Johnson & Johnson

Psychological symptom reports

Female, 40 - 59 years

Age Reported Symptoms Notes
40 2021-03-06 loss of personal independence in daily activities Dizzy, run down two hours after injection. Woke up 4 am then off and on with extreme body pain, sore... Read more
Dizzy, run down two hours after injection. Woke up 4 am then off and on with extreme body pain, sore neck , lower back, right hand and arm. Headache and fatigue at 6:45 am got up with two children (2 yrs and 10 months) ate small breakfast by 9 am I couldn?t get off the couch or stay awake. My head started aching and my eyes hurt, I felt extreme chills two thick blankets weren?t enough to warm me. Extreme fatigue, stomach pain and loss of appetite. I fell asleep and didnt have the energy to walk to my bed until 2:30 pm. It set off my stomach and I was vomiting off and on until around 9 pm. By then I could keep little bits of fluid and food down. Then I was hot. I felt flushed but had no fever. My usual heart rate is 52-54 bpm via Watch while laying down. My heart rate during this hot period laying in bed was 102 -101 bpm. Which is consistent for my workout heart rate. I went to sleep and woke up 7 am with my kids and was well enough to take care of them but not do all my usual chores. I couldn?t bend down or put my head lower than chest or the extreme throbbing headache was back. Still had body aches and fatigue but nowhere near yesterday. It is 11:22 pm Sunday and I feel spent.
40 2021-03-09 feeling abnormal patient received Janssen Covid 19 vaccine at our clinic inside store. pt was waiting in waiting area... Read more
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.
40 2021-03-10 feeling abnormal A few seconds after vaccine was given I had a sensation go up my left jawline that felt similar to a... Read more
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.
40 2021-03-11 insomnia Headache from 10:00pm-5:30am (3/11/21-3/12/21) and 11:00am-4:00pm (3/12/21). Sleeplessness on the ni... Read more
Headache from 10:00pm-5:30am (3/11/21-3/12/21) and 11:00am-4:00pm (3/12/21). Sleeplessness on the night of 3/11/21.
40 2021-03-12 feeling abnormal Symptom Onset 3/12/21 4:30pm - 4am Fever of 101.9, muscle pain, joint pain, numbness in fingers, ... Read more
Symptom Onset 3/12/21 4:30pm - 4am Fever of 101.9, muscle pain, joint pain, numbness in fingers, muscle weakness, difficult to move on my own, skin pain, migraine-like headache . 3/13/21 9 am - muscle fatigue, muscle pain, headache, sensitive skin, joint pain, brain fog.
40 2021-03-13 sleep disorder Headache/migraines 3/13 night with limited relief from imitrex. Body aches starting with injection s... Read more
Headache/migraines 3/13 night with limited relief from imitrex. Body aches starting with injection site working down arm to hand, then all joint throughout the night. Unable to sleep with pain. By morning I had a fever. Took two Tylenol and slept. Final helped with aches and fever. 4pm Sunday still have pains in the head when I get out of bed.
40 2021-03-15 feeling abnormal 7:30pm 3/14: feeling feverish/flu like 9:15pm: chills starting 10:30pm/ massive chills and body ach... Read more
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
40 2021-03-16 feeling abnormal Headache, dizziness and brain fog initially. Significant arm, shoulder and neck pain on left side. ... Read more
Headache, dizziness and brain fog initially. Significant arm, shoulder and neck pain on left side. (Injection site). Neck pain continues after two days/seems worse.
40 2021-03-16 feeling abnormal Moderate to significant muscle aches in entire body started to develop about 7 hours after the vacci... Read more
Moderate to significant muscle aches in entire body started to develop about 7 hours after the vaccine. Mild headache and moderate mental fogginess started about 8 hours after receiving the vaccine.
40 2021-03-21 insomnia Headache Tiredness Insomnia Fever Night sweats Muscle aches
40 2021-03-22 feeling drunk I felt light headedness right away. The night that I got the injection, I felt kind of drunk. I felt... Read more
I felt light headedness right away. The night that I got the injection, I felt kind of drunk. I felt like I had too much alcohol. I am very sensitive to things. I felt silly - loose - tired. In the night, I had aches and chills - no fever. The next day I felt achy and really really tired. I had a pain at the injection site. That evolved into a left side migraine (the achiness and fatigue and pain from shot) It created tension up my arm and up my neck - and I did get nausea with the headache - on Saturday. Sunday, I felt a little bit better but energy was still low - unusual tiredness; couldn't exercise as I felt a heavy fatigue. On Sunday, I went to a dance class but it was difficult as I was tired. On Monday, I felt a tiny bit better but still fatigued and did another dance class which went a little better. On Monday evening, I felt like I did the night of the injection - a little loopy and "drunk like." Monday night, I woke up with a Fiery, achy, itchy, burning rash on both of my arms and the tops of my legs. If I would itch it, it would exaggerate it. When I woke up the next day - the rash went everywhere in my body - it would come and go in different places - neck, face, down and up my legs and feet and on my butt. Pretty much every spot had the rash at one time or another. It was really bad on Tuesday morning, I called the doctor. Was treated with Benadryl and cortisone cream which helped with the symptoms. Tuesday night, it was excruciating - it was all up and down my legs, arms, neck and face and stomach and rear end and feet. It was very achy, burning and itchy - very intense. It would hurt if I scratched it. Accompanied with really intense fatigue. Wednesday, after taking Benadryl, I woke up and it was a tiny bit better. It was still on my legs, neck and face. Sometimes my arms would flare up and sometimes they wouldn't. Any kind of exertion - like my dance class - would trigger the rash - so I took a break from exercising that week. It started getting incrementally better - very slowly. Still there on Thursday - still fatigued and I was still taking Benadryl. Friday, also. Saturday, it was pretty much gone but it would threaten to come back and I felt itchiness in my legs when I went for a walk. It still feels a little lingering - my legs are itchy. I'm still building back my energy. Incrementally my energy is increasing. Still not 100% there but it's getting better day by day. Note: My history with my skin: I do get flare ups when I get bug bites and when I get poison ivy - I have very sensitive skin.
40 2021-03-22 nervousness Have felt shaky with muscle twitches since day 1. I would describe as similar to being on a low dos... Read more
Have felt shaky with muscle twitches since day 1. I would describe as similar to being on a low dose of steroids'.
40 2021-03-24 confusional state Site: Pain at Injection Site-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizz... Read more
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.
40 2021-03-25 sleep disorder, loss of personal independence in daily activities 4 hours post-vaccine, started to shiver 6 hours post-vaccine spiked fever of 102.2 7 hours post-vacc... Read more
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.
40 2021-03-31 feeling abnormal From 5:30-11:30pm: fever, severe chills, breaking out in sweats, could not form fist with hand and s... Read more
From 5:30-11:30pm: fever, severe chills, breaking out in sweats, could not form fist with hand and severe mental fogginess. 11:30-7:30am: migraine, breaking out in sweats 7:30-8:00pm: migraine, major GI issues, stomach hurt to the touch, mental fogginess
40 2021-03-31 feeling abnormal I got the shot at 6:00 pm on March 29th. Around 12:30 am (March 30th) (about 6 hours after receiving... Read more
I got the shot at 6:00 pm on March 29th. Around 12:30 am (March 30th) (about 6 hours after receiving the Johnson and Johnson COVID) vaccine I woke up with chills, body aches all over and a headache. That along with fatigue continued for about 28 hours. I missed a day of work due to not feeling well. The following day (March 31st) I still felt tired and spacey. My headache was better. But I started having hot flashes and more minor body aches. Not as severe body aches as the previous day. April 1st I felt back to normal. I called my doctor's nurse on March 30th to ask if I could take Tylenol to help with my bad headache. She advised not to so I didn't take any Tylenol or Ibprophen.
40 2021-04-01 impaired work ability Fever of 101.8 plus body aches and severe headache on 3/31/21 resulting in inability to work. Sore a... Read more
Fever of 101.8 plus body aches and severe headache on 3/31/21 resulting in inability to work. Sore arm On 4/1/21, mild symptoms, sore arm, mild body aches and mild headache On 4/2/21 same mild symptoms as previous day plus some shortness of breath followed by an asthma attack at 5:30pm. An asthma attack is extremely unusual for me and I haven?t had an asthma attack in 20 years
40 2021-04-02 anxiety, insomnia I had insomnia and a racing heart that evening. It lasted from when I went to bed until late mornin... Read more
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.
40 2021-04-02 anxiety Client reported 5 minutes after vaccination ears tingling, facial flushing, mouth swelling, high anx... Read more
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.
40 2021-04-02 disturbance in attention Around 6 hours after vaccine, I had uncontrollable chills. This led to a low grade fever. I tried to... Read more
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.
40 2021-04-06 feeling abnormal Injection site bleeding at time of shot. Second bandaid applied. Dizziness and nausea within 20 min... Read more
Injection site bleeding at time of shot. Second bandaid applied. Dizziness and nausea within 20 mins of shot Shortness of breath (when walking) within one hour Fogginess Extreme fatigue Muscle weakness Arm pain at and around injection site radiating up left side neck area Over 24+ hours later all side effects persists
40 2021-04-06 feeling abnormal During 15 min waiting period around 0945 at vaccination site, patient became flushed and had increas... Read more
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.
40 2021-04-06 feeling abnormal Started with extreme fatigue on April 6, 2021 at 2 pm. On April 6, 2021 at 8 pm my stomach and right... Read more
Started with extreme fatigue on April 6, 2021 at 2 pm. On April 6, 2021 at 8 pm my stomach and right side started to feel horrible. I felt and continue to feel right side stomach ache and nausea. Started a full headache on April 7, 2021 at 430 pm.
40 2021-04-06 sleep disorder I woke up at 3am (of following day) not feeling well; with headache and fever (100F). It felt like t... Read more
I woke up at 3am (of following day) not feeling well; with headache and fever (100F). It felt like the beginning of a flue. My body was feeling heavier. I tried to sleep again and was waking up every 1 hour. In the morning, I was feeling like a truck went over me: headache, feeling tired and body pain. I was monitoring the fever and it went away at around 6am. But I was feeling very tired the entire day and headache stopped at around 3pm. in the night, symptoms were mild. Next day (today) I'm feeling better than yesterday (back to work), but not 100% - would say 80%.
40 2021-04-07 feeling abnormal My vaccine was administered at 12:30pm. I waited until 12:55 at CVS after the vaccine to make sure t... Read more
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.
40 2021-04-07 impaired work ability, sleep disorder 4 1/2 hours after the vaccination I experienced extreme pain in my upper body all the way through my... Read more
4 1/2 hours after the vaccination I experienced extreme pain in my upper body all the way through my neck 4 1/2 hours after the vaccination I experienced extreme pain in my upper body all the way through my neck. Then very tired. Around midnight I woke up with an excruciating headache fever chills. Was not able to go to work the following morning go to the headache and bodyaches all over with a stabbing pains in my side. The following morning I woke up with red hives all over my body. The hive started at my neck and went down with my torso around my back and on the inner of my arms. My headache has gone away but I still have the hives
40 2021-04-07 insomnia, anxiety, panic attack, abnormal dreams, restlessness Sore/swollen lymph nodes on the side of injection, very vivid dreams, restlessness, significant incr... Read more
Sore/swollen lymph nodes on the side of injection, very vivid dreams, restlessness, significant increase in anxiety/panic attacks, hard time falling asleep
40 2021-04-08 disturbance in attention, feeling abnormal Started an hour after with feeling loopy then progressed at 4pm to chills,fast climbing fever. Reach... Read more
Started an hour after with feeling loopy then progressed at 4pm to chills,fast climbing fever. Reached 104 by 7pm. Felt lethargic. The fever scared me. I still have a 101 fever. Very bad migraine and can?t focus
40 2021-04-08 insomnia Metal Mouth within 15 minutes; 5 hours later sever chills and violent shakes for the next 8 hours; r... Read more
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.
40 2021-04-08 irritability irritability, fatigue, chills, body aches, headache, nausea, dry-heaving, and vomiting.
40 2021-04-09 insomnia Almost immediately began to experience nausea and some mild lightheadedness. Within an hour began ... Read more
Almost immediately began to experience nausea and some mild lightheadedness. Within an hour began to feel like I had taken a sedative (reminded me of how klonopin made me feel when I was taking it for anxiety). Sedative type feeling lasted for approximately 4 hours. Headache developed approximately 2 hours after receiving vaccination. Headache and nausea persisted until bedtime. Had major issues sleeping and had night sweats all night. Nausea is gone this morning but headache is still present. Some mild tenderness at injection site that is still present this morning.
40 2021-04-09 loss of personal independence in daily activities I went to bed that night 6 hours after vaccine, and woke up with extreme flu 8 and half hours after... Read more
I went to bed that night 6 hours after vaccine, and woke up with extreme flu 8 and half hours after vaccine. High fever chills, vomiting, body aches. The next morning 15 hours after vaccine my arm started to hurt so badly I could barely move. The nerves in the injected arm running up and down with shooting and pulsing, lack of feeling in hands and extreme pain through the the arm and shoulder on the injected side. The pain was extreme for 13 days I lost work time. I saw several doctors who sent me on my way. My arm still hurts right now 24 days since vaccine. The pain is not extreme but the nerves still shoot pain and oils and there is often extreme pain by the end of the day.
40 2021-04-10 disorientation, feeling abnormal, anxiety I had shot and sat to be observed at 8:30 am. After about three minutes I felt a wave of adrenaline... Read more
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.
40 2021-04-10 sleep disorder, nightmare A very bad headache all most 24 hours from Thursday morning (4/8/2021) until Friday morning (4/9/202... Read more
A very bad headache all most 24 hours from Thursday morning (4/8/2021) until Friday morning (4/9/2021). Could not do anything but lying down the bed. I slept in and sleep out. I can feel hot sometimes and feel cold sometimes. No treatment. Three very bad dreams and scared me out three times on the Friday night (4/09/2021).
40 2021-04-11 feeling abnormal, disturbance in attention Had a sore arm within hour of shot (got it at 7:30pm). Felt a little yucky before going to bed. I ma... Read more
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.
40 2021-04-12 anxiety At time event started I was throwing up, dizzy, and had a burning sensation at the top of my throat.... Read more
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.
40 2021-04-12 depression, disturbance in attention March 6th evening hours- joint pain in left elbow and left knee March 7th at approximately 3AM fever... Read more
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.
40 2021-04-12 feeling abnormal, anxiety 3/24/21 Anxious Reflux symptoms - took Pepcid complete 3/23/21 Chest pressure Reflux - feels bett... Read more
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
40 2021-04-12 nervousness, impaired work ability Seizure-like incident while at a restaurant. Eyes rolled back in to my head, according to my friend ... Read more
Seizure-like incident while at a restaurant. Eyes rolled back in to my head, according to my friend who was with me. My vision got blurry, I started feeling nauseous, shivers, cold sweats, body felt shaky, and at first I thought I had been drugged. This "attack" lasted for a couple of minutes. After being able to get home I was in bed until 4 pm the next day. At first I had several hours where I was freezing despite being in bed fully dressed with the heat blasting, the following hours, I was sweating. I had a headache, felt nauseous, and uncomfortable all day Saturday. My reaction to the vaccine was much worse than having Covid-19. Missed work due to the symptoms from getting the vaccone.
40 2021-04-13 amnesia, mental impairment Fever, chills, some short term memory loss, loss of appetite, lethargy the day following vaccination... Read more
Fever, chills, some short term memory loss, loss of appetite, lethargy the day following vaccination. Massive headache for 12+ hours beginning on 04/13/2021 with diminished headache, loss of appetite and difficulty with thought processing continuing currently at 9pm on 04/14/2021.
40 2021-04-13 feeling abnormal, crying Pain in right arm immediately after the injection, couldn't move it for 30 minutes, blurred vision, ... Read more
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.
40 2021-04-13 excessive sleepiness, feeling abnormal On Friday after the shot, I felt ok, but my left arm was swollen to the point of taking off my weddi... Read more
On Friday after the shot, I felt ok, but my left arm was swollen to the point of taking off my wedding rings because they hurt. The leg pain started on Friday night. Saturday woke up with a groggy head and tired. Sunday I had leg pain, headache, and foggy brain. Saturday into Monday I had night sweats (pouring in sweat) fever, headache, body aches, tired (could not keep my eyes open) I slept all day and could barely move comfortably. Tuesday I was extremely exhausted, leg pain continuing, headache, and weird feeling. The swollen arm is back. Today is Wednesday, almost a week after with leg pain, headache, swollen arm, and weird feeling.
40 2021-04-14 anxiety pt says she had an achy left arm w/ fatigue. Next day she had a low-grade fever and hives on her st... Read more
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.
40 2021-04-14 disorientation experienced a sudden pain to the forehead. Pain increased from 0-100 very rapidly, I became very nau... Read more
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.
40 2021-04-14 feeling abnormal Following the shot I had "normal" side effects. Tired, headache, foggy/light headed. These began abo... Read more
Following the shot I had "normal" side effects. Tired, headache, foggy/light headed. These began about an hour after the shot and continued. 48 hours after the shot, Monday morning, I began having stomach pains and diarrhea. I continued to feel light headed and foggy. The stomach pains and diarrhea are still present today, Thursday, 04/15/21, nearly 5 days after receiving the vaccination.
40 2021-04-14 impaired work ability Immediate headache behind left ear in lymph node, fatigue and worsening headaches within 5 hours. Mi... Read more
Immediate headache behind left ear in lymph node, fatigue and worsening headaches within 5 hours. Missed one week of work due to fatigue. Following week vomiting and diarrhea in addition to the fatigue. Abdominal pain. ER visit to rehydrate and evaluate.
40 2021-04-15 anxiety NOT FEELING HUNGRY; FELT SCARED WORSENED/ANXIOUS WORSENED; OFF LABEL USE; TEMPERATURE OF 101; FATIGU... Read more
NOT FEELING HUNGRY; FELT SCARED WORSENED/ANXIOUS WORSENED; OFF LABEL USE; TEMPERATURE OF 101; FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included felt muscle aches in legs, and concurrent conditions included multiple sclerosis, numbness, tingling, visual disturbances, swollen ankles, trouble sleeping, crohns disease, not able to do things which friends could do, nausea, vomiting, felt anxious/scared, sometimes pain in stomach or abdomen, and eight watery stools/loose stools. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, The batch number was not reported. The company was unable to perform follow up to request batch number. expiry: unknown) dose was not reported, administered on 22-MAR-2021, and dose was not reported, administered on 22-FEB-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 14 days from 22-JAN-2021 to 22-JAN-2021, and dose was not reported, 1 time every 14 days from 05-FEB-2021 to 05-FEB-2021 for crohns disease; and adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 14 days from 19-FEB-2021 to 19-FEB-2021 for crohn's disease. No concomitant medications were reported. On 2021, the subject experienced fatigue. On 2021, the subject experienced headache. On 23-MAR-2021, the subject experienced temperature of 101. Laboratory data included: Body temperature (NR: not provided) 101.01 F. On an unspecified date, the subject experienced not feeling hungry, felt scared worsened/anxious worsened, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache on 2021, had not recovered from not feeling hungry, and the outcome of temperature of 101, felt scared worsened/anxious worsened and off label use was not reported. This report was non-serious.
40 2021-04-15 sleep disorder Later that day I started getting pain in the hip/groin area of my left leg preventing me from puttin... Read more
Later that day I started getting pain in the hip/groin area of my left leg preventing me from putting pressure on it or walking. The acute pain diminshed after about 3 hr and I could walk again but the hip flexor area remained tender and felt like a sore muscle had been pulled for about 3 days. About 5pm I developed really bad chills which lasted about 24 hrs and was really intense about the first 6hr. About 11pm I developed a severe headache preventing me from sleeping which lasted about 9hrs. 4/10 I had occassional chills, the headache had subsided a little but had a nagging tension feeling and I was really fatigued and really wiped out the remainder of that day. My Gynecologist advised I stopped taking my Birth Control for the next month to lower my risk of blood clots.
40 2021-04-19 feeling abnormal Saturday, April 10th- ? Received Johnson & Johnson / Janssen Covid 19 Vaccine at pharmacy at 10:00 ... Read more
Saturday, April 10th- ? Received Johnson & Johnson / Janssen Covid 19 Vaccine at pharmacy at 10:00 AM o Vial 205A21A ? Had chills and overall yucky/flu like symptoms for that night, Sunday was pretty much back to normal Friday (April 16th) evening- ? Started feeling weird ? headache ? facial area tight/flushed/tick ? Worsened/blurry vision especially in right eye ? Noticed leg bruising, not sure when it?s from ? No appetite Overnight Friday into Saturday, woke up several times covered in sweat Saturday (April 17th) - ? Fatigue, no appetite, headache / blurry vision continued, brain ?fog?/hard to concentrate ? Rested most of the day, went for small walks ? Off / on low grade fever seemingly worse at night and getting out of shower Sunday (April 19th) - ? Fatigue, no appetite, headache / blurry vision continued, brain ?fog?/hard to concentrate ? Rested most of the day, went for small walks ? Bloodshot, tired, red eyes that don?t go away with drops Monday (April 20th)- ? Fatigue, no appetite, headache / blurry vision continued, brain ?fog?/hard to concentrate ? Went on normal 3 mile walk and did fine ? Bloodshot, tired, red eyes that don?t go away with drops Tuesday (April 21st)- ? Fatigue, no appetite, headache / blurry vision continued, brain ?fog?/hard to concentrate ? Went on normal 3 mile walk and did fine ? Bloodshot, tired, red eyes that don?t go away with drops
40 2021-04-19 insomnia, anxiety, feeling abnormal HIGH BLOOD PRESSURE; FAST HEART BEAT; FELT LIKE BODY WAS SHUTTING DOWN; VOMITING; DIFFICULTY BREATHI... Read more
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.
40 2021-04-19 restlessness 8hrs after injection onset of fatigue, Fever with chills, body aches, major lower back aching, nause... Read more
8hrs after injection onset of fatigue, Fever with chills, body aches, major lower back aching, nausea, dizziness restlessness. Lasted for 24 hrs. Majority of symptoms have subsided. Random lightheaded and dizzy spells have continued multiple times daily, with occasional nausea.
40 2021-04-19 sleep disorder On 4/16/21 patient reported the following: "I have been experiencing dizziness, being really tired a... Read more
On 4/16/21 patient reported the following: "I have been experiencing dizziness, being really tired and then when I try to go to sleep I cannot go to sleep, and being able to focus". States symptoms started around 11am on 4/8/21 after receiving the vaccine that morning at 9:45am. As of 4/19 her symptoms were improving.
40 2021-04-20 insomnia, feeling abnormal, sleep disorder, loss of personal independence in daily activities About six hours after the vaccine I had a headache. I woke up during the night with all over body ac... Read more
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.
40 2021-04-20 panic attack Fainted within 5 minutes of receiving vaccine. Taken by ambulance to hospital. Have been sick with... Read more
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).
40 2021-04-21 feeling abnormal NAUSEA; TIREDNESS/SLUGGISHNESS; BRUISED ARM AT THE ADMINISTRATION SITE; DIZZINESS; FEELS A LITTLE OF... Read more
NAUSEA; TIREDNESS/SLUGGISHNESS; BRUISED ARM AT THE ADMINISTRATION SITE; DIZZINESS; FEELS A LITTLE OFF; HEADACHE; This spontaneous report received from a patient concerned a 40 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 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced bruised arm at the administration site. On 04-APR-2021, the subject experienced dizziness. On 04-APR-2021, the subject experienced feels a little off. On 04-APR-2021, the subject experienced tiredness/sluggishness. 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 headache on 06-APR-2021, was recovering from nausea, dizziness, and tiredness/sluggishness, and had not recovered from bruised arm at the administration site, and feels a little off. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures.
40 2021-04-21 excessive sleepiness Light headed rocking back and forth sweating pooping can?t eat headache sleeping more
40 2021-04-21 sleep disorder 4-5 DAYS AFTER VACCINATION, LEFT ARM PAIN DISTAL TO SITE OF INJECTION, NUMBNESS OF LEFT HAND. PAIN I... Read more
4-5 DAYS AFTER VACCINATION, LEFT ARM PAIN DISTAL TO SITE OF INJECTION, NUMBNESS OF LEFT HAND. PAIN IS INTERMITTENT, WORSENING, WAKING PT UP FROM SLEEP LAST NIGHT. PT WAS SENT TO THE ED FOR FULL EVALUATION.
40 2021-04-23 disturbance in attention, sleep disorder, feeling abnormal - Injection site pain (burning, stinging) immediately after shot that dissipated within a few minute... Read more
- 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.
40 2021-04-26 excessive sleepiness STOMACH FLU; CHEST PAIN UNSPECIFIED; SHORTNESS OF BREATH; EKG SINUS TACHYCARDIA, LOW VOLTAGE PERIODI... Read more
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).
40 2021-04-26 memory impairment, feeling abnormal, anxiety headaches, brain fog, forgetfulness, chest pain, anxiety ...
40 2021-04-27 sleep disorder Vaccine was received at 11:30 am, 4/27/21. Very minor headache started a few hours later. Fatigue,... Read more
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
40 2021-04-28 sleep disorder Patient is a 40 y.o. female who presents for evaluation of adverse reaction to Johnson and Johnson C... Read more
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.
40 2021-04-30 nightmare SICKNESS; PAIN; NIGHTMARES; This spontaneous report received from a patient concerned a 40 year old ... Read more
SICKNESS; PAIN; NIGHTMARES; This spontaneous report received from a patient concerned a 40 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: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain. On APR-2021, the subject experienced nightmares. Laboratory data included: Diagnostic ultrasound (NR: not provided) ultrasound of leg showed subject was not sick. On 08-APR-2021, the subject experienced sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain, nightmares and sickness was not reported. This report was non-serious.
40 2021-05-02 amnesia, feeling abnormal, excessive sleepiness I woke up on April 22 and could not feel or move my entire body. This lasted from the time I woke up... Read more
I woke up on April 22 and could not feel or move my entire body. This lasted from the time I woke up (5:15am) until I was discharged from the hospital later that night. I was weak and in a brain fog the entire weekend (Thursday, Friday, and Saturday). I slept all weekend and have no memory of the entire weekend.
40 2021-05-06 disturbance in attention Feeling very sick since vaccine, night sweats, diarrhea, Dry heaving in morning, loss of appetite, w... Read more
Feeling very sick since vaccine, night sweats, diarrhea, Dry heaving in morning, loss of appetite, weight loss, flu like feeling, fatigue, aching, lack of concentration, no fever
40 2021-05-10 loss of personal independence in daily activities 4 hours after administration bilateral leg.thigh numbness. Could still walk. 18 hours after adminis... Read more
4 hours after administration bilateral leg.thigh numbness. Could still walk. 18 hours after administration had severe mid back pain, that limited ability do activities.
40 2021-05-11 excessive sleepiness, sleep disorder Had a few cocktails and I blacked out, was highly sensitive to the alcohol. I was throwing up for tw... Read more
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.
40 2021-05-12 panic attack, disturbance in attention, feeling abnormal, memory impairment The first symptom I noticed was extreme brain fog and forgetfulness. Then, 6 days after the vaccine,... Read more
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.
40 2021-05-14 anxiety Patient received the vaccine and felt lightheaded within a few minutes. She sat down, put her feet ... Read more
Patient received the vaccine and felt lightheaded within a few minutes. She sat down, put her feet up, and drank some water. She became very anxious and felt like she was going to pass out. Paramedics examined her and she remained seated for another 20 minutes before leaving.
40 2021-05-18 insomnia ANAPHYLAXIS; HOT AND BRUISED SHOULDER; FLUSHING; BODY ACHES; LOSS OF FEELING IN FACE; LOSS OF APPETI... Read more
ANAPHYLAXIS; HOT AND BRUISED SHOULDER; FLUSHING; BODY ACHES; LOSS OF FEELING IN FACE; LOSS OF APPETITE; VOMITING; CAN NOT SLEEP; CAN NOT DRINK WATER; STOMACH FEELS LIKE SODA; SWOLLEN ARM AND SHOULDER; COULD NOT MOVE FINGER; VERY HOT LEFT ARM; LEFT ARM SENSITIVE TO TOUCH; HOT SHOULDER; LOWER BACK PAIN; DEHYDRATED; SORE ARM; RASH; HIVES AND BUMPS AROUND THE INJECTION SITE; WEAKNESS; INJECTION SITE PAIN; HEADACHE; VERY TENDER ARM AND SHOULDER; TERRIBLE NAUSEA; FEVER; LOSS OF TASTE; LOSS OF SMELL; BRUISE ON LEFT WRIST; PALMS TURNED BLUE FROM CLAPPING; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, non-alcoholic, crohn's disease, heart murmur, chronic vertigo, panic attack disorder, depression, drug allergy, fish allergy, and perimenopause, anxiety and other pre-existing medical conditions included patient had no drug abuse or illicit drug, patient is allergic to all the narcotics, passes large clots of blood during menstruation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: unknown) dose was not reported, administered on 06-MAY-2021 13:15 for prophylactic vaccination. Concomitant medication included meclozine for vertigo. After receiving vaccination the first thing she felt like there was hot lava going down her left arm ( where she got injected) and she could not move her finger then that went away after 10-15 minutes later. they told her that symptom was normal and everyone experience the same kind of symptom. She completely lost her appetite, the smell of food made her sick ever since she got the shot. Patient stated her left arm was very hot, sensitive to the touch, bumpy around the injection site and sore. all these symptoms were the same day of her shot (on 6-MAY-2021). since the injection she had the headache and it wont go away and she still has the headache today. her relative was telling her that her shoulder was hot. she had body aches ( lower back pain and everywhere, the pain was moving though her body). the second day everything got worse; her arm where she received the injection her whole shoulder was black it looks like if someone threw brick at her, she had hives and bumps around the injection site. she cannot sleep, she cannot eat and she cannot drink water. she was tired and she was not feeling good. she had anaphylaxis 30 hours, dizziness, loss of feeling in her face, her heart was racing. she took two tablets of antihistamine to manage the anaphylaxis reaction. 30 hours after the vaccination she has dizziness, wheezing, she had flushing , rapid pulse, she was throwing up for hours then she had to take the antihistamine. On an unspecified date patient had weakness. Patient said that her fever gets worse every day. On the day of vaccination (on 6-MAY-2021) her temperature was 99.4, and has checked it 5 to 6 times with the same reading. on 7-MAY-2021 it was 99.6 and on 8-MAY-2021 it was 100.3. she said it felt like both sides of her throat were touching. Patient had barely been able to eat since 6-MAY-2021, but has been able to drink small amounts of water. Patient stated her saliva makes her nauseated. On 10-MAY-2021 she clapped her hands and they turned blue and also developed an egg shaped bump/hematoma on her left wrist after bumping it. She went to urgent care where she was instructed to use ice pack for bump, which gave her no relief. There, she was stuck with a needle 4 times to get blood work because she was dehydrated. Patient stated that her whole body felt like a walking pin cushion and skin was hypersensitive. Urgent care checked platelets and hemoglobin which came back normal. Patient stated her menstrual cycle started on 10-MAY-2021 was different than usual with super heavy, red flow, no clots, and soaked pad in an hour, it was slowed down since but flow was heavy. Urgent care advised this may be normal due to change of hormone during perimenopause. As of today, patient could not smell or taste anything. Patient was taking antihistamines 2 a day. Temperature was normal. Patient stated nausea and vomiting were better but would definitely come back if she stopped taking meclizine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move finger, had not recovered from sore arm, headache, loss of appetite, vomiting, injection site pain, stomach feels like soda, terrible nausea, swollen arm and shoulder, feels like both sides of throat are touching, weakness, bruise on left wrist, loss of taste, and loss of smell, and the outcome of sore body, hot and bruised shoulder, rash, anaphylaxis, flushing, body aches, not feeling good, dizziness, loss of feeling in face, wheezing, rapid pulse, hives and bumps around the injection site, can not sleep, can not drink water, fever, very tender arm and shoulder, very hot left arm, left arm sensitive to touch, hot shoulder, lower back pain, palms turned blue from clapping and dehydrated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210516682-COVID-19 VACCINE AD26.COV2.S-Anaphylaxis. This event(s) is labeled per RSI and is therefore considered potentially related.
40 2021-05-23 feeling abnormal, insomnia That night, starting around 11:00, I started getting chills and feeling abnormally fatigued and achy... Read more
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.
40 2021-05-24 sleep disorder The side affects: fever, body aches, headache, and flu-like symptoms (chills, sweats) and that laste... Read more
The side affects: fever, body aches, headache, and flu-like symptoms (chills, sweats) and that lasted between 11:00 am - 03:00 am Tuesday morning. What continued was the extreme body and joint pain. That was probably about a 6 or 7 on the pain scale. That lasted from Monday and then on Thursday and Friday I couldn't sleep because of the pain. I called the doctor because there were things on the news about calling dr. with leg pain. I couldn't bend down and pick up anything. It felt like I had horrible arthritis. Dr said to take Advil and Tylenol if I needed help - that helped when I slept. I have a very physical job that probably made it worse - lifting and pushing - it would be worse.
40 2021-05-25 anxiety I wasn't feeling well, I started having a really bad headache, fever, sore and achy like I had the f... Read more
I wasn't feeling well, I started having a really bad headache, fever, sore and achy like I had the flu. I started having problems heaviness and shortness of breath. I started getting a rash that turned into hives all over my entire body. I was having feelings of anxiety and overall not well. I'm still getting hives from it. The other clinic I saw was the clinic 5096342913. I still am using an inhaler from the shortness of breath.
40 2021-05-31 abnormal dreams NOSE/HEAD CONGESTION; UNABLE TO BREATH; NIGHT SWEATS; CRAZY DREAMS; DIARRHEA; VOMITING; DEHYDRATION;... Read more
NOSE/HEAD CONGESTION; UNABLE TO BREATH; NIGHT SWEATS; CRAZY DREAMS; DIARRHEA; VOMITING; DEHYDRATION; DRY HEAVING; NAUSEA; SLUGGISH/TIRED; 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 flu, and concurrent conditions included overweight, and pcn (penicillin) allergy, and other pre-existing medical conditions included patient took a product (vaccine) as directed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced sluggish/tired. On 25-MAY-2021, the subject experienced diarrhea. On 25-MAY-2021, the subject experienced vomiting. On 25-MAY-2021, the subject experienced dehydration. On 25-MAY-2021, the subject experienced dry heaving. On 25-MAY-2021, the subject experienced nausea. On 26-MAY-2021, the subject experienced nose/head congestion. On 26-MAY-2021, the subject experienced unable to breath. On 26-MAY-2021, the subject experienced night sweats. On 26-MAY-2021, the subject experienced crazy dreams. Treatment medications included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sluggish/tired, nausea, vomiting, diarrhea, nose/head congestion, dehydration, dry heaving, night sweats, unable to breath, and crazy dreams. This report was non-serious.
40 2021-05-31 confusional state, feeling abnormal, disorientation FEELING HAZY; RAISED BUMP AT INJECTION SITE; HEADACHE; WATER BLISTERS UNDER NOSE AND TURNED INTO SOR... Read more
FEELING HAZY; RAISED BUMP AT INJECTION SITE; HEADACHE; WATER BLISTERS UNDER NOSE AND TURNED INTO SORES ON UPPER LIP AND UNDER LEFT NOSTRIL AND COMING DOWN TO LIP; FELT HORRIBLE; DISORIENTATED; DIZZINESS; SHORTNESS OF BREATH; TIREDNESS; This spontaneous report received from a patient concerned a 40 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: 042A21A, and expiry: 21/06/2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced tiredness. On 26-MAY-2021, the subject experienced water blisters under nose and turned into sores on upper lip and under left nostril and coming down to lip. On 26-MAY-2021, the subject experienced felt horrible. On 26-MAY-2021, the subject experienced disorientated. On 26-MAY-2021, the subject experienced dizziness. On 26-MAY-2021, the subject experienced shortness of breath. On 26-MAY-2021, the subject experienced raised bump at injection site. On 26-MAY-2021, the subject experienced headache. On 28-MAY-2021, the subject experienced feeling hazy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt horrible, disorientated, dizziness, tiredness, and headache, had not recovered from water blisters under nose and turned into sores on upper lip and under left nostril and coming down to lip, raised bump at injection site, and shortness of breath, and the outcome of feeling hazy was not reported. This report was non-serious.
40 2021-06-13 loss of personal independence in daily activities Five weeks after the vaccine I started to have sharp pain in spots on my legs. I felt like I need to... Read more
Five weeks after the vaccine I started to have sharp pain in spots on my legs. I felt like I need to rub them. The pain moves all over my legs. Sometimes one spot is worse than another. There is no visible sign of the spots that cause pain. I noticed that there were some spots at first and they would improve. Then when the pain returns it is in a different area. Originally I noticed it on my lower legs and currently it is on my thigh. It is painful to touch like a deep pain in the muscle. Some days it is worse than others. I used to walk on the treadmill for twenty minutes a day and now I cannot do any walking. It has not improved any and the areas where it hurts changes over the course of a couple of weeks.
40 2021-06-14 confusional state Syncopal reaction-she passed out while standing about 5 min. after receiving vaccine. She came back... Read more
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.
40 2021-06-14 feeling abnormal headaches for a month, brain fog (only fog still present)
40 2021-06-23 sleep disorder Extreme fatigue within a week or two. Assumed it was work related. A month later I started waking up... Read more
Extreme fatigue within a week or two. Assumed it was work related. A month later I started waking up and arms felt tingly or numb. Arm pain increased, so I made an appointment with my doctor and have started running tests to find out why the pain is increasing and how to correct it.
40 2021-06-24 restlessness 12 hours after injection, I experienced exactly 12 hours of severe body ache, incredible headache, a... Read more
12 hours after injection, I experienced exactly 12 hours of severe body ache, incredible headache, and extreme restlessness. Compared to experiencing actual Covid, this was much, much more magnified.
40 2021-07-19 anxiety 10 days after the vaccine I started experiencing heart palpitations, elevated pulse, anxiety, troubl... Read more
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
40 2021-07-24 nightmare, disorientation Night Sweats, bad dreams, fever, disorientation, loss of balance, fainting, difficult for me to get ... Read more
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.
40 2021-07-26 loss of personal independence in daily activities So about ten hours after the vaccine, I had a fever and left work not feeling well. I had a fever al... Read more
So about ten hours after the vaccine, I had a fever and left work not feeling well. I had a fever all day Tuesday and then Wednesday I was nauseas and had muscle pains as well. I have also had sharp pains in my back and shooting into my legs, I cannot get dressed by myself or go to the bathroom. I have not ever had any problems before. It's like a sciatic pain, a back pain. I went to the Dr. Wednesday or Thursday (21st or 22nd of July), I am not sure when. The Dr. can't really do anything for me except take Tylenol. I have an x-ray scheduled, and my next step is Chiropractic work and possibly Physical therapy. I struggle daily just to do my normal daily activities at this point.
41 2021-03-10 insomnia I noticed it felt like a sinus cold coming on along with face, head and minor toothaches to the my l... Read more
I noticed it felt like a sinus cold coming on along with face, head and minor toothaches to the my left side of my face on the the 8th or 9th. I took Tylenol everyday for my sore arm and the headaches but it did help suppress them so I didn?t think much of it. My throat also started to feel kind of raw or itchy but I didn?t have a cough and I noticed a slight post nasal drip. Ok the 10th in the evening I felt exhausted and my face and sinuses were much worse. I took cold medicine and fell asleep early but had a hard time sleeping. I?m a side sleeper and if I turned on my left side, my ear felt like it was burning and my face would go numb. It also made me very dizzy. I woke up with body aches and light headed. My throat doesn?t hurt but it feels different. Almost numb like nothing and I can?t smell or taste.
41 2021-03-10 sleep disorder Pain at sight immediately that continued for 30min At 7:30pm fever chills constant shaking that subs... Read more
Pain at sight immediately that continued for 30min At 7:30pm fever chills constant shaking that subsided at 9:00pm woke up at 10:45pm and can?t stop shaking legs and rapid breathing....still going in at 12;30am as I wrote this
41 2021-03-12 sleep disorder strong chills overnight (approx5-6 hours after injection), could not sleep through it, whole body ac... Read more
strong chills overnight (approx5-6 hours after injection), could not sleep through it, whole body aches, headache, took Motrin and felt a little better (by 2pm the following day) but not 100%. Notably better by second day but still a tad sore.
41 2021-03-13 feeling abnormal Chills, sweating, vomiting, fever (102.4), pain in the left arm at the injection site, headache for ... Read more
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.
41 2021-03-17 anxiety pt. complains of headache on her right side of the head and seems anxious. pt. out of her car wait... Read more
pt. complains of headache on her right side of the head and seems anxious. pt. out of her car waiting her dogs states that she feels better. H/R 102
41 2021-03-21 loss of personal independence in daily activities The adverse event I experienced was more fatigue (than usual at 36 weeks pregnant) a day after rece... Read more
The adverse event I experienced was more fatigue (than usual at 36 weeks pregnant) a day after receiving the Covid Janssen vaccine. I slept a good portion of the day and felt I didn?t have the energy to go about daily chores around the house. I am now 37 weeks pregnant and due on April 9th. I was able to return resume normal activities the next day and have not experienced any other side effects since then that have restricted me from performing my daily activities.
41 2021-03-23 sleep disorder Day 1 tired. Day 2 - 6 horrible GI symptoms(gas, bloating, diarrhea, acid reflux) Day 8- hives Day 9... Read more
Day 1 tired. Day 2 - 6 horrible GI symptoms(gas, bloating, diarrhea, acid reflux) Day 8- hives Day 9 bad pain in breast. Ariola starts peeling. Intense pain in butt, hip, knee, shin, & feet. These symptoms have not stopped. Pain keeps me up at night. Also feel somewhat weak! Still experiencing symptoms!
41 2021-03-25 insomnia Sharp headache, fever, chills, exhaustion, sleeplessness, mild dizziness, pain at injection site tha... Read more
Sharp headache, fever, chills, exhaustion, sleeplessness, mild dizziness, pain at injection site that increases with time
41 2021-03-27 sleep disorder Chills, headache, muscle ache, neck pain, started 12 hours after injection. It got worse through out... Read more
Chills, headache, muscle ache, neck pain, started 12 hours after injection. It got worse through out the day, could not sleep. Took tylenol, which helped with the pains. Headache came back, chills went away, injections site hurt worse with 22 hours.
41 2021-04-02 depression, suicidal thoughts Headache one hour after Dry mouth and metal taste right after Fever the next day Severe depression ... Read more
Headache one hour after Dry mouth and metal taste right after Fever the next day Severe depression with suicidal thoughts starting the next day and continuing to present Itchy started a few hours after especially on hands Upset stomach a few hours after
41 2021-04-02 hallucination Work up with fever over 104°, hallucinations and talking out of my head, right eye swollen shut, he... Read more
Work up with fever over 104°, hallucinations and talking out of my head, right eye swollen shut, headaches, body aches, chest pain, cough
41 2021-04-02 nervousness Patient began feeling dizzy, lightheaded, nauseated, shaky, tingling in legs, arms, face, and throat... Read more
Patient began feeling dizzy, lightheaded, nauseated, shaky, tingling in legs, arms, face, and throat. With history of panic attacks we observed closely. After 25 minutes, and symptoms getting worse, we decided it was best to administer epi-pen and called 911. Symptoms got a bit better after a minute. After about 7 minutes another epi-pen was administered as symptoms were starting to get worse again.
41 2021-04-03 nervousness PATIENT STATED HAVING HISTORY OF FAINTING. UPON ASKING, PATIENT STATED FAINTING ON THE SIGHT OF BLO... Read more
PATIENT STATED HAVING HISTORY OF FAINTING. UPON ASKING, PATIENT STATED FAINTING ON THE SIGHT OF BLOOD, AND SHE WAS NERVOUS. WITHIN 5 MINUTES OF THE VACCITATION, PATIENT WAS SHAKING AND WARM/ SWEATING. SHE WAS BREATHING WAS NORMAL. PATIENT SAT DOWN IN A CHAIR, WE GAVE HER SOME WATER AND AN ICE PACK. PATIENT THEN DECIDED TO LAY DOWN AFTER 5 MINUTES. HER HUSBAND WAS CALLED, SHE STARTED FEELING BETTER. SHE STAYED SITTING/LAYING DOWN FOR AT LEAST 30 MINUTES. PATIENTS HUSBAND TOOK HER HOME.
41 2021-04-04 insomnia, feeling abnormal Day 1: Ten hours later: exhaustion, body ache, fatigue without being able to sleep, diarrhea, headac... Read more
Day 1: Ten hours later: exhaustion, body ache, fatigue without being able to sleep, diarrhea, headache Day 2: Extreme body ached and headache Day 3: spaciness and exhaustion Day 4: Joint cracking with movement Day 5: Mild/nothing Day 6: Fever and chills
41 2021-04-04 insomnia Headache Fever Chills Insomnia Joint soreness
41 2021-04-05 feeling abnormal Immediately felt a sense of being off followed by brain fog, headache, and fatigue which last for a... Read more
Immediately felt a sense of being off followed by brain fog, headache, and fatigue which last for approximately 5 hours. Then 9 hours after injection, onset of uncontrollable chills for 1 hour then a fever for approximately 4-6 hours. All adverse events were gone within 24 hours of injection.
41 2021-04-05 loss of personal independence in daily activities, impaired work ability Vertigo and continuous nausea since Thursday, April 1, I have taken antivert 25 mg but it still per... Read more
Vertigo and continuous nausea since Thursday, April 1, I have taken antivert 25 mg but it still persists impeding me from working and doing the daily routine
41 2021-04-07 depressed mood Headache - severe Tinnitus Diarrhea Fever 102 Joint pain - hips Muscle pain - whole body Shaking Ch... Read more
Headache - severe Tinnitus Diarrhea Fever 102 Joint pain - hips Muscle pain - whole body Shaking Chills Feeling of dread/hopelessness
41 2021-04-09 feeling abnormal, memory impairment, sleep disorder, loss of personal independence in daily activities *Fatigue: Starting around 7pm, I started feeling tired at the time of day when I am most awake. I ... Read more
*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
41 2021-04-10 anxiety, panic attack gave pt janssen covid vaccine.She was anxious to begin with. She went to sit down after vaccination ... Read more
gave pt janssen covid vaccine.She was anxious to begin with. She went to sit down after vaccination and was doing fine. I checked in with her 5 minutes into her wait and she said she was fine. Then she complained she was dizzy. I asked her if she had eaten yet (1230pm) and she said no. I had her sit down and drink some orange juice. She then said she wanted to lay down, so I took her back into the booth and she stretched out over a few chairs and boosted her legs up. She said her hands and arms were getting tingly and she started to panic. I took her phone and dialed her husband who was outside and told him to come in. She asked me to call 911, I did. I applied an ice pack to her forehead neck and shoulder areas and she said she was feeling better. I gave her another juice bottle an verified any meds she was on. She wasnt taking any meds. I called mngt also to take a statement. her husband came in and told her to calm down she was just anxious and didnt eat. When the paramedics finally showed up she was feeling much better. they took her out the the ambulance to check her over. They asked her if she wanted to go to the hospital, and she said no. I will call her later to check in on her.
41 2021-04-11 anxiety Patient with self-reported history of anxiety, syncope and near syncope with medical procedures/need... Read more
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.
41 2021-04-11 feeling abnormal 4/7/21 @ around 2:00 pm - dizziness, headache, "tunnel vision" and felt faint. I drank water, stopp... Read more
4/7/21 @ around 2:00 pm - dizziness, headache, "tunnel vision" and felt faint. I drank water, stopped activity (walking) and rested. It passed within about 30 mins. These dizzy spells have reoccured 4 times since then. 4/8/21 @ 2:15 am - fever of 101.8, chills, muscle spasms, extreme muscle aches all over body esp in back and legs, **unable to use my hands freely. My hands became very ridged and I could not open or close them well. I could not hold a glass of water to take a Tylenol. I finally did take a Benedryl and a 500 mg Tylenol. These symptoms lasted until around 5:00 am when I dozed back off. I woke at 7:00 am feeling tired and had a bad headache. My back and legs were still aching but were much better. 4/8/21 all-day - fatigue, bouts of dizziness, and nausea. 4/8/21 @9:00pm - diarrhea for about 4 hours. Stomach pain. 4/9/21 @ around 3:00 dizziness that last about 30 mins 4/10/21 throughout the day - diarrhea and stomach pain 4/11/21 - tired and headache persists. I started to feel more normal. 4/12/21- headache still there. Won't go away. I feel "foggy" and unable to think about things as I normally do. I returned to work today and still feel "yucky". I feel as though I'm recovering from the flu.
41 2021-04-11 loss of personal independence in daily activities, sleep disorder 36 hrs after injection (~9pm Thursday night): fast heartbeat, unable to relax, up all night with fas... Read more
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.
41 2021-04-12 crying, feeling abnormal P/C from patient. States she took the vaccine on 4/1/21 @ 1:30 PM. When she heard of the issues that... Read more
P/C from patient. States she took the vaccine on 4/1/21 @ 1:30 PM. When she heard of the issues that were in the news about the vaccine she thought she should call. 4/1/21 Thursday: That evening around 6 PM she started to have a rash. It started on her L arm where she got her vaccination traveled up her neck, covered her face and trunk. It started out as an itchy red rash but became raised hives. It resolved on it's own and on Saturday she did not have the rash anymore. Never had any difficulty with breathing. Her left arm where she received her vaccination still has some discoloration. States on Thursday evening she started having a "brain fog". 4/2/21 Friday: The next morning she woke up and was unable to finish a sentence, states she was confused, "felt like I was on pain medication, like I was drugged". States she was confused, could not think and could not remember anything. Cried all day over nothing. Would tell her daughter something and then immediately ask what did I just say as she couldn't remember what she said. She was working on the graduation hooding ceremony and scribbled all over her papers like a 3 year old and the papers were strewn all over the floor. She reports that she had a mild headache all over her head dull pain and pressure 4/10. Took tylenol but that didn't help at all. Denies having any visual problems, trouble breathing or chest pain. Did have some abdominal dull cramping with nausea and even though it felt like she was going to have diarrhea there was no diarrhea or vomiting . The abdominal pain went away after friday but the nausea stayed through Sunday.She states she got lightheaded if she stood up too fast or turned her head too fast. This just happened on Friday. Denies having any weakness, lack of coordination, or speech issues. She states she was crying and could not stop all day on Friday. She told her boss she was having a mental breakdown and had to go home. 4/3/21 Saturday: Patient states she felt stupid, could not think, could not remember anything she said. States that the horrible headache came on Saturday. It was so bad she had to lay down in a dark room with a wet washcloth over her eyes. The horrible headache.lasted about 1 hour at a 10/10 level. Took some more tylenol but does not think it helped. Went to sleep and when she woke up the headache was still there at a rete of 4/10. She was still nauseate but the crying had resolved. 4/4/21 Sunday: Again, had a severe migraine when she woke up. 7/10, not as bad as the one on Saturday. It lasted a couple of hours and then went back to the 4/10 headache that has persisted at the 3-4/10 level the entire time since she got her vaccination. The headache never stops hurting and stays 3-4/10. 4/5/21 Monday: Had a regular headache 3-4/10. Still felt "loopy" and with brain fog. Went to work on Monday and told her boss about it and that she still says she can't think straight. Her boss has been very supportive and has helped her to complete her assignments to get them in on time. 4/6/21 Tuesday: Still had a headache, It has been continuous ever since Friday. Still taking Tylenol and it doesn't seem to help. Yesterday she even tried Ibuprofen and it didn't help. 4/13/21 Today is day 13 and she still can't think straight. still has 3-4/10 headache, still all over her head. Feels that she still has brain fog, but not as "loopy". Feels like she can remember what she has said better. She called the nurse line at her husband's work.They told her that it was just a reaction to the vaccine. The patient didn't think to report it to the Health Center. She got the vaccine from the Health Center (she asked if employees could get the vaccine and said she would prefer that) She is not pregnant. She has no chronic health conditions and takes no medications routinely She denies being allergic to any medications and states she has taken the Flu shot without any reaction in the past. NOTE: Tested positive for COVID on 2/4/21 and was told it was OK to get the vaccine. She lost her taste and smell and said she felt she had a mild flu for a couple of days. Has regained her sense of taste and smell and has had no residual symptoms. Instructed patient to go to the ER for an exam. She needs a full neuro exam and at least a C_T scan of the head. She would like to contact her Primary Care Provider. States she hasn't seen him for a couple of years but feels like he would want to know. Instructed patient to call me with the outcome of her visit to her PCP or the ER. Patient verbalized understanding of and agreement with plan. Signed by: APRN-CNP on Apr-13-2021 at 04:04 PM Locked by: APRN-CNP on Apr-13-2021 at 04:04 PM
41 2021-04-12 crying, sleep disorder, feeling abnormal, impaired work ability With prior vaccines and flu shots, I have either had no side effects or mild. But with the COVID va... Read more
With prior vaccines and flu shots, I have either had no side effects or mild. But with the COVID vaccine, I was sicker than sick! I wasn't expecting to miss as much work as I did, nor go to the doctor three times in a week's time. I received it around 11:30am on Thursday, March 18. Around 1pm, my mild headache started to intensify and had ringing in my ears that would repeatedly come and go (still is doing so today, just not as frequent). Around 4pm is when all of the "normal" side effects started?chills, hot flashes, sore arm, and super sleepy. I woke up a couple hours later, with a headache that was WAY worse and was super nauseous. This was close to 10pm. Then, around 11pm that same night, I developed HORRID shooting ear pains and took my first Tylenol. The ear/jaw pain was more than I could stand - had it in both ears, but the right ear was more intense. It felt like I had a lighting rod between both ears and had these intense "zings" that kept going back and forth, like they were playing ping-pong. The painful "zings" reminded me of those felt during an ear infection but WAY MORE INTENSE. My jaw was super tight, as well, with a horribly intense headache. I spent the entire night night doing warm compresses on my ears, taking Tylenol every 4-6 hours, staying in the shower, and lots of crying. It was so bad that I felt the need to go to the ER but didn't feel comfortable driving and didn't want to go the ambulance route?and thought it was pointless because going to the ER for ear pain would leave me there for hours and hours since I didn't feel it would be viewed an an urgent emergency. My goal was to make it through the night and see if I could get into my PCP doctor the following morning. I took another Tylenol around 5am, and I thankfully cried myself to sleep for a couple of hours. When I woke up, I called my PCP but couldn't get in, so I did an online doctor visit through my insurance company. My fever was about 103.06 at its highest during the night but was gone by 3:34pm Friday afternoon (assuming because I was taking more Tylenol than I had been post-online doctor's appointment). Around 7pm Friday evening, I knew I needed to go to the ER or urgent care. I got a ride and was taken to urgent care for my intense ear pain. They gave me a Toradol injection and Tramadol prescription. By bedtime Friday night, the injection was doing its job and made the ear pain and zings were much less intense (didn't get the prescription until a couple days later). On March 20, Saturday night, is when I developed a red, itchy rash on my back and tummy. Over the next couple of days, it was on my chest, arms, legs?pretty much come and was in various places. I called my PCP Monday morning (March 22), left a message, and they called me back to tell me to restart taking my Zyrtec/HCL to see if it would help the itching. It has and am just mildly breaking out at this time. The stinkin' ear/jaw pain returned on Tuesday the 23rd, so I loaded up on OTC ear drops and made an appointment with my PCP for Wednesday, March 24. She saw no ear infection and essentially told me to keep taking the pain meds. I received the vaccine on March 18 and did not return to work until the following Thursday. In retrospect, I should have just missed the remainder of that week, too.
41 2021-04-12 feeling abnormal, amnesia Severe headache (stabbing pain right temple) caused body to sweat from pain night sweats severe join... Read more
Severe headache (stabbing pain right temple) caused body to sweat from pain night sweats severe joint aches and pain brain fog memory loss dizzy weak vision impairment tiredness fatigue nausea severe rib pain (left side) - hard to breath with it
41 2021-04-12 feeling abnormal, disorientation 3 hours after shot I became dizzy & disoriented...my hands very shaking & heart rate & blood pressur... Read more
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.
41 2021-04-12 feeling abnormal, emotional distress, loss of personal independence in daily activities Rash/Hives starting the evening of the vaccine. The next morning severe brain fog to the point of no... Read more
Rash/Hives starting the evening of the vaccine. The next morning severe brain fog to the point of not being able to complete any daily task, uncontrollable emotional and mental melt down, severe headache, feeling of being highly medicated, nausea, and stomach cramps. All of the sever symptoms lasted for 3 days after the vaccine. It has been 13 days now and the brain fog is still present, unable to focus on work tasks, and daily headache are still present.
41 2021-04-12 feeling abnormal Day 1- out of it, lightheaded Day 2-4 flu-like symptoms, temperature regulation issues, upset stomac... Read more
Day 1- out of it, lightheaded Day 2-4 flu-like symptoms, temperature regulation issues, upset stomach Day 2-6 skin flushed, facial skin extremely dry and patchy/scaly- eventually went away Day 2-6 easy bruising- mostly on legs; small fingerprint sized bruises- common for me
41 2021-04-12 feeling abnormal Vaccine was administered and two minutes later patient reported to feel "weird." She kneeled over an... Read more
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.
41 2021-04-12 loss of personal independence in daily activities Extreme nerve pain in hands and arms. (Neuropathy) This pain is debilitating at times. The pain caus... Read more
Extreme nerve pain in hands and arms. (Neuropathy) This pain is debilitating at times. The pain causes me to be unable to perform daily tasks. The pain dissipates at times and then comes back. Tingling and pain around spine.
41 2021-04-12 memory impairment, confusional state About 25 minutes after receiving the vaccine, I felt numbness and tingling on the right side of my f... Read more
About 25 minutes after receiving the vaccine, I felt numbness and tingling on the right side of my face. This subsided about an hour later. That was one week ago and I'm feeling a little numbness and tingling again in the same part of my face. I've also had some bouts of forgetfulness and confusion. Starting at roughly 11 pm on the same day as receiving the vaccine, I endured common symptoms of fever, severe chills, and body aches. I felt terrible but I knew these side effects were to be expected. I'd say they were in the range of moderate-severe. The symptoms all subsided the following day around 5 pm.
41 2021-04-12 restlessness, sleep disorder, anxiety, insomnia When I first got the shot I noticed it in my throat. I told the nurses they had me wait 20 minutes b... Read more
When I first got the shot I noticed it in my throat. I told the nurses they had me wait 20 minutes before I could leave. I felt dizzy but not dizzy enough to not go home. It felt like it went to my stomach, then my head, and then I could feel it in my joints. I drove home from the city. Two hours pass, I notice a rash but I didn't think anything of it due to indoor allergens, springtime plus it went away within an hour. I started to get chills and fever. I had a lack of sleep due to pain throughout the first night. I was waking up feeling like my head was on fire from my ears to the top of the skull area and in front of my face by my eyes too. My eyes felt like they were going to burst. I layed in bed for 24 hours. Day two: pain, tiredness, headache, and sensitivity to light for the next few days. Symptoms come and go for days then wean off. Next, I had issues with anxiety, sleeping, yet being really tired as well coupled with problems sitting still. These are subsiding but still there. I am still very tired today and a bit anxious on April 13th, 2021. I also notice my typing skills, as well as testing skills, are not as sharp as before the vaccination.
41 2021-04-12 restlessness The day of and the following day, flu like symptoms- fever (102 at highest) chills, sweats, headache... Read more
The day of and the following day, flu like symptoms- fever (102 at highest) chills, sweats, headache, fatigue, restlessness (had to sit and sway at night because my body could not stay still. loss of apatite, nausea, injection site pain. tightness in head, upper back/shoulder and neck on the side of the injection (left). Everything but the soreness of the injection site and tightness in the muscles on that side lasted about 48 hours. The tight muscles and soreness lasted about a week. *** THREE WEEKS AFTER THE SHOT**** Sunday, 4/12/2021 I woke up and stepped out of bed and my left ankle gave out when I stepped down. Internal rotation, weakness in left ankle. It happened again as I walked shortly after. That day I tripped many times due to weakness in that ankle. When I showered and shaved my legs I realized that I had absolutely no feeling in the left lateral part of my lower leg. It felt like I had a novocaine injection in my leg. I could not even feel a pin prick there. By Friday 4/9/2021 I started to have some sensation, but still decreased sensation and weakness in my left ankle even at this moment. ****4 WEEKS AFTER THE SHOT**** My period started Monday, April 5th, 2 days early. By Friday, 4/9/2021 and through the day and night Saturday 4/10/2021, I had such a heavy period that I kept soaking through tampons, pads, and 2 pairs of jeans. I have never blead like that and could not keep up.
41 2021-04-12 sleep disorder The same day of vaccine I was sore and having body aches. The next day I woke up at 2:00 am with a b... Read more
The same day of vaccine I was sore and having body aches. The next day I woke up at 2:00 am with a bad headache took a Motrin and went back to sleep. Woke up the a few hours later and went to work and headache came back so I kept taking Motrin until I got off. When I got home I was tired and my headache came back so I went to lay down because I was cold as well. I went to bed and woke up really cold and my husband came in to check on me and I was running a fever of 101.5. My body was hurting really bad as well I took another Motrin and went back to sleep. I woke up the next morning a little weak with a fever blister. I was still sore and has a headache as well. I took some more Motrin all day and the pain went away. I didn?t report to any doctor because I thought this may be normal.
41 2021-04-12 thinking abnormal Day of post-vaccination, my shot area bled. No pain, no initial adverse reaction. Second day when ... Read more
Day of post-vaccination, my shot area bled. No pain, no initial adverse reaction. Second day when I woke up at 5:00am, my arms was swollen, I was in pain for 2 weeks, no fever, I was not in my right sense of mind and I was bruised up on the shot area for 3 weeks. Ice pack, Tylenol and massaging my arm with CBD lotion helped me.
41 2021-04-13 feeling abnormal Initially after injection I had dizziness and slight mental fog. Four days later my lumph nodes in ... Read more
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.
41 2021-04-14 memory impairment Dx: Acute DVT of the left posterior tibial vein (distal to popliteal) shown on US, opted for repeat ... Read more
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
41 2021-04-14 mental impairment Extreme exhaustion, unable to think clearly, in a dream like state, body ache, muscle weakness and t... Read more
Extreme exhaustion, unable to think clearly, in a dream like state, body ache, muscle weakness and twitching, fever, nausea, vomiting
41 2021-04-15 insomnia, disorientation HEADACHE ELEVATED TO MIGRAINE; SEVERE BODY ACHES; SEVERE FATIGUE; HEADACHE; NAUSEA; FEVER; BONE ACHE... Read more
HEADACHE ELEVATED TO MIGRAINE; SEVERE BODY ACHES; SEVERE FATIGUE; HEADACHE; NAUSEA; FEVER; BONE ACHE IN LOW BACK, HIPS,BONES CONNECTING SPINE; FEELING DISORIENTED; NIGHT SWEAT; DIZZINESS AND LIGHT HEADED; LOSS OF APPETITE; UNABLE TO SLEEP; 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 covid infection. 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 10-APR-2021 12:21 for prophylactic vaccination. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) unknown. On APR-2021, the subject experienced unable to sleep. On 10-APR-2021, the subject experienced feeling disoriented. On 10-APR-2021, the subject experienced night sweat. On 10-APR-2021, the subject experienced bone ache in low back, hips, bones connecting spine. On 10-APR-2021, the subject experienced dizziness and light headed. On 10-APR-2021, the subject experienced loss of appetite. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. On 10-APR-2021 15:21, the subject experienced severe fatigue. On 10-APR-2021 16:21, the subject experienced severe body aches. On 10-APR-2021 17:21, the subject experienced headache elevated to migraine. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive, positive, positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to sleep, feeling disoriented, night sweat, headache elevated to migraine, severe body aches, loss of appetite, headache, and fever, and bone ache in low back, hips, bones connecting spine on 12-APR-2021, and had not recovered from severe fatigue, dizziness and light headed, and nausea. This report was non-serious.
41 2021-04-18 feeling abnormal BRAIN FOG; MIGRAINE; TIRED; NAUSEA; TINGLING IN HANDS; NUMBNESS IN HANDS; ARM HURT; VERY SHARP STABB... Read more
BRAIN FOG; MIGRAINE; TIRED; NAUSEA; TINGLING IN HANDS; NUMBNESS IN HANDS; ARM HURT; VERY SHARP STABBING PAIN IN RIGHT SHOULDER; FEVER >103; This spontaneous report received from a patient concerned a 41 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced tingling in hands. On 25-MAR-2021, the subject experienced numbness in hands. On 25-MAR-2021, the subject experienced arm hurt. On 25-MAR-2021, the subject experienced very sharp stabbing pain in right shoulder. On 25-MAR-2021, the subject experienced fever >103. On 25-MAR-2021, the subject experienced nausea. On 26-MAR-2021, the subject experienced migraine. On 26-MAR-2021, the subject experienced brain fog. On 26-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt, and nausea on 25-MAR-2021, and fever >103 on 28-MAR-2021, and was recovering from numbness in hands, migraine, brain fog, tired, very sharp stabbing pain in right shoulder, and tingling in hands. This report was non-serious. This case is associated with PQC number: 90000175693.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
41 2021-04-18 impaired work ability Patient complains of swollen and painful arm - stated that immunizer "hit a nerve". She stated she w... Read more
Patient complains of swollen and painful arm - stated that immunizer "hit a nerve". She stated she was unable to work for the 3 days after. Patient went to the walk in clinic 5 days after immunization and was prescribed cyclobenzaprine.
41 2021-04-19 feeling abnormal Night sweats, muscle aches, headache, fatigue, dizziness, lighted headed, brain fog all began less t... Read more
Night sweats, muscle aches, headache, fatigue, dizziness, lighted headed, brain fog all began less than 24 hours after vaccination. Period cycle started early and was very intense cramps, heavy bleeding, vomiting. To date, the headache, dizziness, light headed, brain fog and fatigue are still being experienced 13 days after being vaccinated. I called a nurse line on 4/16/2021 to talk over my side effects and was told to visit an urgent care center, who then sent me to the ER for bloodwork and an MRI of the brain. Was told all results came back normal, to continue to monitor myself and make an appointment with a primary care physician if I feel the same in week.
41 2021-04-19 feeling abnormal Patient presented for J&J Covid-19 Vaccination. Reported feeling anxious in anticipation of vaccinat... Read more
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.
41 2021-04-19 memory impairment PRESSURE ON CHEST; FORGETFUL; FEELING HEAT GOING THROUGH BODY; THROAT BEGAN TO CLOSE; DIZZINESS; TIN... Read more
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.
41 2021-04-20 feeling abnormal, sleep disorder About 9 pm I felt fatigue, I went to bed. I took 800 mg of ibuprofen and 1000 mg Tylenol as a pain m... Read more
About 9 pm I felt fatigue, I went to bed. I took 800 mg of ibuprofen and 1000 mg Tylenol as a pain medication. I drank a bunch of water and took an Emergen-C. I fell asleep by 10:00. I slept and I woke up - shocked awake around 04:30 am - I was super thirsty. My whole body was really sore and stiff and I had a headache. It was uncomfortable but not unmanageable. I decided to take more Tylenol and Ibuprofen and drink more water again. I got back in bed and was feeling a lot of symptoms - I was really sore in my thigh muscles, lower back, knees and forearms. I had slight chills; I was pretty uncomfortable. I couldn't get back to sleep - I couldn't sleep on my arm with the injection site. This was about 5 pm. I never actually had a fever. But just a lot of fatigue and body aches. For the next day or two - I took 800 mg of ibuprofen and 1000 mg Tylenol every 6 hours. Within 48 hours, the body aches started to subside. I still felt a bit fatigued and I still do feel fatigued to this day. Into the next week, I started feeling like (towards the middle of the week - about the 7th) I was having an urinary urgency feeling. It was a sensation in my lower back like a UTI was coming on. I haven't gotten one in a long time ( I use to). On Friday or Saturday, when I wiped, I was seeing a slight pinkish hue - a trace of blood - in my urine. Decided to take probiotics and Vit C. and I started to feel better. But Sunday morning, I was back to feeling pretty bad. I visited the Urgent Care on Sunday, the 11th. In the visit, they took a urine specimen. Dr. saw blood in my urine from the test. And an absence of nitrates in the urine and she said it wasn't a typical UTI. They decided to culture the urine specimen. Macrobid - 2 times a day for 7 days - antibiotics was prescribed. I felt a little better the second day of taking it, I thought, but it was up and down. Culture showed there was no UTI. Friday, the 16th, I had my annual visit with my PCP, I was feeling okay by this time. But I still had a sensation in my lower back - not a pain but a sensation and I still feel this sensation now (on my left side). She asked me to come back after the antibiotics to take another urine sample. Lab test. I feel some fatigue but I'm doing normal daily life.
41 2021-04-20 feeling abnormal 4/10 - sore arm, no other symptoms 4/11 - headache 8/10, brain fog, nausea, dizziness, 7/10 neck and... Read more
4/10 - sore arm, no other symptoms 4/11 - headache 8/10, brain fog, nausea, dizziness, 7/10 neck and back pain, 8/10 exhaustion 4/12-4/17 - low grade headache 3-4/10 4/19 - 8/10 headache, 8/10 exhaustion, extreme weakness on right-side, rapid onset of stroke-like symptoms (Est 815am) to right side (face droop with impaired slurred slow speech, right arm, right leg immobility) facial symptoms resolved quickly (less than 1 minute), complete speech impairment lasting 2-3 minutes, partial speech impairment sustaining through to mid-day, complete right side weakness lasting 3-5 minutes before total resolve and intermittent R-side weakness after transport to hospital. Arrived at Emergency department about 930/10am, most symptoms subsided by time of admission - slowed speech persisted to mid-day. Discharged at 4pm to home. 4/19 - 6/10 exhaustion through most of the day 4/20-4-21 unusually high level of energy 4/21 - back pain and low grade headache return 3/10 4/22 - back pain more intense 4/10, intermittent headache 3/10 - report to CDC 4/26 - scheduled follow up appointment with Neurology
41 2021-04-20 feeling abnormal 48 hours of fever, chills, malaise, headache Followed by constant dizziness, acute joint pain (knees... Read more
48 hours of fever, chills, malaise, headache Followed by constant dizziness, acute joint pain (knees, ankles, shoulders, and hands), brain fog, fatigue, intermittent headaches, pain in calves, backache, and locking/swollen hands - for ~8 straight days.
41 2021-04-20 insomnia neuropathy on bottom of feet. I felt an intense heat and pins/needles sensation on the bottom of my ... Read more
neuropathy on bottom of feet. I felt an intense heat and pins/needles sensation on the bottom of my feet for hours on the night of my vaccine. I couldn't sleep from the pain and heat.
41 2021-04-20 insomnia COULDN'T SLEEP AT NIGHT; ACHES; CHILLS; FEVER; IRREGULAR HEART BEAT; This spontaneous report receive... Read more
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.
41 2021-04-20 sleep disorder I woke up in the middle of the night with extreme abdominal pain, cramping, cold sweats, diarrhea. ... Read more
I woke up in the middle of the night with extreme abdominal pain, cramping, cold sweats, diarrhea. I thought it would pass but the next day things did not get any bettor so I went to the emergency room in the afternoon. Several hours and tests later I was sent home with colitis diagnosis a 10 day course of antibiotics. I still have the occasional discomfort but am feeling much better.
41 2021-04-27 sleep disorder Patient reports waking up in the early morning hours with pain in center of chest and between should... Read more
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.
41 2021-04-28 feeling abnormal Next day full body red rash, 103-104 degree fever, deep body aches, skin sensitivity, joint pain, he... Read more
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
41 2021-05-01 sleep disorder, restlessness immediately after the injection the injection site was sore. The injection site still remains sore 3... Read more
immediately after the injection the injection site was sore. The injection site still remains sore 3.5 days later. Approximately 7 hours after the injection (6:45pm), physical exhaustion set in; mental state was wide awake (thinking about everything/mind racing), however. Approximately 1 hour after the exhaustion began, slight fever and chills started. By 9 pm the fever and chills increased to the point of teeth chattering and touch to the body felt raw. Throughout the night, the fever and chills continued. Sleep was mixed with pain in the legs and restlessness, coupled with a mild headache. In the morning, the headache increased, but the chills subsided and the fever had broken (8am); slight nausea. Eating food seemed to keep the nausea at bay; body exhaustion still existed. headache subsided by the evening. no further chills/fever symptoms. 1.5 days for major adverse symptoms. Soreness at injection is still continuing (no discoloration or lump, just soreness). no vomiting, diarrhea, migraine perhaps related, but not sure...my right leg had a broken fibula a month prior, but was ~98% healed. The evening of the injection, that ankle was swollen to the size when the injury first occurred. Earlier that day, the ankle had no visible signs of injury (no swelling, discoloration, etc). In the morning, the ankle appeared as it had the day/week before.
41 2021-05-03 sleep disorder the night of 4/30/21 started to get a slight fever of 100.5. at 2:00am on 5/1/21 i woke straight up ... Read more
the night of 4/30/21 started to get a slight fever of 100.5. at 2:00am on 5/1/21 i woke straight up with bodyaches, fever of 102.8, headache, nausea, vomited x 3 times, SOB, diarrhea, chills which all lasted till sunday 5/2/21. on 5/2/21 the area of the injection started to itchy, be painful and the become red and swollen with heat, the injection site to this day on 5/4/21 the redness of the site getting bigger and itching and painful more and going up my left shoulder area.
41 2021-05-09 impaired work ability Patient stated on the phone today she has body aches, flu like symptoms, and arm soreness. She had t... Read more
Patient stated on the phone today she has body aches, flu like symptoms, and arm soreness. She had to call out of work today. Sunday was the worst day, now shes feeling better. She received the Janssen covid-19 vaccine
41 2021-05-13 feeling abnormal Dizziness, mildly blurred vision when reading print, "brain fog"
41 2021-05-14 feeling abnormal I developed a headache within about an hour and that has continued for almost two days off and on. O... Read more
I developed a headache within about an hour and that has continued for almost two days off and on. On the second day I developed a fever. I have also experienced lightheartedness and dizziness.
41 2021-05-16 loss of personal independence in daily activities Ear infection Throat infection Nausea/vomiting Fatigue Diarrhea Then after antibiotics and Mucinex ... Read more
Ear infection Throat infection Nausea/vomiting Fatigue Diarrhea Then after antibiotics and Mucinex treatment with no improvements Severe headache sent me to ER with no findings other then doctors are thinking it is Viral meningitis that could be causing it. I am still having headache nausea and diarrhea and Almost passed out yesterday from cooking My activities are very light or I pass out.
41 2021-05-19 feeling abnormal Long-term (6 weeks) dizziness, brain fog, headaches
41 2021-05-19 feeling abnormal I woke up 6 hours after vaccination and started getting the chills with a fever of 101.3. I took som... Read more
I woke up 6 hours after vaccination and started getting the chills with a fever of 101.3. I took some Tylenol which brought the fever down for a few hours but it later shot back up to 104. I had a headache, muscle pain, and fatigue. On Monday, I got a sharp pain on the side of my head causing my eyes to hurt. I called doctor who said that it sounded like a sinus infection and prescribed me Azithromycin. Days later the doctor called me and I told him that I wasn't feeling better and was referred to take a Doppler test which showed nothing wrong. I went to another doctor that prescribed me Bactrim which cleared up my sinus infection and I felt a little better. I still feel fatigued, have brain fog, and double vision. I went to a neurologist and was given a CT scan. That was two weeks ago and I never heard about the results. I'm scared to drive because I don't know what will happen. The vaccine also threw off my cycle and I have gained so much weight since my vaccination.
41 2021-05-21 impaired work ability patient received the J&J vaccine at 9 am and was monitored for 15 minutes. She is a store associate.... Read more
patient received the J&J vaccine at 9 am and was monitored for 15 minutes. She is a store associate. Patient returned to work. At 1:30 patient was moving a lot of items from the pallet shipper. Patient felt dizzy and reported that she may need to faint. Patient was monitored by the pharmacist. She was counseled to drink water. We took blood pressure at 129/85 and 133/80. Patient was alert and oriented. Patient was sent home to rest. Follow up counsel on 05/26/2021
41 2021-05-21 insomnia UNCOMFORTABLE; FATIGUE; TOTAL BODY ACHES; CAN'T SLEEP; DIZZY; UNWELL; CHILLS; LEFT ARM IS SORE AT IN... Read more
UNCOMFORTABLE; FATIGUE; TOTAL BODY ACHES; CAN'T SLEEP; DIZZY; UNWELL; CHILLS; LEFT ARM IS SORE AT INJECTION SITE; WEAK; FELT NAUSEOUS; 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 pineapple allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 19-MAY-2021, the subject experienced total body aches. On 19-MAY-2021, the subject experienced can't sleep. On 19-MAY-2021, the subject experienced dizzy. On 19-MAY-2021, the subject experienced unwell. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced left arm is sore at injection site. On 19-MAY-2021, the subject experienced weak. On 19-MAY-2021, the subject experienced nausea. On 20-MAY-2021, the subject experienced uncomfortable. On 20-MAY-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unwell, dizzy, nausea, can't sleep, chills, uncomfortable, left arm is sore at injection site, total body aches, weak, and fatigue. This report was non-serious.
41 2021-05-23 feeling abnormal I had severe joint pain, headache, nausea, and extreme fatigue. And symptoms that went on for a mont... Read more
I had severe joint pain, headache, nausea, and extreme fatigue. And symptoms that went on for a month were dizziness and brain fog.
41 2021-05-31 anxiety, depression Patient presents with ? SUICIDAL pt intoxicated and tried to hang herself on the shower curtain ... Read more
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
41 2021-05-31 fear Istated having a pain in the neck later that evening and I started getting headaches, so I went to t... Read more
Istated having a pain in the neck later that evening and I started getting headaches, so I went to the doctor 2 weeks later. I normally don't get headaches and I still have them a lot. I was very scared so I went to the doctor.
41 2021-05-31 sleep disorder Started with vomiting , which was severe and very sudden Fever started and was really tired and coul... Read more
Started with vomiting , which was severe and very sudden Fever started and was really tired and couldn't sleep had chills and muscle spasm everywhere very severe leg muscle spasm are worse in right leg. Next morning the muscle spasms stopped in right leg and then left leg started hurting really bad became more severe thorough out the day Couldn't walk Pain in the left leg by hip started moving down her leg I noticed that behind my left knee was hurting Pain throughout entire body After a week hip and knee started feeling better Left calf feeling funny Went to doctor the second week Every since shot I have had muscle fatigue Pain in hand Taking Motrin around the clck.
41 2021-06-07 mental status changes Quick onset of flu like symptoms, progressed to altered mental state, unable to close her eyes. Una... Read more
Quick onset of flu like symptoms, progressed to altered mental state, unable to close her eyes. Unable to eat or drink. Her face was frozen with her open eyes fixed to the top of her head, jaw dropped. Unresponsive, unable to verbalize. I have cared for her over 15 years and have never seen anything like this . ER visit.
41 2021-06-10 anxiety I developed high blood pressure about a month after the vaccine...historically, my blood pressure ha... Read more
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.
41 2021-06-10 feeling abnormal About ten minutes after leaving the vaccination site, I began feeling a strange dizziness; an intern... Read more
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.
41 2021-06-20 feeling abnormal FREEZING COLD; HEAD WAS COLD LIKE ICE/SEEMED LIKE DYING; WHOLE BODY COULD NOT MOVE; SHAKING; SORE AR... Read more
FREEZING COLD; HEAD WAS COLD LIKE ICE/SEEMED LIKE DYING; WHOLE BODY COULD NOT MOVE; SHAKING; SORE ARM; NO ENERGY; This spontaneous report received from a patient concerned a 41 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 (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced no energy. On 18-APR-2021, the subject experienced freezing cold. On 18-APR-2021, the subject experienced head was cold like ice/seemed like dying. On 18-APR-2021, the subject experienced whole body could not move. On 18-APR-2021, the subject experienced shaking. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from freezing cold, head was cold like ice/seemed like dying, whole body could not move, and shaking, and the outcome of sore arm and no energy was not reported. This report was non-serious.
41 2021-06-23 nervousness Patient felt nervous/afraid Denied SOB, pain, dizziness patient had anxiety attack after vaccination... Read more
Patient felt nervous/afraid Denied SOB, pain, dizziness patient had anxiety attack after vaccination since childhood offered cold water and large breathing slowly
41 2021-07-01 sleep disorder Left arm and neck pain. Feels like a deep bone pain, wakes her up at night. Can't sleep on her side ... Read more
Left arm and neck pain. Feels like a deep bone pain, wakes her up at night. Can't sleep on her side because of the pain. Started after receiving the Johnson and Johnson vaccine.
41 2021-07-13 feeling abnormal On May 10th i started to feel dizzy while laying down with my son. Since then it has been weird he... Read more
On May 10th i started to feel dizzy while laying down with my son. Since then it has been weird head sensations (light headed, brain fog, feelings of me moving when I am not) combined with terrible sinue pressure and pain, sinus headaches and facial pain
41 2021-07-13 feeling abnormal NAUSEOUS; PULMONARY EMBOLISM; FELT LIKE TRYING TO GET SICK; FELT LIKE COMING DOWN WITH A COLD; This ... Read more
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.
41 2021-07-22 sleep disorder Vaccine given around 4:30 PM 07/22/2021 Started feeling achy, feverish, chills and headache around 8... Read more
Vaccine given around 4:30 PM 07/22/2021 Started feeling achy, feverish, chills and headache around 8:00 PM 07/22/2021 Went to bed around 11:30 PM tossed and turned waking every hour 07/22/2021 Temperature taken @ 3:45 AM was 101.9 and @ 5:30 AM was 102.1 07/23/2021 Called NP at 6:30 AM asking about taking Tylenol and Ibuprofen due to the pamphlet stating to check with health professional first . Was advised to alternate OTC Tylenol and Ibuprofen. 10:00 AM 07/23/2021 low grade fever, still achy and headache 7:00 PM 07/23/2021 feeling better just achy from laying around
42 2021-03-08 euphoric mood Dizziness Euphoria feeling Diarrhea Cold sweats Sore throat Injection site pain
42 2021-03-09 nervousness, confusional state Continued to have Dizziness Followed (15minutes later) Nervousness Confusion Overall body weakness... Read more
Continued to have Dizziness Followed (15minutes later) Nervousness Confusion Overall body weakness Continued to experience Sore throat with dehydration in my lips and mouth (happening more quickly than I thought possible) Water (16 ounces) did not reduce the dehydration Cold sweats all over (excessive moisture) Diarrhea did decrease quickly (within 2 hours of vaccine) Was released from work (United Supermarket Deli) at 7:00 pm Got home and immediately laying down Called the hospital Hospital said call the Pharmacy that administered the vaccine Pharmacy was already closed Fell asleep a while later feeling very exhausted
42 2021-03-11 feeling abnormal, impaired work ability, sleep disorder That night about the time I went to bed I started with cold chills and felt like I may be running a ... Read more
That night about the time I went to bed I started with cold chills and felt like I may be running a low fever. In the morning about 4 AM I could not sleep I achedall over and just felt generally unwell. I did run a low-grade fever and I could not work because of it.I was a bit foggy lightheaded dizzy at some points. It might be worth noting that I am a redhead and overall we are very sensitive.
42 2021-03-13 feeling abnormal, feeling drunk 3pm: Immediate body-wide, internal feeling that can only be described as "intoxication." Felt loopy ... Read more
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.
42 2021-03-14 abnormal dreams, insomnia About 7 hours after the vaccine injection I started to feel flu-like symptoms: aches, chills, woozy ... Read more
About 7 hours after the vaccine injection I started to feel flu-like symptoms: aches, chills, woozy and slightly nauseous. Within the next few hours the symptoms became increasingly worse, but not different other than the addition of a headache. I took 2 Tylenol to help with the headache and fever. Overnight sleep was difficult due to chills, sweats, fever dreams and aches. The symptoms lessened the next day (24-hours post injection), but still included muscle/body aches, headache, and extreme fatigue. Again took 2 Tylenol to help. Today (48-hours post injection) I'm feeling quite a bit better although still not 100%. Soreness at injection site persists, especially when lifting my arm.
42 2021-03-16 confusional state, feeling abnormal Chills 24 hours Body aches 24 hours, started 2 hours after vaccine Exhaustion/fatigue 60 hours, star... Read more
Chills 24 hours Body aches 24 hours, started 2 hours after vaccine Exhaustion/fatigue 60 hours, started 2 hours after vaccine Confusion/brain fog, feeling spaced out stated 2 hours after vaccine lasted 4 days Fever started at 9 pm, latex about 12 hours. Ten 101.5°
42 2021-03-17 feeling abnormal 2 nights of 103 fever, chills, extreme headache, dizziness, lethargy, brain fog (forgetting names of... Read more
2 nights of 103 fever, chills, extreme headache, dizziness, lethargy, brain fog (forgetting names of words, not knowing normal things), light headed ness,
42 2021-03-17 sleep disorder Ten hours later felt achey, then chills, and fever of 101-102 all night with SEVERE joint pain. I ha... Read more
Ten hours later felt achey, then chills, and fever of 101-102 all night with SEVERE joint pain. I have a herniated disc in my lower back and this was severely aggravated by the vaccine. My back and fingers hurt so bad I couldn?t sleep at all. Tried not to take Tylenol finally took some after 3-4 hours and it helped a lot with fever and joint pain. Also had a headache. Fever and pain was gone after 8 hours. Then felt very low energy with a headache all the second day. Third day I felt great except are sore.
42 2021-03-19 sensation of foreign body Sore throat, feeling as if lump in throat, difficulty swallowing
42 2021-03-21 insomnia Day of Vaccination: Headache started approximately 4:30PM Fatigue and feeling cold began around 5:3... Read more
Day of Vaccination: Headache started approximately 4:30PM Fatigue and feeling cold began around 5:30PM Chills began around 8PM continued through the night, difficulty sleeping and muscle pain/myalgia began Day after Vaccination: Muscle pain/myalgia, headache and fatigue noted as continued through the following day Following Days: Fatigue noted through today
42 2021-03-21 panic reaction Client has previous allergies to cows milk and aloe. Reported her face was hot and swelling after v... Read more
Client has previous allergies to cows milk and aloe. Reported her face was hot and swelling after vaccine. Family member in car with client confirmed her face was swollen as not visible initially. Client tearful and panicked. Reclined in car seat and Dr and Epi Pen called for. Dr spoke with client and examined the swelling, stating her Uvula was swollen. He administered an epi pen to left thigh muscle. 0.3ml . Blood pressure was 135/75 with pulse of 82 RR22 and oxygen saturation of 100%. EMS on site. Epi pen was administered on 12.10 pm. Client responded quickly and stated the she felt much better. second vital signs in 5 minutes were blood pressure 133/77 pulse 78 RR 18 and oxygen saturation of 97%. Transported by EMR to hospital.
42 2021-03-22 insomnia Fever (102.0 F) Chills, body aches, pounding headache, insomnia from 12:01AM - 5:30AM 3/20/21 From ... Read more
Fever (102.0 F) Chills, body aches, pounding headache, insomnia from 12:01AM - 5:30AM 3/20/21 From 5:30AM- 4:30 PM - exhaustion, headache Starting at 4:30 PM on 3/20/21 (after 2 hour nap) felt great!! On and off lingering tiredness for a couple more days
42 2021-03-24 sleep disorder Uncontrollable chills for over 3 hours followed by a few hours of extreme perspiration. Inability to... Read more
Uncontrollable chills for over 3 hours followed by a few hours of extreme perspiration. Inability to sleep soundly. Fatigue during following day and muscle soreness.
42 2021-03-25 insomnia Day of vaccine, I felt like my lymph nodes were swollen. Two days later the injection site started t... Read more
Day of vaccine, I felt like my lymph nodes were swollen. Two days later the injection site started to get deep red. Friday I started to about an inch of so, swell up some. Saturday I had a rash on my arm by the injection site, the top part on my bicep was pretty red and swollen. I didn't take my Humara or Zolar injection. On Sunday the rash got worse and grew in size and really hot to touch, the pain was radiating all the way to my wrist and hurt really bad causing pain when I moved my wrist. It was hard for me to go to sleep so I called the dr and went in . The dr. said it looked less red that what it was and told me to take Ibuprofen 800mg* 3x day. The pain is now in both wrist and hard for to grip stuff and a little hot to touch. You can see the difference in the skin tone where the rash was, it looks bruised.
42 2021-03-27 feeling abnormal, impaired work ability I received my shot at 9:15AM at 11.5 hours later I began feeling foggy, fatigue and flu like symptom... Read more
I received my shot at 9:15AM at 11.5 hours later I began feeling foggy, fatigue and flu like symptoms. I had a slight fever and just stayed in bed the day after. Ibuprofen seemed to help the headaches but not the body aches. No nausea. Within 72 hours I was almost back to my normal self, but still extremely tired, and my neck and back hurt quite a bit. Today marks 13 days. As of 5 days ago I began to get cold like symptoms. Neck and back still extremely uncomfortable, neck barely able to move side to side. I have a bit of a cough with phlegm. Headaches are still happening quite a bit, and still super tired all the time. I feel like I?ve been sick ever since I took the shot, and have to take several days off work.
