Johnson & Johnson

Chills, body aches and fever about 7 hours after the shot. I took Tylenol and it made the symptoms more mild. I was fever free at about 11am the next day. My injection site and arm still hurts 3 days later and I have a swollen and sore gland in my collar bone on the same side as my shot was given.

8-10 hours after had aches, 102 temp wouldn?t go down with Tylenol, chills, dizzy (all manageable) 24-30 hours later arm formed warm red lump which has continued to harden and spread. It?s now a very hard lump that is the largest it?s been . I?ve been treating with prescription triderm and it is helping some but when I tried clobetasol the opposite happened and it aggravated the site. This redness , itching, swelling and warm to the touch has been going on since Sunday evening and it is not Wednesday night and doesn?t look better yet.

5:00 pm 3-9-21 I became instantly exhausted and had fatigue. I got chills and ran a 99.8 fever. I went to bed and about 5 hours later my fever broke and I felt fine in the morning when I woke up. 9:30pm on 3-13-21 I found both of my thighs bright red. It was not itchy, but it was warm to the touch. 7:45pm on 3-14-21 My butt cheeks were bright red and warm to the touch. Then about 30 minutes later my thighs became red. Everything red started itching was raised like hives. I found three dots on my arm and later those spread into large spots of hives. Then over the next 9 hours, a new spot would start, it would spread, then it would itch like crazy. I took 25mg of Diphenhydramine at 8pm. I took another 50mg at 10 when I was having no relief and it continued to spread. At 1:15am both of my hands and wrists had hives and these hurt and itched the most because they were swollen and hard to bend. At 3am both of my feet started to flair up. Finally around 5am the hives stopped. I was not able to sleep through it. I did not ever have a fever, I checked that 4 times. I also did not have trouble breathing or have any swelling on my face. 3-15-21 @ 9:20am I went to see my doctor. All of my vitals were good. All of my hives were gone. He put me on Prednisone in case it came back and at 11am I took 4 pills and went to bed. I woke up 2 hours later and my feet were itching again. My left foot broke out in hives bad. It lasted for over an hour. My toes were hard to bend. 4:34pm on 3-15-21 currently I don't have any hives and I am tired. I thoroughly thought through everything that I have eaten, worn, and used, and I have changed nothing over the past 2 weeks.

After 15 minutes of sitting in the waiting area in case of adverse effects, (which I didn't have any) I went outside and sat in the parking lot for another 10 min. After no side effects, I drove away. Only to have a sudden reaction as I was driving. I've felt dizzy with flu vaccines before and have felt the same symptoms as with the covid vaccine when IV dye was injected for a CT scan 5 months ago. Felt faint/ dizzy, Got severe tachycardia, thought my heart was gonna explode. I drove back in a hurry, scared and confused. I was waiting to be seen, and no one ever came out. Symptoms subsided on their own after 15 min, therefore I just left without notifying anyone. 2 hours after vaccine, my arm looked moderately red and swollen, with minimal pain. 7 hours after getting the vaccine I started with chills and body aches. 8 hours after getting the vaccine I felt feverish and malaise. After taking Tylenol with feverish symptoms (didn't check temp) slept for 2 hours and felt a little better.

24 hrs later - Rapid heart rate (150 resting) exhaustion, Swollen red arm, body aches, low grade fever

In addition to the known side effects of extreme fatigue, low grade fever and body aches, I also have right arm pain at the site of injection with right arm swelling, warmth and right axilla swelling and tenderness. The arm pain was began immediately at the time of injection and did initially lessen some for the first 12 hours until it started worsening mid-morning 22-24 hours after the injection. Around 26 hours after the injection the arm pain worsened such that it couldn't be ignored and the axilla pain became very prominent almost worse than the arm pain. Upon inspection I noticed obvious swelling and pain in my right axilla. The right arm and axilla pain has persisted and worsened over the last 2 days to now include upper biceps, upper triceps, lower deltoid, trapezius, clavicular and right lateral breast pain. The axilla and arm swelling has persisted and worsened over the last two days to now include swelling in my upper arm, around my clavicle, my upper chest and upper back. The initial axilla swelling has not decreased any and is more prominent than any of the swelling located elsewhere. Of note, I cannot easily palpate any axilla, clavicular or cervical lymph nodes. If there is lymp involvement the nodes are not appearing to be extremely swollen with palpation exam.

Headache began 1 hour after vaccine, followed by vomiting repeatedly 4 hours after vaccine. Vomiting continued over night to the present time (4/6/21 - nearly 24 hours later). Headache became migraine. Woke up this morning with 102 fever with chills, and swelling extending from left shoulder up along neck.

Sore/swollen lymph nodes on the side of injection, very vivid dreams, restlessness, significant increase in anxiety/panic attacks, hard time falling asleep

High fever (103.5) approximately 8 hours after shot, persisting for 3 days at over 101 with Tylenol every 4-6 hours Body aches and chills lasting for 24 hours Nausea and vomiting for 72 hours after injection Diarrhea for 72 hours after injection Bitter taste in mouth and all food tastes bitter ? still persisting as of 4/10/21 Patches of dry skin on left side of face that burn and itch and are flaky. Areas are swollen and hot to the touch? appeared on 4/7/21 and as of 4/10/21 still there.

Patient had covid19 vaccine yesterday in her left arm. Today, she noted some swelling at the base of her neck on the left and it is quite tender to touch. The upper arm is only mildly tender. The vaccine was Johnson and Johnson. She has no breathing difficulties and no trouble swallowing. No fever, chills or myalgia. No chest pain. Acute onset. Stable. She has no evidence of airway compromise or difficulty swallowing. This does not appear to be lymphadenopathy. I want her to monitor closely. Apply ice to area as directed on after visit summary. Acetaminophen for pain. If enlarges with any evidence of airway compromise at all, she must go directly to Emergency Department or call 911. I encouraged her to report this on VAERS site for adverse vaccine reaction. As of 4/11 1:41pm pain at collarbone is same, but swelling is down a bit. Injection site is now very tender/ painful to touch.

At time of injection, dizziness, pain at injection site, pain in right arm fingers, inability to grip with fingers on right arm. Next day swelling of hands and feet. Veins large and visible thru skin more than usual. Continued dizziness. Tylenol taken to deal with pain. 7 days later still minor dizziness. Swelling of feet and hands continues. Pain in right arm. Pain in right hand and unable to grip with right hand.

Throat and lymph node swelling that is not going away. All other normal symptoms came and went. Throat continues to swell, hard to swallow. I think this is an allergic reaction. I will take a benadryl today and call doctor tomorrow if this doesn?t go away.

Day 16 post vaccine: significant top of foot/ankle edema with pitting edema also minor swelling up to groin (~1cm larger compared to right up the leg). Right lower leg and F&A also had minor pitting, but not the pronounced swelling seen in the left. Did self MLD massage, elevated and wore compression. Tingling in left leg overnight and felt heavy. Called doctor's office as soon as they opened on Day 17 post. Saw them that afternoon. Swelling had already gone down significantly either on its own or due to compression, elevation, and massage. Practitioner noted pitting edema in both ankles, more pronounced in left. It was not painful or warm, so she ordered a D-dimer test if I still had swelling over the weekend. Since swelling continued to improve, nothing else was done.

On Friday after the shot, I felt ok, but my left arm was swollen to the point of taking off my wedding rings because they hurt. The leg pain started on Friday night. Saturday woke up with a groggy head and tired. Sunday I had leg pain, headache, and foggy brain. Saturday into Monday I had night sweats (pouring in sweat) fever, headache, body aches, tired (could not keep my eyes open) I slept all day and could barely move comfortably. Tuesday I was extremely exhausted, leg pain continuing, headache, and weird feeling. The swollen arm is back. Today is Wednesday, almost a week after with leg pain, headache, swollen arm, and weird feeling.

3/22/21- Raging headache, extreme chills. 4/9/21- Left foot swelled up like a grapefruit, was worried about blood clot when I saw them on 4/10/21.

I have been presenting a lot of pain in my legs, swelling in my feet and in my right hand, I also see that the veins in my legs are showing

About six hours after the vaccine I had a headache. I woke up during the night with all over body aches that were very painful. I also had a headache and fever of 100-102 degrees. I was in bed for three days and I was still very fatigued for a whole week. My hands and legs were swelling off and on. I also had some shortness of breath, coughing and chest pain. I was dizzy and lightheaded. I have been very uncomfortable and unable to sleep. I still have tingling and pain in my feet. I get easily winded and I am still experiencing headaches. It has been almost three weeks. My feet and hands are still swelling and my hands are very red. I am seeing my doctor today for a breathing treatment. Everything seems to be slowly improving but the headaches are still coming and going. I have a weird feeling of bubbles all over.

Patient first reactions were within the first 3 days of extreme fatigue, shortness of breath, palpitations, and extreme headache of migraine magnitude. Leg pain, heaviness to legs, difficulty to walk was a week after vaccine. Easy bruising and swelling 2 1/2 weeks after vaccine. Palpitations never went away.

Swollen lymph node in left breast. Painful, very swollen for 4 to 5 days, then slowly resolved over the next couple days. No doctor seen for this. About one week after vaccination, i started to get headaches and feel dizzy on and off. I did go to the hospital for this because I have never had anything like that happen before.

Two weeks after vaccine swelling of feet and hands begin to turn purple and black and her feet were swollen and numb

Started with a fever, on day 3 fever was higher and I was short of breath as well as wheezing. On Thursday the 15th I went to the dr. The x-ray didn't show anything however my cbc was of concern and she also did a d timer. It came back elevated, so she sent me over for a CAT scan with contrast. It showed pneumonia in my upper and lower right lung and also my lower left lung. She sent me home to try and treat it there. Over the weekend I felt worse and my husband took me to the ER. Upon arrival my blood pressure was 160 over 120 and heart rate was 140. They admitted me to the hospital for treatment of sepsis and pneumonia and pain management. I was there for 4 days. I was released on the 22nd of April and I am still feeling all of these effects on my body. Headache that I have not been able to get rid of even with the help of prescription medication.

Period delayed two weeks. My cycle is very regular but after the vaccine it was delayed two weeks from the expected date. Additionally, I had a cold sore outbreak starting on April 11.

ANAPHYLAXIS; HOT AND BRUISED SHOULDER; FLUSHING; BODY ACHES; LOSS OF FEELING IN FACE; LOSS OF APPETITE; VOMITING; CAN NOT SLEEP; CAN NOT DRINK WATER; STOMACH FEELS LIKE SODA; SWOLLEN ARM AND SHOULDER; COULD NOT MOVE FINGER; VERY HOT LEFT ARM; LEFT ARM SENSITIVE TO TOUCH; HOT SHOULDER; LOWER BACK PAIN; DEHYDRATED; SORE ARM; RASH; HIVES AND BUMPS AROUND THE INJECTION SITE; WEAKNESS; INJECTION SITE PAIN; HEADACHE; VERY TENDER ARM AND SHOULDER; TERRIBLE NAUSEA; FEVER; LOSS OF TASTE; LOSS OF SMELL; BRUISE ON LEFT WRIST; PALMS TURNED BLUE FROM CLAPPING; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, non-alcoholic, crohn's disease, heart murmur, chronic vertigo, panic attack disorder, depression, drug allergy, fish allergy, and perimenopause, anxiety and other pre-existing medical conditions included patient had no drug abuse or illicit drug, patient is allergic to all the narcotics, passes large clots of blood during menstruation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: unknown) dose was not reported, administered on 06-MAY-2021 13:15 for prophylactic vaccination. Concomitant medication included meclozine for vertigo. After receiving vaccination the first thing she felt like there was hot lava going down her left arm ( where she got injected) and she could not move her finger then that went away after 10-15 minutes later. they told her that symptom was normal and everyone experience the same kind of symptom. She completely lost her appetite, the smell of food made her sick ever since she got the shot. Patient stated her left arm was very hot, sensitive to the touch, bumpy around the injection site and sore. all these symptoms were the same day of her shot (on 6-MAY-2021). since the injection she had the headache and it wont go away and she still has the headache today. her relative was telling her that her shoulder was hot. she had body aches ( lower back pain and everywhere, the pain was moving though her body). the second day everything got worse; her arm where she received the injection her whole shoulder was black it looks like if someone threw brick at her, she had hives and bumps around the injection site. she cannot sleep, she cannot eat and she cannot drink water. she was tired and she was not feeling good. she had anaphylaxis 30 hours, dizziness, loss of feeling in her face, her heart was racing. she took two tablets of antihistamine to manage the anaphylaxis reaction. 30 hours after the vaccination she has dizziness, wheezing, she had flushing , rapid pulse, she was throwing up for hours then she had to take the antihistamine. On an unspecified date patient had weakness. Patient said that her fever gets worse every day. On the day of vaccination (on 6-MAY-2021) her temperature was 99.4, and has checked it 5 to 6 times with the same reading. on 7-MAY-2021 it was 99.6 and on 8-MAY-2021 it was 100.3. she said it felt like both sides of her throat were touching. Patient had barely been able to eat since 6-MAY-2021, but has been able to drink small amounts of water. Patient stated her saliva makes her nauseated. On 10-MAY-2021 she clapped her hands and they turned blue and also developed an egg shaped bump/hematoma on her left wrist after bumping it. She went to urgent care where she was instructed to use ice pack for bump, which gave her no relief. There, she was stuck with a needle 4 times to get blood work because she was dehydrated. Patient stated that her whole body felt like a walking pin cushion and skin was hypersensitive. Urgent care checked platelets and hemoglobin which came back normal. Patient stated her menstrual cycle started on 10-MAY-2021 was different than usual with super heavy, red flow, no clots, and soaked pad in an hour, it was slowed down since but flow was heavy. Urgent care advised this may be normal due to change of hormone during perimenopause. As of today, patient could not smell or taste anything. Patient was taking antihistamines 2 a day. Temperature was normal. Patient stated nausea and vomiting were better but would definitely come back if she stopped taking meclizine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move finger, had not recovered from sore arm, headache, loss of appetite, vomiting, injection site pain, stomach feels like soda, terrible nausea, swollen arm and shoulder, feels like both sides of throat are touching, weakness, bruise on left wrist, loss of taste, and loss of smell, and the outcome of sore body, hot and bruised shoulder, rash, anaphylaxis, flushing, body aches, not feeling good, dizziness, loss of feeling in face, wheezing, rapid pulse, hives and bumps around the injection site, can not sleep, can not drink water, fever, very tender arm and shoulder, very hot left arm, left arm sensitive to touch, hot shoulder, lower back pain, palms turned blue from clapping and dehydrated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210516682-COVID-19 VACCINE AD26.COV2.S-Anaphylaxis. This event(s) is labeled per RSI and is therefore considered potentially related.

within moments red dot, turned to red arm and severe itching, moderate swelling next day, incredible headache, body aches, bone pain, feeling of spine splitting in low back. tylenol every 4 hrs, advil every 4 hours (alternating). low grade fever for 5 days- right around 100F after medication. development of vertigo 5/14/21- question of relationship

pt started with arm pain that would not go away. On May 6, 2021 her arm swelled up to 3 times its size. She went to an urgent care and was diagnosed with a blood clot. She was given a prescription for Eliquis. She was not hospitalized and is doing OK now. She reported this to us on 06/10/2021

Received vaccine on 6/9/2021, the next day she started feeling cramp in left leg and swelling. Went to see her physician. Diagnosed with blood clots to left leg. Given 1 lovenox shot at time of visit and put on 81 mg ASA twice a day for 2 days.

Persisting local swelling, induration, pruritis, and pain. Pain radiates into neck/head, chest, and lower arm. Arm tender to touch. With associated nausea, blurred vision, and intermittent sharp chest pain.

Side effects in the first month: hypotension, light headed, felt faint, heart racing, shaking, fever, chills, fatigue, heavy feeling/pressure/pain/tight feeling in chest, difficulty breathing deep, swollen glands in armpits for longer, intense body pain Side effects in 2-4 months after, these symptoms come and go: numb tongue, gastro pain, loose stools, heart racing (seems to be at bedtime), hypotension, feel like body underwater, elevated blood pressure, pressure in chest, tongue sores, tingling in calves, fatigue, feeling faint, eye redness, redness and itchy cheeks (with dry flaky skin), chest discomfort/pain/tightness, foggy thinking Current treatment plan is to raise low blood pressure.

I, patient was vaccinated on March 30, 2021 at the time mentioned above in the form with the Janssen COVID-19 vaccine at a Medical Center hospital, for 24 hours after the vaccination, I am unwell general: (headache, body ache, diarrhea, stomach ache, chills, fever and discouragement), at the hospital they recommended taking tylenol, after 24 hours all symptoms started to improve, then I was able to go back to my work. As the days passed, I began to present discomfort in my legs: (extreme fatigue, pain, swelling, redness and a lot of itching) being the symptoms more severe in the right leg, I also had a headache, chest pain and back. By April 15, 2021, I could no longer bear the By April 15, 2021, I could no longer bear the discomfort and pain so strong and decided to go for emergencies to the Bergen New Bridge Medical Center hospital, where I was hospitalized for two days, on April 15 and 16, 2021, there too. . I was diagnosed with venous thrombosis in my right leg due to the Janssen COVID-19 vaccine. After leaving the hospital, I was prescribed a medicine of (Xarelto) 20 milligrams, for 3 months and 10 days of disability, being able to return to work on April 28, 2021. After 3 months and I finished my medication on July 9, 2021, after 7 days I returned to present the same symptoms that I had presented on April 15, 2021, seeing myself in the obligation to return to the emergency center of the Medical Center hospital, there they gave me medications until July 21, 2021 where I had my follow-up appointment with my general practitioner MD, that day my doctor told me that I had not had any improvement and would have to send me medications again for another month until next month where I will have a follow-up appointment for my illness. Personally I feel that I am not evolving for the better, I feel more and more tired in my legs and the pains and swelling are getting stronger. In advance, I thank you very much for your attention.

De evening that day I started with chills , throbbing head pain I never have headaches so it felt like fluid building up over the back of my head like it?s swelling and later on I had post nasal dripping massively - muscle aches , pain and swelling of half of the left arm that stood for about 1 week and the day after I deceased rash all over my neck, arm ,chest back and hip Since I seem to have nerve pain in my foot and my left hip and lower back and lower left belly muscles aching badly I have had nasal bleedings sitting in front of the tv doing nothing, I am as well bruising occasional in ca 10-15 cm purple bruises without having a injury , I haven?t had my menstruation for a about 3 months Regulare dizziness lately with no previous event or reason

3/13/2021 11pm chills, body aches 3/14/2021 fever, sweats, shaking chills 3/15/2021 midnight : swelling of face and eyes, chest pressure, shortenss of breath 3/15/2021 3am : swelling of tongue 3/16/2021 11am EMS called : symptoms had improved per patient but face was still puffy; Patient notes SpO2 98%. She refused EMS transport to ER. 3/16/2021 6:45pm : I had a virtual visit for the patient's workman's comp case. She continues to have some chest pressure but noted improvement. I advised her to seek in-person evaluation and treatment for her continued symptoms. 3/17/21 I spoke with patient. She feels better but did not seek in-person treatment. Symptoms resolved.

03/18/21- ct called-reports developed fever (103 F) evening post vaccination, this am developed angioedema-self tx w/ Claritin, midday feeling much better, -PCP aware of s/s, no further tx at this time, - day 2 evening- low grade fever, slept 11 hrs, feeling 'great today'. Hx anaphylaxis x2, 6-7th grade r/t aspirin, dx salicylate allergy, has epipen. Hx chronic hives/angioedema that can last 5-7yrs, tx w/ steroids. 3/19/21- PCP aware of s/s, no further tx at this time, last evening (day 2) low grade fever, slept 11 hrs, feeling 'great today'

Exactly an hour after recieving the shot, I started horribly itching from head to toe and had a red rash. I took 2 zyrtec. The allergy meds helped but once they wore off I would start itching. Two days after the shot my face got really puffy especially around the eyes. For six days I took 2 Zyrtec in the morning and 1 benadryl at night. After 6 days of the allergy meds I finally was back to normal.

rash on chest, neck and face started about 24 hours post vaccination. 48 hours later facial swelling and rash continued. Spoke to allergist and did a regiment of Claritin and bendaryl for three days which contained reaction.

Janssen COVID-19 Vaccine EUA. My left arm swelled and a red rash covered my arm. The next day I had hives on my head and itching. Hives appeared on my trunk and legs. Benadryl kept is under control, but I am still experiencing itching and hives but it is decreasing.

10 minutes after shot administered in left arm upper bicep. Anaphylactic Reaction: sore throat went to very sore strep throat feeling, throat felt like closing, difficult breathing 15 minutes: coughing asthma began. Blood sugar felt it was dropping ( 20 min prior had breakfast sandwich before shot). Right arm hand tremors began, week in legs even when sitting sever headache. Asked staff get a Benadryl- call 911. Took 25 mg tab benedryl 5 min prior to EMT arrived. Same time another woman started difficulty breathing and staff at facility asked if Emt could look at her too. Emt called another ambulance to scene as strap into gurney. Way to ER gave me liquid steroid. ER given epi, nebulizer breathing treatment Abuterol help breathing, pepicid too. Discharge after 3:30 pm. 40 mg prednisone ( 2 tabs a day for 4 days) and instructed Benedryl 4-6 hours. Use epi pen if throat and sever sore throat comes back- return to er.

The same day of vaccine I was sore and having body aches. The next day I woke up at 2:00 am with a bad headache took a Motrin and went back to sleep. Woke up the a few hours later and went to work and headache came back so I kept taking Motrin until I got off. When I got home I was tired and my headache came back so I went to lay down because I was cold as well. I went to bed and woke up really cold and my husband came in to check on me and I was running a fever of 101.5. My body was hurting really bad as well I took another Motrin and went back to sleep. I woke up the next morning a little weak with a fever blister. I was still sore and has a headache as well. I took some more Motrin all day and the pain went away. I didn?t report to any doctor because I thought this may be normal.

Day of post-vaccination, my shot area bled. No pain, no initial adverse reaction. Second day when I woke up at 5:00am, my arms was swollen, I was in pain for 2 weeks, no fever, I was not in my right sense of mind and I was bruised up on the shot area for 3 weeks. Ice pack, Tylenol and massaging my arm with CBD lotion helped me.

Initially after injection I had dizziness and slight mental fog. Four days later my lumph nodes in face and neck swelled and I had heart palpitations, abnormal ECG, and excess fluid in lungs. Went to urgent care and doctor recommended to wait it out. On 4/15/21 symptoms peaked and I began to have severe frothy phlegm, raised blood pressure, and heart palpitation. I went to the ER and was given and was prescribed antibiotics, steroid, and inhaler.

immediate redness, swelling post injection. pt continues to have swelling to face and legs, redness to face.

ITCHINESS TO THE HEAD/ITCHINESS THROUGHOUT THE BODY; HIVES THROUGHOUT THE BODY; SWELLING TO THE LEFT ARM; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulpha allergies. The patient experienced drug allergy when treated with bupropion hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978) dose was not reported, administered to left deltoid on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced swelling to the left arm. On 02-APR-2021, the subject experienced itchiness to the head/itchiness throughout the body. On 02-APR-2021, the subject experienced hives throughout the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling to the left arm on 02-APR-2021, and was recovering from itchiness to the head/itchiness throughout the body, and hives throughout the body. This report was non-serious.

The first two days I had a normal reaction with fatigue and soreness. On the second night I developed a severe sinus issue that caused my tongue to turn white/gray and be dry and sore. Frequent diarrhea, headache, sore throat, soreness, low grade fever for half a day and a resulting acid reflux condition. (I have never had acid reflux before) I was tested for Covid and Strep, both negative. Continued lymph node sensitivity for two weeks. 3.5 weeks in, I developed muscle tension, unrelenting, from the back of my head all the way down my spine. I had continued chest pressure and some numbness on my left side in my arm, leg and later my face. No home remedies worked and rarely do I get back/neck/shoulder pain. I was not doing anything strenuous. I went to the ER where they tested me for blood clots (J&J news had just come out and I have a family history) and prescribed valium for the muscle tension which has somewhat helped. I fully recognize that this might be bad luck, a series of unfortunate events after I received my shot. However, I have not been sick all year, I have never had acid reflux issues or pain like this in my neck/back/shoulders previously. The fact that in the 4 weeks after the shot I have not had a single day where I felt normal is a red flag to me. I feel like it is worth reporting in case anyone else has had a similar experience.

Patient complains of swollen and painful arm - stated that immunizer "hit a nerve". She stated she was unable to work for the 3 days after. Patient went to the walk in clinic 5 days after immunization and was prescribed cyclobenzaprine.

48 hours of fever, chills, malaise, headache Followed by constant dizziness, acute joint pain (knees, ankles, shoulders, and hands), brain fog, fatigue, intermittent headaches, pain in calves, backache, and locking/swollen hands - for ~8 straight days.

Left calf and thigh pain and swelling on the 6th day following vaccine which continued intermittently for a total of 12 days. I was seen at an urgent care, a left leg ultrasound was completed and I was diagnosed with deep venous thrombosis. I was prescribed Xarelto.

As soon as I took the vaccine shot I had an immediate headache, after taking the vaccine I took Tylenol and slept in the rest of the day. The next day I woke up and my arm was red and swollen. I was running fever, still had the headache and now blurry vision. My entire body was hurting. My left side of my body felt numb and tingling. The next two days the pain became worse. I did not really have an appetite. When I did eat I could barely hold my food down. On Wednesday morning I could barely get out of bed, I also felt extreme pain in my lower legs, stabbing pain in stomach and right lower side. I also had ringing in my ears, more in the right ear. I then notice a bruise on my left leg, that it was not originally there, and was also tender to touch. I went to the emergency room on the same day and I was admitted. I was in there for 4 days, they tested my leg and stated it was not a blood clot, although it look and felt like one. They discharge me and advise me that it was a migraine that was causing all my pain. This was on Sunday, I had a follow up with my PCP on the Friday, however to being in so much pain and shortness of breath, and arm pain I was advise to go to the ER on the Thursday and was admitted again. I was told in the ER I had a blood clot in my right arm and it was most likely from the IV from the previous visit. My blood pressure and heart rate was so high that they put me on medication. No matter the pain medication they gave me, it would not completely take the pain away. They discharge me again on Monday and after me begging them to get run any and all test, they said they found nothing. I'm still in the same amount of pain and same symptoms, still having trouble keeping my food down. The only thing that changed is my left arm is not as sore, however I still have a huge knot and its still warm to touch. I don't know what else to do that is why im contacting the CDC for help. I'm in a extreme amount of pain and pounding headaches. Please help

She got the vaccine, she was fine at first, sent her home at 11:45, by 11:50 she started getting itchy around her lips, then she got tingling and numbness in her left cheek about 5 minutes later. She then started to see slight swelling in the left cheek by 12:00. She then took 2 Benadryl. By 12:10 she had tightening of the throat, and by 12:20 she was in the ER at Hospital, and at 12:40 she was seen and they gave her Pepcid at 1:00 PM on top of the Benadryl. She is currently in observation waiting to see the progress of the reaction. She is feeling better now, she was not intubated.

I did have leg injury in April - and ever since the vaccine, I now have an issue with swelling that won't stop - still have swelling. I was checked with blood clots - and it was elevated so they gave me an ultrasound in leg - no blood clot. Swelling on right leg was enlarged after the vaccine. Two missed menstrual cycles; now I have had the cycle but it's a longer cycle than I normally would have. It's abnormal - the length and flow is off. Spotted for a week before I started bleeding. I had slightly elevated blood pressure after the vaccine - 117/83 usual but it was elevated 141/95 - and it's never high ever like that before. So they had thought I had a potential blood clot. Have an upcoming doctor's appt scheduled.

Raised area of skin, reddish in color, hot to touch, 3cm in diameter, very sensitive to touch, pain upon any contact with objects or breeze lasting 10 days, sensitive to touch for an additional 7 days, but less painful, not hot, then reduced in size, returned to normal color, but still hard tissue at injection site 1 month later. Red rash appeared within 8 hours of injection spreading from injection site over the next 4 days to reach, pink in color, sensitive to touch, measured 10 cm tall by 16 cm in width, remained visible for 10 days and then faded over next 7 days to normal skin color. Burning sensation in shoulders, elbows, knees worse with movement starting 6 hours after injection lasting another 18 hours and then disappeared immediately (24 hours post vaccine). Areas of itching on body starting on back below shoulder blade on left side, spreading to shoulders, arms, waist, torso, neck, face and thighs beginning 24 hours after injection. Red raised blemishes developed over these areas sparsely spaced, raised, hard, itchy, extremely painful when scratched. One on back of arm formed a pustule that was extremely painful if touched. Day 5 visited the doctor about reaction, told to watch and see if symptoms worsened. Symptoms remained the same for the next 5 days and then began to subside. Raised bumps on face, neck, and arms still visible 3 weeks post injection, finally resolving around 4 weeks.

I went in for a scheduled MRI of my foot and the MRI found that I have a 7mm blood clot on my foot. It was found on my left foot plantar region (bottom of my foot). A few days after the vaccine I had swelling on the top and bottom of my left foot. I got two vascular images completed and the MRI was never sent to the vascular department. My podiatrist confirmed the blood clot on an ultrasound. I'm still experiencing swelling.

She was having muscle aches, joint aches, was having breast pain and arm pitt pain also went to the different doctors had a fever that last about five days and chronic chest pain.

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

Short of breath, swelling in limbs, chest pain over the next few weeks. Diagnosed with diastolic dysfunction/congestive heart failure.

Immediately got dizzy, had pins and needles in the arm and hand on the injection side also has swelling of the face on that side and itching at injection site. Layer that evening and the next day I had heart erratic heart rate

Client has previous allergies to cows milk and aloe. Reported her face was hot and swelling after vaccine. Family member in car with client confirmed her face was swollen as not visible initially. Client tearful and panicked. Reclined in car seat and Dr and Epi Pen called for. Dr spoke with client and examined the swelling, stating her Uvula was swollen. He administered an epi pen to left thigh muscle. 0.3ml . Blood pressure was 135/75 with pulse of 82 RR22 and oxygen saturation of 100%. EMS on site. Epi pen was administered on 12.10 pm. Client responded quickly and stated the she felt much better. second vital signs in 5 minutes were blood pressure 133/77 pulse 78 RR 18 and oxygen saturation of 97%. Transported by EMR to hospital.

Patient received Vaccine March 10 at 8am, Couple hours (10am) headache, muscle aches, Low Grade fever 38.4 chills. Lasting for the remainder of the day and symptoms dissipated next morning

Day of vaccine, I felt like my lymph nodes were swollen. Two days later the injection site started to get deep red. Friday I started to about an inch of so, swell up some. Saturday I had a rash on my arm by the injection site, the top part on my bicep was pretty red and swollen. I didn't take my Humara or Zolar injection. On Sunday the rash got worse and grew in size and really hot to touch, the pain was radiating all the way to my wrist and hurt really bad causing pain when I moved my wrist. It was hard for me to go to sleep so I called the dr and went in . The dr. said it looked less red that what it was and told me to take Ibuprofen 800mg* 3x day. The pain is now in both wrist and hard for to grip stuff and a little hot to touch. You can see the difference in the skin tone where the rash was, it looks bruised.

Chart note of 3/22/21-" Local, delayed reaction to the COVID-19 vaccine. Discussed the self-limiting nature of this. Recommend treating with ibuprofen (she has tolerated this NSAID well in the past despite her other reactions to NSAIDS), Tylenol, ice, and OTC antihistamines. Provided her with an ACE bandage today to limit mobility of the wrist due to pain. F/u if no improvement in 2 weeks." chart note of 3/29/21-"Patient is a 42 year old female who presents to the office for wrist pain and rash. Both have been going on since covid vaccine. Has been wrapping her wrists intermittently with no improvement. Swelling has decreased in her arm- left upper arm. States had hives bilaterally in the upper arms although patient has chronic urticaria. States all weekend wrists will hurt later on in the night. Will get shooting pain at night. No swelling of her wrists. When pain happens doesn't have full ROM. Does right now. When pain gets worse cant make a full fist. No fever or chills. States will get a charlie horse pain in the right back of the leg. Has been taking the motrin 800 mg tid. Doesn't want to take that much. States has taken it a couple of times, otherwise takes tylenol. Has done ice on the arm not on the wrists. Thinks turning into a worry wart. Johnson vaccine was on 3/16. History of chronic urticaria. Does take zyrtec three times a day. Singluair patient was unable to get her allergy shot this month due to getting the covid vaccine. " A referral has been placed to Rheumatology based on labs.

I had swelling of my arms, legs, feet, face, eyes and throat. I was dizzy and my heart was racing. I had hives all over my body for many hours. I have taken 2 rounds of Benadryl and it starting to go away.

Right away I started to feel very hot. I waited the time (15 minutes) they recomemnded to stay at pharmacy. I drove home and started to feel nausea, a light headache, and mildly dizzy. I started to get short of breath about 45 to 50 minutes after the injection. I climbed a flight of stairs and was completely winded I was having trouble catching my breath. My lymph nodes in my neck swelled up a lot and I was developing a sore throat and small bumps on roof of mouth. I called the nurses line and was directed to take a 50 mcg dose of benadryl and that if the shortness got worse to call 911 and use my epi pen. After about 2.5 hours the breathing seemed to primarily resolve itself and resume more normally. I woke up this morning with a very sore arm, body aches, a mild headache, congested sinuses, and with a sore throat. I do feel like I am not tasting as well as normal, it could be the congestion. I do not feel great but only seem mildly winded and short of breath walking across the house.

It's reported client developed right-sided facial swelling while in observation area after receiving vaccine. Patient was administered 50mg IM, but unable to start IV. Client transported to Emergency room for further assessment.

On day 5 I started exp sore arm causing muscle pain. About 16 days I had swollen lymph nodes under both under my arms. I contacted my PCP on 4/5 and as of today 4/12 doing better.

Patient reported swelling in both hands, knee and throat that occurred several hours after getting the vaccine. Patient reported associated symptoms of itching of the entire body, body aches, ear ache, and swelling at the injection site. Patient reports improvement of symptoms with the use of Benadryl.

Janssen COVID-19 Vaccine EUA" Sunday 4-11-2021 woke up with mild itch and Hives on shoulders and face. At 12PM I went to Urgent Care, and was given prescriptions Cetirizine HCL 10 MG Tablets. when i got home, I notice my lips was beginning to swell and forehead with Welt. Monday 4-12-2021 The Hives spread to my arms legs, feet, back and neck....I went to the ER. at 10:37AM I was given by IV the following: dexAMETHasone (Decadron) / diphenhydraAMINE (Benadryl) / famotidine (PEPCID) and Sodium Cloride (NS) I stay for about 4-5 hours. where the Hives on the forehead, shoulders and arm was starting to disappear...I was discharged. with Prescriptions: Famotidine and to continue to take the Cetirizine but 2 times a day rather then once a day that was previously prescribed, and to take Benadryl twice a day within 6 hours. Hives was appearing to decrease by the evening, on shoulders, forehead Tuesday 4-13-2021 I woke up with hives all over my stomach, sides, back and inner thighs. some spots on forehead and welts on neck and face.

2 hrs, onset fever lasting 9 days average temp 99.9 Headache, fatigue, 4/3-4/4 Brady cardia 60 bpm, 4/5 tachycardia 136bpm, increased arrhythmia activity 3/31 to present, leg pain 4/9 to present, nerve pain, swollen lymph nodes, increased headaches 3/31-4/14, blurred vision, intense fatigue w/extreme exhaustion after moderate activity like walking around grocery store

Evening of vaccine (Thursday night): chills, headache, aches and pains First day after vaccine (Friday April 2): chills, sweats, dizziness and fuzzy thinking, extreme fatigue, headache, joint pain Second day (Sat April 3): fatigue, headache, aches and pains Evening of the second day (Sat April 3): fatigue, acute pain in my left armpit/swollen glands in my armpit/breast/neck Third day (Sunday April 4): fatigue, headache, armpit pain and swelling radiating to the entire upper left side of my body Fourth day (Monday April 5): fatigue, headache, armpit pain slightly abated Fifth day (Tuesday April 6): fatigue, armpit pain slightly abated Sixth day (Wednesday April 7): neck still stiff, left armpit still very tender Seventh day (Thursday April 8): left armpit tender 8th day (Friday April 9) until now: still tender/sore in and around left armpit, still a bit stiff in the neck

I had a headache the next morning but no other symptoms initially. Then, Saturday evening, just over 24 hours after receiving the J&J vaccine I was sitting in landscape pavers outside in jeans and a long sleeve shirt next to the pool. My husband looked over and said what is wrong with your feet, they are blue. He said that is not good with circulation and you should probably talk to your doctor. Unfortunately I did not take a picture at the time and noted I was a little chilly but would reach out to my doctor if it continued and didn?t think anything more of it until I saw the reports Tuesday morning of them recommending to stop the J&J vaccine. I called my doctors office Tuesday morning and they asked me to come in over lunch to see the doctor. While sitting waiting to see the doctor my feel replicated the situation from Saturday night. My toes were especially blue up through my ankle and the doctor pointed out I had red patches looking like a rash. She also noticed my right leg was worse and more swollen up to just below my knee. We did take pictures that we can share if prompted.

Severe Dizziness day of injection and mild dizziness for next 3 days severe migraine like headache with vomiting starting 4 days after injection and continuing to present. Day 8 post injection the headache has started to move into front of my head and face. As well as retaining fluid and swelling in my lower legs.

Immediately after the vaccine (faint, nauseous, dizzy, pain in injection site) 2 hours after vaccine severe headache left arm swelling (injection site) 7 hours after vaccine severe headache left arm swelling and pain (injection site), sweating, fever 1-6 days vaccine severe headache left arm swelling and pain (injection site), sweating, fever, chest pain, hallucinations, nightmares

: Thigh: R leg 21'' L leg 23'', Calf: equal bilaterally. L leg pain and swelling. Started after receiving the Janssen COVID vaccine on Thursday. The pain started as bilateral and then resolved. It returned on Monday in her left leg, starting in her anterior thigh and radiating down her leg. States that her leg began swelling today and had increased pain. Denies redness and heat to her leg. Pain is worse with ambulation. She states that it does not feel like the sciatica that she experienced in the past. Patellar reflexes equal bilaterally. Denies chest pain, shortness of breath. Admits to headache that has been present for a number of days and is resolving. Denis light and noise sensitivity. Neuro exam WNL.

Patient said later the day of vaccination her hands, feet, eyes, fingers started swelling --NO issues breathing and NO tongue swelling. Patient took benadryl. Following day patient took benadryl again. When she told pharmacist about it they suggested she been seen at an urgent care or hospital, they may want to prescribe steroid treatment. Patient did go to hospital and reported they did put her on steroids.

FEELING COLD; PAIN IN LEFT ARMPIT; PAIN IN LEFT SIDE OF NECK; BODY ACHE; PAIN IN THE INJECTED ARM (LEFT SIDE); ANAPHYLAXIS; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection on an unspecified date in MAY-2020. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 03-APR-2021 around 11:00 a.m. on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in MAY-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) positive, (3.72). On an unspecified date in 2021, Laboratory data included: COVID-19 antibody test (NR: not provided) level of 0.2. On 03-APR-2021, the patient experienced anaphylaxis. It was reported that within 5 minutes after vaccination patient experienced tongue was swollen, throat started closing, throat breaking in hives. The pharmacy called the emergency service, and the consumer was taken to the hospital. On 04-APR-2021, the patient experienced feeling cold, pain in left armpit, pain in left side of neck, body ache and pain in the injected arm (left side). She was treated with routine treatment for anaphylaxis, and she was put on prednisone and Benadryl. It was reported that, the treatment was still on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anaphylaxis, and had not recovered from feeling cold, pain in the injected arm (left side), pain in left armpit, body ache, and pain in left side of neck. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to AER20210409478.; Sender's Comments: V0 20210410075-Covid-19 vaccine ad26.cov2.s Anaphylaxis. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).

1 Day of the vaccination: Swelling in the left arm, pain in my armpit and left breast pain and discomfort in the left leg sensation of heaviness, stomach pain nausea, headache. 2 Day: 4 bruises appeared on different parts of my body, 1 on the inside of the arm where I received the vaccine, another on my left breast that was small and two more on my 2 feet right on the instep where the veins are In the following days a lot of muscle pain in my legs that does not let me rest, the nausea has not stopped. So I went to the emergency room on April 17, 2021.

4/8 3:30pm chills, fever, and severe headache started 4/8 8pm fever 102.7, severe headache, left foot and knee swollen, ringing/muffled sound in left ear 4/8 11pm unable to sleep due to headache 4/9 severe headache, fever all day. Unable to sleep 4/10 fever, severe headache, yellow bruising on shin left leg, back pain between should blades. 4/11 fever, severe headache, back pain between shoulder blades. 4/12 low grade fever, headache 4/13 thru currently, random severe headaches (debilitating - need to close eyes, limit light and noise, headache worse when walking)

TINGLING OF THE LEFT LEG; SWELLING; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit usage of drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 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 soreness at injection site. On 12-APR-2021, the subject experienced tingling of the left leg. On 12-APR-2021, the subject experienced swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling of the left leg, and swelling, and the outcome of soreness at injection site was not reported. This report was non-serious.

LUMP ON LEFT SIDE OF NECK; CHILLS; FATIGUE; HEADACHE; FEVER; SHAKING; FLU-LIKE SYMPTOMS; ACHYING JOINTS; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimoto's disease, seasonal allergies, and certain metal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, 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 shaking. On 10-APR-2021, the subject experienced flu-like symptoms. On 10-APR-2021, the subject experienced achying joints. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced lump on left side of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, flu-like symptoms, achying joints, chills, fatigue, headache, and fever on 13-APR-2021, and had not recovered from lump on left side of neck. This report was non-serious.

Coughing, fever, body aches, swelling of hands and feet, the roof of your mouth is torn. Crowded lines continue to swell, short of breath.

8 days after my vaccine, I had to have my appendix removed. Previous blood work (within a few months prior) showed zero issues. Also, I never had an allergic reaction to steri-strips or surgical tape and ended up breaking out in a rash from shoulders to mid-thigh. Finally, I never had cold sores and I had to treat cold sores for 8 days.

Leg swelling started on April 9th, had ultrasound to check for blood clot. Negative for blood clot. Still swollen doctor told me to report it to vaccine page

Aching left heel: April 26, progress into calf with swelling of foot, ankle & calf: evening April 27, dvt found in left leg, pulmonary emboli in both lungs, right worse than left lung, shortness of breathe, tachycardia

Swollen cheeks, throat, metallic taste, pain in old scar tissue (surgery at L5-S1) within twenty/thirty minutes of injection Fever/headache/chills/sweating for four nights Hair shedding started 4-14-2021 and continues still

Five days after the vaccine I woke up and could feel a lump on my collar bone that was very painful and could move when touched. The pain eventually subsided but the swollen lymph node is still there to date. A week after I noticed another swollen lymph node appeared in my neck and once it became inflammed my face and scalp became very to the touch and my whole mouth got inflammed also. I went to the PCP who prescribed an antibiotic which did reduce some of the inflammation and pain in my face but the enlarge lymph node on my shoulder is still there.

I was diagnosed with shingles a moth later. On the lower right side of my back. Swollen lymph nodes on the right groin area.

I had - as soon as she gave me an injection - I felt like it was a little bit hot. I told her that. I knew I had a lot of allergies so I was being careful. Within a minute of sitting down, my right arm became swollen and bright red and felt burning and itchy. And it spread across my chest and went to my left arm. The rash or hives continued up my neck up to my face and that all happened within first five minutes. Immediately after that, I had excessive coughing - couldn't cough up anything. I couldn't catch my breath and my throat started swelling a bit. they gave me 25 mg of Benadryl - capsule over the counter - and the 9-1-1 operator advised not to use the epi- pen. Paramedics came - gave me addition 50 mg of Benadryl - and they took me to the ER across the street and I was administered another 25 mg of Benadryl and also some steroid - Solumedrol - and after receiving these - then these symptoms went away. I continued on Benadryl and prednisone for a few weeks - the very next week - I had a large streak that went from injection site to left chest and I had a second red streak from left chest that ran down to my left arm. For two weeks, that burning fire rash would just come. No rhyme or reason as to when or why - arm, neck, chest, legs and sides. And I'd have to take extra Benadryl every time it would happen and I was still on the high dose of steroids as well. I also had - the next day - 24 -48 hours after vaccine - I had a severe headache and it lasted all day long. And about 24 hours after the vaccine- extreme fatigue, body aches and headache and weakness and that lasted for about three days. Fatigue lasted three to four weeks. Joint aches lasted three to four aches. Headaches have still continued. They have almost been worse actually. I had two headaches that I was so concerned about that would not go away - worst headaches I have ever had: one on May 1 and one on May 9 - and I took Maxalt and some Benadryl - the Benadryl did help a little bit (enough for me to go to sleep). Each headache lasted 12 -15 hours and they were the most severe headaches I had ever had. I didn't have anyone to take me to take me to hospital so I just tried to sleep. I saw my primary care doctor - virtual visit. I took the prednisone for two to three weeks. I still contend with the headaches.

It started as soon as I got the vaccine. I had a feeling of heat travelling down my arm followed by a pins and needles sensation. I stayed for 30 minutes and I could feel a strange feeling of pins and needles seemed to be travelling up my neck and into my face. When I saw that my arm was swollen. My arm started to itch and I was taken into the observation area and checked out. I went home and four hours later I felt like I couldn't take a deep breath and I started to get a headache, chills and fatigue. The next day my arm and face were still little numb and I was still having a little trouble breathing. On day four I still felt like I couldn't take a deep breath and my heart rate was erratic. On the fifth day I went to an Urgent Care clinic. My blood pressure and heartrate were a little high. I went to the doctor the next day because they had found some hardening of my heart. After five weeks I still have a little feeling of pins and needles in my left arm and in the left side of my face.

About two weeks later, I started to get a headache. The pain was massive and it was on one side of my head. I thought I was having a stoke. I took Excedrin and went to sleep and woke up and it was a vain popping out of my head. I had blood clot in my leg.

Anaphylactic shock-5 minutes post injection Throat and tongue swelling Required 3 epipen injections EMS to the hospital 50 mg of IV Benadryl and IV Pepcid

Low grade fever for 5 days. Extreme nausea for 24 hours. Diarrhea for 72 hours. 24 hours after the injection the lymph node under my left arm swelled up to about the size of a baseball, it was extremely hot and painful. It stayed that size for 4 days, and then finally started getting a little smaller each day. It's officially been 10 days and I would say that lymph node is about golf ball sized now. I did see my doctor and she said it can be a normal side effect and as long as it's going down not to worry. I also was having pain in my back and the doctor suspected a possible pe, my d-dimer test came back positive twice but my platelets remained in the normal range. The second d-dimer was only 513 and considered barely out of range so we assume whatever clot I had dissolved on its own.

Both feet hurt the day shot. As days go by the pain was in lymph nodes on my shins. The pain started moving up my legs as days passed. Fatigue. Headaches. By may 18th the pain was up to my hips, arms, and hands. My joins felt swollen. Muscle weakness in legs and arms. Difficult to walk.Was admitted to the hospital on the 19th. For 5 days

Sore arm immediately after receving the vaccine. On Friday 4/16, my left upper thigh had a throbbing pain, almost like a charlie horse. That continued for 2 weeks, alternating legs. It ended up becoming prominent in my left leg, so much so that I had an ultrasound on my left leg on 4/23/21. On 4/24/21 I got a sharp headache, the whole right side of my face went numb. On 4/26/21 I called my doctor to tell them what happened and they sent me to the ER. I was in the ER for 16 hours. In the ER I had bloodwork, MRI and an ultrasound on left leg. I was discharged from the ER. On 4/30/21 I started getting chest pain/burning sensation. I went to urgent care on 5/3/21 for it. I was given lidocaine to numb my esophagus to rule out heart related chest pain. They did an EKG of my heart as well. I was sent home with pantoprazole. They diagnosed that it was heart burn related to the vaccine. I went back to the urgent care 5/7/21 because the chest pain was worse. They did a chest xray, and told me to continue, pantoprazole, tylenol and mylanta and stated they did not see anything wrong with my heart. After this I went to family doctor for a follow up closer to the end of May. The chest pain was still there and soft to the touch, along with pain (squeezing feeling) in my left arm. Also, my armpits have been swollen. The doctors think I have Costochondritis. They tell me to take 2 tylenol every 4 hours. It does get better for about 2 weeks then 6/10/21 it comes back with the same symptoms. On 6/14/21 I go back to the doctor and was given a steroid for one week, the steroid alleviates the inflammation. When the steroid is done, the symptoms come back. The symptoms come and go, some days are better than others.

It started with joint pain on left side at the elbow and wrist. Then it progressed to all-over body aches. Then every joint became achy, even spine and toes. One of the left lymph nodes at the base of the skull became swollen like a golf ball. Then the throat lymph nodes also became swollen. I had fatigue to the point of needing to nap throughout the day; this comes and goes. I have weakness in the hands. Most recently, I have had shortness of breath, even after doing nothing. I have had earaches recently. I tested positive for mono, even though no one in my life has it. This has all been going on for over 2 months now. The doctor says I display some of the symptoms of Guillain-Barre Syndrome. He says that if I display tingling in the extremities, I am to go to the ER. On 7/19/2021, I am going to have my spleen examined, because I have had nausea and pain in that area.

Tongue started swelling about 7 hours after injection; swelling worsened after biting it; unable to eat, take medication and have trouble breathing when lying down. Presented to hospital 07/17 with lymphadenopathy and enlarged tongue; VSS. Treatments included epinephrine IM, solu-medrol IV; Benadryl IV; and famotidine IV

Lower back pain beginning day after vaccine. Vertigo & nausea beginning days after vaccine, lasting 2-3 days. Fatigue beginning day after vaccine and is improved, but still present. Leg muscle pain and slight swelling beginning 5 days post-vaccine.

The patient had swelling of the face and hives on her arms and chest. Also itching of the head, eyebrows, and ears. This started 2 days after the vaccine. She had fever and chills the night after the vaccine

3/9/2021 0800: Took dog outside. Upon coming in, I had sever chills and could not get warm the rest of the day and night. 3/10/2021 0630: Upon waking up, arm was very sore 3/11/2021-3/16/2021: Arm was in various stages of redness, swelling, and soreness 3/17/2020: Arm is still raised at the injection site, soreness has lessened.

