Johnson & Johnson

Patient stated that her heart was racing and her feeling shaking in her limbs. Vitals were BP 135/80, HR 90, RR.14. Patient denied any other symptoms. After about 15 minutes patient stated that she felt better, Denies any medical history and instructed to follow up with her PCP. Patient stated that she wanted to return to work and denied any further medical treatment.

patient received Janssen Covid 19 vaccine at our clinic inside store. pt was waiting in waiting area for 15 minutes and she informed us she was not feeling well and felt like passing out. She had been waiting less than 10 minutes. I went to her and she said she was feeling very strange and was nauseous. I tried to get her up but she couldn't walk so I let her sit back down. She was not able to communicate with me but was conscious. She said her vision was distorted. her lips started to turn blue and I continued to monitor her. I called 911 and she said she was having difficulty catching her breath so I went for the epipen and gave her 0.3 mg in the outer thigh of her right leg. her color started to improve and she was able to comunicate better. I followed EMS instructions and continued to monitor her until they arrived.

A few seconds after vaccine was given I had a sensation go up my left jawline that felt similar to a nerve pain. I didn't think much of it and waited the 10 minutes after my vaccine and had no other symptoms. I left the pharmacy and started driving home and had a sudden sensation of a heaviness in my chest and trouble taking a deep breath. I also felt like my tongue and throat were swelling slightly. I had a warm sensation throughout the middle of my back that felt like a heating pad was on it. I felt light-headed and called my husband. As I continued to drive my symptoms worsened and I called 911. I made it home in my car and the ambulance met me there. My husband called the pharmacy to ask them what we should do and they said that it would be ok for him to give me Benadryl. I took 15mL of liquid Benadryl shortly before the ambulance arrived. Within 15-20 minutes, I felt like I was able to swallow better. In the ER, I received IV Benadryl and Famotidine. I was also given 800mg of Ibuprofen for a bad headache I developed. My oxygen level remained in the high 90's and my symptoms were much improved after the IV medication. I was instructed to continue taking Benadryl capsules for the next few days along with Pepcid to keep my symptoms from flaring back up. I noticed this morning when waking up that the left side of my face as well as my throat felt odd so I took the Pepcid and Benadryl and symptoms were relieved in 30 mins or so.

10-15 min. After shot, throat felt slightly tight, heart beating fast, slight itch in inner right ear. Given Benadryl. After about an hour, felt better to go home and rest. Two days after injection, left foot-big toe goes numb periodically. That?s occurred a couple of times now. Today I?m very fatigue, heart beating fast, at times hard to catch my breath.

7:30pm 3/14: feeling feverish/flu like 9:15pm: chills starting 10:30pm/ massive chills and body aches. Migraine starting 12:00am 3/15: cold sweats, migraine, nausea, dizziness 3:00am: racing heart beat, cold sweats, migraine, nausea, dizziness 7:00am: lethargy, body aches, headache, chills 10:00am: mild headache, body aches, lethargy 2:00pm: lethargy, shaky, very mild headache 7:00pm: extreme fatigue, shaky. Nausea 7:00am 3/16: massive muscle fatigue, shaky, racing heart 1:30pm: tried to shower, loss of muscle control, very shaky, hard to breathe, body and mind slow

About 6 hours after receiving the shot I started experiencing skin sensitivity (common when I feel ill), chills, aches in my legs and a slight headache. The chills subsided after about 2 hours, but then my resting heart rate went up to 110-120 bpm rather than the normal 75-85 for me. It felt like my heart was beating out of my chest even though I was laying down in bed. That lasted through the night and I felt back to normal around mid-morning.

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

At 16:30 Patient complained of ears feeling stuffy and scratchy throat. V/S BP 151/102, HR 93, 02 98 %. Water was giving to patient and she sat their for an additional 25 minutes while monitoring. V/S at 16:40 158/108, HR 87, at 16:55 V/S BP 153/107, HR 89. Patient feels good to leave. No dizziness or bad reactions. Advised patient to call primary doctor to advise she received vaccines and had a slightly elevated blood pressure.

Site: Pain at Injection Site-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: vasovagal reaction -Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Additional Details: patient started hyperventilationg after vaccine. Was flush and said dizzy. Had patient lay down said getting hot and sweaty. Then said having trouble breathing. Checked pulse rapid. BP was 168/92. Repeated that having problems breathing so called 911. They did EKG-normal, BP was back to normal after I laid her down,elevated feet, put fan on her, gave cold compress and had do breathing exercises. EMT after assessement and refused blood glucose test said probable vaso vagal rxn.

4 hours post-vaccine, started to shiver 6 hours post-vaccine spiked fever of 102.2 7 hours post-vaccine developed headache and began to vomit 8 hours post-vaccine, I went to the ER They found I had tachycardia for the duration of my visit (11pm - 3 am). Administered Toradol and IV fluids, discharged me with good vitals, but still tachycardia, headache, and vomiting. The next day (3/20), I still had a bad headache and could not keep liquids down. I vomited perhaps 12 times, then called the doctor. She sent me to Urgent Care to receive injections of Toradol and Phenergan. Within the hour, I could drink. Then shortly after, I could eat. I felt better for one day. The next day (3/22), my heart started pounding, and I was unable to sleep horizontally. I needed to sleep on 3 pillows due to chest discomfort. My chest still feels very uncomfortable. Abdominal breathing is helping to an extent. I have had to stay in bed and greatly reduce my activities since receiving the vaccine. Today is one week, and I am still in bed.

Day after vaccine, heart beating fast, chest hurt, back aches, headache, dizzy, difficulty breathing. Lasted all day. 2nd day after shot- no symptoms. Theses side effects aren?t told To you at the time of shot. Should be a warning.

Husband reports that within 24 hours, patient was extremely weak and had fainted x2 in the home. She continued to feel weak for a total of 48 hours post vaccination.

Constant fever, body ache and headaches for one week along with extreme high blood pressure which is still ongoing as of today. Latest high being 177/111.

Within about 7 hours my body temperature felt like it dropped (almost like hypothermia symptoms) and I had uncontrollable cold/shivering shakes for about 1-2 hrs. I tried taking a warm bath, but it felt cold. Once I bundled up and got into bed, the chills wore off and transitioned almost immediately to a fever spike, which reached 103.8 at its peak at around 9-9:30p. The fever stayed at that level for about 4-5 hrs, before it started to subside, at around 3a. By 10a on April 4, my fever was down to 99.5 or so, with a headache. Today, April 2, I have no fever and only a mild headache.

Client reported 5 minutes after vaccination ears tingling, facial flushing, mouth swelling, high anxiety, chest tightness. Client had communicated with allergist and took cromolyn 8 ampules and hydroxy HCL 50 mgx2 on her own. At this point paramedic was consulted and they evaluated and recommended continued monitoring for the rest of 30 minutes. At end of monitoring period, client symptoms had resolved and client was driven home by father.

I had insomnia and a racing heart that evening. It lasted from when I went to bed until late morning. All is well now. I slept well the next evening. It was strange. Felt like anxiety.

Around 6 hours after vaccine, I had uncontrollable chills. This led to a low grade fever. I tried to sleep it off, but woke up with my heart racing- My resting BPM was around 120. My skin was super sensitive. I started taking 2 extra strength Tylenol every 6 hours around 5pm, and that helped a little. I couldn't focus on anything- I could basically stare at the wall while my heart was hammering. I finally slept, and woke up soaked in sweat with my fever broken (my fever never got above 99) around 2am, and improved steadily after that.

Went to bed with chills, body aches, sweating and headache. Woke up a few hours later with heart palpitations with 128 bmp that kept climbing, dizziness and shortness of breath. Went to ER and was monitored for several hours. Had an EKG, temperature check and was given Tylenol. Headache pain increased but heart rate started to come down enough to be discharged, heart rate was down to around 80 bmp.

Pt had received the Janssen Covid 19 vaccine and five minutes later had fallen out of the chair she was sitting in. While talking to the patient she leaned forward and was held to prevent her from falling out of chair. She was very sweaty and was slow to regain full consciousness. Emergency services was called where she was evaluated and found to have had a vasovagal response. Paramedics had her lie down before she was sent home.

During 15 min waiting period around 0945 at vaccination site, patient became flushed and had increased heart rate of 106 bpm at rest per patient's Apple iWatch. Provider onsite was notified and immediately evaluated the patient. Instructed patient to remove face mask to allow ease of breathing. Heart rate returned to normal for patient (68bpm) within a couple of minutes. Patient stated she informed the provider that she was feeling better and was cleared to return to work. Patient states that throughout the day, she was mentally "foggy", sleepy, yawning frequently. States at around 1300, she began to itch on her arms, then around 1400 she noticed her arms were blotchy with purple/white rash. In areas where she scratched, she reports the rash was dark red with a bit of orange tint. Reports legs had rash that appeared has hives. Patient also reports that about 1-2 hours post vaccination, she started having chest tightness and shortness of breath. At 1600 she called the clinic and spoke with a medic on the phone. She informed him of her symptoms (chest tightness, shortness of breath and full body rash and hives). She was instructed by medic to report to the nearest ER for evaluation and treatment. Patient states that she did not feel that she needed to go to ER at that time. She states that at 1800 she took Benadryl which did not seem to help the symptoms however she states they did not worsen. She took a second dose of Benadryl at 2200 and fell asleep. Patient states when she woke up this morning at 0600, all symptoms had resolved. She denies any symptoms now except for some minor itching on a couple areas of her wrist, ankle and under arm. No full body rash or hives noted. Denies any further administration of Benadryl at this time, as of 1630 on 7 APR 2021.

My vaccine was administered at 12:30pm. I waited until 12:55 at CVS after the vaccine to make sure there were no reactions. I also move my arm around a lot after the injection to keep it from hurting. I drove home, at lunch and about 2:45 was hit with a very noticeable headache. I never get headaches and eat healthy and consume about a gallon of water a day. I knew it wasn't from dehydration or being hungry. Headache was in the temple area and made my eyes hurt in the same way they would if you had cried for an extended period of time or were overtired. At 3pm a wave of exhaustion hit me. I was sitting working trying to combat the headache and felt almost wiped out. I got through the rest of my work day (4:30) and went to lay down immediately. I passed out almost instantly until 7 pm. I work up and showered, ate dinner and started to feel a little warm. It should be noted it was an unseasonably warm day and got up to 77, so it was a tiny bit warm in my home. I put on loose fitting clothes and slayed on the couch still with the bad headache and the injection site started to throb so I placed and ice pack on for 20 minutes. I could only stay awake until 8:45 and got in bed. I could not get comfortable for several hours feeling very warm. I tried a fan on high and drinking more water but i felt very warm like how you feel with the flu. I took my temp at 1130pm it was normal. I continued to toss and turn and feel very warm and slightly dizzy, in the sense that I hadn't been able to sleep and with the headache my body was just exhausted. Around 2 am i woke up for more water and got in the shower because I had sweated so much my sheets were wet and my clothes. I got out of the shower around 10 minutes later, changed and got new sheets and got back in bad. Around 330 I felt very hot again and opened the windows and got another ice pack for my arm which was throbbing again. I finally fell asleep after 3:45am. I got up for work at 6am. I felt slightly foggy, and very hot. But no fever. My temp is normally around 97.4-97.9 and it was 98.4. Still normal but I was running warmer than usual. It took a long time to get ready and despite hot water in the shower I was freezing. i got dress and debated going to work. Got in the car at 6:45 and my drive to work is 30 minutes. 1/2 way into my drive I got very sweaty again and went home to change my clothes because they were too warm. Got to work around 7:20 and still felt warm but they take our temps at the door and min was still okay, no fever. I drank a lot of water and ate, and at 8:30 am all of a sudden the exhaustion was gone and I felt normal. I got home form work at 5:30p and took a 3 hour nap and felt normal again.

Metal Mouth within 15 minutes; 5 hours later sever chills and violent shakes for the next 8 hours; resting heart rate between 96 to 100 bpm (my average resting heart rate if 65-68 bpm) until 18 hours after receiving the shot; no sleep the first night after the shot; intense headache that over the counter medicine could not help nor did meditation; my body was shaking so hard it threw out my hip and muscles in my back spasmed; hard to walk; joint pain in back, arms, and legs; fever up to 102; the following 24 hours after the first day felt like I had COVID with a cold, sinus headache, exhaustion, and body aches. Second night difficult sleeping as well.

Fatigue, intense full body pain, rapid heartbeat, winded by just walking, diarrhea, loss of appetite, chills, sweats, fever, abnormal headache- shooting pain in back rt side of head Fever broke after about 24 hours. Heartbeat, breathing, chills after 36 hours. Pain and fatigue lasted 48 hours+ Able to eat after 48 hours . Still have headache but not severe.

I suddenly became lightheaded and had extreme weakness, then collapsed, then immediately began having chest pain and pressure, shortness of breath, arm numbness, and uncontrollable shaking. All of these symptoms happened at the same time. We called the paramedics but all my vitals were totally normal. The severe symptoms passed after about three hours. I continued to have chest pain and pressure, but was able to breathe normally and had 100% oxygen saturation. I am not a smoker and don't have asthma or any breathing issues so the sudden inability to breathe coupled with the other symptoms all at once was very alarming.

Janssen COVID-19 Vaccine Body Chills and teeth chattering 3/23/2021 @ 6pm Body Hot/overheated 3/23/2021 @ 11pm Sweating and felt overheated Fainted 3/24/2021 @ 5:36am

Immediately following the vaccine administering I stood up and felt very sick and nauseated. I began to sit down again and was brought water. I tried to drink some water and my husband and I tried to walk to the tent for observation. I fell down and fainted. I was wheeled in a wheelchair to the ER and vital sign and blood sugar and EKG were performed. I declined being admitted to the hospital for further investigation.

I had shot and sat to be observed at 8:30 am. After about three minutes I felt a wave of adrenaline type feeling wash over me and my heart raced and I felt really out of it/fearful. I sat for a minute hoping it would pass, and it didn't so I asked for help. EMT gave me pulse check and blood pressure, both were very very high (don't know what) and irregular so they brought ECG. The ECG was also irregular. I felt disoriented and had waves of heat/blood racing/pulse racing. I was taken by ambulance to Hospital. Within 2.5 hours I was feeling better, not recovered but not as acute. They did another ECG, still irregular and did some blood draws which seemed to satisfy the Dr. that nothing was acute. Once I had returned to a more normal level they released me. Tonight at home I still have a bit of a racy clammy feeling but have felt more stable thus far. It was an awful, scary feeling and it come on in just two or three minutes after shot.

Had a sore arm within hour of shot (got it at 7:30pm). Felt a little yucky before going to bed. I made sure to hydrate significantly before the shot and after. I woke up at 3am with chills and had them for about an hour. Woke up the next morning at 9am with with medium neck and head pain and feeling a little chilly and out of it. Mild ache in joints and body overall. At 10am I took one ibuprofen, but at 11am (200mg), kept pushing fluids. 11am headache got worse temp 98.7 (slightly high for me, I am usually about 97). Started having some gastrointestinal issues around noon. Felt nausea and sweaty palms loss of appetite. Had a bowel movement (normal in appearance). That all seemed to pass and I felt better, still tired, for most of the afternoon. Arm was sore to the touch and when moving. I managed to eat a few small meals, kept up hydration, and took a nap late in the day. I woke up at 5pm with headache and body aches all over. No appetite again. Had very little to eat, kept hydrating, At 7pm my vision got a little blurry and I had a minor vasovagal episode. Center of vision blurred, got chills and sweaty, nausea, and I had to poop (it was less formed). I rested, cool compress, and raised my feet. It all passed in about 20 minutes. I had major loss of appetite rest of the night (couldn't eat anything), kept hydrating, and went to bed. Slept through the night with no incidents. Woke up at 9am second day and had a small breakfast, though my appetite is still not back. Generally feeling exhausted, but no headache or aches in the body anymore. My arm is still sore. Had some more GI distress (another less formed poop around 11am). My appetite returned by early afternoon on the 2nd day post-vaccine. Still tired and generally feeling "off," especially mentally. Had brain fog all afternoon and my ears felt plugged today. Hard to concentrate on a task.

Fainted/ sweats while walking to car. Recovered, but became very light headed in car and reclined seat to avoid losing consciousness ( was not driver).

Janssen COVID-19 Vaccine EUA: twelve days after vaccination patient presents to emergency department with a headache that started seven days prior to arrival. Patient describes headache as different than normal headaches: worse with movement and episodes of dizziness. Patient also has rash/redness on right cheek of the face. Vital signs within normal ranges except blood pressure 141/96 mmHg. Patient admitted to hospital for further testing and management.

3/24/21 Anxious Reflux symptoms - took Pepcid complete 3/23/21 Chest pressure Reflux - feels better with deep breathing Left arm pain radiating to elbow Momentarily could not breath Fuzziness/dizziness Anxiety with overwhelming emotion 3/18-3/20 Pain in right calf - constant Tried stretches to relieve Went away Monday 3/21/21 Reflux symptoms but not bad enough to take medicine March 11th Covid vaccine December 2020 tested positive for COVID-19

104 degree temperature, EXTREME headache, chest pain, heartburn, chills, heart palpitations, restless leg that still has not subsided. I had covid in December and this was 100 times worse and I had pretty tough symptoms then. The headache is still affecting me now.

day of vaccine experienced body aches, cough, congestion, sore throat, clogged ears, subjective fevers and chills which resolved after 24 hours. 4/11 began with diffuse chest pain and left calf pain. shortness of breath

dose received at 2 pm on 4/9 - Woke up 4/10 - 9 am with eyes swollen shut, temperature 99.7 F, body aches, headache. During the day woke up with dried blood in nose (no history of nose bleeds) Nose bleed resolved by 9 pm 4/11 work up with temp of 99 F, chills, less body aches, nose bleed resolved. 4/13 all symptoms resolved

March 6th evening hours- joint pain in left elbow and left knee March 7th at approximately 3AM fever 102.6 March 7th severe headache/ shooting pulses in my head March 7th at approximately 9PM- mild nose bleed. fresh bright red blood March 7th at approximately 9:30 PM -vomiting with streaks of blood in my vomit March 7th, 8th, 9th, and 10th Dizziness/Unable to concentrate/Depression March 11th Symptom free/ I did not seek treatment.

Elevated resting heart rate of 120 - 135 lasting 24 hours. Patient remained resting during the full period

At time event started I was throwing up, dizzy, and had a burning sensation at the top of my throat. I laid down after being sick and had the chills. I spent the rest of the day and the next day sleeping or laying in bed. By the 3rd day, I was less nauseous at night and was able to eat some dry Cheerios. The 4th day, I became nauseous and dry heaving again, sleep until the early evening. By the 5th day I was a little better that I could work from home. Did not feel completely like myself until the following Tuesday.

On April 8th at 4am, I woke up feeling a strong pain in my heart / esophagus region. I was alone and out of town and didn't know what to do, so I just sat in the hotel bed and waited for morning to come. I didn't know if i was having a heart attack or if it was gas from drinking soda the previous day. I went to work. At work, the left side of my tongue suddenly started swelling and a tingling and numbness set in my upper lip. I was very scared, rushed to the drugstore and bought GasX, Ricola drops (my throat was slightly sore, too) and Allegra 24 hours. I immediately took the Allegra pill but still went to the hospital. When getting to the parking of the hospital, though, the anti-allergic started kicking in and the tongue started getting back to normal, so I went back to work and didn't enter the hospital. I was ok for a while. Hours later, rashes started showing all over my body. Starting in my arms then under my breasts. On the night of the 8th, I even had fever and chills. Still, I had to go to work so it was a real nightmare. I also had diarreah. I then went to the drugstore again and also bought regular and night Advil, lots of water and electrolytes drink, Peptobismol and Benadryl (only Allegra was not enough). The following day, April 9th, the rashes started spreading all over my body, the fever was only being controlled by Advil. I flew back to Miami and was bedridden until the April the 11th. On the night of April the 11th I still woke up with very strong headache and on the 12th spent the day with a headache, but since have gotten better.

Patient started with swollen injection site 2 and 1/4 inch in diameter. Hurt to touch and hot to touch. Headache, bodyache, severe fatigue, and nausea. On April 13th blood pressure started to rise and was 160/106. Patient decided to go to the Emergency Department and was seen by Dr. She was prescribed ibuprofen, Zofran, acetaminophen. Dr concluded that all symptoms were from the Janssen vaccine.

Pain in right arm immediately after the injection, couldn't move it for 30 minutes, blurred vision, heart palpations (first 30 minutes), throughout the day I felt foggy and strange, by 6pm I had a fever, horrible muscles aches and headache, became extremely nauseous all night and my muscles and joints hurt so bad I was crying (and I've had five kids with a high pain tolerance), fever, and at 6am my fever broke with a sweat. I felt clear headed but exhausted for the rest of the day. My chest has been tight and congested since then. Hard to breath and my voice is rough and raspy. This is ongoing and I still have chest tightness and a raspy voice. On 4/12/21 I started having horrible joint and muscle aches again throughout my body and felt so tired. Horrible headache and stomach pain, bloating and nausea.

Chills/shaking began approximately 8 hours after injection. Other symptoms of an achy upper body, temperature of 103.1, and nausea came shortly after initial symptoms (within 1 hr.). In the middle of the night, I began heavily sweating (something I have never experienced). I was drenched with sweat and needed to change in the middle of the night. Absolutely no energy and a horrible headache. 24 hrs. after the injection I no longer had a high fever. However, consistently for a week, every day, I had at least one symptom (headache, nausea, chills, or lack of energy) at some point throughout the day. When I received the injection, I was on day 2 of my period. It ended one day later than normal. However, what was not normal was that on 4/3/21, I began to bleed again. I passed 2 clots and had spotting for an additional 5 days. This is in no way normal to my cycle.

2 hours after receiving vaccination, patient had nausea and vomiting. She states she had a subjective fever for the next two days, along with headache, body pain, fatigue, nausea, diarrhea, acid reflux and intermittent chest pain. At time of visit on 4/14/21, patient reported still feeling fatigue, body pain, diarrhea, nausea, headache and acid reflux. She did not have chest pain at time of appointment, but did have it the day prior.

experienced a sudden pain to the forehead. Pain increased from 0-100 very rapidly, I became very nauseated to the point of having projectile vomit. Experienced blackout segments. Took 1 dose of 100mg Sumatriptan at about 930pm and tried to sleep w/the immense pain. Took 2nd dose at about 12am. Pain did not dissipate but fell asleep. When i woke up pain was gone but felt very sore, dizzy and disoriented. Fast forward to April 9th while laughing uncontrollably the right side of my face spasmed/cramped closing my right eye and contracting my right cheek as if having Bell's Palsy. I have never experienced this before. Face did not continue to droop but has left a tick/twitch sensation under my right eye.

I stood up and then blacked out (no dizziness beforehand). After I felt dizzy and sweaty (no nausea). The blackout was for less than 30 seconds. Did not seek medical treatment since did not injure self and felt back to normal after about 5 to 10 minutes.

Onset of chills at 4:45pm, followed by fever of 104 degrees, heart palpitations and tachycardia, red rash on cheeks from fever, severe headache and body ache, random spasms in arms and legs. These symptoms were intense and lasted throughout the night. Headache, muscle aches and spasms lasted three days.

pt says she had an achy left arm w/ fatigue. Next day she had a low-grade fever and hives on her stomach. She started taking Benadryl per Teladoc. She started getting very dizzy and her hives were moving towards her shoulders and her throat was closing up. 911 was called. She was told her anxiety was very high. She was transported to Hospital ER. She was put on fluids and steroids, (methylprednisolone 125mg, famotidine 20mg, sodium chloride 100ml) They did blood work which showed low platelets. Her rash was bright red and spreading down her arms and her stomach while she was being monitored. She was discharged w/ DX; Acute allergic reaction and given an EPI pen and oral steroids. She has a FU w/PCP on 5/3/2021 to check blood platelets and will go from there.

High fever for 3 days, lost of taste. Stomach pains and heavy menstrual cramps and bleeding. Blood cloths while menstrual cycle.

I went on Sunday March, 14, 2021 to get the Johnson and Johnson shot offered through the school system. I noticed that my blurred vision intensified. I went to the eye doctor 3/16 and that is where they found blood clots behind my right eye close to my center. I was referred to a Retinol specialist 3/26/21 and sent me to get a physical to check for diabetes. It had started to heal a little. There was not clear diagnosis on what could have been causing the the blood behind my eye. 4/2/2021 Went for physical at PCP and results of physical was good with no Diabetes.

THE PATIENT WAS VASOVAGAL SYNCOPE WITHIN FIVE MINUTES OF GETTING THE SHOT AND WALKING TO OBSERVATION AREA. THE PATIENT HAD LOW BP/ AND WAS TAKEN IN BY AMBULANCE TO THE ER

Seemed to very much effect my menstruation. My period came 10 days late, then this month?s period was 2 weeks early. Very bad clotting with menstrual bleeding. I am normally very regular so this was extremely unusual.

Patient is a healthy 40 y/o female who received J&J vaccine on 4/7/21. She started having intermittent fevers and headaches 24-48 hours after. Headache became so bad she seeked medical attention on 4/16/21, and was found to be profoundly thrombocytopenic. She additionally had a CT scan that was concerning for a right sided subdural/epidural fluid collection and a MRI that confirmed that she had multiple epidermoid cysts. A full thrombocytopenia workup was completed and the patient was diagnosed with ITP and started on high dose steroids and IVIG. Patient's lowest platelet count was 9K.

SUPERFICIAL THROMBOPHLEBITIS; This spontaneous report received from a patient and concerned a 40 year old white, not Hispanic or Latino female. 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, batch number: Unknown) dose was not reported, frequency 1 total administered on 17-MAR-2021 to Left deltoid in arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-MAR-2021 and on 31-MAR-2021, the patient experienced severe leg pain on right side. Patient tried hot and cold compress. The patient wore compression stockings but nothing helped. Patient went to doctor on 13-APR-2021 and doctor diagnosed Superficial thrombophlebitis. The patient planned to get ultrasound on 14-APR-2021, next day, at 6 pm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from superficial thrombophlebitis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: A 40-year-old woman with a history of varicose veins experienced superficial thrombophlebitis 13 days after vaccine. An ultrasound was planned to confirm the diagnosis. Varicose veins provide a plausible alternate risk factor for the event. However, there is insufficient information to make a meaningful medical assessment. Additional information has been requested, including the ultrasound report.

HIGH BLOOD PRESSURE; FAST HEART BEAT; FELT LIKE BODY WAS SHUTTING DOWN; VOMITING; DIFFICULTY BREATHING; FATIGUE; GAS WENT BACK TO CHEST/CANNOT PASS GAS OR BURP; DIGESTION ISSUES; FELT ANXIOUS; COULD NOT SLEEP; This spontaneous report received from a patient, a 40-year-old female. The patient's height, and weight were not reported. The patient did not consume alcohol, did not smoke and had no known drug allergies. 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 02-APR-2021 at 14:00 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, at night, the patient experienced fatigue but, it was not extreme. On 03-APR-2021, the patient woke up vomiting, had difficulty breathing, fast heartbeats and felt like her body was shutting down following which her mother called the ambulance. On the same day, the patient was admitted to the emergency room (ER) of a hospital where her blood pressure was found to be very high and she was also given an intravenous (IV) as she had difficulty breathing. The patient was given Miralax (macrogol 3350) and was discharged on 03-APR-2021 itself. On 04-APR-2021, patient went to urgent care with the same symptoms. The doctor advised her to take magnesium citrate as she had digestion issues and the gas went back to her chest which made it difficult for her to breath. She could not pass gas/burp or eat whole foods. On an unspecified date in APR-2021, she felt anxious and could not sleep. At the time of report, her digestion issues persisted and the difficulty in breathing comes and goes. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure, and fast heart beat on APR-2021, had not recovered from difficulty breathing, gas went back to chest/cannot pass gas or burp, and digestion issues, and the outcome of fatigue, vomiting, felt anxious, could not sleep and felt like body was shutting down was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210417726.; Sender's Comments: V0: 20210417680-Covid-19 vaccine .ad26.cov2.s- Difficuty breathing, High blood pressure, Fast heartbeat, Felt like body was shutting down, Vomiting,. 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). 20210417680-Covid-19 vaccine .ad26.cov2.s-Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.

Fatigue, fever 102, aching joints, chills, rapid heart rate - 135 bpm per Polar heart rate monitor while at rest. Began around 6:00pm day of injection. Worsened until 10:00pm when I contacted the 24 hour nurse about my hear rate. Was advised to monitor it and rest. Slept until 8:00am next day and woke in pool of sweat with slight headache. Fever was gone and heart was back to normal. Drank lots of water and rested. By noon I felt 100% fine again.

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.

After my J&J vaccine, I experienced low platelet count, excessive bleeding more than normal bleeding issues and had trouble breathing. my symptoms went away after 14 days. I contacted physician if this was normal, they told me to go to ER if my nose bleeds did not stop or if I felt light headed.

Fainted within 5 minutes of receiving vaccine. Taken by ambulance to hospital. Have been sick with chills, severe shaking, panic attacks, sweating, since then (almost 3 weeks).

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.

CHEST TIGHTNESS; INTERMITTENT HEADACHES; 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 past medical history included basilar artery thrombosis, and vertebral artery thrombosis, and concurrent conditions included non-smoker, and other pre-existing medical conditions included no illicit use of drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included . On 12-APR-2021, the subject experienced chest tightness. On 12-APR-2021, the subject experienced intermittent headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intermittent headaches, and chest tightness. This report was non-serious.; Sender's Comments: V0; MAC Comment is not required for non serious case as per standard protocol.

The day after the vaccine was administered, she had increased heart rate and dizziness prompting her to get evaluated at Regional ER. On 4/21/21, she was seen in primary care- she complains of ongoing increased palpitations. EKG performed and was normal.

body aches, chills, fatigue and malaise, rapid heart beat while sleeping (caught by apple watch 123 beats per minute, sleep rate is usually low 50s to 60), very painful and heavier than usual period that i felt really bad during

- Injection site pain (burning, stinging) immediately after shot that dissipated within a few minutes, followed by arm soreness that lasted approx. 3 days. -Fatigue late afternoon followed by chills beginning 6-7 hours after injection. Chills became more severe (uncontrollable) as the night progressed and affected the whole body. Layered clothing and blankets, and was still shaking. -Approx. 8 hours after injection, developed a low grade fever (99.9) which progressed into a high grade fever (101.2) by late night. Fever continued overnight, breaking at about 11 am the following day. No medication was taken for the fever. -Overnight experienced join pain and muscle aches, and developed a migraine headache with nausea. Experienced heart racing/rapid pulse and could feel /hear pulsing and whooshing noise in my ears. Was unable to sleep. Muscle and join pain continued and was noticeable for about two days post vaccine. Migraine became a mild headache by mid morning. About 6 pm took a Bayer Back and Body for the lingering joint/muscle/headache issue (24+ after vaccine). -Loss of appetite first few days post vaccine. -Feeling of brain fog, difficulty concentrating, very noticeable during first two weeks. -For two and half weeks following the vaccine, felt bouts of fatigue, muscle aches and joint pain, and occasional whooshing noise in my ears.

STOMACH FLU; CHEST PAIN UNSPECIFIED; SHORTNESS OF BREATH; EKG SINUS TACHYCARDIA, LOW VOLTAGE PERIODICAL, UNCONFIRMED DIAGNOSIS; DIZZINESS; SLEEPING 14 HOURS; LARGE NODULE AT INJECTION SITE; SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; SORENESS/PAIN AT INJECTION SITE; HIGH BLOOD PRESSURE; 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 pre-existing medical conditions included the patient had no known allergies. 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, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 (following vaccination), the patient's area around the injection site was swollen, a large nodule formed, it was red, sore and painful. These local symptoms lasted for a week then disappeared. The patient felt very fatigued, and reports sleeping 14 hours that night. On 10-APR-2021 the patient experienced headache and felt like his head was in a vise around each cheekbone. The fatigue and headache was gone on 11-APR-2021. On 19-APR-2021 the patient had vomiting and diarrhea for about 16 hours. The local symptoms swelling, redness, pain at injection site reappeared. On 19-APR-2021 the patient was very fatigued and took Pedialyte (calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate) to get rehydrated. On 21-APR-2021, the patient visited the emergency room as new symptoms appeared stomach pain, chest pain, shortness of breath and dizziness and her blood work and electrocardiogram(EKG) was done. The health care professional(HCPs) ruled out heart attack and told patient nothing in the symptoms or blood work warranted a scan for blood clots. The patient received anti-nausea intravenous (IV) medication, diagnosis of stomach flu and was sent home. The patient reports that her blood pressure readings were 144/104 and a pulse was 119. The emergency room health care professional instructed the patient to follow up with doctor and discharge diagnosis was made as chest pain unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling at injection site, redness at injection site, soreness/pain at injection site, and large nodule at injection site, had not recovered from chest pain unspecified, shortness of breath, dizziness, and EKG sinus tachycardia, low voltage periodical, unconfirmed diagnosis, and the outcome of stomach flu, high blood pressure and sleeping 14 hours was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210443030-covid-19 vaccine ad26.cov2.s-Stomach flu. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

CHILLS; TIRED; FEVER; HEADACHE; NAUSEA; DIZZINESS; SEVERE HEART RACING; PASSING OUT; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight was 110 pounds, and height was not reported. The patient's concurrent conditions included migraines, non alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. 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: 1805022, and expiry: 25-MAY-2021) .5 ml, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced severe heart racing. On 13-MAR-2021, the subject experienced passing out. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021 06:00, the subject experienced chills. On 13-MAR-2021 06:00, the subject experienced tired. On 13-MAR-2021 06:00, the subject experienced fever. On 13-MAR-2021 06:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe heart racing, passing out, and nausea on 13-MAR-2021, dizziness, chills, and fever on 14-MAR-2021, tired on 15-MAR-2021, and headache on 17-MAR-2021. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.

Patient reports history of Bell's Palsy that developed end of 2016 and resolved in early 2017 and a history of gastric sleeve surgery in February 2019. No known allergies. Patient reports symptoms that started on 4/8/2021, the day after receiving her vaccine. Patient with ?groggy? feeling that has since resolved, headaches that haven?t resolved rated at a 4-5/10 that are relieved with OTC pain medication, and pain in left arm near injection site along with pain in left neck that radiates to left elbow rated at 4/10 that worsens with left arm abduction and isn?t alleviated with OTC pain medication. On 4/24/2021, patient reported a worsening of headaches rated at 7-8/10 that were eventually relieved by OTC pain medication, chest pain rated at 9/10 described as constant tightness that lasted for about an hour, and LUQ pain rated at 9/10 described as a stabbing pain that was relieved after sitting down/relaxing for about an hour. Patient did not seek medical attention. On 4/26/2021 during patient interview, reviewed the importance of following up with PCP based on her symptoms and patient stated she will be reaching out to her HCP.

Vaccine was received at 11:30 am, 4/27/21. Very minor headache started a few hours later. Fatigue, aches and chills started around 6pm. At 8pm, temp was normal at 97.7. Around 11pm, while sleeping, heart rate increased to above 100, ranging from 105-140. At 12:30am, after no decrease in heart rate, I went to ER. After receiving 2 bags of IV fluids and multiple tests later, heart rate was down to around 105 and I was discharged at 2am. Heart rate returned to normal (about 61 for me) around 3pm on 4/28/21

Patient is a 40 y.o. female who presents for evaluation of adverse reaction to Johnson and Johnson COVID vaccine (received on 4/11/21). She received the vaccine on April 11th, around 2:30 p.m. at 8:00 p.m. that night she developed fever with temp 100.4°, chills, headache, nausea and body aches. At 10:00 p.m. that night she developed palpitations, heart racing, shortness of breath, tightness in her throat and chest. She was unable to sleep that night. The next day on April 12th, she continued to have low-grade fever with temp 99°, shortness of breath, chest tightness. She reports taking a pregnancy test at home which revealed a faint positive pink line. That night she took Tylenol which helped relieve some of her symptoms. On April 13th, she continued to have shortness of breath and chest tightness, her heart palpitations improved slightly. She reports retaking the home pregnancy test and this time it was negative. On April 14th, she had a same-day clinic visit, labs that day revealed slightly elevated D-dimer and normal chest x-ray. She continued to have shortness of breath and on April 16th, she presented to the ER due to sudden onset of bad headache, nausea, diarrhea and heart palpitations. She was discharged from the ER with close follow-up with her primary care doctor. Her symptoms did not improve and subsequently on April 20th, she began to have left-sided facial numbness. On April 21st, she went to the ER and was found to have left-sided facial weakness and suspected Bell's palsy. She was admitted for further diagnostic workup (CT Brain normal, MRI Brain normal, and MRV Brain with no evidence of venous sinus thrombosis, carotid doppler normal, MRA Brain normal, MRI sella (pituitary) normal), and treatment was initiated with prednisone and antiviral medications. On April 23rd she developed left arm weakness as well. She was discharged with closed follow up with her PMD and specialists. She recently was seen by pulm Dr and scheduled for PFTs. She is nearly completed with course of prednisone and valacyclovir, left facial weakness slightly improved but not resolved, has follow up with neuro this week.

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.

DEATH; BLOOD CLOT; This spontaneous report received from a consumer news/social media platform concerned a 5 decade 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. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient developed a rare blood clot and died within two weeks of getting the Janssen covid vaccine. On an unspecified date, the patient died from unknown cause of death. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to.; Sender's Comments: V0-covid-19 vaccine ad26.cov2.s-This case concerns with 5 decade old female. Death, 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

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

pt experienced a syncopal episode secondary to receiving Johnson and Johnson vaccinated. pt stated feeling "hot, dizzy" and her ears became "muffled" and she then became nauseated. pt sat down and "passed out" en route to the bathroom. History of Anxiety and Bi-Polar, unknown medications and pt stated NKDA. pt refused further treatment or transportation.

The first few days, I had flu-like symptoms. After I got the vaccine - my migraines became very severe - they would last for days. They became unmanageable and I had to go to ER. I have asthma - it's a lot harder to breathe - this is on and off. It used to be once in awhile I need my inhaler but now I need to use it more. It feels like I'm catching my breath a lot more now.. My rashes went away - but I had had rashes (random places - arms/legs) that came and went for the first two weeks after the vaccine. I went to hospital ER on the 12th of April - because my migraines were so bad that my blood pressure went up to 200 something and they had to clear me to make sure I wasn't having a stroke. I have always had migraines but the only thing different that has changed the severity is the vaccine. I just finished off the steroids' - Progesterone that the neurologist (at ER)(the one that called the cold stroke) prescribed to me. But that didn't really help. I'm waiting for approval from insurance for another medication. Saw another neurologist - after the ER visit.

Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: syncope episode, did not pass out, pale,sweating,visual changes-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: vaccine 2:40pm, CC@ 2:55pm, sweating, visual changes, sweating, feeling of going to pass out, cold compress, vitals BP 93/55 pulse 81. slight tingling feeling in hands, pale, laid on floor/feet elevated, monitored and after 30+ additional minutes felt better,sipped some water& walked out of store, advise lots of water/rest/come back or ER if further issues

The patient developed headache approximately 2 weeks after receiving her vaccine and was found to have intraparenchymal hemorrhage (i.e. hemorrhagic stroke) and intraventricular hemorrhage in the setting of thrombocytopenia with a platelet count of 47 thousand. She was intubated and mechanically ventilated. Platelet count normalized 9 days after admission. She underwent ventriculoperitoneal shunt placement 11 days after admission and was extubated 4 days later, then transferred out of the ICU 2 days after that. Course complicated by pulmonary embolism diagnosed 4 days after she left the ICU which is being treated with apixiban. She has a right hemiparesis and continues to have dysphagia and dysarthria. She is dependent on NG feeds for nutrition. Anticipate discharge to long-term acute care within the next 2-3 days.

Was diagnosed with a DVT 3.5 weeks after vaccination. Started experiencing symptoms of DVT 20 days after the vaccine. Symptoms were not atypical and were almost not checked for DVT at ER. Started with twinges in my right leg for several days. Then pain in my back right behind my heart. Then developed sporadic chest pain and heart palpitations. I was afraid to go to the ER because of COVID because my 12-year-old daughter has a heart condition. Then on April 30 mid-day my right thigh began to hurt like a pulled muscle although I had not injured it or pulled it. I couldn't walk on my leg the pain was so intense. My family was very worried about a blood clot because of the Johnson and Johnson vaccine. That night I had really sharp chest pains and my thigh pain was no better by the next morning. I went to the ER told them my symptoms. After the ER doctor examined me he said he was 99% sure I didn't have a blood clot because my pain was in my thigh and there was no redness or swelling. He told me my chest pain was probably due to anxiety. I asked if he would check my leg anyway. Once the ultrasound of my leg was done the DR came back and said I had a DVT. Then I had to have an MRI of my chest which he told me was a lot of radiation. I did not have a PE. They did not prescribe Heparin because they felt the DVT was from the vaccine. So I was giving Eliquis. Since then my family DR has run more tests and I do not have any genetic reason to have the DVT. I do not and have not taken birth control in the past 20 years. I am now on a blood thinner for at least 90 days if not longer and I am continuing to have twinges and chest pain twinges.

Had a few cocktails and I blacked out, was highly sensitive to the alcohol. I was throwing up for two hours. I couldn?t move. I couldn?t stop the overwhelming need to vomit. I would try and lay down and was in pain. I ended up telling my partner to call an ambulance after two hours of being in such pain. We were across the street from a hospital so we drove. I was given fluid and blood work was done. I left before receiving the results. I couldn?t stand another minute lying there freezing. The machine that was monitoring me kept beeping quickly. I was able to get home and I slept for 12 hours and woke up feeling achy and was having hot flashes for a few hours.