42 2021-03-29 anxiety Janssen COVID-19 Vaccine EUA Patient reported feeling dizzy about 10 minutes post vaccination. BP w... Read more
Janssen COVID-19 Vaccine EUA Patient reported feeling dizzy about 10 minutes post vaccination. BP within normal range. Skin cool and sweaty. Patient stated that she has "anxiety when getting shots". Patient monitored on-site for 45 minutes. Patient stated she felt better. Left with husband. clinic.
42 2021-03-30 loss of personal independence in daily activities 24hr post vaccine: paresthesias, sharp pains, throbbing pains, & a heavy/leaden feeling began in bot... Read more
24hr post vaccine: paresthesias, sharp pains, throbbing pains, & a heavy/leaden feeling began in both legs from knees down. Continued nocturnally for 4-5 nights before beginning during daytime hours encompassing both legs & both feet. Spread to left arm on day 5 & then to include right arm a day later. Weakness in all limb muscles. Difficulty walking. Unable to carry heavier items, unable to lift over 5lbs with both arms, unable to move arm from plate to mouth at its worst. All symptoms waxed & waned, Guillian Barre was ruled out due to this. Currently 20 days post vaccine with little relief. Medical care has been sought & is continuing at this time.
42 2021-03-30 restlessness Experienced dizziness the first 15 minutes and that evening around 9 or 10 experienced severe chills... Read more
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.
42 2021-04-03 feeling abnormal Fever of 101 by the night of the vaccine. Severe chills. Next day- low grade fever 99. Exhaustion, ... Read more
Fever of 101 by the night of the vaccine. Severe chills. Next day- low grade fever 99. Exhaustion, foggy/hazy feeling. Day 3- back to normal. Still a bit sleepy.
42 2021-04-06 anxiety Patient reported having history of having ? vasovagal episodes? Patient reported feeling dizzy and ... Read more
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
42 2021-04-06 disturbance in attention, emotional distress Visual aura 3 hours later, headache for 2 days, then at 3 days sudden onset nausea, vomiting, emotio... Read more
Visual aura 3 hours later, headache for 2 days, then at 3 days sudden onset nausea, vomiting, emotional upset then sleepiness, pupils to me seemed very constricted on that day, stiffness of neck for several days and right sided head/ face pain for 5 days difficulty concentrating/ reading.I took ibuprofen for 5 days which helped symptoms
42 2021-04-06 loss of personal independence in daily activities, sleep disorder Injection Tuesday at 10am, felt fine until 6-7pm. By 7pm overcome by crushing exhaustion, unable to ... Read more
Injection Tuesday at 10am, felt fine until 6-7pm. By 7pm overcome by crushing exhaustion, unable to complete simple meal prep but no appetite. By 8pm, intense shivering, feeling freezing cold. By 9pm, back/neck/leg/arm muscles stiff & cramped, joints achey, terrible headache. By 11pm, unable to sleep due to discomfort of symptoms - temp 100.1, tylenol taken. Poor, intermittent sleep 12-7am. Wed 7am - ibuprofen for sore achey muscles & joints and headache. Ibuprofen helpful, but exhaustion from poor sleep. Had friend come to care for children because I could not do it. Ibuprofen helpful for symptoms, able to nap. Symptoms slowly resolved. All symptoms gone by Thursday morning.
42 2021-04-06 nervousness Patient reported feeling dizzy, lightheaded, nauseated, and shaky Patient provided with water and se... Read more
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
42 2021-04-07 disorientation Woke up in middle of night with intense chills and could not breathe. Fainted. Woke up on floor diso... Read more
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.
42 2021-04-07 feeling abnormal Patient rec'd Janssen COVID-19 vaccine at 0912. Immediately started vomiting. Stated "arm burned all... Read more
Patient rec'd Janssen COVID-19 vaccine at 0912. Immediately started vomiting. Stated "arm burned all the way to her hand with injection". Reported felt dizzy, lightheaded, hot". BP 98/62. Assisted to cot and side-lying position. Continued to vomit/dry heave. At 0921, pt stated she was "really tired" and couldn't keep her eyes open. Able to answer questions, but not always able to finish sentence. EMS called. BP returned to normal limits within about 5-10 minutes. Patient contiued to dry heave and c/o feeling cold and nauseous, as well as "really tired" until EMS transported her. 4/8/2021: Nurse called patient. Patient stated she "feels foggy today". States her arm is "extremely sore".
42 2021-04-08 anxiety The feeling of anxiety and swelling of tongue
42 2021-04-08 confusional state Evening after vaccine (+8 hours) had a fever that reached 102.5, extreme chills, vomiting, confusion... Read more
Evening after vaccine (+8 hours) had a fever that reached 102.5, extreme chills, vomiting, confusion, body aches and muscle spasms. Fever broke after a few hours. Soreness, muscle aches and nauseousness for + 3 days post vaccine.
42 2021-04-08 sleep disorder 8 hours after vaccine, the chills started. Violent, body shaking chills. It sounded like woody woodp... Read more
8 hours after vaccine, the chills started. Violent, body shaking chills. It sounded like woody woodpecker when my teeth were chattering against my mouth guard. Then the fever came in. 17 hours after the vaccine, my fever is still at 101. Did not sleep much. Woke up with severe headache and muscle pain. Drank a gallon of water yesterday and 32 oz in the middle of the night. Despite that, I?m still thirsty.
42 2021-04-09 anxiety 11:30 pm: chills, body aches, headache 3:00 am: chills subsided, then fever of 101 along with all-ov... Read more
11:30 pm: chills, body aches, headache 3:00 am: chills subsided, then fever of 101 along with all-over aches 5:00 am: took ibuprofen, called in sick to work! 8:00 am: fever and body aches subsided, nausea began 11:00 am: nausea finally subsided after bout of emesis, headache subsided as well. Exhaustion, lightheadedness, and occasional anxiety continued for next 48 hours
42 2021-04-09 anxiety Woke up about 12 hours after receiving shot feeling like my heart was racing. Tried to relax thinki... Read more
Woke up about 12 hours after receiving shot feeling like my heart was racing. Tried to relax thinking it was anxiety from receiving the vaccine. Wouldn't go away, checked heart rate on pulse ox. Read 130. Went to Er to be checked out to be safe. They did a cardiac work up, chest xray, checked urine & gave me IV fluids. Heart rate was in the 120's at the hospital & came down to the 90's after awhile. Didn't feel the racing anymore. Was released from hospital. After about 3 hours, heart rate was back in the 70's. Haven't felt any racing since. Did a follow up with PCP a couple weeks later. No issues since.
42 2021-04-09 loss of personal independence in daily activities Extreme fatigue, severe neck pain (right side only), nausea. Began at wakeup on 4/7 (6am). The same ... Read more
Extreme fatigue, severe neck pain (right side only), nausea. Began at wakeup on 4/7 (6am). The same symptoms and severity lasted all of 4/7, 4/8 and 4/9. On 4/10 (today) I was able to function better but only at 50% of normal rate. Pushed lots of water and slept 18-20 hours 4/7 & 4/8
42 2021-04-09 memory impairment, disturbance in attention, mental impairment, feeling abnormal 10:45 am 3/11/2021 brain fog or loss of thought process about 3 minutes after shot, heart palpitatio... Read more
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.
42 2021-04-10 feeling abnormal PATIENT GOT JANSSEN COVID-19 VACCINE @ 12:58 AND CAME BACK TO THE PHARMACY AT ABOUT 13:50 WITH A COM... Read more
PATIENT GOT JANSSEN COVID-19 VACCINE @ 12:58 AND CAME BACK TO THE PHARMACY AT ABOUT 13:50 WITH A COMPLAINTS OF NOT FEELING GOOD . THE STORE ASSOCIATES CALLED 911 AND PATIENT WAS SUPPORTED BEFORE SHE WAS TAKEN TO THE HOSPITAL PATIENT WAS RESPONDING WHEN THE EMS CAME.
42 2021-04-10 impaired work ability Headache and nausea: 04/07/2021 at approx 9pm until bed (10pm). Woke up at 3:30am for work. Headache... Read more
Headache and nausea: 04/07/2021 at approx 9pm until bed (10pm). Woke up at 3:30am for work. Headache not very bad. Nausea much worse. Fatigue. Called out sick from work. Very bad nausea from 04/07/21 at 9pm until 04/09/21 at 11:30pm (bedtime). Vomited twice and felt fatigued during that period of time. Woke up on 04/10/21 at 8:30am feeling much better.
42 2021-04-10 incoherent Nausea followed by incoherence/fainting, rapid breathing, sweating, chills and and diarrhea.
42 2021-04-11 insomnia 1st 24 hours: Sleeplessness, headache, all body aches 24 hours: Left side of torso - skin was sensit... Read more
1st 24 hours: Sleeplessness, headache, all body aches 24 hours: Left side of torso - skin was sensitive 24-48 hours: initial blister rash appears on torso, skin continues to be sensitive and painful on the left side 48- hours: Diagnosed with shingles/herpes zoster, put on Acyclovir, rash spreading on left side back and front; is itchy, painful and blistering
42 2021-04-12 feeling abnormal Thursday 04/08/21 - 1:35 PM Went to Fairgrounds to get the Johnson & Johnson - Janssen COVID-19 vacc... Read more
Thursday 04/08/21 - 1:35 PM Went to Fairgrounds to get the Johnson & Johnson - Janssen COVID-19 vaccine shot with my husband. Both of us wore our masks, walked in together, went through the line together, we both got the shot in our left arms and then set together and waited the 15 minutes before we could leave. A little later at home we were working on some landscape lighting and I felt a bit foggy, light headed and kind of out of it. I was drilling into masonry and the first hole went fine but the second one for some reason just wasn?t going and I touched the drill bit with my fingertip on my left hand to see if it had smoothed out and I knew in my head not to do it and that it should be hot as heck but I didn?t feel anything at all so later that evening when I took a shower my finger was burning and I knew I had burnt it. That evening I begin to feel crippling cold, my fingernail and toenail beds had turned purple and I was shivering violently. I got under a pile of blankets with my dog and tried to slow my breathing I could feel my heart beating in my chest and it felt like the air I was breathing was cold and frosty. I had a 104+ fever that night. My husband got me some aspirin a cold washcloth for my head a popsicle and water to help bring down the fever. And I was able to sleep on and off that night. When I woke up I had a 103+ fever and a tingling and numbness in my arms. Before the fever my arms felt tight and cold and I had a tingle that ran from my elbows to my fingertips. Again it was aspirin cold washcloth and lots of water to drink to try and get my fever down. Friday 04/09/21 Was spent in bed trying to drink water and sleep through it. My arm was sore, not at the injection site but the whole top part of my arm felt like I had been hit by a truck. I had a fever again that evening. Saturday 04/10/21 I thankfully woke up fever free but my arms were tingling. I had to take my husband to the airport that morning at 6:30 AM. I came back home and went back to bed until about nine when I woke up my arms were cold and sore and tingling it seemed to be getting worse in my left arm and I felt shots of electricity from my elbow down to my fingertips. At one point I took a picture because my left arm hurt so much more than the right and my fingertip beds were purple on my left and pink on my right. I took aspirin and took a nap. I couldn?t hold my phone with both hands hands like normal sitting in bed because my left hand goes cold and achy. Woke up worried that both my arms were aching and tingling from my elbows to my fingertips seems to be where it stays the most. Then that pain subsided and my lip started to tingle. After a few hours that stopped but the tingling in my arms is about constant not as strong sometimes, not in both arms sometimes, it seems to almost always be in my left arm and at one point scary enough that I almost went to the ER. Went to bed around 11:30 PM and the tips of the toes on my left side were tingling and it went to the whole leg. Sunday 04/12/21 I woke up with a coughing fit and mucus at around 1:00AM and my right leg with a little tingly at 4:24 AM awake again and coughing woke me had to get a drink and my stomach was buzzing and stopped now just back to the bottom half of my left leg. All of a sudden after a coughing and sneezing fit I got a tremendously sore burning throat out of no where that only lasted about five minutes. I noticed my left arm straining to hold up the pizza box tonight when my right arm had no trouble at all. Then a little later in the day stiffness in the back of my neck. It is a weird strong dry cough and I was scared to go to the ER because my symptoms were so varied and ever-changing I didn?t know what they would do with me and I didn?t want to just get stuck in there for days with him not knowing or making it worse. I told my husband ? It?s so random I?m a little scared no one is going to know what to do with me...?I?ve had issues with allergic reactions and no one being able to diagnose them and me having to figure it out on my own on the Internet that I had Thyroid problems and that I was allergic to the sun for a few years in the past and aloe vera... I didn?t wanna wind up going, them not fixing anything and having a huge bill to pay. But this whole time my body is buzzing and tingling and going through something strange. At this point I am just telling my family I?m okay and what random symptoms I have had since we spoke last. They are on standby to watch my children if I need to go to the ER. The constant buzzing, numbness, cold tingling in my arms is worrisome. Monday 04/12/21 I am use to the numbness and tingling being a constant thing on some part of my body... There are times when I feel fine but I know it won?t last long. We can add an upset stomach and diarrhea to the list. I had a metal taste in my mouth for a little bit today. Both arms legs and my lips have randomly buzzed, ached or tingled. The websites say call 911 for emergency or call your local medical provider for assistance so I called the local ER to see if they could tell me if my symptoms were normal or if it?s something I should come in for and they couldn?t give me any advice... I was told if you feel like you should come in then come in. I had a very strong sharp pain at my elbow of my right arm tonight that made me sit up in bed... Tuesday 4/13/21 My left arm is still sore if people touch me or if I try to sleep on my side like I normally do it hurts trying to hold my phone with both hands my arm still goes cold and achy. So far this morning my arms are both tingling and my left leg and my lips so at this point I just say I?m buzzy. 11:25 AM randomly my right arm decided to feel worse for a change but is back to a low buzz... after a few minutes. I find myself holding them up or lifting them when they hurt it seems to help a little to elevate my arms to my chest. I am just waiting to see what comes out in the media, or to see if this gets any better, or if they learn what to do about it... It isnt over, it hasnt stopped yet.
42 2021-04-12 feeling abnormal Received the shot 12 pm on Friday 4/9 and at 7:30 pm that night started with fever,chills and body a... Read more
Received the shot 12 pm on Friday 4/9 and at 7:30 pm that night started with fever,chills and body aches this lasted till Sunday 4/11 mid afternoon. Monday extreme exhaustion left side of the if the body leg pain tiredness arm in extreme pain. 4/13/21 woke up with leg and arm and now neck and throat achy and foggy brain. Called doctor and she was not concerned stated to take Advil and drink a lot of water
42 2021-04-12 impaired work ability Felt tired after the vaccine and continued to be more and more tired each day after the vaccine. 3 d... Read more
Felt tired after the vaccine and continued to be more and more tired each day after the vaccine. 3 days after the vaccine I had to leave work to sleep and felt terrible (weak, shortness of breath, extreme exhaustion) on the 5th and 6th days after the vaccine with shortness of breath. On the 7th day, I went to the ER and was diagnosed with pneumonia.
42 2021-04-12 panic attack Client experienced a panic attack after receiving vaccine, EMS assessed vitals and everything was no... Read more
Client experienced a panic attack after receiving vaccine, EMS assessed vitals and everything was normal, she laid down and was observed, cleared to leave by EMS
42 2021-04-13 feeling abnormal Evening of vaccine (Thursday night): chills, headache, aches and pains First day after vaccine (Fri... Read more
Evening of vaccine (Thursday night): chills, headache, aches and pains First day after vaccine (Friday April 2): chills, sweats, dizziness and fuzzy thinking, extreme fatigue, headache, joint pain Second day (Sat April 3): fatigue, headache, aches and pains Evening of the second day (Sat April 3): fatigue, acute pain in my left armpit/swollen glands in my armpit/breast/neck Third day (Sunday April 4): fatigue, headache, armpit pain and swelling radiating to the entire upper left side of my body Fourth day (Monday April 5): fatigue, headache, armpit pain slightly abated Fifth day (Tuesday April 6): fatigue, armpit pain slightly abated Sixth day (Wednesday April 7): neck still stiff, left armpit still very tender Seventh day (Thursday April 8): left armpit tender 8th day (Friday April 9) until now: still tender/sore in and around left armpit, still a bit stiff in the neck
42 2021-04-13 feeling abnormal 15 minutes after injection: out of nowhere became extremely dizzy, nauseous, and fainted. stayed on... Read more
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.
42 2021-04-13 mental impairment 18 hours after vaccination, developed headache with severe nausea and intermittent vomiting and feve... Read more
18 hours after vaccination, developed headache with severe nausea and intermittent vomiting and fever of between 99.5-101 when read via forehead. Symptoms lasted for approximately 10 hours, with 1-3 bouts of vomiting during that time. Due to vomiting, OTC pain relievers taken by mouth were not effective. Symptoms have since subsided except for weakness, slight headache, and mental fog.
42 2021-04-14 hallucination, nightmare Immediately after the vaccine (faint, nauseous, dizzy, pain in injection site) 2 hours after vaccine... Read more
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
42 2021-04-14 excessive sleepiness fever over 103 with 7/10 bodyaches that lasted approx. 9 hours, then tylonol, then about 7 hours lat... Read more
fever over 103 with 7/10 bodyaches that lasted approx. 9 hours, then tylonol, then about 7 hours later 7/10 headache, 8/10 bodyaches, fever of 102 with nausea, tylonol, slept most of next 24 hours. Lingering lethergy for approx. 3 days, lingering nausea 7 days
42 2021-04-15 fear, feeling abnormal, anxiety HUNGRY; VERY ANXIOUS; FEELING UNSAFE TO WALK BY HERSELF; FEELING TRAPPED; BAD HEADACHE; FEELING TIRE... Read more
HUNGRY; VERY ANXIOUS; FEELING UNSAFE TO WALK BY HERSELF; FEELING TRAPPED; BAD HEADACHE; FEELING TIRED; SORE ARM; 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 bipolar, no alcohol use, cigarette smoker and too stressed to take care of herself. The patient experienced drug abuse when treated with metamfetamine, and drug allergy when treated with lisinopril. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included lorazepam for bipolar disorder. On 02-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced very anxious. On 08-APR-2021, the subject experienced feeling unsafe to walk by herself. On 08-APR-2021, the subject experienced feeling trapped. On 08-APR-2021, the subject experienced bad headache. On 08-APR-2021, the subject experienced feeling tired. On an unspecified date, the subject experienced hungry. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very anxious, and feeling unsafe to walk by herself on 09-APR-2021, and feeling trapped, and sore arm on APR-2021, and was recovering from feeling tired, bad headache, and hungry. This report was non-serious.
42 2021-04-15 sleep disorder Patient complained of having a headache the evening after the vaccination which continued for a coup... Read more
Patient complained of having a headache the evening after the vaccination which continued for a couple days and is now intermittent but better with consistent Ibuprofen. Bilateral leg pain also started that evening which has been continuous, but some relief with Ibuprofen use. Patient describes the pain as a dull ache in each thigh and wakes her up at night. The pain is more intense when Ibuprofen wears off going to a more shooting pain down each leg. Patient also complains of unusual fatigue that is not normal/baseline for her.
42 2021-04-16 insomnia 1 Day of the vaccination: Swelling in the left arm, pain in my armpit and left breast pain and disco... Read more
1 Day of the vaccination: Swelling in the left arm, pain in my armpit and left breast pain and discomfort in the left leg sensation of heaviness, stomach pain nausea, headache. 2 Day: 4 bruises appeared on different parts of my body, 1 on the inside of the arm where I received the vaccine, another on my left breast that was small and two more on my 2 feet right on the instep where the veins are In the following days a lot of muscle pain in my legs that does not let me rest, the nausea has not stopped. So I went to the emergency room on April 17, 2021.
42 2021-04-18 anxiety Woke up the next day at 6 am felt fine and fell back asleep at 730 am until 930 am. Woke up with a p... Read more
Woke up the next day at 6 am felt fine and fell back asleep at 730 am until 930 am. Woke up with a pounding headache. Arm started to be really sore and a tight swollen bump at injection site. Severe nausea and dizziness immediately following by 10 am and extremely tired. Now almost 9 days later the lump at injection site is still there and sore. I find this very concerning and uncomfortable. The nausea lasted about 12 hours. The tiredness and dizziness lasted about 7 days. The bad pounding headache lasted all day followed by mild headaches throughout the week.
42 2021-04-18 insomnia 4/8 3:30pm chills, fever, and severe headache started 4/8 8pm fever 102.7, severe headache, left foo... Read more
4/8 3:30pm chills, fever, and severe headache started 4/8 8pm fever 102.7, severe headache, left foot and knee swollen, ringing/muffled sound in left ear 4/8 11pm unable to sleep due to headache 4/9 severe headache, fever all day. Unable to sleep 4/10 fever, severe headache, yellow bruising on shin left leg, back pain between should blades. 4/11 fever, severe headache, back pain between shoulder blades. 4/12 low grade fever, headache 4/13 thru currently, random severe headaches (debilitating - need to close eyes, limit light and noise, headache worse when walking)
42 2021-04-19 disorientation My smell and taster are gone. I can only smell cooked foods and they all smell like trash or garbage... Read more
My smell and taster are gone. I can only smell cooked foods and they all smell like trash or garbage compost mixture. My taste is starting to taste the same too like the trash smell. It?s going on two-three weeks now. The day of the vaccine I had every symptom. Body aches, headache, chills, fever, nausea, dizziness, and fatigue for 4 days the fifth day I was fatigued and disoriented at times. 6th day just fatigued and still to this day. But now with no smell and taste now and it?s still very much gone.
42 2021-04-19 feeling abnormal Fever 12 hour duration Chills 24 hour duration headache 12 hour duration sore arm 5 day duration Bod... Read more
Fever 12 hour duration Chills 24 hour duration headache 12 hour duration sore arm 5 day duration Body aches 24 hour duration Brain fog 2 day duration exhaustion 5 day duration
42 2021-04-21 insomnia NERVE PAIN IN LEG AND ARM; EAR ACHE; FELT COLD; CHILLS; JOINT PAIN IN KNEES; HEADACHE; PRESSURE IN C... Read more
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.
42 2021-04-24 impaired work ability Super intense headache that I had never felt in my life for 3 days, now it hurts from time to time b... Read more
Super intense headache that I had never felt in my life for 3 days, now it hurts from time to time but less intense. Nausea, dizziness, maybe temperature. An intense body pain (it was the first thing that happened to me along with a headache), because of that I had a fall with scrapes on my knee, to this day the body pain continues although it is minor but that causes me a lot of tiredness and for that reason I stopped working. In summary the symptoms continue but with less intensity, as well as dizziness and nausea from time to time.
42 2021-04-26 feeling abnormal FEELING BAD; SICK; JOINT ACHE; HEADACHE; INJECTION SITE PAIN; SEVERE CHILLS; SEVERE BODY ACHES; TROU... Read more
FEELING BAD; SICK; JOINT ACHE; HEADACHE; INJECTION SITE PAIN; SEVERE CHILLS; SEVERE BODY ACHES; TROUBLE REGULATING BODY TEMPERATURE; HOT AND COLD FLASHES; SEVERE BREAST TENDERNESS; INCORRECT ROUTE OF DRUG ADMINISTRATION; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight was 175 pounds, and height was 155 centimeters. The patient's concurrent conditions included drug allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. the patient was not breastfeeding at the time of vaccination. no history of drug abuse. the patient had no illness at the time of vaccination. no history of similar event in the past. the patient had no adverse events after any previous vaccination(s). the patient was allergic to amoxycillin. no pre-existing acute illness prior to vaccination. no history of hospitalization 30 days prior to vaccination. no family history of any disease relevant to vaccination or allergy. The patient was previously treated with amoxicillin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced incorrect route of drug administration. On 08-MAR-2021, the subject experienced severe body aches. On 08-MAR-2021, the subject experienced trouble regulating body temperature. On 08-MAR-2021, the subject experienced hot and cold flashes. On 08-MAR-2021, the subject experienced severe breast tenderness. On 08-MAR-2021, the subject experienced severe chills. On an unspecified date, the subject experienced feeling bad, sick, joint ache, headache, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches, trouble regulating body temperature, hot and cold flashes, severe breast tenderness, and severe chills on 22-MAR-2021, was recovering from sick, had not recovered from joint ache, headache, injection site pain, and feeling bad, and the outcome of incorrect route of drug administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210318992.
42 2021-04-26 impaired work ability HEAVINESS IN LEGS; MISSED WORK DUE TO THE FEVER; PAIN AT INJECTION SITE; FEVER; HEADACHE; This spon... Read more
HEAVINESS IN LEGS; MISSED WORK DUE TO THE FEVER; PAIN AT INJECTION SITE; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no medications prior to the janssen covid-19 vaccine. the patient had no diabetes, no circulation problems, and was not overweight. the patient was not taking birth control pills. 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pain at injection site. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced heaviness in legs. On 13-APR-2021, the subject experienced missed work due to the fever. Laboratory data included: Body temperature (NR: not provided) 100.1. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from missed work due to the fever, and fever on APR-2021, had not recovered from heaviness in legs, and the outcome of pain at injection site and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425979.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
42 2021-05-04 sleep disorder notes: times are approximate. I got the vaccine on day two of my period. I moved my arm a lot aft... Read more
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.
42 2021-05-05 confusional state 3/31 stroke like symptoms ED with admission for testing 4/20 stroke like symptoms ED with admission... Read more
3/31 stroke like symptoms ED with admission for testing 4/20 stroke like symptoms ED with admission for testing 4/27 seizure 4/28 seizure during MRV confirmed no stroke 5/2 15 seizures ED visit to stop seizure activity 5/3 19 seizures, admission for LP and EEG study 5/4 4 seizures discharged, tests inconclusive 5/5 2 seizures 5/6 2 seizures All are accompanied by severe headache, blurred vision, confusion
42 2021-05-06 feeling abnormal, anxiety The day of and the first week after I only felt a little lightheaded. Seven days after the vaccine I... Read more
The day of and the first week after I only felt a little lightheaded. Seven days after the vaccine I began having dizzy spells, extreme fatigue and nausea, blurred vision, extreme right head pressure, floaty sensation, numbness and tingling in my right arm and leg, muscle spasms, and extreme anxiety. All things I have never experienced before. And they have persisted daily since they began. My first period one week after the injection was a couple days late and very light and only lasted a few days, which is also not normal roe me. I have short periods of relief and then the symptoms return. It is very scary and I need help. I have been to my pcp several times and the Er. They can?t explain my symptoms.
42 2021-05-08 feeling abnormal Within 8 hours of the shot experienced: full-body muscle aches. Full body joint pain to the point t... Read more
Within 8 hours of the shot experienced: full-body muscle aches. Full body joint pain to the point that I couldn?t move. My body felt like it was on fire. Stomach ache, severe headache. This pain lasted around 14 hours. After that, the joint/muscle pain lingered for about 3 days. The headache for about 3 days. I felt and still feel weak, and have a fuzzy head. My sense of smell and taste still hasn?t fully recovered. I feel fatigue from Covid-19 since I had it in December and this vaccine seemed to make me feel worse all over again.
42 2021-05-08 memory impairment, disturbance in attention, feeling abnormal April 12/Day 1 - 1:35pm : 5 minutes after the shot my throat hurt Afternoon: Felt light-headed, woo... Read more
April 12/Day 1 - 1:35pm : 5 minutes after the shot my throat hurt Afternoon: Felt light-headed, woozy and hard to focus on work. No fever yet. 8:30pm: Chills so bad I was convulsing and could barely hold anything in my hands. Got in bed and stayed there. 9:30pm: 102.6 fever Evening and in the middle of the night: Drank lots of water and coconut water. Took 2 Tylenol before bed. April 13/Day 2 - Morning - took 2 more Tylenol Had fever all day, around 101.8 and going down to 101.3. Slept all morning. 12:30pm - Got out of bed to try to eat chicken soup and crackers - took 3 bites and felt nauseated, like I would throw up so I got back in bed and went back to sleep. 5pm - Woke up and ate a little dinner. April 14/Day 3 - Temperature dropped to normal. April 15 - present: Didn't have fever but continued to feel sick and have symptoms: Day 3-5: Hard to focus at work. Someone would call me to talk about something. Then we started talking about other things and I couldn't remember why they called in the first place - what was the topic we were talking about. Felt very tired and had to rest periodically throughout the day, in between work meetings. Day 6-12: Continued to feel tired and weak. Have to take at least 1 nap to get through the day. Brain fog - memory not as good. Felt sick, like I had a cold (eyes hot and itchy, throat periodically hurt. I don't normally have allergies.) Took lots of echinacea, elderberry syrup and Vitamin C. Day 12 - Present: Still feel tired all day long except for the first 4 hours after I have coffee in the morning. Need to take a nap most days. I don't feel as healthy as I did prior to taking the shot on April 12.
42 2021-05-10 feeling abnormal The evening of the vaccine I got a rash on my trunk and a ulcer on my tongue. The ulcer was toward t... Read more
The evening of the vaccine I got a rash on my trunk and a ulcer on my tongue. The ulcer was toward the back of my tongue. I felt drunk. The rash was on my trunk near where my bra is. It was a strawberry rash and I took some Benadryl it lasted three days. A few days later I started to get leg cramps like my legs were tired. On the right leg it went up into my thigh and my hip. It was cramping sensation that was constant and lasted for a week. It helped if I put my feet up it improved. Overall the leg cramps lasted for two weeks. I am recovered right now and the symptoms have not returned.
42 2021-05-19 anxiety 1 1/2 weeks after the vaccination, got a headache then started not feeling well. Treated for sinus i... Read more
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.
42 2021-05-20 depressed mood, impaired work ability Started that day chills and three four hours hot and shaky. I could not work a couple days feeling l... Read more
Started that day chills and three four hours hot and shaky. I could not work a couple days feeling like very very sick, nauseous. three or four days and went away slow. Missed work last week, diarrhea, getting sick off and on since the covid shot feeling like the flu. But tests negative. Sometimes I am perfectly fine, sometimes very sick and very down. Happens randomly. Could not even get up from the bed. Still taking nausea pills and pills for pain, body aches.
42 2021-05-20 feeling abnormal Started off with chills fever around midnight. Body aches severally coughing couldn't breath very we... Read more
Started off with chills fever around midnight. Body aches severally coughing couldn't breath very well just felt awful. Slept 22 hours very nauseas. Arm felt like I got punched at the injection site, bruise and the arm is still sore.
42 2021-06-10 anxiety At 1642 PM (~18mins post vaccination) pt c/o nausea and dizziness. Observation nurse noticed pt to a... Read more
At 1642 PM (~18mins post vaccination) pt c/o nausea and dizziness. Observation nurse noticed pt to also be diaphoretic. Pt brought inside and given water. NP made aware. VS taken: BP 149/88, HR 95, O2 100% on RA, Resp 18. Pt brought to the triage area to recline. Pt reported anxiety surrounding the vaccine administration. Pt VS rechecked at 1701 PM: BP 139/84, HR 85, SpO2 100% on RA. Pt stated that nausea and dizziness had resolved. No SOB or acute distress noted. Pt discharged from vaccination clinic in stable condition.
42 2021-07-12 insomnia After 2 days of getting the injection, experiencing numbing and tingling in the left and right hand... Read more
After 2 days of getting the injection, experiencing numbing and tingling in the left and right hand and arm. Causing sleepless nights. After a week, numbing in right side neck, cheek, and ear. Symptoms still continue through today.
42 2021-07-12 insomnia The pain at first was minor So I?ve began to take Tylenol now three months later the pain is horribl... Read more
The pain at first was minor So I?ve began to take Tylenol now three months later the pain is horrible as is my right arm from my back shoulder down my back right side up by under my right breast my chest goes like numb /dead for like days its bad. Hurts so bad I can barely sleep
42 2021-07-18 loss of personal independence in daily activities, sleep disorder Immediate extreme pain shooting from my shoulder to my elbow. I asked at the waiting area how long t... Read more
Immediate extreme pain shooting from my shoulder to my elbow. I asked at the waiting area how long the pain was supposed to last and they told me a few weeks. I couldn't use my arm at all for a few hours and for a few days I couldn't do my hair or dress normally. For a few weeks I experienced pain and weakness when doing simple tasks like lifting a glass or buckling a seatbelt. For a few months I have experienced pain when sleeping, jogging, hugging, etc. My arm now feels weaker than before and I avoid using it on a regular basis because of the pain. The pain has evolved from being acute and achey all of the time to mostly aching during use or when moved. Many people initially told me pain was normal would last a few weeks and that I might just be healing slowly. After 6 weeks, I determined that this was likely not normal to be in such pain. Now, 3.5 months later, I am really ready to get answers, as the pain and weakness are lingering and don't seem to be completely healing. My mom, a physical therapist, suspects that the needle might have entered the bursa, and my husband and I have suspected that it might have damaged my rotator cuff.
42 2021-07-20 loss of personal independence in daily activities Experienced headaches, chills and extreme fatigue approximately 9 hours after receiving the injectio... Read more
Experienced headaches, chills and extreme fatigue approximately 9 hours after receiving the injection. The fatigue lasted approximately a day and a half. I was unable to perform normal daily activities due to the fatigue.
43 2021-03-10 sleep disorder, feeling abnormal At 5:30 pm, I started to have a headache, so I took some Tylenol. I started to feel a little better... Read more
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.
43 2021-03-17 crying From 1 to 3 hours after vaccination : uncontrolled crying. From 1 to 4 hours after the vaccination:... Read more
From 1 to 3 hours after vaccination : uncontrolled crying. From 1 to 4 hours after the vaccination: weakness in legs and arms, unable to raise legs to walk or no strength in arms, I couldn?t hold objects in hand or close hands. About 3 hours after vaccination: numbness in all face like if under anesthesia, and I could barely been heard when trying to speak, no strength to talk other than single words. First 24 hrs extremely sleepy and lethargic the next day.
43 2021-03-25 feeling abnormal Day of injection-Extreme pain/heat in arm that traveled up neck. Runny nose, swollen tongue and ears... Read more
Day of injection-Extreme pain/heat in arm that traveled up neck. Runny nose, swollen tongue and ears, sweating, general spacey or brain fog feeling for about 10 minutes. Went home and had to take 3 doses of benadryl, over the course of the evening. Didn't warrant my epi pen, I didn't feel. Night of injection-night sweats and pain at injection site and down arm. Next day-fever, chills, joint pain, body aches. Taking tylenol
43 2021-03-31 sleep disorder I started to develop a headache and extreme fatigue about 4 hours after getting the shot. By 6pm I s... Read more
I started to develop a headache and extreme fatigue about 4 hours after getting the shot. By 6pm I started getting severe chills and body aches. About 2 hours later the chills were alternating with fever and I could barely stand because I felt so weak from the muscle aches. I was in so much physical pain I didn't sleep at all that night. The fever lasted until late afternoon the next day (about 24 hrs total), and the body aches lasted until late afternoon the day after that (about 48 hrs total).
43 2021-04-01 sleep disorder Pain in arm 4 hours later. 8 hours later severe headache, chills, body aches. Took 600mg Motrin & 10... Read more
Pain in arm 4 hours later. 8 hours later severe headache, chills, body aches. Took 600mg Motrin & 10mg melatonin to help sleep 11 hours after injection. Woke up numerous times throughout the night with night sweats, chills, body aches, leg cramps, arm site pain. Woke up in the morning (21 hours after injection) feeling fatigued but no other symptoms
43 2021-04-06 sleep disorder Woke up at 3:00am after going to sleep at 11:00pm with a racing heartbeat. My heart rate was 140 bpm... Read more
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.
43 2021-04-07 sleep disorder Started with the lower right leg and foot being itchy and red 7 days post vaccine. It then progresse... Read more
Started with the lower right leg and foot being itchy and red 7 days post vaccine. It then progressed to the right lower leg. After a few hours, the upper legs became red and itchy. It then affected my right arm, a little on my abdomen, and then the right elbow area. Benadryl, a cold shower, and icing the areas made the symptoms go away for several hours, but they returned over night at 3am. Day 8, the symptoms were gone most of the day, but returned in the evening around 8pm. Benadryl taken and iced down the arms and legs. Symptoms subsided. They returned again at 3am and woke me from sleeping. It affected both feet, both legs, both arms, a little on my back and sides.
43 2021-04-08 anxiety elevated HR, lots of anxiety, hives by injection site that went away the next day. high temp of 101 ... Read more
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.
43 2021-04-08 anxiety 43 yo female with a c/c of Anxiety with weakness status post vaccination. pt had no signs of allerg... Read more
43 yo female with a c/c of Anxiety with weakness status post vaccination. pt had no signs of allergic reaction. Pt denied any sob or difficulty breathing noted. pt states good oral intake and food intake today. pt wanted to be transported for anxiety. pt was transported to PMC for further eval.
43 2021-04-08 confusional state Immediate dizziness, followed by severe nausea, body aches, chills, high fever, fatigue, confusion, ... Read more
Immediate dizziness, followed by severe nausea, body aches, chills, high fever, fatigue, confusion, light-headed, the onset of which all began about 3 hours after the vaccination. Most symptoms lasted three full days. One week after the vaccination and I still have confusion, dizziness, and vertigo like symptoms. If I look up or down or side to side too quickly, I feel extremely dizzy and nauseated. I can?t stand for more than about 5 minutes without feeling dizziness and nausea set in, even getting on my bike causes nausea and dizziness, driving, walking, anything related to movement. **Only had one vaccine - the form added a second set of boxes above and won?t let me remove it on this form.
43 2021-04-08 insomnia, impaired work ability, confusional state, restlessness Approximately 13 hours after receiving the vaccine, I woke up in the night with nausea, chills, feve... Read more
Approximately 13 hours after receiving the vaccine, I woke up in the night with nausea, chills, fever, spinal pain, joint and bone pain, and the worst headache of my life that I could feel in my brain stem and spinal cord. I also experienced confusion and difficulty walking to the bathroom. The headache was not relieved by OTC pain relievers. I had difficulty sleeping and felt restless. I felt the fever ?break? around 5am with profuse sweating. I had to miss work today (I am a nurse myself who was actually working at the clinic when I received my vaccine). It is now 3pm and after taking a sleep aid and sleeping all day, I do feel better, but the headache remains. I had H1N1 about 10 years ago and aside from that, this is probably the sickest I?ve ever been and it is, with certainty, due to the Covid vaccine.
43 2021-04-09 feeling abnormal Within 5 minutes of shot I was nauseous on scale of 1-5 1 being hardly and 5 being Extremely I was 4... Read more
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.
43 2021-04-09 nervousness, thinking abnormal I began to feel nauseous and shaky within 20 minutes. I was dizzy, but almost more feeling like my t... Read more
I began to feel nauseous and shaky within 20 minutes. I was dizzy, but almost more feeling like my thoughts were jumbled and I had a hard time speaking. I began to get a terrible headache and then began vomiting. I was shaking and out of breath. I was terrified because this was something I had never felt before. The symptoms began to fade within 4 hours and then I experienced the "normal" side effects, such as arm pain and tiredness.
43 2021-04-10 abnormal dreams Cold sweats, joint stiffness, vivid dreams
43 2021-04-10 impaired work ability, feeling abnormal Woke up the day after vaccine feeling fine so I got ready & headed for work. On the way to work I s... Read more
Woke up the day after vaccine feeling fine so I got ready & headed for work. On the way to work I started feeling a little off & nauseous. Ended up leaving work a little over 2 hours after I started. I was feeling nausea, achy, chills, fatigue, dizziness/lightheaded, sore arm. Went home and to bed. Still fatigued, sore arm and a little achy the next day. Now on day 4 since vaccine and am still experiencing a sore arm & fatigue(improving but not back to my normal energy level). On a positive note my ongoing sinus symptoms(since June 2020) have improved. They are not gone but noticeably improved. I'm thankful for that and hoping it lasts!!!!
43 2021-04-10 nervousness syncopal episode, shaky, diaphoretic, EMS evaluated, pt. refused transport.
43 2021-04-11 insomnia chills, very nauseous, couldn't sleep, terrible head aches followed by bad stomach pains. All of th... Read more
chills, very nauseous, couldn't sleep, terrible head aches followed by bad stomach pains. All of this for 24 hours. Then more stomach pains couldn't eat because of nausea for another 24 hours. Very tired and weak. Each day gets a little better
43 2021-04-11 sleep disorder Metallic taste in mouth within 3 minutes of Injection lasting overnight,104 degree temperature for 7... Read more
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
43 2021-04-11 sleep disorder About 7 hours after the shot (around 9pm) nausea began. Then violent shaking chills. Then a severe m... Read more
About 7 hours after the shot (around 9pm) nausea began. Then violent shaking chills. Then a severe migraine. There was NO fever. Was unable to sleep. This kept me up all night. By the early morning, the chills and nausea had subsided, but the migraine continued for several more hours.
43 2021-04-12 confusional state Patient reports receiving vaccine at 4:00pm 4/7/21. Around 12:30am on 4/8/21 she developed severe na... Read more
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.
43 2021-04-12 feeling abnormal Lost appetite for 9 days. I was not nauseous and food smelled and tasted good but I had no feelings... Read more
Lost appetite for 9 days. I was not nauseous and food smelled and tasted good but I had no feelings of hunger. I had to set a reminder to eat otherwise I would go hours without food and never once would I feel hungry. Other events - odd headache that lasted about 24 hours, pain when touching face lasted about 12 hours, & back, neck, shoulder and upper arms all painful like I had been at the gym for three days straight - lasted about 24 hours. Brain fog that lasted about 5 to 6 days. Dizzy spells for about 5 days.
43 2021-04-12 feeling abnormal Profuse sweating, light headed, hard to hear, almost fainted within minutes of receiving the shot. ... Read more
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.
43 2021-04-12 impaired work ability Fever of 101.7; severe headache; body aches; chills/sweats; extreme fatigue; extreme pain at injecti... Read more
Fever of 101.7; severe headache; body aches; chills/sweats; extreme fatigue; extreme pain at injection site - all developed within 5-6 hours of recieving vaccination. All syptoms lasted approximately 24 hours, causing missed work. (Used Tylenol to help with fever and pain) The second day, fever, body aches, chills/sweats subsided but extreme fatigue and arm pain lingered for the next 3-4 days.
43 2021-04-12 sleep disorder Chills, fever, body ache, headache, sore at injection site. Lasted for several hours through the nig... Read more
Chills, fever, body ache, headache, sore at injection site. Lasted for several hours through the night. Better in the morning but lingering fatigue for 24 hours.
43 2021-04-13 feeling abnormal I felt very dizzy about 15 minutes after the vaccine. The girl next to me that had just had it had... Read more
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
43 2021-04-13 restlessness Within 6 hours I started to feel weak, had muscle spasm, left leg cramps, headaches Went to the Eme... Read more
Within 6 hours I started to feel weak, had muscle spasm, left leg cramps, headaches Went to the Emergency Room about 12 days later due to having continue to have severe headaches and my leg would not stop cramping. There was an immediate suspicion that I may have blood clotting even being on Eliquis or bleeding in my brain. A brain cat scan and other tests were performed. I was discharged from the hospital the same day. I am past a monthly the Janssen vaccine now and still have left leg cramps and headaches. My body feels weak and is restless.
43 2021-04-13 sleep disorder Lightheadedness and exhaustion set in 15-25 minutes post injection. Later that same evening, experie... Read more
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.
43 2021-04-14 feeling abnormal, sleep disorder Immediate extreme pain in the injection site. Subsided slightly within the first 15 minutes. As the ... Read more
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.
43 2021-04-15 impaired work ability, insomnia Received the J&J Covid Vaccine shoot on Sunday, April 11th at the Clinic. The night of receiving my... Read more
Received the J&J Covid Vaccine shoot on Sunday, April 11th at the Clinic. The night of receiving my shot, I had a migraine and neck pain which resulted in trouble sleeping. When I got up in the morning, I started having severe muscle pain in my thighs and in my calf, mild cramps in the abdomen. The leg pain lasted the entire day with exhaustion, which interfered with my ability to work a full day. When I went to bed later that night, I still had pain behind my left knee and I was worried about if there was a blood clot. I got up the next morning and my legs were still cramping but improved from the prior day. When I saw the news discussing the blood clot issue associated with the J&J vaccine, I felt it was important to contact my Dr. to discuss the leg pain. They did an ultrasound (vascular scan) on my left leg and follow up with my doctor's office walk-in clinic after the scan. My legs were examined and no clots were identified. We discussed things to watch for.
43 2021-04-17 feeling abnormal, anxiety Approximately 6-8 hours after the vaccine experienced chills, body aches and developed 100.3 fever. ... Read more
Approximately 6-8 hours after the vaccine experienced chills, body aches and developed 100.3 fever. The night was miserable with fever, chills and dizziness when walking to the bathroom. The next day low grade fever and chills that began to subside around 24 hours post vaccination. For the next 48 hours had residual aches and fatigue. Began feeling significantly better after the 72 hour mark. However, after learning about blood clot issue has been having anxiety and some left sided pain that I'm not sure if it's anxiety or migraine related or possibly something worse.
43 2021-04-19 excessive sleepiness, impaired work ability Patient reports: "I received my covid 19 vaccine on Friday April 9th (J&J) and need to report my rea... Read more
Patient reports: "I received my covid 19 vaccine on Friday April 9th (J&J) and need to report my reactions afterward. Had the usual immediate arm pain after injection along with nausea. Took a Benadryl and napped when got home and woke up 6 hours after injection with a tingling and swollen lower lip and constricted breathing. Took 3 Benadryl in fear of going to hospital and waited it out. Once lip went back to normal as well as breathing went to bed since it was late and slept all day Saturday. Woke up Sunday in agony from lower back pain and tailbone. Now, thurs 4/15 still in extreme pain in my tailbone. Went twice to chiropractor to help and nothing is alleviating the pain and have been practically bed ridden since Sunday. Can?t work, can?t sit, can?t walk can?t stand can?t anything without extreme pain. Been taking ibuprofen everyday and not helping." She had a visit with us on 4/15/2021: "Patient here for extreme pain on her tailbone. She had the Johnson and Johnson vaccine about 6 days ago and about 6 hours later she woke up with a tingling and swollen lip, constricted breathing, and dizziness. She wanted to avoid the hospital, so she took benadryl 75 mg and it slowly resolved her symptoms. These symptoms have not returned since. She was finally able to fall asleep that night and then slept all day the next day. The following day she woke up and experienced extreme pain in her lower back and tailbone. She saw her chiropractor twice this past week, which helped to resolve her low back pain. Per patient her chiropractor noted that her back seemed very inflamed. However, she is still having extreme pain with her tailbone and is unable to sit, stand, bend or work for more than 20 minutes without extreme pain. The only thing that seems to improve her pain is laying on her back with several pillows tucked behind and all around her. However, she is only able to stay in this position for a period of time before her body becomes stiff from immobility. She has been taking ibuprofen 600 mg TID, flexeril PRN, icing and applying moist heat to her back, but none of these measures seem to improve her pain. Lastly she has noticed that when she sits/stands for too long, her buttocks start to spasm. Denies fever, chills, n/v, numbness, tingling, incontinence or loss of bowel/bladder function."
43 2021-04-20 anxiety JOINT PAIN; INFLAMMATION OF THE RIBS; VAGINAL BLEEDING/CLOTS; CYSTS ABOVE THE LEFT ELBOW; FATIGUE; A... Read more
JOINT PAIN; INFLAMMATION OF THE RIBS; VAGINAL BLEEDING/CLOTS; CYSTS ABOVE THE LEFT ELBOW; FATIGUE; ANXIETY (TINGLING ALL OVER THE BODY ESPECIALLY THE WAIST, SHORTNESS OF BREATH, WEAKNESS); BACK PAIN; NECK PAIN; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol consumer, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies, no relevant medical history prior to the start of these symptoms. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative, Negative. On 2021, Laboratory data included: Biopsy (NR: not provided) Not reported. On 28-MAR-2021, the subject experienced anxiety (tingling all over the body especially the waist, shortness of breath, weakness). On 28-MAR-2021, the subject experienced back pain. On 28-MAR-2021, the subject experienced neck pain. On 30-MAR-2021, the subject experienced fatigue. On 31-MAR-2021, the subject experienced vaginal bleeding/clots. On 31-MAR-2021, the subject experienced cysts above the left elbow. On 05-APR-2021, the subject experienced inflammation of the ribs. On 06-APR-2021, the subject experienced joint pain. Treatment medications (dates unspecified) included: paracetamol, salbutamol, norethisterone acetate, trazodone, and hydroxyzine embonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cysts above the left elbow, and had not recovered from back pain, neck pain, anxiety (tingling all over the body especially the waist, shortness of breath, weakness), vaginal bleeding/clots, joint pain, fatigue, and inflammation of the ribs. This report was non-serious.
43 2021-04-21 feeling abnormal, disturbance in attention fatigue, chills, body aches, brain fog, difficulty concentrating, chest pains, earlier menstruation,... Read more
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.
43 2021-04-21 feeling abnormal Reports bilateral calf pain with numbness concerning for bilateral DVT. Symptoms began night of 4/2... Read more
Reports bilateral calf pain with numbness concerning for bilateral DVT. Symptoms began night of 4/21/21. Reports feeling brain fog and fatigue.
43 2021-04-22 disturbance in attention Numb left arm, intense headaches, inability to coordinate a fraise, pinches on the brain, blurred vi... Read more
Numb left arm, intense headaches, inability to coordinate a fraise, pinches on the brain, blurred vision, problems to be focus. (attention problem)
43 2021-04-22 loss of personal independence in daily activities, sleep disorder The night of the vaccine I woke up around 1am with chills and a lot of pain on the vaccine site I co... Read more
The night of the vaccine I woke up around 1am with chills and a lot of pain on the vaccine site I could not sleep that night. The next day when I tried to work I couldn't go down the stairs because my legs where hurting a lot. I also had a huge headache I couldn't eat I felt very nauseas. My worst symptoms were my headaches it was a sever headache. On 4/12/2021 & 4/13/2021 I had diarrhea. On 04/1 4/2021 I went to the ER they did blood work they did a heart exam everything came out good and they just said it was just a reaction to the vaccine. I kept drinking Tylenol for my headache. On 4/17/2021 is when I did not feel the headache anymore. Now I just feel very fatigue.
43 2021-04-23 anxiety, excessive sleepiness VERY EMOTIONAL; SEVERE BODY ACHE; ANXIETY; SEVERE CHILLS; JOINT PAIN; HEADACHE; FELT FEVERISH; SLEPT... Read more
VERY EMOTIONAL; SEVERE BODY ACHE; ANXIETY; SEVERE CHILLS; JOINT PAIN; HEADACHE; FELT FEVERISH; SLEPT MOST OF THE DAY; 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 past medical history included bronchitis, shoulder and hip issue, and the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, 1 total, administered on 12-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, after midnight the patient had chills and felt feverish. She was very emotional and had body aches, joint pain which was for about three hours. She had slept most of the day next day and had some body aches and headache. She felt better by Sunday 14-MAR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very emotional, severe body ache, anxiety, severe chills, joint pain, headache, felt feverish and slept most of the day on 14-MAR-2021. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and headache, felt feverish, severe chills, severe body ache and anxiety as related and between covid-19 vaccine ad26.cov2.s and very emotional, joint pain and slept most of the day as possible. Company causality between covid-19 vaccine ad26.cov2.s and headache, felt feverish, severe chills, severe body ache, anxiety and slept most of the day was possible. 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.
43 2021-04-23 feeling abnormal 18 hours after shot -- began to have a headache, then 5 hours later (at 5pm) my face felt hot. I rar... Read more
18 hours after shot -- began to have a headache, then 5 hours later (at 5pm) my face felt hot. I rarely have headaches. I checked my temperature, but it was in the normal range (98.3 degrees) I took Tylenol (2 pill), hydrated, ate dinner and slept. I felt ok the next day, just a little strange (hard to pinpoint issue ... but "off"). Took another 2-pill dose of Tylenol just in case.
43 2021-04-29 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild
43 2021-05-05 confusional state, feeling abnormal The first 3 days after the vaccination, I didn't feel safe driving, my coordination was impacted, I ... Read more
The first 3 days after the vaccination, I didn't feel safe driving, my coordination was impacted, I was not able to think straight (heavy brain fog). I was hoping this would subside, but here I am a month later, not being able to remember my own friends names, not able to do simply Math, I feel as if the vaccine may have caused some brain swelling.
43 2021-05-05 sleep disorder Pain in left arm still persists over a month later.. hard to lift anything.. causing twitching and t... Read more
Pain in left arm still persists over a month later.. hard to lift anything.. causing twitching and tingling in my neck and left side of my face. Horrible Severe all-over-body itching three weeks after still persists and is getting worse as of today's date. No rash or any sign of reasoning. Went to an urgent care facility, ran a full CBC, all is healthy as normal-must be from vaccine. Suffering and losing consistent sleep from the itching rages that come and go.
43 2021-05-08 nervousness, loss of personal independence in daily activities Received Vaccine on 4/8/2021 and had Immediate Vertigo 5 minutes after shot. I drove home scared bec... Read more
Received Vaccine on 4/8/2021 and had Immediate Vertigo 5 minutes after shot. I drove home scared because I was very dizzy. It is 1 month today and I still cannot drive. Left side of face went numb for a few hours on that day as well. I now have left side weakness, dizzy, off balance and lightheaded. I get occasional bouts of nausea. Prior to getting this vaccine I was running 10 miles a day. It is now difficult to walk much less run. 1 month after getting this vaccine and I have not gone back to normal yet. I want my life back
43 2021-05-08 nervousness, panic attack, loss of personal independence in daily activities, impaired work ability, feeling abnormal 1st few days expected to be sick. Then the ?pause? so expected to be nervous, but 2 weeks out starte... Read more
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
43 2021-05-09 feeling abnormal, loss of personal independence in daily activities Ongoing serious fatigue often accompanied by weakness and dizziness Almost every single day over th... Read more
Ongoing serious fatigue often accompanied by weakness and dizziness Almost every single day over the past month I have felt awful and struggle to complete my daily responsibilities. I was an extremely healthy, athletic individual 5'4" 114" and haven't had any other vaccines since 2 travel immunizations 5 years ago. Nothing else about my lifestyle has changed.
43 2021-05-16 feeling drunk, disturbance in attention By 7:30, I felt drunk. My brain was not functioning normally and had a fever all night. By 7:15 I fe... Read more
By 7:30, I felt drunk. My brain was not functioning normally and had a fever all night. By 7:15 I felt fine, with the exception for random joint pain. The following Friday, April 9th, I had bloodwork done. It felt like I had hit my funny bone. I had shooting pain up my arm and into my neck and down my spine. I thought it was just the blood draw, so I suffered all weekend. My husband made me go to the doctor on Monday. My doctor said I had the same symptoms of a blood clot. They sent me to the hospital for an ultrasound and blood tests recommended, but everything was negative. She told me to just watch out for any changes and it went away after a few days.
43 2021-05-19 impaired work ability The night I started getting feverish. I rested. On Monday, I called out sick. Monday, Tuesday - it w... Read more
The night I started getting feverish. I rested. On Monday, I called out sick. Monday, Tuesday - it was chills, fever. 2nd day, my legs started having a sensation I've never ever felt - like cramping/charlie horse. I went to work on the third day but I needed to go home. When I came home, my legs were doubled the size. I tried to ride it out by resting. Ever since then, my legs have weird sensations - not cramps but aches. I have never felt this before. Once in a while, when I'm walking, I get cramps. It still hasn't gone away. At the end of the day, my legs will be swollen but not as bad as the third day after the vaccine. I think my platelets are actually too high so I think that is a good thing. Upcoming doctor's appt on July 9 - she is going to do a whole physical with bloodwork.
43 2021-05-25 restlessness Severe pain where the shot was given. Unable to raise arm, unable to sleep on the left arm. 05/26 Fe... Read more
Severe pain where the shot was given. Unable to raise arm, unable to sleep on the left arm. 05/26 Fever of 101. 3 05/26 Skin sensitive to touch on whole body, restless body, upper back pain.
43 2021-05-26 emotional distress, depression, insomnia Severe migraine overnight, difficulty sleeping. Slight headache for several days after. Slightly e... Read more
Severe migraine overnight, difficulty sleeping. Slight headache for several days after. Slightly elevated temperature overnight. Inconsolable crying and sadness overnight. Depression symptoms worsening and continuing to be worse than before vaccination.
43 2021-05-27 confusional state, mental impairment, amnesia, memory impairment HYPOXEMIA; UNABLE TO FOCUS; COLD CHILLS; WEAK; TIRED; FEVER; PAIN; VERY FORGETFUL; HARD TO TALK; LOS... Read more
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).
43 2021-05-29 disorientation At the 2 week mark after taking the vaccine I developed severe backache ,a fever,fatigue and disorie... Read more
At the 2 week mark after taking the vaccine I developed severe backache ,a fever,fatigue and disorientation.
43 2021-05-29 feeling abnormal Sudden nausea, overall larthagic feeling, very tired. Today, Sunday 5/30/21, symptoms returned stron... Read more
Sudden nausea, overall larthagic feeling, very tired. Today, Sunday 5/30/21, symptoms returned strong. I am feeling very bad right now. Injection site stinging and arm very sore.
43 2021-05-29 feeling abnormal First felt light headed, then my tongue, throat, and neck felt sore within approximately one hour of... Read more
First felt light headed, then my tongue, throat, and neck felt sore within approximately one hour of injection. Then my eyes started itching and it was more difficult to breathe through my nose. Things looked funny/off and I felt off; heavy/like lead and fuzzy and spacey at the same time. My vision was blurry when I tried to look at objects up close - like my phone. I had to blink several times and hold the object further away to see it. By dinner time, around 5:30, I noticed raised bumps on the sides and back of my tongue. To my knowledge, they were not there prior to the injection, but I don?t usually inspect my tongue. I did so around dinner because of how sore, puffy, swollen, and big my tongue felt. It looked splotchy in shades of white and yellow. My throat also felt puffy and swollen. At 3:50 am I woke up and my left eye was puffy and difficult to see out of. I was cold, clammy, and sweating. I had a really bad headache and felt nauseous. I took 2 ibuprofen and went back to bed. Around 7:30 or 8:00 am I got up and moved around. My left eye was no longer puffy and I could open it, but my eyes, nose, and throat were itching so badly that I wanted to scratch at them. My tongue, throat, and respiratory system felt puffy and swollen. I noticed it took much more effort to breathe. I got some water and took a Benadryl. I layed down and put my feet up. I covered up because I was cold. I fell asleep. A few hours later I woke up and could breathe easier. The itching was less intense and my tongue, throat, and respiratory system felt less swollen and more normal.
43 2021-06-14 depression, anxiety, sleep disorder initial - 20 minutes after shot - 1 quick shot of vertigo but I was already in the car. Next day - h... Read more
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.
43 2021-06-15 feeling abnormal LEFT SIDE OF TONGUE FEELS LAZY AND LINGERING; UNABLE TO PRODUCE WORDS OUT OF MOUTH; NOT ABLE TO SEE ... Read more
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.
43 2021-06-17 impaired work ability Developed pneumonia and is still having on-going problems which I'm being treated for now. Haven't b... Read more
Developed pneumonia and is still having on-going problems which I'm being treated for now. Haven't been able to work since 04/19/2021
43 2021-06-25 loss of personal independence in daily activities Patient complains of frequent headaches since getting the vaccine almost 3 weeks ago. Headaches inte... Read more
Patient complains of frequent headaches since getting the vaccine almost 3 weeks ago. Headaches interfere with activities of daily life.
43 2021-07-07 feeling abnormal Fatigue, joint pain, injection site pain, redness of skin, brain fog, clammy
43 2021-07-07 feeling abnormal I had some dizziness, headaches, right side neuropathy. I was also tired all the time. I went to the... Read more
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.
43 2021-07-11 loss of personal independence in daily activities Horrible migraine 5/30-6/4 went to PCP to get a migraine shot because my migraine breakthrough medic... Read more
Horrible migraine 5/30-6/4 went to PCP to get a migraine shot because my migraine breakthrough medicines would not work.Strep throat on 6/11/21 and then my back went out -I was in ER 7/2/21 i couldnt walk or move without crying out in pain.I could not move my legs. Released from theER when I could stand up even though I was still in excruciating pain. I was given a cocktail of muscle relaxer, anti-inflammatory, nausea& 4mg of morphine. I could still feel the pain.Finished the prednisone 7/6 went to a dr at my PC office prescribed me tizanidine 4mg 3x a day, but it isnt helping. Can barely walk, cant drive,I cant turn in bed to roll to my other side. Once I get in one spot I have to stay to stay there.
43 2021-07-15 anxiety, loss of personal independence in daily activities, panic reaction I had the dose on 04/09/2021 and on 04/12/2021 I started having some symptoms and on Tuesday I start... Read more
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.
43 2021-07-27 anxiety 2 weeks after vaccine pt developed increased anxiety, shortness of breath, fatigue and palpitations.... Read more
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.
44 2021-03-09 excessive sleepiness Extreme fatigue. Slept most of the time for two days. Got shot at 10:40 AM. Left Arm immediately... Read more
Extreme fatigue. Slept most of the time for two days. Got shot at 10:40 AM. Left Arm immediately felt odd---sore, heavy, tingly all the way down to my wrist. By noon, I was asleep. Slept for about 3 hours. Up for 3 hours. Slept for 3. Up for 3. Then slept all night. I had a headache and slept most of the next day. Definitely felt like my body was fighting something. I have an approximately 3 inch diameter circle around injection site that is a red, swollen, hard, lump, It is hot to the touch and extremely sore---at times it itches. I am shocked how big and hard the knot is. Its crazy! I cannot put weight on that arm. Extremely sore. It is now 4 days after the vaccine and the knot does not seem to be getting smaller. In fact, it may be bigger.
44 2021-03-12 feeling abnormal I suffered a fever from 3/10/21 at 2am until 3/12/21 at 11pm. 9n 3/13 at 7am I woke up with red blot... Read more
I suffered a fever from 3/10/21 at 2am until 3/12/21 at 11pm. 9n 3/13 at 7am I woke up with red blotches all over the tops of my feet and toes and my hair is falling out in clumps. I've also had migraines off and on and brain fog.
44 2021-03-13 feeling abnormal Patient received vaccine and after checking on her in about 10 minutes, she reported that her tongue... Read more
Patient received vaccine and after checking on her in about 10 minutes, she reported that her tongue felt weird, kind of tingly. I said I wanted to give her benadryl and patient refused. Sat with patient and she reported no changes, just felt different and tingled a little. Patient stated that it did not feel like allergic reactions she has had in the past. Checked tongue and lips for swelling, no sign of anything like that or other signs of anaphylaxis. By the end of allotted 30 min waiting period, patient said she felt normal again. She stayed in the store for another 30 minutes and reported back that she was fine.
44 2021-03-16 restlessness Dizziness, Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Palpitations, Tachycardia... Read more
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:
44 2021-03-17 feeling abnormal Around 7 pm on 3/13, I developed brain fog, trouble walking, and then fever, severe muscle pain wors... Read more
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.
44 2021-03-26 sleep disorder My left arm started hurting on Friday March 19 and is still hurting. I can not sleep on the left si... Read more
My left arm started hurting on Friday March 19 and is still hurting. I can not sleep on the left side since getting the vaccine. It hurts to move the arm different ways. Many times, I have to lay flat to get relief from the pain. I don't have alot of strength in my left arm since getting the vaccine. I consulted the school nurse about my effects and she stated it could be an inflamed nerve.
44 2021-03-28 feeling abnormal Left foot became tingly as if it had fallen asleep starting at around 8:00 pm the evening of the inj... Read more
Left foot became tingly as if it had fallen asleep starting at around 8:00 pm the evening of the injection. I was sitting on the couch with my legs outstretched and crossed at the ankle in front of me. I thought it was because I had my legs crossed. I uncrossed them. The feeling did not go away. It is now the next day and the feeling is still present. I sit this way often and have never had this happen before. I assume it is due to the vaccine. It is extremely weird to feel pins and needles constantly in your foot.
44 2021-03-28 impaired work ability Headache started 3 hours after vaccine was administered. Extreme fatigue, nausea, low grade fever (1... Read more
Headache started 3 hours after vaccine was administered. Extreme fatigue, nausea, low grade fever (100.2), extremely sore arm and slight shortness of breath followed. Symptoms lasted 3 days (missed a day of work) and I still have a sore arm 9 days later. If my arm is bumped or touched at all still quite painful.
44 2021-03-31 abnormal dreams Headache, fever, chills, body aches, joint pain, sweating, fatigue, vivid dreams
44 2021-03-31 feeling drunk Headache, nausea, fever, chills, muscle aches, tired, feeling like I'm drunk
44 2021-04-02 anxiety Patient is a * year old * who received a single dose of J&J COVID 19 vaccine in the right deltoid. ... Read more
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
44 2021-04-03 sleep disorder At 12h post injection: muscle aches, fever, headache, thirst, unable to sleep, arm sore at injection... Read more
At 12h post injection: muscle aches, fever, headache, thirst, unable to sleep, arm sore at injection site. From 12 to 28h post injection these symptoms persisted. At 28h post injection - took 500mg acetaminophen (only time it was taken). At 32h post injection - symptoms improved and slept 10 hours. At 42h post injection - fatigue and lack of stamina (weak and short of breath with exertion). At 48h post injection - some energy level returned At 66h post injection - still fatigue and sore arm
44 2021-04-03 sleep disorder Headache - started just after midnight ~8 hours after injection Muscle Aches - severe on left side ... Read more
Headache - started just after midnight ~8 hours after injection Muscle Aches - severe on left side Joint pain - severe on left side/elbow Fever - 102 degrees at 4am Took 2 extra strength Tylenol Headache, aches, pains continued not quite as bad Nausea started around 9 am Vomiting & diarrhea about 10 am Nausea continued most of day until 8 pm or so but no more vomiting. Aches, pains, headache continued all day and into the evening. Fever fluctuated between 98.4 and 102.5. Stayed in bed all day with no appetite, kept eyes mostly closed, but couldn?t sleep more than ~30 minutes at a time. 9pm finally able to eat a little apple and took 2 more extra strength Tylenol. Still headache, Fever, aches, pains when I went to sleep for night but was was able to sleep 2-4 hour increments. 4/4/21 morning ~8 am (about 40 hours post injection) muscle aches and pain improved a lot. Left arm & joint still a little sore. Fever and headache improved. Very weak and tired and no appetite after a day in bed with yesterday?s symptoms.
44 2021-04-07 disturbance in attention, mental impairment PT CALLED STATING 2HRS AFTER HER VACCINE, SHE FELT LIKE SHE WAS "HIT IN THE HEAD WITH A BRICK"; THIS... Read more
PT CALLED STATING 2HRS AFTER HER VACCINE, SHE FELT LIKE SHE WAS "HIT IN THE HEAD WITH A BRICK"; THIS CONTINUED OFF AND ON, THEN AROUND 7PM SHE DEVELOPED SUDDEN, SEVERE FATIGUE, THE AROUND 9PM SHE STATES SHE DIFFICULTY WITH HER THOUGHT PROCESSES AND DIFFICULTY WITH COMMUNICATING WORDS THAT SHE WOULD TRY TO SAY. SHE STATES THE SYMPTOMS HAVE BEEN IMPROVING OVER THE LAST COUPLE DAYS AND IS FEELING BETTER BUT SHE HAS DIFFICULTY CONCENTRATING ON THINGS. DENIES ANY OTHER S/S.
44 2021-04-08 anxiety 3/31/2021 2:44 PM B/P 140/88 Pulse 90 Respirations 18. Patient stated "I'm having a reaction to vacc... Read more
3/31/2021 2:44 PM B/P 140/88 Pulse 90 Respirations 18. Patient stated "I'm having a reaction to vaccine", evaluated in First Aid area, feeling dizzy, anxious, face and neck flushed, no uticaria, lungs clear and equal, no wheeze. 3:05 PM B/P 118/76 Pulse 78 Respirations 16 Discharged home with instructions to monitor for return of symptoms, seek further care if symptoms persisit
44 2021-04-08 disturbance in attention - Extreme fatigue, starting one hour after shot for more than 48 hours, sleep/rest/Aleve - Painful j... Read more
- Extreme fatigue, starting one hour after shot for more than 48 hours, sleep/rest/Aleve - Painful joints/most noticeable in arms, elbows, ankles, hips, starting one hour after shot for more than 48 hours, sleep/rest/Aleve - Painful muscles in fully body, starting one hour after shot for 48 hours, sleep/rest/Aleve - Dizziness and weakness, starting one hour after shot for 48 hours, sleep/rest/Aleve - Lightheadedness, starting one hour after shot for 48 hours, sleep/rest/Aleve - Swelling of arms and hands, starting one hour after shot for 48 hours, sleep/rest/Aleve - Headache, starting one hour after shot for 24 hours, sleep/rest/Aleve - Decreased mental clarity/slow to process information and speak, starting one hour after shot for 24 hours, sleep/rest/Aleve
44 2021-04-08 feeling abnormal Janssen COVID-19 Vaccine EUA: Immediately after the vaccination my arm was sore and shortly after m... Read more
Janssen COVID-19 Vaccine EUA: Immediately after the vaccination my arm was sore and shortly after my right hand was stiff. About 8 hours after receiving the vaccination I began to have extreme chills and a fever that was near 102 F. I had a fever and chills all night and woke up with a migraine. After sleeping most the day from extreme tiredness I woke up to my head feeling very weird and I was acting very sleepy and irritable according to those around me. After 24 hours, most reactions have gone away except for soreness at the injection site and a pain in my right leg.
44 2021-04-08 insomnia Within the first few minutes I had a flushed red face and pins and needle feeling on top of my head ... Read more
Within the first few minutes I had a flushed red face and pins and needle feeling on top of my head 6 hrs after shot I started with chills and a temp of 101.7 Achy and uncomfortable Insomnia Next day headache and no appetite Day three headache persisted with diarrhea and arm pain at injection site
44 2021-04-10 feeling abnormal Headache, dizziness, muscle fatigue, tiredness, fever, brain fog. 24 hour point after injection cou... Read more
Headache, dizziness, muscle fatigue, tiredness, fever, brain fog. 24 hour point after injection couldn't even get out of bed. Took fever reducer and started to feel better 36 hour mark. Was dizzy with headache and brain fog until 48 hour mark.
44 2021-04-12 feeling abnormal BODY ACHES; BRAIN FOG; ARM WAS EXTREMELY SORE FROM SHOULDER TO ELBOW; CHILLS; FEVER; CHEST PAIN; HEA... Read more
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.
44 2021-04-12 feeling abnormal Woke up at 2AM on April 12 with severe muscle aches throughout entire body and jaw. Worst pain was... Read more
Woke up at 2AM on April 12 with severe muscle aches throughout entire body and jaw. Worst pain was in my lower back and neck. Reflux symptoms at 4AM which caused me to take 2 OTC Gaviscon which gave relief. At 7AM experienced a fogginess and severe fatigue. Lack of appetite throughout the day. All symptoms continued throughout the day and that night. Next morning at 7AM muscle aches had subsided except for some aching at injection site. Took two ibuprofen for that pain. Felt foggy and fatigued through time of report at 1:22 PM April 13.
44 2021-04-12 excessive sleepiness On the 8th of April I got my shot at 1:30 p.m. My my arm was sore immediately when the vaccine was p... Read more
On the 8th of April I got my shot at 1:30 p.m. My my arm was sore immediately when the vaccine was put into my muscle. Around 5:30 p.m. I started feeling muscle aches, headache, and fatigue. Took my temperature and later on that night it was at started having chills around 8:30 p.m. severe muscle pain. It almost felt like there was pain in my bones. Still had a headache loss of appetite. Extreme fatigue. Took ibuprofen and went to bed. Got up the next day on the 9th took some more ibuprofen still loss of appetite, muscle aches, joint aches. Took my temperature had a temperature of 100.6 still cold in very fatigued. I slept a lot. Got my temperature down. On the 10th I still had muscle aches off and on, still fatigued had to rest a lot, injection site hurt, headache too. On the 11th off and on muscle aches, fatigue, loss of appetite, almost like my taste buds were off too. On the 12th less muscle aches ,small headache, still fatigued. On the 13th still fatigued.
44 2021-04-12 impaired work ability The patient called today complaining of pain, primarily in her legs, that had not improved since rec... Read more
The patient called today complaining of pain, primarily in her legs, that had not improved since receiving the Janssen vaccine on 4/10. She thought it felt muscular but wasn't sure. The pain was affecting her ability to work today. I advised her to contact her primary care dr's office or go to urgent care. She called back after seeing her dr today - the dr recommended ibuprofen for pain and said she had a "strong reaction" to the vaccine. According to the patient, no further concerns were identified.
44 2021-04-12 mental status changes, incoherent, altered state of consciousness Patient resting in car.....she was not making eye contact and short with answers to questions. Pati... Read more
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.
44 2021-04-13 feeling abnormal I was give the vaccine 7pm at night and woke up the following morning and started to feel tingling f... Read more
I was give the vaccine 7pm at night and woke up the following morning and started to feel tingling from my elbows to finger tips. It felt odd but no other symptoms. I was at the grocery store and while reading the label of a mustard jar I inadvertently dropped it which was also odd. This was 2 days ago and at the time it seemed like a harmless mild side effect but now that I see incidence I'm reporting it.
44 2021-04-13 feeling abnormal Immediate dizziness and nausea. Became tachycardic within an hour. This is still an issue 3 weeks ou... Read more
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.
44 2021-04-13 feeling abnormal Peristent headache, pain in lower abdomen, tightness of skin in left leg, consistent fatigue, and br... Read more
Peristent headache, pain in lower abdomen, tightness of skin in left leg, consistent fatigue, and brain fog. Loss of appetite.
44 2021-04-13 mental status changes, amnesia, anxiety, feeling abnormal on the day of vaccination: rash, redness of face and shoulders and neck, vomiting, extreme fatigue t... Read more
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
44 2021-04-14 anxiety My arm was immediately sore and was sore for a week. Within a few hours from the vaccine being admi... Read more
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.
44 2021-04-14 crying vaccinated 3/31/2021 w/o any problem. on 4/8/2021 about 6 pm she had ?allergic reaction? with sudd... Read more
vaccinated 3/31/2021 w/o any problem. on 4/8/2021 about 6 pm she had ?allergic reaction? with sudden severe bilat eyelid swelling and swelling both external ears with "weeping" (transudate) and bilat ear pain. no swelling lips/tongue, no wheeze, no SOB, no hives. Seen at a Urgent care on 4/9/2021 diagnosed with bilat otitis media, bilat otitis externa, started on Augmentin and ciprofolxacin drops. seen by me 4/15/2021 with ear pain, congestion, hearing loss. exam shows bilat suppurative otitis media. I switched her to DS Septra and have asked her to follow up with ENT if not improving. she has never had an ear infection nor allergic reaction like this before.
44 2021-04-14 feeling abnormal Dizziness, muscle aches and soreness, random muscle pain in wrist, jaw, lower back, neck. Had to u... Read more
Dizziness, muscle aches and soreness, random muscle pain in wrist, jaw, lower back, neck. Had to use rescue inhaler once(normally only use before exercise) fatigue Brain Fog
44 2021-04-15 feeling abnormal Strange headache began and continued after about 24 hours after receiving vaccine, headache continue... Read more
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.
44 2021-04-15 feeling abnormal TIRED; NUMB FACE,PRIVATE AREA,TONGUE,LEGS AND SKIN(NO PAIN SENSATION IN TONGUE WHILE BITING); DIARRH... Read more
TIRED; NUMB FACE,PRIVATE AREA,TONGUE,LEGS AND SKIN(NO PAIN SENSATION IN TONGUE WHILE BITING); DIARRHEA; HEAD CLOUDINESS; BODY ACHE WHILE IN SLEEP; NAUSEA; 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 hypothyroidism. The patient had no history of anaphylaxis reaction. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism. On 06-APR-2021, the subject experienced numb face, private area, tongue, legs and skin (no pain sensation in tongue while biting). On 06-APR-2021, the subject experienced diarrhea. On 06-APR-2021, the subject experienced head cloudiness. On 06-APR-2021, the subject experienced body ache while in sleep. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, head cloudiness, and body ache while in sleep on 06-APR-2021, had not recovered from numb face, private area, tongue, legs and skin(no pain sensation in tongue while biting), and the outcome of nausea and tired was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
44 2021-04-15 feeling abnormal I will begin by noting that I am known for high pain tolerance and have been a strong, healthy, prof... Read more
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.
44 2021-04-15 sleep disorder The evening that I got my shot I felt the common side effects like flu symptoms. I also had a rapid ... Read more
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.
44 2021-04-18 sleep disorder At approx 11:30pm my wife woke up and ran to the bathroom complaining of extreme nausea, fatigue, an... Read more
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.
44 2021-04-21 feeling abnormal HIVES; FEVER; NAUSEA; COLD; BODY PARTS FELT BAD; This spontaneous report received from a patient con... Read more
HIVES; FEVER; NAUSEA; COLD; BODY PARTS FELT BAD; 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, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced cold. On 09-APR-2021, the subject experienced body parts felt bad. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, and nausea, had not recovered from hives, and the outcome of fever and body parts felt bad was not reported. This report was non-serious.
44 2021-04-21 loss of personal independence in daily activities, feeling abnormal A few hours after the vaccine I felt really bad. I had severe diarreah and abdominal pains which ca... Read more
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
44 2021-04-21 sleep disorder Three days after the vaccine I started to get a feeling of pressure on my chest. I woke up during th... Read more
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.
44 2021-04-24 anxiety Within 24hours pt with fever, myalgia, chills, rigors, weakness and extreme dizziness with headache ... Read more
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.
44 2021-04-25 crying The day I received the Janssen vaccine, I had pain at the injection site immediately, which was to b... Read more
The day I received the Janssen vaccine, I had pain at the injection site immediately, which was to be expected. My arm was very sore for over a week. I felt ill at dinnertime but was able to eat. Around 10:30 PM I started to feel like my skin was on fire. It was hot to the touch as well. However, I was freezing and couldn't get warm. My teeth were chattering. I started crying uncontrollably. I have never had tears run so hard down my face. The tears felt like they were burning my skin because my skin felt so hot. I awoke my husband to help me. He wanted to take me to the Emergency Room, but I wanted to wait. My muscles ached terribly. I had to pace back and forth because of the intense pain. My head also felt like it was going to blow off of my body. It wasn't like a normal headache. It felt like I had swelling in my brain. The left side of my head was sore for days afterwards. I then became terribly nauseated. I didn't throw up but felt like I was going to. I also felt extremely dehydrated. I was able to drink some water. It was a very long night. Looking back, I probably should have gone to the ER. My husband worked from home the next day so he could be available if needed. It took a long time for me to fully recover. I woke up exhausted and struggled with fatigue for a while and had extreme exhaustion in the evenings. My ears would turn bright red in the evenings and feel hot to the touch. I still have some fatigue now but am mostly better.
44 2021-04-26 excessive sleepiness The night of the vaccine I had normal symptoms - chills, discomfort, headache. The next day I vomite... Read more
The night of the vaccine I had normal symptoms - chills, discomfort, headache. The next day I vomited. For the 15 (FIFTEEN) days that followed I experienced severe nausea. I was unable to eat almost all solid food. I slept about 18 hours per day solid sleep. Blunt headache all the time. Diarrhea started week 2 and the intense nausea did not subside. It was not until a full 15 days later that the nausea finally subsided and I was able to get out of bed for more than a couple of hours at a time. Finally now April 27th I feel almost back to my normal self.
44 2021-05-02 sleep disorder About a month after the vaccine late that night I developed increased leg pain. My hip and knee joi... Read more
About a month after the vaccine late that night I developed increased leg pain. My hip and knee joint is so inflammed it cause issues with sleeping and I was diagnosed with Versitis in my hip and sent me to physical theraphy
44 2021-05-06 anxiety, anxiety Pt is a 44 yo female who received the J&J vaccination on 4/1/2021. She calls this institution on 4/1... Read more
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.
44 2021-05-07 disorientation Neurological disorientation such as staggered motor function. It has been challenging to walk- ext... Read more
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
44 2021-05-09 depression, feeling abnormal, panic attack, insomnia, anxiety 3/12/21 fatigue, brain fog, chills for about 12 hours as expected 3/16-3/21 extreme fatigue 3/21-3/... Read more
3/12/21 fatigue, brain fog, chills for about 12 hours as expected 3/16-3/21 extreme fatigue 3/21-3/22 stomach upset, dizziness, severe anxiety and panic 3/27/21 ER visit due to anxiety and panic; prescribed Ativan with no tests run 3/23- present Severe anxiety and panic, depression, heart burn, diahhrea, dizziness, headaches, weight loss of 20 lbs (unintentional), lack of appetite, insomnia, fatigue On 4/16/21 I had my thyroid levels checked. TSH in a October 2020 was 1.42. On 4/16/21 it was 0.21. Ultrasound of thyroid on 4/30/21 showed normal thyroid but 3 measurable calcium deposits on the side of the thyroid that are now being monitored. I have been unable to work on-site in school due to the anxiety and panic. I?ve tried 2 different anxiety meds but unable to take due to side effects.
44 2021-05-11 excessive sleepiness PT CALLED HEALTH PHARMACY REPORTING: RECIEVED VACCINE ON 4/29/21. SLEPT 18 HOURS AFTERWARDS. WOKE UP... Read more
PT CALLED HEALTH PHARMACY REPORTING: RECIEVED VACCINE ON 4/29/21. SLEPT 18 HOURS AFTERWARDS. WOKE UP NEXT DAY WITH CONSTATNT HEADACHE. HAS CONTINUED THROUGHOUT ENTIRE TIME. IS RELIEVED SOME WITH TYLENOL THEN RETURNS. STILL HAS TODAY.
44 2021-05-17 feeling abnormal Extreme vertigo, nausea, brain fog and fatigue that began approximately 36 post vaccine, followed by... Read more
Extreme vertigo, nausea, brain fog and fatigue that began approximately 36 post vaccine, followed by facial swelling .
44 2021-05-27 sleep disorder In mid-April I began to notice very mild neurological symptoms in my right arm and leg - pins and ne... Read more
In mid-April I began to notice very mild neurological symptoms in my right arm and leg - pins and needles, shooting pain down the extremity, numbness, very slight weakness. I have a history of radiculopathy and lumbar spinal arthritis but no recent history of injury or falls, so I attempted home treatment for a while but when that was ineffective after 2 weeks and symptoms were gradually and slowly worsening, I scheduled an appointment with my physician. I saw my physician on 05/21/2021 and he ordered x-rays (taken 5/26/2021), lab work, and an EMG/neurology consult (scheduled September). After the x-ray, the numbness, tingling, and pain in my R arm and R leg worsened and is now causing significant sleep disruption. Also now accompanied by similar symptoms in my R flank/side and pain in my spine from neck to tailbone. On 05/27/2021, I noticed that the right side of my face appears to be affected as well, with muscle spasm/jerking in my right cheek when I smile broadly. No facial drooping, difficulty speaking or swallowing, or respiratory involvement is noted at this time.
44 2021-05-31 sleep disorder SEVERE NERVE INFLAMMATION; RESTLESS LEG SYNDROME; MUSCLE CONTRACTIONS; PAIN FROM HEAD TO TOE, INCLUD... Read more
SEVERE NERVE INFLAMMATION; RESTLESS LEG SYNDROME; MUSCLE CONTRACTIONS; PAIN FROM HEAD TO TOE, INCLUDES FINGERS, TOES, EYELIDS, CHEEKS, ABDOMEN; SLEPT INTERMITTENTLY 5 TO15 MINUTES AT A TIME; CHILLS; EXTREME BURNING OF MUSCLES; MUSCLE PAIN THROUGHOUT BODY; SEVERE HEADACHE; This spontaneous report received from a patient by a Business partner on 27-MAY-2021 was received on 27-MAY-2021 and concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, and other pre-existing medical conditions included the patient had codeine allergy and no other illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021 23:30, the subject experienced severe nerve inflammation. On 25-MAY-2021 23:30, the subject experienced restless leg syndrome. On 25-MAY-2021 23:30, the subject experienced muscle contractions. On 25-MAY-2021 23:30, the subject experienced pain from head to toe, includes fingers, toes, eyelids, cheeks, abdomen. On 25-MAY-2021 23:30, the subject experienced slept intermittently 5 to15 minutes at a time. On 25-MAY-2021 23:30, the subject experienced chills. On 25-MAY-2021 23:30, the subject experienced extreme burning of muscles. On 25-MAY-2021 23:30, the subject experienced muscle pain throughout body. On 25-MAY-2021 23:30, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe nerve inflammation, restless leg syndrome, and extreme burning of muscles on 26-MAY-2021 11:30, muscle contractions, and muscle pain throughout body on 26-MAY-2021 15:00, and severe headache on 26-MAY-2021 20:00, and the outcome of chills, pain from head to toe, includes fingers, toes, eyelids, cheeks, abdomen and slept intermittently 5 to15 minutes at a time was not reported. This report was non-serious.
44 2021-06-09 loss of personal independence in daily activities as soon as i received the vaccine i had really bad arm pain then a tightness across my chest but was... Read more
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.
44 2021-06-14 loss of personal independence in daily activities, sleep disorder Vaccine was administered high and towards the back of the upper left arm. Retired, older lady was g... Read more
Vaccine was administered high and towards the back of the upper left arm. Retired, older lady was giving the shot, she didn't squeeze the arm muscle or check the arm for correct placement. Longer needle than was needed was used. Arm was relaxed during the entire duration of injection. As soon as the injection went in, deep pain was felt down to the wrist and mentioned to those administering the vaccine. They instructed me to move my arm as I left the area. I experienced immediate pain in the shoulder, never had arm muscle pain. Shoulder pain became excruciating over the next 2 weeks. Went to orthopedic walk-in clinic, they took x-rays and diagnosed me with impingement syndrome based off of my symptoms of pain and decreased range of motion. I started physical therapy April 26, 2021 and continue to present. Physical therapy has helped to increase range of motion and build some strength in the shoulder, but specific areas of pain (front and top/outside of shoulder area) continue to disrupt daily activities and interrupt sleep at night.
44 2021-06-15 impaired work ability, restlessness body aches restlessness, headache will not go away. not helped with Tylenol or advil. couldn't slee... Read more
body aches restlessness, headache will not go away. not helped with Tylenol or advil. couldn't sleep couldn't get comfortable. then runny nose, cough, sneezing, then dizziness, had to call out of work on Friday 6/11. then Saturday 6/12 significant face swelling. Tiredness-sleeping all day now for past week. called out of work Monday, Tuesday and Wednesday, severe weakness.
44 2021-06-18 impaired work ability, disorientation Within one minute of receiving the vaccine, I lost consciousness/ passed out. When I came to, it too... Read more
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?
44 2021-06-20 loss of personal independence in daily activities The varicose veins in my calves that I've had since my 20's started throbbing and aching. I wasn't ... Read more
The varicose veins in my calves that I've had since my 20's started throbbing and aching. I wasn't that concerned at the time because they do that sometimes during my menstrual cycle. I did find it odd and was frustrated because my entire body, and then varicose veins just ached and I couldn't do my morning runs. The veins in my hands burned and throbbed when I took a leisurely walk around the neighborhood with my husband. I told him at the time it felt like even my skin hurt.
44 2021-06-20 loss of personal independence in daily activities As of June 15, 2021 I was still experiencing head and face pressure and was not able to lay down, ex... Read more
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.
44 2021-06-20 sleep disorder, anxiety Severe headaches turned into sever pressure in my head, face (specifically nose, behind my eyes, and... Read more
Severe headaches turned into sever pressure in my head, face (specifically nose, behind my eyes, and temples.) My ears were pulsating and I was having daily dizziness. The pressure in my face and head was almost unbearable as nothing seemed to help make it go away. I went to my doctor's office for the 2nd time that week. I was feeling extremely anxious because I had been experiencing this head, face and ear pressure for days on end. I saw a PA in my doctor's office and she had me start taking anti-histamines, a low dose decongestant, and said to continue Advil throughout the day. I started the anti-histamines and then started taking Advil 3 times a day just to keep the head pressure at bay enough to function. At this time I had now been sleeping almost completely propped sitting up in my bed for weeks because the pressure in my head and nose area bacame unbearable whenever I attempted to lay down.