Nausea vomiting diarrhea headache and chest pain that began 15 minutes after vaccination and persisted over the next 7 days.

fever, chills, body aches, swelling of lymph nodes in left side of neck and shoulder (injection site was left arm), fatigue/sleepiness

Symptoms were total body aches, low grade fever, headache, sore and swollen lymph node in left armpit

Dizzy after injection. 20 minutes later tongue and face swelling, head pressure, coughing blood, low blood pressure, trouble breathing. Used epipen.

10:00 AM Sore at injection site. 10:40 AM Dizzy and sleepy 10:50 AM vomiting 12:10 AM Ran 99.9 fever 3:00PM Same symptoms swelling at injection site. Took 600 mg Ibuprofen 5:30 PM Same symptoms, swelling from arm to neck. Fever at 100.2. Took 2 Tylenol PM tablets. 8:30 PM Vomiting and same symptoms as all day. L/Side Neck and Left arm sore. Very intense headache. Took 2 Tylenol PM tablets. 3:30AM Same and very sore arm and head ache 11:00 AM

face and hand swelling, shortness of breath, increased heart rate to 120 BPM, dizziness and nearly fainted. Lasted 3-4 minutes. Was observed, blood pressure taken and was slightly elevated. Symptoms dissipated and was released to go home. Later had lasting headache and muscle pins for approx 18 hrs along with hot flashes. On 4/11/21 I then experienced the same episode lasting over an hour.

Bad pain at injection site and swelling starting 1 hr later, and lasting over 1 week. Decr over time but lasting at least 10 days. bad rash all over body, worse on both arms, rash on upper legs as well with rash lasting at least 10 days. Peeling skin both arms, legs, moderate, lasting through day 6. Swelling in face, arms, legs, torso - Severe. Lasting at least 10 days. Dizziness, starting 2 hr, lasting at least 10 d. Weakness - start 2 hr. last at least 9 d

8pm: Sharp, shooting pains in my head (similar to shingle pain). 3am on 04/10/21: Extreme fever, chills, body pains so intensive that I was screaming for over an hour, could not put a sheet on my body to warm up because the weight of the sheet caused more pain. This occurred for several hours. When finally able to stand upright, I was too dizzy to stand until approximately 12pm on 04/10/21. Symptoms subsided and appeared to be gone by 8pm on 04/10/21.

Day 1 - Immediate small hives all over body for 1 hour, flush, fever, shaking, nausea, then hives lef. Day 1 evening - Fever 103, blurry eyes, severe headache, swollen tongue, severe pain all over, all major surgery sites spasming, vomit and diarrhea , hard to breath and blackout. Day 2 - Fever, eyes blurry, Blood pressure spike, headache severe, tongue swollen, severe hives, vomit, and diarrhea, cannot move body, pain increased tenfold Day 3 - Worse than day 2, hives are severe and can barely move body, Blood pressure spike, off to the ER. They admitted me and gave me different combos of steroids, pain killer, lorazepam, etc. to figure out the right combination to keep me steady. Day 4 - evening I was able to go on home care with the correct combination of medication. If my numbers don't stay steady I would have had to go back. During the rest of this time - Severe pain throughout body, fever, shortness of breath. The hives are now just my my skin flushing. Heat flashes. My fever has just gone down to normal degrees today. My Blood Pressure has gone from 175/111 back and forth to normal. My headache is still there and body pain. Hives are now just flushed skin. Swollen Lymph nodes in throat. No more vomit or diarrhea.

Pt called LPHA to report she was seen in the ER on 4/8/21 for a potential blood clot in her left leg. Pt reported she awoke from sleep late 4/7/21 early 4/8/21 with severe pain in her left leg. She reported it hurt so bad she was "screaming". She stated it felt like a "charley horse" and her husband noted a knot in her leg. She went to the ER on 4/8/21 due to the inability to put pressure on her leg and/or walk on her leg. She reports having a CT scan of her chest at the ER and no clots were noted. She stated they did not image her leg at that time and scheduled an ultrasound/doppler for around 4/27. She was prescribed some oral blood thinner, but could not recall the name. She stated she stopped the blood thinner on 4/12/21 after the new reports regarding the J & J vaccine and not using blood thinners to treat. Today she states her leg is purple, black and blue and is swelling more when she is up on it at work. RN instructed pt to call her primary provider regarding stopping the blood thinner and to see if re-evaluation of her leg is needed. Pt also instructed to seek emergency treatment for increased swelling or pain to her leg, headache, abdominal pain, shortness of breath or any other concerns. Pt plans to speak with or see her primary provider today.

Had cold like symptoms and lots of phlegm, developed a cold sore. The coughing and runny nose went away after 7 days but the phlegm and headache have remained. The headache goes from mild to extreme especially at night

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Additional Details: Patient received the injection. After a couple of minutes, patients breathing became rapid. I tried to calm her down. A couple of minutes the patient said her throat was closing. She made some gasping sounds. I gave her an injection of epinephrine 0.3mg. i called 911. EMS took her to unspecified hospital after treating her.

Swollen lymph nodes in armpit and chest of the injection arm. feels like edema to the touch and tender when arm is in a lowered position.

Facial swelling and extreme flushing of the face neck and arms. Headache turned to migraine with in two days.

On 04-07-2021- I experienced a lump on my neck and developed pain to both of my shoulders. I went to the ER where x-rays and lab work was done. X-rays showed that my lymphatic glands inflamed. I also experienced a cramps from my neck that radiated upwards to the base of my head. My pain was so intense that I took OTC Tylenol to help with my pain. I went again to the ER eight days later because I was having pain to my heart, chest, neck and shoulders and x-rays again demonstrated lymphatic glands inflamed and was told to take Ibuprofen for pain. To this day I continue to have pain to my shoulders, neck and head but the pain is not as intense as before although the pain is still present daily. I can not work my full 8 hours of work due to my symptoms and can not over-exert myself in performing my daily tasks at work.

The night I started getting feverish. I rested. On Monday, I called out sick. Monday, Tuesday - it was chills, fever. 2nd day, my legs started having a sensation I've never ever felt - like cramping/charlie horse. I went to work on the third day but I needed to go home. When I came home, my legs were doubled the size. I tried to ride it out by resting. Ever since then, my legs have weird sensations - not cramps but aches. I have never felt this before. Once in a while, when I'm walking, I get cramps. It still hasn't gone away. At the end of the day, my legs will be swollen but not as bad as the third day after the vaccine. I think my platelets are actually too high so I think that is a good thing. Upcoming doctor's appt on July 9 - she is going to do a whole physical with bloodwork.

Fever 101 - 8 hours after shot Fever 100 - 24 hours after shot Pain in lymph nodes under left arm - 12 hours after shot Soreness in muscles near shoulder and knee - 8 hours after shot Headache - 6-8 hours after shot Sweats - 12 hours after shot Pain in arm - immediately after shot Dry mouth - 10 hours after shot

Intractable headache beginning 3/13/21, double vision in right eye, blurry vision in left eye, severe pain in right eye, right temple, right side neck, severely elevated blood pressure

Began with leg pain/soreness, then progressed over the next few days to more intense pain and some swelling. Ultrasound determined phlebitis (not DVT) in right leg treatable with OTC NSAIDs

Systemic Allergic Reaction 20 minutes after injection. Felt it hit my spine, torso and head felt flush and hives started on torso. Had I not taken the Allegra D that morning and Famotidine 1 hour before the shot, I would have gotten hives all over my torso and face and swelling would have started in my face. I had an anaphylactic reaction but the histamine blocker and anti histamine kicked in after about 10-15minutes and I felt better. Had I not taken the medicine I would have ended up in the Emergency Room. That night I developed Oral Lichen Planus. This became extremely bad and uncomfortable for the next 48 hours. Then it started to heal. It fully went away after 6-7 days.

Pain in left leg, pit in left leg, swollen left calf. Received care at Patient First. Platelets and white blood cell counts were normal. Received ultrasound of left leg from Progressive Radiology. Results were normal, no sign of clots.

LEFT THUMB SWOLLEN; LEFT THUMB BRUISED; LEFT THUMB CHANGED TO BLACK COLOR; HEART RACING; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced left thumb swollen. On 07-APR-2021, the subject experienced left thumb bruised. On 07-APR-2021, the subject experienced left thumb changed to black color. On 07-APR-2021, the subject experienced heart racing. Laboratory data included: Diagnostic ultrasound (NR: not provided) Could not find anything, EKG (NR: not provided) Unknown, and Vital signs measurement (NR: not provided) Unknown. Treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left thumb swollen, left thumb bruised, and left thumb changed to black color on 10-APR-2021, and the outcome of heart racing was not reported. This report was non-serious.

initial - 20 minutes after shot - 1 quick shot of vertigo but I was already in the car. Next day - headache, tired, low grade fever lasted 1 day. On March 30 & 31 I would have massive nausea. On 4/2 after dinner I started to have chest pain. This lasted into the night and I had cold sweats, nausea, vertigo and went to the ER. CTScan w/contrast was done, chest Xray, EKG was adnormal. Was admitted to the cardiac unit for observation. Was there 24 hours. On 4/4, I was still having the chest pain, went to another cardiologist where I had another EKG, Stress test, blood work. Everything looked good, couldn't figure out why I was having chest pain. Echo was scheduled. The night of 4/6 the vertigo increased drastically where I couldn't close my eyes and go to sleep, went to the dr on 4/7 and that is when it was thought that it was tied to the vaccine. Was put on meclazine for the vertigo as needed. It was then that the anxiety and depression started. By body broke out in Hives, was put on allergy medicine to help with those. Unexplained bruising was occurring on my legs. Was put on a Mediterranean diet which is supposed to help with inflammation. Stopped drinking caffeine and alcohol. The vertigo, anxiety and depression continues. I had an MRI of my brain to see if there was anything showing. Bloodwork was done. Started to experience breast pain, went to my dr, had a mammogram and ultrasound to see if anything was there. Lymph nodes are still swollen, have to go back in 6 weeks. Went to an ENT for the vertigo and he found some of the crystals in my ears, I've never had that before. On 4/29 I had a hair appt where 1 minute after she put the hair dye on my hair, I experienced more vertigo. Still experience the depression and anxiety, hoping that subsides very soon.

LEFT SIDE OF TONGUE FEELS LAZY AND LINGERING; UNABLE TO PRODUCE WORDS OUT OF MOUTH; NOT ABLE TO SEE DUE TO SWOLLEN EYE; LEFT EYE ALMOST SWOLLEN SHUT; RIGHT SIDE BACK PAIN/KIDNEY-MID LOW BACK RIGHT SIDE; INNER THIGHS BOTH VEINS POPPING OUT; ANAPHYLACTIC SIDE EFFECT; LEFT EYE FELT NUMB/ LEFT EYE PIERCING; HEADACHE; FEEL WEIRD; This spontaneous report received from a patient concerned a 43-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy (itchy throat/swelling), and doxycycline allergy (throat swells shut and marbles in there). The patient was previously treated with escitalopram oxalate (Lexapro 20mg). The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported,1 total administered on 09-APR-2021 15:30:00 on left deltoid for prophylactic vaccination. No concomitant medications were reported. It was reported that after vaccination on 9-APR-2021, the patient immediately got headache but her left eye felt numb. She waited 30 minute because she had anaphylactic side effects and it felt really weird. The headache and left eye felt numb/left eye piercing while she was driving back (from vaccination center) which lasted for hour and half (short lived and resolved). On 11-APR-2021 she experienced right back pain (that radiates) which lasted for about five days. After that her inner thigh veins all got bright red for 2 days (only inner thigh nowhere else) and she thought she had something on her and tried wiping it off. On 16-APR-2021, she went to the doctor it was about one week from she received the shot, her left eye was swollen almost shut and that swelling lasted about five days. She was not able to see out of her eyes. She was not able to produce a word which was kind of weird for her. After that, the side effect she had, was her left side of tongue felt lazy and was lingering. She went to the doctor 3 days later news of clot came out doctor said those were the side effect of Janssen COVID-19 vaccine and there was nothing to worry about. She was trying to figure out why her eye was so big and performed D-dimer test which came back normal. She attempted Benadryl for 2 days did nothing but made her tired and she stopped taking it. She thought may be those were allergies at that time. She used an ice pack on her eye, so that swelling would go down a little. There was no discharge from her eye it was just swollen. In APR- 2021, Laboratory data included: Fibrin D dimer (NR: not provided) as Normal. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride (Benadryl). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left eye felt numb/left eye piercing, and headache on 09-APR-2021, right side back pain/kidney-mid low back right side on 16-APR-2021, inner thighs both veins popping out on 13-APR-2021, and left eye almost swollen shut (not able to see due to swollen eye) on 21-APR-2021, had not recovered from left side of tongue feels lazy and lingering, and unable to produce words out of mouth, and the outcome of anaphylactic side effect, feel weird was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210624549-COVID-19 VACCINE AD26.COV2.S-Anaphylactic reaction. This event is labeled per RSI and is therefore considered potentially related.

After receiving the vaccine on 3/31, experienced typical side effects noted such as sore arm, body aches, etc. - however two days after felt numbness and tingling in feet and hands which went away a few days later. On 4/14, the tingling in feet returned. Went to ER on 4/16 as tingling/numbness getting worse and progressing upward to legs; evaluated and sent home. Returned to ER on 4/22 as numbness/tingling continued to progress upward, evaluated and sent home. On 4/25, in addition to constant numbness/tingling, started experiencing tachycardia. Resting heart rate as well as heart rate doing simple tasks was high. Also began experiencing difficulty getting a full breath. Woke up 4/27 to worsening breathing and tachycardia, as well as new feelings of adrenaline rushes and Internal tremors throughout the body. PCP ordered Troponin and D Dimer and D Dimer elevated. Back to ER that day - negative Covid test - CT of chest showed no blood clots; sent home. That evening, resting heart rate was high and elevated even while lying down (90-110 bpm). The next day, 4/28, all symptoms continued and worsened as day progressed. Returned to ER and in the way experienced a pre syncope episode - upon arrival to ER blood pressure was 70/30; stabilized and sent home. Continued tachycardia and another pre-syncope episode that evening. Was referred to neurology and had appointment 4/29; all symptoms remained and were increasingly debilitating. Neurologist determined more testing needed, and was admitted to the hospital for observation/testing. Diagnosed with Guillain Barre Syndrome after head/neck/spine MRI and lumbar puncture, which showed elevated protein. Hospitalized for 5 day course of IVIG and discharged 5/4. Started feeling better for a few weeks, although numbness/tingling in legs/feet never went away. The week of 5/17 started feeling burning in throat/nose/chest and returning tachycardia; returned to ER 5/23, was admitted for observation as D Dimer high again - checked for DVT, all clear; testing and suspicion of Postural Orthostatic Tachycardia Syndrome (POTS); discharged 5/25. On evening of 5/30, experienced new concerning neurological tremors and sudden involuntary movements, as well as stiff neck/head. Returned to ER 5/31; evaluated and released. Have continued to experience autonomic nervous system dysfunction, POTS symptoms, tachycardia and bradycardia, constant numbness and tingling in extremities and occasional tingling/numbness in other areas in the body, pressure in head, internal tremors, adrenaline rushes, feelings of burning in throat/chest, suspected reflux; upcoming appointments with an Electrophysiologist and Neuromuscular Doctor for further evaluation. Note - also reported this using v-safe up until the weekly check ins were over

chills, fever, body aches and nausea all lasted 24 hours- tylenol and motrin to treat symptoms hives- lasted a few hours dizzy, headache and tired- lasted 48 hours tylenol and motrin to treat symptoms left arm soreness- lasted 5 days tylenol and motrin to treat symptoms enlarged lymph node left armpit- treated by dr...Doxycycline Hyclate 100 MG 2x a day for 7-10 days, warm compress and motrin to relieve pain. Day 3 of antibiotics starting to feel better.

Following day, arm severely sore. 3 days after injection, spot turned red and warm. Hut if anything touched it. Lump and tenderness remaining almost 2 weeks after injection.

Severe swelling in both legs to the point that my feet felt like they were going to burst. Received injection on Wednesday, symptoms started Saturday, went to doctor on Monday. Doctor did bloodwork and check all my levels - they were good. He treated the symptoms with anti-inflammatories and fluid pill. Still swollen but not as bad.

Flulike symptoms, 101-102 temp, aching all over body, swelling on face, lips, and inside throat that didn?t start until the next morning and continued throughout the day. Swelling continues still.

3/11/21 Left side of face went numb, jaw pain, felt like electric bolts through head, involuntary muscle contacting in face (both sides), Jittery, Eye twitching, headache. Ear pain. 3/12 -3/13/21 Face numbness got worse, left side started to droop. Muscle soreness in left arm, headache, tired. 3/14/21 ER visit to rule out Stroke. Diagnosed with Bells Palsey. 3/15-3/17/21 Left side of face still numb, pain/muscle spasms come and go. 3/18/21 Woke up with skin hypersensitive- feels like I have a severe sun burn from my neck to waist area, swollen glands, eye twitching, lips, tongue and throat swelled up. Severe jaw and ear pain, trouble breathing. Face still tingly/numb. Legs became extremely sore and heavy feeling, hard to walk. Called Dr- put on Prednisone (60mg and decreasing) and an anti-viral. 3/19/21 Same symptoms as previous day plus stomach area began to hurt/burning sensation- like all my organs were inflammed. Uncomfortable pain in my right side. Took first dose of meds this am. 3/20/21 Extreme jaw/ear pain, clenching feeling, loss of strength on the left side of my face Symptoms tapered off fir a few days, face numbness decreased and swelling seemed to improve. 3/25/21 Woke up with Skin burning again and glands in neck swollen. Called Dr- placed back on a higher dose of Predisone . At night, throat and tongue swelled up 3/26/21 Tongue and throat swelling, still facial tingling and numbness

Symptom progression: Sudden onset of left trapezius tightening w/ radiation to left posterior neck. Progressed to sinus swelling, right eye pain w/ pressure & right anterior headache & nausea. Tachycardia, tachypnea, chest pressure & tightness, air hunger & angioedema. Treatment 03/30/2021: Epinephrine (Adrenalin) @ 0215 Famotidine (Pepcid) @ 0255 Loratadine (Claritin) @ 0255 Lorazepam (Ativan) @ 0220 Magnesium Oxide (Mag-Ox) @ 0540 Methylprednisolone sodium succinate (Solu-Medrol) @ 0210 Ondansetron (Zofran) @ 0210 Potassium Chloride (KLOR-Con) @ 0356

At 1AM on 4/2/21 I had fever, muscle aches, and headache. All that day I was sick with fever, severe muscles aches, fatigue, and headache. On 4/3 I noticed pain in my right arm, a large knot/ swelling, redness, and itchiness.

- Extreme fatigue, starting one hour after shot for more than 48 hours, sleep/rest/Aleve - Painful joints/most noticeable in arms, elbows, ankles, hips, starting one hour after shot for more than 48 hours, sleep/rest/Aleve - Painful muscles in fully body, starting one hour after shot for 48 hours, sleep/rest/Aleve - Dizziness and weakness, starting one hour after shot for 48 hours, sleep/rest/Aleve - Lightheadedness, starting one hour after shot for 48 hours, sleep/rest/Aleve - Swelling of arms and hands, starting one hour after shot for 48 hours, sleep/rest/Aleve - Headache, starting one hour after shot for 24 hours, sleep/rest/Aleve - Decreased mental clarity/slow to process information and speak, starting one hour after shot for 24 hours, sleep/rest/Aleve

I started having an annaphylaxis reaction a short time after i left. At first it was intense all over body itching that felt like it was from the inside out. By the time i got home i was getting red blotchy patches over my face, neck, and chest. I took benedryl which did nothing to subside the reaction. When my chest started feeling tight i went to the emergency room. My lips were itching and puffy. At the er i received treatment for annaphylaxis once and about a half hour to forty minutes before i was to be discharge i had a reoccurance of symptoms and was treated for it a second time and admitted to the hospital. This was from the March 31st clinic held at the fire department.

prolonged headache, ongoing fatigue, nausea, low appetite, sluggish. dull pain in lower abdomen. swelling in left leg.

My arm was immediately sore and was sore for a week. Within a few hours from the vaccine being administered I was tired, hands and feet very cold, chills, headache and a fever. This lasted for 3 days. I was and am still fatigued and it has been 2 weeks since my vaccine. On Friday, April 9, 2021 (8 days after vaccine) I woke up with a sore throat and a swollen gland in my neck on the right side (side of my injection). The sore throat and my swollen gland is starting to subside on Day 14. Throughout these whole 14 days I have had hot and cold "flashes" and while I already have anxiety my anxiety has been much worse (feeling of a pounding heart) since the vaccine. It is not my normal anxiety. On Day 11, Tuesday April 13, 2021 I woke up with a black spot on the right side of my chin closer to my bottom lip. It does not hurt, not raised and it is just a black spot. It is still there on Day 14 and slowly starting to fade but not by much.

Around 06:00 pm, which was about 9 hours after having received the J&J vaccine, I began having a slight fever and chills. The most pain I had was in the back of my legs. Both of my calves felt as if they had both been kicked and were badly bruised. It was painful to walk for about 48 hours/2 days (Sunday - Monday). That was the first time in my life that I had that kind of pain in my back calves. Never had before from running or walking. Then around 09:00 pm on Tuesday, a reddish dot appeared on the left side of my cheek. I thought it was just a big zit. But the following day, the dot got bigger, and looked like a scratch. On Wednesday, it was definitely a scratch-like shape (2 lines, less than an inch long) and had begun to feel itchy. That was when I had realized that it had the same pus-like dotted features of a cold sore. But oddly, it's not right next to either side of my lips. Instead, it is further down, towards the left side of my chin. It is very rare for me to get cold sores. I can't remember when my last one was, as it was years ago. So I am wondering if this cold sore is due to having received the vaccine. The fever, chills, and leg pain have not returned after those first 2 days.

4/2/2021 3PM, Exhaustion and Chills 4/3/2021 8AM, Swollen left foot, painful to walk on 10/10 level of pain. Low back pain left side. 4/4/2021 - 4/15/2021: Exhaustion continues on and off

Came to the ED for shortness of breath for the past 3 days; also claims was treated for anaphylaxis at other institution after receiving the vaccine (patient has schizoaffective disorder). Patient tested positive for COVID-19 on 3/20/21 and treated with remdesivir and convalescent plasma

About 4 days after the vaccination, I developed a rash, first a large patch on my lower back, followed by other areas, including another large one on my upper left arm (the injection site) and many other smaller ones on my fingers, abdomen, leg, and arms. The rash was initially made up of small clusters of intensely itchy bumps, which would eventually redden and join together. The worst areas also swelled a bit and the skin started to feel dry and began peeling in places. The rash drove me crazy all day and woke me at night. I treated myself at home with o/c antihistamines, anti-itch creams (hydrocortisone, etc.), and ice packs for a week and a half; but the rash did not subside and was continuing to pop up in new places. I had my appt with the doctor on 04/7/21. Due to my allergy to medrol, I was not prescribed oral steroids. I was prescribed doxepin for pm (sleep and itching), o/c Allegra for am, and a steroid cream. The treatment has been effective and the affected skin is healing.

patient complained of leg pain and swellin on the 14th of April and was admitted to Hospital on the 16th of April due to pain increasing in severity and affecting ability to ambulate. She later spiked a temp of 100.9. Left forefoot erythematous and warm to touch with large bulla over fourth metatarsal extending to webspace between 4th and 5th toes. Patient is currently in ICU, Intubated and unresponsive.

Started feeling like I was getting a cold 12 hours after getting vaccine. Symptom cleared up within 18 hours of receiving vaccine. Felt tired for 24 hours after getting vaccine. Noticed swollen lymph node above collarbone on same side of body as vaccination site 5 day after receiving vaccine.

TRANSIENT DIZZINESS AND LIGHT HEADED; STOMACH PAIN; SWOLLEN LEGS; LEG PAIN; MIGRAINES /MIGRAINE TYPE HEADACHE TOWARDS RIGHT EYE; HEAVY LEGS; RASH ON BOTH LEGS; DIARRHEA; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included no medical history. The patient had 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: 042821A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced rash on both legs. On 06-APR-2021, the subject experienced migraines /migraine type headache towards right eye. On 06-APR-2021, the subject experienced heavy legs. On 12-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced swollen legs. On 12-APR-2021, the subject experienced leg pain. On 15-APR-2021, the subject experienced transient dizziness and light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraines /migraine type headache towards right eye, stomach pain, and swollen legs on APR-2021, had not recovered from rash on both legs, leg pain, transient dizziness and light headed, and heavy legs, and the outcome of diarrhea was not reported. This report was non-serious.

First 2 days: fever 101.5, whole left side pain, abdominal pain, headache, lower right leg pain 3rd day: low grade fever 100.5, lower right leg pain, left arm pain 4th day: lower right leg pain increased along with redness, swelling, red lines, and eventually I couldn't apply weight on my right leg. After visiting Urgent Care hospital, blood clots were found in my small veins.

Within 24 hours, normal side effects including, muscle pain and aches; Resolved after 1 day On 4/23/2021, 14 days after vaccine, patient began experiencing loss of appetite On 4/26/2021, 16 days after vaccine midday on 2, patient began experiencing sudden onset of upper stomach pain, heart palpitations 4/29/2021, patient went to ER due to extreme upper abdominal pain and intermittent back pain and intermittent heart racing. Prior to going to hospital, patient was healthy with no prior health issues or diagnoses. She also took baby aspirin, 81 mg several days prior to being admitted, took 2 chewable gas- except tablets and had her glucose checked which was a 96. Patient was not admitted and discharged the same day with a diagnosis of acute pancreatitis. She has had 2 children in the last 3 1/2 years and still nursing a 14 month old and hasn't count alcohol in years. Pain meds prescribed but using them every 8 hours to manage pain and barely eating or drinking, yet pain still persists.

Venous dilation/varicosities in bilateral lower extremities with associated mild bilateral lower extremity edema and paresthesias.

pt developed b/l LE edema 1+ pitting edema roughly 2-3 weeks after getting covid vaccine cbc, cmp, trop, bnp were normal during ER visit 4/30 pt complained of "red dots" like rash at first but no petichial rash noted on exam

Daily facial flushing. Hand and feet swelling turns red and hot, burning pain on body . Every day occurrence since 4/26/21

Extreme vertigo, nausea, brain fog and fatigue that began approximately 36 post vaccine, followed by facial swelling .

I took a shower Saturday morning and noticed that there was swelling under my right armpit. It was painful to use that arm to brush my teeth. I called the Nursing Line and they explained that it is common to noticed swelling and pain in the armpit area after receiving the Vaccine and it the pain or selling became worst to make an appointment to see a Doctor.

8 hrs later 99.7 temp , sweat body aches, dizziness 5/17 2am fever 100.7 fever chills severe headache, vomiting fly like symptoms, stomach aches, could not stand no energy finally 2pm 5/18 drove to urgent care as I could not go any further

body aches restlessness, headache will not go away. not helped with Tylenol or advil. couldn't sleep couldn't get comfortable. then runny nose, cough, sneezing, then dizziness, had to call out of work on Friday 6/11. then Saturday 6/12 significant face swelling. Tiredness-sleeping all day now for past week. called out of work Monday, Tuesday and Wednesday, severe weakness.

tongue swelling that patient felt was onset of anaphylaxis, began about 5 minutes after vaccine was given, pt was given one dose of EpiPen and went to ER where they received IV steroids, benadryl, pepcid and observed for 45 minutes. Upon discharge they were prescribed a 5 day course of prednisone

I have had more cold sores since getting my vaccine than I ever have in one year, ever. I have been getting cold sores since I was about 5 years old. I have taken Valtrex to prevent them, and that is not helping when it used to always help. Since April, I have had a new cold sore every other week. That means, after one heals, a week goes by and a new one starts.

Immediately 10 minutes after receiving the vaccination, I started sweating really bad, I got a metal taste in my mouth. The next morning, I woke up with a huge migraine, couldn't concentrate, pain in my arm, and my whole body was just very hot. Over the next few months, I had developed swelling from my toes to my mid-calf, which went into my thigh the next week. It got to where I could no longer fit into my jeans. My whole body turned red. I went to the urgent care, which they immediately sent me to the ER. They did an ultrasound all over my body to test out blood clots, they took blood work. They ruled out having a heart attack and blood clots. They sent me home. A Few weeks later, I was at work and the pants I was wearing were cutting into my abdomen. I went to my PCP; I was so swollen head to toe. He put me on a steroid. PCP did blood work and everything is still going on and they still can't figure out why and having more symptoms on top of swelling. I have been on many different kinds of steroids. Had hallucinations, my PCP told me to go to the ER again. My breasts got super enlarged, the doctor I got at the ER still didn't figure anything out. They did a CT, Blood work, EKG, more ultrasounds. They then sent me to another ER, they did another CT, my brain was smaller than normal, my eyes were in the wrong place. To this day I am still experiencing all of these symptoms.

The back of my head and neck were very swollen and sore since I received the vaccine. My fingers and fingertips have been experiencing extreme pain, numbness, and tingling since I received the vaccine. My right hand and arm have been having burning pain, numbness and tingling. The pinky finger on my right hand has hurt the worst and the pain hasn?t gone away.

My injection was on a Monday at 1pm. I had no issues for about a day and a half. On Wednesday afternoon I started having itching and redness on my forearms and top of both hands. Both arms on Wednesday evening were swollen, quite red and sore (a bit of a burning sensation). It almost feels like a bad sunburn at times. I took an antihistamine to help with the itching and swelling and this morning actually put calamine lotion on my arms to help soothe the burning feeling. It is more irritating that painful and nothing needing medical attention but I thought it should be reported.

A bumpy itchy rash started first in my arms and after in wrists and hands so i took 2mg of betamethasone and after 45 minutes another tablet of 1 mg. After 2,5 hours the rash calmed down on the upper part but it started on legs, tighs and foot. I was on fire and to have a bit of relief i put a wet cloth on the skin and i took another tablet of 1 mg of betamethasone and 1 of benadryl allergy. Around 11 pm the rash stopped and the skin became normal. I slept with no problem, but the next morning after 20 minutes I woke up the rash started again in all the body so I took 2 mg of betamethasone and 1 benadryl allergy. I went to the vaccination center but there wasn't any doctor, only a nurse that told me to keep on taking antisthamine and corticosteroids. It calmed down around 12 am and started again in the late afternoon.I took a benadryl, i used the wet cloth and around 10 pm stopped. Night with no problem, but around 9.30am the rash started again so i took 1 mg of betamethasone and 1 benadryl. Around 1 pm calmed down and at 2pm i took 2 benadryl. Around 8 pm i had some itchy spot on the legs but it didnt turn out in rash. Today after 30 minutes i woke up i had some spots on the legs, i took a benadryl and after 1 hour disappeared.

On march 18 (Thursday)I woke up with fever and muscle pain. But 2 days later I already had fever and my arm were with a " red and hot bump" to much pain and iching..... I went to facility on Saturday at night because I was worst and the doctor told me to don't worry because It is normal when you got a shot but she never looked to my arm. she went into the room only to give me the diagnostic but without look to my arm. The diagnostic were: adverse reaction to vaccine. I already have the syntoms and tomorrow it will be 1 week since I got the vaccine. I don't know it is normal. If you want I have pictures.

Besides flu like symptoms beginning 12 hours after injection and lasting 24-30 hrs, i woke up with a very swollen lymph node in pectoral/underarm area 48 hrs after injection. Dr ordered ultrasound of site. Determined 2 lymph nodes were enlarged. Prescribed cephalexin 500 mg 2 times a day for 10 days, ibuprofen and warm compresses. After 48 hours on antibiotics has slightly gone down in size.

PATIENT PROVIDED VACCINE DURING VACCINE CLINIC AS SCHOOL SYSTEM EMPLOYEE. NOTIFIED TODAY BY SCHOOL CLINIC NURSE THAT PATIENT COMPLAINT OF LYMPHNODE SWELLING AT RIGHT AXILLA WHICH STARTED 1 DAY POST VACCINATION. PATIENT COMPLAINT THAT AREA IS TENDER TO TOUCH AND SWOLLEN. REPORTED TAKING TYLENOL AND BENADRYL. STATES THAT 2 DAYS POST VACCINE SHE "SLEPT MOST OF THE DAY". TODAY, 03/29/21 SCHOOL CLINIC NURSE REPORTS THAT RIGHT AXILLA NODE REMAINS TENDER AND IS VISIBLY SWOLLEN.

Approximately two hours after receiving Janssen Covid19 vaccine, patient experienced swollen hands, tingly lips, eyes, face. Patient feel better after administer liquid benadryl

Face, beginning with upper lip and eventually all of face numbness, started about 45 minutes after receiving the vaccine and lasted about 15 minutes. Cheeks felt swollen, like a chipmunk, but no real difficulty breathing, very minor if at all. Facial numbness returned about 8:45pm, less noticeable than before, Random itchy spots on arms, scalp, and face, but no noticeable hives. Taking Allegra

Day 1: 101.7 fever, chills, body aches, headache, sore arm Day 2: 99.8 fever, chills, body aches, headache, severe pain in lymph nodes (same arm as injection), fatigue Day 3: still some soreness in arm and lymph nodes

Janssen COVID-19 Vaccine EUA: During the post-observation period, vaccine recipient developed pruritus, fine raised rash on face, itchy throat, swollen under left eye. She was treated with diphenhydramine by EMS. She was monitored for additional 45 minutes. Then she continued to have itchy throat and felt that throat was swelling. She was transported to the emergency department.

4 afters after - severe chest pain that lasted for 2 hours. 12 hours after, face swelling - started on left cheek/lip and migrated across face. Resolved after 24 hours. Continuing random hives. High fever - 102.5, and all the other effects that are more common.

Janssen COVID -19 Vaccine. 9 hours after the shot I woke up freezing cold, all my joints hurt, my muscles were stiff, and I felt disoriented. I stayed in bed for a couple of hours. At 5am I got up with all the same symptoms and took my temp which was 101.4. My head hurt like there was too much pressure in my skull. I ate toast and took some ibuprofen and went back to bed. These symptoms lasted for 10 hours. Then for the next 5 hours I just had a fever off and on and fatigue. 3 days after the shot the gland in my left armpit became swollen. It has gone down in size but still sore 5 days later. I still feel tired too.

Later on that evening I started feeling tired, chills, & fever. This lasted about 4 days on the 2nd or 3rd day I had a swollen lymph node under my left armpit. It lasted just a couple of days. On 3/21/2021 I missed my period I did not get it the month of march. Now on the month of April I first started spotting on April 7th it was very light then it went heavy till this day 4/13/2021 I'm still bleeding which is not normal because my period normally only lasts for 4 days. On 3/31/2021 I also had chest pain that lasted for 4 days then it started subsiding. On 3/12/2021 and on 04/11/2021 I got a weird abdominal pain that lasted for less than 5 minutes.

It gave me Covid symptoms that started about 12 hours after the shot. Body aches, fever, chills, congestion, exhaustion, nausea & dizziness. That mostly resolved after 2 days. Then 1 week later on Saturday, I started having pain in my left leg where I had had RFA of the greater saphenous vein 6 months prior. Leg swelled up got a hard knot. I got dizzy & nauseated. The pain increased, & I went to the ER on 3/21. They diagnosed it as thrombophlebitis. The pain & inflammation has continued for 3 weeks now despite the use of anti-inflammatory meds & support hose. I have also had rapid weight gain of 12 lbs and edema not relieved by lasix. Two weeks after the shot I also started having severe nose bleeds.

Within 8 hours post-vaccination: pain, tenderness, and swelling at injection site and pins and needles sensation in lower arm and hand of arm injected (largely resolved by 7 days post vaccination) Within 18 hours post-vaccination: significant headache, exhaustion, fever, body aches, and full body itchiness (largely resolved within 3 days) Within 48 hours post-vaccination: headache, significant itchiness and skin burning sensation over most of body but especially arms, hands, lower legs, neck, stomach, and back (largely resolved by 7 days post-vaccination but persisting less intently in multiple locations) Within 5 days post-vaccination: painful swelling on back of right leg near groin area (unresolved) Within 7 days post-vaccination: dizziness and headache ( lasted approximately 30 minutes and resolved with hydration and food)

Patient had a fever for 8 hours post-vaccine on 04/10/2021. On 04/11/2021, patient states fever resolved but then developed swelling around lips, "goose-egg lump on forehead", around 9AM. Swelling has moved from lips to jawline and still present on 04/13/2021. Patient reports having a "chicken pox like rash" on arms, "welt-like spot" on left inner wrist and ankle, and also had itchiness. Patient took cold-medicine hoping that would help with swelling. Patient states rash and welts have disappeared as of 04/13/2021. Patient advised to contact healthcare provider and consider taking Benadryl/antihistamine.

The first side effect I noticed was hives on the arm of the injection site as well as the arm being painful. I became light headed and very tired after the first hour of getting the vaccine. As the evening progressed I begin to get chills and a fever. My body ached from head to toe. I was nauseous and achy all over. I was feeling sick for the next 24 hours, I stayed in bed and could barley move because my body ached so bad. I had a extreme head ache as well. By the 3rd day I felt much better and only had pain in the arm of the injection site. After day 10 I noticed a lump near my collar bone and assumed based on web searching that it may be a swollen lymph node. It's day 12 and I still have a little tenderness near the injection site and my lymph node is still swollen.

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

PAIN ON HER CHEST THAT WOULD COME AND GO; PAIN ON RIGHT LEG FROM FOOT TO THE UPPER THIGH; SWELLING OF FOOT AND LEG; TINGLING OF TOES; CANNOT FLEX RIGHT FOOT THAT MUCH; TONGUE FELT HEAVY; SWOLLEN PRONOUNCED VEINS ON BACK OF LEG; SWEATY; CHILLS; MALAISE; HEADACHE; FATIGUE; FEVER; This spontaneous report received from a consumer concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included synthetic dyes allergy, egg allergy, meat allergy, dairy allergy, and non smoker, and other pre-existing medical conditions included the patient has no drug abuse or illicit drug usage. the patient is non alcoholic.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced pain on her chest that would come and go, pain on right leg from foot to the upper thigh, swelling of foot and leg, tingling of toes, cannot flex right foot that much, tongue felt heavy, swollen pronounced veins on back of leg, sweaty, chills, malaise, headache, fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tongue felt heavy, headache, and fatigue, had not recovered from fever, malaise, sweaty, chills, and pain on her chest that would come and go, and the outcome of pain on right leg from foot to the upper thigh, swelling of foot and leg, swollen pronounced veins on back of leg, tingling of toes and cannot flex right foot that much 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.

Swelling in the face, particularly on the right side cheek close to the nose Painful to touch 10 day course of antibiotics Swelling disappeared after 6 days on the antibiotics

reported feeling itching, abdominal pain, unusual swelling ( inside mouth upper lip and left side of face), swelling of throat, pain on soles of feet and swelling hands on 4/19, she took an antihistamine and symptoms lessened and went away

FELT RED STREAK UNDER ARM FROM SHOULDER; EAR PAIN ON RIGHT SIDE; HOARSE VOICE; LOOSE STOOLS; HYPERGLYCEMIA; SWEATING; LEFT BREAST BURNING; PALPITATIONS; LEFT ARMPIT BURNING; FELT RUN OVER BY A TRUCK; LEFT ARM SMELLS AND LOOKED LIKE AN AVACADO UNDER THE ARMPIT; TEMPERATURE 99.7-100.4; LEFT ARM DELTOID SORE/LEFT ARM SORE; This spontaneous report received from a patient concerned a 45 year female. The patient's height, and weight were not reported. The patient's past medical history included tick bite, and concurrent conditions included obesity, type 2 diabetes mellitus, hypertension, and anxiety. The patient was not pregnant at the time of this report. 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, 1 total, administered on 08-APR-2021 to left arm as prophylactic vaccination. Concomitant medications included fluvoxamine for anxiety, furosemide for hypertension, insulin degludec for type 2 diabetes mellitus, liraglutide for type 2 diabetes mellitus, sitagliptin for type 2 diabetes mellitus, and rosuvastatin. On 09-APR-2021, the patient experienced left arm smells and looked like an avacado under the armpit; she also felt run over by a truck. She had a temperature of 99.7-100.4 (unit unspecified) and had pain in left deltoid arm. On 10-APR-2021, the patient experienced palpitations, left armpit burning and left breast burning. On 11-APR-2021, the patient blood sugar was high 258 (unit unspecified) and experienced sweating and loose stools. On 12-APR-2021, the patient experienced ear pain on right side and had a hoarse voice. The patient had done lab tests at her physician's office; her blood sugar was 230 (unit unspecified), had palpitations at 144 (unit unspecified) and blood pressure was 157/95 mmHg. She was tested negative for covid-19 and had a sedimentation rate of 51(unit unspecified); her magnesium was at low level. She also did an unspecified lab test for lyme disease and was negative. The patient was prescribed with Nystatin cream and nystatin powder and she also took paracetamol (Tylenol) with no relief. The patient felt that she had a red streak under her arm from her shoulder and was going back to her urgent care; she also called her endocrinologist regarding her hyperglycemia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temperature 99.7-100.4 on 10-APR-2021, was recovering from left breast burning, left arm deltoid sore/left arm sore, sweating, and felt run over by a truck, had not recovered from left armpit burning, palpitations, hyperglycemia, ear pain on right side, loose stools, and left arm smells and looked like an avacado under the armpit, and the outcome of hoarse voice and felt red streak under arm from shoulder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210425219 -COVID-19 VACCINE AD26.COV2.S-Hyperglycemia .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

Injection given at 2PM I had neck pain and headache at 9PM that evening. At 3am woke up with chills, full muscle aches, headache and felt flu like. At 9am following morning still a very bad headache along with chills and extreme fatigue. By noon headache gone but fatigue an chills continued for several hours. Exactly 3 days later I developed an awful rash started on hands. This rash is extremely itchy an painful at times. The rash is on hands, arms, legs, belly, neck an back pretty much everywhere. My legs started swelling on day 6.

Flu-like symptoms that have lasted over 3 weeks Body aches Swelling on arm Dr thought I had cellulitis in my arm, so I began taking antibiotics. 4 days later, not feeling better. Cellulitis was ruled out. I feel like poison was injected into my body. I thought I was going to die

FLANK PAIN (LEFT); SWELLING (FRONT OF CHEST); LUMP ON LEFT CLAVICLE; NECK PAIN; LYMPHADENOPATHY; PAIN IN ARM; This spontaneous report received from a pharmacist concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 204A21A expiry: 22/JUN/2021) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced flank pain (left). On 03-MAY-2021, the subject experienced swelling (front of chest). On 03-MAY-2021, the subject experienced lump on left clavicle. On 03-MAY-2021, the subject experienced neck pain. On 03-MAY-2021, the subject experienced lymphadenopathy. On 03-MAY-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flank pain (left), swelling (front of chest), lump on left clavicle, pain in arm, neck pain, and lymphadenopathy. This report was non-serious.

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

I suddenly felt very lightheaded and weak. I thru up and passed out. Then I went to sleep. It happened again a couple of weeks later, and I went to the ER room. The doctors have not found out any correlating event that would make sense yet. I was told to follow up with a cardiologist, I haven't done this yet. I am not sure if this is from the shot or not.

Fever, body aches, joint pain, exhaustion, breast pain, shortness of breath, migraines, cough, chest tightness, diarrhea Ventolin Amoxicillin-clav 875-125mg Azithromycin 250mg dose pack Benzonatate 200mg Cefdinir 300mg Levofloxacin 750mg Methylprednisolone 4 mg Prednisone 20mg

5/6 1pm Immediately after shot administered had a small headache but barely noticeable. 5/6 11pm Fever started with body aches. Fever was low and then rose to ~102 for the next 24 hours. During this time for a short period of time, ~1 hr, my throat/back of my mouth went numb. The feeling in my mouth returned. During the fever I was dizzy but not as bad as a Vertigo feeling. (I experienced Vertigo 17 years ago - postpartum.). I also experienced slight stomach pains during this time. 5/8 starting on this day going forward for 2 weeks I experienced headaches, which came on in the evenings, just after work. From around 4pm till 8pm I was in bed daily with headaches. I usually do not get headaches unless................ unless it is my period times. During this 2 weeks I also added 5 lbs of weight, which I believe is water weight. Lately I have consistently been 125 lbs (up from 120lbs since I was a teenager) and I went to 130 lbs in 2 weeks. I feel as I am retaining water weight. Pain in my legs attest to the weight. The headaches ended for a few days and returned yesterday afternoon. I can tell my body is trying to fight this Covid-19 shot. I am hopeful these body changes will subside, weight gain and headaches overtime. Also, during the first 2 weeks after the shot I also experienced vision blurriness. This has since gone away and my vision has been self corrected. I have not gone to the doctors as I viewed all of this associated with the vaccine and normally I am a healthy 45 year old woman otherwise. I haven't needed to see a doctor in over a year. If these headaches and body aches/weight gain continues I will be at the doctors for help. I figured I would give it time to enter and exit my body first. Ibuprofen sometimes worked to lessen the headaches, but not always. You can email me any further questions you have. Thank you.

CONFUSED; BRAIN WASN'T WORKING RIGHT; REALLY DIZZY; LEGS COULD BARELY HOLD UP; NO ENERGY; HEADACHE; FEVER; SWOLLEN GLANDS; ACHY; PAIN IN BACK OF RIGHT KNEE/PAIN IN LEFT KNEE; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included obsessive-compulsive disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 23-JUL-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for fever. On 15-MAY-2021, the subject experienced swollen glands. On 15-MAY-2021, the subject experienced achy. On 15-MAY-2021, the subject experienced pain in back of right knee/pain in left knee. On 15-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 Unit Not reported. On 16-MAY-2021, the subject experienced no energy. On 23-MAY-2021, the subject experienced legs could barely hold up. On 24-MAY-2021, the subject experienced really dizzy. On 25-MAY-2021, the subject experienced confused. On 25-MAY-2021, the subject experienced brain wasn't working right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen glands, achy, and fever on 16-MAY-2021, and confused, and brain wasn't working right on 27-MAY-2021, and had not recovered from headache, no energy, pain in back of right knee/pain in left knee, legs could barely hold up, and really dizzy. This report was non-serious.

I went to the ER 5/25/2021 for headaches, nausea and calves, ankles, and feet swollen badly. Dr, prescribed a fluid pills and the swelling was gone after a couple of days.

Patient had an anaphylactic reaction, her throat began to swell shut. She was given 3 doses of epinephrine 0.3mg SQ (left thigh, left thigh, and right thigh). 911 was called and EMS arrived in approximately 10 minutes, they proceeded to take her to the hospital. She was being monitored after the vaccine for 30 mins due to multiple allergies including anaphylactic reactions to bee stings and food allergies.

45 year old female presents with cc of left axillary pain and swelling since yesterday 6/29/2021 s/p J&J Covid19 Vaccine on 6/28/2021 to left deltoid. Pt reports pain is moderate, nonradiating, constant, minimally relieved despite use of tylenol and ibuprofen. Pt denies trauma to affected region. She denies fever, chills, cough, chest pain, SOB, palpitations, weakness, numbness, tingling, headaches, neck pain, back pain, rash, dizziness. Pt offers no other complaints.

Low-grade fever every day for 2 weeks between 99 and 101 degrees that did not respond to Motrin, Advil or Tylenol, flu-like body aches, extreme fatigue, migraines that interfered with daily activities. Called my doctor who ordered lab work. Lab worked showed active Epstein Barr infection, positive Covid antibodies, elevated SED rate and high c-reactive protein. As of July 2, 2021. Still suffering from fatigue, body aches and less frequent fevers. I have sought out alternative medicine with chiropractor care and acupuncture for relief from chronic pain and headaches.

Since receiving vaccination, pt has had subjective intermittent fevers, persistent shortness of breath, dizziness, multiple joint pains, bodyaches and mild leg edema. Currently undergoing lab and imaging evaluation for many other possible causes

a week after treatment started breaking out in hives and face swelling; experience on and off for last two weeks

At 3:00 pm the day after I received the Johnson&Johnson COVID-19 vaccine I developed a red, raised, swollen, hot, painful circle 5'' in diameter on my left arm under the injection site. My arm is hot to touch, swollen, and still painful the next day and the circle has spread more and has started to turn purple.

woke up 12 hours with facial swelling in my left eye, eyes were itchy -- and eye was extremely swollen. The swelling spread to my face throughout the day, controlled with Benadryl.

Date and time adverse event started: Sunday 3/21/21 patient took vaccine at 1:20pm and on sunday night patient started to feel very very cold with extreme body pain. Pain continued on Monday 3/22/21 with the addition of headache, swollen tonsils with pus in back of throat (white/yellow), gland under her armpit is swollen (left arm-injection arm), dry mouth and dry lips Patient has contacted her PCP but they didn't want to see patient yet. PCP stated they don't want to prescribe the patient any meds due to MD not knowledgeable of vaccine and any contraindications. Patient has not taken any tylenol/ibuprofen after the vaccine

15 minutes after shot: significant, noticeable swelling and pain in injection arm, flushed face, neck, and chest; 30 minutes after shot: swelling in face, discomfort in throat, tingling in limbs, anxiety, heart rate increase. Pretreated with benadryl (25mg) 30 minutes prior (at 3 pm); pretreated with benadryl (25mg) 10 minutes prior (3:20pm). Left pharmacy at 3:45, drove to ER as symptoms were worsening. Waited at ER (not triaged) until symptoms significantly subsided - around 5:15pm. Continued benadryl every 4 hours for 12 hours (tried delaying benadryl at 7:30pm, but symptoms began returning). The reduced to 25mg every 5-6 hours, for 24 hours (symptoms returned without benadryl). Other side effects: Began ~ 7 pm: temperature spikes and drops (hands and feet freezing cold), chills, stomach pain, nausea, extreme headache, extreme muscle pain and joint pain, shooting pain, fatigue. 400 mg ibuprofen every 4-6 hours. first 24 hours very bad, 36 hours reesolved,

Small Cold Sore began to appear on bottom lip midday - 1/2pm Fatigue hit hard - 4pm Fever/chills - 7pm Numbness and mild paralysis on left side of face - 11pm

Almost immediate - soreness at injection site Four hours post injection - nausea lasting approx 6 hours Five hours post injection - vomiting lasting approx 5 hours Five hours post injection - chills, fever, headache, bodyaches lasting 20 approx hours Five hours post injection - exhaustion lasting 2 days Two weeks post injection - painful swollen lump under right armpit lasting 3 days, lump did not completely go away for 7 days, but pain/swelling subsided after 3 days.

