienced muscle aches. On 17-MAY-2021, the subject experienced nausea. On 17-MAY-2021, the subject experienced soreness at injection site. On 17-MAY-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and nausea on 17-MAY-2021, was recovering from muscle aches, and soreness at injection site, and had not recovered from headaches. This report was non-serious.

Increased pain and swelling in left arm - started within 12 hours and continued for 2 weeks Fever over 100 - started within 12 hours and continued for 1 month (fever between 100 and 102) Nausea - within 12 hours (continued for 1 month) Vomiting - within 24 hours (continued for 3 days) / then again 2 weeks out for 3 days) Migraine Headache - started within 12 hours and continued for 6 weeks (and on-going) Labored breathing - started within 12 hours and continued for 5 weeks (and on-going) Low oxygen - started within 36 hours and continued for 1 month) General muscle and body aches and pains (started within 24 hours and continued for 6 weeks (and on-going) Extreme exhaustion and lethargy (started within 6 hours and continued for 6 weeks (and on-going)

Covid-19 Janssen vaccination administered on 5/24/2021 at approximately 1230. At approximately 1247 patient noted to have flat red rash to left side of neck moving towards chest and same rash on left antecubital space. Patient reported feeling hot. Diphenhydramine 50mg IM administered. Patient reported feeling short of breath, epi-pen 0.3mg IM administered. Respirations at 16 per minute, lungs clear to auscultation. Noted bilateral flat rash to underarms, improved with removing clothing from area. Patient symptoms improved. At approximately 1330 patient reported starting to feel short of breath. Patient self administered albuterol inhaler, two puffs. Lung sounds per auscultated expiratory wheezing bilateral upper posterior lobes and right middle lobe, no stridor. Post inhaler lung sounds very faint expiratory wheezing upper posterior lobe, right middle lobe cleared. At approximately 1400 noted rash to bilateral underarms started to return, rash to left side of neck started to raise, noted dermatography to bilateral sides. EMS activated. Perioral edema noted, patient reported starting to feel short of breath, epi-pen 0.3mg IM administered, oxygen at 2L per NC applied. Ambulance on prison grounds at approximately 1412, left grounds at approximately 1429 to Emergency Room for a higher level of care. Treatment at ER not available. Discharged from ER on same date at 2246. On 5/25/2021 at approximately 0215 patient reported pain in jaw, neck and chest. EKG obtained, normal EKG. Follow up scheduled with medical provider.

Shot was painless the first. Next day was severe enough to limit movement for the next 2 days. Eventually shoulder pain s as me shooting pain down my arms. 3 weeks later noticing pain in all my joints, especially shoulder that was injected and my knees and hips. 4 weeks later all pain persists and the site of injection still is sore.

Patient fainted 10 minutes after getting the vaccine, he felt light headed and had seizure like symptoms, and his body was rigid and shaking . He wasn't able to breathe, patient was put on his back and CPR was performed for 20 seconds, and 911 was called. Patient was able to breathe again and felt okay. Patient stated that he didn't eat or drink anything prior, he was given a sports drink and sat back in a chair for 20 minutes after. EMTs showed up and took his vital signs, patient refused to go to the hospital.

Monday, March 29 I was warming up for a chest workout - bench press with 135# (2- 45# plates) on the bar. On my first rep I noticed the muscles in my right arm were not firing properly and I pressed the wt up very unevenly - I repeated two more reps (total of 3) and repacked the bar. I then proceeded to attempt push ups- on my first rep my wt shift over my left arm and my right arm only served to balance me- again no pushing strength. I then proceeded to do a pull up- as I attempted my first pull-up my weight again shift to my left side- no pulling strength in right arm. The week prior I was showing signs of tennis elbow in my right arm. The week of March 29, the intensity of discomfort was high as I experienced muscle spasms alternating between my right tricep, right lateral muscle and my right pectoral muscle- my tennis elbow pain was intense and I experienced tingling in my right ring finger and pinky. On April 9 I went to family Dr they gave me a muscle relaxer and pain pills and scheduled an x-ray of right elbow and shoulder. April 16 the pain continued and I went back into the doctor and had an MRI scheduled for Sunday May 2 along with a referral to an ortho doctor. May 17 I went to the ortho doctor who did another X-ray. The ortho doctor first Mentioned that this could be GBS. I started Physical therapy on June 21.

severe lower back pain, radiating down left leg; legs became wobbly; lost balance; fell several times enroute to ER. Admitted to hospital. MRI x3. Diagnosis Guillain Barre syndrome; treated with IVIG & steroids x 1 week Transferred to Rehabilitation Institute. Dr. primary rehab doctor. Neurologists consultants.

Approximately 12 hours after getting the vaccine, I began shivering uncontrollably for about an hour and felt hot (like a fever) at the same time. I also ached all over. I took 2 Tylenol and was able to fall back asleep. I woke up sweaty, but the chills and fever were gone. I?m now just stiff, with some mild pain at the injection site.

Redness and itching at injection site Severe joint pain in neck, shoulder, hipd, knees, ankles for 36 hours

Chills lasted for about 16 hours Fever in the middle of the night Muscle pain in injection arm (current) Pain in arm pit of injection arm (current) Headache lasted about 24 hours

I started having the next day after vaccine a fever and a severe muscle and body aches, headache , then a day later I had severe knee and foot pain that is continuing to this day it?s unbearable.

Patient received the J&J vaccine on 3/10. On 3/13 he developed slurred speech, unilateral lower facial droop, weakness of extremities, generalized fatigue. On 3/15 he sought medical attention and was sent to ER -- > diagnosed w/ TIA. Pt sent back to jail where simvastatin -- > atorvastatin, pt started lisinopril, ASA. Pt denies deficits today

rapid heart rate, excessive sweating, chills, muscle aches, pain all over body, chest pain. Weakness, brain fog, out of sorts, flu like symptoms, break outs on face, trouble breathing. These conditions have lasted over 5 days so far.

Full body sweats, migraine for 2 days, threw up 4 times, shakes, pain at injection site/shoulder/chest, extreme fatigue, body aches

Just before going to bed I started feeling very cold, shivering, I had similar sensation in the past when fever went up extremely quick. I did not measure my body temperature because I immediately ran under the blanket. Icy-cold hands and feet, even after my body temperature seemed to stabilize. I fell asleep but not a restful sleep. I woke up after 2.5 to 3 hours with the feeling that it was morning, but in fact it was between 2am and 3 am. At that point I felt the worst part had gone, I felt weak and with muscle aches but I could drink water and go back to bed. I did not have a restful sleep all night and I woke up may times. By the morning I was tired but no fever.

Headache, Very Tired, Fever, Muscle Aches Started at 6pm (9 hrs after injection) and finished at 2am (17 hrs after injection).

BODY ACHE/PAIN; ITCHY EYES; SKIN SENSITIVE TO TOUCH; FLU LIKE SYMPTOMS; CHILLS; GENERAL JOINT PAIN; MILD HEADACHE; FEELING TIRED; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 01808978, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 14:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced body ache/pain. On 03-APR-2021, the subject experienced itchy eyes. On 03-APR-2021, the subject experienced skin sensitive to touch. On 03-APR-2021, the subject experienced mild headache. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced feeling tired. On 03-APR-2021, the subject experienced flu like symptoms. On 03-APR-2021, the subject experienced general joint pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache/pain, itchy eyes, skin sensitive to touch, mild headache, chills, flu like symptoms, and general joint pain, and was recovering from feeling tired. This report was non-serious.

At 5:40pm had J&J shot at Pharmacy on 4/8/2021. Had me wait for 10min before I left was okay at 6:03pm. Went to bed at 9pm. Woke up at around 12:10am with high fever chills and sore joints and muscles all over with headache. This lasted all day Friday the 9th until I went to bed at 9pm. Woke up Saturday and was fine can tell that I was sick the day before no headache or fever feel great.

Started with chills and fever, progressed into body aches and joint pain in knees and ankles, continued with 102.5 degree fever and exhaustion over the course of 2 days. Third day was severe dehydration and exhuastion. Pain continues in legs, knees, hips, feet and ankles.

Began with headache. Turned to nausea roughly 8 hours after shot. Nausea turned to sever vomiting and for several hours. Tremors. Sweating. Fatigue. More headache. Loss of appetite. Joint and muscle aches. Continued joint pain, appetite loss and fatigue.

I started sweating profusely within 30 min of the shot. Was light headed and dizzy for approximately 4-5 hrs. Once the sweating stopped I felt severe pain in both knees and ankles. If felt as if you were trying to snap my knees and ankles in half. That lasted 4-5 hrs. After I slept for a few hrs over night I woke up and felt pretty good. Approximately 3-4 hrs after I woke up I felt light headed and nauseated for approximately 3-4 hrs. I felt pretty much back to normal into the third day after the shot. I was slightly light headed and fatigued for approximately 8 days after the shot. After about the 8th day I felt normal again. I said I will never get that shot again. Approximately 25 years ago I had gotten my first flew shot and I was very sick for a week. Never received another flew shot again. Besides the stress and anxiety issues I am a healthy guy. Every 2 years we get full blood work up and my blood levels have always been spot on of where they should be.

The following morning I felt mild flu like symptoms and very low energy. While at working my right upper ankle/ lower knee became extremely sore for no reason. A mild headache and upper respiratory irritation also occurred. My right arm at injection point was extremely sore. I figured it was a immune response and didn?t get too worried. These symptoms have persisted. Hopefully will subside soon

CHILLS; HEADACHE; MUSCLE ACHE; LOW GRADE FEVER BELOW 100F; This spontaneous report received from a patient via a company representative concerned a 48 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: CA3A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On 07-APR-2021 20:00, the subject experienced headache. On 07-APR-2021 20:00, the subject experienced muscle ache. On 07-APR-2021 20:00, the subject experienced low grade fever below 100f. On 07-APR-2021 20:00, the subject experienced chills. Treatment medications included: paracetamol. On 08-APR-2021 12:00, treatment medications included: paracetamol. On 08-APR-2021 16:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, muscle ache, low grade fever below 100f, and chills on 09-APR-2021. This report was non-serious.

EXTREME DIZZINES; BRAIN FOG; VERTIGO; NAUSEA; MUSCLE PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was not reported and height was 175 centimeters. The patient's concurrent conditions included alcohol use 1-2 drinks, and non-smoker, and other pre-existing medical conditions included the patient had no allergies and no history of drug abuse. no prior history of dizziness or vertigo. 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, administered on 08-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced muscle pain. On 09-MAR-2021, the subject experienced extreme dizzines. On 09-MAR-2021, the subject experienced brain fog. On 09-MAR-2021, the subject experienced vertigo. On 09-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme dizzines, nausea, brain fog, and vertigo, and the outcome of muscle pain was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided. did not meet pqc criteria. based on the PQC evaluation/investigation performed. Additional information was received on 11-MAR-2021.The following information was updated and incorporated into case narrative: investigation result added. Additional information was received on 12-MAR-2021.The following information was updated and incorporated into case narrative: reporter telephone number and zip code, event (vertigo, brain fog) and treatment, product (batch number, vaccination time and site), patient history, event description were added.

PAIN IN THE ARMPIT OF VACCINATED ARM; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced pain in the armpit of vaccinated arm. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in the armpit of vaccinated arm. This report was non-serious.

TIGHT BURNING FEELING IN UPPER RIGHT BACK AND RIGHT ELBOW; CRIPPLING CONSTANT PAIN; MUSCLE WEAKNESS TO THE RIGHT ARM; TIGHTNESS ON UPPER RIGHT SIDE ON BACK NEAR RIGHT SHOULDER; INJECTION SITE PAIN; INITIAL BURN WHEN VACCINATED; DISCOMFORT; DID NOT SLEEP WELL AT NIGHT; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced discomfort. On MAR-2021, the subject experienced did not sleep well at night. On 11-MAR-2021, the subject experienced muscle weakness to the right arm. On 11-MAR-2021, the subject experienced injection site pain. On 11-MAR-2021, the subject experienced tight burning feeling in upper right back and right elbow. On 11-MAR-2021, the subject experienced crippling constant pain. On 11-MAR-2021, the subject experienced tightness on upper right side on back near right shoulder. On 11-MAR-2021, the subject experienced initial burn when vaccinated. Treatment medications (dates unspecified) included: ibuprofen, naproxen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 12-MAR-2021, was recovering from tight burning feeling in upper right back and right elbow, crippling constant pain, did not sleep well at night, discomfort, initial burn when vaccinated, and tightness on upper right side on back near right shoulder, and had not recovered from muscle weakness to the right arm. This report was non-serious. Additional information was received on 19/Mar/2021. The following information was updated and incorporated into the case narrative. Reporter details added, patient information (date of birth, sex, ethnic origin, race) added. patient allergy details, batch number of suspect, site of administration, Vaccine facility details, events: injection site pain and muscle weakness to the right arm were added.; Sender's Comments: V1:Medical assessment comments not required as per the standard procedure as the case is considered non serious.

on 4/9/21 around 8pm extreme cold chills , headache , body aches fever all night , flu like feeling for 3 days body ache and little sleep , consistent headaches . Had out patient knee surgery on 4/14 . Continues nasty headaches and body aches after . on saturday 4/17 bad headaches all night , bones in upperbody and skin hurt , from waist up felt like i had sunburn including on top of head , little sleep again . Went to Emergency room on 4/18 am . Tested for blood clot in leg and was negative , they gave me something for headaches and i was dehydrated , tongue was white and continues to wake up everyday white and feeling like dehydration , continues head aches from front to back with some continues neck pain in back . Havent slept more than 2 hours at a time . wake up with headache everyday and at night headaches are bad . i drink plenty of fluids all day , should not be feeling dehydrated . its now 15 days since vaccine and have no answers , i need to be able to sleep to do my job , vaccine was a mistake

Headaches? nothing helps Fatigue Right side body pain?especially joints, wrist shoulder and hip and knee Two bumps on right side chest Loose stool General achiness No energy Bad sleep Intermittent nausea Higher bp

CHEST PAIN; RIGHT HAND/WRIST WEAKNESS; REDUCED HAND/GRIP STRENGTH; PLEURISY; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non alcohol user, and non smoker. 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, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pleurisy. Laboratory data included: Computerised tomogram (NR: not provided) It was clear, and Fibrin D dimer (NR: not provided) Elevated. On APR-2021, the subject experienced reduced hand/grip strength. On 20-APR-2021, the subject experienced chest pain. On 20-APR-2021, the subject experienced right hand/wrist weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 30-APR-2021, had not recovered from right hand/wrist weakness, and the outcome of reduced hand/grip strength and pleurisy 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.

backache began 5/10/2021 at 6:30pm and lasted 24 hours fever of 102 degrees / pyrexia began 5/10/2021 at 7:30pm and lasted 24 hours oscillopsia occurred on 5/17/2021 at 4pm and lasted 5 minutes

Approximately 8 hours after vaccine, high fever ranging 102-103 degrees began. Severe chills set in. Shaking and teeth chattering to the point one tooth was chipped (small) Fever and chill continue through the rest of the day. Down to 100 by 5pm on 5-20-21. Also extreme fatigue, joint and muscle aches, as common with the flu.

PATIENT CALLED JUNE 10TH OF 2021 AND REPORTED HE HAD A SORENESS IN THE MIDDLE OF HIS BACK STARTING THE DAY AFTER THE COVID-19 JANSSEN VACCINATION. PATIENT REPORTED THE SORENESS IN HIS ARM WENT AWAY AFTER THE THIRD DAY FROM RECEIVING VACCINE. PATIENT REPORTED THE SORENESS IN THE MIDDLE OF HIS BACK CONTINUED TO BE SORE TO PAINFUL. PHARMACY HAS THE PATIENT RECEIVING VACCINE IN THE LEFT ARM. PATIENT REPORTED ABOUT A WEEK PRIOR TO HIM CALLING THE PHARMACY HIS LEFT ARM HAVING NUMBNESS AND NOW HIS HAND IS GOING NUMB. PHARMACY TOLD HIM TO CONTACT HIS DOCTOR. PHARMACY CHECK WITH PATIENT ON JUNE THE 11TH OF 2021 AND PATIENT STATED HE HAD MADE AN APPOINTMENT WITH HIS DOCTOR'S CLINIC.

RED MARKS ON ANKLE, FEET AND CALVES OF LEGS; SWOLLEN WRIST; SWOLLEN RIGHT FOREARM; SWELLING OF LEFT LEG CALF; PAIN; REACTION ON LEFT LEG WORSENED AND SPREAD TO RIGHT LEG AND INNER THIGHS; This spontaneous report received from a consumer concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, alcohol user (occasionally on weekend), and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage and no complaints of medical issues. The patient was previously treated with fexofenadine hydrochloride for seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced swollen wrist. On APR-2021, the subject experienced swollen right forearm. On APR-2021, the subject experienced swelling of left leg calf. On APR-2021, the subject experienced pain. On APR-2021, the subject experienced reaction on left leg worsened and spread to right leg and inner thighs. On 20-APR-2021, the subject experienced red marks on ankle, feet and calves of legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen wrist, swollen right forearm, swelling of left leg calf, and pain on APR-2021, had not recovered from reaction on left leg worsened and spread to right leg and inner thighs, and the outcome of red marks on ankle, feet and calves of legs was not reported. This report was non-serious.

About a month after receiving the J&J vaccine, I noticed a bump in the top of my left calf, which caused some discomfort and also noticed slight numbness in left foot / toes. Primary, Dr., sent me for ultrasound, which showed I had several blood clots in my leg. I have never had any blood clots before. Dr. referred me to Hematologist, Dr. She ran extensive blood tests and found no genetic predisposition for clots. She stated it was likely the vaccine that caused me to develop blood clots. I am now on blood thinners to try to dissolve them and may have to take them for life if the clots don't go away in the new few months. Follow up ultrasound scheduled 9/7/21.

Fever 99.8 for 24 hours; head ache approx 9 hours; joint pain mostly neck, shoulders, hips continues to persist; muscular weakness which persists as well localized primarily to upper extremities; had sharp pains in mediastinum left side, intermittent for several hours the day after the injection, difficult to tell if the pains were heart or lung related. These pains were the most scary part.; General malaise for about 24 hours.

JAW OPENING AND CLOSING VIOLENTLY ON IT OWN; STIFFNESS IN ANKLES; DIFFICULTY WALKING; LACK OF COORDINATION; EQUILIBRIUM AND BALANCE COMPROMISED; BAD DEXTERITY; ITCHING AROUND THE MOUTH; HANDS AND FEET CURLED DOWN; NUMBNESS (HANDS AND FEET); ELECTRICAL IMPULSES IN FACE AND SCALP AND ELECTRICAL IMPULSE AROUND MOUTH AND HAND; TINGLING AROUND THE MOUTH; PAIN IN ANKLES; TINGLING IN EXTREMITIES (HAND AND FEET); CONSTANT BRIGHT LIGHT FLASHING; LIP HANGING; UNCONTROLLABLE MOUTH MOVEMENT AND JERKING; MILD FLU LIKE SYMPTOMS; LACK OF APPETITE; TWITCHING ALL OVER; TREMORS; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 182 pounds, and height was 68 inches. The patient's past medical history included extreme motor vehicle accident (other driver was drunk), and broken neck, and concurrent conditions included penicillin allergy. The patient was previously treated with methadone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2042T21H, and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. Concomitant medications included oxycodone. On MAY-2021, the subject experienced tremors. On MAY-2021, the subject experienced twitching all over. On 05-MAY-2021, the subject experienced mild flu like symptoms. On 05-MAY-2021, the subject experienced lack of appetite. On JUN-2021, the subject experienced uncontrollable mouth movement and jerking. On an unspecified date, the subject experienced numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, tingling around the mouth, pain in ankles, tingling in extremities (hand and feet), constant bright light flashing, and lip hanging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from mild flu like symptoms, and lack of appetite on 08-MAY-2021, was recovering from tremors, had not recovered from numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, uncontrollable mouth movement and jerking, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, pain in ankles, tingling around the mouth, twitching all over, and tingling in extremities (hand and feet), and the outcome of constant bright light flashing and lip hanging was not reported. This report was non-serious.

OVERALL ACHINESS IN UPPER BODY; LABORED BREATHING; EXTREME PAIN IN JOINTS/PAIN IN RIGHT WRIST/SHOULDER PAIN/ELBOW PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180869 and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced overall achiness in upper body. On 03-APR-2021, the subject experienced labored breathing. On 03-APR-2021, the subject experienced extreme pain in joints/pain in right wrist/shoulder pain/elbow pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from labored breathing, overall achiness in upper body, and extreme pain in joints/pain in right wrist/shoulder pain/elbow pain. 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.

Torso: Pain/Discomfort across front of chest (about 2 inches above nipple) ? started on left side but also presented on the right too. Pain/Discomfort in back on both sides. Sometimes upper back, sometimes lower. Pain/Discomfort and sometimes a burning sensation in ribs. Many times this presented itself at the lower tips of the ribs. Arms: Pain/Discomfort under armpits. Tingling in arms. There was a point where my arms would fall asleep when I was laying down at night. General weakness/fatigue in the arm. Sometimes arms (particularly the forearms) feel tight Leg Pain/Discomfort in calves. Many times, the pain would be a sharp, pointed sensation in both calves. This discomfort always presents itself in the back of my calves. *Weakness/Fatigue in thighs. Many times my thighs will feel weak/fatigued. Neck: Pain/Discomfort in my neck. Primarily this occurs on the sides of my neck. There is also a tightness that occurs on the sides of my neck too. At times, the back of my neck is also tight and uncomfortable. Spine: General tightness and discomfort running down the middle of my back. This occurs primarily in the upper to middle part of my back. Overall: Along with the different sensations listed, I have battled constant fatigue and a feeling of weakness. This weakness could be overall throughout the body or sometimes just in certain regions in my body. For example, some days I might feel like my arms are weak/fatigued, other days it might be my legs, and then sometimes throughout my body. I have also been dealing with persistent headaches from time to time.

Pain in left arm, left shoulder and left shoulder blade. The pain comes and goes, but has not waned since getting the vaccine shot in April.

"Janssen COVID-19 Vaccine EUA" Joint pain, including shoulders, hips knees and ankles. Chills. Sweating during sleep. Low grade fever. General body aches. Symptoms began approx 12 hours after dose was given and still persist approx 36 hours later. No doctor or hospital visit is required at this time.

Headache, leg musle aches, fatigue / all started at around 4 pm on 3/13 and. Ended about 9 pm on 3/14.

3/15 13:30 Tightness in right shoulder about 30 minutes after application. 21:00 Burning in lower back and hips. 23:00 Burning extending down the legs and further around the core. No swelling, but almost as though nerves are being stimulated. Chills. Pain at a 6. 3/16 Same burning in joints down legs, pain still at 6. Persistent with low dosage of Tramadol. 3/17 02:00 still burning, with pain generalized in the hips, back and legs. Still at a pain level of 6

Debilitating headache from 1030pm on night of vaccination til about 48 hours later. Lower right back of head. Random muscle aches overnight. Night sweats on 2nd night. Weak and tired 2nd day.

muscle aches, chills, and high fever. Ran a fever of about 103 for about 24 hours. Rested and drank a lot of fluids and was fine about a day and a half after the injection

hard chills, cold hands, fever of 101.4 Fahrenheit, muscle aches, joint pain began approximately 10 hours after receiving vaccination. Acetaminophen was taken every 4 hours to reduce fever.......by 2a.m. the fever broke and fatigue sat in.......by the next morning around 10:30am, subject had normal temperature and returned to regular activity. The side effects of the vaccination lasted only about 14 hours total but were severe.

Initial aches and chills that developed the evening of and subsided after 2 to 3 days. Then, on the 4th day, fingers on right hand started to swell. Has continued to improve but is still having some discomfort and stiffness in the right hand. Is now 2 weeks since initial injection.

Extreme anxiety since day 3. Dry sinus since day 2. Inflamed sinus. Off and on rapid/hard heartbeat since injection. Insomnia. Rapid weight loss. Dry mouth. Loss of appetite. Ongoing chills (10 days after shot). Depression. Lack of energy.