44 2021-06-20 sleep disorder I woke up in the middle of the night to a throbbing headache. I got up because continuing to lay do... Read more
I woke up in the middle of the night to a throbbing headache. I got up because continuing to lay down wasn't an option. I took 2 Advil and sat in my living room waiting for it to kick in. I have a history of migraines, but this was unlike any headache or migraine I've ever had. It felt like every vein in my head was throbbing and pulsating. It was even pulsating and throbbing through my face and in my ears. Every time I tried to lay back down it caused tremendous pressure in my head, so I had to sit back up. I wound up staying up all night due to not being able to lay back down. The headache finally subsided by morning.
44 2021-06-27 impaired work ability The evening of the vaccine I had severe chills, headache and I threw up. The next day the chills wer... Read more
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.
44 2021-07-08 hallucination, disturbance in attention Immediately 10 minutes after receiving the vaccination, I started sweating really bad, I got a metal... Read more
Immediately 10 minutes after receiving the vaccination, I started sweating really bad, I got a metal taste in my mouth. The next morning, I woke up with a huge migraine, couldn't concentrate, pain in my arm, and my whole body was just very hot. Over the next few months, I had developed swelling from my toes to my mid-calf, which went into my thigh the next week. It got to where I could no longer fit into my jeans. My whole body turned red. I went to the urgent care, which they immediately sent me to the ER. They did an ultrasound all over my body to test out blood clots, they took blood work. They ruled out having a heart attack and blood clots. They sent me home. A Few weeks later, I was at work and the pants I was wearing were cutting into my abdomen. I went to my PCP; I was so swollen head to toe. He put me on a steroid. PCP did blood work and everything is still going on and they still can't figure out why and having more symptoms on top of swelling. I have been on many different kinds of steroids. Had hallucinations, my PCP told me to go to the ER again. My breasts got super enlarged, the doctor I got at the ER still didn't figure anything out. They did a CT, Blood work, EKG, more ultrasounds. They then sent me to another ER, they did another CT, my brain was smaller than normal, my eyes were in the wrong place. To this day I am still experiencing all of these symptoms.
44 2021-07-14 excessive sleepiness I received the J&J vaccine last Thursday afternoon 7.8.21 and had a very strong reaction to the shot... Read more
I received the J&J vaccine last Thursday afternoon 7.8.21 and had a very strong reaction to the shot. The vaccine was received at 3:30pm and sometime after midnight I started experiencing intense body aches and pain with some abdominal pain. After waking up I was also having severe headaches and was light sensitive. This continued throughout the day Friday and I was unable to get out of bed at all. I slept for hours at a time and was so uncomfortable the other times that it was difficult to even find a position that felt good. On Saturday this got a little better but remained with body aches and bad headaches until late afternoon where I was sweating for several hours and then quickly regained my energy and the headaches resolved early evening. It was about 40 hours worth and pretty difficult. I reported this to my Doctor who suggested I enter the information into the vaers site.
44 2021-07-27 loss of personal independence in daily activities, sleep disorder My shoulder remained in pain as the usual Covid Vaccine reactions. From Day 5 and beyond my arm was... Read more
My shoulder remained in pain as the usual Covid Vaccine reactions. From Day 5 and beyond my arm was extra soar, started losing sensation in my left hand and forearm. Sleeping became unbearable after 10 days. I was unable to tend to normal daily thing slike cooking, dressing myself, shampoo, putting on sunscreen (by that time I was on vacation in Florida). It did not get better. My arm hurt, shoulder, forearm hand, weakness and pins and needs in my hand as well. I booked a doctors appointment for July 16.
45 2021-03-07 hallucination Severe pain, fever, hallucinations, dizziness, spasms loss of balance lasting until now ( 3/8)
45 2021-03-14 sleep disorder, feeling abnormal Sunday 3am night sweats, two days of heat rash with welting around my neck. three days of headaches ... Read more
Sunday 3am night sweats, two days of heat rash with welting around my neck. three days of headaches and nausea, four days of brain fog, and eight days of fatigue and sleep issues
45 2021-03-16 anxiety Later that evening I developed horrible anxiety and rapid HR which has caused me to have to stop ta... Read more
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
45 2021-03-17 impaired work ability Fever 101, chills, nausea, vomiting, dizziness first 24 hours. After 24 hours, ongoing severe nause... Read more
Fever 101, chills, nausea, vomiting, dizziness first 24 hours. After 24 hours, ongoing severe nausea and dizziness. Missed four days of work so far and was told symptoms may last up to 8 weeks by doctor.
45 2021-03-18 impaired work ability, sleep disorder I woke up nauseated and dizzy in the middle of the night. At 5 AM when I tried to get up for work, I... Read more
I woke up nauseated and dizzy in the middle of the night. At 5 AM when I tried to get up for work, I couldn?t walk due to the dizziness and headache. I attempted to shower, but was so dizzy I had to go back to bed. I felt terrible all day - nausea, headache, dizziness, muscle aches, pain at the injection site, and severe fatigue.
45 2021-03-18 mental status changes Diagnosis: Cortical vein thrombosis, massive intracerebral hemorrhage with tentorial herniation, thr... Read more
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.
45 2021-03-23 feeling abnormal 3 hours later, 5:30 pm Heaviness in legs 9 hours later, 11:30pm low fever, chills, aches for 2 hour... Read more
3 hours later, 5:30 pm Heaviness in legs 9 hours later, 11:30pm low fever, chills, aches for 2 hours. Took acetaminophen for relief. Symptoms did not return. 12-27 hours later, until 5pm the next day, sheer fatigue and exhaustion. Mind seemed sharp. No symptoms again until 3 days later, (72 hours), fatigue and heaviness feeling in head and body, headache, thirsty Sleep helped headache go. Drank water. 3 1/2 days later, in morning, woke with dizziness and vertigo like feelings. Stumbled and head fog. Dull feeling still on this 4th day. Muscles weakness in limbs, feeling faint, tightness in head, dehydrated feeling, congested. Drinking water. Sitting. Still working desk job, teacher.
45 2021-04-02 feeling abnormal Brain fog Fatigue Dryness / Dehydration
45 2021-04-04 disturbance in attention, feeling abnormal I got the vaccine on Tuesday. That night, I had some slight aches and was warm, but nothing awful. T... Read more
I got the vaccine on Tuesday. That night, I had some slight aches and was warm, but nothing awful. The next day, I was just a bit warm. I exercised on Thursday morning because I felt better (stand up paddling). Then the rest of the day, I was very tired and then Friday and Saturday and Sunday, I was very dizzy, foggy, fatigued, no mental clarity, difficult to hold a conversation and answer questions, no focus. Today, Monday, I still feel like I have a brain fog and am talking very slowly. No focus. Conversations feel tiring.
45 2021-04-04 feeling abnormal Woke up with chills the morning after receiving the vaccine. Piercing headaches in temples, all ove... Read more
Woke up with chills the morning after receiving the vaccine. Piercing headaches in temples, all over body aches, mostly in the back and neck. Body felt very fatigued. Nausea. Brain fog.
45 2021-04-05 feeling abnormal Received vaccine at 745a, at 8a patient stated "tongue felt weird", patient was offered 25mg of liqu... Read more
Received vaccine at 745a, at 8a patient stated "tongue felt weird", patient was offered 25mg of liquid benadryl. Patient's husband drove her home soon after. Checked on patient at 10am and she stated benadryl helped but her "throat felt uncomfortable" a few minutes prior to the call. Called again at 4:41p and patient said she now had a headache, nausea, chills, hot but no fever.
45 2021-04-05 feeling abnormal It is now 6 days after the shot and I feel like my brain is working slow. Almost like being drunk. T... Read more
It is now 6 days after the shot and I feel like my brain is working slow. Almost like being drunk. The night of the vaccine I had a 102 fever, chills. I was tired for 3 days after. Now the only remaining symptom is living in a fog. I have no health conditions. I am praying this goes away. I am not one to get sick or have any health issues. I don't use drugs or drink, smoke etc. Very scary. It is impacting my ability to do my job.
45 2021-04-06 anxiety Patient complained of shortness of breath, chest pain, dizziness, nausea and vomiting and dry mouth.... Read more
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
45 2021-04-07 confusional state Severe nausea, cold sweats, and severe dizziness which caused inability to comprehend or understand ... Read more
Severe nausea, cold sweats, and severe dizziness which caused inability to comprehend or understand what was going on around me and almost loss of consciousness. I was laid on the pharmacy floor immediately after reactions with a cold pack under my neck and my feet elevated. Within 5 minutes I was able to open my eyes and able to stand. I left with some dizziness and a headache that remained for a few days. I also had severe body aches for a couple of days and fatigue. Only thing is the arm pain and a little tiredness today.
45 2021-04-09 loss of personal independence in daily activities, feeling abnormal 4/6/21Day 1: Severe headache/Migraine, arm pain and tingling, loopy drugged feeling, dizzy, sleepy, ... Read more
4/6/21Day 1: Severe headache/Migraine, arm pain and tingling, loopy drugged feeling, dizzy, sleepy, nausea Day2: tired weak, migraine, nausea, dizzy, loopy, sore throat Day 3: : Severe diarrhea, nausea, faintish, not hungry, weak, dizzy, loopy, sore throat. headache Stayed in bed Day4: moderate diarrhea, (took Imodium) moderate nausea, slight dizzy, very weak, not able to leave house I am still experiencing symptoms.
45 2021-04-09 loss of personal independence in daily activities Joint pain by 10 PM on day of injection. By 11 PM Monday rejection severe body chills shaking uncont... Read more
Joint pain by 10 PM on day of injection. By 11 PM Monday rejection severe body chills shaking uncontrollable muscle twitches to the point where I could not speak or walk correctly which lasted for approximately one hour. By the by 8am the next day Fever 99.1 but my baseline temp is 96.7 to 97.1. Headache and nausea started around the time of the fever. I was unable to go to work on fri 4/9/21. Symptoms resolved by about 11 PM Friday 4/9
45 2021-04-09 sleep disorder myalgias, fever to 101, and fatigue approx 6 hours after administration. Abdominal pain throughout t... Read more
myalgias, fever to 101, and fatigue approx 6 hours after administration. Abdominal pain throughout the night. The next day around 3pm the patient developed severe, diffuse crippling abdominal pain, 10/10, while walking in the park. EMS was alerted by her husband because she was unable to get up or move from the spot due to pain. He gave her Pecid AC and by the time EMS arrived she was doing much better.
45 2021-04-11 anxiety Almost immediately pain at injection site, tingling down arm and through fingers, dizziness and n... Read more
Almost immediately pain at injection site, tingling down arm and through fingers, dizziness and nausea. Within 5 hours progressed to fever, extreme body pain, headache, dizziness shakiness and feelings of doom.
45 2021-04-11 loss of personal independence in daily activities, excessive sleepiness Normal reaction at first, tired, chills, fever, but for the first week I could hardly get out of bed... Read more
Normal reaction at first, tired, chills, fever, but for the first week I could hardly get out of bed, I was so tired. Would sleep 16 hours a day, at two weeks I was still very fatigued I went to doc to get flu n covid test in case, stated coughing too. A month later I got upper respiratory that I still have and have not been the same since getting it. Still fatigued.
45 2021-04-12 anxiety Restless leg syndrome and anxiety
45 2021-04-12 confusional state I had fatigue, body aches, unclear thinking for the first 2 days. On the third day I had a fever of... Read more
I had fatigue, body aches, unclear thinking for the first 2 days. On the third day I had a fever of 102 for 3 days, sever body aches, fatigue, unable to think clearly. I could not follow simple verbal or written instructions. I still have a cough, SOB, daily headache and fatigue. It is harder to breath when I am laying down and SOB increases with activity.
45 2021-04-12 disorientation Janssen COVID -19 Vaccine. 9 hours after the shot I woke up freezing cold, all my joints hurt, my mu... Read more
Janssen COVID -19 Vaccine. 9 hours after the shot I woke up freezing cold, all my joints hurt, my muscles were stiff, and I felt disoriented. I stayed in bed for a couple of hours. At 5am I got up with all the same symptoms and took my temp which was 101.4. My head hurt like there was too much pressure in my skull. I ate toast and took some ibuprofen and went back to bed. These symptoms lasted for 10 hours. Then for the next 5 hours I just had a fever off and on and fatigue. 3 days after the shot the gland in my left armpit became swollen. It has gone down in size but still sore 5 days later. I still feel tired too.
45 2021-04-12 fear Later on that evening I started feeling tired, chills, & fever. This lasted about 4 days on the 2nd ... Read more
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.
45 2021-04-12 feeling abnormal Administered around 10am. By 4pm, starting to feel lethargic, exhausted, achy. All of these were t... Read more
Administered around 10am. By 4pm, starting to feel lethargic, exhausted, achy. All of these were the feelings of being "sick" but not fully sick. By 6pm, I had a 102.2 fever which lasted through the night (approx 4am). I took 2 Tylenol a total of 3 times throughout the night and drank water. In addition to the fever, I experienced body aches and was drenched in sweat. By 6:45 am, I had broken the fever and showered. I worked throughout the day but felt very foggy in my head and just tired. I did not have another fever but did sweat through the night again on Wednesday evening. I had a dull headache on Thursday which eventually went away with OTC meds. Again exhausted on Thursday evening. By Friday, I was finally feeling a bit more normal.
45 2021-04-12 feeling abnormal slight fever, loss of appetite, very tired, lethargic, spacy for 4 days currently
45 2021-04-12 feeling abnormal pt started getting weak with a persistent headache. She states she has brain fog and light headines... Read more
pt started getting weak with a persistent headache. She states she has brain fog and light headiness. She says the symptoms come and go but seem worse after she has had something to eat or moves around excessively. She has been Tylenol and Pepto Bismol. She says the symptoms are some better but she still has them and cant seem to get rid of them. Pt is going to call her PCP if she doesnt feel better.
45 2021-04-12 feeling abnormal Other than feeling warmer than usual within minutes after the injection at 0715 AM I had no other s... Read more
Other than feeling warmer than usual within minutes after the injection at 0715 AM I had no other symptoms until 430 PM when I began to develop a headache, muscle aches and joint pain. It came on slowly but by 930 that evening I was shaking uncontrollably for about 3 hours with chills and severe joint pain. My headache grew worse and lingered for several days after as well. I still have a mild headache today (4/13/21) and feel lethargic and almost foggy.
45 2021-04-12 impaired work ability, feeling abnormal Janssen COVID-19 Vaccine On 4/12 I started having a lot of pain overnight, especially the left side... Read more
Janssen COVID-19 Vaccine On 4/12 I started having a lot of pain overnight, especially the left side of my body. My left hip is hurting really bad, my left arm sometimes hurts. My back is also now hurting. Nothing I take alleviates the pain, I have tried Aleve, Tylenol and Ibuprofen. I am extremely fatigued both day and night now. My bones feel very painful even sometimes down to my feet. While most of my body hurts, the left side seems to hurt more than my right side. When I got the vaccine I felt very "out of body" if that makes any sense, but now I feel very off. I also seem to be bruising easier than I used to before as well.
45 2021-04-12 insomnia worse headache, neck pain, bodyache, chills, sweats, jaw pain, nausea, upper body rash, dizziness, l... Read more
worse headache, neck pain, bodyache, chills, sweats, jaw pain, nausea, upper body rash, dizziness, lightheaded, insomnia,
45 2021-04-12 loss of personal independence in daily activities, anxiety Posterior leg bilateral pain (at knees) , sweats, dizziness, sleepiness, lethargic, was unable to ... Read more
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
45 2021-04-12 nervousness, sleep disorder, loss of personal independence in daily activities When I got the vaccine I fainted. I never fainted before with vaccines. The real problem started a w... Read more
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.
45 2021-04-13 feeling abnormal I started getting muscle cramps and flu-like symptoms on Mar. 7th. I felt better Mar. 9th and 10th. ... Read more
I started getting muscle cramps and flu-like symptoms on Mar. 7th. I felt better Mar. 9th and 10th. On March 11th, I started projectile vomiting and getting migraine headaches. (Day 6). On Mar. 13th, I developed a fever of 101. 2 days later, I continued with headaches daily and started developing respiratory symptoms. I felt better on March 15th except for daily migraines. I've had episodes when I have high fevers, leg cramps, or shortness of breath on and off since this point. I haven't felt right, the migraines have been on and off. I've had random high fevers and respiratory symptoms.
45 2021-04-13 excessive sleepiness, disorientation, impaired work ability, feeling abnormal Fine until next morning. On 4/6, the as to week to get out of bed until 1:30 pm. Took Tylenol and s... Read more
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
45 2021-04-13 insomnia MIGRAINE HEADACHE; CHILLS; NOT FEELING GOOD; FEVER; BONES ACHE; DIFFICULTY SLEEPING; This spontaneou... Read more
MIGRAINE HEADACHE; CHILLS; NOT FEELING GOOD; FEVER; BONES ACHE; DIFFICULTY SLEEPING; 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 past medical history included hysterectomy, and gall bladder disorder, and concurrent conditions included migraine, and cigarette smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 17:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced bones ache. On 10-APR-2021, the subject experienced migraine headache. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced not feeling good. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 10-APR-2021 10:00, Laboratory data included: Body temperature (NR: not provided) 99.4 F. On an unspecified date, the subject experienced difficulty sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, bones ache, migraine headache, and chills, and the outcome of not feeling good and difficulty sleeping was not reported. This report was non-serious.
45 2021-04-14 nervousness Approximately 30 minutes after the injection I developed a significant headache and nausea. Appro... Read more
Approximately 30 minutes after the injection I developed a significant headache and nausea. Approximately one hour later if I was in the sun I became overheated, flush and an overall feeling of nervousness, I adapted to these symptoms knowing they would considered normal but I no longer feel these should be considered normal. Around 7pm on Monday I started running a fever that started at 101.1. Between Monday night and Thursday morning it bounced around but stayed between 101.1 and 103.2. It did not go away completely until Thursday morning. At least I hope it is gone for good. On Wednesday around 10am I developed abdominal pain that by 4pm had me sitting by my car unable to continue for about 10 minutes. It was extremely stressful and still to the time of this report is still has not completely gone away. The most concerning for me is the back pain with it. At the time of this report I still have a headache, nausea, abdominal pain with back pain and vertigo. I have contacted my doctor's office and they have made notes but suggested I report everything here. They have started me on baby aspirin and electrolytes as I am also experiencing interment diarrhea.
45 2021-04-14 sleep disorder Still 2 weeks and pain at injection site. Cannot sleep on that arm as it hurts like a muscle was tor... Read more
Still 2 weeks and pain at injection site. Cannot sleep on that arm as it hurts like a muscle was torn
45 2021-04-17 impaired work ability On 4/6 around 7pm I started getting a headache so I took a 600mg ibuprofen and laid down. The fan wa... Read more
On 4/6 around 7pm I started getting a headache so I took a 600mg ibuprofen and laid down. The fan was blowing on me and it made me feel really cold. Then I got the chills and bundled up. And then the body aches started really bad. I could barely walk to the bathroom. I went to bed. The next morning I called in to work and stayed in bed all day. I could barely wake long enough to go to the bathroom and still body aches bad. I slept till about 8pm. When I ate and went back to bed.
45 2021-04-18 insomnia I have had body aches and severe joint pain since the day after I got the vaccine. Some days I can'... Read more
I have had body aches and severe joint pain since the day after I got the vaccine. Some days I can't get out of bed. Sleeping is becoming more difficult due to the intense pain in my joints. Knees, hips, shoulders and hands are the worst.
45 2021-04-18 restlessness, sleep disorder Immediate pain in arm that got worse first 12 hours. About 15 hours post vaccine and an unrestful n... Read more
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.
45 2021-04-19 sleep disorder PALE; WEAK; COULDN'T SLEEP; FLU-LIKE SYMPTOMS/HEADACHE/FATIGUE/LOST APPETITE/GENERALIZED BODY ACHES/... Read more
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.
45 2021-04-20 anxiety States that soon after she has experienced really severe headaches and increase in anxiety
45 2021-04-20 feeling abnormal, excessive sleepiness I slept 15 to 20 hours a day from Tuesday until Friday. I also had suffered severe brain zaps.
45 2021-04-21 anxiety I had nausea and generalized malaise, body aches and pretty intense swelling about 6 inches, distal ... Read more
I had nausea and generalized malaise, body aches and pretty intense swelling about 6 inches, distal at the vaccination site. I put ice, massaged it and tried to break it up. I talked to my doctor who recommended me to apply light pressure massage. These symptoms lasted for 1-2 days. My left arm is still sore but doing better. I feel anxious due to the side effects the J&J vaccine is having. I do not have the lot # with me at the moment.
45 2021-04-22 feeling abnormal, insomnia RECTAL BLEEDING; FELT REALLY BAD; JOINT PAIN; CHILLS; WEAKNESS; RASH ON FACE; HEADACHE; FEVER; PAIN ... Read more
RECTAL BLEEDING; FELT REALLY BAD; JOINT PAIN; CHILLS; WEAKNESS; RASH ON FACE; HEADACHE; FEVER; PAIN TO RIGHT LUNG; COULDNT SLEEP; BODY ACHES; THROAT PAIN; EAR PAIN; KNEES TO BOTTOM FELT HOT FOR SIX DAYS; FEELS LIKE LEG IS ASLEEP; LOCALIZED HEAT TO RIGHT INNER KNEE; This spontaneous report received from a patient concerned a 45 year old Hispanic or Latino female. The patient's weight was 185 pounds, and height was 63 inches. The patient's past medical history included hypothyroidism, and concurrent conditions included pollen allergy, alcohol user twice a year, and non smoker, and other pre-existing medical conditions included the patient had mecroabenola hitosesiario (in Spanish). The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25/MAY/2021) dose was not reported, 1 total, administered on 25-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced weakness and rash on face. On 25-MAR-2021 patient felt really bad On 27-MAR-2021, patient was menstruating but at the same time she had rectal bleeding but was not sure. That Saturday (27-MAR-2021) she though had abundant rectal bleeding twice. The second episode came two hours after the first one. She also had bleeding on Sunday (28-MAR-2021) but it was mild. Patient had fever, chills, pain to her right lung, joint pain, she could not sleep, She had body aches, throat pain, ear pain, headaches, (took Tylenol as treatment drug with specified dose) and her knees to the bottom felt hot for six days. Now that has resolved except she had localized heat to the right inner knee. It felt like spiders, like her leg was asleep. Lung pain was on and off, can be mild sometimes stronger. The rest of the side effects resolved The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rectal bleeding, could not sleep, body aches, throat pain, ear pain, knees to bottom felt hot for six days, joint pain, chills, rash on face, headache, fever, and weakness on 2021, had not recovered from pain to right lung, localized heat to right inner knee, and feels like leg is asleep, and the outcome of felt really bad was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- Covid-19 vaccine ad26.cov2.s-rectal bleeding. 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.
45 2021-04-22 insomnia Vertigo, body aches, headache first 2-3 days. Then a few days later major fatigue set in, chest pain... Read more
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.
45 2021-04-22 sleep disorder Dizziness, lightheaded at 12:30 pm, to the point of losing balance. Itchy arm at site of injection. ... Read more
Dizziness, lightheaded at 12:30 pm, to the point of losing balance. Itchy arm at site of injection. Itchy bumps on arm for days/weeks after at site of injection. Extreme bone and joint pain at 1:00 am following the injection, that lasted for the next few days on and off. Dizzy spells continue sporadically to this date, on and off.
45 2021-04-23 feeling abnormal FELT RED STREAK UNDER ARM FROM SHOULDER; EAR PAIN ON RIGHT SIDE; HOARSE VOICE; LOOSE STOOLS; HYPERGL... Read more
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
45 2021-04-25 anxiety, confusional state Crushing headaches, dizziness, blurred vision, confusion, anxiety. Muscle pain and stiffness, heart... Read more
Crushing headaches, dizziness, blurred vision, confusion, anxiety. Muscle pain and stiffness, heart palpitations, loss of coordination. Sinus and jaw pain.
45 2021-04-28 mental status changes Presented to ED for stroke-like symptoms (AMS, L side deficits). Was found on floor by son.
45 2021-04-29 impaired work ability Injection given at 2PM I had neck pain and headache at 9PM that evening. At 3am woke up with chills,... Read more
Injection given at 2PM I had neck pain and headache at 9PM that evening. At 3am woke up with chills, full muscle aches, headache and felt flu like. At 9am following morning still a very bad headache along with chills and extreme fatigue. By noon headache gone but fatigue an chills continued for several hours. Exactly 3 days later I developed an awful rash started on hands. This rash is extremely itchy an painful at times. The rash is on hands, arms, legs, belly, neck an back pretty much everywhere. My legs started swelling on day 6.
45 2021-04-30 loss of personal independence in daily activities LOSS OF BLOOD; VOMITING; BACK PAIN; ABDOMINAL PAIN; FEELING WEAK; HEADACHE; BLOOD CLOTTING; COULD NO... Read more
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.
45 2021-05-02 sleep disorder The day after the vaccine my left arm hurt, and I thought it was normal. After two days I was in a l... Read more
The day after the vaccine my left arm hurt, and I thought it was normal. After two days I was in a lot of pain and I couldn't lift my arm up. I have to lay on the other side at nights because it hurts. It is constant pain and Motrin does not help the pain. It is still painful at the end of the day after three weeks. I went to the ER and they thought that it was nerve damage from the vaccine administration. I was given Steroids which helped a little at first but then the pain returned. It was only a three day course because I am Diabetic and it effects my blood sugar. I can raise my arm a little now but not above my head. Three weeks after the vaccine my right ear started to ring and it was very intense and I couldn't hear for about four hours. I went to the ER and all the tests were negative. The ringing in my ears is still coming and going. It is very sensitive to sound and it is hard for me to hear. If there is any loud noise the ringing becomes very uncomfortable. It feels like I need to pop my ear all the time. I was told it might be related to the vaccine. I have never experienced anything like this before.
45 2021-05-05 depressed mood Patient complained of having low blood pressure and feeling "down". Patients legs were elevated. Pat... Read more
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.
45 2021-05-06 sleep disorder Shot Date/Time: Thursday, 5/6/2020 4:15p.m. Jansssen That evening I started having minor stomach ... Read more
Shot Date/Time: Thursday, 5/6/2020 4:15p.m. Jansssen That evening I started having minor stomach cramping initially. Overnight I was unable to sleep. About 5a.m. I was incredibly nauseous. I was incredibly weak. I didn't have the strength to stand or sit upright. I sat on the bathroom floor & had to have someone prop me up in front of the commode to vomit into it I was so weak. I repeatedly vomited forcefully for about an hour with accompanying repeated bowel movements. I had a fever.I broke out in a sweat repeatedly - clammy. The most painful part as SEVERE, SHARP NON-STOP ABDOMINAL CRAMPING. I was in the fetal position on the floor writhing in pain after the vomiting & bowel movements slowed. After hours of this... my clamminess turned into chills with my entire body shaking strongly & continuously as I lay on the floor unable to do anything but shiver. I considered going to the emergency room but was able to move in my current state. Who & where should I report this severe adverse event? Note: I'm a 45-year old VERY physically fit athletic female. My only health condition: I take Enbrel for Rheumatoid Arthritis.
45 2021-05-11 feeling abnormal Major hot flashes.. sweating like crazy.. headache, major fatigue, brain fog
45 2021-05-13 impaired work ability Four weeks after the vaccine I was getting unexplained dizziness. I am not sure if it is Vertigo. I ... Read more
Four weeks after the vaccine I was getting unexplained dizziness. I am not sure if it is Vertigo. I thought maybe it was my blood pressure being low but the doctor confirmed that the reading was normal for me. It was happening every day for the first week and then nothing the following week. I was unable to work because I needed to lay down when the dizziness happens. It is still coming back after eight weeks but it is not often, maybe twice a week. It is hard to drive when it is happening. It comes on me all of a sudden when I am sitting down working.
45 2021-05-14 insomnia PRESSURE IN EAR; SEVERE TINNITUS; STRUGGLE TO SLEEP; BODY ACHES; ILL FEELING; FEVER; This spontaneou... Read more
PRESSURE IN EAR; SEVERE TINNITUS; STRUGGLE TO SLEEP; BODY ACHES; ILL FEELING; FEVER; 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 pre-existing medical conditions included the patient had no history of ear infection or tinnitus. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pressure in ear. On 12-APR-2021, the subject experienced severe tinnitus. On 12-APR-2021, the subject experienced struggle to sleep. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced ill feeling. On 12-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from severe tinnitus, and the outcome of ill feeling, fever, body aches, pressure in ear and struggle to sleep was not reported. This report was non-serious.
45 2021-05-16 anxiety, feeling abnormal, impaired work ability, panic attack About 2 hours after receiving shot, I was feeling very run-down and sore. My neck had pressure build... Read more
About 2 hours after receiving shot, I was feeling very run-down and sore. My neck had pressure building at the base. Left work early to get rest. My next day entire head and shoulders were pressurized and shooting pains down neck, through arms, numbing left side of body cramping feet and arms, all triggering anxiety /panic attacks. By Friday I sought help. Urgent care sent me ER because they?d be able to run better tests. ER gave me an Ativan and sent me mental health referral. After a couple more days of trying to rest and get ease, went to different urgent care. Received muscle relaxer for cramping, and appointment for primary care provider. Saw ENT dr for throat, referred to neurologist, had MRI for neck pressure and painful spinal release sensation I feel every morning. Follow-up is end of June. Brain in fog, pressure in head building still daily. Acupuncturist gave me info for this Reporting. Been to acupuncture twice, not improving yet.
45 2021-05-18 feeling abnormal, hallucination 4/1 J&J Vaccine, exactly 7 hrs later, intense chills, woke up next morning a-okay 4/3 A few min afte... Read more
4/1 J&J Vaccine, exactly 7 hrs later, intense chills, woke up next morning a-okay 4/3 A few min after waking up, itchy wrists (bilateral), then itchy shins (bilateral), last about 20min 4/5(?) Possible tick (on back - couldn?t really see or reach, scratched at it?) 4/10 Back pain/extreme tightness (fascia from back of knee to upper back feels like sheet of hard leather, extremely limited forward flexion, maybe 50% of normal?) 4/11 Painful intermittent scalp spasms over left ear for 2-ish hours 4/17 Hypersensitive mucus membranes 4/18 Right side of face falls down - Bell?s Palsy? 4/19 Weird hard-leather back pain fading 4/20 ?Headache? - actually feels like seizing scalp muscles behind top of ears 4/20 ?Cold? spots on skin, particularly legs 4/20 Painful knot (familiar) mid/upper right side 4/20 Out of breath 4/21 Leatherback returns 4/22 Awake 3am head pain back of right ear down neck 4/22 Awake 3am - I can feel my face! (BP resolving) 4/22 Extreme pain during asana, leatherback, shakey, lightheaded, out of breath, severe brain fog (almost hallucinatory) 4/23 Awake 1am extreme head, upper right back pain 4/23 Cold spots front of thighs above knee and left foot 4/24 Weird right upper arm/shoulder pain (hours after carrying around a dozen-ish 100lb-ish rocks) 4/25 Awake 1am -6am in extreme insanely excruciating pain right arm (upper/outer/upperback-ish) paced house for 5 hrs. Tylenol & vicodan useless 4/25 Period 2 weeks early (prednisone?) 4/28(ish) Starting to feel increasingly yeasty (doxy?) 4/29 Last day prednisone (accidentally took 1 extra day, grr) 4/29 Extreme weakness and pain - right arm utterly crippled, shoulder partially paralyzed??? (acute and continuous still as of 5/19) 4/29 Very off balance 4/29 Very jittery 4/29 Emergency visit with Dr (Grrr.) 4/30 Left bicep totally dead with pain like an ice pick through it, extreme weakness (pain, limited mobility and some weakness continuous still as of 5/19) 5/1 I can see in my notes that I am switching words!?! (left for right) ?someone mentioned to me on May 2(?) that I was switching left for right? 5/3 Dr video appointment 5/5 Brain fog approaching hallucinatory (hard to explain, everything around me slightly ?fun-house mirror-esque?, judgement is vey skewed, not fun!) 5/7 Last day doxy
45 2021-05-18 insomnia Started with headache on the evening of injection, both husband and I could not sleep the evening of... Read more
Started with headache on the evening of injection, both husband and I could not sleep the evening of 4/1/2021. Minor headache and fatigue for approx 2-3 days. Approx.4/8-4/9/2021 had SEVERE abdominal pain and abdominal swelling. Loss of appetite, extreme fatigue. These symptoms continued until about 4/15/21. I had video call with primary care physician on Mon. April 12,2021 due to unusual abdominal pain and swelling. Swelling would come and go. Most symptoms subsided by mid April 2021.
45 2021-05-20 feeling abnormal, crying 3/13 vaccination. 3-4 hours later, I started having symptoms to include tickle in throat, post nasal... Read more
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.
45 2021-05-22 abnormal dreams, restlessness, sleep disorder - Very fatigued within 4 hours of injection - muscle / body aches within 7 hours, became worse withi... Read more
- Very fatigued within 4 hours of injection - muscle / body aches within 7 hours, became worse within 14 hours and ended within 48 hours, especially stiff neck and shoulder pain - Restlessness, chills/shivering, tossing and turning and strange dreams/sleep patterns during first night after vaccine shot - felt very heavy within 12 hours, ended within 36 hours - exhausted within 12 hours, ended within 36 hours - fullness and ringing in ears within 12 hours, ended within 36 hours - low temperature within 12 hours, ended within 36 hours - no appetite for 36 hours - low grade headache started at 12 hours, ended within 40 hours
45 2021-05-31 thinking abnormal, confusional state CONFUSED; BRAIN WASN'T WORKING RIGHT; REALLY DIZZY; LEGS COULD BARELY HOLD UP; NO ENERGY; HEADACHE; ... Read more
CONFUSED; BRAIN WASN'T WORKING RIGHT; REALLY DIZZY; LEGS COULD BARELY HOLD UP; NO ENERGY; HEADACHE; FEVER; SWOLLEN GLANDS; ACHY; PAIN IN BACK OF RIGHT KNEE/PAIN IN LEFT KNEE; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included obsessive-compulsive disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 23-JUL-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for fever. On 15-MAY-2021, the subject experienced swollen glands. On 15-MAY-2021, the subject experienced achy. On 15-MAY-2021, the subject experienced pain in back of right knee/pain in left knee. On 15-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 Unit Not reported. On 16-MAY-2021, the subject experienced no energy. On 23-MAY-2021, the subject experienced legs could barely hold up. On 24-MAY-2021, the subject experienced really dizzy. On 25-MAY-2021, the subject experienced confused. On 25-MAY-2021, the subject experienced brain wasn't working right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen glands, achy, and fever on 16-MAY-2021, and confused, and brain wasn't working right on 27-MAY-2021, and had not recovered from headache, no energy, pain in back of right knee/pain in left knee, legs could barely hold up, and really dizzy. This report was non-serious.
45 2021-06-02 feeling abnormal THE MORNING AFTER MY VACCINE MY TOES AND LEGS WERE NUMB AND TINGLY AND FELT HEAVY AND FELT WEIRD WAL... Read more
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.
45 2021-06-03 loss of personal independence in daily activities, mental impairment, feeling abnormal, impaired work ability 5/22 9pm 10 out of 10 pain headache at back left side behind ear, like a threaded plug was being scr... Read more
5/22 9pm 10 out of 10 pain headache at back left side behind ear, like a threaded plug was being screwed into my skull. Never felt pain like that before. Could think, brought me to tears. 5/23 brain fog continued. 2pm Burned myself cooking because I wasn't myself. 5/24 5am screwball headache returned (10 out of 10 pain) Could not work. Called off sick. 5/25 brain fog all-day. 9am slight headache (same area). 6/3 4pm left arm pain (injection site arm). Feels like arm numb. Intense pain (7/10). 10pm Took 3 baby aspirin. 1030pm arm pain still intense (7/10), no relief yet.
45 2021-06-07 mental impairment I felt extremely dizzy after getting the shot. It was about an hour after. I could not walk or think... Read more
I felt extremely dizzy after getting the shot. It was about an hour after. I could not walk or think straight. I felt like I wanted to pass out. My stomach was sick for a week.
45 2021-06-09 disturbance in attention I have been light headed and lethargic for 2 weeks now. Started with headaches and exhaustion. Still... Read more
I have been light headed and lethargic for 2 weeks now. Started with headaches and exhaustion. Still tired and unstable. Hard to concentrate and keep my balance.
45 2021-06-14 agitation, confusional state PARALYSIS ON LEFT SIDE; NO FEELING OR STRENGTH IN LEFT SIDE; BLOOD CLOT IN THE BRAIN; CONFUSION; SLU... Read more
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.
45 2021-06-16 sleep disorder Severe heart palpitations - Palpitations last throughout the entire day and are severe enough that s... Read more
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.
45 2021-06-28 disturbance in attention, insomnia SPEECH IS SLURRED, SLOWED DOWN; TINGING - HEAD TO BOTTOM; HARD TO CONCENTRATE; DIFFICULTY SWALLOWING... Read more
SPEECH IS SLURRED, SLOWED DOWN; TINGING - HEAD TO BOTTOM; HARD TO CONCENTRATE; DIFFICULTY SWALLOWING; DIFFICULTY BREATHING; LIGHT HEADED; GRASPING THINGS BOTH HANDS; PRESSUE IN MY EYES; TIGHTNESS IN THE THROAT; COULD NOT TALK; DIFFICULTY SLEEPING; HEADACHE; NAUSEA; SPEED UP PROCESS OF NARROWING OF ARTERY IN NECK; VERTIGO; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 123 pounds, and height was 67 inches. The patient's concurrent conditions included sulfa allergy, nonsmoker, non alcoholic, and narrowing of artery in neck The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23-JUN-2021) 1 total dose, administered on 21-MAY-2021 around 11:00 in right deltoid for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, during the flight patient started experiencing symptoms, she had vertigo which lasted the entire trip and progressed ever since then. She believed that on 26-MAY-2021 injection might have speed up the process of narrowing of artery in neck. On 15-JUN-2021, she started experiencing nausea, stronger than it had ever been, she got tongue twisted, tingling on whole body from head to toe, because of this she had difficulty grasping items and sometimes sliping out of hands, difficulty sleeping for 3 days, difficulty swallowing. She mentioned she was not able to swallow at times and would need to regurgitate the food and re-swallow. On 15-JUN-2021, she also difficulty breathing, it was not continuous She would just need to take a time out and catch her breath, headache on the middle of the head all the way to the back of the head. It was intermittent. Lightheaded, balance was completely off and that balance made her nauseous, tightness in the throat related to the difficulties with breathing at time. She had to use her daughters nebulizer past weekend due to breathing issue, which was relieving and made her relax, for 2 nights, for a split sec, she could not talk or breathe, she had to remind herself to relax and breathe, she felt wasted and stoned all day. All the symptoms were just at once. Healthcare professional (HCP) was aware of symptoms. She went to the emergency room (ER) twice because of all the symptoms on 18-JUN-2021 and 21-JUN-2021. Bloodwork was done twice, no results reported. As per CAT Scan (Computerised tomogram), there was no blood clot. HCP wanted her to see neuro for her vein in her neck, as they saw a narrowing during the CAT scan. As per patient narrowing may have been there at an earlier age, but she never had any symptoms. As per patient vaccine shot made all the symptoms because never felt like this before, it was really odd. She felt perfectly fine before shot. She was given anti-nausea and anti-anxiety medications from the ER. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vertigo, speech is slurred, slowed down, tinging - head to bottom, hard to concentrate, nausea, difficulty swallowing, difficulty breathing, headache, light headed, grasping things both hands, pressue in my eyes, tightness in the throat, could not talk, speed up process of narrowing of artery in neck, and difficulty sleeping. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210648094-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Arterial stenosis. 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.
45 2021-07-02 loss of personal independence in daily activities Low-grade fever every day for 2 weeks between 99 and 101 degrees that did not respond to Motrin, Adv... Read more
Low-grade fever every day for 2 weeks between 99 and 101 degrees that did not respond to Motrin, Advil or Tylenol, flu-like body aches, extreme fatigue, migraines that interfered with daily activities. Called my doctor who ordered lab work. Lab worked showed active Epstein Barr infection, positive Covid antibodies, elevated SED rate and high c-reactive protein. As of July 2, 2021. Still suffering from fatigue, body aches and less frequent fevers. I have sought out alternative medicine with chiropractor care and acupuncture for relief from chronic pain and headaches.
45 2021-07-12 loss of personal independence in daily activities, anxiety, impaired work ability Severe pain in left leg. Couldn't walk. Went to urgent care . Did blood work and x-ray. A week late... Read more
Severe pain in left leg. Couldn't walk. Went to urgent care . Did blood work and x-ray. A week later, severe in right shoulder blade and upper back. Had to leave work. Took pain medication. The next day, woke up with severe pain in right calve, felt tingling in numbness in both legs. Went to ER. Given pain medication. Did Dopler untrasound on right leg to rule out blood clot. Still have severe pain in different locations. Still having numbness and tingling in arm and legs. Went to a neurologist. Feeling discomfort in throat. Feeling aniexty. Can't do activities like before.
45 2021-07-20 impaired work ability 5/24 - nausea (zofran ODT) resolved 6/03 - nausea / vomiting (Zofran ODT) resolved; increased arthra... Read more
5/24 - nausea (zofran ODT) resolved 6/03 - nausea / vomiting (Zofran ODT) resolved; increased arthralgia (tramadol w/acet 1000mg QD PRN) improved not resolved, more prominent malar rash (no treatment) with moderate warmth at rash site; fatigue / malaise. (missed 2 days of work) 6/24 - moderate to severe arthralgia to major joints (increased tramadol w/acet to BID/PRN) improved, not resolved; n/v (Zofran ODT) improved but lingered; weakness, fatigue / malaise (missed 2 days of work) 7/12 - n/v (changed to zofran as ODT increased n/v), pain / arthralgia moderate to severe (tramadol w/acet 1000mg increased to TID PRN & methylprednisolone 4mg dose pack); Migraine headache x4 days unrelieved (Imitrex, Aleve, & Acet. rest
45 2021-07-22 disturbance in attention, confusional state SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; DIFFICULTY SPEAKING; SLEEPY; BLURRED VISION 80 PERCENT OF T... Read more
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; DIFFICULTY SPEAKING; SLEEPY; BLURRED VISION 80 PERCENT OF THE TIME; CONFUSION; DIZZINESS; PROBLEM CONCENTRATING; JETLAGGED; CAN'T BE ON FEET FOR MORE THAN 20 MIN; TIREDNESS; FEELING SICK; This spontaneous report received from a patient concerned a 46 year white and Hispanic or Latino old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimoto disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, frequency was 1 total administered on 24-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-JUL-2021, Laboratory data included: PCR (NR: not provided) negative. On 08-JUL-2021, Laboratory data included: PCR (NR: not provided) negative. On 9 Jul 2021, the patient started to feel very tired as if she is Jetlagged. Her eye lid would close from being so tired even after 11 hours of sleeping. She is having difficulty speaking, concentrating and she is feeling dizzy and confused. On 19 Jul 2021, she felt well and better, but she still had problem concentrating and blurred vision 80 percent of the time. She can't be on her feet for more than 20 min. On 19-Jul-2021 (for 10 days), she could not go to work or take care of her kids. Her doctor was suspecting she may have Covid infection during her visit and those symptoms were post Covid syndrome. She suffered from hypothyroidism due to Hashimoto disease. She started taking anti-inflammatory medication and omega 3 as suggested by her Doctor. She was worried as she heard that she may be getting a swelling of the brain. On 13-JUL-2021, Laboratory data included: Laboratory test (NR: not provided) high levels of ATPO which are the antibodies against thyroid gland but normal TSH and T3. On 17-JUL-2021, Laboratory data included: Laboratory test (NR: not provided) high levels of ATPO which are the antibodies against the thyroid gland but normal TSH and T3. MRI (NR: not provided) neurological functions are fine, and PCR (NR: not provided) negative. On 18-JUL-2021, Laboratory data included: IgG normal (NR: not provided) negative. On 28-JUN-2021, she experienced feeling sick. On an unspecified date, the patient experienced suspected immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling sick, had not recovered from dizziness, difficulty speaking, tiredness, sleepy, blurred vision 80 percent of the time, confusion, and problem concentrating, and the outcome of jetlagged, can't be on feet for more than 20 min, and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210741759-COVID-19 VACCINE AD26.COV2.S-Suspected immunological vaccine 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
46 2021-03-09 impaired work ability "right after the shot I got really lightheaded, but it went away in a few minutes. then about 2am (... Read more
"right after the shot I got really lightheaded, but it went away in a few minutes. then about 2am (3/10) I started having hard chills, my temperature went up to around 102, I have body aches and headache still. missed work today"
46 2021-03-09 sleep disorder At around 8 pm on 3/5/2021 started with a severe headache, around 10 fatigue and muscle aches. Unabl... Read more
At around 8 pm on 3/5/2021 started with a severe headache, around 10 fatigue and muscle aches. Unable to get to sleep, around 12am 3/6/2021 fell asleep but kept wake up very hot, No fever but did have sweats. Around 2 am 3/6/2021 headache so severe had to get up and take Aleve. Had throbbing behind eyes and sensitive to light. This lasted till around 9pm 3/6/2021. Had fatigue most of the day also. All symptoms gone on 3/7/2021 except I have had a couple of small headaches on and off till 3/9/2021.
46 2021-03-16 feeling abnormal Fever, skin irritation/sensitivity, fatigue, brain fog, sore throat, gunky throat, headache. Signifi... Read more
Fever, skin irritation/sensitivity, fatigue, brain fog, sore throat, gunky throat, headache. Significantly sore arm (going on 5 days)
46 2021-03-21 impaired work ability reported to school nurse on 3/16/21 @ 0900 with "crawling" and itching. Nurse also noted patient to ... Read more
reported to school nurse on 3/16/21 @ 0900 with "crawling" and itching. Nurse also noted patient to have erythema to upper chest and arms bilaterally. Patient then reported febrile, chills, body aches and sweating on 3/16/21 @ 23:00 and missed work on 3/17/21 due to symptoms. Patient received Benadryl 25 mg 1 tab every 4 hours while at work (09:00 & 13:00), then took Aleve and Tylenol at home for other symptoms (unsure of dosage and frequency)
46 2021-03-29 anxiety 15 minutes after shot: significant, noticeable swelling and pain in injection arm, flushed face, nec... Read more
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,
46 2021-03-29 depressed mood, anxiety, confusional state, crying, sleep disorder I was directed to my seat (if walking into the room, the first table but the 2nd seat). The woman w... Read more
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.
46 2021-03-30 feeling abnormal Soreness in left arm, but not severe by any means. By 8pm, felt chills. By 10pm, had 99.6 fever. To... Read more
Soreness in left arm, but not severe by any means. By 8pm, felt chills. By 10pm, had 99.6 fever. Took one Tylenol 500mg. By 5am, has 100.8 fever. Took two 500mg Tylenol. By 10am, has no fever. Just tired and a little weak. Rested throughout the day and felt better. No more fever since. Feel a little odd numbness on my tongue, but no lost of taste. Still have the odd numbness on the tongue. All other symptoms are gone (still a little sore in the left arm, but not a big deal).
46 2021-03-31 feeling abnormal post 8 hours - sore arm, post 9 hours - sore back, hard to take a deep breath, foggy head feeling, ... Read more
post 8 hours - sore arm, post 9 hours - sore back, hard to take a deep breath, foggy head feeling, post 10 hours - sore legs and overall body aches
46 2021-04-02 impaired work ability, sleep disorder Flu-like symptoms developed and got progressively worse in the first 12 hours after the vaccine and ... Read more
Flu-like symptoms developed and got progressively worse in the first 12 hours after the vaccine and remained for approximately 36 hours. The flu-like symptoms included muscle aches, nausea, stomach pain including more significant pain in the upper left stomach area, headache and fatigue with difficulty sleeping. I needed to take time off from work due to these side effects and had difficulty performing daily activities. Also experienced pain at injection site that got worse in the first 12 hours and lasted also approximately 36 hours. Minor nausea, stomach pain and injection site pain have continued after 36 hours with ability to return to daily living activities.
46 2021-04-05 feeling abnormal RESTLESS LEGS; FEELING WEIRD; SUPER EMOTIONAL AND CRIED VERY EASILY; ACHING PAIN IN LEGS; FEELING T... Read more
RESTLESS LEGS; FEELING WEIRD; SUPER EMOTIONAL AND CRIED VERY EASILY; ACHING PAIN IN LEGS; FEELING TIRED; THROBBING; TINGLING OF BODY AND TINGLING IN LEGS; 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 asthma, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced throbbing. On 23-MAR-2021, the subject experienced tingling of body and tingling in legs. On 23-MAR-2021, the subject experienced aching pain in legs. On 23-MAR-2021, the subject experienced feeling tired. On 24-MAR-2021, the subject experienced restless legs. On 24-MAR-2021, the subject experienced feeling weird. On 24-MAR-2021, the subject experienced super emotional and cried very easily. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throbbing, tingling of body and tingling in legs, restless legs, feeling weird, super emotional and cried very easily, aching pain in legs, and feeling tired on 30-MAR-2021. This report was non-serious. Additional information received from patient on 30-MAR-2021 The following information was updated and incorporated into the case narrative: Outcome of the events updated.
46 2021-04-06 loss of personal independence in daily activities At time of shot, burning in arm as serum was being injected, and extreme dizziness where I almost fe... Read more
At time of shot, burning in arm as serum was being injected, and extreme dizziness where I almost fell off the chair. Dizziness lasted for a few minutes which created nausea. Sat at site for approximately 25 minutes after shot. Left arm was sore between shoulder and elbow, which was to be expected. Later in the evening, experienced fatigue. When trying to go to bed around 11pm, my left are was throbbing. I did take Tylenol at about 6pm. Throughout the AM hours, sever body aches started, extreme fatigue throughout the following day. Flu like symptoms continued the next day. I had heard of these symptoms for the other shots but not for Johnson and Johnson. Hungry but too weak to actually cook.
46 2021-04-07 disturbance in attention Day 1-Day 3:Sore arm, swollen, hot to the touch, red irritation at injection site, tiredness, troubl... Read more
Day 1-Day 3:Sore arm, swollen, hot to the touch, red irritation at injection site, tiredness, trouble concentrating. Day 4-6: arm swollen more, hot to touch, irritation at Injection site, mobility of arm impaired. Day 5: massaged arm to get swelling to go down. Day 6: woke up with massive headache and swelling went down. Day 7: broke out in hives that turned into blisters, taken to ER and given prednisone and antihistamine. Day 8-10: arm is black and blue bruised at injection site, small lump at site, continuous rotating hives and blisters with Prednisone 160mg and antihistamine and creams.
46 2021-04-08 depression, fear, anxiety Extreme and new/sudden otherwise unexplained feeling of dread/depression/anxiety about 30 hours afte... Read more
Extreme and new/sudden otherwise unexplained feeling of dread/depression/anxiety about 30 hours after vaccine
46 2021-04-09 feeling abnormal Hot sweats followed by light headed and faint like spells. Episodes of feeling off for the past 5 da... Read more
Hot sweats followed by light headed and faint like spells. Episodes of feeling off for the past 5 days now
46 2021-04-09 thinking abnormal, confusional state Dizziness, nausea, uncontrollable shaking lasting for 4 hours, chills, lethargy, barely able to walk... Read more
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.
46 2021-04-11 sleep disorder 4/6 night of i had night sweats all night 4/7 woke up horrible headache and body aches 4/8 really re... Read more
4/6 night of i had night sweats all night 4/7 woke up horrible headache and body aches 4/8 really really bad headaches and body aches 4/9 weakness, nausea, dizzy tiredness 4/10 weakness, nausea, dizzy slept all day 4/11 started a period. I have already gone through menapause and haven't had a period in over 3 yrs.
46 2021-04-12 feeling abnormal I had the J&J vaccine on 4/1/21. I have a history of blood clots. I have tested positive twice. On... Read more
I had the J&J vaccine on 4/1/21. I have a history of blood clots. I have tested positive twice. Once back in 2001 when I was pregnant and later on around 2008. I have had these symptoms before, but since I have a rare bone disease and have medical issues I really don't like to complain and just deal with this stuff with the pain pills I have a prescription for. Anyway, yesterday I was feeling a little off. My hands, feet and limbs in general tingling. I had a headache which is rare for me and tried to drink extra water, but by 5pmish came I took a handful of tylenol since I had an after work walk to go on with a girlfriend. After the walk I came home and had a desire to lay down and go to sleep. my leg was starting to go from tingle to burn. i decided that i needed to eat some dinner. after dinner i was struggling with breathing while sitting in the recliner chair watching TV, so I told my other half I needed to lay down, this was around 7pm. Then it was just a crazy leg burn from the back of my knee into my foot. I was describing it as if I someone pour gasoline on me and lite the match and I was burning alive. I took a muscle relaxer and forced myself to sleep. The day after the J&J shot. i had chills and was so cold that mid day when I had breaks during my work from home, i climbed in bed with a heating pad to warm up. the shot also left a scare on my arm, which i found odd since i give myself six injections a week for my bone disease. I tested positive with Covid December 20th, 2020 and it was a rough first week, but after about 10 days I was pretty much back to walking around and feeling better. You're more than welcome to have all of my medical record information, just let me know what you need. My doctor switched over to a different portal that I don't have access to and I haven't talked to her or her office since I had covid back in December and it's still a few hours before her office opens to report this, but I saw this on the news. My leg is still tingling and stiff. Again this is not my first time going through this, so I usually just push through it, but since I saw the news I am reporting it.
46 2021-04-12 feeling abnormal About five minutes after receiving the vaccine I began to feel something was terribly wrong. I then ... Read more
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.
46 2021-04-12 feeling abnormal Still a little nausea, very fatigue and foggy, body pain periodically and very cold chills periodica... Read more
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
46 2021-04-12 feeling abnormal shortly after vaccination (about an hour), I felt like I was disconnected in my words and responses.... Read more
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.
46 2021-04-12 impaired work ability First day of menstrual cycle has produced large clots and severe cramping. Normally my periods are l... Read more
First day of menstrual cycle has produced large clots and severe cramping. Normally my periods are light with zero cramps. I was in so pain today I was unable to work even after taking 1200mg of ibuprofen
46 2021-04-12 sleep disorder, poor quality sleep Injection was administered very high on shoulder next to what feels like a bone. As injection was be... Read more
Injection was administered very high on shoulder next to what feels like a bone. As injection was being administered I felt pain on inside upper arm down to wrist. Pain subsided. Day progressed. I used my arm to grocery shop. About 6:30 -7:00pm I noticed stiffness and inability to lift arm with extreme pain in attempts to lift arm. During the night had restless sleep. Had to use other hand to move arm into resting positions. No comfortable position. Saw general practitioner on 4/12/2021. Received a paper with physical therapy exercises. Today, 4/13/2021, Still extreme pain to stretch arm to side and in front. If raising arm overhead with help in range of motion exercises (abduction) cannot lower arm without severe excruciating pain in inner shoulder area. New symptom includes numbness in wrist and forearm.
46 2021-04-13 disturbance in attention Non-stop tinnitus. all day, everyday - I cannot concentrate. Horrible headache that won't go away wi... Read more
Non-stop tinnitus. all day, everyday - I cannot concentrate. Horrible headache that won't go away with Advil.
46 2021-04-14 nervousness I have had a headache every day since receiving the vaccine. 4 days ago my legs began to feel weak ... Read more
I have had a headache every day since receiving the vaccine. 4 days ago my legs began to feel weak and shaky. At some points it is so bad that I have to sit because they feel like they can?t support me. I have never experienced this before.
46 2021-04-16 crying I got Jonson and Jonson vaccine on 4/8/2021 . I was fine after that and suddenly on 4/13 /2021 I had... Read more
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 .
46 2021-04-19 impaired work ability, anxiety The evening that I took the vaccination I was running a fever body aches and chills the day after ta... Read more
The evening that I took the vaccination I was running a fever body aches and chills the day after taking the vaccination I had the same effects fever body aches chills 5 days after taking the vaccination very sick not feeling well not feeling myself passed out twice at home the sixth day after taking the vaccination I proceeded to work was sent home before I could even get in the building went to ER was treated for an allergic reaction after telling them I was 6 days from vaccination then on 4-9-2021 I was taken by my husband to the ER my entire left side was numb tingling sensation couldn't lift my leg couldn't hold my arm up had no peripheral vision severe headache at the ER I was seen my neurologist and I was told that I had 20 minutes to make a decision whether to take the TPA shot which I chose to take I was released from the hospital on 4/11/2021 I am finally going back to work tomorrow ( 4-21-2021) I am now having more anxiety I've had extreme weight loss I've lost 20 lb since this occurred
46 2021-04-19 panic reaction, insomnia Within a half hour of injection, I experienced pain in my left leg (thigh muscle mostly). Throughout... Read more
Within a half hour of injection, I experienced pain in my left leg (thigh muscle mostly). Throughout the day the pain spread to my left hip and left calf. Additionally, I felt like my muscles were ?on fire? on the left side of my body. I also felt a ?tingling? in my body, fingers and toes, leg muscles, primarily on left side. (I assumed at that time that this was ?normal?.) About 11 hours after injection, I experienced extreme muscle pain all over my body, lasting for about 12 hours. (Flu-like muscle pain and the feeling that all of my muscles were on fire.) The following day, I began to feel the feeling of pins and needles everywhere but primarily on left leg, thigh and calf. By Thursday evening (three days following injection), I felt the most severe pins and needles feeling as well as ?itching? primarily in calves and hands and feet. I was so uncomfortable and panicked, I couldn?t sleep. On Friday evening, I felt intense leg pain and ?heat? on left side in both calf and thigh muscle and couldn?t sleep. On Saturday evening and all day Sunday I had a headache which I can?t say was related but caused me great concern. Now, eight days later, most of the pins and needles feeling has subsided but the pain in my left leg (thigh muscle) is at an all time high. Extra strength Tylenol is not helping. I did have a consult with my doctor last Thursday and I called again yesterday and I?m waiting for a call back. (Last Thursday, she agreed that my symptoms were unusual and thought I might need to see a neurologist.) Additionally - my left knee has bothered me and feels like someone hit it with a bat. I?m not sure if this is joint pain? FYI - I have no apparent swelling in legs, no numbness, no trouble breathing and no significant headache today. I never had a fever or chills. The injection site burned for a few days (mild) but was never red.
46 2021-04-20 feeling abnormal, sleep disorder I had reaction right away five minutes afterwards drowsy and metallic taste in mouth and :30 observa... Read more
I had reaction right away five minutes afterwards drowsy and metallic taste in mouth and :30 observation and extremely fatigue and a neck pain and 4-5 pain level issue 04/12/2021 04/13/2021. Doctor phone and recommended ER and next day tired and off and fatigue and felt off and went to urgent care 04/16/2021 and fever and blood pressure electro cardio gram and for stroke and heart and stroke and clots and no symptoms for clots results was good and not able to sleep and Friday was extremely exhausted and neck pain and fever and medication. Fatigue and fatigue come and Motrine or Tyler. Still have neck pain and fatigue that comes and go not recovered.
46 2021-04-21 thinking abnormal significant nausea and abdominal pain, that lasted 3 days, followed by severe severe headaches makin... Read more
significant nausea and abdominal pain, that lasted 3 days, followed by severe severe headaches making me feel unable to think and nearly cried on days 6-12, headaches sometimes still occur, also odd bruise to right size of chin that is not improving, about the size of a quarter.
46 2021-04-22 nightmare BAD DREAMS; NO APPETITE; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient co... Read more
BAD DREAMS; NO APPETITE; FEVER; NAUSEA; HEADACHE; 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 no alcohol consumption, and non smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 16/AUG/2070) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced bad dreams. On 08-APR-2021, the subject experienced no appetite. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad dreams, no appetite, fever, and nausea on 10-APR-2021, and had not recovered from headache. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
46 2021-04-23 impaired work ability That evening at 08:00 pm, I had chills, very slight fever (right under 100 degrees); fatigue. Saturd... Read more
That evening at 08:00 pm, I had chills, very slight fever (right under 100 degrees); fatigue. Saturday, I woke up without any of those symptoms but a terrible headache on Saturday morning - I had to go to work. It was severe enough for me to not go to work. Headache remained up until yesterday. The headache was pretty severe on Saturday, Sunday and I went to the doctor on Monday or Tuesday. I went because of the length of time of the headache. No meds were prescribed. They offered a brain scan which I decline based on the Dr's explanation of what the scan really does. Dr told me to take Tylenol. It was a "cluster" headache - the right side of my head towards the low part of my neck. The headache was always at that location. Tylenol was enough to lower my headache from the moderate to a minor. I didn't take much of it. I have not had a headache today for the first time since that Saturday. Muscle pain on my upper chest wall - it felt like I had been bench pressing - that symptom was on Wednesday and Thursday of last week (14th and 15th).
46 2021-04-25 sleep disorder Patient presents with concern for Covid vaccine reaction. Patient states she had the Johnson & John... Read more
Patient presents with concern for Covid vaccine reaction. Patient states she had the Johnson & Johnson vaccine about 2 weeks ago. Patient reports she had a headache about 1 week ago that woke her up from sleep about 1 AM but resolved by 4:30 AM. Patient denies having a headache since then. Patient noticed some small red dots on her nose today and was concerned when her friend told her this could be from the vaccine. Patient called her PCP who advised her to come to the ED for evaluation for thrombotic thrombocytopenia.
46 2021-04-26 feeling abnormal NUMBING SENSATION; WHOLE ARM FEELS WEIRD; TOP OF THE HAND HURTS; SORE ARM; INJECTION SITE PAIN; FEVE... Read more
NUMBING SENSATION; WHOLE ARM FEELS WEIRD; TOP OF THE HAND HURTS; SORE ARM; INJECTION SITE PAIN; FEVER; CHILLS; 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, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced sore arm. On 15-APR-2021, the subject experienced injection site pain. On 23-APR-2021, the subject experienced numbing sensation. On 23-APR-2021, the subject experienced whole arm feels weird. On 23-APR-2021, the subject experienced top of the hand hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 04-APR-2021, and had not recovered from sore arm, injection site pain, top of the hand hurts, numbing sensation, and whole arm feels weird. This report was non-serious.
46 2021-05-02 feeling abnormal About 5 minutes after I received the shot, had a sudden burning sensation in the middle of my chest ... Read more
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.
46 2021-05-16 disorientation, disturbance in attention, feeling abnormal I had the expected chills, fever, headache, fatigue and body aches beginning about 7-8 hours after t... Read more
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.
46 2021-05-17 confusional state BODY ACHES; THROAT ACHE; CEPHALGIA; PAIN ON APPLICATION SPOT; DROWSINESS; LIGHTHEADED; MIXED UP WORD... Read more
BODY ACHES; THROAT ACHE; CEPHALGIA; PAIN ON APPLICATION SPOT; DROWSINESS; LIGHTHEADED; MIXED UP WORDS; INCREASED BOWEL MOVEMENT; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ibuprofen. On an unspecified date, the subject experienced body aches, drowsiness, lightheaded, mixed up words, increased bowel movement, throat ache, pain on application spot, and cephalgia. The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches, drowsiness, lightheaded, mixed up words, increased bowel movement, pain on application spot, and cephalgia, and the outcome of throat ache was not reported. This report was non-serious.
46 2021-05-20 feeling abnormal, depression The main adverse event, depressive episode, lasting 8 weeks post vaccination. The other side effect... Read more
The main adverse event, depressive episode, lasting 8 weeks post vaccination. The other side effects I had: chills (lasted 3 days), hot flashes (lasted 2-3 days), fever (lasted 3 days), nausea (lasted for 5 days), vomiting, brain fog (lasted 3 weeks), body aches (lasted for 5 days), headaches (lasted 5 days), left sore arm (lasted 3 days). I consulted with my psychiatrist about my symptoms. As of today I am still recovering from the depressive episodes. .
46 2021-05-23 loss of personal independence in daily activities I started with body aches, head ache, chills then my fever got really high, vertigo, the worst heada... Read more
I started with body aches, head ache, chills then my fever got really high, vertigo, the worst headache I ever had in my life and my body pain was really bad I could get out of bed that night and the next day and it was 3 days before I was up and moving again
46 2021-05-31 feeling abnormal, nervousness FEET DISCOLORATION (PURPLE/BLUE) WHEN SITTING DOWN; CALVES FELT LIKE GOING TO SLEEP; TINGLING IN FEE... Read more
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.
46 2021-06-03 disorientation Patient passed out, was briefly unconscious in chair. She woke up and felt disorientated. She felt t... Read more
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.
46 2021-06-09 insomnia Insomnia really bad last for 3 weeks. Only slept once I was so exhausted that I slept for 2 days th... Read more
Insomnia really bad last for 3 weeks. Only slept once I was so exhausted that I slept for 2 days then it started over again. Getting better now...I would call it mild
46 2021-06-20 disturbance in attention, impaired work ability Fever Sweating Pain in muscles Pain in joints Skin feels hot and sensitive Dry mouth Headache Extr... Read more
Fever Sweating Pain in muscles Pain in joints Skin feels hot and sensitive Dry mouth Headache Extreme Fatigue Tremors Inability to concentrate Shortness of breath Sore throat Impaired ability to work
46 2021-06-21 anxiety, feeling abnormal I woke up on 4th with pins and needles in my hands and I called the doctor's office. They said that ... Read more
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.
46 2021-06-22 depression, feeling abnormal REQUIRING NAPS ALMOST DAILY; WOOZY FEELING/BROWN OUT; DEPRESSION; DOES NOT FEEL LIKE HERSELF; LACK O... Read more
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
46 2021-06-24 anxiety Nausea at the 8th min, reported feelings of anxiety; monitored , acknowledged, empathized, and cool ... Read more
Nausea at the 8th min, reported feelings of anxiety; monitored , acknowledged, empathized, and cool compress cloths. Resolved in 24 minutes after nursing empathy.
46 2021-07-07 depression, suicidal thoughts First 15 days suicidal and depression. Spoke therapist . Also lots of joint pain and hard to move . ... Read more
First 15 days suicidal and depression. Spoke therapist . Also lots of joint pain and hard to move . Feels really stiff. Diarrhea all day since May 7th .
46 2021-07-12 sleep disorder See previous.
47 2021-03-11 feeling abnormal Vaccination administered 3/12/2021 @ 1213, left deltoid (Johnson and Johnson lot 1805020) While in ... Read more
Vaccination administered 3/12/2021 @ 1213, left deltoid (Johnson and Johnson lot 1805020) While in recovery area at 1243, patient stands from her chair and states that "I feel funny, and I have to walk". RN asks patient to elaborate on reasons why she is needing to ambulate and encourages patient to sit for assessment. She states, "No, I really don't want to sit, I feel like I need to walk. I have a tingling down the back of my neck, it really feels warm actually hot, I think if you take my vitals it will only make it worse". RN again requests that patient sit and allow for vital signs to be taken, patient refuses, and asks for water. RN provides a bottle of water for patient and she says that she would like to stay in recovery a little longer. Patient ambulates in area for (with RN observation) and verbalizes that she is feeling a little better with walking. Again, upon visual examination no changes noted in patient skin on neck or sholders. At 1248 patient agrees to sit, but again refuses additional assessment. By 1247, patient states that she is feeling better, denies dizziness and states that heat in neck has decreased. Patient reports having similar reaction after taking Compazine. By 1250, patient verbally expresses that she is ready to depart clinic. Advised to seek medical attention after departure if necessary, with increase or significant change in symptoms. Patient verbalizes understanding. Ambulates from clinic alone at 1251.
47 2021-03-11 insomnia Exhaustion Headache Dizziness Watery eyes Feels like bronchitis Muscle aches Arm discomfort Radiatin... Read more
Exhaustion Headache Dizziness Watery eyes Feels like bronchitis Muscle aches Arm discomfort Radiating pain all Over body Double vision Hazy vision Easily get out of breath Bright yellow urine output Insomnia
47 2021-03-13 feeling abnormal Janssen COVID-19 Vaccine EUA- nausea first at 4:45am, followed upon rising by severe joint pain and ... Read more
Janssen COVID-19 Vaccine EUA- nausea first at 4:45am, followed upon rising by severe joint pain and an extreme migraine. It felt like my bones were made out of glass and someone had taken a hammer to my bones. My face was swollen and red. Unable to sit up. Walk from bed to toilet only. Overall, I would say extreme flu-like symptoms. Temperature 99.6 all day. I could not take the pain any further at 4:20 pm and took 1,000 mg of Tylenol. I finally fell asleep and woke up at 8:30pm and could walk again and my fever had broken. I still don't feel great, but I think the worst is behind me.
47 2021-03-13 feeling abnormal 2 hours after the vaccine, I started to feel very achy, and had terrible chills. That lasted throug... Read more
2 hours after the vaccine, I started to feel very achy, and had terrible chills. That lasted through the night and I woke up with a slight fever, 99.9. The aches were in my joints and muscles. It actually felt like I was having back labor. I took advil, and I was able to sleep and sweat out the fever. These symptoms were similar to one of my worst Lupus flares. These symptoms lasted until Tuesday, 3/9/21, afternoon. The following Sunday, my joints feel extremely stiff and achy. Not sure if it has anything to do with the vaccine. I took Advil and it seemed to help.
47 2021-03-18 feeling abnormal, impaired work ability Immediately broke out in a sweat and was very hot. Didn't think much about it. The staff noticed I... Read more
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.
47 2021-03-24 feeling abnormal 1018 Janssen vaccination given to left deltoid per LPN. 1031 Pt reported "my head started hurting".... Read more
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.
47 2021-04-03 impaired work ability patient complaines of headache fever body aches fatigue and nausea continuing into the second day u... Read more
patient complaines of headache fever body aches fatigue and nausea continuing into the second day unable to work
47 2021-04-04 anxiety Immediately after shot patient said she didn?t feel well... said she felt very warm and she was extr... Read more
Immediately after shot patient said she didn?t feel well... said she felt very warm and she was extremely anxious .. said something about not being able to see asked for a energy water she carries ... apparently did not eat all day and had exercised yoga before shot .. her relative told me she has had problems with vaccines.. called 911 they checked her and she was released to go home ... the ambulance people implied it was an anxiety attack mixed with perhaps dehydration
47 2021-04-04 insomnia BODY ACHES MOSTLY IN THE JOINTS AND ESPECIALLY THE ANKLES; COULD NOT SLEEP- WOKE EVERY 15 MIN; CHILL... Read more
BODY ACHES MOSTLY IN THE JOINTS AND ESPECIALLY THE ANKLES; COULD NOT SLEEP- WOKE EVERY 15 MIN; CHILLS-FREEZING; JOINT PAINS WRISTS, SHOULDERS, HIPS, KNEES AND ANKLES; FEVER; SEVERE POUNDING HEADACHE; This spontaneous report received from a patient concerned a 47 year old. The patient's weight was 130 pounds, and height was 62 inches. The patient's concurrent conditions included percocet allergy, seasonal allergy, gluten allergy, alcohol use, nonsmoker, bile salt malabsorption -gi condition, anxiety, and vitamin d deficiency, and other pre-existing medical conditions included the patient reported no other relevant medical history. the patient had no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 to Left Arm for prophylactic vaccination. Concomitant medications included loratadine for allergies, sertraline hydrochloride for anxiety, colestipol for bile salt malabsorption, colecalciferol for vitamin d deficiency, and vitamins nos for vitamin d deficiency. On 06-MAR-2021, the subject experienced body aches mostly in the joints and especially the ankles. On 06-MAR-2021, the subject experienced could not sleep- woke every 15 min. On 06-MAR-2021, the subject experienced chills-freezing. On 06-MAR-2021, the subject experienced joint pains wrists, shoulders, hips, knees and ankles. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced severe pounding headache. Laboratory data included: Body temperature (NR: not provided) 103 degrees F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep- woke every 15 min, joint pains wrists, shoulders, hips, knees and ankles, and severe pounding headache on 08-MAR-2021, and chills-freezing on 06-MAR-2021, and had not recovered from body aches mostly in the joints and especially the ankles, and fever. This report was non-serious. Additional information was received on 30-Mar-2021. The following information was updated and incorporated into the case narrative: Reporter email, Patient demographic details( age, height, weight), age at time of vaccination, Patient history (seasonal, gluten allergy, alcohol use, nonsmoker, anxiety, vitamin d deficiency), events(could not sleep, joint pain, headache) Product batch no, therapy start date and end date, Concomitant medications.
47 2021-04-07 confusional state 1 hour later - perception off driving 3 hours later - light headed/ soreness 7 hours later - Every ... Read more
1 hour later - perception off driving 3 hours later - light headed/ soreness 7 hours later - Every joint ached painfully 8 hours later - fever (high of 103.2) before Tylenol & Advil 19 hours later - slight fever 100.4 before Advil 21 hours later - feeling off/confused 25 hours later - achy / tired
47 2021-04-07 feeling abnormal Upon receiving the shot, I immediately felt lightheaded, not dizzy or vertigo but just detached from... Read more
Upon receiving the shot, I immediately felt lightheaded, not dizzy or vertigo but just detached from my surroundings. I felt spacey. I felt like that for the rest of the day. I took Tylenol as the clinic recommended. Then after I went to bed later that evening I developed a headache that woke me up around 3:00am. I was very uncomfortable, experienced chills and was sore all over like I had worked out hard. I also experienced joint pain which I don't normally have. I still feel rough this morning and running a slight fever of 100F. I just wanted to report my side effects.
47 2021-04-07 insomnia First night at home work up with chills and had trouble getting to sleep had bad tummy pains and had... Read more
First night at home work up with chills and had trouble getting to sleep had bad tummy pains and had some diarrhea. Woke up next day feeling cold, lethargic, chills, and lack of appetite. Second day still the same. Noticed I was breathing harder after completing anything. Third day just feel hot behind the eyes, lethargic, very congested.
47 2021-04-08 nervousness vomit, headache-- we did cold compresses, gave a drink of water and husband came to pick her up afte... Read more
vomit, headache-- we did cold compresses, gave a drink of water and husband came to pick her up after 28 minute wait time
47 2021-04-09 feeling abnormal Around five hours after shot I felt what I would describe as brain fog and light headache, by the ev... Read more
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.
47 2021-04-09 insomnia Hi I had been given vaccine at 12:30 pm Had very unusual burping non stop till Later that day arou... Read more
Hi I had been given vaccine at 12:30 pm Had very unusual burping non stop till Later that day around 8 pm I got chills Fir about few hours I got tightness of the head Then my body started to hurt , like my bones where braking , kidney very fast filled up with urine I had to pee very often Then I felt like every molecule of my body was burning that was for few hours I couldn?t sleep The burning was all over body Though I didn?t take temperature I didn?t sweat Was unusual burning not topical of high fever It?s all stored by 2:30 am I have noticed that I got skin allergy Rash on my fingers And also they are swollen Like as if my body has holding liquid
47 2021-04-10 feeling abnormal 8 hours later , I had 101 fever , shivers , nausea and full on body aches . Since feeling so bad , n... Read more
8 hours later , I had 101 fever , shivers , nausea and full on body aches . Since feeling so bad , next day I had a thc gummy to help with pain . That night , I could not move my legs ... a paralysis feeling went from feet to face . Half of my fave was crooked and I could barely talk .
47 2021-04-11 impaired work ability Woke up 1145pm freezing shivering my whole left side from my neck to my foot was bothering me my le... Read more
Woke up 1145pm freezing shivering my whole left side from my neck to my foot was bothering me my left arm is extremely sore all the way to my hand then after freezing I sweat through my pajamas on april 12 7 am I called out of work I was still extremely uncomfortable in pain with headache dizziness nasua weekness neck and body pain throughout my left side and a low grade fever very tired.
47 2021-04-11 insomnia 4/8 @ 12:00 pm - headache 4/8 @ 11:20pm - cold chills to the bone , fever of 102.0 for 3 hours, he... Read more
4/8 @ 12:00 pm - headache 4/8 @ 11:20pm - cold chills to the bone , fever of 102.0 for 3 hours, headache, could not sleep 4/9 all day - body temp of 100.1, cold chills, sweating, bones aching, skin hurting when touched, headache, dizzy and off balance when standing to walk, could not sleep 4/9 @ 2:30pm - fever of 102.3 for 6 hours 4/10 all day - headache 4/11 all day - slight headache
47 2021-04-12 feeling abnormal by 10-11 p.m. that night severe chills. did not sleep the entire night due to extreme headache, chil... Read more
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.
47 2021-04-12 excessive sleepiness Fri 4/9- got vaccine around 5:30 p.m. Sat 4/10 5:00 a.m. I had to go to work. I felt achy, my arm wa... Read more
Fri 4/9- got vaccine around 5:30 p.m. Sat 4/10 5:00 a.m. I had to go to work. I felt achy, my arm was sore where I got the shot, and I had a headache. I was achy all day off and on. Sunday 4/11 I felt okay all day until around 10 p.m. At this time I noticed my throat was sore and swollen. I started coughing and feeling achy again. If I laid down I started to wheeze. I was very tired. Monday 4/12 I slept all day until 2:00 p.m. When I got up I felt achy and my throat was sore. I had a dry cough. I could not taste or smell. 4:15 p.m. went to my Doctor and was tested for Strep and Covid 19. I tested positive for Covid 19.
47 2021-04-13 feeling abnormal 24 hrs of fever, aches and pains, chills. could not get out of bed. Day 3 fever blister occurs. Day ... Read more
24 hrs of fever, aches and pains, chills. could not get out of bed. Day 3 fever blister occurs. Day 7 still feel very tired, headache, heavy arms/ legs. I just do not feel like myself. Slighty blurred vision and brain fog.
47 2021-04-13 impaired work ability I had a very intense headache for which I needed to miss work. This lasted 3 days.
47 2021-04-13 sleep disorder I had chills - severe- all night long. Couldn't sleep. Muscle joints and muscles were hurting me an... Read more
I had chills - severe- all night long. Couldn't sleep. Muscle joints and muscles were hurting me and fatigue. Next day, fatigue and muscle and joint soreness. It continued for almost three weeks. The third week I got calf pain that was very painful. I went to Urgent Care. It lasted until the next day (so for two days total). When I woke up on the 6th it was gone like it wasn't even there. The third day after the vaccine, the injection site started hurting - but not swollen or anything. The muscle at the injection site still hurts - the pain comes and goes. I did get an iron transfusion (march 8th) before the vaccine - I had a doctor's pass to take the vaccine.
47 2021-04-14 impaired work ability I go to work but I can breathe. I said to my manager I can't work. I need to come back home. I drov... Read more
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.
47 2021-04-14 insomnia, feeling abnormal Headache and general tiredness began 30-45 min after shot. Muscle soreness (injection site, rib mus... Read more
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
47 2021-04-14 sleep disorder Shot received 6pm. By 4am woke with fever of 101, chills and headache. Fever lasted 24 hrs. Headache... Read more
Shot received 6pm. By 4am woke with fever of 101, chills and headache. Fever lasted 24 hrs. Headache lingered another 4-6 hrs. All resolved after that.
47 2021-04-15 disturbance in attention, anxiety, feeling abnormal PAINS/ACHES; SWEATY; WEIRD ANXIETY; FEELING COMATOSE; LACK OF CONCENTRATION; WEIRD TWITCHING IN ARMS... Read more
PAINS/ACHES; SWEATY; WEIRD ANXIETY; FEELING COMATOSE; LACK OF CONCENTRATION; WEIRD TWITCHING IN ARMS/ WHOLE BODY; DIZZY; HEADACHE; This spontaneous report received from a patient concerned a 47 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced pains/aches. On 02-APR-2021, the subject experienced sweaty. On 02-APR-2021, the subject experienced weird anxiety. On 02-APR-2021, the subject experienced lack of concentration. On 02-APR-2021, the subject experienced weird twitching in arms/ whole body. On 02-APR-2021, the subject experienced feeling comatose. On 02-APR-2021, the subject experienced dizzy. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pains/aches, sweaty, weird anxiety, and feeling comatose on APR-2021, had not recovered from headache, lack of concentration, and weird twitching in arms/ whole body, and the outcome of dizzy was not reported. This report was non-serious.
47 2021-04-18 sleep disorder Site pain soreness, woke up with 100.7 fever, body aches, chill, nausea, headache and extreme fatigu... Read more
Site pain soreness, woke up with 100.7 fever, body aches, chill, nausea, headache and extreme fatigueand felt like this for 3 full days. Then 7 days later awoke with extreme headache behind left eye, sensitivity to light, sensitive/sore spot on top of head, exhausted but trouble sleeping, upset stomach.
47 2021-04-20 loss of personal independence in daily activities, confusional state, feeling abnormal, anxiety, impaired work ability Immediately had flu symptoms the same night as vaccine that went away within 2 days. HOWEVER, twent... Read more
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.
47 2021-04-20 sleep disorder 12 hours after vaccination, a really bad headache woke me up in the middle of the night. I also had... Read more
12 hours after vaccination, a really bad headache woke me up in the middle of the night. I also had fever (normally, my body temperature is below standard) and my joints hurt me. I took acetaminophen. Next morning, after light breakfast I took more acetaminophen mixed with ibuprofen and went to sleep. I kept alternating both medications every 4 to 6 hours and I got better in the next 36 hours.
47 2021-04-26 feeling abnormal FAINT; NAUSEA; RIGHT SHOULDER BACK PAIN; LEFT CHEST PAIN; DIZZINESS; RIGHT HAND NUMBNESS; COULD NOT ... Read more
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.
47 2021-04-26 feeling abnormal ALTERATIONS TO TASTE AND SMELL; BRAIN FOG OR COULD NOT THINK STRAIGHT; FLU LIKE SYMPTOMS SUCH AS BO... Read more
ALTERATIONS TO TASTE AND SMELL; BRAIN FOG OR COULD NOT THINK STRAIGHT; FLU LIKE SYMPTOMS SUCH AS BODYACHE AND NAUSEA; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced alterations to taste and smell. On MAR-2021, the patient experienced brain fog or could not think straight. On MAR-2021, the patient experienced flu like symptoms such as body ache and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms such as body ache and nausea on MAR-2021, and the outcome of alterations to taste and smell and brain fog or could not think straight was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
47 2021-05-02 feeling abnormal Felt like mild flu at first - fatigue, headache, nausea. The nausea continued for a couple of weeks ... Read more
Felt like mild flu at first - fatigue, headache, nausea. The nausea continued for a couple of weeks off and on and resulted in vomiting on 4-17-21. I vomit maybe once every few years. The nausea seemed to be slowly resolving, but I began feeling terrible the afternoon of 4-29-21. By 4-30, my feet began throbbing with stabbing pain, pain radiated up to knee in right leg. Entire body pain started, hurt to walk, started vomiting and diarrhea, with fever until 5-3. I still haven?t kept food in me. I used Aleve and Tylenol for fever, drank Pepto to attempt calming stomach, and used ice packs on my feet and a heating pad on stomach to try and decrease the cramping. Don?t know temp, thermometer battery was dead, but went between freezing cold sweating to burning up (dry hot and sweaty at other times). I can?t attribute feeling like this to anything else and there?s no possibility of being pregnant.
47 2021-05-16 sleep disorder The shot was given very high on my shoulder and was extremely painful. My range of motion was limite... Read more
The shot was given very high on my shoulder and was extremely painful. My range of motion was limited, but I thought it was normal because all people report pain, but then a few days later my whole shoulder really started to hurt very badly so that it was even waking me up if I rolled over on it at night. It was very, very sore. I thought I might have injured myself somehow, but recently I was told that some people have this strange shoulder reaction that can come later, so I figured I should report it. It's been two months now and the intense pain is gone, but I still do not have full range of motion in my left arm. It still hurts if I try to raise my arm straight up. I don't know if it pierced my bursa or what happened. The pain is deep around the joint of the shoulder.
47 2021-05-19 memory impairment Sickness like the flu at first. Later in March, severe headaches, visual auras, sense of smell chang... Read more
Sickness like the flu at first. Later in March, severe headaches, visual auras, sense of smell change. Continued on while April begin neck pain and severe nerve pain in right arm. Later in April, vision problems in right eye began. May, right arm completely numb, right eye vision problems, balance problems, right leg issues, memory problems, word retention problems. MRIs and x-rays by neurosurgeon in May showed collapsed disc in C5/C6 for no reason (no accident, no trauma) impinging the flow of spinal fluid. Continuing visit to neurologist and another MRI for suspected TIA. Treatment - multiple medications for nerve pain; surgery scheduled to replace collapsed disc and possible other disc (C4/C5) in June; 2nd MRI scheduled to review brain tissue last week of May.
47 2021-05-19 restlessness, feeling abnormal, amnesia Immediately felt dizzy & vertigo-ish, w/in 30mins I had to lay down, violent migraine, pain behind ... Read more
Immediately felt dizzy & vertigo-ish, w/in 30mins I had to lay down, violent migraine, pain behind eyes , radiated through neck, upper back, shoulder. Felt better the next day, then one week later migraine persisted & all covid symptoms returned at an alarming rate. Fatigue, fever, hot/cold sweats. Freezing & burning up at the same time. Migraine w/vertigo, loss of taste, no appetite, restlessness, brain fogged , short term memory loss, blurred vision, ringing in ears. Vertigo/migraine also worsened w/change in weather, before rain, or a drop in barometric pressure, or increase in humidity, or a cold front coming in. Any drastic temperature change outside seems to prompt or increase the migraine/vertigo, dizziness.
47 2021-05-23 depression She got her vaccine, was fine. The next day she was exhausted, but nothing unusual. Then about 4/... Read more
She got her vaccine, was fine. The next day she was exhausted, but nothing unusual. Then about 4/6/21, a month later she started slowly loosing her vision, and got her vision back for about 2 weeks, and then she slowly started loosing it again. She went to her primary care who told her nothing, and told her to go to the ER. She went to two walk in clinics, the ER, an ophthalmologist, a neuro-ophthalmologist. She has been to a retina specialists, two other neuro-ophthalmologists, and a neurologist who do not know what is wrong with her. They tell her that her eyes look healthy and good but she cannot see. Her left eye she may have about 5% of her vision and 15-20% in the right eye. She was given dry eye drops by one of the earlier physicians. She has had some follow ups, and the neurologist told her to drink water eat low carbs. So, she is frustrated at this point that nobody knows what to do and treat her eyes and is depressed. She lives alone and is not able to see to read her credit card info to order food or to see what she has to eat. She was also given Xanax, which she has not taken yet.
47 2021-05-25 feeling abnormal I woke up feeling nauseous with a throbbing headache that would not go away. I also had brain fog, i... Read more
I woke up feeling nauseous with a throbbing headache that would not go away. I also had brain fog, if I was walking I would lose my step. I reached out to my primary care physician, Dr. and was advised to visit the ER if I didn't feel any better in a few days. Two days later, I went to the Hospital ER in. I feel better but my energy levels are still low.
47 2021-05-26 panic attack, feeling abnormal pt states around 6 pm on 3/28/21 she developed a stomachache. This lasted until 4/2/2021. She deve... Read more
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.
47 2021-05-31 altered state of consciousness, euphoric mood Feeling lack of oxygen and felt faint and high, passed out later. Still feel issues including variou... Read more
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.
47 2021-06-08 feeling abnormal Since I got the vaccine not the day of but days after I started getting very severe migraines. I've ... Read more
Since I got the vaccine not the day of but days after I started getting very severe migraines. I've had them every single day since the vaccine. I had to send the doctor a request to fill an old prescription for the headaches that is not really helping. I've had migraines before but I haven't had a migraine since 2016. My brain feels like swollen and like its flipping. Not a dizzy feeling but a feeling like my brain is doing a cartwheel in my head.
47 2021-06-09 impaired work ability, loss of personal independence in daily activities After about 15 minutes I started to feel my scalp itching and tingling. The itching started to sprea... Read more
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.
47 2021-06-17 insomnia VOMITING; BODY ACHES WHICH FELT LIKE AFTER A VERY HARD WORKOUT; PAIN IN STOMACH LIKE CRAMPING; HEART... Read more
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.
47 2021-06-28 feeling abnormal BRAIN FOG; This spontaneous report received from a patient concerned a 47 year old female. The patie... Read more
BRAIN FOG; 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 got covid-19, and concurrent conditions included alcoholic, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced brain fog. On 21-JUN-2021, Laboratory data included: Computerized tomography scan (NR: not provided) UNKNOWN, and Electroencephalogram (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of brain fog was not reported. This report was non-serious. This case, from the same reporter is linked to 20210648429.
47 2021-06-30 crying, loss of personal independence in daily activities, feeling abnormal COULD NOT SPEAK A FULL SENTENCE; VERY PAINFUL INFLAMMATION OF CHEST, INFLAMED CHEST WALLS; CRAZY RID... Read more
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).
47 2021-07-10 confusional state FAINTED; PUKE/ VOMITING; RETCHING; CONFUSED OR COULD NOT FIGURE OUT; FELT HOT; SWEATING PROFUSELY; C... Read more
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).