Left arm became warm, swollen, painful (cellulitis). Treatment with ice, Tylenol and cephalexin 500mg 1 capsule by mouth four times a day for 7 days

for approx 24 hours: significant pain in shot arm, fever, aches, chills, migraine/headache. Next 24-48 hours: rash on both arms and chest, swollen hands and continued pain in shot arm.

Patient was ok 15 minutes after vaccination on 4-8-21 (Thursday) . On 4-10-21 Saturday but start to feel headache, body aches , chills , no appetite, unable to get out of bed, fever . Today 4-13-21 Patient has swelling in her legs and chest tightness. Recommended the patient to go to the hospital.

Within 2 hours of vaccine I started experiencing shortness of breath and my throat tightened up. I tried to drive to the ER but stopped at urgent care since they were closest. They found that along wit my breathing issues my BP was also running higher than normal. I was given a steroid to get my breathing and BP under control. I was released to go home, but told that if symptoms returned that I was to go to the ER immediately. Given a 5-day prescription for Prednisone to keep future symptoms at bay. The next few days my face and neck were very swelled, but I was able to breathe. I was given the vaccination in my left arm, and my fingers have been swollen on my left hand. The fingernails on my middle, ring, and pinky fingers are also very sore to the touch.

Fever 102.2 for days. Shortness of breath. Sweating and chills. Severe body aching. Severe fatigue. Severe Pain on injection site (right arm). Lightheaded frequently. Water body retention.

LEFT ARM BURNING SENSATION, SLIGHT SWELLING & EXTREME PAIN ON GOING, ACTIVE FROM 04/01/2021 - PRESENT DATE.

Patient is a 47 y.o. female who is evaluated today for the above concerns. Patient presents with concerns related to possible reaction to the J&J COVID vaccine she received last week. She developed some face tingling/numbness, then felt like her throat was closing - not sure if due to lymph nodes swelling or possible reaction. She thought about going to ED or using epipen, but ultimately did not need to do either. She has been on zyrtec for her allergies which have been really bad too, so was not sure if that could be contributing. Later that evening she developed headache, chills, joint/muscle pains and fatigue which continued through the night and into the next day. She also had burning of her skin, specifically her hands and feet. She continues to have some fatigue, joint/muscle pains and mild headache. She is worried about recent development of potential clotting with J&J vaccine - she has factor V Leiden and is supposed to travel later this week. Headache not described as severe, no SOB, leg pain or swelling or abdominal pain reported. Tachycardia "

Left arm swelling and some bruising. bruising resolved after few days. also some cervical lymphadenopathy and rash x few days, now resolved. patient with residual arm swelling 2 weeks post vaccination.

SEVERE STOMACH CRAMPS/SHARP PAIN; SEVERE FLUSHING ON EAR, FACE AND CHEST; HIVES; SCRATCHY THROAT; SWELLING ON GROIN AREA; NODULES ON INJECTION SITE; NUMB TONGUE; BUMPS AND RASH ALL OVER HER BODY; DIARRHEA; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mast-cell activation syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 10-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 10-MAR-2021 30 min after vaccination the patient experienced severe stomach cramps/sharp pain. On 10-MAR-2021, 4 hours after vaccination the subject experienced multiple symptoms like severe flushing on ear, face, and chest. hives, bumps, and rash all over her body, scratchy throat, diarrhea, swelling on groin area, nodules on injection site and numb tongue. The patient was expecting to have these side effects since she has mast-cell activation syndrome an took Benadryl which seemed to help, and she did not go to emergency room (ER). The patient would follow up with her PCP. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach cramps/sharp pain, severe flushing on ear, face and chest, hives, scratchy throat, swelling on groin area, nodules on injection site, bumps and rash all over her body, and diarrhea on 10-MAR-2021, and the outcome of numb tongue was not reported. This report was non-serious.; Sender's Comments: MAC- MAC not required per standard procedure as the case assessed as non-serious.

Within first few days of Johnson andJohnson vaccine....swollen lymph nodes, lymphedema. 2 weeks after vaccine...leg pain, bruising on legs (with no injury), peticiae rash on legs. Now after nearly a month...still having random bruising and pain on my body (without injury), still feel very unwell, having feelings of pressure and visible swelling in neck that comes and goes, still having pain. Yesterday a new bruise appeared on wrist with swelling, pressure, and pain.

This is a continuation from report on 4/8 Pt has worsened symptoms. I went to Gynecologist on 4/19 still exp night sweats.The Gynecologist stated I have high disblasha on my cells I'm scheduled for cervical procedure on 5/17. I went to my physician EKG I'm scheduled on 5/6 Physical Stress test.I also went to dermatologist on 4/22 removed (burned) 9 places on my skin (face,chest stomach) that had abnormal cells.The dermatologist recommend have a upcoming scan for my lymph nodes. As of now my lymph nodes (both sides) are swollen still exp day and night sweats, joint pain and tired. I'm now on high blood pressure medication.Both doctors have stated the vaccine has sent me into "haywire with my immune system".

LIP SWELLING; HIVES; SEAFOOD ALLERGY; BODY HOT; SORE LYMPH NODES; This spontaneous report received from a patient concerned a 46 year old female. 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, intramuscular, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, treatment medications included: oxycodone/paracetamol. On 07-MAR-2021 17:00, the subject experienced sore lymph nodes. On 10-MAR-2021, the subject experienced body hot. On APR-2021, treatment medications included: epinephrine. On 13-APR-2021, the subject experienced seafood allergy. On 13-APR-2021, the subject experienced hives. On 20-APR-2021, the subject experienced lip swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore lymph nodes on 09-MAR-2021, had not recovered from seafood allergy, and body hot, and the outcome of hives and lip swelling was not reported. This report was non-serious.

About 5 minutes after I received the shot, had a sudden burning sensation in the middle of my chest that radiated out. I thought that was it for me. Nausea, dizziness, numbness in my left cheek and arm, got a funny taste in my mouth. This got pretty intense and lasted about 10 minutes. They had me stay in observation for another 45 minutes as those symptoms came in waves but never as intense as the first time. They let me go and I went home to rest. On the way home my cheeks became flushed and it felt like my eyes and cheeks were swelling. I had a lot of other symptoms over the next several hours which I wrote down. Early Tuesday morning those symptoms went away and I was left with some flu like symptoms, dizziness and a brain fog like I have never had before.

I felt nauseated right after my J&J vaccine. I also have dry heaviness. I also experienced flu like symptoms. My chin also swelled up really big and I had hard time breathing. I went to the ER due to my throat swelling up and my difficulty to breathe for three days straight and also felt a pressure sensation in my throat and chest. At the ER they performed lab work, gave me a Toradol injection and also gave me steroids. I also took a homeopathic remedy which was given to me by a friend who is a doctor and my symptoms started to get better. On another note, my sister also had the J&J vaccine and she also had nausea symptoms but only lasted 3-4 days but I do not know if this is a genetic component.

I had chills, fatigue, headache, and bilateral calf and thigh muscle pain that started about 6 hours after the vaccination and lasted about 36-48 hours. I took Tylenol 500mg after the onset of symptoms and three times a day. The symptoms went away by mid-day on 4/13/2021. Since then, I have been experiencing bilateral calf muscle pain off and on. I also had an enlarged axillary lymph node n the left side (side of vaccination). I reported it to urgent care on 4/18/2021 and was told the muscle pain was unlikely to be a clot since it was bilateral and there was no swelling or discoloration. I was told to hydrate and follow up with my primary care provider if it continues. The calf muscle pain has continued - almost every other day - and responds to Advil. I have an appointment to talk to an MD tomorrow (May 5th)

Started with a mild headache which hasn't gone away despite otc pain meds. Then progressed to fatigue, swollen legs and ankles, shortness of breath, mild chest pain and several instances of abnormal heart rhythm (flutter in chest). Still having these issues

FEET DISCOLORATION (PURPLE/BLUE) WHEN SITTING DOWN; CALVES FELT LIKE GOING TO SLEEP; TINGLING IN FEET; YUCKY AND TOXIC FEELING; NERVOUSNESS; HIGH BLOOD PRESSURE; SHORTNESS OF BREATH; FACIAL PUFFINESS; BAD FEELING (FELT LIKE HIT BY TRUCK); LIGHT HEADEDNESS AND DIZZINESS; PUFFY AND SWOLLEN FEET; HAND PUFFINESS; SORENESS OF ARM; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, alcohol use, and non smoker, and other pre-existing medical conditions included the patient did not had 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: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure. On MAR-2021, the subject experienced soreness of arm. On MAR-2021, the subject experienced flu-like symptoms. On APR-2021, the subject experienced hand puffiness. On 09-APR-2021, the subject experienced puffy and swollen feet. On 13-APR-2021, the subject experienced facial puffiness. On 13-APR-2021, the subject experienced bad feeling (felt like hit by truck). On 13-APR-2021, the subject experienced light headedness and dizziness. On 28-APR-2021, the subject experienced high blood pressure. On 28-APR-2021, the subject experienced shortness of breath. On MAY-2021, the subject experienced calves felt like going to sleep. On MAY-2021, the subject experienced tingling in feet. On MAY-2021, the subject experienced yucky and toxic feeling. On MAY-2021, the subject experienced nervousness. On 25-MAY-2021, the subject experienced feet discoloration (purple/blue) when sitting down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from puffy and swollen feet, and feet discoloration (purple/blue) when sitting down, and the outcome of high blood pressure, shortness of breath, flu-like symptoms, soreness of arm, facial puffiness, bad feeling (felt like hit by truck), light headedness and dizziness, hand puffiness, calves felt like going to sleep, tingling in feet, yucky and toxic feeling and nervousness 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.

Developed swollen legs tight and discolored.. had a massage to relieve pressure on Friday.. started noticing Thirsday and at present have very bad vision changes that isn't normal. I also have on and off cheat pains this morning with numbness in my left arm and tingling fingers. Pain move from my right under breast area to left side before subsiding. But vision problem persists with swollen face and headache.

Injection site is red and swollen. Left armpit to upper side of left breast is swollen and hurts when pressed. I received the shot on Sunday afternoon and by Monday morning my armpit was slightly swollen but went away late morning. Today, Tuesday morning the swelling came back and is considerably larger and has not gone away yet.

FELT PARALYSED; DIAGNOSED WITH GUILLEN BARRE SYNDROME; INJURED RIGHT FOOT; NUMBNESS IN FACE; LEFT LEG WEAKNESS; SWELLING IN LEGS; TIREDNESS; FEELINGS OF WEAKNESS; NUMBNESS IN LEFT HAND; This spontaneous report received from a consumer concerned a 46 year old female. The patient's weight was 113 kilograms, and height was 66 inches. 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, intramuscular, batch number: 201A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 01-MAY-2021 to left arm for prophylactic vaccination. Concomitant medications included immunoglobulin human normal for guillen barre syndrome. On 01-MAY-2021, the subject experienced feelings of weakness, numbness in left hand. On 28-MAY-2021, the subject experienced tiredness. On 29-MAY-2021, the subject experienced left leg weakness and swelling in legs. On 02-JUN-2021, the subject experienced numbness in face. On 09-JUN-2021, the subject experienced diagnosed with guillen barre syndrome, and was hospitalized. On an unspecified date, the subject experienced injured right foot, and felt paralysed, and was hospitalized on 08-Jun-2021. On 01-MAY-2021, the patient developed numbness in her hand on the left side and felt weak. The patient travelled overseas and had a connection to a country and her husband stated that she started to have swelling in her legs. When she reached her destination, she was admitted to the hospital and was diagnosed with Guillen Barre Syndrome by the neurologist per her husband's recollection. In the hospital she was given Immunoglobulin G for 5-7 days and she did regain some feeling in her legs. Based on patient's husband recollection this may have occurred "maybe tired due to travelling," but when she arrived to the country that was when her left leg weak and requested a wheelchair. The patient then injured her "right foot" in another country, but "she didn't feel it and she requested help because she couldn't walk." per her husband. After she reached her final destination, she felt tired and then she completely fell. It was reported that she could not "control herself and felt paralyzed." On 08-JUN-2021, she entered the hospital and was still in hospital at the time of this report. Her husband states that he "does not know any side effect from any vaccine" that caused this in the past. Lastly, he mentioned "she may have numbness in her face when she reached original country". He also stated that the on 04-JUN-2021, doctors conducted a computerized tomography scan and did not find a blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feelings of weakness, swelling in legs, diagnosed with guillen barre syndrome, numbness in left hand, tiredness, left leg weakness, numbness in face, injured right foot and felt paralysed was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This is a spontaneous report received from consumer concerning a 46 year old female, unknown ethnicity, who experienced weakness and numbness of the left hand on the same day after receiving the Janssen Covid-19 vaccine and was diagnosed with Guillain-Barre Syndrome 39 days after. Patient's height was 66 inches and weight was 113 kilograms. Past medical, previous surgery, current illnesses and medications taken as well as history of allergy, smoking, drug abuse and alcohol abuse were not reported. On the same day as the vaccine was given, patient developed weakness and numbness on the left hand. Patient still travelled. Twenty-eight (28) days post vaccine, patient experienced left leg weakness and swelling on the legs. Patient was noted to feel tired the day before. Thirty-two (32) days post vaccine, patient developed numbness on the face. Computerized Tomography (CT) scan was done and there was no blood clot found. Thirty-eight (38) days post vaccine, patient felt 'paralyzed' and injured her right foot. Patient was brought to the hospital the following day and was subsequently admitted. Patient was diagnosed with Guillain-Barre Syndrome and was given IVIG. Information regarding other potential etiologies was insufficient. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.

This spontaneous report received from a patient concerned a 46-year-old, mixed race, Hispanic or Latino female. The patient's height, and weight were not reported. The patient experienced brain inflammation, inflammation of spine and pneumonia when treated with influenza vaccine for prophylactic vaccination many year ago, and drug allergy when treated with ciprofloxacin. Patient had not taken any flu vaccine since but taken other vaccines with particular no adverse reactions. The patient was not pregnant at the time of vaccination. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: not reported) dose was not reported,1 total, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, after the vaccination, patient felt dizzy, hence patient kept to the vaccine facility for 45 minutes. On 09-MAY-2021, on next day morning, she felt fine. On same day, she woke up with nausea, fever of 103.9 F, sweating and chills. On 09-MAY-2021, she also had soreness at injection site arm and started developing rash on chest, legs and both arms. She drank lot of water and administered the Tylenol and Advil. Patient took the Tylenol and Advil for first 4-5 days. After administration of Tylenol and Advil, her body temperature was 101 degrees. On 09-MAY-2021, she also had loss of appetite, sores on tongue (Inflamed, red and white) and knees joint pain in first 4-5 days following the vaccination. On 15-MAY-2021, her left side of the face was tingling and numb. She examined herself in mirror and found the left side of face was droopy and patient was drooling. Patient was scared and felt like that was Bell's Palsy. Symptoms disappeared within 18-24 hours. On 16-JUN-2021, patient had a on and off fever (body temperature is 100.9), on and off dizziness, fall because of dizziness, scraping ankle, on and off joint pain, rash, fever blister on lip and face numbness. On 16-Jun-2021, she told that joint pain was much better than when first occurred, rash was only on face and arm at that point and face numbness was much better than when first occurred. On 09-MAY-2021, Laboratory data included: Body temperature (NR: not provided) as 103.9 degrees Fahrenheit. In MAY-2021, Laboratory data included: Body temperature (NR: not provided) as 101 degrees. On 16-JUN-2021, Laboratory data included: Body temperature (NR: not provided) as 100.9 (Units were not reported). Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, sweating, chills, injection site soreness, and nausea on 13-MAY-2021, was recovering from left side of face numbness, had not recovered from on and off fever, woozy /dizzy /on and off dizziness, rash on chest, legs, both arms and face, fever blister on lip, sores on tongue, on and off knees joint pain, left side of face tingling, face drooping, face drooling, and tongue inflammation, and the outcome of fall because dizziness and scraping ankle was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210634553-COVID-19 vaccine ad26.cov2.s -Face drooping. 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).

REQUIRING NAPS ALMOST DAILY; WOOZY FEELING/BROWN OUT; DEPRESSION; DOES NOT FEEL LIKE HERSELF; LACK OF ENERGY; HEADACHE; LETHARGY; HARD TO TAKE A DEEP BREATH; WEIGHT GAIN; METALLIC/NUMB TASTE IN MOUTH; SWELLING; LOWER BACK PAIN; STOMACH CRAMPING; BODY SORENESS; ALMOST PASSING OUT; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause. The patient experienced anaphylaxis when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 005A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced lethargy. On 15-MAY-2021, the subject experienced hard to take a deep breath. On 15-MAY-2021, the subject experienced weight gain. On 15-MAY-2021, the subject experienced metallic/numb taste in mouth. On 15-MAY-2021, the subject experienced swelling. On 15-MAY-2021, the subject experienced lower back pain. On 15-MAY-2021, the subject experienced stomach cramping. On 15-MAY-2021, the subject experienced body soreness. On 15-MAY-2021, the subject experienced almost passing out. On 15-MAY-2021, the subject experienced woozy feeling/brown out. On 15-MAY-2021, the subject experienced depression. On 15-MAY-2021, the subject experienced does not feel like herself. On 15-MAY-2021, the subject experienced lack of energy. On 15-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced requiring naps almost daily. Laboratory data (dates unspecified) included: Weight (NR: not provided) 16 pounds gained. Treatment medications (dates unspecified) included: caffeine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from woozy feeling/brown out, headache, lower back pain, stomach cramping, body soreness, depression, and hard to take a deep breath, had not recovered from lethargy, weight gain, metallic/numb taste in mouth, swelling, lack of energy, does not feel like herself, and requiring naps almost daily, and the outcome of almost passing out 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

SUN REACTIVE; HIVES ON FACE, NECK AND CHEST; SWELLING OF THE FACE; SKIN ISSUES DOWN ARMS; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 260 pounds, and height was 62 inches. The patient's concurrent conditions included heavy plegic migraine, rheumatoid arthritis, and non smoker. The patient experienced drug allergy when treated with amoxicillin/clavulanic acid, moxifloxacin hydrochloride, and oseltamivir phosphate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included adalimumab for rheumatoid arthritis. On 15-APR-2021, the subject experienced swelling of the face. On 15-APR-2021, the subject experienced skin issues down arms. On 15-APR-2021, the subject experienced hives on face, neck and chest. On an unspecified date, the subject experienced sun reactive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of the face, hives on face, neck and chest, and skin issues down arms, and the outcome of sun reactive was not reported. This report was non-serious.

LEFT ARM LYMPH NODE SWOLLEN; ARM IS WARM TO THE TOUCH; REDNESS AT INJECTION SITE; TENDERNESS OF LYMPH NODES; FEVER; BODY ACHES; CHILLS; SORE ARM; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and smoker, 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: 1821286 expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported On 24-JUN-2021, the subject experienced sore arm. On 25-JUN-2021, the subject experienced body aches. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced fever. On 01-JUL-2021, the subject experienced arm is warm to the touch. On 01-JUL-2021, the subject experienced tenderness of lymph nodes. On 01-JUL-2021, the subject experienced redness at injection site. On an unspecified date, the subject experienced left arm lymph node swollen. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, sore arm, and fever on 25-JUN-2021, was recovering from tenderness of lymph nodes, and left arm lymph node swollen, and had not recovered from redness at injection site, and arm is warm to the touch. This report was non-serious.

Neurologic symptoms (numbness, tingling in body, facial paralysis) Diagnosed with Guillain Barre on 3/30/2021. Hospitalized 5 days. 5 doses of IVIG. Currently some weakness in face and nerve pain.

All over body hives started 3 hrs after receiving vaccine. 2 doses of prednisone, pepcid bid x 5 days, Singulair 10 MG at bedtime. Hives come back when off prednisone. Atarax for itching. Lymph nodes in armpits, elbows. Neck, behind necks all enlarged and swollen. Day # 28 still have hives, swollen lymph nodes. Per doctor has to run course. Not enough data

Janssen COVID-19 Vaccine EUA- nausea first at 4:45am, followed upon rising by severe joint pain and an extreme migraine. It felt like my bones were made out of glass and someone had taken a hammer to my bones. My face was swollen and red. Unable to sit up. Walk from bed to toilet only. Overall, I would say extreme flu-like symptoms. Temperature 99.6 all day. I could not take the pain any further at 4:20 pm and took 1,000 mg of Tylenol. I finally fell asleep and woke up at 8:30pm and could walk again and my fever had broken. I still don't feel great, but I think the worst is behind me.

Anaphalatic Shock - Rash / Hives / redness / heat / inability to communicate / swelling of the throat. Epi pen , Epinephrane in Ambulance, Steroids and Benedryl, overnight stay

Immediately broke out in a sweat and was very hot. Didn't think much about it. The staff noticed I was in some distress and kept asking if I was okay to which I replied I thought I'd be fine once I got some fresh air. Left the facility to drive home and didn't feel right, Within 30 minutes, developed chest pains, rash and labored breathing. I recognize the symptoms as the same symptoms I get when I've had morphine, which I now must list as an allergy. This lasted 4 hours, then got better. The next day around 1:00, I became ill again with flu-like symptoms and had to leave work. Headache and body aches mostly. I was ill with these symptoms for a 24 hour period. Hopefully all symptoms have passed, except my arm which is red, swollen, itchy and feverish.

raised lumps on legs unable to barely walk due to severe muscle aches starting evening of vaccine. Severe chills and night sweats x two weeks. Numbness, tingling in packages. Almost unable to walk.Gait is affected.

Day 1: Chills, fatigue, aches, low grade fever (under 100). Day 2: Intense fatigue Day 3: Some fatigue Day 4: Light fatigue Day 5: Sore neck on left side, as if in muscle or lymph node, slight swelling along neck, intermittent recurring rash, extreme skin sensitivity, periodic itching various sites Day 6: Same as above. Last day reported. Symptoms still existing as of writing.

With the first 8 hours, I had the typical symptoms including aches, chills, fever, pain throughout arm. The next day, sysmptoms worsened, with a fever of 101, and increased pain in my arm. It is now April 9, 2021 and my fever is gone but my arm feel numb and I have swelling in my arm pit by lymph nodes and painful to touch. I feel like my vaccine arm is not as responsive and slow. I feel tired, short of breath when I walk which keep me from my usual workout routine. I work out three times a week and before the vaccine, considered myself to be in very good health. I did have Covid 12/31/20 and my symptoms were far more mild than what I experienced taking this vaccine.

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

Tuesday 2pm-Jansen vaccine administered . Tuesday 8pm-Violent chills for 2hours followed by what felt like hot flashes and sweating, extreme joint and muscle pain. Wednesday 6am- awake w fever 101.5, horrific headache and body aches. Can barely walk to bathroom to get aspirin. Fever breaks late morning but still feel terrible, Sleep all day. Thursday am- extreme diarrhea, fever 99.5. Took aspirin and Pepto bismol Fatigue all day Thursday pm- pain and swelling at injection site. Feels like a Hard mass about 3.5 inches in diameter and raised. Extremely painful, even clothes against it causes pain that feels like a bad burn. It is now Saturday late Pm and arm is still swollen and extremely painful to The touch. Wondering if I should get it looked at. Awoke next morning w 101.5 fever Horrific body aches and headache, Exhaustion Lasted until evening (slept most of the day) extreme fatigue into following day, diarrhea and 99.5 fever two mornings later.

Became itchy on extremities. Developed rash but chest and throat. Started to have swelling to forehead and eyes. Denies SOA but states chest feels heavy. PT sent tp ED via Ambulance.

24 hrs of fever, aches and pains, chills. could not get out of bed. Day 3 fever blister occurs. Day 7 still feel very tired, headache, heavy arms/ legs. I just do not feel like myself. Slighty blurred vision and brain fog.

4/14/2021 - Patient received shot on 4/9 in left arm at an off site vaccination clinic. Developed 102 temp and some nausea. By 4/12 developed SOB and sore nodules above her collarbone on left side, but no injection site hurting or redness. Testing as done below and patient sent home with ProAir HFA and Doxycycline 100 mg bid x 7 days. Assessments: 1. Lymph node enlargement. 2. SOB Follow up 4/22/2021

Consistent non stop headache, sinus pain and inner ear ache, primarily on the left side of the body/ head. swollen lymph glands on the left side of the neck. Pain on sinuses and above eye on the left side of the head. Headache and ear pain have been present and consistent for 7 days. Abdominal pain started on day 6 and bloating of the upper abdominal area.

R arm swollen and bruised, from shoulder to elbow on the underside. Underarm tender and swollen. Took Motrin with no relieve, as of today 4/16/21 arm is still swollen from shoulder to elbow on underside and very sore, hurts to move or bend.

Left arm localized swelling, erythema, ecchymosis with warmth. Area is 11x9 cm with central area of induration without fluctuance. Started 1 day after vaccine and has persisted for 10 days. Appears more inflammatory but will treat as cellulitis as patient reports it is worsening.

Within first 2 hours: dizziness Between 1-7pm: Faster heartbeat Nausea Soreness in sacrum Lower intestine and vagina sore/tight On/off sore throat & metallic taste similar to when sick in December At 8:15pm: Chills Fever - temp 99.3 (normal is 97.5) Heels sore 10:20pm - Fever - temp 100.4 4:30am - Fever - temp 101.2 9:30am - Fever - temp 99.6 12:30pm - Temp back to normal at 97.5 Minor, dull headache for 2-3 days after Then, starting on around April 8, I have been feeling, and still feel today: soreness in my left heel, inflammation all over my body, slightly faster heartbeat, sensations in gland areas of my body (lips, neck, groin, etc), headache that comes and goes.

PAIN; BODY ACHES; SORE ARM; FEVER; TIREDNESS; SHINGLES; RASH; SWOLLEN LYMPH NODES AT HIP; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced shingles. On MAR-2021, the subject experienced swollen lymph nodes at hip. On MAR-2021, the subject experienced rash. On 26-MAR-2021, the subject experienced pain. On 26-MAR-2021, the subject experienced body aches. On 26-MAR-2021, the subject experienced sore arm. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain, body aches, sore arm, fever, and tiredness on 27-MAR-2021, had not recovered from shingles, and the outcome of swollen lymph nodes at hip and rash was not reported. This report was non-serious.

Patient described having a severe headache about 36 hours after vaccine. She also stated that she had a bruise appear on her left leg within 4 days of vaccine. A day after, she appeared to have a bump on her left hip that looked like a bug bite. She developed parathesia and was so severe that she went to the ER 04/14/2021. She returned for a second visit to the ER on 04/16/2021.

Fiery burning in both big toes, far worse in the left one. Left toe is swollen, red, at joint just below the joint.

Her arm was red and still is, swollen, and hot to the touch, on Friday and Saturday. Today the symptoms have gotten worse and it is very painful. She is wearing a loose shirt and noticed that it is sore to the touch. Pharmacist, counseled her to take two naproxen tablets 220mg every 12 hours. She went ahead and took two tablets and the pharmacist will follow up later in the day. Also advised to take diphenhydramine 25mg in a few hours if the symptoms have not resolved.

3 hours after vaccine, swollen, sore lymph nodes in neck, 4-5 hours after periods of exhaustion that would come in waves. I went to bed. The next morning, I felt extreme fatigue. I was in bed all day. About 27 hrs after vaccine (approx 6pm), I had chills. Took temp was 99.7 (my temp is always 97.6-as a baseline). Took 2 Tylenol. Took temp 30 min later was 100.6. Laid in body with 4 blankets trying to get warm. Temp lasted until Tylenol kicked in. Next day, (2 days after vaccine), left armpit lymph node sore/swollen.

Twelve days after the vaccine I got a severe headache with blurry vision. I was also short of breath and my legs were swollen. I was dizzy and had body aches mostly on my left side. My left kidney was inflamed. The pain went all the way on the left side of my body from my ribs to my legs. My left leg was the most swollen. Many of the symptoms lasted for two and a half weeks. The headache lasted for three days. The first week was the worst. When I went to the ER after a week they did not find any blood clots. The aches pains and swelling in my legs came and went over the course of three weeks. I was very tired when the symptoms were present.

A couple of hours after the shot, I had flu like symptoms, chills, fever, and a severe headache for 24 hours. I called the doctor and the headache went away. A few days later, my fingers and toes started tingling like electricity was flowing through them, with numbness. The circulation in my legs slowed down and ached really badly. I received comfort by forcing myself to walk to increase the circulation of my legs. This lasted for two weeks and was so bad that I almost went to the ER. The glands of my neck and the lymph nodes under my arms are still swollen and sore.

Patient explains that she has pain in her left shoulder, and decreased range of motion. She explains that she saw her PCP who did an x-ray of her left shoulder which showed a bursitis. Patient explains that she did a course of oral steroids. Her range of motion to that shoulder has returned to normal, she continues to have some pain, which she says she takes Motrin for.

SUBCLAVICAL LYMPH NODE SWELLING ON THE LEFT SIDE; RAISE AND TENDER ON THE RIDGE OF JAW; TENDER ON THE NECK WHEN PRESSED HURTS; LITTLE BIT WARM SWELLING ON THE RIDGE OF JAW; WARM SWELLING ON THE NECK; FATIGUE; BODY ACHES; FEVER OVER 101 DEGREES; This spontaneous report received from a patient concerned a 47 year old female. 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 expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced body aches. On 07-JUN-2021, the subject experienced fever over 101 degrees. Laboratory data included: Body temperature (NR: not provided) Over 101 degrees. On 08-JUN-2021, the subject experienced subclavical lymph node swelling on the left side. On 08-JUN-2021, the subject experienced raise and tender on the ridge of jaw. On 08-JUN-2021, the subject experienced tender on the neck when pressed hurts. On 08-JUN-2021, the subject experienced little bit warm swelling on the ridge of jaw. On 08-JUN-2021, the subject experienced warm swelling on the neck. On 08-JUN-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 09-JUN-2021, and fever over 101 degrees on 08-JUN-2021, and had not recovered from subclavical lymph node swelling on the left side, raise and tender on the ridge of jaw, fatigue, tender on the neck when pressed hurts, little bit warm swelling on the ridge of jaw, and warm swelling on the neck. This report was non-serious.

Pains in my legs severe joint pain in knees, ankles, and muscles. I ended up going to doctor first. The primary care doctor about a week after the vaccine on a Thursday he gave me Prednisone to try to get the swelling down. It kind of worked for a time. As soon as the Prednisone stopped, I couldn't walk. I was at work and they sent me home from work. I ended up in the ER and that was on 4/19/2021. They gave me shot of pain killer and a couple of prednisone again. That helped me to walk for a few days. Then I ended up back in the hospital on 5/6/2021 for the same thing. They did bloodwork and x-rays again and gave me pain killers. No prednisone at that time. Then I got in touch with a Rheumatoid Doctor, and she ordered tons of bloodwork on 5/21/2021. All of that was normal as well. If I try to walk at work, I have to go home within three days because of the pain and legs swell up so badly. I work as a teacher's aide. I have fallen a couple of times when the legs swell up. My doctor doesn't know what kind of treatment to give me until when I see the Pulmonologist except for pain killers Tramadol 50mg as needed. Try to just take one or two a day if that. I try not to take anything but I'm at the point where I can't sleep at night because of the pain ice it at night even just to stop the pain. Can't walk my dog and help take care of my mother. I would use to hit 12,000 steps by noon at work. Meth prednisone 5 pills a day at 4mgs to keep swelling just at a minimum. Still, if I try to go food shopping by 03:00 pm I am in excruciating pain for being on my legs too much. If I do laundry, I'm okay for a bit but then it's just exhaustion for the day and then I'm done for the day and that's just not me. I've lived with these autoimmune diseases my entire life and I've never had my joints swell up like they have or have been in this much pain ever.

At about day six, I developed a headache that didn't respond to Tylenol. I got joint aches in my arms, legs, and back. The headache triggered the doctor to do a CT scan which was clear, no blood clots found. The joint pains lasted about 10 days to 2 weeks and eventually went away. I have developed hamstring issues and bursitis in both of my ankles/feet area and being treated for that.

FELT SICK; SWOLLEN LYMPH NODES; INTERMITTENT FEVER; MIGRAINE; SHORTNESS OF BREATH; CHEST PAIN; CHEST PRESSURE / LUNG PRESSURE; COUGH; LETHARGY; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetic, non-alcohol user, and non-smoker, and other 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUN-2021, the subject experienced migraine. On 16-JUN-2021, the subject experienced shortness of breath. On 16-JUN-2021, the subject experienced chest pain. On 16-JUN-2021, the subject experienced chest pressure / lung pressure. On 16-JUN-2021, the subject experienced cough. On 16-JUN-2021, the subject experienced lethargy. On 16-JUN-2021, the subject experienced intermittent fever. On 19-JUN-2021, the subject experienced swollen lymph nodes. On 21-JUN-2021, the subject experienced felt sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen lymph nodes, and had not recovered from migraine, shortness of breath, chest pain, cough, lethargy, intermittent fever, chest pressure / lung pressure, and felt sick. This report was non-serious.

Patient received J&J vaccine in April. No detail on the exact date and lot number is available in system. Patient reported developing bilateral ulnar numbness and swelling at night.

Fatigue began day of vaccine, followed by chills, body aches, fever (101.7) and headache for the next approximately 36 hours. By the second or third day post-vaccine I developed hives on the back of my neck and shoulders and cold sores on my mouth and nose and continued to have a headache. I was seen by my doctor on March 12th and was told that I had a sinus infection. I was prescribed 100 mg Doxycycline Hyclate and began seeing improvements within 36 hours to the sinus infection. The hives are still clearing up and were not treated.

Headache late in the day- motrin cured Swollen arm, painful to touch- motrin, movement, and cold compresses have NOT worked as of today red, knot size lump still present on day 4

Head aches, body aches, low grade fever, sore throat, and swelling, itching and warming of injection site.

Vaccine was received Friday evening. No effects until I woke up the following morning. Saturday Only (03/13): Fever (102.3), Chills, Fatigue, Headache, Body Aches in Upper Back & Cervical Area, Knot, Swelling, & Soreness in Underarm Area of Right Arm, No Bruising but Extreme Soreness in Muscle Area of Right Arm Sunday (03/14): Fever, Chills, & Fatigue (Gone) Continuing: Headache, Body Aches in Upper Back & Cervical Area, Knot, Swelling, & Soreness in Underarm Area of Right Arm, No Bruising but Extreme Soreness in Muscle Area of Right Arm Monday (03/15): Headache (Gone) Continuing: Body Aches in Upper Back & Cervical Area, Knot, Swelling, & Soreness in Underarm Area of Right Arm, No Bruising but Extreme Soreness in Muscle Area of Right Arm Tuesday-Thursday (03/16-03/18): Body Aches in Upper Back & Cervical Area, Knot, Swelling, & Soreness in Underarm Area of Right Arm, No Bruising but Extreme Soreness in Muscle Area of Right Arm (Most of everything phased away) Tuesday (03/23): Continuing Swelling in Underarm Area of Right Arm, Faint Remaining Soreness in Muscle Area of Right Arm Side effects are phasing away slowly.

Injection arm twice size of other arm, hot to touch, huge knot, if touched causes immediate headache, painful. Also still have fatigue.

11pm I began to feel dizzy. Throughout the night started with chills, fever, sweating, headache, sore muscles, back ache, swollen left arm.

Patient presents to emergency department with allergic reaction including hives, redness over face, urticaria, and swelling since 3/23/21. Patient has taken occasional Bendaryl doses. Patient given Benadryl, Pepcid, and Solu-Medrol.

3.27: my left foot was swollen when i woke up 3.28 by 7 pm: i had hives all over my body, i was itchy everywhere and my throat began to close - i took two benadryl and when to bed 3.29 7 am: I woke up and my hives weren't as bad - only on stomach and back - continued benadryl 3.30 7 am: Same as day before - hives on stomach and back - continued benadryl, i threw up due to nausia twice and had diarrhea 3.30 8pm: I had a fever of 101 3.31 8 am: I woke up with a few hives on my stomach and back and a fever of between 100-101, i threw up from nausia.

Fever, chills, cold, tingling/burning in feet, hives, swollen hands and feet, headaches .day 4 inflamed lymph nodes still reactive.overall joints ached.

Had face and tongue swelling and tingling plus rashes starting about 15 minutes after. It was not severe but lasted entire day. At night I was shivering with fever of 100.6 - 101.3. I had such severe joint and muscle pain I could not lie down. I was so sleepy but had to get out of bed every 90 minutes or so and walk around because the pain was so bad. I was severely nauseated.

Patient recieved Janssen vaccine from us on 4/7/21. She felt fine for 24 hours after but then on 4/8/21 she started to experience extreme joint pain and aches as well as generalized all over body swelling. This lasted for about 4 days. She is finally feeling better as of today 4/12/21. Patient states when she had covid she had the same all over body swelling.

BILATERAL LYMPH NODE SWELLING BEHIND THE EARS/ LYMPH NODE SWELLING ON THE COLLARBONE TO THE RIGHT SIDE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced bilateral lymph node swelling behind the ears/ lymph node swelling on the collarbone to the right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever, and had not recovered from bilateral lymph node swelling behind the ears/ lymph node swelling on the collarbone to the right side. This report was non-serious.

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

Red, swollen, itchy, sore arm with fever and a knot . Shot taken 03/24/2021 still have a knot and tenderness in the spot where i had the shot. I used Ice packs, Tylenol

Fatigue and Swelling in face which spread to entire body and I took 5mg loratadine initially because I was at work. Headache which was intermittent throughout vaccine day and 4/12/2021 thru 4/14/2021. I took 800mg ibuprofen and 25mg diphenhydramine at 8pm 4/12/2021. Fever presented at 6:30pm on 4/12/2021. At 6:45p,m chills and shivering. I turned heater to 81 degrees . At 9;58pm my fever was 100.8 degrees F. I took 1075mg Aspirin at some point during the evening of 4/12/2021. During the day of 4/12/2021 I had joint pain and pain that progressed throughout my body. I had intense back pain from below my shoulder blades to below my waist during the day of 4/12/2021 and got progressively worse as the day progressed. Swelling slowly getting better still a little swelling on 4/14/2021. Muscle aches, Pain, still remain on 4/14/2021 but are less. Fatigue is still intense on 4/14/2021. Diphenhydramine 25mg and Aspirin 1075mg have been taken intermittently from 4/12/2021 to 4/14/2021. One dose of Meclizine 12.5mg because of dizziness on 4/13/2021.

fatigue, body aches, swelling on left side from her neck down to her feet. She reported with these symptoms on Monday 4/12/21, we gave her benedryl to take and some extra to have and recommended she follow up with her primary care phycisian. Symptoms are still ongoing as of 4/14/21.

pt says that she had a low grade temp, body aches and pains. On 4/11/2021 she was walking across the room and her knee dislocated then when back into place. Her shoulders, ankles, wrist and joints in her spine go in and out. Her CSF leak has gotten much worse. She cannot turn her head without having a problem. Her tremors from EDS are getting worse. She has an enlarged uvula and lymph nodes. She had virtual appt w/ PCP on 4/14/2021. she was prescribed antibiotics and told this was a flare up and her symptoms should get better within 6 weeks but is also going to FU w/ her specialist on 4/22/2021.hlers-Danlos Syndrome, MCAS, CSF, Spinal Instability, POTS, Dysautonomia, Asthma

Pt states she noticed Tues left leg cramping in calf back and knee and thigh that feels like a charlie horse. denies hx of blood clots or long travel Left calf swollen cool to touch. Pt states her foot is more swollen to her. Patient found to have an indeterminate age deep vein thrombosis. Discharged home from the emergency department with a prescription for Apixaban.

Severe sudden headache Friday evening, continues today... its been over 50 hours of nonstop pain. Took advil, tylenol, tylenol cold, day quil, night quil, benadryl, nothing is working totaled the headache away. The drs office gave me an injection of toradol. It took the edge off for about 30 minutes. Did not kill the pain. My temples feel very tight and veins are protruding from my temples

She got her vaccine, had some swelling, but that disappeared after about 3 days. Then on Friday 4/16/21 started having coughing, which gradually got worse to where she was having difficulty breathing when she talked which caused more coughing, and feeling like her throat was closing. She called her doctor and is waiting on a call back to go see him, but did go through a Pharmacy drive through to see if she had COVID, and if she's clear she will see her doctor when they call her back.

At approximately 9 -9:15 felt a little fuzzy headed & went to sleep. woke up at 11:30 pm and could not go back to sleep. When I woke up at 10:30 am Saturday my face was extremely swollen. My left side seemed to be more swollen then my right side. Called Dr. on Monday & decided to wait a few days. Also started to have diarrhea as well on Monday. The swelling was better by Friday. Also found that I was having trouble sleeping even though I was feeling extremely tired. That Thursday I had an extreme burning in my stomach. Only way I can describe it is that it felt like there were flames in my stomach. The burning was so bad that it was making me extremely nauseous. Friday the burning was better but the burning is still coming &going but no where near as bad as the first time. Please note that I stopped all vitamins & supplements after I received the shot on Friday. Im only still taking my adder all.

Prominent left axillary lymph nodes in area of left arm and breast. Had to get mammogram and ultrasounds done. Extensive lymph swelling and pain in left axillary area.

DISLOCATING AND SUBLUXING JOINTS; UVULA; SWOLLEN NODE; INFECTION; PAIN; TENDERNESS ON THE ARM; LOW GRADE TEMPERATURE; EHLERS-DANLOS SYNDROME; This spontaneous report received from a physician concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included ehlers-danlos syndrome (eds), and concurrent conditions included asthma, csf leak, osteoarthritis, and tendonitis. The patient experienced drug allergy when treated with erythromycin. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced ehlers-danlos syndrome. On 08-APR-2021, the subject experienced tenderness on the arm. On 08-APR-2021, the subject experienced low grade temperature. On 09-APR-2021, the subject experienced pain. On 10-APR-2021, the subject experienced dislocating and subluxing joints. On 10-APR-2021, the subject experienced uvula. On 10-APR-2021, the subject experienced swollen node. On 10-APR-2021, the subject experienced infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tenderness on the arm on 12-APR-2021, was recovering from low grade temperature, uvula, swollen node, and infection, had not recovered from pain, and dislocating and subluxing joints, and the outcome of ehlers-danlos syndrome was not reported. This report was non-serious.

About 12 hours after I received the Johnson-Covid vaccine I had moderate to severe flu like symptoms. The symptoms lasted in their intensity and severity for aproximatly 13 days. I was pretty much bed ridden. My symptoms were: moderate to severe chills and body aches, EXTREME fatigue, Lymphnodes swollen in neck, the lymp in the right side of neck is still VERY sore (oddly, the oposide side of where I recieved the vaccine). Today is the 14th day, and the symptoms have finally decreased. I thought I should let you know. I did contact my doctor twice to inform her. She suggested rest and lots of liquids.

Patient had severe lower quadrant abdominal pain and fever to 38.2 C at home. Fever starting on 4/20, abdominal pain starting on 4/21. Presented to ED and was found to have bilateral ovarian vein thromboses. Was found to be septic with WBC 23.1, blood culture growing GPC in pairs and chains (anaerobic bottle) and GPC in chains (aerobic bottle). Further speciation pending.

Events: Vaccine was given on 3/19/21; Hysterectomy on 3/25/21; blood clots diagnosed on 3/30/21 Left forearm was swollen, with a light reddish tint to it, and tender. After getting an ultra sound on my forearm a DVT was found and I was sent to the emergency room. I then had a CT scan done of my chest and it was discovered I had several pulmonary emboli. I was admitted to the hospital and put on a heparin drip. I am currently taking Eliquis and will be following up with a pulmonologist and a hematologist in a week or two.

Patient came in this evening 4/26 after emergency room visit for blood clot in leg/shin. She received Janssen IMZ 4/10. Her symptoms of painful leg began several days after her IMZ and continued to worsen with her leg shin swollen, painful, bruised with a knot until she sought medical help in the ER. Ultrasound was done and ruled out deep vein thrombosis, determined to be peripheral blood clot. She was sent home on meloxicam for pain and inflammation.

COVID-19 PNEUMONIA; ALLERGY TO VACCINE; STOOLS HARD; STOMACH SWELL UP; MUSCLE SPASMS/ CRAMPS; BREAST SWELLING; PAIN FROM BACK OF SPINE TO TOP OF THE HEAD; NUMBNESS IN THE FINGERS; ABDOMINAL TENDERNESS; BLANKED OUT; RINGING IN THE EAR; FACIAL SWELLING; PAINFUL BLISTER; DIFFICULTY EATING; This spontaneous report received from a patient concerned a 48 year old (Indian or Native/aboriginal) female. The patient's weight was 272 pounds, and height was 66 inches. The patient's past medical history included partial tubal ligation, and part of colon removed, and concurrent conditions included asthma, bronchitis, bleeding disorder (irregular period), cyst on ovary, gerd, high blood pressure, adhd, dysmenorrhea, tingling of extremities, asa allergy, narcotics allergy, soap residue allergy, lactose intolerance, tramadol allergy, sulfa antibiotics allergy, strawberry extract allergy, penicillin allergy, metronidazole allergy, nalbuphine allergy, oxybutynin allergy, bees wax allergy, haloperidol allergy, fluoxetine allergy, medroxy progesterone allergy, gabapentin allergy, and latex allergy. The patient had a blood test with her MD prior to and was told did not have Covid and could get the shot. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, administered to right arm on 16-MAR-2021, around 16:00 for prophylactic vaccination. No concomitant medications were reported. The patient was treated with injections to prevent blood clots (they did injection in the stomach area). On 16-MAR-2021, around 09:00 PM, patient experienced facial swelling and blister on the right side of her lip was burst and formed a scab and that made it difficult to eat. On next morning, 17-MAR-2021, patient had excruciating pain from top of her head to nostrils, it caused being weak and blanked out. On the day after, 18-MAR-2021, patient had a different taste and a different smell, also had ringing in the ear and was nauseous. On the 5th day, 20-MAR-2021, patient's stomach was swelled and was really tender and breast was also swelled. The patient had a lot of headache, cramps, muscle spasms, body ache and was cold and hot. The patient had diarrhoea and had to lay down and had to crawl to bathroom with throwing up. The patient had high fever and could not keep anything down. On 20-MAR-2021, the patient experienced pain from back of spine to top of the head, numbness in the fingers. On 22-APR-2021, the patient experienced hard stools. On 27-MAR-2021, patient was hospitalized as she was coughing blood. On an unknown date, patient had patches on the x-ray and was diagnosed with pneumonia and her Covid (unknown) test was positive. Patient reported that she was given injections to prevent blood clots in the stomach area. The patient had pain back from spine to top of the head, was weak, had numbness in the fingers. She had headache, had lost appetite. The patient reported that as per her healthcare providers, was allergic to the vaccine as they noted shortness of breath, nausea and diarrhea. Laboratory data included: Body temperature (NR: not provided) High. On 27-MAR-2021, COVID-19 virus test positive (NR: not provided) positive, and X-ray (NR: not provided) blood patched, pneumonia. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 pneumonia, and ringing in the ear, was recovering from facial swelling, painful blister, difficulty eating, stomach swell up, muscle spasms/ cramps, blanked out, and abdominal tenderness, had not recovered from pain from back of spine to top of the head, numbness in the fingers, and stools hard, and the outcome of allergy to vaccine and breast swelling was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210507603-covid-19 vaccine ad26.cov2.s -covid-19 pneumonia. 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: UNDERLYING DISEASE

SWOLLEN FACE; RASH WENT DOWN THE BODY TO THE KNEES; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included poison ivy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: amoxicillin/clavulanic acid ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On APR-2021, the subject experienced rash went down the body to the knees. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fever. Laboratory data included: Blood test (NR: not provided) High inflammatory markers present (markers unspecified), and COVID-19 virus test (NR: not provided) Negative. On 11-APR-2021, the subject experienced swollen face. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash went down the body to the knees, and swollen face, and the outcome of nausea and fever was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

On Saturday, April 10, 2021, I had started having pain and swelling in my right calf that lasted for several days on and Tuesday, April 13th, I started having pain on the left side of my chest. On Thursday, April 15th, I went to the ER due to pain and selling in my leg and it was discovered that I had 2 clots in my leg (on at my calf and a second one on the right side of my knee). Not realizing my chest pain was related, I discussed with my primary care at a follow up visit on Monday, April 19th, and a CT scan was performed confirming I have an pulmonary embolism (extensive pulmonary emboli in both lungs). I was immediately put on Xarelto blood thinner and sent home.

Within 2 days, the lymph nodes at my collar bone/neck on the left side began to swell. By the following Tuesday, I went to the ER for the enlargement. Routine blood tests showed nothing unusual (lymphoma). Was sent home to see my doctor if the swelling doesn't subside. Scheduled an appointment with my PCM on 23 Apr 2021 (virtual - they are not seeing in-person patients yet). By this point, the swelling had not subsided and there was new pain in my left elbow shooting dow nto my hand. The doctor prescribed Naprosyn, lidocaine patches, and a wrist brace to keep the nerves stable. Was told it was "pain management" until the swelling from the lymph nodes go down. It is now 6 weeks post-vaccine and the pain and swelling is still the same. I have been unable to secure an appointment with my PCM. For the past 6 weeks, my pain level has been at a steady 8 out 10.

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

Still ongoing 4 days after shot and still ongoing - fever, chills, stiff, achy all over, drowsy, sweats, headache, nausea, wheezing and congestion, terrible pain in lymph nodes in L armpit and neck - - injection site is hard, hot, red, and worsening still today (three days later), getting bigger and bigger. Occasional sharp pain in injection site area. Itchy skin in injection site area.

At 1615 (3/23/21), experienced left leg heaviness, intermittent chest pain, body aches, fever 102.5, headache, chills, rigors, and tachycardia - most symptoms lasted only 36 hours. Left leg heaviness persisted and is still present. Intermittent chest pain x 10 days. Near syncope lasting from days 4-11 post vaccine - with one syncopal event occurring on day 5. Tachycardia and palpitations persist. April 14 - chest pain returned. On April 15 - Went to Emergency Department for heart rate of 172, shortness of breath, and palpitiations. Persistent left leg heaviness since vaccination. Evaluated for potential pulmonary embolism, myocardial infarction, DVT, and post Covid vaccine infectious pericarditis, Admitted to Hospital overnight. Tested negative for Covid-19. Left leg heaviness persists. Intermittent tachycardia persists. May 10 developed a cold sore 1 day post sun exposure (normal for me). Evening of May 11 - fever, tachycardia, body aches, headache, chills. May 11 - negative Covid test May 20 - message from CDC requesting I fill out a VAERS.