The first symptom I noticed was extreme brain fog and forgetfulness. Then, 6 days after the vaccine, I started having terrifying episodes of acute dysautonomia and panic attacks that included dissociation. These episodes persisted intermittently for 3 weeks. Between the episodes, I was extremely fatigued, brain dead, and unable to concentrate, with a fine resting tremor and constant heart palpitations. I am finally getting treatment from a chiropractic neurologist for subacute encephalitis that caused the dysautonomia and limbic system derangement. A month later, I am still restricted in my activities and have some remaining symptoms of ANS and brain dysfunction, but I am getting better.

right when the injection was given, patient c/o dizziness. RN attention was called. patient look pale, clammy. briefly loss consciousness, called 911. Vital signs taken, BP 93/59, HR 59, Sat 100% in room air. repositioned patient, BP 94/64, hr is 57, 97% in room air. paramedics came. patient transferred to gurney. A/Ox4. patient awake. feeling better. BP stable. EKG done by paramedics. patient refused to go to ED for further eval. will monitor patient onsite

That night, starting around 11:00, I started getting chills and feeling abnormally fatigued and achy. Pretty quickly, the chills got really violent and I felt really bad; like I had the flu. I noticed I was having trouble breathing. I have had anaphylaxis in the past before this. I did have a fever, it was low. I was up most of the night - bad night sweats; hurt all over, couldn't sleep as I was really miserable. The next day, I took Tylenol - around 03:00 am, but the next day I couldn't get out of bed and I had really violent chills, fever, body aches and headache was coming and going. I was still having trouble breathing. I took one Tylenol twice that day - one in the late morning and one in the evening sometime. Two days post vaccination, I started feel less bad, I still had a bit of a headache and I still had trouble breathing - chest was really tight. I was very low energy. I finally contacted my doctor after four days with trouble breathing. He told me to take an Advil or Tylenol and thought it was allergic response to vaccine. I took an Advil. The tightness decreased a bit. Didn't go away but noticeably better. The tightness was just continuing. The next day all the news came out about J&J vaccine, I called the doctor to tell him I was still having chest tightness and trouble breathing and they told me to call my PCP because they couldn't get me in. I called my PCP and she called back 2 hour later and I had just seen her the day before the vaccine and everything was very good that day she had seen me with oxygen, etc. . I went and go a pulse oximeter at Target - it came back at 100% and it would vacillate between 90-100%. My oxygen seemed fine. I thought it was a mass cell reaction to the vaccine - that's what I felt - and I continued to take Advil every so often. It was about a week post vaccine when the tightness in my chest finally normalized. I continued to have fatigue. I felt pretty bad for two weeks post vaccine - tired, blah, and flared up with my disease and run down but no trouble breathing after about a week.

Approximately 20 minutes after receiving Janssen COVID19 vaccine patient was noted to complain of a headache and nausea. Also reported being able to taste the vaccination in her mouth. Patient was monitored for additional 15 minutes and began to complain of dizziness. Patient did not experience any respiratory distress.

BLOOD CLOT IN RIGHT CALF; BLOOD CLOT IN LEFT LUNG; COULDN'T WALK; FATIGUED WHEN WALKING; MUSCLE PAIN; WALKING SLOW / STUMBLING; LEFT CALF PAIN; This spontaneous report received from a consumer concerned a 40-year-old female of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1808980 00040604, expiry: not reported) dose was not reported,1 total, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. In APR-2021, about a week after vaccination, the patient experienced right calf pain/right lower leg pain and muscle pain. Patient was unable to walk, experienced fatigue while walking and was out of breath/unable to breath and on 20-APR-2021, the patient went to the urgent care (Emergency room) and then to the hospital. At hospital, patient had done Ultrasound Test and found blood clot in right calf (right leg) and in left lung. Patient was unable to breath. At hospital, patient was given with medication for blood clotting. After taking medication, patient was able to take breath. On 21-APR-2021, patient was discharged from hospital with medication to prevent blood clotting. Patient was hospitalized for 2 days. Patient was taking the medication one each in morning and evening. On 02-JUN-2021, patient was still walking slowly, tumbling and was not able to walk. On same day, patient also had a pain in left calf and fatigued. On 03-JUN-2021, patient went to the Emergency room(ER). Laboratory data included: Ultrasound scan (NR: not provided) which showed a blood clot in the right leg and left lung. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigued when walking, had not recovered from couldn't walk and left calf pain, and the outcome of walking slow / stumbling, muscle pain, blood clot in right calf and blood clot in left lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210607546-covid-19 vaccine ad26.cov2.s -Blood clot in right calf, Blood clot in left lung, Couldn't walk. 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). 20210607546-covid-19 vaccine ad26.cov2.s -Fatigue when walking, muscle pain. This event(s) is labeled per RSI and is therefore considered potentially related.

patient started having headache a week after vaccination. Within 6 weeks, patient was found to have headache on the left side of her head, and then developed right sided blurry vision and RUE numbness/weakness. Per EMS, patient was having word-finding difficulty. Last known normal: 19:10 5/17/21. Patient got diagnosed with acute ischemic stroke that required tPA.

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.

Syncopal reaction-she passed out while standing about 5 min. after receiving vaccine. She came back to within 1-2 min but was confused for a few minutes and then could recall what happened and how she felt just prior to passing out. For about 15 minutes after awakening, she was clammy and pale. We kept her for 30 min. and then she felt well enough to leave but was with her husband.

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.

patient was admitted overnight to ER, found 2 embolism and was diagnosed with pulmonary embolism. being treated with blood thinners. discharged 6/19/21

Received immunization 9:13am. Approximately 10 minutes later, patient complained of a feeling of her lower lip swelling. Also complained of chest tightness and clearing her throat. 9: 27am patient was given 0.30cc epinephrine at the doctor's office. She was then sent to the emergency room where she was given Benadryl and sent home.

Heart fluttering for 7 days after than vertigo and jumpy/blurry vision from day 4 post vaccination through today-day 15

She was a little faint and dizzy and weak, No EMS was called for her, she said she had not eaten or hydrated well., Has low blood pressure, has low heart rate and low blood pressure the patient stated. Pt was observed for over an hour. When she had experienced the lightheadedness and dizziness she was assisted to the cot and her legs were elevated. She continued to feel lightheaded, she refused to have ems called and vitals were taken several times. At 12:50 she started to feel better she did not complain of any discomfort and was encouraged to walk before discharged.

BLOOD CLOTS NEARBY RIGHT THIGH; This spontaneous report received from a patient concerned an adult 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, and batch number were not reported) dose, 1 total administered in an unspecified date in 2021, around April for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, after vaccination, the patient experienced blood clots nearby right thigh and later blood clot increased in centimeters. The physician advised her to take rivaroxaban (Xarelto). The patient was bit nervous and stated that she never experienced blood disorder issue before. The patient also has send her reports for further review. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots nearby right thigh was not reported. This report was serious (Other Medically Important Condition). This case was reassessed as serious based on additional information received from the patient on 04-JUN-2021, the following information was updated and incorporated into case narrative: event added (blood clots nearby right thigh), product tab: suspect added, vaccine facility added and narrative updated. Upon review following information was amended: Source added as spontaneous, deleted the disease history, deleted events such as off label use and incorrect initiation dose of rivaroxaban, Drug Xarelto added as drug used to treat AE.; Sender's Comments: V2: 20210612004-covid-19 vaccine ad26.cov2.s-blood clots nearby right thigh . 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).

PASSED OUT; HEART PALPITATION; SENSATION ON HEAD LIKE FLASH OF LIGHT; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, weight and medical history were not reported. The patient was not pregnant at the time of reporting. The patient does not have diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in JUN-2021, the patient experienced heart palpitation and passed out. It was reported that the patient heard her heart beat very fast. The patient went to emergency room (ER) and they sent her home. The patient had couple more episodes. The patient also reported that while sleeping she felt the sensation on head like flash of light. The patient's palpitation comes and goes, she feels palpitation then sensation of passing out. The patient went to ER again and she mentioned that they said nothing was wrong. In JUN-2021, electrocardiogram (EKG) performed was not normal. ER recommended the patient to go to heart doctor once she has insurance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from passed out, and heart palpitation, and the outcome of sensation on head like flash of light was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210666494-covid-19 vaccine ad26.cov2.s-passed out. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

I woke up with a pounding headache, body aches, and chills after getting the vaccine. I had Covid a year ago and I just felt like I was having Covid again. Having had Covid before it really scared me to have it again. My eyes were getting blurry. The other symptoms subsided but not the headaches. They gave me migraine medication, but it did not touch it at all, I almost feel like it is brain damage. After a month of this constant headache my husband and I have been having weird heart palpitations. I had an EKG and they said my heart was working ok. We were having weird things. The head aches never went away. After a month I started getting vertigo and it got worse and worse. I went into the doctor and told them about the vertigo and headache. They checked out my ears and they said there was no infection. I went to an audiologist and did a nerve testing and they said I had acute nerve damage and I had lost 44% of hearing in my ear. It just kind of happened fast. I have been going to vestibular therapy trying to get my balance back. I also had an MRI on my brain for an unrelated issue and they said there was nothing wrong in my brain that could cause this.

5 mins after shot I got really hot, flush and got tunnel vision. Had a partial pass out episode. I felt this way for about 10 mins. 4 hours later I started to get a heavy chest feeling and 24 hours later my chest is still heavy. Feels like I can?t get a deep breathe.

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.

Subconjunctival hemorrhage. Petechiae. Headache. Cardiac insufficiency. SOB. Syncope. Fever. Splinter hemorrhages.

10 days after the vaccine I started experiencing heart palpitations, elevated pulse, anxiety, trouble falling asleep, some hair loss. The anxiety was very pronounced from April 22, 2021 to April 27, 2021 but got better subsequently. The palpitations started on April 22, 2021 and continued almost daily through June 2021

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.

Night Sweats, bad dreams, fever, disorientation, loss of balance, fainting, difficult for me to get the energy to wake up early. No energy for about 2-3 weeks afterwards.

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

Pt was released after 15 min of monitoring. As soon as pt got in her car 9Parking lot is 3 minutes away from vaccination site) Pt developed palpitations (HR:156/min) Pt drove to the ER (3 blocks away from parking lot) Pt is currently in the ER, HR between 107-119.

Fever of 102 all night, taken with forehead scanner. Highest fever 103. Headache and rapid heartbeat all night. Next day headache. Arm soreness started Two days after the shot and continues, very painful in the muscle and skin is itchy over the injection site.

burning and hot arm lt side, metal taste in mouth, headache, dizziness, nausea, high blood pressure, Tylenol for headache, Benadryl, tongue started to burn, lt earache, unwell, weak, chest hurting, can't concentrate, rash on right side of face

Chills, sweating, vomiting, fever (102.4), pain in the left arm at the injection site, headache for 12 hours. Muscle ache, fatigue, nausea, headache, chest pain/tightness 72 hours. Chest tightness, nausea, headache, fatigue, muscle ache, general bad feeling current as of 3-14-21.

Per patient after 15 minutes she was having to take deep breathes and heart rate increased. Vitals were taken and heart rate and blood pressure were extremely high. Client sent ER per 911 and was released to home later that day.

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.

Started on day 5. Began day feeling extreme fatigue, dizziness, chest pain. Went to emergency room for chest pain. No indication of heart attack per ER. Extreme fatigue lasted for 3 days.

VASOVAGAL SYNCOPE- PATIENT FELT FAINT, AND LIGHT HEADED BUT DID NOT PASS OUT. PATIENT FELT WARM FOLLOWED BY A PERIOD OF COLD CHILLS. PATIENT STATED WAS SIMILAR TO A PREVIOUS EPISODE AND IDENTIFIED A VASAVAGAL REACTION IN THE PAST.

within 1 minute if receiving vaccine while resident was ambulating to observation area she collapsed. ems and nurse on site immediately went to residents aide.

Nose bleed followed by fatigue, muscle aches, headache, and fever. Symptoms started 5 hours after injection and lasted approximately 15 hours.

Low back pain began about 6 hours after shot. Next morning, 12 hours after shot, woke with muscle aches, headache, chills and sweating. Approximately 18 hours after shot, hives began to appear at wrists, thighs. About the same time, diarrhea occurred twice, and severe dizziness occurred. Likely brief loss of consciousness occurred, resulting in fall due to sudden dizziness upon standing. Hives became progressively worse, became severe and full-body. Called doctor, who instructed us to go to ER for IV steroids and additional care.

03/05/2021 A 42 years old female received Janssen vaccine. Lot #1805018 Exp 05/25/2021 to left deltoid. Immediately after vaccines patient C/O left arm pain. 10:15 am patient continue to C/O left arm pain radiating up and down arm. C/O dizziness and nausea. Patient fading in and out of conscientiousness. V/S 97 BP 136/86 Left arm. O2 sats 100 %. room air. 10:30 am patient still experiencing dizziness and fading in and out of conscientiousness. Emergency services notified. Patient offered ice chips unable to consume. 10:45 am EMS arrived and resumed care for patient. Patient left facility by ambulance Lupon departure. Patient still experiencing dizziness and fading in and out of conscientiousness.

She got the vaccine, she was fine, no problems. She woke up, Down's syndrome, and her sister-in-law saw that she was white faced, and looked like she was going to throw up, but said that she was achy and nauseous. She has swelling to the injection site, a small dot. She feels a little warm, but no fever, 97.9. Has not taken anything for her symptoms.

Work up with fever over 104°, hallucinations and talking out of my head, right eye swollen shut, headaches, body aches, chest pain, cough

Patient was instructed to wait and sat down in observation area for 15 minutes. She fainted within first 5 minutes. I immediately got to her, felt her pulse and she was breathing so I lifted her legs. She immediately came to. We gave her ice packs and sat with her until she was able to move on her own accord. She was light headed and nauseated and had a friend take her home.

BODY TEMPERATURE GET LOW; CHILLS; HEADACHE; NAUSEA; DRUG USE VIA UNAPPROVED ADMINISTRATION ROUTE; OFF-LABEL USE; TIREDNESS; MUSCLE PAIN INCLUDING CHEST AND BACK; STOMACH ACHE; DIARRHOEA; BODY ACHES; SORE THROAT; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 158 pounds, and height was 62 inches. The patient's past medical history included rash, vomiting, nauseas, pass out, and tachycardia, and concurrent conditions included non-alcohol user, non-smoker, latex allergy, clindamycin allergy, and hydrocodone allergy, and other pre-existing medical conditions included the patient had no history of drug abuse. the patient did not have acute illness 30 days prior to vaccination. the patient did not have significant family history of diseases or hospitalizations. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 18:45 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced stomach ache. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced muscle pain including chest and back. On 12-MAR-2021 18:45, the subject experienced drug use via unapproved administration route. On 12-MAR-2021 18:45, the subject experienced off-label use. On 12-MAR-2021 18:55, the subject experienced body temperature get low. On 12-MAR-2021 18:55, the subject experienced chills. On 12-MAR-2021 18:55, the subject experienced headache. On 12-MAR-2021 18:55, the subject experienced nausea. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Done, COVID-19 PCR test (NR: not provided) Negative, Negative, Negative, Urine analysis (NR: not provided) Done, and X-ray (NR: not provided) Done. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, chills, and body temperature get low, and the outcome of stomach ache, diarrhea, sore throat, tiredness, muscle pain including chest and back, body aches, drug use via unapproved administration route and off-label use was not reported. This report was non-serious.

Increased heart rate, lowered blood pressure, sneezing, coughing (2 hours after injection), severe fatigue/lethargy approximately 24 hours after injection. Also, chills and headache.

Got the vaccine at 10:30am on 4/5/21 and felt ok all day. About 10:30pm when trying to go to bed I started having severe body aches, extremely high fever, all over and uncontrollable body shaking (thought I was having a seizure), racing heart, severe headache, very sensitive and sore injection site. This lasted through the night, for a good 6 hours. As of 10:30am on 4/6/21 I still have a very bad headache and mild to moderate body aches and an extremely sore injection site.

Patient reported waking up with arm soreness at 2:30am. She got out of bed to get a pain reliever, felt lightheaded and passed out. She woke up and passed out again, but feels fine now.

chills and haigh blood pressure the night of the 7 and the next day on the afternoon, the 9, 2 days after the arm is itchy and red warm and swollen on the area of the vaccine

*Fatigue: Starting around 7pm, I started feeling tired at the time of day when I am most awake. I experienced strong fatigue over the next couple of days, including sleeping 11 hours on 4/9. I am still tired today, 4/10. *Dizziness: Late in the evening, I was very dizzy for a couple of minutes. My head felt strange on and off throughout the night. Maybe lightheaded and definitely strange. *Not able to complete normal daily activities because of: Nausea, chills and hot spells: These 3 were experienced starting around 11pm. Each symptom would come and go in waves. I was miserable and could not sleep for very long. I took lots of naps the next day. Also, I was unusually forgetful. These 3 symptoms (chills, nausea, hot spells), along with the fatigue, were so strong that I was unable to do most of my daily activities on 4/8. I felt only about 50% functional on 4/9 and I'm mostly OK today. *Fever: none *Heart rate: frequently elevated about 20 beats per minute from my baseline

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

Injection site reactions: pain, redness, and swelling, hot skin lasting longer than 6 days General reactions: Headache, fever, nausea, stiffness of the neck, muscle aches, fatigue, fast heart rate, dizziness

36 hrs after injection (~9pm Thursday night): fast heartbeat, unable to relax, up all night with fast heartrate (counts were 96-100 bpm, when rested heartrate is between 60-70). Friday morning felt dizzy, light headed, weak, not able to taste food (everything tasted bland), able to sleep for about 6 hours into Saturday morning. Saturday felt more weak than previously, not able to perform simple activities without shortness of breath, dizzy, light headed, fast heartrate, no appetite, food tasted bland, very weak all day. Sunday improved a lot, more energy, no dizziness or light headed. Heartrate was still fast around 94 bpm, felt a lot better.

Patient with self-reported history of anxiety, syncope and near syncope with medical procedures/needles. Complained of feeling anxious, light-headed, jittery after vaccination. Became pale, placed in a supine position, provided oral fluids, including fluids with sugar, VS stable, hypotensive to 77/57, pulse ox 99%, blood glucose 185, NSR on monitor reported by EMT on site. Husband called, patient declined EMS transport, was able to ambulate with supervision to husband's car, husband transport to local ER in private vehicle. Follow up with patient <24 hrs post vaccination: patient reported feeling better. Admitted she was anxious about receiving vaccination since appointment was made one week ago.

Client vaccinated at 6:30pm on 4/10/2021 During 15 mins observation. Someone yelled stating that client fell. Upon arrival, RN noted that client face was very dusky and pale. She was assisted by other providers to lie down on her back and legs elevated. BP 132/79 P 86, O2 86%, RN noted carpal spasm started on right arm and then to left arm. 911 called, Fire Department arrived O2 applied. BP 128/81 P105, O2 95% Client went to Hospital via ambulance.

First day usual symptoms, headache , body aches, fever,chills, nausea, sweating. Second day, body aches, headache, heart palpitations . Until day 11 extreme body aches concentrated on lower back sacrum and thighs. Day 13 still having body aches but they have lessened slightly .

Fever 102- 104.8, increased heart rate and blood pressure, chills, headache, achy Symptoms for 24hrs then fever broke Tylenol/Advil and cool towels to reduce fever

102.4 temperature, body aches, headache that lasted 3 days, chest discomfort, and smell and taste sulfur all day. The sense of smell and taste of sulfur is still occurring a month later. On and off chest discomfort since vaccination also. Shortness of breath occurred for 5 days after vaccination.

Right after receiving the vaccine, I felt light headed and dizzy; this continued for several days; about five days after receiving the shot, I felt pressure in my ears and had slight ringing in my right ear, on the evening of 4/8/21, my lips started to feel numb; the following day, the side of my face begin to feel numb and this sensation now comes and goes; I continue to feel light headed and dizzy and have sporadic episodes of tightness or pain in areas such as my legs, thighs, neck, chest, and back

About 5-6 hours after my shot, i started to get a fever. It eventually reached about 103 (the highest I recorded). I had severe chills (it felt like my muscles were all contracting as I lay in the fetal position trying to stay warm). Over the course of about 12 hours (starting with the onset of the fever) I experienced nausea, vomiting, headache, cough and elevated heart rate. According to my apple watch my heart rate hit 140 at points. It was over a 100 for quite some time. My resting heart rate is usually in the 70s. The worst of my symptoms were experienced for 12-14 hours from the onset of the fever (5:30 PM 4/10/21 - 7:00AM 4/11/21. 4/11/21 7:00am - the rest of 4/11/21 i experienced fatigue, headache (though less severe) and had no appetite. I vomiting a couple more times early in the day, and had trouble keeping water down unless it was a sip at a time. Mild body aches. Fever hovered at 99-100 most of the day. elevated resting heart rate 4/12/21 mostly symptom free but for fatigue and elevated heart rate As of today, 4/13/21, I am still experiencing a slightly elevated resting heart, mid 80's.

3 hours after shot I became dizzy & disoriented...my hands very shaking & heart rate & blood pressure high. I felt like I was on a drug. I was hearing & seeing things very differently.

Vaccine was administered and two minutes later patient reported to feel "weird." She kneeled over and started to breathe heavy. Pharmacist was asking if the patient is okay and the patient stopped responding so the pharmacist kneeled over to pick up the patients head and she looked flushed, her eyes were bulging and she began to sweat. The pharmacist asked the technician to call 911, asked the patient if she could breathe and the patient said yes but said she is not feeling well. She kneeled back over and the pharmacist was holding her hand telling her to continue breathing. The patient was very sweaty continued to breathe heavily. About two minutes passed and the patient was expressing she was feeling better and better as the pharmacist was speaking to her. The EMTs arrived 7 minutes after the call the patient had sat up already and was speaking and feeling alert. She expressed that she felt like she was underwater and the pharmacists voice was fading during the minutes after the shot and she felt like her heart was racing. She explained that she suffers from anxiety. The EMTs took her blood pressure when the patient was sitting and standing up, blood pressure was in normal range and also checked her blood glucose with a finger stick which was also in normal range. The patient had mentioned previously that she biked to the pharmacy. Later on the pharmacist called to check on the patient she said that she is feeling well and biked back home.

Client became light headed and dizzy and had an episode of syncope. EMS alerted, Client regained consciousness. client laid down for 30 mins. Client escorted to car with no evidence of shakiness or lightheadedness

Within 6 hours of the injection, I experienced a severe headache, 101-degree fever, chills, severe leg pain, and fainting spells when attempting to walk. The symptoms lasted approximately 24-hours.

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

Pt states that she experienced low back pain and extreme fatigue after imz but resolved in 24 hours. On Sunday, (4/11/21) which is roughly 3 weeks later pt noticed pain in lower right leg (calf) which was warm and tender to touch. Pt went to urgent care and was immediately sent to ER. Diagnosis was DVT in right lower leg . Pt was administered 2 shots of heparin injection in abdomen and discharged on Eliquis. Pt followed up with PCP on today 4/14/21 and was told to continue Eliquis and to follow up in 1 week for another ultrasound to ensure medication is working.

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.

Moderate to Severe Body Aches, Chest Tightness and SOB, limb pain, calf pain, atypical chest pain, fatigue.

Chest Pain on 14 APR 2021 at 5 PM Chest Pain getting worse on 15 APR 2021 around 6 PM after dinner. Will visit to doctor office tomorrow 16 APR 2021 if appointment available.

Dx: Acute DVT of the left posterior tibial vein (distal to popliteal) shown on US, opted for repeat CBC next AM to confirm platelet count stability and US in 1 week to assess DVT progression vs stability Symptoms: Headache, nausea, myalgia, shortness of breath, forgetfulness, leg pain starting from bilateral feet cramping

Monday evening after vaccine - fever over 101, chills with uncontrollable shaking, rapid heartbeat that could be felt within eyes, nausea, muscle aches & pain - including back and left leg Tuesday morning through Thursday - lower fever, pain in leg continued, shortness of breath, fatigue

vasovagal symptoms -- lightheaded, cold sweats, nausea, diarrhea, extremely low blood pressure and heart rate for ~30 minutes

Immediately after the JANSSEN vaccine I felt tenderness in my jaw that lasted for about two days. My body was sore, my Legs felt like I was having cramps ?growing pains? I also was experiencing allergy/asthma like symptoms that included difficulty breathing and shortness of breath that worsened over time I couldn't speak in full sentences or laugh I was unable to walk 10 steps without gasping for air, after a couple of days of trying to maintain and cope with my theses symptoms. I couldn?t take it anymore, as I was preparing myself to go to the emergency room. I got into the shower the steam from the shower felt like it was suffocating me and I passed out my children took me out of the bathtub and rushed me to the emergency room where I was given several tests that include x-ray, CAT scan, artery bloodwork and vein bloodwork. I was being treated for asthma and given several different breathing treatments and steroids, unable to keep my stats at a decent level and the hard rebound even after continuous treatments, I was admitted because the breathing treatments were not effective. I am still uncertain of the ?actual outcome? the Hospital doctors treated me for an asthmatic episode and gave me directions how to handle my asthma i was prescribed prednisone and referred to my primary that would then refer me to a pulmonologist and cardiologist. At the hospital I was told that there was black spots on my lungs I was told that I was being treated for infection, but then also told it could be pneumonia no certain answer was ever given and i was given and antibiotic and was also told that I needed to see my primary for a way to maintain my asthma. The antibiotics seem to work for a couple of days and again I'm back to having difficulty breathing, shortness of breath, muscle pain soreness and mild lingering headaches. STATUS ASTHMATICUS ASTHMA EXACERBATION ACUTE TRACHEOBRONCHITIS SHORTNESS OF BREATH

day 1-7 arm wasn't sore it freakin HURT and there was heat and pink color... day 2-7 i had diaheara, nausea/vomiting, chronic headache that my migraine meds wouldn't quite get rid of...biggest concern was it triggered my tachycardia and bp...I had to take alot of extra heart meds during that week due to how hard my heart pounded and worked

? Acute CVA (cerebrovascular accident) Hospital Course/test results: Work up with MRI showed 2 small acute infarcts in R temporal lobe region, and findings which could represent subacute infarcts in L frontal lobe. Neuro deficits now resolved. Neurology consulting. Suspicious for embolic phenomenon. She does also have a IUD to treat her menorrhagia, which may predispose her to clotting. However when we did further research Mirena IUDs were not found to raise the risk for blood clot-related heart attack and strokes but the company does recommend clinical consideration for removal in such situations. We contacted OBGYN oncall physician and spoke to doctor today. From his recommendation is not to remove the IUD at present time because the risk is very low comparing to the higher risk of severe menorrhagia that patient had experienced in the past. Since she will have annual visit with her GYN at OBGYN, patient should have that conversation with her GYN for options. Patient remains stable and symptoms free. Repeated brain MRI and new MRV did not reveal new findings. Her HA resolved on its own. She was initially started statin and full dose of ASA then changed to low dose ASA plus Plavix (21 days) then ASA as monotherapy after. Currently hypercoag panel is still pending. Echo showed no evidence of intracardiac shunting with fair quality and technically adequate study. Neurology recommended outpatient follow up with neurologist and 30 days heart monitor to look for Afib/flutter. Currently her headache is resolved as well R hand weakness/tingling is resolved. She is stable to go home today. A1C is 7.3 while on Metformin (2000mg daily). She may need additional agent to get A1C < 7 as outpatient. Neuro also recommended outpatient sleep study.

*This description is per the director of this substance treatment recovery facility* Resident was found by her roommate and seemed unresponsive to normal questions. Resident began convulsing and eventually stopped. Resident claimed that she was OK but an ambulance was still called and she was taken to The Hospital. She returned to the recovery home the same night. Diagnosis on hospital discharge paperwork "Syncope."

Extreme fatigue - days 2-7 after vaccine Prolonged dizziness - comes and goes - not only from standing up too quickly - starting 4/14 - can be anything from momentary to 30 minutes. Occasionally fainting. Fainting - starting 4/14 - following dizziness - has happened 4 times Tinnitus - starting 4/14 - comes and goes - severity/loudness increases before dizziness

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.

Two hours after vaccine started with headache nonstop, two days later my left ear popped and suddenly got a ringing in the ear causing to lose my hearing, went to urgent care Dr gave me steroids and antibiotics, 6 days after that(tonight) had to go back to ER cause the symptoms don't get any better still have headache, blood pressure is been high all the time and my hearing is gone and the ear ringing is getting worse and worse, also been very dizzy, ER gave me prescription for more antibiotics and now I have to see an ear specialist. Before the shot I was perfect and never got the Covid.

Patient is a 41 yo woman with no PMH who presented to an outside urgent care with left flank pain found to have a wedgelike defect in the posterior left lower renal pole suggestive of a renal infarct. She underwent CTA which did not show any embolism, thrombus, dissection. The radiologist did note mild beading of the bilateral renal arteries, however the radiologist at Valley View reviewed the images as well and was not as convinced. Left renal infarct: Given suggestion of mild feeding of the bilateral renal arteries, patient underwent CTA of the chest, head and neck which did not show any other signs of fibromuscular dysplasia. Echocardiogram did not have any thrombus or decrease in function. Patient did not have any arrhythmias on telemetry. Blood cultures were ordered and pending on discharge, but patient did not have any of endocarditis A hypercoagulable work-up including factor V Leiden, protein C, protein S, Antithrombin, lupus anticoagulant, beta-2 microglobulin, anticardiolipin antibodies were all sent and are pending at the time of discharge Discussed the case with hematology at hospital: Most experts treat with 3 months of anticoagulation other evidence is not entirely clear and aspirin 81 mg may be a reasonable choice. In light of the patient's lack of insurance, decision was made to treat with 1 month of apixaban followed by 81 mg of aspirin daily indefinitely Discharged with a short course of oxycodone 5 mg #15

PRESSURE ON CHEST; FORGETFUL; FEELING HEAT GOING THROUGH BODY; THROAT BEGAN TO CLOSE; DIZZINESS; TINGLING SENSATION; THROAT HURTS; FEVER; NOT FEELING WELL; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 122 pounds, and height was 161 centimeters. The patient's concurrent conditions included penicillin allergy, abstains from alcohol, and non smoker, and other pre-existing medical conditions included 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: UNKNOWN) dose was not reported, administered on 12-MAR-2021 14:55 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced not feeling well. On 12-MAR-2021, the subject experienced tingling sensation. On 12-MAR-2021, the subject experienced throat hurts. On 12-MAR-2021, the subject experienced feeling heat going through body. On 12-MAR-2021, the subject experienced throat began to close. On 12-MAR-2021, the subject experienced dizziness. On 12-MAR-2021, the subject experienced fever. On an unspecified date, the subject experienced pressure on chest, and forgetful. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pressure on chest, forgetful, and dizziness on 15-MAR-2021, and feeling heat going through body, throat began to close, and fever, had not recovered from tingling sensation, and throat hurts, and the outcome of not feeling well was not reported. This report was non-serious.

Patient presented for J&J Covid-19 Vaccination. Reported feeling anxious in anticipation of vaccination and stated that she felt like her heart was racing. Patient denies chest pain, shortness of breath or any other s/s. Assisted patient to wheelchair for safety and monitoring. 11:40 BP 137/90, p=132 regular, rr=18/min, o2 sat 98%RA. 11:45 BP 127/83, p=116 regular , rr= 18/min, o2sat 98%RA. Patient denies chest pain, shortness of breath or any other s/s. 11:52 BP 131/86, p=124 regular, rr=18/min, o2sat 96%RA. Patient denies chest pain, shortness of breath or any other s/s. 12:08 BP 115/80, p=96 regular, rr=18/min, o2sat 97%RA. Patient denies chest pain, shortness of breath or any other s/s. 12:20 BP 126/84, p=105, rr/16/min, o2sat 98%RA. Patient denies chest pain, shortness of breath or any other symptoms. 12:22 BP 132/86, p=132, rr= 18/min, o2 sat 98%RA. Patient stated that she feels like her heart is racing again and now she feels "foggy and not right". Called 9-1-1 for transport to hospital for further evaluation. EMS arrived, assessed patient and transported patient to the hospital for further evaluation. Spouse with patient and meet patient at the hospital.

COULDN'T SLEEP AT NIGHT; ACHES; CHILLS; FEVER; IRREGULAR HEART BEAT; 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 pre-existing medical conditions included no medical conditions, not on any medications. no history of irregular heart beat. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced irregular heart beat. On an unspecified date, the subject experienced couldn't sleep at night, aches, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, chills, and fever, had not recovered from irregular heart beat, and the outcome of couldn't sleep at night was not reported. This report was non-serious.

HEART PALPITATION; MUSCLES SPASM IN RIGHT ARM; BODY ACHE; INJECTION SITE ARM SORENESS; MILD FATIGUE; STOMACH UPSET; TWITCHING IN RIGHT 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 penicillin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced stomach upset. On 20-MAR-2021, the subject experienced twitching in right arm. On 20-MAR-2021, the subject experienced muscles spasm in right arm. On 20-MAR-2021, the subject experienced body ache. On 20-MAR-2021, the subject experienced injection site arm soreness. On 20-MAR-2021, the subject experienced mild fatigue. On 03-APR-2021, the subject experienced heart palpitation. On 12-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Electrocardiogram (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach upset, body ache, injection site arm soreness, and mild fatigue on 23-MAR-2021, and was recovering from twitching in right arm, heart palpitation, and muscles spasm in right arm. This report was non-serious.

My period was supposed to start on 04/09 the day I got the vaccine. It was delayed until 04/13 when it began to bleed BLACK clotty sticky sludge. It had the appearance and consistency of vegemite or molasses. Black sludge. At first it was extremely heavy with very large black clots. Then it became tiny little black clots suspended in a brown sludge. This continued for 6 days until 04/18. Then on 04/19 my menstruation turned bright red with no clots, but has not abated at all for another 4 days. I am currently today on Thurday 04/22 still bleeding almost 2 weeks after taking the J&J shot. I cannot believe I am still bleeding after 10 full days!!! Never in 30 years of menstruating have I had a 10 day period. I am very scared and upset.

I took the vaccine at 2:10pm on 4/8/21 and 20 minutes later at 2:30pm on 4/8/21 my cycle started a whole week early, which is very abnormal for me. I am bleeding clots of blood for 5 days now with weakness and pains. My normal cycle is very regular and lasts 3 days, the first day is heavy then moderate, then light on the third day i barely need a liner. This has been heavy bleeding with sizable blood clots.

Delayed menstrual cycle by 4 days, when started very painful and heavy. Much more clots than usual and lasting longer than usual. Uncomfortable enough to require rest. Still going heavy when it should be tapering off.?

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.

Patient received J&J vaccine on April 9th. She stated to experience a left sided headache on 4/14/21. She was hospitalized late on 4/17/21 and was diagnosed with a pulmonary embolism on 4/18/21.

Deep venous thrombosis at the site of vascular access line-Initially started on heparin, now switched to Rivaroxaban Thrombocytopenia-Supportive treatment and monitoring

Patient states that bruising started about 3 days after her shot. The bruising started at the injection site, then it spread to her left leg and thigh. She woke up two days ago with bruises on her shin. Her on/off headaches began when bruising started. They intensified when her shortness of breath began three days ago.

HYPERTENSION; ALLERGIC REACTION; 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 hypertension, and theophylline allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included fluoxetine. On an unspecified date, the subject experienced hypertension, and allergic reaction. Treatment medications (dates unspecified) included: amlodipine and fexofenadine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hypertension and allergic reaction was not reported. This report was non-serious. This case linked to 20210415566 as reported by the same reporter.

First night had chills and fever that lasted about two days Area around right knee swelled quite a lot about two days after shot given with some pain, most swelling has subsided but some superficial veins still more visible than before

Patient reports waking up in the early morning hours with pain in center of chest and between shoulder blades. She felt like her throat was closing up, unable to take a deep breath. Dizziness, feeling faint and heavy arms also reported along with headache. Her husband gave her acetaminophen and shower and ice pack and she returned to sleep. Upon waking in the morning, she felt fatigued and arms ached "like she had been doing push ups" The pain in her neck and chest heaviness persisted. She made an appointment for later in the day with her PCP and was promptly sent to the emergency room for further evaluation. X-rays and labs were drawn.

Within 4 hours had nausea, headache. Lasted for about a day. 12 days later vertigo, nausea, headache resumed. Went to primary who detected a drop in oxygen levels, was then sent to ER where many tests were done. Included chest scan, to look for clots. None were found. Took dramamin for vertigo which helped. Symptoms of nausea, headache, vertigo continue to persist off and on. On Friday 4/23 I died my hair. Within 2 minutes an allergic reaction too place: sudden nausea, some shaking, headache. Took benedryl which help. At this point, I have continued bouts of nausea and no appetite. Its been close to a month and I'm really scared for my health. I was completely healthy before.

5pm started with chills, followed by headache and rapid heart rate and fever. Syncope upon standing. Heart rate stayed elevated for over 5 hours. Fever came down with Tylenol amd Motrin.

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

April 10, late evening: fever developed. Most of the night it was 102.2 F. Also, my lying down heart rate was 130, which is 50-60 bpm higher than normal April 11: A fever between 100 and 101 all day. Took a Tylenol in evening. April 12: Fever, headache gone. Just a little tired and fatigued. Then I seemed to have been recovered. April 21-22: Achiness, tingling pain in arms, left back, shoulders. Then this seemed to have abated. April 28-29: Tingling pain in arms, hands, sometime back and feet. I have never experienced these symptoms pre-vaccine so it makes me wonder if it is related to the vaccine

Next day full body red rash, 103-104 degree fever, deep body aches, skin sensitivity, joint pain, headache, brain fog,lasted 4 days, One week later period started with large chicken-egg sized blood clots, heavy flow lasted 2 days longer than typical period for me. Second cycle after vaccine started 4.22.21 with same very large clots, intense cramping and bloating

Approximately 30 hours of sharp chest pain when taking a deep breath or twisting torso from 3am on 4/13 till 8am on 4/14. Period delayed 6 days, starting on 4/21 when it should have started 4/16. This was 34 days between cycles and an irregular occurance.

Janssen COVID-19 Vaccine EUA Fast heart rate, 115 and up, most noticeable while at rest Experienced on 5/6 and 5/7

Symptoms - Difficulty breathing, chest pain, fever, headache Diagnosis - Pulmonary embolism Treatment - Xarelto and pain medications (Narco, Tylenol)

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.

Pain with injection all the way down my arm into my fingers. Arm felt very heavy. Sharp pain in left chest area Lightheaded Tired

Sick for 48 hours afterward with flu-like symptoms (headache, nausea, fever, aches, chills, fatigue). Developed persistent cough and chest pain a month later and was treated with prednisone and an inhaler

Patient passed out approximately 10 minutes after getting her shot. She was given a bottle of water (by her spouse). EMS was called and evaluated patient. She declined further care and left with her husband once she felt better.

After receiving the vaccination I experienced chest tightness, wheezing and congestion. Also a fever of 101.6 and congestion.

The morning after I received the vaccine, I started having chest pressure and acid reflux. There was a hard pressure in my chest and my heart was beating weird. I started to develop a headache. I had low blood pressure a couple days later. I went to the clinic and they said I may have a blood clot. I also went to Hospital and they took some blood and did an X-ray and they told me I was fine. I was told that it may be anxiety or stress. The chest pain started to go away, but now my teeth are hurting and are sensitive. I feel that the adverse event lasted for three 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.

Within 2 mins of receiving injection, I experienced full body sweats, deadening of sound, blackness in eyes, lightheaded, unable to hold things in my hands, uneasy stomach, very pale all over, especially face. Talked/deep breathed my way out of fainting. Within 10 minutes all the above symptoms started to lessen. 15 minutes after receiving the injection, the near fainting experience was over and I was comfortable leaving and driving. But the 10 minutes were terrible and I came very close to passing out. My husband experienced the exact same symptoms 2 days later. I will be reporting that immediately following this submission.

THE PATIENT CAME TO THE PHARMACY TO BE VACCINATED FOR COVID-19, WITH JOHNSON & JOHNSON, ON FRIDAY, MAY 21, 2021 AT ROUGHLY 2PM. I GAVE HER THE VACCINATION IN HER DELTOID MUSCLE ON HER LEFT ARM. SHE ALMOST IMMEDIATELY COMPLAINED OF DISCOMFORT AND ASKED IF I HAD A COLD PACK. I PROVIDED HER WITH ONE, WHICH SHE USED WHILE WAITING THE 15 MINUTE POST-VACCINATION OBSERVATION TIME. SHE LEFT THE PHARMACY WITHOUT INCIDENT. ONLY A COUPLE HOURS LATER, SHE CALLED THE PHARMACY TO REPORT ERYTHEMA AT AND AROUND THE INJECTION SITE. I DID NOT KNOW AT THAT TIME WHETHER THE ERYTHEMA WAS DUE TO THE COLD PACK OR IF IT WAS A VACCINE-INDUCED RASH, SO I INSTRUCTED HER TO TAKE A DOSE OF ANTIHISTAMINE. AS SHE HAD CETIRIZINE IN THE HOUSE, SHE TOOK THAT. SHE WAS HOME WITH HER HUSBAND. I RECOMMENDED HE KEEP AN EYE ON HER AND IF SHE DEVELOPED ANY ADDITIONAL SYMPTOMS OR WORSENING RASH, SHE SHOULD GO TO THE HOSPITAL FOR EVALUATION. ADDITIONAL SYMPTOMS INCLUDED SWELLING, TROUBLE BREATHING, WHEEZING, CHEST OR THROAT TIGHTNESS, OR HIVES. THOUGH SHE DID NOT EXPERIENCE ADDITIONAL SYMPTOMS, SHE DECIDED TO GO TO UCONN HEALTH CENTER ER IN FARMINGTON. THEY DID BELIEVE THE RASH WAS VACCINE-INDUCED BUT DID NOT FEEL SHE REQUIRED ANY ADDITIONAL TREATMENT AND DISCHARGED HER (I.E., NO EPINEPHRINE). THE PATIENT NOTED THAT HER BLOOD PRESSURE AT THE ER WAS HIGHER THAN "HER NORMAL" AT 152/95. THE FOLLOWING TWO DAYS, THE RASH STAYED THE SAME AND WAS DESCRIBED BY THE PATIENT AS THE "WORST SUNBURN SHE'S EVER HAD". SHE ALSO HAD NORMAL SIDE EFFECTS OF BODY ACHES AND CHILLS/SWEATS. ON MONDAY, 5/24/21, SHE FOLLOWED UP WITH HER PCP. HE AGREED WITH THE HOSPITAL THAT THE RASH WAS VACCINE-INDUCED AND TOLD HER THAT HE DIDN'T WANT HER GETTING ANY COVID-19 VACCINES IN THE FUTURE. HE DID BLOODWORK TO RULE OUT PLATELET ISSUES, WHICH, PER PATIENT, WERE NORMAL; SHE NOTED THAT HER RBC'S AND HEMATOCRIT WERE SLIGHTLY ELEVATED. HER PCP GAVE HER A MEDROL DOSEPAK FOR THE RASH. THE PATIENT IS RECOVERING. I BELIEVE IT IS WORTH NOTING, HOWEVER, THAT THE PATIENT APPLIED THE COLD PACK DIRECTLY TO HER ARM FOR AN EXTENDED PERIOD OF TIME AND DID NOT PROVIDE THIS INFORMATION TO EITHER THE ER OR HER PCP. SHE SENT ME A PHOTO OF HER ARM WHICH SHOWS GENERALIZED ERYTHEMA (THE SIZE OF THE COLD PACK) - THE ONLY PART THAT IS COMPLETELY NORMAL IS THE SKIN BELOW THE BAND-AID. I BELIEVE THE PATIENT CREATED AN ICE BURN BY USING A COLD PACK TOO DIRECTLY, FOR TOO LONG, AND THAT THE UNDER BAND-AID AREA WAS NOT RED BECAUSE IT PROTECTED THE SKIN FROM COLD BURN. I SUGGESTED TO THE PATIENT THAT SHE RUN THIS THEORY BY HER PCP, AS I BELIEVE IT IS IMPORTANT "MISSING INFORMATION", THAT COULD POTENTIALLY CHANGE THE DIAGNOSIS AND ALTER HIS RECOMMENDATION TO AVOID FUTURE COVID VACCINATION. WHETHER OR NOT THE PATIENT CONTACTED HIM AGAIN IS UNKNOWN.