47 2021-07-17 feeling abnormal Menstrual cycle stoped for 2 months returning with a massive heavy flow. My cycles usually run 3 to... Read more
Menstrual cycle stoped for 2 months returning with a massive heavy flow. My cycles usually run 3 to 3 1/2 day and now I have a full 7 day cycle with extreme heavy flow! I also experience Brain fog along with muscles in fingers, thumb and arm twich intermittently.
47 2021-07-27 impaired work ability Soreness at injection site. Stiff arm. Can't lay on it. Can't raise it. Gets numb, and arm and hands... Read more
Soreness at injection site. Stiff arm. Can't lay on it. Can't raise it. Gets numb, and arm and hands tingle. Can't use arm. Can't go to work.
47 2021-07-28 sleep disorder Chest pain behind sternum that woke me from sleep-ongoing Upper abdominal pain-ongoing Headache-3 da... Read more
Chest pain behind sternum that woke me from sleep-ongoing Upper abdominal pain-ongoing Headache-3 days Fatigue-3 days
48 2021-03-07 sleep disorder, feeling abnormal I got the COVID-19 vaccine on Saturday (janssen). I just wanted to let you know that I experience mi... Read more
I got the COVID-19 vaccine on Saturday (janssen). I just wanted to let you know that I experience mid back pain after the covid vaccine was administer on my left arm. it felt like a sharp pain but only in my mid back area. by the evening i got chills and also a fever which i took tylenol, i felt nauseous, my head felt like it was not attached to my body, i havent sleep anything in 2 days. I had a severe migraine and also vomiting but most of all is the spinning of y head like when people have vertigo. I havent been able to eat food because it comes out both ways, either i vomit or constant diarrhea. i made a call to my doctor waiting for her response. this symptos started around 6pm on 03/06/21 and still until today 03/08/21
48 2021-03-09 feeling abnormal within an hour, it my head felt like a had sinus pressure and had foggy "mind". Arm was sore but no ... Read more
within an hour, it my head felt like a had sinus pressure and had foggy "mind". Arm was sore but no more than any other vaccine. close to 4 hours later, headache started, felt hot and cold. Hard to sleep, sweating a lot during the night. Headache was so bad it felt like a combination of a bad flu with a hangover. felt very thirty. In the morning I was dizzy, hot, cold, temp 99.8, sick to my stomach, coudn't taste food very well, just like when you have the flu, nothing taste good. I spend the following day in and out of sleep, very tired, hard to focus. The sensation for being hot and cold continued. Took Imitrex to alleviate the headache/migraine . I did help, but not much. Hard to eat due to an upset stomach. Today is the first full day. I hope I'm better tomorrow
48 2021-03-12 restlessness When I first took the Covid vaccination I had no symptoms then later that day into the next morning... Read more
When I first took the Covid vaccination I had no symptoms then later that day into the next morning about 1-2 am 3/12/21 started feeling fever, chills, headache, body aches, restlessness weak. Later the same day no appetite. Made myself eat so I could take some tylenol for fever and pain.
48 2021-03-14 anxiety anxiety, hot flash, unusual tongue sensation
48 2021-03-14 insomnia, restlessness Body aches, fatigue, sleeplessness, restless, uncontrollable shaking, feeling cold,, sore and tender... Read more
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.
48 2021-03-15 feeling abnormal 03/16/2021 @ 1340 received vaccine 03/16/2021@1346 reported feeling "funny", lightheaded and nauseou... Read more
03/16/2021 @ 1340 received vaccine 03/16/2021@1346 reported feeling "funny", lightheaded and nauseous 03/16/2021@ 1354 vomiting multiple times and complaints of trouble breathing . HR 140's, B/P 140/84, RR 26, O2 Sat 100% on room air. Continuous monitoring in place (monitor O2 saturation, EKG leads in place for HR and Rhythm, B/P to cycle every 5 minutes) nurse and physician at bedside. @ 1403- medications given (decadron. benadryl, pepcid and zofran) denies shortness of breath at this time but vomiting continues. @ 14:15- Ativan IV Given. @14:30 Pt sleeping, HR in the 80's, O2 saturation 100% on room air, blood pressure stable, pt easy to arouse, denies shortness of breath @15:00- patient vital signs stable. Continue to monitor. @16:00- patient remained stable. Vital signs with in normal limits and pt denies any shortness of breath or feeling funny. Discharged to home with husband.
48 2021-03-15 insomnia chills, uncontrollable shaking (boby would tense up/hurt every time shake. felt like I was having c... Read more
chills, uncontrollable shaking (boby would tense up/hurt every time shake. felt like I was having convulses. my teeth would not stop chattering), body felt cold/hot, unable to sleep, and full body achy/sore, and tired feeling. The chills and uncontrollable body shaking happened twice (around 7:00-8:00 pm and sometime in middle night). I took alieve and probably 15 to 30 min later the body shake would stop.
48 2021-03-15 sleep disorder Fever Chills Severe Headache Nauseous Joint pain Couldn?t sleep long periods
48 2021-03-18 sleep disorder Left arm was sore after injection, but on day 8 after receiving the vaccine my arm throbs all the ti... Read more
Left arm was sore after injection, but on day 8 after receiving the vaccine my arm throbs all the time. I have had pain in my left arm from the shoulder to the elbow for the past 5 days and it seems to get worse. Ibuprofen and Tylenol did not seem to help much. It is difficult to use the arm because of the pain . I can?t sleep right now so I figured I would fill this out.
48 2021-03-20 feeling abnormal The next day after the shot, I had a small rash on my wrist. It disappeared during the day. Saturd... Read more
The next day after the shot, I had a small rash on my wrist. It disappeared during the day. Saturday evening, my right thigh felt like it received a trauma like a hit, but I did not have an injury. An area the size of my hand is slightly pink on the thigh. On Tuesday, I tried starting ibuprofen, but it did not really remedy the pain. I went to urgent care Wed. evening. They sent me for an ultrasound to rule out blood clots. No blood clots, but lymph nodes were visible in ultrasound. They suggested I follow-up with PCP. On Thursday and Friday, the leg felt crampy but less painful. Friday night the pain traveled down my right leg to ankle as well as right lower lung had dull ache. Returned to urgent care. They are treating the leg for cellulitis (1000mg daily of generic Keflex.) They said if the leg felt better in 24 hrs, probably cellulitis, but if not, it might be a response to vaccine. There is no relief after 3 doses and 24 hr + later.
48 2021-03-20 sleep disorder I went to bed with a stomach ache around 10:00pm. At 3:00am I was awoken by severe abdominal pains/... Read more
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.
48 2021-03-22 feeling abnormal Approximately a half hour after the Janssen vaccine was administered on Monday, March 15, 2021 at 2:... Read more
Approximately a half hour after the Janssen vaccine was administered on Monday, March 15, 2021 at 2:00pm, I felt a dull ache/sensation in the back, lower part of my head. No other symptoms that day. Today is Tuesday, March 23 and I am still experiencing side effects from the vaccine. The side effects, other than the "brain ache" come and go. The side effects include what I can describe as a "brain" ache, some itching (3/16), random sweating, arms feeling like dead weight, overall general feeling sick, random body aches (don't last long), dragging of feet when walking, noises being louder than what they actually are, brain "fog", dizziness, nausea, tingling in legs and feet . What I describe as a "brain ache is a different feeling than a headache or migraine. It is as if my brain actually hurts. A very notable side effect that occurred on Wednesday, March 17, was an episode of Alice in Wonderland Syndrome. Throughout my life I have experienced AIWS at bedtime. On Wednesday, I experienced an episode during the day and it lasted for three hours. My session is going to log me out. I cannot type anymore. Please contact me for more inforamtion.
48 2021-03-26 sleep disorder Body aches started in the evening. Middle of the night woke to aches chills and possible low grade ... Read more
Body aches started in the evening. Middle of the night woke to aches chills and possible low grade fever. Never took my temperature. Took two Tylenol. By morning was just tired and had a slight headache all day. By evening day after shot was back to normal.
48 2021-03-29 feeling abnormal Severe diarrhea on Sat then vomiting the next morning, Sun. I was in bed all day Sunday unable to d... Read more
Severe diarrhea on Sat then vomiting the next morning, Sun. I was in bed all day Sunday unable to do much with a headache and lethargy. I woke a bit better on Monday but still had a headache. Today, Tuesday I feel foggy brained and don't feel like I'm breathing at full capacity.
48 2021-03-30 mental status changes, disturbance in attention after receiving vaccine, she slumped in the chair, pupils were fixed eyes became red and tearing, sh... Read more
after receiving vaccine, she slumped in the chair, pupils were fixed eyes became red and tearing, she had a change in mental status was slow to respond to questions, body was shaking, it was difficult to keep her awake, focused, and talking
48 2021-03-31 impaired work ability Immediately after the shot I started feeling tingling in my left hand fingers. At 2 pm I started fee... Read more
Immediately after the shot I started feeling tingling in my left hand fingers. At 2 pm I started feeling warm, not feverish. 12 hours after the shot I started feeling achy and cold. When I woke up on March 25th, I was achy, with chills and internal heat, no fever though. Basically every muscle hurt and I really couldn't move. I spent the entire day in bed unable to eat or even move. I had to take the day off from work. I think I had Covid in Feb 2020 before testing began. The symptoms I felt in February 2020 were exactly the same beginning 12 hours after the vaccine.
48 2021-04-02 anxiety brought to medical area to calm down, states :this has happened before" knows its anxiety. resolved ... Read more
brought to medical area to calm down, states :this has happened before" knows its anxiety. resolved after a few minutes of sitting
48 2021-04-06 insomnia I received the J&J shot in the arm at 12:30 PM on 4/6. At 7:00 PM -I started experiencing severe mu... Read more
I received the J&J shot in the arm at 12:30 PM on 4/6. At 7:00 PM -I started experiencing severe muscle cramping in both arms and both legs. By 9:00 PM chills started and were added to the severe muscle cramping experienced earlier. I took one Ibuprofen pill at 10:00 PM and tried going to sleep. I was up all night with insomnia and muscular pain. I had a low grade temperature of 100.3 starting around 12:30 AM. Today, 4/7 I've had low grade temperature around 99 and severe muscle cramping in both legs early morning. Right now at 4:30 PM on 4/7, my temp is gone but I remain extremely fatigued and have muscle cramping in both legs. I tried taking a nap today and failed to sleep. The last time I was able to sleep was Monday night 4/5. I am hoping this will resolve itself by tomorrow 4/8. If symptoms don't resolve by 4/8 I will contact my PCP on 4/9. Thank you hope this information helps. I didn't expect to have insomnia as a symptom of this vaccine.
48 2021-04-07 disorientation Fever 101.9, Body aches, chills, headache, feeling slightly disoriented Started at 4pm, approx 7 ho... Read more
Fever 101.9, Body aches, chills, headache, feeling slightly disoriented Started at 4pm, approx 7 hours after injection Treated with Tylenol, 3 extra strength tablets, every 4 hours Fever is down to 99.9 as of 5p 4/8 or 25 hours from symptoms onset
48 2021-04-07 feeling abnormal Chills, fatigue, mental fog starting about 8 hours after injection. Symptoms lasted about 8 to 10 ho... Read more
Chills, fatigue, mental fog starting about 8 hours after injection. Symptoms lasted about 8 to 10 hours.
48 2021-04-08 anxiety 48yr old female with history of anxiety, previous episodes of arm and leg weakness currently undergo... Read more
48yr old female with history of anxiety, previous episodes of arm and leg weakness currently undergoing work-up for intermittent neurologic symptoms x 2yrs (on , allergies (insect venom: hives, shortness of breath; poison ivy: hives, shortness of breath; sulfa: hives) presented for COVID-19 J&J vaccine on 4/8/21. RN administered JANSSEN COVID19 VACC (LOT # 207A21A, exp 6/23/21) IM in patient's left deltoid at 1410. Approximately 5 minutes after receiving vaccine, patient complained of dizziness which later manifested as increased fatigue, malaise, weakness of the extremities with eventual report of tingling in the face. Patient unable to ambulate. Patient transported to exam room via wheelchair and transferred
48 2021-04-08 feeling abnormal, anxiety Felt a click. and then anxiety.
48 2021-04-08 insomnia, feeling abnormal SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UN... Read more
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.
48 2021-04-09 confusional state, feeling abnormal, disturbance in attention Metal taste in mouth 40 minutes after vaccine (4/7/2021). 7 hours after vaccine a Headache (11:30... Read more
Metal taste in mouth 40 minutes after vaccine (4/7/2021). 7 hours after vaccine a Headache (11:30pm), Next day, strong headache, very painful upper& lower gum (mouth) pain, Face throbbing, Fever up to 100.9, Chills, Body/bone aches. Following morning (4/9/2021), headache & fever gone but fuzzy brain, unable to focus, hard to read and comprehend emails quickly. Confusion while putting dishes away in wrong places. Fuzzy brain cleared up by the end of the day.
48 2021-04-09 crying, sleep disorder Janssen COVID-19 Vaccine EUA 9:30am vaccine 9:45am Faint headache started 10:30am or so took one T... Read more
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.
48 2021-04-11 feeling abnormal * felt serum enter my arm, painful immediately / * nothing but mild arm pain until about an hour aft... Read more
* felt serum enter my arm, painful immediately / * nothing but mild arm pain until about an hour after the shot/ * entire arm ached all the way to my hand / * became extremely tired within an hour of shot / * neckache, throbbing arm pain, over all achy, VERY tired, slightly dizzy on and off, fuzzy thought processes on and off / * felt feverish but no fever / * eyes felt warm when I closed them/ * slight heart racing the first night - all of these symptoms lasted about 2 days. Not severe enough to see my doctor or go to a hospital but felt it was important to report the effects. Even today, 5 days later, my upper arm is still sore and my neck still aches slightly.
48 2021-04-13 feeling abnormal Still suffering from side effects of vaccine, SIX DAYS later, including chills, body aches, headache... Read more
Still suffering from side effects of vaccine, SIX DAYS later, including chills, body aches, headache, nausea, brain fog, chest tightness, chest pain, cold symptoms (sore throat, facial pressure, runny nose), muscle weakness, fatigue.
48 2021-04-13 impaired work ability Cerebral infarction 163.9. I was admitted to the hospital on April 4th, 15 days after taking the Ja... Read more
Cerebral infarction 163.9. I was admitted to the hospital on April 4th, 15 days after taking the Janssen shot. My initial symptoms included tingling, numbness, and inability to walk. The doctors confirmed during MRI that I had had a stroke. I was in the hospital for four days, and released to PT/OT three times a week for the next 4 weeks to regain full use of the right side. I am also unable to work during this time.
48 2021-04-13 restlessness On 03-23-2021, 5pm. my symptoms started with chills and lethargic by 530p had chest pain and i felt ... Read more
On 03-23-2021, 5pm. my symptoms started with chills and lethargic by 530p had chest pain and i felt burning my body and felt restless. The next day i had pain in my kidney area nd rib cage, was nauseous, my body was still aching, had a bead headaches, had a temperature of 99.87 and my body was so sore. I still had the kidney pain. My fever had jumped to 101.7F. The next day I had fever, chills, dizziness, kidney pain on one side, strange pain under my rib cage and sore teeth and gums. My glands were swelled up in my neck, my taste was a little off. On 3-25-2021, had two large lymph node and my felt I had a ball in my throat. the pain on my right side, I might had a right kidney stone. an ultrasound of the right kidney was performed but I do not have the results yet.
48 2021-04-13 sleep disorder I received my shot on 4/5/21 at 1:00pm and by 11:30pm that evening something felt very wrong! It hi... Read more
I received my shot on 4/5/21 at 1:00pm and by 11:30pm that evening something felt very wrong! It hit me very fast! I was standing in my kitchen and all of the sudden I became dizzy, my heart rate shot up, I became very nauseous and my entire body became sweaty and hot and every muscle in my body hurt. My husband also received the J&J shot at the same time and day and at 11:45 pm (15 min after I got sick) he was abruptly woken up out of a dead sleep to find himself running to the bathroom with severe nausea and vomiting. He was very pale and very very dizzy, his heart rate was elevated and this lasted for about 24 hours for him. We are about 10 days out from getting the vaccine and I still have muscle pain in my legs. All other symptoms lasted about 24 hours.
48 2021-04-14 feeling abnormal 2 weeks After the vaccination got a Very strong headache and vomit ; the next few days got mild and... Read more
2 weeks After the vaccination got a Very strong headache and vomit ; the next few days got mild and spacey out . ; headaches also feel poor circulation on my right leg. At the beginning though headache were related to vision or the need to change prescription of my glasses until The J&J announce. I called my primary doctor and they say it is normal and gave me an appointment for the end of the month. Till today I still have sporadic mild headaches some of them only on the right side and eulment on my leg
48 2021-04-14 excessive sleepiness 4/11/2021 3:00am Dizzy when got up from bed 8:01am - dizzy and nauseous had to crawl, fainted - hit ... Read more
4/11/2021 3:00am Dizzy when got up from bed 8:01am - dizzy and nauseous had to crawl, fainted - hit head, injection site very sor Slept rest of day low blood pressure - 102/67 4/12/2021 - High blood pressure, dizzy and nauseous 4/13/2021 High blood pressure - went to ER - 177/111 - ER doctor was not aware that J&J was being paused and told me results had nothing to do with vaccine. 4/15 - Followup phone call with different Dr to review symptons encouraged me to submit symptons
48 2021-04-14 insomnia Arm swelling Headache Tinnitus and ear pain Insomnia
48 2021-04-14 sleep disorder 5 hours post injection - violent chills, shortness of breath, elevated heart rate (100+), temperatur... Read more
5 hours post injection - violent chills, shortness of breath, elevated heart rate (100+), temperature went from 98.1 to 101.3 in less than 30 mins, weakness, severe full body muscle pain. Unable to sleep, rest or eat. Day 2 - intense, severe full body muscle pain, temperature 101.7 even with tylenol taken ever 4-6 hours, severe headache and light sensitivity, nausea, unable to eat and unable to sleep. Day 3 - ongoing headache and light sensitivity. Vomited stomach acid. Day 3 around 5pm went to Immediate Care - covid test negative; was referred to Emergency Room and eventually admitted to inpatient floor. ER tests showed - 2 bags of fluid given. Admitted as inpatient, 1 additional bag fluid.
48 2021-04-15 feeling abnormal Progressive slight numbness in my left arm follow day. Most noticeable in fingertips. Just didn?t fe... Read more
Progressive slight numbness in my left arm follow day. Most noticeable in fingertips. Just didn?t feel right through day and took blood pressure at approx 5pm. Reading was 171/108. Took a clonidine (which I have on hand in emergency. This was only the 2nd time I?ve ever taken it) I emailed my doctor a short time later. Doctor advises if symptoms progressed to go to ER(although sent following morning, I did not see until Thurs evening) Friday morning met with Doctor. Fingers still feel peculiar but BP ok.
48 2021-04-15 thinking abnormal Pt states she noticed Tues left leg cramping in calf back and knee and thigh that feels like a charl... Read more
Pt states she noticed Tues left leg cramping in calf back and knee and thigh that feels like a charlie horse. denies hx of blood clots or long travel Left calf swollen cool to touch. Pt states her foot is more swollen to her. Patient found to have an indeterminate age deep vein thrombosis. Discharged home from the emergency department with a prescription for Apixaban.
48 2021-04-17 feeling abnormal Persistent headache for days, lightheadedness, blurred vision, heavy, almost vertigo-like. Fog
48 2021-04-17 sleep disorder started getting 'chills' about 9 hrs after injection (8pm), then proceeded to get violent chills, fe... Read more
started getting 'chills' about 9 hrs after injection (8pm), then proceeded to get violent chills, fever, and nauseau until about 4am the following morning. the following day was still minor nauseau and tired from prior evening of not sleeping. Injection sight felt like a bruise, but very tolerable. Did not feel 'normal' again until >48 hrs after injection.
48 2021-04-18 delirium Persisted for three days: 3-degree fever Body Aches Chills Feverishness Delirium Fourth day: Body A... Read more
Persisted for three days: 3-degree fever Body Aches Chills Feverishness Delirium Fourth day: Body Aches Chills Vice-like, stabbing migraine on right side--similiar to post herpetic neuralgia
48 2021-04-19 sleep disorder, feeling abnormal At approximately 9 -9:15 felt a little fuzzy headed & went to sleep. woke up at 11:30 pm and could ... Read more
At approximately 9 -9:15 felt a little fuzzy headed & went to sleep. woke up at 11:30 pm and could not go back to sleep. When I woke up at 10:30 am Saturday my face was extremely swollen. My left side seemed to be more swollen then my right side. Called Dr. on Monday & decided to wait a few days. Also started to have diarrhea as well on Monday. The swelling was better by Friday. Also found that I was having trouble sleeping even though I was feeling extremely tired. That Thursday I had an extreme burning in my stomach. Only way I can describe it is that it felt like there were flames in my stomach. The burning was so bad that it was making me extremely nauseous. Friday the burning was better but the burning is still coming &going but no where near as bad as the first time. Please note that I stopped all vitamins & supplements after I received the shot on Friday. Im only still taking my adder all.
48 2021-04-20 feeling abnormal About 8 days after the shot, my stomach started to have weird pains. Those lasted from Thursday Apr... Read more
About 8 days after the shot, my stomach started to have weird pains. Those lasted from Thursday April 15 through Sunday April 18. Starting Monday morning April 19 I began to experience intense diarrhea for all of Monday. It has continued, although less intensely, Tuesday April 20 and Wed April 21.
48 2021-04-21 abnormal dreams I got the J&J covid vaccine on 4/10/2021 at 11:40am. Later on that day, my left arm was sore so I t... Read more
I got the J&J covid vaccine on 4/10/2021 at 11:40am. Later on that day, my left arm was sore so I took Tylenol. After my shower that night around 10pm, I felt cold/shaky/chills & had really weird dreams. The next morning (4/11/2021), I slept in late & was very tired when I woke up. I also had a headache, fever (100.2F) & nausea. Took 2 Tylenol 500 mg each & these symptoms went away later that night. Two days after the vaccine, on 4/12/2021, I woke up with itchy red rashes all over both of my legs & feet (~30 small-med size). Took 2 doses of Zyrtec & Benadryl 50mg twice that day so it wouldn?t itch so much. Also applied mometasone ointment to rashes. On 4/13/2021, I did a video visit with a doctor. She said my rashes were probably due to an immune response to the J&J covid vaccine (meaning it is working) & it didn?t look serious since it was only on my legs. She said to continue the Zyrtec up to 2x/day, Benadryl every 6 hrs if needed, & apply mometasone steroid ointment for the rashes 1x/day. On 4/14/2021, the rashes have improved and I had less than 10 rashes on my legs. Since I still had some rashes, I continued to take 1 Zyrtec 10mg in the morning & applied mometasone ointment to the rashes. On 4/16/2021, the rashes had resolved.
48 2021-04-22 insomnia On the night of my J&J my vaccine , I felt very tired and sleepy but I could not sleep. The next mor... Read more
On the night of my J&J my vaccine , I felt very tired and sleepy but I could not sleep. The next morning I felt a burning sensation to my eyes as well to my right ear and that went away. I went to see my PCP that day as well because I was having a pressure sensation down my right calf and leg. On Wednesday I felt numbness sensation down my right arm and the right side of my body was weak. On Thursday, I called my PCP who advised me to go to the ER and to get monitored for thrombosis. I also began to have headaches and blurry vision. At the ER they performed an ultrasound and did lab work. The ultrasound exam did not show evidence of thrombosis or blood clots. The ER physicians told me to rest and elevate my legs. I also noticed that my BP was 130/90 which I never had before. To this day I still have throbbing sensation to my right calf and leg. I again went to the ER and thy monitored me. They told me to take Ibuprofen for pain and again did an ultrasound which did not show any blood clots. I then started to have a burning sensation to my skull and scalp and also my left arm. I have not fully recovered from my symptoms.
48 2021-04-23 insomnia INJECTION SITE IS HARD AS A ROCK; GENERALLY DOES NOT FEEL WELL; ARMS HURT WHILE TRYING TO USE THEM; ... Read more
INJECTION SITE IS HARD AS A ROCK; GENERALLY DOES NOT FEEL WELL; ARMS HURT WHILE TRYING TO USE THEM; INJECTION SITE DOUBLE IN SIZE; INJECTION SITE BRIGHT RED; FEVER; FEELING WEAK; HURTS ALL OVER BODY; BONES ACHING (HAS ARTHRITIS); LEFT ARM USELESS; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included raynaud's disease, lupus, arthritis, penicillin allergy, and red dye 40 allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on left arm on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced left arm useless. On 24-MAR-2021, the subject experienced trouble sleeping. On 24-MAR-2021, the subject experienced hurts all over body. On 24-MAR-2021, the subject experienced feeling weak. On 24-MAR-2021, the subject experienced bones aching (has arthritis). On 24-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 C. On 25-MAR-2021, the subject experienced injection site is hard as a rock. On 25-MAR-2021, the subject experienced generally does not feel well. On 25-MAR-2021, the subject experienced arms hurt while trying to use them. On 25-MAR-2021, the subject experienced injection site double in size. On 25-MAR-2021, the subject experienced injection site bright red. Laboratory data included: Body temperature (NR: not provided) 101.5 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling weak, injection site is hard as a rock, arms hurt while trying to use them, generally does not feel well, fever, bones aching (has arthritis), hurts all over body, left arm useless, injection site double in size, injection site bright red, and trouble sleeping. This report was non-serious.
48 2021-04-25 confusional state, irritability, disorientation Confusion, disorientation, discombobulated, dizzy, nausea, irritability, persistent headache.
48 2021-04-27 irritability weakness, Lethargy, uncharacteristic irritability beginning one day post vaccine 3/23/21. Labs... Read more
weakness, Lethargy, uncharacteristic irritability beginning one day post vaccine 3/23/21. Labs: Thrombocytopenia: PLT 85 4/23/21, repeat PLT 4/26/21 75, repeat PLT 4/28/21 pending
48 2021-04-27 sleep disorder Received shot in upper right arm and it was painful. My arm grew more painful throughout the day. ... Read more
Received shot in upper right arm and it was painful. My arm grew more painful throughout the day. I became very tired as the day went on. Went to bed for the evening, Monday 4/26/2021 and woke up at 1:50am on Tuesday morning, 4/27/2021 in full body sweats, dripping with sweat. So weak I couldn't get up or lift my head. My husband took my temperature which was 103. Massive headaches, full body aches and pains, chills which made my body shake uncontrollably. My whole body hurt. Could not get up to use the restroom, tried and fainted back into the bed. Heart felt like it was beating out of my chest. My husband wanted to call 911 but I didn't want to. Felt like I had COVID again.
48 2021-04-29 amnesia Patient reports sudden change in vision and "zapping " sensation in brain as well as short term memo... Read more
Patient reports sudden change in vision and "zapping " sensation in brain as well as short term memory loss that started within 1 week of vaccination and is progressively worsening
48 2021-05-02 feeling abnormal Calf and forearm muscle stiff and harden, numbness on fee and hand and fuzzy feeling on leg and arm.... Read more
Calf and forearm muscle stiff and harden, numbness on fee and hand and fuzzy feeling on leg and arm. Fingertips tingling, leg cramp if walk, can't form word, sharp pain on collar bone (only happen once). Janssen vaccine was administered on Apr 12, 2021. On the same day I have severe headache and mild pain on muscle. Severe headache extends to the next day and occasionally happen during the first week along with mild to moderate muscle pain. On the second week (Apr 19 to Apr 23, 2021) have frequent muscle pain, muscle on calf becomes stiff and harden and occur more frequent. It alternates between right calf and right forearm. I also often have tingling on fingertips, numbness on hand and feeling fuzzy on arm, legs. Symptoms comes and goes but get worse if have short walk. Foot and back of the knee on right leg cramp and more stiffness and more pain. On May 2, I woke up with numbness on my right foot and discover red spot on the instep. This prompt me to go to Urgent care. Since numbness and feeling of fuzzy along arms and legs but at the urgent care could not diagnose since they don't have tools to run the test so they advise if it bothers me, I should go to the ER. I worry about high cost of ER so I went home and plan to go see family doctor on Monday but just 5 minutes away from urgent care, I have trouble saying out the word that I want to say. It just doesn't come out although I try to form a word. At that point I more concern if I would have stroke so I ask my husband to turn around to go to Emergency Room. While waiting to be treated, numbness occurs more on feet and under of the forearms, Doctor run blood test, order ultrasounds, MRI scan on the head and EKG. All result came back normal but numbness and headache still persistent. I was discharge in the evening but still have no idea what cause it. The discharge paper indicate that it is "Paresthesia" and I believe Janssen vaccine is the cause for all the symptoms that I have. I still have numbness on feet and leg stiffness still occur even sit down for less than 5 minutes. Should the staff administered the Moderna type that I have signed up for. I believe this side effect won't happen to me. I signed up for Moderna but after check in, the staff show a note "L@837" to the fire fighter. I don't know what it means but heard their conversation that "We don't do that today" then after vaccine was administered, I found out that it is Janssen that I have not signed up for.
48 2021-05-03 impaired work ability, loss of personal independence in daily activities Janssen COVID-19 Vaccine EUA. 7 days after shot I have the worst headache/migraine. I have gone to E... Read more
Janssen COVID-19 Vaccine EUA. 7 days after shot I have the worst headache/migraine. I have gone to Er for CT scans that show clear so no blog clots. I do not have a history of migraines. I am unable to move. Work. Do anything. This is day 2. Idk how I'm to get thru this!!
48 2021-05-04 emotional distress EXTREME ABDOMINAL PAIN; VOMIT SEVERAL TIMES; 12 HOURS OF DISTRESS; NAUSEA; This spontaneous report r... Read more
EXTREME ABDOMINAL PAIN; VOMIT SEVERAL TIMES; 12 HOURS OF DISTRESS; NAUSEA; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause. 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 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-APR-2021, the subject experienced extreme abdominal pain. On 29-APR-2021, the subject experienced vomit several times. On 29-APR-2021, the subject experienced 12 hours of distress. On 29-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, extreme abdominal pain, vomit several times and 12 hours of distress was not reported. This report was non-serious.
48 2021-05-09 insomnia, sensation of foreign body Difficulty swallowing Extreme throat pain and feeling of obstruction in throat Difficulty sleeping ... Read more
Difficulty swallowing Extreme throat pain and feeling of obstruction in throat Difficulty sleeping and staying asleep
48 2021-05-12 amnesia COVID-19 PNEUMONIA; ALLERGY TO VACCINE; STOOLS HARD; STOMACH SWELL UP; MUSCLE SPASMS/ CRAMPS; BREAST... Read more
COVID-19 PNEUMONIA; ALLERGY TO VACCINE; STOOLS HARD; STOMACH SWELL UP; MUSCLE SPASMS/ CRAMPS; BREAST SWELLING; PAIN FROM BACK OF SPINE TO TOP OF THE HEAD; NUMBNESS IN THE FINGERS; ABDOMINAL TENDERNESS; BLANKED OUT; RINGING IN THE EAR; FACIAL SWELLING; PAINFUL BLISTER; DIFFICULTY EATING; This spontaneous report received from a patient concerned a 48 year old (Indian or Native/aboriginal) female. The patient's weight was 272 pounds, and height was 66 inches. The patient's past medical history included partial tubal ligation, and part of colon removed, and concurrent conditions included asthma, bronchitis, bleeding disorder (irregular period), cyst on ovary, gerd, high blood pressure, adhd, dysmenorrhea, tingling of extremities, asa allergy, narcotics allergy, soap residue allergy, lactose intolerance, tramadol allergy, sulfa antibiotics allergy, strawberry extract allergy, penicillin allergy, metronidazole allergy, nalbuphine allergy, oxybutynin allergy, bees wax allergy, haloperidol allergy, fluoxetine allergy, medroxy progesterone allergy, gabapentin allergy, and latex allergy. The patient had a blood test with her MD prior to and was told did not have Covid and could get the shot. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, administered to right arm on 16-MAR-2021, around 16:00 for prophylactic vaccination. No concomitant medications were reported. The patient was treated with injections to prevent blood clots (they did injection in the stomach area). On 16-MAR-2021, around 09:00 PM, patient experienced facial swelling and blister on the right side of her lip was burst and formed a scab and that made it difficult to eat. On next morning, 17-MAR-2021, patient had excruciating pain from top of her head to nostrils, it caused being weak and blanked out. On the day after, 18-MAR-2021, patient had a different taste and a different smell, also had ringing in the ear and was nauseous. On the 5th day, 20-MAR-2021, patient's stomach was swelled and was really tender and breast was also swelled. The patient had a lot of headache, cramps, muscle spasms, body ache and was cold and hot. The patient had diarrhoea and had to lay down and had to crawl to bathroom with throwing up. The patient had high fever and could not keep anything down. On 20-MAR-2021, the patient experienced pain from back of spine to top of the head, numbness in the fingers. On 22-APR-2021, the patient experienced hard stools. On 27-MAR-2021, patient was hospitalized as she was coughing blood. On an unknown date, patient had patches on the x-ray and was diagnosed with pneumonia and her Covid (unknown) test was positive. Patient reported that she was given injections to prevent blood clots in the stomach area. The patient had pain back from spine to top of the head, was weak, had numbness in the fingers. She had headache, had lost appetite. The patient reported that as per her healthcare providers, was allergic to the vaccine as they noted shortness of breath, nausea and diarrhea. Laboratory data included: Body temperature (NR: not provided) High. On 27-MAR-2021, COVID-19 virus test positive (NR: not provided) positive, and X-ray (NR: not provided) blood patched, pneumonia. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 pneumonia, and ringing in the ear, was recovering from facial swelling, painful blister, difficulty eating, stomach swell up, muscle spasms/ cramps, blanked out, and abdominal tenderness, had not recovered from pain from back of spine to top of the head, numbness in the fingers, and stools hard, and the outcome of allergy to vaccine and breast swelling was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210507603-covid-19 vaccine ad26.cov2.s -covid-19 pneumonia. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
48 2021-05-16 feeling abnormal on the 04/14 I started feeling pretty bad at home, I tested positive for covid because my daughter h... Read more
on the 04/14 I started feeling pretty bad at home, I tested positive for covid because my daughter had tested positive on the 04/12. by the 04/16 I was sick short or breathe , coughing telehealth call on 04/17 was prescribed an inhaler by the 04/21 I was coughing uncontrollably I felt like I had a cold called my doctor he told me to wait it out on the 04/24 I wasn't feeling better went to the er I couldn't breathe short of breathe walking short distances, I was released on the 04/27 and I was diagnosed with covid phenonium hospital I had to go to 05/15 was re admitted to hospital for chest pain and I was having problems breathing
48 2021-05-19 impaired work ability I knew I was going to get sick, My arm felt heavy, all of a sudden I broke out in hives all over my ... Read more
I knew I was going to get sick, My arm felt heavy, all of a sudden I broke out in hives all over my lips, had bloody noses, I threw up constantly, 3 bloody noses, I thought I was having my period through my nose. I don't even go to the doctor. I went to clinic they prescribed me meds called acyclovir, the second time I went back the blisters were cracking open they gave me Valacyclovir. I was an able to work because of the open blisters., I looked like Donald Duck.
48 2021-05-20 disorientation ADMINSTERED JANSSEN VACCINE IN MORNING , NO SIGNS OF REACTION WHILE PT'S WAS AT ADMINISTERING FACILI... Read more
ADMINSTERED JANSSEN VACCINE IN MORNING , NO SIGNS OF REACTION WHILE PT'S WAS AT ADMINISTERING FACILITY. LATER AFTERNOON, AT ARROUND 3 PM PER PT'S, PT'S FELT BLURRY VISSION (WORE GLAASES FOR CLEAR VISION), STILL DIZZY (FELT LIKE FAINT FOR A SECOND TWICE), DISORIENTED, NAUSEA, SWEATING (BODY TEMPERATURE 93 F WHEN CHECKED AT EMERGENCY ROOM). PT'S CALLED HUSBAND TO TAKE HER TO EMERGENCY ROOM FACILITY. AT EMERGENCY PT'S BLOOD WORK DONE, PT'S NOTIFIED PROVIDER SHE HAVE THYROID DISEASE AND ABOUT COVID-19 JANSSEN VACCINE. AT EMERGENCY ROOM PT'S GIVEN EPINEPHRINE FOR ALLERGIC REACTION, PT'S FELT BETTER AFTER ~ 25-30 MINUTES OF EPINEPHRINE (GIVEN ONCE). PT'S SPENT ~ 4 HOURS AT EMERGENCY ROOM AND GOT DISCHARGE.
48 2021-05-23 feeling abnormal About 30 minutes after the shot, I didn't feel right, my face, my arm and my chest was broken out in... Read more
About 30 minutes after the shot, I didn't feel right, my face, my arm and my chest was broken out in hives. The arm that I got the shot in felt numb. I called the medical people over and they wanted to check me right away. They observed me for 20 minutes and I started having a hard time breathing. I used my epi pen and the ambulance was called and I went to the ER. On Monday, I went to see my doctor and was prescribed medication. I had a hard to walking and still have a hard time breathing and have a cough.
48 2021-05-23 impaired work ability On 4/5, I started with upper stomach pain and then two days later I had a fever and a very rapid pul... Read more
On 4/5, I started with upper stomach pain and then two days later I had a fever and a very rapid pulse. I went the walk-in clinic on 4/7 and they performed COVID (negative), an EKG and CT Scan of abdomen (both were normal). The fever went away, the stomach pain eased but I still had SOB, fatigue and rapid pulse. Three days later, the symptoms remained, so I saw a gastro doctor and he said it could be COVID or blood clots, then sent me to hospital on Monday, 4/12 and 4/13. They did 2 more EKGs, COVID tests and bloodwork. I still had SOB and pain in my upper stomach towards my chest. On 4/14, I woke up with a massive headache and saw the news about the vaccine, so I went back to the ER to get checked for blood clots. They did an EKG, CT Scan of the abdomen and head, along with more bloodwork. Everything was normal, but my bloodwork showed an elevation of something that indicated that I have an infection, but they weren't sure what. They sent me home with no diagnosis. Over the next two days, I rested and I gradually started to get my strength back. I went back to work that Friday for the first time since 4/7.
48 2021-05-25 impaired work ability Patient is a 48 y/o female who speaks only Spanish. Patient had interpreter present during client r... Read more
Patient is a 48 y/o female who speaks only Spanish. Patient had interpreter present during client registration, vaccination and post vaccine occurrence. Patient was given Janssen COVID vaccine Lot # 1805031 in the left deltoid by this nurse at approximately 2:00PM. Client left the event without c/o after 15-minute observation. 2:55PM Client returned to the event and according to the RN client c/o drowsiness and dizziness. RN reports client HR 80 bmp (strong & regular); client B/P in right arm 152/100. Client c/o a headache at #8, on the pain scale of 1-10. Client also c/o pain in the front of her head. Client was alert and oriented skin warm and dry, color WNL and no gross dyspnea noted; client c/o left side chest pain traveling up the left side of her arm. 2:57PM Explained to client 911 will be called and 911 will decide if emergency room visit was warranted. 3PM Client remains alert and oriented with some diaphoresis and change in color noted. 3:02PM Client color returned diaphoresis improved 3:04PM Client reports she is ?feeling better?. 3:05PM Paramedics arrived. Client evaluated by paramedics. Paramedics applied oxygen and checked client vital signs. According to the paramedic client breathing was normal with good oxygenation. Client reports to paramedics she had COVID last year. The paramedic conducting the client assessment reports he felt client is hyperventilating and has no s/s of an anaphylaxis reaction. Client relayed to paramedic her headache is gone but her head, left arm and leg feels ?numb?. Client agreed to go to the emergency room. 3:25PM client left with via stretcher for ambulance transport to Emergency Room (according to paramedic ED was on diversion). 5/26/21 1:00PM Spoke with RN who reports client was discharged from the ED 5/25/21 to home and is feeling better. Per RN client plans to return to work 5/27/21.
48 2021-05-25 sleep disorder Headache, hot and cold (no actual temperature) joints hurt, muscles hurt. I STILL have issues wit... Read more
Headache, hot and cold (no actual temperature) joints hurt, muscles hurt. I STILL have issues with my right arm getting tingly feeling and can't sleep on it. Had abnormal tightness in my chest, and called my PCP, they said it had too too long after the shot (only 10 days) that it was not related! I had just about every side affect if not all of them!
48 2021-05-30 impaired work ability, loss of personal independence in daily activities Ten minutes after I received the vaccine, my left arm and leg felt very heavy, like I was uneven. I ... Read more
Ten minutes after I received the vaccine, my left arm and leg felt very heavy, like I was uneven. I started to feel very dizzy and my left eye became very blurry. I started feeling nauseous, as well. On the car ride home I noticed a rash. We thought it was an allergic reaction. After I got out of the car I noticed it went away. It came back later again, around my neck that evening, but it only lasted 5 minutes. It was a rash with white bumps and then it went away. At night I experienced chills. When I woke up I had a blistering headache with neck pain that lasted a couple days. The nausea and balance picked up and got worse. I spent two weeks being unable to see, walk, read or drive safely. I have had to take time off of work. I cannot view a computer screen without feeling nauseous. Most of the first week I spent on the floor because of the nausea and spinning issues. I sought medical treatment. I had a CAT scan and they ruled out a blood clot. I still have low grade nausea. I have regained peripheral vision in my left eye, which was missing for three weeks. I have been off work for more than 2 weeks. I still cannot work at my normal capacity. I still have a very strong chemical taste in my mouth. It is getting less and less, but I can still taste it. I've have a lot of swelling at the base of my skull, that has not resolved.
48 2021-05-30 sleep disorder There was extreme pain in the injection site immediately. Twelve hours after the shot, I had terribl... Read more
There was extreme pain in the injection site immediately. Twelve hours after the shot, I had terrible chills and flu like symptoms that lasted for several days. I then started getting strange pulsing in my legs that moved around and was more prominent at night. I was somewhat short of breath when exerting myself for about a month. Then I had pain that would travel throughout my legs and in my groin. 2 1/2 weeks later it was so bad that I went to the emergency room to be tested for blood clots, which were negative. The pain in my arm dissipated gradually, but 7 weeks later it still hurts enough to wake me up in the middle of the night. The pulsing in my legs has for the most part finally dissipated, but continues from time to time.
48 2021-06-01 insomnia The night of vaccine unable to sleep due to fever and body aches. Continued fever and body aches the... Read more
The night of vaccine unable to sleep due to fever and body aches. Continued fever and body aches the next day May 22. Started to feel better May 23, but still not quite right. Felt completely back to normal Monday, May 24. Sunday May 30 I started have itchy blisters on elbows and hands. This has spread to 70 % of my body and they are now painful and blood filled.
48 2021-06-02 sleep disorder, fear Starting 5/14 evening, I started having tingling and pins and needles in my extremities, and that sa... Read more
Starting 5/14 evening, I started having tingling and pins and needles in my extremities, and that same evening, I started having shortness of breath/difficulty breathing. I was wide awake and had a very difficult time sleeping. I woke up numerous times hot and flushed and at 1am, I could barely breathe because my heart was beating extremely fast. I was very scared. I couldn't even slow my breath with meditation or breathing. I somehow finally fell back asleep after about 2 hours, even though my heart continued to beat very fast. I woke up the next morning naturally exhausted. I have since experienced occasional tachycardia and frequent bouts of tingling and pins and needles particularly in my extremities. Yesterday, 6/2, I woke up with extreme pins and needles in my extremities to the point of pain and discomfort, particularly my hands/fingers but throughout my body, and they kept up all day long and well into the night, worsening into the night. I woke up today with less pins and needles, but there are still felt in my upper limbs, particularly my left arm/hands.
48 2021-06-07 crying Severe fatigue for about a week and a half - ( I do have periods of fatigue because I'm disabled) - ... Read more
Severe fatigue for about a week and a half - ( I do have periods of fatigue because I'm disabled) - but this was unbelievable fatigue. One day, I was in bed the whole day - maybe the 25th. On 22nd and 23rd, I wash having hopeless and crying - which is unusually for me. On 24th, I started feeling better. I talked to my psychiatrist - I had my thyroid meds changed on 13th (Levythroxine) and dr thought it was the meds and he wanted me to see Dr. - who was my primary care at the time. I saw Dr on the 26th of May. When I saw the doctor, on 26th, I had been starting to limp and my joints were swollen. I do have problems with my joints but this has been more than usual. Now after the vaccine, anything I do, I do have to ice my knees when I come home. And when I sit Indian style my knees are going to hurt really bad. And occasionally my kneecap comes out of joint. It usually has to do with if I twist too much. It usually only happens a few times a year but now it is happening really regularly. Even when I sleep at night. Range of motion with my knee - there will be a moment when it comes out of joint and floats. A couple of years ago when I had severe reaction - immunosuppressant - I'm not on this now and haven't been for the time during the pandemic. But when I took that - a couple of years ago, within 10 minutes my joints were stiff and it was hard to walk. And so these symptoms I'm experiencing now is a bit similar to that as far as muscles and joints. I've had more pain. One of the other symptoms I've had with the vaccine, is a more intense allergy reactions when have exposure to one of the things I'm sensitive too. Dr said I was having the symptoms of hypo-thyroid and hyper-thyroid. Thyroid tests completed. Will see dr on the 10th to get the results. I think this is an auto-immune flare. I do have a pain log that I've been that I've been keeping if that would be helpful. I can send that to you.
48 2021-06-08 feeling abnormal, memory impairment Fever chills and hip pain within 7 hours of the vaccine. Hours 8-24 hours post vaccine extreme hip ... Read more
Fever chills and hip pain within 7 hours of the vaccine. Hours 8-24 hours post vaccine extreme hip and knee joint pain (unable to stand for greater than 5 minutes) , exhaustion, loss of appetite, blurred vision, foggy memory/thoughts. Hours 25-96 (current ongoing) joint pain in hips and knees, pain at base of skull radiating down neck and into back limiting movement, blurred vision, inflammation and swelling of right hand pointer finger joint (limited movement of joint), skin rash on legs, foggy memory.
48 2021-06-11 mental impairment, feeling abnormal Within 6 hours, I developed a fever, all over body aches (from neck to toes), headache, inability to... Read more
Within 6 hours, I developed a fever, all over body aches (from neck to toes), headache, inability to think clearly, difficulty speaking. This lasted for approximately 48 hours until the fever broke. Fogginess and headache lasted for another 48 hours.
48 2021-06-14 excessive sleepiness About 2 hours after getting the vaccine I became very tired. I did not feel hungry so did not eat di... Read more
About 2 hours after getting the vaccine I became very tired. I did not feel hungry so did not eat dinner and went to bed early from the extreme fatigue. The entire next day I spent asleep with headache and fever. I was unable to eat, drink, or even get out of bed from the extreme fatigue.
48 2021-06-14 impaired work ability I experienced a week later after receiving my J&J vaccine, inflammation to my legs and hands, I have... Read more
I experienced a week later after receiving my J&J vaccine, inflammation to my legs and hands, I have water retention, feel very sick, have kidney pain which I did not have before getting the J&J vaccine. When I was getting my vaccine, I told the nurse that was putting the injection, that I have history of high blood pressure but I do not take any medicine, the nurse said it was fine that I should be okay. I also experienced swollenness to my face. I went to the ER on 05-27-2021 due to how I was feeling. AT the ER they performed lab work and did an echocardiogram. I recently got a type of medical insurance. I am also not working at this time due to my symptoms of retaining water in my body, where I get so inflamed to my legs and hands and face. At the ER I was told I needed to see a PCP but I do not have one at the moment since I did not have insurance when I received my J&J vaccine. I feel my quality of life has decreased since receiving the J&J vaccine. I do not have my lot# to provide at this time..
48 2021-06-16 poor quality sleep 12 hrs after vaccinated: loss of taste/smell 4/19-26: fatigue 4/26-5/9: shortness of breath during n... Read more
12 hrs after vaccinated: loss of taste/smell 4/19-26: fatigue 4/26-5/9: shortness of breath during night.. restless sleep 5/10-13: periodic shortness of breath throughout day 5/13-20: admitted to hospital - pulmonary embolism & congestive heart failure IV treatment: heparin 5 days Several medications each day/night taken
48 2021-06-17 depression, irritability Blacked out, neck pains, weakness, soarness in injection sight, depression, and irritable.
48 2021-06-20 impaired work ability CALL OFF WORK; JOINT PAIN; NAUSEA; HEADACHE; FATIGUE/ TIREDNESS; ARM ACHE; NEUROPATHY; DIARRHEA; BOD... Read more
CALL OFF WORK; JOINT PAIN; NAUSEA; HEADACHE; FATIGUE/ TIREDNESS; ARM ACHE; NEUROPATHY; DIARRHEA; BODYACHE AND LITTLE SHARP PAINS EVERYWHERE; SWOLLEN LYMPH NODES; BLURRY VISION; LETHARGIC; STOMACH CRAMPS; SWEATS; VOMITING; STOMACH DISCOMFORT; This spontaneous report received from a patient concerned a 48 year old female of unspecified ethnic origin. The patient's weight was 195 pounds and height was 70 inches. The patient's past medical history included Covid-19 (DEC-2020) and concurrent conditions included Hashimoto's disease, thyroid disease, blood pressure, leukocytosis, celiac disease, anemia, and auto immune disease. She had loss of smell, loss of taste since last 6 months. Patient was non alcohol user and non smoker. She was on a gluten free diet. The patient experienced drug allergy when treated with Dilaudid and Neomycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: 23-JUN-2021) dose was not reported, 1 total dose administered on 10-JUN-2021 at 15:15 to right arm for prophylactic vaccination. Concomitant medications included Synthroid (levothyroxine sodium), hydrochlorothiazide and Claritin D (Loratadine/pseudoephedrine sulfate). On 12-JUN-2021, the patient experienced neuropathy, diarrhea, body ache, little sharp pains everywhere, swollen lymph nodes, blurry vision, lethargy/ tiredness, stomach cramps, sweats, vomiting, arm ache, nausea and headache. On 13-JUN-2021, the patient experienced joint pain. On JUN-2021, the patient experienced stomach discomfort and fatigue. On 14-JUN-2021 patient reported that she had to call off work and she did not have fever. She had not seen her doctor yet but would call the doctor. Treatment medications (dates unspecified) included: Aspirin (acetylsalicylic acid), Tylenol (paracetamol) and Ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neuropathy on JUN-2021, was recovering from nausea, and vomiting, had not recovered from diarrhea, bodyache and little sharp pains everywhere, arm ache, headache, swollen lymph nodes, blurry vision, lethargic, stomach cramps, sweats, joint pain, stomach discomfort, and fatigue/ tiredness, and the outcome of call off work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210629819- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Neuropathy. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
48 2021-07-08 insomnia The day after I got my shot I had a lot of pain in my arm at the injection site. I was a little fati... Read more
The day after I got my shot I had a lot of pain in my arm at the injection site. I was a little fatigued. The pain remained in my arm and is still there currently. My doctor advised me my vaccine may have been injected to high . As a result of the pain I was prescribed an anti inflammatory Diclofenac Sodium 75mg 2xdaily which I have been taking for 2 weeks now. My doctor also referred me to a physical therapist because he felt there was a possibility of a pinched nerve in my neck. The pain has since moved through my entire arm and through my fingers as well. It feels similar to Tennis arm. It has also caused difficulty with sleeping at night.
48 2021-07-11 anxiety, feeling drunk SEVERE BODY ACHE; GIGGLES; HIGH ANXIETY; FEELING DRUNK; LOW GRADE FEVER; MILD AND DRY SORE THROAT; T... Read more
SEVERE BODY ACHE; GIGGLES; HIGH ANXIETY; FEELING DRUNK; LOW GRADE FEVER; MILD AND DRY SORE THROAT; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to some topical polyethylene glycol (peg), and hand injury. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included naproxen for hand injury. On 09-JUL-2021, the subject experienced mild and dry sore throat. On 09-JUL-2021, the subject experienced giggles. On 09-JUL-2021, the subject experienced high anxiety. On 09-JUL-2021, the subject experienced feeling drunk. On 09-JUL-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 98.8. On 10-JUL-2021, the subject experienced severe body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild and dry sore throat, severe body ache, low grade fever, feeling drunk, giggles, and high anxiety. This report was non-serious.
48 2021-07-15 insomnia Started feeling some extra fatigue in May and occasional headaches and also insomnia. I told I my do... Read more
Started feeling some extra fatigue in May and occasional headaches and also insomnia. I told I my doctor - I had a physical completed - I scheduled the physical for the symptoms I was experiencing. No treatment except she said if I needed melatonin I could take that. I started using the Olly Sleep Formula gummies with Melatonin - 3 mg per dose and it also has some herbs and amino acids. I take two which is one serving at night. Sometimes it helps with my insomnia and sometimes it doesn't. I started noticing Chest stinging - a sting which makes me pause - It started two days ago - it happened in the evening a couple of times and yesterday it happened more at night at 10 pm. It isn't a persistent thing - it goes away. My ring finger feels numb. I had to actually remove the ring. The two fingers next to the ring finger feel tingly and numb. The numbness is persistent but they are not totally numb. I feel it in the tips of my fingers that are next to my ring finger. My ring finger I felt it more in the base. I haven't been able to speak with doctor about these things yet. I still have extra fatigue and the headaches I have on occasion still.
48 2021-07-20 insomnia I had severe arm burning while shot going in. It never went away and was noticeable when laying on ... Read more
I had severe arm burning while shot going in. It never went away and was noticeable when laying on the arm. I?ve started working out and the pain has intensified to the point that it is radiating to my neck and back and I cannot sleep on that side. It sometimes is a deep throbbing pain and other times feels like sand paper. Last week I noticed a small scab right where the shot was. I picked it off and it bled a lot. Since then the pain is almost constant and limiting my daily abilities. Red dot remains where the shot was administered. Sometimes feels warm to the touch. This is staring to cause me distress and worry. I had two boys that just got first vaccine but I don?t think I will be getting them the second. I work in health care and I?m finding it difficult to do my job at times.
48 2021-07-28 loss of personal independence in daily activities, impaired work ability within 2 weeks of the vaccine- I started to get terrible pain in my right elbow. I even had to call... Read more
within 2 weeks of the vaccine- I started to get terrible pain in my right elbow. I even had to call into work for this (which I never do). I wasn't sure what was going on at first. I have not been using my right arm any differently or more frequently. I am right-hand dominant though and this was very painful and disruptive to my daily activities. I have since been using a "tennis elbow strap" which only helps slightly. The pain has lessened over the past 2 months but continues to be bothersome. I have been speaking to my co-workers and I also work as a nurse - so I hear a lot of comments from the public. There have been MULTIPLE instances of people complaining of elbow pain after taking the Covid vaccine. On the chance this may not just be a coincidence - I decided to complete this form. It's way too difficult to find any information other than serious adverse events online so I'm not sure if there is something to this or not. If you have any data on if this is a side effect or when I can expect this to go away/ subside... that would be great. I understand you are just collecting data at this point but I thought this important to report.
49 2021-03-03 anxiety Started to experience anxiety and dizziness approx 1 hour after receiving vaccine. BP elevated at ti... Read more
Started to experience anxiety and dizziness approx 1 hour after receiving vaccine. BP elevated at time of observation (168/102). Obesrvation time extended to 1.5 hours. Provided hydration and light meal. Discharged per team member request after she stated she felt better. Encouraged to take BP meds as directed per PCP. Encouraged to go to ER for symptom return or additional adverse reactions per handout/Agency guidelines.
49 2021-03-07 panic attack Sore arm at sight of injection Nausea Headache Body aches Weakness Panic attacks
49 2021-03-10 feeling abnormal pt had difficulty breathing, was was coughing and feeling abnormal. She vomited and lost conscious... Read more
pt had difficulty breathing, was was coughing and feeling abnormal. She vomited and lost consciousness and epipen was administered. She was feeling much better by the time the paramedics arived
49 2021-03-10 restlessness Fever, body aches, nausea, headache, fatigue, restlessness, muscle and joint aches
49 2021-03-11 insomnia Janssen COVID-19 Vaccine EUA @ 10:30 am 3/11/2021 Begining at 8 pm, I got chills (shivering and shak... Read more
Janssen COVID-19 Vaccine EUA @ 10:30 am 3/11/2021 Begining at 8 pm, I got chills (shivering and shaking uncontrolably) for over an hour, then a fever of 103 less than an hour after the chills started. I took Ibuprophen and was able to fall asleep. Woke to a fever of just 99. Feeling better the next morning.
49 2021-03-15 feeling abnormal, sleep disorder Started with nausea. Then omitting (without GI disturbances). Around noon, symptoms included severe ... Read more
Started with nausea. Then omitting (without GI disturbances). Around noon, symptoms included severe body pain, feet swelling, headache, light and noise sensitivity, foggy thought process, and facial rash with noticeable hair loss comparable to a Lupus flare prior to treatment several years ago. Low grade temperature of 99 for a few days. The symptoms have improved, however, thinking is very foggy. Physician ordered Phenergan for nausea and vomiting; as well as: hydration and rest. Ibuprofen for headache and joint and body pain. Ambien to sleep. This has been going on for four days.
49 2021-03-17 insomnia Extreme shaking and chills to the point of needing assistance to walk, nausea, migraine and headache... Read more
Extreme shaking and chills to the point of needing assistance to walk, nausea, migraine and headache, low grade fever, numbness in fingertips, extreme muscle pain (body), sleeplessness, fatigue
49 2021-03-18 sensation of foreign body Patient stated she felt like she had a lump in her throat. IM Benadryl given. Patient stated after d... Read more
Patient stated she felt like she had a lump in her throat. IM Benadryl given. Patient stated after dose of Benadryl that she was feeling better.
49 2021-03-20 sleep disorder At 4:41 AM,11 hours after injection, extreme joint pain all over my body including spine, ankles, to... Read more
At 4:41 AM,11 hours after injection, extreme joint pain all over my body including spine, ankles, toes, elbows, wrists, fingers. On a scale of 1-10, it was 8-9.Woke me up from a deep sleep. Took 10 minutes to walk to bathroom (approximately 15 feet away) to get ibuprofen. Could not get comfortable lying, sitting or standing. Eventually fell back asleep. Woke up four hours later, and pain had subsided. Probably a 2-3 on the scale.
49 2021-03-20 sleep disorder Jansen COVID-19 Vaccine EUA Chills, headache, body aches, fever (101.3), trouble sleeping and pain ... Read more
Jansen COVID-19 Vaccine EUA Chills, headache, body aches, fever (101.3), trouble sleeping and pain at injection site.
49 2021-03-22 insomnia injection site pain - lasted 3 days body/muscle aches - last 3 days chills - lasted about 12 hours f... Read more
injection site pain - lasted 3 days body/muscle aches - last 3 days chills - lasted about 12 hours fever - lasted about 24 hours headache - lasted about 36 hours nausea - lasted about 12 hours fatigue - 3 days insomnia - one night
49 2021-03-23 disturbance in attention Cold chills Friday afternoon and night(but consider those the mild side effects) Saturday morning no... Read more
Cold chills Friday afternoon and night(but consider those the mild side effects) Saturday morning noticed: dizziness with movement(like motion sickness); nausea has continued since then(Sat, Sun, Mon, Tues, Wed) Dizziness has been severe and causing nasea with gagging but not vomiting. Feeling off balance, using walls etc in order to walk straight. Blurred vision (comes and goes as dizziness increases/decreases) Difficulty concentrating. Yesterday(Tuesday) pulling sensation down right side of neck, confusion, blurred vision. Slight hesitation to writing with right hand(had to concentrate to sign my name etc)
49 2021-03-24 impaired work ability Headache, Fever, NauseaVomiting, fatigue and chills Narrative: Employee reported fever, headache, f... Read more
Headache, Fever, NauseaVomiting, fatigue and chills Narrative: Employee reported fever, headache, fatigue, nausea and chills. Resulted in unable to work 3/15/2021.
49 2021-03-25 excessive sleepiness, sleep disorder Since the vaccination and now two weeks later, I am experiencing dizziness and lightheadedness, and ... Read more
Since the vaccination and now two weeks later, I am experiencing dizziness and lightheadedness, and unbalance. Also, a general unwell feeling, fatigue, extreme sleep disturbance, and temperature regulation difficulty, especially at night. NONE of these symptoms were present at all in any form before the vaccine.
49 2021-04-07 feeling abnormal chills with shaking and headache. Took Tylenol to control shaking and chills which turned to feeling... Read more
chills with shaking and headache. Took Tylenol to control shaking and chills which turned to feeling very hot after taking Tylenol. Foggy head with headache. Still have chills 4/8/21. Still taking Tylenol
49 2021-04-08 feeling abnormal 9:45 c/o dizziness, "foggy" brain 9:48 throat tightness, pale lips 9:50 epi injection 9:52 Benadryl ... Read more
9:45 c/o dizziness, "foggy" brain 9:48 throat tightness, pale lips 9:50 epi injection 9:52 Benadryl 50mg IM 9:58 throat sill tight, speech slightly hoarse 10:05 A + O x3, Throat tightness, speech clear EMS transported to ER
49 2021-04-08 panic attack PT IS A 49 YO/F REPORTING THAT SHE SUDDENLY FEELS TIRED WITH A HEADACHE. PT REPORTS THESE SYMPTOMS S... Read more
PT IS A 49 YO/F REPORTING THAT SHE SUDDENLY FEELS TIRED WITH A HEADACHE. PT REPORTS THESE SYMPTOMS STARTED SOON AFTER HER SHOT. PT DOES NOT APPEAR TO BE IN ANY IMMEDIATE DISTRESS, WOB APPEARS NON-LABORED, SKIN IS WARM/DRY/COLOR APPROPRIATE. SHE IS AAOx4, SPEAKING AND ANSWERING QUESTIONS APPROPRIATELY. PT VITALS ARE OBTAINED AND SHE PRESENTS AS HYPERTENSIVE. PT ADVISES THAT SHE HAS BEEN DIAGNOSED WITH ANXIETY AND SHE BELIEVES SHE IS HAVING A MILD PANIC ATTACK. PT IS REASSESSED AND HER BP DECREASES. SHE STATES THAT HER HUSBAND IS COMING TO PICK HER UP FROM THE OBSERVATION AREA. DUE TO PT COMPLAINT OF HEADACHE AND ELEVATED BP, SHE IS ADVISED BY EMS CREW THAT SHE CAN NOT MEDICALLY CLEARED WITHOUT A PHYSICIAN EXAM. SHE IS ADVISED OF REFUSAL PROCEDURE AND POSSIBLE RISKS DUE TO HYPERTENSION. SHE REMAINS AAOx4 AND ADVISES THAT SHE UNDERSTANDS. PT SIGNS A REFUSAL AND HER HUSBAND IS ON SCENE TO PICK HER UP.
49 2021-04-08 restlessness, insomnia, sleep disorder 0213A21A -(The lot number is hard to read and it could be this number or the one above.) Wednesday, ... Read more
0213A21A -(The lot number is hard to read and it could be this number or the one above.) Wednesday, Thursday and Friday - I had headaches and I had extra fatigue (I already do have fatigue because I have insomnia). My arm soreness was on the other arm not on the one that I had an injection. Friday and up until yesterday, I had nausea. Saturday, I had headache and being tired. Sunday, I had chest pain (woke up with it) like a burning in my chest. My left arm, I felt a tingling down my arm to my legs - it almost felt like a blood clot was there in my arm. I had to put heat on and then ice. I couldn't extend arm because it hurt. Midnight on Monday, the burning and the chest pain was too much and I was getting worried. The only thing I have is asthma, otherwise I'm healthy. I went to ER - they gave a Cocktail of Lidocaine; Malex and something else to see if it would help with the burning in my chest. Monday, I took Tylenol. Tuesday, the chest pains were more intense. 03:00 on Wednesday am - I went back to ER. They brought me to a full chest x-ray - front, side and back and a CAT SCAN and gave me another Cocktail and also put something in my IV. This time, they sent me home with four different medicines. The meds are: Generic of Nexium; Aspirin low dose of 81 mg - bayers children - one a day; Generic version of Bentil Triacetin - I take this when I want to be still; Generic version of Valium - they gave me four of these - and I have one left that I will take tonight so I can sleep. I am taking Vit D. I haven't taken Tylenol since getting on these. I try to stay hydrated. I still have a really really funny feeling inside me. Last night, I was very restless and couldn't sleep. It makes me on borderline and dizzy and my heart starts palpitating. It's a scary feeling in my chest.
49 2021-04-09 sleep disorder Approximated 12-13 minutes after receiving the shot; my respiration increased, heart rate, and my vi... Read more
Approximated 12-13 minutes after receiving the shot; my respiration increased, heart rate, and my vision became blurred. I reported the blurred vision to the Pharmacist and she said they have not heard reports forth this symptom. Based upon events following the injection relative to my blood pressure; it is likely that my blood pressure became elevated following the injection, resulting in blurred vision. My blurred vision resolved several minutes later. However, my heart rate increased later that evening to the point I slept upright in my recliner that evening. During sleep, I awoke from my sleep gasping because my heart felt like it was beating too slowly. It has not been several weeks since receiving the injection, and during this time period, my Blood Pressure (BP) has been fluctuating from "very high" to normal. Yesterday, I presented to the ER due to High Blood Pressure (145/100), by the recommendation of a NP. I have NEVER had any history of high BP prior to the injection.
49 2021-04-10 feeling abnormal Patient was observed for 15 minutes; complained lips felt swollen had patient take off mask lips app... Read more
Patient was observed for 15 minutes; complained lips felt swollen had patient take off mask lips appeared normal, Patient was a bit pale and said she might faint. Rushed to her and held her avoiding fall. Patient closed he eyes for 1 to 2 seconds and responded to taps on the chest and calling her name. Opened her eyes, patient had pulse and was coherent.Called 911, police arrived within 10 minutes. In the mean time store management was alerted and BP was taken 157/121. EMS came and patient stated she was better they checked her BP 121/70. Patient refused to go to the hospital. EMS walked her out to her husband waiting in the car.
49 2021-04-10 hallucination, loss of personal independence in daily activities, feeling abnormal Heathcare professional or Clinic Site: After approximately eight hours after the shot, I woke up wit... Read more
Heathcare professional or Clinic Site: After approximately eight hours after the shot, I woke up with SEVERE; chills, fever( hallucinating), headache, body aches- could not hold myself upright, sever nausea and stomach pains, vomiting for eight consecutive hours. For the next 48 hours, I felt spacey, couldn't remember words, could not go to work, very fatigued.
49 2021-04-11 depression The day after the injection I was severely depressed the entire day. I was fine the day before and t... Read more
The day after the injection I was severely depressed the entire day. I was fine the day before and the day after. I happened to have an appointment with my psychiatrist that day and told her about it.
49 2021-04-11 depression Depressive symptoms, been very depressed
49 2021-04-11 sleep disorder, impaired work ability Received the shot at 4:45 pm. A little after 11 pm that night, I had mild fever (did not take temp)... Read more
Received the shot at 4:45 pm. A little after 11 pm that night, I had mild fever (did not take temp) and severe chills that lasted about 2 hours. I had a very severe headache and felt very nauseous. I was not able to sleep well during the night. The next day, between 7 am and 5 pm, I stayed in bed with the most severe headache I have ever had, severe nausea and extreme fatigue, and sometimes felt hot and/or had mild chills. I was not able to go to work, as I could not get out of bed. I was finally able to get up around 5 pm (24 hours after shot) and eat a little something as the nausea had finally subsided. I was still very fatigued and had a less severe headache. I was able to sleep well that night, and woke the next day (about 36-37 hours after shot) with only a slight headache, which went away with a few hours.
49 2021-04-12 anxiety Patient reports feeling hot and anxious, she has history of anxiety attacks. Patient placed in comfo... Read more
Patient reports feeling hot and anxious, she has history of anxiety attacks. Patient placed in comfortable settings. Vitals @ 5:20pm Pulse 82 BP 140/100 RESP 20. Patient had water and a cereal bar patient state she feels better ,BP 115/75 Pulse 85 RESP 18@5:36pm.
49 2021-04-12 feeling abnormal I felt body aches all over, my skin hurt to the touch , the rim of my eyes feels burning . bottom of... Read more
I felt body aches all over, my skin hurt to the touch , the rim of my eyes feels burning . bottom of my feet hurts. I felt like the core of my body hurts. I felt like dying . even my hair hurts. I took Tylenol around 8 pm. by 12 all the aches were gone , I felt better.
49 2021-04-12 feeling abnormal Weird, bad feeling at first followed by bad aching , joint pain, headache, shoulder pain, neck pain ... Read more
Weird, bad feeling at first followed by bad aching , joint pain, headache, shoulder pain, neck pain , back pain.
49 2021-04-12 impaired work ability My mother received the Jansen vaccination on April 6, 2021. 2 days post vaccination she had 2 asthm... Read more
My mother received the Jansen vaccination on April 6, 2021. 2 days post vaccination she had 2 asthma attack at work. That following Friday she was not able to attend work due to shortness of breath. Saturday morning she cold not inhale and couldn?t stop coughing. She was then attempted to be taken to urgent care, but upon arrival she was coughing up blood and was instructed to go straight to the hospital. At the hospital upon test being done she was admitted to the covid unit and diagnosed with pneumonia due to covid 19 virus, bilateral pulmonary embolism in both lungs. She is now home in quarantine taking blood thinners for the next three months and unable to work.
49 2021-04-12 impaired work ability Patient immediately felt pain in her arm and then described feeling "woozy". She was given a quiet p... Read more
Patient immediately felt pain in her arm and then described feeling "woozy". She was given a quiet place to sit and then lie down. She was given water, juice, and snacks. She felt dizzy and a bit nauseated at times. She admitted to not having eaten anything prior to the vaccine. At 1500, an hour after she received the vaccine she felt like her heart was racing and she reported that the whole right side of her body felt cold. People with her that knew her well stated that she "was not herself". She also reported at this time that she felt like her heart was racing. This nurse recommended, by phone (patient had left the clinic site by this time) that the patient's mother take her in to urgent care or the ED, just to be sure everything was okay. Upon follow up, the patient did not go in but called the ED triage nurse. She was told this was likely a normal response to the vaccine. Patient went home to rest and her mother stayed with her overnight. Today client is back at work- tired and sore but nothing more reported.
49 2021-04-12 loss of personal independence in daily activities On the day of my vaccine I had typical symptoms - chills, fatigue, and headache. The next day I fel... Read more
On the day of my vaccine I had typical symptoms - chills, fatigue, and headache. The next day I felt better, just tired. On Tuesday the 23rd I returned to work and felt fine, but I did have an occasion of dizziness and I was tired. I felt good on the 24th and returned to life/exercise as normal. I woke up on the 25th in the early morning with a strange sensation in my head. (I described it to my husband that it felt like I had worms in my head.) When I got up I experienced dizziness that seemed like vertigo. I tried to proceed with my day, but I got an intense headache, loss of appetite, and sore upper leg muscles. I reached out to my doctors office. I saw a doctor on the 26th. (My dizziness was better, but I still had a headache and muscle aches.) We discussed vertigo and possible reactions to the vaccine. He also found some liquid in my ears and so we questioned allergies. I got allergy medicine and took it when I got home. The next day in the early morning the headache and muscle aches returned and I called a hotline through my doctor's office. (The headache was quite intense.) I spoke with a nurse - I was concerned that I may have Covid. We discussed my reaching out to get a test if my symptoms were not better by Monday. By Sunday I was feeling a bit better. My headache had improved but I still had muscle aches in my legs. I determined I would be able to go back to work on Monday. The last symptom to remain was aches in my legs. On Wednesday the aches were in my upper legs , by 3/30 the aches were in my ankles. I was feeling better by early April.
49 2021-04-12 memory impairment Client states she started feeling dizzy or light headed. Progressed to a very bad headache. Chills, ... Read more
Client states she started feeling dizzy or light headed. Progressed to a very bad headache. Chills, fatigue developed. Temperature 105.9*F. Nauseous. Has a very hard time remembering Saturday evening. Took 500mg of Tylenol and went to bed. No fever the following day but still felt achy, fatigued, headache, hot/cold flashes, nauseous, extreme thirsty. Developed an unseen rash all over her body, itched very bad that lasted hours. Mainly scalp, hands, and feet.
49 2021-04-13 feeling abnormal I waited in the pharmacy for 15 minutes; soon after I got in my car to drive home and felt a strange... Read more
I waited in the pharmacy for 15 minutes; soon after I got in my car to drive home and felt a strange sensation on the left side of my face. While driving, my entire left side went numb. I kept checking my face in the rear-view mirror to see if it was drooping. It was not. My upper lip appeared and felt swollen. Six days later, on March 28th, I came down with a really bad migraine. It started in my left eye and then was a really bad headache. I called the eye doctor the following day because the pain was not subsiding. The migraine lasted from Sunday, March 28th to Wednesday, March 31st. Following the migraine, I have been getting headaches (not as severe, but still painful) almost daily. The headache is not over my eyes or in the temple. Instead the headaches are on the top of my head and towards the back. Today is three weeks and two days after my vaccine, and I am still having headaches on the top of my head.
49 2021-04-13 nightmare Background: With Chrohn's and with the Erythromycin - I had some fatigue; stomach upset; and joint p... Read more
Background: With Chrohn's and with the Erythromycin - I had some fatigue; stomach upset; and joint pain. I didn't go into it with no symptoms. These that I am reporting would be increased. I could feel injection go into the arm. By the morning of the 15th, I think, increase joint pain and fatigue from my baseline. My knees; feet hands - achy in the joints themselves. Fatigue: wishing I could have a nap throughout the day. These lasted for about a week. I had stomach upset that I believe may have been from the Erythromycin - but that didn't change that stomach upset - still had it... it may have gotten a little worse (the nausea. By morning of the 23rd, I took 2 mg Ondansetron for that nausea. That helped a lot with the nausea. Around 2 am on the 24th, I woke up from a very bad nightmare and I woke up with a pounding heartrate. My chest was really thumping. I got up to the bathroom. My heart kept pounding harder and faster and didn't come down. My watch said tit started going up to: 122 to 144 to 154 and it kept gradually going up. I was petting the dog and sitting in the recliner. I phone my Dr's on-call number and spoke to him on the phone. I called 9-1-1 by his advice. Paramedics came - Heartrate stayed up. I was still able to walk around the house. I followed up to their truck and they checked me over. By that time as they were taking my vitals my heart rate started to calm down. (It was elevated about 15 minutes about all together) My blood pressure - 160 over 110 when the paramedics checked me but that was coming down as they had me at the truck and the heart rate went down to 80-90 and was continuing to go down. It hasn't come back. They listened to my heart. Never had that happen to me before like that. Didn't have to go to ER. I do have the apple records of my heart rate, etc. if needed. The joint pain and fatigue faded back to my baseline.
49 2021-04-14 feeling abnormal Severe headache, body aches, fever 104.8 at highest and lowest for 3 days was 102, brain fog, fatigu... Read more
Severe headache, body aches, fever 104.8 at highest and lowest for 3 days was 102, brain fog, fatigue, shortness of breath
49 2021-04-14 impaired work ability Developed a severe migraine about 7 days after receiving shot. Migraine has persisted despite multip... Read more
Developed a severe migraine about 7 days after receiving shot. Migraine has persisted despite multiple treatment attempts. Patient has thrown up and lost 10 pounds due to the severity of migraine and has only been able to work about 3 days since she received her vaccine. Patient medicated with advil so much that she ended up with a stomach ulcer. Provider has tried toradol, nurtec, dicyclomine and patient is currently on emgality 120mg, zofran 8mg and omeprazole 40mg.
49 2021-04-14 sleep disorder Low grade fever, headache and body aches approximately 16hrs after injection which resolved approxim... Read more
Low grade fever, headache and body aches approximately 16hrs after injection which resolved approximately 12-18hrs after onset. This report concerns sudden and progressive right ear pain in mastoid region beginning 8 days after immunization. Causing aching, tenderness, pain and pressure behind bottom of right ear and just below ear canal area which causes waking at night and pain throughout the day. Initial appointment with primary care MD for workup and treatment on 15April21. Outcome pending at time of this report.
49 2021-04-15 confusional state 9 hours post injection patient started chills; fever rose to 104.9 - was brought below 104 with acet... Read more
9 hours post injection patient started chills; fever rose to 104.9 - was brought below 104 with acetaminophen. Fever, chills, body aches, severe headache, mental confusion lasted until 48 hours post injection and then subsided.
49 2021-04-15 impaired work ability About 3 hours after receiving the , vaccine on April 5 at 3:15 pm, I had uncontrollable shivers and ... Read more
About 3 hours after receiving the , vaccine on April 5 at 3:15 pm, I had uncontrollable shivers and chills, shaking violently through my whole entire body. I was freezing cold to the bone. I felt nauseous and threw up my entire dinner. That didn't make the nausea go away - I continued to throw up that evening 5 or 6 more times. The nausea continued the next day making me throw up 3 more times. And yet the nausea persisted for a whole entire week. I had a horrible headache that night that has stuck with me these last ten days. My muscles ached and shot strange pangs through my body. I was exhausted. I could not stay awake. I was so weak and tired. I had no energy and just laid in bed for a solid four days. My throat hurt, my neck hurt, my head hurt, my arm where the shot went in hurt so bad. Very strangely, my stomach was constantly bloated and hurt inside like a bad stomach ache - even if I hadn't eaten anything it still bloated and hurt. The painful stomach lasted seven or eight days. I had diarrhea for those seven /eight days. I was completely dehydrated. The diarrhea lasted way too long - it was difficult to return to work. The second day after the shot I woke up to my left eye red, like some blood vessels had burst. It took four or five days for my eye to go back to normal. my heart has a stabbing feeling randomly all the time now and it is hard to breathe. I wheeze and cough all the time. It is very uncomfortable. This heart issue has persisted the entire time since getting the vaccine.
49 2021-04-18 feeling drunk DIZZINESS; DRUNK FEELING; SLIGHT HEADACHE; This spontaneous report received from a patient concerned... Read more
DIZZINESS; DRUNK FEELING; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, arthritis, asthma, and sulfa allergy, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with amlodipine besilate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) .5 ml, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced dizziness. On 11-MAR-2021, the subject experienced drunk feeling. On 11-MAR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight headache, and had not recovered from dizziness, and drunk feeling. This report was non-serious.
49 2021-04-19 anxiety, insomnia I have already reported the events that have happened on the day of the vaccine and the following mo... Read more
I have already reported the events that have happened on the day of the vaccine and the following morning. Muscle aches and pains were horrendous for 3 days. Severe flu symptoms for 1 day. It has been 12 days now and I still have muscle aches, lightheaded, cold sweats, fast heart beat, anxiety and insomnia. I have not been able to work since. Blood pressure has been up and down and doesn't seem to want to regulate itself like normal.
49 2021-04-20 impaired work ability, feeling abnormal The day after the vaccine I could not move. My legs and arms were numb, and I barely had the energy ... Read more
The day after the vaccine I could not move. My legs and arms were numb, and I barely had the energy to move. I had a headache, body aches fever and chills. I experienced nausea for a couple of days and a rash on my back. It was a bumpy rash started a week after the shot and is still present. I was very unsteady on my feet and needed help to the bathroom. I missed work that day but went to work the next day. I felt very poorly with no energy for a week. I was super achy and have no balance. I have gotten stabbing pains in my legs especially in my right thigh which dissipate after a while. It has been ten days and I am still very tired with intermittent headaches, but I was able to work out today. My leg pain is less often and less than it used to be.
49 2021-04-21 feeling abnormal MINOR STUFFY NOSE; COUGH; CHILLS; NAUSEA; FELT LIKE WAS HIT BY TRUCK; BRAIN FOG; SHAKY/JITTERY; ACHY... Read more
MINOR STUFFY NOSE; COUGH; CHILLS; NAUSEA; FELT LIKE WAS HIT BY TRUCK; BRAIN FOG; SHAKY/JITTERY; ACHY; LETHARGIC; This spontaneous report received from a patient concerned a 49 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: 201A01A and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced brain fog. On APR-2021, the subject experienced shaky or jittery. On APR-2021, the subject experienced achy. On APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced felt like was hit by truck. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced minor stuffy nose. On 09-APR-2021, the subject experienced cough. On 12-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative and Rapid influenza diagnostic test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt like was hit by truck, chills, minor stuffy nose, and cough, had not recovered from nausea, brain fog, shaky/jittery, and lethargic, and the outcome of achy was not reported. This report was non-serious.
49 2021-04-21 feeling abnormal WEIRD FEELING ON EATING NUTS; NUMB ARM; PAINFUL ARM; This spontaneous report received from a patien... Read more
WEIRD FEELING ON EATING NUTS; NUMB ARM; PAINFUL ARM; This spontaneous report received from a patient via a company representative concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menorrhagia due to fibroids in uterus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included cetirizine hydrochloride for seasonal allergy. On APR-2021, the subject experienced painful arm. On APR-2021, the subject experienced weird feeling on eating nuts. On APR-2021, the subject experienced numb arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weird feeling on eating nuts, painful arm and numb arm was not reported. This report was non-serious.
49 2021-04-22 anxiety SINUS CLOGGED/ SINUS HEADACHE; SHOOTING NERVE PAIN IN BACK; FACE SWOLLEN; SHAKES; ITCHY; SHARP NERVE... Read more
SINUS CLOGGED/ SINUS HEADACHE; SHOOTING NERVE PAIN IN BACK; FACE SWOLLEN; SHAKES; ITCHY; SHARP NERVE PAIN IN SPINE; INCREASED BLOOD PRESSURE; FEELING LIKE FLU; ARTHRITIC PAIN; LEG CRAMPS; NAUSEA; DIZZINESS; ANXIETY; BLURRING OF EYES; This spontaneous report received from a patient concerned a 49-year-old female. The patient's weight was 185 pounds, and height was not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021, Laboratory data included: Blood pressure (NR: not provided) 160/90 mmHg. On 08-APR-2021, within 5 minutes after vaccination the patient experienced dizziness, chills with shakes, nausea, anxiety and 20 minutes later she was evaluated by an emergency medical services onsite. On 08-Apr-2021, Blood pressure (BP) reading was 240/130 mmHg. She was kept under evaluation at the vaccination site until BP was 160/90. She experienced pain (body aches, shooting nerve pain in back with itching, arthritic pain from neck to spine and in hands) which began around midnight on 09-Apr-2021 and in morning she experienced full blown flu (ringing of ears, face swollen, sinus clogged, headache, body ache, chill). On 09-Apr-2021, Blood pressure (BP) reading was 153/87 mmHg The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, blurring of eyes, and nausea on 08-APR-2021, had not recovered from increased blood pressure, itchy, arthritic pain, sharp nerve pain in spine, leg cramps, feeling like flu, and anxiety, and the outcome of sinus clogged/ sinus headache, shooting nerve pain in back, face swollen and shakes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210417592-Covid-19 vaccine ad26.cov2.s-Increased blood pressure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
49 2021-04-22 sleep disorder That evening, I began to have difficulty breathing as I did after out of quarantine from COVID. I us... Read more
That evening, I began to have difficulty breathing as I did after out of quarantine from COVID. I used my inhaler prescribed to me from having covid in November of 2020. That helped. Then about a week later I started to have leg pain. Not sharp pain, but achey pain in both legs that can not be controlled by Tylenol or Ibuprofen. It has been occurring every few days and some nights like last night are bothersome and I can not sleep well. Also after about a week, I had dryness and redness on the bottom part of my mouth and chin. In the last week I have had flush on my neck and chest. It is hot, sometimes causes dryness and pealing and is sometimes itchy.
49 2021-04-24 disturbance in attention Early the next morning around 6 am started feeling unwell with chills, headache took Tylenol but did... Read more
Early the next morning around 6 am started feeling unwell with chills, headache took Tylenol but did not help symptoms increased. Took migraine meds. March 28-30th severe chills and headaches, chest pain on left side with tight chest increase cough along with increased joint pain. April 1st appointment with Dr. for my Xolair injection, discussed symptoms seemed to be resolving some and lung function test normal. Took xolair. April 2-5 th increased tight chest headaches, low body temp, arm and leg numbness, right side, later very sore. April 7 -15th right side leg pain comes and goes increase hip pain, chest tightness, extremely tired, lack of concentration with continues headaches. On April 15th went to ED after Dr contacted me to go there after information had been released about other cases of reactions similar.
49 2021-04-25 feeling abnormal, anxiety The adverse reactions of light headedness, throat irritation, heaviness in my chest and difficulty i... Read more
The adverse reactions of light headedness, throat irritation, heaviness in my chest and difficulty inhaling began about 20 min after my injection, It lasted 5 minutes. About 30 min afterwards the 2nd wave of reaction came on, with the same symptoms but was even harder to inhale and lasted twice as long. I took a combination of benadryl, motrin and pepcid which alleviated the worst of the symptoms after about an hour. To this day, I still cannot take a deep breath in. About 72 hours after the vaccine I began to have diarrhea (and still have it 20 days later), lethargy, nausea and shortness of breath. The next day I had a little more energy, but still had continued shortness of breath. My vision had become less clear and my thought process a bit fuzzy. This is still happening today. Seven days after the vaccine, I suddenly became extremely light headed just simply walking. To the extent that I needed to sit or lay down before I began to pass out. After the light headedness came on heavily, I also noticed a very heavy weight on my upper chest and found it quite difficult to inhale. These moments would come and go throughout the day. Regardless of whether I was just sitting and relaxing or walking around. These symptoms would last anywhere from a couple minutes to a couple of hours. I found it very hard to catch my breath and could feel my heart flushing often. Additionally I would wake in the middle of the night feeling that I needed to gasp for air. I sought medical assistance from a clinic, an ER and even my allergist and I am scheduled to see my family physician later this week. I am not an anxious person, but have experienced many episodes in the last 20 days that have truly made me feel that I was going to die (no exaggeration!) due to the inability to breathe or that I may have been having a heart attack. I began to have chest pain that would travel from the center of my chest to my left shoulder. The pain also would move to my right lung area. During this I also had heaviness in my chest and felt I could not breathe in or out easily. I am still very light headed and have difficulty walking very far without taking a break because I feel I cannot catch my breath. I still have all of the same symptoms that I experienced 20 minutes after my vaccine. These symptoms have varied in intensity. I have often commented to my family that I feel the symptoms of the chest heaviness and heart flushing seem to come in waves. I am a health conscious person and have never had poor health in my life. The events in the last few weeks have definitely taught me how terrible life must be for those who chronically suffer from heart or lung issues. I am still currently battling these symptoms, however, the last few days seem the symptoms have often been less severe.
49 2021-04-25 feeling abnormal Seven hours after I got the vaccine, I got a severe headache. It lasted all night and into the next ... Read more
Seven hours after I got the vaccine, I got a severe headache. It lasted all night and into the next day. I called the Nurse and she told me it might last two days. I tried multiple pain killers, and nothing worked. After twenty four hours I had a pressure sensation in my head. My normal Migraines cause dizziness. This time my head felt very full and it lasted 24 hours. On the third day I started to get light-headed ,and it lasted all day. Four days after the vaccine I started to get a more general headache and it lasted all day and it came and went for a few more days. Ice packs worked to relieve the pain with Aleve. I did not feel normal for twelve days after the vaccine.
49 2021-04-26 feeling abnormal CHEST DISCOMFORT; LYMPH NODE IN RIGHT ARM PIT SWOLLEN; FELT LIKE FLU; HEAD FOGGINESS; This spontaneo... Read more
CHEST DISCOMFORT; LYMPH NODE IN RIGHT ARM PIT SWOLLEN; FELT LIKE FLU; HEAD FOGGINESS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included mild case of covid, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2020, Laboratory data included: Platelet count (NR: not provided) 417K/mcL. On 07-APR-2021, the subject experienced head fogginess. On 08-APR-2021, the subject experienced felt like flu. On 09-APR-2021, the subject experienced chest discomfort. On 09-APR-2021, the subject experienced lymph node in right arm pit swollen. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Platelet count (NR: not provided) 331K/mcL. On 16-APR-2021, Laboratory data included: CT scan (NR: not provided) unknown, and Chest X-ray (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest discomfort on 21-APR-2021, and lymph node in right arm pit swollen on 13-APR-2021, and had not recovered from felt like flu, and head fogginess. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure since case is assessed as non-serious.
49 2021-04-26 sleep disorder On 04/26/21 @ 2 am.. felt a sharp pain on left side of chest.. felt weird . Got out of bed to see if... Read more
On 04/26/21 @ 2 am.. felt a sharp pain on left side of chest.. felt weird . Got out of bed to see if Id feel better... began to get clammy/sweaty- especially behind my neck... felt faint and dizzy- woke my husband up and told him my symptoms in case I d pass out.. he helped me to car and took me to hospital...