RECEIVED vaccine 5/18/21; 5/20/21 evening, large red, swollen area with moderate tenderness to injection site - arm was one inch bigger in diameter than non vaccinated arm - lasted close to a week; 5/23/21 afternoon, noted moderate swelling on lymph node under ear lobe behind jaw, tenderness to palpation, fatigue, any chewing on that side of mouth was unbearable as sharp shooting pains in the swollen area resulted; was unable to close jaw fully due to pain during this time; remained on soft food and liquids only through 5/27/21. Lymph swelling subsided this day, while tenderness continued through 5/30/21.

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

CALL OFF WORK; JOINT PAIN; NAUSEA; HEADACHE; FATIGUE/ TIREDNESS; ARM ACHE; NEUROPATHY; DIARRHEA; BODYACHE AND LITTLE SHARP PAINS EVERYWHERE; SWOLLEN LYMPH NODES; BLURRY VISION; LETHARGIC; STOMACH CRAMPS; SWEATS; VOMITING; STOMACH DISCOMFORT; This spontaneous report received from a patient concerned a 48 year old female of unspecified ethnic origin. The patient's weight was 195 pounds and height was 70 inches. The patient's past medical history included Covid-19 (DEC-2020) and concurrent conditions included Hashimoto's disease, thyroid disease, blood pressure, leukocytosis, celiac disease, anemia, and auto immune disease. She had loss of smell, loss of taste since last 6 months. Patient was non alcohol user and non smoker. She was on a gluten free diet. The patient experienced drug allergy when treated with Dilaudid and Neomycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: 23-JUN-2021) dose was not reported, 1 total dose administered on 10-JUN-2021 at 15:15 to right arm for prophylactic vaccination. Concomitant medications included Synthroid (levothyroxine sodium), hydrochlorothiazide and Claritin D (Loratadine/pseudoephedrine sulfate). On 12-JUN-2021, the patient experienced neuropathy, diarrhea, body ache, little sharp pains everywhere, swollen lymph nodes, blurry vision, lethargy/ tiredness, stomach cramps, sweats, vomiting, arm ache, nausea and headache. On 13-JUN-2021, the patient experienced joint pain. On JUN-2021, the patient experienced stomach discomfort and fatigue. On 14-JUN-2021 patient reported that she had to call off work and she did not have fever. She had not seen her doctor yet but would call the doctor. Treatment medications (dates unspecified) included: Aspirin (acetylsalicylic acid), Tylenol (paracetamol) and Ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neuropathy on JUN-2021, was recovering from nausea, and vomiting, had not recovered from diarrhea, bodyache and little sharp pains everywhere, arm ache, headache, swollen lymph nodes, blurry vision, lethargic, stomach cramps, sweats, joint pain, stomach discomfort, and fatigue/ tiredness, and the outcome of call off work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210629819- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Neuropathy. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Since last report the chemical taste in my mouth went away. I managed to get bac my balance, ability to read, drive and my left and right side are working together again, vision has improved, pain continues at base of neck. I still have some nausea with the ear issue. The tinnitus has gotten worse but only on left ear, It was buzzing but now it is loud ringing. On 06/14/2021 I started getting a fullness of fluid and pain in left ear. I am also having runny eye in left eye, almost allergy like, the eye thing has cleared but the ear thing has not, lymph nodes still very swollen. I did get a cat scan before to rule out a clot and stroke symptoms so they did rule out stroke symptoms. I am redhead and I have heard that people with red hair are more sensitive to the vaccine and I am also small in stature so possibly the dose might be too high. I am also very sensitive to most meds.

ITCHING; JOINT PAIN; HEADACHE; ADMINISTERED HALF DOSE OF JANSSEN COVID-19 VACCINE; OFF LABEL USE; ANAPHYLACTIC SHOCK; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mast cell activation syndrome, non smoker, and non alcoholic, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with moxifloxacin hydrochloride, azithromycin, methylprednisolone, phenelzine, and bupropion hydrochloride for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, one total, administered on right deltoid on 17-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Benadryl continuous IV - 300 mg/24 hours for drug used for unknown indication and takes rescue Benadryl - 50 mg as needed for drug used for unknown indication. On 17-JUN-2021, Doctor administered half dose of vaccine because of patient's condition (mast cell activation syndrome). On 17-JUN-2021, patient went into anaphylactic shock 3 minutes later after vaccination and was administered Epi-pen (epinephrine). On 17-JUN-2021, the patient experienced headache. On 19-JUN-2021, the patient experienced itching and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic shock, and headache on 17-JUN-2021, was recovering from itching, had not recovered from joint pain, and the outcome of administered half dose of Janssen covid-19 vaccine and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210660183- Covid-19 vaccine ad26.cov2.s- Anaphylactic shock, itching. 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 20210660183- Covid-19 vaccine ad26.cov2.s- Joint pain, headache. This event(s) is labeled per RSI and is therefore considered potentially related.

SHORTNESS OF BREATH; BLURRED VISION; LEG SWELLING; TACHYCARDIA; EASY BRUISING; LEG PAIN; HEADACHES; INJECTION SITE PAIN; WEAKNESS; This spontaneous report received from a patient concerned a 48 year old female. 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, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication. On 28-MAY-2021, the subject experienced shortness of breath. On 28-MAY-2021, the subject experienced blurred vision. On 28-MAY-2021, the subject experienced leg swelling. On 28-MAY-2021, the subject experienced tachycardia. On 28-MAY-2021, the subject experienced easy bruising. On 28-MAY-2021, the subject experienced leg pain. On 28-MAY-2021, the subject experienced headaches. On 28-MAY-2021, the subject experienced injection site pain. On 28-MAY-2021, the subject experienced weakness. On 06-JUN-2021, Laboratory data included: Duplex ultrasound (NR: not provided) Negative. Treatment medications (dates unspecified) included: tramadol, and naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, blurred vision, tachycardia, easy bruising, headaches, injection site pain, and weakness, and had not recovered from leg pain, and leg swelling. This report was non-serious.

Started with nausea. Then omitting (without GI disturbances). Around noon, symptoms included severe body pain, feet swelling, headache, light and noise sensitivity, foggy thought process, and facial rash with noticeable hair loss comparable to a Lupus flare prior to treatment several years ago. Low grade temperature of 99 for a few days. The symptoms have improved, however, thinking is very foggy. Physician ordered Phenergan for nausea and vomiting; as well as: hydration and rest. Ibuprofen for headache and joint and body pain. Ambien to sleep. This has been going on for four days.

Day 1 Sweats, Severe Headache, Fatigue and aches Day 2 Headaches and Sweats Day 3 Profuse sweating, fatigue, headache and aches Day 4 Sweats, Headache Day 5 HIVES, Headache Day 6 HIVES, ANAPHYLAXIC Swelling in hands, feet, tongue & throat. Had to go to the ER! Day 7 Swelling, hives Day 8 Hives Day 9 Hives Day 10 Hives Day 11 Hives Day 12 started to subside

Woke up with discomfort/pain in my breastbone area. It spread to my esophageal tube (extremely tender), a couple hours later my throat became strep-like sore, could not take a full breath, and throat swelling impacted my ability to talk clearly. About 12 hours later, I had facial swelling. One full day later, a chain-like rash appeared on my arms, chest, thighs, and feet. Each subsequent day is spread to a new body part (but never occurred on my face), I had to take Benadryl EVERY 4-5 hours to keep everything at bay. Three days into the event my neck and torso skin were extremely painful to touch. Most days since, I am exhausted and get winded easily. Today is 30MAR21 and it's happening again as it began on 21MAR21. I took two Benadryl in the hopes I will not have to go to ER again.

Soon after the shot I felt a herpes breakout coming. I almost never get break outs, I think it was kicked off by the vaccine.

Started between the night of the vaccine, flu like symptoms, chills, extreme headache that floored me, cold sweats, fever, I couldn't eat or drink, and because of extreme exhaustion could not get out of bed and I ended up going to the ER Monday night I had an itchy throat and my arm was swollen, red and itchy.

HERPES OUTBREAK; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non smoker, and herpes, and other pre-existing medical conditions included no known allergies. no drug abuse illicit drug use. 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 to left arm on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced herpes outbreak. Treatment medications (dates unspecified) included: valaciclovir hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from herpes outbreak. This report was non-serious.; Sender's Comments: V0: medical assessment comment not required as per standard procedure as the case is assessed as non serious

(Pharmacy was the pharmacy that provided the Vaccination.) I had fever, headache and body aches that started 24 hours after and they lasted about 36 hours. OTC cold and pain medication was taken for those. I had significant swelling under my left arm in the armpit. That lasted for about a week. At the same time as the fever, headache and body aches started, I had swelling under the eyes that started in the upper eyelids for about a week and that went down to the lower lids about a week post vaccination and since then it has been upper and lower eyelids - significant swelling and on March 30th (started me on the Prednisone on this date) - it initially helped and then it went back to worse than it was before. and on April 7th Benadryl and Neomycin- a topical steroid I've been applying under the eyes for that. The swelling was significant until this last Wednesday when I got on these two meds. Today I had a phone call visit with my doctor as a follow up to how the meds were doing. Recovery is progressing at this time.

At the time of injection my tongue got itchy. I could feel it traveling across my face. I sat inside for 30 minutes and another 30 in the parking lot. Around 7 pm I got flu like symptoms that lasted for 36 hours and a vise like headache that lasted for about 60 hours. A week later I got hives on both arms swollen and itchy all over my body. I felt my throat constricting a bit. The rash itchiness is still ongoing.

patient woke with Left leg swelling and pain, s/p Johnson/johnson vaccine. Pt referred to ER for R/O DVT

Vaccination given- Janssen, 03/15/2021, right deltoid c/o fever day of vaccine, subjective lasted 3 days 03/18/21,onset of upper abdominal pain,left arm pain, left foot sweeling, ankle to toes, currenlty swelling to foot has resolved, continues to have left arm pain, tingling sensation to left arm and abdominal pain with intermittent SOB "It is not related to my asthma" abdominal pain is intermittent, happens at random times, currently abdominal pain 4//10, best 0/10, worse 9/10, Acetaminophen relieves the symtoms, not sure what is exacerbating the pain >denies pain, swelling to injection site, fever, chills, fatigue, bodyaches, leg pain, hives, n/v, diarrhea, neurological deficits, change in level of consciousness, seizure activity, visual disturbances

Husband called this am ( 04/14/2021) to ask questions about pt" side effects of vaccine" Called and spoke to pt. .Pt reports receiving J&J vaccine on 04/12/2021 at 12:30 pm. She began noticing " a severe headache" about 5:30 pm. She relays between 8:00 and 10:00 pm she begin experiencing " leg weakness that made it hard to walk" " I was suddenly walking like a 95 year old woman". This continued and on 04/13/2021 she reports that she noted " the tops of both feet became numb and my left foot was swollen" Relays legs now hurt to front and back of thighs and also at times behind knees. This am ( 04/14/2021) she reports " when I take a deep breath a pain shoots from my throat to underneath my right armpit. Advised pt to go to ED now and notify them of recent vaccine.

Monday night had very bad sweats/chills and was tired/sore as expected. Tuesday my lymph node glands in my throat on the side where I got the vaccine swelled nearly three times their size. I felt flu-like symptoms: fever, exhaustion, weakness, body aches and a headache. Wednesday I felt the same and nauseous in the evening. I had iced my lymph nodes and that helped a little with the soreness. (Took IB off/on since Monday as I thought I had a low fever and was achey/headachey). Thursday, I noticed that the soreness/pain in my lymph nodes moved up my jaw and to my ear (on the side where I got the vaccine). I still felt weak and tired. I tried to work at 11:15a and felt my brain couldn't quite think straight. Today (Fri.), pain in jaw/side of head and headache continue. Think the swollen glands are making it hurt when I swallow. Felt a little something in my leg; but would not say it was painful. NO abdominal pain or trouble breathing.

Within 5 minutes of the shot, I started to have difficulty swallowing. I notified the staff at the clinic, They put me in a separate room where I took 50mg Benadryl. I continued having difficulty swallowing along with tingling in tongue and lips. I then decided to give myself an Epipen 0.3mg shot. I had this with me because I had a severe allergic reaction in January to Pfizer COVID 19 vaccine. 911 was called. In the ambulance, IV Benadryl and Solu-Medrol was administered. My face was starting to itch on the way to hospital even after IV medication administered. I was monitored for 2 hours in hospital. I was also given normal saline IV in the hospital. I was discharged with Pepcid 20mg daily for 4 days and Prednisone 50mg daily for 3 days. I consistently had to take Benadryl 50mg for three days to keep itching and swelling at bay.

ON 4/15 had an anaphylactic reaction and went to the ER at medical center (throat closing and body swelling) saw MD, no admittance sent home, provided bendadryl, steroids and Pepcid . No blood work or scans. On 4/16 had collapsed/fainted at home. Went to ER at different medical center. Saw MD Just gave fluids, CT scan and chest X-ray and blood work. sent home.

Abdominal pain, nausea and dizziness started two hours after shot. Following day flu symptoms with tenderness to all lymphnodes, especially abdominal and groin area. Abdominal pain and nausea persisted for 10 days. Still experiencing some tenderness and nausea.

Injection at approximately 9:15 am (Saturday, March 6th). Nausea, vomiting, and diarrhea began at 6:30 pm. High fever (103+) began at approximately 7:45pm, and lasted until 4:00 am (Sunday, March 7th). SEVERE ringing in both ears lasted until 1:00 pm the following day (Monday, March 8th). Woke up to 2 fever blisters on Monday, March 8th (Note: I have never had these in my life).

About a week after the vaccine I noticed a lymph node was swollen underneath my right pectoral muscle. My chiropractor pointed it out that it was visible. One at the base of my skull one on my right pectoral muscle and in both arm pits. The one on my occipital region is the most painful. The one on the left side are still swollen after four weeks. The one in my arm pit was painful with palpating it. They have seemed ot reduce in size but they are still swollen.

On the 4th day following the vaccine I woke up with swelling in my left armpit about the size of a golf ball. Achiness on the left side of my face, neck and shoulders that lasted till the 8th day. By the 14th day, the swelling in my left armpit had shrunk to the size of a large acorn with an enlarged vein like tissue protruding down my inner armpit. This area was still sore. On Day 21st I saw a doctor who suspected a blood clot and ordered an ultrasound at the hospital and blood work. After an ultrasound for approximately an hour the technical did not detect a blood clot and sent me home. The doctor phoned me to tell me they did not find anything and that if the pain and swelling continues I could see a surgeon to have the enlarged area surgically removed.

SINUS CLOGGED/ SINUS HEADACHE; SHOOTING NERVE PAIN IN BACK; FACE SWOLLEN; SHAKES; ITCHY; SHARP NERVE PAIN IN SPINE; INCREASED BLOOD PRESSURE; FEELING LIKE FLU; ARTHRITIC PAIN; LEG CRAMPS; NAUSEA; DIZZINESS; ANXIETY; BLURRING OF EYES; This spontaneous report received from a patient concerned a 49-year-old female. The patient's weight was 185 pounds, and height was not reported. The patient's 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: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021, Laboratory data included: Blood pressure (NR: not provided) 160/90 mmHg. On 08-APR-2021, within 5 minutes after vaccination the patient experienced dizziness, chills with shakes, nausea, anxiety and 20 minutes later she was evaluated by an emergency medical services onsite. On 08-Apr-2021, Blood pressure (BP) reading was 240/130 mmHg. She was kept under evaluation at the vaccination site until BP was 160/90. She experienced pain (body aches, shooting nerve pain in back with itching, arthritic pain from neck to spine and in hands) which began around midnight on 09-Apr-2021 and in morning she experienced full blown flu (ringing of ears, face swollen, sinus clogged, headache, body ache, chill). On 09-Apr-2021, Blood pressure (BP) reading was 153/87 mmHg The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, blurring of eyes, and nausea on 08-APR-2021, had not recovered from increased blood pressure, itchy, arthritic pain, sharp nerve pain in spine, leg cramps, feeling like flu, and anxiety, and the outcome of sinus clogged/ sinus headache, shooting nerve pain in back, face swollen and shakes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210417592-Covid-19 vaccine ad26.cov2.s-Increased blood pressure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Chronic full intense back and knee pain with radiating stomach bloat and pain with intermittent diarrhea and constipation. Nauseous on and off. Extreme fatigue with off and on chills. All Started about 7 days after shot.

I applied it on Sunday, April 4, that day my head hurt a lot, my arm and neck took me acetaminophen and it produced a lot of sleep I fell asleep from 11 am to 700 pm without waking up The next day my head hurt a lot, my arm and in general my body and so 4 days went by on the fourth day My general discomfort and headache decreased. On Saturday 10 the general malaise the headache a little fever and on Monday the symptoms worsened on Wednesday I can not hold it anymore and my legs began to swell more and to redden and my veins were began to sprout and I felt that I was burning, I requested a medical appointment and I have been disabled since that day and the symptoms yes

CHEST DISCOMFORT; LYMPH NODE IN RIGHT ARM PIT SWOLLEN; FELT LIKE FLU; HEAD FOGGINESS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included mild case of covid, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2020, Laboratory data included: Platelet count (NR: not provided) 417K/mcL. On 07-APR-2021, the subject experienced head fogginess. On 08-APR-2021, the subject experienced felt like flu. On 09-APR-2021, the subject experienced chest discomfort. On 09-APR-2021, the subject experienced lymph node in right arm pit swollen. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Platelet count (NR: not provided) 331K/mcL. On 16-APR-2021, Laboratory data included: CT scan (NR: not provided) unknown, and Chest X-ray (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest discomfort on 21-APR-2021, and lymph node in right arm pit swollen on 13-APR-2021, and had not recovered from felt like flu, and head fogginess. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure since case is assessed as non-serious.

PATIENT COUDN'T WALK SINCE 23RD, 12DAYS AFTER RECEIVING VACCINE. LEFT LEG SWEELLED UP. HUSBAND TOOK HER TO EMERGENCY DR'S DID FULL STROKE PROTOCOL. PATIENT IS STILL IN ICU.

Fever and chills first night. Then for two weeks major fatigue, dizziness, weakness. I could barely walk up stairs. Neck lymph nodes still swollrn

LYMPH NODE SWELLING; MUSCLE TWITCHING; TACHYCARDIA; CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 49 year old female. 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: 1808609 and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Heart rate (NR: not provided) 120-130 heart rate when resting. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced tachycardia. On 18-APR-2021, the subject experienced lymph node swelling. On 18-APR-2021, the subject experienced muscle twitching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 03-APR-2021, and fever, and headache on 06-APR-2021, and was recovering from tachycardia, lymph node swelling, and muscle twitching. This report was non-serious.

Systemic: Lymph Node Swelling-Severe, Additional Details: Knot size of a tennis ball developed under vaccinated arm, in armpit area. very painful and swollen

HIGH BLOOD PRESSURE; NO APPETITE; SWOLLEN ARM; PALPITATION; PAIN; HEADACHE; This spontaneous report received from a physician concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included tendon surgery on the right limb, and concurrent conditions included COPD (chronic obstructive pulmonary disorder), non alcohol user, non smoker, thyroid, diabetic, no drug abuse or illicit drug usage, and hysterectomy, 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, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the patient experienced high blood pressure, no appetite, swollen arm, pain, palpitation and headache, and was hospitalized for same. On 06-May-2021, the patient was discharged. Laboratory data included: Blood pressure high (NR: not provided) 140/126, 159/156, 172/111. Treatment medications (dates unspecified) included: tramadol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure, headache, no appetite, and swollen arm, and the outcome of palpitation and pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210516972-JANSSEN COVID-19 VACCINE-High blood pressure ,no appetite, swollen arm, palpitations, pain - 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) 20210516972-JANSSEN COVID-19 VACCINE- Headache. This event(s) is labeled per RSI and is therefore considered potentially related.

4/6 vaccination 4/12 HA 4/13 HA turned into migraine, legs started to tingle, achy. Zero sleep due to pain. 4/14 Both extremities very swollen. Rotating between Tylenol and Ibuprofen (started on Tues). I went to my PCM. BP 130/98. Prescribed water pill but only to take on Friday if symptoms got worse, not better. 4/15 Sick all day. By 5pm, I couldn't even focus, my legs were so swollen, my 'head was ready to explode' and I 'didn't feel right. I went to urgent care; 160/98 BP and referred to the ER. I went to the ER, BP was still elevated, legs still swollen. Checked my heart, ultra sound on my legs and x-ray. I was kind of 'out of it'. They did everything to check for blood clots and heart; everything came back clear. They gave me some medicine for my head thru IV. I still left with HA but didn't feel as bad. That helped my BP went down. I was at the ER 2-3 hours, drinking lots of water. The next day the swelling started to go down on the legs and migraine was subsided. By Sat., I felt fine.

8 hr post vaccine, typical side fx (fever, headache), but also significant bi-lateral leg cramping and spasms that continued for 6-8 hours. Spasms were prominent in inner thigh/groin and down entire legs. Legs were not movable (heavy), difficult to get out of bed or walk. Very strange and nothing like this ever experienced before shot. Fine next day. Around 4/9, pain began in ball of R foot in the AM, hard to walk. Over next few days, pain extended up to medial posterior calf (very painful), back of knee and groin. Unexplained bruising on lateral calf. 4/20 woke to swelling of R leg (ankle, posterior knee, groin), went to Urgent Care that night and was sent directly to ER for DVT symptoms. ER Ultrasound showed no clot, was sent home. Pain continued to increase, with burning and difficulty walking. Second Ultrasound done 4/22. No clots found. Pain continued to worsen, with swelling/aching on front of calf and severe foot pain. Veins/skin tender. Painful groin spasms happen again, same as night of shot. PCP ordered ABI and spine Xray. ABI was normal. Xray showed same issue as 29 yrs ago (prior known L5S1 anterolisthesis; have not had back pain for many years...when I did, it was localised to spine and sciatic in the L hip, was not at all similar to these current issues in R leg. perhaps related if inflammed, but is vastly different in symptoms and unlike past history). Saw Vascular Surgeon 4/30, ordered abdominal CT Abdomen Pelvis w IV Contrast. results normal. arm bruising at IV and blood draw site. Saw second Vascular Surgeon 5/4 who felt pain related to inflammation response and ordered CBC. Platelets 178. (patient had requested this test starting on 4/20, this was the first doctor to order it). Pain continued but some relief found with compression socks. on 5/10 US Bilateral lower extremity venous duplex with reflux study was done on both legs. No DVTs, but damaged valves and reflux in the external iliac common femoral vein and femoral veins proximal segment (worse in R leg) and great saphenous vein at the sapheno-femoral junction (R only). These areas are where the spasms are happening but doctor not able to conclude relation, wants neuro consult, could be nerves causing spasms. Doctor prescribed compression socks for venous insufficiency concerns, to be rescanned annually for life. Vascular test results don't explain severe pain in calf and foot and referred to Neurologist for 5/28 visit. As of today, 5/22, pain is persistent. Pain/swelling is reduced with use of compression socks but returns without them; walking is difficult in the AM and PM hours; night time spasms. Have also had shooting pains in L calf, both forearms, and ribs (back). These occur mostly in the evening (nerve?). Taking magnesium & extra vitamin D seems to help some. On strict anti-inflammatory diet. I'd really like some guidance for treatment and what to do about boosters - do I switch to an mRNA vaccine? I am a very healthy active 49 yr old woman who felt fine before the shot, and now I've been in a lot of pain, working greatly reduced hours for almost 4 weeks. Please advise on what can be done to help. Concerned about permanent damage and how to handle future vaccines. (also of note: first menstruation period was skipped after the shot, second period came a week late and was very heavy with bright red blood. I am normally extremely regular, mod-heavy flow; also, the J&J shot I had was a "last shot of the day" extra dose. I was offered it while having a routine physical. Could it have been improperly stored, as the last leftover dose? Very unlikely since it was a doctors office, but including this info)

INCREASED FATIGUE, HEADACHE, CHILLS, FEVER, LOSS OF SMELL/TASTE, ALL OVER PAIN (JOINT,BONES, MUSCLES, SKIN) FEELS LIKE IM 90 ALMOST CRIPPLING, DONT HAVE TO DO ANYTHING TO BE IN PAIN, EXTREME TEMP VARIATION FREEZING COLD OR BURNING UP, BRUISING, SWELLING, RASH ITCHY/TINGLING/TIGHT SKIN, NUMBNESS, MILD VISION CHANGES, SOME SHORTNESS OF BREATH (UNSURE IF INCREASED OR SAME) WEIGHT CHANGES, INCREASED MALAISE.

The next day after my left arm got really swole and it begin to tingle. I reached out to my PCP who advised I see a Specialist and gave an Anti-inflammatory but it did nothing. A couple week later around 2:30am I woke up out of my sleep with severe shakes in my chest area, my arms and hands go so clammy and I felt so anxious I couldnt sit still and was pasing back and forward. I had the sense of feeling choked. The shakes were so bad causing me to get up and walk around. At 4am I went for a walk in the neighborhood because I still could not stop shaking and remain still. I was so adjitated around 6am I got up and began to drive to the beach then all of the sudden after about 20 minutes I had to pull over because my arms from elbow down went numb and I couldn't drive. I was still so jittery and shaky but was able to make it to the ER where I was monitor for about 5 hrs. CBC and Urinalysis were done but everything seemed normal. For about 10 days I had that shaky feeling, tightness in my chest area and just felt really crappy. My PCP perscribed a few different Anti-anxiety meds but I had an allergic reaction to those so I could not take any of those either. I have an appointment with the Neurologist 7/26.

SWOLLEN LYMPH NODES UNDER HER ARMPIT; PAIN IN LEFT BREAST; KNOT IN BREAST; EXCRUCIATING BACK PAIN THAT COMES SHARPELY AND GOSE QUICKLY; ARM PAIN WHEN THE INJECTION SIDE HAS BEEN SQUEEZED OR PRESSED; This spontaneous report received from a patient concerned a 49 year old female. 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, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced arm pain when the injection side has been squeezed or pressed. On 14-JUN-2021, the subject experienced excruciating back pain that comes sharpely and gose quickly. On an unspecified date, the subject experienced swollen lymph nodes under her armpit, pain in left breast, and knot in breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain when the injection side has been squeezed or pressed, swollen lymph nodes under her armpit, pain in left breast, excruciating back pain that comes sharpely and gose quickly, and knot in breast. This report was non-serious.

Injection site swelling under arm for 2 weeks, 3 weeks after injection had an A-Fib event, now on blood thinners and heart meds, no issues BEFORE vaccination

Dizziness, vomiting, diarrhea, headache on the left side, stiff eyes, ear ache left ear, heart racing, tired easily, left shoulder stiff, muscles on left side of upper back very tense, left wrist sore, left nostril swollen and sore inside and swelling of the face mostly on the left side. Doctor visit, prescribed promethazine and told to take acetaminophen. Labs were ordered.

SEVERE INFLAMMATION; WEAK RIGHT LEG; ANXIETY; SEVERE HEADACHES/ "BUBBLES" GOING UP THE BACK OF THE HEAD; SHOOTING PAIN IN FOREARM; NAUSEA; VALVES DAMAGED (SAME AREAS WHERE THE SPASMS WERE OCCURRING); NERVE PAIN; HARD TIME SLEEPING; SKIN HURT TO TOUCH (SENSATION OF BUGS CRAWLING UP THE LEG).; 4-5 BRUISES FROM CALF TO ANKLE THAT DID NOT LINE UP WITH THE PAIN.; SWELLING AROUND THE ANKLE, KNEE AND GROIN (ALL IN THE RIGHT LEG); PAIN AND CRAMPING IN CALF; DIFFICULT TO GET OUT OF THE BED (DUE TO THE SPAMS AND THE FEELING IN HER LEGS); LEGS FELT LIKE WEIGHED 500 LBS (NOT PAINFULL); STRANGE SPAMS LIKE FULL BODY TREMORED (CONCENTRATED IN THE LEGS AND GROIN)/ SPASM IN BOTH LEGS; NUMBNESS IN FOOT; SWELLING IN LEG; BURNING SENSATION; IRREGULAR MENSTRUAL CYCLE (NO SIGNS OF MENOPAUSE); EXTRA DOSE; CHILLS; ICKY; SMALL PATCH OF PAIN OF THE FOOT PAD TOWARDS THE OUTSIDE OF THE FOOT/ SORE ARM/ PAIN IN ARM/ AREA OF PAIN GOT BIGGER; FEVER; TIRED; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 115 pounds, and height was 62 inches. The patient's past medical history included spinal injury, and left sided sciatica pain, and concurrent conditions included non-smoker, gluten allergy, and alcohol user (occasionally (1 drink/day)), and other pre-existing medical conditions included the 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: 042A421A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced irregular menstrual cycle (no signs of menopause). On 31-MAR-2021, the subject experienced extra dose. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced icky. On 31-MAR-2021, the subject experienced small patch of pain of the foot pad towards the outside of the foot/ sore arm/ pain in arm/ area of pain got bigger. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced tired. On APR-2021, the subject experienced swelling in leg. On APR-2021, the subject experienced burning sensation. On 01-APR-2021, the subject experienced strange spams like full body tremored (concentrated in the legs and groin) / spasm in both legs. On 01-APR-2021, the subject experienced numbness in foot. On 01-APR-2021, the subject experienced difficult to get out of the bed (due to the spams and the feeling in her legs). On 01-APR-2021, the subject experienced legs felt like weighed 500 lbs (not painfull). On 11-APR-2021, the subject experienced pain and cramping in calf. On 20-APR-2021, the subject experienced 4-5 bruises from calf to ankle that did not line up with the pain. On 20-APR-2021, the subject experienced swelling around the ankle, knee and groin (all in the right leg). On 20-APR-2021, the subject experienced skin hurt to touch (sensation of bugs crawling up the leg). Laboratory data included: Diagnostic ultrasound (NR: not provided) Didn't find a clot. On 23-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative. On 29-APR-2021, the subject experienced hard time sleeping. On 30-APR-2021, Laboratory data included: Ankle brachial index (NR: not provided) all clear, Computerized tomogram pelvis and abdomen (NR: not provided) all clear, and Spine X-ray (NR: not provided) all clear. On MAY-2021, the subject experienced valves damaged (same areas where the spasms were occurring). On MAY-2021, the subject experienced nerve pain. Laboratory data included: Cardiac ultrasound (NR: not provided) valvular damage coinciding with pain on legs. On 04-MAY-2021, Laboratory data included: CBC (NR: not provided) all normal, Platelet count (NR: not provided) 178 (lower than her normal), and Protein (NR: not provided) Result not reported. On JUN-2021, the subject experienced nausea. On an unspecified date, the subject experienced shooting pain in forearm, severe inflammation, anxiety, weak right leg, and severe headaches/ "bubbles" going up the back of the head. Laboratory data (dates unspecified) included: Reflex test (NR: not provided) result not reported, Right leg was weaker. Treatment medications (dates unspecified) included: ibuprofen, magnesium, acetylsalicylic acid, paracetamol, tocopheryl acetate, and ergocalciferol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from strange spams like full body tremored (concentrated in the legs and groin)/ spasm in both legs, burning sensation, chills, fever, and tired, irregular menstrual cycle (no signs of menopause) on 31-MAR-2021, and difficult to get out of the bed (due to the spams and the feeling in her legs), and legs felt like weighed 500 lbs (not painfull) on 01-APR-2021, was recovering from small patch of pain of the foot pad towards the outside of the foot/ sore arm/ pain in arm/ area of pain got bigger, severe headaches/ "bubbles" going up the back of the head, numbness in foot, pain and cramping in calf, 4-5 bruises from calf to ankle that did not line up with the pain., weak right leg, nausea, icky, extra dose, swelling in leg, swelling around the ankle, knee and groin (all in the right leg), skin hurt to touch (sensation of bugs crawling up the leg)., hard time sleeping, severe inflammation, valves damaged (same areas where the spasms were occurring), nerve pain, and anxiety, and had not recovered from shooting pain in forearm. This report was non-serious.

nausea. vomiting. stomach pain. existing acid reflux is much worse. lack of appetite. this is over about 36 hour period. sleep disruption due to stomach pain and acid in throat. drinking both decaf black tea and regular green tea with honey, milk. occassional calcium carbonate chew. also some swelling and tightness in ankles, feet, and shins. massages to these areas. digestive disruptions are the most painful and disruptive.

Began with visual changes, numbness on June 25th; admitted to hospital July 9-12th, 2021 w/ presumtive Guillain Barre syndrome; has had CT scan showing no lesions

Patient with swelling of face, throat, Immediately after getting Johnson and Johnson COVID vaccine, improved with epinephrine.

14:59 - RN responded to waiting lot. Pt c/o sensation of facial swelling and heart racing. Denied other complaints. At 1500 BP 110/80, HR 140, R 12. 1503: Pt helt HR slowing down. No further feeling of swelling in face, throat, or elsewhere. 1505: HR 128. 1510: Pt talking, breathing without difficulty. Advised to seek medical attention if s/sx worsen. 3/5/21 @ 1040: Another RN followed up with ph call. Pt reported that after leaving site, she felt HR beginning to speed up. Went to ED and was monitored x 2 hrs. Systolic pressure there was 161. HR was in 140's. No interventions. After 2 hrs VS stabilized and pt was discharged home. Is fine today.

Headache, nausea, chills, fever, hives, (within 5 hours) facial swelling ( right side) itching (1 day later)

Individual responded to waiting parking lot. Patient c/o sensation of facial swelling and heart racing. Denied other complaints. 1500 B/P 110/80. HR 140 Resp 12. 1503 Pt states she felt heart rate slowing down. No further feeling of swelling in face, throat, or elsewhere. 1505 HR 128. 1510 Patient talking and breathing without difficulty. Advised to seek medical attention if s/s worsen. 3/5/2021 @ 1040 employee f/u with patient with phone call. Patient reported that after leaving the site, she felt HR increasing. Went to ED and was monitored for two hours. Systolic pressure there was 161. HR was in 140s. No interventions by ED after monitor. States is fine today.

Swelling, redness, and itching of the hand, same side as injection. Has happened once/ day for past 5 days.

Mouth watering, body aches, fever, chills, headache, fever blister on mouth( 2 days later) sweats, achey rib area

left arm is sore after the shot and it never goes away. On 03/29/2021 i woke up my arms was very sore, i can barely lift my arm. I am still feeling the soreness and it is swollen and it's warm. I have been moving this arm all the time as instructed.

The next day after my shot in my left arm in my armpit it hurt and felt like it was swollen. Possibly a lymph node. By Tues, March 31, 2021 the pain and swelling had subsided.

She had the vaccine and within 1 minute she had tingling in her tongue and numbness that went away immediately. She did not have any other symptoms until 8 days later when she had 104 fever, could not walk, had stiffness in all of her muscles and aching, diarrhea. They went to the doctor office and he did a COVID test that came back negative. The fever still continued and her husband took her to the hospital on Tuesday 3/16/21. They ran fluids on her and at the end of the day they said she was okay to go home. The next day the fever started again and he ended up calling an ambulance to take her to the hospital. She went to Hospital on 3/16, who took her to another Hospital. They sent her home about 4 days later and said that her symptoms were from the vaccine. He called and he filed a report with them. They sent her home the next day, got another high fever, and her husband took her to the ER at again that evening. She had high fever, extremes aches and pains and headaches. They kept her a couple of days and then released her again. She was home for a couple of days and they were managing her fever as it would spike at night. She also had 8 other medications to take. She then woke up yesterday 4/4/21 with severe back pain, cannot walk real well, and her husband called the ambulance again. Now she has swelling in her heart, swelling around her heat and not breathing very well, and 104 fever and getting progressively worse They said that she now has pericarditis and pericardial effusion and are going to release the fluid today. She is still in the hospital.

The night of my injection I woke up with extreme left arm and scapular pain. It radiated down to my fingers. It all was heavy and number and tingling. That continued most of the day. The next day I was extremely fatigued and weak and stayed in bed. I think had left ear and lymph node pain on the left side of my face and neck. This continued for days. By the 1 week mark after my injection, I ended up at the urgent care with facial swelling and extreme lymph node pain. They stated it was an adverse reaction to the vaccine. As of yesterday, I continue to have some swelling in my jaw and occipital region as noted by the PTA where I go for physical therapy. I continue to experience extreme fatigue, worse than normal and dizziness. My left pinky still has some tingling and vibration feeling. I also still get cramping on this finger and on the ulnar side of my palm.

Chill, muscle numbness, tremors, joint pain, pain in glands of the head, severe headache, excessive cold

Janssen CCOVID-19 Vaccine EUA 4/9/21: metallic taste in mouth when eating/drinking; nauseous; mild headache; fatigue; Overnight - leg cramping, coughing, heaviness in chest. 4/10/21: fever (high of 101.5 most of day); chills; mild headache; severe fatigue; muscle cramping; dizziness; difficulty focusing & remembering. 4/11/21: fever (high of 100.3 in am only); severe fatigue; extreme pain in lymph nodes in left armpit (difficulty moving arm); pain behind right eye (began in evening); difficulty focusing & remembering; random short term muscle cramping

On 4/13/2021 at 11:00 AM pt. began experiencing left leg pain with swelling noted around left knee and extended above knee. By 11:00 PM pt. felt faint and nauseated and left leg was swollen and discolored. Rescue squad was called and took pt. to Hosp where she was told it was sciaticia. After showing the medical professionals her leg and insisting upon an ultrasound of her leg she was told the "machine" was not available and she would be called the next day to be scheduled. Per pt's daughter, she was never called and daughter called hospital to have U/S scheduled. Pt. went back to hospital on 4/14 at 3:15 PM for U/S and she was diagnosed with multi DVT's in left leg which at that time had swelling all the way down to her foot. Pt. was put on Coumadin.

I had some issues with facial swelling and fatigue described in VAERS report # 1178881 The day after vaccination I also had nausea and a low grade fever. I had vague abdominal pain which intensified in the last week. I am four weeks out from vaccination and I get acute gastric pain after I eat with diarrhea. The pain is from my midline to upper right quadrant pain that radiates out. It is a constant pain at a 3-4 intensity level which intensifies to a 9-10 for a few hours after I eat. I have been trying to treat with heat. I try not to eat too often but it is difficult. I have had to visit the ER and the doctor because of the acute GI pain. There was imaging and IV fluids and labs in the ER yesterday. The CT scan did not indicate anything but I have scheduled an endoscopy to check up higher in my GI tract.

Monday started having swelling behind my neck between my two shoulders and then a headache began. Went to Healthcare expressed by the doctor did not think it was blood clot, but probably related to the vaccine. Gave me a steroid and muscle relaxer sent me home to call provider next day. Had Televisit with primary?s Wednesday April 14, 2021, by then news had broke about the new type of blood clot CVST and the low platelet count, I explained still had headache and swelling, sour stomach over night(have had this before) and felt weak for a brief few minutes on right side but quickly went away, also was walking for a brief few minutes like I was drunk, again went away after a few minutes. Discussed with primary my anxiety could be contributing to some of the extra feelings I was having, agreed to do bloodwork to check platelet levels. She did not think it was blood clots discussed with me about what I needed to look for and to go to ER immediately if I experienced any of them. Blood work did today, Thursday April 15, 2021. still headache and some swelling in back of neck between shoulders, dizzy off and on. All pain moderate to mild. Awaiting blood work for next step.

3/20/2021 - the next day after vaccination, the side effects were fatigued, c light hills and injection site was swollen. The fatigue and chills side effects resolved the next day. The swollen arm resolved in 2 weeks However, on 4/9/2021 I developed a rash as of today(4/16/2021) it still has not resolved.

Within 15 min of vaccine, headache, woozy dizzy feeling. Lightheaded. That night, fatigue and arm pain. Next day tender warm swollen lymph nodes left supraclavicular nodes and (much less axillae.). 3rd day. Extreme fatigue. Fever 103. Could not get out of bed. Nausea diarrhea. Malaise. Felt like the flu. Painful lymph nodes worse and arm pain worse.

Patient's husband called about reactions after the vaccine as patient does not speak english. She experiencing trouble breathing for the whole week and feels very tired. Also reports swelling and pain in the legs and hand, significant enough to prevent her from removing her wedding ring. I recommended them to go to the emergency room as soon as possible as her symtoms resemble a possible clot. She does not have a PCP to refer her to nor does she has insurance. He agrees to take her to the emergency room.

Tuesday, March 30 - COVID19 vaccination / Friday, April 2 - severe headache, arm pit pain in left arm pit, sore arm / Saturday, April 3 headache (less than on Friday), chest constriction, back pain, anxiety, hives and itching, took Benadryl and hives went away / Sunday, April 4 anxiety, intermittent chest constriction & back pain / Monday, April 5 & Tuesday, April 6 intermittent headache, tired / Wednesday, April 7 swollen fingers and feet / Thursday, April 8 - fingers remain still swollen

Severe pain in lymph nodes under left arm for 3-4 hours after vaccine Fever for 36 hours after vaccine Chills to date Red raised warm rash on chest a week later Rash itchy and spread to back, neck, hips, legs and arms despite antihistamines (benadryl, zyrtec)

Pain still in my left arm. Now in my right side. It?s like a ghost image of pain. Numbness in my right arm and leg. Also a bruise on my right side under my rib, that After 4-5 days it has become a lump. Endless heads Please tell me where I can get the best help for my concerns with the J&J vaccine I received.

around 8 pm on the same day of my vaccine I began to feel chills. around 10pm then the body aches started. this continued for about 3 days until I started feeling my usual self again. at midnight my husband took my temperature and told me it was 100.2. the following day I noticed a lump in my armpit. it continued to get bigger so i decided to go to Dr. she advised me to give it a week to see if it will go back down. It did.

I had 2 adverse reactions to the Janssen Covid-19 Vaccine EUA: AE #1) Roughly 15 minutes after receiving the vaccination, the lower half of my face went numb for approximately 3 hours. The people who administered the vaccine made me stay at the site for about an hour and a half to make sure that the reaction did not get worse. AE #2) 10 days after receiving the vaccination, the lower part of my left leg began to swell significantly. I went to the emergency room on 4/13/2021. When I was there, they did tests and confirmed that I have a blood clot behind my knee. To treat the blood clot, the emergency room doctor gave me lovenox 110mg and warfarin 5mg. Since then, I have followed up with my primary doctor who has me taking warfarin 10mg ( 1x daily) and lovenox (as needed).

Flu-like symptoms (2 days), headaches (3 days), soreness (2 days) and swollen lymph nodes in the neck (5 days). Treatment was Tylenol and ibuprofen. Doctor did not prescribe anything due to he suspected it was in result of the COVID19 shot.

Sever flare up of Lupus symptoms. Swelling of joints. Pain internal organ swelling. Symptoms sever for four weeks until infusion of drugs. Symptom relief within 2 hours of treatment.

PRESYNCOPAL SYMPTOMS/ALMOST FAINTED; LEFT ARM RADIANT PAIN; HEART PALPITATIONS; ABDOMINAL PAIN; SEVERE ENOUGH THAT SHE COULD NOT EAT; BURNING SENSATION OF STOMACH; TENDER/SORE SUBMANDIBULAR LYMPH NODE; LEFT JAW SWOLLEN; INFLAMMATION ON LEFT JAW; CHEST PAIN; TINGLING LEFT ARM; NUMBING OF LEFT ARM; DIZZINESS; LEFT ARM TENDERNESS AT INJECTION SITE; NAUSEA; HEADACHE; NECK LEFT LYMPH NODE INFLAMED; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain injury, and concurrent conditions included hypothyroidism, asthma, food allergies, latex allergy, nsaids (ibuprofen and aspirin) allergy, erythromycin allergy, betadine allergy, ct scan iodine allergy, dizziness, nausea, intermittent headache, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included fluticasone propionate for asthma, midodrine for brain injury, and levothyroxine for hypothyroidism. On MAR-2021, the subject experienced neck left lymph node inflamed. On 24-MAR-2021, the subject experienced dizziness. On 24-MAR-2021, the subject experienced left arm tenderness at injection site. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced numbing of left arm. On 25-MAR-2021 01:30, the subject experienced chest pain. On 25-MAR-2021 01:30, the subject experienced tingling left arm. On 31-MAR-2021, the subject experienced tender/sore submandibular lymph node. On 31-MAR-2021, the subject experienced left jaw swollen. On 31-MAR-2021, the subject experienced inflammation on left jaw. On 07-APR-2021, the subject experienced abdominal pain. On 07-APR-2021, the subject experienced severe enough that she could not eat. On 07-APR-2021, the subject experienced burning sensation of stomach. Laboratory data included: CT scan (NR: not provided) came out clear. On 13-APR-2021, Laboratory data included: Endoscopy (NR: not provided) came out clear. On 26-APR-2021, the subject experienced presyncopal symptoms/almost fainted. On 26-APR-2021, the subject experienced left arm radiant pain. On 26-APR-2021, the subject experienced heart palpitations. Laboratory data included: Diagnostic ultrasound (NR: not provided) came out clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, and tingling left arm on 25-MAR-2021, recovered with sequelae from numbing of left arm on 25-MAR-2021, had not recovered from dizziness, nausea, headache, and left arm tenderness at injection site, and the outcome of tender/sore submandibular lymph node, left jaw swollen, abdominal pain, burning sensation of stomach, presyncopal symptoms/almost fainted, left arm radiant pain, heart palpitations, severe enough that she could not eat, inflammation on left jaw and neck left lymph node inflamed was not reported. This report was non-serious.

I received the Johnson and Johnson Covid-19 vaccine on 5/1/2021. Starting on 5/11/2021 I started to get acute joint pain and swelling of the hands and wrists. I went to the Dr. on 5/14/2021. He prescribed Benadryl and Pepcid AC taken together to lessen the swelling, pain and reaction.

The vaccination was administered into my shoulder joint and NOT into my arm muscle. The pain was immediate and I have lost significant range of motion on that side. The joint also is extremely painful and I have lost the ability to use my left arm as fully as normal. I have sought medical attention via an orthopedist, who put me on steroids, which did not help. All anti-inflamatories has been ineffective. I have since begun physical therapy for treatment, and have yet to experience any relief. Therapy is scheduled to continue at minimum twice/week for at least a month. I will be getting an MRI of the area soon. Diagnoses as of 4/21 (follow-up pending): bursitis, rotator cuff tendonitis, and adhesive capsulitis. As of today, this has been going on for 39 days, with no sign of improvement/relief.

From march 23 to april 16: Enlarged lymph nodes under arm and pain on left side? pain sometimes shooting into left breast. March 11- april 16; headaches 4-5 times a week. On march 27 i had a series of 4 severe migraine style headaches over a week period? days this was not even close to the short lived migraines i get a couple times a year. March 23-April 16: extreme exhaustion

Hello, I received the J&J vaccine on 3/12/2021. Eight days later on the 20th when I went to bed I had a lot of pain in my left heel and left thumb. The next day, on a Sunday, the pain was now in my left heel, left thumb at the big knuckle and top and bottom below my thumb, and just behind the inside of my left ankle, and I had a terrible headache. I was unable to grasp anything or widen my grip because the pain was so intense in my thumb. It was so bad I went to my local ER who did xrays and told me it was just osteoarthritis. The next day, Monday, the pain was terrible. It was in my left thumb, the middle of my left hand, left ankle, the arch of my left foot top and bottom, the big knuckle at the bottom of my left big toe, my right hand was also now hurting at my middle finger the big knuckle at the bottom. I went to see my family doctor who really was unsure at the time what was going on and said it's still just must be the osteoarthritis. The next day on Tuesday I still have the headache I was out unable to open my own water bottles or prescription bottles because the pain was so intense in my left hand. It was now extremely painful to walk on my left foot and I had no appetite. The following day on Wednesday the pain was bad and my right hand that I was unable to touch my ring finger or my pinky with my thumb. As hard as I try my thumb just would not reach those two fingers oh. I now couldn't open any of the doors in my house unless I use the base of my Palms on both hands turn the knob. I now couldn't even comb my own hair or pull my pants up wipe myself properly. I couldn't hold a pencil or anything because the pain was so unbearable. I had no appetite and now I have diarrhea. I called my husband at work and had him come home and we went to the emergency room because it was a bigger facility. The doctor there told me he thought it was something more like rheumatoid arthritis or lupus. This was by far my worst d ay even though I was unable to work this entire week. Oh and did I mention the only reason I got that back who was because my boss with bullying me and pressuring me every day to get the vaccine. He even went so far as to come of my office and he wanted to use my keyboard to schedule my vaccine himself. The next day on Thursday I was still having a hard time walking I still couldn't touch my ring finger on my pinky with my right hand still unable to open anything with either one of my hands. My husband had to open all the water bottles and prescription bottles and just set the caps on them before he went to work. I now had flashing light in my eyes which lasted about a week. The following day I had all the same symptoms but now my left foot was so swollen I couldn't even get a shoe on it. The big knuckle at the base of my right hand hurts so bad at this point and so does the big knuckle at the base of my left thumb. The swelling and the pain is just unbearable at this point. The following day on Saturday my mom had come up from Florida and stay with me for two weeks take care of me someday the next day on March 28th I start all the same symptoms but now my muscles were quivering on the back of both thighs. By the middle of next week I still had all of the same pain and now I'm realizing that I can't span open my fingers on my right hand and I'm unable to snap my fingers. Side note as of today I still cannot snap my fingers on my right hand. At this point I have been keeping a diary every day of where my pain was in what the pain level was each day. So strange that it's affecting joints on both sides but just in my hands the inside of my wrist and my left foot. Are April 28th I finally got into the rheumatologist. He had me go to the hospital and get blood work done and x-rays. On Thursday May 6th I was unable to go to work. It seems like I can go to work about 3 days a week and the pain is so intense that I'm missing about two days a week. Dr called me and said all of my tests came negative for rheumatoid arthritis.He told me not just because I was a patient but if I was his own sister he would suggest going to the Clinic right away. He said they have a larger database and if anybody else was having the same reaction to the covid vaccine they would know about it. My husband came home from work and made the four-hour drive to the Clinic. I was there Thursday and Friday they the blood work a sonogram x-rays the whole gamut of tests. The rheumatologist in the ER said that he thinks it's still something like rheumatoid arthritis or lupus but that was in the early stages and not showing up positive on the test. On Friday I met with dr. a rheumatologist oh, and the chairman at the Clinic. They said this is a very rare reaction to the J&J vaccine and they're hopeful by prescribing me a non-steroidal anti-inflammatory and Voltaren gel that hopefully I will have some relief within a week and they were hopeful that the symptoms will go away within 3 months. They also took me off work for the next week. Did I mention got the first month that was going on they have me on 50 mg of Prednisone for one week then 100 mg of Prednisone for 2 weeks and then back down to 50 mg for one week. After being on that high dosage of Prednisone for an entire month I still have all of the swelling and pain in my joints. My joints are very stiff at this point. The prednisone maybe eased the pain just a touch but the pain and swelling was definitely there, and the pain is excruciating. I'm feeling so alone, and scared because I don't know anybody else that's having the same reaction. I'm also fearful I'm going to lose my job I'm missing so much work. But I also feel like my boss pressured me into this and now I'm suffering. If anybody is having the same reactions to Johnson & Johnson vaccine please reach out to me. I have my vaccination card I can show you and I have a ton of doctor and hospital records to verify my story. I'm really worried because I'm not sure what's going on with me, how long it's going to last, and is it going to come back if I do get these symptoms to go away. My work place offers no paid extended leave, and has repeatedly asked me I'd I was quitting my job. I'm only having these problems because I was pressured and bullied into getting this vaccine. I completely blame my boss. I would have never got vaccinated if he wasn't on me about it every single day repeatedly. I'm at a loss as to what to do from here. I have no income coming in. Do I qualify for unemployment or some sort of disability benefits? If anybody can please give me some suggestions I'm open to whatever you have to say

I got a severe stomach flu and joint elbow pain and went behind my knee, lesions started on lower leg with red bumps and went across ankles and feet but still experiencing lesions which are extremely painful, feet are swollen and tingling and numbness of pain. I've been to ER and had an EKG and ultrasound performed.