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.

I had chest pains a few days after receiving the vaccine and went to see my Doctor who referred to the ER to check to see if I had a blood clot.

Patient presents with ? SUICIDAL pt intoxicated and tried to hang herself on the shower curtain rod. boyfriend called 911. pt states this was a suicide attempt HPI: This is a 41y.o. female with significant past medical history of polysubstance abuse that presented to the hospital with chief complaint of suicide attempt. The patient apparently tried to hang herself on the shower curtain rod after reportedly drinking 1 liter of Captain Morgan's rum. She was found on the ground by her boyfriend whom reports she was 'blue in the face." On examination she is resting in bed in no acute distress. She denies any fever, chills, chest pain/pressure, palpitations, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, constipation, or urinary complaints. She denies any illicit drug use or ingestion of toxins. In the ED, patient mildly hypertensive, afebrile, stable SPO2 99% on room air. CBC, BMP, coags, UA unremarkable. Ethanol level 410. UDS negative. COVID positive. CT head and CTA neck unremarkable for injury. Admitted for further evaluation and management with psychiatry consultation. Suicide precautions implemented in ED. Pt seen and examined only by the attending physician. NP only responsible for chart review in an effort to limit exposure given the current pandemic and patient's COVID positive status. ROS: Constitutional: Denies fatigue, fever or chills. Eyes: Denies change in visual acuity, diplopia or pain. HENT: Denies nasal congestion, sore throat or tinnitus. Respiratory: Denies cough,difficulty in breathing or shortness of breath. Cardiovascular: Denies chest pain, palpitations or edema. GI: Denies abdominal pain, nausea, vomiting, constipation or diarrhea. GU: Denies dysuria, urinary frequency or hematuria. Musculoskeletal: Denies back pain, atrophy, spasticity or joint pain. Hematologic: Denies anemia, bleeding, or bruising. Integument: Denies rash or lesions. Neurologic: Denies headache, focal weakness, seizure or stroke. Endocrine: Denies temperature intolerance, polyuria, or polydipsia. Psychiatric: Denies irritability, +depression +anxiety. +suicide attempt

Immediate dizziness. Arm felt like dead weight. Had trouble driving to waiting area. Within 20 minutes, chest, neck, arms, and face tightened, I couldn?t move my arms, paramedics found blood pressure to be very high. Was light headed for 48 hours after. Almost fell over multiple times. Arms and legs very heavy and tired easily. On 4/21/2021 my leg cramped up and went numb. Week later my chest constricted with same issue from injection day. Went to hospital. Blood pressure again elevated. Concerned of a blood clot, did chest mri and ultrasound of blood vessel in leg. No blood clot found, but new lesions in chest were found and no explanation of leg issues. As of today?s date, no one can figure out why my right leg is numb from mid thigh down, but has major pain and causing me not to be able to walk and go up stairs. Feels like a constant charley horse in my calf with pain radiating through my knee and up my thigh. No injury was sustained. It happened all of the sudden while laying on the couch reading. I?ve seen regular doc, pt specialist, sports med doc, headed to a spine specialist next. No explanation of strange pain and numbness.

Went over pertinent information with patient including disclaimer regarding blood clots associated with J and J vaccine. Patient stated no issues and to proceed. When asked if there were any allergies or adverse effects from previous vaccine administrations, patient stated no issues at all. Once vaccine was administered, the patient immediately broke out in a deep sweat, and fainted. I immediately had one of my techs call 911, during this time patient started to seize/convulsions. We had patient at an angle while patient was convulsing. Once patient stopped convulsing, patient gasped for air and regained consciousness. I asked patient if she was doing ok and identified myself as the pharmacist. Patient stated that they remembered who I was but did not remember anything after the vaccine was administered. EMS was called and while they tried to set up a quick triage IV line, patient started to faint again but did not lose full consciousness. Patient was transported to ER.

Had typical symptoms within 24 hrs - low grade fever (101F), body aches and arm pain. On second day developed mild headache that went across forehead. On 5/15/21, developed right ear pain - pressure in ear and headaches continued. Intermittently the left ear would also have pain. Started developing stiffness on the right side of neck that accompanied the ear pain. Went to urgent care on 5/20/21. Doctor said both ears were visibly full, especially the right ear. Prescribed Azelastine nasal spray. Called PCP in morning of 5/21/21, and was prescribed prednisone for 5 days to control inflammation. Prednisone worked after a few days but was still run down and pain developed in my abdomen and along the right side of back/leg. Went to ER on 5/24.21. Doctors performed tests for blood clots. Was told I was weak and dehydrated and given IV and pain meds. Was negative for blood clots but my IVC was dilated. Pains persisted for about 2 weeks - especially in the right abdomen. Went to cardiologist on 6/4/21 and had a normal EKG but low BP. Doctor believes abdominal pain is gastrointestinal and put me on proton pump inhibitor. I am getting echocardiogram on 6/10./21 to check IVC. Since then most pains have subsided except weak, right sided abdominal pain. The right ear pain is back. Starts in the morning with outer cartilage of ear getting inflamed, followed by pressure/pain in right ear, then pain in right neck. Has been going on for a month now. 100% related to vaccine - came after vaccination and never had before.

I developed high blood pressure about a month after the vaccine...historically, my blood pressure has been low. I have stage 3 kidney disease so having high blood pressure can lead to kidney damage and/or kidney failure. At the end of April 2021, I was prescribed and reluctant to take medicine for high blood pressure, specifically Carvedilol (Coreg). Around the same time, I began having hot flashes and premenopause symptoms. I went to my gynecologist and my bloodwork revealed that my ovaries were barely functioning and I was in perimenoupause at the age of 42 years old!! Therefore, my doctor informed me that my chances of pregnancy and birthing a child were extremely slim. This was devastating news.

About ten minutes after leaving the vaccination site, I began feeling a strange dizziness; an internal wobbly-Jello-like sensation. I felt a pin/needle/ stabbing sensation on my left fingers, particularly on the dorsal side of the third and fourth fingers, and in the middle of the tongue. The tongue felt as if was receiving a subtle electric charge that immobilized it with every shock. It lasted about 5 minutes. My vision was blurry. After that, my mind was foggy. At about midnight, flu-like symptoms began sudden, but they were the expected symptoms for a covid vaccine (fever, body aches, sweats, sore throat, severe headache, pain on injection site, etc.) However, the pin/needle/ stabbing sensation was felt throughout the body. It sometimes felt as if a bubble, waves, or something was moving inside of me, in different areas of the body (rib cage, legs, chest, arms, legs, face, and top of the head (like when a baby moves inside of a pregnant woman, without the visible bump). My body, head, and neck felt stiff. Symptoms were milder after 48 hours, on and off, until 4/13/2021 when I felt a sunken feeling, like something dropped inside of me (sugar, blood pressure, blood rush, I do not know). The tense feeling of the body returned. I felt dizzy. Left arm and leg felt tingly. There were palpitations, but I think that it was due to being scared about all the other symptoms. I felt cold and was shivering. The head felt stiff again. I was very thirsty. In the following days, symptoms got milder. On 4/22/2021, at about 4pm, the sunken feeling returned, along with the dizziness, wave or bubble-like sensation through head, face, body. The wave-like sensation flashed across my face, head, and neck intermittently. It was hard to speak, pronounce words, and swallow. The tongue felt numb. It lasted about two hours. I felt exhausted, so I took a nap until 8pm. When I woke up, I felt like nothing had happened, no symptoms until 1:00 am. At 1:00 pm, 4/23/2021, the sunken feeling, dizziness, palpitations, heavy breathing without shortness of breath, cold/shiver, blurred vision, the wave-like sensation, and pokes suddenly returned. The waves were more intense and felt like pressure on the right side of the head and left side of the chest. Went to the Emergency Room. With every wave of sensations, was accompanied by an urgency to urinate. I urinated like 3 times in a span of 30 to 45 minutes (full bladder). Findings were normal but symptoms continued through 4/24/2021, on and off. Each episode lasts anywhere from 1 to 4 hours. Short lasting, mild symptoms returned Monday 04/26/2021, at night, until Wednesday 04/27. However, that Wednesday night, I felt a belt like, tight sensation around the left bicep and neck. It felt as if I was being grabbed by the left arm. On 4/29/2021, around 5:00 pm, I called an ambulance because all symptoms had returned ?full force?, such as sunken feeling, blurred vision, dizziness (like passing out), intense head and left chest pressure (in waves, like having a huge fish or parasite inside the chest and head), numb mouth (like dental anesthesia), hard to speak (hard time sending the message from brain to mouth). It took great effort to speak and felt that I had to decide whether continue speaking or staying conscious. I also had blurred vision with the first sunken feeling. Symptoms continued 2 to 3 times a day. Since 4/29 a feeling of being inside of an elevator, airplane, or earthquake, and the numbness on the left side of chest and arm remain, even when no other symptoms are present. Also, both arms become numb while sleeping, every night, multiple times a night, since 4/29. Since then, I sleep on 3 pillows (two in my head, one on the shoulders to create an angle) to minimize the numbness of the arms and the head/neck pressure while sleeping. On 5/5/21, symptoms began while car riding as a passenger and upper body felt tight. Strangely, symptoms ended when car stopped moving. Later that day, while walking through a department store, nostrils felt uneven, as if the left nostil were breathing cold air while the right was taking warm air. That night, symptoms intensified (the attack). Like all other times, urinating was too frequent while ?the attack? is present. This time, my body felt sore and tired (Flu-like). There was an intense pressure on the right side of the eye and forehead. The neck stiffness was intense. For the past two weeks, ?attacks? have been less frequent, about 2 to 3 times a week, lasting a maximum of 2 hours. The numbness on the left side of the chest and arm continues. The feeling of something moving or pins/needles may appear sporadically throughout the day. At times, they feel like twitches. The woozy feeling of being inside of an elevator remains. Breathing still feels heavy, like trying to breathe with the face in front of a fan. All test results from the 2 ER visits were normal, including the CT scan. A brain MRI, done on 5/5, was also normal. A 24-hour heart monitor also had normal results.

Thursday pm I began to experience palpitations, indigestion, substernal pain, and back pain between the shoulder blades when breathing deeply. Friday the symptoms continued, particularly in the evening. I began monitoring my blood pressure Friday evening with the electronic arm cuff that we normally use. It is staying abnormally low, ranging between 105/68 - 109/70 on 4 different measures. My normal range stays between 115/78 at the lowest - 130/90 at the highest. Today, all symptoms remain unchanged and blood pressure remains <110/70

14 hours after injection I had normal reactions of headache, nauseous, fever, body ache, but I also had every joint hurt even my knuckles I couldn't bend my fingers neck was stiff I couldn't turn my head and I had the heart palpitations like a racing heart.

Lab test first on 6/20/2021. No Sample available for further testing from this date. 6/25/2021 - Chest pain, Xray (-). Received albuterol treatments and discharged. Told she did not qualify for Regeneron 6/30/2021 - Visit to healthcare facility 07/01/2021 – Admitted Interview on 7/2/2021 case stated she was going to receive Remdesivir Sx onset – 06/18/2021 – Sore throat. Achy, sever headache; worse by 6/20/2021 6/22/2021 – abdominal cramping, vomiting, diarrhea 6/23/2021 – anosmia 6/25/2021 – chest pain On 7/2/21, case was admitted, on O2 (no vent), not in ICU. Chest Xray negative for pleural effusion, blood clots. 7/6/21 case was transferred to ICU.

CHEST PRESSURE; FAST HEART RATE; TEETH PAIN; GUM PAIN; JAW PAIN; LOW BLOOD PRESSURE; MUSCLE ACHES; FATIGUE; SLIGHT HEADACHE; This spontaneous report was received from a 41-year-old, female patient of other (unspecified) race. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, non alcohol user, and non smoker. The patient had no known allergies and no drug abuse/illicit drug use. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 2021421A, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 (1 day post vaccination), the patient experienced symptoms of fatigue, muscle aches, chest pressure, fast heart rate, teeth/gums/jaw pain, low blood pressure, slight headache. The patient's doctor had a suspicion of blood clots and hence, on 14-APR-2021, the patient was hospitalized. The patient got her blood work, chest X-ray, electrocardiogram (EKG), and heart monitoring done and results of all tests were normal and she was cleared. No blood clots were found. On 14-APR-2021, the patient was discharged from the hospital. On 15-APR-2021, she felt a little bit better and then on 16-APR-2021 (two days post hospitalization), her symptoms completely subsided. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, fast heart rate, teeth pain, gum pain, jaw pain, low blood pressure, muscle aches, fatigue, and slight headache on 16-APR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210702888-COVID-19 VACCINE AD26.COV2.S-chest pressure, fast heart rate, teeth pain, gum pain, jaw pain, low blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210702888-COVID-19 VACCINE AD26.COV2.S-muscle aches, fatigue, slight headache. This event(s) is labeled per RSI and is therefore considered potentially related.

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

NAUSEOUS; PULMONARY EMBOLISM; FELT LIKE TRYING TO GET SICK; FELT LIKE COMING DOWN WITH A COLD; This spontaneous report received from a patient concerned a 41 year old African American, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and the patient did not have any history of previous clots and no medical condition reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: 05-AUG-2021) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, after vaccination, the patient felt like she was trying to get sick, and felt like she was coming down with a cold but did not really get sick. On 30-MAY-2021, the patient was working and ended up getting admitted in the hospital on 17-JUN-2021 night at 7 PM. On an unspecified date in JUN-2021, laboratory data included: chest X-ray (NR: not provided) multiple clots in both the lungs, and scan with contrast (NR: not provided) multiple clots in both the lungs and was diagnosed with pulmonary embolism. The physician were not sure if it was because of the vaccine. The patient was hospitalized until 28-JUN-2021 or 29-JUN-2021. The duration of hospitalization was 12 days. On an unspecified date, the patient felt like there was something sitting on her chest, was nauseous so she thought she had food poisoning. The patient had been a little short of breath, thought it was because she just started working out but it was not much noticeable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, and the outcome of felt like coming down with a cold, nauseous and felt like trying to get sick was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210713153-COVID-19 VACCINE AD26.COV2.S-Pulmonary Embolism. 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). 20210713153-COVID-19 VACCINE AD26.COV2.S-Nauseous. This event(s) is labeled and is therefore considered potentially related.

shakiness, dizziness, vomiting, muscle weakness, vertigo, difficulty walking, difficulty raising the left foot, muscle aches, fast heartbeat

Stabbing pains in right hip, numbness upper right leg, pain in leg down to knee. After shot got high blood pressure.

Since the vaccination, my menstrual cycles are not the same. They last way longer and I pass very large blood clots that are not normal for me, to the point that I feel very weak. They have been like this every month since, the pain it?s excruciating at times and I?m not someone that complains, but this doesn?t feel normal.

Started with feeling tired around 6pm, woke up at 3:30 am (ish) to wanting to vomit, shivering, high fever over 103, aweful headache, dizzy, breathing feels labored. Now at 12:30 pm, arm is extremely sore at site, chest still feels funny when taking deep breaths, head still aches but not as bad, not quite as tired.

Three hours after shot: clear runny nose- constant drip. Around 11pm same evening: woke up clammy 6:30 next day: Headache. Very Sore . Felt like I?d been tubing on the lake all day. Took ibuprofen and felt better. Very tired. 9:00 pm: very bad stomach cramps. Diarrhea started around 11pm. Many times. 7:30am next morning (3/10): faster heart rate. Stomach hurt but not as bad. Little headache. Hot and clammy.

Pharmacy knew that patient was experiencing symptoms (chest tightening) at 3:50pm. Unknown the exact time of outset of symptoms. Patient progressed to coughing and shortness of breath. Patient remained responsive. Pharmacist asked patient if she could administered epi-pen. Patient said yes. Pharmacist administered epi pen and call 911 at 3:58pm, pharmacist stayed with patient till paramedics arrived. Symptoms somewhat improved and patient left with paramedics.

Started pretty immediately with feeling overheated like a wave of heat then started feeling unwell or not right then my right hand went numb that was about five minutes after the shot. Told the nurses they took me back in a room took my vitals at that time I started to feel weak like my arms and legs were Jell-O or jelly. I also felt jittery the nurses gave me apple juice and crackers they put me in a private room they check my vitals again my heart rate was elevated and my blood pressure also went up . 02 That?s normalsats normal My feet are they just started to feel numb as well. A doctor came in and checked me out they felt like my exam was normal but they also felt like I might be having a mild reaction around 1500 I started to get itchy but no hives noted I took a Benadryl 25 mg at 1500 around 1515 my feet were still numb but I definitely felt better still kind of felt like my arms and legs were weak but not as bad so after an hour and a half I was allowed to leave and was told to rest for the rest The day and you call or go to the emergency room if I had trouble some side-effects about four hours after the shot my lips did start tingling at home I did check my oxygen saturations and it was normal I look at my lips to make sure that they weren?t swelling the only thing I noticed was that a scar I have on my lip that usually you can?t see was more prominent and you could actually see it my lower back hurts a lot

Immediately after receiving the vaccine, I felt pretty good. Just some soreness in arm and a minor headache an hour later. I took Tylenol and symptoms were bearable the rest of the day. By around 6 or 7p that night, I experienced full body pain and chills, similar to the flu. I also had some chest pain and tightness but attributed that to the overall body pain. I was also very winded and short of breath. I called my Primary Care Doctor to report this, and she said this was a normal reaction and it meant my immune system was working. It continued into the next day, and I took my temperature and had a 102 fever. I slept most of the day and was unable to work. I also had a severe headache. The next day, on Day 3, my flu symptoms were getting better; however, I felt dizzy and short of breath. I also fainted . This is the first time this has ever happened to me. I have never fainted in my life. My symptoms seemed to resolve after eating and drinking, so I figured it may have been dehydration. On Day 4, I was concerned because I was having shortness of breath and chest pain, along with dizziness. I could not take a deep breath without having pain. I called my Primary Care Doctor, and she told me she was concerned I might have covid and to go to the ER. I do not believe I have covid. No one in my household has these symptoms except for me. I believe it is from this vaccine. My chest pain/shortness of breath seemed to go away. for a bit so I did not go to ER. I'm on Day 5 now, and the chest pain/shortness of breath has come back, so I decided to report this because I do not listed on the list of common side effects for the Johnson and Johnson vaccine. I joined a J&J social media group where others are also reporting these symptoms, so I decided to report to Vaers. I also have had night sweats every day since taking the vaccine and my blood pressure is lower since taking the vaccine.

3:30pm Blood pressure/ pulse rate elevated/ low temperature/arm soreness, 4:30pm uncontrollable shivering/ rising temperature/ body aches, 5pm fever 101.4/body aches/took 2 acetaminophen 500mg tablets, 6pm fever reduced, 9pm fever/ took more tylenol, 1am fever/ vomiting/ took more tylenol..... more of the same until fever subsided roughly 28-29 hours after injection

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

Fever of above 104 degrees Full body shaking/trembling Lips turned blue ---Reaction began with body aches and progressed to a fever that started from 101 and quickly climbed and held at above 104. Patient was unable to swallow fever reducers due to fever and body trembling. Physician ordered Tylenol suppositories and Benadryl 50mg for suspected allergic reaction. Suppositories brought fever down to 103 and stopped trembling so patient was able to take Benadryl 50mg orally. Fever continued but was controlled with Tylenol.

Patient was vaccinated with Janssen vaccine. After the fifteen minute observation period, Patient complained of dizziness and was medically assessed. During the assessment, the patient presented with hypertension, but all other vitals signs were normal. There were no signs of allergic reaction. Patient was transported by the Fire Department to Medical Center.

3pm: Immediate body-wide, internal feeling that can only be described as "intoxication." Felt loopy & woozy -- not lightheaded or dizzy. Felt as if I were floating to chair. Sat for 20mins, legs weak, odd sensation across shoulder blades & cervical spine. "Slow" & woozy for duration of evening. Physically moved slow, cognitively slowed down, inability to focus. Internal body-wide sensation difficult to define. All very similar to immediate effects I have from alcohol. Passed out (sleep) 9hrs later & woke 100% fine at 8am.

6 hrs after shot was given the following side effects appeared: 100 degree fever, hot flashes/chills, shaking, chest pain, headache, joint aches. Numbness and loss of color in finger tips. Side effects lasted for 24 hrs. Fever broke within 3hrs of onset.

My symptoms started 12 1/2 after the vaccine. I had body aches, headache, chills, fever, very dizzy light headed, fatigue. Most of the symptoms lasted for a couple days, by Friday the 12th I was fever free and muscle aches went away. The day after the vaccine I blacked out at school, the nurse took my pulse and blood pressure and everything seemed ok. My husband picked me up and I went home to sleep. Sunday the 21st for the firs today I made it through the day without sleeping or having any issues. I did go to the Dr. for a follow up my heart was a little up and down but still within the normal wrong. She told me to take a week off.

Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Additional Details: Patient had a few seconds of syncope after patient came back to consciousness she experienced difficulty breathing that was alleviated by taking off her mask. She was lighted head ed and nauseous while 911 came

Experienced dizziness the first 15 minutes and that evening around 9 or 10 experienced severe chills. and I took one Tylenol for it that night. I woke up at about 05:00 am with a fever of 101.6. My heart rate was elevated - racing heart. I took some more Tylenol -and I tried to sleep but it was hard to. After a few hours, I felt achy and sore but better. Three days later, had a run of skipped heart beats (Thursday) and heart palpitations. I called my regular doctor on Monday and on Thursday, I called the Cardiologist. I take a beta blocker when I have bad heart palpitations and they continued to happen but were better with the beta blocker. Within a few hours, on Thursday, the symptoms resolved. I still have heart palpitations but the vaccine may have increased them.

Increased heart rate immediately following the injection along with ringing in the ears for about 3 hours

Patient reported feeling dizzy, lightheaded, nauseated, and shaky Patient provided with water and seen by medical team, patients blood pressure and heart rate low Ambulance called for medical transport Patient advised and agreed to go to hospital Patient transported to hospital via ambulance

Patient reported having history of having ? vasovagal episodes? Patient reported feeling dizzy and anxious Patient provided water and seen by medical team Patient refused medical transport and signed AMA form Patient?s symptoms resolved

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.

Woke up in middle of night with intense chills and could not breathe. Fainted. Woke up on floor disoriented. Partner was ready to call 911 until I was able to breathe again.

pt states she developed chest pain and pressure last evening after receiving Johnson and Johnson covid vaccine and worse today -- pressure and sharp pains - and hurts to breathe

Light headed, nauseous. 2nd day extreme body aches with tiredness, headache and fever. 3rd day body aches and stomach discomfort and pain on right side of chest.

Pt experienced vasovagal syncope within 15 minutes of vaccination. Supportive care provided and pt recovered without incidence.

About 3 hours after the vaccine was given, I had chest pains and started running a fever. I had acute lower back pain and felt overall very lethargic. The fever continued through the night and broke around 3am. The next morning I felt okay but by 10am started to run a fever again for the remainder of the day and chest pains and headache/body aches were now VERY present. It is now 5 days after the shot and I?m just starting to feel like myself again. The headaches and overall body aches lasted for days. I also had blurry vision on and off during this time. My husband and I workout every day and eat very well. We?re not overweight and don?t smoke. The injection site is still sore 5 days later. I will complete another form for my husband but he experienced the EXACT SAME reactions....every one of them.

Vaccine given at 10:00AM Around 6:00 pm : super cold Around 9:00pm: super cold and achy From 10:00pm-1:00pm the next day: heart racing, difficulty breathing and could only say 2-3 words with one breath, very dizzy, super cold, headache, weak, exhausted, felt like I would pass out, vomited once, diarrhea a few times.

10:45 am 3/11/2021 brain fog or loss of thought process about 3 minutes after shot, heart palpitations, shortness of breath 5:00 pm 3/11/2021 begin running fever, tired, slight body aches 6:00 am 3/12/2021 fever of 100.3, tiredness, body aches, chills, headache, forgetfulness, these continued for approx 24 hours; fever broke 3/13/2021 about 11:00 pm. Continued body aches, head aches, severe dizziness, forgetfulness through 3/17/2021 3/16/2021 went to walk-in clinic due to symptoms; treated for possible ear/ sinus infection and given antibiotic; no real diagnosis for symptoms 3/17/2021- 3/272021 took antibiotics from doctor. Fever went away, dizziness slowly improves 4/10/2021 - continued dizziness, headaches and brain fog, forgetfulness. It is a struggle to pay attention.

Started with feeling a brick on my chest. Them my ribs hurt. Every breath hurt and I couldn?t take a deep breath. The pain spread all across my ribs and up my chest. It hurt to the touch.

1 hour after injection; Jittery/rapid hear rate (lasted for a few hours) Day 2: Extreme body/muscle aches Day 1- present.-pain on injection arm, pain on injection site, redness on injection site, continued swelling of injection site, hot to the touch on the injection site. Day2- present; Fatigue

No side effects until day 5 (Sunday) after vaccination which were: Migraine, nosebleed, light-headed, weakness, easily winded/fatigued, abdominal pain, heavy menstrual cycle, diarrhea. All side effects ended within 24 hours after they started except for heavy menstruation and fatigue.

severe headache, bad bruising, extreme fatigue, very sore muscles, odd sensation in muscles in back bled terribly after injection

Allergic reaction, fever (104.6), tachycardic (+150 bpm), elevated blood pressure, difficulty moving extremities, severe pain, headache

Woke with: Blood Clots in my left arm at injection pt and lower arm, wrist, hand. Blood Clots in my left leg, mainly calf, lower leg, ankle, some in thigh. Larger, more numerically present than in past from antihistamines. None present before Vax, allergen-free diet prevents usually.

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

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.

Body aches, fever, chills, headache, and heart palpitations that started approximately 12 hours administration of vaccine. Fever, chills and body aches subsided within 36 hours. Heart palpitations reduced but continue to occur periodically

30 minutes after vaccination heart started racing very fast and got extremely dizzy. This lasted from 30 mins after injection until the following evening of 4/8/2021. About 1 hour after the vaccination my face, lips and mouth felt numb and were tingling. This lasted a few hours. About 3 hours after the vaccination, was having difficulty breathing. Throat was itchy and felt like was being blocked and my airway closing up. This lasted a few hours. About 3 hours after the vaccination came down with a severe headache that would not subside. This severe headache lasted from day of vaccination 4/07/2021 until Sunday 4/11/2021.

Felt ill and fainted the day after the vaccine. Had persistent headaches and went to the ER on 3/27/21. Feeling better now. Reported to me, her PCP on 4/13/21.

15 minutes after injection: out of nowhere became extremely dizzy, nauseous, and fainted. stayed on floor, drank water, juice, crackers, tried to get up but was too weak and almost fainted again. sweating profusely and cloudy vision so lied back down. After 1+ hour felt mostly better so left . 30 minutes into my drive home felt sudden onset of nausea, left fingers tingling & numbing with save wave of extreme dizziness. Pulled onto median and called 911. My face started stiffening into a pucker like position and my muscles all through my body stiffened, but weakened with sharp tingling. I couldn't stand so they carried me out of car and took me to Hospital. The rooms were full so I was in wheelchair waiting for room, shaking profusely, blue fingers, nauseous, dizzy and couldn't stand on my own. I was able to go to restroom w/assistance but My muscles were stiffened for 1 hour+ and over and i felt awful. over the course of 5 hours I gained strength back and started to feel better with just mild headache and nausea. They did EKG, blood panel and chest xray which looked ok. Diagnoses as allergic reaction and told me to come back if more issues. The day after shot and every day since have had a headache at base of neck and pressure in cheek/forehead + nauseau + dizziness and extreme tired. Today is 14th and no headache today.

24 hours post (4/11) n/v, chills, fatigue; 4/14 numbness/tingling R arm (opposite); chest tightness. local site small swollen, red area;

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 SEEN IN THE EMERGENCY ROOM WITH SHORTNESS OF BREATHE, INCREASED BLOOD PRESSURE, INCREASED HEART RATE, HEADACHE, AND PAIN IN THE NECK/ARM ARM AREA. STILL UNRESOLVED.

Date of vaccine 4/5/2021. Date of adverse event: 4/15/2021 acute onset of worst headache of life and imaging consistent w/ subarachnoid hemorrhage likely from rupture of anterior communicating artery rupture. She was seen in ER and transferred to Hospital and is admitted, awaiting cerebral angiography. Has not had an intervention. Available records will be faxed today to your fax number listed.

PATIENT COMPLAINING OF GENERALIZED JOINT/MUSCLE PAIN, NAUSEA BEGINNING ON 4/9/2021, PATIENT FAINTED ON 4/12/2021 AND HAS COMPLAINED OF LACK OF ENERGY AND INABILITY TO EVEN HAVE STRENGTH TO HOLD HER HEAD UP AS OF CURRENT DATE FROM DAY AFTER VACCINE ADMINISTERED

NERVE PAIN IN LEG AND ARM; EAR ACHE; FELT COLD; CHILLS; JOINT PAIN IN KNEES; HEADACHE; PRESSURE IN CHEST; NO SLEEP; 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 penicillin allergy, and restless leg syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced no sleep. On 10-APR-2021, the subject experienced pressure in chest. On 10-APR-2021, the subject experienced ear ache. On 10-APR-2021, the subject experienced felt cold. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced joint pain in knees. On 10-APR-2021, the subject experienced headache. On 10-APR-2021 03:00, the subject experienced nerve pain in leg and arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no sleep on 10-APR-2021, was recovering from nerve pain in leg and arm, and had not recovered from joint pain in knees, ear ache, pressure in chest, felt cold, chills, and headache. 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.

CHEST PRESSURE WHICH FELT LIKE INDIGESTION; ABDOMINAL PAIN; DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a 42 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: 043A21A, and 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 difficulty breathing. On 13-APR-2021, the subject experienced chest pressure which felt like indigestion. On 13-APR-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain on 13-APR-2021, had not recovered from chest pressure which felt like indigestion, and the outcome of difficulty breathing 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.

RACING HEART RATE; TACHYCARDIA; HYPERTENSION; This spontaneous report received from a health care professional via the VAERS (Vaccine Adverse Event Reporting System) concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 13:55 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced racing heart rate. On APR-2021, the subject experienced tachycardia. On APR-2021, the subject experienced hypertension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the racing heart rate, tachycardia and hypertension was not reported. This report was non-serious. This case, from the same reporter is linked to 20210415566 and 20210441555.

pt developed symptoms after taking covid vax. She has extreme fatigue, has SOB, loss of appetite, body aches, headache, lightheaded, dizziness, and vomiting. Pt feels as if she is going to die. She is in the woman's corrections facility. She has had blood work and told she is loosing blood. Her hemoglobin is 7 and she is anemic. She is still waiting on more labs results.

24 hours after rec' the vaccine she had started her cycle with blood clots. Her cycle did not come on that day. She had to use the bathroom no matter what time for it to come on. Doctor office, Doctor perfomed a series of lab test. Doctor states that she is getting blood clots and think it may be from the vaccine. SHe had her cycle for 16 days straight and now has become anemic.

Fainted approximately 2 minutes after injection. Woke up approximately 1 minute later and immediately vomited.

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

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

Patient began experiencing chest tightness between 10-15 minutes after vaccination, followed by throat tightness and tongue thickness. Banophen (diphenhydramine) 50 mg administered PO. Shortness of breath began about 10 minutes after initial complaint, at which time epinephrine 0.3 mg was administered IM R thigh. Patient reported increasing shortness of breath and tightness of chest and throat, 0.3 mg epinephrine administered again IM left thigh about 6 minutes after previous dose. Patient requested additional diphenhydramine, so 50 mg Banophen administered PO. Continued increasing severity of symptoms, another epinephrine 0.3 mg IM right thigh 7-9 minutes after previous dose. Patient care was then transferred to EMS services.

KNOT ON THE BREAST; MOOD SHIFTING; HEART RACING; FELT SICK; VARICOSE VEINS AGGRAVATED; SLUGGISH; FELT HOT; SWEATING; DIZZY; SORENESS IN EXTREMITIES; HEAVINESS IN EXTREMITIES; COLLAR BONE PAIN; 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 varicose veins, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. breast cancer runs heavy in the family. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced collar bone pain. On 01-APR-2021, the subject experienced soreness in extremities. On 01-APR-2021, the subject experienced heaviness in extremities. On 02-APR-2021, the subject experienced varicose veins aggravated. On 02-APR-2021, the subject experienced sluggish. On 02-APR-2021, the subject experienced felt hot. On 02-APR-2021, the subject experienced sweating. On 02-APR-2021, the subject experienced dizzy. On 02-APR-2021, the subject experienced felt sick. On 03-APR-2021, the subject experienced heart racing. On 17-APR-2021, the subject experienced mood shifting. On 03-MAY-2021, the subject experienced knot on the breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt hot, sweating, dizzy, and heart racing on 2021, was recovering from sluggish, and varicose veins aggravated, had not recovered from soreness in extremities, knot on the breast, and heaviness in extremities, and the outcome of mood shifting, collar bone pain and felt sick was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

ELEVATED D DIMER; ITCHY AND UNCOMFORTABLE RASH ( BOTH LEGS AND RIGHT FLANK); This spontaneous report received from a health care professional concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no other pertinent medical history shared. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number:1805018 and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced elevated d dimer, and itchy and uncomfortable rash (both legs and right flank). Laboratory data (dates unspecified) included: Blood test (NR: not provided) Platelets, white blood cells and red blood cells are normal, and Fibrin D dimer (NR: not provided) weakly positive. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from itchy and uncomfortable rash (both legs and right flank), and the outcome of elevated d dimer 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.

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.

BODY ACHES; CHILLS; FEVER; DEEP VEIN THROMBOSIS; This spontaneous report received from a patient concerned a 42 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: 043A21A, and expiry: 21-JUN-2021) 1 total, dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient had body aches, chills and fever. In APR-2021 (a week after vaccination), the patient experienced right leg pain and felt heavy and visited her primary care physician who recommended ultrasound scan of the leg. On 10-MAY-2021, the patient's ultrasound scan revealed deep vein thrombosis and she was treated with unspecified blood thinners. The patient was also put on Xarelto (rivaroxaban) therapy 15 milligram for 21 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever on 11-APR-2021, and the outcome of deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210520235-covid-19 vaccine ad26.cov2.s -Deep vein thrombosis. 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.

1 1/2 weeks after the vaccination, got a headache then started not feeling well. Treated for sinus infection and things worsened from there. Total of 4 ER visits, ultra sound scan, brain scan, lung and heart xray, and countless pcp visits. I am now suffering from high blood pressure and severe anxiety that has kept me at home. I have still have cardiologist appts and blood work scheduled.

10 Hours after, fever, sweating, very thirsty. 3 Days after vaccination, heaviness in my chest, breathing problems, very tired. Thought it would get better did not. Went to Hospital Emergency Room on May 22, 2021. D-dimer was elevated. Dr was concerned about blood clots. The hospital did a CT Scan of my chest with dye. Did not find any evidence of clots. I was released and told this could be a side effect of the Johnson & Johnson vaccination. I was told to monitor if it doesn't go away or get worse follow-up on further investigation. Was also told to report this side effect. I still have the heaviness and pressure in my chest as well as a bit of breathing problems.

Numbness, blood count platelets went very low. April 11th. Swollen, migraines, inject in Left arm. Does not usually get side affects. Was given prednisone, did not lessen symptoms.

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.

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.

Client rec'd vaccine at 9:05. Around 9:15 she verbalized that her heart rate was going very fast, that her chest was tight, and that she was having trouble moving her hands. Client appeared very pale and was breathing rapidly. Emergency response was called and 0.3 mL dose of epinephrine was administered around 9:20am. BP was 110/68, HR was 95, pulse ox was 96%, respiration elevated. Emergency response arrived and vitals remained stable. Client decided not to be transported to a hospital. Client was alert and oriented the entire duration of her reaction. Client was ambulatory when she left the clinic around 10:30am.

April 17th, 2021 - Feeling jaw and ear pain in AM. Progressed to severe chest pain, shortness of breath, chest tightness. Went to ER. Elevated Troponins(hi specificity) x 2 over 2 hrs then improved. Pain persisted for hours, Medrol dose pak for 6 days did not improve symptoms. Continued symptoms for over greater than 6 weeks continues to come and go intermittently lasting 15 minutes at a time 5-6 times per week. Not associated with activity or eating. NSAIDs continuously diminish symptoms.

Client was waiting in observation 30 mins when she asked EMTs to check her blood pressure as she was feeling palpitations. First vitals at 1512: blood pressure 158/100, pulse 82, oxygen 98%. PHNs arrived shortly. Client sitting in chair, alert and oriented x4. Per client had reaction to Pfizer first dose and medical team had recommended Janssen as second dose instead. Per client feeling nausea, headache, and palpitations. PHN gave client emesis bag. Client assessed for swelling, flushing, per client no shortness of breath at this time. Retake of blood pressure at 1513: 150/100. Per client history of hypertension, diabetes, thyroid, and took her medications today. No other allergies except Pfizer vaccine. 1515 client reported feeling warmth sensation to throat area and feeling itchiness. Per client it was same reaction to Pfizer vaccine. PHN asked client if she drove, per client had family outside waiting. PHN offered client Benadryl and client accepted. PHN administered 50mg IM on right deltoid at 1519. Vitals: pulse 107, oxygen 98%. At 1522 client stated stronger itchy throat and felt like it was starting to close. No swelling noted, per client feeling tingling around lips. Client stated shortness of breath, unable to take deep breaths. PHN Ae called 911. 1524 pulse 104, oxygen 99%. Per client feeling very dry mouth. PHN kept speaking with client, alert and oriented x4, able to answer all questions in short answers. 1527 pulse 103, oxygen 99%. Client stated feeling warmth in throat area again, began coughing intermittently. Per client new onset of strong headache to occipital area, dizziness and chills. 1531 paramedics arrived and assumed care. Client transported to facility via gurney at 1540.

Patient was given 0.5mL of Janssen vaccine IM into her right deltoid muscle. Post vaccine patient, fainted during the 15 minute wait period. She was promptly attended to, and did not exhibit signs of anaphylaxis. EMS came to assess patient even though she felt "completely normal" after she fainted.

Patient described: April 3rd, 2021: Normal COVID19 vaccine symptoms including fever, headache, and body chills, April 10th, 2021: Dizziness, unbearable headache on the left side of the head, constant/continuous headache (headache will not go away), complete hearing loss on the right side, and nose bleeds. April 14th, 2021: Visited clinic with symptoms that initiated on April 10th, 2021. New symptoms include vision impairment including white lines, black and yellow spots, and blurred vision. Additional symptoms: constant headache, dizziness, vertigo. The clinic advised that they could not help with treatment due to a possible link with the vaccine. Receiptionist unable to refer the patient to a hospital no reason provided. The clinic could not help. Gave patient the option to go to the hospital if the patient could not breathe. After April 14th, kept attempting to make an appointment with a healthcare provider. No response from clinics. Symptoms described continued and did not get any better. Received appointment at the Clinic for May 17th. Immediate referral to a specialist on May 18th. MRI scan gave on May 18th. Diagnosed on May 24th with a brain aneurysm. Brain aneurysm treatment will begin June 14th, a catheter will be inserted to identify the brain aneurysm location. Permanent damage has not been outrulled.

2 days of terrible chest pain I didn?t go to the dr because we were in the mountains when the pain started. The people I was with thought it was possibly dehydration or affects to altitude. It lasted 2 days and began to lessen on the 3rd day.

within 15 minutes, I had an immediate headache. Over the next 72 hours, my headache worsened and a firefighter friend came to check my blood pressure. It was 240/110 for the next 4 days. I had not had blood pressure problems before. I also developed a rash on my legs that appeared at hour 26 after the vaccine but resolved after 48 hours of the vaccine. My heart was racing and extreme headache persisted. My cardiologist saw me and put me on a heart monitor and had me record daily blood pressure numbers. On day 18 after the vaccine all symptoms mysteriously resolved. The doctor continued to monitor for 30 days total and then we decided if anything serious were to happen, it would have by then. So monitoring discontinued. I had not blood pressure problems before. Now its somewhat higher but within acceptable ranges (140/90 now)

woke up gasping for breath, difficulty breathing, chest constriction with pain, heart pressure, pulse pressure in shoulders, neck and top of head treated with Cardio Care and Aconitum Napellus 30 C every 1/2 hr to 1 hr depending on symptom expression and walking and staying up right caused improvement of symptoms. Laying down and lack of movement cause symptom worsening, difficulty in breathing and increasing chest & heart pressure

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.