49 2021-04-27 feeling abnormal, thinking abnormal HEADACHE/PAIN IN HEAD; HEAD FELT FLUIDY,FLOATING,FOGGY,/FREAKING OUT; FLUCTUATING LUCIDITY/FELT LUCI... Read more
HEADACHE/PAIN IN HEAD; HEAD FELT FLUIDY,FLOATING,FOGGY,/FREAKING OUT; FLUCTUATING LUCIDITY/FELT LUCID; PAIN IN NECK; WOKE UP AND STUMBLED; RED BLOOD (AND CLOT) WHEN BLEW NOSE; RED BLOOD (AND CLOT) WHEN BLEW NOSE; DREAMING DIZZY/DIZZY; FEELS JITTERY/NOT FEELING WELL; This spontaneous report received from a 49 year old female patient reporting on self. 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: 1808982,expiry: UNKNOWN) dose was not reported,1 total administered on 12-APR-2021 09:00 in right arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, in the evening she had headache. On 12-APR-2021 the patient was dizzy and not feeling well at night she woke up in sleep feeling dizzy as she was dreaming dizzy, got up from bed and stumbled. She told her husband not feeling well but he tried to brush it aside. up from bed and stumbled. She took Advil. The doctor on-call told her to calm down and to take 2 Advil and went to sleep and if it did not went away to ER. The consumer did so. On 13-APR-2021, (Tuesday morning) the consumer blew her nose and noticed red blood and clots (coming from further up higher than sinuses). She was concerned and talked to people (friends). On 14-APR-2021, around 3:00 Wednesday morning she was freaking out she called her doctor and was not available she was referred to another physician. The patient was lucid, head felt fluidy, floating and dizzy. She had pain in the head and the neck. On 15-APR-2021, Thursday morning the physician called her back and said to stop taking Advil and went to ER. Her head was heavy and fog, everything was slow and lucid. In the hospital as soon as they gave her saline IV fluid, the fog was half lifted. Laboratory data (dates unspecified) included they also did MRI and blood work which were normal. They discharged her the same day and suggested she could take Tylenol which she did Thursday night. On 16-APR-2021, Friday she felt jittery but good and will buy some Gatorade for hydration and patient also stated that both dizzy and heavy head was reduced to faint (coming down from 10 to 3.5 on a scale). The consumer suggested that the dose of the vaccine may be too much for certain individuals and suggested to reduce the dose to like half the dose or to give it in 2 shots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red blood (and clot) when blew nose, and stumbling on 15-APR-2021, was recovering from dizziness, fluctuating lucidity, head felt fluidy, floating, foggy,/freaking out, pain in neck, and feels jittery/not feeling well, and the outcome of headache/pain in head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210436432- covid-19 vaccine ad26.cov2.s-head felt fluidy, floating, foggy,/freaking out, red blood (and clot) when blew nose. 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).
49 2021-04-28 anxiety Increased heart rate, anxiety, fever - symtoms only lasted about 14 hours
49 2021-04-29 impaired work ability Eleven Hours after the vaccine I got a fever body aches, chills and chest pain. The fever and flu sy... Read more
Eleven Hours after the vaccine I got a fever body aches, chills and chest pain. The fever and flu symptoms went away after 24 hours but the stabbing chest pain lasted for 37 days. The pain was in the center of my chest in different places and it felt like tightening and clenching. The D-Dimer was elevated and other tests were normal. My Platelets were tested later and were normal. Doctors indicated it was an inflammatory immune response. I went to a Cardiologist for a Stress test which showed ST depression. The chest pain stopped after 37 days. I did have shortness of breath which came and went over the course of four weeks. I am normally in good shape and I run, dance and work out two to four times a week. I have been unable to work out since this began. I also had lightheadedness, chest pain and palpitations seemed to go together. I still have lower back pain and Tinnitus which started two and a half weeks after the shot. It has been five weeks.
49 2021-04-30 abnormal dreams Very vivid and bizarre dreams every night starting 4 nights ago. Also, deeper sleep but I wake up we... Read more
Very vivid and bizarre dreams every night starting 4 nights ago. Also, deeper sleep but I wake up well rested.
49 2021-04-30 feeling abnormal SUSPECTED COVID-19 INFECTION; BRAIN FOG; This spontaneous report received from a patient concerned a... Read more
SUSPECTED COVID-19 INFECTION; BRAIN FOG; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sharp pain in ear, and covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced brain fog. On 12-APR-2021, the subject experienced suspected covid-19 infection. Laboratory data included: COVID-19 rapid POC test positive (NR: not provided) Positive. Treatment medications (dates unspecified) included: vitamins nos, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, and suspected covid-19 infection. This report was non-serious. This case, involving the same patient is linked to 20210449934. .; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
49 2021-04-30 irritability LOUD HEARING; BARELY GET OUT OF BED; SENSATION OF PRESSURE IN EAR; TIREDNESS; HEADACHE; SKIN HURTS T... Read more
LOUD HEARING; BARELY GET OUT OF BED; SENSATION OF PRESSURE IN EAR; TIREDNESS; HEADACHE; SKIN HURTS TO TOUCH; PAIN IN SPINE; EAR RINGING; ITCHING TOE AND LEFT EAR; DISCOMFORT; DIARRHEA; IRRITABLE; COUGH; JOINT PAIN; EXHAUSTION; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included experienced rare side effects for past medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced skin hurts to touch. On APR-2021, the subject experienced pain in spine. On APR-2021, the subject experienced ear ringing. On APR-2021, the subject experienced itching toe and left ear. On APR-2021, the subject experienced discomfort. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced irritable. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced exhaustion. On APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced sensation of pressure in ear. On 09-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced barely get out of bed. On 10-APR-2021, the subject experienced loud hearing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sensation of pressure in ear, tiredness, skin hurts to touch, pain in spine, discomfort, ear ringing, irritable, headache, cough, joint pain, diarrhea, itching toe and left ear, exhaustion, barely get out of bed and loud hearing 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.
49 2021-05-03 excessive sleepiness, feeling abnormal, amnesia Shortly after getting the shot she reported feeling "off" as she was driving she started feeling sho... Read more
Shortly after getting the shot she reported feeling "off" as she was driving she started feeling short of breath and her heart was racing. When she got home around 5 PM she was still feeling short of breath and reported that her heart was racing. She was unable to speak clearly, but was stating that it was due to be being short of breath. She also reported feeling lethargic and fell asleep until the next morning. She slept until approximately 12 pm the next day. When she woke up she reported feeling right sided cheek tingling. At that time she thought she had just slept wrong. When she attempted to walk down stairs she was limping and reported just feeling very weak on her left side. On Wednesday she slept in late again complaining of lethargy. When she awoke that Wednesday (3/10) her speech was markedly slurred. She was also saying things that didn't make sense. She was dragging her left leg when she tried to walk. We immediately took her to the ER and she was worked up for stroke. When she was triaged in the ER we mentioned that she had just had her COVID vaccine and voiced concerned that maybe she had a reaction to her COVID vaccine. She was admitted to hospital on 3/10 for a possible stroke. Her MRI was done later on 3/11, Her MRI showed that she has strokes on both sides of her brain in the frontal, parietal and occipital lobes. The doctor referred to her stroke as being caused by a "showering of clots". The doctor said this usually only happens to someone with cardiac issues. My mom has no cardiac history. Her doctor ordered an 2D Echo of her heart and no abnormalities were found (3/12). She is still disabled from her stroke. She was hospitalized from 3/10 - 3/16. She was the discharged to other care facility from 3/16-3/26. She is currently needing outpatient rehab in a day neuro program. She attends this at outpatient facility. She has to walk with a cane due to persistent left leg weakness. Her speech has a slight slur, and she suffers from short term memory loss. She intermittently has trouble with her equilibrium and reports feeling dizzy. She sometimes has a hard time swallowing or says that it doesn't feel right when she swallows. She also trouble with word retrieval. She has left-sided neglect which correlates left eye visual deficits. She currently requires care from a general physician, neurologist, physical therapist, occupational therapist, speech therapist, neuro ophthalmologist and neuo psychologist. She was started on a new medication regime 325 mg aspirin daily, plavix for 21 days (now completed), metformin, amlodipine, coreg and losartan. She is going to need outpatient rehab until at least June from the last update we received from her rehab doctor.
49 2021-05-06 hallucination, confusional state, delirium, disorientation Within 15 minutes of the Janssen injection, I felted light headed and dizzy which became much worse ... Read more
Within 15 minutes of the Janssen injection, I felted light headed and dizzy which became much worse with disordered speech, confused thinking, uncontrollable laughter and hallucinations. I walked down my road singing and laughing just total delirium. Maybe bad choice of word but I don't know how to completely describe the disorientation. My son, helped me get back home in which I laid down on the grass and just stared at the sky. My son, assisted me in to my home in which I slept several hours and woke up about 8:30 pm. I feel embarrassed of my behavior although I know for a fact it is correlated to the vaccine shot.
49 2021-05-08 anxiety, feeling abnormal, sleep disorder The adverse reactions of light headedness, throat irritation, heaviness in my chest and difficulty i... Read more
The adverse reactions of light headedness, throat irritation, heaviness in my chest and difficulty inhaling began about 20 min after my injection, It lasted 5 minutes. About 30 min afterwards the 2nd wave of reaction came on, with the same symptoms but was even harder to inhale and lasted twice as long. I took a combination of benadryl, motrin and pepcid which alleviated the worst of the symptoms after about an hour. To this day, I still cannot take a deep breath in. About 72 hours after the vaccine I began to have diarrhea (and still have it 20 days later), lethargy, nausea and shortness of breath. The next day I had a little more energy, but still had continued shortness of breath. My vision had become less clear and my thought process a bit fuzzy. This is still happening today. Seven days after the vaccine, I suddenly became extremely light headed just simply walking. To the extent that I needed to sit or lay down before I began to pass out. After the light headedness came on heavily, I also noticed a very heavy weight on my upper chest and found it quite difficult to inhale. These moments would come and go throughout the day. Regardless of whether I was just sitting and relaxing or walking around. These symptoms would last anywhere from a couple minutes to a couple of hours. I found it very hard to catch my breath and could feel my heart flushing often. Additionally I would wake in the middle of the night feeling that I needed to gasp for air. I sought medical assistance from a clinic, an ER and even my allergist and I am scheduled to see my family physician later this week. I am not an anxious person, but have experienced many episodes in the last 20 days that have truly made me feel that I was going to die (no exaggeration!) due to the inability to breathe or that I may have been having a heart attack. I began to have chest pain that would travel from the center of my chest to my left shoulder. The pain also would move to my right lung area. During this I also had heaviness in my chest and felt I could not breathe in or out easily. I am still very light headed and have difficulty walking very far without taking a break because I feel I cannot catch my breath. I still have all of the same symptoms that I experienced 20 minutes after my vaccine. These symptoms have varied in intensity. I have often commented to my family that I feel the symptoms of the chest heaviness and heart flushing seem to come in waves. I am a health conscious person and have never had poor health in my life. The events in the last few weeks have definitely taught me how terrible life must be for those who chronically suffer from heart or lung issues. I am still currently battling these symptoms, however, the last few days seem the symptoms have often been less severe.
49 2021-05-08 feeling abnormal "Patient received Janssen Vaccine. While in post vaccine observation area patient reported feeling l... Read more
"Patient received Janssen Vaccine. While in post vaccine observation area patient reported feeling like she was going to pass out. Patient escorted to EMS Observation Room. BP 116/68, HR 62, RR18, SpO298%. Patient rested and felt better. Patient refused transport to hospital for evaluation and left clinic ambulatory with no complaints." Site Supervisor Report
49 2021-05-17 anxiety, sensation of foreign body Allergic reaction to TDAP. cleared by med. evaluator, Spoke to patient. 30 min wait. While in recove... Read more
Allergic reaction to TDAP. cleared by med. evaluator, Spoke to patient. 30 min wait. While in recovery after 20 min after vaccine pt complained of "lump in throat and feeling warm" no LOC, no SOB AAO. No tongue swelling, no lip swelling + diaphoresis. Lung sounds clear = bialterally, no wheezing no difficulty wheezing. MD assessed surmised mild anxiety Globus Hystericus. Left deltoid site benign no redness, no swelling, no hives no LOC, no syncope. Ice pack to back of neck. 1:55 pm VS 160/90, HR 96, resp 14 reg non labored, 99% O2 Sat. Monitored 45 min, water for hydration, provided reassurance no further complaints. 2:08 pm 130/85, HR 80, resp 12 reg non labored, O2 sat 99%. Pt stated "feel much better, I'm OK. OK'd to exit. walked to door.
49 2021-05-17 loss of personal independence in daily activities Three weeks after vaccination woke up with aching pain in legs and feet. Within 48 hours it progress... Read more
Three weeks after vaccination woke up with aching pain in legs and feet. Within 48 hours it progressed to roaming pain in arms, legs, hands, and feet which includes general aching pain, occasional muscle cramp, numb sensations that come and go - hours at a time, some tingling, very significant pain in feet when trying to walk barefoot on sand. About 10 or 11 days after that onset, I developed vertigo, having the feeling of being tipped to the left nearly constantly. Symptoms are interfering with my ability to go about daily activities, slowing me down, especially the vertigo. The pain persists even in the night. It has been 18 days with no improvement and I am waiting for an appointment with a neurologist.
49 2021-05-19 feeling abnormal I received my vaccine at 5;35pm on Thursday 4/8/21. I started feeling arm soreness in both arms and ... Read more
I received my vaccine at 5;35pm on Thursday 4/8/21. I started feeling arm soreness in both arms and developed a headache, I took Tylenol at 10pm. I woke up at 3am Friday morning with body aches and still had the headache. I took more Tylenol. By 9am Friday morning I had severe adverse reactions. I still had a severe headache and body aches with muscle soreness and extreme fatigue. I also experienced chills, light sensitivity and brain fog. Around 4:30 pm I developed chest pains that lasted about one hour. My headache, body aches and fatigue have not subsided as of today. I have had a televisit with my physicians office on may 10 where bloodwork. Some of my headaches rk was requested. The results showed elevated kidney function due to the amount of Advil I had taken to control the headache and muscle soreness. The recommended Tylenol did not alleviate my headache or muscle soreness so I have not taken either medicine. Some of my headaches have been accompanied with nausea and light sensitivity. I went for a physical exam on 5/18/21 and more bloodwork was requested. It has been 6 weeks and these adverse effects have not subsided.
49 2021-05-19 feeling abnormal 4/7/2021 vaccination About 12.5 hours later, 2AM, I woke up with violent chills, trembling, 104 temp... Read more
4/7/2021 vaccination About 12.5 hours later, 2AM, I woke up with violent chills, trembling, 104 temperature, shaking, achiness, HA. I probably had a HA for 25 days. 4/21 urgent care. The Dr. dismissed and stated it was upper respiratory. I wanted to timeline that something wasn't right, was dismissed and prescribed an antibiotic. 4/22 PCM. PCM stated I had all the symptoms for COVID. Tested COVID+. She had me come back in on 4/29/2021 and retest; negative. But positive for a bacterial infection, round of antibiotics. Steroid, 5 day antibiotic 4/7 - 5/16 I had had the HA for 25 days. Fever went away prob around 4/28th. I have had the dry cough, productive cough, breathing issues. *residual 'brain fog'.
49 2021-05-20 feeling abnormal, insomnia 4/6 vaccination 4/12 HA 4/13 HA turned into migraine, legs started to tingle, achy. Zero sleep due t... Read more
4/6 vaccination 4/12 HA 4/13 HA turned into migraine, legs started to tingle, achy. Zero sleep due to pain. 4/14 Both extremities very swollen. Rotating between Tylenol and Ibuprofen (started on Tues). I went to my PCM. BP 130/98. Prescribed water pill but only to take on Friday if symptoms got worse, not better. 4/15 Sick all day. By 5pm, I couldn't even focus, my legs were so swollen, my 'head was ready to explode' and I 'didn't feel right. I went to urgent care; 160/98 BP and referred to the ER. I went to the ER, BP was still elevated, legs still swollen. Checked my heart, ultra sound on my legs and x-ray. I was kind of 'out of it'. They did everything to check for blood clots and heart; everything came back clear. They gave me some medicine for my head thru IV. I still left with HA but didn't feel as bad. That helped my BP went down. I was at the ER 2-3 hours, drinking lots of water. The next day the swelling started to go down on the legs and migraine was subsided. By Sat., I felt fine.
49 2021-05-21 impaired work ability 8 hr post vaccine, typical side fx (fever, headache), but also significant bi-lateral leg cramping a... Read more
8 hr post vaccine, typical side fx (fever, headache), but also significant bi-lateral leg cramping and spasms that continued for 6-8 hours. Spasms were prominent in inner thigh/groin and down entire legs. Legs were not movable (heavy), difficult to get out of bed or walk. Very strange and nothing like this ever experienced before shot. Fine next day. Around 4/9, pain began in ball of R foot in the AM, hard to walk. Over next few days, pain extended up to medial posterior calf (very painful), back of knee and groin. Unexplained bruising on lateral calf. 4/20 woke to swelling of R leg (ankle, posterior knee, groin), went to Urgent Care that night and was sent directly to ER for DVT symptoms. ER Ultrasound showed no clot, was sent home. Pain continued to increase, with burning and difficulty walking. Second Ultrasound done 4/22. No clots found. Pain continued to worsen, with swelling/aching on front of calf and severe foot pain. Veins/skin tender. Painful groin spasms happen again, same as night of shot. PCP ordered ABI and spine Xray. ABI was normal. Xray showed same issue as 29 yrs ago (prior known L5S1 anterolisthesis; have not had back pain for many years...when I did, it was localised to spine and sciatic in the L hip, was not at all similar to these current issues in R leg. perhaps related if inflammed, but is vastly different in symptoms and unlike past history). Saw Vascular Surgeon 4/30, ordered abdominal CT Abdomen Pelvis w IV Contrast. results normal. arm bruising at IV and blood draw site. Saw second Vascular Surgeon 5/4 who felt pain related to inflammation response and ordered CBC. Platelets 178. (patient had requested this test starting on 4/20, this was the first doctor to order it). Pain continued but some relief found with compression socks. on 5/10 US Bilateral lower extremity venous duplex with reflux study was done on both legs. No DVTs, but damaged valves and reflux in the external iliac common femoral vein and femoral veins proximal segment (worse in R leg) and great saphenous vein at the sapheno-femoral junction (R only). These areas are where the spasms are happening but doctor not able to conclude relation, wants neuro consult, could be nerves causing spasms. Doctor prescribed compression socks for venous insufficiency concerns, to be rescanned annually for life. Vascular test results don't explain severe pain in calf and foot and referred to Neurologist for 5/28 visit. As of today, 5/22, pain is persistent. Pain/swelling is reduced with use of compression socks but returns without them; walking is difficult in the AM and PM hours; night time spasms. Have also had shooting pains in L calf, both forearms, and ribs (back). These occur mostly in the evening (nerve?). Taking magnesium & extra vitamin D seems to help some. On strict anti-inflammatory diet. I'd really like some guidance for treatment and what to do about boosters - do I switch to an mRNA vaccine? I am a very healthy active 49 yr old woman who felt fine before the shot, and now I've been in a lot of pain, working greatly reduced hours for almost 4 weeks. Please advise on what can be done to help. Concerned about permanent damage and how to handle future vaccines. (also of note: first menstruation period was skipped after the shot, second period came a week late and was very heavy with bright red blood. I am normally extremely regular, mod-heavy flow; also, the J&J shot I had was a "last shot of the day" extra dose. I was offered it while having a routine physical. Could it have been improperly stored, as the last leftover dose? Very unlikely since it was a doctors office, but including this info)
49 2021-05-25 incoherent Seizure, sweating, not coherent
49 2021-05-26 impaired work ability, feeling abnormal Two-week delay, after receiving the vaccination, a flare up of allergy Asma, call out to allergy spe... Read more
Two-week delay, after receiving the vaccination, a flare up of allergy Asma, call out to allergy specialist told them about what was going on and the nurse gave the vaccination told wait 14 days before taking the allergy medication because it could make her immune to the Covid shot. Allergist (nurse practitonare) told her to wait was not able to take medicinal for Asma 21 day dizzy off balance fatigue and also diabetics and the steroids days. At 21 set day she went to the office to the nurse auctioneer at her Primary office, he prescribed, musnex antibodies and steroids by that Friday, stated to feel bad, dizzy, fatigue, could not taste or smell anything and blood sugar was high, loss taste and smell and had type A flu and was not able to work. Primary Dr. prescribed, put on flu medication with quarantine for three days and Covid and flu and another test. At st urgent care. ID Testing
49 2021-05-27 feeling abnormal INCREASED FATIGUE, HEADACHE, CHILLS, FEVER, LOSS OF SMELL/TASTE, ALL OVER PAIN (JOINT,BONES, MUSCLES... Read more
INCREASED FATIGUE, HEADACHE, CHILLS, FEVER, LOSS OF SMELL/TASTE, ALL OVER PAIN (JOINT,BONES, MUSCLES, SKIN) FEELS LIKE IM 90 ALMOST CRIPPLING, DONT HAVE TO DO ANYTHING TO BE IN PAIN, EXTREME TEMP VARIATION FREEZING COLD OR BURNING UP, BRUISING, SWELLING, RASH ITCHY/TINGLING/TIGHT SKIN, NUMBNESS, MILD VISION CHANGES, SOME SHORTNESS OF BREATH (UNSURE IF INCREASED OR SAME) WEIGHT CHANGES, INCREASED MALAISE.
49 2021-05-31 insomnia TROUBLE SLEEPING; NUMB PINKY AND RING FINGER; TINGLING IN THE LEFT PINKY/RING FINGER; JOINT PAIN; LO... Read more
TROUBLE SLEEPING; NUMB PINKY AND RING FINGER; TINGLING IN THE LEFT PINKY/RING FINGER; JOINT PAIN; LOW GRADE FEVER; NAUSEA; MUSCLE ACHES; HEADACHE; LEFT ARM PAIN; LEFT SHOULDER PAIN; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1808982 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 left shoulder pain. On 10-APR-2021, the subject experienced left arm pain. On 11-APR-2021, the subject experienced joint pain. On 11-APR-2021, the subject experienced low grade fever. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced muscle aches. On 11-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.5 degrees. On 15-MAY-2021, the subject experienced numb pinky and ring finger. On 15-MAY-2021, the subject experienced tingling in the left pinky/ring finger. On an unspecified date, the subject experienced trouble sleeping. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, nausea, and muscle aches on 17-APR-2021, low grade fever on 12-APR-2021, and headache on 13-APR-2021, had not recovered from left arm pain, left shoulder pain, numb pinky and ring finger, and trouble sleeping, and the outcome of tingling in the left pinky/ring finger was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
49 2021-06-17 anxiety, nervousness, feeling abnormal, agitation The next day after my left arm got really swole and it begin to tingle. I reached out to my PCP who... Read more
The next day after my left arm got really swole and it begin to tingle. I reached out to my PCP who advised I see a Specialist and gave an Anti-inflammatory but it did nothing. A couple week later around 2:30am I woke up out of my sleep with severe shakes in my chest area, my arms and hands go so clammy and I felt so anxious I couldnt sit still and was pasing back and forward. I had the sense of feeling choked. The shakes were so bad causing me to get up and walk around. At 4am I went for a walk in the neighborhood because I still could not stop shaking and remain still. I was so adjitated around 6am I got up and began to drive to the beach then all of the sudden after about 20 minutes I had to pull over because my arms from elbow down went numb and I couldn't drive. I was still so jittery and shaky but was able to make it to the ER where I was monitor for about 5 hrs. CBC and Urinalysis were done but everything seemed normal. For about 10 days I had that shaky feeling, tightness in my chest area and just felt really crappy. My PCP perscribed a few different Anti-anxiety meds but I had an allergic reaction to those so I could not take any of those either. I have an appointment with the Neurologist 7/26.
49 2021-06-21 feeling abnormal About 2 weeks after receiving it, in the afternoon/evening, I got extremely dizzy. I had to lay down... Read more
About 2 weeks after receiving it, in the afternoon/evening, I got extremely dizzy. I had to lay down; everything was spinning. I had to rest on the couch the entire night. I didn't know what it was from. I didn't have any other symptoms. I thought maybe I was coming down with something. I went to bed. I then dealt with dizziness for two or three weeks after that - I would be slightly dizzy on and off. It came and went. I had trouble breathing. At times, I felt like I couldn't get enough air in. I'm a teacher and I would feel sometimes like I would have to stop to get more air to talk - and at that moment I would be having some slight dizziness, too. I had to be calm and focus on breathing. For about 2 months and during that time, my head felt funny. It was like pressure on the top and back of my head. It wasn't a headache. It was slight pressure on the top and back of my head and that happened for a month or two. It's only been two weeks since I haven't had that. Today I saw my doctor and I don't have any of those symptoms anymore.
49 2021-06-26 disorientation Patient received a COVID vaccine immediately after which she stated she passes out sometimes with sh... Read more
Patient received a COVID vaccine immediately after which she stated she passes out sometimes with shot. Immediately thereafter she became pale, her head fell backwards in the chair , eyes rolled back, her hands curled under, her body became ridged and she started shaking. She was unresponsive and was laid on the ground. in the process of turning her on her side she became conscious again but did not know where she was or why she was on the floor. She was sweating and was still quite pale. She said she felt sick while she was laying on the floor at which point she sat up and we moved her to a chair. Upon sitting in the chair she was still feeling sick and was pale and sweating. she began to throw up a few times and I took her blood pressure after. 116/70 Pulse was 60. She did not want an ambulance. After about 10 minutes of sitting her color was back to normal she was no longer sweating and was alert and conversing normally. Pt was advised to head to urgent care or contact her doctor if she experienced any further symptoms as she may have experienced a seizure. She has no prior history of seizure and has only ever passed out from previous shots.
49 2021-06-29 anxiety, insomnia SEVERE INFLAMMATION; WEAK RIGHT LEG; ANXIETY; SEVERE HEADACHES/ "BUBBLES" GOING UP THE BACK OF THE H... Read more
SEVERE INFLAMMATION; WEAK RIGHT LEG; ANXIETY; SEVERE HEADACHES/ "BUBBLES" GOING UP THE BACK OF THE HEAD; SHOOTING PAIN IN FOREARM; NAUSEA; VALVES DAMAGED (SAME AREAS WHERE THE SPASMS WERE OCCURRING); NERVE PAIN; HARD TIME SLEEPING; SKIN HURT TO TOUCH (SENSATION OF BUGS CRAWLING UP THE LEG).; 4-5 BRUISES FROM CALF TO ANKLE THAT DID NOT LINE UP WITH THE PAIN.; SWELLING AROUND THE ANKLE, KNEE AND GROIN (ALL IN THE RIGHT LEG); PAIN AND CRAMPING IN CALF; DIFFICULT TO GET OUT OF THE BED (DUE TO THE SPAMS AND THE FEELING IN HER LEGS); LEGS FELT LIKE WEIGHED 500 LBS (NOT PAINFULL); STRANGE SPAMS LIKE FULL BODY TREMORED (CONCENTRATED IN THE LEGS AND GROIN)/ SPASM IN BOTH LEGS; NUMBNESS IN FOOT; SWELLING IN LEG; BURNING SENSATION; IRREGULAR MENSTRUAL CYCLE (NO SIGNS OF MENOPAUSE); EXTRA DOSE; CHILLS; ICKY; SMALL PATCH OF PAIN OF THE FOOT PAD TOWARDS THE OUTSIDE OF THE FOOT/ SORE ARM/ PAIN IN ARM/ AREA OF PAIN GOT BIGGER; FEVER; TIRED; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 115 pounds, and height was 62 inches. The patient's past medical history included spinal injury, and left sided sciatica pain, and concurrent conditions included non-smoker, gluten allergy, and alcohol user (occasionally (1 drink/day)), and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A421A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced irregular menstrual cycle (no signs of menopause). On 31-MAR-2021, the subject experienced extra dose. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced icky. On 31-MAR-2021, the subject experienced small patch of pain of the foot pad towards the outside of the foot/ sore arm/ pain in arm/ area of pain got bigger. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced tired. On APR-2021, the subject experienced swelling in leg. On APR-2021, the subject experienced burning sensation. On 01-APR-2021, the subject experienced strange spams like full body tremored (concentrated in the legs and groin) / spasm in both legs. On 01-APR-2021, the subject experienced numbness in foot. On 01-APR-2021, the subject experienced difficult to get out of the bed (due to the spams and the feeling in her legs). On 01-APR-2021, the subject experienced legs felt like weighed 500 lbs (not painfull). On 11-APR-2021, the subject experienced pain and cramping in calf. On 20-APR-2021, the subject experienced 4-5 bruises from calf to ankle that did not line up with the pain. On 20-APR-2021, the subject experienced swelling around the ankle, knee and groin (all in the right leg). On 20-APR-2021, the subject experienced skin hurt to touch (sensation of bugs crawling up the leg). Laboratory data included: Diagnostic ultrasound (NR: not provided) Didn't find a clot. On 23-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative. On 29-APR-2021, the subject experienced hard time sleeping. On 30-APR-2021, Laboratory data included: Ankle brachial index (NR: not provided) all clear, Computerized tomogram pelvis and abdomen (NR: not provided) all clear, and Spine X-ray (NR: not provided) all clear. On MAY-2021, the subject experienced valves damaged (same areas where the spasms were occurring). On MAY-2021, the subject experienced nerve pain. Laboratory data included: Cardiac ultrasound (NR: not provided) valvular damage coinciding with pain on legs. On 04-MAY-2021, Laboratory data included: CBC (NR: not provided) all normal, Platelet count (NR: not provided) 178 (lower than her normal), and Protein (NR: not provided) Result not reported. On JUN-2021, the subject experienced nausea. On an unspecified date, the subject experienced shooting pain in forearm, severe inflammation, anxiety, weak right leg, and severe headaches/ "bubbles" going up the back of the head. Laboratory data (dates unspecified) included: Reflex test (NR: not provided) result not reported, Right leg was weaker. Treatment medications (dates unspecified) included: ibuprofen, magnesium, acetylsalicylic acid, paracetamol, tocopheryl acetate, and ergocalciferol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from strange spams like full body tremored (concentrated in the legs and groin)/ spasm in both legs, burning sensation, chills, fever, and tired, irregular menstrual cycle (no signs of menopause) on 31-MAR-2021, and difficult to get out of the bed (due to the spams and the feeling in her legs), and legs felt like weighed 500 lbs (not painfull) on 01-APR-2021, was recovering from small patch of pain of the foot pad towards the outside of the foot/ sore arm/ pain in arm/ area of pain got bigger, severe headaches/ "bubbles" going up the back of the head, numbness in foot, pain and cramping in calf, 4-5 bruises from calf to ankle that did not line up with the pain., weak right leg, nausea, icky, extra dose, swelling in leg, swelling around the ankle, knee and groin (all in the right leg), skin hurt to touch (sensation of bugs crawling up the leg)., hard time sleeping, severe inflammation, valves damaged (same areas where the spasms were occurring), nerve pain, and anxiety, and had not recovered from shooting pain in forearm. This report was non-serious.
49 2021-07-02 sleep disorder nausea. vomiting. stomach pain. existing acid reflux is much worse. lack of appetite. this is ove... Read more
nausea. vomiting. stomach pain. existing acid reflux is much worse. lack of appetite. this is over about 36 hour period. sleep disruption due to stomach pain and acid in throat. drinking both decaf black tea and regular green tea with honey, milk. occassional calcium carbonate chew. also some swelling and tightness in ankles, feet, and shins. massages to these areas. digestive disruptions are the most painful and disruptive.
49 2021-07-14 loss of personal independence in daily activities Developed neurological systems starting 4/12/31, worsening over 2 weeks -- face tingling, leg tingli... Read more
Developed neurological systems starting 4/12/31, worsening over 2 weeks -- face tingling, leg tingling, full body nerve pain, muscle weakness (developed difficulty walking, grasping, etc), nausea, inability to regulate body temperature, heart rate fluctuations
49 2021-07-15 feeling abnormal Patient began feeling tingling in her arm, felt left side of face go numb. Stated she just didn't f... Read more
Patient began feeling tingling in her arm, felt left side of face go numb. Stated she just didn't feel right. Then stated her throat was starting to close up and became hoarse. EPI was administered x 1 at clinic and patient transported to ED where she was observed and discharged on Prednisone.
49 2021-07-18 incoherent within 10 minutes of vaccine administration, patient could not communicate verbally. She could unde... Read more
within 10 minutes of vaccine administration, patient could not communicate verbally. She could understand questions being asked and shake her head, but she could not speak. She was given benadryl which she swallowed with no issues. 911 was called to the scene. Blood pressure was taken and SBP >200 using a wrist monitor. Blood pressure was taken again with traditional monitor and SBP >190. Baby Aspirin 81mg was given orally, and the patient swallowed with no issues. While waiting for EMS to arrive, patient continued to understand questions being asked and was able to shake head yes/no. She would try to speak, but words were incoherent. She was asked to squeeze both hands, she recognized the request and acknowledged that she was squeezing, but minimal force was being applied. EMS arrived by 11:30am and patient was taken to the hospital.
49 2021-07-25 feeling abnormal, insomnia AEs lasting <48 hours: moderate headache, moderate nausea, severe fatigue, severe diarrhea, mild fev... Read more
AEs lasting <48 hours: moderate headache, moderate nausea, severe fatigue, severe diarrhea, mild fever, insomnia, moderate flushing, moderate joint aches, severe muscle aches, mild facial tingling, severe arm pain at injection site, severe shoulder joint pain on right (injection) side, severe pain in the armpit with and without use of the arm, moderate cough, moderate dizziness, mild hot flashes, moderate chills, severe brain fog. AEs lasting <2 weeks: mild headache, mild fatigue, moderate diarrhea, mild joint aches, moderate arm pain at injection site, moderate, shoulder joint pain on right (injection) side, moderate pain in the armpit with and without use of the arm, mild dizziness, moderate brain fog. AEs that have not yet resolved: recurring diarrhea, mild joint aches, mild arm pain at injection site, mild shoulder joint pain on right (injection) side, moderate pain in the armpit with and without use of the arm, mild dizziness, mild brain fog.
49 2021-07-25 feeling abnormal Patient felt funny after receiving vaccination.
50 2021-03-07 insomnia patient experienced racing heartbeat, heart pounding sound in ears, chest tightness without shortnes... Read more
patient experienced racing heartbeat, heart pounding sound in ears, chest tightness without shortness of breath., and insomnia. She stated that the symptoms subsided by morning except her heartbeat was still a little elevated in the morning. She did not do anything to treat the symptoms and did not seek medical advice. She contacted me to report her symptoms.
50 2021-03-15 insomnia About 5 or 6 hours after the shot , I developed body aches and chills and had a fever of 101. This l... Read more
About 5 or 6 hours after the shot , I developed body aches and chills and had a fever of 101. This lasted through the night, along with a sharp pain in my chest that developed in the night and radiated from front to back, which made it difficult to sleep. During the night, I took some rolaids and moved the couch to sleep more upright, because I think the pain may have been heartburn or some other GI thing (I rarely get this feeling, but I have had it before, and my last meal of the day was several hours before i went to bed and before my symptoms started). By morning the next day (Sunday), my whole left arm was achy, down to my hand and fingers, and my right arm also but not as severe. My left armpit felt tender (and still does today, but not as bad). By mid-day, I started to feel better, the fever was gone, and by late afternoon, the body aches were gone. My left arm and hand was still tender, but not as bad. By Sunday night i would say I was back to about 80%, and by Monday morning, 95%, and by late Monday morning, back to normal, other than the slight tenderness I still feel (today being Tuesday) in my left armpit.
50 2021-03-17 disorientation Janssen COVID-19 Vaccine EUA I blacked out while getting ready for work. I was feeling a little lig... Read more
Janssen COVID-19 Vaccine EUA I blacked out while getting ready for work. I was feeling a little light headed and thirsty. Next thing I know, I was on the floor. When I came to, I was disoriented and very sweaty. The fall caused a cut to my head, bleeding and a bruised elbow. Within an hour, I was feeling less dizzy.
50 2021-03-20 sleep disorder at 12:30am woke with headache and violent shaking chills at 2:15am woke with nausea and vomited, per... Read more
at 12:30am woke with headache and violent shaking chills at 2:15am woke with nausea and vomited, persistent headache at 3:30 am woke with headache and full body aches, took a tylenol at 4:45 am woke with fever, oral temp 100.4F, headache and body aches continue at 6 am woke with mild headache and full body aches which persisted throughout the day with fatigue, oral temp 98.6F all symptoms resolved the next day after a full night of sleep
50 2021-03-23 insomnia, disturbance in attention Roughly 7 hours after shot (3/21), overcome by all over body aches, chills, and general malaise. Wh... Read more
Roughly 7 hours after shot (3/21), overcome by all over body aches, chills, and general malaise. While resting, my resting pulse rate raced to 120 beats per minute (normal for me is btw 79-82). Headache and sleeplessness followed. Could not work the following day (3/22), same symptoms, all over muscle pain, chills, inability to focus, deeply fatigued. Finally, morning of 3/23, awoke feeling fine. Entire duration was abt 36 hours.
50 2021-03-24 anxiety Patient experienced cold feeling that traveled from feet and rose up to knees 3-4 minutes after rece... Read more
Patient experienced cold feeling that traveled from feet and rose up to knees 3-4 minutes after receiving vaccination. When she walked, it traveled up to her thighs. When she sat down, it went back to her lower extremities (from knees to feet). She drank water and gatorade, but this didn't help the situation. Patient was also anxious and feeling lightheadedness, but she's feeling better. She's not having difficulty breathing or any other symptoms. Oxygen saturation is at 99.
50 2021-03-25 sleep disorder Day of Vaccine March 12: 5:30 pm chills, arm pain (left/injection side); 6:30 pm + fatigue, mild nau... Read more
Day of Vaccine March 12: 5:30 pm chills, arm pain (left/injection side); 6:30 pm + fatigue, mild nausea; 7:30 pm + neckache and headache; 8:30 pm + shivering / teeth chattering, fever 99.8; 9:30 pm fever 100.5, dizziness, took 1 ibuprofen; 10:00 pm + extremely hot, ache in low back, (no chills); woke multiple times during night with body pain and "busy-ness" of thoughts. Day after Vaccine March 13: 8:15 am fever reduced 99.4, headache, back ache (reduced arm soreness), fatigue ,took 1 ibuprofen, back to bed; 10:30 am no fever (temp 98.8), more alert, body tired, head mildy wonky, appetite good; 10:00 pm no fever (temp 98.3), able to sleep.
50 2021-03-27 disorientation Fever, Pain, Disoriented, Body Aches, Dizzy,
50 2021-03-30 feeling abnormal Recipient states she "felt a hot sensation and pain in arm at injection that radiated through her wh... Read more
Recipient states she "felt a hot sensation and pain in arm at injection that radiated through her whole immediately after the vaccine injection. She then described that her scalp started to itch and she started to feel dizzy and in a fog. She almost fell out of her chair. EMS called then her feet started itching and progressed to her whole body. Her breathing remained WNL.
50 2021-03-31 impaired work ability I started with a fever (103) and chills the first night Arm hurting so bad, could barely move it. T... Read more
I started with a fever (103) and chills the first night Arm hurting so bad, could barely move it. Took some Tylenol. Second day, I was extremely tired with a fever. I couldn't work for the remaining day. I noticed a small rash on my right leg which was not there before. I was itchy. fever went down to 100. I've taken over the counter medication. I'm still exhausted. I experience some numbness last night. it has subsided but my arm is still extremely soar. I'm still exhausted.
50 2021-04-01 insomnia Symptoms started around midnight with having string headache, joint pains, extremely sore arm, numb... Read more
Symptoms started around midnight with having string headache, joint pains, extremely sore arm, numbness in left hand fingers and insomnia.
50 2021-04-04 anxiety Pt complained of numbness in tongue. Benadryl 25mg given. Very anxious and diaphoretic. Pt left with... Read more
Pt complained of numbness in tongue. Benadryl 25mg given. Very anxious and diaphoretic. Pt left with husband.
50 2021-04-04 feeling abnormal I had the shot on weds afternoon. On Thursday I felt ill with flu-like symptoms, mainly body aches a... Read more
I had the shot on weds afternoon. On Thursday I felt ill with flu-like symptoms, mainly body aches and headache. These symptoms were gone by Friday and I felt great. I woke up Saturday morning at 4:30am and needed to use the bathroom/, which is about 10 steps from my bed. As I entered the bathroom I completely blacked out, causing me to fall and break my ribs. This has never happened to me, and there was nothing else wrong with me (I spent 2 days in the hospital checking heart, brain, inner ear, etc). In addition to the 4:30am blackout, it also happened again several hours later at 11am, saturday morning. This time I again got so dizzy I couldn't stay on my feet, and while my husband was right there lowering me to the floor I was in a daze, a cold sweat, and absolutely no control over it.
50 2021-04-06 euphoric mood, feeling abnormal Patient states she feels high/ and out of body experience. She is feeling Loopy
50 2021-04-07 anxiety Pt recieved the Janssen vaccine in her left arm. Pt was in observation and pt reported shortness of... Read more
Pt recieved the Janssen vaccine in her left arm. Pt was in observation and pt reported shortness of breath. Pt stated she felt anxious. Pt was vitals stable. Pt was coached and no longer felt SOB. Pt had no other complaints and signed up AMA.
50 2021-04-08 depressed mood Continued fever, heaviness in my chest, breathlessness, sore throat, feeling really down
50 2021-04-08 feeling abnormal, confusional state At 12 hours through 16 hours after administration of the vaccine I experienced rigorous shivers, fee... Read more
At 12 hours through 16 hours after administration of the vaccine I experienced rigorous shivers, feeling freezing cold to the bone for hours and couldn't get warm (even with piles of blankets), periodic heart pain and some chest pressure, periodic knife like stabbing pain in my right knee, mild nausea, dizziness, lightheadedness, severe weakness, sometimes a cough. At 16 hours I got up to get water and had to hold onto things to keep my balance. After drinking a couple of cups of water, I turned away from the bathroom sink and lost consciousness, fainting and falling onto my bathroom floor. The jolt of the fall woke me up and it took a lot of strength to get up. The symptoms were vicious. When I fainted, the brunt of my weight must of been on my upper left rib cage. My ribs were so sore for a week. It was difficult to walk, breath, blow my nose, or cough. My health provider recommended a Tylenol regime for pain control so that I could take deep breaths and prevent pneumonia. I had a low grade fever of 99 degrees F for one to two days following the vaccine. During the week that followed I felt periodically very ill, had a constant headache for a day or two, and had extremely foggy thinking and sometimes confusion. I was very fatigued all week long. I lost my appetite and have still not gained my typical appetite back. Day 8 to 9 is when I was finally feeling closer to normal. Today I feel I may be back to 100%, but my rib cage is still healing, either from a contusion, fracture, or break (likely a contusion).
50 2021-04-10 feeling abnormal 4/7/21 - arm pain 4/8/21 - severe headache/migraine, dizziness, extreme fatigue, weakness, light sen... Read more
4/7/21 - arm pain 4/8/21 - severe headache/migraine, dizziness, extreme fatigue, weakness, light sensitivity, nausea, burping, insatiable thirst despite being well hydrated, dry mouth, hot/cold fluctuations, low grade fever 99.1, congestion, loss of appetite, constipation despite eating foods that help, unusual internal sensation (not sure how to describe; perhaps flutter), heaviness in breathing, brain fog. 4/9/21 - varying durations and frequencies of vertigo, nausea, chronic fatigue, malaise, chronic thirst, headache, dizziness, heaviness in breathing, constipation, congestion, brain fog. 4/10/21 - varying durations and frequencies of fatigue, dizziness, chronic thirst, constipation, headache, heaviness in breathing, brain fog 4/11/21 - varying durations and frequencies of headache, malaise, dizziness, fatigue, thirst, brain fog
50 2021-04-10 feeling abnormal Within 10 seconds of receiving the shot, I was nauseous. Within 20 seconds very nauseous and dizzy.... Read more
Within 10 seconds of receiving the shot, I was nauseous. Within 20 seconds very nauseous and dizzy. Passed out. Woke up on pharmacy floor. Do not know how long I was out. Continued to be nauseous and sweaty for 10 minutes. Had someone drive me home, nauseous and dizzy for 2 hours at home. Headache, body aches and sweaty all night. Nausea to a lesser degree with headache and body aches for another 24 hours. Feel still slightly off/slight nausea currently which is 6th day after vaccine.
50 2021-04-10 memory impairment Janssen CCOVID-19 Vaccine EUA 4/9/21: metallic taste in mouth when eating/drinking; nauseous; mild ... Read more
Janssen CCOVID-19 Vaccine EUA 4/9/21: metallic taste in mouth when eating/drinking; nauseous; mild headache; fatigue; Overnight - leg cramping, coughing, heaviness in chest. 4/10/21: fever (high of 101.5 most of day); chills; mild headache; severe fatigue; muscle cramping; dizziness; difficulty focusing & remembering. 4/11/21: fever (high of 100.3 in am only); severe fatigue; extreme pain in lymph nodes in left armpit (difficulty moving arm); pain behind right eye (began in evening); difficulty focusing & remembering; random short term muscle cramping
50 2021-04-11 anxiety Post-vaccination, patient began trembling and stated she had the chills (shivering). She took 2 tab... Read more
Post-vaccination, patient began trembling and stated she had the chills (shivering). She took 2 tablets of her own personal oral Benadryl. Blood pressure and heart rate per checked; BP 168/90 HR 123. When checked 15 minutes later, BP was the same and HR was 118. Patient stated she was anxious and did not take her fluoxetine that morning. EMS was called and patient was transported.
50 2021-04-11 impaired work ability 5 hours after administration chills. Six hours after violently shaking, unable to get warm. Seven ho... Read more
5 hours after administration chills. Six hours after violently shaking, unable to get warm. Seven hours later temp 104.2 degrees on mercury thermometer and 103.8 on digital. Tylenol taken. Eight hours later unable to move due to shivers and shaking. Husband and son believe should go to hospital, I did not lose consciousness so refused. Saturday 1AM temp not budge took Advil 400 mg by 0600 temp to 102. All day Saturday taking Advil 400 mg every 5 hours temp 102 and feeling wiped out. Sunday able to move around temp 101 with Advil. Monday AM temp 100 with out Advil-need to take day off of work. And since vaccination have had a feeling of nausea I can't shake. Today -three days later able to eat some but nausea continues.
50 2021-04-12 anxiety 10 days after the vaccine I developed dizziness, tachycardia, dry mouth,chest pressure, shortness of... Read more
10 days after the vaccine I developed dizziness, tachycardia, dry mouth,chest pressure, shortness of breath and felt like I was going to pass out, and I had a feeling of extreme doom. I was transported to a clinic. There I had a heart rate of 140 with irregular beats. Continued feeling of doom. An EKG showed ST depression. Symptoms improved with nitroglycerin. The clinic didn't have the technology to provide care so I was emergently transported again. At that hospital my D-dimer was positive and that lead to a CT Angiogram. This showed a pulmonary embolism. Doppler studies of both legs were negative. I was placed on Heparin for several hours and then switched to Eliquis. About 6 hours after being on Eliquis I had the exact same original symptoms and again nitro was given which helped the symptoms. I was placed back on Heparin for a longer period of time. Once I was anticoagulated I was then switch to Eliquis 10mg BID for 7 days then 5mg BID for 6-9 months. I had a CT Angiogram of the head and neck which was normal. At this time I still have dizziness with standing and intermittently with sitting, extreme fatigue, shortness of breath.
50 2021-04-12 feeling abnormal Exactly six hours post dose (8pm), joint aches, fatigue, slight chills and lite headache began. Too... Read more
Exactly six hours post dose (8pm), joint aches, fatigue, slight chills and lite headache began. Took 2 Tylenol went to bed. Approx 1 hour later(9pm), severe, body shaking chills and low back pain began and lasted many hours. Tylenol, additional clothes, blanket and heating pad for low back added. All symptoms continued with headache now with pounding and pressure that required 50mg of Sumatripan. Fever began at this time, mid grade. Additional Tylenol and sweating began fever reduced to low grade. Slept. Woke once again to the same pressure and pounding headache, severe chills. Took temperature and it was an astounding 107.7. I had experienced a high 106 as a teen, so the "feeling" was familiar. To be sure and calibrate, we took my temp x3, changed batteries, checked my girlfriend's and then rechecked mine. 107.7. At this time, took a cool shower, applied a cool compress and weighted down with blankets. Temperature broke within an hour and maintained til Monday morning when it returned at 103.6. Tylenol , fluid and rest. Today (Tuesday). I feel " off" but have no fever or other symptoms with exception of site soreness.
50 2021-04-12 impaired work ability I felt extreme fatigue & headache from 2am until 10pm on Thirsday. I went to work but could not driv... Read more
I felt extreme fatigue & headache from 2am until 10pm on Thirsday. I went to work but could not drive. I missed 4 hours of work and came home to sleep. I could not lift my arm Thursday but that went away by Froday morning. On Friday I had fever and chills.
50 2021-04-12 insomnia It has been 10 days since I had the vaccine. I felt sick within about 24 hours, aches, chills, skin... Read more
It has been 10 days since I had the vaccine. I felt sick within about 24 hours, aches, chills, skin hurt, tired. That subsided within a day and then joint pain, muscle pain in legs, hips and rear end, shoulders and pain behind eyes started and lasted for about a week. I have had a steady headache for probably the past 6 days or so. No fevers, just significant muscle pain and headache, low energy and difficulty sleeping.
50 2021-04-12 sleep disorder Very lethargic, muscle and joint aches , nausea. I had a dream I was beaten with a bat. That is how ... Read more
Very lethargic, muscle and joint aches , nausea. I had a dream I was beaten with a bat. That is how I was feeling at the time. (evening and night one) next morning same but started to feel a little better that afternoon/evening. the next day shaky legs but went on a little walk and threw up the following evening had very bad lower abdominal pain in lower right side and progressed to upper right thigh (like a charlie horse) kind of on and off pain throughout the night. currently weak and tired but much better. (I hope thats it and its over)
50 2021-04-12 sleep disorder At 5:00 pm I started to have severe cold chills. I then developed a fever of 102.2 at 10 pm. I had s... Read more
At 5:00 pm I started to have severe cold chills. I then developed a fever of 102.2 at 10 pm. I had severe nausea, body and muscle ache through the night. My fever spiked as high as 103.5 several times during the first night. I took 600 mg of ibuprofen and it did bring it down. All symptoms continued through out the next day 04.09.21. About 2 am on 4.10.21 I woke up and felt much better and that continued through out the day. Sunday 4.11.21 I started experience nausea again with slight fever of 101 no chills. I have since developed some nausea in the following days but no other symptoms.
50 2021-04-13 impaired work ability, feeling abnormal I became extremely dizzy and had to stop working for the day the day after the shot, originally thou... Read more
I became extremely dizzy and had to stop working for the day the day after the shot, originally thought it was my sinuses because of the dry air in the house but had never been that dizzy where I could not function and had to stop working. Slight dizziness the following day intermittently but not too bad but dizzy while walking the dog midway through the 20 minute walk. Woke fine the next day and the next. Saturday night it felt like I was coming down with something as I started running a small fever, felt burning hot, nausea( no puking), loss of appetite, dizziness, clouded head, stuffiness. Thought it was allergies to the cat but I have never had such a reaction, ever, and I have been near this cat numerous times before. Woke up in the morning feeling fine like nothing was wrong, except slight loss of appetite but was eating. Have been fine since.
50 2021-04-13 impaired work ability I received my shot at 10 a.m. on a Thursday morning. Around 6 p.m. on the evening of the shot, I beg... Read more
I received my shot at 10 a.m. on a Thursday morning. Around 6 p.m. on the evening of the shot, I began experiencing severe chills, and I threw up once. The chills lasted approximately four hours. In addition, I had an extreme headache. Once the chills subsided, I began sweating profusely through my clothes. I still had the headache. Around 2 a.m. in the morning, I was unable to stand or speak for about an hour. Once I was finally able to move again, my skin - not my body, but my skin - hurt all over. I could not lay on my back due to extreme pain in my skin, particularly the skin on my back, shoulders and buttocks. Anything that touched my skin, no matter how light of a touch, felt like I was being severely bruised. My skin was in pain for about four hours. The sweating continued through the following Sunday morning. I soaked through multiple sets of clothing and woke up every morning completely drenched. When I weighed myself Sunday morning, concerned about dehydration, the scale reflected a 4.2 pound weight loss over the course of less than three full days. The headache lasted through Tuesday, April 14th, a total of five days with a strong headache. I am still experiencing some sweating but not like the initial round of sweating. Because my shot was given on a Thursday, I only missed one full day of work. However, had the shot been given at the beginning of the week, I am confident that I would have missed at least three full days, it was so debilitating.
50 2021-04-13 insomnia After a few hours, experienced fatigue, dizziness, insomnia, headache that lasted for less than 24 h... Read more
After a few hours, experienced fatigue, dizziness, insomnia, headache that lasted for less than 24 hours. I felt normal but tired after 24 hours.
50 2021-04-13 insomnia I got the vaccine Apr7th afternoon. While at injection of the J&J Covid vaccine to my left arm, I co... Read more
I got the vaccine Apr7th afternoon. While at injection of the J&J Covid vaccine to my left arm, I could felt strong but manageable pain. Except minor pain from the arm, I felt all fine till going to bed that night. I started to get a headache and discomfort all over my body that night and couldn't sleep at all. Next day Apr 8th, my headache became much worse. I also felt extremely tired and got a low fever (98.3 - 99 F). I had to lie in bed for the whole morning. After taking Tylenol in the afternoon, my temperature came down to normal and my headache was also relived. I got a normal sleep Apr8th night, and felt all fine from Apr 9th till now (Apr 14th).
50 2021-04-13 loss of personal independence in daily activities The night of the vaccination (3/8), my body felt very hot (not fever) like it was going to catch on ... Read more
The night of the vaccination (3/8), my body felt very hot (not fever) like it was going to catch on fire. I took Tylenol to be safe and went to bed taking it as a sign that the vaccine was working. I thought I was mostly over the next day, but four days later on 3/12, I started bleeding only two weeks after my last period, and the it was quite different than usual - very fresh blood and lots of it. This continued for 15 days at time with very heavy flow - I bleed non-stop, and I worried that I was going to bleed to death. The worst adverse effect happened 10 days after the vaccination on 3/18. Out of blue without anything unusual, I started feeling very dizzy, nausea, and vomiting. After much vomiting, nausea stopped, but the dizziness just got so bad, I couldn't move or even keep my eyes open (things were spinning even with my eyes closed). I couldn't even stand up by myself. This most horrible severe vertigo lasted two and got gradually better. It took about 5 days before I felt safe enough to be alone by myself. During this time, I had a excruciating headache on my left side. It was so bad, I quickly took some painkillers which knock me out for a day. The important thing is that I don't ever get headaches; this is the first one I had aside from one I had when going through IVF more than a decade ago.
50 2021-04-13 sleep disorder The night after the night of my vaccine I had a tightening of my whole left side, from my eye, down ... Read more
The night after the night of my vaccine I had a tightening of my whole left side, from my eye, down my neck, into my shoulder and chest and down left arm. Then I started to get shooting pain all around my shoulder blades. I brushed it off thinking that most people had complaints of feeling pain or sick the few days after their vaccines and then they said it went away. Mine never went away. After about 5 days it really started to worry me. The pain was very intense- unbearable even- and i couldnt move my left arm or lie back in any way without incredible pain. I called urgent care and they told me I could come in if the pain was bad but that maybe I wanted to see my regular physician to see what was going on. I made an appointment with my doctor but it wasn?t until the end of the next week. After 8 days, I couldn?t take it anymore. I went to urgent care- they did an EKG and a chest xray and said all was normal. They gave me an anti-inflammatory (naproxen) and a muscle relaxer. They took blood and the only thing they noted to me was that I should have my doctor check my platelette count. They told me they thought it must be muscular. I went home. Neither of those medications seemed to help. The pain was less in the day when I was moving around, but towards the end of the day it was getting so bad (still is) that I can?t sleep or get comfortable. My doctor did blood work and couldn?t seem to find the source of what was going on with me either. She prescribed me a new anti-inflammatory (meloxicam), a new muscle relaxer (cyclobenzaprine) and a pain killer (hydrocodone acetamin). Sometimes those medications help- they knock me out- but when I wake up I feel the same. I can?t take them in the day because they make me too loopy and tired. I don?t know what is wrong. I can?t seem to get answers and nobody can figure it out. It is definitely my left side. I feel it in ky head, my chest, my shoulder and down my left arm and it has been almost 5 weeks. It seems to be getting worse not better. Looking for help or direction please
50 2021-04-14 anxiety Monday started having swelling behind my neck between my two shoulders and then a headache began. We... Read more
Monday started having swelling behind my neck between my two shoulders and then a headache began. Went to Healthcare expressed by the doctor did not think it was blood clot, but probably related to the vaccine. Gave me a steroid and muscle relaxer sent me home to call provider next day. Had Televisit with primary?s Wednesday April 14, 2021, by then news had broke about the new type of blood clot CVST and the low platelet count, I explained still had headache and swelling, sour stomach over night(have had this before) and felt weak for a brief few minutes on right side but quickly went away, also was walking for a brief few minutes like I was drunk, again went away after a few minutes. Discussed with primary my anxiety could be contributing to some of the extra feelings I was having, agreed to do bloodwork to check platelet levels. She did not think it was blood clots discussed with me about what I needed to look for and to go to ER immediately if I experienced any of them. Blood work did today, Thursday April 15, 2021. still headache and some swelling in back of neck between shoulders, dizzy off and on. All pain moderate to mild. Awaiting blood work for next step.
50 2021-04-14 feeling abnormal Per patient, 6 days after she received the Janssen vaccine she developed a rash on her feet and legs... Read more
Per patient, 6 days after she received the Janssen vaccine she developed a rash on her feet and legs. Initially she thought it was fleas, so she thoroughly cleaned everything but the rash started to spread and on one else in the house was having a problem. She said the rash is extremely itchy and she is miserable. She went and saw PA , at the Walk-In Clinic on Sunday, 4/11/21. She said she started Prednisone that day, now day 4 of taking it she said her rash may be a little better, but not sure. She said it's still extremely itchy and she's miserable.
50 2021-04-14 insomnia Immediately after shot ...probably within 10 minutes or so I had vasodilation of my sinuses & headac... Read more
Immediately after shot ...probably within 10 minutes or so I had vasodilation of my sinuses & headache. It came together & was quick like feeling inside of my nose swell & slight headache. I WAS VACCINATED WITH MY DAUGHTER 18 YRS OLD WITH TYPE 1 DIABETES AND SON 20 WITH PRIOR HISTORY OF DENGUE IN PHILIPPINES. At night as it was getting dark,severe symptoms hit us at home all around the same time. Severe excruciating pain in the back of our head and it ran down into our necks & jaw. I have had migraines & it was worse pain in the back of the head. My son said it felt like dengue when he spent a week in the hospital,which comes with low platelets count. To me it felt like when I had infection in my left mound after double mastectomy and spent five days in hospital hooked to Ivs with 2 antibiotics & they thought I had staff & going septic. I had horrible headache with that. My daughter reacted the worse,she was crying with head pain & shivering non-stop & her body aches hit all over first. She slept with a hot pad on her head & had ringing in the ears & if she tried to get up she heard rushing water sound in ears & felt like going to pass out. My body aches hit as I was trying to get strength to drive to ER if needs be,but if felt like crippling arthritis in arms wrists jaw legs knees & ankles. I slept with hit pad on my head & would move it to joints. Really none of us slept. Son had body aches all night too. Bad headache in back of head for all of us. Took 2 arthritis tylenil. All had stomach aches. Yesterday I was spinning & severely dizzy. We are fatigued & barely moving.
50 2021-04-14 loss of personal independence in daily activities Eyesight has significantly deteriorated after vaccination. First realized on Monday 05Apr2021 as oth... Read more
Eyesight has significantly deteriorated after vaccination. First realized on Monday 05Apr2021 as other side affects such as muscle soreness, dizziness, and fevers prevented me from getting up. Eye sight has not deteriorated since Monday.
50 2021-04-16 excessive sleepiness Nausea, dizziness It lasted couple hours so I laid down and slept all day
50 2021-04-16 mental impairment 04/14/21 8:00 PM; Pain on right side of head with blood inside of right eye. Drove to emergency room... Read more
04/14/21 8:00 PM; Pain on right side of head with blood inside of right eye. Drove to emergency room. Had pressure and pain 4 more times while waiting in emergency room. Evaluated in Emergency room. Admitted to hospital 04/15/21. Had testing CAT scans and MRI determined minor stroke or Ischemic stoke. Numbness on Right side involving right cheek, weakness in RH leg and arm, speech is a little slow; during hospital stay and continued after into April 17th. Released from hospital at 6PM on April 16. As of April 17 at 10:30 AM Still having issues, difficulty thinking, headache, numbness and slight pain in head and arm. Right leg is weak. Will call doctor on Monday April 19 to set up appointment.
50 2021-04-17 restlessness, amnesia Dizziness, extreme nausea, headache, weakness about 10 minutes following vaccine. Still having seve... Read more
Dizziness, extreme nausea, headache, weakness about 10 minutes following vaccine. Still having severe headaches, dizziness, memory loss, blurred vision, fatigue, restlessness.
50 2021-04-18 anxiety Tuesday, March 30 - COVID19 vaccination / Friday, April 2 - severe headache, arm pit pain in left ar... Read more
Tuesday, March 30 - COVID19 vaccination / Friday, April 2 - severe headache, arm pit pain in left arm pit, sore arm / Saturday, April 3 headache (less than on Friday), chest constriction, back pain, anxiety, hives and itching, took Benadryl and hives went away / Sunday, April 4 anxiety, intermittent chest constriction & back pain / Monday, April 5 & Tuesday, April 6 intermittent headache, tired / Wednesday, April 7 swollen fingers and feet / Thursday, April 8 - fingers remain still swollen
50 2021-04-18 disorientation 103F fever, full body tremors, body aches and headache, 4 hours past injection. Fever lasted 9 hour... Read more
103F fever, full body tremors, body aches and headache, 4 hours past injection. Fever lasted 9 hours from 4/5 pm until 4/6 am and returned approximately 20 hours after first starting. Second fever round was at 101F and lasted from 4/6 afternoon until 4/7 am. Visit on 4/8 to the emergency room for severe dizziness and disorientation. Dizziness was in waves and lasted for most of the day into the next day and has tapered off over the last 2 weeks.
50 2021-04-18 insomnia pain in legs, pain in back, itching in eyes, little headache, insomnia
50 2021-04-18 loss of personal independence in daily activities Severe headache behind left ear, hot sweats, fever, nausea and fatigue for two days. The headaches h... Read more
Severe headache behind left ear, hot sweats, fever, nausea and fatigue for two days. The headaches have still occurred everyday at varies times. It is a sharp pain that interrupts my thought process and I have to stop what I am doing until it passes.
50 2021-04-19 confusional state Blood pressure readings of 240/187 . Severe headaches, eye pain, numbness, dizziness, confusion, sti... Read more
Blood pressure readings of 240/187 . Severe headaches, eye pain, numbness, dizziness, confusion, stinging pain on left side of body. Extreme fatigue. Went to urgent care sent via ambulance to hospital.on 4/15/21 Released. Back in hospital on 4/19/21. Same symptoms. Ct scan done no issues. Still have severe high bp.
50 2021-04-19 disorientation, confusional state I am currently experiencing fatigue, muscle/body aches, headache, and confusion. Sometimes I feel di... Read more
I am currently experiencing fatigue, muscle/body aches, headache, and confusion. Sometimes I feel disoriented.
50 2021-04-19 loss of personal independence in daily activities Severe Headaches, Eye Pressure, and pain extended all the way to the back of my head. Joint pain is ... Read more
Severe Headaches, Eye Pressure, and pain extended all the way to the back of my head. Joint pain is constant, especially in the legs.
50 2021-04-19 nervousness Pain still in my left arm. Now in my right side. It?s like a ghost image of pain. Numbness in my ri... Read more
Pain still in my left arm. Now in my right side. It?s like a ghost image of pain. Numbness in my right arm and leg. Also a bruise on my right side under my rib, that After 4-5 days it has become a lump. Endless heads Please tell me where I can get the best help for my concerns with the J&J vaccine I received.
50 2021-04-20 feeling abnormal 4/19/20/21- vertigo, nausea, vomiting, headache, head fog, abdominal pain, fatigue, chills, low grad... Read more
4/19/20/21- vertigo, nausea, vomiting, headache, head fog, abdominal pain, fatigue, chills, low grade fever - Meclizine and Advil 4/22/2021- headache and head fog - Meclizine and Advil
50 2021-04-21 insomnia DECREASE IN RANGE OF MOTION OF RIGHT ARM; DIFFICULTY SLEEPING; ARM SORE / PAINFUL RIGHT ARM; This s... Read more
DECREASE IN RANGE OF MOTION OF RIGHT ARM; DIFFICULTY SLEEPING; ARM SORE / PAINFUL RIGHT ARM; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced decrease in range of motion of right arm. On 20-MAR-2021, the subject experienced difficulty sleeping. On 20-MAR-2021, the subject experienced arm sore / painful right arm. On APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm sore / painful right arm, decrease in range of motion of right arm, and difficulty sleeping. This report was non-serious.
50 2021-04-22 feeling abnormal SHORTNESS OF BREATH (SLIGHT AND NOT ALL THE TIME); VERTIGO; FELT OFF BALANCE; PRESSURE PRIMARILY O... Read more
SHORTNESS OF BREATH (SLIGHT AND NOT ALL THE TIME); VERTIGO; FELT OFF BALANCE; PRESSURE PRIMARILY ON LEFT SIDE OF HEAD; LOCALIZED HEADACHE PRIMARILY TO THE LEFT SIDE; TIRED; ACHES AND PAIN; FOGGY; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced aches and pain. On 11-APR-2021, the subject experienced foggy. On 11-APR-2021, the subject experienced tired. On 12-APR-2021, the subject experienced pressure primarily on left side of head. On 12-APR-2021, the subject experienced localized headache primarily to the left side. On 14-APR-2021, the subject experienced vertigo. On 14-APR-2021, the subject experienced felt off balance. On 18-APR-2021, the subject experienced shortness of breath (slight and not all the time). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches and pain, foggy, and tired on 11-APR-2021, and vertigo, and felt off balance on 14-APR-2021, was recovering from shortness of breath (slight and not all the time), and had not recovered from pressure primarily on left side of head, and localized headache primarily to the left side. This report was non-serious.
50 2021-04-26 sleep disorder Feeling numbness, tightness, hotness, warmth, spotting and discoloration in right and alternates to ... Read more
Feeling numbness, tightness, hotness, warmth, spotting and discoloration in right and alternates to the left leg today. Also started feeling some tightness in the left eye today. Have a Dr appointment but on May 17th and going to urgent care today. Advised to go to HCF instead of urgent just to ensure they can get imaging, US and appropriate testing's to r/o all cause of complications. 4/20-f/u pc to caller; couldn't sleep last night; used a heating pad on her leg but didn't work; states both legs hurt; feel tight; 4/10 pain; worried when also saw spots on her left leg and became concerned because saw news of clots; the episode started with tightness of her right leg which progressed to most of leg as well as left leg. Has not gotten worse today and denies any concominant effects. Normally healthy. Did not go to the hospital because says she wouldn't be able to afford it. Has appointment with primary care in 2 weeks. rec'd that since she is still ok today then it's likely ok to skip the ER and go see MD as planned; warned to go to the ER right away or dial 911 if any of the following effects: sudden shortness of breath, severe headache, vision changes, loss of motor or/sensory function, chest pain. Call us back if having any effects at all besides the ones already noted so we may help determine if needs ER care.
50 2021-04-26 thinking abnormal, crying Patient states still has open sore where received vaccine. Lost 35 lbs in the last two weeks. Reall... Read more
Patient states still has open sore where received vaccine. Lost 35 lbs in the last two weeks. Really emotional, always crying, can't thinking right.
50 2021-04-28 confusional state This patient received the Janssen COVID-19 Vaccine on 4/10/2021. She was subsequently admitted for i... Read more
This patient received the Janssen COVID-19 Vaccine on 4/10/2021. She was subsequently admitted for ischemic stroke of unknown etiology on 4/16/2021. She was found in the bathroom down on the floor, confused, with right-sided weakness, and aphasia. Patient was treated with TPA.
50 2021-04-29 feeling abnormal Ongoing extreme fatigue, brain fog, dizziness/wooziness. Headaches
50 2021-05-02 sleep disorder Increased difficulty breathing, wheezing on inhale, high pitched crowing sounds on inhale and exhale... Read more
Increased difficulty breathing, wheezing on inhale, high pitched crowing sounds on inhale and exhale, shortness of breath, fatigue, constant cough, drainage down back of throat, pulse O2 Sat variations, inability to sleep due to wheezing, cough
50 2021-05-04 feeling abnormal April 10- shot administered at store; waited the obligatory 10 minutes. On the way home my upper ar... Read more
April 10- shot administered at store; waited the obligatory 10 minutes. On the way home my upper arm got extremely hot, felt a bit foggy, major fatigue. April 11- vomiting, fatigue, congestion April 12- vomiting, fatigue, congestion April 13- vomiting, fatigue, congestion April 14- vomiting, fatigue, congestion, sore throat/ telehealth visit; dr. prescribes nausea meds April 15- fatigue, congestion April 16-fatigue, congestion, muscle pain April 17- congestion, muscle pain April 18- feeling 50% active. congestion April 19- feeling 70% active, still fatigue & congestion April 20- vomiting, fatigue, congestion April 21- vomiting, fatigue, congestion/ spoke w/ doctor, nausea meds refilled April 22- [didn?t record] April 23- 70% active, congestion April 24- 80% active, congestion April 25- 90% active, congestion April 26- vomiting, congestion April 27- 80% active, congestion April 28- 90% active, congestion April 29- 90% active, congestion April 30- vomiting, congestion, fatigue, chills/ went to hospital 7:30 pm- 4:15 am May 2- Admitted to Hospital Diagnosis 1. Dissection of vertebral artery & 2. Acute cholecystitis
50 2021-05-05 feeling abnormal Extreme tinnitus, brain fog, dizzieness and stomach pain 1-4 weeks after. Extreme tinnitus has not r... Read more
Extreme tinnitus, brain fog, dizzieness and stomach pain 1-4 weeks after. Extreme tinnitus has not resolved yet.
50 2021-05-10 feeling abnormal My arm still has pain in the local area where I received the shot. It is a dull ache about a 2-3 on... Read more
My arm still has pain in the local area where I received the shot. It is a dull ache about a 2-3 on scale and persistent. It feels deep as if in the bone. There is no rash or swelling and never was a rash or swelling. This persistent ache is over a month now and has not diminished. I did have mild fever and felt puny 2 days after the shot which is fine/expected and that went away. The arm pain concerns me.
50 2021-05-11 feeling abnormal STOMACH PAIN (RIGHT-SIDE); HEADACHE; TIREDNESS; FOGGY; This spontaneous report received from a patie... Read more
STOMACH PAIN (RIGHT-SIDE); HEADACHE; TIREDNESS; FOGGY; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and have 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: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced foggy. On MAY-2021, the subject experienced tiredness. On 03-MAY-2021, the subject experienced stomach pain (right-side). On 03-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy, and tiredness on MAY-2021, and stomach pain (right-side) on 04-MAY-2021, and had not recovered from headache. This report was non-serious. This case, from the same reporter is linked to 20210506681.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
50 2021-05-12 feeling abnormal Within 5 minutes from receiving my J&J vaccine, I went to sit down and I started feeling very hot in... Read more
Within 5 minutes from receiving my J&J vaccine, I went to sit down and I started feeling very hot in my body. My heart started to race, had chest discomfort and had trouble breathing, my trachea closed up, had blurry vision and pain in my chest. I felt like I could not breathe and when the nurse came over to ask me I could not speak to her, I went into a shock and I was placed on the floor and I could not hear anything nor could open my eyes, from my hips down to my feet I could not feel anything, my legs went completely numb and I had a syncope. What I was told from the nurse that I was given an Epi-pen to help with my reaction. When I came back my body was having convulsions, felt my head spinning, had pain in my chest that so very intense and the nurse got me up and took me to a nearby ambulance and the EMT staff placed like a heart monitor because my heart was racing super fast. I also felt heaviness in my chest and inside the ambulance I was given two injections on my left arm and when I slowly started coming back, I was already at the hospital. I was at the hospital from 2pm to 4:30pm more less being monitored. At the hospital x-ray of the chest was performed as well as lab work and I was discharged home. When I got home, I still did not feel good, I felt heaviness to my chest, still have trouble breathing and get chills during the night. I also could not stand up and have a nerve sensation to my body and the chest pain to my left side is still very present. I have blurry vision, dizziness, headaches, and my heart-beat continues to race very fast. I get headaches, have abdominal pain and I peed blood few times then that's when I was able to pee, my abdominal pain was painful like having a baby. On Friday 04-08-2021, I again went to the hospital because I had fallen to the floor on my kitchen floor and my daughter took me to the hospital. I let the nurse staff know that I still have continued chest pain and pressure, difficulty breathing and headaches, dizziness and they monitored and gave me three pills as medication. I was discharged home about 5pm with a referral to see a neurologist due to my chest pain, blurry vision, dizziness and fever which I had these past three weeks. I do not know why I felt all these symptoms after my J&J vaccine.
50 2021-05-16 anxiety ANXIOUS, FEEL FAINT, CODE GREEN CALLED BP 110/72 , HR 60, SX IMPROVED, REFUSED TRANSPORT.
50 2021-05-16 panic attack, confusional state because they were unable to use a bandaid they used a cotton ball to put pressure, within two minute... Read more
because they were unable to use a bandaid they used a cotton ball to put pressure, within two minutes it was a sense of pain up and down her arm from shoulder to elbow where she was vaccinated. after 5 minutes it calmed down, after the 30 minutes she felt all her joints hurt and felt swollen, prior to vaccine her whole body was sore from the day prior, the doctor came in and she was given an icepack for her shoulder. She was then getting very confused and just couldn't focus when the doctor asked for her medical condition and needed to call in her mom to assist because she was beginning to panic, blood pressure did go up and was then given Benadryl, within this time she had drank 2 big cups of water, after the ice pack and benadryl the bones felt better but not okay. She said an hour after the vaccine, the shoulder and neck area felt bad for 10 days after, she still has irritating pain in her neck and shoulder, on 4/30/21 she got a migraine and it hasn't gone away since, she is unable to return to work, since the migraine she has gone to the ER twice, an acute care once and a neurologist, she can't be in front of a screen or read a book it hurts to think, when she tried looking at a screen after 1 hour she couldn't continue, today on 5/17/21 she can't bear the shoulder pain,
50 2021-05-17 loss of personal independence in daily activities, impaired work ability Hello, I received the J&J vaccine on 3/12/2021. Eight days later on the 20th when I went to bed I ha... Read more
Hello, I received the J&J vaccine on 3/12/2021. Eight days later on the 20th when I went to bed I had a lot of pain in my left heel and left thumb. The next day, on a Sunday, the pain was now in my left heel, left thumb at the big knuckle and top and bottom below my thumb, and just behind the inside of my left ankle, and I had a terrible headache. I was unable to grasp anything or widen my grip because the pain was so intense in my thumb. It was so bad I went to my local ER who did xrays and told me it was just osteoarthritis. The next day, Monday, the pain was terrible. It was in my left thumb, the middle of my left hand, left ankle, the arch of my left foot top and bottom, the big knuckle at the bottom of my left big toe, my right hand was also now hurting at my middle finger the big knuckle at the bottom. I went to see my family doctor who really was unsure at the time what was going on and said it's still just must be the osteoarthritis. The next day on Tuesday I still have the headache I was out unable to open my own water bottles or prescription bottles because the pain was so intense in my left hand. It was now extremely painful to walk on my left foot and I had no appetite. The following day on Wednesday the pain was bad and my right hand that I was unable to touch my ring finger or my pinky with my thumb. As hard as I try my thumb just would not reach those two fingers oh. I now couldn't open any of the doors in my house unless I use the base of my Palms on both hands turn the knob. I now couldn't even comb my own hair or pull my pants up wipe myself properly. I couldn't hold a pencil or anything because the pain was so unbearable. I had no appetite and now I have diarrhea. I called my husband at work and had him come home and we went to the emergency room because it was a bigger facility. The doctor there told me he thought it was something more like rheumatoid arthritis or lupus. This was by far my worst d ay even though I was unable to work this entire week. Oh and did I mention the only reason I got that back who was because my boss with bullying me and pressuring me every day to get the vaccine. He even went so far as to come of my office and he wanted to use my keyboard to schedule my vaccine himself. The next day on Thursday I was still having a hard time walking I still couldn't touch my ring finger on my pinky with my right hand still unable to open anything with either one of my hands. My husband had to open all the water bottles and prescription bottles and just set the caps on them before he went to work. I now had flashing light in my eyes which lasted about a week. The following day I had all the same symptoms but now my left foot was so swollen I couldn't even get a shoe on it. The big knuckle at the base of my right hand hurts so bad at this point and so does the big knuckle at the base of my left thumb. The swelling and the pain is just unbearable at this point. The following day on Saturday my mom had come up from Florida and stay with me for two weeks take care of me someday the next day on March 28th I start all the same symptoms but now my muscles were quivering on the back of both thighs. By the middle of next week I still had all of the same pain and now I'm realizing that I can't span open my fingers on my right hand and I'm unable to snap my fingers. Side note as of today I still cannot snap my fingers on my right hand. At this point I have been keeping a diary every day of where my pain was in what the pain level was each day. So strange that it's affecting joints on both sides but just in my hands the inside of my wrist and my left foot. Are April 28th I finally got into the rheumatologist. He had me go to the hospital and get blood work done and x-rays. On Thursday May 6th I was unable to go to work. It seems like I can go to work about 3 days a week and the pain is so intense that I'm missing about two days a week. Dr called me and said all of my tests came negative for rheumatoid arthritis.He told me not just because I was a patient but if I was his own sister he would suggest going to the Clinic right away. He said they have a larger database and if anybody else was having the same reaction to the covid vaccine they would know about it. My husband came home from work and made the four-hour drive to the Clinic. I was there Thursday and Friday they the blood work a sonogram x-rays the whole gamut of tests. The rheumatologist in the ER said that he thinks it's still something like rheumatoid arthritis or lupus but that was in the early stages and not showing up positive on the test. On Friday I met with dr. a rheumatologist oh, and the chairman at the Clinic. They said this is a very rare reaction to the J&J vaccine and they're hopeful by prescribing me a non-steroidal anti-inflammatory and Voltaren gel that hopefully I will have some relief within a week and they were hopeful that the symptoms will go away within 3 months. They also took me off work for the next week. Did I mention got the first month that was going on they have me on 50 mg of Prednisone for one week then 100 mg of Prednisone for 2 weeks and then back down to 50 mg for one week. After being on that high dosage of Prednisone for an entire month I still have all of the swelling and pain in my joints. My joints are very stiff at this point. The prednisone maybe eased the pain just a touch but the pain and swelling was definitely there, and the pain is excruciating. I'm feeling so alone, and scared because I don't know anybody else that's having the same reaction. I'm also fearful I'm going to lose my job I'm missing so much work. But I also feel like my boss pressured me into this and now I'm suffering. If anybody is having the same reactions to Johnson & Johnson vaccine please reach out to me. I have my vaccination card I can show you and I have a ton of doctor and hospital records to verify my story. I'm really worried because I'm not sure what's going on with me, how long it's going to last, and is it going to come back if I do get these symptoms to go away. My work place offers no paid extended leave, and has repeatedly asked me I'd I was quitting my job. I'm only having these problems because I was pressured and bullied into getting this vaccine. I completely blame my boss. I would have never got vaccinated if he wasn't on me about it every single day repeatedly. I'm at a loss as to what to do from here. I have no income coming in. Do I qualify for unemployment or some sort of disability benefits? If anybody can please give me some suggestions I'm open to whatever you have to say
50 2021-05-21 amnesia Patient fainted after leaving booth . It appears she may have whacked her head on the concrete floor... Read more
Patient fainted after leaving booth . It appears she may have whacked her head on the concrete floor. No blood. She was back to consciousness but didn't remember what happened. Ambulance came, took her away in stretcher.
50 2021-05-26 feeling abnormal I felt really fatigue and I was very ill for the first 24hrs. I wasn't feeling like myself. I got br... Read more
I felt really fatigue and I was very ill for the first 24hrs. I wasn't feeling like myself. I got bronchitis and now its as mastic bronchitis. I had chest pains and wheezing and the first few weeks of April.
50 2021-05-27 feeling abnormal HAD ALLERGIC REACTION TO VACCINE. ADMINISTERED VACCINE AT 8:05P. AT 8:20 PT REPORTED FEELING FUNNY, ... Read more
HAD ALLERGIC REACTION TO VACCINE. ADMINISTERED VACCINE AT 8:05P. AT 8:20 PT REPORTED FEELING FUNNY, TIGHTNESS IN ABDOMEN AND CHEST. CALLED 911 AT 8:20P. TOOK BP - 179/108 PULSE 82. STARTED HAVING DIFFICULTY BREATHING. ADMINISTERED EPIPEN AT 8:25P. EMS ARRIVED, ADMINISTERED IV BENADRYL AND TOOK PT TO EMERGENCY DEPARTMENT. PRIOR TO VACCINE ADMINISTRATION REVIEWED ALLERGY FILE. DECIDED TO GO WITH ONE DOSE JANSSEN DUE TO HISTORY OF ALLERGIC REACTIONS, NO REACTIONS TO POLYETHYLENE GLYCOL OR POLYSORBATE NOTED. REVIEWED RISK AND BENEFIT WITH PATIENT PRIOR TO ADMINISTRATION
50 2021-05-27 impaired work ability, feeling abnormal Patient received the Janssen vaccine on April 6 2021 and over the next week felt that her body was n... Read more
Patient received the Janssen vaccine on April 6 2021 and over the next week felt that her body was not right. She felt unsteady on her feet. These symptoms continued and she was admitted to the hospital on 5/2/21. Her blood pressure was elevated at home and she was worried about a stroke. But had no focal weakness or headache. BP per report went to 220/110. CT scan was negative for stroke. MRI was unremarkable. She was given meclizine started on aspirin and atorvastatin and discharged. Since then she continues to have daily vertigo which prevents driving and she has been unable to work. She also has some nausea at times.
50 2021-05-31 anxiety 24 hours after receiving the shot. I had normal reaction, 3 days of fatigue and not feeling well. ... Read more
24 hours after receiving the shot. I had normal reaction, 3 days of fatigue and not feeling well. After the 3 days started to feel much better. Than 9 days after I began to feel dizziness and light headedness. This reaction is still continuing today. I have been seen by my PCP and he insists its anxiety. I have also been seen by PT to help relieve dizziness symptoms with no changes. In doing research I have found that this type of reaction can happen to regular flu vaccine.
50 2021-06-25 feeling drunk MEDICATION CAUSED FEELING OF SEVERELY DRUNK; TEMPORAL ARTERITIS; WEAK VOMITTING; This spontaneous re... Read more
MEDICATION CAUSED FEELING OF SEVERELY DRUNK; TEMPORAL ARTERITIS; WEAK VOMITTING; This spontaneous report received from a patient via a company representative concerned a 50 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced temporal arteritis. On 07-APR-2021, the subject experienced weak vomiting. On MAY-2021, Laboratory data included: CT scan (NR: not provided) temporal arteritis, and Ultrasound scan (NR: not provided) temporal arteritis. On 28-MAY-2021, Laboratory data included: Biopsy artery (NR: not provided) Negative to giant cell. On an unspecified date, the subject experienced medication caused feeling of severely drunk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weak vomiting on 10-APR-2021, was recovering from temporal arteritis, and had not recovered from medication caused feeling of severely drunk. 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.
50 2021-07-07 insomnia Fever, body aches and I couldn't sleep. It progressively got worse; didn't sleep well that night. I ... Read more
Fever, body aches and I couldn't sleep. It progressively got worse; didn't sleep well that night. I ached everywhere. Next day, I felt lethargic and fatigue. All day the 6th, I laid around with a fever off and on. I felt better on the 7th. The following week after the vaccine, I noticed pressure in my head. The sinus pressure has progressively gotten worse and the postnasal drip. I have been taking Flonase every day and OTC allergy medicine and I was very lightheaded, so I went to Urgent Care about a month ago. They gave me Prednisone. I was on that for five days, but I still didn't clear it up. I went to the doctor last week, wanted to change OTC medicine to see if body had built up an immunity to the allergy pill, I had been taking. I stayed on the Flonase. The pressure is crazy, it gives me headaches. It gives me postnasal drip. I still have the symptoms now and it didn't make a difference to change up the OTC med. I have an appt next week again with the doctor to see what to do next.
50 2021-07-13 feeling abnormal The patient complains of finger tips and feet numb and has also felt "off balance." The patient sta... Read more
The patient complains of finger tips and feet numb and has also felt "off balance." The patient stated her symptoms have been ongoing for about 3 months
50 2021-07-13 excessive sleepiness, feeling abnormal I got my shot. It lightly sting nothing bad. - About 40 min later on both sides of my back I felt t... Read more
I got my shot. It lightly sting nothing bad. - About 40 min later on both sides of my back I felt tingling right below my shoulder blades and then this spread out like a waterfall going down my back . - about an hour later it was like someone turned my power off. I was so tired I could barely open the car door and walk inside - laid down and slept maybe 3 hours ? - woke up hurting and puking - hot and cold and exhausted - slept next day . Not hungry but husband bright oatmeal and coffee. I ate a bite and threw it all up - my body get like it had become broken glass . It hurt . It hurt to walk to the kitchen . My eyelashes hurt , my nails hurt . Stayed in bed. Ate a TV dinner and threw it up . Feverish . Sweating hot cold . Felt like a migraine headache I guess around my forehead and eyes - and I have never had one . - day 3 - nauseous. Took shower and big clumps of my hair fell out . Feet hurt and tingled. Felt like a spike gong through my right side off and on . Day 4 - slept all day and had to drive 8 hours home. My left eye hurt and was draining . When I got home I looked in the mirror and the left side of my face was swollen really badly and eye about swollen shut. Felt bad . Achy and stabbing side pain . Went to Urgent Er care due to face swelling . They had no explanation . Had a cyst like pimple on left side under eye that went back up to eye lid Could not turn my neck and really sore . Went to Chiropractor doctor. He and his assistant examined me and said I was not out of alignment but my lymph nodes around my neck area and left side of my spleen were very swollen . He said to go to dentist over face swelling and I probably had an infected tooth Went to dentist . Teeth were fine but he said to go to the eye doctor . Still feeling sick and very achy . Hurt to walk . Knees hurt . Felt like I was 100 years old Went to eye doctor . He examined my eye then had me go to another room and machine . Then a variety of students came in to look at my eye . I asked why and one said because they only read about this in text book. Doctor came bAck and said I had acute narrow angle eye closure and had to do emergency surgery . Still feel horrible Labs now coming back with odd things . Doctor sending me to rheumatoid / endocrinologist and integrative doc but can?t get appointments til October Now have holes in my iris to relieve the pressure and other auto immune things going on . Doctor said tissue swelled on optic nerve . Saw glitter like out of side of eye . He said I?d loose my eyesight if I did not have the emergency surgery
50 2021-07-13 restlessness, insomnia On July 11,2021 my arm was sore an at different times numb I was very fatigued an nauseous than on t... Read more
On July 11,2021 my arm was sore an at different times numb I was very fatigued an nauseous than on the morning of July 12,2021 my face swelled I took a Benadryl that relieve it but than again during the day it swelled again an my lips so I took another Benadryl I also had trouble sleeping very restless than July 14, 2021 I woke up several times sweating with my hair wet from sweating an still nauseous.
50 2021-07-19 disturbance in attention Within hours of receiving vaccine I have had ringing in both ears as well as a muffled hearing. Thi... Read more
Within hours of receiving vaccine I have had ringing in both ears as well as a muffled hearing. This is something I did not have before receiving vaccine and has not went away nor gotten any better as of yet. This is causing me to be dizzy from time to time throughout the day and a headache by the end of the day. As well as loss of concentration, this is very distracting and bothersome. Contacted my PCP and she advised the I see an ENT/ OTO still waiting for my appointment on 7/22/21 to see if they can help me.
50 2021-07-23 anxiety dizziness, shaking, tremor, elevated BP, anxiety, cold to touch from 09:59 AM to 10:15 AM, shakiness... Read more
dizziness, shaking, tremor, elevated BP, anxiety, cold to touch from 09:59 AM to 10:15 AM, shakiness was still going on but patient left the pharmacy area
51 2021-03-08 sleep disorder, abnormal dreams I had dizziness for the majority of the day Saturday and Sunday. I was fatigued, but made myself st... Read more
I had dizziness for the majority of the day Saturday and Sunday. I was fatigued, but made myself stay awake up the whole day Saturday. I had a very weird dream Saturday night and woke up very tired Sunday morning around 8 am. I went back to bed 11:15 am and slept until 1:30. The dizziness lasted the rest of Sunday. I have only slept for 5 hours between Sunday night and today (Tuesday March 9th).