BACK OF THIGHS WERE QUIVERING; SWOLLEN LEFT FOOT AND PAIN; FLASHING LIGHTS IN EYES; UNABLE TO WALK ON LEFT FOOT; NOT APPETITE; JOINT PAIN/LEFT ANKLE PAIN/LEFT WRIST PAIN/PAIN IN LEFT PALM; TERRIBLE HEADACHE; PAIN LEFT THUMB/LEFT HEEL PAIN/RIGHT HAND PAIN/COULD NOT OPEN BOTTLES DUE TO JOINT/HAND PAIN/UNABLE TO USE HAND/BAD HAND PAIN/TERRIBLE PAIN IN BOTH HANDS/LEFT HEEL PAIN/L FOOT PAIN/LEFT ARM PAIN; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced pain left thumb/left heel pain/right hand pain/could not open bottles due to joint/hand pain/unable to use hand/bad hand pain/terrible pain in both hands/left heel pain/l foot pain/left arm pain. On 21-MAR-2021, the subject experienced joint pain/left ankle pain/left wrist pain/pain in left palm. On 21-MAR-2021, the subject experienced terrible headache. Laboratory data included: X-ray (NR: not provided) Not reported. Treatment medications included: tramadol. On 22-MAR-2021, the subject experienced unable to walk on left foot. On 22-MAR-2021, the subject experienced not appetite. Treatment medications included: prednisone. On 25-MAR-2021, the subject experienced flashing lights in eyes. On 26-MAR-2021, the subject experienced swollen left foot and pain. On 28-MAR-2021, the subject experienced back of thighs were quivering. On 28-APR-2021, Laboratory data included: Laboratory test (NR: not provided) Not reported, and X-ray (NR: not provided) Not reported. The action taken with covid-19 vaccine was not applicable. The patient recovered from flashing lights in eyes on 01-APR-2021, and back of thighs were quivering on 31-MAR-2021, had not recovered from swollen left foot and pain, terrible headache, and pain left thumb/left heel pain/right hand pain/could not open bottles due to joint/hand pain/unable to use hand/bad hand pain/terrible pain in both hands/left heel pain/l foot pain/left arm pain, and the outcome of joint pain/left ankle pain/left wrist pain/pain in left palm, not appetite and unable to walk on left foot was not reported. This report was non-serious.

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

3/15/21: Within a few hours of the vaccine, I felt fatigued, followed by chills, severe body aches, fever, and dehydration (in that order). Improved by Day 5. 4/5/21: Lump on left thigh appeared. Raised up, hard, red, and warm. Went to Clinic ER immediately. Ultrasound of area and blood work showed no obvious abnormalities. Symptoms were diagnosed as "insect bite". Lump became painful several hours later. Antibiotics, Benadryl, and Corticortisone prescribed for 10 days. Took medication as instructed. Improvement by Day 7. Lump shrunk but did not completely resolve. Swelling and pain gone. Completed medication on 4/15/21. 4/22/21: Lump returned on left thigh, quickly turning into a large, solid mass. Red, warm, more swollen than the first time, and more tender to the touch and painful. 4/23/21: Went to Walk-In Clinic , Nurse Practitioner ordered MRI and more blood work. 4/25/21: Lump appeared on right thigh, same characteristics as the left thigh, also quickly turning into a large mass. Very painful. Hip size increased from 40 to 42 inches within a few days from the swelling. Unable to wear underwear due to how excruciatingly painful the area(s) were. Painful to sit, painful to stand up, painful to remain standing. Sharp shooting pains. Legs would feel as though they would give in if I stayed standing up too long. 4/28/21: Returned to Walk-In Clinic due to unbearable pain and nightly fevers. Antibiotics were prescribed on this visit, and a referral to a general surgeon and a Hematologist were made by the Nurse Practitioner who tended to me, . 5/3/21: Went to see Orthopedic Surgeon Dr. . He reviewed the MRI with me and showed me the areas where fluid was all over in the area affected (thigh). Referred me to Dr. , Rheumatologist. 5/4/21: Dr. examined both thighs and determined a biopsy under general anesthesia was needed in order to do deep tissue removal. He also ordered more blood work. 5/4/21: Initiated surgery preparations: Lab work, COVID testing, EKG, Chest X-Ray, Visit with General Practitioner to be cleared for the surgical procedure, Visit with surgery department. 5/6/21: Surgical biopsy under general anesthesia performed. 5/13/21: Visit with Dr. to remove surgical gauze, and examine the area. 5/14/21: Visit with Dr. for pathology / biopsy results. I was informed that inflammation levels in my body were at 45%, where they should normally be at 8%. Pathology concluded that an external cause was to blame for the inflammation, further stating that it was a foreign substance consistent with silicone injected in the area. It is noted that I have no silicone implants in any part of my lower body. Nor have I had any silicone injected in my thighs. 5/17/21: While using a pair of scissors and exercising normal pressure to cut a paper tag from new clothing, the area below my right thumb suddenly became swollen, purplish, and extremely tender. After two hours of no improvement, went to Health where they took an X-ray and determined it was a Sprain. I did not exercise any force to justify a sprain in that region. I was prescribed cortisone for 6 days. 5/20/21: Follow up visit with Dr. , Rheumatologist, for second opinion on pathology results. Dr. ordered blood work done in-office, as well as ordered additional blood work to be done at the lab. Results pending. After also examining all of my blood work done up until that point, she deduced that the issue with my hand was also likely caused by inflammation in my body, and whatever is causing the swelling in my thighs. The area of the hand turned black and blue the likes of severe trauma, yet there was no blunt force to the area. At the time of this reporting, I continue on blood thinner and anti-inflammatory medication for another 10 days to complete the 30 days post surgery. Additional blood work has been ordered to measure the inflammation levels and proceed accordingly. Currently I feel throbbing in my legs mostly at night when I lie down. Prior to the Johnson & Johnson COVID-19 Vaccine, I had no medical issues. My only visits were routine control visits annually. I do not drink or smoke; and exercise regularly (until this happened).

Person who administered hit a nerve, headache, dizziness, nausea, and a metal taste in my mouth. After 45 minutes. resting heart rate jumped to 140 and normally 70, after 45 minutes, it went down to 130 and I had my husband take me to the car. After 10 days I continued heachache, ear ache, extreme fatigue, nausea, my resting heart rate was still at 130 it would not go down, I had swollen lymph nodes under both arms. On the 10th day i called the doctor and went to ER my left leg began swelling up and I had extreme pain from my hip all the way down to my ankle. and plus all the prior symptoms. The doctor did a vein ulta sound didn't find anything. The doctor laughed at me like I was crazy. I have high pain tolerance and I was in extreme pain. And the doctor did not take me seriously. I followed up with the physician the next day. and asked her to report it, but as far as I know she didn't report it. I just started feeling better, May 20 th, from april 6. for me to start feeling normal again. I'm starting menopause, and I had not had my period since November 2019, And after I received the vaccine, I started my period , twice a month. my hormones are messed up and I have to take a nap in the afternoon from feeling fatigue.

About 1 week after vaccination. I had pain in my legs and swelling in my feet, it made it difficult to walk. It was like I was carrying around a dead leg. I did have blood clots in leg. I ended up up being hospitalized 3 days to receive blood transfusions due to anemia after taking blood thinners.

pt reported shooting pain since 5/12/21 (day of shot), pt reported swollen, red arm since 6/5/21. Pt is in the process of seeing a provider today 6/6/21

Numb lips and face intermittently for 3 weeks after the injection. Tingling on left side of body for 3 weeks after injection. Swollen feet for 2 weeks after injection.

sore arm, achy body, muscle aches from head to toes, headache: these were all within an hour. it progressed that night to: sinus pressure/teeth even hurt, hurt to move or shift body, chills, fever- my whole body was puffy, red and hot. fever broke the next morning and chills returned. Exhaustion, muscle pain, weakness, headache, sinus pressure the entire next day. drank lots of water and ate crackers. woke up the 3rd day a bit drained but by mid morning I felt back to normal

I got my shot. It lightly sting nothing bad. - About 40 min later on both sides of my back I felt tingling right below my shoulder blades and then this spread out like a waterfall going down my back . - about an hour later it was like someone turned my power off. I was so tired I could barely open the car door and walk inside - laid down and slept maybe 3 hours ? - woke up hurting and puking - hot and cold and exhausted - slept next day . Not hungry but husband bright oatmeal and coffee. I ate a bite and threw it all up - my body get like it had become broken glass . It hurt . It hurt to walk to the kitchen . My eyelashes hurt , my nails hurt . Stayed in bed. Ate a TV dinner and threw it up . Feverish . Sweating hot cold . Felt like a migraine headache I guess around my forehead and eyes - and I have never had one . - day 3 - nauseous. Took shower and big clumps of my hair fell out . Feet hurt and tingled. Felt like a spike gong through my right side off and on . Day 4 - slept all day and had to drive 8 hours home. My left eye hurt and was draining . When I got home I looked in the mirror and the left side of my face was swollen really badly and eye about swollen shut. Felt bad . Achy and stabbing side pain . Went to Urgent Er care due to face swelling . They had no explanation . Had a cyst like pimple on left side under eye that went back up to eye lid Could not turn my neck and really sore . Went to Chiropractor doctor. He and his assistant examined me and said I was not out of alignment but my lymph nodes around my neck area and left side of my spleen were very swollen . He said to go to dentist over face swelling and I probably had an infected tooth Went to dentist . Teeth were fine but he said to go to the eye doctor . Still feeling sick and very achy . Hurt to walk . Knees hurt . Felt like I was 100 years old Went to eye doctor . He examined my eye then had me go to another room and machine . Then a variety of students came in to look at my eye . I asked why and one said because they only read about this in text book. Doctor came bAck and said I had acute narrow angle eye closure and had to do emergency surgery . Still feel horrible Labs now coming back with odd things . Doctor sending me to rheumatoid / endocrinologist and integrative doc but can?t get appointments til October Now have holes in my iris to relieve the pressure and other auto immune things going on . Doctor said tissue swelled on optic nerve . Saw glitter like out of side of eye . He said I?d loose my eyesight if I did not have the emergency surgery

On July 11,2021 my arm was sore an at different times numb I was very fatigued an nauseous than on the morning of July 12,2021 my face swelled I took a Benadryl that relieve it but than again during the day it swelled again an my lips so I took another Benadryl I also had trouble sleeping very restless than July 14, 2021 I woke up several times sweating with my hair wet from sweating an still nauseous.

FELT LIKE ANTS WERE CRAWLING ALL OVER TINGLING AND POKING FROM HEAD TO TOE; FELT LIKE A BEE STING IN THE ARM; SWOLLEN LYMPH NODES; PAIN IN THE LUNGS; ITCHINESS ON THE CHEST; RED BLOOD DOT; TIREDNESS; This spontaneous report received from a patient concerned a 50 year old female. 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, administered on 12-JUL-2021 18:45 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced swollen lymph nodes. On JUL-2021, the subject experienced pain in the lungs. On JUL-2021, the subject experienced itchiness on the chest. On JUL-2021, the subject experienced red blood dot. On JUL-2021, the subject experienced tiredness. On 12-JUL-2021, the subject experienced felt like a bee sting in the arm. On 12-JUL-2021, the subject experienced felt like ants were crawling all over tingling and poking from head to toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt like a bee sting in the arm, and red blood dot, and had not recovered from tiredness, swollen lymph nodes, pain in the lungs, felt like ants were crawling all over tingling and poking from head to toe, and itchiness on the chest. This report was non-serious.

Day 1-7: Headache, fatigue, dizziness, tinnitus, severe cramping in feet, foot pain, menorrhagia Day 8: Syncope, lightheadedness, tinnitus, numbness and tingling in left foot and left hand, metrohaggia Day 8-30: Headache, dizziness, tinnitus, left foot swelling, foot pain, numbness and tingling in left hand and foot, polymenorrhagia Day 26-27: Epistaxis, headache, fatigue, dizziness Day 28: CT scan detected layering fluid in the posterior left ethmoid air cell

Swelling of face; tightness in chest and shortness of breath and difficulty talking (with the exception of the swelling of the face, these are typical of my reactive airway) Treatment: Benedryl, albuteral, Outcome: Swelling has gone down, breathing is somewhat better

I woke up with swollen lymphnodes the next day and the area is still swollen and tender to the touch.

After the vaccination, I felt a little dizzy waiting in the parking lot and had a sore arm, but felt fine otherwise. (12:00-1:00 pm) After returning home, I felt increasingly tired and warm. I laid down and took my temperature after walking the dog around 3:00 pm. My temperature read 99 degrees. I drank a lot of pedialyte to hydrate. Throughout the afternoon, I felt sluggish and the glands seemed to swell up on the side of my neck. I also got a headache. My temperature dropped down to 98.7 before I went to bed, but this morning, my glands under my jawline are a bit more swollen and I still have a slight temperature; 98.9 degrees. My eyelids are puffy and I feel a little feverish, but it is tolerable.

Vax Clinic note: Approximately 10 minutes after receiving J&J vaccine c/o lips tingling and tongue feeling thick. Medicated with 10 MG cetirizine. VS o2Sat 97%, Pulse 84, BP 146/74. Pt states has had allergic reactions to IV contrast that involved tongue swelling. staets this feels similar but not as bad. o2Sat continues at 97%, Pulse 58, BP 128/68, pt trying to relax, c/o slight headache. Swellig has spread to her lips, and cheeks feeling heavy, O2Sat 97%, Pulse 75, medicated with 50mg benadryl. 911 called to transfer pt to ED for further eval. States throat is feeling tighter. And unable to swallow Epi given 11:18, daughter aware and will meet her at ED. BP 148/82, PUlse 75, O2Stat 97% swelling in tongue decreasing, throat n o longer tight, tongue still feels thick, has some hives between her eyes, and forehead. Pt transported via EMS to ED Intake ED note: 51 y.o. F here after getting J&J vaccine and 10 min. After she c/o her tongue feeling thick and lips tingling Pt given zertec Then 15 min later pt felt lips swelling and had hives around eyes and forehead Pt c/o difficulty swallowing and was rx'd with epi pen Pt has no stridor, or resp issues on arrival, able to speak in full sentences. Pt denies COVID sx 2nd ED note: Pt arrived to ED via EMS from community health center S/P Covid vaccination. About 15 minutes after receiving vaccine - felt nausea and smelled "medicine" followed with upper lip swelling and numbness to tongue associated with difficulty swallowing and redness to forehead. Pt alert and oriented at this time. Speaking in full sentence, drinking bottled water without any difficulty. No drooling noted. Denies SOB, chills or fever. Emergency Department Attending Attestation Note See resident/PA/student note for further details of HPI, history, exam, ED course, and diagnoses. Briefly, this is a 51 y.o. female with PMH reviewed in chart and w/ patient notable for insulin dependent diabetes, depression, prothrombin mutation, migraine, p/w concern for allergic reaction. Emesis or change in Covid vaccine today. 10 minutes after receiving the vaccine, patient reports feeling thick in her tongue with tingling in her lips. Patient was given Zertec. The minutes later, her lips began to swell up and was also noted to have new erythematous rash between her eyes and forehead. Patient was given 50 mg of Benadryl. Patient felt like she could not swallow with worsening lip swelling. She was given EpiPen and 911 was called. No stridors. No wheezing. Reports continued tingling and the numbness in her mouth but no lip swelling or tongue swelling. Denies any difficulty swallowing at this time. No wheezing. No abdominal pain or nausea. No rash at this time. Of note, patient also notes left-sided facial, arm, and leg numbness starting about 10 minutes prior to arrival to the emergency department. She reports that she has had recurrent numbness on the left side in the past, which was thought to be due to migraine versus TIA. She has had extensive work-up and multiple hospitalization for this symptom. She reports that she is allergic to iodine and gadolinium containing contrast. Denies any headache at this time though she had a mild headache after receiving the vaccine. Denies any blurry vision. Denies any weakness in her bilateral upper and lower extremities. Assessment and Plan: Vital signs notable for O2 sat of 96 to 98% on room air without tachypnea. Patient is mildly hypertensive. Patient is well-appearing speaking full sentences without any dysarthria. Pupils are equal and reactive to light. Extraocular movement intact. She notes diminished sensation to her left face, left upper extremity, and left lower extremity. Tongue is midline. Hearing is intact bilaterally. No facial droop. She has 5 out of 5 strength in bilateral upper and lower extremities. No pronator drift. Normal gait. No tongue swelling or lip swelling. No stridors. No uvula swelling. No pharyngeal or erythema. Lungs are clear to auscultation bilaterally without wheezing or rhonchi. Cardiac exam without murmurs rubs or gallops. Regular rhythm. No abdominal distention or tenderness on palpation. No CVA tenderness. 51-year-old female who is presenting to the emergency department with improving lip swelling and numbness in her mouth, raising a concern for anaphylaxis related to her Covid vaccine. Reassuringly, status post EpiPen, her symptoms are improving. However, she has new onset left-sided numbness, with without any headache. She reports that she has had this numbness in the past the last time she had the numbness on the left side was approximately 10 years ago. Her neurologic exam is only notable for diffuse numbness on her left side including her face. Differential diagnosis include migraine headache and TIA. Stroke is possible though less likely given the patient has had the same symptoms in the past with negative work-up. Will defer code stroke at this time but will emergently consult neurology. Will get labs including BMP and CBC. We will continue to monitor her from the anaphylaxis perspective. We will also give her a dose of steroid. Prednisone 60 mg by mouth given 12:29 PM NEUROLOGY CONSULT NOTE Assessment: Formulation- Diagnosis is guarded. Localization structurally would suggest subcortical (thalamic) or small brain-stem in a sensory territory on the right. Etiologies could be stroke given her vascular risk factors but seems unlikely given there is stereotypy of earlier symptomatology. Demyelinating would be another possibility as well, but again, the stereotype. Seizure unlikely because of the timing of rush from toes to body was minutes and duration of some occasions being days. Complicated migraine possible, has some risk factors, but should be treated as dx of exclusion. She does make complaint of headache, which could support. Some FND elaboration on her anxiety-ridden allergic reaction is also possible, but no objective non-structural signs to support.

3/10/21 - right arm (injection site) pain 3/11/21 - right arm(injection site) pain/soreness 3/11/21 - under right armpit swelling; injection site mild soreness 3/12/21 - under right armpit swelling

The day of the vaccine not much trouble, the injection site was a little sore. As the evening came I started feeling the body aches, the chills. The next morning I had a headache, I had joint pains (elbow, knee and hip). My arm pain was really severe. I could not even sleep on that side of my arm, the pain was excruciating. I also noticed as I woke up that I also had hives, and it was red and hot and itching, blisters, all over my hand. I then contacted my PCP and they suggested Benadryl capsules. It took about a week for the rash to go away, I finally can wear my ring back (hands were very swollen). Now, I noticed I developed a cough about after a week after the vaccine. The rash is gone off my hands but the skin looks like it is peeling (reminds me of when a person has a real bad sunburn on skin and the burnt skin starts peeling off) from all the blistering and the rash on my hands. I did have COVID in late November, early December. I tested positive on 11/30/2020. The new skin that is being exposed is really tender and sore. I notice with each passing day skin feels better not so sensitive. I get a little bit better each day, a little more energy each day.

Started as mild swelling and headache. Then fever 102.4 and aches. Today 3/27/2021 very bad aches in bones and joints, swelling gone, temp 100.2 Extremely tired and ANY activity feels like I've ran a marathon. Chills, mild sore throat.

Night of the injection, developed itching on left side of the neck and hives, which has developed to include hives/swelling of the R arm as well as hives/swelling of the left wrist

fever x 3 days (102.5), rigors, diaphoresis, severe fatigue, contralateral side inguinal lymphadenopathy (right side), severe localized arm pain x 4 days, severe muscle and bone pain at site of NSCLC metastatic lesion (right pelvic bone) x 3 days. Left axillary lymph nodes remain unremarkable. Partially responsive to acetaminophen. Fever and pain resolved 4/5/21. Inguinal Lymphadenopathy, mild edema inner right thigh, presence of tortuous vessels right inguinal region with pain present on pressure, and mild left arm pain persist as of 4/7/2021.

Pain at the injection site shortly after the injection. Pain and tenderness in bicep began generally later the first day and lasted 2 weeks; I still have some bicep stiffness and tenderness today on Day 18. I had tenderness under the right armpit for about a week (assumed swollen lymph nodes).I had redness on the bicep below the injection site on Days 5-7. I also was tired on Day 2, 3, and 16 and took short naps. I experienced some muscle twitching in the bicep on Day 1, which still continues. On Day 6, I woke up with muscle twitching all over my body, randomly and intermittently. I was able to go about my day normally, but every few minutes something would twitch for a few seconds (my right arm, my left arm, my left knee, my right hip, my lower back, my left pointer finger, my left eyebrow, my diaphragm, etc). I drank a lot of fluids and took magnesium, zinc, D, B, C, omegas, turmeric, a multivitamin, and ate a banana for potassium on Day 6 and 7. Day 7 and 8, I only had muscle twitching in the right bicep again. Starting on Day 9 and continuing through the present, I continue to have intermittent twitches lasting a few seconds all over my body again. It is less frequent than on Day 6, but continues.

Pain, swelling, redness, and hot to touch at injection site from the time of administration of vaccine that persisted for almost 3 weeks. Around 6:00pm the same day I received vaccine, I started getting chills and strong aches in my back and legs. I felt very dizzy, lightheaded and sleepy. Chills were gone by the next morning, but aches and sleepiness continued for 4 days. Dizziness and lightheadedness continues til now. A little over a week after vaccination, I had random bruising on my legs on the same side I received vaccine. My lymph nodes were visibly swollen and my breasts felt extremely tender. Bruises are still healing, but lymph nodes and breasts seem relatively normal now, exactly 3 weeks after initial vaccination

BEEN EXPERIENCING LINGERING HEADACHES, JOINT SWELLING AND PAIN ESP. IN HANDS AND KNEES, FATIGUE MORE THEN USUAL, DEEP COUGH ON AND OFF, AND LIGHT HEADED/OFF BALANCE. NAIL BEDS ARE SWOLLEN IN HANDS AND FEET.

Server chills, extremely high heart rate though out the night, muscle weakness, dry cough, swollen legs.

Immediately following injection (within 15 minutes) arm pain and numbness/tingling to fingers, slight nausea and dizziness. Lasted approximately 4 hours. Extreme dizziness for approximately 2-3 minutes while sitting still at 4 hour mark - resolved with rest except arm pain, which lessened slightly over the first hour but remained unresolved after 4 hours. Within 30 minutes post injection - redness, heat, and swelling at injection site. After injection (approximately 12-13 hours post injection) - Fever (100-101.7 consistently over 3 days), extreme fatigue, headache, muscle aches/joint pain, severe chills. Fever broke midday April 4, and other symptoms except arm pain and headaches slowly resolved by April 7. Arm pain remained at a fairly steady level throughout that time and past April 8 (one week). Currently (April 14, two weeks post injection) - arm pain has lessened, but remains in upper arm. Particularly sensitive to touch or movement, but can be felt at rest. Redness is gone, but palpable hard lump and heat remain at injection site. Pain and sensitivity noted when medical provider palpated underarm lymph nodes on right side. Not noted in same action under left arm. Headaches continue intermittently.

High fever for 24 hours. After than I came down with really nasty and massive number of cold sores (at least 20 of cold sores) all around my mouth, nose, inside two nostrils. Tip of my nose and nostrils are deformed because of size of cold sores inside my nose. It has been 12 days that I have this condition and sores are being persistent and there is no sign of getting better. I took several pictures of the affected area to document the case.

Right after the dose I got an immediate headache, dizzy and light headed. About an hour later I became nauseous and my face became very flush red and hot. I went to bed and woke up feeling like I got hit by a truck and was very tired with a sore arm. By the next day I was better. The following week I began with a red hot circle on my arm where the shot was given, it had a ring around it. That lasted for about a week. I then started to get stinging sensations in that part of my arm like I was being stung by a bee. These lasted for about 2 days. I then started getting muscle rolls/spasms in the same spot on that arm. They lasted about 3 days. I then started having pain in that arm like I had just gotten the shot and as I was rubbing it, I noticed a large indent in my arm. I went to the doctor, and they said they had no idea why it happened but if I get more symptoms to come back. The doc appt was on 4/12/21. It has been over a month of these side effects. Doctor not sure if it will be a permanent disfigure.

* MAR 8th = Vaccine shot * MAR 15th = alleged "sore throat" * MAR 19th = watery eyes; dry eyes; tired eyes. Onset of right eye not blinking/closing. * MAR 21st = Emergency Room. Diagnosed w/ BELLS PALSY. [Ruled out stroke] The following week after my vaccination (approximately MAR 15th), I experienced a strange feeling at the back of my throat. It can best described as a "sore throat". I noticed it upon waking up. I could feel it at the back of my throat when swallowing; the act of swallowing would enable me to "feel" the sensation at the back of my throat. This was unusual and not normal for me. I thought I was coming down with a cold virus. I had not been sick for over a year and thought it was a strange feeling. I was concerned. With the recent schools, restaurants, and gyms opening up with less restrictions, I learned from coworkers that there was an increase of illnesses because our immune systems are not as strong and germs are easily transferable during the usual interactions. Therefore, I expected my sore throat to be the start of a harmless cold virus. Then, later in the week (MAR 19th), I noticed my eyes were abnormally dripping tears. It is my experience that I get this effect in the office setting or during winter when my eyes are "dry". However, I was neither in the workplace (office), nor was it winter. I was not sure why my eyes had excessive tears coming out. Finally, on SUN (MAR 21st), an obvious physical symptom finally became apparent to me and my family members. My speech was impaired. I could not chew properly. I could not drink from a cup. I struggled during breakfast. I was not sure if I was having a STROKE. I recited the alphabet to hear for a slurred speech. I looked in the mirror, and my smile was not perfect. I got dressed and went to the Emergency Room. The doctors performed physical PUSH-PULL tests, eye tests, etc. DIAGNOSIS = Bells Palsy. OTHER SYMPTOMS = + shortness of breath. + leg swelling. + headaches. + excruciating pain in the neck, especially during sleep (laying down).

Within first 30 minutes was experiencing body and face swelling and shortness of breath. Within first 3-4 hours had bad rash on arms, legs, face, neck and chest, fast heartrate, breathing and out of it sensation. I felt like I was having a partial analpylaxis reaction - like throat 1/2 closed but that I would be ok. I took Benadryl and used a Ventolin inhaler. Rash was better by 2nd day. On 2nd and 3rd day I was having massive headache (felt like pressure from inside all over out to all cranial sutures), severe neck stiffness on rt side, lumbar vertebrate pain, iliosacral and hip pain, felt painful radiating spasms down my left and right legs, also jaw and teeth pain. Taking Naproxen and now ASA. Very shakey and jittery. Occasionally have lower arm pain and numbness on left side. Also have injection site symptoms but minor compared to above. It's been 1 week and allergic part of rxn is over but concerned with possible neuro and bloodclot possibilties.. On day 2 or 3 I also had problems with my brain with reading comprahension.

SWELLING OF LEGS; LEG PAINS; This spontaneous report received from a patient concerned a 51 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included varicose veins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced leg pains. On an unspecified date, the subject experienced swelling of legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the leg pains and swelling of legs was not reported. This report was non-serious.

Day after vaccine, 4/4/21 I had severe headache. Unable to get out of bed. Took tylenol (1000mg)around 9 am, headache still severe. Then about noon took prescription migraine medication. Slept until 4 pm. Headache less severe until 8 p.m that I took again migraine prescribed medication and slept until 11 am on 4/5/21. Headache started decreasing and felt ok again to take Tylenol. Saturday 10 and Sunday 11 Severe headache again. Medication worked only late (about 5pm) on Sunday 11 when headache started decreasing and I was able to sleep the night. Wednesday 14th, left lower leg and uncle area swollen (never before I had a swollen leg or foot) and right leg 3 red spots near my uncle (they kind of look like a mosquito bite but a little bigger). Today the red spots look smaller but I have bruises on both of my legs lower and upper sections (I been working in the garden so I might have bumped into things perhaps) I thought I just report this symptoms so you can add data to your system.

Presented to emergency department for evaluation of weakness and aphasia. The patient has her eyes open on arrival. She does follow commands with mild weakness to the right upper and lower extremities. Mild right facial droop is noted on physical exam. The patient does not speak otherwise. Initial CT concerning for ischemic stroke. CTA with perfusion was then obtained that shows evidence of a small area of core infarct with a large area of penumbra. Carotid occlusion from the bifurcation LP is noted on the left side with collateral circulation coming from the Act. Patient transfered from this emergency department to tertiary care center for possible thrombectomy.

NUMBNESS ON FINGERS AND FINGER TIPS; BODY ACHE; TIGHTNESS ON FOREARM; SWOLLEN ARMPIT; SORE AND TENDER LEFT ARMPIT; FEVER; HEADACHES; CHILLS; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202421A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced swollen armpit. On 09-APR-2021, the subject experienced sore and tender left armpit. On 09-APR-2021, the subject experienced body ache. On 09-APR-2021, the subject experienced tightness on forearm. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headaches. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 11-APR-2021, the subject experienced numbness on fingers and finger tips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and headaches on 10-APR-2021, chills on 11-APR-2021, and fever on 09-APR-2021, and had not recovered from tightness on forearm, swollen armpit, sore and tender left armpit, and numbness on fingers and finger tips. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.

Patient reports right hand severe swelling starting one week after Johnson and Johnson covid vaccine with pain in the hand. She went to ER and US showed a DVT in forearm. Patient was placed on aspirin and states the swelling has improved some but still has some swelling and pain.

Immediately felt weakness in arm/hand of injection with tingling in hand. Minutes later tingling in left foot. Tingling continues to occur but less frequently. Early morning the next day (4/13) had chills and fever. Fever continued through early afternoon. On 4/19 both feet felt like they were on fire and the soles itched like crazy. Went away after an hour. Around 5:30 am red spots appeared on the bottoms of feet which were very warm. This went away. Throughout the day I had red spots on my feet and legs that would be red, warm, and some itchy that would come and go. My thighs had spots that appeared to be heat rash. At 7:30 pm areas on feet were bright red, warm and slightly swollen.Diagnosed with allergic

METALLIC TASTE; SWELLING OF TONGUE; SWELLING; RED BLEMISHES AROUND EAR; BODY ACHE; DIZZINESS; RASH/MOSQUITO TYPE RED DOT UNDER LEFT EYE AND LEFT EARLOBE; LARGE RED SPOT ON NECK, ALMOST LIKE HIVES; WEAKNESS; FEVER; HEADACHE; INCREASED HEART RATE; SLEPT ONLY 3 HOURS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included hernia surgery, and smoker, and concurrent conditions included seasonal asthma, heart palpitations, overweight, and metallic taste reaction with contrast dyes use with scans. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced slept only 3 hours. Laboratory data included: Heart rate (NR: not provided) 118-120. On 10-APR-2021, the subject experienced increased heart rate. On 10-APR-2021, the subject experienced metallic taste. On 10-APR-2021, the subject experienced swelling of tongue. On 10-APR-2021, the subject experienced swelling. On 10-APR-2021, the subject experienced red blemishes around ear. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced rash/mosquito type red dot under left eye and left earlobe. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced large red spot on neck, almost like hives. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 98.9. On 11-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste, swelling of tongue, and swelling on 10-APR-2021, and dizziness, and weakness on APR-2021, was recovering from rash/mosquito type red dot under left eye and left earlobe, and large red spot on neck, almost like hives, had not recovered from red blemishes around ear, fever, headache, body ache, and increased heart rate, and the outcome of slept only 3 hours 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.

DRY MOUTH; NO ENERGY; SEVERE PAIN IN RIGHT LEG; HEADACHE; FEELING LIKE BODY TORN APART; WHOLE BODY NUMB/NUMBNESS TO RIGHT LEG, FACE, RIGHT ARM/HAND/EAR; WHOLE BODY PAIN; COUGH; HOLDING FLUID; BUTTOCKS BURNING HEAVY; LOSS OF SENSATION; LACK OF SALIVA; LIPS DRY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included mucous in chest, and cough, and concurrent conditions included hyperlipidemia, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205821A 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 feeling like body torn apart. On APR-2021, the subject experienced whole body numb/numbness to right leg, face, right arm/hand/ear. On APR-2021, the subject experienced whole body pain. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced holding fluid. On APR-2021, the subject experienced buttocks burning heavy. On APR-2021, the subject experienced loss of sensation. On APR-2021, the subject experienced lack of saliva. On APR-2021, the subject experienced lips dry. On APR-2021, the subject experienced severe pain in right leg. On APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced dry mouth. On 11-APR-2021, the subject experienced no energy. On 13-APR-2021, Laboratory data included: PCR (NR: not provided) NEGATIVE. Treatment medications (dates unspecified) included: furosemide/potassium chloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no energy, dry mouth, and whole body numb/numbness to right leg, face, right arm/hand/ear, and the outcome of feeling like body torn apart, whole body pain, cough, holding fluid, severe pain in right leg, buttocks burning heavy, loss of sensation, headache, lack of saliva and lips dry was not reported. This report was non-serious.

On March 6, low grade fever, body aches March 10, heart palpitations started, still having palpitations seeing cardiologist March15, joint pain in right knee, the knee was swollen and hot to touch, could barely walk on the leg. within two weeks pain has stopped March 18 blister on top of palette and nerve endings on face painful. I believe it was shingles. Took Valtrex which help stop the pain and blister

BLOOD CLOT FOUND IN RADIAL ARTERY OF RIGHT ARM; SWELLING OF LYMPH NODES ON BOTH SIDES OF NECK; ARM SORENESS PROGRESSED TO ACHING OF RIGHT ARM; NUMB RIGHT ARM; FATIGUE; This spontaneous report was received from a patient and concerned a 51 years old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805025, expiry: unknown) dose was not reported, 1 total, administered on 16-MAR-2021 at her right arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, after receiving vaccine, the patient felt fatigue and right arm soreness where she got the vaccine. The arm soreness progressed to aching and numbness. On 01-APR-2021, the patient noticed swelling of lymph nodes on both sides of her neck. On the same day she was sent to emergency room (ER) and was told that a blood clot was found in the radial artery of her right arm; diagnostic data not reported. She was given Plavix (clopidogrel) and sent home. On 06-APR-2021, the patient returned to ER because she was not feeling any improvement on her right arm, and it was still hurting. She was told that a surgery was planned to remove the clot but it was later cancelled. She was sent home on the same day with XARELTO (rivaroxaban). At the time of report, the patient had a pending appointment with a surgeon regarding the clot; no date was provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 19-MAR-2021, was recovering from arm soreness progressed to aching of right arm, and numb right arm, and had not recovered from blood clot found in radial artery of right arm, and swelling of lymph nodes on both sides of neck. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 This report concerns a 51 years old female patient who had a blood clot in the radial artery of her right arm, 15 days after receiving Jansen COVID-19 vaccine. On the same day of vaccination, patient experienced fatigue and right arm sore where she got the vaccine. The arm soreness progressed to aching and numbness. 15 days after vaccination, the patient noticed swelling of lymph nodes on both sides of her neck and was sent to ER. She was told that a blood clot was found in the radial artery of her right arm (diagnostic data not reported) and was treated with Plavix and later with Xarelto. Based on the reported information, the causality of event blood clot in the radial artery of her right arm is considered plausible to the vaccination. Additional information has been requested.

Fevers chills big lump under left arm small bump still present felt like something was going on with brain wasn't a headache. For like 3 days didnt feel like my self stomach was aching for a day

SWOLLEN ANKLE WITH RED STREAKS; PAIN IN LEG; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 160 pounds and height was 67.2 inches. The patient's concurrent conditions included psoriatic arthritis, fibromyalgia, insomnia, restless leg syndrome, anxiety, nightmares and headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 and expiry: unknown) dose was not reported, administered at left arm on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included Prazosin for nightmares, Methotrexate for psoriatic arthritis, Norco (hydrocodone bitartrate/paracetamol) for psoriatic arthritis pain, Pramipexole for restless leg syndrome, Bupropion for smoking cessation, sleeping pills, anxiety medication as needed and headache medication. On APR-2021, the patient experienced swollen ankle with red streaks (her leg was huge and going over her shoe) and pain in leg. She went to hospital and did several tests like an ultrasound which ruled out blood clots and was also prescribed a 7 day course of antibiotics. On 22-APR-2021, she was admitted to hospital due to events and was prescribed IV antibiotics. On an unspecified date in APR-2021, Blood pressure result was good, Diagnostic ultrasound ruled out infection and blood clot and X-ray ruled out infection and blood clot. On 26-APR-2021, she was discharged and another 7 day course of antibiotics was given. Treatment medications included: fentanyl and IV pain medication. She had purchased compression hose for the swelling and had been wearing these. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen ankle with red streaks and pain in leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210452933-Covid vaccine-swollen ankle. 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 V0- 20210452933-Covid vaccine-pain in leg. This event(s) is labeled by standard procedures. The event(s) is considered not related.

FEET SWELLING UP; EDEMA IN LEGS; PRESSURE ON CHEST; WATER RETENTION; This spontaneous report received from a patient via a company representative concerned a 51 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced water retention. On 18-MAR-2021, the subject experienced feet swelling up. On 18-MAR-2021, the subject experienced edema in legs. On 18-MAR-2021, the subject experienced pressure on chest. Treatment medications (dates unspecified) included: furosemide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pressure on chest, feet swelling up, and edema in legs, and the outcome of water retention was not reported. This report was non-serious.

SWELLING OF LEGS; SWELLING OF FEET; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced swelling of right leg, and swelling of right feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of legs, and swelling of feet. This report was non-serious.

She got her vaccine, she felt the burning sensation all the way down to her fingers and her wrist. I proceeded to go forward and wait the 15 minutes. She then started to have pain in the side of her neck on the right side, discomfort and pain in her arm. Within the hour she started to have headaches (has had COVID in the past). She went home and it was a nagging pain in her arm, not at the site but the whole arm was sore and limited using the arm due to the discomfort. That night is when she came on the news and started that the vaccine was being pulled from administration. That night it was like a pulling sensation right in her upper arm, up near the armpit and the fatty tissue from the breast and where you raise your arm. When she started noticing the discoloration started in her skin. Her hands started getting black, under both arms were black, the back of her legs was black, and she started feeling worsening fatigue. She started getting worried and was looking at how her veins turned purple blue/green just in the one arm. She was trying to figure out why she had limited use of her arm, and was holding it as if she had a sling on it as when it hung to her side it had the pulling sensation and a crawling sensation in her veins (that night and going into the next day). The next morning she was so exhausted and tired, as was her mother who had the vaccine at the same time, and was not feeling well. She was feeling that possibly due to the fibromyalgia she was have worsening symptoms than her mother. She then started bruises on her body, on the arm itself as if somebody grabbed and squeezed her arm, purplish/black bruising. It had her forearm develop 3 large pockets of swollen, almost as if the medicine was sitting in her arm. She was slowly getting the pulling sensation down to her hand, and she called the UC first and due to the high volume of COVID she wanted to know how long of a wait she would have. They instructed her to go to the ER due to the development of the blood clots on the news. There was no change in her symptoms, and got to the point that she could not move her arm, and the knots stayed in there and there was a reddish discoloration around them. Now she was having a pulling sensation in her chest and palpitations of pain near her heart. She was having soreness in her legs to the point that she was not able to walk, and felt it was in her nerves 3 days after the vaccine. She stayed in the bed the entire week just due to the exhaustion and effects. Every time she would go to reach for something she would have the pulling sensation down to her hand, and the entire arm was swollen with the bruising all over. Her body started having purple and blue knots and also in the left leg. Her arm and fingers were swollen as well. She then started having itching of her arm, and her lips started swelling and got up and went to Hospital and was able to be seen. She was having problems with her stomach as well, having a knot in the stomach where it was protruding and started loosing weight since the vaccine. The ER doctor told her she had a reaction to the vaccine, and did a Doppler to see if she had blood clots. They did not give her the results and didn't feel that she didn't have problems. She also went to the UC and back and forth to the ER, and still had the knots and finally looked at the knots and her jaw was swollen, and her arm was still swollen. The UC told her that she was having a fibromyalgia flare. She is still having the same symptoms green/blue and have started protruding. Due to the fatigue she has mainly just stayed in bed and knew that she was to have COVID symptoms, but knows that the crawling sensation and the knots sitting in her arm, and now her arm looks disfigured and the swelling is not going down. They told her that the test was negative for the blood clots. She had made an appointment with her neurologist and has an APT on Tuesday 5/25/21. She continues to loose weight no matter how much she consumes and still continues to have the knots and pain in the arm.

After receiving the vaccine, my throat began to swell and I began to turn red in throat and chest. I was observed by County EMT for about 30 minutes. I was asked if I needed treatment while being observed but went I went home and took a Benadryl. The throat swelling went down but did take another Benadryl that night. The next week, my left arm was swollen and I had pain in my hand and wrist.

Both sides of my neck were very swollen. There was extreme pain on my right arm. The pain was severe and numbness in my finger. I went to the ER and they said I have radial thrombus, a clot in the radial artery. Before the shot, my heart was checked multiple times and I was fine. After the shot, my coronary arteries are now very small. There are now luminal changes inside my coronary arteries which are still now very small. I now have been diagnosed with CAD. I had a heart cath on March 29. My arm is still in a lot of pain. My neck is still swollen.

A swollen lymph node on right ear - hard painful knot - felt like a bruise - it kept swelling after a few days. I went to the doctor - I saw a Dr - as mine was on vacation. They gave me amoxicillin and through taking that it went away. It's completely gone away. It doesn't hurt to poke at it anymore.

1. 24 hours of chills, body aches, fatigue, and low grade fever on the day after my shot. 2. On March 20, 2021 I woke up with swollen lips and face, and hives on my arms, legs and trunk. I also had a cough, watery eyes and itchy throat, like typical allergy symptoms. I went to the emergency room and was treated for an allergic reaction. No one, including myself, considered the COVID shot as the reason. The hives were gone within 24 hours, but the other allergy symptoms lasted for one week exactly. They had not gotten any better with a variety of over the counter allergy medications. When I went to my primary doctor for a follow up visit on March 29th all of the symptoms were gone. They were the ones that recommended I sign up with the vaers system, and they suggested the possible/likely connection to the vaccine.

On May 15th, she got the J&J vaccine. Then on May 17th, while she was walking, she tripped on a curb and fell and then landed on her left knee. Then, this past Thursday on May 20th, she noticed swelling and pain in the left leg. She presented to urgent care the following day on Friday and had an ultrasound done that revealed blood clot in the superficial veins. Patient recalls of had a similar episode of superficial vein clot about 6 years ago. Referred to vascular and second ultrasound done revealing DVT

Pt. had swelling all over her body starting 4/8/21 at 8:45pm, she had these symptoms for two weeks. Pt went to the ER on 4/21/21 since symptoms did not go away or got better. Pt had a CAT Scan and blood work done during that visit, and she was discharged and was diagnosed with foot edemas. Pt reported having the following symptoms continue after ER visit: inflammation in all of her body, swelling of hands and legs, sharp pain in eyes, toes, and arm, extreme fatigue, at night she has difficulty breathing, itching all over her body, headache, pain in lower calf and ankles of both legs but more severe on left calf.

FELT LIKE IMMUNE SYSTEM TAXED; COLD SORE; LARGE SCABS ON NOSE; TIRED; EXTREMELY HEAVY PERIOD; DIARRHEA/ STOOL WAS LIQUID; CLAMMINESS; SHORTNESS OF BREATH; FEVER; STOMACH PAIN; NAUSEA; AREA BELOW EYES ALL THE WAY DOWN TO HER CHEST BECAME NUMB; GENERALLY UNWELL; HEART SLOWED DOWN; EXTREME DROWSINESS; SPEECH SLOWED DOWN; ITCHINESS SPREAD TO THE ENTIRE BODY/ ITCHINESS IN HER EYES AND NOSE; NIGHT SWEATS; WEIRD DREAMS; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 175 pounds, and height was 69 inches. The patient's concurrent conditions included allergic to cats, allergic to pollen, alcohol use, and cigarette smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. the patient was healthy and not pregnant at the time of the reporting. 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 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced heart slowed down. On 06-MAY-2021, the subject experienced extreme drowsiness. On 06-MAY-2021, the subject experienced speech slowed down. On 06-MAY-2021, the subject experienced itchiness spread to the entire body/ itchiness in her eyes and nose. On 06-MAY-2021, the subject experienced night sweats. On 06-MAY-2021, the subject experienced weird dreams. On 06-MAY-2021, the subject experienced area below eyes all the way down to her chest became numb. On 06-MAY-2021, the subject experienced generally unwell. On 07-MAY-2021, the subject experienced stomach pain. On 07-MAY-2021, the subject experienced nausea. On 07-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101-102 F, and Pain scale (NR: not provided) 8/10 (unit not reported). On 10-MAY-2021, the subject experienced clamminess. On 10-MAY-2021, the subject experienced shortness of breath. On 10-MAY-2021, the subject experienced diarrhea/ stool was liquid. Laboratory data included: Body temperature (NR: not provided) 99 -100 F. On 11-MAY-2021, the subject experienced extremely heavy period. On 12-MAY-2021, the subject experienced tired. On 03-JUN-2021, the subject experienced cold sore. On 03-JUN-2021, the subject experienced large scabs on nose. On an unspecified date, the subject experienced felt like immune system taxed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme drowsiness, and area below eyes all the way down to her chest became numb on 06-MAY-2021, itchiness spread to the entire body/ itchiness in her eyes and nose on 07-MAY-2021, weird dreams, and diarrhea/ stool was liquid on 14-MAY-2021, stomach pain on 08-MAY-2021, clamminess, shortness of breath, and nausea on 12-MAY-2021, and tired on 17-MAY-2021, was recovering from fever, cold sore, large scabs on nose, and felt like immune system taxed, had not recovered from night sweats, and generally unwell, and the outcome of extremely heavy period, heart slowed down and speech slowed down was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.

Itchy throat within 4 hours of administration, initially small pea-sized reaction which has continued to grow to the size of an orange and still continues to grow larger each day. The swelling protrudes by 1 cm and causes pressure to radiate towards my fingers.

PERIOD NOT AS HEAVY AS NORMAL; SPOTTING CONTINUED FOR 3 WEEKS; LOW BODY TEMPERATURE; DOES NOT FEEL NORMAL OR RIGHT; SWELLING IN LEGS AND FEET; DID NOT FEEL GREAT; FELT FEVERISH; HEAVY MENSTRUAL BLEEDING FOR 2.5 WEEKS; WATER RETENTION IN LEGS AND FEET DAILY; WEIRD BLOATING; PERIOD (BLOOD VOLUME) UP AND DOWN; 28 TO 30-DAY CYCLE ERRATIC, PERIOD WOULD START AND STOP AND MONTHLY CYCLES THROWN OFF; DID NOT HAVE A PERIOD AND PERIOD STOPPED; ANAPHYLAXIS REACTION; HEAD AND NECK NUMB; IV INFILTRATED; RED ARM; SWOLLEN ARM; FATIGUE; This spontaneous report received from a patient concerned a 51 year old white female of not hispanic or latino ethnicity. The patient's weight was 179 pounds, and height was 64 inches. The patient's past medical history included 28 to 30-day menstruation cycles with heavy bleeding for the first 4 days then tapers off, water retention, and swelling, and concurrent conditions included daily over the conter medication allergy, allergy related to asthma, flu shot has similar sore arm, bees allergy, dust mites allergy, cats allergy, dogs allergy, alcohol drinker (occasionally, special occasions, 2 per month), and non smoker, and other pre-existing medical conditions included patient had no menstruation changes since 13 years. patient was uses medications prn and 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: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced anaphylaxis reaction. Before the needle got out of the patient's arm the patient experienced hives on wrist and arm on the same arm used for vaccination after that the patient's throat began to close. On the same day the patient head and neck numb. Patient further described that it was not numbness but rather the blocked of oxygen due to her throat swelling. Soon after patient was taken to the emergency room through ambulance and treated her with diphenhydramine hydrochloride, epinephrine, and prednisone. Patient experienced iv infiltrated while in the ambulance ride. Patient remained in the emergency room for the protocol specified number of hours for monitoring. Patient had electrocardiogram (NR: not provided) Normal. Patient got released from hospital the same day when stable and normalized. On10-APR-2021, the patient experienced common vaccine reaction of a red and swollen arm, the patient did not have a period and period stopped and patient experienced fatigue. On MAY-2021, the patient experienced 28 to 30-day cycle erratic and period would start and stop and monthly cycles thrown off. On JUN-2021, the patient experienced spotting, water retention in legs and feet daily, weird bloating and period (blood volume) up and down. On JUL-2021, the patient experienced heavy menstrual bleeding for 2.5 weeks. On an unspecified date, the patient experienced low body temperature. period not as heavy as normal, spotting continued for 3 weeks, more menstrual bleeding, extensive time frame for period, does not feel normal or right, swelling in legs and feet, did not feel great, and felt feverish. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low. Additional treatment medications (dates unspecified) included: hyetellose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylaxis reaction, and head and neck numb on 10-APR-2021, period not as heavy as normal, and weird bloating, and fatigue, and felt feverish on 21-JUN-2021, was recovering from did not have a period and period stopped, 28 to 30-day cycle erratic, period would start and stop and monthly cycles thrown off, water retention in legs and feet daily, and swelling in legs and feet, had not recovered from spotting continued for 3 weeks, and period (blood volume) up and down, and the outcome of iv infiltrated, red arm, did not feel great, low body temperature, heavy menstrual bleeding for 2.5 weeks, does not feel normal or right and swollen arm was not reported. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210757746. .; Sender's Comments: V0: 20210745140- Covid-19 vaccine ad26.cov2.s-Anaphylaxis reaction. This event(s) is labeled per RSI and is therefore considered potentially related.