Patient received J&J vaccine on 4/7 and suspected to have CVST on 5/5 when she presented to hospital with significant headaches and seizures. Patient was started on bivalirudin and steroids and given 1 dose of IVIG. Unclear etiology, patient followed by Neurology and Hematology to determine anticoagulation and management of headaches.

Patient developed shortness of breath and fast heart since receiving vaccine. No tachycardia in the emergency room. Blood pressure = 153-92

no reaction at first, since then issues with fatigue, joint issue, muscles aches. Then Blood pressure began to rise and jump, has gone as high as 220/120 then it will come down and then bump up again.. Problems producing urine, sometimes empties and sometimes not.

local reaction on left arm, red, warm and 3" red circle, increased HR 100-110 BPM (my normal is about70)

At 5:30 pm, I started to have a headache, so I took some Tylenol. I started to feel a little better. From about 7:00 pm to about midnight, I felt awful. I couldn't walk down a short hall without assistance. I was so sore and achy I couldn't really sleep. I felt insanely hot, yet had chills and I had a terrible headache. I am type 1 diabetic, and my blood sugar spiked to over 200, where it hovered between 200 & 300 most of the night, despite the fact that I used insulin to try and lower it. From 10 pm to midnight, I felt nauseous. Overnight was ok. I still had some of those symptoms, but could sleep off and on. I probably woke up every couple of hours. I was till very sore and hot, but not as hot, and still had a headache. Today, I took Tylenol this morning. I still have a mild headache, sore body, tired and a little slow, but significantly better than last night.

About 10 minutes after pt received the vaccine, she started to feel dizzy. After that, she developed a racing heart and dry mouth. She has a history of palpitations. EMS was called to evaluate her

Patient received the vaccine and went to sit down in the chair. Patient stated she started feeling nauseous and light headed so asked if she can wait outside for some fresh air. When she went outside, she sat on the edge of the stairs and fell backwards and passed out. The store manager was there to catch her before her head hit the pavement. Patient wasn't alert for about 2 minutes. Pharmacist came out and assessed the patient and she was communicative. She was in and out but was able to tell us her name, DOB and where she was. We sat her up, gave her some water, and waited with her. She requested not to call the ambulance. I checked her pulse at 1:15pm and it was 92. I checked her pulse again at 1:30pm and it went down to 72. Patient was fully alert and speaking in full sentences by 1:35pm. She called her mom and was able to stand up without feeling dizzy. She walked to the car with assistance and was driven home by her mother.

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

covid 19 vaccine event .. Client received a covid 19 Janssen vaccine and shortly following complained of breathing issues. Client reported her chest felt "Tight" and she felt like her blood pressure was "High" Client also reported that she takes blood pressure medication daily and was advised by the Dr. present to take another 12.5mg of her HCTZ. Initial Blood pressure was 178/115 and the second in 5 minutes was 174/109. Pulse 100 both times. oxygen saturation 99-100% EMS responded and client was discharged home by Dr following improvement in chest tightness and breathing. Advised to seek emergency services if needed following discharge.

I got the chills, nausea and was very tired. I went to bed and woke up with a fever higher than 104. I was extremely sick. I had tightness in my chest and the worst headache. I felt like I should have gone to the hospital. Even after Advil and Tylenol, I had a 102 temperature. I am still weak, tired and nauseous, but my fever is gone. It?s been 33 hours and I?m just beginning to feel better!

Pt was in observation and had witnessed syncopal event. Is prediabetic and had not eaten that day. Witnessed by nurse. 911 called, assessed and transported to hospital.

Bodyaches, sweats, chills, fast heart rate(130?s) and dizziness, felt like I could faint. Eyes felt like they moved funny and threw off my balance. Had to hold onto wall. Symptoms started about 9 hours after vaccine. Still having weird balance issues when walking and slight bodyaches and I am over 36 hours after vaccine.

@7pm on the evening of the vaccination, I developed weakness, severe chills, body aches, muscle pain and a severe headache. @7am on 3/26/21 severe chills subsided but weakness, severe chills, body aches, muscle pain and a severe headache remained. Left arm shot site pain started. @1pm on 3/26/21 muscle pain (left side of body neck, underarm, pectoral, lower back, and calf muscles) as well as shot site pain remained. 3/27/21 - 3/28/21 muscle pain subsided as shot site pain remained and redness of the area and below the area grew. @7am on 3/29/21 Shot site pain and redness of the area and below the area grew even larger. the shape of a snowman: the top (shot site) the size of a nickel. the bottom the size of a golf ball. Area has a knot in the muscle and is hot and extremely tender.

Started in the evening of the 24th, I had a very sore swollen throat. Next day, about noon, I had a cough and severe congestion. Still painful swollen sore throat. By that evening, my chest was tight and I was having difficult breathing because of swollen throat. I called doctor, 26th, and got some meds. He gave me Singulair and Flonase and a cough suppressant - Benzonatate. I am almost back to normal today - just still have some congestion and a little bit of a cough.

Developed red rash along left side of face and neck followed by mild pruritis. Then, developed tachycardia with normal blood pressure and mild shortness of breath. Then, nausea and vomiting. Treated with epinephrine .3mg and .5mg five minutes later due to lack of improvement in symptoms. Transported to hospital ER. patient reportedly felt much better by arrival at ER.

At 11:30pm I started shaking uncontrollably which lasted for nearly an hour (my husband thought I was having a panic attack, but I told him no it wasn?t stress) - (the only time I had a panic attack was as a teenager from a roller coaster and just once). In addition to the shaking, I ran a fever of 102 F, and my heart began racing - my husband is an RN and he checked my blood pressure which was normal and my heart rate which was 122 ( normal for me is about 72). Until about 6am my heart continued to race, and even with Advil and Tylenol my fever didn?t stop until the next morning. The next two days I felt pretty beat up, had a headache, and have been very tired.

Patient felt dizzy during 15 minute wait time after given Janssen COVID19 vaccination and wanted to lay down on the floor but stressed that she was fine and just needed some water. Patient was not feeling better after 15 minutes so 911 was called at 4:59PM and a member of management was called for a Code White to report to the pharmacy. The Rescue Squad arrived at 5:08PM and started to assess the patient. BP: 100/70 and BG: 113. Patient states that this has happened before but not after a vaccination. All vitals were normal but patient was still fainting in an out, Emergency Squad recommended patient and husband to go to the hospital for further observation.

Patient had some chest tightness about 10 minutes after vaccine administration (about 11:20am). I Considered the use of epipen, but she had no complaints of difficulty breathing or throat symptoms. She is an asthmatic, I called her MD, obtained a Proair inhaler and gave it to her since she did not have her inhaler with her. About 15 to 20 minutes after, she was feeling better. I had her wait until 12:28pm before I gave her the ok to leave

patient felt "dizzy" and noted to be pale, assisted to lying position, wheel chaired to extended observation but not admitted, discharged home

Woke up at 3:00am after going to sleep at 11:00pm with a racing heartbeat. My heart rate was 140 bpm for 2 hours and then finally slowed to 100bpm. I did have a fever 99.6 during this time. I took 800mg of Motrin at 4:30am which broke my fever.

Started feeling chills/dizziness/fatigue with fever 8 hours after vaccination with elevated heart rate that continued for 12 hours until heart rate came down, fever and fatigue persisted for another 16 hours. Still feeling weakness and dizziness as of 4/8 but otherwise no other persistent effects.

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

chills, shaking uncontrollably then skin on fire, sensitive to touch, severe sweating, headache, pressure on chest. rapid heart beat, body aches

PER PATIENT: APPROXIMATELY 1 HOUR POST-VACCINATION, A.C. STARTED TO EXPERIENCE NAUSEA, NUMBNESS AND TINGLY SENSATIONS, RASH ON ARMS, LEGS, SWELLING IN ELBOWS, KNEES, CHEST PAIN, CHILLS, SLIGHT SHORTNESS OF BREATH. THESE SIDE EFFECTS PROGRESSED AND WERE WORSE 4 HOURS POST-VACCINATION. THE DAY AFTER VACCINATION, AFTER REGISTERING WITH V-SAFE, A REPRESENTATIVE CALLED A.C. AND TOLD HER TO TAKE 75 MG DIPHENHYDRAMINE. THE REPRESENTATIVE STATED THAT A.C. WAS HAVING A MODERATE REACTION TO THE VACCINE (A.C. DID NOT EXPERIENCE ANAPHYLAXIS). MOST OF THESE ADVERSE REACTIONS IMPROVED AFTER TAKING THE DIPHENHYDRAMINE. TODAY, 2 DAYS POST-VACCINATION, A.C. IS NO LONGER HAVING ANY SIDE EFFECTS AND IS RECOVERED.

An odd ache here and there during the day, then at night muscle aches all over the body, chills, slight fever, headache, fast heartbeat. No treatment until morning. Took acetaminophen in the morning, helped with the aches. Heartbeat came down on its own by morning.

elevated HR, lots of anxiety, hives by injection site that went away the next day. high temp of 101 the next morning, headache and whole body hurts.

Severe burning sensation when injected. Extremely sore arm once injection removed. Directed to park car for to be monitored for 15 minutes. Parked the car. Car was in park but still running. Attendant at the clinic instructed me to move my car forward. I put the car in Drive and as I moved forward I lost consciousness. Completely blacked out. Unconscious in the car, the car carried on moving forward and crashed in parked car. I came to once someone tried to wake me up. Presently have no smell and have been very tired with the chills. I was sweating in my sleep, shivering and woke up in a wet bed from all my sweat. The next day I am just weak.

chills, fever got up to 103.8, body aches all over, skin all over felt like a sunburn, nausea, vomiting, headache, fatigue, pale, clammy, chest tightness, tachycardia

Within 5 minutes of shot I was nauseous on scale of 1-5 1 being hardly and 5 being Extremely I was 4. This remained at a 4 for over 36 hours. By 930 pm approximately 12 hours after shot I was running a Very high fever and had EXTREME chills, body aches, latharic and my arm hurt bad. There was no discoloration or swelling in the arm however. I expected these side effects but they were so much worse then expected or discribed. My husband had same effects. We are both very healthy and active young adults. This felt like a SEVERE 24 hour flu. Not, "flu-like". I would be very afraid of we had ANY underlying health conditions. Also my heart had a cramping burning pain that came and went. No fluttering, it felt like the muscle was contracting around my heart or the actual heart was contracting and staying contracted for about 5 minutes at a time. This occured only to me and happened about 3-4 times withing the first 24 hours with the first experience while I was at the pharmacy being monitored for the 15 minute post shot. I have no known underlying heart issues and have never been diagnosed with any heart problems or been seen for any such issue. But it was real and it was scary. I took 1, 500mg tylenol at 930pm the day of the shot for the fever and aches. I took 1, 500mg tylenol at 9am the fallowing morning, as I was still experiencing aches and a low fever. It has been 48hours and I am still feeling lathargic. But more as expected.

Pt c/o throat throat itching, , Benadryl given. Epipen given after no resolution and for c/o chest tightness and sob. EMS galled to evaluate, refused transport

43 y/o female reports "throat closing up" 10-12 minutes after receiving Janssen vaccine at 12:43pm. Patient with intractable, non-productive cough and dry heaving. Elevated blood pressure however oxygen saturation and pulse remained within normal limits throughout assessment period; 12:53-1:23pm. Medical doctors with verbal order for Epi Pen administration. 1:23pm Epi-Pen administered. Paramedics were already on site and took over patient care at 1:24pm. Patient transferred by ambulance to hospital for emergency care at 1;33pm.

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.

Metallic taste in mouth within 3 minutes of Injection lasting overnight,104 degree temperature for 7 hours, severe chills, severe body aches, racing heartbeat , unable to sleep. I currently have low grade fever, body aches, headache, moderate low back pain Me

Vaso vagal syncopy symptoms developed while sleeping. Brief shallow breathing, not responsive to verbal questions for 2-3 minutes. History of Vaso vagal responses to shots as child, but not for past 20 years. Symptoms this evening were consistent with experience as a child .

c/o dizziness, nausea and shaking. BP elevated and tachycardic. Blood glucose 110. Started to resolve and then felt worse again. Transported by POV with husband driving to Er. Refused 911.

Fever Severe Cold/Chills Fatigue Headache Nausea Body Aches Chest pressure Knot (perhaps a clot in left leg behind the knee)-(still as of 4/13) Severe on-going Dizziness (still as of 4/13)

Rectal bleeding about 5 days after vaccine, lasting for 3 days now. No SOB, CP, palps, dizziness, petechiae.

Profuse sweating, light headed, hard to hear, almost fainted within minutes of receiving the shot. Was fanned, given orange juice and a cool towel. After 30 minutes I felt okay to leave the pharmacy. Felt lightheaded the rest of the day and really out of it. Developed a fever later that evening that ran throughout the night. Loss of appetite for 3-4 days. Diarrhea on day 4. Pain in arm at injection site for 4 days.

Patient reports receiving vaccine at 4:00pm 4/7/21. Around 12:30am on 4/8/21 she developed severe nausea, vomiting, diarrhea, lethargy, confusion, and syncopal episode. Went to ER at 4am and was given IV fluids, nausea meds, labs. Was told a liver enzyme was elevated. Sxs persisted. She was seen for f/u at urgent care on 4/12/21 c/o upper abdominal pain and cramping, persistent nausea and vomiting, diarrhea, lethargy, dry mouth, dizziness. Patient was referred from urgent care to nearby Emergency Room for IV fluids and further evaluation/treatment.

On Wednesday April 7 started to feel like she was getting a cold. Because her husband tested positive for Covid April 6 and her daughter's were showing symptoms, she and her daughters were tested. All of their tests were positive. So her first positive test was April 7th which was a PCR but was taking long to come back so she got a rapid test on April 9th and that was positive as well. She had cold like symptoms, a low grade fever that never went above 100.0 and cough for about 5 days. She felt tightness in her chest but no shortness of breath and her pulse ox was 98-99. She took Tylenol every 6 hours as needed. The cough and fever resolved after about 4 days but the nasal congestion is severe and very uncomfortable. She also has a burning sensation of nose and no taste or smell. She is also very fatigued but able to maintain ADL's and care for her family.

I felt very dizzy about 15 minutes after the vaccine. The girl next to me that had just had it had a seizure so thought it was nerves at first. That went into pressure in my head, my tongue got numb and started to swell, started coughing up blood. I took prednisone and used my epipen. When I got home I was terrified to go to the hospital. The oral swelling subsided. The head pressure lasted at least 12 hours. My bp was real low (70/45). It did slowly come back up. Cough and chest congestion is still present. Brain fog. Fever lasted about 4 days. This is the second report I?m putting in. I did not hear back on the last one submitted 4/8

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.

Began face numbness across cheek bones, eye pressure, dizziness when stood. Went to ER , everything in normal limits, CT clear. 3 days later blacked out driving, husband in car took me back to er labs still normal values had PVCs. Now wearing cardiac monitor waiting for cardiac consultation. No previous cardiac issues nor cardiac family hx.

Lightheadedness and exhaustion set in 15-25 minutes post injection. Later that same evening, experienced nausea, muscle, bone, and joint aches as well as chest pain that were much reduced by the following morning. Malaise continued as did symptoms of nausea without vomiting. 24 hours post injection, experienced a low grade fever of 99.6 F (for me, this is a low grade temp). Fever broke after another 24 hours. Experienced severe headaches in the middle of the forehead for 8-12 hours on 3/25/2021, 3/29/2021, 4/3/2021. Experienced difficulty breathing 3/30/2021. Woke up from deep sleep feeling starved for oxygen and a sensation that a deep enough breath could not be taken--the lungs could not expand enough. Respiratory rate seemed slightly depressed. It passed after about 30 minutes with focused effort on taking deep, regular breaths. Fell asleep again and did not consult a medical provider about it. The oxygen hunger / breathing issue did not repeat. Medical professionals were not consulted for any of the episodes described above.

Patient presented with leg pain and shortness of breath to the emergency department. Was subsequently found to have a DVT

Immediate extreme pain in the injection site. Subsided slightly within the first 15 minutes. As the day went on, started feeling more soreness and headache. By 7 pm that night, I was extremely fatigued and nauseated. Pain very bad in my arm that night to where I could not sleep. Each day that has gone on, I have had worsening fatigue, headaches, and an increase in my heart rate, and a decrease in my blood pressure. I've had an increase in brain fog and an increase in sleep issues. The pain in my arm went away after 4 or 5 days.

At 8 hours post vaccination the following symptoms occurred: muscle pain and weakness, 104 fever, pain at injection site, shortness of breath, dizziness, vomiting, diarrhea, tacchycardia, fatigue headache, and profuse sweating. These symptoms continued for 4 days. Three days after vaccination pain in left calf started. Still continues to present day. Hot flashes started with fever have continued, and continue to present day. Hot flashes and night sweats cause to wake at night. Hot flashes continue 12 or more times each day.

Left leg hurting bad, cramping really bad, Charlie Horses, knee hurting and calf muscle area, my sugar levels were a little higher because of the pain for the first 72 hours now just a little elevated

7:00 started chills 9:00 started fever 101.8/chills/fatigue 10:00 fever 103.2 /chills/ fatigue/ headache/ nausea / crazy sweats continues until Monday Morning of the 12th fever drops to 101. 8 Diarrhea started Sunday stays that way until Monday after noon . Puking starts and diarrhea continues until Weds. Headache gets milder everyday still need aspirin to keep under control. Sweats are still happening. Went to hospital Tuesday because my legs felt like lead. High BP

Pt reports shortness of breath at rest and exertion; headache and nausea; reports that she is using her inhaler much more than usual and "I don't feel like myself"; she denied any change in vision or speech; she reports that she has been having issues with her left hand shaking as well as "racing heart" that self terminates

7 hours after: temperature spiked to 103 within the course of an hour. 8 hours after: chills so severe I considered seeking urgent care, wondering whether they were seizures. 12 hours after: felt some sort of mass move through my heart, wondered if it was a transient ischemic attack; but nothing followed. 7 days after: bridge of nose (only) turned red, almost burgundy, unusually/ strangely/ heavily flushed; woke up with unexplained headaches for 3 out of 4 days that week (and I never get headaches). 12 days after: nose flushing had faded; no more headaches; but routine exercise (even stairs) feels unusually/ markedly more difficult. 4 weeks later: gradually beginning to run/ jog again, slowly improving times/ getting back toward normal cardiopulmonary strength.

after my hour drive home I started to feel tingling sensation in both legs and pain at the front where my foot meets my leg ankle, some chest pain, labored breathing for about 3 days and on the 6th day leg pain has come back. I am currently struggling with my right leg in pain hard to walk sometimes.

LIGHT-HEADED AND DIZZY; BODY ACHE; LEFT LEG THROBBING; INCREASE HEART RATE; HIGH BLOOD PRESSURE; NAUSEOUS; FEVER; HEART RACING; CHILLS; WEAKNESS; 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 high blood pressure, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced heart racing. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced weakness. On 07-APR-2021, the subject experienced increase heart rate. On 07-APR-2021, the subject experienced high blood pressure. On 07-APR-2021, the subject experienced light-headed and dizzy. On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced left leg throbbing. On 07-APR-2021, the subject experienced nauseous. On 07-APR-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) 130/105 mmHg, and Heart rate (NR: not provided) 110bpm. On 08-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 140/103 bpm, and Body temperature (NR: not provided) 99.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increase heart rate, and had not recovered from light-headed and dizzy, nauseous, body ache, fever, high blood pressure, left leg throbbing, weakness, heart racing, and chills. 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.

fatigue, chills, body aches, brain fog, difficulty concentrating, chest pains, earlier menstruation, pain at injection site into arm, back and chest. Sought treatment due to chest pains.

On April 16th, I started having heart palpitations. Racing of the heart. It?s bothersome when I eat. Pain in the upper back. Discomfort in the chest.

The night after I received the Johnson and Johnson vaccine I had 101.7 fever, chills, shaking. The next two days my hands got really dry and the skin peeled off them. 3 days later I fainted.

Day after Janssen vaccine: Patient called the Health Department on 4-9-21 at 11:45am to report that last night she reported that her face and lips were "hot" to touch, felt sunburnt, and when applying lotion it burns her face. I encouraged her to use cold compresses to face and if short of breath or swelling of tongue to immediately seek emergency medical attention. Encouraged her to reach out to PCP if rash symptoms worsen. Patient, presented to the ER on 4-16-21 due to rash to her neck, torso, and BUE and pain to her joints. The patient reported that she received the Janssen Vaccine 8 days ago and within 15 minutes of receiving it she became flushed and feeling unwell. The nurse at the vaccination clinic monitored her. The patient saw her PCP 4-15-21 and was started on Hydroxyzine q6. The patient states that she was feeling better, but now her symptoms are increasing with severity. The patient denies that she is currently on steroids and says she does better with liquid steroids. The patient BP was elevated on arrival at 171/107. The patient reports that her BP is high in clinical settings . She had a stress test by Dr that was normal and her PCP is going to have her monitor her BP at home before starting antihypertensives. No other complaints at this time.

Janssen COVID-19 vaccine EUA Patient presented to hospital after crushing chest pain and syncopal event. Found to be hypotensive and hypoxic and echocardiogram revealed RV dilation and dysfunction with clot visualized in R atrium of heart. Patient received IV alteplase followed by start of IV heparin infusion. Currently intubated in ICU, on 3 vasopressors for shock.

Patient had vaccination 4/7/2021 and started having symptoms 04/25/2021 arrived at the ER today with hypoxia

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild

COVID-19; BRONCHITIS; This spontaneous report received from a consumer (patient's husband) concerned a 43 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered at Left Deltoid on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient was given a dose of the vaccine and she did not show up. On next day 10-APR-2021, she started shivering very badly and was feverish. On 11-APR-2021, the patient also had a headache. On 12-APR-2021, all symptoms gone. The next day on 13-APR-2021 when she got up she had chest tightness and went to doctor due to fever, chills, headache resumed. Since that day was the clot information in the news and they did testing for clot stuff which was all negative. Also the patient diagnosed with bronchitis. After the 13th she had 'on/off' days of experiencing symptoms. On 16-APR-2021, she tested for covid-19 via 'non-rapid' test and the results of test came on the 17th were positive for covid-19 (diarrhea, vomiting, chest tightness, shivering, chills, headache, feverish and nausea). On 17-APR-2021, she developed diarrhea and vomiting. By the 19-APR-2021, they went to the hospital where she received unspecified fluids and pain pills for the fever and to calm her down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bronchitis and covid-19 was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210443606 - Covid-19 vaccine ad26.cov2.s-Covid 19. 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.

Nausea, diarrhea, headache, rash on chest, shortness of breath, loss of color in face, dizziness, light-headed, extreme fatigue (could not drive home from site), elevated blood pressure

Patient present to ED on 5/3 with leg pain. found to have blood clot in left leg via ultrasound. started on rivaroxaban and discharged

1st few days expected to be sick. Then the ?pause? so expected to be nervous, but 2 weeks out started the dizziness, panic attack, heart arrhythmia headache, brain fog, muscle soreness and overall unwell feeling. I have lost time at work. The money this is going to cost me out of pocket for ER visits. Wasting peoples time. I meditate have good people in my life, I?ve never had this typ of panic and feeling and legit arrhythmia. On beta blocker. Told to schedule a cardiologist visit. Prob gonna need some anti anxiety meds. There is no help out there for this. Thought doing the right thing to get vaccine. I?m not antivax but this is super upsetting. I?m an otherwise normal healthy social person. I cannot even go to friend house b/c of dizziness racing heart and panic

she?s had blood clots and has had surgery 3 times, she is unconscious at the moment. the whole left side of her brain has been removed and she is paralyzed on the left side. this is definitely from the shot.

Stroke requiring 911 call and subsequent hospitalization after ER visit. Heart arrhythmia after stroke and subsequent hospitalization after ER visit.

ON 4/30/21 3 HOURS AFTER I HAD THE VACCINE MY BLOOD PRESSURE WENT THROUGH THE ROOF. MY HAND/ARMS WERE SHAKING, I WAS VERY SHORT OF BREATH AND COULD FEEL MY HEART BEATING OUT OF MY CHEST. I WAS DRIVIN HALF WAY TO THE EMERGENCY ROOM THEN SAT IN THE CAR FOR ABOUT 30 MINUTES TO CALM DOWN. THE NIGHT OF 5/4/21 I WAS RELAXING AT HOME AND A LARGE DARK VEIN POPPED OUT IN MY LEFT CALF AND BECAME VERY SENSITIVE. THE MORNING OF 5/5/21 I WENT AND SAW MY PRIMARY DR. HE DIAGNOSED IT AS VERRUCOUS VIENS . THE PAIN AND SENSITIVITY NEVER WENT AWAY. 5/10/21 MY LEGS BEGAN TO HAVE CONSTANT PINCHING ON BOTH MY CALFS AND THIGHS. 5/12/21 THE PINCHING STARTED IN MY ARMS. TODAY 5/14/21 I STILL HAVE PINCHING IN BOTH LEGS AND ARMS IT IS NOT AS CONSTANT BUT STILL PRESENT.

4/3/2021 - severe headache, nausea, and vomiting. I experienced fatigue in subsequent weeks. 4/6/2021 - virtual nurse visit. Lab work. Low vitamin D identified. 4/13/2021 - 11;30 PM - numbness on right side 4/14/2021 - 12:00 PM - numbness on right side (arm, face, tongue, toes), weakness - right leg. Called nurse triage and was advised to go to emergency room. Was admitted as a stroke alert. CT, MRI, echocardio - all negative. Diagnosed with parasthesia. Medical records indicate I had a TIA. Discharged on 4/16/2021. 5/05/2021 - Hospital follow up visit with neurologist. Prescribed baby aspirin for TIA and additional lab work to rule out blood disorder.

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.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: FAINTING LEAD TO SCRAPE ON FOREHEAD-Severe

I immediately felt sharp pain and burning in my arm while being injected. The burning in my arm lasted for about 20 minutes. I got a severe migraine about an hour after the vaccine that lasted for about ten hours. I broke out in hives all over my body later that night, the same day as the vaccine. I also had intense heartburn. I never get heartburn so this is not normal for me. The following day, I was still having hives and started also having chest pains. I was consistently taking antihistamines to keep the hives under control. On Saturday morning, 2 days after the vaccine, I was still breaking out in hives. My throat also started to swell and I was having a hard time breathing. My heartburn was also getting more severe. I ended up going to urgent care. There I was prescribed 2 stronger antihistamines and prednisone to help with my reaction. I was also given an epi pen. Later that night, I ended up going to the ER as I was having severe chest pain. I have a history of DVT so I was concerned about blood clots. I had several tests done along with a chest CT scan. Thankfully everything came back clear for blood clots and heart attack. The ER doctor could not explain why I was having chest pain and advised me to monitor it and to come back in if it got worse. The following day, I was still needing antihistamines for hives and difficulty breathing. I woke up in the middle of the night with severe stomach pain and cramping. I had intense vomiting and diarrhea. The diarrhea started to have a lot of blood in it. I went back urgent care and they sent me for a CT scan which showed I now had colitis. The bleeding lasted for about 3 days.

I was having strange heart palpitation. i had really bad gas that caused heart racing, vomiting all the way until the 4/20/21. I starting feeling better 21st and I was at 100 percent on the 6th of May

After the 15 minute waiting period, I felt fine. I did my grocery shopping while I was at the store, went home and worked the rest of the day at my desk. We ran errands in the evening like normal. I hadn't really noticed because we were busy, but my heart rate had been steadily increasing all afternoon and into the evening. My watch tracks my pulse rate and reports on screen. After I took a shower at 9:30, I noticed that my pulse felt high. I laid down, thinking it was just from taking a hot shower and it would go back down to normal. That's when I looked at my watch report and it looked like a stair step, with my heart rate increasing steadily every few hours, starting at 4 p.m. It was currently 110-120 (my normal RHR is 60, and drops into the 50s when I'm asleep). I went to bed, hoping I was just in my own head about this and it would be fine. I woke at 2 a.m. and my heart rate had not dropped below 100 while I was asleep and was at 130. I went to the ER at 2:00 a.m. because it was alarming. There were points where it spiked to 150 while sitting still. The ER ran an EKG, full blood and urine labs, monitored my heart rate and BP - my BP was in the normal range the whole time. The doctor who saw me in the ER was awesome. Her husband is still dealing with lingering neurological damage from having COVID last year. She informed me that I was not in a-fib or any type of cardiac distress and my labs were all normal, but was likely having an immune response to the vaccine. They did a chest x-ray and CT to check for blood clots and both came back negative. My platelet count was well within normal range as well. I returned home about 6 a.m. and my heart rate was still higher than normal, but had already started to work its way down. It stair-stepped down just like it went up and by 4 p.m., my RHR was back down to 70 and it was down in the 50s overnight. Aside from that, I had the typical headache, low-grade temp and overall body aches. Everything had subsided by Sunday afternoon. I did make an appointment see my PCP as instructed by the ER doctor on Tuesday, April 13. She had read all reports from the ER and was pleased with how my heart rate had come back down to normal. This was the same day that the authorities stopped use of the Jannsen shot due to the blood clot concerns. Dr ran another platelet count for my own peace of mind and it was a little higher than it was when I was in the ER, so she was confident that I was not in any danger, but did review the symptoms/warning signs of blood clots with me just in case. I have not had any issues or symptoms since.

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

Janssen COVID-19 Vaccine EUA I got the vaccine the evening of 03/23/21. Overnight I noticed my body starting to hurt and felt chills. The morning of 03/24/21 I woke up with full body aches, chills, and fever over 100 F. These symptoms lasted all day. Fever went up to 102 F. Recently I have noticed a change in my menses since having the vaccine and I wonder if it is linked. I have been on birth control since last year to control heavy bleeding. It was helping very well. The period I had in April and May were like it was before I started the pill. It was heavy and I had numerous large clots. I will be scheduling an appt with my ob/gyn regarding this change.

The day I received my shot I had a fever and chills 2 hours later. I started my period on Sunday 04/11/2021 and I couldn't stop bleeding . plenty of blood clots and fever. I called my Dr and he called medicine in and after 3 days the symptoms stopped . I had a Dr appointment on 4/27/2021 and my iron was very low and blood pressure was at stroke level. I go back to the Dr. in 3 weeks for blood work.

HYPOXEMIA; UNABLE TO FOCUS; COLD CHILLS; WEAK; TIRED; FEVER; PAIN; VERY FORGETFUL; HARD TO TALK; LOSS OF CONSCIOUSNESS; FOGGY THINKING; SHORTNESS OF BREATH; SHORT-TERM MEMORY LOSS; MUSCLE CRAMPS IN FEET, TOES AND ARMS; FALLING OVER; CONFUSED; DIZZY; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight was 245 pounds, and height was 70 inches. The patient's past medical history included stroke, and concurrent conditions included chronic bronchitis, anxiety, emphysema, dizziness, unspecified lung disorder and handicapped (uses a walker) due to a stroke, the patient had history of abandonment disorder. Patient was on oxygen (since last year) due to lung problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: Unknown) dose was not reported, 1 total administered on 19-MAY-2021 14:00 for prophylactic vaccination on right arm. No concomitant medications were reported. On 20-MAY-2021 at 1:30, patient had very intense cold chills from hell and unable to focus. The next day the patient's sister had to help patient to stay upright in bed because patient kept falling over in bed and could not stay upright. The patient's sister was concerned and insisted that the patient go to the hospital to seek medical care but the patient refused. Patient then experienced periods of loss of consciousness and patient's sister was having a hard time waking patient up and then checked oxygen saturation and noted that it was low at 72%. The patient's sister subsequently managed to wake patient up and turned up patient's oxygen tank from a previous setting of 2 to a higher setting of 3. At this point the patient's sister managed to help patient sit up. The patient has been confused and dizzy and oxygen kept dropping and it will go back up then go back down. The patient then stated it was not as bad as it was, more like it was a side effect. The patient called doctor on 20-MAY-2021 at 19:30 and told what had happened and what was going on. The patient's doctor told patient she had hypoxemia and gave instructions to keep oxygen on and to see if patient was feeling better. Patient felt very confused and found hard to talk, very tired and not focused at that moment. Patient could not remember what was told 15 seconds ago. Patient had oxygen currently in the low 80s to 96 depending on the lungs. Patient started to fall and lean over. Patient's sister had a hard time waking up patient. After the episode when patient's sister could not wake patient up, patient had developed a fever of 101.9. Patient alternated Ibuprofen and Tylenol as treatment for fever. Patient was short of breath and it was twice as worse as it was. Patient also mentioned that eyelid on left eye went down. Patient could not seem to return to normal and had written notes so that could keep on track and that patient had become very forgetful and that patient's sister had moved in to help after patient received the vaccine since patient was weak. Patient stated that had severe muscle cramps in feet, toes, arms and that hands clench up like a fist for a minute due to the pain. The clenching relieved the pain but as patient unclenches the pain started again. Patient stated that was in pain and hurting, had focus fog. The HCP had told patient of side effects and that symptoms would last for about 24 hours but patient had been experiencing them for a few days. Patient was worried and fever kept coming and going. Patient took meclizine for dizziness, as since patient received the vaccine, the dizziness was much worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hypoxemia, and the outcome of muscle cramps in feet, toes and arms, cold chills, falling over, loss of consciousness, confused, dizzy, unable to focus, foggy thinking, fever, shortness of breath, pain, short-term memory loss, tired, weak, very forgetful and hard to talk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210544835 - Covid-19 vaccine ad26.cov2.s - HYPOXEMIA , LOSS OF CONSCIOUSNESS and FOGGY THINKING . 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).

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.

I would be standing up and had to sit down because my heart started to race and was bedridden for a week (Pots Syndrome). I'm in the process of trying to get diagnosis on it to find out correlation between the two to find out if it was due to the vaccine because my health started going downhill shortly after receiving my vaccination. I have been going to a couple of Cardiologists so far and am mentioning the correlation with the vaccination to see what they are saying and it is still an ongoing investigation. My heart rate increases drastically when I stand up and goes down rapidly when I sit down within 30 seconds.

intermittent chest pain, heart palpitations, elevated heart rate, headache, hands tingling, feet tingling, shortness of breath, extreme fatigue

I felt a heart flutter in my chest my husband took me to the ER. My blood pressure was elevated. All test came back negative. I followed up with Cardiologist for Stress Test and Heart Monitor all the events happened on May 10. Nothing has been resolved.

Lots of fatigue 2 days after vaccine, sharp stabbing pain on left side that afternoon underneath breast, struggling to breathe, went to ER, ER thought it was blood clot in lung, found to have normal lung, take ibuprofen, pain lasted most of the day, more pain when breathing in, pain gradually faded but occasionally flared up for 2 weeks after the first adverse event. Had been having some mild symptoms previous to that, medical people concluded it was inflammation exacerbated by vaccine. Palpitations, rapid heart rate.

I woke up with severe pain in my neck and across my shoulder blades(upper back.) Not long after this, my Fit bit signaled a prolonged period of high pulse. My resting heart rate peaked over 135 and stayed about 110 for 6 hours.

Cough, dizzy, faint, short of breath, headaches at onset. These are the symptoms since May 22nd through today, June 9th. Cough still persists, along w/ headaches and dizzy. Still short of breath...

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.

04/01/2021 I went to the Emergency Room and was diagnose with pneumonia, I then went back 2 more weeks in a row with symptoms not getting better. My chest stills hurt, headaches getting worse, body aches getting worse, rash, vision is blurry. My doctor has no clue why I'm still having these symptoms. I a 43 YO female that suffer from hEDS,

Within 5 minutes of receiving her Janssen Covid vaccine, the patient became dizzy and lightheaded. We moved her to a sitting position. She stated she really didn't feel well and we prepared to move her to a lying down position. Before lying down patient passed out. She continued breathing with a pulse. We called 911. She remained out for approximately one minute, with stimulus not waking her. While moving patient out of the chair to a lying down position she awoke on her own. She had no previous medical conditions or routine medications, though did say she had passed out before. EMTs arrived and questioned patient but did not do a physical assessment. She did not want to go to the hospital. Patient did remain in the pharmacy for 45 minutes after. We checked HR and BP, both were within normal limits. We drove patient home where here daughter was present. Patient stated she was still nauseated when she got home but seemed better an hour later

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

After one week of COVID vaccination, the patient started experiencing a sharp pain on the left side of her chest. The pain didn't go away but slowly spread to neck, back, head and lower side of her body. She didn't think of the vaccine as a potential cause of these symptoms, so started going to acupuncture and got blood and other lab tests. After taking Aspirin on 6/25/2021, she felt a little bit better. She gave Pharmacy a call on 6/30/2021 for the first time to discuss this issue, and I recommended her to see a medical doctor to discuss symptoms and treatment.

HYPERTENSIVE CRISIS DURING HER PERIODS; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight was 215 pounds, and height was 66 inches. The patient's concurrent conditions included hypertension, chronic kidney disease, left breast cancer, seasonal allergies (mold), non smoker, and non alcohol user. 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: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included biotin for drug used for unknown indication, hydrochlorothiazide for drug used for unknown indication, pyridoxine hydrochloride for drug used for unknown indication, valsartan for drug used for unknown indication, vitamins nos for drug used for unknown indication, and withania somnifera for drug used for unknown indication. On 04-MAY-2021, the subject experienced hypertensive crisis during her periods. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hypertensive crisis during her periods. This report was non-serious.

I had some dizziness, headaches, right side neuropathy. I was also tired all the time. I went to the doctor where my doctor tried looking for other things aside from the pulmonary embolism. A brain MRI was done which came back normal. A thyroid test was done which showed hypothyroidism. I went to a specialist after this where a thyroid ultrasound was done and showed a swollen thyroid. I was diagnosed with Graves? disease. I have never had this before. I am now on methimazole 20mg/day. I had labs drawn to see if dose needs to be adjusted. I was told that it will be about 2 years before it can be determined if that medication is working. I also experience brain fog. I have lost 10 lbs in the past months due to this as well.

I had the dose on 04/09/2021 and on 04/12/2021 I started having some symptoms and on Tuesday I started having a lot of anxiety and panic and chest pain. I could not breathe. I ran outside and my husband behind me. I told him I was not feeling well. We called an ambulance and they checked me at home. They told me my vitals were ok but they said if I wanted to go to the hospital I could but I did not. I have felt changes in me. I always have headaches and anxiety. Sometimes I do not do my house chores because I get tired. I still have the chest pain. Sometimes I cannot take care of my kids because the symptoms do not let me. I have not taken any medication. My doctor did some blood work and it was normal.

On 7/14/2021 pain started in left leg. On 7/15/2021 my primary doctor sent me to the ER where tests were performed. On 7/15/2021 diagnosed with DVT blood clot in left leg in the popliteal vein. Prescribed Eliquis 10mg twice a day for 7 days then 5mg twice a day for 3 months. My allergy and primary discussing a CT scan of brain.

2 weeks after vaccine pt developed increased anxiety, shortness of breath, fatigue and palpitations. She has associated chest pain and cannot complete her usual exercise routines.

Immediately tasted a metallic taste and numbness in my cheeks. When I got home I had a rapid heart rate and slight shortness of breath. That night I ran a fever of 102 and had horrible chills and nausea. The next day these were gone but I had a horrible headache that even Tylenol wouldn?t get rid of. The second day these symptoms had stopped.

Starting 4 hrs after I was vaccinated, I developed a 102 degree fever, body aches, chills, fatigue, pounding headache, fast heartbeat. I was very sick for 20 hrs, and then I developed humming/ringing in the ear and vertigo for several days after. It has been a week after now and I still am not 100 percent myself, have ringing in ear and vertigo periodically and fatigue.

Dizziness, Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Palpitations, Tachycardia "skin feeling on fire", random pain that moved around body (ankle, knee, calf, hip neck) restlessness. left sided chest pain Narrative: Other Relevant History:

Around 7 pm on 3/13, I developed brain fog, trouble walking, and then fever, severe muscle pain worse in legs, and chills. Most of these symptoms seemed to improve on 3/14, but then on 3/15, I developed new onset of shortness of breath and chest discomfort. On 3/16 around 1 pm the shortness of breath worsened and I went to the emergency room. I felt that I couldn't take a deep breath in and I had chest discomfort on the left side of my chest worse when taking a deep breath. My legs were hurting as well, especially my left leg. I had sinus tachycardia (heart rate 106-120) and increased respiratory rate (rate of 20) with O2 sats 100% on room air. My breathing and heart rate improved somewhat with 1 liter oxygen therapy, 1 liter of IV fluids, albuterol inhaler, and decadron 6 mg orally. It was thought that I had a delayed asthmatic/allergic reaction to the vaccine. I do not have a history of asthma. I was prescribed a Medrol dose pack and albuterol inhaler. My hands and feet are very cold and tingling on 3/18. Shortness of breath and chest pain seems to have improved but not completely gone as of the time of this submission on 3/18.

Throat tightening and racing pulse almost within one minute. Oral meds: Benadryl, famotidine 40, Zyrtec, and prednisone Developed hives day 5 after injection. Full body itching remains unresolved. Treated with eucerin and hydrocortisone topical cream. 2 visits to ER for iv steroids and normal saline fluids. Epi administered on second visit today 3/20/21 with good relief (best I?ve felt since getting it on Monday) 10/10 migraine today not relieved by oral triptans. Relieved by triple cocktail IV.

PATIENT WENT UNCONSCIOUS FOR APPROXIMATELY 30 TO 60 SECONDS. WE CALLED AMBULANCE. THEY EVALUATED HER AND SAID SHE WAS OKAY.