April 01 2021 09:00 Am, Severe Chills with 102.8 Fever lasted until 10:00PM. April 02 2021 11:00 AM Wide Spread Muscle Pain continuing April 03 2021 06:00AM April 03 2021 06:00AM Continuing Wide Muscle Pain with Nausea starting 04:30AM

Patient received Johnson&Johnson COVID vaccine in the afternoon on 3/31/21. Patient reported having right arm pain, diaphoresis, chills, nausea, and muscle aches/pain in upper leg/lower back at 5:30am the following morning. Patient took 2 tablets of 500mg naproxen in the morning and in the afternoon. Symptoms did not resolve and patient had to leave work early. Upon getting home patient took 2 tablets of 650mg tylenol and symptoms resolved within 48 hours. On 4/3/21 patient reported mild to severe pain in heel of left foot. The following day the patient went to WellNow urgent care to get his heel examined. During examination provider noticed patient's lesions and patient stated more lesions have appeared since getting the vaccine. 1 on his stomach, 1 on the dorsum of his left foot, 1 on his back, 1 on his left elbow, in between his toes of his left foot, and in between the fingers of his right hand. Patient stated that these lesions cause a burning sensation and can become itchy. Patient was sent to Hopsital ED as provider at urgent care was concerned patient may have purpura. Patient was seen and discharged on 4/4/21 from the ED. The heel pain was determined to be plantar fascitis which was treated with at home exercises with a heel cup. The patient was given clotrimazole for his lesions. The patient had a follow-up visit with his primary care provider at hospital on 4/6/21 in which he explained the clotrimazole only made his lesions worse. Patient was referred to follow up with dermatology on 4/8/21. Primary care provider believes progression of the lesions since getting the vaccine leads to concern of an underlying autoimmune exacerbated by vaccine.

back pain. could be do to regular work because patient went back to work right away and performed regular lifting duties.

chills; started night of started 09Apr2021 fatigue started 09Apr2021 muscle aches started 09Apr2021 anal bleeding when going to restroom - quite a lot and did not stop right away - started 11Apr2021 migraine starting 09Apr2021

Fever 102, pain, chest tightness, chest pain, difficulty breathing, unable to move limbs or sit up, general pain in muscles, joints, bones, acute pain in wrist

Pain started in buttocks; then numbness in legs, then progressed up back to mid back pain, then to neck fullness and tightness, pain on both sides of neck, jaw and chin, feeling of something popping in neck and then Bell's Palsy of right side of face, difficulty speaking, eating, numbness of tongue; right eyelid unable to close, more pain on both sides of neck and back of head; cold and hot sensations on limbs today and no improvement of facial paralysis; hearing cricket noises in right ear at times, burning pain in patches of face.

Patient began having back pain on Friday but by Saturday was having a hard time walking. Having pain at the left elbow, both shoulders, left knee and left foot. Dr. came in to examine patient as well. Think he is having tendinopathy as pain was not in the joint itself. Patient having pin point tenderness. Denies fever.

pt says he is not feeling well. He has become light headed, dizzy, and has severe stomach pain. He has developed some diarhea and has a sour taste in his stomach. He says when he stands up he feels like he may fall and he feels like he has a buzzing in head. He has back pain on this lower right side of his body. He has been taking anti-diarhea medicine medicine and Tylenol. He is not getting any better and will have to contact his PCP.

Swollen lymph nodes and abdominal pain from right him bone down to scrotum. Pain on 4/7 was such that i though i was suffering a hernia. Couldn't get out of car or move my right leg across my body. Could put right leg into pants leg. Hurt to bend over and do much of anything on 4/7. Initially thought pain was in testicle but doesn't hurt at all to the touch. Realized it more a swollen area in the groin between hip bone and scrotum. Nothing hurts to the touch at all in that area either which lead my to believe it was swollen lymph nodes. The Feeling is as if i got hit in the right groin and my testicle has been hit and discomfort is 8 inches above right testicle in my groin area. It has been improving every day since then, the more i walk the better it is. It only hurts when i sit now and it seems to aggravate it pretty well but once i start moving the pain goes away. It has been 9 days now and the i don't notice it all day until i come back to the office and sit at my desk and again it gets aggravated and the discomfort feels like my right testicle is near my appendix Since this all started my legs feel heavier in the calf and have little nerve sensations when i sit too, which concerns me about the blood clot possibility and so i have been emailing with my doctor. I am going to make appt for Monday 4/19

Headache, chills, fever, body headache, rigors, fatigue, malaise, through the vaccination night. Since vacation has continuous fatigue and headache. 4/12/21 right side neck/face pain and headache on right side.-worsening 4/16/21-went to walk in clinic. 4/17/21 headache/neck pain extreme went to ED. Continues to have neck/face and headache.

Day 10 after vaccine injection, patient had new onset severe acute gout episode in left thumb joint/ left wrist. (Same arm as vaccination injection.) Patient described gout much more likely to present when immune system is under stress, though he had never had a severe gout symptom in upper part of body before this event. Gout cleared by Day 18 after vaccination.

ELASTICITY ON BACK OF HANDS UNRESPONSIVE; TIREDNESS; BACKACHE; NIGHTMARES; DIARRHEA; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included herniated disc, and concurrent conditions included penicillin allergy, high blood pressure, smoker, back pain, plantars wart, diabetes, and alcohol user. The patient experienced drug allergy when treated with Cleocin (clindamycin hydrochloride). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes, losartan for high blood pressure, salicylic acid for plantars wart, and Wellbutrin (bupropion hydrochloride). On 08-APR-2021, the subject experienced nightmares. On 08-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced backache. On 10-APR-2021, the subject experienced tiredness. On 16-APR-2021, the subject experienced elasticity on back of hands unresponsive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elasticity on back of hands unresponsive, and the outcome of backache, tiredness, nightmares and diarrhea was not reported. This report was non-serious.

I told the doctor at the Clinic immediately that it hurt very bad. The shot was given high up on my left shoulder. I continued to feel pain. Now Its been a month and I struggle to dress myself. My shoulder hurts really bad. On a scale from 1-10 its usually a 3-4 during the day and sometimes a 9 at night. The only thing that helps is Aleve and my family doctor told me I can't take Aleve anymore because I'm on blood thinners. She said take Tylenol. I followed her advice and It doesn't work. She said if it keeps hurting, to come back in 2 weeks.

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

I started having a lot of pain in my right leg. I could actually feel and see that my veins were swollen. It progressed and started moving around. I started having chest pain and headaches. I ended up at ER. They gave me pain meds and did a CT Scan and ultrasound, which were both clear. The next day, I was walking around and my hand and arm started hurting and then went numb. My right wrist was swollen to twice its size. I went to care and they told me to go back to the ER. They eventually did another ultrasound, but the swelling had gone down by then. A few hours later, my left arm started to swell and lasted for about 4 hours. From there, I had pain in my arms and legs for a few days after that, but then I was fine.

Sore arm, extreme exhaustion, fever, body aches, racing heartbeat while resting, headaches out of the blue that's don't fade away, fluid in ears, soreness in left knee/inflamed hamstring, fever, sweaty, post nasal drip, minor cough, rattling noise in lung when breathing

I went to do my annual physical on 5/31/21 and the following symptoms got worse: Nausea, muscle pain, high temperature, cough, chest pain, and pain in the left side of the stomach.

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

CONSTIPATION; PROBLEMS WITH BOWEL MOVEMENTS; DIARRHEA; PANIC ATTACK; HOT FLASHES; PAIN IN KNEES; PAIN IN CALVES,LEGS AND RIGHT ARM; COULDN'T SEE WELL; FELT CONFUSED; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included patient has taken tylenol.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 25-MAY-2021 for an unspecified indication. The batch number was not reported and has been requested Concomitant medications included paracetamol. On 25-MAY-2021, the subject experienced couldn't see well. On 25-MAY-2021, the subject experienced felt confused. On 25-MAY-2021, the subject experienced pain in calves, legs and right arm. On 26-MAY-2021, the subject experienced hot flashes. On 26-MAY-2021, the subject experienced pain in knees. On 01-JUN-2021, the subject experienced panic attack. On 02-JUN-2021, the subject experienced constipation. On 02-JUN-2021, the subject experienced problems with bowel movements. On 02-JUN-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't see well, and felt confused, had not recovered from pain in knees, hot flashes, problems with bowel movements, and pain in calves,legs and right arm, and the outcome of panic atack, diarrhea and constipation was not reported. This report was non-serious.

Gout flare up in right big toe, peaking 6/12/21, exactly one month after vaccination. All previous four flares had been in left foot. Progression of flare similar to other events except that it escalated much more quickly than usual. No other known triggers around time of current flare were present.

May 31 - Hip soreness moved to groin. I am not sure if this is vaccine related. After a few days I went to the doctor - received a naproxin prescription and some stretches. It got worse so I went back to get an MRI and x-rays. I was not able to lift up my right leg while sitting.

Aching joints, upset stomach, sleepiness, slurred speech, drowsiness, blurred vision, weak muscles, lack of thirst and appetite, fever

Strong pain in the hips. Numbness in the legs. Tingling in the legs.Difficulty to walk. Trouble breathing. Numbness in my left fingers. Pressure on the chest.High blood pressure.

Strong pain in the hips. Difficulty to walk.Numbness in the legs. Tingling in the legs. Numbness in my fingers. Pressure on the chest. High blood pressure.

- Severe fatigue, muscle cramps and weakness, dizzy, light headed, blurred vision - numbness and tingling in feet and hands, headaches, chest tightness, - prolonged severe daily headaches, blurred vision, high blood pressure

49M with PMH significant for anxiety and depression; unmedicated due to lack of health insurance presenting with vasovagal syncope 15 minutes after Janssen vaccine administration in left arm. Pt reported feeling nervous prior to vaccine administration with remote history of fainting one time due to needle phobia, pt was offered to prophylactically lie down in a cot to receive the vaccine, he refused. Pt stated that he began feeling flushed and sweaty when he lost consciousness falling from a seated position, hitting his face and head. Pt was lying in prone position unconscious for 10-15 seconds, EMS was notified and pt was turned using C-spine precautions and transferred to stretcher. Pt was placed in trendelenberg,

PLATELET COUNT WENT DOWN TO 96; NEUROLOGICAL SYMPTOMS; ANXIETY; DIMINISHED QUALITY OF LIFE; LOSING INTEREST IN LIFE; DIFFICULTY IN WALKING/ DIFFICULTY GETTING OUT OF THE CAR; GENERALIZED HEAVY MUSCLE PAIN ALL OVER THE BODY ESPECIALLY ON ARMS AND HANDS; FEELING OF ELECTRIC SHOCK ON LEFT SIDE OF BODY ESPECIALLY UNDERNEATH THE LEFT FEET AND LEFT INDEX FINGER; SEVERE HEADACHE MOSTLY ON LEFT SIDE AND TOP PART OF HEAD; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, pre-diabetes which the patient controls with exercise and diet and no medications, alcohol user (had been drinking vodka for the past few weeks), and non-smoker. The patient had no known allergies and no history of 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: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 27-MAR-2021 for prophylactic vaccination. Concomitant medications included olmesartan for blood pressure. On an unspecified date before vaccination the laboratory data (dates unspecified) included: Platelet count (NR: not provided) 160. On 18-APR-2021 (3 weeks after vaccination), the patient experienced severe headache mostly on left side and top part of head and ended up in the emergency room at 01:00 AM in the morning. In the emergency room, the patient had a brain scan and he was told that the brain scan showed no blood clot and that his platelet counts were good. After these tests the patient was sent back home. On 27-JUN-2021 (for the past 2 weeks prior to this report), the patient experienced generalized heavy muscle pain all over the body especially on arms and hands and difficulty in walking and getting out of the car. On an unspecified date in JUN-2021, the patient experienced feeling of electric shock on left side of body especially underneath the left feet and left index finger. On an unspecified date, patient reported that his platelet count went down to 96 after the vaccination, had anxiety and had been drinking vodka every night because his quality of life was diminished and he refused to go back to the emergency room. The patient was irritated and he was losing interest in life. The patient had not experienced any fever or nausea. The patient had scheduled an appointment with the physician on 26-JUL-2021 due to his concern about the neurological symptoms. It was reported that, the emergency services were called and informed about the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache mostly on left side and top part of head, platelet count went down to 96, generalized heavy muscle pain all over the body especially on arms and hands, difficulty in walking/ difficulty getting out of the car, anxiety, losing interest in life, feeling of electric shock on left side of body especially underneath the left feet and left index finger, diminished quality of life, and neurological symptoms. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738395-Covid-19 vaccine ad26.cov2.s-Platelet count went down to 96. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY

NUMBNESS IN THE LEFT SIDE OF NECK; TINGLING SENSATION IN THE LEFT SIDE OF NECK AND IN FINGERS; SLURRED SPEECH; STRAIN; LOSS OF SENSATION IN LEFT ARM; CRACK JOINT; UNABLE TO TURN ARM AT 360 DEGREE; PAIN GOES TO LEFT SHOULDER; SORENESS AND PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18200095, and expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced soreness and pain in left arm. On JUL-2021, the subject experienced numbness in the left side of neck. On JUL-2021, the subject experienced tingling sensation in the left side of neck and in fingers. On JUL-2021, the subject experienced slurred speech. On JUL-2021, the subject experienced strain. On JUL-2021, the subject experienced loss of sensation in left arm. On JUL-2021, the subject experienced crack joint. On JUL-2021, the subject experienced unable to turn arm at 360 degree. On JUL-2021, the subject experienced pain goes to left shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness and pain in left arm, numbness in the left side of neck, and slurred speech, and the outcome of tingling sensation in the left side of neck and in fingers, strain, loss of sensation in left arm, crack joint, unable to turn arm at 360 degree and pain goes to left shoulder was not reported. This report was non-serious.

Starting approx 7 hours after injection I started to feel run down. I then played tennis for about 45 minutes. I got home around 8:30 and started to experience extreme chills, fever of 100.4, joint aches in feet, hands, neck, wrists, shoulders, hips. Headache. I did not take any additional medication - toughed it out. This morning is approx 22 hours after vaccine. I could not sleep more than an hour or so, I was very chilled and achy. I am currently feeling a little better but still have aches in my back and wrists and ankles, have a headache

Upon waking the morning after my vaccine, I experienced arthralgia, mainly in the knees, myalgia, injection site pain, head heaviness, palpitations/premature ventricular contractions, and general tiredness/malaise. All AEs lasted the entire day until I went to sleep at 10:30 PM, and all were resolved upon waking the following morning at 7:00 AM.

About 8 hours after the vaccine shot, I started to experience joint aches, then strong chills where I could not get warm, then a splitting headache. Then the injection spot hurt badly, These symptoms lasted for approximately 36 hours

severe body and joint pain, 101.1 fever, chills, nausea started approx 5 1/2 hours after injection. Next morning, approx 20 hours after injection strong head ache in top of head and nausea. 30 hours after injection, all negative effects subsided. 48 hours after injection, normal function- no effects.

About 20 hours after injection, I had mild flu-like symptoms, including headache and muscle ache, lasting about 12 hours. But about 5 days after my injection (5 days + 5 hours, actually), I experienced a bewildering all-over rash that freaked me out. It started as itching around my elbows and ankles -- it felt like mosquito bites and sunburn together -- and spread to wrist and knee areas. The rash climbed by legs and arms. I applied coat after coat of Benadryl, which seemed to help. The rash would disappear and move somewhere else. I had it on my left foot, but then that resolved, only to find it on my right foot. After about 3 hours, it had spread to my stomach, the bridge of my nose, and my cheeks. It started to calm down around midnight. I woke up at 6:00 am (12 hours after onset) with extremely itchy hands. At 8:00 am (14 hours after onset), it had mostly disappeared except for patches on my back, and my wrists still itch. I'm hoping it goes away later today! It was crazy!

First, pain around the injection site; it appeared within a few hours after the injection, but it was bearable. Then, after about 23 hours after the injection, bad headache (especially around the eyes - which also caused light sensitivity) and general malaise. Shortly thereafter, low-grade fever (99.5 F) and significant muscle pain, all over the body. The most worrisome side effect was the last one, which appeared during the second night after the injection (about 32-33 hours after the injection): extremely fast heartbeat / racing heart. I did not use any treatments for these side effects.

Injection site swelling and extreme soreness Fatigue Stomach cramping Nauseous Chills Muscle aches Migrane

Brief but very painful chest pain. Felt on left side about half way up my ribs. Thought I was having a heart attack for about a minute. No signs of arrhythmia or faintness. Feel fine now.

Had a headache at the time of vaccine but the headache - after the vaccine the pain went to the bottom part of my my head and down to my shoulder on the opposite arm of where I had the shot- like my shoulder knotted up .The headache lasted from the 17th to right before April 4, 2021. My shoulder is still stiff on the opposite side of the injection site at this time. My doctor told me it might be sinus pressure and he put me on some steroids - had a five day dose and I finished them.

Chills, mild fever, joint aches, skin sensitivity. Fatigue but difficulty sleeping. Similar to onset of flu, but milder.

LOW ABDOMINAL PAIN; LOW BACK PAIN NEAR SPINE; LOW ABDOMINAL PRESSURE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, copd, hypertension (htn), alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergy and there was no 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: Unknown) dose was not reported, administered on 31-MAR-2021 09:30 on right arm for prophylactic vaccination. No concomitant medications were reported. On 01-MAR-2021, Laboratory data included: PCR (NR: not provided) Negative. On 31-MAR-2021 21:30, the subject experienced low abdominal pain. On 31-MAR-2021 21:30, the subject experienced low back pain near spine. On 31-MAR-2021 21:30, the subject experienced low abdominal pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low abdominal pain, low back pain near spine, and low abdominal pressure. This report was non-serious.

Started with chills and progressed with body aches, sharp pain in lower back, fever. At 7:30 pm temperature was 101.2. At 11 pm temperature rose to 101.6 and heartbeat was very elevated and felt to be pounding and rapid. Around 4 am fever had diminished and minor soreness. At 7 am no further issues.

Vaccination + 3 hrs - Headache, Fatigue Vaccination + 8 hrs - Headache, Severe Fatigue (took over the counter Ibuprofen) Vaccination + 14 hrs - Severe Chills, Headache, Muscle Ache (took over the counter Tylenol) Vaccination + 16 hrs - Cold sweats, Headache, Muscle Ache, Fever = 103 deg F Vaccination + 20 hrs - Headache, Muscle Ache, fever = 101 deg F Vaccination + 24 hrs - Headache, Muscle Ache (took over the counter Ibuprofen)

About 4 hours after getting the vaccine, I experienced diarrhea. Overnight I had a headache, slight chills. The next morning I was tired, had muscle aches, had a headache, had a bit more diarrhea. The diarrhea has gone away, but still feel aches and tiredness and headache 18 hours after the vaccine shot.

Fever (100.5), cold chills, aches, headache, joint pain, fatigue, confusion, sore arm started 24 hours after shot and progressively got worse for two days. Symptoms have got better, but still lingering. A few red scabs appeared on upper arm of arm shot administered to, but not sure if related or not.

Shortness of breath, mild upper back pain, ache behind both knees, bloating and increased bowel movements, mild headache

Within 2-3 hours , felt achy, and fatigued (mild) Next 24 hours felt about the same 36-48 hours later achy, fatigue , Temp 99.4 By 4/10/21 symptoms were more intense Sinusitis began with sneezing, nasal congestion. 4/11/21 still fatigued, muscle aches, nasal congestion wax and waned 4/11/21 rest seemed to help but noticed fatigue through the day, and more nasal congestion 4/12/21 symptoms still about the same. Moderate to severe 4/13/21 lethargy 4/14/21 seemed better but tired easily with activity (nasal congestion. Moderately controlled with DayQuil/NyQuil generic product 4/15/21 Nasal Swab tested for COVID awaiting results Still mod / severe signs of fatigue, muscle aches, nasal congestion , weakness, shortness of breath(at times) Moderate cough of sputum

Immediate onset with pre-syncope. Persistent profound fatigue, diaphoresis, nausea, foggy, weak legs, muscle aches. Improving after 8 days.

A week and a half after taking the Janssen COVID shot I had a knot and pain come up in my lower back. After going to the chiropractor two times the knot and pain ended up in my right leg. I then went to Urgent Care where they diagnosed me with a large blood clot. They sent me to imaging and after scanning the area confirmed that there was a blood clot in my right leg. Urgent Care then set me up with a specialist.

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

MUSCLE WEAKNESS; NO ENERGY; TIRED; HEADACHE; LIGHT-HEADED; FACIAL SWELLING; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid- 19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced facial swelling. On 29-MAR-2021, the subject experienced light-headed. On 29-MAR-2021, the subject experienced headache. On 30-MAR-2021, the subject experienced muscle weakness. On 30-MAR-2021, the subject experienced no energy. On 30-MAR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from facial swelling on 02-APR-2021, was recovering from muscle weakness, and tired, and had not recovered from light-headed, headache, and no energy. This report was non-serious.

Achy; No appetite; Mild dizziness; Feeling flushed; Soreness at the vaccine site; Fever; MILD JOINT PAIN; Chills; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included liver disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, administered on 05-MAR-2021 10:45 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced mild joint pain. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 05-MAR-2021 11:00, the subject experienced mild dizziness. On 05-MAR-2021 11:00, the subject experienced feeling flushed. On 05-MAR-2021 11:00, the subject experienced soreness at the vaccine site. On 06-MAR-2021, the subject experienced achy. On 06-MAR-2021, the subject experienced no appetite. On 07-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 (high fever). On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild joint pain, and fever, had not recovered from soreness at the vaccine site, and the outcome of mild dizziness, feeling flushed, chills, achy and no appetite was not reported. This report was non-serious.

PAIN EXTENDING TO THE NECK; FEELING PAIN FROM SHOULDER TO ARM; This spontaneous report received from a patient concerned a 50 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-APR-2021, the subject experienced pain extending to the neck. On 17-APR-2021, the subject experienced feeling pain from shoulder to arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling pain from shoulder to arm, and pain extending to the neck. This report was non-serious.

About a week after receiving vaccine, both my shoulders and both hips started experiencing pain and weakness that is still ongoing, though improving. Until recently, it was difficult to raise my hands over my head, and it would be difficult to stand up from a sitting position. I have regularly exercised and done resistance training for several years. I'm not sure if this is coincidental nor am I concerned, but a pharmacist encouraged me to report it here.

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

I experienced pain in my left shoulder after my J&J vaccine, have trouble any pushups. My pain is constant in my left arm above my head. The day I went to the doctor, a guy crashed into me and the pain I experienced was more. I can put my fingers into my shoulder region and it is very painful. I saw a doctor 04-23-2021 ad he advised me if my symptoms persists I should come back for a re-evaluation. I can not put my left arm first, my left arm is unstable. Before the J&J vaccine, I did not have this pain to my left shoulder. I have also taken OTC Tylenol but it does not help with my pain.

LUMP IN ELBOW; CHILLS; JOINT PAIN; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included patient had no known allergies or 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: 1816022 expiry: 01-JUL-2021) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. Concomitant medications included diphenhydramine. On 16-MAY-2021, the subject experienced lump in elbow. On 16-MAY-2021, the subject experienced chills. On 16-MAY-2021, the subject experienced joint pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 17-MAY-2021, was recovering from joint pain, and had not recovered from lump in elbow. This report was non-serious.

?Janssen COVID-19 Vaccine EUA? Severe shoulder pain at injection site in muscle and joint that has worsened over time. Currently unable to sleep because of pain.

TWO TO THREE DAYS AFTER SHOT 5/2-5/3 PT HAD STIFF/ CRICK IN NECK FELT LIKE IT NEEDED TO VBE CRACKED BUT COULDNT CRACK IT.. ONE WEEK AFTER INJECTION 5/8 PT DEVELOPED BELLS PALSEY ON LEFT SIDE OF FACE PT STILL HAS BELLS PALSELY PT WAS SEEN BY HIS PHYSICIAN AND WAS ADVISED TO REPORT ADVERSE EVENT(S) TO PHARMACY TO REPORT TO VAERS

Fever over 104.8, chills, shakes, headache, muscular aches and pain, fever continues at 20 hours after shot hovering around 101.