Chills, fever, heart racing, swollen axial lymph nodes, headache and teeth pain. Symptoms are resolving.

About six or seven hours after the shot I started to feel bad, first some in my chest, then a scratchy throat with swollen glands, then mild body aches. The next day the sore throat was gone, and body aches got worse. All my joints ache. I felt chilled in spite of outdoor temperature of 79, and a hot bath, blankets and sitting in front of a fire. It was 74 inside the house. I started to get a bit of a headache but it never developed into a full headache. At about 6pm (day 2) I started to get hot. Anything touching my skin bothered me. At about 7pm (day 2) I took two Tylenol and the symptoms improved by about 8:30pm.

mild facial swelling, peripheral edema, hypotension - started about 12 hours after vaccination. pt does have history of dermo-filler where facial swelling is present

SORE VACCINATION SITE FOR 1 ST DAY, THEN KNOT UNDER SKIN, SWELLING, REDNESS, HEAT, ITCHING, SORENESS FOR DAYS 2,3,4 AND CONTINUING

Vaccination was 10:30 am. Around 6:30 pm, my right knee started to throb. I took an epsom salt bath, where my upper back started to hurt. I went to sleep around 8:00. I woke up around 10 pm unable to open my eyes all the way. I believe they were swollen nearly shut. I could see a slit of light coming in from outside. I couldn't move my left hand at all (left arm is where I received vaccination). I held it up to the outside light, and it was swollen. The light coming in from outside hurt my eyes. I couldn't see enough to call for help. Around 1:30 a.m., the swelling went down enough for me to open my eyes. I have never seen them look so bloodshot. It was scary. I could move my hand again as well. I spent next day in bed resting. Monday, I noticed a small rash on my right shoulder. I went to work and was there about 20 minutes before I started feeling hot and dizzy. I went home and spent the day in bed. I was able to go to work the next day, Tuesday, without problem. One week after vaccination, the rash on my shoulder went away, but a small rash broke out on my right shin. This one was deeper. One week later, there are just a couple of small scabs left in the spot on my shin. I feel my energy level is close to normal.

After 24 hours of only occasional stabbing head pains, I experienced 12 hours of fever and chills, followed by 36 hours of feeling well, then vomitting (only once) and diarrhea for 12 hours. swollen arm - red, swollen, hot, painful, itchy the size of my palm. Has diminished to a hard spot the size of a quarter 3 weeks after injection

Severe migraine, pain and swelling of all joints, muscle pain, dizziness, nausea, swelling of hands and feet. Within the first couple hours there were changes in taste and smell, coldness on left side of body. Those resolved within 5 hours.

Immediately after injection, my heart raced, I got a metallic taste in my mouth, and my fingers got cold and tingly. The next day, I developed chest pain, racing heart, shortness of breath, and insomnia. I continue to have chest pain. On 04/08/2021, without injury or anything that I did, my right middle finger swelled and turned purple and it's still purple. The ER doctor said it was a hematoma.

SWELLING ARM; HARD LUMP UNDER THE SHOT; CHILLS; FEVER 102.2; EXCRUCIATING HEADACHES; This spontaneous report received from a 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: 180503, expiry: UNKNOWN) dose was not reported, administered in left Arm on 06-APR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102.2 (units unspecified). On 07-APR-2021, treatment medications included: paracetamol. On 07-APR-2021 01:30, the subject experienced chills. On 07-APR-2021 01:30, the subject experienced shivering. On 07-APR-2021 01:30, the subject experienced fever 102.2. On 07-APR-2021 01:30, the subject experienced excruciating headaches. On an unspecified date, the subject experienced swelling arm, and hard lump under the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and excruciating headaches, and the outcome of shivering, fever 102.2, swelling arm and hard lump under the shot was not reported. This report was non-serious.

Symptoms started 4/2/21. Stated as numbness and tingling in lower extremities and progressed to numbness of tongue and upper extremities along with back pain. Patient admitted to Hospital with R/O Guillian Barre Syndrome.

Swelling of arm that received injection. No pain. Swelling occurred shortly after vaccination date and subsided a little, but got bigger in the last few days.

8pm- face got puffy, mostly around the nose. Itchy as well/seemed like a histamine reaction. Settled down after around an hour. Took screenshot selfie of face with phone. 10-13 days after shot- gums felt inflamed near base. On day 13 went to dentist and he said looked like an allergic reaction/irritation, not gingivitis, as not above teeth but near roof of mouth. Speculated could have reaction to shot in combination with toothpaste. (Evening of shot had chills/ache/low grade fever/head pains/nausea/diarrhea next morning. Took over the counter Tylenol).

Exactly A week later i developed fever, chills, fever blisters and my urticaria kicked in where i needed to spray myself on a regular basis to cool down my body

ANAPHYLACTIC REACTION; LIGHT HEADED; SYNCOPE/LOST CONSCIOUSNESS; STOPPED BREATHING; VOMITING/PERSISTENT EMESIS; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and anaphylaxis to peanuts. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 02-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, after vaccination patient experienced an anaphylactic reaction. The patient was at her local pharmacy and was waiting in chairs as instructed; then she walked to her vehicle and began to feel light-headed and lost consciousness. Her husband was with her and was able to administer life saving measures, the local pharmacist was able to administer an epi-pen to her right thigh. On 02-APR-2021, the patient stopped breathing and was then transported to the local ER(emergency room) where she was treated. She regained consciousness and had persistent emesis and the patient was kept in hospital for 24 hours before being discharged. The patient was hospitalized for one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope/lost consciousness, and was recovering from light headed, vomiting/persistent emesis, and anaphylactic reaction, stopped breathing. This report was serious (Hospitalization Caused/ Prolonged, and Life Threatening).; Sender's Comments: v0 A 52-year-old female patient with the past medical history remarkable for anaphylaxis to peanuts experienced anaphylactic reaction the same day the Janssen COVID-19 Vaccine Ad26.COV2 was administered. The patient began to feel light-headed and lost consciousness, an epi-pen was administered. The next day the patient stopped breathing and was treated in the local ER (emergency room). Later she had persistent emesis. Given the close temporal relationship and history of anaphylaxis to peanuts the events are considered related.

sores on mouth- could be impentigo or a cold sore. I did also suffer from fever/chills for 24 hours after vaccine (already reported to CDC via app). no doctor seen.

RIGHT MIDDLE FINGER TURNED PURPLE; FINGERS SWELLING; INSOMNIA; RINGING IN THE EARS; CHEST PAIN; SHORTNESS OF BREATH; FATIGUE; BODY ACHE; METALLIC TASTE IN MOUTH; FINGERS TURNED COLD AND TINGLY; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, "over Christmas" and had since recovered. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 23-MAR-2021, the subject experienced metallic taste in mouth. On 23-MAR-2021, the subject experienced fingers turned cold and tingly. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced insomnia. On 25-MAR-2021, the subject experienced ringing in the ears. On 25-MAR-2021, the subject experienced chest pain. On 25-MAR-2021, the subject experienced shortness of breath. On 08-APR-2021, the subject experienced right middle finger turned purple. On 08-APR-2021, the subject experienced fingers swelling. Treatment medications (dates unspecified) included: doxycycline, and azithromycin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right middle finger turned purple, chest pain, metallic taste in mouth, and fingers swelling, had not recovered from insomnia, ringing in the ears, and shortness of breath, and the outcome of fingers turned cold and tingly, body ache and fatigue was not reported. This report was non-serious.

Had a headache within an hour, felt slightly flu-ish.. Developed a rash on my face on about day three. It kept getting worse and painful (swollen and near the eye) so I saw the doctor on April 16th. He treated me for shingles. The rash and pain was on the left side of my face and neck and in my hair. I felt better on about April 20th except the headache is still there and I still have nerve pain in my hair and one spot on the left side of my head, near my temple. It comes and goes.

Rash covering chest, neck and face. Also swelling of face and around eyes. Started on 4/14 was still present when I visited doctor on 4/23 and was placed on Benadryl. Finally started going away 4/25. Still have rash and swelling if Benadryl wears off

REDNESS OF THE LEFT ARM; SWELLING OF THE LEFT ARM; ITCHINESS OF THE LEFT ARM; HOT LEFT ARM IN TOUCH; LEG PAIN; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included lymph node, and concurrent conditions included cancer. 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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced redness of the left arm, swelling of the left arm, itchiness of the left arm, hot left arm in touch, and leg pain. Laboratory data (dates unspecified) included: Blood test (NR: not provided) everything clear, and Diagnostic ultrasound (NR: not provided) everything clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from redness of the left arm, swelling of the left arm, itchiness of the left arm, and leg pain, and the outcome of hot left arm in touch was not reported. This report was non-serious.

Fever 101. 2 - 2 days Diarrhea - 1 day tightness in chest and harder to breathe from the start and lasted 3 weeks - still gets tight and hard to breathe but not constant Swelling of my feet (also felt like it was a sunburn) was worse than prior to the vaccine (I never had this problem until I had covid) l Could not sleep - wired - lasted at least 2 weeks - I'd wake up and was wide a wake after 2 hours of sleep. Exhausted even when I could sleep some - still tire fairly easily extreme leg pain , bone pain, hip pain - lasted over 3 days then it was just really bad pain for 5 weeks horrible headache - really horrible for the first 3 days - headaches seem to be gone Processing takes longer - words, thoughts, understanding - has continued from the beginning until now - but has improved earache that comes and goes - no ear infection 4/12 started slurring my words - not all of them and not all day - lasted 4 days

The patient began to notice that her face/eye was swollen/finger tingling. She then proceeded to have an itchy and scratchy and burning sensation. Her fever increased to 101.6. During her telehealth evaluation on April 14, 2021 8 macular papular rash that was not deemed to be proper was noted on the lower extremities. They were nonblanchable and no pain was elicited with palpation by the patient under my direction.

Woke up April 25, 2021 at 9:00 am with left shoulder pain. Throughout the day the pain became intense and unbearable. It had also swelled considerably. I could not lift my arm at that point. At approximately 10:00 pm I went to the hospital. I was given an Ultrasound on left arm and shoulder to check for blood clots which was negative. I was also given an Xray on left shoulder to check for bone abnormalities which was negative. I was diagnosed with "COVID shoulder", released and given pain medication. Was told to follow up with family practitioner. Went to Dr. on Tuesday, April 27, 2021 who confirmed the diagnosis. Blood was taken which showed elevated white blood cells.

She had the vaccine, no reaction at all other than soreness, the inside of her elbow was a little achy and a little swollen but nothing major. Then yesterday morning was a little achy and by afternoon was miserable the next day she got really tired, joints hurting and had to take a nap. She cancelled one of her appointments she's a home health nurse and went to sleep and when she woke up her throat was swollen, hurting, labored swallowing and when she would drink her ears would pop, and her tongue was swollen but could breathe fine, and then it progressed to where she could not swallow at all. She took two Benadryl's and went to rest, and she was not able to move and had to have help getting dressed. Her joints are swollen, her hands are swollen, but her throat is not hurting like she was yesterday.

Patient called 5/17- 2 weeks post vaccine stating arm is still tender, swollen, and warm to the touch. Patient states it is not red

REALLY HARD TO CHEW AND NOT REALLY TO TALK BUT TO CHEW FOOD; EARACHE ON THE RIGHT SIDE OF MY FACE; PUFFY FACE; JAW PAIN; HEADACHE; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced headache. On 05-MAY-2021, the subject experienced jaw pain. On 05-MAY-2021, the subject experienced earache on the right side of my face. On 05-MAY-2021, the subject experienced puffy face. On an unspecified date, the subject experienced really hard to chew and not really to talk but to chew food. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache on 05-MAY-2021, had not recovered from jaw pain, earache on the right side of my face, and puffy face, and the outcome of really hard to chew and not really to talk but to chew food was not reported. This report was non-serious.

COVID SHOULDER; WHITE BLOOD CELLS ELEVATED; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, and other pre-existing medical conditions included the patient had no allergies to medication, food or other products. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 00:40 for prophylactic vaccination. Concomitant medications included ethinylestradiol/norethisterone acetate for drug used for unknown indication, rosuvastatin for drug used for unknown indication, and venlafaxine hydrochloride for drug used for unknown indication. On APR-2021, the subject experienced white blood cells elevated. Laboratory data included: Blood test (NR: not provided) White blood cells elevated, Diagnostic ultrasound (NR: not provided) Negative for blood clots, and X-ray (NR: not provided) Negative for bone abnormalities. On 25-APR-2021, the subject experienced covid shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid shoulder, and white blood cells elevated. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.

The same afternoon about 7pm my arm started to swell, it moved to arm and wrist. I couldn't sleep. It lasted about 5 hours. I had fever and chills that had subsided by morning. I still had arm pain and my blood pressure was trough the roof. I went to see the doctor the next day. The doctor did not not see anything concerning.

Swollen lymph nodes after vaccine, abdominal pain for 2 days, subsided shooting pain from left arm to ear, ringing ear for 10 minutes, several days later. 10-14 days later could not move or lay on left arm (site of vaccination). Lymph nodes on left arm very swollen. Treated with advil for 1 week, swelling subsided, but arm has not fully recovered.

After normal 45 min walk sat down got up 20 minutes later and it felt like rocks were in my right foot. I couldn?t walk normally. Bottom of foot was swollen. Next day the same thing happened a few times but I was able to walk. Then bottom of right foot turned purple and white kinda like Reynard

Very sore arm immediately following hot, right rah that stayed for twenty minutes the rash did not recur the sore arm continued for a couple of weeks, developed a fever around 11:00pm the day f the shot fever temp was 101 F had a heart rate over 100 racing heart all night the fever came and went 36 hours after the shot the fever went down to 99 F, fever went away three days later, was very nauseated and fatigue for about a week, had a very sore ball at left foot was swollen couldn't put weight on my foot and could barely walk went away a week later then later resolved and also had morning stiffness in elbow that still is recurring

after receiving the vaccine, I was fine for 10 hours, then got sick for 24 hours -high fever, chills, headache. Was getting better for a week after the vaccine, and then started to feel worse and worse. I have swollen throat, swollen face and body, foggy head, feeling cold, then sweating. Used to be very active person, would walk a lot, jog, ride bicycle for miles. Now can't go even for a walk, feel very tired. , have to force myself to work. on day off could not get out of bed for 3 hours. sleeping poorly, waking up because my hands go numb, have to shake them. Coming up stairs making me to seat and catch the breath , and calm the fast heart beat. Fell like hear is squeezed. Went to my physician 6/03, took blood test on 6/04, blood showed higher than normal thyroid. It was perfectly fine in February of this year. Physician sent me to endocrinologist, had phone appointment today, will be taking an other blood work next week. Endocrinologist said to contact Infectious disease doctor, as these are not his symptoms, left a message for appointment with Infectionist , don't think will get a quick one.

describes symptoms beginning 11 days later as swelling to bilateral medial elbows, without pruritis or erythema. The swelling on the right arm was associated with digital paresthesias of the 4th and 5th digits. About two days had macular erythema and pruritis on medial arms, trunk, back, legs, starting small and coalesced to grew, accompanied by intense pruritis and sought care in the ED x 2. With complaint of arm swelling, had negative DX, determined not to be a venous thrombotic disorder. On 22 Apr patient presented again to clinic and diagnosed with acute generalized urticaria. Reported rash lasted less than 24 hrs. No airway involvement. Arm swelling lasted about 1 wk. Did report low grade fever and slight site soreness the day of vaccine that lasted less than 24 hrs. Symptoms: URTICARIA, UNSPECIFIED(L509), EDEMA, UNSPECIFIED(R609).

I had an auto-immune flare up starting the day after the vaccine. I took care of myself. Then over the course of the next couple of weeks. I had on and off headaches. My thyroid then in April 2021 - it swelled (I had another auto-immune flare up). My neck gets really thick feeling and kind of swollen. In May, on and off, I had symptoms of my legs falling asleep more often. My vision has gotten worse in the last three months. It is a little more blurry. I had a lot of breast tenderness happen. I went for a mammogram. My anxiety and depression is off the charts and I'm able to manage things pretty well usually. I talked to someone this morning and a therapist, too. Thinking what to do given insurance. I had been discounting the symptoms because I was not thinking it was vaccine. It has increased a lot in the last three months, though, all the doctoring and symptoms I have had. I've felt out of whack; exhausted a lot and have put on a lot of weight. It's still all happening.

I started with getting red, hard knots in my leg. They were hard, hard knots. Almost felt like blood clot. My blood pressure rose extremely high like never before. Then I got edema. I went to the vein doctor. I saw the nurse assistant and they said it wasn't a blood clot. Finally, I got to see him at another visit and he thought it was bug bites. But it sounded odd like that I would have these red splotches up and down my legs and they were hard and he put me on Prednisone. The symptoms disappeared completely. About 4 -6 days after the medication was over, all the symptoms re-appeared. At some point, I went to the ER - because I was worried about blood clots. They gave me Cephlex - as they thought it was bug bites - so I was on that for 6 or 7 days. And the symptoms got better with this medication - made it better but not disappear like Prednisone did. Then after that, it was horrible again - the symptoms. I have an appt tomorrow to get checked again. I have never have had this stuff before in my life. My blood pressure is elevated but not so high as it was in the beginning. My legs are in pain - I can't even touch them. My skin so red - it looks like it's on fire. I went to Orthopedic doctor thinking it was related to a previous injury or sprain. But they said it wasn't related to that at all .The skin so tight gets so tight and sore that I can barely walk. The skin is broken like it's thin and very fragile. My left leg is significantly worse than the right leg in the calf area (it's two times the size as the right calf). Still have edema I can't hardly wear shoes. At the end of the day, it's worse, but still in the morning now they are still swollen.

Left arm sore for about 9days. On 5/18/21, my right ringer started to swell at the joint, by 5/21/21 finger pain went thru hand and painful bumps started to appear on elbows and fingers. By 5/28/21 both hands were swollen and left foot. I had a follow-up appt with my doctor on 6/29/21 and by then both feet were swollen, both hands were swollen and the left knee.

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

I received my shot on 04/12/2021 in the afternoon and started to feel the effects immediately, It started with sharp shooting head pain and through my neck. I stayed at the clinic for like 30 minutes and on the drive home extreme fatigue started to set in. By the time I got home the fatigue was the main symptom that lasted about 24 hours. The next morning I noticed edema in my right fore arm where I had a prior injury from 2012. The extreme fatigue lasted for about 2 weeks before I was able to do my job again. The edema kept getting worse until the day I went to the emergency room. I also had sharp shooting head pain, it felt like electricity going through my head and that continued for about 7 weeks. At the emergency room they just gave me fluids and that was it. The hospital did bloodwork and did an EKG. Nothing abnormal was found. I was told if things got worse that I should come back. The fluids helped and it took about 3 weeks for the edema to go away. At some point in the process of my events, I had eye palsy that also lasted about 7 weeks. It has been about 8-12 weeks, I think I am better, but still feel fatigue, but I am not certain that is from the above mention events, it could be from the sleep apnea.

10 days after shot had Sciatica for a week (Muscle relaxer and pain killer) 15 days after shot got Bells Palsy lasting 2 days (Anti Viral medicine and Prednisone) 33 days later had tremors and could barely walk. 38 days hands and feet numb 42 days after shot in hospital with Gillian Barre Syndrom

In the beginning i was very tired and exhausted and dizzy. I was delusional the first day and very out of it on the second day, by the third or fourth day my arm stared to swell and I had a phone doctor visit the doctor prescribed doxycycline. my ears starting ringing really bad and my vision got weird. the top of my head was burning and had only a low grade fever. My hands and fingers are tingling. and My chest has been hurting. The pain in my hands and feet feel like nerve pain.

Since the shot, I have very hard swelling in the lower legs, with a red bumpy rash and little blisters on the front of my calves. It burns and is the worst in the mornings when I wake up. It is extremely tender to the touch. I also have a hardness in the lower legs. The other issue I started experiencing is a one day menstrual period every week since the shot. Thirdly, I have an odd peanut size bump on my left hand middle finger right under the nail that is squishy.

onset of left neck mass with adjacent rash 3 days after vaccination. Rash resolved, but now burning/paresthesias are reported around the left neck/shoulder. Ultrasound pending

PERIPHERAL SWELLING; JOINT SWELLING; LABORATORY TEST; PAIN IN EXTREMITY; RASH; RHEUMATOID ARTHRITIS; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (reference number 1437585) concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient experienced drug allergy when treated with levothyroxine, and lisinopril. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 04-MAY-2021 to left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid (aspirin low dose), atorvastatin, estradiol, gemfibrozil, insulin glargine (Lantus Solo star Pen), levothyroxine sodium(Synthroid), metformin, and omeprazole. On 18-MAY-2021, the patient experienced Left arm sore (pain in extremity) for about 9days and the patient's right finger had started to swell at the joint (joint swelling), On the same day the patient experienced rash, undergone laboratory test and was diagnosed with rheumatoid arthritis. By 21-MAY-2021, the patient's finger pain went through hand and had painful bumps on elbows and fingers. On 28-MAY-2021, the patient both hands and left foot were swollen (peripheral swelling). It was reported that the patient had follow up appointment with doctor on 29-JUN-2021 and by then both the feet, hands and left knee were swollen. The patient's laboratory data included: Laboratory test (NR: not provided) Lupus, autoimmune negative and the patient was diagnosed with Rheumatoid arthritis based on symptoms. The patient visited physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rheumatoid arthritis, pain in extremity, peripheral swelling, rash, joint swelling, and laboratory test. This report was serious (Other Medically Important Condition). version created to amend previously reported information on 09-JUL-2021. Upon review, the following information was amended: onset date of rheumatoid arthritis, pain in extremity, laboratory test captured as 18-MAY-2021, narrative updated.; Sender's Comments: V1 - This version created to amend previously reported information on 09-JUL-2021 regarding : onset date of rheumatoid arthritis, pain in extremity, laboratory test captured as 18-MAY-2021. This does not change causality of previously reported events. 20210722011-covid-19 vaccine ad26.cov2.s-Rheumatoid Arthritis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Janssen COVID-19 Vaccine EUA Injection @ 1130a 1hr after - diarrhea 5hrs after- Rt Arm (opposite arm of shot) tingling sensitive to touch 7hrs after- Skin Crawling painful to touch - low back,thighs, arms, scalp 9hrs after- Freezing and fever sweating 12hrs after- 102 fever, racing BP about 180 high for me, Wrist and Elbows Ached terribly, Lower legs - knee down felt swollen but no sign of swelling. Low back Ached with Pain in Right rear side. Felt like I needed to stretch back and legs tight/anxious. slight Headache 14hrs after- took 2 Tylenol PM & slept restlessly until 8:30 a (12hrs later) 8:30a - Much better with slightly achey back and forearms and occasional headache ting... not constant. Moving slow Had Covid Nov11 2020. Symptoms lasted 6week, each week one symptom would go away and a new would arise- -fever 2days -intensively painful skin crawling 2days -loss of taste and smell -diarrhea (still have loose stools and occasional watery) had diarrhea morning of shot -eyes painfully itchy irritated dry - still occurs most days about 3p -extreme exhaustion in afternoon about 1-3p still

swollen painful glands under arm at vaccination site, painful groin gland, runny nose, cough mucous, headache, light headed , weakness, abdominal pain chest pain , rt arm pain.

I currently have numerous cold sores (herpes labialis) on my upper lip - started as tingling. I typically get a single cold sore when I am on the verge of having a cold or flu, but not three at once. I also experienced pain in my left armpit (assuming lymph nodes) for two days post-vaccine.

Slightly sore arm with red spot. Very sore underarm (lymph node area) - hard ball and tender area. Discomfort is slowing subsiding. Not treating with anything.

Given the Janssen covid-19 Vaccine EUA at pharmacy. Left arm swelled right away and I lost around 3 tablespoons of blood from the vaccine site. I am concerned that the vaccine came out of the arm with the blood. I was asked to wait 30 min before going home. The bleeding stopped after 30 seconds. Swelling went down over next hour. No other side effects. I am concerned that I may not be vaccinated if the vaccine came out of the arm with the blood.

Local pain, swelling, redness is expected and should; subside within the next 24-72 hrs. Advised may take Tylenol for pain, apply warm compresses to site and call back if any questions.

severe migraine sore throat swollen glands loss of appetite diarrhea nauseous light-headed fainted earaches cough tired and no energy I went to Hospital

3/23/2021 about 10 am headache, about 11am chills, fever, joints ache, lower back pain, tired, sore arm slight bump and redness. Went to bed at 6pm. 3/23/2021 bump on arm getting bigger, warm, more sore and larger red spot. Chills off and on. 3/24 - 3/28 just the arm now - bump is about 2.5" in diameter. Warm, red and sore. Random pain twinges often - better with ibprofin. 3/29 and today 3/30 redness has decreased. Not as warm. Lump is like a large marble and not soft. Sore if you touch it. Random twinges are getting better. No ibprofin anymore.

Patient filled out vaccine consent form stating no to all questions (denying anything that might exclude her from receiving the vaccine), fever was taken (non-feverish), and signed under the bolded statement stating the patient is to wait in the pharmacy at least 15-20 minutes after receiving vaccination. Patient was then given the J&J covid-19 vaccine in left deltoid and told that it is recommended by CDC to wait in the pharmacy for 15-20 minutes after vaccination. However, the patient immediately proceeded to leave. Patient states upon getting to her car in the parking lot, she started noticing signs of anaphylaxis such as throat swelling, however patient did not come back into the pharmacy and left the premises. Patient did not report seeking any sort of treatment for her anaphylaxis side effects. Patient received vaccine on 3/30/21, did not report this event to the pharmacy until 4/2/21. Patient also states she is a registered nurse.

Chills within 8 hours. 18 hrs later on Wednesday the 30th muscle aches, extreme fatigue, slept all day Wednesday the 30th. Left arm developed large red swollen area that as of today, April 2 at 11 pm is still getting a little worse. 2 ulcers have formed in my mouth. Still tired and achy.

Over a four hour period developed exacerbation of angioedema of the neck and moderate worsening of asthma that lasted for approximately two weeks. Also developed diarrhea, which lasted approximately two days.

On 3/17/2021 I noticed I had swollen lymph nodes all on my neck. I saw my doctor he gave me a referral to an ENT and now today 4/8/2021 I will be getting a CT scan.

At the 14 day I had a severe head ache and hip pain on both sides for 3 days, at days 28 , 29, & 30 I was lethargic, both legs were severely swollen from my feet to mid calf, and I was nauseated and vomiting

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

Patient reports that she received the Johnson & Johnson vaccine on Sunday 4/11/21. She reports feeling no symptoms until Tuesday 4/13/21. She is experiencing tenderness under her left armpit and feels that her breathing is tighter than normal (COPD, emphysema, smoker).

04/09/2021 - None at time of injection. 04/15/2021 - Left leg pain, left foot swelling, left foot tingling.

Swelling of left ear for first 6 days, then swelling worked way down into neck, causing swollen lymph nodes and body aches and headaches. Also suffer from RA and it seemed to have caused a painful flare up or swollen and stiffness in shoulders.

Nauseau, vomitting, lightheaded, tingling around lips thought they were swollen, speaking weird cause of feeling of swelling and left palm and forearm numbing and thighs of legs. Stomach cramping and diarrhea after 1st night and still coninuing tonight as of 04/16/2021. On first night (04/08/2021) extreme painful body aches.

7 days after the shot I had my first ever herpes outbreak (I was tested 20 years ago & told it was in my system). My doctor called it an ?atypical outbreak? because there are only 2 small lesions that look like blisters. No pain, just a little discomfort. Dr said to get a sample of discharge if there is any. She also thought it might be a staff infection? I?ve been put on: valacyclovir 1gram 2x/day for 5 days Gabapentin 100mg 3x/day Mupirocin ointment 2% 3x/day

AS soon as received shot, severe pain in my shoulder/arm. This has not subsided and I received my shot 3 weeks ago. My shoulder/upper arm is extremely painful, sore, stiff and hurts to move shoulder/arm. I can pinpoint where I was injected.

Within an hour of the vaccine, I started to feel a fever blister under my nose and it was very painful. I woke up the next day and I had fever blisters all around my nose and inside my nose. They were very painful, and my nose was a little swollen. I also had a big fever blister on my lip which was really big. I went to the doctor and she gave me some antibiotic cream and they went down within four days of using the cream. Several of my coworkers had similar fever blisters.

Diarrhea, neck pain, face pain, earache, swollen lymph in armpit and neck all on right side. It is now 2 weeks today and still have symptoms.

Muscle aches started about 12 hours after the injection. First my legs and back but after another 12 hours it was mostly my legs. Legs felt like the muscles were being pulled. (It felt like the beginnings of the extreme reaction I had to ampicillin 2 decades earlier, though not nearly as severe.) My arm swelled slightly, was warm at the injection site and ached about 12 hrs after the injection. The leg aches lasted about 2 days, the arm ache lasted about 1 day and the slight arm swelling lasted about 6 days... Reason for my reporting: I had an annual eye exam 4/14/21 where a retinal scan was done. The optometrist saw some blood spots in my left eye and referred me to an ophthalmologist. Ophthalmologist performed additional scans and tests including a Fluroescein angiography and determined I have BRVO (Branch Retinal Vein Occlusion) which is a series of blot clots in small vessels of the eye's main vein. He did not say it could be a result of the vaccine but I have no risk factors associated with getting BRVO. Since it is not affecting my vision yet, the doctor wants to monitor it in 3 months to make sure it has not worsened. Since the Janssen vaccine was put on hold for causing other types of blot clots in women in my age group, I am wondering if the vaccine caused the blood clots in my eye.

4/3 vaccination The day after I got the typical bump in arm Rash all over chest and neck area, both sides, horseshoe. 20 mg of steroid. Reaction to the shot. The skin got pussy. The rash wasn't affected by the steroids. Getting more spots. Got the spots on my leg and several more down my right arm. Back to the doctor; increased steroids for another round and its finally clearing up. Permanent stain on skin. *still taking the steroids. Never seen anything like it before. PCM told me it was a reaction to the steroid. **did have COVID back in 11/2020; maybe 200 days since I had COVID to when I had vaccination

NAUSEA; SEVERE FATIGUE; HEADACHE; SWOLLEN LYMPH NODES IN NECK; RUNNY NOSE; WATERY EYES; FLU LIKE/BAD COLD; SWOLLEN LIPS; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 190 pounds, and height was 62 inches. The patient's past medical history included chf, asthma, and congestive heart failure, and concurrent conditions included seasonal allergy, penicillin allergy, alcoholic, no smoking, and nonsmoker, and other pre-existing medical conditions included the patient has no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clarithromycin, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced swollen lips. On 14-MAR-2021, the subject experienced swollen lymph nodes in neck. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced watery eyes. On 14-MAR-2021, the subject experienced flu like/bad cold. On 14-MAR-2021, the subject experienced severe fatigue. On 14-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced nausea. Treatment medications included: diphenhydramine hydrochloride. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from runny nose, and flu like/bad cold, and had not recovered from headache, swollen lymph nodes in neck, nausea, severe fatigue, watery eyes, and swollen lips. This report was non-serious. Version created to amend the previously reported information on 15-MAR-2021. Upon review, following information was amended: Medically confirmed field was unchecked.

Pt. developed right lower medial leg pain on Friday. She states the pain radiated up her leg and she felt there was warmth to the area. She denies injury. She states she had the J&J covid vaccine two weeks ago and has concerns of a DVT. There is minimal swelling and ecchymosis in the area. There is no redness or warmth noted. There is no tenderness, redness or warmth noted in her calf area. She has good pedal pulse and good capillary refill of her nail beds. She has no significant PMH and denies any recent air travel, long car rides or prolonged sitting. She states she is active.

Pt has malaise, headache and a swollen right Pre-auricular node 3x4cm, which appeared 36 days after vaccine.

Slight swelling up near neck area that has lasted approximately six hours has now seem to gone away also have small red dots on both hands and halfway up both arms and small area in the middle of upper part of chest not itching doesn?t seem to be spreading since this morning but also has not gone away took Benadryl at 730 this morning also at approximately 1 PM but does not seem to be helping will continue to monitor sure it does not spread cause other problems

4/29/2021 1. Localized edema 2. H/O factor V Leiden mutation 3. History of deep vein thrombosis (DVT) of lower extremity - patient had Johnson and John vaccine on 4/9/2021. She then developed bilateral leg pain with calf swelling, redness, and warmth about 1 week ago. Patient has a history of DVT and factor V Leiden mutation. She has previously been treated with Eliquis for DVT. Patient concerned for repeat DVT. Recommended bilateral venous dopplers. - VAS US Doppler Venous Lower Extremity Left; Future - VAS US Doppler Venous Lower Extremity Right; Future . Acute deep vein thrombosis (DVT) of calf muscle vein of left lower extremity (HCC) 5. H/O factor V Leiden mutation - patient diagnosed with a new DVT on 4/29/2021. She is currently anticoagulated with Eliquis 5mg 1 tablet BID with plan to continue anticoagulation for at least 6 months. Patient follows with hematology

I had a severe case of Covid-19 in December of 2020 and was hospitalized for twenty days. The day after the vaccine I got swelling in my left leg which was severe and painful. Testing revealed that there were blood clots in my legs. I have been having problems with bold clots since having Covid-19. My blood Sugar was over 500 the day after the shot and my blood pressure was very high. My blood sugar has been under control for a long time, and it is never this high. I also started to get headaches daily which I am still getting but they are not as often. I now only get headaches two to three times a week especially toward the end of the work week. Before the vaccine I was getting the occasional headache, but they were controlled with Excedrin. The new headaches are only controlled with prescription medication. The swelling in my left leg is still happening on occasion. I had been experiencing Long Covid-19 symptoms before the vaccine but they were much improved and the vaccine seemed to cause all of the symptoms to regress.

Patient without a prior history or risk factors for DVT, developed acute DVT left leg confirmed by U/S; WBC mildly elevated and platelets were low. Treated with DOAC

Shingles Headaches dizziness pain in lower right side front very bad constant swelling in feet, toes, ankles, legs, and hands leg gave out

Patient presented to ED on 6/13/21 with left sided chest pain for 3 days with radiation to left arm and left neck, improved with nitroglycerin sublingual. EKG unremarkable, troponin 0.23. D-dimer 0.66, CT angiogram chest negative for PE. Patient admitted and cardiac workup done, CT coronary score 0, new onset atrial fibrillation started on Multaq and Eliquis, Pt converted to NSR, chest pain improved. Final diagnosis = chest pain due to myopericarditis, elevated troponin due to acute myopericarditis unlikely NSTEMI, new onset paroxysmal atrial fibrillation.

INJECTION RELATED REACTION; WEARING OFF EFFECT; INJECTION SITE REDNESS; INJECTION SITE BURNING; ANAPHYLACTIC SHOCK; PAIN; This spontaneous report received from a patient concerned a 53 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient felt pain a few days before next injection was due. She was going on this way for years. She loved it, and did not want to stop because of this. She had injections burn but insurance, did not want to allow citrate free version. She gets a red spot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown expire: unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: Humira (adalimumab) (solution for injection, subcutaneous, batch number: 1136781 and expire: Unknown) dose, frequency, and therapy dates were not reported for ankylosing spondylitis. Non-company suspect vaccine included: influenza vaccines (form of admin, route of admin, and batch number: Unknown expire: Unknown), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On unknown dates, the patient experienced reaction to flu injection, feels pain a few days before next injection was due and burning on injection/gets a red spot. On an unspecified date in 2021, the patient experienced pain. On an unspecified date in Mar-2021, the patient experienced anaphylactic shock from covid vaccine. On an unspecified date in 2021, the anaphylactic shock from covid vaccine and pain resolved. COVID-19 VACCINE was also considered suspect. Epinephrine was given and cleared up within a few minutes. She got a reaction to flu injections too. She did not take Humira for 56 days while getting the covid vaccine. Physician said to take a break as long as possible. She went as long as she could, but she was having a lot of pain. The patient was taken Flu injection as a co-suspect drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic shock on an unspecified date in 2021, had not recovered from pain, wearing off effect, and injection site burning, and the outcome of injection related reaction and injection site redness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210661838-covid-19 vaccine ad26.cov2.s -Anaphylactic shock, Pain, Wearing off effect, Injection related reaction. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).20210661838-covid-19 vaccine ad26.cov2.s -injection site burning ,injection site redness. This event(s) is labeled per other facility and is therefore considered potentially related.

On April 20th I got an extreme headache that would not go away. I went to the ER and got migraine medicines, but it still did not help. I went to my family doctor no less than 6 times over the next 2 weeks. After a couple days I started having eye disturbances. Not double vision, but halos and problems focusing. My head still hurt. On May 3rd I went back to the ER because my left arm was numb. I thought maybe it was a heart attack. Still had the eye disturbances and headache also. They did a CT with contrast at the hospital and confirmed that I had had a stroke. On May 10th I saw a neurologist that ordered an indepth MRI and he found a brain aneurysm.

SWELLING IN THE CHIN; SWELLING IN THE DOWN THROAT; SWELLING IN THE NECK; THROAT IS GOING TO CLOSE; LUMP IN THE FRONT OF THE NECK; UNABLE TO TURN NECK OR SIT; PAINFUL TO LIE DOWN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, and other pre-existing medical conditions included the patient had given the plant based trigger shot for pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 10/JUL/2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lump in the front of the neck. On APR-2021, the subject experienced unable to turn neck or sit. On APR-2021, the subject experienced painful to lie down. On 06-APR-2021, the subject experienced swelling in the neck. On 06-APR-2021, the subject experienced throat is going to close. On 14-JUL-2021, the subject experienced swelling in the chin. On 14-JUL-2021, the subject experienced swelling in the down throat. Laboratory data (dates unspecified) included: Blood test (NR: not provided) NORMAL, Diagnostic ultrasound (NR: not provided) NORMAL, and X-ray (NR: not provided) NORMAL. Treatment medications (dates unspecified) included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat is going to close, lump in the front of the neck, unable to turn neck or sit, and painful to lie down, and had not recovered from swelling in the neck, swelling in the chin, and swelling in the down throat. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

Right eyelid felt funny, like it was swelling but it visually looked ok. About 30 min after I left the vaccination site I notice my face (cheek area) seemed to feel numb and swollen. This all went away after a few hours.

Started with nodal swelling within 10minutes of injection. Worsening fatigue as day progressed, developed runny nose and watery eyes, pain in my arm at injection site then spreading to the rest of my body. Took Sudafed for the cold like symptoms that evening and then in the morning. Went to sleep woke in the morning with severe fatigue, nausea, headache. At 11:00 noted that a bitter taste in my mouth that lead to loosing my sense of taste for 6 hours. I started getting a fever, which got up to 102 degrees, took Tylenol for this. At the same time my lips started swelling, then my hands, and approximately around 1900 my buccal lining of my mouth. Took 50mg of Benadryl which helped with swelling and went sleep. Woke up 6 to 7 hours later and took 50mg of Benadryl for good effect. Continue to have mild fatigue, headache and nausea this morning.

raised area around injection site about one hour after vaccine given. Within 23 hours, arm painful and swollen. As of 3/22/2021, arm is hot to touch, welts and painful.

ANAPHYLACTIC REACTION, NAUSEA, VOMITING, DIARRHEA, PAIN, DISTRESS AND HEADACHE.; BLOOD PRESSURE ESCALATED; TINNITUS AND RINGING; NUMBNESS; TINGLING OF THE EARS; HYPERSENSITIVE TO SOUNDS; This spontaneous report received from a physician and concerned a 54 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On an unspecified date, the patient experienced anaphylactic reaction, tingling of the ears, numbness and tingling of ears, blood pressure escalated, hypersensitive to sounds, pain/distress, diarrhea, vomiting, tinnitus, headache, and nausea. Treatment medications (dates unspecified) included: epinephrine, triamcinolone acetonide, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling of the ears, numbness and tingling of ears, and vomiting, had not recovered from headache, nausea, diarrhea, and tinnitus, and the outcome of anaphylactic reaction, blood pressure escalated, hypersensitive to sounds and pain/distress was not reported. Initial information was processed along with the additional information received on 27-mar-2021. additional event of tinnitus was added. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210350839-Covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. V0: 20210350839-Covid-19 vaccine ad26.cov2.s-Blood pressure escalated, tingling of ear, numbness, hypersensitive to sound, tinnitus. 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.

3:40 4/10/2021 itchy throat, hot tingly feeling and headache... 4pm throat felt tighter .. felt anxious... took benadryl 10ml liquid about4 30.. was feeling very hot... no fever.. Woke up 4/11 around 3-4 am.. worst headache ever, my ears hurt, teeth like every individual one were infected,freezing, shaking, dizzy, nausated, whole body itching, not able to stand up without help because I couldn't balance.. took pain medication to help take the edge off the pain and bendryl.. couldn't stay awake, next day throat feeling like it was swollen, icy hot feeling similar to contrast put in me, cramping in my lower left leg, monday.. same conditons except not the constant headache, blured vision better, still dizzy monday at 5 am chest feels slight pressure.. lower back pain like labor pains, sharp pain in stomach like the injection they give you to thin blood before surgery painful sharp pain.. later in day.. headache again, itchy body, throat sore, continual stoache pain, tuesday same.. wed.. my neck slightly swollen and sore

Major stiffness and swelling of neck on left side, lack of mobility turning head in any ratio, over 36 hours now. Throbbing pain at times, and cannot lean over with major throbbing pain.

Bad headache and very fatigued for 36 hours. Most sever cold sore (HSV-1) I've ever had came on 6 days after. Haven't had one for 6 years.

Immediately after the vaccine I experienced sleepiness, running nose, tiredness. The following day I experienced body aching, chills, headache. For the last three weeks, headaches, body aching, swollen legs, loss of appetite, tiredness, bone aching; my jaws hurting; nausea;

Dizziness at injection time. Fever the next day. Terrible full body rash, raised hives, itchiness, Swollen uvula, difficulty breathing, dizziness, excessive thirst. Ended up in Emergency room. Swollen hands and limbs

The next day I had very limited energy/felt like a shell of myself. Day 3 I woke up with extreme sinus cavity pain on my left side and a stye in my eye which progressed to get very severe to the point of on day 4 the top part of my face swelling and being hot. I called HCP and did a virtual visit and was placed on an antibiotic and eye ointment for 7 days. At the end of the antibiotic being completely taken the stye was completely gone but there was a still an aching in the sinus cavity. A week later it became severe again and my left eye started swelling underneath so I had another tele appointment with HCP and was given a 10 day antibiotic - Augmentin and antibiotic eye drops

STOMACH PAIN; LEFT LEG CRAMP; KNEE ACHE; TIRED; FEVER; FELT FOGGY AND DAZE; LOSS OF APPETITE; EYE PAIN; DIARRHEA; STOMACH FLU; VOMITING; HOT FLASHES ON BACK; HEADACHE; BODY TREMBLING; ARM BURNING; LYMPH NODE PAIN; UNDER ARM PAIN; INJECTION SITE WARM; ARM SORE; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included sore arm, injection site redness, and hand numbness, and concurrent conditions included asthma. The patient was previously treated with tetanus vaccine for tetanus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 15:00 for prophylactic vaccination. Concomitant medications included salbutamol for asthma, and salbutamol sulfate for asthma. On 07-APR-2021, the subject experienced body trembling. On 07-APR-2021, the subject experienced arm burning. On 07-APR-2021, the subject experienced lymph node pain. On 07-APR-2021, the subject experienced under arm pain. On 07-APR-2021, the subject experienced injection site warm. On 07-APR-2021, the subject experienced arm sore. Treatment medications included: paracetamol. On 08-APR-2021, the subject experienced eye pain. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced stomach flu. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced hot flashes on back. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced felt foggy and daze. On 09-APR-2021, the subject experienced loss of appetite. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 100.1 T. On 10-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced left leg cramp. On 10-APR-2021, the subject experienced knee ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and vomiting on 08-APR-2021, and hot flashes on back on 11-APR-2021, had not recovered from headache, and stomach pain, and the outcome of body trembling, arm burning, arm sore, lymph node pain, under arm pain, injection site warm, eye pain, stomach flu, fever, left leg cramp, knee ache, felt foggy and daze, loss of appetite and tired was not reported. This report was non-serious.

BRUISED PURPLE SPOTS AROUND INJECTION SITE; BODY ACHES; LEFT ARM SWELLING; LEFT ARM SORENESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, diabetes, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no drug or non-drug allergies. the patient did not have any 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, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced left arm swelling. On 30-MAR-2021, the subject experienced left arm soreness. On 31-MAR-2021, the subject experienced body aches. On 05-APR-2021, the subject experienced bruised purple spots around injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bruised purple spots around injection site, and had not recovered from left arm soreness, body aches, and left arm swelling. This report was non-serious.

Patient had a syncopal episode while on the toilet and moving her bowels on night of 4/15. She struck head and sustained left peri-orbital laceration. Was seen at ER on 4/16. Had CT of head showing cutaneous injury only. Was discharged home. On 4/20 she first noted swelling in right calf. This worsened and was seen in Care Center on 4/23. Had high D-dimer and had ultrasound of leg at ER. This showed right leg DVT extending from the distal femoral vein through the popliteal and posterior tibial veins. She had a long wait and left. She called PCP's on 4/24 on was prescribed Eliquis. She had trouble getting prescription filled due to cost and need for insurance pre-approval. Finally picked up and started Eliquis on the morning of 4/25. She contacted PCP's office on morning of 4/26 with new complaint of "terrible shortness of breath and lightheadedness". Patient was seen. CTA of chest done at hospital. showed "a large bilateral acute bilateral pulmonary embolism with saddle embolus, involving the right and left main pulmonary arteries, as well as the lateral lower lobe, upper lobe, right middle lobe, and lingular segmental and subsegmental branches. There is slight bowing of the interatrial ventricular septum to the left consistent with right heart strain." Patient to be admitted for thrombectomy

I began having a burning and tingling sensation around my ribcage on my right side. I attributed it to possible swollen lymph nodes as the result of the vaccine. I had tenderness there for about a week. It started getting better and on my right side in my waist area, I had a sensation on my skin with no visible rash or anything, but it felt like my skin was burning and tingling. I thought maybe I was getting shingles, but never broke out. The same pain then went to my inside upper arms, both of them and then it spread into my armpits. and down both my sides. At times, the sensation was across the top of my chest. There is no rash, there is no visible inflammation and my skin doesn't feel warm to the touch although it is burning and tingling to me. It has been going on now for weeks. I have taken naproxen to see if it was some kind of inflammation as an immune response and it has helped on some days but not on others. I feel stupid to make a Dr appointment because there is nothing to see, but the painful sensation is real. It feels like a really bad sunburn.

I ended up with an infection in the glands in my neck and throat. Caused edema and cellulitis ended up in the hospital for an overnight of IV antibiotics, steroids' and pain meds because my throat was closing. The swelling was restricting my airway. I was instructed by my MD to file this report.

4/13/21 - Lymph nodes in armpit (size of lemon), breasts, and near collar bone became very large and extremely painful. Leg weakness, exhaustion, and dizziness also began. Contacted doctor when symptoms did not subside. Visited doctor on 4/22/21 for leg pain and dizziness. Lymph nodes no longer painful or as large but still present. Ordered a doppler on right leg - no clots. Visited doctor on 4/29/21 because legs hurt all the time, still exhausted, still occasional dizziness. Ordered blood tests for 4/30/21.

BRUISE IN LEFT GROIN; BUMP IN LEFT GROIN; MIGRAINE; HAMSTRING AND QUADRICEP PAIN; MAJOR ARM PAIN; INTERMITTENT HEADACHES; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, and allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031,expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included norethisterone. On APR-2021, treatment medications included: acetylsalicylic acid, ibuprofen, and paracetamol. On 09-APR-2021, the subject experienced intermittent headaches. On 09-APR-2021, the subject experienced sore arm at injection site. On 14-APR-2021, the subject experienced major arm pain. On 19-APR-2021, the subject experienced migraine. On 19-APR-2021, the subject experienced hamstring and quadricep pain. On 24-APR-2021, the subject experienced bruise in left groin. On 24-APR-2021, the subject experienced bump in left groin. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 20-APR-2021, major arm pain on 17-APR-2021, and sore arm at injection site on 16-APR-2021, was recovering from hamstring and quadricep pain, bruise in left groin, and bump in left groin, and had not recovered from intermittent headaches. This report was non-serious. This case, from the same reporter is linked to 20210458898.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Patient woke up 5 days later with red, raised, painful spots on wrist, this then started on hands 5 days later and then several days later on the legs. These spots eventually turned black and blue.

I experienced neck puffiness, eye puffiness, chills, chattering teeth, neck pain, red face and skin as well. I also experienced scalp discomfort it felt itchy and skin felt different. I also had face and head flushing with hot flashes. Didn't feel well the full weekend duration of 3 days.

The day after receiving the vaccine i had a couple of swollen lymph nodes in my neck, and i had a slight headache. I went to the the doctor for an appointment not related to the vaccine and about six weeks later they gave me results and it was said that i was diagnosed with shingles.

My fingers and joints kept swelling and swelling (fingers, knees, hips and elbows) and I contacted my doctor to find out if I needed to do anything. She placed me on oral steroids. I was referred to an Orthopedic Specialists who did injections to get the swelling down in my knees. My elbows and fingers continue to swell during the day and I have to ice/elevate the to relieve the soreness/swelling.