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

1030 shot Administered 1130 sleepiness 1230 jaw tightening 1300 neck sore 1630 neck, along spine, lower back sore 1855 body aches 2045 nausea/ chills/ fever/ headache/ rapid heart rate over 100bpm 2045-0700 rapid heart rate/ fever over 100

Within hour mild nausea and pain by 10pm everything increased freezing, entire arm pain, nausea, intense headache, chest hurt 2am sweats and chills. 1:45 pm next day back to mild head, nausea, but extreme whole arm pain

patient had vaccine at 12:05pm. She went to sit down and raised her hand that she didn't feel well. She proceeded to pass out onto the nurse. The patient was placed onto the ground and EMS was called at 12:10. She came to and was able to state her name. EMS arrived and performed their assessment. She stayed lying for several minutes and was eventually able to sit up. She was coherent and she was cleared by EMS to go home. She was able to leave the facility walking with minimal to no assistance and was driven home by her husband. She stayed until 12:45

Patient felt dizzy and nauseous. Patient's Pulse, Oxygen level and Blood pressure were checked. Patient Blood pressure was 208/119. Patient was transported to Emergency Room, where her high blood pressure was treated and brought under control. Patient was then discharged from the ER to home on 4/2/2021.

Patient was waiting in lobby for 15 observation period. During this time she started to feel faint and approached the counter. I asked her to return to her chair, she passed out. The patient fainted but did not hit her head. Her breathing was monitored, her husband was called, and I sat with her until paramedics arrived. The patient was able to walk out of the store after her examination with the paramedics.

Patient is a * year old * who received a single dose of J&J COVID 19 vaccine in the right deltoid. Immediately following administration of the vaccine, patient began experiencing the sensation of heart racing, difficulty breathing, and feelings of anxiety. Patient relates this has happened with vaccines received in the past, as she has postural orthostatic tachycardic syndrome (POTS). She feels as if this is an aggravation of her POTS. Patient states she has allergies/sensitivities to ciprofloxacin, bactrim, and sulfa drugs, but she has never needed to use epinephrine. She denies chest pain/tightness, wheezing, swelling of the face/lips/mouth/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting. She does not take any medications on a daily basis. POTS aggravation. Patient was not displaying active signs and symptoms of anaphylaxis. Patient?s heart rate and breathing continued to slow down once patient was brought to a quiet place and started to enact breathing techniques. Vital signs continued to improve as patient sat. Patient encouraged to consult her PCP and inform them of their post-vaccination reaction. She was instructed to go to the emergency department if she should develop chest pain, difficulty breathing, swelling of the face/lips/airway, cramping abdominal pain with nausea and vomiting. Patient discharged to home

12:16 shot. 12:30. 15 minutes after shot Heart racing, body tingling, light headed, dizzy. 2:30 same symptoms plus face tight, lips and tongue tingling , tongue swollen, body numb 3:30 same symptoms plus head is hot 4:30 same symptoms plus chest pains 24 hours after shot - most other symptoms are gone. Now fever 100 degrees and body aches, headache

Next day Nausea then passing out resulting in large facial laceration (multiple stitches needed), neck injury and concussion

Patient had syncopal episode, was diaphoretic , pale, hypotensive and bradycardic. EMS was called but patient refused to go to hospital .

Three to four minutes after vaccination, patient alerted me that she was not feeling well. Symptoms included rapid heartbeat and "full body sweat." Patient became unresponsive with eyes open, at which point I retrieved an EpiPen and instructed my technician to call 911. Patient became responsive within 20 seconds. Patient remained seated over course of following hour, at which point she reported feeling like her normal self.

After vaccination, patient passed out in observation area. Patient diaphoretic, pale, hypotensive and bradycardic. Heart rate in the 40s and EMS called by nurse. Patient evaluated by EMS, but patient decided against transport.

Patient got lightheaded/dizzy, BP dropped as low as 66/33 P50. Placed supine with legs elevated. Given oral fluids total of 4 bottles (240mL) and 1 bottle (500mL), BP improved to 107/81 P55. Only drank milk in AM and no breakfast. Felt chills, given ASA 650mg PO. Given additional 500mL bottle of water, discharged in stable condition

onset evening/night of vaccine: major chills, muscle spasms (including isolated spasms in leg and fingers), extreme fatigue (had to crawl, not walk), extreme spinal pains, low-grade fever. Resolved about 36 hours after vaccine onset ca. 12 hours after vaccine: high resting heart rate (irregular heart rate, approx. 140 bpm), tinnitus. heart rate slowed approx. 36 hours post vaccine, tinnitus still comes and goes onset ca. 24 hours after vaccine: vertigo, dizziness, mild nausea: still ongoing.

Throat closing, tachycardia. Later fever 100.7, severe muscle aches, shaking chills, headache. Still muscle spasm and pain 8 days later.

Fainted and got hurt on the forehead with the fall , Went for urgent care next day and was advised to go to emergency for further examination. Feeling better now

Immediately after getting the vaccine I began to feel very strange with symptoms of light-headedness, dizziness, and lethargy. Around 3-4 hours later is when the real symptoms began. First, an extremely rapid heartbeat. My left arm began to feel numb. And I was seized by an episode of extraordinary fatigue. 6 hours after the shot, I was having muscle and joint pain to the point that I felt like I was being stabbed with knives - particularly in my tailbone, ankles, and shoulders. High fever followed, uncontrollable chills and shivering, intestinal pain, diarrhea, and intestinal cramps. The following day I had a headache and continuing extreme fatigue as well as pain in both arms.

Shortness of breath, tightening of throat, near syncope. PT had a Hx asthma and allergic reactions to antibiotics. 0.3 mg EPI via autoinjector left medical thigh. 8 doses of albuterol MDI PT improved after treatment. Evaluated, treated by EMS. Transported to ED for further evaluation and treatment.

patient had a syncope; was sweaty, then felt a little dizzy then fainted. This happen within about 5 minutes while waiting after the vaccination. Patient was laid on the floor before fainted for about few seconds (@5sec). Patient waited in the pharmacy for about 30 mins and felt better. After follow up with patient, she said she felt tired for couple more days then felt better

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.

BODY ACHES; BRAIN FOG; ARM WAS EXTREMELY SORE FROM SHOULDER TO ELBOW; CHILLS; FEVER; CHEST PAIN; HEAD FELT HOT; RACING HEART; BODY TINGLING; LIGHTHEADED; LIP AND TONGUE TINGLING; LIP SWELLING; FACE FEELS TIGHT; WHOLE BODY NUMBNESS; TONGUE SWELLING; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 around 12:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced lip and tongue tingling. On 06-APR-2021, the subject experienced lip swelling. On 06-APR-2021, the subject experienced face feels tight. On 06-APR-2021, the subject experienced whole body numbness. On 06-APR-2021, the subject experienced tongue swelling. On 06-APR-2021 12:30, the subject experienced racing heart. On 06-APR-2021 12:30, the subject experienced body tingling. On 06-APR-2021 12:30, the subject experienced lightheaded. On 06-APR-2021 15:30, the subject experienced head felt hot. On 06-APR-2021 16:30, the subject experienced chest pain. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced brain fog. On 07-APR-2021, the subject experienced arm was extremely sore from shoulder to elbow. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) more than 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart, body tingling, lightheaded, lip and tongue tingling, lip swelling, face feels tight, whole body numbness, head felt hot, chest pain, and tongue swelling on 06-APR-2021, and had not recovered from fever, body aches, chills, brain fog, and arm was extremely sore from shoulder to elbow. This report was non-serious. This case, from the same reporter is linked to 20210415021.

PATIENT RECEIVED VACCINE IN THE MORNING AND AT NIGHT HAD NUMBNESS IN ARM AND CHEST PAIN. PATIENT WENT TO SLEEP AND WOKE UP THE NEXT MORNING WITH CONTINUED CHEST PAIN AND THEN CALLED PHARMACY. WAS ADVISED TO GO STRAIGHT TO EMERGENCY ROOM

Patient resting in car.....she was not making eye contact and short with answers to questions. Patient was unresponsive, breathing and head movement with eye abnormal movement, attempted to wake patient but unable to , remained unresponsive but breathing. EMS called10:55 Patient continued to be unresponsive SPO2 98+, HR 78 patient pale and diaphoretic. 10:56 Patient was unresponsive ammonia activated and attempted X3 patient continues to be noncoherent and nonverbal. 10:57 Patient with altered mental status and began vomiting, pt aware of name and location. 11:01 B/P 105/76 vomiting continuing with continued altered mental status 11:03 Vomiting and incoherent 11:06 Ems arrived and patient was transported to the local hospital. Patient awake and state she had a bowel movement on self. Assisted patient to Cot for EMS.

Had chest pain on and off for 5 days (started Thursday 3/25), which I thought was related to acid reflux. On Tuesday 3/30 when it became worse and was no longer managed with ibuprofen I went to patient 1st. I was given an ekg which was abnormal and then sent to ER. There it was determined that I had a blood clot and 100% blockage in my right coronary artery. That night I had surgery and they placed a stent.

on the day of vaccination: rash, redness of face and shoulders and neck, vomiting, extreme fatigue these symptoms continued for 48 hours then I started to feel better on 04/12 around 6pm I started feeling foggy, dizzy and felt like I was going to pass out. I called the neighbor for help. I couldn't communicate, my body was shaking, trembling, I stuttered as I was trying to form words. I was taken to hospital by ambulance. I was unable to speak, I was shaking and my blood pressure went up and down. I was given IV fluids and Ativan for anxiety, dysarthria and altered mental state. As of 04/14 I have memory loss, loss of taste and appetite, extreme fatigue

Immediate dizziness and nausea. Became tachycardic within an hour. This is still an issue 3 weeks out. Day after vaccine I felt mild flu symptoms all day and was struck with a severe chest pain and intense nausea in the afternoon. I went to the hospital emergency room and had multiple tests run. No cause was found for the chest pain. It began in the center of my chest and moved to the right side of my back. I have been dizzy, nauseous and extremely fatigued as well as a headache for the last three weeks. The doctor didn't know what caused the pain. He checked me for a pulmonary embolism because my clotting factors were slightly elevated. They have not been rechecked, though I requested my doctor have them and my platelets rechecked. I still do not feel well. My brain is foggy, my vision gets blurry at times, and I still have the dizziness, fatigue and nausea. I am no longer achy and I have not had another chest pain like the one I had on the 26th.

Fever first 12 hours. Extreme fatigue one month later. Low White Blood Count. After vaccine 3.2 one week later 3.0 Extreme malaise and faint. Palpitations, dizzy spells, complete inflammation. Head aches.

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.

Patient started not feeling well on 3/24. She was experiencing dizziness, headache, chills and fever. She contacted her doctor on 3/25 and he thought maybe she had an inner ear infection. Symptoms continued to worsen and eventually an ambulance was called on 3/27 because patient stated she was having severe SOB and headache along with dizziness and fever. Patient was transported to Hospital where they tested her for covid and pneumonia. Both came back negative. After several tests it was confirmed she had a blood clot in her lung and was also told she had clots in her leg and heart as well. She was in the hospital for 3 days where she was given heparin and several medications for the headache. Patient was discharged on lovenox and coumadin and eventually switched to xarelto by pcp who is managing her anticoagulation. She still has follow up appointments with a cardiologist and neurologist. She said she is still experiencing some dizziness and SOB but overall doing better

The evening that I got my shot I felt the common side effects like flu symptoms. I also had a rapid heart rate and high blood pressure. It woke me up from sleep. My blood pressure remained high and I felt pressure on my chest for three days. Five days after the shot the pressure on my chest felt worse and my blood pressure was still very high, I also have shortness of breath when I am moving around which started three days after the shot. I saw my doctor who ran some tests which were negative. I am still feeling the pressure on my chest and the shortness of breath after one week but it is a little better than it was and less often.

Strange headache began and continued after about 24 hours after receiving vaccine, headache continued and on 4/15 turned into a wrapping tingling headache that included both arms going numb, chest discomfort, shortness of breath, and extreme hot flash like sensation. Continued strange feeling in chest and headache, hospital did CAT scans, EKG, bloodwork and could not find what caused all of the symptoms to occur but noted I had the vaccine just 2 weeks prior with a continued symptom leading up to the ?neurological event? and head that continues after as is still present. Pain and numbness also continues in left arm.

I will begin by noting that I am known for high pain tolerance and have been a strong, healthy, professional athlete for thirty years. The evening of the vaccination, I went to bed at 9pm feeling odd. By midnight, I became paralyzed with excruciating pain throughout my torso and arms with such an extreme fever that it felt as if my heart was going to stop. I had crushing chest pain which inhibiting my breathing ability in a way that could only be compared to being crushed under a burning truck. The paralyzation was so intense, with pre-existing pain multiplied by a thousand, that I couldn't even speak to alert my husband, who was right beside me. This continued for several hours until it subsided enough for me to pass out from exhaustion. The following day I battled residual aches throughout my torso and arms, accompanied by a mild fever. The trauma of fearing for my life that night and over the past week, exacerbated by the news of this vaccine I received being paused for issues related to my demographic, had made me too afraid to report my extreme side effects until now. With the encouragement and support of my family, I have worked up the courage to do so. It was the scariest, most intense pain and fever I have ever experienced in my life all at once and no one I have described this to has ever heard of the severity of what happened to me.

Feels hot, dizzy, passed out . transported by medics to observation area. BP low, Pulse stable. In observation for 30 minutes recuperate and went home on her own.

4/13/2021 1am shortness of breath, chest tightness, 10:30 am Dr Visit (X -ray, EKG, Blood clots lab done) 12:00pm Sent to Hospital, Again everything done(X-Ray,EKG,Blood work, CT scan) They gave me an albuterol treatment which alleviated some chest tightness. I was released around 4pm from hospital. Once home I took some Benadryl 25mg

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.

According to patient, she woke up at 2:00 a.m. to use the restroom and noticed she had a very dry mouth and was thirsty. She passed out and when she came to she experienced decreased vision. She was taken to the emergency room via ambulance for tests. She was diagnosed with a blood clot to her lungs after CT scans. She also had aditional scans and blood work and stayed at Hospital in town (I am having trouble adding this to the shaded area in question 21).

At approx 11:30pm my wife woke up and ran to the bathroom complaining of extreme nausea, fatigue, and back pain. While I was getting her tylenol she fainted, hitting her head on the floor. When she came to, she started experiencing the chills along with an irregular body temperature. I put blankets on her, gave her water, and tended to her eye. I was able to move her from the floor to the bed within 15 minutes. She fell asleep around 2am. She has been doing better but has been experiencing off & on headaches & nausea. We did not go to the doctor since we do not have insurance.

Started to feel chest pain and shortness of breath 3 days after the vaccine. Ended up in the hospital 5 days after the vaccine and diagnosed with blot clots in the lungs.

COVID-19 - Janssen ADR Come to ER on 4/8/2021 with chills, fever, weakness and dx with pneumonia after receiving COVID-19 vaccine 1 week ago and discharged on azithromycin. On 4/13/2021, came back to ED with worsening SOB, weakness, nausea and now with right thigh and leg pain, ground glass findings on CT thorax, positive for acute DVT on right leg and negative COVID testing. 4/14/2021 - right femoral vein thrombectomy and right external iliac vein angioplasty

pt said she had isolated pain above her left elbow around 4/13/2021. the pain is now from her elbow to mid bi-cep. (she had given blood on 3/4/2021) pt saw a provider on 4/19/2021 regarding her symptoms. She was referred for a US. Results were superficial thrombosis left cephalic vein at the level of the mid upper arm extending into the forearm. She had blood work and was told to take Ibuprofen for pain and to stop taking her birth control. Pt will have a FU appt to discuss blood work results.

Three days after the vaccine I started to get a feeling of pressure on my chest. I woke up during the night because it was hard to breath. I had leg pain in both my sides. The leg pain lasted three days. I took it easy for the next two days. I called the doctor and she advised me to go to the ER. I was given an EKG and Chest X-Ray and blood work. I still have the feeling of pressure on your chest after two and a half weeks. It is a similar feeling to when I had the Covid-19 in October of 2020. It is not any better or worse than when it started.

ELEVATED D-DIMER; SHORTNESS OF BREATH; NOSE BLEED; BODY ACHES; CHILLS; FEVER; HEADACHE; 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 social alcohol drinker, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced nose bleed. On 12-APR-2021, the subject experienced shortness of breath. On 13-APR-2021, the subject experienced elevated d-dimer. Laboratory data included: CT scan (NR: not provided) Negative, and Fibrin D dimer high (NR: not provided) Elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, nose bleed, chills, and fever on 12-APR-2021, and had not recovered from headache, shortness of breath, and elevated d-dimer. This report was non-serious.

A few hours after the vaccine I felt really bad. I had severe diarreah and abdominal pains which caused me to go to the ER d/t abdominal pain. I was so severly sick, in bed and couldnt hardly move. On Sat I was being transported to the hospital when I got super nauseaed so my husband pulled over and I passed out and went unconscious and fell out the car onto the ground. EMT was called and transported me to the hospital when a CT Scan and EKG was performed. I was given IV fluids, monitored and released after some time. Over the next few days I felt absolutely awful. On 4/15 I had a phone F/U visit with my PCP. I still havent felt to myself to date and had to go back to the ER last night because I was so nauseaed and dizzy I couldnt stand or do anything and I am still having the diarreah also

Employee reported on 4/16 that after receiving the J&J vaccine she was having uterine contractions and pelvic pain. She went to her primary which put her on baby aspirin. Employee then called out for chest pain on 4/20. She went to the ER on 4/19/21 . ER stated she did not have a blood clot and it was muscle related. She was put on medication. She was put out of work for 3 days. Upon her return on 4/23 she returned to work and stated she was advised by her primary to get an MRI.

1 hour after the vaccine I was walking with my sister and began experiencing neurological adverse effects--I was dragging my right lag and slurring my speech. 3 hours after the vaccine my right arm and right leg began tingling, went numb, and became weak. These symptoms persisted and my doctor advised me to go to the ER for brain imaging 24 hours after the vaccine. On day 3 after the vaccine, my symptoms had diminished but not subsided and I began to have new symptoms: extreme heat and pressure starting at my right ear and spreading through my face and head. The heat has subsided but not the pressure, as I am writing this it is day 13. Tests came back normal, but weakness and pressure neurological symptoms persist.

Within 24hours pt with fever, myalgia, chills, rigors, weakness and extreme dizziness with headache and episode of syncope. Had waves of flushing in body with central abdominal pain and redness and pale extremities. Abdominal pain "burning" recurrent for 6 days with diarrhea, nausea and vomiting and stools pale. In clinic 4/16/2021 pt appeared greenish/yellowish on day 6 and had weight loss from baseline 4lbs in 9 days when she was last seen. Pt labs done and normal. Night of 4/16/2021 started with palpitations racing heart. 4/17/2021 presented to ER for worsening palpitations with flushing and diaphoresis. Labs CXR normal. send home. Anxiety like symptoms fluctuating. Was given diazepam. 4/21/2021 seen in clinic again feeling slightly better. Still with nausea and also now dysgeusia. EKG normal. palpitations better. 4/23/2021 seen on video appt doing better. able to keep food down but still tired and weak. no longer needing diazepam. Taste improving.

I went to the ER because I was having Ocular problems. Ten days after the vaccine on 01//19/2021 my vision became blurry. It was a feeling of trying to see under water. My distance vision was not as effected. It lasted a two hours and then it went away. I went to an Ophthalmologist, but it happened again two weeks later on, 4/02/2021 and my vision became blurred. This time it was blurred and almost like double vision. I was scheduled an MRI and my blood work.

My first menstrual period following the vaccine was exceedingly heavy in flow for the first two days, which is atypical for me. Heavy clots of menstrual discharge were observed. It is not yet known whether these side effects will continue for my next menstrual cycle. Lesser effects followed two days after the vaccine with fatigue, sore arm, armpit, and glands in the injection arm. These side effects dissipated by day 3 status post vaccine administration.

TINGLY/NUMB HANDS; DIZZINESS; HIGH BLOOD PRESSURE; COUGHED UP 3 DARK GREEN CHUNKS THAT HAD SOME BLOOD; COVID-19 INFECTION; 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 hysterectomy, type 2 diabetes, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.8 F. On 06-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 12-APR-2021, the subject experienced covid-19 infection. On 12-APR-2021, the subject experienced coughed up 3 dark green chunks that had some blood. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 14-APR-2021, the subject experienced tingly/numb hands. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced high blood pressure. Laboratory data included: Blood pressure (NR: not provided) 156/81. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 175/83. Treatment medications (dates unspecified) included: guaifenesin, and oxycodone hydrochloride/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, tingly/numb hands, and covid-19 infection, and the outcome of high blood pressure and coughed up 3 dark green chunks that had some blood was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.

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.

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

Pt is a 44 yo female who received the J&J vaccination on 4/1/2021. She calls this institution on 4/13, reporting sciatic pain, IBS flare ups, and chest tightness that started after her vaccination and have continue since. She has no difficulty breathing. PCP visit on 4/20 showed unremarkable assessment. Patient diagnosed with anxiety during this encounter. Plan to follow up with PCP again in one month.

Neurological disorientation such as staggered motor function. It has been challenging to walk- extremely noticeable as if you are tipsy on new years eve - Headache in center of forehead that hasn't waned 24-48 hour period of visual abnormalities Extreme pain at injection site since shot and untol now although getting better Extreme Lethargy Shortness of Breath Plugged ears Congestion which went from clear mucus to bright green within an extreme short period of time Dr prescribed augmentin antibiotics ITS NOT COVID 19 I GOT A NEGATIVE TEST 5/5/2021 All over rolling from extreme to mild pains Muscle spasms in places all over the body. A part of my body is always twitching under the skin (not any jerking movements others report ) SEVERE CHEST PAIN Swollen arm at injection site A deep cough not severe and frequent but significant and persistent

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

Janssen COVID-19 Vaccine EUA Patient had her Janssen vaccine on May 10th at a Pharmacy. On May 18th the patient presented to the ED with complaints of abdominal pain and chest pain. At that time troponin was negative, ECG was without acute ischemia or ectopy, D-dimer = 1.94. CT was negative for acute pathology, Ultrasound negative for hepatobiliary etiology. Patient requested discharge home and was referred to GI and cardiology. Patient presented to ED again on 5/19 with worsening symptoms. Repeat CT consistent with bilateral adrenal hemorrhage. Heparin Induced Platelet Antibodies PF4 Absorbance elevated at 2.138 and interpreted as positive. D-dimer greater than 20, and platelet count less than 79.

The symptoms were similar to the ones I had with Covid Pneumonia in January. Headache, fatigue, shortness of breath, high pulse, dizziness

Monday afternoon had a headache, but after waking up on Tuesday after the vaccine constant, Wednesday stiff neck, by Friday all same symptoms, along with not feeling well at all. Went to the local ER at on 04/23/2021, Checked BP and it was high, they did a CT and it looked fine, the ER DR came in and said it was a migraine but I have had migraines before and this was not it. 04/27/2021 went into my primary care dr, BP was still high, and prescribed a water pill called Hydroclorophazide.

More severe Headaches, chest tightness, blurry vision, blood shot eyes, stomach pain, back pain, leg pain (back of knees, dizziness off balance.

DIZZINES, SYNCOPE WHILE SEATED, FELL INTO COFFE TABLE, RANDOM ABNORMAL BRUISING ON ABDOMINAL WALL AND LEGS.

I experienced irregular heart beat, shortness of breathe, chest pains. In result, have to have a cardiac abrasion done.

as soon as i received the vaccine i had really bad arm pain then a tightness across my chest but was not heart related felt like the pain in my arm more muscle. this lasted about 8 days. a few hours after getting the vaccine I got a bad headache. I normally do not get headaches. I have had a headache nearly every day since. I have taken tylenol and when sever a NSAID but I'm not suppose to take NSAIDS due to having a lapband. I wake up with them and go to bed with a headache. a few days it seems like they have stopped but then they come back. I get fatigued easy the next day after the shot it was a struggle to do normal things i just wanted to lie down. I did not feel sick just exhausted. this comes and goes exercise really wipes me out just normal walking afterwards i will want to go to sleep . I feel like i have to keep apologizing when i cant help with things and say give me a minute.

Within one minute of receiving the vaccine, I lost consciousness/ passed out. When I came to, it took me awhile to realize where I was and what had happened. I was alone in the room. I eventually realized that I was sweating profusely as of water have been poured all over me, something I have never experienced before. Then I began vomiting violently. I couldn't move because I kept almost passing out and I continued vomiting. The two vaccine workers kept wanting to call an ambulance for me but I didn't see what an ambulance could do for me and it was hard to respond to them. I could not get up or move myself or leave the store by myself. After about a half-hour I contacted my sons to come to the store and help me. When my son's arrived, approximately 15 minutes after all of my Adverse Events began, they helps me out to the car in the parking lot and I continued vomiting violently, even on the drive home. Once at home, I took anti nausea / anti vomiting meds and after an hour or two I could sit up and sip water. By that night, I had fevers and the continued throughout the night along with a migraine like headache. The next day continue taking the anti-nausea meds but I still was not able to move around or eat and I had fevers add headaches severe muscle aches and soreness throughout the day and the next night. For the next several days, I was no longer taking the anti nausea meds and I just constantly felt like I was going to pass out and vomit. It felt like all the blood had been drained from my face. It was hard for me to sit or stand or walk around. I tried to work remotely but even just sitting up in my home to a computer was very difficult. I felt dizzy and light-headed and nauseous constantly. On a Thursday, the 10th, I suddenly became very cold and chilled even though I had not had a fever that day. I laid down on my bed with a blanket to try to warm up but my teeth were violently chattering and my hands and feet were ice cold but profusely sweating like nothing I've ever experienced on my hands and feet. My arms and legs started shaking so badly it was more like Tremors bordering on convulsions. It was a very scary and I would have gone to the hospital but I could not safely drive. This lasted about an hour and after it went away, it never came back. I last had a fever on Sunday, the 13th. It was approximately 101. I have not had a fever for a headache after that day but I still felt light-headed and nauseous until June 18th. I have been feeling basically normal since the 18th. I am hopeful that I will not have any more effects but I'm wondering how and where I should report any others?

As of June 15, 2021 I was still experiencing head and face pressure and was not able to lay down, exercise, or go more than 6 hours without ibuprofen for the pain. My ears would start feeling full.....almost like they were swelling inside. I went back to see my doctor and she said she thinks I have Vasculitis caused by inflammation, most likely from my vaccine since my symtoms all started within 2 weeks of my shot. I don't tolerate steroids, so she put me on Duexis twice a day for inflammation.

The evening of the vaccine I had severe chills, headache and I threw up. The next day the chills were gone but I still had a headache which I had to take off work, it lasted a week. One week after the shot I experienced shortness of breath and my Reynaud?s symptoms were bad. My fingers and toes were blue. I had leg pain and I was concerned for a blood clot. I returned to the ER a week later because I had shortness of breath and chest pressure. I continued to have sharp chest pain for four weeks. I also saw a Pulmonary specialist six weeks after the vaccine and tests were normal. I am scheduled to see a Rheumatologist.

Soreness of arm severe for two days, severe cramping in legs followed by Lacey rash on both legs, severe headaches with heart palpitations, sitting heart rate at 140, felt like my heart was coming out of my chest. Chicken pox rash of chest

On 7/9/2021, the patient received her dose of Janssen COVID-19 vaccine a little after 0900AM. A couple of minutes after receiving the shot, the patient began to complain about dizziness. The patient was given some water which alleviate some of her symptoms but she remained dizzy. Then the patient was given a lollipop after she stated she had not eaten breakfast and did not have any food allergies. Meanwhile, her vitals were taken: Blood pressure 143/90, respiratory rate 16 breaths/min, heart rate 68, and oxygen saturation 100% on room air. The site lead contacted emergency medical services - her symptoms progressively worsened - she was experiencing worse dizziness, chills, palpitations, and she felt tired. A second set of vitals were taken and her heart rate was 76 and oxygen saturation 100%. The emergency medical services arrived at the site and the patient was taken to the hospital.

STROKE/NUMBNESS OF LEFT SIDE OF BODY/INABILITY TO WALK; This spontaneous report received from a patient concerned a 44 year old. 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, and expiry: UNKNOWN) dose was not reported, 1 total administered on 13-MAY-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 27-JUN-2021, the patient woke up with numbness in left side of the body. The patient visited emergency room and diagnosed with stroke, and was hospitalized in intensive care unit (ICU) (date unspecified). The patient also experienced inability to walk after the stroke and visited physician's office and currently in rehabilitation. The number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke/numbness of left side of body/inability to walk. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210716287-Covid-19 vaccine ad26.cov2.s-Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

BROKEN ANKLE; TWO DEEP VEIN THROMBOSIS IN LEFT LEG; PULMONARY EMBOLISM IN BOTH LUNGS; This spontaneous report received from a patient concerned a 44-year-old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient had no known allergies and no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry date: unknown) dose, start therapy date were not reported, 1 total, administered 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 drug included Skyrizi (risankizumab) [form of administration unknown, subcutaneous, batch number and expiry date were not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date (reported as several months earlier), the patient broke her ankle. On unspecified date, in JUN-2021, the patient had pain and swelling in her left leg. The patient went to an urgent care to check it and discovered that she had two deep vein thrombosis in her left leg and pulmonary embolism in both lungs. She received treatment (unspecified) for it and was recovering. The patient's physician felt that the events was not due to Skyrizi but possibly due to Janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from two deep vein thrombosis in left leg, and pulmonary embolism in both lungs, and the outcome of broken ankle was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210729466-covid-19 vaccine ad26.cov2.s – two deep vein thrombosis in left leg, and pulmonary embolism in both lungs. This event(s) is considered unassessable. The event(s) has a unknown temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

At approximately 1607, observes found patient having a syncope episode. The observation team went over to the patient and safely moved the patient to the floor. The patient was placed on 1.5L oxygen via nonrebreather. The staff paramedic was able arouse the patient with a sternal rub. After arousal the patient did not complain of any difficulty breathing or pain any place. The patient was assisted to chair. The patient was able to answer all orientation questions appropriately at 1612. EMS arrived to the location at 1620. The patient was assisted to the ambulance and care was transferred to EMS.

muscle aches, palpitations, "feels like heart is accelerating and decelerating", chest pain, nausea, vomiting, has hx of GI upset Referred to see primary physician STAT.

Later that evening I developed horrible anxiety and rapid HR which has caused me to have to stop taking my current meds because of this. I have been severely tired and has had chills off and on for about a week. Mild headaches has also been associated as well

7 days of Dizziness, chest and lungs burning sensation and pain (very strong) fatigue. I had fever 103, headache and shaking chills on the first and second day (I think this is normal) I am worried about my lungs and chest.

Diagnosis: Cortical vein thrombosis, massive intracerebral hemorrhage with tentorial herniation, thrombocytopenia. Clinical Presentation and Course: 1 week after receiving Janssen COVID19 vaccination, patient developed gradually worsening headache. On March 17th, patient presented to Hospital with dry heaving, sudden worsening of headache and L sided weakness. Evaluation with head CT revealed a large R temporoparietal intraparenchymal hemorrhage with 1.3cm midline shift. She ended up getting intubated for worsening mental status. On evaluation at arrival in Medical Center, she was noted to have extensor posturing. Repeat imaging revealed worsening midline shift to 1.6cm. CTA showed cortical vein thrombosis involving the right transverse and sigmoid sigmoid sinus with tentorial herniation. Patient developed brain herniation and brain death was pronounced on March 18th, 2021.

Patient state that she was afraid of needles, once injected about five minutes after she started to experience nausea , drowsy, and was lethargic and pale.

I received the shot around noon 3/16 and by 10:30pm my blood sugar was 414. I am type 1 Diabetic and inject insulin by pen. I do not have a CGM, I have to test manually. Today is 3/23 and the first four days of the injection, my sugars were in the 400's. The last three days they have been in the high 200's. Yesterday my endocrinologist had me increase my long-acting insulin. I have bloodwork Friday and I have an appointment with her 4/2.

I have developed burning of the skin on my ears, nose, lips and chest. My skin peels creating sores with the burning sensation.

Minutes after getting the vaccine patient said she was feeling lightheaded. We went to check on her and she fainted. EMS was called. Patient was unconscious for roughly 15 seconds. We checked pulse and positioned on the floor. Once responsive patient said she was feeling okay. She said she faints when she gets anxious (this was not disclosed before vaccine was given). She spoke with EMS who determined she did not need immediate care. She waited another roughly 30 minutes and was able to leave the pharmacy.

Ten minutes after vaccination, patient experienced Chest pain, shortness of breath, dizziness, nausea and vomiting and dry mouth. Since 4:30 AM patient did not eat anything except for crackers and half of a granola bar

Patient complained of shortness of breath, chest pain, dizziness, nausea and vomiting and dry mouth. Patient only ate crackers and half granola bar since 4:30AM. Blood pressure 220/120, anxious

Approximately 8 minutes after the injection patient became light headed, pale, sweating and nauseated. Patient went to the restroom but did not become acutely ill. Gave water and monitored. Patient responded well and after 10 minutes was feeling much better. Monitored for 30 minutes and patient left facility with husband.

Event took place at an off-site event, in a detention facility. Pt received Janssen COVID vaccine around 4:00 pm. Pt immediately reported nausea. Nurse accompanied pt to the restroom about 2 minutes after receiving vaccine, where she gagged into the sink and spit up a little clear fluid. Pt reported feeling hot and sat down in a chair available in the restroom. Pt and nurse joined by a second nurse. Shortly after sitting down pt complained of feeling dizzy and was moved to the floor to lay down. When laying down, pt appeared flushed under her chin and complained of chest tightness. She requested to sit up to help with breathing. Called 911 and first dose of epinephrine (0.5 mL of 1mg/1mL) administered, both at 4:10 pm. Pt reported no change in chest tightness following epi, but continued to respond to questions. She said she felt tired and wanted to go to sleep. Pt continued to report difficulty breathing, and another dose of epinephrine administered at 4:15 pm. A physician at GEO arrived and administered oxygen. He listened to pt's heart and lungs and reported that there was air movement in her lungs. Pt ceased to respond coherently to questions, slurring and moaning, but did not lose consciousness. Pt started tapping her lips and, upon questioning, said they felt numb. Third dose of epinephrine administered at 4:20 pm. Nurse continued to jostle patient and ask her questions, and patient continued to respond with short, slurred answers. EMS arrived at 4:23 pm and transported patient to the hospital.

Visited ER as I thought I was having an allergic reaction. Treated with Pepcid, prescribed prednisone and streeted. Visited personal allergy physician 4/9/21. per MD Allergist/Immunologist DXd = systemic immunological vasculitis. Most probably a delayed hyper immune response to my vaccine. Legs, arms and sides covered in innumerable petechial eruptions beginning 6 days post vaccination and 3 days post vaccination side effects (chills, headache nausea) subsided. Eruptions spread consistently for 36 hours and are constant not intermittent. They are hot, painful to the touch, and do not blanch. I?m on 60mgs of prednisone for 5 days (the highest dose given outside a hospital) and then 40 for 5 days and then 20 for 4 days. If I get any mouth nose or eye or interior genital irritation I have to go to the hospital and be admitted for higher dose steroids and constant monitoring. Dr advised this will take weeks to resolve and the eruptions will likely fade slowly and possibly peel.

SOB and chest tightness about 10 minutes after injection and a sharp pain that radiated down my arm starting at the injection site. Took Pepcid 20 mg and symptoms subsided after 10-15 minutes. A few hours later began to vomit, which subsided quickly. The nest day had body aches which only lasted 1 day.

Client complained of shortness of breath and chest pain. ALS was called, MD and Paramedics on site assessed client. Symptoms self resolved. Client left medical facility did not want to go to the hospital.

I reported previously that the day of the shot (that evening at close to midnight) I fainted. I woke up on my bathroom floor. I walked down my hall and saw black dots and felt dizzy with nausea. The next thing I knew I was on the bathroom floor and didn?t remember how I had gotten there. It is Friday and I now am experiencing shooting pains in the side of my head. I also have been experiencing pains in my calf muscles and some chest pains. I am still extremely tired and having abdominal pain. I have contacted my doctor?s office about the fainting but I am going to call Monday to get an appointment to get checked out. I am concerned about possible blood clots.

My sister received the Janssen vaccine on March 13, 2021. One week later, March 20, 2021, she started complaining of severe headaches, dizziness and vomiting. This continued so she visited the ER on Wednesday, March 24, 2021, where she suffered a cerebral venous sinus thrombosis. She was pronounced brain dead on March 27, 2021, which is also the same day she was pronounced dead.

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.

Approximately 20 hours after receiving the vaccine, and after having no other side effects, I became very light headed and passed out I ended up passing out two times in a span of twenty minutes.

Dizziness/lightheaded, felt hot,hard to breath right after injection. Had lip/tongue tingling, dry mouth, and chest tightness within a few minutes. They had me wait for 30 mins before allowing me to leave. I woke up at 3:30 in the morning with a severe headache, and had stiffness in my neck and trap muscles. I still am having a severe headache, neck/trap muscle pain, dizziness/lightheaded, diarrhea, sweats and I feel like Im having panic attack sypmtoms throughout the day.

Posterior leg bilateral pain (at knees) , sweats, dizziness, sleepiness, lethargic, was unable to go to work, lobe, headache pain in center of head cramps to frontal , vision distortion, anxiety attack, body aches, pain/burning to to appendix area, right leg pain., constipation -loose burning diarrhea (4/13/21) reddish light brown in color, joint pain arm pain collar bone/shoulder, mucous, drink cool water pain to the chest-0wall noted, air bubbles coming up in throat , upper neck, back spasms

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.

Nausea, Rapid heart rate, Fever of 102 F with oral and 104 F no contact forehead. Took Tylenol and drank plenty of water. Fever broke around 5 am and heart rate returned to normal.

Injection site arms feeling heavy & painful for approx 45min. Fast heart beat & palpitation more than 1 hr. Redness of my face last for approx hour & half. Feeling tired for two days. On my second week, having pain in my lower left abdomen. Severely painful 1st of April check in to ER Chet pain & elevated high blood pressure Check in Urgent care

Johnson and Jonson vaccine given in my left arm. Within 5 minutes I passed out cold. When I came too I almost passed out again. The strange thing was that I was having a hard time not passing out for at least 10 minutes after this shot. I have never experienced this before. I had no energy for the rest of the night. By the next day I had a fever and felt like i had the flu for over 24 hours. My husband did as well but he did not pass out.

When I got the vaccine I fainted. I never fainted before with vaccines. The real problem started a week after I got the vaccine I felt extremely exhausted, and I'm having a hard time getting up from bed in the morning. My symptom is that all my joint hurt so much, my ankles, my wrist, my knees, my hips , my elbows anywhere is a joint its hurts. If im sitting it hurts, if I'm standing it hurts, if im laying down it hurts. Besides that I feel nervous, like I'm shaking in the inside, but I'm not shaking.

Fine until next morning. On 4/6, the as to week to get out of bed until 1:30 pm. Took Tylenol and slept most of the day. The following symptoms are still accruing and have lessened about 5% every day, but new symptoms are arising also. Nausea Chills/sweats EXTREME fatigue Dizzy spells Shortness of breath Belching Dull headache General headache Sore joints and stiffness in legs Bloat Bad Bouts of general malaise Fogginess and complete disorientation for 4 days Loss of balance and coordination for 4 days Had to take Off of work until 4/12. Symptoms as of 4/14 Extremely sore legs and calves Clogged ears Heaviness in chest and shortness of breath Tired but not fatigued Less weak Stomach has been upset All over body aches

I had horrible pain in my left calf that travelled to my thigh. I went to the hospital 2 weeks later a d found that I have a blood clot in my lower leg (front ankle area). I am on blood thinners and will be seeing a Hematologist.

Blood in nose for 3 days - not active bleed but when persistent when blowing nose - was blood. Didn't seem like a big deal - felt fine overall.

DAY 1- two hours after vaccine my right arm and right leg felt restricted, numb and had some tingling in my hand, dull headche, muscle pain and dizziness. Day 2- mild pain at injection sight, muscle pain and general tirednes, dull headache,dizzy, right arm& left arm felt restricted and numbness in right pointer finger. Right leg felt restricted and pain behind the knee. Day 3- dizzy, dull headache, faint, high blood pressure, right arm & leg and left arm felt restricted and numbness/tingling in right hand. Pain behind right knee persisted. Went to ER Sunday early afternoon. Diagnosis is a cerebral venous thrombosis in sinus cavity. Still experiencing general weakness/tired, dizzy/unbalanced.

Janssen COVID-19 Vaccine EUA: patient presents to emergency department (ED) reporting vertigo for four days starting soon after vaccination. At the time of vaccination patient administered multiple doses of epinephrine for suspected allergic reaction to vaccination and transported to ED for persistent nausea, vomiting, and tachycardia. Those symptoms resolved and patient was discharged to home stable. Since that event patient has experienced persistent vertigo. Vital signs within normal ranges except blood pressure 143/106 mmHg. Exam documents no focal neurologic defects. Diagnosed with vestibular inflammation, prescribed prednisone, and discharged to home stable.

Headache, nausea, dizziness/lightheadedness, blurred vision, muscle and body aches, fever 102.4, increased heart rate and palpitations, shortness of breath.

ELEVATED BLOOD PRESSURE; LIGHT HEADED; CHILLS; BODY ACHE; FEELING HOT; FEELING TIRED; 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 htn(hypertension), alcohol user, non smoker, and sessional allergy, and other pre-existing medical conditions included patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included losartan for hypertension. On 28-JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 01-FEB-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced feeling tired. On 08-APR-2021 10:00, the subject experienced body ache. On 09-APR-2021, the subject experienced elevated blood pressure. On 09-APR-2021, the subject experienced light headed. On 09-APR-2021, the subject experienced chills. Laboratory data included: Blood pressure (NR: not provided) elevated. On 09-APR-2021 15:00, Laboratory data included: Body temperature (NR: not provided) 97.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and chills on 09-APR-2021, and feeling hot on 09-APR-2021 15:00, had not recovered from feeling tired, and light headed, and the outcome of elevated blood pressure was not reported. This report was non-serious.