C/o shoulder pain day of vaccination. Increasing pain over two weeks. Has seen ortho and is trying conservative treatment but is still in pain and will follow up again for more treatment.

left shoulder pain immediate but expected some...thought little odd got the shot more in back part of shoulder than upper arm.....pain from shot hurt more than any flu shot I ever got.......would not go away...had to stop lifting light weights after about 9 days, still did not go away, putting on and taking of shirts hurt, sleeping movement hurt in shoulder, was not getting better so saw ortho on 5/19...ortho prescribed 9 advil a day, ice and volentrane ...if not better in 2-3 weeks come back and will take next step...in between that now....pain less cause advil but feel not getting better and will probably see dr again ....have not lifted weights since ( I can't read hand writing exactly for lot#

FATIGUE; BODY ACHES; LOWER BACK PAIN ON LEFT SIDE/BACK PAIN; PAIN IN HIS WHOLE UPPER ARM (SHOULDER TO ELBOW) OF THE INJECTION SITE/LEFT ARM SORENESS; COLD CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headaches, blood pressure abnormal, iodine allergy, non-alcohol user, and non-smoker.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 12-APR-2021 for prophylactic vaccination. Concomitant medications included losartan for blood pressure abnormal, and verapamil for headaches. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced lower back pain on left side/back pain. On 13-APR-2021, the subject experienced pain in his whole upper arm (shoulder to elbow) of the injection site/left arm soreness. On 13-APR-2021, the subject experienced cold chills. On 13-APR-2021, the subject experienced injection site pain. On 05-JUN-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and cold chills on 15-APR-2021, lower back pain on left side/back pain, and fatigue on 06-JUN-2021, and injection site pain on APR-2021, and had not recovered from pain in his whole upper arm (shoulder to elbow) of the injection site/left arm soreness. This report was non-serious.

2 days after shot, numbness/weakness in left leg and pins and needles in left hand. Upper arm pain where injection given. Neck pain. Seems to be autoimmune reaction. Hospitalized for 2 nights, seeing neurologist, having physical therapy for leg and neck

Bump behind my left knee. From doctor visit on 3/23/2021: On exam of the left knee there is a soft ballotable nontender 4 x 4 centimeter cystic lesion in the popliteal fossa. No distal edema. Negative Homans' sign This appeared on 3/18/2021. It is not painful and is not stopping me from exercising. There is some mild swelling in my right leg.

Within two weeks of vaccination: energy level down, muscle ache, diarrhea, congestion, extra gas (intestinal). Ongoing: extra gas (intestinal); cold flashes that course quickly through body; tingling in arms, hands (like a buzz or very fine pins and needles); irritability; itchiness (upper body, face and head); numbness on front of tongue; stiff finger joints; brain fog; quick onset of fatigue; sudden faint feeling; feeling of weakness in muscles; bruise on right upper arm which remained for a couple weeks; apparent reduced allergen/pollen resistance. Also, it seems I may now be having novel allergic reactions to peanuts. I had long consumed peanuts and peanut butter without incident before taking the vaccine.

I WOKE UP SATURDAY MORNING WITH FLU LIKE SYMPTOMS (FREEZING ONE MOMENT THEN BURNING UP THE NEXT). THAT WENT ON UNTIL MONDAY AFTERNOON. SATURDAY MORNING I ALSO NOTICED MY LEFT LEG WAS SWOLLEN AND HAD A BLUEISH/REDDISH COLOR AND WAS THROBBING. FROM TIME TO TIME i WOULD EXPERIENCE A SHARP PAIN BEHIND MY KNEE AND THIGH. AFTER A WEEK THE SYMPTOMS DID NOT GO AWAY SO I WENT TO THE DOCTOR. HE ORDERED AN ULTRASOUND ON MY LEG. THAT SAME DAY I HAD THE ULTRASOUND WHERE THEY FOUND MULTIPLE BLOOD CLOTS IN MY LEFT LEG. DOCTOR IMMEDIATELY PUT ME ON ELIQUIS. THE DOSE FOR THE FIRST 2 WEEKS WAS 10MG TWICE A DAY (10 MG MORNING AROUND 8AM AND 10 MG AROUND 8 PM). AFTER 14 DAYS HE REDUCED MY DOSE TO 5 MG AM AND 5 MG PM.

After approx 10 mins of monitoring after injection in exam room, patient reported tingling and pain in his fingers and joints of both hands. Provider was alerted and patient was examined. recommended to stay an extra 15 minutes for monitoring. Patient was monitored for an extra 15 mins before being assessed again by MA and let go after determining he was fit to leave.

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

developed a myelitis, presenting and paresthesias and leg weakness, responsive to high dose steroids.

Chills, Fever (101.0), Achy, Sore muscles, Stiffness, injection site pain, mental fuzziness, Headache

Sore arm. About 3 hours after getting the shot, I started getting aches, feeling cold, and tired. The next morning my joints ached and I had a sore throat. I took a couple of Ibuprofen (200 mg each) and about an hour later, my aches started going away. By 8 pm the next day, I didn't have many side effects.

2 hours after vaccination I noticed left arm started hurting . Went to bed at my usual time and woke up at 2:00 am with the chills I could not get warm late that night around 5:00 am I started having joint pain and fatigue with a headache and hot skin. I had taken my temperature and it was 100.7. I tried to wait out symptoms but I seem to bee get worse throughout the morning. Around 10:00 am I was in terrible pain and my body hurt all over. I once again took my temperature and it had gone up to 101.9. I had to call of work because I was so ?out of it?. I started taking Tylenol ever 4 hrs for my fever and I was trying to hydrate. My temperature slowly went down but still had body pain. I then started thank ibuprofen to help. Later that night around 9:00 pm my temperature was 99. The next day I called off work for fatigue and body pain. Today my temperature is normal and I?m starting to feel like my self again

Injection site: pain, redness of the skin and swelling. In general: headache, feeling very tired, muscle aches, fever and chills. Duration: approx. 24 hrs

Within 24 hours I experienced profuse sweating followed by aching in my neck, shoulders, arms and lower back. This was then followed with severe fatigue, cold chills and diarrhea. Symptoms subsided after approximately 24 hrs of onset.

Janssen Covid-19 Vaccine EUA recieved shot at around 2:15 Pm, around 8:00 pm I started feeling extreme fatigue, dizziness, and sleepiness. About 1 hour later I started getting the cold chills, a headache and shaking. About 1 more hour later I had a fever, achy joints and muscle aches. The symptoms lasted through the night until about 8:30 the next morning when I started sweating. I decided then to take aceteminiphen and Naproxen. This helped me to feel a little better. Side effects were resolved after 24 hours

Patient had arm tingling shortly after injection. Pt stayed in store for about 4 hours after 2pm injection, no redness or swelling noticed. Pt was quite anxious & nervous (but already has severe anxiety). Pharmacist called patient following afternoon, the 11th and patient noted he was doing marginally better but still sounded anxious. Pharmacist called patient on Fri the 12th 5:16p and this was when the patient explained the following: Muscle stiffness on left side & pain down left leg; cranial pain; shoulder stiffness; nasal congestion; some shortness of breath; soreness & fatigue. Patient called back and said he had partial shortness of breath at 7:34p on the 12th. On Sat the 13th at 11am, pharmacist called to check on pt; found him quite agitated & saying, "He feels the shot was botched", noted he had called Janssen to report his issues. At 4:30pm, pt came to pharmacy, looked fine, arm showed no redness, was more subdued in person than on the phone earlier. He said he was feeling better but was not happy with Janssen and wanted the Moderna 2 series shot because he feels Janssen's vaccine wasn't doing what it was supposed to.

Fatigue that lasted for 15 hours. General muscle and joint aches for about 12 hours. Minor Injection site pain that lasted for 2 days.

Janssen COVID-19 Vaccine EUA On the (Saturday) morning after receiving the vaccine I woke up with mild fever and chills and pretty significant muscle and joint pain. I basically stayed in bed most of the day, I took Tylenol throughout the day as indicated on the container. I took my last dose of Tylenol at approximately 9pm. The following morning (Sunday), all these symptoms had gone away. That day I had minor fatigue, The following day (Monday)I would consider myself symptom free.

Sore arm at injection site immediately after and still after 24 hours post-injection. Overall feeling of malaise, fatigue, slight chills, body aches, joint pain from about 8 hours post-vaccination continuing to 24 hours post-vaccination. Slight cough and chest congestion, feel warm but no fever (36.6 C).

Day 1: injection site soreness Day 2: Extreme fatigue, muscle soreness, aches, fevers, chills, dizziness, nausea Day 3: Extreme fatigue, muscle and joint soreness, aches, fevers, chills, dizziness, nausea Day 4: moderate fatigue, chills, fever spikes, dizziness

Paramedic assessed patient. Pt stated neck tension on the side (R) arm, 3/10 pain, light head, natural low pulse rate. Vitals BP 159/78, HR 51 bpm, respiratory 16. Pt was monitored and stale to leave upon expired observation time frame.

JOINT PAIN; FATIGUE; FEVER; MILD HEADACHE; This spontaneous report received from a patient concerned a 51 year old. 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: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced mild headache. On 06-APR-2021, the patient experienced joint pain. On 06-APR-2021, the patient experienced fatigue. On 06-APR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, joint pain, fever, and mild headache. This report was non-serious.

Starting 96 hours after vaccination: extreme stabbing pain in left deltoid (injection site). Soon, this was accompanied by dull but severe pain in left shoulder and upper left back (top of scapula and around collar bone), extending to base of neck. This pain lasted 2 weeks, and was severe enough to prevent patient from sitting or standing for more than a few minutes at a time, especially during the first week of pain. Painkillers (Acetaminophen or NSAIDs) or muscle relaxants (cyclobenzaprine) did not help alleviate the pain. The pain started on March 17, and finally eased up on April 2 (the vaccination was on March 13). There is still some pain and stiffness in the left arm (currently in the biceps), but it is no longer severe. By the way, in addition to the above symptoms starting at 96 hours, there were the usual expected systemic symptoms immediately after the vaccination (starting at 6 hours and ending at 36 hours): light fever, mild body ache, fatigue and mild local pain at injection site.

Pain to right leg (hip to foot) started at 7:30pm on 4/7/2020 and continued to worsen until medication ordered on 4/12/2020. Also developed rash to right shin on 4/10. Several "knots" to arms, neck, and back.

On or about 3/31/21 I began feeling extremely week and lethargic. On 4/6/21 I came home from work about 7:00 am due to an extreme headache and muscle weakness. By the afternoon my fever was up to 101. On 4/7 my fever went up to 102.7 and I was shaking uncontrollably, sweating , dizzy, headache, and had heaviness in my chest. I felt as if I were going to have a stroke. The headache was excruciating. I took acetaminophen 500 x 2 and 400 mg of ibuprofen, and Theraflu to try and alleviate the symptoms. On 4/9/21 my fever broke, but the weakness, dizziness and headaches have continued. I currently have ongoing headaches and dizziness. I have not gone to the doctor because I do not have a PCP. I am looking for one now.

EXTREME muscle aches and fatigue. Started the next morning. Time and rest have been the only thing that is working. Still ongoing. Doing better, just not back to "normal "

KNEE HURT; BARELY WALK; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included fexofenadine hydrochloride. On 13-APR-2021, the subject experienced knee hurt. On 13-APR-2021, the subject experienced barely walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from knee hurt, and barely walk. This report was non-serious.

HEAVINESS ON UPPER TORSO UPON STANDING / FELT LIKE LOWER SPINE OR BACK WAS COLLAPSING OR BUCKLING UNDER WEIGHT; MUSCLE WEAKNESS; JOINT PAIN IN LOWER BACK / KNEE AND RIGHT HAND KNUCKLES; CHILLS; MUSCLE ACHES; MILD HEADACHES; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced heaviness on upper torso upon standing//felt like lower spine or back was collapsing or buckling under weight. On APR-2021, the subject experienced muscle weakness. On APR-2021, the subject experienced joint pain in lower back, knee and right hand knuckles. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced mild headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and mild headaches on APR-2021, and the outcome of muscle aches, muscle weakness, joint pain in lower back, knee and right hand knuckles and heaviness on upper torso upon standing//felt like lower spine or back was collapsing or buckling under weight was not reported. This report was non-serious.

NOSE BLEED; MUSCLE CRAMPING; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 51 year old. 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: 041A21A, expiry: unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced muscle cramping. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed on 13-APR-2021, and fever on 10-APR-2021, and had not recovered from muscle aches, and muscle cramping. This report was non-serious. This case, from the same reporter is linked to 20210427147.

I received an injection in June and July 2020 to control my herniated discs problems that caused me severe sciatic pain down my left leg. After those injections I have led a normal life. NO issues whatsoever. No discomfort, no leg pain, no back pain. Within about an hour after receiving the COVID-19 injection, I started to have discomfort and pain in my lower back. Within a few days my sciatic pain had returned. I am now scheduled for another injection in my back for 4-23-21 to get rid of the sciatic pain.

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

Approximately 10-11 hours after receiving the vaccine injection I developed severe flu like symptoms. I developed a fever of 102 F, a headache, chills and severe joint and muscle pain. The majority of the symptoms resolved within 36 hours of onset but I am still experience severe joint and muscle pains, headaches, fatique/exhaustion and difficulty thinking clearly.

Severe bone pain, feet, ankles, risk, hands , and especially legs pain hands everything resolve within a week with exception being hand and fingers. Hand and fingers severe pain for a 3 weeks got better for a week and came back more severe and the sought treatment form doctor . NPN sent for blood test for inflammation and arthritis. Rheumatologist arthritis negative and inflammation factors was high. Referred Rheumatologist.

headache and back and bilateral hip pain after vaccination that lingered for a month, followed by left sided bell's palsy on 4/30 (26 days after injection) that was mild, and resolved with prednisone

progressive skin tingling, back pain, neck pain First noted a problem 2- 2 ½ wks ago : tingling; touching cool surfaces would feel wet Mostly his legs at first: Tingling just in the spots where he would contact states he developed some back pain behind the lungs that he noted when he moved in a certain way would ? twisting side to side or standing up Couple days ago noted tingling was constant down the arms and legs and around the mouth: numbness around the lips like tingly cool sensation; as would feel with Novocaine Pain down the L side of his neck, mostly at night Now feels the pressure behind the muscles behind the lungs - feels it with deep breath or moving 5/22 a.m.when brushing his teeth, gargling couldn?t hold his lips together If tries to, only the R side puckers, weak on the L upper lip (in that area has less tingling) - denies any other weakness diffuse headache that he ranked as a 2 or 3

Pt c/o abd pain x2 days of lower abd and sides. Denies da/ns/v. Pt reports pain worsening while laying on back and while rotating torso. Pt took 800mg ibuprofen with temporary relief. Recieved janssen vaccine 25th May.

No taste Muscle pains over the entire body Sore Throat Constant Cough Weak & Extremely Fatigued Nausea - throw up after eating Started within 7-8 hours of receiving the vaccine Took 2 Tylenol Felt better by the third day (Monday) - nausea has persisted and throat remains a bit sore and still cannot taste food

Intense headaches, back and hip pain and right arm pain. The pain got so bad and lasted for a few months ultimately landing me in the Emergency Room for 3 visits in 2 days. I also had Bells Palsy. They were pumping me full of morphine and it did not take away the pain. Treatment was pain management - vicodin and prednisone for the bells palsy. Severe pain is gone , but now have joint pain, weird skin sensations and dealing with fatigue and some depression. This is vaccine related - I had no issues with any of this prior to the shot.

Had the expected fever within 24hrs which okay. But 5 days later out of the blue I felt shaky, disoriented, sweats, fatigued hardly had the energy to stand or even speak, I was fearing I was having some kind of heart attack or stroke. Something in my body was telling me something was very wrong, I have never had a feeling like this before in my life it was pretty scary. I went to a place to be alone and sit since I could hardly stand, I sat for an hour and started to feel some relief. It took almost 4 hours until some sense of normal was back. I came home and went to sleep for the event tired me out immensely. Since that days event and still ongoing I have been having random dizzy spells, I have days with absolutely not enough energy to walk out of bed and have called out of work because of it. I get the feeling I am unplugged and then plugged back in as far as energy goes almost every day. I have worse and better days with that. About 2 to 3 times a week I experience sudden pains and tingling that can go anywhere on my body but seems to focus more on all my extremities and back. Feels like fire/pins/needles and it stays with me for a few hours to an entire day the pain ranges from a 5 to an 8. My legs feel stiff every day now and at times sore yet I have done nothing exertive to cause that. With the stiffness I have trouble getting my shoes and socks on, and getting up from sitting. All these symptoms I didnt have until I took the shot.

Shot was given at max vaccination site in a shopping mall store. Shot was given in upper rear of shoulder. Continuing shoulder pain that got gradually worse over time. Pain also eventually felt from shoulder down arm. Restricted range of motion. Affects daily activities and ability to sleep. .

After the initial injection site pain, I have experienced constant intramuscular pain at the site and adjacent areas in the muscle upon movement or use. Something as simple as flexion or extension causes a sharp pain in that area. I initially put that off to the trauma of the injection itself, but now four months later with no improvement, I can only conclude that the injection caused more than normal injection trauma. I am also experiencing numbness and tingling in the whole arm after periods of immobility (such as sleeping). Getting up in the morning, that arm is moderately sore, and I experience particular pain around the injection site. There has been no injury to that arm or that muscle group. I have no pre-existing injuries or conditions that would have a bearing on this pain. I have not sought medical attention, as I feel certain that there is not enough known about this vaccine to reliably come up with a treatment plan.

Pt reports 2 days after vaccine having swelling in joints, hands, and facial area. Numbness/tingling in hands b/l. Reports still having numbness/tingling in hands as well as swelling in facial area

BELL'S PALSY; AFFECTING ABILITY TO THINK CLEARLY; DEPRIVATION OF SLEEP; PAIN IN THE BACK; TINGLING SENSATION OVER THE BODY BUT MORE IN THE EXTREMITIES; PERCEPTION OF HEAT AND COLD REVERSED OR DELAYED; MIGRAINE HEADACHES; MUSCLE WEAKNESS IN THIGHS AND LOWER BACK; CONTINUOUSLY EXHAUSTED WHICH IS AFFECTING ABILITY TO THINK CLEARLY; MUSCLES PAIN IN THE THIGHS AND LOWER BACK; This spontaneous report received from a patient via a company representative concerned a 52 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: unknown) dose was not reported, 1 total, administered on 11-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. After several weeks of vaccination on an unspecified date, the patient developed muscle pain and muscle weakness in his thighs and lower back, and the pain extended to his back. Patient experienced tingling sensation over the body but more in the extremities. He experienced perception of heat and cold reversed or delayed. The development migraine headaches increased dramatically, but as per reporter it was possible to had consequence of exhaustion from being sleep deprived. While brushing teeth patient discovered that he had partial paralysis of the left side of face and he was unable to spit, purse his lips, whistle, smile, twitch nose, or raise his eyebrow and the face area was mostly numb. Patient went to emergency room and where he had been told that he had Bell's palsy, but they did not know what to think about the non-facial symptoms and asked him to see a neurologist. The patient was prescribed with prednisone and an antiviral. By the end of the same day, he lost most sense of taste. Patient later saw a neurologist who ordered Magnetic resonance imaging (MRIs) of brain, sinuses, and upper spine to look for signs of neuronal demyelination, but there were not any significant findings. During follow up appointment on 15-JUL-2021 with the neurologist, they discussed potential association between vaccine and Guillain barre syndrome. He ordered patient to do nerve conduction test to look for evidence of peripheral nerve damage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the back, and muscles pain in the thighs and lower back, had not recovered from deprivation of sleep, tingling sensation over the body but more in the extremities, bell's palsy, lost most sense of taste, continuously exhausted which was affecting ability to think clearly, and muscle weakness in thighs and lower back, and the outcome of perception of heat and cold reversed or delayed and migraine headaches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210739148-COVID-19 VACCINE AD26.COV2.S -Bell's palsy and affecting ability to think clearly. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

nausea set in that night, sleepless night, pain in joints, nausea and pain in joints is continuing the day after.

Headache, muscle aches, stuffy nose, chills, fatigue. All very mild. All gone by the following morning.

At approximately 1 AM I woke up to chills and sweats. Had a fever of approximately 102°F, body achiness from head to toe a severe headache, slight cough and general muscle fatigue. Slight pain at injection site.

Initial symptoms began with pain at the injection site and generalized fatigue. This developed into soft tissue pain in proximity of the large and small joints which could be elicited further on palpation. I had eye pain (left more severe than the right) which could be further elicited on palpation, headache, dizziness, chills, and an inability to feel warm. There was also significant skin sensitivity over the trunk, scalp, and upper extremities and more in the left arm than the right. The symptoms persisted over the second day albeit at less severity. Presently on the third day, I am experiencing continued eye pain, mainly in the left eye and mild dizziness.

Rash face/both arms/back, pain joints including ankles right hip and lower back, pain at injection site, mild headache,

FELT BILATERAL LUNG CONGESTION (Lung congestion, Pulmonary congestion) BILATERAL SIDE PAIN (Flank pain, Flank pain) VOMITING (Vomiting, Vomiting) LEFT ARM PAIN (Painful L arm, Pain in extremity) DIFFICULTY BREATHING (Difficulty breathing, Dyspnoea) MISSED WORK TODAY (Loss of personal independence in daily activities, Loss of personal independence in daily activities) PAIN WHEN BREATHS (Painful respiration, Painful respiration) FEVER OF 100 F (Fever, Pyrexia) FATIGUE (Fatigue, Fatigue) This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021 (mentioned as yesterday), the symptoms of the patient started, and he missed work today (loss of personal independence in daily activities) and left arm pain (painful L arm) because he was not feeling well. The reporter advised him to contact his primary care provider, but he said he called and they are not able to see him without an appointment also advised him to seek medical attention by going to the emergency room. The patient agrees to go to the Emergency Room. On 11-MAR-2021, the patient experienced bilateral side pain (flank pain) , vomiting, felt bilateral lung congestion (lung congestion), difficulty breathing, fever of 100 F, fatigue, pain when breaths (painful respiration) . Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 100 f, had not recovered from bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, and pain when breaths, and the outcome of missed work today was not reported. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, pain when breaths, fever f 100 f and missed work today as possible. Company causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, pain when breaths, fever of 100 f and of missed work today as possible. This report was serious (Other Medically Important Condition).

fever and chills; skin sensitivity; joint aches; lethargy starting approximately 6-hours after injection; effects are slightly ebbing 24-hours after injection (18-hours after onset of effects)

This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included marjuana, and concurrent conditions included allergy to skunks, non alcohol user, and non smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: not reported) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced flush. On 02-APR-2021, the subject experienced ringing in ears. On 02-APR-2021, the subject experienced sweating to feet. On 02-APR-2021, the subject experienced sore arm/aching to legs. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced aching to back. On 03-APR-2021, the subject experienced morning wood. On 03-APR-2021, the subject experienced increased appetite. On 03-APR-2021, the subject experienced aching to neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flush, and headache on 02-APR-2021, ringing in ears, and aching to back, and sweating to feet on 04-APR-2021, was recovering from sore arm/aching to legs, had not recovered from increased appetite, and morning wood, and the outcome of aching to neck was not reported. This report was non-serious.

Johnson & Johnson Vaccine: Tired and sleepy with a headache starting at 6:45pm April 8. Then his arms started to have pain and aching in the body more on the arm where he did not get the shot. This happened around 8:30pm. Patient chest started to ache. He went to bed. The entire night he experienced aches and pains in his body, his stomach and hips. When he woke up at 8:00 am on April 9 his legs and the back of his thighs were aching. He could barely move. He took two Tylenol that morning. He continued to experience aching in his body all day. He said it felt like flu like symptoms. Then he took more Tylenol that evening. By 9:30pm he started feeling better. He woke up Saturday, April 10 feeling better.