51 2021-03-09 sleep disorder Shot was at 7:20 am 3/9. Started feeling very cold and shaky about 1PM, took an Advil and that help... Read more
Shot was at 7:20 am 3/9. Started feeling very cold and shaky about 1PM, took an Advil and that helped for a couple hours. By 4:30PM uncontrollable shakes, felt electric zaps, and very, very cold. Temperature around 100.9F. For a couple hours continued shaking and couldn't get warm. Finally stopped shaking and then very hot around 8pm, Temperature was 103.5F. Took Advil and tried to cool down. Heart rate was around 120bpm and pounding hard for a number of hours. Couldn't sleep due to pounding heart. Finally around 3am the next morning heart rate back to normal and temperature back to 100.9. Achy throughout the afternoon and night yesterday and this morning. Feeling much improved at 3pm on 3/10. Temperature 99.5F.
51 2021-03-10 nervousness After getting vaccinated and escorted to waiting area patient fainted out of chair and hit head on f... Read more
After getting vaccinated and escorted to waiting area patient fainted out of chair and hit head on floor. She was briefly unconscious and pale for a few minutes after coming back to consciousness. She remained on the floor feeling dizzy, shaky, and nauseous until she was taken to the hospital by paramedics.
51 2021-03-12 poor quality sleep, feeling abnormal 3/8/21 - woke up at 2:30am with elevated temp (normally at 97.6 and showed 98.9) sleep was restless... Read more
3/8/21 - woke up at 2:30am with elevated temp (normally at 97.6 and showed 98.9) sleep was restless, couldn?t go back to sleep and had chills. Felt punky on 3/8/21 - still worked all day and all week. 3/13/21 - woke up at 4:30am and had exact same symptoms as above but with a 99.7 temp. Feeling punky.
51 2021-03-17 feeling abnormal Patient describes a seizure episode that occurred this morning. Patient was feeling fine at her usu... Read more
Patient describes a seizure episode that occurred this morning. Patient was feeling fine at her usual health, went and got the Johnson & Johnson vaccine. Was monitored for minutes afterwards. Patient stated soon as she got the vaccine, it just made her feel little bit funny but not really able to describe the symptoms further. Went back to work and spoke with her coworker, and walls during the conversation, patient had approximately 2-minute seizure episode in which she became unresponsive, generalized shaking patient did not fall on the floor she was still in the chair. She had a brief cessation of the seizure but then the had a 45-second seizure episode. Patient was post ictal and afterwards became alert and oriented x4 however she had a persistent stuttering which is new.
51 2021-03-18 excessive sleepiness Dizziness, Throwing up, nausea, headache, weak, muscle aches, diarrhea , no energy, sleeping more, f... Read more
Dizziness, Throwing up, nausea, headache, weak, muscle aches, diarrhea , no energy, sleeping more, flu like feeling; All symptoms kept for the week and still have them 5 days later. Loss of appetite as well. Monday and Thursday of the week was only time of throwing up.
51 2021-03-20 feeling abnormal low grade fever, brain fog, fatigue for 10 days and still going
51 2021-03-22 confusional state Unconscious by 8pm after shot on Saturday, awoke on Monday after 4pm confused and lightheaded. Fell ... Read more
Unconscious by 8pm after shot on Saturday, awoke on Monday after 4pm confused and lightheaded. Fell back asleep until Tuesday around 11am. Barely remember speaking to anyone, didn?t drink any fluid or go to bathroom.
51 2021-03-23 feeling abnormal I feel out of it since I got the vaccine, like I am in a fog, my reactions seem slower than usual. N... Read more
I feel out of it since I got the vaccine, like I am in a fog, my reactions seem slower than usual. Not myself a week and a day later,
51 2021-03-25 feeling abnormal fever, chills, body aches, headache, stuffy nose drainage, diarrhea, foggy brain
51 2021-03-29 restlessness Called to lobby where client was sitting upright in chair after receiving J&J vaccine. She had brou... Read more
Called to lobby where client was sitting upright in chair after receiving J&J vaccine. She had brought her own ice pack from home and stated when she gets shots she sometimes feels like the room is going black and feels faint. Patient requested to lie down. Myself and nurse assisted patient to wheelchair and assited her to exam room 2 where she got on the exam table with our assistance.Patient did not lose consciousness but was pale and clammy. B/P at 16:06 82/56, P 65, spo2 98% on RA. Patient voiced she felt a little better. V/S at 16:09 B/P 88/62, P 86,spo2 98% on RA. Patient then became restless and began to complain of not being able to feel her tongue and her fingers, noted decorticate posturing and patient complained of feeling like she needed to vomit. Pt. remained conscious. I had nurse call 911 and I administered EpiPen 0.3mg in Right thigh.Nurse to room to assist and administered Benadryl 50mg in left VG. Supplemental 02 was provided by NRB initially and then via nasal cannula at 6L/min. Pt. voiced she could feel her tongue again and felt some better. EMS arrived and patient was
51 2021-03-29 sleep disorder I began vomitting in the middle of the night. This continued every 15 minutes for 13 hours straight.... Read more
I began vomitting in the middle of the night. This continued every 15 minutes for 13 hours straight. I was seen in the ED and was treated with IV fluids and nausea medication.
51 2021-03-30 irritability Severe headache, extreme fatigue, warm sensation in chest for about an hour, numbness in hands, di... Read more
Severe headache, extreme fatigue, warm sensation in chest for about an hour, numbness in hands, dizziness and extreme irritability. This lasted until day 3 after the shot. Then, all of the sudden, like someone turned on a light, 8 was better. It was instant. The strangest thing I've ever experienced!
51 2021-03-31 feeling abnormal FAINTED; LOW BLOOD PRESSURE; FEELING FUNNY; This spontaneous report received from a patient concerne... Read more
FAINTED; LOW BLOOD PRESSURE; FEELING FUNNY; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 72.7 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. The patient received selexipag (form of admin and route of admin were not reported, batch number: 031491701) 800 ug, every 2 days, frequency, and therapy dates were not reported for primary pulmonary hypertension. Concomitant medications included ambrisentan, and riociguat. On 09-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) Low blood pressure. On 09-MAR-2021 13:00, the patient experienced low blood pressure, felt funny and she fainted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of selexipag was not changed. The outcome of the low blood pressure, fainted and feeling funny was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210342442-Covid-19 vaccine ad26.cov2.s-Fainted, Low blood pressure. These events are considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS V0 20210342442-Selexipag-Fainted. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY AND UNDERLYING DISEASE V0 20210342442-Selexipag-Low blood pressure. This event is labeled and is therefore considered potentially related
51 2021-04-02 disturbance in attention About 1 HR after, trouble breathing, rapid heartbeat, weakness, nausea, swollen injection site, dizz... Read more
About 1 HR after, trouble breathing, rapid heartbeat, weakness, nausea, swollen injection site, dizzy & couldn't focus
51 2021-04-04 insomnia Hour or so after the vaccine experienced rapid heart rate and onset of headache and fatigue, injecti... Read more
Hour or so after the vaccine experienced rapid heart rate and onset of headache and fatigue, injection site pain. 8-10 hours after vaccine symptoms increased to include headache, body aches, fever, chills, muscle and joint pain as well as continued injection site pain. Inability to sleep first night frequent urge to urinate. Symptoms lasted 48 hours.
51 2021-04-07 feeling abnormal, mental impairment My mind is foggy, my body feels numb, I am extremely exhausted, I cant concentrate, forgetting more ... Read more
My mind is foggy, my body feels numb, I am extremely exhausted, I cant concentrate, forgetting more than usual, headache, body aches, week no energy.
51 2021-04-08 abnormal dreams Severe fatigue, severe muscle aches, vivid dreams. Tylenol and rest. Much better after 48 hours, but... Read more
Severe fatigue, severe muscle aches, vivid dreams. Tylenol and rest. Much better after 48 hours, but persistent muscle aches.
51 2021-04-08 anxiety Dizziness, Nausea, Anxiety and diaphoresis then syncopal event, LOC for 15 seconds, airway maintain... Read more
Dizziness, Nausea, Anxiety and diaphoresis then syncopal event, LOC for 15 seconds, airway maintained throughout. Ammonia used to increase conscience. Pt went home with husband after eating cookies
51 2021-04-08 feeling abnormal I received my vaccine about 3pm Sat. April 3rd. About an hour or so later I started to feel ?run dow... Read more
I received my vaccine about 3pm Sat. April 3rd. About an hour or so later I started to feel ?run down? but nothing major. At 9pm I began getting chills but did not feel feverish. By 9:15 my body was aggressively trembling. Even my teeth were chattering. I could not control the shaking. I put many layers of blankets on me and turned my heat up to 80 in an effort to get warm. At some point I dozed off. I woke up at 12:30am and had a fever of a little over 101 degrees. I fell asleep about 3am, still aggressively shaking. I woke up at 9am (April 4th) and my head was throbbing. My fever was now 102.2. Also, every muscle in my back and shoulders ached. I sat up because I needed to get to the kitchen for some water. Once I stood up, my body felt like it was weighed down by heavy sandbags. I could barely walk to my kitchen and back. I went back to bed and covered up in massive blankets and tried to stay still. I did not take any pain reliever because I was too nervous to. I never had any nausea but smells bothered me and I had no appetite. My fever stayed at 102.2 until I went to sleep (around 10pm). Monday (April 5th) I still had chills but much milder. My temp was just over 101 all day. My head felt better but my muscles still hurt. By late evening (10pm) my fever was just over 99 degrees. I was feeling better and I no longer had chills. Tuesday (April 6th) I woke up fever free. I felt mostly normal again except for my muscle aches. Today is Friday (April 9th) and I continue to have muscle aches. The worst of it is in my lower back and it?s pretty severe. It feels like I lifted heavy weights with my lower back muscles. I have not been seen by a Doctor yet as I have no insurance. I?m not sure if I need to or not. I wanted to contact you because I am a healthy person and what I experienced was BRUTAL. I have NO IDEA how a frail or vulnerable person could go through what I went through. Also, people need to know that they may have to take time off of work to deal with these side effects.
51 2021-04-09 feeling abnormal Tiredness, dizziness, fever, brain fog, headache (not migraine), severe chills
51 2021-04-09 impaired work ability With in 45 mins I started getting dizzy,nauseous at 2:30 went to work left early 4:30felt I needed t... Read more
With in 45 mins I started getting dizzy,nauseous at 2:30 went to work left early 4:30felt I needed to lay down immediately was home at 5:00 passed right out woke 6:30 felt sick by 8 pm I had chills in my bones for 4 hrs I shivered under 3 comforters the first 24 hrs was hell my entire head started pounding headache was9 hrs I couldn't hold my head up 36 hrs no strength ,nauseous .on 3rd day I still feel nauseous to point i can't be stand and function more 10 mins.I would never do this again
51 2021-04-10 feeling abnormal, sleep disorder Vaccine received at approximately 1:30pm. Around 6pm, had noticeable chills, progressing to severe ... Read more
Vaccine received at approximately 1:30pm. Around 6pm, had noticeable chills, progressing to severe chills by 7pm. Muscle aches and headache also began about that time. Went to sleep. Around 1:30 woke up with nausea and sweaty chills. Walking to the bathroom was difficult due to extreme fatigue. Fever measured at 103 degrees. Took Tylenol. Nausea resolved by 7am 4/10, but had no appetite. Fatigue throughout day (4/10) - slept most of the day. As of 7am on 4/11, mostly better. Remaining symptoms are a lingering headache, moderate fatigue, and vaccine site muscle soreness. Perhaps some brain fog, as this form seems challenging and it shouldn't. Note: I had had little sleep the week prior to the vaccine, which may have affected my reaction.
51 2021-04-10 insomnia Severe headache, nausea, vomiting, upset stomach, chills without fever, unable to sleep
51 2021-04-10 sleep disorder Fever 102 degrees, violent chills, headache, overall weakness, extreme pain in arthritic hip and leg... Read more
Fever 102 degrees, violent chills, headache, overall weakness, extreme pain in arthritic hip and leg. Began around 9pm and lasted through most of the night. Fever, chills subsided by next morning, had minor headache which was resolved with ibuprofen. No lingering symptoms other than tiredness from lack of sleep due to chills and pain during the night.
51 2021-04-11 feeling abnormal My head started feeling not clear. I began monitoring my temperature & I noticed an increase. My sto... Read more
My head started feeling not clear. I began monitoring my temperature & I noticed an increase. My stomach became upset and my temperature continued to climb to 102.8. My head ached for about 6 hours. I had chills & my stomach was cramping. I had the shakes and I attempted to reach out to my doctor. As I waited to hear from my doctor, most of my symptoms subsided the next day.
51 2021-04-12 anxiety Anxiety Dizzy Bp 146/93 HR 50 Held 1 hour Improved
51 2021-04-12 feeling abnormal Pt had her vaccine at 1550pm and then proceeded to the monitoring area for her 30 minutes of monitor... Read more
Pt had her vaccine at 1550pm and then proceeded to the monitoring area for her 30 minutes of monitoring. At 1620 she complained to the monitoring RN of tongue tingling and a flushed feeling. RN provided pt with diphenhydramine 25mg PO x 1 and water. Pt noted slow and continued improvement of symptoms. Pt monitored longer and discharged to home at 1635.
51 2021-04-12 feeling abnormal FELT AWFUL AND NOT GREAT; FELT LIKE FLU; SORE, ACHES ALL OVER; HIGH FEVER; INJECTION SITE PAIN; DIZ... Read more
FELT AWFUL AND NOT GREAT; FELT LIKE FLU; SORE, ACHES ALL OVER; HIGH FEVER; INJECTION SITE PAIN; DIZZY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin bees. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1848422, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced dizzy. On 18-MAR-2021, the subject experienced injection site pain. On 19-MAR-2021, the subject experienced felt awful and not great. On 19-MAR-2021, the subject experienced felt like flu. On 19-MAR-2021, the subject experienced sore, aches all over. On 19-MAR-2021, the subject experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 18-MAR-2021, and felt like flu, sore aches all over, and high fever on 21-MAR-2021, and had not recovered from injection site pain, and felt awful and not great. This report was non-serious.
51 2021-04-12 feeling abnormal 4/10 7:00 Pm fever started. By 9:30 pm, Fever 104.1 on Tylenol, Vomiting, Dizziness, Shaking, Stoma... Read more
4/10 7:00 Pm fever started. By 9:30 pm, Fever 104.1 on Tylenol, Vomiting, Dizziness, Shaking, Stomach discomfort. I was not able to get my temperature down. I had to go to the local emergency room. I was given IV fluids with anti nausea. 4/11 Fever still 102 in the morning. Vomiting had stopped after trip to the emergency room. Still had fever (101) at bedtime. Genrally felt cruddy. Bad headache. 4/12 Low grade fever in the morning and over all malaise. 4/13 Feel better but not great
51 2021-04-12 insomnia COULD NOT SLEEP; SORE ARM; This spontaneous report received from a patient concerned a 51 year old f... Read more
COULD NOT SLEEP; SORE ARM; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered to left arm on 07-APR-2021 19:20 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced could not sleep. On 07-APR-2021, the subject experienced sore arm. Treatment medications included: diphenhydramine citrate/ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and the outcome of could not sleep was not reported. This report was non-serious.
51 2021-04-12 sleep disorder 9pm began with extreme chills and I was burning up but didn?t get out of bed for a thermometer becau... Read more
9pm began with extreme chills and I was burning up but didn?t get out of bed for a thermometer because I was nauseous then began vomiting at 11pm until about 2am
51 2021-04-12 sleep disorder I had terrible pain in the calves of both legs but the left side more. It began within two hours of... Read more
I had terrible pain in the calves of both legs but the left side more. It began within two hours of getting the vaccine and worsened over the night. I woke up at about 4:00 a.m. with a severe cramp in the left calf and I had to jump around until it loosened up. It was extremely sore afterwards. I was exhausted all day on Wednesday and my legs hurt the entire day. By Thursday my legs were a little better and by Friday it was significantly better. I am still feeling some pain in my left calf but it?s not all the time.
51 2021-04-13 impaired work ability, excessive sleepiness When I left, I immediately needed to go home and sleep and developed a headache. As the week conti... Read more
When I left, I immediately needed to go home and sleep and developed a headache. As the week continued my normal nausea intensified as well as having a headache and began to have episodes of becoming extremely warm with sweat and then was cold. I did not eat this week except very minimal crackers or toast. Thursday I vomited, Friday I stayed home from work and vomited again. Saturday- Sunday I did not work but slept all day. Monday, I had a work appointment that I went to. It lasted about 2 hours when I vomited some more. Tuesday-Wednesday while I wanted to go to work, did not feel at all confident in my ability to not vomit as well as hot and cold spells. My abdomen has been distended throughout this with several days of not being comfortable touching this area I have not seen a physician, however health department said I should report this and I did email my gastroenterologist at the university about what I have been experiencing
51 2021-04-13 impaired work ability Nausea and dizziness by evening. Nausea increased. Woke up at 11:45 pm and went to the bathroom. Cou... Read more
Nausea and dizziness by evening. Nausea increased. Woke up at 11:45 pm and went to the bathroom. Could not get up from toilet. Too dizzy. Called husband to help. Threw up three times. Body aches and chills came on very quickly. Body aches became severe. Returned to the bathroom about 30 mins later and had bowel movement and some diarrhea. Difficulty sleeping due to the pain from body aches and chills. Fever developed by morning. At 6:00 am fever was 99.8. Took one Advil. Fever subsided. Slept off and on all day. Body aches and chills lasted most of the next day on 4/13. By 4/14 symptoms lessened. Still feeling queasy in the stomach and weak. Headache in the afternoon around 3:45 pm after waking up from a 30 min nap.
51 2021-04-13 sleep disorder, loss of personal independence in daily activities My shoulders and hips became so stiff and painful that I could not sleep. It was difficult to comple... Read more
My shoulders and hips became so stiff and painful that I could not sleep. It was difficult to complete normal duties. The soreness lasted a five days, and then tapered off. I have not had any issues once the pain left.
51 2021-04-14 amnesia Dizziness, Nausea, lost feeling in legs, unable to use muscle in left leg for about 4 hours, weaknes... Read more
Dizziness, Nausea, lost feeling in legs, unable to use muscle in left leg for about 4 hours, weakness, headache, brief loss of memory.
51 2021-04-14 feeling abnormal, sleep disorder * MAR 8th = Vaccine shot * MAR 15th = alleged "sore throat" * MAR 19th = watery eyes; dry eyes; tir... Read more
* MAR 8th = Vaccine shot * MAR 15th = alleged "sore throat" * MAR 19th = watery eyes; dry eyes; tired eyes. Onset of right eye not blinking/closing. * MAR 21st = Emergency Room. Diagnosed w/ BELLS PALSY. [Ruled out stroke] The following week after my vaccination (approximately MAR 15th), I experienced a strange feeling at the back of my throat. It can best described as a "sore throat". I noticed it upon waking up. I could feel it at the back of my throat when swallowing; the act of swallowing would enable me to "feel" the sensation at the back of my throat. This was unusual and not normal for me. I thought I was coming down with a cold virus. I had not been sick for over a year and thought it was a strange feeling. I was concerned. With the recent schools, restaurants, and gyms opening up with less restrictions, I learned from coworkers that there was an increase of illnesses because our immune systems are not as strong and germs are easily transferable during the usual interactions. Therefore, I expected my sore throat to be the start of a harmless cold virus. Then, later in the week (MAR 19th), I noticed my eyes were abnormally dripping tears. It is my experience that I get this effect in the office setting or during winter when my eyes are "dry". However, I was neither in the workplace (office), nor was it winter. I was not sure why my eyes had excessive tears coming out. Finally, on SUN (MAR 21st), an obvious physical symptom finally became apparent to me and my family members. My speech was impaired. I could not chew properly. I could not drink from a cup. I struggled during breakfast. I was not sure if I was having a STROKE. I recited the alphabet to hear for a slurred speech. I looked in the mirror, and my smile was not perfect. I got dressed and went to the Emergency Room. The doctors performed physical PUSH-PULL tests, eye tests, etc. DIAGNOSIS = Bells Palsy. OTHER SYMPTOMS = + shortness of breath. + leg swelling. + headaches. + excruciating pain in the neck, especially during sleep (laying down).
51 2021-04-14 feeling abnormal FEVER, CHILLS, SEVERE BODY ACHES, FOGGINESS/ PALMS OF HANDS HURT AND STILL HURTING
51 2021-04-14 feeling abnormal Within first 30 minutes was experiencing body and face swelling and shortness of breath. Within firs... Read more
Within first 30 minutes was experiencing body and face swelling and shortness of breath. Within first 3-4 hours had bad rash on arms, legs, face, neck and chest, fast heartrate, breathing and out of it sensation. I felt like I was having a partial analpylaxis reaction - like throat 1/2 closed but that I would be ok. I took Benadryl and used a Ventolin inhaler. Rash was better by 2nd day. On 2nd and 3rd day I was having massive headache (felt like pressure from inside all over out to all cranial sutures), severe neck stiffness on rt side, lumbar vertebrate pain, iliosacral and hip pain, felt painful radiating spasms down my left and right legs, also jaw and teeth pain. Taking Naproxen and now ASA. Very shakey and jittery. Occasionally have lower arm pain and numbness on left side. Also have injection site symptoms but minor compared to above. It's been 1 week and allergic part of rxn is over but concerned with possible neuro and bloodclot possibilties.. On day 2 or 3 I also had problems with my brain with reading comprahension.
51 2021-04-14 sleep disorder Right after the dose I got an immediate headache, dizzy and light headed. About an hour later I beca... Read more
Right after the dose I got an immediate headache, dizzy and light headed. About an hour later I became nauseous and my face became very flush red and hot. I went to bed and woke up feeling like I got hit by a truck and was very tired with a sore arm. By the next day I was better. The following week I began with a red hot circle on my arm where the shot was given, it had a ring around it. That lasted for about a week. I then started to get stinging sensations in that part of my arm like I was being stung by a bee. These lasted for about 2 days. I then started getting muscle rolls/spasms in the same spot on that arm. They lasted about 3 days. I then started having pain in that arm like I had just gotten the shot and as I was rubbing it, I noticed a large indent in my arm. I went to the doctor, and they said they had no idea why it happened but if I get more symptoms to come back. The doc appt was on 4/12/21. It has been over a month of these side effects. Doctor not sure if it will be a permanent disfigure.
51 2021-04-15 confusional state, memory impairment Received dose on Friday 4.9.21. Called on 4.16.21 to report symptoms / ADR experienced on Monday 4.... Read more
Received dose on Friday 4.9.21. Called on 4.16.21 to report symptoms / ADR experienced on Monday 4.12.21. Monday -3 days after receiving J and J vaccine - patient reported forgetfulness altered consciousness. Does not remember driving home and then backing in drove all over lawn and hit the house and gate. Symptoms: Pt received Johnson and Johnson COVID vaccine 4/9. States symptoms started 4/12 with chest pain. States she drove all over the lawn and hit house/gate. Pt states this is very unusual for her. Felt very "out of sorts" for an hour and a half and also doesn't remember the whole ride home. Since then she feels fine and is currently having no other symptoms. No other episodes of memory loss or strange behavior since Monday 4/12. Called and spoke with pt. She denies symptoms since the incident on 4/12. I advised she can monitor at home and schedule an appointment or seek care in UCC/ED if symptoms return. Pt was agreeable to this.
51 2021-04-15 feeling abnormal I was starting to feel a little off in thirty minutes and about 9 PM that night I had body aches. My... Read more
I was starting to feel a little off in thirty minutes and about 9 PM that night I had body aches. My body and joints hurt and really really tired. Those lasted until Sunday at 09:00. It just abruptly stopped. I woke up with rash all over my face and itchy and swollen eyes on Saturday and I went to the eye doctor on Saturday. I was given eye drops and and an anti-histamine; That is helping. I am still a little bit itchy on my face but it's better.
51 2021-04-17 amnesia Bad headache developed on April 8th at 11 AM. By 2:30, needed to sleep. Unconscious for 3 and 1/2... Read more
Bad headache developed on April 8th at 11 AM. By 2:30, needed to sleep. Unconscious for 3 and 1/2 days. I have no recollection of any of this time. I?m only listening to what have told by the medical field and my family. My husband started calling MEDICAL CENTER Friday morning and A called the helicopter by Friday afternoon at three. They were ruling out a stroke. By the time they landed the helicopter they knew it was not a stroke and started doing testing like CAT scans , lumbar punctures. From what I?ve been told they ran four antibiotics IVs. I remember waking up Sunday morning and someone was sitting in the chair next to me and all I kept saying was that I was hungry. The lady started crying and said that I had been unconscious. She tried to tell me who I was and that I was something called married and that I had children. She tried to explain what had happened but I wasn?t able to comprehend. I didn?t know what it meant that I lived on a farm or that I had animals. Or that we had a vet practice. I remember medical people asking me who I was and what the date was and if I remember how I got there and all I could do was smile. It?s like the words just would not come. And they diagnosed it as an cephalitis over the next couple days. Where the brain swells up and you have memory loss and I had a high fever. I had a lot of nausea after they put me on oral anabiotic?s. I kept hearing from nurse reports that I had almost died. These were hard things to here. I?m forever thankful for all the people that have gone before me for doing the drug trials. I am a energetic lady and I?m slowly getting back to myself. I feel very thankful for the great care at the medical center. I appreciate everything that you do every day. I would not recommend getting vaccinated with this drug. I am one of the healthiest people that I know. No I can?t believe this is happened to me. I take good care and eat healthy and have no bad habits. I meditate and pray and have a joy filled life.
51 2021-04-17 insomnia 24 hour headache Painful joints for about 2 days Fatigue about 2 days Insomnia for two nights Took ... Read more
24 hour headache Painful joints for about 2 days Fatigue about 2 days Insomnia for two nights Took Tylenol and that helped a bit
51 2021-04-17 nervousness FLARE UP; NERVOUS; ACIDIC PH; TINGLING; NUMBNESS; SHAKING; JITTERY; ABNORMAL VITALS; This spontaneou... Read more
FLARE UP; NERVOUS; ACIDIC PH; TINGLING; NUMBNESS; SHAKING; JITTERY; ABNORMAL VITALS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, anxiety, seasonal allergies, social drinker, and smoker, and other pre-existing medical conditions included patient takes allergy shots for her seasonal allergies. no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068JJ and expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Right Arm for prophylactic vaccination. Concomitant medications included bupropion for anxiety, and depression, azithromycin for seasonal allergies, cetirizine hydrochloride for seasonal allergies, and montelukast sodium for seasonal allergies. On 07-MAR-2021, the subject experienced tingling. On 07-MAR-2021, the subject experienced numbness. On 07-MAR-2021, the subject experienced shaking. On 07-MAR-2021, the subject experienced jittery. On 07-MAR-2021, the subject experienced abnormal vitals. Laboratory data included: Blood pressure (NR: not provided) 170/110 mmHg, Heart rate (NR: not provided) 106 bpm, and Pulse rate (NR: not provided) 80-90 bpm. On 08-MAR-2021, the subject experienced flare up. On 08-MAR-2021, the subject experienced nervous. On 08-MAR-2021, the subject experienced acidic ph. Laboratory data included: Blood pressure (NR: not provided) 136/97 mmHg, 154/92 mmHg, 114/75 mmHg, 114/75 mmHg, Heart rate (NR: not provided) 80 bpm, 110 bpm, 129 bpm, and (NR: not provided) Acidic pH level. Treatment medications (dates unspecified) included: lorazepam. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abnormal vitals on 08-MAR-2021, was recovering from numbness, jittery, flare up, and nervous, had not recovered from tingling, and shaking, and the outcome of acidic ph was not reported. This report was non-serious.
51 2021-04-17 suicidal thoughts Extreme fatigue, chills, aches, headache, nausea, every bone hurt, suicidal ideations
51 2021-04-19 anxiety Patient experienced shortness of breath and anxiety post vaccination, recovered and released.
51 2021-04-19 feeling abnormal FEELING BAD; BODY WAS HURTING; LOSS OF ENERGY; HEADACHE; GETTING A COLD; DRY MOUTH; DIARRHEA; This s... Read more
FEELING BAD; BODY WAS HURTING; LOSS OF ENERGY; HEADACHE; GETTING A COLD; DRY MOUTH; DIARRHEA; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dry mouth. On 2021, the subject experienced diarrhea. On 2021, the subject experienced body was hurting. On 2021, the subject experienced loss of energy. On 2021, the subject experienced headache. On 2021, the subject experienced getting a cold. On 10-APR-2021, the subject experienced feeling bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dry mouth, and feeling bad, and the outcome of diarrhea, body was hurting, headache, loss of energy and getting a cold was not reported. This report was non-serious.
51 2021-04-20 confusional state confusion, intense headache, nausea for 13 days of this,
51 2021-04-20 feeling drunk, motion sickness Within 6 hours after the vaccination, I experienced significant chills, then high fever, then body a... Read more
Within 6 hours after the vaccination, I experienced significant chills, then high fever, then body aches, then intense nausea. These symptoms were as expected and seemed to subside within 48 hours. However, the nausea did not subside and for the following 2 weeks, I experienced significant 'waves' of nausea brought on by various factors such as car/plane (motion sickness), sun exposure (75 degrees on a beach for 20 minutes), various foods, etc. Approximately one week after the vaccination, I had several glasses of red wine (4 glasses within an 8 hour time period). I am not a big drinker, so this amount caused me to feel intoxicated but not enough to be completely inebriated. I slept for 6 hours and woke up feeling 'drunk'- extremely dizzy and nauseous. I proceeded to vomit non-stop (approximately 7 times) over the following 6 hours and could not get the nausea under control. In fact, I had to have a physician prescribe Zofran to stop the dizziness and nausea or else I was going to need fluids administered. This is extremely unusual for me. It felt like the nausea I had been feeling from the vaccine had somehow been intensified 10-fold because of the wine. The Zofran helped immensely however, the nausea (slight at this point- back down to what it was prior to the alcohol episode) continued to persist for another two weeks and a half weeks. A few days ago, it felt like I 'turned the corner'. I am now three weeks out from the vaccination and the nausea is almost gone (90% gone).
51 2021-04-20 sleep disorder Reported adverse effects to J&J after a horrible day/night from severe allergic reaction. We were 5 ... Read more
Reported adverse effects to J&J after a horrible day/night from severe allergic reaction. We were 5 hrs from home, on a weekend, could not get vaccines in our county. Drove to County. After the 15 min when walking out of the building noticed strong metallic taste in mouth (no fillings), thought odd. Then while driving noticed red blemishes/rash on neck, swelling of my tongue. Once arrived at hotel (too far to drive back home and not feeling well), noticed red rash on front of neck, ear lobes bright red, hot to the touch and swollen. Vertigo and low fever came on along with elevated heart rate. These lasted all Saturday into Sunday. Didn't and couldn't sleep Saturday night, Sunday morning rash on face with heart rate BPM elevated all day with fever and bad vertigo. All these symptoms continued all week with exception to the rash and swollen tongue those subsided late Sunday. The vertigo, fevers, skin sensitivity and complete fatigue along with bump at injection site persisted even to today.
51 2021-04-21 poor quality sleep METALLIC TASTE; SWELLING OF TONGUE; SWELLING; RED BLEMISHES AROUND EAR; BODY ACHE; DIZZINESS; RASH/M... Read more
METALLIC TASTE; SWELLING OF TONGUE; SWELLING; RED BLEMISHES AROUND EAR; BODY ACHE; DIZZINESS; RASH/MOSQUITO TYPE RED DOT UNDER LEFT EYE AND LEFT EARLOBE; LARGE RED SPOT ON NECK, ALMOST LIKE HIVES; WEAKNESS; FEVER; HEADACHE; INCREASED HEART RATE; SLEPT ONLY 3 HOURS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included hernia surgery, and smoker, and concurrent conditions included seasonal asthma, heart palpitations, overweight, and metallic taste reaction with contrast dyes use with scans. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced slept only 3 hours. Laboratory data included: Heart rate (NR: not provided) 118-120. On 10-APR-2021, the subject experienced increased heart rate. On 10-APR-2021, the subject experienced metallic taste. On 10-APR-2021, the subject experienced swelling of tongue. On 10-APR-2021, the subject experienced swelling. On 10-APR-2021, the subject experienced red blemishes around ear. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced rash/mosquito type red dot under left eye and left earlobe. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced large red spot on neck, almost like hives. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 98.9. On 11-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste, swelling of tongue, and swelling on 10-APR-2021, and dizziness, and weakness on APR-2021, was recovering from rash/mosquito type red dot under left eye and left earlobe, and large red spot on neck, almost like hives, had not recovered from red blemishes around ear, fever, headache, body ache, and increased heart rate, and the outcome of slept only 3 hours was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
51 2021-04-22 feeling abnormal DRY MOUTH; NO ENERGY; SEVERE PAIN IN RIGHT LEG; HEADACHE; FEELING LIKE BODY TORN APART; WHOLE BODY N... Read more
DRY MOUTH; NO ENERGY; SEVERE PAIN IN RIGHT LEG; HEADACHE; FEELING LIKE BODY TORN APART; WHOLE BODY NUMB/NUMBNESS TO RIGHT LEG, FACE, RIGHT ARM/HAND/EAR; WHOLE BODY PAIN; COUGH; HOLDING FLUID; BUTTOCKS BURNING HEAVY; LOSS OF SENSATION; LACK OF SALIVA; LIPS DRY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included mucous in chest, and cough, and concurrent conditions included hyperlipidemia, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205821A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feeling like body torn apart. On APR-2021, the subject experienced whole body numb/numbness to right leg, face, right arm/hand/ear. On APR-2021, the subject experienced whole body pain. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced holding fluid. On APR-2021, the subject experienced buttocks burning heavy. On APR-2021, the subject experienced loss of sensation. On APR-2021, the subject experienced lack of saliva. On APR-2021, the subject experienced lips dry. On APR-2021, the subject experienced severe pain in right leg. On APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced dry mouth. On 11-APR-2021, the subject experienced no energy. On 13-APR-2021, Laboratory data included: PCR (NR: not provided) NEGATIVE. Treatment medications (dates unspecified) included: furosemide/potassium chloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no energy, dry mouth, and whole body numb/numbness to right leg, face, right arm/hand/ear, and the outcome of feeling like body torn apart, whole body pain, cough, holding fluid, severe pain in right leg, buttocks burning heavy, loss of sensation, headache, lack of saliva and lips dry was not reported. This report was non-serious.
51 2021-04-22 loss of personal independence in daily activities I had severe leg cramps 1.5 days after vaccination. Then, the morning of the 2nd day after vaccinati... Read more
I had severe leg cramps 1.5 days after vaccination. Then, the morning of the 2nd day after vaccination, I was so tired I couldn't get out of bed all day (didn't get up until 6:30 pm). That evening though, I felt totally fine & have been fine ever since.
51 2021-04-22 sleep disorder, nightmare SLEEPING PROBLEM; TINNITUS; MUSCLE ACHES; NAUSEA; FATIGUE; HEADACHES; NIGHTMARES; MOVEMENTS REDUCED;... Read more
SLEEPING PROBLEM; TINNITUS; MUSCLE ACHES; NAUSEA; FATIGUE; HEADACHES; NIGHTMARES; MOVEMENTS REDUCED; WEIGHT LOSS; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 140 pounds, and height was 69 inches. The patient's concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid for drug used for unknown indication, and ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for drug used for unknown indication. On APR-2021, the subject experienced weight loss. On 07-APR-2021, the subject experienced nightmares. On 07-APR-2021, the subject experienced movements reduced. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced headaches. On 18-APR-2021, the subject experienced sleeping problem. On 18-APR-2021, the subject experienced tinnitus. Treatment medications included: cannabinoids nos/cannabis sativa. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares on 07-APR-2021, had not recovered from headaches, fatigue, nausea, muscle aches, movements reduced, and tinnitus, and the outcome of weight loss and sleeping problem was not reported. This report was non-serious.
51 2021-04-26 sleep disorder, crying, nervousness By 6pm I noticed something wasn?t right. I could t get warm, even when sitting in the sunshine. By 9... Read more
By 6pm I noticed something wasn?t right. I could t get warm, even when sitting in the sunshine. By 9pm the chills had turned to fever. My temperature at 9pm was 101.2F. I also had a headache and started to feel a bit shaky. By 10pm I had body aches and was in bed with 3 blankets on me and still could not get warm. My temp was 102.7 at 10pm. I tried to sleep. At midnight I awoke to a fever of 104.8 and could only cry. The worst body aches, headache, racing heart and dizziness, nausea and vomiting (after additional aspirin were taken to relieve the fever). I was very weak in an alarmingly rapid period. I stayed in this condition until approximately 6:30am on 4/26. At 7am my temp was 102.5 and I found it hard to make it back and forth to the bathroom, due to dizziness and weakness. By noon, the temp was back up to 103.1 and I could barely cry, as I suspected I was then close to dehydration. I focused on hydration and slept as much as possible. The fever slowly came down to its current 100.4 at 11pm on 4/27. This has been an alarming reaction to a vaccine. I have had serum sickness previously, so maybe that is a factor that should also be considered. I hope this is helpful.
51 2021-04-27 feeling abnormal, insomnia Severe chills - whole body shaking, severe nausea, could not sleep, and fatigue, for three hours str... Read more
Severe chills - whole body shaking, severe nausea, could not sleep, and fatigue, for three hours straight. Could not sleep the first night. Night sweats for the next two nights. Foggy brain and spacey for the next four days.
51 2021-04-29 feeling abnormal Fevers chills big lump under left arm small bump still present felt like something was going on with... Read more
Fevers chills big lump under left arm small bump still present felt like something was going on with brain wasn't a headache. For like 3 days didnt feel like my self stomach was aching for a day
51 2021-04-29 loss of personal independence in daily activities Sore Arm beginning the moment patient received vaccine. Pain never improved. 3 weeks after receivi... Read more
Sore Arm beginning the moment patient received vaccine. Pain never improved. 3 weeks after receiving vaccine, pain worsened. Pain is currently at 7 (on a scale of 1-10). Patient experiences pain when trying to reach above her shoulder. Unable to wash hair, difficulty putting on clothing.
51 2021-05-02 sleep disorder 4/6/2021 vaccination 4/7/2021 body aches and chills 4/8/2021 That morning, I woke up because I had R... Read more
4/6/2021 vaccination 4/7/2021 body aches and chills 4/8/2021 That morning, I woke up because I had R side of my face, in my teeth; Trigeminal Neuralgia. Lasted for several hours. I found some codeine in medicine cabinet to help with pain and I could go back to sleep. It was achy on that side my face, throbbing for 48 hours. It tapered off by that Saturday 4/10/2021 4/16/2021 I started having tingling in my face again. Largely numb on R side of my face and low ache. Lasted till presently and still presenting but not as persistent; 2 weeks. Constant ache but not sharp as it had been at the beginning. The numbness went from my ear to my nose 4/23/2021. I went to urgent care. They confirmed it was Trigeminal Neuralgia. Dr. ordered blood test and referral to see a neurologist. *Appt with NEW PCP 05/14/2021 telehealth **still waiting on appt with neurologist
51 2021-05-13 anxiety She got her vaccine, she felt the burning sensation all the way down to her fingers and her wrist. ... Read more
She got her vaccine, she felt the burning sensation all the way down to her fingers and her wrist. I proceeded to go forward and wait the 15 minutes. She then started to have pain in the side of her neck on the right side, discomfort and pain in her arm. Within the hour she started to have headaches (has had COVID in the past). She went home and it was a nagging pain in her arm, not at the site but the whole arm was sore and limited using the arm due to the discomfort. That night is when she came on the news and started that the vaccine was being pulled from administration. That night it was like a pulling sensation right in her upper arm, up near the armpit and the fatty tissue from the breast and where you raise your arm. When she started noticing the discoloration started in her skin. Her hands started getting black, under both arms were black, the back of her legs was black, and she started feeling worsening fatigue. She started getting worried and was looking at how her veins turned purple blue/green just in the one arm. She was trying to figure out why she had limited use of her arm, and was holding it as if she had a sling on it as when it hung to her side it had the pulling sensation and a crawling sensation in her veins (that night and going into the next day). The next morning she was so exhausted and tired, as was her mother who had the vaccine at the same time, and was not feeling well. She was feeling that possibly due to the fibromyalgia she was have worsening symptoms than her mother. She then started bruises on her body, on the arm itself as if somebody grabbed and squeezed her arm, purplish/black bruising. It had her forearm develop 3 large pockets of swollen, almost as if the medicine was sitting in her arm. She was slowly getting the pulling sensation down to her hand, and she called the UC first and due to the high volume of COVID she wanted to know how long of a wait she would have. They instructed her to go to the ER due to the development of the blood clots on the news. There was no change in her symptoms, and got to the point that she could not move her arm, and the knots stayed in there and there was a reddish discoloration around them. Now she was having a pulling sensation in her chest and palpitations of pain near her heart. She was having soreness in her legs to the point that she was not able to walk, and felt it was in her nerves 3 days after the vaccine. She stayed in the bed the entire week just due to the exhaustion and effects. Every time she would go to reach for something she would have the pulling sensation down to her hand, and the entire arm was swollen with the bruising all over. Her body started having purple and blue knots and also in the left leg. Her arm and fingers were swollen as well. She then started having itching of her arm, and her lips started swelling and got up and went to Hospital and was able to be seen. She was having problems with her stomach as well, having a knot in the stomach where it was protruding and started loosing weight since the vaccine. The ER doctor told her she had a reaction to the vaccine, and did a Doppler to see if she had blood clots. They did not give her the results and didn't feel that she didn't have problems. She also went to the UC and back and forth to the ER, and still had the knots and finally looked at the knots and her jaw was swollen, and her arm was still swollen. The UC told her that she was having a fibromyalgia flare. She is still having the same symptoms green/blue and have started protruding. Due to the fatigue she has mainly just stayed in bed and knew that she was to have COVID symptoms, but knows that the crawling sensation and the knots sitting in her arm, and now her arm looks disfigured and the swelling is not going down. They told her that the test was negative for the blood clots. She had made an appointment with her neurologist and has an APT on Tuesday 5/25/21. She continues to loose weight no matter how much she consumes and still continues to have the knots and pain in the arm.
51 2021-05-18 feeling abnormal BRAIN FOG; D-DIMER OF 32; STRONG HEADACHE; This spontaneous report received from a consumer concerne... Read more
BRAIN FOG; D-DIMER OF 32; STRONG HEADACHE; This spontaneous report received from a consumer concerned a 51 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced elevated d-dimer, brain fog, and strong headache. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not Reported, and Fibrin D dimer high (NR: not provided) 32. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the strong headache, brain fog and elevated d-dimer was not reported. This report was non-serious.
51 2021-06-07 insomnia CANNOT MOVE HANDS WITHOUT PAIN, PAIN IN FEET AND LEG; NUMBNESS TONGUE AND WHOLE MOUTH; FLAVOR OF ANE... Read more
CANNOT MOVE HANDS WITHOUT PAIN, PAIN IN FEET AND LEG; NUMBNESS TONGUE AND WHOLE MOUTH; FLAVOR OF ANESTHESIA IN MOUTH; FACE AND CHEST GOT RED; VEINS IN HANDS SWOLLEN AND IN ARMS TO ELBOW SWOLLEN; LOT OF PAIN; CANNOT WALK WITHOUT PAIN; PAIN BEHIND KNEES; PAIN IN VEINS IN LEGS; UNABLE TO SLEEP; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included scleroderma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included prednisone for scleroderma. On 2021, the subject experienced pain in veins in legs. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced cannot walk without pain. On 2021, the subject experienced pain behind knees. On APR-2021, the subject experienced veins in hands swollen and in arms to elbow swollen. On APR-2021, the subject experienced lot of pain. On 01-APR-2021, the subject experienced numbness tongue and whole mouth. On 01-APR-2021, the subject experienced flavor of anesthesia in mouth. On 01-APR-2021, the subject experienced face and chest got red. On MAY-2021, the subject experienced cannot move hands without pain, pain in feet and leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness tongue and whole mouth, flavor of anesthesia in mouth, and face and chest got red on 05-APR-2021, and had not recovered from veins in hands swollen and in arms to elbow swollen, cannot move hands without pain, pain in feet and leg, pain in veins in legs, pain behind knees, unable to sleep, cannot walk without pain, and lot of pain. This report was non-serious.
51 2021-06-13 disturbance in attention Following vaccination patient developed symptoms of extreme fatigue, body aches/chills for 3 days. A... Read more
Following vaccination patient developed symptoms of extreme fatigue, body aches/chills for 3 days. After day 3 she developed dizziness/vertigo, extreme headaches with intermittent blurred vision and difficulty focusing. She was seen in office by this provider 6/4/21 and labs ordered to rule out blood clot. She was seen again 6/14/21 and is feeling somewhat improved but has developed significant abdominal pain with nausea. She has been treated with observation and hydration. Declined medication.
51 2021-06-13 sleep disorder Initial reaction within the hour, dizziness. 6.5 hours later, heart pounding so hard that it woke m... Read more
Initial reaction within the hour, dizziness. 6.5 hours later, heart pounding so hard that it woke me up from a sound sleep. Erratic heart beating for 30 hours and residual effects for 2 weeks. Palpitations, skipping beats. In addition, the first 30 hours included Hugh fever, sweats, chills, shivering. Dizziness, ears ringing, head noises, shortness of breath, exhaustion.
51 2021-06-14 abnormal dreams, feeling abnormal FELT LIKE IMMUNE SYSTEM TAXED; COLD SORE; LARGE SCABS ON NOSE; TIRED; EXTREMELY HEAVY PERIOD; DIARRH... Read more
FELT LIKE IMMUNE SYSTEM TAXED; COLD SORE; LARGE SCABS ON NOSE; TIRED; EXTREMELY HEAVY PERIOD; DIARRHEA/ STOOL WAS LIQUID; CLAMMINESS; SHORTNESS OF BREATH; FEVER; STOMACH PAIN; NAUSEA; AREA BELOW EYES ALL THE WAY DOWN TO HER CHEST BECAME NUMB; GENERALLY UNWELL; HEART SLOWED DOWN; EXTREME DROWSINESS; SPEECH SLOWED DOWN; ITCHINESS SPREAD TO THE ENTIRE BODY/ ITCHINESS IN HER EYES AND NOSE; NIGHT SWEATS; WEIRD DREAMS; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 175 pounds, and height was 69 inches. The patient's concurrent conditions included allergic to cats, allergic to pollen, alcohol use, and cigarette smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. the patient was healthy and not pregnant at the time of the reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced heart slowed down. On 06-MAY-2021, the subject experienced extreme drowsiness. On 06-MAY-2021, the subject experienced speech slowed down. On 06-MAY-2021, the subject experienced itchiness spread to the entire body/ itchiness in her eyes and nose. On 06-MAY-2021, the subject experienced night sweats. On 06-MAY-2021, the subject experienced weird dreams. On 06-MAY-2021, the subject experienced area below eyes all the way down to her chest became numb. On 06-MAY-2021, the subject experienced generally unwell. On 07-MAY-2021, the subject experienced stomach pain. On 07-MAY-2021, the subject experienced nausea. On 07-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101-102 F, and Pain scale (NR: not provided) 8/10 (unit not reported). On 10-MAY-2021, the subject experienced clamminess. On 10-MAY-2021, the subject experienced shortness of breath. On 10-MAY-2021, the subject experienced diarrhea/ stool was liquid. Laboratory data included: Body temperature (NR: not provided) 99 -100 F. On 11-MAY-2021, the subject experienced extremely heavy period. On 12-MAY-2021, the subject experienced tired. On 03-JUN-2021, the subject experienced cold sore. On 03-JUN-2021, the subject experienced large scabs on nose. On an unspecified date, the subject experienced felt like immune system taxed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme drowsiness, and area below eyes all the way down to her chest became numb on 06-MAY-2021, itchiness spread to the entire body/ itchiness in her eyes and nose on 07-MAY-2021, weird dreams, and diarrhea/ stool was liquid on 14-MAY-2021, stomach pain on 08-MAY-2021, clamminess, shortness of breath, and nausea on 12-MAY-2021, and tired on 17-MAY-2021, was recovering from fever, cold sore, large scabs on nose, and felt like immune system taxed, had not recovered from night sweats, and generally unwell, and the outcome of extremely heavy period, heart slowed down and speech slowed down was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
51 2021-06-25 depressed mood PAIN IN LEFT ARMPIT THAT RADIATES TO HER LEFT BREAST; FEELING DOWN; FEVER; PAIN AT THE INJECTION SIT... Read more
PAIN IN LEFT ARMPIT THAT RADIATES TO HER LEFT BREAST; FEELING DOWN; FEVER; PAIN AT THE INJECTION SITE; HEADACHE; MUSCLES ACHES; This spontaneous report received from a patient concerned a 51 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: 1805025 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced feeling down. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced pain at the injection site. On 31-MAR-2021, the subject experienced headache. On 31-MAR-2021, the subject experienced muscles aches. On 14-APR-2021, the subject experienced pain in left armpit that radiates to her left breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling down, fever, headache, and muscles aches on 02-APR-2021, and pain at the injection site on APR-2021, and had not recovered from pain in left armpit that radiates to her left breast. This report was non-serious.
51 2021-07-04 feeling abnormal Extreme fatigue, foggy brain, headache, stiff joints, achey muscles,
51 2021-07-07 feeling abnormal Around the first week of May I was experiencing a stuffy nose. Around the middle of May I felt like ... Read more
Around the first week of May I was experiencing a stuffy nose. Around the middle of May I felt like it had moved to my throat and something was gagging me. I went to Urgent Care and they tested me for strep. They gave me steroids and a Z-pack. The steroid was injectable. The next morning you feeling okay, but in the evening I went back to Urgent Care because it felt bad again. They gave me 3 more days of prednisone, 20 mg per day. One week later I went to my GP. There was a rash on my neck and my doctor gave me 10 days of Bactrim. On the last day of the medicine, I developed a painful sinus headache. I went back to see my GP 2 days later and they treated me for the sinus pressure/headache. They gave me a prescription for 5 days of another antibiotic. I went back a week later and they stopped giving me antibiotics because it had been 20 days. They told me to get over the counter nose spray and told me to clean my nose with saline. Last week I went to an ENT. They told me to continue with the saline and the nose spray.
51 2021-07-18 emotional distress HEAD TREMORS; BLURRED VISION; CONSTANT MUSCLE FAILURE; FLU-LIKE SYMPTOMS; SEVERE MUSCLE WEAKNESS; IN... Read more
HEAD TREMORS; BLURRED VISION; CONSTANT MUSCLE FAILURE; FLU-LIKE SYMPTOMS; SEVERE MUSCLE WEAKNESS; INJECTION SITE SORENESS; WEAKNESS, NO ENERGY, NO STRENGTH; EMOTIONALLY DEGRADING; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, 1 pack per day medical marijuana a joint per day for pain, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: 15-SEP-2021) dose was not reported, administered on 03-JUL-2021 11:00:00 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced emotionally degrading. On 04-JUL-2021, the subject experienced head tremors. On 04-JUL-2021, the subject experienced blurred vision. On 04-JUL-2021, the subject experienced constant muscle failure. On 04-JUL-2021, the subject experienced flu-like symptoms. On 04-JUL-2021, the subject experienced severe muscle weakness. On 04-JUL-2021, the subject experienced injection site soreness. On 04-JUL-2021, the subject experienced weakness, no energy, no strength. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and weakness, no energy, no strength on 06-JUL-2021, had not recovered from injection site soreness, severe muscle weakness, head tremors, blurred vision, and constant muscle failure, and the outcome of emotionally degrading was not reported. This report was non-serious.
51 2021-07-18 sleep disorder When the vaccine was administered when the needle entered the arm she felt pain immediately. When t... Read more
When the vaccine was administered when the needle entered the arm she felt pain immediately. When the vaccine was administered it had a burning feeling. That eventually resolved and then the muscle became sore. The soreness has continued to come and go over the past two months and changes in intensity. It sometimes will disturb her sleep. It is sore to the touch. Sometimes the pain will go down her arm. Range of motion is good except for if she is reaching up and trying to get something heavy off of a shelf she will have pain. This has lasted for the past two months and she has become concerned.
51 2021-07-21 feeling abnormal throughout the day of April 29, 2021 I started get tingling on my lips, and my right side of my face... Read more
throughout the day of April 29, 2021 I started get tingling on my lips, and my right side of my face was feeling different in a weird way ... once I left work at 5 pm, I went straight home and by then, the right side of my lip was drooping since I was not sure of what was happening to me, my husband took me to the hospital where they treatment me with possible stroke. After all test had be performed, the outcome was that I had a case of bell's palsy on the right side of the face.
51 2021-07-27 feeling abnormal PERIOD NOT AS HEAVY AS NORMAL; SPOTTING CONTINUED FOR 3 WEEKS; LOW BODY TEMPERATURE; DOES NOT FEEL N... Read more
PERIOD NOT AS HEAVY AS NORMAL; SPOTTING CONTINUED FOR 3 WEEKS; LOW BODY TEMPERATURE; DOES NOT FEEL NORMAL OR RIGHT; SWELLING IN LEGS AND FEET; DID NOT FEEL GREAT; FELT FEVERISH; HEAVY MENSTRUAL BLEEDING FOR 2.5 WEEKS; WATER RETENTION IN LEGS AND FEET DAILY; WEIRD BLOATING; PERIOD (BLOOD VOLUME) UP AND DOWN; 28 TO 30-DAY CYCLE ERRATIC, PERIOD WOULD START AND STOP AND MONTHLY CYCLES THROWN OFF; DID NOT HAVE A PERIOD AND PERIOD STOPPED; ANAPHYLAXIS REACTION; HEAD AND NECK NUMB; IV INFILTRATED; RED ARM; SWOLLEN ARM; FATIGUE; This spontaneous report received from a patient concerned a 51 year old white female of not hispanic or latino ethnicity. The patient's weight was 179 pounds, and height was 64 inches. The patient's past medical history included 28 to 30-day menstruation cycles with heavy bleeding for the first 4 days then tapers off, water retention, and swelling, and concurrent conditions included daily over the conter medication allergy, allergy related to asthma, flu shot has similar sore arm, bees allergy, dust mites allergy, cats allergy, dogs allergy, alcohol drinker (occasionally, special occasions, 2 per month), and non smoker, and other pre-existing medical conditions included patient had no menstruation changes since 13 years. patient was uses medications prn and patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced anaphylaxis reaction. Before the needle got out of the patient's arm the patient experienced hives on wrist and arm on the same arm used for vaccination after that the patient's throat began to close. On the same day the patient head and neck numb. Patient further described that it was not numbness but rather the blocked of oxygen due to her throat swelling. Soon after patient was taken to the emergency room through ambulance and treated her with diphenhydramine hydrochloride, epinephrine, and prednisone. Patient experienced iv infiltrated while in the ambulance ride. Patient remained in the emergency room for the protocol specified number of hours for monitoring. Patient had electrocardiogram (NR: not provided) Normal. Patient got released from hospital the same day when stable and normalized. On10-APR-2021, the patient experienced common vaccine reaction of a red and swollen arm, the patient did not have a period and period stopped and patient experienced fatigue. On MAY-2021, the patient experienced 28 to 30-day cycle erratic and period would start and stop and monthly cycles thrown off. On JUN-2021, the patient experienced spotting, water retention in legs and feet daily, weird bloating and period (blood volume) up and down. On JUL-2021, the patient experienced heavy menstrual bleeding for 2.5 weeks. On an unspecified date, the patient experienced low body temperature. period not as heavy as normal, spotting continued for 3 weeks, more menstrual bleeding, extensive time frame for period, does not feel normal or right, swelling in legs and feet, did not feel great, and felt feverish. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low. Additional treatment medications (dates unspecified) included: hyetellose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylaxis reaction, and head and neck numb on 10-APR-2021, period not as heavy as normal, and weird bloating, and fatigue, and felt feverish on 21-JUN-2021, was recovering from did not have a period and period stopped, 28 to 30-day cycle erratic, period would start and stop and monthly cycles thrown off, water retention in legs and feet daily, and swelling in legs and feet, had not recovered from spotting continued for 3 weeks, and period (blood volume) up and down, and the outcome of iv infiltrated, red arm, did not feel great, low body temperature, heavy menstrual bleeding for 2.5 weeks, does not feel normal or right and swollen arm was not reported. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210757746. .; Sender's Comments: V0: 20210745140- Covid-19 vaccine ad26.cov2.s-Anaphylaxis reaction. This event(s) is labeled per RSI and is therefore considered potentially related.
51 2021-07-29 feeling abnormal WEIRD SPINNING; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION/FEVER/SPLITTING... Read more
WEIRD SPINNING; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION/FEVER/SPLITTING HEADACHE/SINUS PRESSURE/COUGH/CONGESTION/FEELING SICK; FELT ROTTEN AFTER THE SHOT/FELT LIKE BRAIN WAS FLOATING IN HOT WATER; This spontaneous report received from a patient concerned a 51 year old female. Initial information was processed along with the additional information received on 26-JUL-2021 The patient's height, and weight were not reported. The patient's past medical history included Lyme disease, and concurrent conditions included non-smoker, alcohol user (Occasional glass of wine), and penicillin allergy. The patient was not pregnant at the time of reporting. The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 07-AUG-2021) dose was not reported, 1 total administered to left arm on 16-MAY-2021 for prophylactic vaccination. Concomitant medications included vitamins nos. On 16-MAY-2021, after the vaccination, the patient felt rotten for a day and a half but no other side effects. On 23-JUL-2021, the patient started experiencing fever, splitting headache and sinus pressure. On 24-JUL-2021, the patient went to get a rapid covid-19 test and result came as positive to Covid-19 (suspected covid-19 infection and suspected clinical vaccination failure). The patient also had symptoms such as congestion, headache, and cough which was present at the time of reporting. It was reported that, the patient's symptoms were like waves sometimes she felt better then she felt sick. The patient stated that her fever was 99 F and not more than 100 F. The patient also stated that she felt like her brain was floating in hot water and felt weird spinning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt rotten after the shot/felt like brain was floating in hot water on MAY-2021, had not recovered from suspected covid-19 infection/fever/splitting headache/sinus pressure/cough/congestion/feeling sick, and the outcome of suspected clinical vaccination failure and weird spinning was not reported. This report was serious (Other Medically Important Condition). This report was associated with product complaint number 90000187262. The suspected product quality complaint has been confirmed to be not voided (meet PQC) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210755349-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
52 2021-03-07 anxiety Patient reported a tingling sensation in her throat/tongue within 5 mins of receiving vaccine. This ... Read more
Patient reported a tingling sensation in her throat/tongue within 5 mins of receiving vaccine. This lasted for less than 15 minutes. Patient was still able to drink water normally and talk normally. She didn't feel her breathing was affected, although she noted she felt her heart was racing as she was becoming more anxious. No treatment was administered. Patient stayed approx 45 minutes after shot and reported she felt fine at the 45 minute mark and was able to leave.
52 2021-03-10 feeling abnormal Day 1 within 20 minutes difficulty swallowing water felt like my throat was closing up. Subsided af... Read more
Day 1 within 20 minutes difficulty swallowing water felt like my throat was closing up. Subsided after an hour. at 2:00am woke up with sever abdominal pains, diarrhea, body aches, chills and hot flashes. Continued till am of day 3 woke up with just headache and stiff neck. Brain fog was really bad and a litter better today. Eyes are a little fuzzy.
52 2021-03-15 sleep disorder On Friday 03-12-2021, went to wash my face and my whole face was red, flushed and very itchy. I then... Read more
On Friday 03-12-2021, went to wash my face and my whole face was red, flushed and very itchy. I then went to sleep and on Saturday morning when I woke up my right wrist was itching a lot as well as my legs, buttocks and hands. All over my body was red and very itchy. I did not sleep due to the itchiness on Saturday night. I developed little red bumps on my entire body. I ate lentils for food but I do not think it was the food. I went to urgent care and saw a doctor who gave me Benadryl, took one dose and then it slowly started to go away.
52 2021-03-17 hallucination, poor quality sleep Around 8:30pm I had halo in my vision- I took my contacts out and out glasses on it went away shortl... Read more
Around 8:30pm I had halo in my vision- I took my contacts out and out glasses on it went away shortly after that. Around 9:00pm started chills and aching. Around 9:30 headache & arm sore vaccine area All these symptoms lasted through the night., I tossed and turned up getting drinks of water. Woke the next morning with headache & body aches. The chills where gone. Took excedrine headache started to subside still ache & started feeling nauseous. Felt like this most of the day. Slept fine the night of the 17th. Woke 18th feeling very tired but most of the other symptoms gone. Arm still sore from vaccine Hoping tomorrow to feel 100% again.
52 2021-03-17 sleep disorder Patient awoken by joint pain, primarily of hip and knees, progression to wide spread neuralgias, fo... Read more
Patient awoken by joint pain, primarily of hip and knees, progression to wide spread neuralgias, focal kidney pain, temp 99.9 degrees, emesis x 12, loss of appetite, paresthesia of hands and feet, headache and sinus headache (worst headache pain of life, pain scale 9), sinus drainage, photosensitivity, inability to focus eyes to read, extreme fatigue lasting 30 hours. headache and paresthesia unresolved at time of this report. UC worsened.
52 2021-03-22 feeling abnormal Within a few hours of the vaccine I felt tired and a little out of it. I woke at 5:30 the next mor... Read more
Within a few hours of the vaccine I felt tired and a little out of it. I woke at 5:30 the next morning with a fever of 99.9 F, a headache, chills and body aches. These symptoms continued throughout the day and were alleviated somewhat by tylenol. I slept a large part of the day and felt better when I woke the next day, Monday. On Monday I felt mostly normal but still had some body aches including a back ache on my left side. I also had more injection site pain and a red rash about a half dollar in size that was tender to touch and by night time was itchy.
52 2021-03-23 fear I have had tingling feelings all over body for 21/2 weeks now ..... I am very scared and have been t... Read more
I have had tingling feelings all over body for 21/2 weeks now ..... I am very scared and have been to the ER twice and they won?t do a lumbar puncture to check for Gillian Barre because my symptoms aren?t bad enough - I don?t want to wait ! This is Very scary
52 2021-03-24 feeling abnormal fever for 3 days, fatigue, body ache (to be expected)...but on day 3, Monday, March 8th, I had shor... Read more
fever for 3 days, fatigue, body ache (to be expected)...but on day 3, Monday, March 8th, I had shortness of breath, sharp pains, and it felt like my breasts were on fire. I have never experienced anything like it before. It only lasted a few hours, but it was a very strange feeling. I also had waves of fatigue and felt achey on and off for two weeks afterward.
52 2021-03-27 sleep disorder, feeling abnormal Received vaccine at 10am - 20 mins later felt slight prickly itching in both arms between armpit and... Read more
Received vaccine at 10am - 20 mins later felt slight prickly itching in both arms between armpit and elbow. Lasted about 10 minutes. Around 4pm the same day I had bad neck pain. And pounding heading, about 1 hour later starting getting chills and fatigued. By 10pm had body aches and muscles pains. I took some Motrin and went to bed. I couldn?t sleep as my mind kept racing. In the morning (day after vaccine) I was feeling worse. All symptoms continued in full force and I couldn?t get out of bed. 10am I was able to drink some Alka seltzer cold medicine and lay back down. I continued to have chills pounding headache bodyaches muscle aches and sweating, but no fever. I felt like I had a bad case of the flu. I?ve continued taking 600 mg Motrin every eight hours and this has helped with the pains and bodyaches. Day 3 woke up feeling much better, noticed a funny smell in my nose, I haven?t been blowing my nose or had any mucus, but I can?t explain the smell. I still have body aches and muscles pains.
52 2021-03-30 feeling abnormal Within 5 minutes of receiving the vaccine, my heart began racing fast & hard, hyperventilating, out... Read more
Within 5 minutes of receiving the vaccine, my heart began racing fast & hard, hyperventilating, out of breath, uncontrollable full body tremors/shaking, severe brain fog. Lasted for approximately 45 minutes. Got back in my car to leave & it happened again. Second episode lasted about 30 minutes. The brain fog is still with me.
52 2021-04-02 insomnia Sleeplessness, insomnia, fatigue on day 1, severe fatigue the next day, aches, sore arm at injectio... Read more
Sleeplessness, insomnia, fatigue on day 1, severe fatigue the next day, aches, sore arm at injection site
52 2021-04-02 sleep disorder Body aches, tiredness and headache around 7 hours after injection. Then chills shortly after and ina... Read more
Body aches, tiredness and headache around 7 hours after injection. Then chills shortly after and inability to sleep. Around 14 hours after injection chills passed. Fatigue and headache remained for around 32 hours after with headache finally passing after 36 hours.
52 2021-04-05 insomnia Chills, teeth chattering for approximately two hours, then overheated with sweating for another two ... Read more
Chills, teeth chattering for approximately two hours, then overheated with sweating for another two hours, insomnia, fatigue and muscle aches x2 days
52 2021-04-06 feeling abnormal, insomnia HEART RACING; FELT LIKE ADRENALINE RUSH; SKIN TINGLING; GOOSEBUMPS; TROUBLE SLEEPING; LOW ENERGY; Th... Read more
HEART RACING; FELT LIKE ADRENALINE RUSH; SKIN TINGLING; GOOSEBUMPS; TROUBLE SLEEPING; LOW ENERGY; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021, vaccinated to left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021 (Saturday), the patient experienced low energy. On 28-MAR-2021, the subject experienced heart racing and adrenaline was rush. On 28-MAR-2021, the patient also experienced tingling in her skin, goosebumps, trouble sleeping and heart racing. The patient still having these symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low energy on MAR-2021, and had not recovered from felt like adrenaline rush, skin tingling, goosebumps, trouble sleeping, and heart racing. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
52 2021-04-07 anxiety patient was vaccinated at 10:55 by 11:00 was anxious and pacing with tachycardia and sweating. at 1... Read more
patient was vaccinated at 10:55 by 11:00 was anxious and pacing with tachycardia and sweating. at 11:05 patient was given 50mg diphenhydramine in liquid form (20cc) and EMT personnel arrived at 11:15 to evaluate patient. Patient chose to go hospital for evaluation
52 2021-04-08 feeling abnormal Covid shots administered at airport for employees. I received shot, and within a minute or two- my ... Read more
Covid shots administered at airport for employees. I received shot, and within a minute or two- my lips and tongue started to tingle, swell and go numb. My throat started to swell too. Had a hard time starting to breathe and took my xopenex inhaler. I had taken a benadryl beforehand, and ended up taking two more as EMT came over to help me there at the site. She kept an eye on me. My A Fib was speeding up and getting irregular too. After about half an hour, it stopped getting worse and seemed to level off. They offered to take me to ER, and had me promise to call 911 if it got bad again. Still felt bad the rest of the day. Felt a little better later the next day, and a little better (today is day 3), but still not 100%. I did contact my doctor to check in
52 2021-04-08 impaired work ability, nervousness 4/6/21 (2pm) Arm slightly sore after shot. No symptoms at all for 32 hrs. 4/8/21 (3:12am) woke up t... Read more
4/6/21 (2pm) Arm slightly sore after shot. No symptoms at all for 32 hrs. 4/8/21 (3:12am) woke up to use restroom and I felt as though I was spinning. Dizzily staggered to the restroom and back. Laid down and my body felt like it was slowly spinning. At (7:45am) called my employer to work from home. Checked my blood pressure (8am) and it was elevated at 142/96. Throughout the day everytime I stood up I felt like I was dizzy as though I was walking on a moving boat. With the dizziness I felt nauseated. I had diarrhea several times during the day especially within an hour of eating anything. If I bent down I was dizzy. Looking to the left or right dizzy. My dizziness would subside when I was sitting stationary and looking forward. Blood pressure at (4:20pm) 142/95. At (9:15pm) I started to get a headache so I took one Excederin Migraine and it went away. Blood pressure at (10:09pm) 144/91. 4/9/21 (6:15am) Dizziness 50% better, no spinning but feel unbalanced. Feel weak and shaky even after eating. No diarrhea so far and current time is now 1:11pm. Blood pressure at (1:11pm) 130/91. My blood pressure before taking Jansen was 118/80 on 3/27/21.
52 2021-04-08 impaired work ability Fever day after (Thursday) and felt run down. Felt a little better by Friday - then by Monday horri... Read more
Fever day after (Thursday) and felt run down. Felt a little better by Friday - then by Monday horrible vertigo which I had never had before and feel like my head is in a vice. Went to dr. to see if it was ear or something else but she found nothing. I couldn't work barely at all this whole week - today, Friday, my head feels like a watermelon and I am still dizzy - constant dizzy feeling although not falling over. quite debilitating.
52 2021-04-09 insomnia Immediately after injection, my heart raced, I got a metallic taste in my mouth, and my fingers got ... Read more
Immediately after injection, my heart raced, I got a metallic taste in my mouth, and my fingers got cold and tingly. The next day, I developed chest pain, racing heart, shortness of breath, and insomnia. I continue to have chest pain. On 04/08/2021, without injury or anything that I did, my right middle finger swelled and turned purple and it's still purple. The ER doctor said it was a hematoma.
52 2021-04-09 sleep disorder 0900, 8 Apr: Vaccine administered. 2100, 8 Apr: Muscle aches and pains. "Pinprick" sensations on ... Read more
0900, 8 Apr: Vaccine administered. 2100, 8 Apr: Muscle aches and pains. "Pinprick" sensations on body. 2230, 8 Apr: Went to bed. Exceptionally poor night's sleep, with constant wakefulness (confirmed by FitBit). 0816, 9 Apr: Got out of bed. Went downstairs. Began washing dishes and making breakfast. 0820, 9 Apr: Felt light-headed. Sat down in a chair. 0825, 9 Apr: Husband reports finding me with muscles constricted, eyes wide open, and pupils fully dilated. I did not respond to his touches or yells to get my attention. 0916, 9 Apr: Ambulance arrives at Hospital Emergency Room. Attending physician examines me and blood samples are taken. 1207, 9 Apr: Discharged with diagnosis of vasovagal syncope. Instructed to follow up with primary care manager and cardiologist on 12 Apr for further evaluation.
52 2021-04-10 nervousness Severe dizziness, nausea, sweating, shaky. Woke in the middle of the night with these symptoms and w... Read more
Severe dizziness, nausea, sweating, shaky. Woke in the middle of the night with these symptoms and was having difficulty walking. Almost called 911 and decided against it. Feeling better today for 4/11/21. Still having shakiness, nausea, and some cold and flu-like symptoms.
52 2021-04-10 restlessness, abnormal dreams Thursday, 7 hours after the vaccine: nausea, headache, fever, chills through the night. I felt my h... Read more
Thursday, 7 hours after the vaccine: nausea, headache, fever, chills through the night. I felt my heart feel like it was occasionally fluttering (overall felt this about 4 times). Restlessness through the night. I took two Tylenol at 10pm, one Tylenol at 4 am and one Tylenol at 6am. The Tylenol helped but I could tell when it was leaving my system Friday, the following day: fever of 101.6, acute nausea. Took Tylenol every 4 hours which did help. Saturday, felt much better but had sweating most of the day. The sweating subsided at night Sunday morning, still sweating. I also had weird vivid dreams since taking the vaccine. Could be unrelated but I usually don't have dreams like that
52 2021-04-11 feeling abnormal, insomnia Everything was fine at time of shot which was at 11:45. I had no effects, I left clinic around 12: ... Read more
Everything was fine at time of shot which was at 11:45. I had no effects, I left clinic around 12: 30 that afternoon, and went to do a job. I headed home around 4 pm and started to feel warm, but thought it was the sun. Around 5:15 I got the chills, very bad. So bad my jaws were shaking. I tried to use a heating blanket to get warm, but was very miserable. About an hour later I started running a fever that kept going up. My ears started to hurt and the ringing was really bad. By 8:30 my fever had spiked to 102 and I was so nauseous I had a hard time moving around, I almost used the bathroom on myself twice. Started burning up but still unable to move, I went outside to cool down and had a family member take me to the urgent care. They said my arm was swollen from the injection site and that everything was normal and that it was a good thing I was having these experiences because it means the vaccine was working. Gave me nausea medicine and aspirin and sent me home. I was unable to sleep from all the pain in my body and just laid here in pain starting to get really hot. Woke up around 4 soaking wet where I broke the fever and then continued to have a mild fever all day Sunday, April 11, with mild sweats on and off when my body would get too hot. Today just been trying to move around but very tired and exhausted. Had hard time sitting up to do some work at the table, so been laying down most of the day.
52 2021-04-11 feeling abnormal 11 am the next day felt slight fatigue and slight pain at the injection site. Around 4 pm, felt mor... Read more
11 am the next day felt slight fatigue and slight pain at the injection site. Around 4 pm, felt more fatigued and fuzzy-headed, similar to mild cold or flu symptoms. As of 9 pm, I am still tired and fuzzy-headed, but not ache-y
52 2021-04-11 feeling abnormal Right after the shot I felt like my throat closed up, but went away. I felt a little dizzy as well. ... Read more
Right after the shot I felt like my throat closed up, but went away. I felt a little dizzy as well. Within an hour the right side of my face and ear started to hurt, almost like it felt burnt, The nerve endings was super sensitive and has still not gone away. That night I didn't feel good, tired and out of it. On the third day I woke up with a rash on various parts of my body and moved to my eye lids as well. I called for a telehealth, and asked for a low dose steroid and he said not because I would "disrupt my immune response". I'm still having issues.
52 2021-04-11 restlessness, excessive sleepiness Very bad chills, high fever (102), nausea, muscle aches, restless. Those symptoms persisted for aro... Read more
Very bad chills, high fever (102), nausea, muscle aches, restless. Those symptoms persisted for around 14 hours, and then the fever began to go down, and i began to feel slightly better. I was very sick and extremely fatigued sleeping all day for about the next 48 hours. I had no appetite for several days. Overall I felt very sick like I had a very bad flu.
52 2021-04-11 sleep disorder Approximately 14-15 hours after the vaccine, while asleep I developed rapid heart palpitations. It w... Read more
Approximately 14-15 hours after the vaccine, while asleep I developed rapid heart palpitations. It was so strong it woke me up around 2:20am. Unable to fall back to sleep I continued to lie in down. Around 8 hours later, it had slowed down a lot. This is when I checked my pulse with our machine and it registered at 126 while resting. It was already much slower than during the night which I would guess the range to be 150-160. In hindsight, I probably should have gone to the emergency but I was very tired and running a low grade temperature.
52 2021-04-12 anxiety Anxiety BP - 127/84 Per paramedic okay to d/c no interventions needed
52 2021-04-12 feeling abnormal I EXPERIENCED "SPLOTCHY VISION" LASTING A FEW MINUTES, FELT ODD (ALMOST LIKE A BRAIN FOG), AROUNG 1... Read more
I EXPERIENCED "SPLOTCHY VISION" LASTING A FEW MINUTES, FELT ODD (ALMOST LIKE A BRAIN FOG), AROUNG 1/2 HOUR LATER I LOST THE ABILITY TO SPEAK. I COULD THINK BUT I COULDN'T SPEAK. I WAS TRYING TO SAY THE WORD "WATER". INSTEAD I WOULD SAY "WA" "CHHH". I WAS CONCENTRATING REALLY HARD TO TRY TO SAY THE WORD CORRECTLY BUT I COULDN'T. IN A FEW MINUTES THE EPISODE WAS OVER AND I COULD SPEAK NORMALLY. NO LASTING EFFECTS OTHER THAN FATIGUE.
52 2021-04-12 loss of personal independence in daily activities knot in patients arm, inability to move/utilize arm
52 2021-04-12 sleep disorder, loss of personal independence in daily activities Less than 12 hours after the vaccination I woke up at 1 a.m. with severe chills and body aches, a 10... Read more
Less than 12 hours after the vaccination I woke up at 1 a.m. with severe chills and body aches, a 102 fever and terrible headache. The worst of this lasted 5 or 6 hours and slowly improved, although I could not get back to sleep. I was out of commission for the entire day. At 6 p.m that evening my temperature was still at 100 degrees and the headache remained. The following day, April 8th, I did feel better. I was still fatigued and only then did I notice any pain/sensitivity at the injection site (I think the body aches masked anything less severe). This pain was to be expected and nothing out of the ordinary. I am fine now. I was taken aback at the severity of the adverse reaction. Also, my 20-year-old son got the shot at the same place -- with the same Lot Number 043A21A -- and had exactly the same reactions as I did. (They even started one hour after mine -- the same amount of time our injections were spaced out). (He may not be reporting it. Being only 20, he's not as thorough with these things although I will try to get him to do so).
52 2021-04-13 anxiety Lady had vaccine, was told it was Janssen but lot # is Moderna. She got the vaccine, the night of t... Read more
Lady had vaccine, was told it was Janssen but lot # is Moderna. She got the vaccine, the night of the vaccine around 5:30 she got a raging headache (she does get reactions to most vaccines). She took Tylenol and her arm did hurt. The next day she was still really hurting, her headache was really, really bad, and it stayed until Sunday. Then on Sunday she was ok. On Monday when she went to work and her right arm went limp, and while she was walking her right leg gave way and almost fell, grabbed hold and steadied herself. The raging headache/migraine came back and she started getting nauseous, her lower back hurt, her upper neck area hurt like somebody was pounding her neck. Then she got diarrhea and really really tired on Monday and Tuesday and also had loss of appetite. Then yesterday 4/13/201 she just had the headache and a sound in her ear, went to UC and got drops for it. Her temperature was 96.5, and her normal is 98.7, and was told that she was really cold. Her PB was really high and the doctor took it again but it was not as high, attributed it to anxiety. Last night the lower abdomen pain started, feeling like she was getting her period which she has not had in over a year. She saw a little blood on her panty liner, and was thinking she was going to have a period, but the pain is excruciating in her lower abdomen. She has also taken Tylenol off and on for her symptoms, and feels like she is cramping. She is having hot/cold flashes as well, and has not had these issues from menopause.
52 2021-04-13 feeling abnormal, impaired work ability Day of vaccine: within a few hours of receiving the vaccine (around 12:00pm or 1:00pm), I developed... Read more
Day of vaccine: within a few hours of receiving the vaccine (around 12:00pm or 1:00pm), I developed a headache, body aches, pain at the injection site, and brain fog. The brain fog was such that I could no longer work, so I laid down. Late in the afternoon (around 4:00pm), I developed numbness and tingling in my finder tips. This continued to get worse, particularly when walking around, so I continued to rest. Around 9:00pm, I was also getting dizzy when walking. I went to bed, and awoke symptom-free in the morning. Treatment included bed rest, ibuprofen, applied heat, and increased fluid intake. Day after vaccine: I had the first HSV-2 outbreak I've had in 5 years.
52 2021-04-13 excessive sleepiness 1) Immediately after receiving the shot, during the "waiting period" before being allowed to leave t... Read more
1) Immediately after receiving the shot, during the "waiting period" before being allowed to leave the clinic, I experienced slight light-headedness and then a feeling of great hunger pains in stomach ... 2) Woke up at approximately 1:00am on Sunday, 4/4/21 with a very hot sweaty clammy feeling, had a headache, body aches, temperature was 99.9 - symptoms then proceeded to worsen with a heavy headache (light over the whole head, with a slight sinus headache feeling & increased pain on Left side of sinus, eye, forehead, ear, behind ear, down back of skull), this headache 'pulsed' mostly on the Left side of head; felt nauseous, runny nose, sore throat (felt strep-like), fatigued (slept alot), body/muscle aches, strange dull aching in Left leg which seemed to move around the leg at different times (had to keep moving positions of Left leg when sitting or laying down). These symptoms lasted without break for approximately 4 days/nights at which it tapered off. Also, on the morning of Sunday 4/11/21 I noticed a vein that seemed to 'inflate' on my Left upper forehead and pulsed for a few minutes and then subsided with the feeling of a slight headache mostly on the Left side.
52 2021-04-17 sleep disorder 12:00 a.m. Thursday going into 5th day after vaccine, whole body very itchy - enough to wake up fro... Read more
12:00 a.m. Thursday going into 5th day after vaccine, whole body very itchy - enough to wake up from sleep several times. Thursday and into Friday, on and off itchiness and raised bumps around elbows, behind knees, at wrists. Friday afternoon hives appeared (large welts pea sized/dime sized ) at bikini line, upper legs front/back, and sporadically on torso. No shortness of breath, no fever (remained 97.6) no racing heart rate. Benadryl tablet helped. On and off contunued reaction all weekend culminating in another outbreak on Sunday - Benadryl again helped- same symptoms. Called Urgent Care. No different food or drink consumed, using same detergents, not wearing any new, unwashed clothes, no new contact with animals. Only change in lifestyle was getting vaccine.
52 2021-04-18 disturbance in attention, loss of personal independence in daily activities, feeling abnormal Day 1: Immediate reaction: soreness of arm, Approx 7 hours after the shot: violent chills, headache,... Read more
Day 1: Immediate reaction: soreness of arm, Approx 7 hours after the shot: violent chills, headache, sweats, body aches. Nausea, vomiting, misery Day 2: Severely dizzy, jittery feeling, achy, exhausted, nauseous, Day 3: Dizzy, jittery, achy, low energy/exhaustion, mind spacey/unable to concentrate Day 4: Continued dizziness & extremely easily exhausted, diarrhea Day 5 to 14 (today): Side effects linger: Weakness, Dizziness, especially when first standing up, Low energy, Thinking is slow, not sharp & concentration difficult, Equilibrium & balance feel off, Cannot drive due to dizziness & brain fog, headaches
52 2021-04-18 feeling abnormal -04/06/2021 approx 03:15 pm Janssen vaccine lot# 042A21A received, intramuscular, left a... Read more
-04/06/2021 approx 03:15 pm Janssen vaccine lot# 042A21A received, intramuscular, left arm -04/06/2021 approx 10 pm Started feeling symptoms: fever, chills, nausea, dizziness, diarrhea, vomiting, body aches, headache, fatigue, SOB -04/08/2021 Symptoms slightly improve -04/09/2021 Patient sees Dr. for a telehealth video visit. Reports chills, nausea, SOB, diarrhea, fatigue, dizziness, bodyaches. Is prescribed Flovent HFA and Zofran -04/15/2021 Still feels fatigued, headaches, and "brain fog" -04/19/2021 Fatigue, headaches, and "brain fog" persist, unchanged
52 2021-04-19 feeling abnormal Within minutes, I felt strange ... went to car and left side of face /eye went numb... and left hand... Read more
Within minutes, I felt strange ... went to car and left side of face /eye went numb... and left hand ... lasted hour or so and felt ok... however the next day, I had 102.7 fever which lasted another day .
52 2021-04-19 sleep disorder, feeling abnormal COUGH; COULD NOT SLEEP; BODY HURTS; FEELS TERRIBLE; HEADACHE; TEMPERATURE KEEPS GOING UP AND DOWN; ... Read more
COUGH; COULD NOT SLEEP; BODY HURTS; FEELS TERRIBLE; HEADACHE; TEMPERATURE KEEPS GOING UP AND DOWN; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included recently diagnosed with metastatic breast cancer which has spread to the lymph nodes, and smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced temperature keeps going up and down. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced could not sleep. On 10-APR-2021, the subject experienced body hurts. On 10-APR-2021, the subject experienced feels terrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021, had not recovered from cough, could not sleep, and body hurts, and the outcome of temperature keeps going up and down and feels terrible was not reported. This report was non-serious.
52 2021-04-21 anxiety About ten days after the vaccine, I started to have headaches, dizziness and nausea. My anxiety leve... Read more
About ten days after the vaccine, I started to have headaches, dizziness and nausea. My anxiety level is up and I have had a feeling of crawling in my back. The headaches last all day and they are like a tight band headache. They were coming back daily. Tylenol helps relieve the pain. The nausea and dizziness lasted about one week. After four weeks I am still getting the headaches, but they are less frequent this week. The feeling of crawling in my back started after three weeks and it is still happening two or three times a day. I have seen a Neurologist.
52 2021-04-22 insomnia RIGHT MIDDLE FINGER TURNED PURPLE; FINGERS SWELLING; INSOMNIA; RINGING IN THE EARS; CHEST PAIN; SHOR... Read more
RIGHT MIDDLE FINGER TURNED PURPLE; FINGERS SWELLING; INSOMNIA; RINGING IN THE EARS; CHEST PAIN; SHORTNESS OF BREATH; FATIGUE; BODY ACHE; METALLIC TASTE IN MOUTH; FINGERS TURNED COLD AND TINGLY; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, "over Christmas" and had since recovered. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 23-MAR-2021, the subject experienced metallic taste in mouth. On 23-MAR-2021, the subject experienced fingers turned cold and tingly. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced insomnia. On 25-MAR-2021, the subject experienced ringing in the ears. On 25-MAR-2021, the subject experienced chest pain. On 25-MAR-2021, the subject experienced shortness of breath. On 08-APR-2021, the subject experienced right middle finger turned purple. On 08-APR-2021, the subject experienced fingers swelling. Treatment medications (dates unspecified) included: doxycycline, and azithromycin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right middle finger turned purple, chest pain, metallic taste in mouth, and fingers swelling, had not recovered from insomnia, ringing in the ears, and shortness of breath, and the outcome of fingers turned cold and tingly, body ache and fatigue was not reported. This report was non-serious.
52 2021-04-23 impaired work ability The day after I received the vaccin I experienced an extreme tension in my two eyes that I still hav... Read more
The day after I received the vaccin I experienced an extreme tension in my two eyes that I still have now but not as intense. My left eye is the most affected - The blood flows really fast in the eye and it is pulsing. I don't have the sensation every day now but still on and off. Both of my eyes feel tension not as much as it was at the beginning but still experiencing symptoms of pressure and pulsions. It feels like I am going to have an ophthalmic migraine. My eyes doesn't feel right either. Overall, I felt weak, highlighted and it felt like if I was experiencing feeling of "dissociation" - caused I think by my sight being affected. I couldn't do a lot as my energy was very low and it felt that my oxygen wasn't at its maximum. Every small activity required a lot of energy and I could barely walk around my block. It affected my work and I couldn't teach at the end of that first week. I wasn't feeling good. I went to my doctor on Monday, April 12th as I was concerned about blood clot or other neurological and pulmonary issues. My Doctor examined me and listened to me and concluded that the sides effects were taking longer than the average to go away. The following day I woke up reading about the blood clots due to J&J vaccin. I called back my doctor and we did a blood test. It came back negative and I got my eyes checked by my ophthalmologist too, and he didn't see anything.
52 2021-04-25 confusional state husband reported patient was more "confused" also with "double chin now" Pt with + weight gain -- -m... Read more
husband reported patient was more "confused" also with "double chin now" Pt with + weight gain -- -medical history reveals Pt is waiting for kidney transplant and has other medical issues
52 2021-04-26 feeling abnormal WHOLE BODY HURTS; LUMP AT INJECTION SITE; ARM SORE; ARM SWOLLEN AT INJECTION SITE; FEELING LIKE IN A... Read more
WHOLE BODY HURTS; LUMP AT INJECTION SITE; ARM SORE; ARM SWOLLEN AT INJECTION SITE; FEELING LIKE IN A FOG; COULD NOT HEAR DISTANT SOUND; COULD NOT MOVE; VISION WAS BLINDED IN MIDDLE; EXTREME SLEEPINESS; BOWEL MOVEMENTS AND URINATION AT SAME TIME; TASTE SWEET; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid radiation, and concurrent conditions included diabetic, and sensitive to taste in her mouth. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: EL043A21A and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 17:50 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced taste sweet. On 11-APR-2021, the subject experienced extreme sleepiness. On 11-APR-2021, the subject experienced bowel movements and urination at same time. On 11-APR-2021 08:00, the subject experienced could not hear distant sound. On 11-APR-2021 08:00, the subject experienced could not move. On 11-APR-2021 08:00, the subject experienced vision was blinded in middle. On 11-APR-2021 08:00, the subject experienced feeling like in a fog. On 12-APR-2021, the subject experienced whole body hurts. On 12-APR-2021, the subject experienced lump at injection site. On 12-APR-2021, the subject experienced arm sore. On 12-APR-2021, the subject experienced arm swollen at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not hear distant sound, could not move, and extreme sleepiness on 11-APR-2021, and bowel movements and urination at same time on 13-APR-2021, was recovering from vision was blinded in middle, and whole body hurts, and had not recovered from arm sore, lump at injection site, arm swollen at injection site, feeling like in a fog, and taste sweet. 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.