Per client self report: Experienced LLE extremity pain beginning on 4/11/2021, but thought nothing of it at the time. Client was previous scheduled for testing/procedure for asthma with pulmonologist on 4/15/2021, with pre-test/procedure lab work scheduled for Monday, 4/12/2021. Client presented for lab work on 4/12/2021 as scheduled and shortly thereafter received phone call from pulmonologist's office stating that the labs showed and elevated D-dimer and that she would be scheduled for a follow-up CT Scan of the chest and ultrasound of the lower extremities, which was scheduled on 4/14/2021. Client presented for CT scan of chest and ultrasound of lower extremities as directed and returned home on 4/14/2021. Client reported in conversation that she "didn't feel right" and noticed some SOB, and had planned to rest outside of going in for scheduled tests. Client received a phone call on 4/14 from pulmonologist's office advising her to go immediately to the emergency room due to a blood clot being found in the left lung as per CT scan report. Client presented to Emergency Room and was started on Eliquis 5mg tablets - 2 tablets by mouth twice daily X1 week and then 1 tablet by mouth twice daily and discharged to home. Client remains at home at the time of interview with no additional or worsening symptoms.

Pt had sob and chest tightness that started hours within vaccine. On 4/14/2021 O2 sat normal at rest, but desaturate to high 80's with exercise. Symptoms have been improved since onset

Immediate pain in arm that got worse first 12 hours. About 15 hours post vaccine and an unrestful night, woke up around 5-6am and almost fainted or passed out. I was very nauseaus, had a fast all over body drenching sweat, dizzy and numbing in fingers/toes (can't remember which but had tingling and was dizzy). Rest of day was low fever, headache and tired. Right arm was sore where couldn't lift it but that subsided after 2-3 days. Just wanted to report the fainting that almost occured the next early AM.

Not too many adverse symptoms the day of and after vaccine... tired at times and sensitivity to light but continued to eat and helped w energy. Also, warm left side of neck and slight red rash. Not expecting to have leg pain in my calf 6 days later then moved to quad muscle and entire left leg felt achy. CDC at this point said to check out any leg pain. Pain was not severe but bothersome... had STAT ultra sound at ER on day 7, turned out negative for blood clots. Returned to my physicians office day 8... still not feeling right with more of a rash on left side of neck and warm to the touch. Tired and slightly light headed and slight pain in left upper chest. Digestion not the best starting day 5 thru 10. Blood test returned normal for platelet levels but low eosinophils... either allergies or body is fighting the vaccine and creating antibodies (most likely). No known allergies besides maybe skin reaction to Timothy Bluegrass. Moderate headache day 9 and 10 which made me more fatigued (pain on both sides of head above ears and temples)... normally I do not get headaches. Also, loss of appetite or feeling slight nauseous on day 8, 9, and 10 after the vaccine. Now on day 11 and 12.. feeling better but still not quite right. Lightheaded and feeling fullness in head but more energy than day 9 and 10 by far. Never heard of people having symptoms after day 1 or 2 of the vaccine, so obviously I think this should be more documented for patients especially after blood clotting as a possibility 6 days after the vaccine.

POUNDING HEADACHES; FEVER; HIGH BLOOD PRESSURE; CHILLS; 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 past medical history included covid-19 infection, and high blood pressure, 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 09:45 for prophylactic vaccination. Concomitant medications included amlodipine for high blood pressure. On 10-APR-2021, the subject experienced high blood pressure. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 10-APR-2021 14:00, the subject experienced pounding headaches. On 12-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 159/110 mmHg. On 13-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 148/102 mmHg, 112/78 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 10-APR-2021, and had not recovered from pounding headaches, and high blood pressure. This report was non-serious.

PALE; WEAK; COULDN'T SLEEP; FLU-LIKE SYMPTOMS/HEADACHE/FATIGUE/LOST APPETITE/GENERALIZED BODY ACHES/SWEATING/DIZZINESS; 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 asthmatic, and low iron, and other pre-existing medical conditions included 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: 041A21A, and batch number: 041A21A 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 flu-like symptoms/headache/fatigue/lost appetite/generalized body aches/sweating/dizziness. On 10-APR-2021, the subject experienced couldn't sleep. On 11-APR-2021, the subject experienced weak. On 13-APR-2021, the subject experienced pale. Laboratory data included: Body temperature (NR: not provided) 97.1 F. Treatment medications (dates unspecified) included: paracetamol, loratadine, and diphenhydramine hydrochloride/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weak, and flu-like symptoms/headache/fatigue/lost appetite/generalized body aches/sweating/dizziness, and the outcome of couldn't sleep and pale was not reported. This report was non-serious.

Immediately after receiving vaccine, pt had complete loss of consciousness for approximately 30-45 seconds. Pt was lowered to the floor and placed in trendelenburg. BP 132/71, HR 93, 98% on RA. BP 10 minutes later with pt lying down dropped to 83/49, HR 52 and 99% on RA. Each time we attempted to have pt sit up, Pt would begin to have tingling in extremities and ringing in ears. EMS called. BP eventually raised to 127/66 with pt sitting upright but EMS preferred to transport pt to Hospital. Pt evaluated in ED and notes indicate that EKG was done and revealed normal sinus rhythm. Determined to be vasovagal reaction leading to syncope. Pt discharged to home in stable condition.

DVT left leg requiring surgical procedure 04/13/2021. Went to ED on 4/12/2021 with severe leg pain, warmth of area.

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.

I had the vaccine n Sunday, Tuesday morning I woke up with a very tight feeling across my chest/ rib cage area, particularly on my right side, underarm, under breast area. I also had some weakness in my left arm where the shot was given. The tightness in my chest was not affecting my ability to breath, I was able to go on my usual daily hour-long walk but it was concerning me enough for a call with a Dr. I had spent the day before (Monday) using a wood pellet BBQ so I though maybe the issue was related to smoke. The Dr prescribed a salbutamol inhaler which I have used before for seasonal allergies but that didn't really d anything to help with the tight feeling. The feeling of tightness remained all week (and still does to some extent 11 days later). On the Friday I noticed a small dark spot, approx 2mm, a bit like a blood blister on the back of my right thigh. I have had these before fairly infrequently, and I see a dermatologist once a year for a check up and they are not concerned, and they usually go away on their own. But, the combination of a new blood spot and the continued tight feeling across my chest had me concerned enough to call my regular Dr's office. I was also feeling occasional sporadic aches in my legs in varying places. I spoke to a practice nurse who was very reassuring that she had spoken to many other patients that had also been experiencing chest tightness that had gone on for days after the Janssen vaccine, so after that I felt less concerned about the symptoms. I am still experiencing the tightness in my chest which has affected my shoulders and neck with what feels like muscle tension, and also been accompanied by some mild headaches at the sides of my head. I was pretty anxious about getting the vaccine which is not something I usually struggle with and on the Tuesday after the vaccine I felt particularly irrational and also very tired.

Vertigo, body aches, headache first 2-3 days. Then a few days later major fatigue set in, chest pain, mouth breaking out in canker sores randomly, broke out in hives, rashes on my legs and arms, skin hurts to touch, dizzy, loss of balance, difficulty sleeping, night sweats, blurred vision, double vision this is probably the worst of all the symptoms, I lost my taste for 5 weeks. I have taken anti-viral homeopathic drops because it really felt like I was getting the chickenpox or something...like a nerve pain burning. I have documentation how perfectly healthy I was before this and now I am not.

Shortness of breath for several days, feeling fatigue and week, pain in right elbow Diagnosed Apr. 17 in ER setting: acute segmental and subsegmental pulmonary embolism without acute cor pulmonale Acute thrombosis of superficial vena basilica right arm

WHEN TAKEN DEEP BREATH LEFT PAIN INSIDE OF THE LEFT BREAST (CENTER OF CHEST); CHEST PAIN, SORENESS OF CHEST; LOWER BACK PAIN; SORE ARM; MILD HEADACHE; FATIGUE; MILD ABDOMINAL DISCOMFORMT (SIDE STITCH) ON LEFT SIDE TO RIGHT; This spontaneous report received from a patient concerned a 45 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Blood test (NR: not provided) platelets were normal. On APR-2021, treatment medications included: naproxen sodium. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced mild headache. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced lower back pain. On 17-APR-2021, the subject experienced chest pain, soreness of chest. On 17-APR-2021, the subject experienced when taken deep breath left pain inside of the left breast (center of chest). On APR-2021, the subject experienced mild abdominal discomformt (side stitch) on left side to right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower back pain on 10-APR-2021, when taken deep breath left pain inside of the left breast (center of chest) on 17-APR-2021, and sore arm, and mild headache on APR-2021, and had not recovered from chest pain, soreness of chest, fatigue, and mild abdominal discomformt (side stitch) on left side to right. This report was non-serious.

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

Crushing headaches, dizziness, blurred vision, confusion, anxiety. Muscle pain and stiffness, heart palpitations, loss of coordination. Sinus and jaw pain.

Occurred over 3 days:nausea, tunnel vision, ringing in the ears, lightheadedness, racing pulse, clamminess but not diaphoresis. Pain, heat induration, redness and itching at injection site. Itching from injection site moving up arm to neck, side of face and hair. Itching to inside of mouth and lips. Feeling of heaviness and weakness to arms and legs. Chest heaviness and increased work of breathing. I wasn?t breathing faster, but I was aware of the fact that I had to work harder to breath. As I said, these symptoms occurred over three days. The Friday I went to the ED at Hospital. I arrived around 14:45 and I think it was somewhere around 20:30 when I left.

I began to experience GI issues on an unknown date after receiving the vaccine. I began to have indigestion, and acid reflux. At times I was nauseous with vomit coming up into my mouth especially while sleeping. As a result I began to take Pepcid Complete and/or tums and frequently slept sitting up. This resolved itself on 3/30/21. I saw my new primary care on 3/31/21 who then reported that I was experiencing high blood pressure even though I usually have good blood pressure. I began to keep a log of my blood pressure which was consistently high. About this time I began to experience localized pressure on my left chest which resulted my shallow breathing to try to minimize anything affecting the pressure. I

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

High fever 104 deg and rapid heart rate I took Tylenol and drank a lot of water and by about 5 am the fever broke and heart rate returned to normal.

10 minutes after the injection I experienced a racing heart for 10-15 minutes, then some mild nausea and dizziness and a feeling of an altered state of mind or sense of unreality (like before passing out) for about 45 minutes. After that I felt like I was coming out of the grips of an experience and felt exhausted by it.

LOSS OF BLOOD; VOMITING; BACK PAIN; ABDOMINAL PAIN; FEELING WEAK; HEADACHE; BLOOD CLOTTING; COULD NOT MOVE; ONLY COULD DO 5 MINUTES OF WORK; 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 fibroids. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070CCHD,expiry: UNKNOWN) dose was not reported,1 total administered on 20-MAR-2021 for prophylactic vaccination to left arm. No concomitant medications were reported. On 22-MAR-2021, the patient experienced blood clotting which lasted for three weeks and resolved as per physician on same day the patient experienced headache which got resolved on 22-Apr-2021. On 18-APR-2021, the patient experienced loss of blood, vomiting, back pain, abdominal pain and patient felt weak. On an unspecified date in 2021, the patient went to hospital, it was also reported that patient was not able to move and could do only 5 minutes of work. Patient got confused between clotting with menstruation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clotting on 12-APR-2021, and headache on 22-MAR-2021, was recovering from loss of blood, feeling weak, vomiting, back pain, and abdominal pain, and the outcome of could not move and only could do 5 minutes of work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: In narrative of source document vaccination date is 20-Mar-2021 and in the structured field of source document vaccination date is 20-Apr-2021. So as per conservative approach, date given in narrative 20-Mar-2021 is taken as vaccination date. V0 20210440392-COVID-19 VACCINE AD26.COV2.S-Blood clotting and loss of blood. 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.

Patient. Complained of feeling her blood pressure dropping. Patient closed her eyes and body became relaxed. EMS contacted , patient layed in stretcher, vital signs monitored by EMS. Patient eventually recovered.

Patient complained of having low blood pressure and feeling "down". Patients legs were elevated. Patient was given water & Power Ade. Medics were notified. Medics arrived and vitals were taken. Her initial blood pressure was 97/36, heart rate of 56, oxygen saturation on room air was 97. Her blood sugar was 125. Five minutes later after consuming both the Power Ade and water patient reported she felt better. Vitals were rechecked. Her blood pressure was 125/75, heart rate 74, oxygen saturation was 98 on room air. Patient advised to stay hydrated and to eat. She verbalized understanding. Patient left without further incident in stable condition.

increased heart rate about 5 min after the injection, felt hot. Heart rate increased, tingling in arms and felt cold in arms. Occurred two times. stayed about 45 min in the room

Patient started to fill faint and pale. Patient was clammy and got dizzy. Patient has set there for 15 minutes and when she started to get up started feeling faint and hot. Patient waited about 10 or 15 minutes more. Her color improved and was feeling better and no issues when she left.

Symptoms: Severe chest pain, shortness of breath Emergency Room screening, CT Scan, chest x-rays and blood work. Findings: Pulmonary embolism in the right middle lung. Treatment: Hospitalization, 24 hour heparin drip for 3 days

4/13/21 Numbness and tingling in feet, moved up legs. Cramping and deep muscle pain with shooting pains up thighs. 4/20/21 went to urgent care as cramping very severe with rapid heart rate. Tachycardia, EKG normal. Labs CBC, BMP, CK normal. 4/25/21 Heart 160, went to ER. Tachycardia, SVT. CT with contrast normal, labs normal. Discharged to cardiology follow-up. 4/30/21 Cardiology appointment. Wearing MCOT monitor 2 weeks 3/5/21 Neurology: EMG normal

Headache, right sided arm and leg numbness, pain in both calves, pain in arm pit which is worse on right side, some center chest pain and extreme tiredness. I have been to ER 3 times as well has PCP once and have follow up with a Neuro.

CONFIRMED IMMUNUNOLOGICAL VACCINATION FAILURE; CHEST PAIN TOWARDS THE LEFT; LEFT SHOULDER PAIN/ PROLONGED JOINT ACHES; FATIGUE; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 133 pounds, and height was 66 centimeters. The patient's concurrent conditions included alcohol use (occasional glass of wine), and non-smoker. The patient was not pregnant at the time of reporting. The patient had no known allergies/no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: 21-JUN-2021) dose was not reported, 1 total administered in left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced confirmed immunological vaccination failure. On 08-APR-2021, the patient experienced left shoulder pain/ prolonged joint aches, chest pain towards the left, and fatigue. On 06-MAY-2021 laboratory data included: C-reactive protein (NR: not provided) normal, CPK (NR: not provided) normal, Electrocardiogram (NR: not provided) normal, Erythrocyte sedimentation rate (NR: not provided) normal, Fibrin D dimer (NR: not provided) normal, and SARS-CoV-2 antibody test (NR: not provided) less than 1 which was negative. On 08-MAY-2021, the patient recovered from prolonged joint aches. The patient had an emergency room visit for left shoulder pain and chest pain towards the left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 29-APR-2021, was recovering from chest pain towards the left, had not recovered from left shoulder pain, and the outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210519849-covid-19 vaccine ad26.cov2.s- confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210519849-covid-19 vaccine ad26.cov2.s- left shoulder pain/ prolonged joint aches, fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.

I was getting severe pain near my right rib and it moved to my back and chest area. I ended up having to have an emergency gallbladder removal surgery.

Experienced a short episode of what felt like heart palpitations and extreme fatigue, then a sudden hearing loss that has persisted for five weeks and continuing. Also experiencing, as a result of hearing loss: tinnitus, balance issues, and headaches. Possible permanent hearing loss.

Starting about noon the next day I was walking outside and completely passed out cold, hit head on the way down. When I came to everyone was standing around me and told me not to move. I was unconscious about 10 sec. Everything went white. An ambulance was called, it took them a while to show up, evaluated inside ambulance, everything was normal. EMT advised that they didn't think I needed to go to the ER.

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.

INTERMITTENT NASAL BLEEDING; VACCINATION ADVERSE REACTION; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 180 pounds, and height was 66 inches. The patient's concurrent conditions included rheumatoid arthritis and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 09-APR-2021 for covid-19 vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number: 1127007 expiry: UNKNOWN) dose and frequency were not reported from 12-MAR-2021 for rheumatoid arthritis. Concomitant medications included duloxetine hydrochloride, folic acid, gabapentin, hydroxychloroquine phosphate, methotrexate, prednisone, sulfasalazine, and tramadol. On 10-APR-2021, the subject experienced intermittent nasal bleeding. On 10-APR-2021, the subject experienced vaccination adverse reaction. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from intermittent nasal bleeding, and vaccination adverse reaction. This report was non-serious.

Janssen COVID-19 Vaccine EUA NO PAIN, just a weird sensation, can only describe as "bubbles" in both my legs: behind the knee and calf. Started the night of May 25th and I didn't think any of it cause I have always had "jumpy" legs when I'm falling asleep. But Then the sensation was getting more intense the night of May 26th so the morning of May 27th I went to the ER.

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.

I had a completely normal evening after receiving the vaccine. I woke up the next morning and didn't feel quite well. I started washing my hands and I woke to my husband calling an ambulance. I had passed out. I refused to go to the hospital per their request because of worries about COVID. I called my PCP and I discussed the situation with him and he told me to get rest and stay hydrated. I met him a couple days later for a virtual appointment. At this point the vaccine had been paused and I was very concerned about the potential of blood clots. I was still feeling fatigue after my episode, but I was feeling better. He told me to take a baby aspirin, once daily for a month, to help prevent any blood clots. After 5-6 weeks of receiving the vaccine, I started coughing, gagging and choking and had to get my daughter to get my husband. My husband gave me an alavert and I was able to breathe better around 10 minutes later. We think it was a severe reaction to possible pollen, or something in the air, but that has never happened before.

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

RAPID HEART BEAT; FEELING OUT OF BREATH; CHEST DISCOMFORT; SWEATING; CHILLS; FEVER; This spontaneous report received from a patient concerned a 45 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced rapid heart beat. On 06-MAR-2021, the subject experienced feeling out of breath. On 06-MAR-2021, the subject experienced chest discomfort. On 06-MAR-2021, the subject experienced sweating. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, chills, and fever, and had not recovered from rapid heart beat, feeling out of breath, and chest discomfort. This report was non-serious.

About ten minutes after the shot I had tightness of the chest and difficulty breathing, An hour later nausea and dizziness. Later that day I experienced muscle aches and joint pain, teeth started to hurt on the right side and jaw was hurting.

THE MORNING AFTER MY VACCINE MY TOES AND LEGS WERE NUMB AND TINGLY AND FELT HEAVY AND FELT WEIRD WALKING. I HAVE NEVER FELT THIS FEELING BEFORE, IT WENT AWAY PRETTY MUCH AFTER A COUPLE DAYS AND THEN CAME BACK A WEEK LATER E VEN WORSE THEN BEFORE AND STAYED FOR AT LEAST 3 DAYS SO I WENT TO URGENT CARE AND THEY SAID IT WAS NOT A BLOOD CLOT AND THEY DIDNT KNOW MUCH ABOUT THE VACCINE. NOW OVER 3 WEEKS LATER I STILL HAVE NUMBNESS IN MY TOES AND LEGS. IT COMES AND GOES, SOME DAYS ARE WORSE THAN OTHERS.

Pt received her vaccine at 1:18pm in RD, at 1:32pm Pt notified RN that she had numbness in her mouth, back of the tongue, and periorbital. She then reported a tingling sensation. Staff monitored & Paramedic assessed VS & noted that she was hypertensive. She requested a juice & drank without difficulty. Shortly after, around 1:55pm, she reported arm numbness bilaterally. AMR was summoned & the Paramedic continued to monitor (1:56pm). AMR arrived at 2:12pm & left with the patient at 2:18pm. She reported global numbness & tingling to AMR staff as she was leaving via gurney with them.

I developed ITP and was hospitalized June 2-4 to stabilize my platelet numbers after hemorrhaging on my period for the second month in a row.

PARALYSIS ON LEFT SIDE; NO FEELING OR STRENGTH IN LEFT SIDE; BLOOD CLOT IN THE BRAIN; CONFUSION; SLURRED SPEECH; UNSTEADY WALKING; FEELS DIZZY; NO ENERGY FOR ANYTHING; AGITATION; LOSS OF HEARING IN LEFT EAR; This spontaneous report received from a patient and her husband and concerned a 45-year-old female patient. Initial information received on 07-JUN-2021 was processed together with additional information received via 2 telephone calls to and from the patient's husband on 11-JUN-2021. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient had no family history of any blood/clotting disorders and that she did not travel anywhere prior to receiving the vaccine. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration not reported, batch number unknown), dose not reported, administered once in total on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date, the patient experienced feeling dizzy, and had no energy for anything. On 14-MAY-2021, the patient started feeling confused, her mouth started feeling like it was drawing, and her speech started slurring. On 28-MAY-2021 she went to bed and got up and she couldn't feel her left side, with paralysis. She was also drooling and her husband took her to the hospital. The patient was flown by helicopter to another hospital. During the telephone call to the reporter, he reported that his wife's laboratory results were all within normal ranges at the second hospital, including her platelet count at 189,000 (units and normal range not reported). On 29-MAY-2021, a magnetic resonance imaging (MRI) scan of her brain revealed a 12 mm blood clot in the thalamus. The patient was treated with Aspirin (acetylsalicylic acid) and Plavix (clopidogrel bisulfate). It was reported that the clot could not be cleared before she was discharged after 4 days hospitalization on 31-MAY-2021. As of 07-JUN-2021, the patient reported being highly agitated and could not hear out of her left ear, had no feeling or strength on her left side and was very unsteady walking. As of 11-JUN-2021, the patient's husband reported that the patient was still experiencing weakness of the left side of her body with no energy for anything (reported as being very active prior to vaccination), trouble walking, feeling dizzy sometimes, trouble hearing with her left ear, was very agitated and was frustrated that these events had happened to her. The patient was on medical leave from work at the time of reporting. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient had not recovered from the events. This report was serious (life-threatening, disability or permanent damage, caused/prolonged hospitalization and other medically important condition).; Sender's Comments: V0: This spontaneous report received from a patient and her husband concerned a 45-year-old woman who experienced blood clot in the thalamus 15 days after vaccine. No past medical history or concurrent conditions were reported. The patient had no family history of any blood/clotting disorders and that she did not travel anywhere prior to receiving the vaccine. On day 15, the patient went to bed and got up and she couldn't feel her left side, with paralysis. She was also drooling and her husband took her to the hospital. The patient was flown by helicopter to another hospital. During the telephone call to the reporter, he reported that his wife's laboratory results were all within normal ranges at the second hospital, including her platelet count at (189,000). On day 16, a magnetic resonance imaging (MRI) scan of her brain revealed a 12 mm blood clot in the thalamus. The patient was treated with aspirin and clopidogrel. It was reported that the clot could not be cleared before she was discharged after 4 days. As of day 25, the patient reported being highly agitated and could not hear out of her left ear, had no feeling or strength on her left side and was very unsteady walking. As of day 29, the patient's husband reported that the patient was still experiencing weakness of the left side of her body with no energy for anything, trouble walking, feeling dizzy sometimes, trouble hearing with her left ear, was very agitated and was frustrated that these events had happened to her. The patient was on medical leave from work at the time of reporting. The occurrence of blood clot in the thalamus could represent background incidence of such events in the general population and the normal platelet count exclude thrombosis with thrombocytopenia syndrome. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.

Severe heart palpitations - Palpitations last throughout the entire day and are severe enough that sometimes I can sleep. I had a normal EKG last week. I'm currently wearing a holter monitor. Mild side effects included injection site pain, achiness and tingling legs.

On first period after vaccine, experiences heaviest bleeding I have ever had, huge blood clots the size of golf balls, and I had severe cramping and body aches for three days of my period. Previous to vaccine had heavy bleeding, but not this heavy and only one evening period period cycle of light cramping and mild body aches. I have become anemic since the vaccine.

Received shot around 3:15pm. A few minutes later the area around the injection site got really hot and painful, and then I started getting really hot from the abdomen up to my chest neck and face. I called out for the nurse who came in to check on me and I almost fainted. I stayed at the facility for almost an hour until I was able to leave. I was not anxious or faint feeling before the shot so anxiety did not cause this. Once at home I was really tired. Today, July 13, I have had a fever, muscle aches, chills, headache, stomach issues, and a random numbness and tingling in my lower left leg that I?ve never had before.

7.2.21: patient seen in ED and diagnosed with COVID-19. 7.5.21: Patient returned to the ED due to symptoms worsening. Symptoms included: myalgias, weakness and cough. Hospitalization due to COVID-19 infection. Diagnosed with community acquired pneumonia and hypoxia. Remdesivir started. 7/8: Completed a 4 day course of remdesivir and was discharged home.

Headache lasted two weeks took Tylenol Very bad lower back pain lasted a week saw my chiropractor and applied heat/ice Lower back pain lasted another week Applied heat Sciatic Nerve pain lasted 4 days saw my Chiropractor Phlebitis in both legs went to ER Took a prescription medication for a week. Pain and inflammation lasted a month Elevated Blood Pressure has not lowered will see heart doctor on August 19th for evaluation Left eye twitching has not stopped. Left arm goes numb when elevated like when driving or when sleeping on left side. Still ongoing.

8:00 p.m. symptoms came on suddenly; sore arm (still sore - three days now) low grade fever(two days) uncontrollable shivers body aches headache (two days) fatigue (two days) heart racing

Adverse Event: Vasovagal syncope 2- 3 minutes after injection , treatment: supine , legs raise, ice back of head , water Outcomes: after 911 evaluation by EMT patient left the pharmacy

Light headed, fever, chills, no appetite, skin sensitive (like crawling but painful), migraine, heart racing, cough, difficulty breathing. Was like when I had Covid, but all in 1 day. Rate rate was 135 when walking and pulse went to 89 only when standing/walking

The night after my vaccination (3/17/21), 6hrs after my vaccination, I had chills, low grade fever, body aches, headache, fatigue, that lasted about 12hrs. Then I was fine after that. Then, on the evening of 3/22/21, I started getting those same symptoms but worse that the first time: 101.4 fever, chills, body aches, headache, fatigue, and also chest tightness and asthma, cough.

Patient experienced vagal response after receiving vaccine. She was unresponsive, non verbal, eyes rolled back. Rapid response paged and EMS services called. Patient was lowered to the ground with legs elevated. She regained consciousness, was alert and speaking. Patient was given 6L oxygen via facemask. EMS arrived and assessed patient.

Around four hours later began with a head, heart beat really fast, small fever, extreme nausea and IBS-like symptoms (gas pains and diarrhea), fatigue. The later lasted for nearly a week, but the rest were gone by day 3. I did not see a dr as my fever never got very high and only occurred the first night. The nausea last maybe a day and a half. I am about two weeks out and I seem to be having a gluten skin reaction (dermatitis herpetiformis) and given most of the symptoms I listed could also be celiac symptoms, I was curious if there was gluten in the shot as it was very much like an extreme reaction to gluten that I normally get with celiac. I usually see gluten rashes a couple of weeks to a month after being exposed and I was not exposed to anything during the last few weeks that could be causing it (that I know of). The nurse who gave me the shot did not know if there was gluten in the shot. Hence, I know the first symptoms were definitely related to the shot, but not if the current rash is from the shot (because gluten, this is definitely DH and not an allergy rash). I hope this helps, if other celiacs have also had a hard time.

Menstrual bleeding (I have not had a period in 3-4 years) Pain and knot at injection site (after 5 days it is worse)

Small red rash on right inside arm last few hours soon after shot, Swelling, red, lump, hot to the touch itching - gets bigger every day causes pain to radiate down left arm at times - reaction is still there on 5 around the jab site on the left arm= started around 11:00 PM on 03/25/2021; 103.7 fever started 03/25/2021 and last about 24 hours; finger extremely and hot and burning lasted about 48 hours. Fingertips still feel like electricity is running through them and fingers/hands still hurt; extremely hungry/thirsty from 03/25/2021 - 03/29/2021; fatigue, pain at base of skull under ears, tinnitus extremely loud and both ears feel like ear ache; During the night of my high fever, lower back where kidneys are started hurting very badly. What is still left of that pain on day 5 is a pain radiating from my lower back down my right leg many times throughout the day (treating with ibuphrophen). Pain around knees, elbows, ankles, and bottom of feet- different than joint pain. All my POTS symptoms are in high gear (tachycardias, very low BP, pain, dizzy, vertigo). If the leg/lower back pain, and left arm problems continue, I will see my neurologist or immunologist. I have reached out to both to make them aware. My husband had the JJ shot same day, same place and had zero side affects.

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,

I was directed to my seat (if walking into the room, the first table but the 2nd seat). The woman was learning the computer system from a gentleman, and she assured me she just didn't know the computer, but knew how to give a shot. I pulled my arm out of my sweatshirt and pushed my short sleeve shirt up. She did the alcohol wipe, then pinched my arm, I looked away as the shot went in. I felt a horrible pain...not even sure how to describe it, just extreme pain and very achy and said Ow maybe 3 times (I am one that can tolerate quite a bit of pain, and I assumed it would sting, but this was different) as she was injecting me. She apologized. The gentleman said Johnson and Johnson is a little thicker. I said to him that I had never ever experienced this much pain with a vaccine before-never. Again, I am talking about as it was injected. I went to sit down for the waiting area, the gentleman who was handing out cards for reviews asked me about it and I said it hurt so bad, I'd never had a shot hurt that bad. Another worker (female) overheard me and asked me if it was a burning-she had a burning with hers (think she said moderna). I said I would not necessarily say it was a burning, it was pain. As I sat there, I texted my husband and told him how bad it hurt (with the injection) and I've never had a vaccine hurt like that. I started to wonder if it was administered incorrectly? I looked over and the gentleman was now doing the vaccines and she was watching. My husband had Pfizer and he said that didn't hurt at all. I was feeling it up into my neck as I was sitting there. I was trying to rub my arm and neck hoping that would help as well as move my arm around. When we could leave, I asked the volunteer if she had heard of anyone else having that much pain DURING the shot. She said she only heard of maybe one other person that said ow. I left, started to cry in the car because of the pain and experience, then spoke with my husband before I left. I came home and got some ice to put on my arm hoping that would help. I did expect pain in the arm after a shot. Within a couple of hours, I noticed pain going down my arm and into my wrist. I thought maybe I needed to be active with my arm and move it so tried that. I started to notice more side effects of the vaccine as the evening progressed: I had the typical side effects I figured I'd have, achy, joint pain, chills, nauseous, no fever though. I was noticing pain into my neck (occasionally even into jaw), shoulder, scapula area of the back, and left side under the bottom part of my ribs. I was feeling tightness in my chest, too, so I decided to try 2 aspirin to see if it helped with any symptoms. I did have slight dizziness, and a weird sensation in my head-like a zapping? I didn't sleep well, and had to stay completely off of my left side. Thursday, I felt better than that night, but still tired, achy, nauseous, chills, and not 100%. My arm still was really affected...it seemed extremely fatigued as well as painful...the pain was radiating up and down and couldn't raise my arm without it hurting. Around noon I decided to take 2 aleve to see if that would help me at all. It did help with the pain and achiness, but was getting a "nerve-type" pain still up and down my left arm into neck/scapula area down to my wrist and hand/fingers. Still couldn't sleep on my left side. Friday, I was definitely doing better with all the other symptoms, I could abduct my arm more than 90 degrees, so I was excited about that. I did wake up with my middle/ring finger hurting (at the base of that area) and a bit numb so put my hand in and out of a fist. The pain subsided, but the numbness/tingling sensation was still there. I continued to take aleve hoping that maybe there was just inflammation around the nerve causing the issue. Aleve did help, but it still never went away completely. By late afternoon, I was getting concerned if I was permanently affected by this. As I was holding a bowl of food and eating, my left arm was going numb. I was even feeling it into my gluts (sciatica?). Again...all of this was after the shot and only on the side I received the shot. That evening I was able to lay on my left side, but not for long periods of time because it became uncomfortable and arm would go numb. Saturday, I still had the nerve pain and was not in a good spot. It made me sad, angry, scared, and I didn't want to talk about it too much-just wanted my arm and all the different radiating pains I was having to be back to normal. I was feeling it up into my neck, scapula, my side(the rib area I previously mentioned), even into my gluts and down leg near ankle as well as down the arm into elbow, forearm, wrist, and hand, fingers (particularly that middle finger and thumb area). I tried to use my arm as normally as possible thinking maybe I need to just keep it moving, but it would fatigue, especially between shoulder and neck. I tried Ibuprofen on this day. Again, the pain relievers helped some, but didn't take it all away. Sunday I was in a horrible spot mentally and crying throughout the day because of the sensations I was feeling still: up and down the arm, shoulder, neck, scapula, side and still into ankle area. I decided I would call my doctor on Monday. Monday, I woke up and was feeling better overall, but still having the nerve sensations down my arm as well as up into shoulder, neck, scapula and my left side. But everything was not as intense. I spoke to my doctor who said there was a protocol, a number I needed to call. Monday night I took ibuprofen because I started to have a horrible headache-didn't go away completely and still have this morning-not sure if it's related or just a normal headache. Still feeling tingling nerve sensations into forearm and fingers. My shoulder/neck area feels fatigued, but so far not noticing the nerve pain yet, so that's a positive. On Monday, it seemed to get worse as the day went on, so we will see. I definitely feel in hand/wrist/fingers as I am typing now. I know this is a lot, and I think I've captured it. Again, I had none of this pre-shot. The pain during injection is what alarmed me most as I expected side effects after the shot, but not this nerve type issue. For this to be lasting as long as it is concerns me, and the fact that it exhibits on my left side where I got the shot. I am very anxious as it hasn't gotten back to normal.

I experienced chills, fever, headache, body aches, feeling very tired, racing heartbeat, and difficulty breathing. I called the on-call nurse line and was advised to go to the emergency room due to my fast heartbeat.

Pt received vaccine and had a safety barrier bandaid put on. Seconds later, the injection site started heavily bleeding over and around the bandaid. Rph applied constant pressure using cotton balls to the area for 5-7 minutes. Bleeding had stopped and a new bandaid was applied. Injection site adverse event was then resolved. Pt expected this due to her having a medical condition of anemia and taking subsequent B-12 injections. Pt was observed for 30 minutes and no bleeding re-occurred or was seen. Pt was directed to put ice and pressure on it for further home care.

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

pt was getting her vaccine . Because of her previous hx of rx with MMR vaccine ( throat swelled up[) I asked pt to wait for atleast 45 mins . Pt started having same rxn again after 30 mins . I administered 1 shot of epipen and pt started feeling better . 911 was called and paramedics checked her vitals . Everything was okay except for the bp which was 199/100 because of the epipen. Pt refused to go to the hospital

Vasovagal syncope resulting in fall to floor. While on ground pt became rigid. Pt began to come to and was transported to medical via cot and EMS was notified. Pt symptoms resolved and EMS was refused.

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

Massive nose bleed with a huge blood clot to follow. Went to urgent care but it had stopped by then so they sent me home and told me if it happened again to go to ER. I haven?t had a nosebleed in years so it was scary to get it the day after my vaccine. The nose bleed lasted about 10 minutes and was very strong once the clot came through it slowed down and then stopped and did not return again.

I received the vaccine at approximately 1:08 pm. Once administered I was instructed to sit in the auditorium for 15 minutes for observation. During that time I had a few heartrate increases and nausea but nothing out of the ordinary or concerning. After the 15 minutes, I walked out to my car and thankfully my husband had driven because what happened next would have caused an accident. Our drive home is approximately 20 minutes from where vaccine was administered. In the car I began to feel a tingling all over my body that gradually began to feel like ?pins and needles? (like when you sit on your legs for too long and they ?fall asleep?), with the worst of the feeling being in both of my hands. I began opening and closing my fingers to try and get them to feel normal. By the time we pulled into the driveway, my hand had locked up in a weird position and I was no longer able to communicate with them and make them move. They were temporarily paralyzed. My husband opened the door for me because I wasn?t capable of doing so. Once I stepped out of the car, my body began to convulse and shake. We stood there for a few minutes because one, I couldn?t make my body cooperate and two, we didn?t want our children seeing me that way. My husband kept asking me if he should call an ambulance. Of course, he should have but I think he was so scared and shocked that he just didn?t know how to react. I had trouble forming words and sentences at that point and could not tell him to call. I felt pretty calm considering what was happening to me and I could not control myself. My husband decided to walk away from me and coerce me to go to him. I stood there for a few minutes trying to communicate with my legs. Once I took my first step, my body stopped shaking and I started to regain feeling in my hands. I went and laid down for a bit and began to feel a bit better. Around 7pm I was feeling extremely cold. So cold that I put on three layers of clothing and two comforters to try and warm myself. That did not work though, as it was more of a cold from nerve endings than it was from temperature. I went to bed around 9pm but didn?t fall asleep until around midnight. I was feeling waves of cold down my body. Like a skin prickling when you hear a beautiful song and you get goosebumps and your hairs stand up. I woke around 3am to an extreme headache and a fever of 102.6. I took Tylenol and went back to bed. When I woke in the morning, I felt better but had weird and random muscle twitching. For the past few days I?ve been suffering with extreme fatigue which is not like me at all. Even when I?m tired, I can still manage to function throughout the day. Not only have I been tired, my body is weak, my muscles are weak and my joints hurt. I?m hoping this ends soon and doesn?t get any worse. It will be two weeks this Sunday.

3 days with migraine headaches, 3 days backaches, extremely rapid heart beats the first night, sweats and chills first 3 days, 3 days of chills. First night Ny Quil and Tylenol to sleep and reduce the fever. I woke up in the middle of the night in sweat, I had to take my thyroid medication to slow down my heart rate. I was having heart palpitations, my heart was beating so fast it woke me up.

Dizziness, nausea, uncontrollable shaking lasting for 4 hours, chills, lethargy, barely able to walk, feeling of being on fire, feeling of being unable to catch a breath, dry eyes and mouth, severe sweating, not being able to control leg movements, unusual thoughts, confusion, stabbing pains in different parts of the body, all over aching in joints and muscles, rapid heartbeat.

Patient started to feel light headed and sweaty approximately 5 minutes after receiving her vaccine. She lost consciousness for a few seconds and was weak and light headed after regaining consciousness.

Hot sweats followed by light headed and faint like spells. Episodes of feeling off for the past 5 days now

Headache, dizziness, ringing in the ears, body aches, tightness in my chest, shortness of breath, increased heart rate.

My heart rate due to my condition is in the 50s for the past 3 years. Once I got the vaccine I felt fatigued and my heart felt it accelerated. My heart rate had spiked to 70 all the way up to 120 in the course of the day. Heart reading was marking if I was being active while I was just in bed all day. My heart rate didn't go back down till the 50s till about 26 hours later.

ACHINESS; CONGESTION; SINUS PRESSURE; ELEVATED BLOOD PRESSURE; COUGH; DRAINAGE; FATIGUE; SWEATING; NOT FEELING WELL; CHILLS; SLIGHT HEADACHE; SLIGHT NAUSEA; LOW GRADE FEVER; 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 seasonal allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 16:30 on right arm for prophylactic vaccination. Non-company suspect drugs included: ibuprofen ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for achiness. No concomitant medications were reported. On 27-MAR-2021 17:30, the subject experienced sweating. On 27-MAR-2021 17:30, the subject experienced not feeling well. On 27-MAR-2021 17:30, the subject experienced chills. On 27-MAR-2021 17:30, the subject experienced slight headache. On 27-MAR-2021 17:30, the subject experienced slight nausea. On 27-MAR-2021 17:30, the subject experienced low grade fever. On 28-MAR-2021, the subject experienced fatigue. On 29-MAR-2021, the subject experienced congestion. On 29-MAR-2021, the subject experienced sinus pressure. On 29-MAR-2021, the subject experienced elevated blood pressure. On 29-MAR-2021, the subject experienced cough. On 29-MAR-2021, the subject experienced drainage. Laboratory data included: Blood pressure (NR: not provided) 146/89 mmHg. On an unspecified date, the subject experienced achiness. Treatment medications (dates unspecified) included: amoxicillin, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ibuprofen was not reported. The patient recovered from sweating on 01-APR-2021, slight headache, and slight nausea on 28-MAR-2021, and low grade fever on 29-MAR-2021, was recovering from not feeling well, fatigue, congestion, sinus pressure, cough, and drainage, and the outcome of elevated blood pressure, chills and achiness was not reported. This report was non-serious.

On Mon, April 5, had the vaccine, fainted at site 5 minutes after getting the vaccine. 9pm Apr 5, had fatigue, fever, slight headache, night sweats, clammy skin feeling. This continued until Wed Apr 7th Wed Apr 7 and Thursday Apr 8th were fine Friday, Apr 9th developed all of the above issues plus dizziness, nausea, upset stomach and dry heaving. This continued into Sat Apr 10th with added shortness of breath and heart palpatations. Went to the emergency room Sat Apr 10th Sunday, Apr 11th, severe nausea and stomach problems continuing along with continued night sweats.

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.

Still a little nausea, very fatigue and foggy, body pain periodically and very cold chills periodically throughout the day. Overall feeling - of consisted unwell feeling all day since the shot. I simply push myself everyday to get out of bed as I have to work. 5 hours after shot ? I felt like all my bones were broken ? severe pain ? Cold chills so bad I was shaking ? Fever ? Nausea ? Migraine ? sensitive to lights ? Could not walk (barely can take 2 steps) ? Severely weak ? Chest tightness and heart racing ? Simply felt I was going to die ? of course I didn?t but it was the worse feeling in life worst than flu symptoms

headache chest pressure severe headaches face pain jaw pain neck pain abdomen pain nausea fatigue all over aching

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.

woke up from sleeping feeling sick sweating and started vomiting tightness in my chest and dizzy with a headache

shortly after vaccination (about an hour), I felt like I was disconnected in my words and responses. My husband would ask me questions and it took longer than normal to respond. That brain fog seemed to have subsided late afternoon. By 7pm the same day, I had chills, low grade fever and by 10pm the same day, I experienced extreme body aches, headache, and fast rate heart beat. I took an Aleve and by 2am, I was able to sleep and my heart rate was down. The next day, 4/12, I had a hoarse voice, body aches and a headache, no fever. Heart rate was still pretty fast.