Approximately three weeks after receiving Johnson & Johnson vaccine, I began to get pains in legs. Calves were aching and throbbing. Didn't think anything of it at first....just thought achy muscles and such. The day before Easter (April 3rd 2021) decided since the pain was continuing and the internet will scare you to death - I went to a local Emergency Room in advance, I had an ultrasound on my left leg and it was noted I had DVT. (blood clot in left calf) To briefly explain: I had an achilles issue back in Nov. 2020 (slight micro tear - achilles tendonitis) I thought maybe this was related to that, as I had not been to the doctor to get it checked until early March 2021. and it bothered me off and on for a few months. I thought the calf pain may have been related to that? I explained to the emergency room doctor about my achilles and thought it was an issue related to that. They decided to perform an ultrasound on my left leg. Which noted the DVT/Blood Clot. They put me on a starter pack of Xarelto and I am to follow up with my normal doctor on April 22, 2021.

Had very cold chill starting about 6:30 pm, about 1:15 am starting to feel better, but arm was still sore and the injection site. soreness site stayed sore for about another 3 to 4 days, but total top arm around site still sore and aching. Arm is hard to lift up at some times and weak to lift anything up sometimes. Arm feels week for about 2 to 3 days and then starts to fill better. Then after a day of the soreness or no weakness in the arm, it starts back hurting again. It now getting worse at night time and sometimes during the day. Some days it hurts so bad that I can't even move it. I don't bother to tell my wife, because it just last for about a 2 to 3 hours. I have been to my doctor yet. But if it keeps bothering me I will make an appointment to see him. It just my arm and hand be very weak to use at sometimes every other day.

High temperature (104-105), muscle and joint cramping. This occurred the night of the 30th. Temperature started to decrease over the next two days so did the cramping. Then starting on 4/5 I started to experience pain in the back of my head along with the sensation of heat/burning. This was accompanied by a stiff neck. This pain and stiffness persists to today. Medication prescribed by my doctor lessens the discomfort but has not rid me of the issue.

Per pt report: Pt started having body aches within a couple hours of vaccine, developed severe 9/10 pain over the next several days. L shoulder pain radiating to ribs and neck w/ muscle spasms, causing HA, R hip and sacral pain, flank pain radiating down R leg. Pt reports that vision in L eye is blurry, R eye vision intact, numbness to L arm and hand, able to move. Pt reports 1in x 0.5 in blood clot when blowing nose Thursday morning, small clot subsequently about 1/2 the size, smaller clots later.

Symptoms started to appear about half an hour to forty-five minutes after the vaccination: 1. The first set of symptoms were that I felt light-headed and I could feel that my neck muscles were a little bit tense when I moved my head to the sides. This first set of symptoms lasted about two to two-and-a-half hours before tapering off. 2. The second symptom which were chills started about three to three-and-a-half hours after vaccinations. The chills lasted about four hours before tapering off. 3. The last symptom was fever that started about nine to ten hours after the vaccination. The fever lasted for about twelve to fourteen hours and tapered off the following morning.

LOWER BACK/KIDNEY PAIN; CHILLS (SEVERE, UNCONTROLLABLE SHAKING, COLD HANDS AND FEET); SORE ARM; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included panic attacks. The patient was previously treated with alprazolam for panic attacks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 09-APR-2021 10:00 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 lower back/kidney pain. On 09-APR-2021, the subject experienced chills (severe, uncontrollable shaking, cold hands and feet). On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 109 F, and Body temperature decreased (NR: not provided) 102.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills (severe, uncontrollable shaking, cold hands and feet), nausea, lower back/kidney pain, sore arm, and fever. This report was non-serious.

104 fever first 3 days day 4/5 swollen arm now joint pain , elbows ,, wrists ,, fingers ,, ankles and toes

PAIN/ACHING JOINTS OF HIPS, KNEES AND ANKLES; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 238 pounds, and height was 74 inches. The patient's concurrent conditions included polymyalgic rheumatica, blood pressure, non-smoker, alcohol use, nut allergy, milk allergy, egg allergy, potato allergy, wheat allergy, orange allergy, food allergies resulted in rash, and food allergy resulted in runny nose, and other pre-existing medical conditions included caller reports he takes blood pressure meds, vitamins, humira for polymyalgic rheumatica, and also unnamed "add medicine". The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 18:00 on left arm for prophylactic vaccination. Concomitant medications included adalimumab for polymyalgia rheumatica. On 11-MAR-2021, the subject experienced pain/aching joints of hips, knees and ankles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain/aching joints of hips, knees and ankles. This report was non-serious.

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

Metallic taste right after injection. Two days later I had joint pain, headache with congestion and more use of my asthma inhaler. These are still on-going as well as tightness through the chest and shoulders. Some coughing.

High fever 2 days... Uncomfortable shaking. A few hours Couldn't hold a glass of water to drink. It would still half full. Fatigue for 3 days

SEVERE BODY ACHES ON LEFT SIDE; MUSCLE SPASMS ON LEFT SIDE LEG EYE ARM AND CRAMPING ON RIGHT SIDE; PRESSURE BEHIND LEFT EYE; CRAMPING AND RIB PAIN ON RIGHT SIDE; This spontaneous report received from a patient via a company representative concerned a 52 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no underline health problems. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced pressure behind left eye. On 2021, the subject experienced cramping and rib pain on right side. On 30-APR-2021, the subject experienced severe body aches on left side. On 30-APR-2021, the subject experienced muscle spasms on left side leg eye arm and cramping on right side. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from severe body aches on left side, muscle spasms on left side leg eye arm and cramping on right side, pressure behind left eye, and cramping and rib pain on right side. This report was non-serious.

abdominal pain. The pain was so severe that my knees would buckle and several times if I was holding anything, it caused me to drop it. After about a week, I had an appointment at 4:30 and was scheduled for the next morning at 8:30 to meet with a back and spine doctor for xrays. Xrays were negative. I was then schedule with a neck and hand specialist a few days later. This appointment could not provide a diagnosis. Back and abdominal pain increase and soreness had spread to the stomach and groin. After the news broke of the cerebral blood clots in 6 women. See attached Continuation Page.

Vaccine administered Thursday, 4/1 1:15 p.m. By Sunday I experienced mild headache and upper respiratory scratchiness. By late Monday 4/5 I experienced fatigue, dizziness, upper respiratory scratchiness and increased post-nasal drip, tightness in my chest, muscle soreness and headache. By Tuesday, 4/6 around 10 a.m. in addition to the above symptoms I had a severe headache and lost feeling in my right arm for half an hour, with severe muscle cramps and loss of use in that arm. The muscle issues subsided by early afternoon leaving only fatigue, headache, dizziness and a lingering respiratory tightness and sinus issues. Concerned about vaccine side-effects I was reading about, I made a doctor's appointment for the following week (earliest available), met with a physician's assistant who prescribed an antibiotic (Doxycycline Mono 100 Mg) for the sinus issues but did not address the other issues.

1st day of vaccine; I felt very tired and fatigued and my joints started to hurt and I could not walk due to the pain in my joints. 3rd and 4th day of vaccine; I started to experience numbness sensation to my hands. I also had numbness sensation to my face, right side and lips and also to my head. I went to Urgent Care where lab work was performed as well as a CT scan of the head to check for blood clots and results came back normal. Also an U/S of the right leg to check for any blood clots was performed which came back normal. I then went to see my PCP who performed more tests and exams, again did lab work to check for blood coagulation and still continued with the numbness sensation to my hands and all to my body. After about 10 days of my vaccine, I noticed that my oxygen level was 87, 96, 86, 92 and where my oxygen level has always been around 98 or 99. I will be also having heart studies in a few weeks. I have not recovered from my symptoms and feel very fatigued and tired all the days.

Patient became dizzy after receiving vaccine and at the five minute mark, patient became unresponsive. His eyes rolled back in his head but stayed open. His jaw became very clinched. He was sweating profusely and not aware of anything goin g on around him. This lasted somewhere between 3-5 minutes.

Was doing well with just some minor joint pain, then a couple of days ago I could not stop itching. Wife looked a day later after my complaints and saw tiny red bump clusters. Some were on my back, shoulder, buttocks and the itching was also spread out; on the head, foot, wrist, and groin region. She found no dots there. I did not contact my primary yet. Cortisone cream and antihistamine pill today are what I took.

Customer did not feel right within 7-10 mins after receving the Janssen vaccine. He complained of vision changes, "seeing dots". When he tried to walk, his legs buckled, but customer was slowly assisted to the floor. While on the floor, my technician heard grunting noises coming from him and his left arm was rigid and bent at the elbow. But within 5-10 seconds, he slowly sat up and said that he "doesn't remember being on the fall" and complained of being sweaty and "seeing dots". Paramedics were contacted and took him the hospital. Contacted the customer later in the evening and was informed that he was resting at home after spending half of the day in the hospital. He mentioned that the paramedics treated him with Epipen and bendadryl and then he felt better. He was treated "other things" but don't recall.

5/15: Two days after vaccine: feelings of paranoia, unable to complete work, up all night, had to miss two days work. 6/18: Feelings of numbness on right side (hand, foot) while going through security at Airport. Weakness in right leg. 6/23: Went to urgent care facility. Was told it sounded like a stroke, sent to hospital for treatment. After imaging at hospital patient was told he had a minor stroke.

Constant pain and numbness in back, legs and arms. I saw my PCP two weeks after the shot. First he prescribed steroid which I took for 10 days, It didn't work. I went to see him again - he told me to take magnesium malate and referred to a rheumatologist. The rheumatologist did blood tests and he said that I don't have any inflammatory disease. He didn't find anything wrong but he said that my symptoms are similar to those of fibromyalgia. he referred me to a physical therapy. I have been going to a physical therapy 3 times a week for the last two months. Nothing works so far. The pain and numbness in my back, legs and arms are as strong as before.

Since I took the vaccine mre than three months ago, I have pain and numbness in my back, legs and arms. I never had such a pain before. This pain is with me all the time now.

Since my J&J shot on 3/20/2021 around11:45am at the drive up parking lot. I had swelling in in ankles. My PCP changed my blood pressure medicine to correct those symptoms. But I've had a tingling sensation in my right arm, starting under my arm pit and goes straight down to my fingers. My right thumb, index, and middle finger is numb at the tips since my J&J vaccine shot.

face tingling, couldn't move, neck pain same side as the shot, fell over in bathroom and couldn't move, and constipation

With in 4 hours of vaccination patient felt nauseated and vomited. Nausea lasted approximately 8 day. At about 8 to 10 days after vaccination began having joint and muscle pain in the lower half of body. Could not stand or walk without assistance, condition continued at same severity for about 7 days, then began to slowly improve. He saw doctor (His current pain specialist for several years) on 7/14/2021 and described his symptoms and condition, but no medication was prescribed for his condition. He currently states that he feels about 80% of himself prior to vaccination. Still has muscle numbness and muscle "burning" while standing and feel fatigued yet. He feels he is still slowly improving

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

Pain in arm. Felt like there was a softball size lump on my arm even though there was no lump. Pain never eased and actually has gotten worse. My left arm is extremely weak now.

DIFFICULTY IN BENDING; WEAKNESS IN LOWER BODY; PAIN ON LOWER BACK; HURTING NECK; MUSCLE WEAKNESS; JOINT PAIN IN LOWER EXTREMITIES/KNEE PAIN/HIP PAIN; LEG PAIN; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 215 pounds, and height was 71 inches. The patient's concurrent conditions included hypothyroidism, alcohol use, non-smoker, and autoimmune disease/vitiligo/skin disease, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroidism. On JUN-2021, the subject experienced pain on lower back. On JUN-2021, the subject experienced hurting neck. On JUN-2021, the subject experienced muscle weakness. On JUN-2021, the subject experienced joint pain in lower extremities/knee pain/hip pain. On JUN-2021, the subject experienced leg pain. On 22-JUN-2021, Laboratory data included: Blood test (NR: not provided) Negative. On an unspecified date, the subject experienced difficulty in bending, and weakness in lower body. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle weakness, joint pain in lower extremities/knee pain/hip pain, hurting neck, pain on lower back, and leg pain, and the outcome of difficulty in bending and weakness in lower body was not reported. This report was non-serious.

The patient started having severe chills, and muscle aches on the back and neck at 10:00 PM . Then he took Tylenol for the pain at around 12:00 AM and then started sweating profusely.

The morning after he received his vaccine he started feeling sick and then started to run a temperature. By evening his temperature was 102.9. Then the seizures started, first his "left" hand up his arm and down his left side. His right hand and arm was shaking rapidly. His left leg stiffened and his toes pointed down and then the seizure traveled to his right side. He remained conscious but somewhat dazed. This went on all night. By 10:00 the next day, Thursday the seizures stopped. His temperature went back to normal Friday morning.

Hand tremors 9 hours after injection lasting for one hour. Fever starting approx. 12 hours after injection. Possible contribution to fainting event approx. 15 hours after injection. Muscular aches in neck and shoulders starting approx. 17 hours after injection.

1) immediate pain 1/2 through injection - fully dissipated within 5 minutes. Felt great all day. 2) Fever conditions (chills, body aches) about 10 hours later and pain in both shoulders that evening (difficulty sleeping). Next day feeling lethargic due to rough night`sleeping (?) and/or body's response to vaccine

Fever, severe aches and pains still continued into the second day now. Chest pain along with major joint pain

Pain in the legs and feet. Same with my hands and fingers. Fatigue. Night sweats. Unable to sleep. Muscle pain in the back and chest area. This started at bedtime around 11:00 pm, approximately 12 hours after the dose. Symptoms lasted a full 24 hours. Fatigue being the symptom lasting the longest. As of now, all symptoms have subsided.

Sore everywhere. Lower stomach & groan is very sore. I can't hardly sit. Motrin is giving me some relief. I was running a fever yesterday 3-29-21. Hands are very stiff and ache.

Lightheaded about 5 minutes after injection. Medical team took HR and BP and was normal Took about 20 minutes and light headedness went away Later that night at around 12:30 am, felt very cold and shivering with severe headache Did not take temperature Had a hard time going back to sleep Got up around 1:00 am to take 800 mg of OTC Advil When walking back up stairs had severe muscle pain in arms and legs Was fine after that Seemed to get better by 2 am No issues next day About 7-10 days later developed severe frontal headaches/sinus pressure No other symptoms Used Neti Pot with saline solution and did nothing Took OTC allergy meds and Advil and did nothing Say my primary care Dr and he prescribed Flonase, Singular and Allegra + continue Neti Pot and Advil as needed Not much improvement on this regime after 3-5 days of use About a week later developed severe pain in bottom right jaw Took OTC Advil and again no improvement Went to Dentist and said not tooth related but probably TMJD Recommend dental appliance to help with grinding About a few days later after this jaw pain developed, developed sharp stabbing pain in bottom of left knee cap. No recollection of any insult that would cause this All three of these pain sites were perfectly fine prior to getting J&J vaccine. No history of pain or injury to these areas prior All of these incidents to me seem to be inflammatory/immune in nature and could be related to J&J vaccine based upon how I reacted to injection. Curious if others are seeing the same thing and if so what should be done or how long should this last?

After getting the shot on Friday at 6:00 pm. I did not have any issues with the shoulder. Sunday evening around 11pm I have started to have shoulder pain. The pain is around the area of the injection. The pain is generally in the deltoid muscle and has spread some to the bicep muscle as well. Uncertain if this is common to the injection process but it caused concern as its onset had been over 48 hours post injection.

Patient was given one dose J+J vaccine about 8 minutes after injection- he felt weak and slumped a bit in his chair. In addition to this he felt pain in Right Pectoral Muscle. Patient was noticed with pale and diaphoretic appearance but within few minutes felt better with increased ventilation and cold compress.

Cluster headaches, pain 3-4/10 beginning approximately seven hours after administration and pain increased to 6-7/10 approximately 12 hours after administration. Pain subsided to 2/10 approximately 24 hours after injection. Chills, beginning approximately seven hours after injection and continuing for approximately 20 hours. Intermittent uncontrolled, severe shivering with teeth chattering approximately 2-3 times per hour for approximately eight hours. Bilateral neck pain 4-5/10 and neck stiffness beginning approximately seven hours after administration and continuing for approximately 20 hours.

fever of 102.2 for 18 hours followed by 98.6 for 24 hours, joint pain, nausea increased need for insulin to control blood glucose levels.

vaccine given on 3/30/2021-no pain till 4/6/2021- on 4/6/2021 patient started having pain in left arm after lifting something one week after injection. 4/7/2021 states that pain radiates from the injection site to the back of the arm when he rises his arm to shoulder level-- arm feels weak after carrying something pain level 8/10 when he lifts his arm. No pain otherwise.

Lost his vaccine card would not give him a new one. He got his vaccine, had burning sensation immediately after the needle was pulled out. About 5-10 minutes later he started sweating, and seemed to have calmed down and felt OK. He was observed for 30 minutes there and went for observation for another 30 minutes. He went to another doctors office and at about 15:00 started feeling light headed and weak. He drove back home, picked up some stuff at a grocery store, and outside the grocery store in 80 degree heat he felt the need to put on a jacket as he had the chills. he went home, went to bed feeling bad, his shoulder was still burning where he got hte vaccin.e He had a little bit of site pain, applied topical and the pain went away. He woke up the next morning feeling really bad, felt like a major flu, his head felt like it was going to explode, but no problem with sinuses, no cough, no sneezing. His eyes were watering from the pain, and chills on and off. He had to change his sheets a couple of times due to sweating. He then developed a fever of 99 degrees at about 18:00 that night, and about 19:00 he went to 102 when he checked it. After that it went to 103, and about 15 minutes after that it was 104, and then higher at 104.+. He took some vodka, honey and lemon juice and took an alcohol bath and the fever had not broken yet. He called the clinic and they told him to call 9-1- 1 and to go to the ER. He went to the ER at about 10:00, gave him fluids, did a chest x-ray and released him about midnight. He apparently disoriented and tried to walk off and didn't remember this. They took him back to the gate and called his son. He went home, took another bath and woke up in sweat and was in bed for the entire weekend. He got up Monday morning, 4/13/21 feeling a little bit better and went to see his doctor, who does not believe he was having any side effects and that the information that is being reported is true. He is still feeling a little weak and still fatigued and on bedrest. He was taking Advil besides his regular medicines every 6 hours with 500 mg of Tylenol for the intense pain as every joint in his body ached, and the worst headache he had ever had, as well as the high fevers. His fever subsided on Saturday morning, and still had some sweats following that. Did have hot/cold flashes on Saturday and Sunday. He was given a COVID test in the ER and he was negative, but did not give him any other information regarding his lab work.

Janssen COVID-19 Vaccine EUA Injection site pain; muscle stiffness; joint pain in shoulders, elbows, knuckles, hips, knees; severe headache; nasua; fatigue; low grade fever

SORE THROAT; SORE ENTIRE UPPER BACK; RIGHT SHOULDER SORE; HEADACHE; SORE NECK; LEFT SHOULDER INJECTION SITE PAIN; ROOF OF MOUTH TENDER; EAR ACHE; RIGHT KNEE AND SHIN BONE PAIN; SORENESS FROM LEFT SIDE TO LEFT WRIST; FLUSHED; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included severe allergies to grass, severe allergies to cat, and severe allergies to bees. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 08:50 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced sore neck. On 08-APR-2021, the subject experienced roof of mouth tender. On 08-APR-2021, the subject experienced ear ache. On 08-APR-2021, the subject experienced right knee and shin bone pain. On 08-APR-2021, the subject experienced soreness from left side to left wrist. On 08-APR-2021, the subject experienced flushed. On 08-APR-2021, the subject experienced left shoulder injection site pain. On 10-APR-2021, the subject experienced sore entire upper back. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced right shoulder sore. On 10-APR-2021, the subject experienced headache. Laboratory data on 08-Apr-2021 included: Body temperature (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore neck, sore entire upper back, roof of mouth tender, ear ache, sore throat, and headache on 12-APR-2021, and flushed on 08-APR-2021, and had not recovered from right knee and shin bone pain, left shoulder injection site pain, right shoulder sore, and soreness from left side to left wrist. This report was non-serious.

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

Blood clot in each lung. Started in legs, spread through heart and settled in lungs. This occured about 3 weeks AFTER J&J/Jansen vaccine. Immediate symptoms were painful leg cramps on both sides back pain, fever sweating, nausea, clammy skin, headache, neck pain.

POSSIBLE THROMBOCYTOPENIA; RASH FROM KNEE TO FEET /SPOTTY RED DOTS ON LEG; SLEEPINESS; NECK ACHE; TIREDNESS; MUSCLE ACHE; HEADACHE; This spontaneous self-report concerned a 53 year old male patient. 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: 1805029 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the patient received the vaccine, waited at facility for 15 minutes, and everything was okay. On 17-APR-2021, the patient experienced neck ache, muscle ache and felt a sense of tiredness, headache, sleepiness, which he treated with Aleve (naproxen sodium). He also noticed his feet had a rash from his knee to feet, and according to his sister (who is a healthcare professional) it looked like small micro-embolisms (thrombocytopenia). The patient went to his physician who said the spotty red dots could be petechiae caused by thrombocytopenia. As recommended by his primary care physician, the patient has an appointment for lab work, including platelet counts, on 20-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, tiredness, neck ache, rash from knee to feet (red dots), muscle ache, and possible thrombocytopenia, and the outcome of sleepiness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This 53-year-old male patient was found to have petechiae-like rash on his knees to feet, that according to attending physician could be caused by thrombocytopenia, 2 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. The patient underwent laboratory procedure including platelet count (results not reported). The patient complained of neck ache, muscle ache and felt a sense of tiredness, headache, sleepiness that he treated with Aleve (naproxen sodium) on the day the petechiae-like rash appeared. No other details reported. The information available precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information as requested.

Massive ringing and tinnitus in both ears within 8 hours of receiving the vaccine. Constant loud ringing in ears is ongoing, it has not gotten any better since the shot. Initially got fever (100.5) and chills and muscle aches and ringing in ears, the fever/chills/aches have resolved after 3 days, but the ringing in both ears is still present and loud.

Body ache, headache, chills/shakes/lightheadedness, lethargy, increased pain in back and other existing condition area- frozen shoulders, trigger fingers thumb tendon.

THROAT PAIN; MUSCLE PAIN; FATIGUE; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a and expiry: 01-MAY-2021) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced muscle pain. On 01-MAY-2021, the subject experienced fatigue. On 02-MAY-2021, the subject experienced throat pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and muscle pain, and had not recovered from throat pain. This report was non-serious.

- Occasional fatigue ranging from mild to moderate. - Occasional "drained" feeling like I pulled man G's. - Mild brief dizziness (1-2 times a day), - Constant soreness in hands with mild sensation of having held something that vibrates (e.g., power tool) - Occasional arthritis-like pain in joints (fingers and knees). A few notes: - All of the above sensations have increased noticeably in intensity/frequency since 5/5/21. - I tested negative for Covid-19 on 5/8/21 (PCR). - I have been diagnosed with arthritis in my pinkies. - I am under doctor's care/monitoring for kidney stones which may give rise to some common symptoms such as the fatigue.

According to his wife, patient received the Janssen COVID-19 vaccine at the Center on a Friday afternoon in March; she could not recall the exact date and could not locate his vaccination card. Several hours later, patient began stuttering and was unable to put his thoughts together. Later that evening, he began experiencing muscle aches, nasal congestion, nausea, and was unable to get out of bed. He took some Advil and by the next morning he felt fine and was back to normal. It should be noted that he died suddenly and unexpectedly on 05/05/2021, and an autopsy showed his death was caused by hypertensive heart disease and cardiomyopathy.

Soreness in shoulder/neck/back/arm on the injected side of body (right side). No worse than annoying, but enough to make me avoid any heavy lifting or other physical exertion with that arm (or turning my head too far). The pain started decreasing after about two weeks, and was mostly gone in around a month.