52 2021-04-26 insomnia, anxiety COULD NOT DRINK WATER; LOSING HER VOICE/CANT SPEAK MORE; GETS SHORTNESS OF BREATH ON EXERTION; VERY ... Read more
COULD NOT DRINK WATER; LOSING HER VOICE/CANT SPEAK MORE; GETS SHORTNESS OF BREATH ON EXERTION; VERY ANXIOUS TO BE CONTACTED; HEAVINESS IN CHEST; HEADACHE; PAIN UNDERNEATH LEFT ARM; TROUBLE BREATHING,FELT LIKE GASPING FOR AIR,SHORTNESS OF BREATH/WINDED EASILY; PAIN IN RIGHT SIDE OF CHEST; TROUBLE SLEEPING; SORE THROAT; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206a21a, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced trouble sleeping. On 08-APR-2021, the subject experienced sore throat. On 09-APR-2021, the subject experienced trouble breathing, felt like gasping for air, shortness of breath/winded easily. On 09-APR-2021, the subject experienced pain in right side of chest. On 09-APR-2021, the subject experienced pain underneath left arm. On an unspecified date, the subject experienced could not drink water, losing her voice/cant speak more, gets shortness of breath on exertion, very anxious to be contacted, heaviness in chest, and headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 12-APR-2021, had not recovered from pain in right side of chest, trouble breathing ,felt like gasping for air, shortness of breath/winded easily, pain underneath left arm, trouble sleeping, and headache, and the outcome of could not drink water, losing her voice/cant speak more, gets shortness of breath on exertion, very anxious to be contacted and heaviness in chest was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
52 2021-04-27 depression Immediate dizziness. Malaise within about four hours. Flu-like symptoms within about 8 hours - heada... Read more
Immediate dizziness. Malaise within about four hours. Flu-like symptoms within about 8 hours - headache, general muscle ache. (This responded well to Advil.) General malaise, slight depression and tiredness for at least one week following the vaccination. (I'm submitting this report because when I saw a recent list of side effects, depression was not included. But not only did I experience it, but I've heard from others that they have as well.)
52 2021-04-27 sleep disorder Fever 101. 2 - 2 days Diarrhea - 1 day tightness in chest and harder to breathe from the start an... Read more
Fever 101. 2 - 2 days Diarrhea - 1 day tightness in chest and harder to breathe from the start and lasted 3 weeks - still gets tight and hard to breathe but not constant Swelling of my feet (also felt like it was a sunburn) was worse than prior to the vaccine (I never had this problem until I had covid) l Could not sleep - wired - lasted at least 2 weeks - I'd wake up and was wide a wake after 2 hours of sleep. Exhausted even when I could sleep some - still tire fairly easily extreme leg pain , bone pain, hip pain - lasted over 3 days then it was just really bad pain for 5 weeks horrible headache - really horrible for the first 3 days - headaches seem to be gone Processing takes longer - words, thoughts, understanding - has continued from the beginning until now - but has improved earache that comes and goes - no ear infection 4/12 started slurring my words - not all of them and not all day - lasted 4 days
52 2021-04-28 feeling abnormal 1. Starting around 6 pm, I felt like I got the flu. Violent shivers, fever of 102.5, intense body ac... Read more
1. Starting around 6 pm, I felt like I got the flu. Violent shivers, fever of 102.5, intense body aches. Lasted about 24 hours. 2. I had noticeable "brain fog" for about a week following the injection.
52 2021-04-28 sleep disorder Tinnitus got significantly louder. I noticed it after about a week, and it went along with other sid... Read more
Tinnitus got significantly louder. I noticed it after about a week, and it went along with other side effects like fatigue and headache and chills. All the other side effects have gone away (it has been 19 days) and the tinnitus is still bad. It is very distracting and I have to try to mask it in order to sleep.
52 2021-04-29 sleep disorder Sunday April 11 at about 11pm I started feeling extremely drained of energy and was experiencing som... Read more
Sunday April 11 at about 11pm I started feeling extremely drained of energy and was experiencing some mild abdominal pain. I went to bed shortly after. Was woken at approximately 5am with severe abdominal pain, and extreme back pain in my left kidney. Kidney area was worse than abdominal pain but both were severe. I have had kidney stones in the past, the pain of this was way worse. Was unable to take a bowel movement. Suffered thru with pain increasing until unspecified date at around 2 am I drove myself to unspecified hospital. Was admitted to emergency room and given an in mild pain meds and anti nausea meds. Was given a ct scan of kidney, then a second ct scan with contrast, as well as blood test. After awhile they came back to re draw blood because they said my blood had clotted and they were unable to use it. I was released after 5 hours with no prescriptions or knowing what or why I was in so much pain. Pain lasted until unspecified date
52 2021-05-03 sleep disorder, insomnia Stopped breathing in a sleep apnea type of scenario from approx 5:30a - 11a on May 2nd. Extreme body... Read more
Stopped breathing in a sleep apnea type of scenario from approx 5:30a - 11a on May 2nd. Extreme body aches and headache for two days. Fever and way overheated for three days. Sweating profusely from 5:30a and still occuring today three days after shot. Intense chest pain 1:50a Tuesday morning 5/4 along with acid reflux and body aches continuing. Insomnia started 30 hrs after injection and has lasted two days. Loss of appetite started 5/3 all day.
52 2021-05-04 feeling abnormal My thyroid numbers have been normal since removal, I test every 6 months with the same dr. My number... Read more
My thyroid numbers have been normal since removal, I test every 6 months with the same dr. My numbers where showing too much levothyroxine, so dr lowered my meds. Now I'm hypo so he has increased. I have tingling in my right butt and hip area since the shot. My diverticulitis is worse. I sleep about 13 hours a night. I have fog brain, sores on my tongue, I have had thrush. I'm always tired. Its hard for me to format words or sentences.
52 2021-05-04 impaired work ability Muscles and joints swelling on both sides of the body. Slow progression of pain until the pain was ... Read more
Muscles and joints swelling on both sides of the body. Slow progression of pain until the pain was to much to work. Muscles feel like the are torn and joints are swelling and painful like arthritis.
52 2021-05-05 nervousness note time of vaccination unknown Morning of 4/18 after up for a few hours noted "humming sensation" ... Read more
note time of vaccination unknown Morning of 4/18 after up for a few hours noted "humming sensation" "internally shaking" mostly on left side - shoulder, chest, abdomen - less in leg. She didn't think these were palpatations. This symptom decreased some over time but still present today. Afternoon 4/18 - left arm felt "tired" ? weak for about 3 days - resolved before I saw her in clinic on 4/22
52 2021-05-08 insomnia, anxiety, depression, feeling abnormal, nervousness This is my second report (same vaccine Johnson and Johnson on March 23 lot #1805031) because my symp... Read more
This is my second report (same vaccine Johnson and Johnson on March 23 lot #1805031) because my symptoms are still present; my first report was on 04/07/2021. I currently have depression, tinnitus, fatigue, brain fog, sometimes I feel shaky on the inside, swaying at times, and dizziness/vertigo. I sent follow-up information for my first VAERS report via mail and a pdf document to VAERS webpage; I attempted to fax several times but it came back unsuccessful; I left a message for a representative to return my call and nobody called back. I want to make sure you get this information, hence this second report. Additional Follow-up Information: Hospital Emergency Room visit on April 8, 2021: purple finger, racing heart, chest pain. EKG, body scan for blood clots, and blood panel. Doctor video visit on April 16, 2021: chest pain, feeling horrible, shortness of breath, metallic taste in the mouth, tinnitus, insomnia, anxiety, and depression. Doctor office visit on April 29, 2021: headache, dizziness, fatigue, brain fog, stress, depression, thirsty, pressure at temples and back of head and forehead, rocking, anxiety.
52 2021-05-11 feeling abnormal, loss of personal independence in daily activities, impaired work ability She had the vaccine, no reaction at all other than soreness, the inside of her elbow was a little ac... Read more
She had the vaccine, no reaction at all other than soreness, the inside of her elbow was a little achy and a little swollen but nothing major. Then yesterday morning was a little achy and by afternoon was miserable the next day she got really tired, joints hurting and had to take a nap. She cancelled one of her appointments she's a home health nurse and went to sleep and when she woke up her throat was swollen, hurting, labored swallowing and when she would drink her ears would pop, and her tongue was swollen but could breathe fine, and then it progressed to where she could not swallow at all. She took two Benadryl's and went to rest, and she was not able to move and had to have help getting dressed. Her joints are swollen, her hands are swollen, but her throat is not hurting like she was yesterday.
52 2021-05-11 feeling abnormal On the 7th, I woke up with flu-like symptoms. Arm was sore. I was fuzzy headed/loopy and general flu... Read more
On the 7th, I woke up with flu-like symptoms. Arm was sore. I was fuzzy headed/loopy and general flu-like symptoms. Lasted one day and it was gone. 2nd event, I felt fine until two weeks or so later. I started having severe abdominal pain - it felt like diverticulitis. I went to my doctor and she ordered a CT scan to be done. I have had diverticulitis in the past. They treated my newly diagnosed (Dx'd on 3/19/2021) diverticulitis with antibiotics and diet. That helped with my symptoms.
52 2021-05-14 thinking abnormal, memory impairment Starting to have memory issue . Day to day simple example signing in to work computer . Can?t rememb... Read more
Starting to have memory issue . Day to day simple example signing in to work computer . Can?t remember if I fed the dogs . Go blank can?t think of common words . Thought process seems interrupted . My son is noticing the same issue we got our shots same day .
52 2021-05-15 feeling abnormal Sore and sensitive arm for 12 days at sight of injection and surrounding tissue, slept for 30 hours ... Read more
Sore and sensitive arm for 12 days at sight of injection and surrounding tissue, slept for 30 hours after injection. The first 6 hours were normal other than soreness in the arm. Extreme fatigue for 48 hours, body aches for 48 hours, low grade fever for 48 hours, foggy cognitive processing for 14 days, nausea, chills and general feeling of illness or being "run down for 72 hours. Was not back to full normal strength and mental clarity for 21 days.
52 2021-05-17 feeling abnormal Day 1) sore arm. Day 2) Sorer arm, mild headache, later in day 2, upset stomach, diarrhea, stayed h... Read more
Day 1) sore arm. Day 2) Sorer arm, mild headache, later in day 2, upset stomach, diarrhea, stayed home from work Day 3) mild to moderate headache, nausea, periods of dizziness, chills, no fever but temp slightly elevated. Day 4) Severe headache, nausea, vomiting, chills, very sleepy, brain fog. Day 5) moderate to severe headache, still very tired and nauseous, dizziness. Day 6) mild to moderate headache, stomach cramps, nausea, cold sweats, periods of dizziness, brain fog. It has been nearly a week, I still do not feel "right".
52 2021-05-18 insomnia 14 hrs after injection I was freezing, three hrs later I was burning up this was at 3am, 4am still b... Read more
14 hrs after injection I was freezing, three hrs later I was burning up this was at 3am, 4am still burning up and not able to sleep, 5am sat up and had a headache that was at least a ten on the pain scale, I went down our flight of stairs to get water and ibuprofen, I had to sit down before I could get the water, when I finally got up I went to the counter and was getting this stuff out and I started to sway and white spread across my field of vision and I grabbed for the counter to lower my self down and passed out before I could grab the counter, I laid there burning up and with a headache that was killing me. I finally got the water and 800mg of ibuprofen went back to bed and slept until 11am, got up no headache but since then I have been experiencing hot flashes daily the rest of March and into April a few in May. I realize that I am of the age to experience hot flashes heading into menopause but this was to coincidental and I had never had hot flashes before.
52 2021-05-24 insomnia The same afternoon about 7pm my arm started to swell, it moved to arm and wrist. I couldn't sleep. I... Read more
The same afternoon about 7pm my arm started to swell, it moved to arm and wrist. I couldn't sleep. It lasted about 5 hours. I had fever and chills that had subsided by morning. I still had arm pain and my blood pressure was trough the roof. I went to see the doctor the next day. The doctor did not not see anything concerning.
52 2021-05-26 insomnia, anxiety My ears haven?t stopped ringing since I got the vaccine. It?s the first noise I hear in the morning ... Read more
My ears haven?t stopped ringing since I got the vaccine. It?s the first noise I hear in the morning it?s the last noise I hear before I fall asleep and every waking moment between, it?s maddening. I can?t take it. It?s anxiety causing and so disruptive I can barely concentrate or sleep, it?s louder than every ambient noise. While the vac may or perhaps not be the cause, getting the J&J vaccine is the only thing in this timeline that I can pin point. There have been no other changes in my life that would indicate it came from anywhere else. What can I do to make it stop. I can?t imagine living the next 40 years of my life this way, it?s unbearable. Had I known this may have been a side effect I never would have done it. I lived through the peak of Covid but I don?t know how I?ll live productively with this plaguing ringing in my ears. Please suggest a remedy, if you know of one. Signed, terribly regretful.
52 2021-05-28 anxiety, panic attack After I received the vaccine I felt like I was going to have a panic attack while I was waiting in t... Read more
After I received the vaccine I felt like I was going to have a panic attack while I was waiting in the chair. My anxieties were already high going in to take the vaccine because I was worried. The next day I started feeling very fatigued, but I kept jumping awake because of the anxiety. I took my temperature and it was between 99-100 degrees. I had a little itchy skin rash, but I'm not sure if it was due to my anxiety. I felt that my anxiety was much higher than normal. The following week I developed stomach issues. I requested that my doctor cut down my metformin mg. My stomach issues went away, so I increased my metformin again. I started feeling better after week 3. I cut back down to 500mg again and started taking a probiotic again. I am starting to feel like I'm having flu like symptoms this week.
52 2021-05-30 feeling abnormal, memory impairment I got the shot and arm was a little sore. After my time period in May on the night of the 7th I star... Read more
I got the shot and arm was a little sore. After my time period in May on the night of the 7th I started to feel sick. Woke up and was real sick for many days. On May 12th I tested positive for covid. My experience has been different than others I know who had it. Most food tasted rotten or like chemicals or medicine. Lost 20 lbs. Still have little energy. Foggy headed as I forget things easily. And other things.
52 2021-06-07 insomnia This is a summary and time line of the issues that I have had since my vaccine on April 1, 2021. No... Read more
This is a summary and time line of the issues that I have had since my vaccine on April 1, 2021. No matter what my pain level was, I always moved and stretched my arm through the pain. I felt that if I stopped moving it, the pain and range of motion would get worse. April 1: received J&J shot. Shot was administered by an MD. The needle made a squirting noise at the end when he pulled it out. Later at night my arm became sore. I could not sleep on it. The pain was internal ? there was no soreness to the exterior touch and no redness. I?ll note here that the injection site NEVER hurt to be touched from the outside, there has never been any injection site soreness to the touch or bumps or redness. The injection site was high up on my arm and to the side. April 2: range of motion limited. Extremely painful to move (symptoms are like Rotator cuff injury). Cannot sleep on it. April 3: same as day before. I called the on call doc. She called me back. She asked some questions about the symptoms. She said she got a COVID vaccine and her arm was super sore too could sleep on it etc., worst arm pain she?s ever had. She also asked me what symptoms I was having and to call back the next day if there was no improvement. April 4: I didn?t call the doctor again as there seemed to be improvement. Range of motion not great but a little better. Hurts a little less. Can?t sleep on it. April 5 ? 8: small improvements but still limited range of motion and pain. Twinges here and there and also when arm moved a certain way it pops. (the ?pop? is in the shoulder - I have never had this prior to shot and pain). April 9: woke up to arm being way worse. A relapse. Limited range of motion. Can lift above head but hurts a lot. Taking off shirts/clothing hurts. Cannot sleep on it or on my back without pain. Cannot sleep most of the night. April 10 -11: same April 12: same as above. Called doctor. Confirms it shouldn?t be this way. Warm compresses. Ibuprofen. Says if not better can come in for ultrasound. I say I may just go to orthopedic doctor ? saves some steps. April 13: same as above. I made an appointment with the orthopedic doctor for May 5th. April 13-28. basically the same as above. There has been little to no improvement and perhaps shoulder is more stiff in some ways (i.e. lifting it to my head difficult). Range of motion is limited. Cannot put on or take off clothes without pain. Arm is very weak and I cannot push myself off the bed or couch with the arm. Cannot sleep on back have to lie on opposite side and prop arm up on pillow. Doesn?t stay comfortable. Try to lie on back. Cannot lie this way for long. Up most of the night. All through night and morning arm is hard to lift and feels like there?s 50 pounds of weight on it. Harder to lift forward than up or to back. Shoulder ?pops? on occasion. April 29-30: all symptoms are the same as above, but it feels like that this a tiny bit of improvement. I cannot lift my arm ?normally? to itch my head. It feels like there is heavy weight on it. The arm is very weak compared to my other arm and there is a lot of pain when I use it for most tasks. The pain is in the shoulder. The ?popping? in the shoulder continues. May 5th ? Appointment with orthopedic doctor. X-rays. Prescribed physical therapy for 4-6 weeks and if I am not better then perhaps an MRI. May 5-19 ? I have had two weeks of physical therapy (six sessions). Pain keeps me up nightly and I do not have full range of motion without pain. Range of motion improving slowly. May 20-June 7 ? Another 8 sessions of physical therapy. Based upon discussions about my pain and progress made, I have been told that I probably saved myself from frozen shoulder by moving it constantly since getting injured (before PT). I have had improvements in how I move my arm, but certain movements still create a lot of pain for me. For instance, I can lift my shirt off with ?some? pain, but it?s much worse if I have use any sort of exertion or use my muscle to pull on the shirt. I also cannot move my arm suddenly or fast without causing pain. At night the pain no longer wakes me up, but when I wake up on my own and have to shift and pull on the covers, I can barely pull them on and my arm pops or ?tweaks?. Then it hurts the rest of the night and I tend to wake up sore in the morning. It?s difficult to exactly describe the pain without visually showing movements, etc. The PT office has projected 5 more sessions (and at home stretching) ending 6/25/21, but they will be assessing my progress. At that point it will be determined if an MRI should be obtained. I believe that on April 1 - the needle was placed too high up on my shoulder (in fact when I first looked at the band aid I couldn?t believe how high and to the side it was). It was NOT in the area when the needle should go. I believe that my neck degeneration and my shoulder issues are NOT related. I believe that if the needle had been placed properly that I would not be in this situation today.
52 2021-06-07 insomnia JOINT PAIN; RINGING IN EARS; DIZZINESS; PAIN IN ARM; INABILITY TO SLEEP; This spontaneous report rec... Read more
JOINT PAIN; RINGING IN EARS; DIZZINESS; PAIN IN ARM; INABILITY TO SLEEP; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 132 pounds, and height was 66 inches. The patient's past medical history included car accident, and bad knee trauma, and concurrent conditions included dyslexia, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced inability to sleep. On 18-MAR-2021, the subject experienced dizziness. On 18-MAR-2021, the subject experienced pain in arm. On APR-2021, the subject experienced ringing in ears. On JUN-2021, the subject experienced joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in ears, and dizziness, and the outcome of pain in arm, joint pain and inability to sleep was not reported. This report was non-serious.
52 2021-06-08 poor quality sleep, sleep disorder, feeling abnormal after receiving the vaccine, I was fine for 10 hours, then got sick for 24 hours -high fever, chills... Read more
after receiving the vaccine, I was fine for 10 hours, then got sick for 24 hours -high fever, chills, headache. Was getting better for a week after the vaccine, and then started to feel worse and worse. I have swollen throat, swollen face and body, foggy head, feeling cold, then sweating. Used to be very active person, would walk a lot, jog, ride bicycle for miles. Now can't go even for a walk, feel very tired. , have to force myself to work. on day off could not get out of bed for 3 hours. sleeping poorly, waking up because my hands go numb, have to shake them. Coming up stairs making me to seat and catch the breath , and calm the fast heart beat. Fell like hear is squeezed. Went to my physician 6/03, took blood test on 6/04, blood showed higher than normal thyroid. It was perfectly fine in February of this year. Physician sent me to endocrinologist, had phone appointment today, will be taking an other blood work next week. Endocrinologist said to contact Infectious disease doctor, as these are not his symptoms, left a message for appointment with Infectionist , don't think will get a quick one.
52 2021-06-09 feeling abnormal, impaired work ability Since receiving my vaccine, I experienced nausea, sore arm. I also have muscular skeletal issues fo... Read more
Since receiving my vaccine, I experienced nausea, sore arm. I also have muscular skeletal issues for 20 years, caused flare-ups, muscle spasms, nausea all these happened within two weeks after my vaccine. I still continue with flare-ups and I am currently receiving physical therapy. I also having muscle movements that are new, have also brain fogginess. I am currently out of work on medical leave due to my symptoms. I can not remember know which arm I received my vaccine.
52 2021-06-13 impaired work ability 5/24/21- 5/27/21 - Tightness in chest, nausea, low grade fever, headache, fatigue 5/27/21-5/29/21 - ... Read more
5/24/21- 5/27/21 - Tightness in chest, nausea, low grade fever, headache, fatigue 5/27/21-5/29/21 - fatigue but able to work 3-4 hour shifts at work 5/30/21-6/4/21 - heavy chest pressure, shortness of breath, fatigue, heart palpitations periodically, ears buzzing loudly/knocking sensation in head 6/4/21 - Went to Dr and she sent me to lab for CT Scan/ Angiogram to check for blood clot told to go to ER if it worsened. 6/7/21 - Tighness of chest and shortness of breath, heart palpitations Went to ER. Released me with nothing found wrong 6/8/21 - had appointment with Cardiologist Dr. Prescribed Arythozmiasin, Steroids and anti anxiety meds. told to go to ER if they symptoms return or worsen. 6/10/21 - Went to ER in AM 6/11/21 - sent home Current - periodic heart pressure, shortness of breath apon activity
52 2021-06-13 loss of personal independence in daily activities The next day after having the vaccine I felt a pain on my arm and I could not lift my arm for about ... Read more
The next day after having the vaccine I felt a pain on my arm and I could not lift my arm for about 2-3 weeks. It was swollen and very painful that I could not move my arm to do my daily activities. I went to the doctor and she said that it was nothing serious and she did not do any tests but she gave me some exercises to do at home and I still have some pain but not as bad as in the beginning. She gave me some medications for the pain and swelling.
52 2021-06-16 depression, anxiety I had an auto-immune flare up starting the day after the vaccine. I took care of myself. Then over t... Read more
I had an auto-immune flare up starting the day after the vaccine. I took care of myself. Then over the course of the next couple of weeks. I had on and off headaches. My thyroid then in April 2021 - it swelled (I had another auto-immune flare up). My neck gets really thick feeling and kind of swollen. In May, on and off, I had symptoms of my legs falling asleep more often. My vision has gotten worse in the last three months. It is a little more blurry. I had a lot of breast tenderness happen. I went for a mammogram. My anxiety and depression is off the charts and I'm able to manage things pretty well usually. I talked to someone this morning and a therapist, too. Thinking what to do given insurance. I had been discounting the symptoms because I was not thinking it was vaccine. It has increased a lot in the last three months, though, all the doctoring and symptoms I have had. I've felt out of whack; exhausted a lot and have put on a lot of weight. It's still all happening.
52 2021-06-21 restlessness I experienced 10 days after my vaccine, the vaccine sent me back to menopause, night sweats, mood ch... Read more
I experienced 10 days after my vaccine, the vaccine sent me back to menopause, night sweats, mood changes, restless nights, weight gain. I went to see Dr. (Name) one month ago to check my symptoms. He does not feel it is my vaccine but rather my thyroid. He did extensive lab work, blood tests, B12, D3, thyroid levels, cholesterol levels, hormone levels.
52 2021-06-23 feeling abnormal, sleep disorder Starting about 1-2 weeks after the vaccine, I had increased pain throughout your body (above and bey... Read more
Starting about 1-2 weeks after the vaccine, I had increased pain throughout your body (above and beyond my baseline). The pain was in my hands, fingers and shoulders. I also had a radiating pain in both legs on the back but more so on the left leg. I took my prescribed medication which did not alleviate the pain. I went to see the doctor and was given a steroid shot in the lumbar region which help alleviate the pain but I still have pain in the back of my legs and I am having trouble sleeping because the pain will wake me up at night. I was prescribed hydrocodone to add to my medication regimen. Currently I am having tinnitus, dizziness, brain fog, fatigue, change in my taste and phantom smell.
52 2021-06-27 sleep disorder Joint pain. Have preexisting nagging right hip that lit up latter that day. Within a couple of day... Read more
Joint pain. Have preexisting nagging right hip that lit up latter that day. Within a couple of days I was having lots of joint pain, including both shoulders which also had preexisting issues (torn cuff in left, bone spurs and arthritis in right). But not intense pain. It sputtered off an on for awhile. In mid May the joint pain got worse and was interfering with sleep. Saw primary care doc May 24. She prescribed Celebrex and referred me to hip specialist. Within a couple days of starting the celebrex, the joint pain greatly subsided. I am doing PT for the hip and had a steroid injection 6/21. The hip is improving but pain does flair with activity. Continue to have intermittent periods of joint/muscle pain - like maybe one every week or so which will last for a day or so. Nothing as bad as before I started the celebrex.
52 2021-07-01 feeling abnormal POSSIBLE BLOOD CLOT ISSUE; ELEVATED HEART RATE (OVER 100 AT REST); KIDNEY PAIN; NO APPETITE; FLU LIK... Read more
POSSIBLE BLOOD CLOT ISSUE; ELEVATED HEART RATE (OVER 100 AT REST); KIDNEY PAIN; NO APPETITE; FLU LIKE SYMPTOMS; SWOLLEN GLANDS IN NECK; SERIOUS BRAIN FOG; DIARRHEA; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to contrast dye. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: unknown) dose was not reported, 1 total, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021 after getting vaccination, the patient experienced elevated heart rate of over 100 at rest for four days. On an unspecified date in JUN-2021 after vaccination, the patient also experienced shortness of breath, headache, kidney pain, diarrhea, no appetite, flu-like symptoms, swollen glands in neck, aches and pains and had severe fatigue. On 14-JUN-2021, after four days of vaccination, the patient heart rate decreased to a healthier range but shortness of breath, headache, swollen glands, extreme fatigue and diarrhea continued. The patient also had serious brain fog. On 21-JUN-2021, after 11 days of vaccination, the patient had a severe shortness of breath and the patient's PCP (primary care physician) directed patient to visit an emergency room in a hospital. The patient took blood test and showed an elevated d-dimer indicating possible blood clot issue. The patient could not perform lung CT (computed tomography) or angiography due to a severe allergy to contrast dye. The patient also had an MRI (magnetic resonance imaging) of brain and ultra sound of the legs and the results were normal. The patient was on day 16 post vaccination at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated heart rate (over 100 at rest) on 14-JUN-2021, had not recovered from flu like symptoms, swollen glands in neck, possible blood clot issue, serious brain fog, and diarrhea, and the outcome of shortness of breath, kidney pain and no appetite was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210660381-Covid 19 Vaccine ad26.cov2.s-Possible blood Clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
52 2021-07-05 anxiety 52 -yo Female came Center vacc.site July 05, 2021.Received Janssen vac. at 10:35am in L arm. Directe... Read more
52 -yo Female came Center vacc.site July 05, 2021.Received Janssen vac. at 10:35am in L arm. Directed to observation area. 10:39 am she reported some discomfort in her chest area, anxiety, some flushing in her face and diaphoretic. 10:40am V/S HR 76,BP135/70, RR26,02Sat % 99%RA.11:03am - Attendee stated she felt better, feeling maybe due to anxiety. She remained sitting. No liquids. No longer diaphoretic, or pale. Attendee's skin warm/dry. Attendee's respirations were not tachypneic/dyspneic. V/S HR64,B/P126/66, RR22, 02Sat%100%.11:09am HR54BP120/58RR17,02Sa100%RA.Went to restroom w/Admin. laughing/talking.11:15am. Educ. given on home discharge/adv reaction. Left clinic independently.
52 2021-07-05 loss of personal independence in daily activities, disturbance in attention, feeling abnormal Suspected TRANSVERSE MYELITIS. Lower spinal cord is swollen and there is radiated pain stemming from... Read more
Suspected TRANSVERSE MYELITIS. Lower spinal cord is swollen and there is radiated pain stemming from lower spine into hips, buttocks and left leg. There was twitching observed on top of left foot and muscle numbness in left leg, mainly in the front of the thigh. At one point I tipped over while trying to hold a simple yoga pose which relied primarily on my left leg, but was not a difficult one. When I reversed to lean on right leg, there was no problem. I saw a chiropractor on 6/21 for an emergency visit. He adjusted my hips and neck and said he could see something was wrong. The problem continued so I received a deep tissue massage days later. Therapist asked if I had been in a car accident. Everything was painful. I continued to use hot packs, epsom salt baths, etc. I even purchase orthopedic seat cushions for my office chair. The pain keeps getting worse, especially when I sit down. I have severe pain like pins and needles persisting in lower back, buttocks and hips. The twitching/numb nerve in the top front of left leg continues. It also seems to be affecting my internal organs as I am very nauseous and urinary and bowel movements have changed dramatically and are distressed. I also feel foggy and unable to focus. The pain is like pins and needles, constant tightness, aches and throbs, not shooting pains. I have been practicing yoga daily for 7 years but am now unable to do some very basic moves due to excess pain. Other poses not connected to the pain are fine.
52 2021-07-21 sleep disorder Within a week after getting vaccine, I started with a prominant heart beat in that arm. It would ac... Read more
Within a week after getting vaccine, I started with a prominant heart beat in that arm. It would actully wake me up it was so strong. I went to a walk in clinic at day 10 because I was worried. They sent me for an ultrasound of that arm and arteries to make sure there wasn't a blockage on day 11 after vaccine. They didn't find anything. I then made an appointment with my family doctor who did bloodwork and didn't find anything. I also went to my cardiologist who did an EKG and didn't find anything. All of my physicians think this is just my bodies reaction to the vaccine. Over the months since getting the vaccine, the heartbeat issue has lessened but I'm now having tingling and light numbness all down the inside of that same arm into my thumb, forfinger and middle finger.
53 2021-03-04 poor quality sleep, anxiety Janssen COVID-19 Vaccine EUA Injection @ 1130a 1hr after - diarrhea 5hrs after- Rt Arm (opposite ar... Read more
Janssen COVID-19 Vaccine EUA Injection @ 1130a 1hr after - diarrhea 5hrs after- Rt Arm (opposite arm of shot) tingling sensitive to touch 7hrs after- Skin Crawling painful to touch - low back,thighs, arms, scalp 9hrs after- Freezing and fever sweating 12hrs after- 102 fever, racing BP about 180 high for me, Wrist and Elbows Ached terribly, Lower legs - knee down felt swollen but no sign of swelling. Low back Ached with Pain in Right rear side. Felt like I needed to stretch back and legs tight/anxious. slight Headache 14hrs after- took 2 Tylenol PM & slept restlessly until 8:30 a (12hrs later) 8:30a - Much better with slightly achey back and forearms and occasional headache ting... not constant. Moving slow Had Covid Nov11 2020. Symptoms lasted 6week, each week one symptom would go away and a new would arise- -fever 2days -intensively painful skin crawling 2days -loss of taste and smell -diarrhea (still have loose stools and occasional watery) had diarrhea morning of shot -eyes painfully itchy irritated dry - still occurs most days about 3p -extreme exhaustion in afternoon about 1-3p still
53 2021-03-10 feeling abnormal Fever 102.8, Chills, Severe back pain and hip pain, muscle aches, breast pain (still happening), Che... Read more
Fever 102.8, Chills, Severe back pain and hip pain, muscle aches, breast pain (still happening), Chest pain, Brain fog
53 2021-03-12 nightmare Pain in right arm, muscle pain through body, fever 102 degrees, chills, nightmares, lethargy, headac... Read more
Pain in right arm, muscle pain through body, fever 102 degrees, chills, nightmares, lethargy, headache, profuse sweating
53 2021-03-13 insomnia, feeling abnormal Flu symptoms, muscle and joints pain, headache, eye pressure, insomnia, fogginess, dizziness.
53 2021-03-13 sleep disorder Bad headache, arm and neck pain, dizziness, fatigue body aches, chills, nausea, stomachache. Did not... Read more
Bad headache, arm and neck pain, dizziness, fatigue body aches, chills, nausea, stomachache. Did not sleep well much Friday night due to these symptoms. Sudden pain in left side of my head about 40 min after the vaccine after I walked to the car and sat down after the 30 min wait. Pain starts as a slow dull ache, increases rather sharply, then goes away quickly. Have this pain several times or so yesterday and today even after taking ibuprofen. Also pain in my neck with what feels like stress headaches with ibuprofen relieving it.
53 2021-03-14 insomnia Fever, Chills, Sweating, Sleeplessness, Sick to Stomach, Diarrhea, Body Aches, Sore at the injection... Read more
Fever, Chills, Sweating, Sleeplessness, Sick to Stomach, Diarrhea, Body Aches, Sore at the injection site
53 2021-03-15 feeling abnormal Janssen COVID-19 Vaccine EUA. Approximately 7 hours after the shot, my body was in a continuous sta... Read more
Janssen COVID-19 Vaccine EUA. Approximately 7 hours after the shot, my body was in a continuous state of needing to stretch. It is like when you wake up in the morning and need to stretch - a whole body stretch- but this was continuous. Over and over and over, right after each other. It went on for many hours. Also, 40 hours after the shot, I noticed a body rash (it could have been there the previous day but I was in bed all day feeling horrible and didn't notice). I also have a rash on my sacrum area, and I could barely walk with the pain in my bones in that area. As the morning has progressed, I am feeling better in that area but it is still sore. It has been 40 hours after my vaccine and I am still not 100%. Aside from the horrible headache, chills and flu-like symptoms, these are the other side effects I thought need to be reported.
53 2021-03-17 amnesia, confusional state, sleep disorder, feeling abnormal Client reported that she had the vaccine yesterday around 10:45 am. At the time she felt a little li... Read more
Client reported that she had the vaccine yesterday around 10:45 am. At the time she felt a little lightheaded and her arm was sore. She went to sleep at 1130pm on the day she received her vaccine. At 4am the following morning, she woke up and her whole body was convulsing--the muscles in her arms and legs were shaking, her hands were balled into fists, and her jaw was clenched. She reported that her husband woke up and asked her if she was ok to which we was able to respond, but cannot remember what she said. She reports that her husband said the episode lasted 3-4 minutes, but that she felt like it lasted an hour. When the episode was over, she was spacey and confused. She did not get out of bed. 10 minutes later, a second episode occurred. This time her left arm and right leg began convulsing, but the rest of her body was unaffected. This episode lasted 2-3 minutes and then ended.
53 2021-03-18 insomnia Severe chills and stabbing pain in joints for 3 hours beginning around 4:15 am on 3/14/2021. Insomni... Read more
Severe chills and stabbing pain in joints for 3 hours beginning around 4:15 am on 3/14/2021. Insomnia from 3/14-3/17/2021.
53 2021-03-20 irritability Chills. Fever. Muscle aches and weakness. Headache. Weakness. Irratibility.
53 2021-03-24 feeling abnormal The first few days I just felt a little sore. Three days after the injections, I came down with flu-... Read more
The first few days I just felt a little sore. Three days after the injections, I came down with flu-like symptoms (achy, brain fog, headache, fatique, chills) This lasted for three days. I started to feel better for a day and then came down with upper respiratory symptoms (sore throat, fatique , stuffy nose, slight cough, brain fog, no energy, loss of appetite) As of today over two weeks from injection, I'm STILL feeling off. Symptoms are like having a mild cold with no energy.
53 2021-03-30 anxiety Extreme fatigue, nausea, weak muscles in arms and legs, anxiety, rapid heartbeat, tingling skin, mus... Read more
Extreme fatigue, nausea, weak muscles in arms and legs, anxiety, rapid heartbeat, tingling skin, muscle aches and pains, shortness of breath . Soreness and itching at site of injection. All symptoms became apparent within five minutes of vaccine and lasted until I went to bed at 10:30 PM. When I woke up at 7 AM the next morning all symptoms were gone.
53 2021-03-30 nervousness Pt. states that "I am having a little trouble swallowing" 12:34pm Benadryl is administered 20 m... Read more
Pt. states that "I am having a little trouble swallowing" 12:34pm Benadryl is administered 20 ml po. Stated she felt better after taking benadryl. Stated she thought she was nervous. Pt was able to drink water, several sips. Vitals: 12:29pm 130/79 101 18 O2 98%. 12:34pm 122/72 85 16 O2 98%. Disposition: Pt. left at 12:45pm with husband. Steady gait, unassisted, calm and cooperative.
53 2021-03-31 delirium DELIRIUM; PAIN IN HEART; DIFFICULTY IN WALKING; COLD EXTREMETIES; BODYACHE; VASCILLATE BETWEEN HOT A... Read more
DELIRIUM; PAIN IN HEART; DIFFICULTY IN WALKING; COLD EXTREMETIES; BODYACHE; VASCILLATE BETWEEN HOT AND CHILLS; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 53 year old female The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known allergies,no drug abuse. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, intramuscular, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered in left arm on 24-MAR-2021 at 19:30 for prophylactic vaccination. Concomitant medications included paracetamol for drug used for unknown indication. On 25-MAR-2021, the patient experienced nausea, difficulty in walking, fever , cold extremities , delirium ,vascillate between hot and chills, pain in heart ,headache body ache . The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from delirium, and pain in heart on 25-MAR-2021, and had not recovered from nausea, difficulty in walking, fever, cold extremeties, vascillate between hot and chills, headache, and bodyache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210350740-COVID-19 VACCINE AD26.COV2.S - Delirium. 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.
53 2021-03-31 insomnia Chills and shaking until 4:00 AM. Along with chills, symptoms of head cold. Slight runny nose, sli... Read more
Chills and shaking until 4:00 AM. Along with chills, symptoms of head cold. Slight runny nose, slight pain in both ears and throat. Feverish feeling, ears, face, and feet hot. By 4:00AM chills subsided and headache began. Also, urinated a lot during the night, but was not drinking. Very uncomfortable and couldn?t sleep. Symptoms as of 5:00 PM: slight headache, post nasal drip, stuffy feeling head. Much better than last night.
53 2021-04-01 sleep disorder 3/29/2021- received vaccine around 12:15pm Within 3 hours, I was extremely "hyper" My husband noti... Read more
3/29/2021- received vaccine around 12:15pm Within 3 hours, I was extremely "hyper" My husband noticed that my entire left arm (which received the shot) was a different color than my entire right arm. I did not sleep at all Monday night. 3/30/2021- felt fine until about 1:00pm when I noticed body aches. It worsened from then until bedtime. My hands, feet, and back hurt the worst. I asked my husband to rub my back, and he gasped when I lifted my shirt. My entire midback area was covered in a bright red, raised rash with blisters. I took Benadryl and applied betamethasone prescription cream (which I use for poison ivy or bug bites). My hands also itched, so I used the cream on my hands as well. I was sweating profusely but freezing. Took my temperature several times but it was never over 98. I could not sleep well, awake for an hour, asleep for 5 minutes off and on all night. 3/31/2021- I notified my primary care physician of the allergic reaction via the patient portal. His reply was to take Benadryl, which I was already doing every couple hours. The itchy back rash remained and more blisters formed. By the time I finished working, the redness was gone but the blisters remained. Itching stopped. Body aches were lessening. 4/1/2021- Rash completely gone, itching completely gone. Feeling lethargic (possibly due to lack of sleep, but maybe from the vaccine). One large blister (size of a quarter) and several smaller blisters remain. 4/2/2021- as of now, my left arm is still a bit sore when I raise it over my head. Main concern is the huge blister that is still on my back.
53 2021-04-02 feeling abnormal A little off or funny feeling for first two hours. After that, flu like symptoms for about 20 hours... Read more
A little off or funny feeling for first two hours. After that, flu like symptoms for about 20 hours. Headache, chills, fatigue, ringing in ear, night sweating (possibly due to fever), minor body aches. No soreness at injection site. A little fatigue on second day after the shot, and am now back to normal.
53 2021-04-07 insomnia, loss of personal independence in daily activities, anxiety Systemic: Bell's Palsy-Severe, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic:... Read more
Systemic: Bell's Palsy-Severe, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Severe, Systemic: Unable to Sleep-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patients' entire right face is drooping, with lack of mobility. Patient cannot blink which is causing additional issues, such as the visual changes. As of this morning patient has experienced some tingling to her face but she states it has not state consistent. She has difficulty eating and sleeping. Patient is also experiencing moderate to severe anxiety about the entire ordeal. Ringing in ear is constant and has not subsided since thursday (4/1). still experiencing symptoms since last week
53 2021-04-09 delirium Delirious dizzy,
53 2021-04-09 disturbance in attention Symptoms began within 24 hours after Janssen vaccine (1 of 1): extreme weakness (lethargy), diarrhea... Read more
Symptoms began within 24 hours after Janssen vaccine (1 of 1): extreme weakness (lethargy), diarrhea, low energy, no appetite, chills/sweats (no fever), some loss of hair (minimal but noticeable), overall malaise, inability to focus/concentrate. Symptoms continue and are ongoing (8+ days). Telemedicine appt on 04/07/21 Labs ordered for 04/09/21
53 2021-04-11 loss of personal independence in daily activities March 13 Fever 12 hours post vaccine. One week later tingling and numbness needle pin pain in finger... Read more
March 13 Fever 12 hours post vaccine. One week later tingling and numbness needle pin pain in finger tips which then proceeded to move up the arm. 2 weeks after same feeling in feet along with muscle spasms in buttocks and calf muscles. March 28 could not hardly move. March 29 went to hospital reported symptoms tests were run legs and arms numb pins needles and then felt like they were on fire. I was told to watch symptoms at home. That Wednesday went back to hospital ran all kind of Tests was told it was how my body is responding to vaccine and no one knows when I will be better. Discharged April 6 I need a Walker and assistance with everything still have the same symptoms. I have been given steroids muscle relaxer b12 and PT at home.
53 2021-04-11 panic attack After about 7 minutes of getting the Janssen Covid-19 vaccines, patient husband said patient is not ... Read more
After about 7 minutes of getting the Janssen Covid-19 vaccines, patient husband said patient is not feeling well. I attended to patient immediately. She said she is not feeling well, and her eye was rolling (as if when she tried to look up and couldn't get their eye to remain open) a for about few seconds and then she her eye was open back to normal. She was sweating on both hands and face were cold to the touch. I got the manager from the store to help me lie patient flat on the floor's surface gently to prevent her from falling off the chair. Based on this our adverse event protocol, patient exhibited similar symptoms to Syncope (paleness, sweating, coldness of extremities), so I patient is lying flat on the floor, feet elevated, and cold compression was apply on her arms and face. Unfortunately, patient conditions was not improving as it seem but she was alert and able to breath (fast pace) the whole entire time the incident occurred where she answer all questions when we myself, then the paramedics asked her questions. Paramedic arrived at scene within 10 minutes after individual got off the phone with 911. They took her away around 9 am and said patient probably experience anxiety attack.
53 2021-04-11 sleep disorder Janssen COVID-19 Vaccine EUA Flu like symptoms: no sleep from low grade fever, bone and joint pain,... Read more
Janssen COVID-19 Vaccine EUA Flu like symptoms: no sleep from low grade fever, bone and joint pain, nausea and headache - lasted 24 hours
53 2021-04-11 sleep disorder Fever, 100.5 with chills and body aches, couldn't sleep all night. Headache and dizziness in the mo... Read more
Fever, 100.5 with chills and body aches, couldn't sleep all night. Headache and dizziness in the morning. Took Tylenol in the morning to reduce fever, which worked. It's only 10:45 AM now and I didn't get up until 9:30 AM.
53 2021-04-12 feeling abnormal, loss of personal independence in daily activities, sleep disorder Starting 8pm that evening sudden fever, extreme weakness, intense body aches, intense chills, inten... Read more
Starting 8pm that evening sudden fever, extreme weakness, intense body aches, intense chills, intense bone, muscle, vein pain uncontrollable tremors , spasms, body tremors. intense headache, freezing despite many blankets. Worst pain in my entire body I have ever felt in my life!! day 2 still fever despite taking Motrin. weakness , body aches. In bed all day. day 3 still fever... feeling of sudden extreme drowsiness, lightheadedness. nausea ... woke 3 am intense pain in left ear. temp.99.5 took more Motrin for pain. day 4 headache still, weakness , fullness feeling in head and ears.. left arm soreness... still left ear discomfort... feeling scared .... feel like my body was poisoned. have not had so much as a cold in 5 years now I am hardly functional. feel like I should go to hospital or urgent care if my body temperature and headache ... disturbing unexpected symptoms doesn't improve soon but wanted to get this info in to document as this is first time I physically felt able to even do this.
53 2021-04-12 feeling abnormal My tongue swelled up about 6 hours after the vaccine was administered. I went out to eat and had st... Read more
My tongue swelled up about 6 hours after the vaccine was administered. I went out to eat and had steak and when I returned home I noticed my tongue felt weird and was sitting on my teeth. It took about 1 1/2 hours to go down but it did so I didn't end up going to the emergency room. My tongue was soar for the next few days because it was like I had bit it on both sides where it went over my teeth.
53 2021-04-13 confusional state I had leg pain beginning 3/16. I also experienced a headache, body aches, fatigue and loss of appet... Read more
I had leg pain beginning 3/16. I also experienced a headache, body aches, fatigue and loss of appetite. On, 3/17, I experienced confusion. On 3/31, I began to experience body chills and congestion which lasted several days. On 4/3, my symptoms increased with lower back pain and abdominal pain on my right side. I went to a clinick on 4/3 and received a positive covid test. My symptoms increased over the following weeks to include: temperature, body aches, sweating, headache, nausea, abdominal pain, fatigue, shortness of breath, coughing, dizziness and persistent diarrhea. I went to the ER for care on 4/8 and have been receiving continued care from my physician regarding possible pneumonia, shortness of breath, and chest tightness.
53 2021-04-13 impaired work ability Shot burned severely going in and for about 30 minutes after. Developed low grade fever that night ... Read more
Shot burned severely going in and for about 30 minutes after. Developed low grade fever that night and arm was very sore. Some mild body aches. The next day, I felt fine other than my arm was sore. I had a very large, firm lump at the injection site for about 8 days.
53 2021-04-14 anxiety heart palpatations, flushed cheeks and left ear anxiety - resolved
53 2021-04-14 anxiety Anxiety, cold, tachycardic. Placed in supine position by EMTs (remained on-site). All symptoms resol... Read more
Anxiety, cold, tachycardic. Placed in supine position by EMTs (remained on-site). All symptoms resolved.
53 2021-04-14 excessive sleepiness Woke up at 12:30 am with 102 fever, chills, body aches and severe headache. Slept most of day and s... Read more
Woke up at 12:30 am with 102 fever, chills, body aches and severe headache. Slept most of day and symptoms resolved by 4pm on Sunday of that day. Took Tylenol and drank gatorade to help symptoms.
53 2021-04-14 sleep disorder Started having excruciating, painful headaches. On about 4/6/21, headache awoke me from sleep. Pai... Read more
Started having excruciating, painful headaches. On about 4/6/21, headache awoke me from sleep. Pain was through my left eye towards the back of my head down to my neck. Lasted for awhile. Took Tylenol and was able to get rest about an hour later. Woke up that morning pain was still there but it was bearable. Two days later it happened again. Awaken with excruciating pain. Didn't think it was related to shot because it had been almost 3 weeks since I had shot. On 04/15/21, it happened again. Never had any issues with headaches. Not only have I been having headaches, I've been having pain in my legs, feeling lethargic, etc.
53 2021-04-14 sleep disorder Very strong abdominal pain, shortness of breath. Chest pain. I chewed an aspirin. The pain woke me u... Read more
Very strong abdominal pain, shortness of breath. Chest pain. I chewed an aspirin. The pain woke me up, everything was recorded on video because I had a camera in the living room of my house where I was sleeping. It happened on March 28 2021 (three weeks after vaccination) Today April15 2021 I notice red dots on my abdomen
53 2021-04-15 feeling abnormal Flu-like symptoms for two days after receiving vaccine, including body aches, extreme fatigue, 100.3... Read more
Flu-like symptoms for two days after receiving vaccine, including body aches, extreme fatigue, 100.3 fever on day after vaccine, diarrhea on second day after vaccine. General brain-fog
53 2021-04-15 impaired work ability Patient reported having vaccine reaction to J&J that she received on 4/8 at federal site. Sx are bod... Read more
Patient reported having vaccine reaction to J&J that she received on 4/8 at federal site. Sx are body aches, arm pain, fatigue and tiredness, cough, congestion, and runny nose. Patient went to PCP and was dx'd with upper resp infection, brought note to EH. Note from PCP clears her to RTW on 4/19. Patient is getting tested off-site 4/15 @ 11am, understands test must be PCR and she needs to fax or email results to EH before she can RTW. TM understands if EH receives neg results before 4/19 she should be clear to RTW. Patient was emailed self-iso instructions, mgr informed she is not clear to work at this time, pay code PTO.
53 2021-04-19 excessive sleepiness, feeling abnormal patient had a headache, weak arm, slept a lot more, experienced pain in arm as well, and a "funny fe... Read more
patient had a headache, weak arm, slept a lot more, experienced pain in arm as well, and a "funny feeling" in her chest. Patient went to the ER and said they found a blood clot.
53 2021-04-20 disorientation DISORIENTED; COULD NOT EVEN WALK; LOSS OF APPETITE; NO STRENGTH; WEAK LEGS; FEVER; HEADACHE; FATIGUE... Read more
DISORIENTED; COULD NOT EVEN WALK; LOSS OF APPETITE; NO STRENGTH; WEAK LEGS; FEVER; HEADACHE; FATIGUE/EXHAUSTED/TIRED IN LEGS; This spontaneous report received from a patient concerned a 53 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: 043AZIA, and batch number: 043AZIA) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced disoriented. On 04-APR-2021, the subject experienced could not even walk. On 04-APR-2021, the subject experienced loss of appetite. On 04-APR-2021, the subject experienced no strength. On 04-APR-2021, the subject experienced weak legs. On 04-APR-2021, the subject experienced fever. On 04-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced fatigue/exhausted/tired in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on APR-2021, had not recovered from weak legs, no strength, headache, fatigue/exhausted/tired in legs, disoriented, and loss of appetite, and the outcome of could not even walk was not reported. This report was non-serious.
53 2021-04-20 sleep disorder BLOODY NOSE WITH CLOTS; COULD NOT SLEEP WELL; FLU LIKE SYMPTOMS; INJECTION SITE DID NOT LOOK NORMAL;... Read more
BLOODY NOSE WITH CLOTS; COULD NOT SLEEP WELL; FLU LIKE SYMPTOMS; INJECTION SITE DID NOT LOOK NORMAL; EXCRUCIATING SHARP PAIN AT BOTTOM OF FEET; BREATHING CHALLENGES; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 110 pounds, and height was 155.448 centimeters. The patient's past medical history included influenza virus, and suspected covid-19. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced breathing challenges. On 10-APR-2021, the subject experienced flu like symptoms. On 10-APR-2021, the subject experienced injection site did not look normal. On 10-APR-2021, the subject experienced excruciating sharp pain at bottom of feet. Laboratory data included: Body temperature (NR: not provided) 101 unit unspecified, 102.3 unit unspecified. On 11-APR-2021, the subject experienced bloody nose with clots. On 11-APR-2021, the subject experienced could not sleep well. Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from breathing challenges, flu like symptoms, and injection site did not look normal, had not recovered from could not sleep well, and the outcome of bloody nose with clots and excruciating sharp pain at bottom of feet was not reported. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
53 2021-04-21 feeling abnormal SHORTNESS OF BREATH; OUT OF BODY FEELING; EPIGASTRIC PAIN; POSSIBLE RHEUMATOID ARTHRITIS FLARE; STIN... Read more
SHORTNESS OF BREATH; OUT OF BODY FEELING; EPIGASTRIC PAIN; POSSIBLE RHEUMATOID ARTHRITIS FLARE; STINGING IN THE RIGHT ARM; This spontaneous report received from a patient concerned a 53-year-old not Hispanic or Latino white female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, gastroesophageal reflux disease (GERD), hashimoto's thyroiditis, possible sjogren's, penicillin allergy and sulfa drugs (sulfonamide) allergy, and other pre-existing medical conditions included opiates allergy causing rash. The patient experienced drug allergy when treated with Azithromycin, Ciprofloxacin and Levofloxacin for an unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 in right deltoid for prophylactic vaccination. Concomitant medications included Acetylsalicylic acid (Aspirin) to prevent blood clot, and Prednisone for an unknown indication. On 09-APR-2021, the patient experienced stinging in the right arm for a few seconds while getting the vaccine shot, then pain in left arm, stomachache in the night, profound weakness in the legs, heaviness in both legs and both arms, shortness of breath, out of body feeling, severe pain in the epigastric area. It was reported that vaccine could have triggered a rheumatoid arthritis reaction in legs hands, feet and arms. The feeling of weakness and heaviness in the arms and legs were still on going, and the reaction with Aspirin occurred about 30 minutes ago but became better once she took a liquid antacid. The patient took the Aspirin to prevent clots because she was on prednisone, which was read on the news that blood clots may form after getting the vaccine. She attributed the heaviness of the arms and legs as a possible rheumatoid arthritis flare. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging in the right arm, and epigastric pain on an unspecified date in APR-2021, was recovering from out of body feeling, and had not recovered from shortness of breath, and possible rheumatoid arthritis flare. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421350-covid-19 vaccine ad26.cov2.s-possible rheumatoid arthritis flare. This event is considered not related. The event 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 than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
53 2021-04-21 insomnia MIGRAINE HEADACHE; BODY PAIN HEAD TO TOE; LOST APPETITE/COULDN'T EAT; STOMACH PAIN; RIB PAIN; CHILLS... Read more
MIGRAINE HEADACHE; BODY PAIN HEAD TO TOE; LOST APPETITE/COULDN'T EAT; STOMACH PAIN; RIB PAIN; CHILLS; WEAKNESS; FEVER; NAUSEA; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no past medical history of migraine disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 12/APR/2021) dose was not reported, administered on 12-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced couldn't sleep. On 12-APR-2021, the subject experienced migraine headache. On 12-APR-2021, the subject experienced body pain head to toe. On 12-APR-2021, the subject experienced lost appetite/couldn't eat. On 12-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced rib pain. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) No temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and nausea on APR-2021, had not recovered from migraine headache, body pain head to toe, lost appetite/couldn't eat, weakness, stomach pain, and rib pain, and the outcome of couldn't sleep was not reported. This report was non-serious.
53 2021-04-26 feeling abnormal HEADACHE; MIGRAINE AND FELT LIKE BACK OF HEAD WAS GOING TO EXPLODE; FELT LIKE CRAP; FELT LIKE HAD BE... Read more
HEADACHE; MIGRAINE AND FELT LIKE BACK OF HEAD WAS GOING TO EXPLODE; FELT LIKE CRAP; FELT LIKE HAD BEEN HIT BY TRUCK; LEFT CALF PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid disorder, addison diseases, leiden factor v, and steroids. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced migraine and felt like back of head was going to explode. On APR-2021, the subject experienced felt like crap. On APR-2021, the subject experienced felt like had been hit by truck. On APR-2021, the subject experienced left calf pain. Laboratory data included: Pain scale (NR: not provided) 5 and 10. Treatment medications included: acetylsalicylic acid, eugenol/menthol/methyl salicylate, and rizatriptan. On 07-APR-2021, the subject experienced headache. Additional treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine and felt like back of head was going to explode, felt like crap, felt like had been hit by truck, left calf pain, and headache on APR-2021. This report was non-serious.
53 2021-04-26 feeling abnormal ALLERGIES /INFLAMMATION REGARDING TO EAR; LEFT EAR NOT DRAIN WELL DUE TO HER EUSTACHIAN TUBE; CHILLS... Read more
ALLERGIES /INFLAMMATION REGARDING TO EAR; LEFT EAR NOT DRAIN WELL DUE TO HER EUSTACHIAN TUBE; CHILLS; HIP ACHE; GENERAL FATIGUE; LEFT EAR CLOGGED; RUNNY NOSE; FELT FOGGY; TOP OF LIP WAS SLIGHTLY NUMB/TINGLING; FEELING OF VACCINE TRAVELING DOWN TO HER RIGHT HIP SOCKET; RIGHT LEG SORE NEAR THE HIP AREA/RIGHT LEG HURT AND HURT THE REST OF THE NIGHT/STILL SORE,COMES AND GOES INTERMITTENTLY ,ESPECIALLY AT NIGHT; FEEL HER HEART BEAT IN HER EARS; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast cancer, and removal of 2 lymph node, and concurrent conditions included ear does not well due to eustachian tube. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980,expiry: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced general fatigue. On 03-APR-2021, the subject experienced top of lip was slightly numb/tingling. On 03-APR-2021, the subject experienced feeling of vaccine traveling down to her right hip socket. On 03-APR-2021, the subject experienced right leg sore near the hip area/right leg hurt and hurt the rest of the night/still sore, comes and goes intermittently, especially at night. On 03-APR-2021, the subject experienced hip ache. On 03-APR-2021, the subject experienced feel her heart beat in her ears. On 03-APR-2021, the subject experienced felt foggy. On 03-APR-2021, the subject experienced left ear clogged. On 03-APR-2021, the subject experienced runny nose. On 04-APR-2021, the subject experienced chills. On an unspecified date, the subject experienced allergies /inflammation regarding to ear, and left ear not drain well due to her eustachian tube. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general fatigue, top of lip was slightly numb/tingling, feeling of vaccine traveling down to her right hip socket, hip ache, feel her heart beat in her ears, felt foggy, left ear clogged, runny nose, and chills on 04-APR-2021, had not recovered from right leg sore near the hip area/right leg hurt and hurt the rest of the night/still sore, comes and goes intermittently ,especially at night, and the outcome of left ear not drain well due to her eustachian tube and allergies /inflammation regarding to ear was not reported. This report was non-serious.
53 2021-04-26 memory impairment, loss of personal independence in daily activities SEVERE DIARRHEA; BURNING RASH; NAUSEA; FLU-LIKE SYMPTOMS; SEVERE BODY ACHES; BURNING SENSATION WHEN ... Read more
SEVERE DIARRHEA; BURNING RASH; NAUSEA; FLU-LIKE SYMPTOMS; SEVERE BODY ACHES; BURNING SENSATION WHEN URINATING; 4 FALLS; FELLS LIKE SOMETHING IN THROAT; BEDRIDDEN; REDUCED ABILITY TO PERFORM DAILY ACTIVITY; MEMORY PROBLEMS; TINNITUS; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included cancer.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced burning sensation when urinating. On 2021, the subject experienced 4 falls. On 2021, the subject experienced fells like something in throat. On 2021, the subject experienced bedridden. On 2021, the subject experienced reduced ability to perform daily activity. On 2021, the subject experienced memory problems. On 2021, the subject experienced tinnitus. On 12-MAR-2021, the subject experienced severe body aches. On 12-MAR-2021, the subject experienced nausea. On 12-MAR-2021, the subject experienced extreme fatigue. On 13-MAR-2021, the subject experienced severe diarrhea. On 13-MAR-2021, the subject experienced flu-like symptoms. On 13-MAR-2021, the subject experienced burning rash. Treatment medications (dates unspecified) included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhea on 22-APR-2021, was recovering from burning rash, and nausea, had not recovered from extreme fatigue, memory problems, flu-like symptoms, and severe body aches, and the outcome of 4 falls, burning sensation when urinating, bedridden, reduced ability to perform daily activity, fells like something in throat and tinnitus was not reported. This report was non-serious.
53 2021-04-28 impaired work ability The first night I got the vaccine, and I had a fever of 103 degrees for about six hours and 101 degr... Read more
The first night I got the vaccine, and I had a fever of 103 degrees for about six hours and 101 degrees at the 24 hours. I had all over body aches for two days but my hands still ache after tree weeks. I woke up in the morning an noticed a big bulging blue vein in my right eyelid right above the outer part of my eye. One week later my thumb started to throb and then a big bulging blue vein in my left thumb. It felt like it had been injured but it looked better within hours. I called my doctor and he advised that I go to the ER. I also had trouble with my head throbbing for a week after the shot. My eye was painful and lasted a little over a week and my eyes were a little blurry. Both problems have resolved but I still have an ache in my hands after three and a half weeks. It is a deep bone ache which makes it difficult to work with my hands.
53 2021-04-28 impaired work ability 3 hrs after I came down with a fever of 100, and body chills. By 2am I had busy aches. Fatigue and ... Read more
3 hrs after I came down with a fever of 100, and body chills. By 2am I had busy aches. Fatigue and really low energy started that following week. By the end of that week, I was feeling like a truck hit me. As of Monday April 5, I couldn't work. Dizziness and light headedness began. I want getting any better. Better vaccine I felt amazing, but I started to feel like death. I called my primary Dr first who ran bloodwork, then Dr took over from there. The vaccine dumped my TSH levels fast, I had hit 30 and with having a total Thyroidectomy my levels need to be about 167 for me to feel my best. I've been stable for quite some time. I have had a drop before in the past but never felt so lathargic and sick as I have this time. I'm returning to work finally Monday May 3. It's been a long haul , getting better, and honestly I was scared to get the vaccine not knowing how my system would react due to having autoimmune diseases. I guess I found out the hard way.
53 2021-05-01 confusional state Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Syste... Read more
Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: Patient self-reported that she \"doesn't do well with needles\". After about 5-10 minutes post-vaccine, she called for help feeling tingling all down her arms into her fingers. She was shaky and it seemed like she fainted but was still somewhat responsive. She was also dazed and shaking. After vomiting, she was more lucid but still felt poorly. EMTs arrived on scene and took her blood pressure & found that she was very hypotensive. Recommended that she be transported to hospital due to low BP.
53 2021-05-02 loss of personal independence in daily activities Later that day I developed chills which became super intense and I could not get warm for nothing. ... Read more
Later that day I developed chills which became super intense and I could not get warm for nothing. Pain started in the lower back which persisted to all over my body with sever bone, joint and muscle pain. A few hours later the chills broke, I vomited and became extremely hot so hot to where nothing I did would allow me to cool off. I may of had a fever but I couldnt get up to check so I am unsure of that. For the next week I was so tired I could hardly function.
53 2021-05-04 insomnia COUGHING; THROBBING/PULSATING SENSATION AT INJECTION SITE; DIFFICULT TO SLEEP; INDENTATION FROM SHOU... Read more
COUGHING; THROBBING/PULSATING SENSATION AT INJECTION SITE; DIFFICULT TO SLEEP; INDENTATION FROM SHOULDER TO TRICEP AREA; FEELING OF PASSING OUT; VOMITING; ACHINESS/BODY ACHES; TIREDNESS; NAUSEA; INJECTION SITE SWELLING; DIFFICULTY IN BREATHING; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included swelling due to penicillins, throat closes due to marijuana, throat swelling due to marijuana, and hives in mouth due to marijuana, and concurrent conditions included type 2 diabetes, migraine, insomnia, penicillin allergy, alcohol user, smoker, and marijuana abuse, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced break out in rash and feeling sick when treated with gabapentin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included zolpidem for insomnia, cyclobenzaprine for migraine, fluoxetine for migraine, ketorolac for migraine, and promethazine for migraine. On 28-APR-2021, the subject experienced difficulty in breathing. On 28-APR-2021 14:00, the subject experienced indentation from shoulder to tricep area. On 28-APR-2021 14:00, the subject experienced feeling of passing out. On 28-APR-2021 14:00, the subject experienced vomiting. On 28-APR-2021 14:00, the subject experienced achiness/body aches. On 28-APR-2021 14:00, the subject experienced tiredness. On 28-APR-2021 14:00, the subject experienced nausea. On 28-APR-2021 14:00, the subject experienced injection site swelling. On 28-APR-2021 17:00, the subject experienced difficult to sleep. On 29-APR-2021, the subject experienced coughing. On 29-APR-2021, the subject experienced throbbing/pulsating sensation at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site swelling, indentation from shoulder to tricep area, tiredness, achiness/body aches, feeling of passing out, nausea, vomiting, difficulty in breathing, coughing, difficult to sleep, and throbbing/pulsating sensation at injection site. This report was non-serious.
53 2021-05-06 crying, depression I had the flu like symptoms twelve hours after the shot. Four days after the shot I was extremely de... Read more
I had the flu like symptoms twelve hours after the shot. Four days after the shot I was extremely depressed. Four days after the shot I got vomiting and Diarrhea that lasted two days. Four days after the shot I was extremely depressed. I do have problems with depression due to grief. This was extreme depression that started on the morning of the fifth day after the shot. I was extremely emotional and weepy and sobbing uncontrollable. It was scary and it lasted for three or four days. I was very lethargic and unmotivated. I consulted my therapist and she advised that it may be related to the vaccine. It was more extreme than I normally experience. but my mood has returned to normal.
53 2021-05-06 feeling abnormal Patient received the COVID vaccine in the RA and immediately complained of the pain and stated she f... Read more
Patient received the COVID vaccine in the RA and immediately complained of the pain and stated she felt dizzy, faint, and lightheaded. She said she thought the needle was still in the arm until she felt the bandaid go on and realized it wasn't. She said she felt nauseous, and slouched down in her seat. I went to get a trash can just in case she got sick and she immediately got out of the chair and said she needed to lie down on the floor. We placed her on the pharmacy floor and she said she was having a hard time breathing and her head "felt funny and weird". I retrieved the EpiPen but she said she never had one and didn't want to get it yet. She was conscious the whole time and appeared to be hyperventilating so we never administered the Epipen. She said her fingers were tingly and requested we call the paramedics so we did. They arrived very timely and took over. They took her BP and it was fine. They asked if she wanted to go to the hospital and she said no. She stated she was starting to feel better, she could breath more easily. She eventually was able to sit up and the paramedics got her to call her son to come pick her up and the paramedics walked her out of the store to meet him.
53 2021-05-10 impaired work ability About 12:30am got cold, sweats, got dizzy so I went home. My hands were stiff from the arthritis. th... Read more
About 12:30am got cold, sweats, got dizzy so I went home. My hands were stiff from the arthritis. the following day I had a Rheumatoid Arthritis appointment gave me an anti inflammatory medication which helped and I have been feeling better.
53 2021-05-12 feeling abnormal FELT BAD; This spontaneous report received from a patient concerned a 53 year old female. The patien... Read more
FELT BAD; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced felt bad. The action taken with covid-19 vaccine was not applicable. The outcome of felt bad was not reported. This report was non-serious.
53 2021-05-19 feeling abnormal 3/24/2021 11am vaccination A couple hours later, I went back to work. I started feeling pains in my ... Read more
3/24/2021 11am vaccination A couple hours later, I went back to work. I started feeling pains in my neck and feeling 'off'. The pain went to my hands, achy, and numbness radiated to feet. Felt awful driving home. Four hours, my body felt like 'hit by a baseball bat'. I did take some Tylenol and Ibuprofen. I went to bed, started to get chills with heating pad, felt like I just needed to sleep. My husband kept me hydrated. It hurt in my neck. My temp was between 103-104. Included shaking, chills, sweats, fatigue. A few days later, pain from shoulder to my neck. Past weekend, I went to see my chiropractor as I couldn't make pain go away, unless I lifted my arms. This is the only time I have ever seen a chiropractor and saw them a total of 8 times. They wanted me to go to 12 but it was 'getting expensive'. *pretty much gone away *COVID +, Jan 2021
53 2021-05-22 sleep disorder vomiting (30 mins only about 11 hrs after injection). Chills fever dizzy headache body aches and can... Read more
vomiting (30 mins only about 11 hrs after injection). Chills fever dizzy headache body aches and can't sleep (still happening 35 hrs after symptoms started - 45 hrs after injection)
53 2021-05-23 anxiety Client received Janssen vaccine approximately 11 am on 5/21/2021. Complained of heart racing, panic ... Read more
Client received Janssen vaccine approximately 11 am on 5/21/2021. Complained of heart racing, panic feeling, anxiety, facial flushing, nausea soon after receiving injection. Appeared pale in color. Reports she was very anxious about getting the injection. Heart rate 149, blood pressure 161/92. 911 called and client was transported to hospital approximately 11:20 am. Blood pressure at that time 154/91, heart rate 130. Client was called at 3:53 pm 5/21/2021 and reports she was sent home from hospital earlier after receiving a shot of Ativan. She stated she did have an EKG while at the hospital and they took her vitals. She reports she was told it was anxiety and discharged. She had actually went back to work at 12:50 pm earlier in the day and was at work when I spoke with her. She said she "felt a little woozy but heart rate was good now and she was feeling pretty calm at work?. Had no other complaints at 3:53pm when I spoke with her.
53 2021-05-27 sleep disorder, impaired work ability I am experiencing severe tingling and numbness in my arms, hands, legs, and feet that barely allows ... Read more
I am experiencing severe tingling and numbness in my arms, hands, legs, and feet that barely allows me to work or sleep. I wake up at night with a shock but at the same time without feeling the extremities. Joint pain. Irritation and veins in the eyes, palpitations and severe chest pain. headache on the left side, fatigue and excessive tiredness.
53 2021-06-02 sleep disorder I wake up in the middle of the night and sometimes during the day due to numbness in my feet.
53 2021-06-03 sleep disorder Patient immediately felt pain in upper left shoulder and felt injection had been given too high base... Read more
Patient immediately felt pain in upper left shoulder and felt injection had been given too high based on other injections in the past. She came in to see Nurse Practitioner as she was still having pain 17 days after the injection. Patient had also had a decrease range of motion with trouble reaching for things and putting on her seatbelt behind her. The NP sent her for physical therapy.. PT did not help so she came in to see Dr. n 4/28/21. Dr. thought it was SIRVA and discussed the case with an orthopedist. Based on that discussion short term therapy on methylprednisolone was tried, which helped minimally briefly. So patient was then seen by the orthopedist on 5/24/21 who ordered an MRI. However, the MRI was denied because the patient had not completed 6 weeks of PT. However after 6 PT sessions there was no improvement of pain or ROM. Pain is 8/10 in the morning and is improved to 5/10 after ibuprofen by afternoon. Ice also helps with the pain. Dr. will appeal getting the MRI as it failed to help, but this has not been approved yet. Patient is still having trouble sleeping on left side and the pain awakens her at night. ROM when reaching for things or putting on seatbelt still a problem and causes increased pain.
53 2021-06-10 feeling abnormal I started getting headaches, which is highly unusual because I NEVER get headaches. Typically I get... Read more
I started getting headaches, which is highly unusual because I NEVER get headaches. Typically I get a headache every 5 years or less, and usually only if my nose is completely stuffed up with a cold. The headache started on Wed night and kind of came and went, but even when it was gone I just didn't feel right. No other cold symptoms, just headache and some fatigue. On Friday I made the vaers report (I think) and contacted my PCP and she did not have any available openings for me to come in so she referred me to walk in clinic. They said they couldn't do anything, and told me to keep monitoring it, and if it persisted to go to the emergency room. On Sunday evening I was still having the headaches so I went to the ER. They did some blood tests, everything was normal, so I left. On Monday I was talking with a friend about what happened, and she said she was having headaches too, but she knew hers were from lilacs which she has been allergic to for many years. I have never been allergic to lilacs or any flowers, but I did have a spray of lilacs in my house and when I thought about it I realized that the headaches started the same night that I brought home the lilacs. So I got rid of the lilacs and the headaches stopped. So the headaches were not directly due to the vaccine, but I am wondering if the vaccine made me more sensitive to allergens??
53 2021-06-11 sleep disorder On May 17 noticed some hearing loss in my right ear by May 18 lost most of my hearing out of my righ... Read more
On May 17 noticed some hearing loss in my right ear by May 18 lost most of my hearing out of my right ear. The extremely loud ringing prevents sleep and gives me headache Went to MD and he referred me to ENT. Dr. stated that this acute event happened due to a virus. The only virus that I know I was exposed to was the J&J shot. Dr. stated I should report this to VAERS
53 2021-06-14 insomnia VERY PAINFUL THROAT PAIN; SLEEPING RANDOMLY NOT WHOLE NIGHT/INSOMNIA; VERY VERY BAD, LIKE SOME SICK... Read more
VERY PAINFUL THROAT PAIN; SLEEPING RANDOMLY NOT WHOLE NIGHT/INSOMNIA; VERY VERY BAD, LIKE SOME SICKNESS; HEAVY HEADACHE; FEELS VERY TIRED AND STILL WANTS TO SLEEP; This spontaneous report received from a patient concerned a 53 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: Unknown) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-JUN-2021, the subject experienced very painful throat pain. On 09-JUN-2021, the subject experienced sleeping randomly not whole night/insomnia. On 09-JUN-2021, the subject experienced very very bad, like some sickness. On 09-JUN-2021, the subject experienced heavy headache. On 09-JUN-2021, the subject experienced feels very tired and still wants to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy headache, very painful throat pain, and very very bad, like some sickness, and the outcome of sleeping randomly not whole night/insomnia and feels very tired and still wants to sleep was not reported. This report was non-serious. This report was associated with product Quality complaint: 90000182408. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.
53 2021-06-16 anxiety, confusional state, agitation Arm was sore right away -the initial impact of it -for a minute or so and then I could feel it still... Read more
Arm was sore right away -the initial impact of it -for a minute or so and then I could feel it still for about 5 minutes. I felt really good the rest of the day, I had more energy for that one day. My mood is different - I have depression - and there are life things that are happening that can be contributing to it. So my mood is going up and down a lot. I'm sleeping in my car, etc. Everything is unorganized, I'm very confused and no one gives me answers. I can't make any decisions. I'm having difficulty with just making anything work for me - it's like a joke. Having problems discerning knowing what to do with my phone emails, etc, and other things. I'm getting the cold shoulder from everyone. And I don't know if the vaccine has anything to do with it. I'm more agitated than at other times, though. Searching for a doctor but I didn't get as far as searching much because I have other things to do for food, shelter, etc.
53 2021-06-26 feeling abnormal, sleep disorder within an hour after vaccine, both arms and face began tingling and went numb.. mouth/gums front tee... Read more
within an hour after vaccine, both arms and face began tingling and went numb.. mouth/gums front teeth numb...felt dizzy and double vision with a headache the entire day.. by evening the numbness went away but headache and dizzy/double vision continued through the night. Noticed eyeballs hurt when touching eyelids and felt like I was looking through a double lense that kept jumping around, couldn't focus or see properly. Through the night had strange pains ping on different areas of body, keeping me from sleeping. The 2nd day still had brain fog, double vision, headache and fatigue but numbness went away. Joints (elbow/shoulder/hips) had extreme pain. 3rd day headache better, but still having vision problems and eyeball pain and joint pain. Day 4 (today) still struggling with vision issues and sore eye sockets and major joint pain.
53 2021-07-13 impaired work ability The 26th, I woke up and my knee joint hurt me terribly and my elbows were hurting. Sunday, the same ... Read more
The 26th, I woke up and my knee joint hurt me terribly and my elbows were hurting. Sunday, the same joints hurt, and my right shoulder joint also hurt and my wrists. Then Monday neck and throat hurt and Tuesday more joints hurt. Wed, I couldn't lift my right arm and my fingers and hands, and wrists hurt. I went to the doctor, shot of Kenalog in my butt. I didn't go to work. Gradually over the following days my symptoms subsided. My ear and joint in my shoulder still hurt.
53 2021-07-14 impaired work ability, insomnia Sudden intense pain in neck, chest, head area (so intense that I had a root canal tooth removed hopi... Read more
Sudden intense pain in neck, chest, head area (so intense that I had a root canal tooth removed hoping this was the cause, although my dentist could not see anything, and it didn't help). Pain and tingling in my arms. In addition a few weeks into it pain in my inner thighs and strange bruising patterns down my thighs, and tingling legs. severe bladder pain, and constant feeling that I need to go to bathroom (bladder infection was ruled out). Pain is usually much worse at night. Sleep has become very difficult. Throat issues to a degree that I constantly have to clear my throat before I'm able to talk Massages, acupuncture helps, also tried PT for jaw area. IV immunity drips (does not help) Saw 2 general practitioners, one osteopath, one gynecologist, and dentist. There are days which are better and then days where I can't work and need to cancel my patients.
53 2021-07-14 insomnia Patient report that he had chills/ fever 4 hours after the vaccine... lasted till 11 pm that night..... Read more
Patient report that he had chills/ fever 4 hours after the vaccine... lasted till 11 pm that night... also nauseous after 11 pm and couldn't sleep... around 130am he started having headaches, nose bleeding... symptoms lasted for 2 weeks
53 2021-07-15 feeling abnormal Felt severe pain in leg for over week. Went to hospital. Hospital reported nothing wrong. A week lat... Read more
Felt severe pain in leg for over week. Went to hospital. Hospital reported nothing wrong. A week later, ER, Afib, In ICU for 4 days. Developed completely neuropothy, starting with legs. Feel like "electrical system is fried."
53 2021-07-18 insomnia PRESSURE IN HEAD; TREMENDOUS AMOUNT OF PAIN IN THE LOWER BACK; GENERALIZED PAIN OVER BODY; FATIGUE; ... Read more
PRESSURE IN HEAD; TREMENDOUS AMOUNT OF PAIN IN THE LOWER BACK; GENERALIZED PAIN OVER BODY; FATIGUE; HEADACHE WITH PRESSURE; INTERMITTENT HEART PALPITATIONS; VERTIGO; DIZZINESS; NUMBNESS/TINGLING IN IN RIGHT HAND THEN SPREAD TO LEFT HAND.; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 129 pounds, and height was 68 inches. The patient's concurrent conditions included fibromyalgia, gluten allergy, casein allergy, alcohol consumption, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. patient was not pregnant at the time of the event.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced numbness/tingling in in right hand then spread to left hand. On 01-JUL-2021, the subject experienced intermittent heart palpitations. On 01-JUL-2021, the subject experienced vertigo. On 01-JUL-2021, the subject experienced dizziness. On 01-JUL-2021, the subject experienced couldn't sleep. On 01-JUL-2021, the subject experienced headache with pressure. On 02-JUL-2021, the subject experienced generalized pain over body. On 02-JUL-2021, the subject experienced tremendous amount of pain in the lower back. On 02-JUL-2021, the subject experienced fatigue. On 16-JUL-2021, the subject experienced pressure in head. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache with pressure on 03-JUL-2021, was recovering from generalized pain over body, and vertigo, had not recovered from numbness/tingling in in right hand then spread to left hand., fatigue, intermittent heart palpitations, dizziness, and pressure in head, and the outcome of tremendous amount of pain in the lower back and couldn't sleep was not reported. This report was non-serious.
53 2021-07-20 feeling abnormal PLATELET COUNT DECREASE; WHITE BLOOD CELL COUNT DECREASE; VERTIGO; HEART PALPITATIONS; CHEST PAIN ON... Read more
PLATELET COUNT DECREASE; WHITE BLOOD CELL COUNT DECREASE; VERTIGO; HEART PALPITATIONS; CHEST PAIN ON THE LEFT SIDE OF THE HEART; MIGRAINE; A FEELING OF ROCKING LIKE ON A BOAT; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. the patient 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: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced vertigo. On 19-JUN-2021, the subject experienced heart palpitations. On 19-JUN-2021, the subject experienced chest pain on the left side of the heart. On 19-JUN-2021, the subject experienced migraine. On 19-JUN-2021, the subject experienced a feeling of rocking like on a boat. On 23-JUN-2021, the subject experienced platelet count decrease. On 23-JUN-2021, the subject experienced white blood cell count decrease. Laboratory data included: Lab test (NR: not provided) Unknown, Platelet count (NR: not provided) Decreased, and White blood cell count (NR: not provided) Decreased. On 01-JUL-2021, Laboratory data included: Platelet count (NR: not provided) Normal, and White blood cell count (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from platelet count decrease, and white blood cell count decrease on 01-JUL-2021, vertigo, heart palpitations, and migraine on 29-JUN-2021, and chest pain on the left side of the heart, and had not recovered from a feeling of rocking like on a boat. 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.
53 2021-07-26 feeling abnormal patient presented to this facility ED with dizziness x 2 hours. Patient stated history of intermitt... Read more
patient presented to this facility ED with dizziness x 2 hours. Patient stated history of intermittent headaches/dizziness/fatigue/brain fog since 4/10/2021 after recieving J&J vaccine. Her symptoms have been intermittent and occur approx 3x/week. patient has been seeing PCP. Patient had a recent negative NRV brain 6/22. Today patient states developed dizziness with headache at her desk. no seizure or LOC, no neck paint/stiffness, no fever/rash, no vision/gait/speech changes. no numbness/tingling/focal weakness. no chest pain, no palpitations, no cough/SOB, no abdominal pain, no vomiting or GI/GU symptoms, No prescription meds, no h/o HTN/HL/DM or tobacco use. Patient was transferred to another facility and stroke ruled out at transferring facility
54 2021-03-08 restlessness, insomnia Feeling somewhat sick with body aches and fatigue. Restless. Can?t sleep even though I?m tired.
54 2021-03-09 feeling abnormal Headache Bodyaches Very weak Chills (not sure if feverish - I didn?t take my temp.) Sore muscles (ba... Read more
Headache Bodyaches Very weak Chills (not sure if feverish - I didn?t take my temp.) Sore muscles (back of legs) Hazy/Foggy mindset Stuffy nose on morning of second day
54 2021-03-09 impaired work ability, insomnia Chills, body ache, headache, slight nausea. ..all except nausea was severe btwn 11pm-8am (got the sh... Read more
Chills, body ache, headache, slight nausea. ..all except nausea was severe btwn 11pm-8am (got the shot around 4pm) with difficulty sleeping; had to take off work the next day (Tues) and slept on and off until 3pm. Felt like the flu but without respiratory issues. Fatigue and headache after that (that evening), more mild. Wednesday worked from home, but developed runny nose, sneezing, and scratchy throat, ears feel clogged; feels like oncoming regular cold (current state, reporting now).
54 2021-03-09 impaired work ability 5:00PM or so the following evening 3/9/21 I started to not feel well. Headache, nausea and general i... Read more
5:00PM or so the following evening 3/9/21 I started to not feel well. Headache, nausea and general ill feeling. 6:30PM started running fever of close to 108. Fever went up to 102 at its highest. 3/10/21 felt "ok" but stayed home from work. No fever until around 3:00 when it was 100.4.
54 2021-03-09 sleep disorder Approx 8 hours after the shot, 12:30am, I started to have chills. The chills prevented me from slee... Read more
Approx 8 hours after the shot, 12:30am, I started to have chills. The chills prevented me from sleeping well. Also when I laid down for the night, I was accutely aware of my heartbeat, which according to my smartwatch was beating at a rate of 71. The next morning, I still was experiencing chills, and felt achy/stiff/sore muscles - possibly from tensing up and shivering all night. Pain at the injection shot also started the morning after the shot. By bedtime the day after the shot, the symptoms had eased up. The next morning the symptoms were gone, except for a little residual injection site discomfort.
54 2021-03-12 feeling abnormal Sudden jump in heart followed by pounding, rapid heart rate which lasted about 2-3 minutes. Somewha... Read more
Sudden jump in heart followed by pounding, rapid heart rate which lasted about 2-3 minutes. Somewhat light feeling throughout body.
54 2021-03-12 sleep disorder Chills started at 10pm on 3/10/21 Woke up very achy, weak & a bit short of breath No energy at all... Read more
Chills started at 10pm on 3/10/21 Woke up very achy, weak & a bit short of breath No energy at all ALL day! Slept off & on all day. No appetite. Most symptoms went away by 9pm on 3/11/21
54 2021-03-22 sleep disorder Left upper arm, shoulder and neck became very achy. I began to experience chills without a fever aro... Read more
Left upper arm, shoulder and neck became very achy. I began to experience chills without a fever around 8:00 pm. Around 11:00pm, I began to feel nauseous. I wasn't able to sleep, my heart was racing. By 3:30 am I had vomited at least 5 times. Throughout the day on Monday, I was still very cold, nauseous (without vomiting) and somewhat lightheaded. It is now Tuesday and my stomach is still upset. I have not contacted my physician at this time. I have been treating myself with ginger ale, Pepto Bismol, saltines and rest. I'm not 100%, but feeling much better.
54 2021-03-23 sleep disorder Could not wake up, could not move and spent a day and half in the bed
54 2021-03-25 feeling drunk Chest pain, light headed, drunk feeling.
54 2021-03-30 insomnia 3/27/21 - racing heart, fever, body aches, headache. Did not sleep entire night. 3/28/21 - Headache... Read more
3/27/21 - racing heart, fever, body aches, headache. Did not sleep entire night. 3/28/21 - Headache, fatigue 3/29/21 - Headache 3/30/21 - Acute unilateral facial numbing, burning and tingling of extremities, rash on arms and torso 3/31/21 - Immune system on high alert, liver pain
54 2021-04-04 panic attack, nervousness Administered vaccine at 12:40pm Pt during administration of vaccine started to pull away but full do... Read more
Administered vaccine at 12:40pm Pt during administration of vaccine started to pull away but full dose was administered, pt was nervous about the needle. After instructing pt to sit in the post vaccine chair for 15 minutes I noticed visible distress at around 12:50pm. I rushed to her aid and asked her how she was feeling and she reported feeling dizzy. I then helped her out of her chair onto the floor to ensure she would not fall and hit her head - told her to lay supine. I then asked my technician to give me the bp monitor. I then checked her bp and it was below 80/60. I informed her this could be contributing to her dizziness and then asked for consent to help raise her bp. She consented and then I told her I would be lifting her legs in the air to raise her BP. I held her legs in the air for 10 minutes or so and then reassessed her BP and it was 110/48. She started to feel better but reported feeling as if ants were all over her left arm which is where I gave her the vaccine. I assessed once again for angioedema, anaphylaxis, hives, redness, swelling, but didnt see anything. Since the pt was dizzy I did not offer her benadryl liquid but instead offered clairitin. The pt was merely having a panic attack post immunization and said she could swallow tablets and was feeling better. I gave her one clairitn tablet otc. She wanted to sit up so I assisted her to a sitting position while she was on the floor. She sat there for additional ten minutes then moved into a chair and was brought food by her husband because he said she did not have breakfast and thought that could be why she was dizzy. She was not a diabetic so I was not concerned about her BG. She said that this never happened in the past when I reviewed her PCQF form prior to giving her the vaccine. She has had zero history of syncope so this was rare for her. After an additional 10 minutes she had a bp reading of 98/60 and left the store feeling much better
54 2021-04-04 sleep disorder I received the shot around 12:30pm around 10pm I started having chills. I went to sleep until about... Read more
I received the shot around 12:30pm around 10pm I started having chills. I went to sleep until about 1 am when I woke up and was itching on my chest, shoulders, under arms and back, my cheeks and nose was also red. There were no hives or rash just itching. At about 3:15am I toke two tylenol because I was still itching my head hurt and I just did not feel well. I did not really sleep all night at 7 I moved from my bed to the coach that is when I really noticed the body aches but the itching had mostly went away. I still did not feel well took my temp it was 99.8 I took two Advil and went to sleep around 3:30 on Saturday I felt better not 100%. Sunday I was fine back to normal.
54 2021-04-06 anxiety Patient was extremely anxious prior to injection and had to lie down for injection. Approximately 1... Read more
Patient was extremely anxious prior to injection and had to lie down for injection. Approximately 10 minutes following injection patient complained of swelling in her tongue and a numbness in her right arm. BP was taken and was normal for patient. No topical signs of allergy were noted. Patient was administered 2x25mg Diphenhydramine and monitored for 30 minutes at which time patient reported that symptoms had completely resolved. She returned to work and was seen to be symptom free 2 hours later.
54 2021-04-06 anxiety dizziness, lightheadness, anxious, headache, observation done, water offered, symptoms resolved, pt ... Read more
dizziness, lightheadness, anxious, headache, observation done, water offered, symptoms resolved, pt went home
54 2021-04-06 impaired work ability, feeling abnormal, insomnia SENSITIVE SKIN; BODY ACHE; COLD; FELT THAT SHE WAS DYING FROM WEDNESDAY-THURSDAY; FREEZE; LEG,ARM,B... Read more
SENSITIVE SKIN; BODY ACHE; COLD; FELT THAT SHE WAS DYING FROM WEDNESDAY-THURSDAY; FREEZE; LEG,ARM,BODY HURT; CHILLS; HIGH FEVER AND BURNING FROM INSIDE OUT; HAIR OF HER SKIN STAND; COULD NOT MAKE IT TO JOB; PRICKLY SKIN AND TOOTHPICKS POKING THE SKIN; COULD NOT SLEEP; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown Expiry: Unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination on right deltoid. 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 MAR-2021, the subject experienced prickly skin. On MAR-2021, the subject experienced could not sleep. On MAR-2021, the subject experienced hair of her skin stand. On MAR-2021, the subject experienced toothpicks poking the skin and toothpicks poking the skin. On MAR-2021, the subject experienced could not make it to job. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, at 4:30--5:15 PM the subject experienced leg, arm, body hurt. On 24-MAR-2021, the subject experienced cold. On 24-MAR-2021, the subject experienced felt that she was dying from Wednesday-Thursday. On 24-MAR-2021, the subject experienced freeze. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced high fever and burning from inside out. Laboratory data included: Body temperature at around At 4:30--5:15 PM (NR: not provided) 101 F. On 25-MAR-2021, the subject experienced sensitive skin. Laboratory data included: Body temperature at night about 1 am (NR: not provided) 103.2 F, 101.9 (units unspecified). On 26-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.8- 99.5 F Laboratory data included: Body temperature (NR: not provided) 100.8- 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 high fever and burning from inside out, sensitive skin, chills, and body ache, and the outcome of prickly skin and toothpicks poking the skin, could not sleep, leg,arm,body hurt, hair of her skin stand, toothpicks poking the skin, cold, felt that she was dying from Wednesday-Thursday, freeze and could not make it to job was not reported. This report was non-serious.