Approximately three days after vaccine, I experienced a blood clot. This caused an acute ischemic stroke in my left frontal lobe, resulting in muscle weakness and partial loss of use in my right leg.

About five minutes after receiving the vaccine I began to feel something was terribly wrong. I then blackout for several minutes. From my son's description I believe I might of had a seizure. He said my eyes were wide open, I was slumped over, and gurgling. I was completely unresponsive to him. He summoned the paramedics who loaded me in an ambulance soon after I came to. They checked my vitals. My heart rate was 47 bpm and blood pressure was 80/40. They also checked my blood sugar. It was 116. They decided I needed to go to the hospital and began giving me iv fluids in route. At the hospital an EKG was taken, which came out normal, they continued iv fluids, and did a urinalysis on me. All test indicated I was healthy. It about three hours before my blood pressure and heart rate stabilized. Just as long for me to feel like I would be ok. They discharged me at this point. Since they I have just been extra tired and have had muscle discomfort.

Woke up in a cold sweat with heart racing. The racing heart quickly turned into pounding heart as well. This caused discomfort in my chest. Called 911. Blood pressure skyrocketed, as well. Event continued for several minutes before heart rate and blood pressure lowered but took quite some time to become normal. I also experienced hot flashes for several days.

onset 4/13/2021 with "excruciating headache, abdominal pain with nausea and vomiting" pt states that she woke up sunday am, with an excruiating headache and had to call the rescue squad and be seen; pt states that she had nausea and vomiting along with the headaches; pt states that she was taking phenergan; pt states that the rescue squad did not take her to the ER; they told her that it was a side effect of her Johnson and Johnson COVID vaccine and that if she could get the phenergan down that would help her; pt states that her bp shot up to 159/96 and that she was dehydrated but that if she could keep her gatorade down to keep hydrated that would help; they told her the bp elevation was related to her headache; pt states that last night she was able to keep down cottage cheese and fruit last night; she states that she ate an orange a little while ago; she states that she has not vomited in two days, monday being the last day she vomited; she states that she has nausea still; she states that she feels weak from sunday; she states that she saw on the news to call your physician if you are experiencing any headaches, nausea or vomiting after receiving the Johnson and Johnson vaccine;

Thursday, 4/8/21: 6:40p: Received vaccination at hospital; 7:00p: Left clinic ( hospital); 7:05p: Center area of chest starts feeling ?tight? and difficult to expand chest, neck felt mildly itchy, tongue felt slightly larger. However, I felt no other symptoms of an immediate allergic reaction: no wheezing or difficulty in breathing, no swelling of my throat, no hives or rashes, no GI issues. Decided to drive back and stay close to hospital in case symptoms worsened; 7:20p: Symptoms did not worsen. Drove back and stayed around downtown hospital in case symptoms worsened; 7:40p: Although chest still felt tight, tongue felt normal again and neck did not itch. Returned home to monitor; 9:30p: chest no longer feels tight; 10:00p: went to sleep with no breathing issues; Friday, 4/9/21: 3:00a: woke up to expected mild fever (100F) and aches (NOTE: did not take any Tylenol or NSAIDS) 12:00p: fever 101F, along with start of headache, fatigue; 5:00p: fever 101.7F, headache and body aches worsen, loss of appetite but drinking plenty of fluids, and urinating, could not stay awake; 10:00p: fever 102.5F, major headache and aches, fatigue, ? finally took Tylenol 650mg; 3:00a: awoke from sleep, temp 99.4F and mild aches, no headache ? took another Tylenol 650mg; Saturday, 4/10/21: 8:00a: awoke with no fever (98.6F), no headache, no aches; 3:00p: temp 99F, mild aches, no loss of appetite, no headache **Have not taken any Tylenol or NSAIDS since then**

04/08 3:00pm had cold sweats & rapid heartbeat 6:00pm blisters in roof mouth & throat Very tender arm at shot site 04/09 Woke up with arm redness and a few blisters on arm (resembled bad sunburn with blisters) Very sore arm with large know size of tennis ball at shot site Still rapid heartbeat and very tired 04/10 Have been taking benedryl every 4 hrs & the blisters have now went down but now feels like burns. Still very sore arm and tired w/ rapid heartbeat 04/11 Still not feeling well and same symptoms of tired, sore arm, burn like feeling on arms & in mouth and throat as well as rapid heartbeat 04/12 Woke this morning with bad headache and now short of breath with any activity & rapid heartbeat and still arms have red like burns and now skin peeling off. 04/13 Woke up this morning with no change in my symptoms so I called my family doctor. Doctor seen me and advise me sounds like possible allergic reaction and to rest and try to ease off benedryl some and callback if any changes. This eve about 8-9pm I started having very dull pains in left chest area and very short of breath with my rapid heartbeat still there. I went to bed. 04/14 Woke up with intense pain in left chest and pulse was getting high with any activity & short of breath along with cold sweats and feeling worse I have ever felt and had and called my family doctor & he sent me to ER At ER they did many tests and labs and xrays and gave me shots of strong steroids and said pleurisy and that seemed like my body was having an overload reaction to vaccine and would take time but should go away. And said rest and follow up with my family doctor in a few days.

Bad headache, shortness of breath, sweaty clammy , non stop violence vomiting , blood coming through nose while vomiting nausea and stomach , dizzy , vision . Weak . Felt like I was dying

I got Jonson and Jonson vaccine on 4/8/2021 . I was fine after that and suddenly on 4/13 /2021 I had cramping in my both leg and foot whole day. At night I woke up from deep sleep and started crying that my leg was hurting badly and felt like something was stuck in my knee couldn?t move for couple min. 5 min later I got up to take pain medicine and try to walk and I was able to walk after that so went to use bathroom ( to urinate) while I got up. After that since I had pain in my leg earlier I went to grab pain medicine than again I started crying and saying I don?t feel good than I passed out completely and was unconscious. My husband picked me up and brought me to bed and said I had black out and fell on my face on floor .

Dizzy/lightheaded about an hour after vaccine then sudden onset of extreme fatigue. Slept about 6 hrs woke up with massive chills, slept another 7 hours. Woke up with dizziness, chills, shortness of breath, weakness, achy, headache. Slept on and off all day. This continued for 2 days. The dizziness, headache, shortness of breath, fatigue and general I?ll feeling continued until day 13. Day 14, April 16th - first day I feel somewhat normal. Still a little fatigue as day went on. Had to take a nap. The dizziness seems to have subsided. Still experiencing Mild intermittent headaches and occasional shortness of breath and palpitations.

6 days after receiving vaccine, I experienced an episode where I got extremely hot, sweaty in neck and chest area, dizzy, loss of balance, blurred vision and blacked out for a few seconds. The episode lastly apprx. 4-5 mins. I laid down and fell asleep for about 20 mins afterward and woke up to moderate headache and slight burry vision still on left side. I saw my primary dr the next morning on 4/1/21 and reported issue.

Shortness of breath, nausea, headache, incident of blurred vision in one eye. Had visit with PCP on March 26th with follow-up testing on March 30th and 31st. Condition worsened and went to emergency room on April 4th and was admitted to ICU. EKOS procedure performed on April 5th. Discharge diagnosis on April 7th: 1) Acute bilateral PE (Pulmonary Embolisms/Blood Clots) with significant right heart strain status EKOS cath directed thrombolytics on April 5th. 2) Extensive bilateral deep vein thrombosis. 3) Significant right heart strain confirmed on the echo 4) Mild anemia 5) Metabolic acidosis with mild hyponatremia 6) Hypercoagulable workup, most results pending at discharge 7) Acute hypoxic respiratory failure

Received Janssen vaccine 4/6. Started menstrual cycle 12 hours after vaccine even though had just completed last cycle 1 week prior. Normally cycles are 28-30 days apart. They have not been quite as regular since Covid and has had some shorter periods between normal cycles. After the vaccine bleeding was heavier than normal with large clots but by end of last week had changed color and looked like it was ending. Today had no discharge upon awakening but again has a small amount of bright blood. Of course, there is concern for coagulopathy related to the vaccination. No leg pain, no shortness of breath. Has had HA off and on since had Covid but no worse now than in previous weeks. Left ear pain has been painful since Covid but now has pain in both ears when that occurs. Quit taking ibuprofen last week for discomfort and switched to Tylenol.

Approximately 6 hours after being vaccinated, the patient's heart rate skyrocketed to 178 bpm, as measured by an Apple watch. In the next few minutes it settle to about 120 bpm. On the way to the ER it skyrocketed again to 150 bpm, then settled to about 115 bpm. Over the next 6 hours it slowly decreased to about 100 bpm and did not return to normal until 24 hours after the initial vaccination shot.

We got a call from Doctor from ER to inform us that this patient came to the ER today & got swollen arm @ the injection site (left arm). They did the ultra sound & found there's a clot in brachial vein on the opposite arm (right arm). Doctor said they'll give pt Eliquist today.

SHORTNESS OF BREATH; HEART PALPITATIONS; SEVERE DIZZINESS; STOMACH UPSET; NAUSEA; HEADACHE; FAINTED; FEELING UNWELL; CLAMMY CHILLS; TEMPERATURE RAISED A LITTLE; GENERAL FATIGUE; NIGHT SWEATS AND WAKE UP FROM SLEEP; DRY HEAVING; 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 past medical history included possible COVID-19 infection in FEB-2020 (not confirmed). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid muscle on 05-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the patient was fainted for about 5 minutes after vaccination and about 8 hours later, she experienced dry heaving, clammy chills, night sweats and wake up from sleep, feeling unwell, temperature raised a little, general fatigue and headache. It was reporter that, the clammy chills subsided by 07-APR-2021 after patient took Tylenol (paracetamol), but then later reported that it was still ongoing. On 09-APR-2021, the patient experienced severe dizziness, more temperature raising, further nausea and stomach upset. On 10-APR-2021, the patient experienced shortness of breath, heart palpitations, increased nausea and stomach upset. It was reported that the patient had visited emergency room at hospital at around 2 PM on the same day for shortness of breath, heart palpitations, increased nausea and stomach upset, dry heaving and temperature increase. The symptoms that were ongoing included the night sweats which wake from sleep, nausea and stomach upset and other symptoms were resolved. On 10-APR-2021, the patient's normal laboratory data included complete blood count (CBC), differential white blood cell count, electrocardiogram, fragment D dimer, glomerular filtration rate, glucose, liver function test, magnesium, metabolic function test, NT-proBNP, and troponin T. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted on 05-APR-2021, severe dizziness, shortness of breath, heart palpitations, dry heaving, feeling unwell, and temperature raised a little on APR-2021, and general fatigue, and headache on 07-APR-2021, and had not recovered from clammy chills, nausea, stomach upset, and night sweats and wake up from sleep. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420859 - covid-19 vaccine ad26.cov2.s - fainted. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

I received the Janssen vaccine on 3/5/2021. My first menstrual cycle after the vaccine, which started on 3/21/21, was significantly different than any other period. I woke in the middle of the night to extreme pain in my abdomen and bled along the floor as I walked to the bathroom. There were clots in the blood in addition to extraordinarily heavy blood flow. The period was so significantly different from any other that I scheduled an appointment with a nurse practitioner that works with my primary care doctor. I asked her to "run" all tests that were available and approved by insurance, which she did. All came back normal. Due to the significant difference in my period this month, the ARNP requested an inner-uterine ultrasound which found the below:

ABDOMINAL PAIN; JAW PAIN; FACIAL PAIN; PRESSURE IN LEG; LEG PAIN; BURNING FROM BRA STRAP TO BRAIN; CHEST PRESSURE AND PAIN; NAUSEA; SEVERE HEADACHE; ACHE; SHORTNESS OF BREATH; FATIGUE; This spontaneous report received from a patient concerned a 46 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: 038A21A expiry: 21-JUN-2021) dose was not reported, administered on 31-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced ache. On 31-MAR-2021, the subject experienced shortness of breath. On 31-MAR-2021, the subject experienced fatigue. Treatment medications included: paracetamol. On 31-MAR-2021 21:00, the subject experienced severe headache. On 04-APR-2021, the subject experienced burning from bra strap to brain. On 04-APR-2021, the subject experienced chest pressure and pain. On 04-APR-2021, the subject experienced pressure in leg. On 04-APR-2021, the subject experienced leg pain. On 04-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced abdominal pain. On 13-APR-2021, the subject experienced jaw pain. On 13-APR-2021, the subject experienced facial pain. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain, and the outcome of severe headache, fatigue, ache, shortness of breath, burning from bra strap to brain, chest pressure and pain, pressure in leg, nausea, abdominal pain, jaw pain and facial pain was not reported. This report was non-serious.

Patient received J&J COVID vaccine on 4/9/21 at pharmacy . Today (4/22/21), patient is admitted to our facility with VTE, submassive, unprovoked, with bilateral high-burden PE and LLE DVT, and right heart strain / acute cor pulmonale; in patient with H/o R PE, provoked 2014 after transcontinental flight, s/p Warfarin x 6 months, reportedly negative hypercoagulable panel; with strong family history of venous thrombosis in mother and sister. Heparin drip started, plan to start DOAC tomorrow. Anticipate hospital admission for at least 2 nights.

Pt experience severe headache, hypertension, head pressure, muscle twitching of the face, numbness on the right side of the head-temporal area, shortness of breath and left sided chest pressure

I?m writing this as a former, trained healthcare professional (physical therapist). 30sec-after injection I raised my left (injected) arm and my deltoid/bicep had a sudden hard spasm. I told my husband (who was in the middle of getting his shot) and the administrator that I was passing out. I blacked out. They ran over. They said 5 minutes passed in which my eyes were wide open and dilated. I suddenly began profuse sweating and convulsions/ severe full body shaking. They could not keep me lucid, and called 911. Paramedics came and got a systolic BP of 36 (I?m unaware of the diastolic BP) with blood sugar at 111 ish. I could not form words and kept going in and out of consciousness. I was transported by ambulance to the ER. A few minutes into the ambulance ride I was able to form words, and vitals stared to return. I?ve passed out a few times and this WAS NOT a normal episode of syncope.

Chills and moderate headache within 6 hours of vaccine. Lasted about 6 hours Severe headache 6 days later that lasted 1 day

Immediately following vaccination: Flu like symptoms. 24 Hours after vaccination: Very severe headaches started and continued. 12 Days after vaccination severe Stroke/Hospitalization/ICU

Got Johnson and Johnson shot 4/10/2021: 4/11/21-4/12/21 headache, hot and cold chills 4/13/21- abdominal pain and shortness of breath 4/14/21- shortness of breath (sob) 4/15/21- headache, pain right side chest 4/16/21- fatigue, pain left side chest 4/17/21- sob (bad) 4/18/21- 4/21/21 sob 4/22/21 -woke up struggling to breath. Family Physician sent me to hospital. She was thinking blood clot lungs 4/23/21-current sob

I had sudden sensorineural hearing loss first in my left ear and then in my right. I still have distorted hearing in my left ear and my right ear is still muffled. It happened a little under 3 weeks after the vaccine. The doctor performed a hearing test in my left ear and it showed moderate sensorineural hearing loss compared to the hearing test I had last August. 2 weeks later my right ear showed decreased hearing. I was put on 60 mg of steroids for 2 weeks and given doxycycline for 2 weeks. The dr also had me do a CT scan. I also had an elevated D-dimer test for clots.

CLOT BLOOD; ACUTE ISCHEMIC STROKE IN LEFT FRONTAL LOBE; PARTIAL LOSS OF USE IN RIGHT LEG; MUSCLE WEAKNESS; 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 amoxicillin and flexeril allergy, and migraine. The patient experienced drug allergy when treated with cyclobenzaprine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 11:30 on left arm for prophylactic vaccination. Concomitant medications included ascorbic acid, ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, ergocalciferol, iron, and withania somnifera. Approximately three days after the vaccine, on 11-APR-2021 08:20, the patient experienced clot blood. Which caused an acute ischemic stroke in left frontal lobe resulting in partial loss of use in right leg and muscle weakness. The patient had a blood test, CT scan, Carotid artery ultrasound, diagnostic ultrasound, electrocardiogram (EKG) and an MRI, results are unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from clot blood, acute ischemic stroke in left frontal lobe, muscle weakness, and partial loss of use in right leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a report of a 46 year old, female patient who experienced a blood clot that caused an acute ischemic stroke in the left fontal lobe 3 days after receiving the covid-19 vaccine ad26.cov.2. Patient's height and weight were not reported. Patient has migraine and allergies to amoxicillin, flexeril and cyclobenzapine hydrochloride. Concomitant medications included ascorbic acid, ascorbic acid/ ergocalciferol/folic acid/ nicotinamide/ panthenol/retinol/ riboflavin/ thiamine hydrochloride, ergocalciferol, iron, and withania somnifera. Smoking history, drug abuse and alcohol intake were not reported. Three (3) days after receiving the vaccine, patient was noted to have a blood clot (unspecified area) that caused an acute ischemic stroke in the left frontal lobe, resulting in muscle weakness and partial loss of use of the right leg. Patient had blood tests done as well as CT Scan, carotid artery ultrasound, electrocardiogram and MRI but the results were not reported. The information provided precludes a meaningful medical assessment. Additional information requested.

Intermittent tachycardia with palpitations, shortness of breath, lightheadedness at rest. Currently undergoing further workup. Onset 7 days ago.

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

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".

Pt had headache for the last week. J&J vaccine on 4/10, dxed with cerebral venous thrombosis. Pt's age is 47, not 46. Form would not allow me to put in pt's age and cited an error with pt's DOB.

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.

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.

flu like symptoms with headache 4/8/21. Chest pain, nausea, sweating, lightheadedness started 4/10/21, was seen in ER and discharged home. White count was noted as 2.8. Chest pain went away after 24 hours and palpitations started 4/11/21, severe at times for several hours at a time. Saw my cardiologist on 4/15/21 for severe palpitations and he ordered a halter monitor to be worn for 2 weeks. I stated to him that I felt like I was in SVT, or something stronger than just palpitations. This continued for several hours a day from 4/11/21 to 4/24/21, when I was on the telemetry pack at work and went into an arrythmia that was later evaluated by my cardiologist as SVT and A FIB. On 4/25/21, I had mild "palpitations" but have not had any incidences since. I am now on metoprolol to control it and did not have a cardiac issue prior to receiving the vaccine.

Headache onset 2 weeks after vaccination. Brain MRI on 4/30/2021 showed subacute dural venous sinus thrombosis affecting the superior sagittal, left transverse and sigmoid sinuses.

TREMENDOUS HEADACHE LIKE MIGRAINE; MILD PAIN IN THE INJECTION SITE; MILD ALLERGY; TIGHTNESS OF CHEST; FLU LIKE SYMPTOMS; THROAT FELT FUNNY; 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 allergy to dust, and acid reflux. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced tightness of chest. On 08-APR-2021, the subject experienced flu like symptoms. On 08-APR-2021, the subject experienced throat felt funny. On 08-APR-2021, the subject experienced mild pain in the injection site. On 08-APR-2021, the subject experienced mild allergy. Laboratory data included: Body temperature (NR: not provided) 102.5 F. On 09-APR-2021 03:00, the subject experienced tremendous headache like migraine. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tightness of chest, throat felt funny, tremendous headache like migraine, mild pain in the injection site, and mild allergy on APR-2021, and flu like symptoms on 2021. This report was non-serious.

I had the expected chills, fever, headache, fatigue and body aches beginning about 7-8 hours after the injection. The headache, fever, chills, and aches subsided after about 36 hours. I had EXTREME fatigue for about 2 weeks, and had some increased heart rate and higher blood pressure as well. Since the vaccine, i have had vertigo, brain fog, some light headedness and an inability to concentrate. It has affected my ability to drive and work when it is at its worst, and I have had some headaches when I am feeling particularly disoriented. Sometimes I have trouble completing sentences and finding the right words. I have seen a cardiologist, PCP, and ObGYN and mentioned my sypmtoms to each of them.I had routine bloodwork done, and all was normal there. It has not improved, and I have an appointment with a neurologist next week. I did not feel this way at all before the vaccine, and it is deeply concerning to me. I am worried about receiving any future vaccines and/or giving them to my children. Please reach out with follow up information. I did not report it sooner, because I kept thinking it would end, but it has continued. I am very frustrated and disturbed by this. thank you.

Patient was vaccinated at 6:00pm and told to stay at the store until 6:15pm. At approximately 6:40, while sitting in her car, she passed out. She had a friend with her that either called 911 or drove her to the emergency room.

Immediately, I noticed that he gave it to me really close to my armpit, so my doctor thinks that my be the issue. I was tingling over my body and my heart was beating fast. From that day, I've had pain in my arm that doesn't stop. It even hurts to the touch. I had an appt two weeks later and my doctor told me to keep taking Tylenol, icing it and alternate hot/cold treatment. It's improved, but it has not gone away.

The same day I took vaccineon April 6, 2021, I had pelvic pain and cramping that increase over the next two. Weeks. I made a appointment with my physician. On 4/29/2021 I was examined by my physician and was told to go to the ER. I had my appendix removed ans the pathology report showed that I had a bllod clot.

within 5 hours of receiving vaccine - i started itching all over my body - under my arms, stomach, chest and back of neck were the most inflamed area. this has now lasted for 10 days. I'm also experiencing tightness in my chest. I feel like someone is choking/pressing on my chest from the inside. I also had a fever, massive headache and muscle pains

2 weeks after receiving johnson and johnson vaccine I began a second period in one month. I am very regular with my menstrual cycle so it was weird. And what is very strange it has large clots and not alot of bleeding. I have never had an period like that since I am 11 years old.

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

She developed shortness of breath the day after receiving the vaccine. Three days later she presented to ED and was found to have extensive right DVT and bilateral PEs. She has no prior history of DVT/PE. She had taken a flight 6 days before getting the vaccine. She has responed to treatment and was discharged the next day.

HIGH BLOOD PRESSURE (138/96 MMHG); FACIAL NUMBNESS; ELECTRIC SHOCK LIKE PAIN BEHIND BOTH EARS IN BRAIN; HEAT UP NECK; 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 past medical history included arm numbness, and concurrent conditions included penicillin allergy, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no prior diagnosis of high blood pressure. The patient did not have any history of drug abuse or illicit drug use. The patient was not pregnant at the time of vaccination. The patient was previously treated with benzylpenicillin. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced facial numbness. On 10-APR-2021, the subject experienced electric shock like pain behind both ears in brain. On 10-APR-2021, the subject experienced heat up neck. On MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 138/96 mmHg. On 12-MAY-2021, the subject experienced high blood pressure (138/96 mmHg). Laboratory data (dates unspecified) included: CT scan (NR: not provided) Normal, and MRI (NR: not provided) Normal. The action taken with covid-19 vaccine was not applicable. The patient was recovering from facial numbness, electric shock like pain behind both ears in brain, and heat up neck, and had not recovered from high blood pressure (138/96 mmHg). This report was non-serious.

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.

Have been in remissions from Grave's disease - auto-immune disease - for over a year. I had gone in for a routine blood exam (may 10th) - my Dr (May 11th - routine visit) saw that my thyroid numbers were elevated. Before the shot, I had no symptoms and now I have had symptoms of Grave's disease. I am starting to get tremors and a bit of an elevated heart rate. When I go running, it gets elevated I have to stop. Weight loss.

Development of superficial vein tromboses in the right lower extremity great saphenous vein with propagation of thrombus.

Patient passed out, was briefly unconscious in chair. She woke up and felt disorientated. She felt tingling sensation throughout body and a burning pain in stomach.

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.

05/25/2021 - 6:00am - 2:00pm: Nauseous, 2:00pm - 5:00pm Dizzy 05/25/2021 - 05/26/2021 5:00pm: Headache on and off 05/26/2021 - 5:00pm : Migraine, light sensitivity: Took Aleve 05/26/2021 - 8:00pm : Migraine, light sensitivity : Emergency Room, Received shot for migraine and CT scan, saw bleeding on brain Transferred to Hospital by ambulance. CT scan done found blood clot in left side of head and blood work showed blood platelets were low. Diagnosis: Cerebral Venous Sinus Thrombosis, Thrombocytopenia. 05/27/2021 : Admitted to hospital in the Neuro ICU Transfusion of Nonautologous Globulin into Peripheral Vein Transfusion of Nonautologous Platelets into Peripheral Vein Placed on blood thinners. 06/02/2021 Discharged from hospital into Doctors' Care

On 04-24-2021 I had four days of extreme headaches that would not go away so I went to the ER where I got checked out. Also on 03-28-2021, I woke up with extreme left leg pain. I had difficulty holding things with my arms and I almost collapsed to the floor due to my left leg pain and weakness. I also had heavy menstrual bleeding with giant clots for the Month of March 2021. I can say today I have no symptoms of my left leg or headaches today.

I woke up on 4th with pins and needles in my hands and I called the doctor's office. They said that I was crazy and nothing was going on with me and call back in a week even though the receptionist at the office had just said they were getting all kinds of calls about it.. For the next week, my hands and my feet were tingling intermittently. I went to the doctor on Friday, June 11th. They did a full metabolic panel - all came back fine. The next morning, June 12th, I felt my face was numb. I called doctor and she said it was anxiety. So my hands were pins and needles. The face numbness was new. I see a naturopath and I told her and she said it was call for concern and she looked at labs and told me to call doctor back and she mentioned that she had seen all kinds of people with these symptoms. My anxiety is super high. I'm not usually an anxious person. I have high blood pressure. I have joint pain in my hands - if I take Naproxen. If I take Aleve the joint pain goes away. I feel like my face is dragging but when I call in the mirror it looks fine. That's the feeling of numbness says my naturopath - and that's the same with my lips. I feel like I have some brain fog and I've been stumbling over words. That happens about once a day. I have a doctor's appt on Friday for blood pressure. I did not have blood pressure before this. Usually my blood pressure is 126/90 (when normal) and it's tracking at 143/103 and 140/100 ever since I had the vaccine.

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

Patient developed a frontal headache, tachycardia and shortness of breath about 6 hours after receiving the vaccine. She was evaluated in the emergency room where her labs including platelets and complete blood count, EKG and vitals were normal.

It probably is my thyroid, I have hypothyroidism, which is an autoimmune disorder, they are still trying to figure it out. My thyroid went really high. High thyroid can cause heart problems, fatigue, all that kind of things. They are trying to lower my medications. On 06/17/2021 I went to the doctor. They did blood work, CAT scan, heart normal, Covid test. I had to be hospitalized for 3 days and 2 nights at medical center because I had chest pain and shortness of breath and heart palpitations. While at the hospital they gave me nitroglycerin for the chest pain and Zofran for the nausea.

I started having multi hour of rapid heart palpation. Heart was going 150. I was taking all kind of remedies

5/25/2021 Feeling of pins and needles in upper middle back and shoulder blades right and left of spine. 06/25 little bumps but thinks it was just scabies. 4/26/2021 Heart palpitation (seems to have a history of it happening once every 2 yrs.).

I discovered patient on the floor at approx. 3:03pm. She was lying face down on the floor next to the chair she was sitting on during her 15-minute observation post-covid19 vaccine. Unknown person turned patient over face-up, Face was clammy and warm/hot to the touch. Pulse was taken (weak). Sweating. Eyes were closed when EpiPen was injected on left thigh through pants. It was decided to inject patient as we did not know what exactly happened, why she was on the floor, and she was unconscious at the time we initially thought to give epi injection. 1 pen injected. Pharmacist called emergency services at 3:05pm. Patient eventually regained consciousness while waiting for the paramedics. She was able to talk and answer questions. She was taken outside the gym on stretcher, but her son met us at the school to pick her up. She declined going to the hospital for further treatment.

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.

FIRST DAY: *HIGH GLUCOSE; *NAUSEAS; *LITTLE HEADACHE; *CHILLS; *TIREDNESS. SECOND DAY: *HIGH GLUCOSE; *TIREDNESS; *HEADACHE; *SMALL BLEEDING. THIRD DAY: *HIGH GLUCOSE; *MODERATE BLEEDING. FOURTH DAY: *HIGH GLUCOSE; *MODERATE BLEEDING. FIFTH DAY: *HIGH GLUCOSE; *MODERATE BLEEDING. SIXTH DAY: *HIGH GLUCOSE; *MODERATE BLEEDING. SEVENTH DAY: *GLUCOSE A LITTLE MORE CONTROLLED; *MODERATE BLEEDING. EIGHTH DAY: *GLUCOSE A LITTLE MORE CONTROLLED; *ENOUGH BLEEDING; *WEAKNESS.

6 hours after shot I began to feel major muscle aches and chills. Within an hour of this onset I had a fever of 102.4 and was wearing 2 coats, had the heat blasting, and was in many many blankets and still chilled. This went on for about 7 hours. Also during this time my heart rate was elevated to about 100 beats per minute (normal is 60-65 for me). and also the hear beat seemed 'loud' like someone was dribbling a basketball in my head (maybe this is a sinus symptom??). After these symptoms subsided I had a splitting headache for several more hours.

Several hours post injection: itchy hands and chest (no rash) Approximately 20 hours post injection: severe muscle cramps and tingling of hands Approximately 25 hours post injection: blacking out, chest pain, trouble breathing, low body temp (94.9), low B/P (60/40), unable to walk or stand, throat swelling up, dizziness, fatigue, profuse sweating through all clothes. My husband was monitoring me, laid down and elevated my legs above my head, took Benadryl, hydrated, and rested. When I could stand, I took a pure hot shower to warm up. I thought I was going to die. The episode started to lessen about 45 minutes after taking Benadryl and elevating legs. Much better today but still not feeling well.

Hives, wheezing, itching,rash chest tightness and respiratory issue. I was treated at the hospital. Treatment medications were Prednisone, metoprolol succinate, Benadryl.

1018 Janssen vaccination given to left deltoid per LPN. 1031 Pt reported "my head started hurting". 1033 Pt reported "my headache is getting is getting worse. It's starting to pound. I'm a little dizzy". No other symptoms reported at that time. 1035 Pt reported "my nose is starting to pour water and my headache is getting worse. I'm getting more dizzy". Respirations even/unlabored. No tightness of chest or throat. No swelling or rash. 1036 Benadryl 25mg (two tabs) given PO by FNP. Pt was able to swallow pills adequately. Reported "I always have trouble swallowing pills". 1037 Pt was assisted out of vehicle to chair beside her truck for better monitoring. BP 120/72, HR 96. Unable to pick up SaO2 on O2 sat monitor. She was speaking in full sentences. She reported "I need to throw up". Ice pack placed on back of neck. Stated that ice pack felt good. 1038 Trash can given for her to vomit in. Pt sitting up in chair. AAO x3. 1039 She reported "I don't feel right. My head is pounding. I feel like I can't catch my breath". EMS called immediately. Respirations were rapid, 30, mildly labored. Lungs CTA but breathing shallow. 1040 EpiPen auto-injector 0.3mg (1st dose) given IM left thigh by FNP. Pt was dry heaving and spitting out saliva in trash can. Reported "this is the worst headache of my life". Respirations mildly labored 1043 Pt developed dry cough, continued to have rapid respirations. Encouraged to slow breathing down and to breath deeply. Reported "still not feeling right". Pt became diaphoretic and pale. 1045 Pt's breathing became more labored and rapid with respirations 34. When asked if her throat was tight, she nodded to indicate yes. 1046 EpiPen auto-injector 0.3mg (2nd dose) given IM left thigh per FNP. Pt continued to breath rapidly, shallow. Pt unable to speak. When asked if she could breath, she shook her head no and began pounding on her chest with her hands. Ambulance arrived. 1049 Pt was assisted to ambulance gurney. Pt was able to assist with transfer. Reported "my head is hurting so bad". Respirations were less labored. Pt transferred to ambulance per EMS staff.

Sudden Body Temp Drop, severe leg cramps, head ache, joint pain, high temperature, lost consciousness, stomach pain

Day one, feeling very cold, chills, trembling, achy joints, headache. After the chills passed low grade fever for the rest of the night. Buzzing in my ears, headache. Day two, buzzing in my ears and headache passes, fever leaves. Start feeling discomfort in the middle of my back and middle of my chest, later became nauseous. The discomfort in my chest/ribs lasted about 9hrs. Both days very tired, little stamina.

I WOKE UP SUNDAY MORNING TO PAIN IN MY BACK AND CHEST. I CALLED MY DR THEY WANTED ME TO CALL 911 INSTEAD I DROVE TO THE HOSPITA. THEY STATED SOUNDS LIKE A HEART ATTACK. THEY DID BLOOD TEST AND EKG'S. DIDNT FIND ANYTHING. I AM STILL HAVING PAIN. THEY WANTED ME TO STAY FOR ADD'L TESTING AND I DIDNT. CALLED MY FAMILY DR WILL BE GOING THERE TOMORROW.

Left side of neck and upper left chest tightness/pain, migraine for 2 days, racing heart, sweats, nauseous, extreme fatigue, ringing in the ears (which still has not gone away)

Day 1 of taking the vaccine, I had some slight itching Day 2 of the vaccine- I had palpitation, weakness, diarrhea, trembling, headache, and slight tingling sensation to my tongue.

shortly after the vaccine she started to fill tightness in her chest and not feeling well. The paramedics were called but she started to fill better and didn't want further care. We monitored her for another 1/2 hr and she started to fill better. We recommended she go to the hospital if she has any other symptoms.

15 minutes after vaccination the room started spinning, felt fine after aprx 30 minutes. About an hour and a half after vaccination I had shortness of breath and chest pain. (went to ER). Had nausea at ER was given medicine. Aprx 8pm had the feeling of something hot and cold being injected into my right wrist that went through my entire body. Called 911. Paramedic stated it was the vaccine running it course and to breath through it. Next day. Little groggy, low grade fever, slight headache and shortness of breath, Saturday morning had another episode of feeling like something was being injected into my wrist. It settled at my chest. Was very painful for about 3-5 minutes. Slept rest of day. Shortness of breath. Woke up Sunday and felt 100% fine.

SYNCOPE - PATIENT LOST CONSCIOUSNESS AFTER ADMINISTERING THE SHOT. PATIENT REGAINED CONSCIOUSNESS QUICKLY. NO FALL OR INJURY INVOLVED.

Fainted, blacked out, for maybe a few seconds - I was alone. Whooshing in my ears, dizziness lasted appx. 15-20 minutes. I didn?t think it was a big deal, but it was unusual for me to faint. I haven?t fainted since I moved in 1985 because of altitude. I also had moderate body aches different from my fibromyalgia or RA symptoms. This all happened about 25 hours after I received the Johnson Johnson vaccine. I didn?t think to report it until I read the news. I am fine now and don?t need any help.

HEADACHE; MUSCLE ACHE; CHILLS; FEVER; PULSE RATE INCREASED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 17:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced pulse rate increased. Laboratory data included: Fever (NR: not provided) 99-102.7 F. Laboratory data (dates unspecified) included: Pulse increased (NR: not provided) 130 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, muscle ache, chills, fever and pulse rate increased was not reported. This report was non-serious.

Around five hours after shot I felt what I would describe as brain fog and light headache, by the evening I was aching, chilling and had 101 fever. Aches in my muscles and joints as if I had Rocky mountain spotted fever again. That is what the side effects reminded me of. This went on for over 48 hours. I have never been so sick. Very nauseous by next day. Also fell to the floor from nearly passing out the following morning. Took a minute for the light headed To pass. Arm pain still today. It was very scary and seemed to be a very serious reaction. Friday after noon finally started feeling better. The other strange part of this is that my daughter and best friend and I received the shot together in the same lot number and every one of us was deathly ill with the same symptoms. I am the only one with the fainting spells. Still feel fatigued today. And shoulders and left arm injection site still sore and achy.

Tachycardia. I was injected on 4-3-21 at 2:15 pm in the left arm. I was instructed to wait 30 minutes due to my given history of anaphylactic events. I took one 25 mg Benadryl and one 180 mg of Allegra one hour prior to the shot due to this history. I was released at 2:45 pm and felt fine. I went home and sat on the sofa to watch tv. I sat there a couple of hours and thought I would take a nap since it was Saturday. At 5:50 pm I felt my heart begin to race and could see the veins on the back of my hands pulsing and my jacket I still had on moving/jumping to my heart beat. I could hear and feel my heart beating too fast. I got the pulse-ox meter that my husband has since he is an EMT and measured my resting heart rate to be 161 bpm. It frightened me as the only other time my heart raced like that was during two other anaphylactic events. I took 50 mg of Benadryl, got my epipens from my pocketbook and tried to breathe slowly and calmly. After about 40 minutes my heart rate slowed to 125 bpm. It took about two hours to reach a normal rate around 79 bpm. I had it fluctuate all evening but not as high as 161 bpm. I took more Benadryl as I went to bed. The next morning my resting heart rate was between 90-115 bpm off and on through lunch time.

pt received J&J vaccine. Registrar talking to pt 3 min then pt stated "I feel warm dizzy like I'm going to pass out". Pt became pale, diaphoretic, warm dizzy - vaccinator put ice pack to back of neck and gave water to hydrate while sipping water pt drooled water out of mouth. pt was shaking and sliding down in chair, ammonia salts were used . Medical evaluator called - pt had vasovagal near syncopal episode. Staff moved her to cot no facial or tongue swelling noted. no LOC increased breathing VS 160/80, HR 88, resp 22 non labored. Medical evaluator NP at side Ice pack to neck, arm pits between legs to cool down. Pt stated very anxious about getting vaccine. family present. Pt stated this happened in 2010 when she received an injection for TMJ. Provided reassurance to calm pt down. EMS called - FD responded transferred care to EMS transported pt to hospital at approx 12:30 pm. 4/11/21 called husband to check on condition no answer no call back as yet

Started with skin above eyebrows itching and redness on face behind mask, then chills, then at about 30 minutes post injection increased heart rate and trouble swallowing/ chest tightness Gave dose of Epi and called 911/ As waited for EMS rash showed on arms and she said hard to breath after a few minutes she started breathing easier and rash started going away and she could swallow ok EMS arrived and transported her to hospital for observation

Patient received vaccine and escorted to monitoring area . Developed chest tightness and headache several minutes after administration. she reported multiple allergies, took own Claritin. VS stable, airway patent, no erythema or edema. speaking clearly. 911 called, she declined transport. Watched for 30 minutes and went to ER by private car

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.

Thursday afternoon at 11:16 I received the Janssen vaccine and started feeling jaw pain, neck pain, chest pressure shortness of breath and extreme nausea at around 7am on Saturday.

Headache (very unusual for me) lasting 2 days, heaviness in chest similar to heartburn, shortness of breath with mild wheezing. All have mostly resolved within 2 days of occurence.

Reaction started with cough and increase phlegm in throat and quickly progressed to swollen throat, dry tongue, unquenchable thirst, shakiness, weakness, ears feeling full, headache, increased blood pressure and increased pulse. Called personal physician who recommended going to the Emergency Department. Took one 25-mg benedryl and went to ED where physician confirmed allergic reaction to the vaccine and administered 20 mg prednisone and pepcid. Symptoms improved over two-hour observation and was released. Continued 20 mg prednisone, pepcid (twice daily) and benedryl (every 6 hrs) daily for 4 days, followed by Allegra and Zyrtec once daily each until 4/13/21. Swollen throat, dry tongue, excess thirst, shakiness, weakness, ears full, headache, and increased heart rate/palpitations persist 7 days post-vaccination. Had in-person visit with primary care physician on 4/13/2021 who recommended Nasocort twice daily for two weeks for fluid behind ears and antihistamine once daily for 5 additional days, and will refer to local allergist for work-up.

Initial symptoms was exhaustion and nausea around 12:00 pm. . Headache, chills and trouble breathing followed. Symptoms worsened as the day progressed. I triggered a high heart rate alarm on my watch while sitting and dozing about 6:00 pm. I ended up in bed at 6:30 that night and slept off and on with fever, chills, headache and throbbing arm pain until 7:00 am 4/9/2021. I had to use my inhaler during the night to help breathe but do not remember the time. The next day I was much better with the exception of tiredness, nausea and headache throughout most the day. I have pretty much fully recovered on Saturday 4/10/2021 with only tiredness continuing to bother me as of the this report. I am sleeping more than usual. I did not notify the clinic of my reaction as they were closed over the weekend.

Nearly immediate extreme dizziness, blurred vision like going to faint, rapid heart, profusely sweating

4/09/21 6:00pm Site pain and swelling 4/10/21 1:00pm Fever 101.5, site swelling, facial flushing, weakness 4/10/21 4:00pm Fever 102.2, site swelling, joints pain, increase heart rate (124 heart rate) 4/10/21 7:00pm Fever 102.0 site swelling, joints pain, lower back, hip & wrist pain/sore, lung congested, increase heart rate (98 heart rate) - took tylenol 4/10/21 11:00pm fever 99.1 heart rate 89, site pain & arm weak, thrifty 4/11/21 1:00pm arm sore, weak and numbness with use, site swelling 4/12/21 10:00a arm sore, weak and numbness, site swelling 4/13/21 1:00a arm pain with extended numbness 4/13/21 11:00p arm soreness, arm weakness and numbness

Immediate massive fatigue, lightheaded, chills, higher than my normal blood pressure. I lied down at the facility for one hour. Fever, severe headache, 6 hours later, diarrhea and vomited. 24 hours after vaccine, extreme fatigue, fever, smaller headache.