Severe joint pain. Mainly in elbows/forearms, shoulders, finger joints. Stiffness. Also tendonitis symptoms. A pulsating inflammation feeling while being stiff to move with pain. Shoulders tight. I work out heavily and always have some joint issues, but this made it impossible to workout. Too much pain and concern.

A 53-yo male patient with a nonsignificant past medical history presented to the hospital with worsening generalized muscle pain, and weakness. Patient reported that he received the Jannsen COVID-19 vaccine 3 weeks prior to admission and symptoms began 8 days later. On the morning of admission the patient also developed pressure-like and pleuritic chest pain. EKG findings showed ST elevations in V5-V6 with depression in aVL. D-dimer was found to be elevated however PE evaluation was negative. Troponins were also found to be elevated. The patient was diagnosed with acute pericarditis and underwent left heart catheterization, selective coronary angiography and left ventriculography. The coronary angiography revealed no significant obstructive coronary artery disease, and left ventriculography revealed normal LV size and function. Patient was subsequently initiated on colchicine therapy for acute pericarditis. He remains admitted at hospital.

on 5/17/2021 pt developed a fever, pain in the left side of his ribs and had SOB. He was brought to Hospital ER. Pt had Chest x-ray, blood work, Doppler on both legs, and CT. His DX was pneumonia, blood clot in left lung and bilateral blood clot in legs. He was admitted and stayed for 5 days.

BOWELS UPSET AND YELLOW SLIME COMING OUT SINCE DAY OF SHOT; BURNING IN ARM; SEVERE PAIN IN ARM AT INJECTION SITE; PSORIASIS; NECK PAIN; BRUISE HAVING THE SIZE OF 50 CENT PIECE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, severe gastroparesis, internal tremors, and psoriasis, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203a21a, expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. Concomitant medications included adalimumab for psoriasis, ixekizumab for psoriasis, risankizumab for psoriasis, and ustekinumab for psoriasis. On MAY-2021, the subject experienced neck pain. On MAY-2021, the subject experienced bruise having the size of 50 cent piece. On MAY-2021, the subject experienced psoriasis. On 10-MAY-2021, the subject experienced bowels upset and yellow slime coming out since day of shot. On 10-MAY-2021, the subject experienced burning in arm. On 10-MAY-2021, the subject experienced severe pain in arm at injection site. The action taken with covid-19 vaccine was not applicable. The patient was recovering from bowels upset and yellow slime coming out since day of shot, had not recovered from severe pain in arm at injection site, and burning in arm, and the outcome of psoriasis, neck pain and bruise having the size of 50 cent piece was not reported. This report was non-serious.

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

I went to Pharmacy on Aril 10 2021, after the vaccine I got fever for three days in a row, then four days with pain in my left leg. On the 19 I was not able to move my left leg with a lot of pain and a little discomfort on my right leg. Rush to the hospital and right away the found blood clots on my left leg, The ER did not check my right leg and two weeks later they found clots on the bottom part of my right leg. They gave me blood thinner and now Im taking Eliquis twice a day. Symptoms continue, I have the same pain, I dont see any improvent. I did went to work yesterday and I realize that I can do any lifting or be sitting down for at least one hour.

Pt felt body aches/chills/headache and then after a few days started to get significant neck pain that he cannot relate to anything else. He is attributing it to the vaccine. He has a hard time turning his head to the side.

Inflammatory storm, crested at 7 weeks post; affected all joints, incl healthy ones. Daily fever by at least afternoon for 7 weeks. New demyelination w inflammation, new vision problems, dysphagia (permanent). Six days post shot, chest pain started, same as post-virally spring 2020. Chest pain, burning sensation ongoing, presumed carditis. Cardiorespiratory performance beginning to lessen further, beyond last year's damage. Day of vaccination, about 1-2 min post injection, strong dizziness, balance problems, identical to past allergic reactions to other injectables, but time limited, only an apparent blood pressure problem - passes in its own, heavy caffeination helps reduce the problem, temporary nuisance only & apparently affected a fair number of folks at the site. Chose not to report that issue at the time, since familiar and not serious, only unpleasant.

Massive headache for 8 days. I believe it was encephalitis. Dizziness, fatigue, nausea, terrible neck pain, pain allover skull. Completely out of it. Disoriented, Fever, rash, missed work. Now I have a purple spot on my inside of left leg, found this morning 6/14/21 7:30 am.

About 4 weeks following vaccination, patient had pain and swelling on the posterior aspect of the L-knee. He could barely flex the knee, and it became discolored initially dark blue and then yellow which extended halfway up the posterior thigh. HE was evaluated by various physicians. Ultimately was diagnosed with hematoma that was aspirated - described as old blood. Cultures were negative. Was feeling better afterwards, but noticed more pain in L-calf. Venous duplex ultrasounds showed no evidence of blood clots. Patient was referred to infectious diseases to evaluate possible ADE secondary to vaccination.

Starting 10 hours after the injection at 2AM Local ET on Thursday, June 24th, I began feeling a severe headache, feverish, and fatigue. I was working a midnight shift so I was awake the whole time. At about 4AM local (12 hours after injection), I began feeling severe stomach and groin cramps as well. All of these symptoms got worse of the next 24 hours. the fever, headaches, and cramps were at their worse about 18-30 hours after the injection. I took Tylenol and tried to sleep but did not sleep long as the fever was very high in this period. I nearly went into the Emergency room on 25 June. At this time, I felt a little better, but still very fatigued and having some stomach/groin cramps still at 9PM on Saturday, June 26th.

Fever begain 6/6/21 for 2 weeks along with 15+ lb. weight loss. Went to Hospital and was admitted 6/21 with Tachacardia, high blood pressure and fever. Diagnised with Hyperthyroidism on 6/23 and relleased on 6/24 with bllod pressure and thyroid medicicine. Follinging up with Dr. and trying to get into Endocronologist. Item # 21: 3 days in hospital

About a month ago I started experiencing (3) distinct symptoms 1- Bladder control issues 2-Numbness/tingling in my left arm which has spread to my hand and is consistently spreading 3-Trouble walking sometimes, my left leg feels out of my control

Pain and weakness in left arm. Constant twitching of muscles in left arm for long periods of time. Pain in my toes to my fingernails. Lots of nerve pain. Feels like an inflammation around heart or chest cavity (that has mostly subsided at this time).

At first warm flu like feeling followed by severe flu like feeling without fever. Ear pressure pain and severe ringing in head. Increase in severe muscle weakness in arms and legs for 3 months plus high blood pressure weakness

I experienced feelings of easily fatigued muscles in forearms within about 1 week of vaccine. I have experienced ongoing periodic feelings of sharp needle-type sensations in lower legs. Starting ~mid-June I have a pain in my right index finger between first and second joint, similar to as though a piece of glass is in my finger. But when i push on it, i sense there is no foreign object in there. I sometimes have experienced tingling in my right hand and up my right arm. I have had intermittent slight headaches.

About 2 days after he received the vaccine he had really bad headaches, which he never gets. They lasted for about 2 weeks off and on. Around two or two in a half weeks later he started having adverse pain in his middle back left side area. Stated it was a sharp stabbing like pain then it started radiating from his back around his left side up into his chest left side. Being concerned his doctor ordered a Cath test but everything was normal. We have been to GI, Cardiologist, his regular doctor, pulumonary and ER and they have done blood work, CT Scans and x-rays and can't find out why my husband is still having severe sharp pains throughout. They just keep telling him to try another type of doctor. He stays in constant pain and states his chest hurts and he has difficulty in breathing from the sharp pains in his chest. He never had this type of pain until he got that J & J vaccine. I am wondering if he has developed Guillain-Barre Syndrome because it sounds like some of the same symptoms. I just want him to stop hurting.

1st of 5 known seizures was an hour after the injection, the 2nd was 2 1/2 hours after the injection, the 3rd was 5 hours after the injection, the 4th was 22 hours after the injection the following day, the 5th was 40 hours after the injection. These seizures were different in nature. His muscles and body tightened heavily for up to 2 minutes, he turned blue and was combative. Muscle spasms for up to 10 minutes after seizure. Aggressively hyper focused and moving around unaware of reality for 20-30 minutes.

Pt.'s sister states after receiving the J&J 06/01/2021, started experiencing nervousness, nauseous, vomiting, anxiety, memory loss, and constant shaking. Weight lost (estimated 15lbs), loss of sleep. Physician visit (07/15/2021) Blood test ran still awaiting results. Cognitive Test 07/15/2021, recommendation for MRI.

I had difficult breathing, I was dizzy, but all my bloodwork shows my red cells decreasing, chest pain, Knee weakness, went to care, 06/01/2021 and I was transferred to hospital and I received a blood transfusion. When I am working I still have shortness of breath.

Severe muscle and joint pain, fever (+1.7 degrees above typical 97.3 = 99.1), upset stomach, lethargic.

i received the vaccine at 5:30 pm no side affect but at midnight 12:05 I woke u with massive headache around my head and muscles pain with temp and shivering cold i could not sleep all night after also with stomach pain too and at one time i felt short of breath i did not take anything until 12:00noon the day with tylenol and i drank lots of Gatorade, i night sweat a lot and i slept all night after taking another two pills of tylenol 500 mg each, i sweat all night and I woke up good thanks god i feel much better

Left-sided Bell's Palsy, facial droop, headache syndrome, neck and jaw pain, facial paralysis and numbness, left eye dryness (does not close) Treatment: ketorolac (TORADOL), followed by 10 days predniSONE 20 mg and 5 days valACYclovir 1gram 2 weeks later, still have all symptoms... some improvement with facial droop. Numbness remains, headache neck and jaw pain remain fairly constant... Ibuprofen and Naproxen used for treatment.

Fever (100.0-100.2); headache/foggy head; muscle aches; pain at injection site. Symptoms lasted 36-48 hours.

About 18 hours after vaccination, I began to feel myalgias and burning skin while in the shower; I began to feel "hot" and very fatigued. Then my temperature went up to 101.9 degrees F, taken by an electronic touchless digital thermometer. Then, the L Deltoid vaccination site began to feel very sore. As the day went on, I felt increasingly fatigued and exhausted, and had trouble concentrating. I felt better the 2nd day after vaccination, but felt intermittent myalgias, increasing L Deltoid soreness, and hot and chilled at the end of the day. Today, I felt better in the morning, exceptfor persistent L deltoid soreness, and fatigue. This evening, I am feeling cold, tired, and myalgias again.

FELL; ROOM SPINNING; DIZZY SPELL WHEN HE LOOKS DOWN MORE THAN 5 SECONDS/ DIZZINESS UPON GETTING UP FROM LYING DOWN/LIGHTHEADEDNESS; HAVE NOT BEEN ABLE TO SLEEP; UNCONTROLLABLE STIFFNESS IN THE LEFT SIDE OF NECK; UNCONTROLLABLE PAIN IN LEFT SIDE OF NECK; UNCONTROLLABLE PAIN IN THE LEFT SHOULDER JOINT; UNCONTROLLABLE MUSCLE TWITCHING IN THE LEFT ARM; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included right shoulder surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced uncontrollable muscle twitching in the left arm. On 17-MAR-2021, the subject experienced uncontrollable stiffness in the left side of neck. On 17-MAR-2021, the subject experienced uncontrollable pain in left side of neck. On 17-MAR-2021, the subject experienced uncontrollable pain in the left shoulder joint. On 19-MAR-2021, the subject experienced have not been able to sleep. On 29-MAR-2021, the subject experienced dizzy spell when he looks down more than 5 seconds/ dizziness upon getting up from lying down/lightheadedness. On 29-MAR-2021, the subject experienced room spinning. On 01-APR-2021, the subject experienced fell. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from uncontrollable pain in the left shoulder joint, uncontrollable stiffness in the left side of neck, uncontrollable pain in left side of neck, have not been able to sleep, dizzy spell when he looks down more than 5 seconds/ dizziness upon getting up from lying down/lightheadedness, uncontrollable muscle twitching in the left arm, and room spinning, and the outcome of fell was not reported. This report was non-serious.

Shortly after receiving the vaccination I started to experience chronic exhaustion, leg cramping and pain in my lower back right side, upper right thigh, behind my right knee and down into my right calf. I figured that the pain would go away but the pain increased and my leg started swelling and the pain increased making it very difficult for me to put my leg down on the ground and put pressure on my right leg.

Right Elbow pains within 7 hrs after shot. Next day elbow and right hand swollen and throbbing pain. still swollen and can not bend all the way 3 days later.

I had a small lump appear at or near the site of injection past the 2 week period. My arm was stiff and sore. My spouse massaged my shoulder and the lump seemed to disappear. Arm felt better. The next day the same thing happened. My spouse massaged my arm and it went away again. I haven't had any other issues beyond that. I'm not completely sure it is related to the vaccine. I was also in the hospital during this time for an unrelated health issue. I had an obstructed bowel that required surgery. My surgeon assured me that they did nothing to my left arm during the surgery and treatment of the bowel obstruction. After a few conversations with the medical staff and my spouse we thought that the arm issue may have been a side effect of the vaccine shot. That's why I'm submitting this to you now. So far I haven't experienced anything else at the injection site. My spouse also had the same vaccine at the same time as me. He hasn't experienced any of the same effects as I have.

Pt rec'd vaccination to LUE on 4.9.21. Pt denies any trauma to LUE. Pt reports L wrist/hand pain, swelling, numbing, burning, tingling that started 4.13.2021 (Friday at around 1700 hrs). In our ED now, awaiting to be seen by our Hospitalist for possible admission to the hospital.

Muscle pain to left leg, calf and knee areas. Has taken Tylenol and ibuprofen for pain, for 3 days. Sought massage therapist for the lower leg, two events of seeking massage therapy. Mid March, and late march. Can't recall dates of massage. Using lidocaine pain patch and knee support brace.

DIAGNOSIS: 1. Superficial thrombophlebitis MEDICAL DECISION MAKING/DIFFERENTIAL DX: Differential diagnosis includes DVT, superficial thrombophlebitis, muscle strain, tendinitis. The patient presented to the emergency department with atraumatic left leg pain. An ultrasound reveals a fairly large blood clot in the greater saphenous vein. Although this is a superficial clot, given its extent, I think it warrants anticoagulation. Per the trial, the patient would benefit from 45 days of 10 mg Xarelto treatment. The patient was given good precautions regarding bleeding risk while on a blood thinner. He will schedule follow-up appoint with his primary care doctor. He will also use Tylenol and warm packs to help with the discomfort from the superficial thrombophlebitis. He was discharged in satisfactory condition.

BODYCHILLS; MUSCLE ACHES; This spontaneous report received from a patient concerned a 54 year old. The patient's weight was 160 pounds, and height was 68 inches. The patient's concurrent conditions included non smoker, alcohol user, and treenut allergy, and other pre-existing medical conditions included the patient was not doing any drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: 05/MAY/2021) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced bodychills. On 06-MAR-2021, the patient experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bodychills, and muscle aches. This report was non-serious.

I had a J&J shot at 11am on March 23rd. I woke up at 12am with extreme chills and body aches including major pain around my groin. About a day later, I was fine but tired. Approximately 3 weeks later on April 9th, I had sharp pain in my lower back when I breathed in and my neck lympth nodes were swollen and sore. I am fine now and the only reason I am reporting this is to document symptoms for your research efforts. Thank you.

BONE PAIN; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and abstains from alcohol, and the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 11:00:00 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced bone pain. On 29-APR-2021, the subject experienced fever. On 29-APR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: Fever (NR: not provided) Not measured. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone pain, fever, and headache. This report was non-serious. This case, from the same reporter is linked to 20210459729 and 20210459724.

Woke up incredibly sore. Muscle aches in my legs and arms. My left arm at the injection site feels like lead. Left side of my chest is sore. Pounding headache.

FEELING HORRIBLE; BLOOD CLOT; BODY ACHES; JOINT PAIN; SPAMS ALL OVER BODY; TOE SWELLING; KNEE SWELLING/ ANKLE SWELLING; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: unknown) dose was not reported, 1 in total administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. After getting the vaccine, the patient had immediate joint pain and body aches. He had spasms since day one. After two weeks, he developed swollen toe looked like a bunyon, then it moved up to the ankle then it moved up to the knee being swollen. The patient was sent to the imagining center. He had following imaging tests done, bilateral Lower extremity Doppler Exam. On 30-APR-2021, he was recommended to go to the emergency room (ER) and was admitted. He was diagnosed with blood clot and stayed overnight. He was prescribed on Xarelto (rivaroxaban) 15 mg twice a day (BID), titrating to 20 mg once a day. The patient was hospitalised for 2 days. He got another follow up on 14-MAY-2021, gave him another prescription for blood thinner to be on for two months. On 18-MAY-2021, he was given tramadol 7 pills for spams which had helped with his pain and currently patient was feeling horrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, body aches, toe swelling, knee swelling/ ankle swelling, spams all over body, and blood clot, and the outcome of feeling horrible was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210540030- Covid-19 vaccine ad26.cov2.s- A 54 yearold male presents with Blood clot, Body aches, Toe swelling, Knee swellng /Ankle swelling, Spasms all over body, feeling horrible. 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). 20210540030- Covid-19 vaccine ad26.cov2.s-Joint pain. This event(s) is labeled per RSI and is therefore considered potentially related.

Severe head ache30+ hrs started 5hrs after injection . abdominal cramping and musscel pain in leg and butt area.sever joint pain in lower back and hips and knees hands and feet.at 5 hrs of injection. Sore throat and inside if ckeeks and swellind of lower lip1 sat after injection. Joint pain in knees and lower back pain was severe and lasted 3 days. Numbness in fingers at 1 day - oresen confysen in thinkinj

About 8 hours after the vaccine at 2:30am I had a fever and bad sweats, back and stomach pain, diarreha, lost of bowel control, achy all over. Which prompt me to call for an ambulance. I went into the ER I had to get 3 bags of IV fluids for dehydration, anti-nausea medication, pain medication for back pain because I passed out and hurt my back and cut my face. I also had swollen in my left foot. I am still having fatigue feeling. I still don't have my energy levels back from before the adverse event.

I got the shot at 1pm and by11pm I had severe shoulder pain with limited movement. 10 am the next day it started to loosen up but still very painful. Went to Dr. and got a anti-inflammatory steroid and pain killers.

Patient reported that he has been experiencing decreased range of motion (limited range past shoulder height), increased pain and soreness with movement, and decreased strength to lift weights that were previously easily lifted. Stated that these symptoms started 2-3 days after he received the vaccine. Stopped by the pharmacy counter 6/12/21 to inquire as to whether this could be related to the vaccine.

My heart has been pounding hard with some pain. Shortness of breath. Coughing. Pain in left chest. Breast bone hurts

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

COUGH; COMMON COLD; EXTREME FATIGUE/ LEG FATIGUE; FUZZY MIND (FOR COUPLE OF WEEKS); BONES HURT; HEADACHE; FELT WEAK; HEAT GLOW (FEELING LIKE HASN'T SLEPT); This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced heat glow (feeling like hasn't slept). On 14-MAY-2021, the subject experienced felt weak. On 15-MAY-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced fuzzy mind (for couple of weeks). On 21-MAY-2021, the subject experienced bones hurt. On 21-MAY-2021, the subject experienced extreme fatigue/ leg fatigue. On 30-JUN-2021, the subject experienced common cold. On an unspecified date, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fuzzy mind (for couple of weeks), bones hurt, headache, felt weak, and extreme fatigue/ leg fatigue, was recovering from common cold, and heat glow (feeling like hasn't slept), and had not recovered from cough. This report was non-serious.

Whole body inflammation water retention adding 1-2 lbs a week. Have gone from 210 lbs. to 222. Muscles aches, fatigue, Got blood and urine tests on June 7th. Trying to find cause for water retention, fatigue and lightheadedness. Doctor stopped losartan and prescribed a daily diuretic. The water retention persists and The body still feel stiff and sore. Especially in the morning.

in mid-June 2021 I started experiencing pain in my feet. They started swelling and feeling tingly... almost like they had fallen asleep. Minor tingling also started occurring in my hands. On certain days the discomfort in my feet was enough to limit my walking. I noticed on certain days my shoes fit tightly and my calfs were very tight with the ankles showing signs of swelling. The symptoms continue through the date of this filing...sometimes better/sometimes worse.

Received vaccine at 8:30am . Just before sleep at 10 pm , Started getting chills and slight nausea. Went to work next day still feeling rundown with muscle fatigue but chills not as bad . Went home after full work day to rest then go to bed early. Next day felt fine . All in all I had a great experience . The people (organizers and others ) at the location that day did a fantastic job. Easy Breezy .

Patient states they received Vaccine on Monday, became confused at work on Tuesday and then presented to ED after multiple seizures overnight Wednesday and then was having trouble ambulating. also complains of left elbow pain

Around 7:00 P.M. on March 12, 2021 approximately 9 hours after receiving the Jansen COVD-19 vaccine in my left arm. I developed extreme fatigue, muscle aches, skin hurt to the touch of anything including clothing, headache, and fever 101.5. I had to go to bed and was very weak. I took ibuprofen and Tylenol for the discomfort. I slept 14 hours and was able to get up at 11:00 A.M. on March 13, 2021. The soreness at the site of the injection is not problematic. There were other odd symptoms overnight I would awake with strange nerve like sensations tingling and itching that occurred on the bottom of the left foot, upper lip, and neck. I also had several episodes of restlessness that was so bad that I had to stand for a few minutes before being able to lay down again. The worst is the skin hurting and headache. I have also had a few dizzy episodes since getting out of bed this morning. It passes if I sit down or hold onto something. None of these symptoms are normal for me and I cannot remember having a reaction to any vaccinations that I have received in the past. I hope this helps with your study.

Woke up next morning with headache. Neck began to ache through the day. By 4pm had 102 fever and muscle aches and cramps in neck, arms, legs, feet, and back. For the next 8 hours had fever and chills. And sweated profusely soaking the bed. Fever broke around 2 am and now just feel sore and weak.

I took the shot at 10:50, first early side effects where mild burning sensation in the legs couple of hours after the vaccine, later pain in the legs in the afternoon. At night I had a mild fever, chills, body aches (everywhere) unbearable headache (still going on 24 hours after the shot), pain at the vaccination site (left shoulder, still strong after 24 hours), pain in the lungs (I sneezed a couple of times). I took Tylenol every 4 hours, but did not improve, only brought the fever down a bit. Today after 24 hours, I still have headache, muscular aches, and fatigue.

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

6 hours after the injection the following side effects started: 1) headache 2) severe muscle aches 3) nausea 4) fever throughout the night spiking at 103.4 The following day Headache, muscle aches and fever continued.

I shortly after the shot I having had random pains in arm, including joints [like when the pressure changes ... don't think I have arthritis]) but they only lasted a few minutes and then would go away. About 10 hours later I started feeling sick. One of the first things I noticed besides a headache was my heart rate jumped up to over 100 beats per minute (it is normally below 84). I started getting chills and fever. It was worse than any flu fever I ever had and I could not sleep. Worst part was my heart rate would not go down, remaining above 100 but below 110-115 beats per minute. I considered calling 911 but after looking online decided not to as long as it remained below 120 bpm. I don't know my maximum temperature - I did not think to take it until after the peak had passed by 20 minutes or so (was 99.4 at that point - normal temperature runs 97.2 (low 96.8, high 98.2)). Heart rate finally started to drop around 3:30 am.

4 days after vaccination, suffered diplopia that resolved, recurred again 7 days after vaccination, lasted 20 minutes and then recurred 8 days after vaccination with associated headache. Patient to emergency department and noted to have orbitopathy with asymmetric swelling of rectus muscles of left eye.

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

Extreme left arm and shoulder neck pain and tightness within a week of shot and has persisted for over a month. Treated with Methocarbamol and Diclofenac Sodium. Within two and a half weeks of the shot, on March 23rd, sudden loss of peripheral vision in right eye. Doctor diagnosed as NAION, non-arthritic anterior ischemic optic neuropathy. Vision loss in one eye is blurred from varying angles and grayed out and is considered permanent. Eye problem caused pain down neck and jaw. Also, a rash developed over chest with symptoms similar to shingles.

fever, chills, muscle pain, joint pain: starting approx. 7hrs. after injection, continued through the night (9hrs). The following morning, all symptoms were gone and continued normal daily routine.