SORE THROAT; COUGHING UP BROWN MUCUS INITIALLY WHICH IS NOW GREENISH WHITE; RIGHT SIDED EARACHE; FATIGUE; SICK TO STOMACH/NAUSEA; PAIN AT INJECTION SITE; EDEMA; CHILLS; TEMPERATURE ELEVATED; BAD HEADACHE; SWELLING UNDER THE ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 175 pounds, and height was 68 inches. The patient's past medical history included covid-19 infection, and concurrent conditions included high cholestrol, gerd, latex allergy, non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient has no history of drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for gerd, and atorvastatin calcium for high cholestrol. On FEB-2021, Laboratory data included: COVID-19 (NR: not provided) Positive. On JUN-2021, the subject experienced swelling under the arm. On 04-JUN-2021, the subject experienced chills. On 04-JUN-2021, the subject experienced temperature elevated. On 04-JUN-2021, the subject experienced bad headache. Laboratory data included: Body temperature (NR: not provided) 102.7 F. On 05-JUN-2021, the subject experienced edema. On 05-JUN-2021, the subject experienced fatigue. On 05-JUN-2021, the subject experienced sick to stomach/nausea. On 05-JUN-2021, the subject experienced pain at injection site. On 06-JUN-2021, the subject experienced coughing up brown mucus initially which is now greenish white. On 06-JUN-2021, the subject experienced right sided earache. On 06-JUN-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick to stomach/nausea on 07-JUN-2021, was recovering from bad headache, chills, edema, right sided earache, and pain at injection site, had not recovered from temperature elevated, fatigue, coughing up brown mucus initially which is now greenish white, and sore throat, and the outcome of swelling under the arm was not reported. This report was non-serious.

LEFT ARM UNDERNEATH THE ARMPIT AREA WAS SWOLLEN; LEFT ARMPIT AREA WAS PUFFY, FELT LIKE THE MEDICATION DRAINED INTO THE LYMPH NODES; This spontaneous report received from a patient concerned a 54 year old female. 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced left arm underneath the armpit area was swollen. On 11-JUN-2021, the subject experienced left armpit area was puffy, felt like the medication drained into the lymph nodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm underneath the armpit area was swollen, and left armpit area was puffy, felt like the medication drained into the lymph nodes. This report was non-serious.

About 8 hours falling the shot I experienced mild to moderate symptoms for about 12 hours. Low fever 99.8, chills, lethargy. 2 weeks after the shot I started experiencing swollen hands and trigger finger (right hand, ring finger). 2 months after the shot I still have swollen hands and trigger finger in both the right and left hand ring finger. Also dull aching in my fingers. I can no longer wear the rings that I had sized on April 21, 2021.

NUMBNESS TO RIGHT SIDE; SWELLING OF RIGHT INDEX FINGER; EXTREME PAIN; This spontaneous report received from a patient via a company representative concerned a 54 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of report. 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 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced numbness to right side, swelling of right index finger, and extreme pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness to right side, swelling of right index finger and extreme pain was not reported. This report was non-serious.

REDNESS ON LEFT ARM; SWELLING ON LEFT ARM; LEFT ARM PAIN; ITCHING ON LEFT ARM SIMILAR TO ALLERGY; This spontaneous report received from a patient concerned a 54 year old female. 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: Unknown) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JUN-2021, the subject experienced itching on left arm similar to allergy. On 23-JUN-2021, the subject experienced left arm pain. On 29-JUN-2021, the subject experienced redness on left arm. On 29-JUN-2021, the subject experienced swelling on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching on left arm, redness on left arm, swelling on left arm, and left arm pain. This report was non-serious.

The day after the J&J vaccine I experienced the typical headaches, backache and sore arm which I was told to expect. My headaches, backache and arm pain lasted approx 4 weeks. I took advil/tylenol daily for weeks due to the discomfort. My arm pain continues to persist three months after the vaccine. I also developed swollen lymph nodes along my collar bones 3 months after the vaccine. It is on the same side as my vaccine. I have went from being 100% healthy and feeling great to constant arm pain, occasional arm numbness, swollen lymph nodes (which I have never had in my life) and generally feeling unlike my self. I reached out to my Dr. and am awaiting bloodwork results. I have three ultrasounds scheduled as well as 2 cat scans. They are looking for blood clots and trying to figure out the pain at the injection site as well as swollen lymph nodes on the vaccine side. In closing, I feel something is very wrong as my symptoms persist and multiply.

Received vaccine at 11:09AM on 7/10/2021. The vaccine in my arm was burning rather badly within a few minutes of it being administered. About 10PM the same day I started feeling dizzy, bad headache, muscles and joint started aching all over my body, joints were hurting, a few hives on my torso and I was experiencing chills. Went to sleep that night and was very ill the entire next day with fever, chills, aching all over, swollen lymph notes in my neck, in my left arm pit, coughing out excessive phlem, headache, sore joints, and hives on my arms, legs and torso. It is now 7/12/2021 at 4:34PM, I am still dealing with hives wheels all over my legs, several small hives on my right arm and several hives on my belly and sides. My antihistamine is helping to keep the hives in check. I am still quite sore all over and the arm I received the injection in hurts a lot.

First night and for about 24 hours very achy, chills, tired and headache. Arm sore where shot given. Then that went away and on day 3, my arm swelled, was red and hot and had a hard lump. That has continued and is still there, 10 days later. The swelling and redness is a bit better, but the soreness and heat are still present.

One and 1/2 hours after shot I began to experience a mild allergic reaction. Face is slightly red, feels flush, warm with slight burning sensation. Hands feel hot, slight burning sensation and slightly swollen. Lips feel slightly swollen.

I started developing hives first down my right leg, then on my stomach and on my tailbone starting 4 days after receiving the vaccine. So far, I continue to develop them slowly. No anaphylaxis, but a strange systemic reaction.

She got the vaccine, she went home, had no reaction. The next day she woke up and her arms was sore, and swollen (huge). Later on she started to have fever, cough, and then headache. She then went to bed and slept 7-8 hours, all day long. The swelling stayed for almost a week in her arm. Then approximately 4-5 days later on 3/21/21 the right side of her face, the lower part of her ear to the lower part of her face started swelling, and her lip was numb. Fearing she had Bell's palsy which she had about 10 years ago she went to see her doctor and the doctor said that it was a reaction from the vaccine. The right side of her face and the swelling is almost gone, but her face is still feeling numb. Her doctor did not give her anything, and since her swelling was almost gone and was improving he didn't want to give her anything for it. He told her to watch it and if it worsens to get back to him, and to report to VAERS.

Upon injection, medication burned going into arm and lasted about 2 minutes. I immediately started feeling odd over my entire body, I felt and looked flush, felt clammy, muscle tightness, started shaking, felt very nauseated, blood pressure went up and experienced slight swelling in hands. This lasted 30-45 minutes. My blood pressure, oxygen saturation level were being monitored. I left office at around 12:00 pm feeling better. I felt off the entire day. At 6:00pm I started with chills, muscles aches and pains. At 7:30pm I took a shower and went to bed very fatigued, muscles pain and cramping and chills. I took my daily meds of 125mg of Diamox, and 100 mg of Azathioprine. At 11:30pm I woke up with a 104 fever, sweating, and a lot of muscle cramping in legs and feet. My head felt like it was going to explode. My cerebral fluid pressure was up and felt in head and down spin. I did not rest well and found it difficult to get comfortable all night. I took an 200 mg of ibuprofen at 12:00am and started to feel some relief.

8 hours after receiving shot, almost to the minute 8:20pm, I spiked fever of 104, severe headache, aches and pains throughout all bones, muscles and joints. Broke fever after 5 hours but headache remained severe for 18 hours. Muscle fatigue remained for approximately 2 days. Remained in bed until symptoms passed. Arm swelled up on 4/4/21, area where received shot. It was almost everything I experienced with COVID in Nov 2019 over the course of 3 weeks squeezed into 24 hours, having suffered before I knew to go to bed and didn't go to ER. If I hadn't experienced this before I would have gone to ER.

The patient called today 4/9/21 to report severe unusual adverse reaction to the Janssen Covid19 vaccine. She received her vaccine on 3/11/21. Beginning on 3/19/21 she reported red and swollen lymph nodes with pustules on the left side near the armpit. She nodes are still swollen and there are bumps but no pustules at this time. Beginning on 3/24/21 she noticed a spot on her ridcage resembling Shingles, but it was a single pustule. On 3/25/21 she noticed that the bottom of her feet started peeling and stinging. The skin seems to be sloughing off. She made an appointment with her dermatologist for today, 4/9/21 but it has been rescheduled to 4/12/21. The patient reports that she has history of chronic shingles and multiple autoimmune disorders. She takes daily antiviral therapy (valacyclovir).

Day 1- Excruciating bone pain in ribs, pelvis, and shins that felt like drill holes. My back felt shattered. Muscles seized up and vein throbbed from inflammation. Lymph nodes swollen and throat was slightly raw. Could choke on water. Body temperature dropped, not chills, but icy cold. Took sleeping pills at 11 pm and never slept from the pain. Started dosing with turmeric and alka seltzer to douse the acidity inside body. Then did ibuprofen at 5 am not able to have BM Day 2- Tiredness, Broken vessels behind right knee that weren?t there before. Abdominal cramping in the uterus area. Still had bone pain. Restless leg symptoms. Not able to have BM Day 3 - a cough has started but only bone pain is In shin.

Blood blisters on arm that was given the vaccine, dizzy/double vision, fatigue, fever, swelling in face and legs, raspy throat, felt weak, vomiting.

Headache, chills for 10 hours, dry mouth, left arm slight swelling had to remove my fit bit and rings for 24 hours, tired 36 hours, blister on roof of mouth finally going away (day three),

About an hour after I started feeling cool in my neck. My whole right side of my face, from the shoulder up and neck felt like it was on fire. I felt red and puffy in my face on that side. I ended up getting flu like symptoms, and my arm hurt for about two weeks. I went to urgent care March 29th and was diagnosed with bronchitis , I did get a Covid test and it was negative. They put me on a antibiotics and inhaler. I followed up with my PCP, she changed the inhaler I was prescribed and told me If I don't get better to give them a call. My arm is better but bronchitis is still there. The coughing is really bad at night and sometimes during the day.

4-6-2021 - woke up and felt a lump above my collar bone, went to the ER. 4-12-2021- woke up covered with hives/rash. Started in my armpits and got worse as the day went on. Stinging, itching, red and hot .

03/16/2021 complained of headache, and lump with warmth/swelling/tenderness to Left lower leg 04/01/2021 complained of lump with warmth/swelling/tenderness to Left lower leg, Rash to Right lower leg and heaviness of upper extremities. 04/12/2021 lump with warmth/swelling/tenderness to Left lower leg

Had migraines (frontal lobe with flashing lights-distorted vision and difficult to hold my eyes open) from 3/20-3/24. (one week after vaccine) I do not get headaches, so this was very strange. On 3/23, I woke up with a bright red Left thumb- it looked and felt like a sunburn. The next day (3/24), it was still bright red (fire engine red), swollen, hot to the touch and had a blister in my webspace. I went to the dr 3/23 pm who was not sure what was going on, but prescribed an antibiotic (Keflex). This reduced my pain and swelling. Today it is still red and is now flaky, but not swollen or hot to the touch. The main thing was the migraines as I do not get headaches. I'm not sure if that or the skin thing is related, but thought I should throw this information your way in case there have been others with similar symptoms.

Covid Toes. My toes became red and inflamed and blistered like a bad burn with no pain after 13 days of getting the vaccine. The swelling went away after a week, but the discoloration of red and purple are still present after one week.

I don?t know if all or any are vaccine related, I just know all but the swelling started after 3/23 shot. Random dizziness, nausea, headache, ache between shoulders and chest, leg swelling. Threw up several times 4/10.

After the vaccine, I had burning and hurting in my arm that lasted for 10 to 15 minutes. On Wednesday, I developed a cough, chills and fatigue that lasted all day. On Thursday, I was better. On Friday, I noticed swelling under my arm but closer to my breast. I went to see my MD and was given something for the cough. My MD wants to watch the swelling under my arm for the next two weeks.

Swollen lymph node on right collar bone/neck (soft, squishy, no pain) [noticed it two days after vaccination and it's still there now, same size]

Extreme dizziness, fever, body aches, vomiting, swollen lymph nodes. Still experiencing extreme dizziness, exhaustion and naseau on 4/24/2021.

next day extreme fatigue, fever lethargy. Got better but never got energy back and had some body aches and trouble sleeping. On Wed. March 25th an EXTREME headache began and I could find no relief with High doses of Tylenol or Ibuprophin or a mixture of both. It was my whole head. Stayed on the couch all day Saturday and Sunday 27th and 28th unable to move because of the pain and extreme fatigue. Monday the 29th made myself go to work but was not able to function or get much relief. On Tuesday the 30th went to see physician who said he thought it was Occipital Neuralgia and gave me prednisone and said use hot compresses. Told him I thought it was more due to other symptoms like hallucinations (shadows I would see) Mind not clear and made me worry about driving. Asked if the shot could be a possibility. He just said he couldn't rule it out. The doctor also mentioned I felt very hot but never took my temperature. I Took the prednisone. Headache did start to clear on Wed the 31st in the evening but my neck seized up where I could no longer turn it to the left and was very painful. Also felt like my lymphnodes were swollen. I called on call doctor and they prescribed a muscle relaxer. I did not start to get better until Sunday April 11th. Experience a couple occular migranes as well during this, Still experiencing some fatigue and almost to a fainting point in the mornings

Muscle pain in arms at joints. right hand swelled up and hurt skin red. Happened next day, inability to lift right arm up past shoulder without pain. Both arms muscle pain at shoulders, elbows and wrists. Using tylenol, muscle relaxants, heat, rest.

Patient started having swelling in both legs and pain in the on 4/11/21 at night. States that legs turned red, burning, tingling and toes were bluish tinged. Contacted heart specialist on Monday and was instructed to put on compression hose and elevate has appointment with him on Thursday. Also had a migraine headache that started Saturday night that continues today.

4 hrs after onset of severe headache and body pain in lymph nodes under arm pit breast, on top of kidneys and in stomach fatigue low fever. After 4 days of that I got a really super heavy period with cramping and blood clots in my menustral flow. It was a horrible period, while the one after the surgery in Feb was very light. Dizzy and fatique 10 days after shot on the April 8 I took a fall from a chair outside, and from Thrusday to the Saturday 10th I ended up in the Emergency room with a concussion and head symptoms including dizziness and nose bleeds. This was from a simple fall, and i suspect the covid shot might have caused complications after the fall with additional swelling and brusing.

TINNITUS has at least doubled in pitch and consistency which is now 24/7 (It was manageable prior to vaccine) It is causing me distress! Left arm still sore to the touch two weeks after shot. Both hands went numb within 10 minutes of receiving vaccine and have stayed swollen and painful joints for two weeks.

Patient started noticing left arm swelling and pain about 2-3 weeks after the vaccine. She then presented to the hospital 4/16/21 and was found to have a deep vein thrombosis in her left brachial vein as well as a thrombosis in her right internal jugular vein. She is currently being further worked up and will be admitted to the hospital for anticoagulation.

Pain on site (lasting 6+hours), nausea! (2 days), headache! (3 days), lightheaded, dizzy, shaky hands, tiredness (2 days), chills, fever (low grade of 99.1* for 1 day), minimal swelling, no significant bruising, muscle pain and soreness (7 days)

My head hurts a lot every day, days, before it didn't hurt and my legs and feet swelling and I feel like burning pain and it hurts between my legs and tingling in my left leg it was weird but I honestly I didn't think about the vaccine until now that I read the message I got worried about the headaches and my left leg

NAUSEA; NUMBNESS OF FACE; TINGLING OF FACE; INJECTION SITE PAIN BUT PAIN UNDER RIGHT ARM; ANAPHYLACTIC REACTION ( FEELING HOT, AND THROAT FELT CLOGGED); This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's height, and weight were not reported. The patient's past medical history included anaphylactic reactions with other vaccines, and concurrent conditions included antibiotic allergy (except ciprofloxacin), non-alcoholic, non-smoker, cancer, cerebral palsy, and pheochromocytoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, 1 total, administered on right arm on 27-MAR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021 12:21, the patient experienced anaphylactic reaction (feeling hot and throat felt clogged and closing). The patient was taken to the emergency room and given epinephrine. Anaphylactic reaction continued during the transport to the emergency room. On 28-MAR-2021, the patient experienced injection site pain but pain under right arm, numbness of face and tingling of face. On an unspecified date, the patient experienced nausea. Patient also received a rapid COVID-19 test on 07-APR-2021 and waiting on lab results. The patient was worried about the cancer surgery planned after 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction ( feeling hot, and throat felt clogged) on 27-MAR-2021, was recovering from injection site pain but pain under right arm, numbness of face, and tingling of face, and the outcome of nausea was not reported. This report was serious (Life Threatening).; Sender's Comments: V0: A 54-year-old female experienced anaphylaxis 6 minutes after vaccine. Past medical history included anaphylactic reactions with other vaccines, and concurrent conditions included antibiotic allergy, cancer, cerebral palsy, and pheochromocytoma. Six minutes after vaccine she reporting feeling hot and throat felt clogged and closing. The patient was taken to the emergency room and given epinephrine and recovered the same day. Given the close temporal relationship, history of anaphylaxis to other vaccines as well as antibiotic allergy, the event is considered related.

BLOOD CLOT IN LEFT THIGH; SWELLING; FATIGUE; This spontaneous report received from a consumer concerned a 55 year old female. Initial information received on 13-APR-2021, processed along with information received via telephone communication on 15-APR-2021 The patient's weight was 100 pounds, and height was 152.4 centimeters. The patient's concurrent conditions included progressive multiple sclerosis, swelling of the left leg and foot, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient was not a pregnant at the time of reporting. The patient had no family history of thrombosis, no prior deep vein thrombosis (DVT). 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, 1 total, administered on 22-MAR-2021 for prophylactic vaccination. Concomitant medications included baclofen, escitalopram oxalate, and risedronate sodium (received 2 doses and stopped after the event). The patient's husband reported that in MAR-2021, the patient had symptoms of fatigue. On 23-MAR-2021, the patient had swelling and fatigue. Her fatigue was resolved on 24-MAR-2021 and swelling was resolving. On 05-APR-2021, the patient developed left thigh swelling. On 06-APR-2021, the patient's swelling was not going down and she visited her primary care physician. The physician could not determine the cause of swelling (left thigh very noticeable clot swollen around where clot was located) and the physician suspected clot and performed an AD dimer (fibrin degradation) test to look for potential blood clotting. The patient also had a venous duplex ultrasound that showed left leg clot. At 19:00 on the same day, the patient's physician advised to visit emergency room and determined there was a clot on left thigh and she was prescribed Eliquis Starter Pack (apixaban) for 3 months treatment and recommended another scan in several months. On 06-APR-2021, the patient's vitals were reported as blood pressure 124/70 mmHg, heart rate 88 bpm and oxygen saturation of 99%. Laboratory data included prothrombin time (PT) 13.4 sec , International normalized ratio (INR) 1.2 and activated partial thromboplastin time (APTT) 34.8 sec. (Normal range not reported for all) d-dimer and platelet count results were not available and Covid-19 test was not performed. Body max index was 19.5 kg/m2. On an unspecified date the patient was feeling better but had not recovered from the event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 24-MAR-2021, had not recovered from blood clot in left thigh, and recovering from swelling. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This case concerns a 55-year- old female subject, immobile due to progressive multiple sclerosis who developed a left thigh swelling 12 days after Janssen COVID-19 vaccine was administered intramuscularly for the prevention of symptomatic SARS-CoV-2 virus infection. The patient's concurrent conditions included body max index of 19.5 kg/m2, progressive multiple sclerosis and swelling of the left leg and foot. She is a non-smoker, no known drug allergies, no family history of thrombosis, or prior deep vein thrombosis (DVT). Symptoms started with swelling of the left thigh and fatigue. The fatigue resolved the next day. The patient's swelling in the left thigh was not going down and she visited her primary care physician who checked her D-dimer dimer (level not known to patient) and scheduled a venous duplex ultrasound that showed a clot in the left thigh. Her vital signs were blood pressure of 124/70 mmHg, heart rate 88 bpm and oxygen saturation of 99%. and she was prescribed Eliquis Starter Pack (apixaban) for 3 months treatment and recommended another scan in several months. Laboratory data included PT 13.4 sec, INR 1.2 and APTT 34.8 sec. D-dimer and platelet count results were not available and Covid-19 test was not performed. The patient is feeling better but had not recovered from blood clot in the left thigh, and is recovering from the swelling. Given underlying progressive multiple sclerosis with immobility and preexisting swelling of the left leg and foot on the same lower extremity, the clotting of the left thigh is considered not related to Janssen COVID-19 vaccine. Additional information has been requested.

LIKE SOMETHING CRAWLING IN BLOOD; NAUSEA; MUSCLES ACHES; INJECTION SITE PAIN (IN LEFT ARM); SWELLING OF THE ARM; BURNING SENSATION IN THE LEFT ARM; ACHES AND PAINS; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and venous insufficiency, and other pre-existing medical conditions included 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: 203A21A, 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 aches and pains. On 09-APR-2021, the subject experienced swelling of the arm. On 09-APR-2021, the subject experienced burning sensation in the left arm. On 09-APR-2021, the subject experienced injection site pain (in left arm). On 10-APR-2021, the subject experienced like something crawling in blood. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced muscles aches. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from like something crawling in blood, nausea on 12-APR-2021, and muscles aches on 11-APR-2021, had not recovered from injection site pain (in left arm), and the outcome of swelling of the arm, burning sensation in the left arm and aches and pains was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.

BREATHING PROBLEMS; THICK HEAVY/SWOLLEN LEGS; LOW BLOOD PRESSURE; PRESSURE IN BREAST AREA; LUMP AT INJECTION SITE; HOT URINE; HUGE RASH ON ARM, SHOULDER AND BACK; INJECTION SITE PAIN/ PAIN DURING INJECTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced pressure in breast area. On 30-MAR-2021, the subject experienced lump at injection site. On 30-MAR-2021, the subject experienced hot urine. On 30-MAR-2021, the subject experienced huge rash on arm, shoulder and back. On 30-MAR-2021, the subject experienced injection site pain/ pain during injection. On 10-APR-2021, the subject experienced breathing problems. On 10-APR-2021, the subject experienced thick heavy/swollen legs. On 10-APR-2021, the subject experienced low blood pressure. Laboratory data included: Blood pressure (NR: not provided) LOW, and Oxygen saturation (NR: not provided) 90s down to 83. On 13-APR-2021, Laboratory data included: Electrocardiogram (NR: not provided) No issue in Heart, and X-ray (NR: not provided) No issue in lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breathing problems, thick heavy/swollen legs, and injection site pain/ pain during injection on 18-APR-2021, low blood pressure on 10-APR-2021, pressure in breast area on 30-MAR-2021, lump at injection site on 17-APR-2021, hot urine on 01-APR-2021, and huge rash on arm, shoulder and back on 19-APR-2021. This report was non-serious.

Pt presented to UC for facial swelling and throat closing sensation. Pt received Johnson and Johnson covid vaccine 4/9 and reports facial swelling, throat closing sensation, and throat pain immediately following vaccination; states she was transported to ER following that vaccine and treated with prednisone. Patient states she was doing well, but began to experience for facial swelling and throat closing sensation again today. Patient treated with 0.3mg epinephrine and 50mg Benadryl IM. Transported to hospital via EMS.

BLOOD VESSELS POPPED IN ARMS AND HANDS; SWELLING IN HANDS AND ARM; NECK PAIN; ACHE; KNEES WERE STIFF; RED RASH ON ARMS, NECK AND FACE; JOINT PAIN; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included sprained knee, and concurrent conditions included heart disease, type 1 diabetes mellitus, type 2 diabetes mellitus, alcohol use, non-smoker, and tetracycline allergy. The patient experienced drug allergy when treated with codeine, and hydrocodone bitartrate/paracetamol. 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 21-MAR-2021 12:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced blood vessels popped in arms and hands. On 21-MAR-2021, the subject experienced peripheral swelling. On 21-MAR-2021, the subject experienced neck pain. On 21-MAR-2021, the subject experienced ache. On 21-MAR-2021, the subject experienced knees were stiff. On 21-MAR-2021, the subject experienced red rash on arms, neck and face. On 21-MAR-2021, the subject experienced joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from red rash on arms, neck and face, peripheral swelling, blood vessels popped in arms and hands, neck pain, joint pain, ache, and knees were stiff. 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.

ANAPHYLACTIC REACTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) 1 total dose was not reported, administered on right arm 18-MAR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for thyroid. On 18-MAR-2021, the patient received the shot and felt the room was coming in and out. she was probably just nervous, sat in room for duration of waiting period, felt like she had to throw up and felt hot and sweaty. She got a trash can, wanted to get some fresh air, everything and face went numb and unable to recall details, can recall nurse asking for recovery kit and oxygen. On same date, she was transported to ER (emergency room) and tongue swelling and hanging out of her mouth and was blue in color and throat was swollen Nurse assisted in lifting her head to open her airway to assist in breathing. It was diagnosed as anaphylactic reaction. Epi, steroid and benadryl received prior to transport. She was discharged on 19-MAR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anaphylactic reaction. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210503257-JANSSEN COVID-19 VACCINE-Anaphylactic reaction. This event is labeled per RSI and is therefore considered potentially related.

Extreme Fatigue (one day) followed by sores on tongue (3 days) followed by swollen lymph nodes and diarhea

timeline of events: 11/2020 seen by cardiology for atypical chest pain, abnormal ekg, and lower leg edema. lexiscan and echo done, negative. 12/2/2020 vein mapping done BLE, negative for clots. med changes done and venodynes ordered. 3/16/2021 vaccine received. approximately 2 weeks later, developed severe GI virus, increasing back pain, left leg tightness and pain. 3/31 follow up with cardiology, told doctor unable to wear venodynes due to severe pain in knee area. 4/1 phone appt with PCP, treated for GI virus. 5/1 went to PCP for increasing pain and difficulty walking. discovered new swelling in left leg, large area medial calf just below left knee. labs done, normal. 5/12 US left leg done. 5/20 back to PCP; told that US showed large hematoma and surgical consult needed.

On first day I had headache within 4 hours and chills. Later that day I started having fatigue. The fatigue has basically continued . About 3-4 weeks in my left arm started tingling then on or about May 10th I started having back pain and joints hurting which I had lifted a case of water and moved a piece of furniture ever so slightly and I normally recover from something like that next day - I have been on anti inflammatory and other meds without relief. Went to a chiropractor which made things worse. I've had on and off episodes of fever/sweating and joints and back have continued to hurt. Doctor did a UA test to rule out any kidney or bladder problems (history of) and my WBC was high for me - course of antibiotics and I still dont feel well. I'm usually pretty pain tolerant , not a complainer but I have felt not myself since the vaccine.

Patient called pharmacy to report that adverse reactions, still hasn't gone away from the Jansen shot they recived on 6/3. They reported having nerve pain from the shot area up to the neck, It is sharp and burns. It has not subbsided since the injection. They had some swelling after the shot, but but has gone down. Patient will follow up with dr.

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

Redness, swelling, bruisig and a hard knot at the injection site which lasted for 6 weeks. Pain in right neck and shoulder, bad enough to wake me from sleeping, still experiencing. Approx. 10 days post injection right thumb and wrist went numb. Still numb today.

The adverse reaction began within hours of the vaccine. It began with flu like symptoms including chills, fatigue, and aches (no fever but Patience rarely runs a fever even if very ill). Aches included sharp pains in her right calf muscle. Flu like symptoms persisted for 5 days and began subside on the 6th day. Patience was able to return to work on the 9th day, although pain in her right leg persisted. Over the next several weeks she had a VQ lung scan, bilateral Doppler ultra sounds of both legs, and chest x-ray as well as an array of blood work which were all negative. The pain continued to worsen to the point where she was not able to walk or drive. She visited an orthopedic urgent care center for evaluation, where it was suggested a nerve in her back was causing the pain. She was prescribed Gabapentin and refereed to Physical Therapy and a back specialist. Because there was a long wait to get an appointment with the back specialist, and the pain was worsening, she went to a different orthopedist who took x-rays and MRI of the leg, as well as additional blood tests. The X-ray showed no breaks or injuries to the bone, and the MRI showed no soft tissue damage but it did show some minor inflamation of the muscle. Her labs were all normal except for a slightly elevated C-Reactive Protein and slightly low Hemoglobin. The orthopedist prescribed a boot and recommended rest and continued Gabapentin. Over the next three weeks the pain subsided. With the MRI results showing no bone damage, she discontinued the boot, and with no remarkable spine abnormalities she discontinued the Gabapentin, and is currently taking a combination of Tylenol and Advil, and has returned to work on a reduced schedule. The pain has subsided but is still present and flares up at times. She is starting to experience similar symptoms on the left leg. The treating Orthopedist has referred her to a Rheumatologist, appointment is pending as of this date

SWOLLEN ARM; TINGLING IN LEG/VACCINATED ARM/HANDS; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with influenza vaccine. 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 19-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUL-2021, the subject experienced swollen arm. On 19-JUL-2021, the subject experienced tingling in leg/vaccinated arm/hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in leg/vaccinated arm/hands, and the outcome of swollen arm was not reported. This report was non-serious.

Low grade fever, pain throughout body, localized swelling and infection on right foot of unknown origin, reocurrence of shingles outbreak previously under control by two shingles vaccines, rash on left leg from knee to hip and above right elbow, stomach issues (uncontrolled diarrhea), burning pain on right leg.

Arm pain and swelling at the injection site; swelling in armpit. Tenderness in the armpit where swollen and there appears to be a knot; chills, and body aches.

Patient called 5 days after vaccination to report a potential adverse reaction to the vaccine. She reports as of today some swelling in her hand along with discoloration.

Fever, muscle pains, pain shot area, headache, chills, swollen arm pit. Took Aleve for the headache that last two days, second day dizziness and continued arm pit pain and swelling.

About 30 minutes after receiving COVID-19 vaccine by Janssen, patient reported having an itchy throat and some feeling swollenness in her throat. Pharmacist asked if she could breathe and she confirmed she can. Pharmacist asked if she would like to be administered IM injection or oral version of diphenhydramine and patient requested IM version. Pharmacist administered diphenhydramine 25mg intramuscularly and monitored for response where patient reported feeling better and less swelling and itchiness. Patient requested an additional dose due to incomplete resolution of symptoms and about 2-3 minutes later, pharmacist administered an additional dose of diphenhydramine 25mg intramuscularly. Pt was monitored for about 40 minutes until her spouse came to pick her up. Patient was advised to contact her provider and potentially request and epinephrine pen for on-hand use. Pharmacist found a pharmacy, CVS, that carried the epinephrine pen and informed patient where that was so she could inform her provider where to call in the script. Patient left premises reporting feeling like she could breathe fine and no swelling upon leaving the store. The store also provided patient with a box of diphenhydramine (Benadryl) oral tablets to take with her as well as a bottle of water. Her spouse took her so she would not need to drive after feeling potentially drowsy upon injection of diphenhydramine.

Arm is sore, red, swollen , huge raised hive that is hot to the touch from my shoulder to my elbow.

About 35 minutes after injection had swelling of tongue and face, tingling lips and pressure felling just above collar bone on throat. I took benadryl as soon as I felt tongue swelling , but it did not stop the advancement of more swelling in my tongue. Eventually I got throbbing jaw pain from the pressure of my tongue.

Patient reported to her doctor's office today with symptoms consistent with Bell's Palsy. She stated that the facial symptoms started mid morning today on 4/5/21. Last week ( week of 3/28 to 4/3) she reports that she felt "weird". She felt as if there were cool water running under her skin at all times. She also states that when anything touches her skin, it feels very cold. For example, when running her hands under warm water, it feels like ice water on her hands. When setting her bare arms on her desk, it feels as if they are being set on ice and when her pants rub against her legs it feels as if they are wet and cold. She also stated that the top 1/3 of her back was tingly and felt as if she had applied Biofreeze to it, but she had put nothing on her back. Her tip of her tongue feels as if it is "burnt" and she can not tasted anything on the front part of her tongue. She needs to get things way in the back of her mouth before she can taste them. On 4/3/21 she states that her lips began tingling as if they were having numbing medication wearing off from a dental visit, but she had done nothing different. On 3/31 her lower back also felt as if it had a pinched nerve. Today on 4/5/21 she has the Bell's Palsy on her face that started mid morning and she complains of her nose feeling tingly also. She also feels as if she is retaining fluid.

SWELLING; RAISED RED MARK UNDER THE INJECTION SITE DESCRIBED THAT IT LOOKED LIKE WICKED SPIDER BITE; RASH; This spontaneous report received from a 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: 1808980 and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 11:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced swelling. On 31-MAR-2021, the subject experienced raised red mark under the injection site described that it looked like wicked spider bite. On 31-MAR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, swelling, and raised red mark under the injection site described that it looked like wicked spider bite. This report was non-serious.

ITCHING ALL OVER BODY; SWOLLEN LYMPH NODES; FLUSHING; HIVES ALL OVER BODY; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, 1 total, administered on 24-MAR-2021 to left arm, for prophylactic vaccination. Concomitant medications included montelukast for asthma. On 25-MAR-2021, the subject experienced itching all over body. On 25-MAR-2021, the subject experienced swollen lymph nodes. On 25-MAR-2021, the subject experienced flushing. On 25-MAR-2021, the subject experienced hives all over body. On 25-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: montelukast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 2021, had not recovered from hives all over body, itching all over body, and swollen lymph nodes, and the outcome of flushing was not reported. This report was non-serious.

On 4/9/2021 - about one hour after vaccine, had difficulty breathing and dizzy. Someone helped her to the car. Had to wait in the car about an hour before she felt well enough to drive. Checked her blood sugar while she was in the car and it was 75 (she had drank half of a Coke.) Usually runs around 200. Otherwise she had usual symptoms, sore swollen arm, fatigue.

Pain, swelling, redness, bruising, tenderness, hot to touch, unable to sleep on left side due to pain

Sustained fever between 101-102 and body tremors for 24 hours. First 48 hours also included severe body aches, lethargy, sensation of lungs burning, visibly swollen glands. Lethargy and the sensation of lungs burning or ?heart burn? counties for five days after the vaccine.

General swelling in the armpit under the shoulder that received the injection. It's sore, and making my arm lightly achy and my hand tingle off and on. I assume it is due to the lymp nodes being super-activated under there. I have had Covid-19 twice (May 2020 and Jan 2021) and guess it may be related to a super-ready immune system. Also, it has re-activated some of the covid symptoms--chills, exhaustion, headache, and a dimming of my taste and smell, which had not even fully returned since the January 20021 bout of Covid. Now I can only discern sweet/sour/salty, with a momentary hint of what I'm eating during the first bite or sip, before it's gone again. Complex mixes of foods, like a taco, for instance, would taste like nothing at all. Zero. Single note flavors, such as orange juice, are weakly flavored at first, then gone after a taste or two, like the tastebuds are used up. Most of the ability to smell is weak again, as well. I do wonder if the losses are due to inflammation response and not the virus activity itself, in light of this?none

Hives on face for and occasional hot flashes for 2 days, fever blister on lip. Benadryl stopped the hives.

Facial tingling on lips and around mouth on day 7. Tingling continues to current day (post 19) and a fever blister appeared on my lip this morning.

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

continued and worsening L arm pain s/p J&J COVID-19 vaccine on 4/4. pt was seen in urgent care on 4/14 and 4/15 for L arm pain and swelling, w/ tingling down to hand/fingers

FALL; DIZZINESS, FEELING FAINT FELT LIKE BLACKOUT, LIKE FALLING DOWN, LIKE PASSING OUT; TINGLING; SHAKING; SKIN REACTION ON LEFT SIDE UPPER ANKLE AREA; FUNNY FEELING; NUMBNESS; HAND SWELLING; UNABLE TO FOCUS; BODY ACHES; FACE SWELLING; CONFUSION; BODY CHILLS; LIGHT HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included black plastics color allergy, and other pre-existing medical conditions included the patient had no known allergies and the patient was not pregnant at the time of event reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 121001A, expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced body chills. On 28-MAR-2021, the subject experienced light headache. On 29-MAR-2021, the subject experienced body aches. On 29-MAR-2021, the subject experienced face swelling. On 29-MAR-2021, the subject experienced confusion. On 29-MAR-2021, the subject experienced hand swelling. On 29-MAR-2021, the subject experienced unable to focus. On 31-MAR-2021, the subject experienced funny feeling. On 31-MAR-2021, the subject experienced numbness. On 31-MAR-2021, the subject experienced skin reaction on left side upper ankle area. On 04-APR-2021, the subject experienced fall. On 04-APR-2021, the subject experienced dizziness, feeling faint felt like blackout, like falling down, like passing out. On 04-APR-2021, the subject experienced tingling. On 04-APR-2021, the subject experienced shaking. Laboratory data included: Blood test (NR: not provided) normal, Computerized tomography (NR: not provided) normal, and Urinalysis (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body chills, body aches, numbness, face swelling, confusion, shaking, dizziness, feeling faint felt like blackout, like falling down, like passing out, light headache, funny feeling, fall, hand swelling, and unable to focus, and had not recovered from tingling, and skin reaction on left side upper ankle area. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

JOINT PAIN; HEAVINESS IN CALVES; DULL HEADACHE; SWELLING FOREHEAD/ SWOLLEN FACE/ LEFT CHEEK SWOLLEN; HEART RACING; PRESSURE IN HEAD; RED FACE; TINGLING IN CALVES AND FEET; NUMBNESS IN FEET; SHORT SHOOTING PAIN IN BACK; FEELING OF WARMTH/ LEFT CHEEK WARM; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced swelling forehead/ swollen face/ left cheek swollen. On 07-APR-2021, the subject experienced heart racing. On 07-APR-2021, the subject experienced pressure in head. On 07-APR-2021, the subject experienced red face. On 07-APR-2021, the subject experienced tingling in calves and feet. On 07-APR-2021, the subject experienced numbness in feet. On 07-APR-2021, the subject experienced short shooting pain in back. On 07-APR-2021, the subject experienced feeling of warmth/ left cheek warm. On 07-APR-2021, the subject experienced joint pain. On 07-APR-2021, the subject experienced heaviness in calves. On 07-APR-2021, the subject experienced dull headache. Treatment medications (dates unspecified) included: famotidine, prednisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart racing, and short shooting pain in back on APR-2021, and had not recovered from pressure in head, dull headache, swelling forehead/ swollen face/ left cheek swollen, red face, joint pain, heaviness in calves, tingling in calves and feet, numbness in feet, and feeling of warmth/ left cheek warm. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

I had rotator cuff surgery 1 year ago and after shot my entire area on this arm swelled up and the veins were bulging on the inside of shoulder was very tender. Arm still hurts today where shot was given after 14 days

malaise, arthralgias requiring tylenol, lasting at this time 4 weeks with mildly elevated CRP and D-dimer

Pt. had minor swelling and itch and rash developing on face, arm and legs. Gave 2 tablets of diphenhydramine 25mg. Seemed fine after about 30 minutes.

2 days after vaccination, patient developed right arm (opposite injection site) swelling, erythema, bruising on her wrist and pain/loss of range of potion in her wrist joint. It gradually worsened over about 2 weeks, then began to improve. She remains with some tenderness and her R wrist and thumb and does not have full range of motion but other symptoms have mostly resolved.

After my vaccine, I had a fever and my leg started to swell up. I also had pain in my right arm, injection site. I also had a covid test because of how I was feeling and the test was negative. I had an u/s of my right leg to check for blood clots. An x-ray of the chest was also performed. I also have had a bad cough since my vaccine which I can not get rid off. I am still not feeling 100% from the vaccine, still tired, fatigued and diarrhea. I do not have my lot #, but I will call back when I get that information.

- 3:00 pm Headache - 5:00 pm Stomach pain + diarrhea - 8:00 pm Chills + fever, muscle and joint pain - 10:00 pm Uncontrollable chills and fever of 103.4, only treatment Advil swelling + pain in joints continues.

Vaccine Induced Thrombotic Thrombocytopenia - confirmed with Lab testing Elisa PF4 highly positive 1.chills, generalized body aches, and noted that some glands in her neck were swollen. for 24-48 hours post vaccine 2. 4/27/2021, worsening headaches, bifrontal, along with some bruising in her right leg and left wrist area. Evaluated at ER. white count was 6.1, her hemoglobin was 12.5 and her platelet count was 91,000.( PLT previously 301,000). MR venogram of the head was performed with and without contrast. There was no dural, venous, sinus thrombosis or significant stenosis. The clinical impression at the time of the treating ER physician was that she had acute sinusitis 3. 4/30/2021 PCP visit Additional testing was obtained PLT 149,000. white count and hemoglobin were in the normal ranges. D-dimer was elevated at greater than 20. The fibrinogen was low at 143. Heparin platelet antibody test - lab - Negative 4. 5/3/2021 presents to Hospital. 12 to 16-hour history of back pain, bilaterally, left greater than right. It also was very painful to take a deep breath. She also noted that her fatigue was progressively worsening. CT Pulmonary Angiogram shows Thrombus within multiple right lower lobe, right middle lobe and posterior left upper lobe and medial left lower lobe pulmonary arteries. white count of 11.4, a hemoglobin of 13, and a platelet count of 254,000. Her ANC was 9. Her reticulocyte count was 1.3 and absolute reticulocytes were 0.06. Treated with Non heparin anticoagulant - argatroban IV infusion titrated to PTT lab results Discharged from Hospital with rivaroxaban ( Xarelto) 5/6/2021

FEVER BLISTER/ COLD SORES; LIPS EXFOLIATING/ PEELING; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fever blister/ cold sores, and lips exfoliating/ peeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever blister/ cold sores and lips exfoliating/ peeling was not reported. This report was non-serious.

4/13/2021 From patient c/o of left leg pain and swelling s/p J&J vaccine on 4/03/21 from her local pharmacist. Patient states the the pain and swelling has increased over the last couple of days. She states she does have a history of varicose veins. Advised patient that due to receiving the J&J vaccine within the past 3 weeks, she should proceed to the nearest ER for evaluation. Patient was resistant to going to ER due to her uninsured status and asked that I contact her PCP for a second opinion. A message was sent to physician who agreed patient should be evaluated in the ER. A return call was made to patient, and again it was reiterated that she should proceed to the ER and the risk associated with not proceeding as instructed. Patient agreed to be evaluated in the ER.

Two weeks after receiving the vaccine my legs started swelling. I went to my PCP and he measured my legs and sent me to hospital because he said that it looked like I had blood clots. While in the ER, they started performing tests, and they found a DVT in the left leg and to PE's, one on each lung. I was under observation because I was given Lovonex to thin my blood. While in the hospital the swelling started to go down and that is when I was discharged. I am now seeing a vein specialist and a pulmonary doctor. I was given Eloquis 5mg 2x per day. I am still having pain and swelling in both legs, but the leg with the DVT is worse. It is very hard to walk around because my left leg will swell a lot.

BLOOD CLOT IN RIGHT ARM; ARM SWOLLEN; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol use (beer at home), and smoker. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 05-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient did not feel sick after vaccination. On an unspecified date in 2021, the patient believed that, she had a blood clot in right arm. In past 2-3 weeks, it had been getting bigger and was moving up in her arm. She probably had the clot for longer but started noticing it more 2-3 weeks ago. Clot was moving from her elbow to the shoulder blade and arm was getting big. Patient did not have any pain but her arm was swollen and due to dark skinned she could not tell if her arm was red. Patient called emergency medical service and told them that she had a blood clot, she could feel and see the blood clot and it was told that she needs to go to the doctor but she did not bother. The blood clot kept moving up. Patient had a regular doctor but she did not inform her doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in right arm and arm swollen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210547027-covid-19 vaccine ad26.cov2.s- blood clot in right arm. This event 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.

ARTRIAL FLUTTER (HEART RATE HIGH, HEART PALPITATIONS, FELT FAINTING, DIZZINESS); SHOULDER PAIN; SORE ARM; NAUSEA; INJECTION SITE PAIN; CALF SWELLING; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with influenza vaccine inact sag 3v for prophylactic vaccination. 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 to left arm, on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, at 18:00, vaccination provider gave shot on side way as she could find the muscle, immediately felt at 3 sites severe pain, at injection site, front and back of the shoulder, top of the shoulder. On the same day, after taking shot, around 14:30 minutes, patient had nausea, dizziness, and felt fainting. The vaccination provider gave her some orange juice and after 2-3 minutes later after drinking orange juice, patient felt better. Patient reported that arm remained sore for two weeks and had no other symptoms. Patient usually wore sock during night on a daily basis. On an unknown date in APR-2021, in the morning, patient noticed swelling (calf swelling) up to the sock at the line where elastic, around mid-calf area. On 28-APR-2021, at evening, patient felt heart beating out of rhythm, heart palpitation, and unusual feeling in the chest. On 29-APR-2021, she went to urgent care at 8:00. Patient was checked with electrocardiogram (EKG) machine, took blood test. Physician Assistance advised patient to go to emergency room (ER). On the report, it said vital signs noted as afebrile and cardio no rubs, no peripheral edema, heart rate was showing a normal rhythm with a rate in the 150s. They gave IV (intravenous) and bunch of fluids. On the same day, patient went to emergency room around 10:00. Patient was connected with EKG machine, had blood test and covid test, and monitored heart around 11:00, arterial fluttered atrium beating 2 times faster than ventricles high based on chest and no other issue. Patient was mildly sedated and was performed cardio version. Patient woke up around 13:30 and did not feel heart beating unusual way. Patient was discharged on same day from emergency room referred to cardio electro physiologist. Patient was given prescription medication metoprolol tartrate 25 mg take 1 tablet 2 times a day dispensing quantity 30, blood thinner xeralto 20 mg take 1 tablet by mouth once daily 30 tablets but patient did not buy medication. Physician said patient had risk of clotting. Laboratory data included: Blood test (NR: not provided) Unknown, COVID-19 virus test (NR: not provided) Unknown, Cardiac monitoring (NR: not provided) Arterial fluttered Atrium beating 2 times faster than ventricles high, EKG (NR: not provided) 150, and Vital signs measurement (NR: not provided) afebrile. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on APR-2021, and injection site pain, and the outcome of nausea, calf swelling, artrial flutter (heart rate high, heart palpitations, felt fainting, dizziness), shoulder pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210557841-covid-19 vaccine ad26.cov2.s-artrial flutter (heart rate high, heart palpitations, felt fainting, dizziness). 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).

Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium

About 20 hours after vaccine I had chills, aches, fatigue--felt like a mini version of COVID. I had COVID in December of 2020. I had a bad case but did not require hospitalization. On Saturday night (May 22, 2021)I developed a sore near my mouth that was quite painful. I went to the dermatologist on Tuesday May 25 and he said I had a cold sore. He gave me medication and it has healed, but it took a while.

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

SWOLLEN LYMPH NODES TO THE NECK, BILATERALLY; JOINT AND MUSCLE PAIN; LOW ENERGY; MORE TIRED THAN USUAL; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mixed connective tissue disease, lupus, latex allergy, and sulphate allergy, and other pre-existing medical conditions included patient had allergies to sulphate. The patient experienced drug allergy when treated with levofloxacin, omeprazole, and omeprazole for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUN-2021, the subject experienced swollen lymph nodes to the neck, bilaterally. On 06-JUN-2021, the subject experienced joint and muscle pain. On 06-JUN-2021, the subject experienced low energy. On 06-JUN-2021, the subject experienced more tired than usual. On 06-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low energy, joint and muscle pain, more tired than usual, headache, and swollen lymph nodes to the neck, bilaterally. This report was non-serious.

Started getting short of breath around 3:30. I was not sick before this. Around 7:30 it got worse. On 5.15/21 breathing got really bad all day. Tried to go to bed around 10pm but breathing go to where I could hardly catch a breath. Had to calll 911. Oxygen go to 82%. Diagnosed with pneumonia both lungs and sepsis. Admitted same day and discharged on 5/22/21 with an oxygen tank. They also had delivered an oxygen concentrator to my home. Was discharged and I should not have been. Discharged without any medication. I could hardly walk and was very dizzy. On 6/3/21 I saw pulmonologist and my oxygen level was at 80% without my oxygen. Had to start respiratory therapy but could not go due to no transportation.

Developed back pain and pain in her torso that spread to the extremities, starting on 7/8. She then developed paresthesias, dysesthesia, and shortness of breath. LP showed elevated protein. The patient has been diagnosed with AIDP/Guillian-Barre.

2 weeks out. Severe pain in neck and back. June 26 went to ER. Pain in back cramping in legs. Giving pain medication sent home . Referred to rheumatology. June 29 return to ER. For severe pain in legs. Numb right side of face, double vision, difficult speaking loss of balance. July 6 return to ER. Diagnosed with thrush Gillian Barre Syndrome. Acute Demyelinating Polyneuropathy.Admitted to hospital

Facial swelling, Diffuse facial rash- 24 hours after vaccine administation Extreme fatigue- immediately following vaccine x2 days Evaluated by PCP and given IM Benadryl and Decadron

As expected soreness in left arm, not unexpected stiffness in left shoulder and left side of neck + back extending down to left shoulderblade. The unexpected effect is tingling and coldness in both hands/fingertips. I could logically assume it is from the swelling in the neck pressing on the nerves, as I have experienced a similar feeling occasionally in the past due to compressed discs in my spine and neck. At this point I am not particularly alarmed but I wanted to make you aware of this side effect.

Five hours after shot the back of my right eye was hurting the next day 03/12/2021 my right side from my head down to my lower back was hurting 03/15/2021 now my right arm is swollen And hurts to the touch and is feverish really hot And sore.

SWELLING OF THROAT, DIFFICULTY BREATHING/SPEAKING. ANAPHYLACTIC REACTION. RECIEVED 0.3ML EPHRINEPHRIN, EMS CALLED AND PATIENT EVALUTAION WAS PERFORMED. PATIENT WAS RELEASED ON OWN ACCORD. PATIENT DENIED FURTHER TREATMENT.

A deep purple bruise formed on my left underarm, lymph nodes swelled, tender to touch. Took Tylenol and Benedryl each night from 3-12-2021 - 2-21-2021. Bruise lasted until 3-21-2021. Still tender but bruise is almost gone.

At about 23 minutes broke out in a cold sweat. At 26 minutes, became hoarse (always my first symptom of anaphylaxis). Progressed to coughing and feeling a lump in my throat and then tightness in my chest. My blood pressure elevated to 152/100. At that point I self administered epi pen and paramedics called 911. This provided relief but after about 5 to 10 minutes the tightness in my chest and the feeling I couldn?t get a deep breath began to return and the paramedics administered two puffs of an albuteral inhaler and transported me to the hospital. At the ER, they did an EKG, started an IV and administered fluids, prednisone and Benadryl. I was discharged about 90 -120 minutes later with a prescription for 3 days of prednisone (50mg) and instructions to continue to take 25 mg oral Benadryl every 4 hours. The next morning my face and chest were red and looked like I was sunburned. My face was also swollen.