Later that day of the vaccine I woke up about 11pm with a fever, all joints hurting, my eyes were hurting and flu like symptoms which continued throughout the night. I was extremely thirsty which caused me to consume over 60 ounces of water overnight. Woke up about 7am and went to prepare coffee and blacked out. When I woke up I was on the floor and had a bursted nose and EMT was called. I was transported to the ER where I was administered IV fluids, EKG and CBC were done but clear and I was diagnosed as severly dehydrated. I was released about 5hrs later but the consistant feeling of constant thirst has remained even still today. I have also had a lingering headache also.

by 10-11 p.m. that night severe chills. did not sleep the entire night due to extreme headache, chills, fever (102+), body aches. felt truly awful. by 6 am Saturday feeling nauseated and wound up vomiting. Saturday night/Sunday -- not 100%, no appetite, intermittent nausea, but able to work/do normal activities. Monday 4/5--nausea at an 8-9 in the morning and kept a trash can next to me during virtual hearings I had that day. Intermittent nausea throughout the week and not much appetite but made sure I was eating/drinking despite that. Wednesday night 4/7 -- I went to use a PT stick on my left leg b/c I had felt a little pain in my left knee and figured my quadriceps were fibrotic. I could barely put any pressure on my left thigh. I had never experienced anything like this. As soon as I started rolling the stick on my leg, my skin was immediately red and warm and my leg was so sore and tender I had to stop. Saturday 4/10 -- woke up with severe headache and later that morning felt very weird in my head/heart, like heart racing and my head felt "spinny." Felt like I might pass out at one point so I had one of my kids sit on my bed with me until I felt a little better. Sunday 4/11 -- had another episode like Saturday (headache and lightheaded/spinny/pass out feeling/slow speech) and asked neighbor (an RN) to take my BP. her at-home device said 147 over something and she suggested I go to urgent care just to double check. About three hours later, I was seen at urgent care. BP was normal, heart rate normal, oxygen was 96. 4/13--followed up with primary doctor. Send me for blood work to check platelets, etc. Feeling pretty good today but nervous after the news and the pause.

55 hrs after vaccination, I was doubled over with severe abdominal pain. Continuous waves of severe pain. Shortly after severe pain started, tremors/teeth chattering chills even under seven heavy blankets, lasted for hours. Headache (which had been there since 6 hrs after vaccination). Pain was so severe that I was getting ready to go to ER and then vomited. Felt a tad better only to vomit again three hours later, body in a pool of sweat but no fever. Aches, tingling hot prickly sensation running from toes to head, almost passed out. Diarreah every hour after second vomit, stomach pain started to subside then but never went away completely until 3 days after.

Patient states that she had acute onset of left arm weakness, numbness, difficulty speaking and slurred speech that started at 22:50. Patient was seen as a code stroke, was FANG?D +. Patient underwent MRI and MRA of the brain which showed multifocal small acute infarcts along the right frontal and right parietal lobes, as well as punctate acute infarcts in the right occipital lobe. No evidence of intracranial bleeding. Also noted a filling defect in the right carotid bifurcation causing severe stenosis of the right ECA origin and moderate stenosis of the right ICA origin. Patient was not given TPA, and was started on heparin drip and admitted to the ICU. Patient did receive the Johnson & Johnson Covid?19 vaccine on 4/9. Patient also complained of right ear and right jaw discomfort, pain behind L eye and L aura, as well as burning discomfort of the back of her tongue for the past two days Started on heparin drip initially and then converted over to argatroban drip based on CDC guidance. No IVIG given as platelets are > 500

Headache and general tiredness began 30-45 min after shot. Muscle soreness (injection site, rib muscles, leg muscles, back muscles and neck muscles) began soon after. By 6pm, muscles had become painful. I had chills but no measurable fever. I got in the bed but unable to sleep due to muscle pain and discomfort. Hip joints and back began to ache. Fever and chills worsened over the next several hours to measurable with highest at 102F. I took 1000mg tylenol generic which did not lower fever but fever did not rise higher. Throughout the night, I experienced calf muscle cramps and foot cramps, stomach pains, joint pains, inability to sleep, worsening injection site soreness and armpit soreness (likely lymph node soreness). Once in middle of night I may have felt chest tightness but I even doubted that I really experienced it as I had been thinking about all the AEs I was experiencing. Symptoms continued through night. Next morning, developed a cough so I made appointment to get a COVID exposure test at 1pm on 13th April because I had flown in plane on 10th April. Cough could have been due to allergy type post-nasal drip because of high pollen in area. By late Tue evening, I felt better. Headache had resolved and muscle symptoms improved. Now (3:45pm on 15th April) I am still experiencing lymph node/armpit soreness and general inability to focus, think clearly. I feel like I am in a fog. I emailed a message to my physician and reported this through VAERS

I go to work but I can breathe. I said to my manager I can't work. I need to come back home. I drove my car very difficult. After I come home, I can't breathe so my husband called 911. I was fainting. I check everything. I have a problem, I can't breathe when I read or phone. Now I am better than old. I don't know what happened. I think it is the problem when I take the vaccine.

BODY ACHES; TINNIUTS; HEART RACING; TACHYCARDIA; DIZZINESS; SWEATING; CHEST TIGHTNESS/CHEST PRESSURE; BRUISING AT INJECTION SITE; HEADACHE; MYALGIA; FATIGUE; 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 allergic to bees.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 01-APR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced tachycardia. On 01-APR-2021, the subject experienced dizziness. On 01-APR-2021, the subject experienced sweating. On 01-APR-2021, the subject experienced chest tightness/chest pressure. On 01-APR-2021, the subject experienced bruising at injection site. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced myalgia. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021 14:00, the subject experienced tinniuts. On 01-APR-2021 14:00, the subject experienced heart racing. On an unspecified date, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, sweating, chest tightness/chest pressure, bruising at injection site, myalgia, and fatigue on 04-APR-2021, dizziness on 01-APR-2021, and headache on 03-APR-2021, was recovering from heart racing, had not recovered from tinniuts, and the outcome of body aches was not reported. 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.

NAUSEA; RACING HEART; SWEATY/SWEATY PALMS; FELT DIZZY; CHILLS; HEADACHE; FEVER; DECREASED APPETITE; 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 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: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced decreased appetite. On 05-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) unknown. On 05-APR-2021 20:00, the subject experienced chills. On 05-APR-2021 20:00, the subject experienced headache. On 05-APR-2021 22:00, the subject experienced racing heart. On 05-APR-2021 22:00, the subject experienced sweaty/sweaty palms. On 05-APR-2021 22:00, the subject experienced felt dizzy. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart, sweaty/sweaty palms, chills, headache, and fever on 06-APR-2021, and nausea on APR-2021, was recovering from decreased appetite, and the outcome of felt dizzy 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

03/24/2021 Blood clot appeared on left arm area of mid forearm. Blood clot raised skin and was painful to touch. Treated with hot pack for approximately 20 min. Blood clot remained for approximately 8 hours and then broke the vein and I was bruised for approximately 5 days.

ARM SORENESS; HIGH HEART RATE WHILE RUNNING; NUMBNESS IN LEFT LEG; CHEST PAIN; POSSIBLE WEAKNESS; 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: 1802070 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced possible weakness. On MAR-2021, the subject experienced high heart rate while running. On MAR-2021, the subject experienced numbness in left leg. On MAR-2021, the subject experienced chest pain. Laboratory data included: Heart rate (NR: not provided) 192 high speed while running. On 06-MAR-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness, high heart rate while running, numbness in left leg, chest pain and possible weakness was not reported. This report was non-serious.

I HAD AN APPOINTMENT FOR ALLERGY TESTING AND MY BLOOD PRESSURE WAS HIGH, THEY ASKED IF I WAS ON MEDICINE. I HAVE NEVER HAD HIGH BLOOD PRESSURE IN MY LIFE, I HAD TO GO TO THE ER AND THEY DID A CARDIAC WORK UP ON ME.

Immediately had flu symptoms the same night as vaccine that went away within 2 days. HOWEVER, twenty-one (21) days later, both eyes were extremely painful to move. Then I lost vision in right eye with extreme blurriness & partial blind spots resulting in a diagnosis of Optic Neuritis by Ophthalmologist and Neurologist. Confirmed optic Neuritis on MRI scan. Twenty-four (24) days later, numbness in legs, feet and right arm started. Hard to walk up and down stairs. Twenty-six (26) days later, extreme pain in in muscles and skin along with tingles all over and numbness. Weakness and Chest pain. Flu like symptoms without fever ie: aches, pains, skin pain, confusion. Dizziness, feeling of being extremely anxious and out of sorts in space. Had to complete round of Steroids and numbness and tingles got better, but did not dissolve. After completion of IV steroids, thirty-four (34) days later all symptoms returned full force and worsening. Checked into ER 4/10 and admitted into hospital. Have not been able to complete normal routine or work level since March 27th due to neurological disturbance and symptoms. Two (2) Eye exams, 3/30/21 confirming swollen optic nerves. MRI 3/31/21 Blood work 4/2/21 CoVid Test 4/9/21 Negative Hospital: April 10-12th. MRI Extensive Blood work Spinal Tap Neuro-Opt exam Outcome pending and further treatment pending results.

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.

On April 8, 2021, around 7pm I began to experience body aches, fatigue, and loss of appetite. By 8pm I began to experience chills along with continue body aches, fatigue, and loss of appetite. At 11pm that night, I was awaken as my heart was pounding very hard. I was still experiencing the body aches, fatigue, chills, and loss of appetite. This continued all through the night into the next day. April 9, 2021. On April 10, 2021, the body aches and chills subsided however I continued to feel fatigue, loss of appetite and I could still feel my heart beating hard. These symptoms continued through Tuesday April April 14, 2021 when I went to see the doctor. I started to get my appetite back later that week after my doctor appointment however I continue to feel heart palpitations and fatigue. I went for a follow up doctor appointment on April 21, 2021.

FELT LIKE FAINTING; BODY ACHES; BILATERAL HIP PAIN; LIMPING; CHILLS; This spontaneous report received from a patient concerned an 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced felt like fainting. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced bilateral hip pain. On 09-MAR-2021, the subject experienced limping. On 09-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient was recovering from chills, body aches, bilateral hip pain, limping, and felt like fainting. 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.

FAINT; NAUSEA; RIGHT SHOULDER BACK PAIN; LEFT CHEST PAIN; DIZZINESS; RIGHT HAND NUMBNESS; COULD NOT MOVE; WEAKNESS; FEVER 102-103 F; BODY ACHES; SLIGHT HEADACHE; FELT LIKE HAVING AN ALLERGIC REACTION/FELT LIKE HIT BY TRUCK; 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 past medical history included pneumonia. 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: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient had a slight headache. On 10-APR-2021, the patient got off at midnight and felt body aches and upon waking up she could not move. On the same day, she felt like hit by a truck and experienced dizziness, right hand numbness, fever of 102-103 Fahrenheit and weakness. The patient took Bayer aspirin (acetylsalicylic acid) and Tylenol (paracetamol). The patient's headaches were excruciating and came and went and some she had all day. The patient also felt like having an allergic reaction. On 12-APR-2021, the patient had left chest pain and right side of her up shoulder back pain upon taking a breath. On 15-APR-2021, the patient had nausea and visited emergency room and had blood test, chest X-ray and electrocardiogram and everything was normal. The patient was treated with unspecified anti-inflammatory medications, Toradol (ketorolac tromethamine) as intravenous, and they advised to visit a heart doctor. On 17-APR-2021, the patient was faint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left chest pain, fever 102-103 F, faint, right shoulder back pain, and right hand numbness, had not recovered from slight headache, weakness, nausea, and dizziness, and the outcome of body aches, could not move and felt like having an allergic reaction/felt like hit by truck was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: :20210436128 -covid-19 vaccine ad26.cov2.s -faint, bodyaches, left chest pain, dizziness, right hand numbness, could not move, right shoulder back 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). 20210436128 -covid-19 vaccine ad26.cov2.s -weakness, fever 102- 103 F, nausea, slight headache, allergic reaction. This event(s) is labeled per Agency and is therefore considered potentially related.

Patient stated she took the vaccine on Thursday 3/11/21 and about 3 days later she started to feel a cramp in both of her legs. On 3/27 patient stated she couldnt move and felt like a tingling sensation on the left arm (felt like ants crawling on body), felt dizzy, headache. She stated she then went to the ER on 4/15/21. CT scan (chest) and ultrasound(legs) was done and she wasnt sure of the results (the ER doctor only informed her that she wouldnt be #7). Then on 4/17 patient state she felt fine and was back to exercising and running. Then on 4/24 she stated she went to the beach to run and felt a sting/cramp on right leg, she looked and noticed a bruise and then as of 4/26 her leg is sore, it's not red, not hot and not hurting, just sore to touch. Bruising is going away but just uncomfortable to touch. Patient states she been feeling a little more fatigued and winded out when doing things now more than before and before taking the vaccine. Been a 1.5years since her last asthma attack. Since a month ago is when she started to feel that she needs to catch her breath more often. Patient stated she saw her PCP on 4/19/21 and she was prescribed another inhaler (can't recall the name) and antibiotic. CT scan was done when she was in the ER because pt had chest pain. No pulmonary embolism indicated on results but she states her scan came back with something on it but she wasnt able to explain what was on there. When she was in the ER the doctor didnt prescribe anything but when she went to see pcp her MD prescribed her an antibiotic (cant recall name, she picked up the rx but hasnt started taking it yet- wasnt home to obtain the name). As of 4/26 her headache, leg cramps have subsided, she just feels very fatigued. She stated that every time she has a headache she takes tylenol. The last time she took tylenol was on Sunday 4/25/21. Advised patient to start taking the antibiotic as prescribed by the pcp and to take the inhaler when she feels winded out. Also advised her that if she feels chest pain or extreme sob then to either contact her pcp again or urgent care She has no follow up scheduled with her PCP.

Fever lasted two days, severe headache lasted two days, body aches lasted over a week, nausea is still present, fatigue is still present, arm soreness lasted a little over a week, dizziness is still present. Stabbing pains in my hands, feet and legs started a few days after the vaccine and my rheumatologist ordered ultrasounds on my legs, which showed no presence of clots. The pains lasted for about 12 days. Pain in my chest and breasts occurred yesterday and lasted about 2 minutes. Nipples are tender.

BLOOD CLOT IN ARM; FEELING SICK; This spontaneous report received from a patient via a company representative concerned a 47 year old female. The patient's weight, height, and medical history were not reported. 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: Unknown) dose was not reported, 1 total, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced burning sensation in arm, tenderness of arm, and pronounced veins on arm; also she was feeling sick. She saw the healthcare professional (HCP) after these symptoms. She was told about a blood clot (tenderness / burning sensation/ pronounced veins) in the arm. HCP recommended her taking aspirin and applying heat to the arm. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in arm, and the outcome of feeling sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: This 47-year-old female patient reported burning sensation and tenderness in arm, pronounced veins in arm, and feeling sick after an unspecified duration from receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. HCP was consulted and was "told" about a blood clot and prescribed aspirin with advice to apply her to the arm. No other details reported. The information available precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.

heart palpitations. Rapid pulse rate. Went to the ER and had an EKG/ Chest xray and blood draw. Low potassium and was referred to the cardiologist. The cardiologist did an EKG and noticed that I had an issue in my QRS complex on V1. I have an echocardiogram on March 17th and a Holter monitor for 48 hours. I am still having the palpations and was advised to eat foods high in potassium.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient has history of fainting with all vaccines. Once receiving vaccine, passed out for 10 seconds and regained consciousness. Vitals were monitored, patient was fine and left after 30mins

Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Mild, Additional Details: Patient reported feeling lightheaded/dizzy ~5 minutes after receiving vaccine. She was given water and placed her head down while her boyfriend held her so she wouldn't fall over. 1st BP reading was taken ~8 minutes after the vaccine was given (87/38 and HR 49). Patient stated that her BP tends to run low. Had patient stay under our supervision for an additional 30 minutes. At the 30-min mark 2nd BP reading was taken (91/53 and HR 56). Patient reported feeling much better with symptoms resolved.

Eight days after the vaccine, I started to feel light headed and I thought I was just fatigued. I woke up at 3am and started to pass out and I couldn't see and falling down. I went to the ER and my pulse and blood pressure were low and I was mildly dehydrated. I had Sinus Bradycardia which they said may be transient. I have never had an unusual rhythm readings. I experienced the lightheadedness for about a week. I did not drive or ride my bike because I might need to lay down. Three weeks after the vaccine it seemed to get better a little a time and the events were less frequent. It has been four weeks and I feel fine now and I have resumed my normal activities.

Immediately felt overwhelmed with heat and fainted (within 5 minutes) of receiving the shot. I was scheduled to have my normal period within a week and have never had another period. I am experiencing full on menopause and I have never had a single symptom. I have full sweats and freezing temperatures all throughout the day.

CAVERNOUS SINUS THROMBOSIS; THROMBOCYTOPENIA; COMPUTERISED TOMOGRAM HEAD ABNORMAL; FIBRIN D DIMER INCREASED; MAGNETIC RESONANCE IMAGING HEAD ABNORMAL; PLATELET COUNT DECREASED; VENOGRAM ABNORMAL; FULL BLOOD COUNT; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) and concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included aspirin allergy, and hypertension. On 31-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered in left arm for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up for Batch/lot numbers. The concomitant medications included unspecified natural pills. On 05-APR-2021, the patient was hospitalized for venous thrombotic cavern sinus and thrombocytopenia 25,000, computerised tomogram head abnormal, fibrin d dimer increased, magnetic resonance imaging head abnormal, and developed platelet count decreased, venogram abnormal. On 05-APR-2021, the subject experienced full blood count. The patient was hospitalized (date unspecified) for 12 days. The following laboratory data (dates unspecified) included: CT scan results not provided, Complete blood count results not reported, Fibrin D dimer was elevated (value not provided), MRI results were not reported and Venogram was abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cavernous sinus thrombosis, thrombocytopenia, computerised tomogram head abnormal, fibrin d dimer increased, magnetic resonance imaging head abnormal, platelet count decreased, venogram abnormal and full blood count was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case version (1) was created on 30-APR-2021 for the purpose of quality improvement the following corrections were made. The MAC was added to the pharmacovigilance narrative.; Sender's Comments: V1: This spontaneous report received from a patient via VAERS (ID: 1238777) concerned a 47-year-old woman who experienced cavernous sinus thrombosis with thrombocytopenia 5 days after vaccine. Concurrent conditions included hypertension and concomitant medications included unspecified natural pills. Five days after vaccine, the patient was hospitalized for venous cavernous sinus thrombosis and thrombocytopenia (25,000) with an elevated D dimer (unspecified.) CT head and MRV were performed with results not provided. The patient was hospitalized for 12 days and treatment details were not provided. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration-BC), the low platelet count and temporal relationship to vaccination (BC Criteria level 1), the events are assessed to have a plausible relationship with vaccination. Reporter contact information was not provided which precludes meaningful additional information in this version.

possible adverse reaction of blood clot following J&J CoVid vaccine. J&J Vaccine received: 4/5/21 Fracture of 5th proximal phalanx: 4/16/21 Pt wearing constrictive device at location of DVT after 4/16/21 Pt taking OCP daily for years

FIBROMYALGIA; BLEEDING NOSE; COLD; SORE AFTER RADIO FREQUENCY PROCEDURE; This spontaneous report received from a patient via a company representative concerned a 47 year old female. The patients height, and weight were not reported. The patients concurrent conditions included rheumatoid arthritis. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, intramuscular, batch number was not reported) dose, administered on 2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Concomitant medications included adalimumab for rheumatoid arthritis. On 2021, the patient experienced fibromyalgia, bleeding nose about a week and a half, cold about a week, and sore after radio frequency procedure. In Mar 2021 patient had a radio frequency procedure completed on lower back and was sore afterwards The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from bleeding nose, and cold, had not recovered from fibromyalgia, and the outcome of sore after radio frequency procedure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210508103- COVID-19 VACCINE AD26.COV2.S -Fibromyalgia. 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

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

Patient in AAOA Vaccine clinic to receive J&J COVID Vaccine. States no previous allergic responses to vaccines or injectables, however does "pass out with lab draws or shots" but does fine afterwards. Vaccine provided at 0949. At 0950, patient became lightheaded and unresponsive, arms twitching and started gurgling. EMS activated. BP 100/60, HR 75, RR 30, hands cold and pulse ox not registering. Placed on O2 per FM. At 0951, patient was arousable. BP 102/60, HR 70, RR 26, pulse ox registering at 96%, no further body twitching. One touch blood sugar 72. From 0952-1000 VSS pulse ox 98%, patient awake, AAO, states she is cold. EMS arrived at 1000, history of events reviewed with EMS. Patient continues to be AAO, BO 149/82, HR 80, RR 18, Pulse Ox 100% . At 10:05, patient remains stable, EMS discussed with patient option of transport to local ER. Per EMS given previous h/o vasovagal response to injections, did not feel necessary to transport unless patient wished to go to ER (patient refused as she was feeling much better). Continued to monitor patient in AAOA vaccine clinic until 11:00. Patient provided apple juice and crackers. VSS BP 122/80 to 142/82, HR 60-64, RR 16-20, pulse ox 99-100% on RA. Stated she feels ok and wished to go home. Friend provided transport home and to stay with her today. Patient instructed to notify PMD of vasovagal response and to call EMS if needed.

3 weeks plus 1 day following vaccine, i developed pain in my left calf. After having an ultrasound, two blood clots were discovered in my left leg (one DTV and one superficial). I was sent to the ER, a CT was performed, blood work was taken, and I was sent home with a prescription for Xarelto blood thinner. I have to be on this for 3 months, and we will evaluate to make sure I'm no longer at risk. My medical bills for the date of 5/3/21 were over $11,000, and my portion so far is over $3300 after insurance.

LEFT ANKLE STARTED SWELLING, LEFT ANKLE SWELLING INCREASED AND REACHED LEFT THIGH, WENT ULTRASOUND WHICH RESULT BLOOD CLOT; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 95.70 kilogram, and height was 167 centimeter. The patient's concurrent condition included Cholesterol. Patient was non alcohol user and non smoker.. Patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry date were unknown) dose was not reported, administered on 11-MAR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included pravastatin for cholesterol. Around 19-MAR-2021 (approximately 1 week after the vaccine), the patient experienced left ankle swelling (as per patient, she did not think much of it, and just elevated her leg and applied hot-cold compress). Around 26-Apr-2021 the patient experienced increased left ankle swelling and had reached her left thigh. On 26-April-2021 patient went to the hospital and was hospitalized, was given an ultrasound procedure which result stated that she had blood clot. Patient was given Eliquis right away, while in the hospital. On an unspecified date patient was discharged and upon discharge she was prescribed Eliquis 5 mg for 2 times per day. Patient stated that she will go back to the doctor will be doing another ultrasound. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot. Patient stated her left leg swelling was not yet completely resolved, but not as worse, whenever she elevates her leg, the pain and swelling gets better, but once she gets up and move around, the swelling starts again. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210529680-covid-19 vaccine ad26.cov2.s ,LEFT ANKLE STARTED SWELLING, LEFT ANKLE SWELLING INCREASED AND REACHED LEFT THIGH, WENT ULTRASOUND WHICH RESULT BLOOD CLOT. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

tingling started from feet and radiated to upper body . paramedics was called right away. She refused to go to emergency as she started feeling better after paramedic came.

Developed deep lowerchest/upper abdomen pain on right side 4 days after vaccine was administered. Pain got progressively worse and a rash developed on right thorax in the Thoracic rib 5 region; Visited Army doctor on 12 MAY. Based on visual exam of multiple, tiny water-filled blisters only on right side of thorax + description of pressing pain in chest similar to feeling of a heart attack, both doctors on shift diagnosed shingles. Forgot I received COVID vaccine 4 days before symptoms started so I never mentioned it to the doctor. TRX= 800mg acyclovir 5x/day x 7 days. Rash continued to get worse and spread more before finally subsiding and starting to crust over. Nearly 3 weeks later, rash is now a combo of scabs and open wounds. Pressing deep pain in right chest is persistent and only relieved partially with 800mg ibuprofen q 8 hours.

I had a 101 fever in bed with chills and I was very fatigue. It continue on the 8th. By the end of the 8th the fever and muscles aches started to leave. I started to get imbalances on Thursday and Friday. I had vertigo and very clammy. May 8th 1:30am I went to the restroom and I got a huge night sweat. Low blood pressure.

pt states around 6 pm on 3/28/21 she developed a stomachache. This lasted until 4/2/2021. She developed a migraine headache on 3/29/21 which continued to get worse. She then started getting dizzy along with a feeling of pins and needles on her head and her feet became numb. She reached out to her Neurologist and she was prescribed chlorpromazine. After taking one dose it caused her heart to race. She was also prescribed duloxetine by her PCP. After one dose her blood pressure went up. BP was 163/110. On 4/11/21 she went to the ER. They did blood test (platelets were 154) and CT that was normal. She was given dexamethasone steroid which helped w/ the heart rate. She was released to go home. Her headache came back the same day. On 4/26/21 she woke shaking and her heart was pounding out of her chest. Her rate was 169. She went back to the Medical ER. Her heart rate was 180. They did EKG. She started shaking more, her feet were tingling and going numb, she had a vibration in her head and heat from her neck going up to her head. Her heart rate was going up to 200. She felt like she was going to die. She laid down and her heart rate would go up and down. They gave her an IV and sent her for an MRI. She was admitted. She was getting ready to have an ECHO she had a vibrating and burning sensation go through her body from her neck to head, back down to the left arm and then down to leg and feet. Her heart rate went up. This episode lasted about 15 minutes. After getting the MRI she had another shaking and vibrating episode that lasted about 10 minutes. She had an ECHO and then had another shaking vibrating episode that lasted about 5 minutes. She was given a beta blocker metoprolol. All test were negative or normal. She stayed in hospital to 2 to 3 days and released to FU w/ multiple doctors including psychiatrist, cardiologist and PCP. She was diagnosed w/ having general anxiety and panic attacks. She saw her PCP and she was taken off metoprolol to propranolol. Pt saw a Cardiologist on 5/14/21. They did an EKG and she was given a heart monitor to wear for 3 days resulting in tachycardia 166 episodes. Overall heart 80 bpm to 119 bpm. Total beat count 340,832. Pt still has dizziness and migraine headaches. Her heart is now enlarged and has pain on her left side under her breast and on top of her breast. She has these episodes daily and feels like she is still going to die. She said she never had anything like this before getting vaccinated. Her Cardiologist is sending her for more tests.

Feeling lack of oxygen and felt faint and high, passed out later. Still feel issues including various levels of inebriation. Prescribed potassium pills. Much better but still dealing with event. Also, had chills, heart racing, and short of breath.

When I got the vaccine I experienced som reactions as itchi eyes, my heart was kind of racing and felt some short breath. I waited 30 minutes and everything went good. The next day I felt some kind of sore in my upper arm, and then I was fine, but later, around 10 days after the shot, I felt very very sleepy for 2 days, and my arm started to sore again and still does, mostly when I move it to the back or when I lift something

After about 15 minutes I started to feel my scalp itching and tingling. The itching started to spread. Took Benadryl. Itching continued to be rather intense all night. In the morning I woke to hear my heart pounding and pulsing in my ears and head - what I am told are heart palpitations. The itching subsided after two days. Flu like symptoms started the next night after the shot and subsided after a day. Extreme fatigue began immediately and continues today. Heart palpitations continued for weeks. I sought out my doctors office after a week. During this time I also experienced alarming chest pains and pain while breathing. This confused gor about 3-4 weeks. My doctors office seemed to not know to report this or seek advice so I lingered while tests were being run. I normally had a low heart per my Watch and during this time my heart rate was double my normal resting rate. The chest pains, breathing pains and heart palpitations have improved, but the extreme fatigue continues to impact my ability to keep my normal routine and I?m having to reduce my work hours and take days off just to rest.

flu like feeling, chest pains, muscle pain, nauseous, tingling sensations in feet and legs, headache, shortness of breath

Since few days after the vaccine administration my blood pressure have been without control. Doctor add me another medicine and doubled my Atenolol original dosis. As today I have been without control...waiting for a cardiologist appointment.

Bells Palsy diagnosed on 5/31/2021. Steroid and antiviral medication. Pulmonary embolism on 6/9/2021. EKOS procedure on 6/10/2021. Heparin IV for 3 days. Oral medication eliquis prescribed.

VOMITING; BODY ACHES WHICH FELT LIKE AFTER A VERY HARD WORKOUT; PAIN IN STOMACH LIKE CRAMPING; HEART POUNDING IT FELT LIKE BLOOD RUSHING THROUGH THE BODY VERY QUICKLY; UNABLE TO SLEEP; HEADACHE ALL THE TOP OF THE HEAD; NAUSEA; ARM HURTS WHEN IT MOVES; SORE ARM IN INJECTION SITE AREA THAT IS CANNOT BE TOUCHED OR LAY ON IT; 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 penicillin allergy, and other pre-existing medical conditions included the patient has not had covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-JUN-2021, the subject experienced arm hurts when it moves. On 08-JUN-2021, the subject experienced sore arm in injection site area that is cannot be touched or lay on it. On 08-JUN-2021, the subject experienced nausea. Laboratory data included: Pain scale (NR: not provided) 6. On 09-JUN-2021, the subject experienced vomiting. On 09-JUN-2021, the subject experienced body aches which felt like after a very hard workout. On 09-JUN-2021, the subject experienced pain in stomach like cramping. On 09-JUN-2021, the subject experienced heart pounding it felt like blood rushing through the body very quickly. On 09-JUN-2021, the subject experienced unable to sleep. On 09-JUN-2021, the subject experienced headache all the top of the head. Laboratory data included: Pain scale (NR: not provided) 6-7. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. Treatment medications (dates unspecified) included: ondansetron, acetylsalicylic acid/caffeine/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm in injection site area that is cannot be touched or lay on it, nausea, vomiting, body aches which felt like after a very hard workout, pain in stomach like cramping, heart pounding it felt like blood rushing through the body very quickly, unable to sleep, and headache all the top of the head, and the outcome of arm hurts when it moves was not reported. This report was non-serious.

COULD NOT SPEAK A FULL SENTENCE; VERY PAINFUL INFLAMMATION OF CHEST, INFLAMED CHEST WALLS; CRAZY RIDICULOUS VAGINAL BLEEDING; ANEMIC; ALMOST DIED; FAINTING AFTER BLOODWORK; CRYING FOR NO REASON; DOING REGULAR THINGS AT A SLOWER PACE; SLOWLY DYING; 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: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total administered on 21-MAR-2021 for prophylactic vaccination. Concomitant medications included iron for anemia. On 21-MAR-2021, shortly after vaccination patient became very tired and felt like getting sick and felt like as it was the expected. Patient stayed on couch next day. On 23-MAR-2021, bleeding was started which was not normal bleeding. Patient knew that she had to see hematologist as oxygenated blood was leaving her body. Patient experienced very heavy vaginal bleeding. Patient called gynecologist and was advised to go to emergency room, if patient bleed more than a pad an hour. Patient went to doctor shortly because patient felt this was not normal and something else was going on. When doctor took patient's blood, she fainted. Patient was healthy before shot and never had this before. Patient had intravenous (IV) so that patient could drive home. Patient was doing regular things at slower pace. Some weird things happened at 17.00 daily, patient cried for no reason. Blood test was received with something low. Patient went to the emergency room where they gave her blood, which patient never needed before in her life. Patient needed 2 units of bloods. Patient was slowing dying but did not know it. Patient was now anemic and needed 4 iron infusions and maybe needed 5th also. Patient had been told to follow-up in august. Patient was not sure that her body was making her own blood again. Patient felt almost died. Patient could not speak a full sentence even after the emergency room visit. Patient was still bleeding. Patient also experienced inflammation in chest which was very painful. Patient started birth control on 14-MAY-2021 and 15-MAY-2021 and stayed on until 24-MAY-2021. Patient started bleeding again on 25-MAY-2021 which continued till 29-MAY-2021. Patient had a lot of shortness of breath and thought may be a blood clot but on 20-MAY-2021, X-ray showed no clots. Cardiologist said this was most likely from the COVID Shot and likely inflammation. Patient chest was still painful to touch and it was better than before. Patient was on iron pills but stopped after the 3rd infusion of iron and patient's anemia levels was improved. On 23-MAR-2021. Laboratory data included: Blood test (NR: not provided) showed low hematocrit and hemoglobin. Laboratory data (dates unspecified) included: Gynecological examination (NR: not provided) fine, and Physical examination (NR: not provided) fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crazy ridiculous vaginal bleeding on 29-MAY-2021, fainting after bloodwork on 09-APR-2021, and crying for no reason on 13-JUN-2021, was recovering from anemic, and could not speak a full sentence, had not recovered from very painful inflammation of chest, inflamed chest walls, and the outcome of almost died, slowly dying and doing regular things at a slower pace was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210651060- JANSSEN COVID-19 VACCINE Ad26.COV2.S –Fainting, Almost died, Vaginal bleeding, Anemia, Could not speak, Chest wall 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).

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

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.

A week after vaccine developed pain in left side, high blood pressure, numbness in left foot, hands, leg, blood test shows anemia, heart rate was 145, referred to a neurologist.

Tachycardia, profuse sweating, lightheaded, dizziness, aggressive heart palpitations, Shortness of breath

Chest pain behind sternum that woke me from sleep-ongoing Upper abdominal pain-ongoing Headache-3 days Fatigue-3 days

EXTREME LOW BACK PAIN; HYPOTENSION; EXCESSIVE DAYTIME SLEEPINESS; SHAKING; HEADACHE; NAUSEA; LOSS OF CONSCIOUSNESS; 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 past medical history included epilepsy. 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 in left arm approximately 10:15 am on 26-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-JUL-2021, the patient woke up with headache, but it was gone. The patient took Tylenol for headache. Treatment medications included: paracetamol. The nurse gave her the vaccine and patient experienced headache and felt like she was going to be sick. Within three minutes after the vaccination patient passed out and slumped over (loss of consciousness). Blood pressure bottomed out, and patient was shaking. Patient experienced hypotension, Laboratory data included: Blood pressure (NR: not provided) 102 (Systolic). Patient experienced excessive daytime sleepiness and she slept off all the day. On the same day patient experienced nausea. On 27-JUL-2021, the patient experienced extreme lower back pain to the point that getting up or walking or bending over was painful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, and shaking on 26-JUL-2021, and excessive daytime sleepiness, headache, and nausea on 27-JUL-2021, had not recovered from extreme low back pain, and the outcome of hypotension was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210757674.; Sender's Comments: V0 20210757738-covid-19 vaccine ad26.cov2.s-Loss of consciousness. 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).

started sore arm soon after, arm pain persisted, heart racing, dry mouth, sore swollen throat, severe headache, spasm in arm

Low grade fever, headache, chills, sweating, dizziness, severe muscle aches, weakness, nausea, exhaustions, flu like symptoms, Severe itching and burning whole body by 6pm the day of injection -took 50 mg of Benadryl. Tightness in chest and throat but could still breath. Symptoms ran their course over 5 days. Still struggling with muscle aches and nausea.

Body aches, fatigue, sleeplessness, restless, uncontrollable shaking, feeling cold,, sore and tender at injection site, headache (full band front and back), fever, sweating, heavy feeling in chest, occasional cough.

Started about 6 hrs after injection, chills, headache, sore muscles, low grade fever, accompanied by chest tightness and rapid heart rate. Resting heart rate was 115, when I stood from bed shot up to 135. Lasted for about 6 hrs. Woke up the next next day and day after just exhausted.

Vaccine given at 3:14 pm, She fainted for 10 seconds then vomited twice. 3:18 pm Pulse: 60, SPO2: 96, 3:20 pm BP 88/56 Left Arm, 3:21 pm BP 87/67 Right Arm

rapid heart rate and tingling/numb face; low grade fever; extreme fatigue; arm that received injection increasingly tender upon touch began ~15 minutes after injection; all but tingling has continued through today (3/19) at one week; fever and arm pain improving but rapid heart rate upon any exertion and painful arm continuing

I went to bed with a stomach ache around 10:00pm. At 3:00am I was awoken by severe abdominal pains/cramps and in a cold sweat. When I got out of bed I was lightheaded and passed out in the bathroom as I was getting Tylenol. I took 2 Tylenol and had diarrhea about 10 mins later. I went to get some gatorade and passed out again in the hallway on the way to the kitchen. About an hour after taking Tylenol symptoms began to improve but became nauseous and couldn't get back to sleep. As of 2pm Sunday current symptoms are extreme nausea and extreme exhaustion.

Chest tightness, numbness and tingling that radiates into her right arm. Throat feels "fat. Complains that right hand is drawing up into a fist, symptoms x 1 week Started on prednisone and flexeril EKG-SR Checking CBC, CMP, and cardiac enzymes

She reported tachycardia (pulse 150), dizziness and lightheadedness five minutes post vaccination. She then started to develop a red rash to her trunk, and throat swelling. Epinephrine administered and EMS called. Symptoms resolved post EPI.

Chills started approx. 7 1/2-8 hours after the vaccine. A few hours later, I had a fever of 100.5 and an elevated resting heart rate (100-105 bpm while normal is 68-70 bpm). I then developed a massive headache in my entire head/face. I waited until 24 hours after the vaccine to take 2 Tylenol. I showed much improvement 2 hours after that. I took 2 more Tylenol about 6 hours later and went to bed. I slept well and woke up completely fine the next day.

received J&J vaccine. after observation period EE left. EE returned at 1124 after 5 minutes to report chest pain / tightness. IMT called for at 1125. Initial Vitals taken . 138/63 P 78 Spo2 100. IMT arrived at 1132. second set of vitals taken 132/72 P 67 Spo2 100. IMT assessed EE. EE declined transport. EE electing to remain and be monitored longer. Next set of vital 108/73 P 60 SPo2 99 at 1145.

I received the shot at the pharmacy location, they had us sit for about 10min after then we could go, my next appointment happened to be at a dr's office thank goodness because about 10 min after sitting in the waiting room I felt faint and spoke out to the receptionist that I needed to lie down, they laid me down on the couch where I was sitting my blood pressure had shot up to 165/126 or I was unable to stand on my own, I was beginning to convulse and my heart rate shot up, they got a wheel chair, put me in it and took me back to one of their rooms where they I think ran a few test and then they made the decision to take me down to the er, the er which I told repeatedly that I had just received the covid shot, they hooked me up to machines, I think did a EKG, wheeled me to get a mri, and then did a chest xray, all while I was convulsing, they allowed this convulsing to continue for over 3+ hrs before they finally gave me something to calm down the convulsions, I was having sensory issues and could not handle, light, etc, for the next many days my heart rate would jump from the 60's too the top was I think 200BPM, I had to lie in a dark room, no sounds for a few days, I am just now felling a little bit better.

Patient currently hospitalized with profound bleeding and clotting, suspect dysfibrinogenemia, otherwise healthy without history of dysfibrinogenmeia

Patient felt like her heart was racing. Took B/P: 186/115 pulse 78. Had patient rest in room. Recheck B/P was still high. Called 911 and B/P was 182/148 pulse 88. She was taken to ER.

Patient complained feeling faint and felt like she was going to pass out. Patient was observed to have heavier breathing than normal. She also complained of numbness in her left arm. EMS was activated immediately. Patient's blood pressure was 51/38 mmHg . Oxygen was measured at 99 % Sp O2, PRbpm 45. Emergency contact for patient was notified. EMS arrived and took over. Patient returned hours later to pharmacy to informed us she was okay. She was told she had experienced vasovagal syncope.

I was held for approx 30 minutes. Drove out and when driving home started to get short of breath, so turned towards the hospital rather than home and called them. My significant other also had his shot, so we switched spots driving at that time. I called the hospital on my way when I started to feel my throat start to close at exactly 1829 on my phone (6:29 pm.). Appointment was at 6pm for shot. Hospital was 13 minutes away. Half way there my tongue started to swell and my lips slightly with tingle. My breathing was more labored to keep up effort as I could not expand my lungs to capacity. I was always able to breath and speak, my voice did become more raspy. Upon ER, Blood Pressure was very Hypertensive around 140s/120s with my respiratory effort to get in. Pulse was stable around 70-80. O2 was 97-99. I was able to lay down and relax my breathing which relaxed my blood pressure to 140s/ 80s. I was given IV Benadryl, IV Dexadron, PO Pepcid with a liter of fluid. Monitor up until after 8pm when I was released with still mild tonge swelling but breathing ok. Continue Benadryl at home with my Epi pen for bees stings available. Did go to work today 07/08/2021. Was wheezy, SOB, no throat swelling, tongue swelling at base. Kept up with Benadryl. Made it 1/2 day and went home. Walking and movement makes increase lung workload. My staff concerned with effort and flush skin while getting supplies. But flush and redness does subside some with rest. When talking need to take a break to breath. But can today notice when Benadryl kicks in. No history of Asthma ever or breathing issues ever. Very active on my farm and at work.

Patient reported mild dizziness and chest tightness Patient stated she received moderna 3/10/21 and had similar worse symptoms and was told by her provider to get Johnson and Johnson Patient seen by medical team, vitals were stable and sinus rhythm and advised to go to hospital but patient refused and signed AMA form Patient driven home by spouse

SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; 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, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.

Within one minute after the vaccine was administered I felt unable to breathe and was very light headed. I took 25 mg. of Bendryl which helped with the breathing. I felt very faint and experienced episodes of high blood pressure which lead to uncontrollable shaking. I broke out in hives accross my arms and chest. I laid with my feet elevated for one hour at which time symptoms subsided and I was able to leave the pharmacy. I had no further allergy type symptoms after leaving the site.

Janssen COVID-19 Vaccine EUA 9:30am vaccine 9:45am Faint headache started 10:30am or so took one Tylenol 3pm started feeling blah 3pm or so.. heart started racing 6pm Headache - aches started 7:30pm. Dinner-pizza and salad 8-9pm. Stomach pains started 9pm. Dying. Worst headache Couldn?t sleep entire day 11pm. Massive headache & aches. Went to bed & cried myself to sleep pretty much 3am Woke up massive headache took one more Tylenol Passed out til 8:15am. Woke up achey and slight headache. Passed back out til 10:30am. Still achey and no energy Drank 12 glasses water yesterday so was well hydrated.