Patient developed pain in both knees and pain and swelling of calves about 36 hours after receiving the J&J COVID19 vaccine. His Allopurinol dose had been increased to 300 mg. daily a few days before that but no other change in health status. Now his left calf still feels a little swollen and he noticed a bruise there without history of trauma.

Day 1 / Wed.: Headache, slight dizziness (starting at 4 PM) Day 2 / Thurs: Headache (All day / night) Day 3 / Fri: Light headache (All day / night) Day 4 / Sat: Very bad body aches, muscle soreness, (All day / night) Day 5 / Sun: Extreme diarrhea, light body and muscle soreness (All day / night) Day 6 / Mon: Extreme diarrhea, light body aches / Stomach gurgling (All day / night) Day7 / Tues: Diarrhea stopped at AM. Stomach gurgling / cloudy mind (All day / night) Day 8 / Wed: Stomach still gurgling / cloudy mind. Still happening at time I write this.

On 4/15/21 client contacted public health office to report adverse effects of COVID Vaccines. Reports late afternoon on 4/6/21 he felt "heavy", had a HA, tired, nausea, body aches, high fever (did not take his fever), sweating, only drank water for 3 days, under arm swelling in the right arm. On 4/7/21 reports right shoulder and arm pain all the way down his arm to his hand began with tingling and sharp pain in his hand. On 4/12/21 he was tested for COVID and tested negative. Denies any rash, redness, or swelling at the site of the actual injection. On 4/15/21 was seen by MD for ongoing arm and shoulder pain.

Immediately after shot had fever and chills with flu symptoms for about 4-5 days after vaccination. On 3/22 went to urgent care for left elbow swelling which had never occured before in this joint visit deteremined was olecranon bursitis. The very next day began complaining about leg pain around 3/23 and by 3/26/2021 pain was unbearable in the leg and went to ER where patient was then admitted for DVT and pulmonary embolisms.

DIFFICULTY IN BENDING RIGHT KNEES; SEVERE RIGHT KNEE PAIN AND JOINT PAIN; HEART PALPITATIONS; DIZZINESS; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 220 pounds, and height was 5.9 inches. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no known allergies and did not had any history of drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A,expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced heart palpitations. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced flu like symptoms. On 24-APR-2021, the subject experienced difficulty in bending right knees. On 24-APR-2021, the subject experienced severe right knee pain and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations on 07-APR-2021, and dizziness, and flu like symptoms on 24-APR-2021, and had not recovered from difficulty in bending right knees, and severe right knee pain and joint pain. This report was non-serious.

1 day after injection, headache + fever + elevated heart rate. This went away by the next day. 2 days after injection, swollen and sore lymph node left arm pit. Still there

Numbness in nose and upper lip shortly after receiving shot. Both arms pain and numbness and tingling. Back and neck pain. Arm swelling.

Flu like symptoms x 5-10 days, back/pleuritic pain the following 5 days, SOB x 3 days later, finally went to ER dx with DVT, and PE

Weakness of lower extremities and arms that started around 5/26 and progressed over the next week until admission on 5/31. MRI brain and spine with diffuse enhancement and CSF with protein > 500. Started on PLEX for presumed Guillan Barre Syndrome. He is slowly improving after 4 sessions.

Severe chills and fever and sweating started at 7pm and continued until around 6am. Severe pain in right calf muscle started at 3am on 6/3 and lasted for 24 hours. At the direction of my dr, i was seen in the ER at hospital. The hospital checked for blood clot but ultra sound showed no clots.

Day one was headache as expected and right arm pain. Day two I had bad headache (9) joint pain in my shoulder and hips, loud ringing ears. shortness of breathe, left lung pain. This repeated for three days so I tested by BP and found it to be 160/130. Past day 3 I started with adrenaline spikes where heart would race up and I felt like hulk and blood pressure spikes out of the random. 5/24/21, I saw my family doctor and since my BP was so random high and then low she did not want to give me meds since it could drops too low at time. For my difficulty breathing and lung pain she gave me an prescription inhaler. As of today I still have the ringing left ear, shoulder joint pain like a pin stuck in it and unable to raise over my head without using my left arm to support, high BP on average 140/132. 167/151, 126/89, 122/91,110/87, 126/84 are some examples. These at the lowest is 10+ point higher than my normal range of 120s over 70s. Headache continues but may be due to the higher than normal BP.

My arm got sorer and stiffer. Followed by I could barely lift it and can hardly steer my car. Hard to put on and take off t-shirts. Hard to lift with my arm and it is weaker now.

Left arm pain, angina equivalent, woke up after going to bed with left arm pain, radiating from shoulder down the arm.

I started to suffer from a numbness in my left hand that radiated into a deep pain and increasingly became intense. That pain radiated up to my shoulder and into the left quadrant of my chest. I started experiencing shortness of breath and a hypersensitivity to the heat. I went to Hospital ER and they ran a bunch of tests. I was diagnosed with a blood clot in my arm. I was given Eliquis. I was on that medication for about 2 weeks and after my second week of being on Eliquis, I started to suffer from the same symptoms. I decided to go to the Hospital. When I went there they admitted me and ran through blood tests to check for a heart attack or stroke or anything relating to the pain I was experiencing. Now I am back home and I am still taking Eliquis. As of today, I am still experiencing the symptoms. The symptoms are mild, but it's still scary. I would like to add that I have had an increase in dietary intolerance.

woke up on June 29, 2021, with the worst back pain ever. email the doctor but he was not there this week. Emailed back on 6.30.2021 and still waiting on the doctor to return. The VA sent me to urgent care for help. They gave me a shot for the pain and prednisone for the inflation on the nerve. They said it was the sciatic nerve going the Peroneal nerve. This didn't help. I contacted the VA on July 2 2021 and they mail out more prednisone. Emailed VA July 7 2021 Told them the perinsone wasn't working and they moved me to tramadol 10mg and lidoderm patches. Contact Va on July8 July 12 July13 still the same

No effect for approx. 6-weeks; then, headache, complete body fatigue and muscle weakness developed overnight. A "charged-nerve"/anxious-energy feeling developed throughout body. Then- over the next couple-weeks- numbness in hands/fingers, feet/toes, tremors in head, neck, face hands and fingers and shakiness in arms and legs, developed and continue until today. The headache and charged-nerve feeling has continued, and pain in neck and mid/lower-spine has developed. Muscles in legs especially continue to be weak and some pain has developed in thighs. A ringing in ears is continuous and fasciculations have developed throughout entire body.

two weeks after shot I starting having pain in my right shoulder. thought I over worked it, but week by week it continue to get worse. To the point that it wakes me up 4-5 times a night. While on vacation it hit a tipping point in pain and my pinky finger and ring finger started going numb on my hand. I started to research and thought it might be a nerve issue... from top of shoulder blade to my fingers I get pain. Pain to the point I have a hard time moving my arm in certain directions. two day prior to returning from vacation I called the doctor to have it checked out. On July 12th I saw my doctor (knowing nothing about J&J) and he thought I just needed a steroid shot for inflammation and was given the shot. watching news I heard about these nerve issue with J&J, men over 50 and everything they were saying fit me perfect. The next day I followed up with my doctor (Put a call into him) and a nurse called me back and informed me it probably had nothing to do with the J&J shot. I called the location that gave me the shot and they recommend that I complete this from. Today, 7/17/21 I am still in pain with numbness in my fingers.

PAIN OF THE LEG AND ARMS; WEAKNESS OF LEGS AND ARMS; DIZZINESS/ FEELING LIGHT HEADEDNESS; TINGLING AND NUMBNESS OF THE LEG AND ARMS; BREATHING DIFFICULTY; TINGLING AND NUMBNESS OF THE LEG AND ARMS; REDNESS OF THE RIGHT HAND; DVT, BLOOD CLOT, IN THE LEFT LEG; SWELLING OF THE RIGHT HAND AND LOWER PART OF THE ARM/ LEFT ARM SWOLLEN; This spontaneous report received from a patient concerned a 55-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: unknown) dose was not reported, one total administered on right arm on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the patient woke up in morning and experienced swollen right hand and the lower part of his arm. On the same day in the evening, nurse (from country jail) gave antibiotic due to redness and swelling of the right hand. On 18-JUN-2021, the patient experienced feeling light headedness, dizziness, continue to feel worse, breathing difficulty, weakness of legs and arms and continue to feel worse throughout the weekend. On 21-Jun-2021 on the afternoon, he took the last dose of antibiotic and noticed swelling went down. On the same day in the evening, he was taken to the hospital emergency room (ER) from the jail due to continued pain and tingling of the arms and legs, swelling, and blood pressure spike. Lab work was done, unable to finish the computer tomography (CT) scan of the chest due to left arm intravenous (IV) line blew out and dye went to the left arm. He was discharged back to the jail and left arm was swollen but was fine the next morning (22-JUN-2021). On 22-JUN-2021, he again returned to the hospital ER to get a chest CT scan but unable to perform the chest CT scan due to unable to get an IV line started. Laboratory work done from the night before resulted elevation of the d-dimer. Ultrasound performed on both legs and deep vein thrombosis (DVT), blood clot, was found on the left leg and no blood clot on the right leg. ER health care professional (HCP) prescribed blood thinner Xarelto (rivaroxaban 15mg) the first 3 weeks and fourth week started 20mg. (He was on his nineteenth dose at the time of reporting). After discharged from the ER on 22-JUN-2021, he was discharged from the county jail due to the current medical conditions. On same day at 17.47, he went to the local ER near home due to same symptoms, swelling and tingling of the arms and legs. ER HCP reviewed the medical records from the prison and agreed with the diagnosis of DVT from the above hospital ER visits. On 25-JUN-2021, he went to see his primary physician. HCP reviewed the medical records and verified the DVT on his left leg. HCP ordered the chest CT scan, ultrasound of both arms, and more blood work. On 27-JUN-2021, CT scan of chest resulted negative finding. On 01-JUL-2021, ultrasound of the arms resulted negative as well. On 09-JUL-2021, follow-up visit with primary physician, confirmed DVT and requested him to continue Xarelto for 3 months. He ordered the spine x-ray due to the pain and tingling of the arms and legs to find out the cause. Primary HCP follow-up appointment scheduled for 17-SEP-2021, Comprehensive Metabolic Panel (CMP), D-dimer test, ultrasound of the left leg due to DVT, B-12 test for the numbness and tingling of the legs and arms ordered to be completed prior to the follow-up appointment on 17-SEP-2021. HCP ordered X-ray of the spine. Tingling and numbness of the arms and legs are still severe at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness/ feeling light headedness on 25-JUN-2021, was recovering from breathing difficulty, and had not recovered from DVT, blood clot, in the left leg, swelling of the right hand and lower part of the arm/ left arm swollen, weakness of legs and arms, tingling and numbness of the leg and arms, tingling and numbness of the leg and arms, redness of the right hand, and pain of the leg and arms. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210725185-covid-19 vaccine ad26.cov2.s-DVT, Blood clot, in the left leg. 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).

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

SARS-CoV-2 RNA Resp Ql NAA+probe~SARS-CoV-2, qPCR performed on 7/18/21. Test came back positive. Case investigation interview completed as of this note. Documentation from case manager mentions case experienced starting 7/16/21 cough, muscle aches, fever and fatigue.

SEVERE SHOULDER PAIN (SHOULDER AT THE INJECTION SITE HURTING); This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 165 pounds, and height was 75 inches. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies and was a skinny man. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced severe shoulder pain (shoulder at the injection site hurting). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe shoulder pain (shoulder at the injection site hurting). This report was non-serious.

slight fever (99.5F), chills, nausea, headache, significant aches and pains all over body (especially in all arm joints in both arms: wrists, elbows and shoulders), fatigue; duration 12 hours

Apprx. 6 hrs after the shots (both my girlfriend and I experience almost identical symptoms) Severe chills, Fever, severe headache, severe muscle pain throughout the body, chest pains, diarrhea, nausea, vertigo, increase heart rate! Two days later and I am still experiencing vertigo, diarrhea, nausea!

woke up at 2:30 am with fever. Did not take it with thermometer but consistent with a 100.00' range no chills, sore injection site and shoulder joint in general including pec insertion. fevevr lasted for three hours, for fever took 2 ibuprofen 200mg and woke at 7am with no fever. Continued ibuprofen for rest of day every 4 hours, last doe at 5:30 pm. Shoulder and injection site pain lasted 3-4 days after

Chest Pain Chest Tightness Lightheadedness Headache Pressure in Head Cough Swelling in Ankles Leg Weakness Tiredness starting from day after shot until today.

Beginning on 3/19 he developed a progressive ascending numbness first in his toes, then progressing to include bilateral legs up to knees and bilateral arms up to mid forearm. He also had mild leg weakness bilaterally. He has absent reflexes. His lumbar puncture showed albuminocytologic dissociation. He was diagnosed with Guillan-Barre syndrome and is being treated with IVIG.

chills Narrative: Patient is a 56-year-old male with history of paranoid schizophrenia, COPD/ emphysema, alcoholic hepatitis and alcohol use remission who presents for ED evaluation of 1 day of pressure-like frontal headache with light sensitivity, myalgias, chills and fatigue, the symptoms are following the first Covid vaccine yesterday. Patient has not tried anything for the headache at this time, describes that is not different from his previous headaches. Does report some nausea without vomiting.

March 31st aches all over body, stiff muscles, extreme night sweats, nights sweats lasting 2 days. All other symptoms on going. Extremely Fatigued.

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

First adverse event was a severe headache. About 12 hours later, experienced chills and muscle aches. 24 hours later , experienced severe pain in both sides of jaw and ears, along with hip pain.

I developed a high pitch ringing in the ears the morning after the vaccine. It was noticed when I woke up. I did have a low fever, high chills, and significant neck muscle "cramping" during the night when this reaction developed. The ringing (Tinnitus) is pretty loud and bothersome. The volume has not changed since the day after my vaccine shot (two weeks now).

At work while sitting at my desk I became dizzy, broke out in sweat, disoriented, blurred vision, slurred speech. Called plant nurse. She said my face was drooping, I couldn't smile or stand. She called Ambulance. Ambulance arrived and decided symptoms of stroke and called for helicopter to take me to medical center. When I arrived they did CT and I was later told it showed possible areas of no oxygen to brain. They gave me TPA drug and almost immediately I could see improvement - my headache cleared. Throughout the next couple hours I regained movement on right side and all functionality returned except weakness in right arm. I stayed in ICU for 24 hours as required after receiving TPA and while additional tests were ran then was discharged on Friday, April 16, 2021

Less than 1 mo following injection pt developed DVT RLE. He presented with rt foot/ankle pain 3/29. The pain improved then around 4/10 he developed significant pain/swelling to rt calf. Venous US confirmed DVT. Pt started on Eliquis. Pt has h/o superficial thrombosis, not h/o DVT.

1 week after receiving the vaccine, what I believe to be a gout flare started in my right foot. The joint of my big toe became very swollen and red, painful to the touch and the rest of the front part of my foot also became swollen. It was difficult to walk or even put pressure on it for 5 days and I treated it with ice, elevation and 600 mg ibuprofen 3X/day. Symptoms are starting to resolve , but the joint is still swollen and red, though the pain is subsiding. I am able to walk with a normal gait, though there is still stiffness and some pain.

slight headache within hours, disappearing within 36 hours. arm soreness beginning next morning, continuing for 5 days, escalating for the first 2 1/2, then decreasing in similar intensity. Yesterday, however, I started to have a bad headache at 4 a.m., then felt generally more ill to a level of almost incapacity by evening - bad headache, general weakness, dizziness, some muscle pain, bad nausea. Used Aleve and Ibuprofen and by 11pm started to feel normal again. By the next morning, I felt fine - tired like I just got over something, but fine. Not sure it was injection related, but wanted to share.

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

I started having bad headaches the day after the vaccine. A few days later I saw blood in my stool. I have experienced blood in my stool seven times up to this point. I have been feeling slight numbness in my biceps and calves. I have also been very sleepy and fatigued. Another thing is also pain around my rib cage area. I have also experienced some shortness of breath.

GROIN PAIN; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203a21a, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced groin pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.t The patient had not recovered from groin pain. This report was non-serious.

BLOOD IN THE STOOL; SHORTNESS OF BREATHE; TINGLING IN THE FINGERTIPS AND THE TOES; SORENESS IN THE RIBCAGE NEAR THE HEART/LEFT CALF SORENESS; PUMPING SENSATION IN RIGHT SIDE OF HEAD; TIREDNESS; RIGHT ARM SORENESS; COUGHING; LIGHT HEADEDNESS SENSATION; HEMORRHOIDS; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient had no relevant medical history and was not on regular medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, once total administered on 01-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. Patient reported that, he received the vaccine on 01-APR-2021. Approximately 2 days after he coughed and felt lightheaded and noticed some lights around his eyes. Approximately 7 days after patient noticed a list of symptoms including a pumping sensation in the right side of his head, left calf soreness, soreness in the ribcage near the heart, a tingling sensation in the fingertips and toes (but not at the center), sense of tiredness, shortness of breath, blood in stool that he referred to repeatedly as clots, right arm soreness (although the injection was given in the left arm). Patient called his doctor twice and was told to go to the hospital. Patient went to the hospital on 04-MAY-2021. Arrived at 12 PM and discharged at 11 PM approximately. Conducted a chest x-ray, took a blood sample twice, and put some stuff on patient's chest. Patient was discharged on 04-MAY-2021 and given a prescription for Motrin 800 mg taken three times per day as needed, and for cyclobenzaprine 10 mg taken twice a day as needed for spasms. Patient decided not to take these medications as he was unsure if they were pain medications and felt apprehensive. He main concerns seemed to be the pumping sensation in the right side of his head and the blood in his stool which he repeatedly referred to as a clot. His family doctor is aware of the situation and says he thinks its hemorrhoids. He refers to the clot as darker red in colour and also mentions that there is regular red blood in stool alongside the darker clot. Patient notices this about 3 times per week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing, and light headedness sensation on 03-APR-2021, was recovering from right arm soreness, and had not recovered from pumping sensation in right side of head, soreness in the ribcage near the heart/left calf soreness, tingling in the fingertips and the toes, tiredness, shortness of breathe, blood in the stool, and hemorrhoids. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210526242-covid-19 vaccine ad26.cov2.s -blood in stool . 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).

Nausea, fever/cold chills, Upper right arm and shoulder stiffness and pain discomfort. Lasting over a month until I seeked medical attention from my doctor.

Pain in the vaccination area began about 18 hours after injection. It has not abated in 3 weeks. General body aches - mostly in feet and in upper right arm, shoulder, and neck area (C1-down to mid-shoulder), fogginess of thought, and overall tiredness and lack of sharpness since about 2-3 days post injection.

After receiving COVID vaccine, patient reported Shortness of Breath, dizziness, loss of appetite, headache and chest pain. On 05/19/2021, patient exhibited right sided extremity weakness. Upon ED evaluation, was found to have suffered a TIA.

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

I received my shot and two days after I felt weak and sick. I fine for a few weeks and then I went outside to cut grass and all of my joints started to ache really bad. I came back inside and checked my temperature. I laid on my couch for a couple hours while running a high temp of 100.7. My eyes started to get really hot. I woke up at 12:30am and it was 90.7. I was checking my blood pressure and it was 110/64. I went to the doctor and it was discovered that I have pneumonia.

Stiff neck the very next day, still have. Right elbow joint soreness. Fatigue, feel weakness in legs.

Left arm started hurting. It hurt for 2 days. Then my right and left arm started hurting. this went on for another 2 days. then both my arms ,across my back and both hands went numb. Went to emergency room. They did test. Said i had blocked heart artery. They removed blockage. I was in serve pain, It felt like my bones was breaking. I end up going to the doctor 2 days in a row. The doctors think that the vaccine may have trigger that reaction.

LOWER BACK STIFFNESS; SEVERE KNEE PAIN ON BOTH KNEES; JOINT PAIN; This spontaneous report received from a consumer concerned a 56 year old male. The patient's weight was 170 pounds, and height was 69 inches. The patient's concurrent conditions included seasonal allergy, non-smoker, and no alcohol consumption, and other pre-existing medical conditions included the patient had no history of 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: 1808609, and expiry: 24-JUL-2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lower back stiffness. On APR-2021, the subject experienced severe knee pain on both knees. On APR-2021, the subject experienced joint pain. On 15-JUN-2021, treatment medications included: meloxicam. On 26-JUN-2021, Laboratory data included: Magnetic resonance imaging (NR: not provided) unspecified. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe knee pain on both knees, joint pain, and lower back stiffness. This report was non-serious.

FELT DIZZINESS; SORENESS IN RIGHT ARM; WEAKNESS IN RIGHT LEG AND RIGHT ARM / CAN'T PICK UP ANYTHING OVER 5 POUNDS; SORENESS AT INJECTION SITE TRAVELLED DOWN RIGHT ARM; NAUSEOUS; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281, and expiry: 06-SEP-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced felt dizziness. On 02-JUL-2021, the subject experienced soreness in right arm. On 02-JUL-2021, the subject experienced weakness in right leg and right arm / can't pick up anything over 5 pounds. On 02-JUL-2021, the subject experienced soreness at injection site travelled down right arm. On 02-JUL-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt dizziness on 02-JUL-2021, and had not recovered from soreness at injection site travelled down right arm, nauseous, weakness in right leg and right arm / can't pick up anything over 5 pounds, and soreness in right arm. This report was non-serious.

Shingles (Herpes Zoster) symptoms began just over 24 hours following the administration of the vaccine. Initial symptoms were pain and numbness radiating from right hip / gluteal area down right leg. Pain/tingling/numbness spread across belly area in the following days. Patient remained unaware it could be shingles until June 1, 2021 when multiple patches of blisters appeared down lower right leg. Medical help sought the following day June 2, 2021. Acyclovir 800mg (5 times daily) was prescribed for 7 days. To date, some soreness remains at the initial site as well as some sensitivity across belly area.

Sore muscles starting in left arm and neck. Weakness mostly left arm so far. Has been ongoing and appears to have increased in severity. I purchased deep massager to assist with muscles aches.

7.8.21: Patient reported weakness, lightheadedness, fever, possible numbness/tingling (also s/p heart cath) 7.9.21: Presented to ED - fever, headache, myalgia, neck stiffness, weakness in lower legs, difficulty walking, numbness - left AMA 7.9.21: Presented to ED - with generalized weakness - He was discharged on 7/7. He had noted BLE weakness during his admission and noted worsening of his weakness following his discharge. He returned to the ER on 7/8 but left AMA. He presented to ER on 7/9 with right arm and BLE weakness and MRI showed numerous small acute ischemic foci bilaterally. CTA was negative for significant stenosis or occlusion. He was evaluated by Neurology and felt that there was a high likelihood of cardioembolism as the etiology of his strokes vs cocaine. They recommended cardiac monitoring for evidence of afib as well as DAPT x 21 days followed by ASA monotherapy. He was noted to have an elevated troponin on admission and was placed on a Heparin drip. Cardiology did not feel that repeat cardiac cath was warranted. An Echo with bubble study was performed and showed EF 45-50%, diffuse hypokinesia, mild DD and no evidence of shunting. He has been accepted at hospital with plan for transfer there today. Assessment / Plan Multifocal stroke - suspect shower embolism vs r/t cocaine use - Echo - no evidence of shunt - per Neuro - DAPT x 21 days followed by ASA monotherapy - 30-day cardiac monitor at discharge Elevated troponin Recent IWMI CAD Ischemic CM - EF 45-50%, diffuse hypokinesia Cocaine use with possible vasospasm - s/p Heparin drip - no indication for repeat cardiac cath per Cardiology - ASA, Plavix, Metoprolol, Lisinopril, Lipitor - Norvasc - counseled on cocaine cessation

PERSISTENT NUMBNESS IN LEFT LEG, BOTH ARMS AND RIGHT LEG HALFWAY FROM SIDE OF LEG TO HALFWAY AROUND THE CALF, BETWEEN ANKLE, KNEE AND HIP; LIGHTHEADEDNESS; SORE ARM; MUSCLE ACHES; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient takes no prescription or over the counter medications and has no medical conditions and describes self as healthy. the patient had no known allergies and was not a drug abuse or illicit drug user.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced sore arm. On 10-MAR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced persistent numbness in left leg, both arms and right leg halfway from side of leg to halfway around the calf, between ankle, knee and hip. On APR-2021, the subject experienced lightheadedness. Laboratory data (dates unspecified) included: Cholesterol (NR: not provided) within range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness, and sore arm, and muscle aches on 12-MAR-2021, and had not recovered from persistent numbness in left leg, both arms and right leg halfway from side of leg to halfway around the calf, between ankle, knee and hip. This report was non-serious.