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

After my vaccine I had tenderness in my right arm at injection site and a sharp pain in my right clavicle bone. The clavicle bone pain slowly went to an ache. But then I noticed my arm was ballooning up a d the injection site was hard. Then, About a week after my COVID vaccine, I experienced leg pain (left) behind my knee and my arm was getting larger and warm to the touch. My first appointment with my doctor was 3/24/2021 at 1215pm. He checked out the areas and ordered a ultrasound Doppler of my left knee. I called the vaccine center as it says on the paper given with the vaccine. I spoke to someone and explained my symptoms. She suggested a ultrasound of my arm as well. I called my primary care doctor who added my arm to the order.

pt states that later in the day after taking the vax she developed a rash both arms, neck and chest. Left hand was swollen and the vein was very enlarged in her left hand. The left arm has a hard knot around the injection site. The next day she was extremely tired and slept an entire day. the second day she got body aches in her lower back, hips and knees. the third day she had fever and chills. on day four she is still very fatigued and has no energy. Pt says she just has an odd feeling and does not feel like herself anymore. Pt will call her PCP for medical advice.

After my J&J vaccine, my right arm felt hot and was red and I also ended up with an upset stomach, had diarrhea and felt sick to my stomach. I also experienced chills, low grade fever of 99.8 and had swelling to my joints in my fingers and toes. My right arm pain radiated upwards to my neck. These symptoms lasted 12 hours and as of today I still have pain in my neck. Since 03-15-2021, I have been seeing a chiropractor for my neck pain. I see him on a weekly basis. At the chiropractor's office they apply ice, heat and do a muscle rub help with my neck pain that still is present.

Hot hands, knees, legs and feet... swelling in feet and ankles, swelling over knees and swelling in right hand and fingers..achy right shoulder( old shoulder injury and surgery here 8 years ago). Shot was given in left arm. Started last evening prior to 8 pm and continues today.

Left upper back: Initially itching, day 2 redness and itching, day 3 itching, redness, swelling, raised pustules, day 4 same as day 3 with spreading.

SKIN SLIGHTLY TENDER TO TOUCH; SWELLING IN THE LEFT ARMPIT AROUND LYMPH NODE AREA; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included gallbladder removal, and ovary removal, and concurrent conditions included allergy to dust mites, consumes alcohol- couple of glasses of wine per week, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse/ illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 around 13:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced swelling in the left armpit around lymph node area. On an unspecified date, the subject experienced skin slightly tender to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in the left armpit around lymph node area, and the outcome of skin slightly tender to touch was not reported. This report was non-serious.

Swollen lymp node on neck on side of shot. Rash on back, chest, and some in my hair that itches like crazy. Steriod creme (Triamcinolone Acetonide) and Cephalexin 500MG. Still have symptoms as of 4/13 and they don't seem to be getting better, has actually spread some more. Started 3/23 and it is now 4/13.

The first day I had pain in my arm, which I expected. But the next day, my arm became swollen, with a large lump in it about 4 cm wide The lump is just not getting better, but it is still there. The other issue is I have muscle ache and soreness starting the day after the shot, and it has never gone away.

Reported to local health department by physician office. Patient reported lower left leg swelling that started on 4/11/2021. Also, reported shortness of air. Venous doppler performed and positive for DVT on 4/12/2021. Patient admitted to hospital on 4/12/2021. Inpatient currently at facility. On Eliquis. Also, tested positive for COVID upon admission to hospital.

After the injection about 15 minutes afterwards I was getting dizzy I was having trouble breathing. Was given a Benadryl. An ambulance was called. I do not remember being transferred to the hospital. I was given solu- Medrol (methylPREDNI solone succinate 125mg IV and 20 mg Pepcid IV for an allergic reaction to the vaccine. I was prescribed an EpiPen. I am still having side effects from the vaccine. Migraines, dizziness, hives, swollen lymph glands.

On April 16th at 1:00AM I woke up to pain in my left foot. When I got up to take a look I was unable to put full weight on my left foot. The side of my foot by the small toe is red and swollen.

severe weakness, muscle aches, probably every lymph node. worse was shortness of breath. could not even walk a few feet without trying to catch my breath

Pt states that for about 12 hours on the day she received the vaccine she noticed tingling through her limbs, veins, and extremities that lasted overnight. Then, about 7 days after she received the vaccine she noticed her hands were swollen. She states they are "arthritic like" and this issue is still present today. She states she is taking advil to help with the pain in her hands.

MUSCLE TIGHTNESS IN THE ARM; SWELLING OF THE LYMPH NODES; FELT TIRED; HEADACHE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included neck injury, and car accident, and concurrent conditions included hashimoto's disease, overweight, sinus infection, and blood clot. The patient was previously treated with ibuprofen. 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 for prophylactic vaccination. The batch number was not reported and it has been requested. Concomitant medications included acetylsalicylic acid for blood clot, curcuma longa rhizome for drug use for unknown indication, zingiber officinale rhizome for drug use for unknown indication, amoxicillin trihydrate/clavulanate potassium for sinus infection, ergocalciferol, magnesium, and . On 2018, Laboratory data included: Platelet aggregation test (NR: not provided) negative. On 09-APR-2021, the subject experienced felt tired. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced muscle tightness in the arm. On 10-APR-2021, the subject experienced swelling of the lymph nodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt tired, headache, muscle tightness in the arm, and swelling of the lymph nodes. This report was non-serious.

Left lower medial aspect swelling , warmth and thrombosis noted. Placed on Naproxen 500mg BID Compression stockings Heat and Cold compresses

STY IN RIGHT EYE; LITTLE LIQUID IN THE EAR; CHILLS; HEADACHE; DID NOT FEEL GOOD; ARM PAIN; SWELLING OF THE NECK; SWELLING OF THE LEFT SHOULDER; ENLARGED LYMPH NODES ON THE LEFT SIDE; NECK PAIN; TENDON TIGHTNESS; POPPING NOISE WHEN SWALLOWING; SUSPECTED COVID-19; SINUS ISSUE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic hives, allergic to sulfa medications (welts all over the body), non-smoker, allergy to percocet (increased heart rate), latex allergy (skin burns), and sleep disorder. 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 15:30 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for chronic hives, and diphenhydramine hydrochloride for sleep disturbance. On APR-2021, the subject experienced popping noise when swallowing. On APR-2021, the subject experienced suspected covid-19. On APR-2021, the subject experienced sinus issue. On 10-APR-2021, the subject experienced swelling of the neck. On 10-APR-2021, the subject experienced swelling of the left shoulder. On 10-APR-2021, the subject experienced enlarged lymph nodes on the left side. On 10-APR-2021, the subject experienced neck pain. On 10-APR-2021, the subject experienced tendon tightness. On 10-APR-2021, the subject experienced did not feel good. On 10-APR-2021, the subject experienced arm pain. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced chills. On 15-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 21-APR-2021, the subject experienced sty in right eye. On 21-APR-2021, the subject experienced little liquid in the ear. Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and X-ray of nasal sinuses (NR: not provided) Normal sinuses. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, paracetamol, guaifenesin/pseudoephedrine hydrochloride, naproxen sodium, fluticasone propionate, dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and cefalexin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of the neck, swelling of the left shoulder, enlarged lymph nodes on the left side, neck pain, tendon tightness, and arm pain on 13-APR-2021, and chills on 12-APR-2021, was recovering from sty in right eye, had not recovered from headache, and the outcome of popping noise when swallowing, suspected covid-19, did not feel good, sinus issue and little liquid in the ear was not reported. This report was non-serious.

SWELLING OF FACE, TONGUE, ARMS AND HANDS; VOMITING; NAUSEA; ABDOMINAL PAIN; SWELLING OF FEET; COULDN'T SLEEP; ITCHY RASH; DIARRHEA; PAIN ALL OVER; SORE THROAT; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no underlying medical conditions. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced pain all over the body, sore throat. On 12-APR-2021, the patient experienced rash. On 13-APR-2021, the patient experienced diarrhea, itching. On 14-APR-2021, the patient experienced abdominal pain, swelling of feet, could not sleep. On 15-APR-2021, the patient experienced swelling of face, tongue, arms and hands, nausea and vomiting. She went to clinic to see a doctor and doctor told the patient to go to ER. In Emergency room, they gave her intravenous fluids and medicine for the nausea and vomiting. All her symptoms were improving but she was worried that she will still have swelling and rash with the itching. She only slept for about 4 hours at night. She did not have insurance and medical bills got expensive and was worried. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea on 15-APR-2021, was recovering from abdominal pain, diarrhea, pain all over, sore throat, and couldn't sleep, and had not recovered from swelling of face, tongue, arms and hands, swelling of feet, and itchy rash. This report was serious (Other Medically Important Condition). .; Sender's Comments: V0;-covid-19 vaccine ad26.cov2. s-swelling of face, tongue, arms, hands and abdominal pain. This events are considered unassessable. The events had a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Anaphylaxis. Patient experienced shortness of breath, tingling in hands and arms, cold chills, and feeling faint.

LOWER BACK PAIN IN BOTH SIDES; BLOATING; COUGH; THROAT TICKLISH; MUCOUS; SWOLLEN ANKLE IN RIGHT LEG; NUMB TONGUE; LOSS OF TASTE; WHITE COAT ON THE TONGUE; RIGHT ARM SWOLLEN; CHILLS; TIRED; HOT FLUSHES; THIRSTY; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced hot flushes. On 31-MAR-2021, the subject experienced thirsty. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced tired. On APR-2021, the subject experienced lower back pain in both sides. On APR-2021, the subject experienced bloating. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced throat ticklish. On APR-2021, the subject experienced mucous. On APR-2021, the subject experienced swollen ankle in right leg. On APR-2021, the subject experienced numb tongue. On APR-2021, the subject experienced loss of taste. On APR-2021, the subject experienced white coat on the tongue. On APR-2021, the subject experienced right arm swollen. Laboratory data included: Chest X-ray (NR: not provided) Normal. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flushes, thirsty, throat ticklish, chills, and tired on APR-2021, was recovering from numb tongue, and loss of taste, had not recovered from lower back pain in both sides, bloating, cough, mucous, swollen ankle in right leg, and white coat on the tongue, and the outcome of right arm swollen was not reported. This report was non-serious.

Vaccine high up in left shoulder joint area & sideways towards body. Immediate severe burning pain, flushing, dizziness, faintness, chest pain, BP 180/115. Incident report was filed by nurses. Paramedics onsite attended patient; documentation was signed by patient. Felt like arm ripped off and put back on. Severe pain left shoulder to elbow, neck, scapula: continunous for 6 weeks, no sleep. Moderate pain at 8 weeks. Pins & needles top-trunk 4wks. 2 weeks out: lump on top of L shoulder for 1 week. 2.5 weeks out: burning rash in armpit for 1 week. 8+ wks of numb/tingling in L hand pinky & ring fingers, limited range of motion w/popping, crunching in shoulder when move left arm. Headache, nausea, muscle aches for 5 days post vaccine. On 3/29/21, 3/30/21, 4/16, 4/19, 4/30/21 sought medical attention @ internal med. doctor & orthopedic doctor.

The first thing that happened, 4:30 pm the following day, extremely nauseated and starting throwing up (I was driving and had to pull over) and felt super dizzy which was vertigo. Drove home, had severe diarrhea , chills, fever. My arm swelled up and hurt. My lower back was in severe pain. My upper right back thigh - between the buttocks and knee had a horrible pain in it. Very severe pain and it started radiating down my calf muscle and then to the front of shin. Stayed for days on the back of my thigh in my right leg. I continued having very severe vertigo. I would have to run and throw up if I tried to move or go back to bed. The nausea never went away. That was lasted for 8 days. I went to my doctor's office - I drove to the office - they moved all the doctor's across town for Sutter and I couldn't make it before they closed and I had to go home. I couldn't make it. Just driving there was impossible - It was really bad. Didn't have a doctor visit at all then. The dr. prescribed a medication for vertigo. The pharmacist said to buy the OTC medication for vertigo so I bought it but it didn't help. That made me doped up and sleepy but still nauseated. I got a spike behind my ear on the right hand side of head - in that little pocket - headaches would come there. I still have weird vertigo and dizziness - intermittently- although I always have a dull nauseous feeling. Every now and then I have to run and throw up - it's like my body is tired of feeling dizzy. Flying in the airplane - looking out the window - made me super nauseous - so I had to close my eyes and not look at anything. Still have the nausea and vertigo. I have mild dull headaches still. Did have golf ball size lump on arm and couldn't raise it but now it's gone.

My arm was in uncomfortable pain, sore, tender, and swollen for a week. The next day I started feeling hot but it was not a fever, my head started hurting and I was just feeling blah. I called the County Hotline and they said that they have heard that before. I felt like I was getting the flu, but it never turned into the flu. I was very fatigued and out of sorts for about a week and then everything went away.

I basically felt like I was run over by a truck, had chills, fever, body aches, swelling, random, pain, open soars started on my left arm and my back really deep, a severe headache and I was really lethargic, and I had diarrhea ended up with a cough, short of breath and hard to breathe.

SWELLING IN BOTH LEGS AND FEET; FLUID RETENTION; This spontaneous report received from a consumer concerned a 57 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced swelling in both legs and feet. On 19-MAY-2021, the subject experienced fluid retention. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in both legs and feet, and fluid retention. This report was non-serious.

About 2 months after shot experienced swollen painful lymph nodes in breast, arm pits, rib cage and throat. Symptoms persistent and now have large, painful lump in breast that was not there before injection. Also hives on upper body that come and go. Also extremely high CBC.

Janssen Covid-19 EUA Ill a week after vaccine for 2 weeks. Had nasal Covid test 4/4/2021 results negative. Have had problems with breathing, swelling of the lower legs, ankles and feet, headaches, dizziness.

After vaccine was introduced felt slight swelling discomfort of left arm (had to remove and reseat my watch strap) followed by both arms seeming flushed (reddish). Ignored both symptoms at the time. About 30 minutes after vaccine on my way home in the car throat started feeling swollen and I found it difficult to swallow. Lips and tongue felt swollen (even though they didn't loot it). Metallic taste in mouth and could smell a weird earthy smell. Went to ER to seek assistance, by the time I got to the ER symptoms were starting to subside. Kept under observation for the rest of the afternoon before being discharged Prescribed an EpiPen and followed up with Primary Care Physician. After about a week started feeling a pain deep in my right calf, no other symptoms so have not sought medical care. Today 2 weeks after vaccine still have slight pain in calf, seems to be subsiding with time.

I have NO INSURANCE and NO MONEY to go a doctor. VERY SWOLLEN LEGS FOR 14 DAYS,, low to high grade headaches AND STILL ON GOING, I HAVE TO TAKE PAID DRUGS EVERY DAY TO WORK AT ALL. I HAVE NOT BEEN ABLE TO WORK EVEN HALF TIME IN LAST 2 WEEKS - NO UNEMPLOMENT IS ALLOWED FOR THIS SO I HAVE ALREADY LOST 2 WEEKS of INCOME!!!

On June 19th I felt swelling on the left side of the face, then within few hours left side of the face become paralyzed, at the Emergency Room was diagnosed with Bell's Palsy.

joints, I'm retaining water really bad, especially on the right side, and my joints are swollen. I have to walk up and down stairs to my bedroom and it really hurts my knee and my foot and I've started to wear a knee brace sometimes. My arm hurts from my shoulder to my fingers and my back and ribs on the right are in constant pain. I have also had diarrhea since getting the shot and I usually do not have that problem.

April 7 - Tachycardia confirmed by EKG lasting 72 hours. May 3 - Extreme knee/ankle and lower back pain, difficulty walking, numbness in feet and hands, extreme fatigue, swollen ankles, feet, elbows, wrists, calf muscle and foot spasms. July 13 - numbness, fatigue and calf/foot muscle spasms continue today.

Fever same day as vaccine in the evening. Following week swollen glands on neck for about a week. Arm site very tender at point of shot for over about 8 weeks.

Patient was febrile at 104F. Found passed out on floor at home. SIRS from vaccine administration is the likely cause of this event

-I waited 30 minutes at Pharmacy after vaccine - all seemed fine -When I got home, I felt tingling in my lips and the skin below my mouth began to swell (angioedema-a reaction I usually get when I have an allergic reaction to anything). -No problems breathing, must itchy throat -Taking Bendedryl around clock - have NOT had to use Epi-pen, but feel like I have really bad allergies

severe chills, vomiting, swelling/pain under RIGHT arm (side of lymph node removal 25 years ago) and fatigue

I felt fine immediately after the injection - just a little pain in the arm where I got the injection and when raising my arm. By 6:30 pm I was achy all over and my legs were aching a lot. When I went to bed around 8:00, I hurt all over (achy and flu-like feeling, but no fever). I dozed off and on and about midnight when I woke up, I had a very rapid heartbeat. This went on all night and into the morning. It was hard to get any sleep at all. When I'd get up to go to the bathroom, I was slightly dizzy and unsteady on my feet. After I got up at 6:30 am, the highest my heartrate got was 113, then it finally began going down. I was still hurting all over, felt extremely tired, and now had fever - 99.8. The fever lasted off and on all day and into the next night. I was also very nauseated all day and I felt extremely bloated. I also had a bad headache. When I woke up on Friday, my fever and the headache was gone, but I felt extremely tired and weak and still nauseated. I slept most of the day and I still ached all over, but not as much. My lymph nodes were also swollen. On Friday afternoon, I walked up to the mailbox and I was winded and unsteady. On Saturday, I felt a little better, but was still extremely tired. By Saturday night, all the aches, pains and headache were back and I didn't sleep well at all. I rested most of Sunday and felt a little better Sunday evening. The aches and pains were going away, but I was still very tired and exhausted. I felt the same way when I woke up on Monday morning. It seemed like the vaccination made the aches and pains I normally had with Fibromyalgia about three times as bad as usual. And I was still very bloated feeling all over. By Monday afternoon the nausea finally went away. By Monday afternoon I was feeling a little better, but still tired. On Tuesday I felt better still and I noticed that I wasn't bloated as much. It seemed like I was getting back to normal.

24 hours after the injection I had a blood shot patch on my left eye which I believe is a subconjunctival hemorrhage. It has gotten smaller but is still visible today on 4/8/21 , six days after the vaccine. Additionally, my lymph nodes under my left arm swelled 36 hours after the injection and were swollen for 4 days. I took two 500 mg of tylenol daily for 4 days. I was very fatigued for 48 hours 24 hours after the injection.

After the vaccine I woke up about 3am throwing up and had diarrah all day. I felt so bad all day that by 9pm I went to the ER and was advised my intestines were inflamed and diagnosed with Colitis. I was prescribed Augumentin to take for 7 days and tylenol for pain and to follow up with my PCP.

Patient said her throat fels funny at first but was not closing on her. later in the evening 7 hours later have swollen lymph nodes, sore body, tremors, fever, congestion, and diarrhea.

SWELLING ARM; BULGING OF THE VEINS; ARM SORENESS/TENDERNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included cancer 11 year ago, and concurrent conditions included lymphedema in right arm, high blood pressure, penicillin allergy, and allergic to some high blood pressure medicine. 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 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced swelling arm. On 2021, the subject experienced bulging of the veins. On 2021, the subject experienced arm soreness/tenderness. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling arm, and arm soreness/tenderness, and the outcome of bulging of the veins was not reported. This report was non-serious.

Janssen COVID-19 Vaccine EUA Approx 20 hours later the headache and some body aches and feeling tired Approximately 26 - 30 hours later noticed my hands really swollen and took rings off * Approximately 48 - 52 hours later very heavy dark slightly clotty nosebleed while eating dinner (no previous issues in years of having a nosebleed)

Day 4 woke up with bone,and muscle pain. , Left leg edema started on 3-23-2021 and still has pitting edema present today and The Medical Doctor is aware of this. Feels Pressure on Left side of the head and pain in left eye cheek bone > Had nose bleed on March 27th and March 23,2021. . Some dizziness noted 4-13-2021 and 4-14-2021.

Patient's arm started swelling about the size of a fist. It is not red. Warmer at site. Around the injection it is hard (about the size of a quarter). Arm is still sore. Patient has been taking tylenol and ibuprofen.

EYE SWELLING; EYE REDNESS; CHEEKS SWELLING; CHEEKS REDNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced eye swelling. On 13-APR-2021, the subject experienced eye redness. On 13-APR-2021, the subject experienced cheeks swelling. On 13-APR-2021, the subject experienced cheeks redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye swelling, eye redness, cheeks swelling, and cheeks redness. This report was non-serious.

Day 1- (April 1st - bearable arm pain & low fever that night (nothing bad) Day 2- @5:00PM - arm pain was unbearable hurt from the root of the arm to my elbow, including lymph nodes and all the part of the arm that touches the ribs, a headache that fluctuates from bad to my head is going to burst, from there it became a very weakening fatigue where I could hardly get around, lots of joint pain, nausea and I do not know if the vaccine provoked the diarrhea or if it triggered the Crohn's. To this day I am still dealing with the headache, the pain not just in the arm but allover, gastro intestinal problems. It has impacted my sleep tremendously because the level of pain is very high. The one thing that went away that very first night was the low fever. But this vaccine is like a Wish (cheap store) Vaccine. They SHOULD NOT give this to immunocompromised people and the "few days" rhetoric does not apply to us and that should be specified! Initially I thought this was to be expected when I heard a Doctor on the news say: "if you fell like you got ran over by a truck, that is normal." So, that is how I felt, so I thought it was normal.

After vaccination, at 10pm I started feeling flu like symptoms, fever chills shakes feeling miserable and this lasted 3 days straight, I also had diarrhea, nausea and vomiting. I woke up with a swollen juggler vein that ended up being a blood clot, 10 days later my arm was swollen up twice the size of my leg, the juggler was still swollen. I call the urgent care nurse they said to go to ER. I went to hospital got a CAT scan and ultrasound, I was given a shot of warfarin that was supposed to last for 12 hours. I went home and the next morning instead of going to the hospital, I went to hospital and they found 2 blood clots in brain, arm and leg and neck. I have had no history of blood clots and this all happened after the J&J vaccine. They did a procedure where they tried to put a balloon to relieve the pressure. The blood clots in the brain cannot be removed because of their location and it would be dangerous to remove and I am on blood thinners for the rest of my life. Multiple blood clots in body brain, arm and shoulder.

BLOOD IN STOOL; SKULL PAIN; FEVER; NAUSEA; FATIGUE; CHILLS; VOMITING; BODY ACHES; FACIAL SWELLING; DIARRHEA; STOMACH PAIN; JAW PAIN; FACIAL AREA PAIN; This spontaneous report was received from a 58-year-old female patient. The patient's height, and weight were not reported. The patient's concurrent condition included allergy to narcotics. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 042A21A and expiry: unknown) dose was not reported, 1 total, administered on left arm on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced vomiting, body aches, facial swelling, diarrhea, stomach pain, chills, fever, nausea and fatigue. On an unspecified date, in APR-2021, after the vaccination, the patient experienced jaw pain and pain in facial area. On 11-APR-2021, the patient experienced skull pain. On 12-APR-2021, the patient discovered blood in her stool and her doctor sent the stool for testing. The doctor did not prescribe any treatment. On an unspecified date, the patient saw her doctor who said it was 'too much' for the patient's immune system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, body aches, fever, chills, skull pain, facial swelling, diarrhea, stomach pain, fatigue, and blood in stool, and the outcome of nausea, jaw pain and facial area pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-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).

PATIENT INDICATED BLOOD GLUCOSE WAS 500, TREMORS, FEVER, SWOLLEN FEET, DIFFICULTY BREATHING, BRUISES IN ARMS AND THIGHS

Large hematoma at injection site with axilla pain and pain in location of brachial artery from day 1. Persistent fatigue and headache. At day 14 (today) experiencing piercing nerve pain and mild swelling in L hand (thumb mainly).

When I received the injection I immediately felt an electric current flow up to the right side of my neck. It passed quickly though. Around eight hours later I developed stiff muscles in my right neck. It became twice the size and was very swollen. I called my PCP and I was told to use moist heat. I used a warm washcloth and kept heat to it. I did not take any medication until the following morning. I took Motrin at 6:00AM. The next day I still felt sore and it took a few days for the muscle ache to go away. Two weeks after the vaccination I started having numbness in my hands and feet. I figured it would just go away and didn't pay much attention to it. 05/25/2021 my right hand was very numb and my right arm was very achy. I went to urgent care because of worry for a blood clot. While at urgent care, I saw a physician, he ruled out a blood clot, but he said that I may have Peripheral neuropathy. I was told to follow up with my PCP and it was suggested to see a neurologist.

GREEN PHLEGM; EARS HURTING; PRESSURE/PAIN IN CHEST; SORE THROAT; TINGLING, BOTHERSOME, HURTING NECK GLANDS; HURTING NECK GLANDS; DISCOMFORT; SWELLING OF THE GLANDS IN THE NECK AREA; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included diagnosis of covid-19, and lost smell in one nostril. The patient was previously treated with ibuprofen for lost smell in one nostril. 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 26-MAY-2021 11:15 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAY-2021, the subject experienced discomfort. On MAY-2021, the subject experienced swelling of the glands in the neck area. Treatment medications included: salbutamol sulfate. On 26-MAY-2021, the subject experienced tingling, bothersome, hurting neck glands. On 26-MAY-2021, the subject experienced hurting neck glands. On 27-MAY-2021, the subject experienced sore throat. On 28-MAY-2021, the subject experienced pressure/pain in chest. On 29-MAY-2021, the subject experienced green phlegm. On 29-MAY-2021, the subject experienced ears hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from discomfort, and the outcome of tingling, bothersome, hurting neck glands, sore throat, pressure/pain in chest, green phlegm, ears hurting, hurting neck glands and swelling of the glands in the neck area was not reported. This report was non-serious.

Radiating pain from the right neck, shoulder and arm that spread to the left side. Tingling sensation in fingers, along with pain. Taken to ED, labs and imaging were done that were inconclusive. Tingling and numbness spreading to feet and legs, but however patient was discharged even in worsening condition with no answers, and told to make an appointment with a neurologist the following week. After being brought home, the numbness spread and patient could not support her weight and would lose balance. Ambulance called and taken back to the same facility. Admitted under observation initially, the following day, a lumbar puncture was completed, at the request from our daughter (who is a nurse) to the doctors, that showed elevated protein in the CSF. It was concluded that patient showed clinical signs of Guillian-Barre Syndrome and was subsequently started on IVIG therapy. Her condition worsened and she was upgraded to progressive care and then the neuro ICU when numbness had spread to her face. A central line was placed and patient was started on plasmapheresis. Patient showed loss of feeling and function in her arms and legs, swelling in her face that did not allow her to speak or eat properly. 3 more rounds of IVIG were done after plasmapheresis was completed. Patient was stabilized and transferred to the rehabilitation hospital for rehab and therapy.

Over the course of 10 days following the injection I had fever spikes (up to 102), fatigue, loss of appetite, muscle soreness and joint stiffness (more than normal), chills, sweating, heaviness in chest, diarrhea, I vomitted the day after, but that was just for a period of 4 hours. On the 4th day I woke up with stiffness in my left arm and underarm, and swollen glands. I went to the urgent care on the following morning, but the stiffness and swelling had started to retreat and has since disappeared. Soreness at the injection site for about two weeks after vaccine. It is still a bit tender to the touch, but does not bother me unless rubbed hard. There was also redness and tenderness and some itching at the injection site. I felt poorly enough (the fatigue, mostly), that I was not able to work for 10 days. At about the two week mark I finally had the feeling that I felt good! I occasionally feel fatigued, but have been able to resume normal activities.

Within 5 minutes fingers started tingling and then toes. Face was getting flush but I thought I was okay. Left vaccine site after 15 minutes. Got in car and started to have face swell up and get red all over. Went back into vaccine site and told them I was having a reaction. They observed my red face and puffiness and gave me 2 benadryl . My neck was feeling tight and red as well. I stayed there another 30 minutes, and it didn't get worse and stayed the same. They told me to keep taking benadryl for 2 days plus an over the counter 24 hour allergy pill. Also they directed me to go to the hospital if it got worse. I took the benadryl as directed and it stayed about the same for a day. Then slowly got better with a few flare ups within the first week.

I woke up the 2nd day after recieving the Janssen Vaccine with a stiff neck and my shoulder hurt. I thought that I slept wrong. The pain did not go away that day or any day after that. My whole arm started hurting, and tingling. My neck hurt and my shoulder hurt severely. It's been 3 weeks agl that I had gotten the vaccine, and it all still hurts. My whole arm is swollen, and there's a big bump swelling at the injection site of my left arm. I went to my doctor on 6/14/2021. He ordered Xrays and gave me a muscle relaxer, and an extended release medicine like aleve. The medicine did not help at all so I went back to the clinic. He perscribed Tramadal 50mg. and it helps a small amount but doesn't really help that much. He ordered an Ultrasound.

Pt is a 58 yr old female with past medical hx of copd on oxygen, pulmonary cachexia, previous strokes secondary to trauma as a result of severe spousal abuse resulting in seizure disorder who received her J and J vaccine on 6/5/21 and was admitted to the hospital on June 18th c/o 3-5 days of fatigue, increasing shortness or breath and cough, poor appetite, and was diagnosed with R middle and R low lobe pneumonia, sepsis and acute hypoxic, hypercarbic respiratory failure to the ICU where she remains admitted in critical condition as of June 24th. Prior to this she was in her usual state of health and had not been hospitalized in 19 years. She has persistent lymphopenia on her cbc and differential. She is requiring high flow oxygen and bipap support. She is being treated with antibioitics, a naso gastric feeding tube and physical therapy.

I had my vaccine on May 18, 2021. Prior to this date I was in good health. I was in remission from Ankylosing Spondylitis and Rheumatoid Arthritis for a 3 year period of time. I was off all meds related to this. I was active and I am not over weight. ( I have HBP and thyroid issues....All controlled). After the vaccine, beginning around May 27, 2021 I started experiencing bi-lateral shoulder pain and my knees began to get stiff. within the next week and after the symptoms got worse and started affecting all major joints. I had a routine appointment with my Rheumatologist on June 21, but I called to been seen sooner because it was becoming difficult to stand, walk and the pain in my shoulders was severe and referred pain down my arms to my elbows. I had an appointment on June 14, 2021 and had a blood test on the 18th. The report came back with the highest numbers that I have ever had for inflammation. There has been a lot of confusion at my doctors office but they are finally getting me approved to go back on biologics. I have been unable to do any of my normal activities and the pain throughout my body is a solid 10 on a 1-10 scale. There isnt any relief currently and I am struggling.

Received Johnson and Johnson vaccine on the 10 th of March, started having flu like symptoms early next Sunday morning, late Monday night my hands began to swell up and hurt when I was laying down. This got progressively worse and I started having pain when breathing, I called my doctor and was told my symptoms were normal for the vaccine and to go back to bed, and call after a day or so if no changes. The next day I called the advice nurse and was advised to go to the urgent care. I didn?t get any information on why this was happening to me, just a bad reaction to the vaccine, I was prescribed medication to help with my breathing, but the pain in my hands now includes my arms, legs and feet. I take a minimum of 600 mg of Advil liquid gels every 5 hours, I?m pretty miserable and cannot do normal life things.

Flushed and sweaty after 20 minutes. Heart started beating fast and irregular. Went by ambulance to ER where given complete smattering of tests, 2 EKG's Chest xrays, Chest CAT scan, blood work and observation. Heart and BP continued to be elevated during stay. PB 168/85 down to 148/74. Heart rate 110 to 85 ish. Discharged from hospital. Bed at 10:15 feeling ok. During the night fever, chills, swollen glands, nausea, severe body aches, headache. fast heart rate, heavy breathing, general malaise, sleeplessness, painful injection site. Took tylenol at 5:00 AM and slept a few hours. Woke at 10 AM with body aches, but heart rate was down to 76 and BP down to 112/74. Continuing the tylenol and wiped out.

My blood pressure went up very high, pain in my chest, shortness of breath, rash on my face, swollen arm and redness at injection site. Went to the hospital. Monday, March 15th at hospital from 2:00 p.m. until 7:00 p.m.

9 hours after vaccine, sudden onset of fever, chills, headache, body ache, fatigue, soreness at site, swollen glands under arm and at collar bone. These lasted about 24 hours and had mostly subsided 48 hours after vaccine.

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

No side effects at time of injection. 5 days later on 3/28, my lymph nodes on right side of face/neck became swollen. Today is 3/30 and they remain the same, swollen.

After getting the shot that afternoon at 3:00 a.m. I woke up in a flu state of chills, fever, headache, achiness. The headache lasted a solid 24 hours almost to the point of vomiting even while taking 4 tylenol every 4 hours then my stomach was empty so I ate a few crackers, but that next night it was hard to go to sleep. At night I suddently realized my forehead seemed larger than normal! It really felt bigger and swollen so I massaged it and could feel my layers of skin/dermis moving around I beleived it was the serum from the shot from all the prone position I was in for so long laying in bed. Thankfully the next day all syptoms went away gradually and by the third day I was back to normal....at least I THINK my forehead has returned to normal so far as I can see or feel.

Strong Headache -- resolved in first 24 hours -- took ibuprofen Swelling and sensitivity in supraclavicular lymph node area on left side (started about 30 hours after shot and still exists as of 4/4/21)

soreness at site of injection - lasted 10 days itchiness at site of injection - lasted 13 days lump a few inches away from injection site - lasted 14 days 9 days after injection, noticed that both thighs were retaining large amount of fluid (like a water balloon). Larger veins were visible at the surface, pronounced, raised in a ridge about the size of my finger...at least 6-8 veins across each thigh. There were literally waves of swollen flesh. Very unusual, in fact, the way they looked was very scary. There was no pain or aching at the time. I elevated legs, iced them, took a diuretic for the next 3 days and they eventually deflated. Following few days had aching from waist down. Nothing since.

SYMPOTMS SUCH AS STUFF NOSE THAT PROGRESSED TO LOSS OF TASTE AND SMELL; CHILLS; ACHEY ALL OVER BODY; FEVER; NAUSEA; REALLY TIRED; SWELLING OF LYMPHOCYTES; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dry cough, and other pre-existing medical conditions included has a dry cough from taking lisinopril, starting medication about a week before getting the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) 1 total, administered on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril. On 25-MAR-2021, the subject experienced swelling of lymphocytes. On 25-MAR-2021 16:00, the subject experienced really tired. On 25-MAR-2021 22:00, the subject experienced achey all over body. On 25-MAR-2021 22:00, the subject experienced chills. On 25-MAR-2021 22:00, the subject experienced fever. On 25-MAR-2021 22:00, the subject experienced nausea. On 26-MAR-2021, the subject experienced symptoms such as stuff nose that progressed to loss of taste and smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from really tired, fever, chills, and swelling of lymphocytes, and the outcome of nausea, sympotms such as stuff nose that progressed to loss of taste and smell and achey all over body was not reported. This report was non-serious.

On 03-22-2021, mild symptoms. I thought it was allergies. In 03-31-2021 had a culture. I felt my lymph nodes in my throat on the inside and outside of my throat and chin on the sides of my chin. It was very strange how I felt, the culture in the clinic was negative. Strep throat was negative. I was given antibiotics and felt better since. It was a bacterial infection as per her doctor. I felt better but sometimes when I swallow I feel my lymph nodes a bit swollen.

20 min after injection became pale and cold. 40 min. dizzy while standing. 1 hour developed chills and 1-1/2 hr fever. Fever continued for 24hrs. (high of 100 degrees). 2 hrs. after facial blotching and swelling. Red spots on face and neck for next 24hrs. Very fatigued. Symptoms dissipated after 48hrs. I have allergy to shellfish and iodine. Previous reaction to irritants are throat tightening, hives and facial swelling. Prior adverse reactions to flu vaccines, dizziness on Albumin based vaccines.

Within 25-30 minutes I felt a very sore area on my right side just up from the bottom of my rib cage. I reached for it and I could touch the exact spot with one finger. It was almost like if you had run into the corner of a table really badly. It came on fast. Within less then 10 min later it felt like a small balloon was getting inflated with the sore spot right in the center expanding. The soreness was not that big just this strange feeling like that area was expanding just like a balloon. I would say it was about an 8" circle. This strange feeling and soreness lasted all evening. It even woke me up in the middle of the night. It was slowly gone by the end of the next day. The next day I only felt a little tired and not well. Nothing major. I have not heard of anything like this. I have no doubt this was from the shot. I had only gotten in my car to drive home. As soon as I pulled in my garage it came on very suddenly. No other reason for this.

April 2nd had stomach pain around noontime. At about 9 pm, I felt chills and fever and thought I was just cold. Fever the entire night until the following day. Went to urgent care for COVID tests to be sure. Fever and headaches April 3 and 4, April 5 started to have diarrhea still with really painful headache. COVID tests came out negative April 6th. Took another COVID test the same date to be sure. Went to Urgent care again April 7th because of headaches and swollen nodes. Nurse Practitioner said severe allergy to pollen. Tests came out negative again April 8th, felt better, headaches diminished. As of today, April 13th, every time I eat, I have to go. My stomach cannot digest my food, liquid and solid.

Patient received Jansen vaccine on 04/01/2021. She reports on 04/10/2021 her left forearm started to itch. She described her left lower arm are slightly swollen, warm to touch, reddened, and has some blister. She also has slight fever. She took Benadryl for itching. She denies left arm pain and limited of motion. She was given Medrol Pack and Cephalexin 500 mg every 6 hours for 10 days on 04/12/2021. Advised to returned for follow up for blood works and ultrasound of the left arm.

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

abdominal pain, leg swelling-- but all of these resolved on their own, also with shortness of breath resolved with albuterol

PATIENT EXPERIENCED PAIN/SWELLING AT STARTING ON SUNDAY APRIL,11 2 DAYS AFTER INJECTION, MORE PAIN THAN WITH OTHER VACCINES. MONDAY MORE PAIN HAD DEVELOPED AND EXTENDED DOWN THE REST OF HER ARM. I SPOKE WITH PT ON APRIL 10, TALKED ABOUT POSSIBLE REMEDIES BUT EXPRESSED THAT SHE MIGHT WANT TO CONSIDER GOING TO THE DR JUST IN CASE THERE WAS INFECTION AND TO RULE OUT ANYTHING ELSE. PATIENT WENT TO ER AFTER PHONE CALL, THEY GAVE HER A ROCEPHIN AND STEROID SHOT, A PRESCRIPTION OF KEFLEX AND INSTRUCTIONS TO FOLLOW UP IF NOT BETTER AFTER 72 HOURS

"Janssen COVID-19 Vaccine EUA" Night of April 4th, severe headache began at 9pm. Took an Aleve, but it did not help. Went to bed to sleep it off. Woke up and the headache was gone the next morning. Have not had any more headaches. Experienced muscle soreness in arm of injection and at the injection spot. Then whole body muscle soreness/heaviness began on April 5th for 3 days. I had swelling in both legs for only one day, on April 12th. First day I noticed I was experiencing shortness of breath was April 6th. Became out of breath walking a small incline. Shortness of breath continues to current, April 16th, perhaps a bit worse, where I seem that a natural breath requires a bit of work. So far, I have no

lymphadenopathy of the right axilla with numbness and tingling in the right arm. Symptoms started 1 day after administration on March 26, 2021. lymphadenopathy has resolved but numbness, tingling, and pain of right arm and right axilla remain.

Patient reports muscle spasms and soreness following vaccination. She states that the spasms are within her pectoral muscle. She presented to her physician who diagnosed her with upper body systemic inflammatory response and recommended she go on a supplement to help with inflammation. She has a follow up scheduled with her provider on 04/22/2021.

LEGS SWOLLEN FROM THE KNEE DOWN; ARMS FEEL KIND OF WEIRD; FEELING OF LEGS KIND OF DETACHING FROM THE BODY; FEELING LIKE WHEN YOU PRESS YOUR FEET AND IT'S DIFFERENT, NOT PUFFY; ARMS FEEL SWOLLEN; TINGLING IN RIGHT ARM; WHEN GOING TO SLEEP LEGS FEEL VERY HEAVY/LEGS FROM THIGHS TO FEET, ENTIRE LEG, FEELS HEAVY JUST BEFORE FALLING ASLEEP; VERY TIRED; A LITTLE BIT OF HEADACHE; FLAVOR IN HER MOUTH LIKE ORANGE OR CHERRY; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was not reported and height was 64 inches. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies and medical conditions. the patient did not take medication regularly. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced flavor in her mouth like orange or cherry. On 08-APR-2021, the subject experienced very tired. On 08-APR-2021, the subject experienced a little bit of headache. On an unspecified date, the subject experienced legs swollen from the knee down, arms feel kind of weird, feeling of legs kind of detaching from the body, feeling like when you press your feet and it's different, not puffy, arms feel swollen, tingling in right arm, and when going to sleep legs feel very heavy/legs from thighs to feet, entire leg, feels heavy just before falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flavor in her mouth like orange or cherry on 08-APR-2021, and very tired, and a little bit of headache on 09-APR-2021, and had not recovered from legs swollen from the knee down, arms feel kind of weird, when going to sleep legs feel very heavy/legs from thighs to feet, entire leg, feels heavy just before falling asleep, feeling of legs kind of detaching from the body, arms feel swollen, tingling in right arm, and feeling like when you press your feet and it's different, not puffy. This report was non-serious.

shoulder pain after vaccination due to injection site being too high on the arm (SIRVA) with signs of subacromial bursitis

Shot arm swelling, pain and bruise, fatigue and loopiness for 5 days, then better for about 5 days. 10 days in upper body stestemic response with muscle twitching, pain and swelling. Shot arm and other arm pain, neck pain and pectoral muscle pain. Went to Dr who diagnosed on the 15th. He ran blood work which was normal other than cholesterol 220, ldl and hdl high and glucose was 102. Then twitching moves to lower limbs with lymph swelling behind knees at 21 days in. Went back to Dr. On the 22nd. He considered it still an inflammatory response. Now at 26 days out, still have some lower limb twitching and upper body muscle spams have begun again mainly on right hand side non shot arm.

Onset of symptoms: piercing sensation in legs, feet, ankles, knees and leg . Pain and pins and needles. Worsened at night. Tingling in fingers. 1:) Urgent care 2.) ER Dept 3.) Primary Care Dr. suspected Guillian Barre

BRUISED; SWELLING ON LEFT SIDE OF LOWER ABDOMEN; HEART PALPITATION; MINOR EAR ACHE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart stent, and concurrent conditions included rag weed allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported,1 total administered to left arm on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the patient experienced minor ear ache at night. On 24-MAR-2021, the patient experienced heart palpitation. On 17-APR-2021 the patient experienced again ear ache. On 13-APR-2021, the patient experienced swelling on left side of lower abdomen. She got on the shower and she found it , she put ice and the ice maintained the swelling. Patient explains her swelling as stuck out a good 2 inches, a size of a soft ball. On 14-APR-2021, the patient experienced bruising on left side of lower abdomen. On 01-APR-2021, Laboratory data included: EKG (Electrocardiogram) and it is Normal. On 18-APR-2021, Laboratory data included: Heart rate that was 20bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bruised, had not recovered from minor ear ache, and heart palpitation, and the outcome of swelling on left side of lower abdomen 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.

Onset of fever, chills, nausea, and intense night sweats 6 weeks and 2 days after vaccination. The fever, nausea, and night sweats lasted for 8 days. While it is unknow if the illness could have been associated with vaccination 6 weeks earlier, I am reporting it in case there are other similar cases of fever of unknown origin after vaccination.

Cough, fatigue and dyspnea on 3/22/21 ER visit on 4/1/21 diagnosed with COVID pneumonia Pain and swelling in right leg Positive for DVT in lower extremity Hospitalized and diagnosed with PE

On 04/21 left knee pain, outside/back of knee 04/23 - left side tingling , went to urgent care and then referred to ED due to concern about stroke. Sent home after leg scan - was told it was normal and referred to neurologist 04/29 - back to ED, admitted overnight, scan from 04/23 showed blood clot behind the knee. Also diagnosed by neuro with TIA Also stated she had swelling, redness, and headaches for 4-5 days after vaccine

On 4/19, I woke up with severe abdominal cramping, vomiting and diarrhea. The diarrhea turned to bright red blood, so I went to the ER. I was diagnosed with severe sepsis and colitis. Although I was diagnosed with sepsis, I never had a fever and all blood cultures came back negative. Before I was released, I went into uncontrolled atrial fibrillation. I never had any history of colitis or atrial fibrillation prior to this. No one can explain why there was no fever or pathogen detected.

Severe body aches the day after with abnormal headache that increased with bending over. Easily bruising to the back of my left thigh from exiting and entering the golf cart and right arm after leaning against the corner of the wall with sensitivity to my skin. Developed lumps under the skin at the bruising site to the back of my left thigh which remain present, however are slowly decreasing in number and size, slightly tender. Today slight dizziness developed with uneasy feeling in my stomach.

I felt pain in the arm, I could feel the shot going into my arm. Within an hour it got extremely painful, I could hardly move it, I could not raise my arm. For the next 3 days, I could not lay on my left side, I could not use my arm and was extremely painful. I also noticed my lymph nodes were all swollen and sore, the ones in my neck were the worst, I had a severe headache, I was extremely fatigued and body aches. The body aches were excruciating. I was bed ridden for 3 days . I also had nausea and completely lost my appetite. I remember being very thirsty. I had really sever fatigue, it took a week before I started feeling better. I had to take a week off of work. I'm having a really hard time with fatigue now. It seemed to cause what I would call is a huge flair up of my fibromyalgia .

She got her vaccine at about 6:30, and the bottom of her foot started swelling, then the to of her foot, ankle, tingling of her feet (both), neuropathy pain came back which she hadn't had in a long time. The spinal stenosis pain came back very strongly and her fibromyalgia pain came back and they were all pretty well managed prior to the vaccine. She is still having that pain. She is on a pain management regimen to control her pain prior to the vaccine, and then it has worsened and was scheduled for an epidural spinal shot and not able to get off the Eliquis due to the vaccine and that has been postponed. She was on Duloxetine for the neuropathy pain and it had been being managed and then all of a sudden that pain has worsened and the medicine she was taking for that did not work anymore. She went to the ER on 5/5/21, and they gave her Morphine for the pain, and discharged her home with Tramadol. The 2nd ER visit was on 5/15/21, as when she woke up both of her legs were numb, and could not feel her legs from her ankle to her hip/waste area. When she opened her eyes she thought she was looking at the side wall and was looking at the ceiling and could not discern where she was, was disoriented and called her doctor and told to go to the ER. She went to the ER and they finally took it seriously and they suggested that she had inflammation in her system that was causing her other problems to flare up. She made appointments with her specialists to see where the inflammation was. She then saw a rheumatologist as when she went to the ER the 2nd time they wanted to put her on steroids and she did not want to be put on it due to her diabetes. She did have drug-induced lupus at one point from isoniazid. Her rheumatologist confirmed she did have inflammation on blood work and told her to take the steroids. The steroids have taken down some of the pain, but not completely. She did have a lumbar epidural steroid injection yesterday 6/9/21 at L4 bilaterally, which has helped as of today. She was put on Tramadol after the first ER visit by her pain management doctor and that did not work. After that she was switched to Hydrocodone which has helped her. Her cardiologist, rheumatologist and PCP told her that it hit things that impacted her nervous system and that she has inflammation in her system, does not know exactly where it is and it has impacted her system and caused intensity of her spinal stenosis, neuropathy and fibromyalgia. She is still undergoing treatment for these symptoms. She was not feeling her neuropathy pain hardly at all prior to the vaccine. On She woke up and both of her legs were numb, and could not feel her legs from her ankle to her hip/waste area. When she opened her eyes she thought she was looking at the side wall and was looking at the ceiling and could not discern where she was, was disoriented and called her doctor and told to go to the ER. She has not been able to return to work as a teacher due to the reaction she has been having. She wants to know what the efficacy is now that she has had a reaction or has it lessened or does she have any protection at all now.

Right arm pain, swelling, went to ER, went to OR, went to neurology, vascular surgeon, got nerve block. On oxyocodone.

JOINT PAIN HANDS FEET, KNEES AND ALL OVER, SWELLING IN UPPER AND LOWER EXTREMITIES, FATIGUE, WEIGHT GAIN

First lymph glands were sensitive, then swollen (pretty much all of them, neck, armpits, groin, ... then very, very sore. But then my legs swelled up a rediculous amount! Very puffy! (My feed have swollen in the past. Sometimes a little bit on the legs. But never leave me this. I just chalked it up to swollen/ possibly blocked lymph nodes. A few days after that I had a raised rash all over the lower legs that eventually blistered and oozed. Very drippy for a long time. I kept paper towels in my shoes to catch the ooze and would replace them 1-3 times a day. Or just let it drop and make puddles on the floor.

Within 1 day swelling of left arm and generalized whole-body erythema that persists now 3.5 weeks later

59 Y female with history of hypothyroidism presenting with fever, cough, and fatigue, admitted for covid pneumonia. COVID PNA/ AMS/ Fever. Pt p/w fever, cough, fatigue, x1wk, found to be covid+ in ED (7/12), p/w mild leukocytosis, fever 101.4, and elevated inflammatory markers. Pt s/p 2L IVF, and started on decadron 10mg in ED given desaturation to mid 80s w/ ambulation. CXR: w/o acute disease. Pt also p/w and transient vision loss in setting of high fever (106), suspect symptoms 2/2 fever, no recurrent episode. Per neurology, no indication for further imaging or workup at this time. Given high fever 106 and tremulousness on admission concern for other etiologies of fever. TSH 0.4 wnl. Psych meds initially held given concern for serotonin synd, however given pt improvement w/ <24hrs of holding meds, and no recent dose changes, will restart. Pt w/ 1/2 Bcx + staph simulans, likely contaminant per ID, initially started on vanc (7/13-7/14), will dc. Worsening leukocytosis likely 2/2 known side effect of steroid use. Inflammatory markers downtrending. Overnight pt w/ episode of desaturation to 87% on ambulation to bathroom, this AM satting 94%. decadron 6mg daily for total tx 10d (7/12-); trend inflammatory markers every other day; Lovenox 40mg SQ BID (BMI>40) and hold for Plt <25k, Fibrinogen <100, active bleeding; Hypothyroidism Last TSH 0.4 on 7/13/21. On PTA levothyroxine 25mcg daily. continue PTA levothyroxine 25mcg daily

1st week chills, nausea, 2nd week and 1st week, headache, elevated blood pressure, rash skin folds, 5th week to 1st week increased muscle and joint pain, swollen lymph nodes left underarm and left side of neck, ear congestion, Continuing 3 months past tachycardia with position changes,