PER PATIENT REPORT: 2 WEEKS AFTER VACCINE PATIENT HAD LOSS OF FUNCTION IN ARMS AND EXTREME FATIGUE. THE PAIN CONTINUED TO INREASE IN HIS JOINTS UNTIL AT 4 WEEKS IT WAS INPACTING HIS SHOULDERS, HIPS AND WRISTS. AT ALMOST 8 WEEKS POST DOSE, HE WAS JUST RELEASED FROM THE HOSPITAL. HE WAS ADMITTED DUE TO INABLILITY TO WALK. HE HAS LOST 27 POUNDS IN 5 WEEKS. HIS CURRENT THERAPY OF PREDNISONE HAS HELPED HIM REGAIN USE OF HIS LEGS BUT HIS ARMS ARE STILL WEAK

12 hours post injection developed severe chills, HA, muscle pain and fever of 101.1 along with moderate injection site tenderness with slight itchy rash on arm. Took 500mg Tylenol and went to bed. Felt better in morning fever down to 98.8 with additional Tylenol taken at 0500 am before arising. Moderate fatigue.

chills, fatigue, ache around both elbows, nausea. Chills and nausea starts early morning at last until late morning early afternoon. Fatigue and elbow ache is stronger during morning hours.

extreme cramping in middle lower back lasting less than an hour. Muscle aches all over in upper torso moderate headache , cold all over .relieved with ibuprofin and tylenol every 6 hours .all ending about 24 hours later with a warm mild fever like sensation and 2 hours of sleep.

Skull crushing headache that started about 12 hours after injection and lasted for about 18 hours. After 48 hours from injection, headache is 90% improved. Took Advil, but that did nothing for headache. It was the worst headache that I can ever remember having. Extreme muscle pain in various parts of the body started at same time as onset of headache. This, too, died out as the headache got better. Slight nausea on day #2. No fever. Was steady at 96.6 throughout these adverse reactions.

9 to 10 days post vaccine: Flu symptoms for 24 hrs, Fatigue the following day with headache and sinus discomfort. Monday the 29th, worked and arrived home feeling like I may have a sinus infection. Tuesday, no headache just extreme fatigue, left work early took a 2 hr nap and feel a bit better. Lower back discomfort during this time period, discomfort urinating. Feeling of constriction but no pain while peeing.

He got his vaccine, had no issues immediately. He went to bed and woke up with headache, aching muscles, dry mouth, sore throat, and now has fever of 100.8. He took 2 baths to soak to get relief.

Injection site reaction: pain, swelling General: headache, muscle aches Worse reaction: swollen left underarm lymph nodes

Patient started complaining of extreme back pain and trouble walking within days after receiving the vaccine. His pain got increasingly worse. On the 23rd he had to be taken into the hospital in an ambulance. He said he felt as if his lower body was separated from his torso, and visible was having trouble walking. They prescribed him Valium, preformed an x-ray, and sent him home. On the 27th he was taken back to the hospital due to leg weakness, tingling in his hands and feet, and extreme pain. He was diagnosed with Guillain-Barre Syndrome. He passed away April 6, 2021 after spending 11 days in the hospital, and 6 days on a ventilator.

First 4 hours post injection no serious side effects, slight headache was settling in. At approx. 8PM (7 hours after shot) I had fairly a severe reaction of horror for the next 16 hours - all night long. Heart racing/energy beyond, deep chills and severe whole body shaking to the point of my back going out (dont' have a bad back), fever, migraine headache so bad (i dont get headaches) and body aches from a horror movie. I'm a jock, run daily, healthy, no smoke, drink or drugs. This lasted all night long well into the morning. At 3Am i considered going to the ER, but didnt. By 2pm the following day most of it went away. Two days later (today) i am dizzy, heart feels fast or racing, naseuous earlier , and exhausted. I can deal with it now, but it's very uncomfortable. Frankly, I regret getting the vaccine, wish i had not. I had covid last March, it was no big deal beyond what a flu would have done...with some shortness of breath on and off for a few months. The reaction to the vaccine is viccious compared to covid itself (for me, just my experience). Hope this all stops and goes away. Thank you for your work!

Fever, sore throat, muscle pain, headache, and sometimes dizziness. Treatment: Tylenol every 4 hours, Emergen-C, Benadryl

COVID-19 Vaccine EUA got J&J vaccine shot @ 2:00pm on Wed, April,7th woke up approx. 2:00am in trembling chills , woke up again @ 7:00a with fever , nagiated and feeling a flu like symtoms, headache , sore bones , been out of work two days now and starting to feel a little better but not anywhere near normal yet and don't have any alergies or alergic to anything.

Headache, chills, muscle aches, dehydration, loss of appetite, blurred vision, loss of taste, and loss of smell.

- general sense of feeling weaker than normal. - feeling of tense and restless muscles (especially legs), a sense that my body was struggling. - inability to sleep. That lasted about 30 hours. I realize this is probably a mild symptom, and probably a normal reaction. But you might need to know that.

4/10 - after 4 hours, (14:00) felt hot and my face was in red color. Generally OK 4/11 - Generally felt hot, red face, and then around 16:00, arm and let joins started to ache and mild pain occurred. 4/12 - After having a dinner around 17:00, with in 30min, chest pain started at left chest. felt more like heart burn sensation. 19:00 pain stopped by drinking some hot tea. 22:00 took my meds, Brilinta, Carvedilol and Atorvastatin 23:30 chest pain came back instead of left side, in the center of chest. took some tums and drank some hot water 26:00 no more pain and was able to go sleep. 4/13 - 07:00 no pain but off and on with discomfort in the chest area from last night chest pain.

Patient called the Facility COVID-19 Nurse Holtline with post-dose vaccine related symptoms or guidance. He stated he just received the J&J covid vac Pt msg re: pause which prompted him to think of ongoing sx he has been experiencing after covid vac. ?sob few days after vaccine, nausea, vomiting, fatigue, congestion, muscle aches (sx on/off since 4/1/2021)

Patient reports: pain and swelling in left leg below knee and calf tender to touch. Patient is currently admitted into hospital for treatment.

Severe throbbing pain in center of chest, jaw pain and severe pain on right side of neck through the night starting about 12 hours after the injection.

Got J&J COVID vaccine on 4/10/21, at noon, in right arm. About 24 hours later suddenly felt dizzy which lasted a minute, but since then has felt dizzy and right leg has felt tight and swollen.

when received the vaccine he got nausea that was mild, it continued and got worse on the 11th and 12th, the 13th he threw up from being sick, headache, fatigue, chills were all experienced through this time with muscle pain.

DIARRHEA; FEELING PRESSURE ON BACK OF THE NECK; PRESSURE ON LEFT ARM; NOSE BLEEDS; ELEVATED BLOOD PRESSURE; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 302 pounds, and height was 72 inches. The patient's past medical history included chronic obstructive pulmonary disease, dm type 2, and myasthenia gravis, and concurrent conditions included allergic to penicillin, non-alcoholic, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clarithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced elevated blood pressure. On 10-APR-2021, the subject experienced nose bleeds. On an unspecified date, the subject experienced diarrhea, feeling pressure on back of the neck, and pressure on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from elevated blood pressure, had not recovered from nose bleeds, and the outcome of pressure on left arm, diarrhea and feeling pressure on back of the neck was not reported. This report was non-serious.

On Wednesday the 21st he came home and was tired. It got gradually worse on the 22nd. Was also feeling rib pain on the right side. Was a little bit short of breath. Went to the ER on 4/23 and they gave him IV fluids and pain medications. Put him on Tylenol, Naproxen, and Eliquis. States today 4/26 he is feeling a little bit better.

Severe muscle spasms and leg pain currently Initially it was in knee and hip joints as well, I was treated with steroids for 5 days, that made the joints feel better. Still having terrible burning type pain in my right thigh muscles

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

Mild to moderate arm pain for first 2 weeks. Progressed to severe arm and shoulder discomfort with decreased mobility during 3rd week.

THROBBING PAIN; UNABLE TO WALK (AFTER 4 HOURS OF VACCINATION); WAKE UP IN MIDDLE OF THE NIGHT (AFTER 4 HOURS OF VACCINATION); PAIN IN HIS SHOULDER AND ARM JOINTS; SEVERE HEADACHE/DULL PAIN ON TOP OF HEAD (AFTER 4 HOURS OF VACCINATION); FEVER; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 182 pounds, and height was 165 centimeters. The patient's concurrent conditions included high cholesterol level, diabetic, high blood pressure, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included naltrexone for alcohol dependence. On 30-APR-2021, the subject experienced throbbing pain. On 30-APR-2021, the subject experienced unable to walk (after 4 hours of vaccination). On 30-APR-2021, the subject experienced wake up in middle of the night (after 4 hours of vaccination). On 30-APR-2021, the subject experienced pain in his shoulder and arm joints. On 30-APR-2021, the subject experienced severe headache/dull pain on top of head (after 4 hours of vaccination). On 30-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) burning, and Pain scale (NR: not provided) 10/10 pain level. On 01-MAY-2021, Laboratory data included: Pain scale (NR: not provided) 05/10 pain level. Laboratory data (dates unspecified) included: Blood glucose (NR: not provided) 160 mg/dL, and Blood pressure (NR: not provided) 145/110 mmHg. The action taken with covid-19 vaccine was not applicable. The patient was recovering from severe headache/dull pain on top of head (after 4 hours of vaccination), and fever, had not recovered from pain in his shoulder and arm joints, and the outcome of throbbing pain, unable to walk (after 4 hours of vaccination) and wake up in middle of the night (after 4 hours of vaccination) was not reported. This report was non-serious.

The evening of the shot I woke up with pain in my legs near my hips which lasted for a day. On 04/12/2021 my left leg was swollen and painful. I was already taking blood thinner. I went to the Emergency Room the next day and they found a blood clot in my leg. The Thrombosis was behind my left knee. My leg was swollen from the knee down and my ankle was very swollen. My Eliquis dosage has been increased from 2.5mg to 5mg twice daily. I did not have a repeat sonogram but my leg is no longer swollen.

Extreme muscle weakness in lower extremities. Currently using a walker when previously never had a gait issue. Developed Bell?s palsy. Weakness and at times severe pain in shoulders and arms. Tingling sensations in hands. Decreased feeling in legs and feet. These weaknesses are bilateral. Started with general feeling ?off? approx April 1, progressed to severe back pain April 13, visit to ER April 16 diagnosed with pneumonia sent home with antibiotics. Back to ER April 21 with severe back pain and beginning to have difficulty walking and weakness. Sent home with naproxen and muscle relaxers. Back to ER on April 24 fearing a stroke due to face droop. Admitted. Several tests run to R/O stroke,myasthenia gravis, lymes disease. Diagnosed with Bell?s palsy. Sent home on April 28. Still extremely weak. Using a walker. Still in pain. Sent back to ER per physician for another brain MRI on may 4. Not done due to argument between ER staff and physician who sent him in.

History of Present Illness: Patient has a history of sinus problems. He was schedule for sinuplasty and had preoperative evaluation on 04/21/2021 with WBC 5.8, Hb 15.5, PLT 193,000. He had J&J covid vaccination on 04/27/2021. He underwent sinuplasty on 05/05/2021. Subsequent to his surgery he was having headache. He had some nasal discharge with blood. He took tramadol but had persistent pain. His symptoms were worsening up with some weakness of his right upper extremity. Was having generalized fatigue and weakness. He states he was getting short of breath with a flight of stairs. He had decreased appetite. He was given Vicodin for his headache with some improvement. He noted discoloration and bruising with pain pain in his left internal thigh area. Was noticing some changes in his vision but no loss of vision. He presented to the ED on 05/11/2021 and laboratory showed WBC 8.7 Hb15.2, PLT 6,000, segs 77%, lymphs 9%. He had no dark colored urine. INR 1.4 PTT 33, immature platelets 30.2. His bili was 2.1. He was treated with dexamethasone 40 mg. There is tiny focus of restricted diffusion in the both cerebellar hemispheres measuring up to 0.4 cm white matter left cerebellar hemisphere of left parietal junction measuring 0.5 cm compatible small lacunar infarcts. Chronic paranasal sinusitis. Patient described minimal blood with flushing his sinuses. Patient was ultimately transferred to Hospital after 3 days (on 5/11) for further acute care management given the multiple clots and bleeds associated with severe thrombocytopenia.

5 days after dose had pain in left calf. On May 8th went to the hospital with pain under my left rib cage. It was determined by testing that I had a blood clot in left leg and one in each lung. There was also heart arrhythmia. I was given blood thinners for the clots which I am still taking. I was also given medication to help with high blood pressure and to help with heart beat.

WHOLE RIGHT ARM STARTED TINGLING FROM SHOULDER TO FINGERS; FINGERS NUMB; BICEP HURTS ALL ON THE INNER SIDE OF ARM; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was in good health and did not have any symptoms before the vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced whole right arm started tingling from shoulder to fingers. On APR-2021, the subject experienced fingers numb. On APR-2021, the subject experienced bicep hurts all on the inner side of arm. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from whole right arm started tingling from shoulder to fingers, fingers numb, and bicep hurts all on the inner side of arm. This report was non-serious.

Extreme dizziness/ vertigo. Room spinning. Started this morning. Had muscle soreness yesterday. Recurring pain down right leg. I need to call Dr.

First few days severe headaches and neck aches. These were gone after a week. Intense pain in legs and knees. VERY difficult to walk and stand from getting up in the morning until mid day. Painful most of the days and evening. I wake up multiple times at night with pain. I wake up about 5 or 7 times/ night. Very difficult to walk up and down stairs.

He got the vaccine, had no issues with it other than being tired and lethargic for 2 days. Then after 9 days the shoulder muscle was sore as if he had just gotten the vaccine. He then had tingling, prickling sensations up and down his arm to his fingertips with occasional slight numbness. He has not gone to his doctor, but it has not gotten any better.

Five weeks (05/16/2021) after receiving the Johnson and Johnson vaccine, my left leg just started feeling numb. I went into my kitchen and all of a sudden I started feeling dizzy. I lost all strength in my legs and in my left arm. I really couldn't move my arms or my legs and I felt really light headed. I had to have my 5 year old boys get me some water to drink. My son noticed that my heart was beating really strong and really fast. I saw water boiling over in the pot on the stove and I couldn't even get out of a chair to turn it off. I couldn't stand up. I finally managed to go back by my bed from the chair and slowly moved around. I tried holding my phone and it dropped out of my hands a couple of times because I couldn't hold it. A couple hours later, I felt a little better, but I had to fight to get around. We fell asleep and when I woke up, I still felt bad. I took my children to school and told them that I was going to the hospital to get checked out. At the hospital they performed multiple tests and they back showing I had stroke. I was treated for suffering from a stroke.

Report bilateral leg heaviness mainly to the calf region and mostly of the right leg that is constant started 2.5 weeks ago. There is no bruising, or feeling of warmth of the lower extremity. He denies chest pain, leg pain, SOB, HA or blurred vision. Reports movement makes it better and inactivity makes it worst. Treatment: None , Outcome: Does not interfere with ADLs

Severe itching behind right and left knee and left arm. Swelling of the left ankle and left arm. Skin erythema left arm and left and right calves Time for 7 days

extreme version of COVID 19 symptoms: extremely hard to breathe only able to take short breaths; vomiting; dry-heaves; coughing; no appetite; fever; cold sweats; chills; lethargy; tired; no energy 15 lb weight loss. This continued from Mid May to June 10, 2021.

My joints started to hurt and I became less flexible/mobile to the extend that I started walking with my cane and experienced difficulty getting up from a seated position. My Doctor did a a steroid injection in my back but it did not work. I took a couple of pain killers and some muscles relaxers when I could not bare the pain which also did not work (even tried using my conversion table and that did not work and then the pain went away on its own). My doctor passively agreed with me that my pain could have been caused by the vaccine since I suffer from chronic pain and it may have been an autoimmune surge in my system.

Pt states weakness in his arm four days after dose, has not visited with Physician. General fatigue, weakness, excessive night sweats. States low appetite, mood swings, and possible hot flashes.

ELEVATED HEART RATE; DISCOMFORT SLEEPING ON THE LEFT SIDE; 4 EPISODES OF CAPILLARY BURSTING, 2 IN EACH EYE; CHRONIC DIARRHEA 2-3 TIMES DAY; RIGHT HAND/FINGERS JOINTS ACHY; SEVERE HEADACHE; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 172 pounds, and height was 71 inches. The patient's past medical history included covid-19. 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, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-MAY-2021, the subject experienced right hand/fingers joints achy. On 12-MAY-2021, the subject experienced severe headache. On 12-MAY-2021, the subject experienced injection site swelling. On 15-MAY-2021, the subject experienced chronic diarrhea 2-3 times day. On 19-MAY-2021, the subject experienced 4 episodes of capillary bursting, 2 in each eye. On an unspecified date, the subject experienced elevated heart rate, and discomfort sleeping on the left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand/fingers joints achy, and injection site swelling on 15-MAY-2021, 4 episodes of capillary bursting, 2 in each eye on 29-MAY-2021, and severe headache on 12-JUN-2021, had not recovered from chronic diarrhea 2-3 times day, and the outcome of elevated heart rate and discomfort sleeping on the left side was not reported. This report was non-serious.

24 hours after getting the vaccine I started feeling sleepy and groggy. 48 hours after the vaccine I felt very groggy and off balance, like I was half asleep or had been drugged with a sedative. I also had low energy and exerting myself (with long walks, etc) made me feel wiped out and exhausted . After one week I started to feel better, but still felt slightly groggy and off balance, like I was drugged with a mild sedative. Now on July 1 -- one full month since getting the vaccine -- I still feel slightly groggy and off balance, no matter how much sleep or rest I get. I also still have lower than normal energy and muscle soreness. The grogginess and off balance is most noticeable when walking or moving my head quickly.

6/28/21 - J&J vaccine administered in right arm 6/29/21 - left calf cramp notice first thing in the morning, assume potassium issue, took supplement - no change 6/30/21 - intermittent numbness left calf, cramping still present 6/30/21 - MD Visit to walk in clinic - ultrasound - for DVT - results negative - doctor diagnosis - likely pulled muscle - ordered prescription for cyclobenzaprine (FLEXERIL) 10 mg tablet 7/1- 7/6 - cramping spread to ball of foot, hamstring, and quad, all left leg. occasional short stinging like bee, on outside of calf, numbness and pins and needles intermittently - flexeril results no benefit 7/7/21 - Visit to PA -D-Dimer test .27 (>.50 indicates blood clot) negative DVT ultrasound. Summary - Ultrasound of legs negative for DVT. Leg cramps likely due to to recent vaccination. Please call the office if there is no improvement after taking ibuprofen as instructed.

Numbness in fingers, toes, and left side of face. Some nausea in stomach and intestines Dizziness and unbalance Malaise with any kind of physical exertion Stiffness/pain in the lower back of head

7/5/2021 he started to notice numbness in his neck and shoulders, which he related to a possible pinched nerve. On Tuesday, 7/6 he noticed increasing numbness to neck a.m. shoulders with new onset left fingers tingling as well as bilateral feet, at which time he started taking Excedrin. On Wednesday, 7/7 he noticed increasing neck pain and numbness with his "entire spine "painful. On Thursday, 7/8 he noticed increase BL feet numbness. Today, 7/10 he woke up with numbness to the left side of his face, facial droop, mumbled speech and continued numbness to left fingers and BLE feet, for which he came to the ED for further evaluation management. Patient is currently hospitalized in ICU at the time of this report.

Tingling in arms and legs. Muscle weakness on arms ,legs and shoulders. Lasted for three weeks. In the 4th week had weakness in left leg and tingling. Tingling also on both thumbs. Progressive reduction in thr 5th week. Looks back to normal in the 6th week

"When I woke up, I felt sick to my stomach, experiencing nausea, sharp pain in my back towards my right shoulder. I felt dizzy, and feeling in my head, detached fatigued, feeling like I kind of had a head cold, but didn't. Dull ache in my head on the (R) side. Strange transient pains in my body. My heart felt like it was racing, and I felt like someone had punched me in my lower stomach".

About 1 month after receiving the J&J Covid vaccine patient noticed numbness/tingling in the smaller 3 fingers of his right hand. Around the same time, he noticed weakness in his right hand also. He received his vaccine in his left deltoid.

About 6-8 hours after receiving injection was having chills, sweating and shivering. Hands and feet were very sore and stiff. All areas of past trauma painful and continue to be so.

Tested positive for COVID on 07/29/2021 has had moderate symptoms, headache, muscle aches, cough, change in taste and smell, fatigue.

Approximately 4 minutes after the injection, while sitting down, I felt light headed, sweating, weak, face turned white. I was close to passing out but didn't. I requested attention after about 10 minutes. While being treated by medics they mentioned color had returned to my face. I felt better enough so I refused to go to hospital and was driven home. Later that morning, 03/08/2021 about 10 AM, I developed a fever and body aches with sharp pains thru out my body and joints. First temperature check was 100.5. My fever, pains/weakness increased thru out that day and overnight with chills. Highest temp check was 102.8 that evening prior to bedtime. I don't know if it could have been higher at some point overnight. It felt like I had a moderate to bad case of the FLU. The next morning, 03/09/2021 the fever broke down to about 101. By 03/11/2021, aside from a little residual weakness I felt more like myself. However, as of the writing of this report my temp seems to fluctuate between normal and 99.8. Will report this to my Doctor on next visit. Worth noting that I haven't had any Flu like symptoms to that degree in many years.

headache, malaise, myalgia, poor appetite x 24 hours - I was flat on my back on 3/6/21, but fully recovered on 3/7/21

chills, fever, muscle contractions/seizures, severe headache, joint pain, sweats,muscle weakness, acid reflux- time course: began approx 8 hrs after shot (12:15am) and continued until 5am,-acetaminophen 1000mg q8h, naproxen 220mg q12h, gaviscon liquid 10ml, the headache, muscle pain has continued at a lower intensity until 12noon on monday 3/22/21

Received Janssen Lot 1808980 at 10:15AM on 4/1/2021. No symptoms at first other than missing appetite. Around 9:00pm started to feel chills and tired with low grade fever (100 C). Around 1:30am started feeling right side back pain in my kidney area that woke me up. By 2:15am the pain was almost unbearable, and I could no longer lay in bed. At 3:00am I took 2x 500mg Tylenol as I debated whether to call my doctor or go straight to ER. By the 3:45am pain was subsiding and was I able to get back in bed by 4am. Today no pain.

Initially (20 minutes after shot) felt numbness in toes on both feet. Chills were next felt within approx an hour. Intense muscle aches were later (approx 6-8 hrs after shot) along with overall fatigue. A medium grade headache began 8-10 hrs after shot and continued throughout night - lowering to a slight headache within 24 hrs after shot. Headache ended 28-30 hrs after shot. Developed a post nasal drip and mild congestion in sinuses about 1.5 days after shot (and continues). Numbness in toes appears to have returned with some stiffness felt in my calf muscles.

NASAL DRIP; MILD CONGESTION; INTENSE BODY ACHES; WEAKNESS BEHIND KNEES WORST ON LEFT SIDE; CHILLS; MEDIUM GRADE HEADACHE; FATIGUE; LOW GRADE FEVER; MUSCLE ACHE; NUMBNESS IN BOTH FEET - FRONTAL FROM BUNION OUTWARD MAINLY ON BOTTOM; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 150 pounds, and height was 180 centimeters. The patient's concurrent conditions included alcohol use, and nonsmoker, and other pre-existing medical conditions included the patient had no allergy to vaccine, drug, or food and no history of drug abuse. the patient had no illness at the time of vaccination, no past history of similar event, no adverse event after any previous vaccination, no family history of any disease or allergy relevant to vaccination and hospitalization in last 30 days. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 on right arm muscle for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced numbness in both feet - frontal from bunion outward mainly on bottom. On 31-MAR-2021, the subject experienced intense body aches. On 31-MAR-2021, the subject experienced weakness behind knees worst on left side. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced medium grade headache. On 31-MAR-2021, the subject experienced fatigue. On 31-MAR-2021, the subject experienced low grade fever. On 31-MAR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced nasal drip. On 01-APR-2021, the subject experienced mild congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 02-APR-2021, was recovering from medium grade headache, intense body aches, nasal drip, mild congestion, low grade fever, and muscle ache, had not recovered from numbness in both feet - frontal from bunion outward mainly on bottom, and weakness behind knees worst on left side, and the outcome of fatigue was not reported. This report was non-serious.

the patient was admitted with severe headache and backpain. over the course of 3-4 days, he developed progressive neurologic symptoms (bilateral facial nerve palsies, numbness and dysesthesia of the lower extremities, bilateral lower extremity weakness and loss of reflexes) consistent with acute inflammatory demyelinating polyneuropathy.

36 hours after injection I started having headaches. Then nausea, regurgitation extreme chills with muscle pain. 6 days later 4/15/21 I still have nausea with lower stomach pain.

After my J&J vaccine, I experienced left hip and joint pain. I could not lift my left leg up. The next morning after my J&J vaccine, my left leg started hurting more and I could not ambulate. My left hip was hurting so bad I could not sleep at night. I went to the doctor 03-17-2021 to get monitored and he said it could be arthritis. I was prescribed by Dr. cyclobenzaprine 10mg and naproxen 500mg. I feel that my pain is inside the joint, hip pain region and to this day, I still have sleeping problems due to my pain in my left leg and left hip pain since the J&J vaccine. I will have a follow up with Dr. in the coming weeks.

About 36 hours after the injection I started to feel some fairly profound fatigue, and had aching joints throughout my body for about 36 hours after the onset. I also had some lingering mild pain in the backs of my thighs for about 12-18 hrs after the aches went away.

FELT LIKE SOMETHING ON CHEST; SKIN HOT; LITTLE BIT OF COUGH; FEELING HOT; CAN'T SLEEP AT NIGHT; DIZZY; BARELY COULD STAND; COULD BARELY WALK; PAINS IN BACK ESPECIALLY BACK UP NECK; CHILLS; VERY WEAK; FELT VERY HOT FEVERISH; NIGHT SWEATS; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced tired. Laboratory data included: Blood test (NR: not provided) everything was ok. On 24-MAR-2021, the subject experienced night sweats. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced very weak. On 24-MAR-2021, the subject experienced felt very hot feverish. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced barely could stand. On 25-MAR-2021, the subject experienced could barely walk. On 25-MAR-2021, the subject experienced pains in back especially back up neck. Treatment medications included: naproxen. On APR-2021, the subject experienced little bit of cough. On APR-2021, the subject experienced feeling hot. On APR-2021, the subject experienced can't sleep at night. On APR-2021, the subject experienced felt like something on chest. On APR-2021, the subject experienced skin hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 2021, was recovering from pains in back especially back up neck, and felt very hot feverish, had not recovered from chills, and the outcome of night sweats, little bit of cough, dizzy, barely could stand, could barely walk, very weak, feeling hot, can't sleep at night, skin hot and felt like something on chest was not reported. This report was non-serious.

NECK PAIN; ARM PAIN; LEFT SIDE BODY PAIN; HEADACHE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, blood pressure, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: ibuprofen, and paracetamol. On 13-APR-2021, the subject experienced neck pain. On 13-APR-2021, the subject experienced arm pain. On 13-APR-2021, the subject experienced left side body pain. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, neck pain, arm pain, and left side body pain. This report was non-serious.

HEADACHE; SOMETIMES LOOSE MEMORY; HIGH BLOOD PRESSURE AFTER VACCINE; DIFFICULTY BREATHING; FEELING ABNORMAL; LOOSING WEIGHT; VOMITING; MY TONGUE WAS SWOLLEN; POOR APPETITE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included blood pressure abnormal, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known allergies or 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: 1200287383 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sometimes loose memory. On APR-2021, the subject experienced high blood pressure after vaccine. On APR-2021, the subject experienced difficulty breathing. On APR-2021, the subject experienced feeling abnormal. On APR-2021, the subject experienced loosing weight. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced my tongue was swollen. On APR-2021, the subject experienced poor appetite. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, fatigue, sometimes loose memory, high blood pressure after vaccine, poor appetite, nausea, vomiting, loosing weight, and feeling abnormal, and the outcome of my tongue was swollen and difficulty breathing was not reported. This report was non-serious.

03/23 Sore arm after shot for three days and general soreness in left shoulder. No other side effects, Soreness fade within a weeks 05/10 /2021: Woke up with what was felt like a closed eustachian tube (right side). Teble, high end hearing muted all day. Minor post nasal drip. 05/11/2021 No nasal drip, sounded better in the morning. By 12pm, hearing in my right ear is completely gone. 05/12/2021 Visit to GP : clean out ear with not relief. Simple Test confirms hearing loss is not viral but sensorinrual loss.

Immediately after injection significant arm pain that resolved quickly. Approximately 36 hours after injection dizziness. 48 hours after injection neck and head pain on left side, arm soreness, and swollen lymph node on left side of throat. Minor pain in mouth and throat with fatigue and dizziness. Neck and head pain decreasing on day 3 with all other effects resolving but injection site is still fairly sore. Overall, I would say this was probably a normal response associated with my immune system reacting to the injection. I had the virus the first week of December 2020. I would classify my infection as moderate. I was sick with fever, chills and severe body aches and it lasted for 10-14 days.

HIGH BLOOD PRESSURE; SHORTNESS OF BREATH; PAIN CONTINUES ALL OVER BODY; HIP PAIN; LEFT KNEE DISCOMFORT; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sickle cell trait. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: Unknown) dose was not reported,1 total administered on 05-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021(10 days later), the patient experienced left knee discomfort and hip pain, for which patient visited primary doctor, who referred him to an orthopedic. Orthopedic prescribed meloxicam; however, the patient took ibuprofen daily instead of it . On an unspecified date, the patient experienced pain all over body for which patient took oxycodone hydrochloride/paracetamol but discontinued due to constipation and for constipation patient took casanthranol/docusate sodium, then patient checked blood pressure and it was found 148/106 mmHg (high) so patient visited to emergency room where patient firstly checked for covid -19 test which was negative. For high blood pressure patient took amlodipine 10 mg daily. The patient took paracetamol for unknown indication. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain continues all over body, and the outcome of left knee discomfort, hip pain, shortness of breath and high blood pressure was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210532847-COVID-19 VACCINE AD26.COV2. S - High blood pressure. 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).

THROAT HOARSE; SNEEZING; COLD; BACK PAIN; ARM SORENESS/ARM FELT SORE/PAIN IN LEGS; MILD HEADACHE; MUSCLE ACHES; FEVER OF 100.4; FLU LIKE SYMPOTOMS; DID NOT SLEEP WELL; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 175 pounds, and height was 70 inches. The patient's past medical history included back surgeries, and concurrent conditions included cigarette smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 05-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced did not sleep well. On 06-MAY-2021, the subject experienced flu like sympotoms. On 06-MAY-2021, the subject experienced back pain. On 06-MAY-2021, the subject experienced arm soreness/arm felt sore/pain in legs. On 06-MAY-2021, the subject experienced mild headache. On 06-MAY-2021, the subject experienced muscle aches. On 06-MAY-2021, the subject experienced fever of 100.4. On an unspecified date, the subject experienced throat hoarse, sneezing, and cold. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.4 F, 99.8-99.9 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from did not sleep well, and flu like sympotoms, and back pain, arm soreness/arm felt sore/pain in legs, and muscle aches on 10-MAY-2021, had not recovered from mild headache, and fever of 100.4, and the outcome of throat hoarse, sneezing and cold was not reported. This report was non-serious.

Pain in left upper arm about 10 days after injection, shooting down arm to hand, reduced mobility of the arm, didn't improve for 3 weeks thus saw my own doctor. She referred to orthopaedic doctor. Saw him on 5/12/2021, he diagnosed adhesive capsulitis in left shoulder possibly caused or exacerbated by the swelling due to the vaccination in that same area. Revisit in 3 weeks after dr. visit. Taking ibuprofen to reduce inflammation.

Overall flu like symptoms and extreme weakness now lasting 12 days. Insomnia for 8 days. Extreme pain from hips up back to neck, and ribs front and back still continue. Periodic cold sweat mainly in the mornings and sense of unsteadiness in my head.

COVID-19 PNEUMONIA; DEPENDENCE ON VENTILATOR; NOT ABLE TO WALK; COULD NOT WORK; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, alcohol user (not often), and non-smoker, and he had no chronic medical history. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: unknown) dose was not reported, 1 total, administered on 09-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. After vaccination on 10-APR-2021 (Saturday), he was feeling bad and 11-APR-2021 (Sunday) and 8 days later went to the hospital. He did a polymerase chain reaction (PCR) covid-19 test at the hospital on 16-April-2021 and result was positive. He went back home but on 28-APR-2021, because his oxygen levels dropped and had trouble breathing. He was ventilated for 18 days. He was hospitalized for Covid-19 pneumonia (pneumonia, feeling bad and lost 45 pounds) for 36 days. He was discharged from hospital on 03-JUN-2021. On an unspecified date, he was not able to walk. He had home therapy and nursing therapy to be able to walk again and he lost 45 pounds. Since unspecified date, he could not work for 3 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 pneumonia on 03-JUN-2021, and dependence on ventilator, and could not work, and had not recovered from not able to walk. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000182426. The suspected product quality complaint has been confirmed to be not voided. The patient received the vaccine on 09-APR-2021 and had a positive Covid-19 test on 16-APR-2021 with 7 days elapsed between vaccination and test. There was not sufficient time elapsed for the patient to achieve immunity; therefore this report was not considered a lack of effect for Janssen COVID-19 vaccine.; Sender's Comments: V0: 20210622074-covid-19 vaccine ad26.cov2. s-Covid 19 Pneumonia, Dependence on Ventilator. 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 Friday June 11 I woke up with itching hands; as the day went on the condition worsened; I applied Aveeno and Benadryl cream; Saturday June 12th I went to urgent care and received a Steroid shot which did help the rash and hives. On Sunday June 13th I noticed my hands starting to hurt ; by Monday the the pain was severe; I saw my family Dr on Tuesday June15th on he prescribed oral steroids. Wednesday the pain had moved to my shoulders and hands where it continues. The pain is not as severe but it still hurts to move my shoulder or to grip things with my hands.

An old injured right ankle I dislocated when I was 20years old swelled up and I was unable to walk on for three days. It still is very sore.

next day after vaccine...developed bad back pain....like an old sports injury....lasted 5 days then resolved...had not had similar symptoms in many years..

2-3 weeks after vaccination patient started with weakness in both legs, general fatigue, progressive weakness in both arms, progressive dysarthria, and fasciculations in both upper arms. Patient followed up with neurologist but did not improve. Patient now has pending appointment with Neurology.

Presented with generalized malaise, fever, chills on June 23. Had headache and cough on and off after receving vaccine. On July 8 admitted to hospital with rash concerning for erythema migrans. Positive Lyme IgM. Started doxycycline. Discharged 7/10. Came back on 7/11 with bilateral facial nerve palsy. noted to have severe back pain of unclear cause as well. Started on Ceftriaxone. Discharged again on 7/13. On 7/14 presented to oupatient ID clinic with increasing back pain and numbness on trunk and upper thighs. Sent back to hospital. CT head, MRI thoracic and lumbar spine normal. LP done normal cell count, mildly elevated protein on CSF. Increasing muscle weakness of extremities (proximal muscles of lower extremities first). Impression: Guillain Barre. Started on IVIG

Chills, back ache, elevated pulse(115) started about 12 hours after vaccination. Lasted about 8 hours. Called cardiologist and he said it was probably a reaction to the vaccine. Took some ibuprofen. Did not do anything else. Felt better the next morning and pulse was fluctuating between 80 and 90.

Severe chills, sweating, low grade fever, intense headache, and pain in the back of my neck. Vaccination was at 10am and symptoms started at 7pm and lasted through the night. By 9am (23 hours later) all symptoms seem to be cleared leaving me very tired from lack of sleep.

21 hours after injection, lethargy and tired. Approximately 40 hours after injection, loss of motor function on left side, specifically, could not lift left leg to climb stairs, combined with soreness in left hip and shoulder. Hip pain is mild to severe, and deep, mostly around the top of the femur. Approximately 8 hours later had sharp, shooting pains deep in the left leg/. Felt like it was in the femur, paint started at the top of the leg and shot down to the knee. Pain duration approximately 1 second, with multiple, sporadic occurrences over the next several days. Approximately 3.5 days after injection, numbness in left hand - small (pinky) finger and radiating along side of hand to wrist. Loss of motor function on left side resolved after approximately 8 hours, pain in hip, pain in shoulder and shooting pain in leg and hand numbness continue. Shooting pain is intermittent, shoulder pain is intermittent, hip pain and numbness in hand are constant.

Moderate flu-like symptoms for 24 hours -- sore muscles, joint pain, headache, fatigue, nausea, constipation, loss of appetite. Severe enough that I took afternoon off from work.

Janssen COVID-19 Vaccine EUA Fever, fatigue, muscle aches, headache, slight nausea. Fever at first was about 101 but has increased to 103. I have taken tylenol to try to control the fever.

Headache, Myalgia, Arthralgia, NauseaVomiting, LIGHTHEADED, FATIGUE Narrative: Other Relevant History:

A week after the patient had the vaccine he developed weakness with numbness in the lower extremities. Patient continued to get worse and was admitted on 04/03 with concerns for Guillain-Barré syndrome ( GBS). Patient is currently getting treatment for GBS.

Started to feel weakened after about 6 hours. Woke up about 12 hours later with very sore muscles, headache, and significant cold shivering. Was unable to go back to sleep.

I received the dose on March 12. On March 16 I got sick, throwing up and head ache. Since then I have had no energy with a slight head ache. My right knee has arthritis and I get cortisone shots. However that knee started really hurting after the vaccination.

Abdominal pain, low fever, headache, muscle and joint soreness, fatigue/ weakness, nausea, diarrhea, congestion.

THROBBING PAIN UNDER ARMPIT; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included vitamins nos for drug used for unknown indication. On 12-APR-2021, the subject experienced throbbing pain under armpit. Treatment medications (dates unspecified) included: amlodipine besilate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throbbing pain under armpit. This report was non-serious.

59-year-old. 3 male see Johnson & Johnson vaccine March 23. A few days after receiving the vaccine, he reports he developed left-sided neck pain and right-sided lower back pain. The left-sided neck pain radiating down left arm and right-sided low back pain radiates down right leg. He denies any injury, car accident, or any sort of heavy lifting. He does drive a limousine many hours per days and remains sitting most of the day. However, he has been performing this order work for many months and never had this order musculoskeletal problem before the vaccine. He has been taking Advil with no improvement. Cervical radiculopathy at C7 Start Medrol (Pak) Tablet, 4 MG, as directed, Orally, AS DIRECTED WITH FOOD, 6 days, 1 Pack, Refills 0 Start Cyclobenzaprine HCl Tablet, 5 MG, 1 tablet, Orally, every 8 hours as needed for muscle spasms, 10 days, 30, Refills 1 Notes: Neck Strain or Sprain: Rehab Exercises material was printed.

Muscle pain in both arms/shoulders, headache for 3 days, fatigue, stomach aches for 3 days (since 4/21/21)

Patient reports hx of back pain. States an episode began on 4/4/2021. His usual back pain episodes last 3 days, maximum. This round of back pain has continued. Patient reports only variance was receiving the Janssen COVID vaccine on 4/7/2021. Patient contacted his PCP for evaluation and is unable to be evaluated until July.

10 days after the vaccine my perfectly healthy husband began developing terrible back pain and abdominal numbness, went to the ER, had a brain bleed and was daignosed with Guillain-Barre Syndrome. He has been in the hospital for a week. He is not being released yet.

This is a 59 year old male that presented to the emergency department at approximately 1447 on 04/27/2021 with sudden onset of left upper and lower extremity weakness and left-sided numbness of his face. The patient stated he may have had some weakness the previous night (04/26/2021), but mostly noticed it when he woke up around 0900 on 04/27/2021. The patient stated he may have also had some transient speech changes which he felt were improved upon emergency department presentation. The patient stated he took an 81 mg aspirin prior to hospital arrival. The patient was overall hemodynamically stable in the emergency department. Past medical history is only significant for benign prostatic hyperplasia. This patient has no history of previous CVA or TIA, no smoking history, no history of clotting disorders, no recent trauma or other injury. CT head revealed a small right frontal subarachnoid hemorrhage with no midline shift and concern for clot. CTA head and neck perfusion study was significant for ?perfusion abnormality involving the right frontal lobe in the region of known subarachnoid hemorrhage, likely related to dural venous sinus thrombosis involving the posterior aspect of the superior sagittal sinus, left greater than right transverse sinus, and left sigmoid sinus.? This patient is noted to have recently received his Johnson and Johnson vaccine on 03/20/2021. The patient was admitted to the intensive care unit. Neurology and hematology were consulted.

ON 4/4/21 PT EXPERIENCED SHOULDER PAIN, HEADACHE AND ANKLE PAIN AND NUMBING ON HANDS, ON 4/27 PT WENT TO URGENT CARE MD PRESCRIBED MEDROL DOSE PACK, AND MOTRIN. PT WAS INSTRUCTED TO FOLLOW UP WITH DR AND RECOMMENDED TO GET AN MRI 4/29 PT DEVELOPED COUGH

(Hips) both left and right. Adverse pain making walking, standing and laying in bed extremely uncomfortable. Ibuprofen for action of course, 3ea 250 mill in AM again at PM. Before ibuprofen pain level 6 out of 10. After ibuprofen 4. NOTE: problems persistent to date...

I woke up the next day with a fever , the fever went and then I had trouble breathing with congestion I went to urgent and went on antibiotic the congestion cleared up then I had extreme tiredness for 3 days I am still having trouble with my left arm and cannot reach it above my head the energy level has returned to normal around Thursday and Friday of last week but the rotation of the left arm is still difficult

Without having taken any pain relievers directly before or after the vaccination, my temperature began to rise yesterday morning into afternoon from 97.1 up to 101.1. At 3:00 p.m. it began descending to 100.3. However, at 6:00 p.m. it quickly jumped up to 101.7. At this time, I took two Tylenol 500 mg caplets, which broke the fever. It was at 101.0 when I went to bed last night at 9:30 p.m. and was at 98.5 when I awoke at 5:00 a.m. Also, since I have had Covid-19 (beginning the morning of November 19th), I have had significant shoulder and knee pain; acupuncture helped alleviate the shoulder pain and shots from a doctor last week helped the knee pain. However, yesterday the pains returned in full force until I took the Tylenol; they are back to being detectable (and mild) as of this morning.

Chills, vomiting, dizziness/vertigo, loss of motor function of right arm and leg, arm and leg were weak, uncoordinated, unbalanced. Could not write. The symptoms starting on May 4 and have been ongoing. Course of steroids have helped but still continue to have symptoms.

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

THROAT SWELLING; BODY ACHES; STOMACH ACHES; CHILLS; DIZZY; SEVERE HEADACHE; FEVER; INJECTION SITE BLEEDING; MILD SHOULDER PAIN; INJECTION SITE "BUBBLED UP"; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included many surgeries post traumatic car accident, and concurrent conditions included a lot of scar tissue on shoulder (at injection site), and high blood pressure.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A2114, and expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced injection site bleeding. On 18-MAY-2021, the subject experienced mild shoulder pain. On 18-MAY-2021, the subject experienced injection site "bubbled up". On 19-MAY-2021, the subject experienced dizzy. On 19-MAY-2021, the subject experienced throat swelling. On 19-MAY-2021, the subject experienced body aches. On 19-MAY-2021, the subject experienced stomach aches. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced severe headache. On 19-MAY-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site bleeding, and injection site "bubbled up" on 18-MAY-2021, and mild shoulder pain, was recovering from severe headache, throat swelling, fever, chills, and body aches, had not recovered from dizzy, and the outcome of stomach aches was not reported. This report was non-serious.

Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Joint Pain-Mild, Additional Details: Pt claimed that after 6 days after vaccination, his left arm is still sore when moved. He also claimed that he is limited mobility of his left arm due to the vaccine with out feeling some level of pain.

When he got the shot he felt hot and sweaty and it cleared and a few day later he had a bad reaction having chills, chest pains, pains in left arm and on left side, and nausea and lower back pain

NECK PAIN; UNDER ARM PAIN; PAIN IN THE ARMS RADIATES FROM ONE ARM TO THE OTHER (BOTH ARMS); CHEST PAIN; BURNING SMELL; STOMACH PAIN; DRY EYE; RED EYE; HEADACHE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non smoker, vitamin b12 allergy, and fish product allergy, and other pre-existing medical conditions included patient had no 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, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced dry eye. On 10-APR-2021, the subject experienced red eye. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced burning smell. Laboratory data included: CT scan (NR: not provided) Normal. On 19-APR-2021, the subject experienced chest pain. On 19-APR-2021, the subject experienced pain in the arms radiates from one arm to the other (both arms). On 22-APR-2021, the subject experienced under arm pain. On 27-APR-2021, the subject experienced neck pain. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry eye, and red eye, was recovering from stomach pain, and had not recovered from chest pain, pain in the arms radiates from one arm to the other (both arms), headache, neck pain, burning smell, and under arm pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.

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

patient experienced lower back pain, nausea, dizziness, tightness in chest, asthma symptoms patient went to see the primary doctor and was evaluated

Cubital tunnel syndrome in injected arm. Hands "fall asleep" occasionally, but this time it did not resolve, resulting in weakness in hand and arm that have only partially recovered in the weeks following. Unable to use left hand since onset to use most tools, turn a valve, etc. Uncertain at this point whether full recovery is possible, but progress seems to be stalled at perhaps 50%-75% capacity. Icing helps with pain, along with regular acetaminophen and occasional ibuprofen. Exercise (including ulnar nerve "flossing") helps with recovery but has plateaued.

Patient called on 6/29 around 10:30 am stating that he has muscle aches, no energy, and trouble breathing since 5/21 (2 days after his vaccination). Pharmacist advised patient to see a doctor immediately since he is very trouble breathing and to rule out any infection or other issues related or not related to vaccine.

Muscle pain in both shoulders. The pain in the opposite shoulder (RT) of the injection has worsened significantly over the past month. Some arm weakness in both arms has been experienced as well.

I did not feel well for several days following the injection. I was tired and had a headache. However as the days went bye I stopped exercising and did not feel like working or even leaving the house. On the night of May 24 I began to have the worst headache of my life, my heart was beating irregular. By the morning of the 25th I got up and passed out. I was sweating, heart pounding, nauseous, chest pain, shortness of breath, pain in my shoulder blades.

Weakness and tingling in your extremities Issues maintaining body temps. Blood sugar hitting crazy numbers on 12 hour fast Tired and sore, left rear neck tingling with head aces

Constant muscle pain, muscle weakness, especially in legs. Initially, no pain in arms or feet. all other muscles affected; lower back, upper back, chest, abdomen, groin. Eventually, tingling in finger tips & toes then numbness in hands and feet, and pain in arms.

Swollen wrist, ankle, knee, and shoulder joints with intense pain at times. Still have soreness and pain at injection site..