54 2021-04-06 impaired work ability, sleep disorder Felt fine in morning next day, 24 hours after shot started feeling I couldn't turn head, extreme nec... Read more
Felt fine in morning next day, 24 hours after shot started feeling I couldn't turn head, extreme neck pain, muscle pain, lethargic, headache. Went home from work about 2 hours later and started feeling I was going to.pass out got very cold with extreme chills and shaking, fever at 102.2. An hour later 103.4, last time took temp. Terrible in and out sleep, felt like I may have to call ambulance. Fell asleep about 8 hours after I left work, slept 2 hours, woke up covered in sweat and roasting hot. Fever had broken, felt a bit better. Slept a bit, made it to work couple hours late next day, felt better as day went on, still felt like I would like to be in bed. No fever. Just a bit achy and tired. Headache still but not bad.
54 2021-04-06 nervousness Client received the Janssen COVID vaccine (lot # 1808980 and expiration date 6/20/21) at 3:25PM. At... Read more
Client received the Janssen COVID vaccine (lot # 1808980 and expiration date 6/20/21) at 3:25PM. At 3:28PM EMT took vitals:Pulse: 82, blood pressure: 116/80, and oxygen: 94% due to client saying she felt a little shaky. Client report that she is allergic to iron infusions and takes hypothyroidism medication and has a history of anxiety. At 3:34PM vitals were Pulse: 85, blood pressure: 120/80, and oxygen: 95%. At 3:40PM PHN was notified and found patient sitting in chair alert and oriented x 4. Client also reports to PHN that she has a history of tachycardia and prior to notifying EMT she had a slight headache develop and a short dizzy spell that resolved. At 3:43PM vitals were oxygen: 97%, blood pressure: 120/78 and pulse:75. Client reports "feeling better and not shaky anymore." and "headache feels better." At 3:50PM client vitals were: blood pressure 116/80, oxygen: 97% and pulse: 76. Client alert and oriented X4 and reports no symptoms at this time and holding a conversation with no problems. At 3:58 PM vitals were oxygen: 97%, blood pressure: 110/80 and pulse:77. Provided client with emergency precautions. Client left facility with a steady gait at 4:03PM.
54 2021-04-07 feeling abnormal, sleep disorder Low blood pressure and rapid heart rate. Resting heart usually is 70 bpm but averaged 100bpms for 2... Read more
Low blood pressure and rapid heart rate. Resting heart usually is 70 bpm but averaged 100bpms for 24 hours. Horrible nausea and dizziness, which still continues. Woke up with severe chills 7 hours after injection. Mild chills continue periodically since. Fever of 100+ for 2 days, mild fever continues Shortness of breath - could not sleep lying flat for the 1st 24 hours because I felt like I could not breathe. Still short of breath when taking stairs Severe headache that has not yet gone away. Minor body aches and occasional feeling of needles being stuck in my hands the 1st 24 hours. Fatigue and brain fog, which continues.
54 2021-04-07 sleep disorder Started with sore arm. During the day following the shot I developed a very low grade fever not goin... Read more
Started with sore arm. During the day following the shot I developed a very low grade fever not going above 99.9. Had severe headache from the left ear to the right ear and going up around my forehead, as if my head was in a vise - all day. Heart was racing all day and night, couldn't sleep on my side because of it. around 24 hours after the shot I felt chest heaviness, which went away after a few minutes. Face was flushed, and I felt clammy. Went to the bathroom more than normal. Aches and joint pain, which weren't too bad. When I woke up the next day, symptoms were gone, except my arm was still sore and had slight fatigue.
54 2021-04-08 disorientation About six minutes after shot, I experienced a sudden drop in blood pressure and heart rate, became d... Read more
About six minutes after shot, I experienced a sudden drop in blood pressure and heart rate, became dizzy, faint, and disoriented and experienced a period of complete blindness for 1-2 minutes. Paramedics were sent to my vehicle, they laid me back, took vitals and assured me that eyesight would return, which it did. They monitored me for 30 minutes and gave me a granola bar which I ate. When I was stable, I drove home.
54 2021-04-09 feeling abnormal Chills, headache, severe joint pain ? especially knees? extreme fatigue, low grade fever, body pain,... Read more
Chills, headache, severe joint pain ? especially knees? extreme fatigue, low grade fever, body pain, brain fog
54 2021-04-09 feeling abnormal FLAT OUT; FEELING BAD; This spontaneous report received from a patient concerned a 54 year old femal... Read more
FLAT OUT; FEELING BAD; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced feeling bad. On 01-APR-2021, the subject experienced flat out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling bad, and flat out. This report was non-serious.
54 2021-04-10 abnormal dreams Symptoms came on suddenly and have lasted through the night and still going the following day. I wou... Read more
Symptoms came on suddenly and have lasted through the night and still going the following day. I would like to add that the side effects seem to have targeted areas that were hurting/ailments prior to the vaccine. 1. Headache 2. Fever 101.4 throughout the night 3. Flu like symptoms (felt like I was hit by a truck) 4. Shot was in left arm, however, no real pain. I have trigger finger in my left thumb that was going away, however, the pain intensified through the night. 5. I have Tennis Elbow and Trigger finger in my right thumb that was also starting to go away, but during the night, the pain was intense. 6. I have cuts on the bottom of my feet. During the night, my feet were on fire! I was having to cool them periodically. 7. Massive strange dream.
54 2021-04-10 loss of personal independence in daily activities Between 7-28 hours after injection experienced severe chills, headache, nausea, body aches. It was ... Read more
Between 7-28 hours after injection experienced severe chills, headache, nausea, body aches. It was completely incapacitating and I needed assistance. Had very difficult time keeping Tylenol down. Was able to get up and use bathroom with assistance. Worsts headache I have ever had. Tylenol didn?t help much. All I could do was try to sleep and not move for fear of throwing up and worsening headache. Will not take this vaccine again as this was a terrible experience. Resolved mostly after 28 hrs after injection
54 2021-04-10 sleep disorder Lack of sleep , not able to sleep at all,
54 2021-04-11 delirium I received the shot on a Friday on my lunch hour and had arm pain for about an hour. That night sta... Read more
I received the shot on a Friday on my lunch hour and had arm pain for about an hour. That night started developing some tiredness and body aches and a slight fever. Saturday I could not get out of bed. Chills, muscle aches and fever, ran a fever so high 104 plus I was delirious and could not get warm. Sunday fever was down to 101. Monday had a full blown head cold that lasted for 24 hrs. About 2 weeks later I developed this right ear ringing. It never stops and it is getting louder. 24 hours a day.
54 2021-04-12 disorientation I started feeling dissy around 9:00 p. m. or shortly after then having a mild headache. As the ni... Read more
I started feeling dissy around 9:00 p. m. or shortly after then having a mild headache. As the night progressed I started having chills and the headache gotten worse. I took a ibuprofen and went to bed. In the morning I woke up feeling very weak with excruciating pain in my joints and muscles and a chronic headache. I could not move around without holding on because I was disoriented. This went on until the second day I woke up without the pain but still feeling weak in my legs and entire body.
54 2021-04-12 feeling abnormal At 4:00am the day after the Johnson & Johnson vaccine, I woke up with a migraine headache, a fever, ... Read more
At 4:00am the day after the Johnson & Johnson vaccine, I woke up with a migraine headache, a fever, chills, muscle soreness, and dry throat. I could hardly raise my head off of the pillow. I was extremely sick for over 24 hours. Four days later, I'm still dizzy and light headed, no appetite and foggy.
54 2021-04-12 impaired work ability Severe spasticity started at 7:00pm 3/31 - couldn't move - all cramped. By midnight started vomitin... Read more
Severe spasticity started at 7:00pm 3/31 - couldn't move - all cramped. By midnight started vomiting which lasted until 7:30am. Spasticity lasted about 8 hours. SHINGLES outbreak noticed Sunday at 5:30am on the left side of my trunk. Full outbreak by Thursday the 8th which wrapped around to the front side of my left side. Went to the doctor at 7:30 on the 9th. Started Valacyclovir at 10:00am - 7 day dose. Tons of pain. Have been out of work since diagnosis so far.
54 2021-04-12 insomnia April 1st she received Johnson and Johnson vaccine Lot # 043A21A 10:20am Left arm 0.5mg --------... Read more
April 1st she received Johnson and Johnson vaccine Lot # 043A21A 10:20am Left arm 0.5mg -----------side effects started around 5pm 103 fever Shaking Terrible headache. Worst of her life. Not able to sleep at all that night. Next morning was better. Slept all day the next day 24 hour mark was feeling better. Did not seek treatment, did not take anything over the counter.
54 2021-04-12 loss of personal independence in daily activities JANSSEN COVID - 19 VACCINE EUA SEVERE CHILLS, HEADACHE, NAUSEA, FEVER, BODY ACHES, JOINT PAIN, EXTRE... Read more
JANSSEN COVID - 19 VACCINE EUA SEVERE CHILLS, HEADACHE, NAUSEA, FEVER, BODY ACHES, JOINT PAIN, EXTREME FATIGUE - INABILITY TO GO ABOUT MY NORMAL ACTIVITIES FOR ONE WEEK
54 2021-04-12 sleep disorder I started feeling pain, burning, in my left arm pit the night of the vaccination. The pain decrease... Read more
I started feeling pain, burning, in my left arm pit the night of the vaccination. The pain decreased next couple of nights until last night when it woke me up with severe intensity and burning pain. I have been struggling with this all day long.
54 2021-04-13 anxiety 3:40 4/10/2021 itchy throat, hot tingly feeling and headache... 4pm throat felt tighter .. felt anx... Read more
3:40 4/10/2021 itchy throat, hot tingly feeling and headache... 4pm throat felt tighter .. felt anxious... took benadryl 10ml liquid about4 30.. was feeling very hot... no fever.. Woke up 4/11 around 3-4 am.. worst headache ever, my ears hurt, teeth like every individual one were infected,freezing, shaking, dizzy, nausated, whole body itching, not able to stand up without help because I couldn't balance.. took pain medication to help take the edge off the pain and bendryl.. couldn't stay awake, next day throat feeling like it was swollen, icy hot feeling similar to contrast put in me, cramping in my lower left leg, monday.. same conditons except not the constant headache, blured vision better, still dizzy monday at 5 am chest feels slight pressure.. lower back pain like labor pains, sharp pain in stomach like the injection they give you to thin blood before surgery painful sharp pain.. later in day.. headache again, itchy body, throat sore, continual stoache pain, tuesday same.. wed.. my neck slightly swollen and sore
54 2021-04-13 disorientation, sleep disorder, disturbance in attention The day after the vaccine (Sunday, 3/21/21), I had severe leg pain--throbbing in both legs. My legs... Read more
The day after the vaccine (Sunday, 3/21/21), I had severe leg pain--throbbing in both legs. My legs felt warm to the touch. I also had a severe headache all day and a feeling of disorientation like I couldn't focus or concentrate. I felt light-headed and very tired. There was swelling, redness, and pain at the injection site (my left arm) all the way down the left side of my body (under my arm and around my ribs). I took Acetaminophen, but the pain persisted all day. The pain in my legs was the worst symptom and it was so painful and uncomfortable that it was impossible to sleep that night. I've never felt anything like it. I was planning to go to an emergency clinic the next day if the pain continued. I finally got to sleep in the morning (Monday, 3/22/21) and slept for several hours. When I woke up later that day (3/22/21), the pain was gone and I felt normal again. I was still tired for the rest of the week and I continued to have swelling in my arm at the injection site, but otherwise, no other symptoms. It took approximately 6 days for the pain and swelling in my arm to feel better. I did not seek medical attention because the leg pain was gone within 24 hours, but I am concerned now and am wondering if there has been any permanent damage to my circulatory system or heart. I have noticed that my pulse has been elevated for the last 3 weeks (as compared to normal).
54 2021-04-13 feeling abnormal Immediate reaction in right arm-it felt like my arm was on fire. The pharmacist gave the shot extrem... Read more
Immediate reaction in right arm-it felt like my arm was on fire. The pharmacist gave the shot extremely high-almost in the shoulder and the reaction was intensely painful. Starting about 6 days later, the soreness of the shot developed into not being able to raise that arm at all without pain. Now, a month later, the pain is worse and is waking me up at night. The injection site is not sore, but the arm itself is not functional without pain. About 2 weeks after the shot, I started having a fuzzy feeling in my head (not painful) and ears. I am extremely sensitive to sound and feel almost dizzy at times. My speech has been slurred and words are not coming to me easily. I am extremely tired and feel foggy.
54 2021-04-13 loss of personal independence in daily activities Started with nausea and headache (within a couple of hours of shot). Woke at 12:20 am with high temp... Read more
Started with nausea and headache (within a couple of hours of shot). Woke at 12:20 am with high temperature, severe shakes, extreme weakness and inability to walk without assistance due to shaking and weakness. Had extreme body aches and full blown migraine. Was too weak to call for help. Had Advil in nightstand and took several to help. Called doctor in the morning and was advised to rotate Advil and Tylenol. Was too weak to get out of bed all next day (Friday) and half of Saturday. Also experienced tightness in chest to where I had to start taking Albuterol (haven't taken that in years). Bad side effects and extreme weakness and total loss of energy lasted 3 days. Persistent headache and tightness in chest lasted up to 7 days.. Horrible experience. I felt like I was poisoned.
54 2021-04-13 mental impairment, feeling abnormal I was fine all day with no sore shoulder until 8:00 when I started getting a headache, feeling cold.... Read more
I was fine all day with no sore shoulder until 8:00 when I started getting a headache, feeling cold. I kept getting more uncomfortable , colder and getting body shakes. By 10:00 I could hardly walk to bed because of uncontrollable muscle shaking, jaw chattering, and was unable to get warm. I took Advil then. It took about an hour to stop shaking and warm up in bed with my husband. I felt terrible for the next 2 1/2 days, just horrible, unable to function. I slept a lot.
54 2021-04-17 loss of personal independence in daily activities, disturbance in attention, amnesia, feeling abnormal 8 hours severe symptoms started: over 100 fever, nausea, every muscle, organ, ligament and fiber in... Read more
8 hours severe symptoms started: over 100 fever, nausea, every muscle, organ, ligament and fiber in body felt on fire and with severe pain, so bad I could barely move. Chills and sweats. Heart rate for all night over 100. Had profound weakness. It was so bad I could not go from laying to sitting up without someone pulling me up to sitting. I was so weak I could not life the water glass and could not twist open orange juice container. Extremely fatigued and in pain with nausea and weakness the next few days. Long hauler symptoms came back and Day 2 had a severe headache & abdominal pain started, abdominal and back pain most days and can be significant. Day 6 Mack truck fatigue and cycling of fatigue symptoms since immunization. Day 7 severe headache. Neuro symptoms returned with memory loss, brain fog, in ability to concentrate and inability to finish tasks.
54 2021-04-18 confusional state I had an electrical jolt run from the back of my neck into the scalp and down the left side of my ne... Read more
I had an electrical jolt run from the back of my neck into the scalp and down the left side of my neck into my left arm with pain pressure and soreness in these area and in the base of my head with some confusion and stiffness in the left side of my face followed by the right side. This lasted for six days afterward
54 2021-04-18 motion sickness Migrane headache, dizziness, motion sickness, arm still hurts, body aches, fatigue, tiredness., chil... Read more
Migrane headache, dizziness, motion sickness, arm still hurts, body aches, fatigue, tiredness., chills.
54 2021-04-19 feeling abnormal Began developing compression in front of head Saturday morning. By mid afternoon began feeling nause... Read more
Began developing compression in front of head Saturday morning. By mid afternoon began feeling nausea, dizzy, foggy brain, fatigue, compression in upper body, muscle aches, and chills. This continued for several days with an added headache. After the 2nd day my left arm also became sore. I took nothing- just rested. The foggy brain has continued for 10 days, at the time of this report. I continue to be light headed and easily get winded. I still have compression in the center of my forehead.
54 2021-04-20 anxiety HEART RATE HIGH; CHILLS; DIFFICULTY BREATHING/SHORTNESS OF BREATH; COUGHING; FEELING ANXIOUS; HEADAC... Read more
HEART RATE HIGH; CHILLS; DIFFICULTY BREATHING/SHORTNESS OF BREATH; COUGHING; FEELING ANXIOUS; HEADACHE; FEELING UNWELL; INJECTION SITE SORE; INJECTION SITE WARMTH; FATIGUE; TIREDNESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced injection site warmth. On 08-APR-2021, the subject experienced injection site sore. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced feeling unwell. On 10-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced difficulty breathing/shortness of breath. On 12-APR-2021, the subject experienced coughing. On 12-APR-2021, the subject experienced feeling anxious. On 13-APR-2021, the subject experienced heart rate high. On 13-APR-2021, the subject experienced chills. Laboratory data included: Heart rate (NR: not provided) unknown, and Pulse rate (NR: not provided) 105. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of injection site sore, injection site warmth, fatigue, difficulty breathing/shortness of breath, coughing, heart rate high, tiredness, feeling unwell, chills and feeling anxious 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
54 2021-04-20 feeling abnormal, disorientation Adverse unexpected extreme dizziness, disorientation, headache and behind "eye" aches (most prominen... Read more
Adverse unexpected extreme dizziness, disorientation, headache and behind "eye" aches (most prominent on left side), along with mild fever of 100.4 degrees on day 6 after vaccine (prior to day 6 the dizziness and disorientation was mild). Symptoms got increasingly worse and peaked around day 6 and 7 after vaccine. Sporadic bouts of "dizziness" or "glitching and buzzy" feeling in head continue, but are not constant as they were in the 2-10 days following the vaccine.
54 2021-04-20 feeling abnormal NERVE TINGLING; BLISTER UNDER THE TONGUE; TIRED; FATIGUE; HEADACHE; MUSCLE ACHE; INJECTION SITE SORE... Read more
NERVE TINGLING; BLISTER UNDER THE TONGUE; TIRED; FATIGUE; HEADACHE; MUSCLE ACHE; INJECTION SITE SORE; INJECTION SITE BRUISED; CRAWLING UNDER THE SKIN; BUZZING; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included menopausal, and concurrent conditions included penicilline allergy, sulfa allergy, wheat allergy, alcohol abstain, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for spinal stenosis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On APR-2021, the subject experienced injection site bruised. On APR-2021, the subject experienced crawling under the skin. On APR-2021, the subject experienced buzzing. On APR-2021, the subject experienced injection site sore. On 07-APR-2021, the subject experienced nerve tingling. On 07-APR-2021, the subject experienced blister under the tongue. On 07-APR-2021, the subject experienced tired. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nerve tingling, blister under the tongue, and headache on 09-APR-2021, and injection site bruised, and injection site sore on APR-2021, and the outcome of tired, fatigue, muscle ache, crawling under the skin and buzzing was not reported. This report was non-serious.
54 2021-04-21 feeling abnormal STOMACH PAIN; LEFT LEG CRAMP; KNEE ACHE; TIRED; FEVER; FELT FOGGY AND DAZE; LOSS OF APPETITE; EYE PA... Read more
STOMACH PAIN; LEFT LEG CRAMP; KNEE ACHE; TIRED; FEVER; FELT FOGGY AND DAZE; LOSS OF APPETITE; EYE PAIN; DIARRHEA; STOMACH FLU; VOMITING; HOT FLASHES ON BACK; HEADACHE; BODY TREMBLING; ARM BURNING; LYMPH NODE PAIN; UNDER ARM PAIN; INJECTION SITE WARM; ARM SORE; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included sore arm, injection site redness, and hand numbness, and concurrent conditions included asthma. The patient was previously treated with tetanus vaccine for tetanus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 15:00 for prophylactic vaccination. Concomitant medications included salbutamol for asthma, and salbutamol sulfate for asthma. On 07-APR-2021, the subject experienced body trembling. On 07-APR-2021, the subject experienced arm burning. On 07-APR-2021, the subject experienced lymph node pain. On 07-APR-2021, the subject experienced under arm pain. On 07-APR-2021, the subject experienced injection site warm. On 07-APR-2021, the subject experienced arm sore. Treatment medications included: paracetamol. On 08-APR-2021, the subject experienced eye pain. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced stomach flu. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced hot flashes on back. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced felt foggy and daze. On 09-APR-2021, the subject experienced loss of appetite. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 100.1 T. On 10-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced left leg cramp. On 10-APR-2021, the subject experienced knee ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and vomiting on 08-APR-2021, and hot flashes on back on 11-APR-2021, had not recovered from headache, and stomach pain, and the outcome of body trembling, arm burning, arm sore, lymph node pain, under arm pain, injection site warm, eye pain, stomach flu, fever, left leg cramp, knee ache, felt foggy and daze, loss of appetite and tired was not reported. This report was non-serious.
54 2021-04-22 impaired work ability, depression pt says she developed a full body rash. About a week and a half later she is now experiencing head... Read more
pt says she developed a full body rash. About a week and a half later she is now experiencing headaches, depression, a metallic taste in her mouth, head pressure, feeling of being high or that her brain is swelling, nausea, and numbness in the last three fingers in both hands. She says her heart rate is really fast. On 4/19/2021 BP was 191/102. The did EKG that was normal and lab work. Pt has not received lab results. Pt says she will go to the ER today since she is still having all of these symptoms and she could not get our of bed to go to work.
54 2021-04-22 insomnia Day 5 after vaccine I got fever, chills, and loud ringing(tinnitus) in both ears. Followed by head... Read more
Day 5 after vaccine I got fever, chills, and loud ringing(tinnitus) in both ears. Followed by headache, fatigue, dizziness, strange ammonia like smell in my nose, shortness of breath, yellow diarrhea, intestinal pain, insomnia, and lack of appetite. Have been very sick for the last 4 weeks and continuing. Have had lowered Blood pressure, elevated fasting glucose, and kidney GFR effected also. The constant ear ringing is just horrible!!!
54 2021-04-26 anxiety, feeling abnormal, insomnia NUMBNESS IN HAND; HEADACHE; BRAIN FOG; INSOMNIA; BODY PAIN; NAUSEA; CHILLS; TIREDNESS; PAIN AT SITE ... Read more
NUMBNESS IN HAND; HEADACHE; BRAIN FOG; INSOMNIA; BODY PAIN; NAUSEA; CHILLS; TIREDNESS; PAIN AT SITE OF INJECTION; RAPID HEARTBEAT; RESTRICTED BREATHING; INCREASED BLOOD PRESSURE; HEAT SENSATION THAT WENT FROM HER FEET TO HER HANDS; LIGHT HEADEDNESS/DIZZINESS; SWEATS; ANXIETY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and over weight, 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: 207A21A, and batch number: 207A21A 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 anxiety. On 09-APR-2021, the subject experienced rapid heartbeat. On 09-APR-2021, the subject experienced restricted breathing. On 09-APR-2021, the subject experienced increased blood pressure. On 09-APR-2021, the subject experienced heat sensation that went from her feet to her hands. On 09-APR-2021, the subject experienced light headedness/dizziness. On 09-APR-2021, the subject experienced sweats. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced pain at site of injection. Laboratory data included: Blood pressure (NR: not provided) Increased. On 10-APR-2021, the subject experienced insomnia. On 10-APR-2021, the subject experienced body pain. On 10-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced brain fog. On 11-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced numbness in hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, restricted breathing, increased blood pressure, heat sensation that went from her feet to her hands, light headedness/dizziness, and sweats on 09-APR-2021, brain fog on 12-APR-2021, anxiety on APR-2021, chills, and nausea on 10-APR-2021, was recovering from pain at site of injection, insomnia, body pain, and headache, and had not recovered from tiredness, and numbness in hand. 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.
54 2021-04-26 feeling abnormal PASSED OUT; VERY HOT FEELING; SKIN WAS BURNING LIKE SEVERE SUNBURN ( ON WAIST, SHOULDER, ARM, HAND, ... Read more
PASSED OUT; VERY HOT FEELING; SKIN WAS BURNING LIKE SEVERE SUNBURN ( ON WAIST, SHOULDER, ARM, HAND, BELLY, NECK, BREAST, AND FACE); BODY DRAINED; SKIN REDNESS; GOOSE BUMPS; FEELING COLD; SCRATCHED BODY; HEADACHE; FELT LIKE FAINTING BUT DID NOT FAINT; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 165 pounds, and height was 154.94 centimeters. The patient's concurrent conditions included high blood pressure, diabetes, penicillin allergy, nonsmoker, and non-alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980,expiry: 20-JUN-2021) .5 ml, administered on 30-MAR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the patient experienced dizziness (felt like fainting but did not faint). Then 15 minutes later, she was fine. On 31-MAR-2021, the patient experienced headache. On 03-APR-2021, three hours into the work, she felt very very hot and her skin was burning like severe sunburn. It was waist, shoulder, arm, hand, belly, neck, breast, and face were hot and red. She scratched the body and was really warm and skin was really red. After 40 min, the patient's body went to back to normal. After 5 min, patient started feeling really cold and goose bumps on her arms that lasted for 30 minutes. After that episode she went home and felt her body was drained and passed out. The patient felt better on 04-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 04-APR-2021, very hot feeling, skin was burning like severe sunburn ( on waist, shoulder, arm, hand, belly, neck, breast, and face), body drained, skin redness, goose bumps, feeling cold, and scratched body on 03-APR-2021, and felt like fainting but did not faint on 30-MAR-2021, and was recovering from headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210430845-covid-19 vaccine ad26.cov2.s-Passed out. -This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
54 2021-04-28 feeling abnormal, emotional distress She got the vaccine, when they put the needle in she said it was far in. The pain was bad, but she ... Read more
She got the vaccine, when they put the needle in she said it was far in. The pain was bad, but she could deal with it. Then 5 days later something hit her and hit her bad. She went to the ER and they gave her Bentyl, diarrhea medicine as she was vomiting, not eating anything, and they gave her some anti-vomiting medicine. They sent her home and said she would feel better. The diarrhea and vomiting stopped but she then started with a rash. it's all over her hands, arms, back, itching, and taking Claritin for it. it won't go away. Her symptoms continued to worsen, and woke up one morning and had so much pain that she could not move or breath and her husband called an ambulance and they took her hospital and diagnosed with a blood clot. She was in the hospital for 3 days and now discharged on Eliquis. She has bruises all over her coming out and very upset that she is still feeling bad and doesn't know how the rash is going to go away. She was also prescribed Oxycodone for pain and also Tessalon Perls to take for coughing.
54 2021-04-29 sleep disorder As I drove away after getting the vaccine, I had some very sharp pain in my stomach. It came back th... Read more
As I drove away after getting the vaccine, I had some very sharp pain in my stomach. It came back the next day but not since then. I woke up during the night with chills and a severe headache which lasted 36 hours. Ten to twelve days after the shot I had extreme fatigue and head pain. It was above my right ear almost to my temple and goes toward the top of my head which was a very sharp pain that lingered. These head pains last hours at a time and feels like the veins in my head are aching. They were daily all day for two weeks but now they are more intermittent. Nothing I took helped with the pain. They are not like headaches. On 04/17/2021 I woke up during the night with a sharp pain in my head. I went to the ER and they did a MRI but they did not find anything. The sharp pains lasted the next two days. My doctor said that the shot had triggered Cranial Neuralgia. I may have to take some medication to calm the nerves down. I still had the pain in my head today which is four weeks after the vaccine. I am also worried about the extreme fatigue which makes me feel like falling asleep at my desk. Some days it is worse than others. I had Covid-19 in April of 2020 and had fatigue for six months.
54 2021-05-11 crying 10 minutes after getting the Johnson and Johnson vaccine, while patient was waiting in the waiting a... Read more
10 minutes after getting the Johnson and Johnson vaccine, while patient was waiting in the waiting area for 30 minutes due to history of bee allergy and anaphylaxis, she reported shortness of breath and dizziness to nurse. Assisted her to the floor with her legs up- obtaining pulse ox and BP/HR, which were stables. Patient reported shortness of breath and dizziness, worsening symptoms, she was tearful, and stated symptoms are the same as her previous anaphylaxis reaction. I informed her I was giving her a dose of epi, and injected 0.3 ml of epi, adult dose to left thigh. Patient reported immediate relief, EMT arrived, At 15 minutes, patient was crying and laughing, reporting worsening SOB again. EMTs arrived and took over the scene. Patient was transported to hospital.
54 2021-05-23 insomnia I experienced worst headache I can imagine, worst pain, could not sleep, the pain was so bad after r... Read more
I experienced worst headache I can imagine, worst pain, could not sleep, the pain was so bad after receiving my Janssen vaccine. The aches in my body was so intense, could not tell you if it was localized. The worse nausea as well and felt sick to my stomach and could not keep anything down. I called Dr told me to start taking Ibuprofen and my pain started to subside slowly. My symptoms lasted over 24 hours and then my symptoms slowly started to improve after taking the Ibuprofen.
54 2021-05-26 sleep disorder Pt started getting daily headaches lasting 5 mins multiple times per day in different parts of her h... Read more
Pt started getting daily headaches lasting 5 mins multiple times per day in different parts of her head. Some can be severe enough that they wake her from her sleep.
54 2021-05-28 insomnia Later that night she could not walk, had chills, had fever, and couldn't sleep and eat for two days,... Read more
Later that night she could not walk, had chills, had fever, and couldn't sleep and eat for two days, went to family doctor Dr. still couldn't figure out what was going on still was having problems breathing and leg was having terrible shivering and is also having menstrual problems that she hasn't had in years; she also stated that she is having a hard time with moving .
54 2021-06-01 insomnia I started with a headache. It lasted for about five days. I didn't have body aches but I had joint a... Read more
I started with a headache. It lasted for about five days. I didn't have body aches but I had joint aches. My ankle, knee, wrist and fingers - all of my joints hurt but they didn't ache. I had gastro-intestinal issues. They all started about the end of day 2 and beginning of day three after the vaccine. I had stomach discomfort. I eventually had diarrhea on day three or four. On the first day after the vaccine, I felt extreme vaccine and that lasted about 7 days. It was the kind of exhaustion as when you're first pregnant but times 10. I couldn't sleep well and I was so, so tired. I got acupuncture for my joint pain. Everything pretty much dissipated by day 8. Except, I do still have some pain in my right ankle - in the Achilles tendon area. That started right away and I have had acupuncture for that a few times. Note: I have MTHFR blood clotting disease - I specifically have A1278C. It can cause blood clotting but the vaccine did not cause this issue in me.
54 2021-06-03 feeling abnormal, anxiety I went to the gym - I did a shoulder and chest day at the gym about 3 or 4 hours after the vaccine. ... Read more
I went to the gym - I did a shoulder and chest day at the gym about 3 or 4 hours after the vaccine. Everything was normal. At 04:00 the next day, I was at the gym and I was about to change my clothes - and I felt this wave of anxiety which is very unusual for me. I took off my top to change and I had a full body rash - it was everywhere and hadn't been there an hour before. It was a histamine response that I was perceiving as anxiety. I was about 7 minutes from an ER, so I went to the Medical Center- nothing was swelling and I was able to breathe. They gave me two mls of Benadryl - they gave me a shot in the "tush." The other "cheek" got a steroid (but not prednisone) dexamethasone, I think. They also gave me Pepcid orally. Told to take Pepcid twice a day for 5 days. They gave me steroid - oral prednisone - three tablets - once a day for three days (20 mg). It stopped the allergic reaction. It was a miserable week or so. The next day, I did my cardio - I had such a bloom of hives on armpits - fire and itching at the same time. I did no physical exercise for about three days. Then I went back to my regular activities. I tolerated what was going on (I was exacerbating the symptoms) but the allergy was done. Every day it got better. At two weeks, I was totally fine. I have returned to all my regular activities.
54 2021-06-17 anxiety, feeling abnormal She states she did not eat breakfast but this is normal for her and had coffee this morning, nothing... Read more
She states she did not eat breakfast but this is normal for her and had coffee this morning, nothing else out of the ordinary. Was very anxious feeling before the vaccine. Pt to ER for dizziness after she received covid vaccine About 5 minutes afterwards she began feeling more anxious, as well as dizzy and lightheaded, vomiting once. No LOC noted. At this point feeling a little "foggy" which has persisted. She has been ambulatory and has no focal weakness or other problems. No history of reactions to other vaccines in the past. Lightheadedness Vasovagal episode . Nausea,Vomiting. ED visit,Monitoring at vaccine site
54 2021-07-03 feeling abnormal The day after the J&J vaccine I experienced the typical headaches, backache and sore arm which I was... Read more
The day after the J&J vaccine I experienced the typical headaches, backache and sore arm which I was told to expect. My headaches, backache and arm pain lasted approx 4 weeks. I took advil/tylenol daily for weeks due to the discomfort. My arm pain continues to persist three months after the vaccine. I also developed swollen lymph nodes along my collar bones 3 months after the vaccine. It is on the same side as my vaccine. I have went from being 100% healthy and feeling great to constant arm pain, occasional arm numbness, swollen lymph nodes (which I have never had in my life) and generally feeling unlike my self. I reached out to my Dr. and am awaiting bloodwork results. I have three ultrasounds scheduled as well as 2 cat scans. They are looking for blood clots and trying to figure out the pain at the injection site as well as swollen lymph nodes on the vaccine side. In closing, I feel something is very wrong as my symptoms persist and multiply.
54 2021-07-11 anxiety, feeling abnormal, loss of personal independence in daily activities On May 13th, I felt my feet go numb and I could not stand. I sat down to immediately find a heat go ... Read more
On May 13th, I felt my feet go numb and I could not stand. I sat down to immediately find a heat go through my bod - heat to head. I then felt my heart racing. Took my pulse and it was 134. (I have had no heart issues at all previously - normal resting heart rate in the 60s). Three more times this happened, with heat going from feet to head (numbness in feet). Each heart rate was progressively lower with each incidence. Then it stopped. This was in the afternoon and by evening felt ok. The 14th, the same thing happened but only 3 times and with hr incidents starting at 123. Then fine again. The morning of the 15th started again, so I went to urgent care appointment in the afternoon. By this time, my heart rate was up and down.. They ran an EKG and it was fine, just showing rapid heart rate. But I was sent to the ER for further tests. At ER another EKG, chest x-ray and blood work. Only item of significance was an elevated TSH. At this point, my heart rate was going up and down (I had a finger monitor so I could watch it). I'll note at this point, the heart rate was random but I was able to walk. Over the next week or so, hr got worse and positional. When I stood up, it would sky rocket to the 140s. I became shaky, developed brain fog, nausea, feeling like I was going to fall over and felt only well laying down or sitting. I visited my primary who initially thought anxiety but as symptoms were getting worse (I could no longer do anything: walk farther than from the living room to the kitchen, do simple tasks while standing or sitting - hr would increase while doing activities even while sitting, and no longer drive).My doctor decided it was more than anxiety when I was continuing to have symptoms that looked like POTS. I have been to the cardiologist - she did a 24 holter and EKG - no significance, but decided my heart was not the primary cause of the positional heart rate increase. I am due for an echocardiogram this week - just to make sure but she did not think that was the issue. An MRI this week, recommended by my neurologist. and have done preliminary blood work/urinalysis for possible endocrine issues - all that have come back normal so far (but seeing an endocrinologist next month anyway). I currently am seeing functional neurologist who has diagnosed me with dysautonomia (so far of unknown reasons) - he is helping me with the heart rate issue (POTS) and other symptoms that have developed over the weeks like electrical zaps throughout my body - some sort of neruopathy. I was in great health until this shot. I had not even had a cold since January of 2020. I may have hypothyroidism but it has been managed with some ups and downs in TSH for the last 20 years with no other issues. Some of my doctors do not correlate the shot to my problem but some have. There does not seem to be any other explanation.
54 2021-07-14 feeling abnormal Extreme chills and low body temperature for 5 hours, beginning 9 hours post injection. Unable to war... Read more
Extreme chills and low body temperature for 5 hours, beginning 9 hours post injection. Unable to warm my body, felt cold to touch, with chills so extreme I would have chipped teeth without my mouth guard. I felt like I was going to have a seizure - woke my husband up to monitor me. Ongoing headache for a week and tinnitus intermittent for 2 months.
54 2021-07-18 disorientation, feeling abnormal ABNORMAL LABWORK; LOW LYMPHOCYTES; HIGH NEUROCYTES; LOSS OF CONSCIOUSNESS; VASOVAGAL EVENT; ALMOST C... Read more
ABNORMAL LABWORK; LOW LYMPHOCYTES; HIGH NEUROCYTES; LOSS OF CONSCIOUSNESS; VASOVAGAL EVENT; ALMOST CONVULSIVE; PROFUSE VOMITING; DISORIENTED; FELT VERY STRANGE; CHILLS; EXTREME FATIGUE; STRANGE HEADACHE ON RIGHT SIDE OF HEAD; This spontaneous report was received from a 54-year-old female patient. The patient's weight was 140 pounds, and height was 62 inches. The patient's concurrent conditions included type 2 diabetes mellitus, fibromyalgia, social alcohol drinker, seasonal allergy, and coronavirus disease (covid-19). The patient had covid in NOV-2020, from which she got severe neurologic effects, and was still not fully recovered from covid and continued to experience severe vertigo, ringing in ears, and taste and smell have still not fully returned at the time of reporting. The patient does not smoke, had no drug abuse/illicit drug use and no drug 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 administration was not reported, batch number: 206A21A, and expiry: 07-AUG-2021) dose was not reported, 1 total, administered on left arm on 08-MAY-2021 for prophylactic vaccination. It was unknown if the product was stored in appropriate temperature conditions and if it was properly stored from receipt to administration. No concomitant medications were reported. On 08-MAY-2021, following vaccination, the patient at first felt totally fine, however, after 4 to 4.5 hours, the patient felt everything was going black and she passed out (loss of consciousness) and vomited profusely. She was out cold for about five minutes and woke up shaking with extreme chills and was almost convulsive following which an ambulance was called. The patient woke up in the back of the ambulance and told the emergency medical technicians (EMTs) that she was vaccinated and the EMTs said it was just a vasovagal event. The patient was taken to the emergency room (ER) and the ER doctor told the same thing. The patient's blood was taken and she was given intravenous (IV) fluids. The patient felt very strange, similar to what she felt at the time she got covid but it was milder. The patient felt disoriented, extreme fatigue, and a strange headache on the right side of head. At the hospital that day, a computed tomogram (CAT) scan was done but, it was clear. The patient was then released on the same day. On 09-MAY-2021, the bloodwork results came and was very alarming (abnormal lab work; detailed results not provided). The patient then reached out to her healthcare professional (HCP) for lab review and they were very concerned about the results. Her lymphocytes were low and 'neurocytes' were high (as reported), 'everything was off'. The patient was asked to wait for few days for more lab tests be taken during that time. The patient was told if it gets better it would be vaccine-related and if it does not it could be leukemia. Her disorientation, fatigue, and headache lasted for about 5 days until around 13-MAY-2021. The blood work started to return to normal after a few more days, and the HCP confirmed it was vaccine-related. The patient stated that her research showed that the adverse events could be a result of her covid, and not vaccine-related. All of her adverse events went on within the first week following the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, vasovagal event, almost convulsive, profuse vomiting, and chills on 08-MAY-2021, and disoriented, felt very strange, extreme fatigue, strange headache on right side of head, abnormal labwork, low lymphocytes, and high neurocytes on 13-MAY-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210730727-Covid-19 vaccine ad26.cov2.s-Loss of consciousness, Vasovagal event, Almost convulsive, Profuse vomiting, Disoriented, Felt very strange. 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). V0: 20210730727-Covid-19 vaccine ad26.cov2.s-Chills ,Extreme fatigue, Strange headache on right side of head. This event(s) is labeled per RSI and is therefore considered potentially related.
54 2021-07-21 memory impairment, feeling abnormal I have been extremely tired. I now have Like a Brain Fog , I can?t remember simple things. I can?t F... Read more
I have been extremely tired. I now have Like a Brain Fog , I can?t remember simple things. I can?t Function the way I used to. My arm is still sore and I?m just tired all the time.
54 2021-07-27 loss of personal independence in daily activities pain starting in legs, spreading through body. rec'd vaccine in May, believes she has Guillan-Barre.... Read more
pain starting in legs, spreading through body. rec'd vaccine in May, believes she has Guillan-Barre. states she normally walks w/out a cane and has some episodes of urinary incontinence. 54 years old with past history of asthma came in for with lower extremity weakness and pain after she was given the Johnson & Johnson COVID-19 vaccine on May 7, 2021. Patient thinks this is related to the vaccine, she thought it was progressive pain and worsening of weakness which has become unsteady. Admitted to the hospital to rule out Gilliam Barré and other progressive post viral infection myelopathies. We will also worried about multiple sclerosis. She did have a spinal tap which is completely normal with no evidence of encephalitis, meningitis or evidence of Gilliam Barre, she did also have MRI of the brain, cervical, thoracic and lumbar spines which is also completely negative. Seen by neurology and think this is likely fibromyalgia because of the weakness and pain together not clinically fitting with any post viral infection neuropathy. Patient was put on Cymbalta but this will take at least about 1-2 weeks to get the effect of improvement. She was seen by PT and OT and has some improvement to her weakness and was able to walk with assistance and recommend that she'll go home with home health to continue therapy and she'll follow-up with neurology. She may also benefit from Tizanidine if Cymbalta is not making a lot of difference.?
55 2021-03-09 feeling abnormal Headache, dizziness, temporary tingling and numbness of lips and loss of smell; foggy brain , inabi... Read more
Headache, dizziness, temporary tingling and numbness of lips and loss of smell; foggy brain , inability to complete sentence and thoughts lasting 3-5 hours with slightly slurred speech
55 2021-03-11 feeling abnormal 6 hours after receiving vaccine, I started to get the chills, then body aches, then very intense sha... Read more
6 hours after receiving vaccine, I started to get the chills, then body aches, then very intense shaking to go along with the chills and body aches. I felt terrible and the shivering was uncontrollable. I took one 200 mg of ibuprofen at 9 or 10pm, and another one at 11pm. That seemed to help and I fell asleep. When I awoke in the morning, I had a pounding headache. The headache was debilitating and lasted all day. The headache subsided around 6 pm 10/11/21 after taking a 200 mg ibuprofen. All of the above is unlike anything I have ever experienced, even with a fever or flu. It was misery, and I am a good sport, I didn't expect to have any side effects. These events came on vicious and strong.
55 2021-03-11 loss of personal independence in daily activities immediate severe arm pain, 102 fever, severe weakness, severe chills, loss of appetite, diarrhea, se... Read more
immediate severe arm pain, 102 fever, severe weakness, severe chills, loss of appetite, diarrhea, severe body aches, the worst of which lasted 24 to 36 hours. Symptoms were to the point I could barely take care of myself and needed help. Considered going to ER
55 2021-03-17 impaired work ability woke up about 12:30 am Friday 3/12 with signs of fever (too sick to look for thermometer) , sweats,... Read more
woke up about 12:30 am Friday 3/12 with signs of fever (too sick to look for thermometer) , sweats, chills, vomiting, until about 5am. I was very sicks. Then continued with fatigue, nausea, terrible headache and neckpain until about 5pm on Saturday 3/13. At that point everything seemed to have passed. I could not go to work on Friday 3/12. Been fine since 5pm on 3/13.
55 2021-03-19 impaired work ability On Saturday, March 13, Woke up at 3 am with a severe headache, started having diarreah, vomiting tha... Read more
On Saturday, March 13, Woke up at 3 am with a severe headache, started having diarreah, vomiting that lasted until 7 PM that night. Stayed in bed all day Sunday, March 14, ate a few crackers and drank some water. Had lower back pain and headache all day. Had to call out sick from work on Monday, March 15. finally got up and ate some soup and took a shower. Rested the whole day. I have been absolutely exhausted and weak all week long.
55 2021-03-20 confusional state 3/15: 10:00pm- severe chills and trembling, lasted six hours. 4:00am- vomiting, lasted two hours. Di... Read more
3/15: 10:00pm- severe chills and trembling, lasted six hours. 4:00am- vomiting, lasted two hours. Dizziness , fatigue and severe headache (ongoing). 3/16- severe tingling and numbness through right arm, right side and right leg. Right hand and right foot numb. Headache and nausea persisted. Dizziness and confusion. Example- need to walk through a door, can?t figure out that turning door handle is the solution. 3/17- tightness in chest and difficulty breathing (ongoing) can?t catch a deep breath(ongoing). Headache and fatigue persisting at this time.
55 2021-03-20 impaired work ability I had awful nausea, loud ringing in the ears, I fainted. The medics provided help, gave me oxygen. ... Read more
I had awful nausea, loud ringing in the ears, I fainted. The medics provided help, gave me oxygen. I started having convulsions. After some time I felt like the lower part of my face went numb and it took tremendous effort to move my lips to talk. At that point, the medical called the ambulance and sent me to ER, where I was under supervision for some time. I was very weak and nauseated. After I was released, I was very weak could not keep the vertical position. The next day I was very nauseated, with awful tinnitus, lightheadedness, and weakness. Staying vertical for more than 15 minutes brought fainting symptoms. I was not able to get out of the house to work. The next day the fainting symptoms disappeared, everything else continued. Too weak to go to work. I started moving about only on the 4th day after the shot. During this event, I did not have any fever or muscle ache, no virus0tyle symptoms.
55 2021-03-22 sleep disorder severe chills came on about 9 hours after dose received. Could not sleep, could not get warm, intens... Read more
severe chills came on about 9 hours after dose received. Could not sleep, could not get warm, intense shivering. Minor headache and dull aches throughout the body. Had to climb under an electric blanket, comforter and then another blanket on top to get warm and comfortable. As i drifted in and out of sleep through to the morning, I noticed the chills and shivering dissapating and was able to get some sleep. Awake now, still feeling a headache and flu-like aches to the body. Moving very slow. Arm not really sore at injection site as it was upon receipt of vaccination.
55 2021-03-25 impaired work ability It appears the injection was high and toward the back of my arm verses the center of my deltoid...sy... Read more
It appears the injection was high and toward the back of my arm verses the center of my deltoid...symptoms started with a headache and feeling flushed....then awoke around 11:30pm with chills, fever 100.5, and horrible body aches..missed work the following day...took tylenol and NSAIDS and sleep all day Thursday...Friday, today doing better but still feeling feverish, and still taking Tylenol every 6 hours
55 2021-03-30 impaired work ability First night, I was okay until about 10 pm - chills - my teeth was chattering I had never experience... Read more
First night, I was okay until about 10 pm - chills - my teeth was chattering I had never experienced , hot, threw up all night and I had to miss work. I was really sick for the next few days. I was tired, too. The reflux made me go to the doctor - a couple weeks after vaccine. Increased symptoms of it real bad. They increased my Omeprazole dose from 20-40 mg. I have loose stools. They added a nose spray as well. I had had my allergy shots the same week as I had my vaccine.
55 2021-04-01 impaired work ability Extreme fatigue, lack of energy for 11 days diarrhea the next day off and on nausea, head ache, swe... Read more
Extreme fatigue, lack of energy for 11 days diarrhea the next day off and on nausea, head ache, sweats, chills for past 11 days One week after vaccine had a telehealth appointment with primary care, COVID test (Negative), and blood work. Blood work was normal and tested negative for antibody to COVID. Have missed work for 7 days. Still no energy (day 11). Exhausted after minimal activity. Sweat through my nightshirt overnight (day 10), extreme chills prior.
55 2021-04-03 insomnia Chills, headache, muscle aches, flushed, hot flashes, insomnia
55 2021-04-04 anxiety, confusional state, feeling abnormal, agitation, crying It wasnt until around 11pm that I started feeling bad. I was getting hot, confused a little uncomfor... Read more
It wasnt until around 11pm that I started feeling bad. I was getting hot, confused a little uncomfortable or agitated, then I went to bed. I woke in the middle of the night in a crying fit because I thought I was going to die I felt soooo bad ! It was worse than any flu Id ever had! My joints hurt, my head wanted to explode , fever of 101.3 , breathing issues , exhaustion, thirsty...this lasted 2 to 3 days. Ive had a couple of days here in beginning of april til now of waking up feeling sick again. It doesnt last all day. Sometimes it just before bedtime. I guess I just feel a bit sick, but that could also be the cancer that ive had since july 2020 that hasnt been treated by a health care system I have?
55 2021-04-05 anxiety 2 to 3 times a day of feeling extremely feverish and clammy eight increase in body temperature. C... Read more
2 to 3 times a day of feeling extremely feverish and clammy eight increase in body temperature. Causing anxiety
55 2021-04-06 feeling abnormal, sleep disorder Upon injection, medication burned going into arm and lasted about 2 minutes. I immediately started ... Read more
Upon injection, medication burned going into arm and lasted about 2 minutes. I immediately started feeling odd over my entire body, I felt and looked flush, felt clammy, muscle tightness, started shaking, felt very nauseated, blood pressure went up and experienced slight swelling in hands. This lasted 30-45 minutes. My blood pressure, oxygen saturation level were being monitored. I left office at around 12:00 pm feeling better. I felt off the entire day. At 6:00pm I started with chills, muscles aches and pains. At 7:30pm I took a shower and went to bed very fatigued, muscles pain and cramping and chills. I took my daily meds of 125mg of Diamox, and 100 mg of Azathioprine. At 11:30pm I woke up with a 104 fever, sweating, and a lot of muscle cramping in legs and feet. My head felt like it was going to explode. My cerebral fluid pressure was up and felt in head and down spin. I did not rest well and found it difficult to get comfortable all night. I took an 200 mg of ibuprofen at 12:00am and started to feel some relief.
55 2021-04-07 sleep disorder It started with just a pain in the arm - normal soreness from the injection site and up the left si... Read more
It started with just a pain in the arm - normal soreness from the injection site and up the left side of my neck - but then it spread to the whole upper part of my left arm. It was very , very painful. It wakes me up almost every single night because it hurts. The pain will radiate - now the pain is more in my arm area and now it's radiating to my back on on the shoulder blade area on the left side - my neck is a tiny bit sore right. The soreness in the arm is always consistent but the radiating pain moves around somewhat. I am wondering if they gave me the injection incorrectly. It doesn't seem like it's what the description of "COVID ARM." I don't have any swelling or redness and I haven't ever. I take Aleve every now and then. I called the doctor last week and she told me to wait a couple of weeks and watch it.
55 2021-04-08 anxiety, sleep disorder, irritability, feeling abnormal Shortly after the shot I felt a little odd. I felt like I had a fast heartbeat or extremely high an... Read more
Shortly after the shot I felt a little odd. I felt like I had a fast heartbeat or extremely high anxiety. Felt like I had 20 cups of coffee. I was really hyper the night of the shot. Only got (4) hours of sleep. The symptoms continued for approx 24 hours. I had shortness of breath at times which could be from my heartbeat flucuating or I had anxiety. I am also very irritable. No other reactions. Other than that I feel back to normal after about 48+ hours. Praying I don't have any heart damage or lunch damage from what was injected into my body.
55 2021-04-08 feeling abnormal blanked out for a few minutes, blank stare. Evaluated by EMS-Cleared
55 2021-04-08 sleep disorder Eight hours post injection very rapid of fever, severe headache, aches and nausea. At 12 hours, I aw... Read more
Eight hours post injection very rapid of fever, severe headache, aches and nausea. At 12 hours, I awoke with HR above 150. After it not resolving within 5 minute, I went to the ER. Rate had gone down by arrival but EKG showed depressed ST waves. By second EKG, two hours later., it looked normal. I since have had bouts of a racing heart both during day and awaking from sleep.
55 2021-04-09 disturbance in attention slightly tingly down arm to pinky finger, slight dizziness, slight headache that day. 5 days later I... Read more
slightly tingly down arm to pinky finger, slight dizziness, slight headache that day. 5 days later I began having diarhea after drinking or eating anything. Severe headache, exhaustion, loss of appetite and taste or smell, wanted to sleep in bed. hard to concentrate, I had severe somach ache and diarhea for 18 days. body and joint aches. Felt thumping on my heart with mile activity and when lying down. sore throat and neck and ear. I had a pretty severe headache and it was difficult to thing through, follow through. I felt too ill to want to follow through to visit the Dr. I did take a Covid test 15 days after reaction started and test was negative.
55 2021-04-09 restlessness, anxiety, insomnia The day of the shot I started having some pain behing my eyes (8 pm). I went to bed at about 11 pm a... Read more
The day of the shot I started having some pain behing my eyes (8 pm). I went to bed at about 11 pm and could not sleep so I took a sleeping pill (Zolpidem 10 mg) but could not sleep all night feeling very exited and restlees. At about 8 am next day (april 8) I started feeling nausea, headache and an overall sick feeling in my body. The nausea went on until about 2 pm, On april 9 I had head ache again at around 2 pm. On april 10 I had a ligh headache at around 1 pm that continued until night (around midnight).
55 2021-04-09 sleep disorder Day 1- Excruciating bone pain in ribs, pelvis, and shins that felt like drill holes. My back felt sh... Read more
Day 1- Excruciating bone pain in ribs, pelvis, and shins that felt like drill holes. My back felt shattered. Muscles seized up and vein throbbed from inflammation. Lymph nodes swollen and throat was slightly raw. Could choke on water. Body temperature dropped, not chills, but icy cold. Took sleeping pills at 11 pm and never slept from the pain. Started dosing with turmeric and alka seltzer to douse the acidity inside body. Then did ibuprofen at 5 am not able to have BM Day 2- Tiredness, Broken vessels behind right knee that weren?t there before. Abdominal cramping in the uterus area. Still had bone pain. Restless leg symptoms. Not able to have BM Day 3 - a cough has started but only bone pain is In shin.
55 2021-04-11 confusional state Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Sys... Read more
Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe
55 2021-04-11 sleep disorder Beginning 04/08/21, soreness at the injection site. I began moving my arm and using the muscles as i... Read more
Beginning 04/08/21, soreness at the injection site. I began moving my arm and using the muscles as instructed. The soreness increased to the point it was uncomfortable to touch or lay on. By the next morning at 8:00 a.m. I had joint pain, primarily in both hands and both elbows, headache, chills, muscle ache in thighs. My a.m. temp was 97.7. By 3:00 p.m. my temp was 99.1 and my symptoms were the same only at a high discomfort level. I took 2 advil. At 9:00 p.m. my temp was 99.4. My symptoms were the same but my hands were so sore even when not moving there was pain. I took 2 tylenol. Sleeping was very difficult due the pain in my left arm and my hands. On 4/10/21, at 7:00 a.m. my temp was 99.4. I had worse joint pain, muscle, pain, fatigue, injection site had a hematoma the size of a quarter. Took two advil. At 12:00 p.m. my temp was 98.6. I took 2 tylenol and a famotidine. My left arm was still sore from shoulder to elbow, tender to the touch and slightly warm, I was fatigued, my hands were very sore at the joints. At 4:00p.m. I experienced about 2 hours of diarrhea. At 7:00p.m. my temp was 97.9 My hands and joints were still sore but to a lesser degree. My left arm was sore and I had a slight headache. I started feeling better with more energy. On 4/11/21 temp was 97.4. my arm was slightly sore still fatigued. My average morning temp is about 97.4.
55 2021-04-12 disturbance in attention Extreme dizziness and difficulty concentrating, and fatigue for 2 days progressively getting worse
55 2021-04-12 feeling abnormal symptoms started 5 days after vaccine and have continued on and off every day, frequent heart beatin... Read more
symptoms started 5 days after vaccine and have continued on and off every day, frequent heart beating felt in chest, throbbing headache, whooshing sound in ears, sweating, stomach cramps, diarrhea, throbbing hands and feet, shortness of breath, exhaustion, one or two instances of bluish lips, fingers, and toes. I visited Dr. and he has ordered tests to check on my heart. I told him I was concerned about the "pause" and the reason for pause because I feel pretty miserable, and he added a CT test that will be done in two to three weeks. I do not know if he will report my symptoms as possibly vaccine related.
55 2021-04-12 feeling abnormal First, when the vaccine was administered, it felt like hot liquid going into my left arm and then my... Read more
First, when the vaccine was administered, it felt like hot liquid going into my left arm and then my left arm down to my elbow felt on fire. Around 4:45 I began to have chills, and when I arrived home about 5:15 I was shivering and freezing and full of body aches. During the night I developed a fever of 103.7, 103.5. My husband woke me to help cool me down with cool cloths and water. My fever went down to 102 by morning and I still had body aches but not as bad. I was lethargic and mentally fuzzy for a few days. I did not feel well until Wednesday, March 24, 2021.
55 2021-04-12 impaired work ability I was under two thick winter blankets with bad,bad chills. A severe headache. Dizziness to the poin... Read more
I was under two thick winter blankets with bad,bad chills. A severe headache. Dizziness to the point where I could not get out of bed. Nausea, bad body aches, chest hurt,throat hurt. I was in bed sick from 5:30 , Tues April 6 until Wed April 7th around 10;30. I had to stay home from work on Wed. I am still having mild headaches and dizzy spells where i have to lean against a wall or hold on to something.
55 2021-04-12 insomnia First two days had flu like symptoms. Oddly, I had insomnia. After about three days everything got b... Read more
First two days had flu like symptoms. Oddly, I had insomnia. After about three days everything got better with the exception of: Marked generalized anxiety General malaise and feeling dragged down Intermittent dizziness A few days ago I had chest congestion. Just not feeling well overall Don?t seem to be able to snap back
55 2021-04-12 sleep disorder Began with chills, had severe chills and slight fever all night long, body in pain, couldn't sleep. ... Read more
Began with chills, had severe chills and slight fever all night long, body in pain, couldn't sleep. The next day I was fatigued and nauseous. I received vaccine Thursday 4/8/21. It is now Tuesday 4/13/21 and I am still a bit fatigued and sick to my stomach.
55 2021-04-13 crying EXTREME reaction of fever, chills, body aches, fatigue, headache, & nausea. Completely bedridden f... Read more
EXTREME reaction of fever, chills, body aches, fatigue, headache, & nausea. Completely bedridden for over 24 hours, crying, begging for life. For the following 72 hours: normal fatigue and nausea plus shortness of breath
55 2021-04-13 feeling abnormal, sleep disorder next day extreme fatigue, fever lethargy. Got better but never got energy back and had some body ac... Read more
next day extreme fatigue, fever lethargy. Got better but never got energy back and had some body aches and trouble sleeping. On Wed. March 25th an EXTREME headache began and I could find no relief with High doses of Tylenol or Ibuprophin or a mixture of both. It was my whole head. Stayed on the couch all day Saturday and Sunday 27th and 28th unable to move because of the pain and extreme fatigue. Monday the 29th made myself go to work but was not able to function or get much relief. On Tuesday the 30th went to see physician who said he thought it was Occipital Neuralgia and gave me prednisone and said use hot compresses. Told him I thought it was more due to other symptoms like hallucinations (shadows I would see) Mind not clear and made me worry about driving. Asked if the shot could be a possibility. He just said he couldn't rule it out. The doctor also mentioned I felt very hot but never took my temperature. I Took the prednisone. Headache did start to clear on Wed the 31st in the evening but my neck seized up where I could no longer turn it to the left and was very painful. Also felt like my lymphnodes were swollen. I called on call doctor and they prescribed a muscle relaxer. I did not start to get better until Sunday April 11th. Experience a couple occular migranes as well during this, Still experiencing some fatigue and almost to a fainting point in the mornings
55 2021-04-13 impaired work ability About an hour after the injection, I had a very sharp pain in my left ear and my left side of my nec... Read more
About an hour after the injection, I had a very sharp pain in my left ear and my left side of my neck got very tight. I had about 2 more very sharp pain in my ear that evening, and feels like I have something trapped inside my ear. I still feel as though something is still in my ear and my neck is very tight. I have had a headache since the injection, and started getting chills and fevers on April 8 and has continued. I have been extremely tired since April 9....it is interfering with my work. My stomach hurts and feel miserable. I have not yet recovered.
55 2021-04-14 impaired work ability Woke up next morning very dizzy, running, 101 fever, headache, body aches, nauseous. pain in left ar... Read more
Woke up next morning very dizzy, running, 101 fever, headache, body aches, nauseous. pain in left arm where injection was administered. Very tired. Stayed home from work. As day progressed symptoms got worse. Headache was very bad and Tylenol would not help. Got very sick and was unable to eat. Fever did not break until Saturday morning. I was dizzy until Sunday morning. Was very tired until Sunday evening. Did not contact my doctor.
55 2021-04-14 sensation of foreign body I received the vaccine 3/12 around 3:00 p.m. On 3/13 around 4:00 a.m., I woke up with a sharp, loca... Read more
I received the vaccine 3/12 around 3:00 p.m. On 3/13 around 4:00 a.m., I woke up with a sharp, localized pain in my right, lateral thigh area. Within a 15 minute period of time the localized pain moved down my thigh, past my outer knee area, and to my calf. After approximately 15 minutes the sharpness of the pain subsided. As far as I know I have had no lasting side effects from this. I have CRPS/RSD in that leg, specifically in that region, so at the time and with the fever I had, I didn't think too much of this. REACTION AFTER VACCINE INJECTION: As an aside, I had some unusual reactions to the vaccine immediately after the injections. Within 5 minutes of getting the vaccine, I developed numbness in my lips, tongue, and palate and a 'lump' in my throat that made it hard to swallow. It took approximately 2 hours fpr these reactions to resolve. I have had these reactions before when I accidentally ingested sugar substitutes. Also, at approximately 15 minutes post injection, both my ears felt internal pressure (as if I had submerged in deep water) and I could not hear well. I have never had this reaction before. This took about 1 hour to resolve leaving me with a moderate headache for 3 days.
55 2021-04-14 sleep disorder After about 4-5 hours (around 9 pm), I started with nausea in addition to body aches. Later, I woke... Read more
After about 4-5 hours (around 9 pm), I started with nausea in addition to body aches. Later, I woke up at 1:30 am. At that point, my bad symptoms started. I was up all night. 1. I had nausea and I threw up. I had body aches and no energy to move. 3. About an hour later, my heart started "racing" really bad. I felt like I was running a marathon, and I couldn't keep up with the pace. I could hardly catch up my breath. 4. Then, my right arm started tingling and feel heavy. I couldn't feel any of my "fingers" on my right hand. 5. My body kept going from extremely hot to extremely cold. I felt like my blood pressure was up and down. I had more nausea. I could barely move. 6. I threw up again and, eventualy, I slept.
55 2021-04-15 emotional distress TINNITUS has at least doubled in pitch and consistency which is now 24/7 (It was manageable prior to... Read more
TINNITUS has at least doubled in pitch and consistency which is now 24/7 (It was manageable prior to vaccine) It is causing me distress! Left arm still sore to the touch two weeks after shot. Both hands went numb within 10 minutes of receiving vaccine and have stayed swollen and painful joints for two weeks.
55 2021-04-15 feeling abnormal LACK OF APPETITE; DIARRHEA; ACHES; EXCESSIVE SWEATING; CHILLS; NAUSEA ON AND OFF; FEVER; LIGHT HEADE... Read more
LACK OF APPETITE; DIARRHEA; ACHES; EXCESSIVE SWEATING; CHILLS; NAUSEA ON AND OFF; FEVER; LIGHT HEADED; LETHARGIC; FELT HORRIBLE; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced light headed. On 23-MAR-2021, the subject experienced lethargic. On 23-MAR-2021, the subject experienced felt horrible. On 23-MAR-2021, the subject experienced excessive sweating. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced nausea on and off. On 23-MAR-2021, the subject experienced fever. Treatment medications included: ondansetron. On 24-MAR-2021, the subject experienced lack of appetite. On 24-MAR-2021, the subject experienced diarrhea. On 24-MAR-2021, the subject experienced aches. On 30-MAR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Normal, Complete blood count (NR: not provided) Normal, and Culture nose (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed, felt horrible, chills, nausea on and off, and fever on 04-APR-2021, diarrhea, and aches on 24-MAR-2021, and excessive sweating on 23-MAR-2021, was recovering from lack of appetite, and had not recovered from lethargic. This report was non-serious.
55 2021-04-18 insomnia, nightmare WEAKNESS; NIGHTMARE; UNABLE TO SLEEP; CHILLS; HEADACHE; This spontaneous report received from a pati... Read more
WEAKNESS; NIGHTMARE; UNABLE TO SLEEP; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to antibiotics, alcohol, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 07-APR-2021, the subject experienced nightmare. On 07-APR-2021, the subject experienced unable to sleep. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. Laboratory data included: Pain scale (NR: not provided) 8/10. On 08-APR-2021, the subject experienced weakness. Laboratory data included: Pain scale (NR: not provided) 2/10. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and chills, had not recovered from weakness, and the outcome of nightmare and unable to sleep 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
55 2021-04-18 sleep disorder on March 16 went to ARNP to complain of breathing issues and provider was dismissive saying will ref... Read more
on March 16 went to ARNP to complain of breathing issues and provider was dismissive saying will refer to cardiologist. Told provider unable to sleep and was given RX for Xanax. Continued to struggle for two more days and ended up in ER then admitted with 6 days on a ventilator, 10 days in ICU and 12 day hospital stay. Discharged with O2 at night. Not sure of long term prognosis. Initial PCR was negative for COVID.
55 2021-04-20 insomnia HEART RACING FEELING; PRESSURE IN THE BACK; TIGHTNESS IN THE BACK; SEVERE HEADACHE LOCALIZED TO TOP ... Read more
HEART RACING FEELING; PRESSURE IN THE BACK; TIGHTNESS IN THE BACK; SEVERE HEADACHE LOCALIZED TO TOP OF HEAD; COULD NOT SLEEP OVER NIGHT; This spontaneous report received from a patient. The patient's concurrent conditions included hypertension, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced could not sleep over night. On 11-APR-2021 21:00, the subject experienced pressure in the back. On 11-APR-2021 21:00, the subject experienced tightness in the back. On 11-APR-2021 21:00, the subject experienced severe headache localized to top of head. On 12-APR-2021, treatment medications included: paracetamol. On 12-APR-2021 10:00, the subject experienced heart racing feeling. Treatment medications included: ibuprofen. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 68. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep over night, had not recovered from severe headache localized to top of head, and heart racing feeling, and the outcome of pressure in the back and tightness in the back 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.
55 2021-04-20 insomnia VOMITING; RASH ON FACE; NAUSEA; COLD; CHILLS; FEVER; HURTS INJECTION SITE; TIREDNESS; SLEEP LOSS; Th... Read more
VOMITING; RASH ON FACE; NAUSEA; COLD; CHILLS; FEVER; HURTS INJECTION SITE; TIREDNESS; SLEEP LOSS; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 13:50 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced sleep loss. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced hurts injection site. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021 22:00, the subject experienced cold. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced rash on face. On 08-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102 F, 101.8 F, 99 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, fever, and nausea, had not recovered from rash on face, hurts injection site, tiredness, and sleep loss, and the outcome of cold was not reported. This report was non-serious.
55 2021-04-21 anxiety ABDOMINAL PAIN; UNABLE TO EAT; ANXIETY; SEVERE HEADACHES; This spontaneous report received from a pa... Read more
ABDOMINAL PAIN; UNABLE TO EAT; ANXIETY; SEVERE HEADACHES; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart problems, and diastolic heart failure, and concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced unable to eat. On 02-APR-2021, the subject experienced anxiety. On 02-APR-2021, the subject experienced severe headaches. On 09-APR-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headaches, abdominal pain, unable to eat, and anxiety. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
55 2021-04-22 loss of personal independence in daily activities, disorientation, feeling abnormal 4/5/2021--Received Janssen vaccine. Felt very hot during the day. 4/6/2021--Woke up with very bad... Read more
4/5/2021--Received Janssen vaccine. Felt very hot during the day. 4/6/2021--Woke up with very bad headache and rash on the injected arm plus on my stomach. Went for a walk and felt pain in my left calf and achilles tendon. Went to work. 4/7/2021--Started my work day as a Personal Trainer/Fitness Instructor at 6am as usual. Taught cycling classes and trained a few clients. Went for walk. Still had a headache. When I got in my car to head home, my vision was super blurry and I felt very dizzy. I ate an orange and peanuts and hydrated more. I was not even sure I could drive home. I got home told my family how I was feeling. My husband noticed my eyes were very red and swollen. I took a shower, drank a smoothie and ate a salad. Used my aunt's BP cuff to check my BP and it was 148/99. I have NEVER had HBP. 4/8/21--Woke up feeling disoriented as if the left side of my face, body were off--neurological stuff. I went to reach for grapes in the refrigerator and could not grab them. I felt like I have never felt before and ask my husband to drive me to the ER. While at the waiting room at the ER, I felt chest tightness and pain and nauseous. My BP was 153/111. Again, I have never been diagnosed or been treated for hypertension. They did EKG, lab tests, chest X-ray. Once my BP came down, they sent me home. This is before all the JJ Janssen vaccine "news" came out and the reasons it was paused. I developed a very bad cough about two hours after I got home from the ER. 4/9/11--Made appointment with a brand new primary care doctor. Saw her on Monday 4/12/2021 as recommended by ER. I had never met her before. She prescribed a very low dose of BP medication, which I did not take because the number one side-effect is dry-cough. I was already coughing a lot, later on with blood. 4/11/2021--Still feeling pretty bad, I woke up to the news of the Janssen vaccine being paused. Frankly, I felt relieved that I was not going crazy. This truly has been one of the hardest things I have ever gone (and still am) going through. I became concerned about the pain in the left calf and heel could be a clot. Called primary care doctor. Had ultrasound of legs and chest x-ray the following day 4/12/2021--Had persistent cough with blood. Went to ER at 9pm. Had EKG, blood work, CT without contrast of chest, covid test--negative. Got home around 2am. 4/19/21--Followed up with primary care doctor who after explaining to her I am extremely fatigued, still blurry vision, dizzy, cough better but not gone, chest discomfort on the left side, she referred me to an ophtamologist and cardiologist. My insurance and this poorly established referral system is very difficult to navigate. Up to now I am still waiting for the referral and pre-aurhtorization to the opthtamologist. (4/23/2021). I want to say, I am pretty healthy. I have worked in fitness and wellness for over 30 years. I have never drank alcohol, smoked or done any drugs. Prior to this no physician has told me I have HBP or any issues for which I have to be medicated. I take zero medications. Even when I had the bad headache from the vaccine I took nothing. I have not worked in two weeks and had not driven until last saturday. If I don't work, I don't get paid. I pay for almost $600/month for my insurance in the marketplace. This has been another stressor of this storm. Getting providers to really listen and insurance companies to take situations like this seriously. I could not drive at night. This has been rough and I look forward to being myself soon. This reaction felt like a heart attack/stroke with extreme fatigue, acid reflux, cough with some blood, muscular pain. The rash and headaches were the least of my concerns. I am not yet recovered from all of this. I sure hope there is no permanent damage and that this too shall pass. It is important to note that I have tried reporting this event several times to the VAERS website online. I completed the 4-5 pages multiple times and it would not let me submit. I also called the VAERS 1-800 number to report and they told me to go back to the online form. I left several messages when I could not get it done online and to this date no one has called me back. I called to report my adverse reaction and they told me they do not take that info. I also called the health dept. After several phone calls to them a nurse called me back but did not take a formal report. When someone is feeling pretty sick, this is a lot to ask of. I persisted because I feel this is important to be reported.
55 2021-04-22 panic reaction, feeling abnormal immediate symptoms - bowel movements are very different and continue to this day. Like babies poop. ... Read more
immediate symptoms - bowel movements are very different and continue to this day. Like babies poop. Specific date of occurrence 3/24/2021 - 2 pm: was standing in my home office feeling just fine and then my heart started racing and I was immediately nauseous to the point I had to lay on the floor on my back and tell myself to breathe. I felt like my heart was going to jump out of my chest, so I got up and grabbed my wrist blood pressure monitor and went and lay back on the floor telling myself to breathe. I took the first reading and it said 200/52/57 so I too it again 199 / 50 / 58. I started to panic and remembered I had bought some cans of oxygen for my father and had one in the bathroom. I went and breathed on that for about 2 minutes. My reading then went back down to a more normal range. Since that time my head doesn't feel the same and it scared me enough to tell my husband and mom, yet they both told me not to stress about it. I have only experienced ongoing bowel movements and the weird head feeling since that time but did contact my Dr. for an appointment. I want be certain I didn't have a stroke or something peculiar. I had noticed my heart rate increasing but wasn't sure if I was imagining it, so I restarted taking my blood pressure numbers on 3/22. My blood pressure that morning at 6 am was 113/59/72.
55 2021-04-24 sleep disorder 6 days after receiving the vaccination, my upper left arm muscles became quite painful. Pain increa... Read more
6 days after receiving the vaccination, my upper left arm muscles became quite painful. Pain increased each day to the point of limiting arm range of motion, especially abduction and internal rotation. Today is 4/25, I am still unable to internally rotate my arm, or reach behind myself due to the severity of the pain in the muscles. Pain also prevents me from sleeping on my left side which is my natural sleep position. I have tried OTC meds, stretching, hot/cold compresses and self massage none of which has worked to loosen up and reduce pain in my arm. Although the level of pain is no longer increasing each day, it is not decreasing at all.
55 2021-04-25 feeling abnormal, nervousness Nausea, headache, fatigue, malaise for first two days, mixed with shakey feeling. Now less severe bu... Read more
Nausea, headache, fatigue, malaise for first two days, mixed with shakey feeling. Now less severe but very noticeable fatigue and malaise every day all days. Three episodes of sinking feeling since 03/21, the most recent was 2 days ago. The tele doc called in labs on Friday 04/23/2021 - CBC, TSH and iron. They were all within normal range
55 2021-04-26 depression DEPRESSED; VERY BLURRY VISION; VERY FATIGUED; SIDE AND MIDDLE OF THROAT SWOLLEN; This spontaneous re... Read more
DEPRESSED; VERY BLURRY VISION; VERY FATIGUED; SIDE AND MIDDLE OF THROAT SWOLLEN; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimoto's disease, and reading glasses user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included varicella zoster vaccine rge (cho) for prophylactic vaccination. On 02-APR-2021, the subject experienced side and middle of throat swollen. On 02-APR-2021, the subject experienced very fatigued. On 03-APR-2021, the subject experienced very blurry vision. On 04-APR-2021, the subject experienced depressed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side and middle of throat swollen on 03-APR-2021, was recovering from very blurry vision, and had not recovered from very fatigued, and depressed. This report was non-serious.
55 2021-04-26 feeling abnormal VISUAL DISTURBANCE; COMPLEX MIGRAINE; HAD DIFFICULTY FINDING WORDS; NOT FEELING NORMAL; FATIGUE; COM... Read more
VISUAL DISTURBANCE; COMPLEX MIGRAINE; HAD DIFFICULTY FINDING WORDS; NOT FEELING NORMAL; FATIGUE; COMPLEX HEADACHES; CHILLS; BODY ACHES; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no previous history of migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced visual disturbance. On 13-APR-2021, the subject experienced complex migraine. On 13-APR-2021, the subject experienced had difficulty finding words. On 13-APR-2021, the subject experienced not feeling normal. On 13-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced complex headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from visual disturbance, complex migraine, and had difficulty finding words, and body aches, and chills on 13-APR-2021, had not recovered from fatigue, and not feeling normal, and the outcome of complex headaches was not reported. 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.
55 2021-04-27 anger, crying, depression SHORTNESS OF BREATH; COULDN'T WALK; COLD; CAN'T COMPREHEND/THINK; FEELS DEPRESSED; ANGRY; CRYING; NO... Read more
SHORTNESS OF BREATH; COULDN'T WALK; COLD; CAN'T COMPREHEND/THINK; FEELS DEPRESSED; ANGRY; CRYING; NOT FEELING WELL; MUSCLE WEAKNESS; THROWING UP; SORE THROAT; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and she is pretty healthy, very athletic and has not been ill in the last 20 years.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-APR-2021, the subject experienced throwing up. On 24-APR-2021, the subject experienced sore throat. On 24-APR-2021, the subject experienced muscle weakness. On an unspecified date, the subject experienced shortness of breath, couldn't walk, cold, can't comprehend/think, feels depressed, angry, crying, and not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle weakness, throwing up, and sore throat, and the outcome of shortness of breath, not feeling well, couldn't walk, cold, can't comprehend/think, angry, crying and feels depressed was not reported. This report was non-serious.
55 2021-04-27 feeling abnormal * First 48 hours: Fever to 101 degrees, headache, excruciating muscular pain, joint pain, nerve pain... Read more
* First 48 hours: Fever to 101 degrees, headache, excruciating muscular pain, joint pain, nerve pain (sensitive to touch), extreme fatigue, stomach discomfort, inflammation of injection site and left underarm * Every day after the first 48 hours: All Mild but lingering symptoms of fatigue, lack of energy (not feeling like my normal self), headache, joint pain, brain fog (memory, concentration, sleep problems), few occasions of fast pounding heartbeat lasting for few minutes, dizziness when I stand up or move quickly. Fatigue, brain fog and dizziness get worse even after mild activities (physical, mental such as studying). All symptoms got better now than the first 7 days but still lingering.
55 2021-04-28 feeling abnormal TINGLING SENSATION IN SPINE TO CRANIUM; BALANCE DISORDER; ODD FEELING; GENERAL MALAISE; This spontan... Read more
TINGLING SENSATION IN SPINE TO CRANIUM; BALANCE DISORDER; ODD FEELING; GENERAL MALAISE; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, every 1 total from 08-MAR-2021 to 08-MAR-2021 on right arm for prophylactic vaccination. The batch number was requested. No concomitant medications were reported. On 08-MAR-2021, the patient experienced tingling sensation in spine to cranium, balance disorder, odd feeling, and general malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling sensation in spine to cranium, balance disorder, odd feeling, and general malaise on 15-MAR-2021. This report was non-serious.
55 2021-05-09 insomnia, sleep disorder My appointment was on time, 4pm on 4/3 at the Pharmacy. The young girl that gave me the shot told m... Read more
My appointment was on time, 4pm on 4/3 at the Pharmacy. The young girl that gave me the shot told me she was certified, and she gave me the shot in the presence of her manager. I have given myself shots for years with diabetes, plus many flu shots, and have never felt pain like that. I expressed this to her, how painful it was, and she just said "I know, I know..." as if it was normal for the shot to be so painful. I knew instantly something was wrong. They were more worried, it seemed, about a potential adverse reaction such as an allergy shock, since I'm allergic to a few things, but I did not experience that. I waited 15 minutes, my arm hurting the whole time, and they suggested I go buy Tylenol for the pain, which I did. My left arm has hurt since then. I got a horrible bruise from this shot (will send picture) that took weeks to heal. Since then I've continued to feel pain and don't have full mobility of my left arm. I can type, but not lifting anything heavy and have to go easy with anything on the left side. I thought at first it might be what people were calling "covid arm" but I discovered that was more about soreness, not pain. I tried ibuprofin, but after three weeks I'd had enough and made a doctors appointment. Since I was also noticing my left shoulder was very tense and tight, and I was starting to get neck stiffness in same area, I started googling before my appointment. When I entered my symptoms, SIRVA kept popping up, so I wondered if that was what I now had because of the improper vaccine administration. I asked my doctor for an MRI order to find out, but she said we needed to do an Xray first (which only showed mild issues related to osteo). She offered a prescription of taking Advil 400 mg three times and day and to use a muscle relaxer when I needed it, such as at night (Cyclobenzaprine). She said to try that for a week, and if it wasn't better, that another Dr could order MRI. Since then I've also added a pain spot under my left shoulder blade. Insurance called and said the order was "under review" so that's where things stand now. If they don't approve, I guess I will go next to an orthopedist for guidance? This has cost me health, due to lack of sleep also - I wake up with pain in the middle of the night, even when I take the meds. Praying for a diagnosis, and solution, soon.
55 2021-05-10 excessive sleepiness Fever of 101 degrees for 10+ hours, chills. Strong muscle cramps across lower back began 5 hours aft... Read more
Fever of 101 degrees for 10+ hours, chills. Strong muscle cramps across lower back began 5 hours after injection + muscle cramps in neck & across both shoulders 6 hours after. Lasted about 4 hours. Cramping was so bad that movement wasn't easily possible. Severe fatigue caused me to sleep for 17 hours. Day 2 (5/6/2020) fatigue came back 4 hours after being awake but no fever (31 hours after injection). Day 3 mild fatigue but otherwise normal
55 2021-05-12 impaired work ability, feeling abnormal Severe headache which was immediate. chills & fever for 3 days, tremors lasted an hour or two day of... Read more
Severe headache which was immediate. chills & fever for 3 days, tremors lasted an hour or two day of vaccine, body aches a day, brain fog example trouble concentrating, forgetfulness hard to focus still have but is improving. I called my Doctor and was prescribed a Migraine medication which seems to helping greatly. Missed two days of work due to fever and headache.
55 2021-05-13 feeling abnormal Seizure, involuntary muscle spasms, fatigue, nasal congestion, eye swelling and feeling out o it
55 2021-05-15 sleep disorder Chronic, shooting pain in right hip / sciatic area. Painful enough to prevent sleeping / sitting / w... Read more
Chronic, shooting pain in right hip / sciatic area. Painful enough to prevent sleeping / sitting / walking. I have been taking Aleve / Advil routinely since the pain started. It helps a little but doesn't completely ease the discomfort.
55 2021-05-18 sleep disorder, anxiety I developed severe headaches which turned into a lot of inflammation. There was nerve pain throughou... Read more
I developed severe headaches which turned into a lot of inflammation. There was nerve pain throughout my body. I wasn't able to sleep or eat for almost 7 days. I was experiencing nerve pain and tremors. They weren't continuous, but they would come and go. Inside I felt like there were quivering muscle sensations and weakness. The pain that was associated with the nerve pain would not go away. I have started to experience severe anxiety. I feel like I'm experiencing PTSD.
55 2021-05-19 feeling abnormal BLOOD CLOTS GALORE; FEELING SICK (NOT FEELING WELL); FEELING OF WOULD NOT MAKE IT AND SAYING GOODBYE... Read more
BLOOD CLOTS GALORE; FEELING SICK (NOT FEELING WELL); FEELING OF WOULD NOT MAKE IT AND SAYING GOODBYE TOMORROW; MUSCLE ACHES; TIRED; LETHARGIC; BODY ACHES; This spontaneous report received from a consumer concerned a 55 year old female of unknown race and ethnicity. 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, expiry date: UNKNOWN) dose was not reported, 1 total, administered on 16-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-APR-2021 after vaccination, the patient got tired, lethargic, was not "feeling well" and body and muscles started to ache and progressed further. The consumer reported that on 08-MAY-2021, the patient was feeling sick and drove herself into the hospital. On 11-MAY-2021, the patient had blood clots galore and was on dialysis. On 12-MAY-2021, the consumer had one note stating the patient was holding steady and during night the consumer stated there's no change in patient's condition. On 13-MAY-2021, patient was going through with computerised tomography scan and told later that patient would not make it and would be saying goodbye tomorrow. On 13-MAY-2021, Laboratory data included: CT scan (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots galore, and the outcome of tired, lethargic, body aches, feeling sick (not feeling well) and muscle aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210529809 - Covid-19 vaccine ad26.cov2.s- blood clots galore. 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).
55 2021-05-23 sensation of foreign body I started having lumpy feeling in my throat. GI cramps, and diarrhea and my knee flared up as well.
55 2021-05-25 insomnia I was pretty sick the day after - fever, severe headache and chills. That started in the first eveni... Read more
I was pretty sick the day after - fever, severe headache and chills. That started in the first evening of April 9th and all day the 10th. On April 11 the chills and fever went away. I had a shooting headache - for a few minutes and sometimes just for a few seconds then it would go away and that continued until the 12th. . And that kept happening for about 5 days or so. Leg pain happened on the 19th - no swelling. It got really uncomfortable and I couldn't sleep at night. I went to the doctor and he did just a visual and physical pushing etc - he thought it was nerve pain. It subsided after quite a bit after 3 days and was gone by a week.
55 2021-06-01 feeling abnormal On first day I had headache within 4 hours and chills. Later that day I started having fatigue. Th... Read more
On first day I had headache within 4 hours and chills. Later that day I started having fatigue. The fatigue has basically continued . About 3-4 weeks in my left arm started tingling then on or about May 10th I started having back pain and joints hurting which I had lifted a case of water and moved a piece of furniture ever so slightly and I normally recover from something like that next day - I have been on anti inflammatory and other meds without relief. Went to a chiropractor which made things worse. I've had on and off episodes of fever/sweating and joints and back have continued to hurt. Doctor did a UA test to rule out any kidney or bladder problems (history of) and my WBC was high for me - course of antibiotics and I still dont feel well. I'm usually pretty pain tolerant , not a complainer but I have felt not myself since the vaccine.
55 2021-06-01 insomnia Vaccine reaction began day of injection: sore arm, difficulty sleeping next day: generalized malaise... Read more
Vaccine reaction began day of injection: sore arm, difficulty sleeping next day: generalized malaise, fever, nausea, vomiting, diarrhea, body aches, cold sweats Transported by EMS to ED for chest pain but patient reports cocaine and beer the night before Admitted for chest pain work-up and patient only has a homeless shelter to return to. Diagnosed with GERD and UTI.
55 2021-06-07 feeling abnormal For 3.5 weeks I experienced headaches, brain fog and join pain. The headaches and brain fog have sub... Read more
For 3.5 weeks I experienced headaches, brain fog and join pain. The headaches and brain fog have subsided but I am still experiencing joint pain. which has radiated from my shoulders to my elbows and now my back.
55 2021-06-08 disorientation, nervousness, euphoric mood, depression 04/28/2021 I felt dizzy, after a few days I felt my legs and feet tingly, a few days more and I felt... Read more
04/28/2021 I felt dizzy, after a few days I felt my legs and feet tingly, a few days more and I felt euphoric then depressed, after that I was okay. I might have had some tingling, but nothing too bad. 2 days before May 20th, 2021, I started feeling nervous then I went to ER, due to feeling lack of oxygen , I was disoriented, dizzy, fainting type of dizzy. I could not breathe, I laid down and I could not breathe and my hands were tingling, then it went away at ER, but then it came back. After that my feet were tingly for days on and then my eyes were twitching, this was 4 days after the ER, 1 week, now I am recovered. I still have some abdominal pain.
55 2021-06-08 feeling abnormal, memory impairment, loss of personal independence in daily activities The next day after vaccine, about 4:00pm - pain hit me and it was so severe I started to throw up fr... Read more
The next day after vaccine, about 4:00pm - pain hit me and it was so severe I started to throw up from the pain. Short term memory/brain fog has been an issue. I've had massive migraines. Complete body aches - even my bones hurt. The worse one was on both of my arms - above the wrist - and it was horrible (mostly on the right). One big blur of pain - I'm in a lot of pain all the time. I have a constant headache. I keep losing consciousness and that started after the vaccine. It use to hit every three hours. Now it's more than that. I have been two ERs in the couple of weeks. I've been to the doctor, too. I am referred to a neurologist - can't get me in until middle of July. I pass out and when I wake up from it I am in excruciating pain - my whole body hurts. I can only take Tylenol because I'm on Warfarin. I use Tylenol as needed and ice pack and heating pad for the pain. I started to almost lose consciousness when I have been completing this but I'm okay - it is like a blanking out of the moment.
55 2021-06-09 feeling abnormal The day after the vaccine I had bad joint pain, heavy fatigue and fever. I also had a cluster headac... Read more
The day after the vaccine I had bad joint pain, heavy fatigue and fever. I also had a cluster headache for one day. The joint pain lasted 4-5 days. For two weeks I felt inflamed and fatigued for two full weeks after that day. I felt very poorly like I had a low grade fever. Two to three weeks after the vaccine I noticed spot on my upper lip that was raw and hot. It is across my whole upper lip at the same time. It is red but not swollen and most noticeable when it becomes dry. Cold seems to help and some balm helps when it is at the dry stage. After it settles down it gets really dry and then it heals up. I keep getting the spots on my upper lips. It cycles for a 5-6 day period and it gets better and it returns and repeats the cycle. I always have a feeling that my lip is twitching before it comes up. It has been eight weeks and I have had the condition with my lip cycle six times since the vaccine. I have never had anything like this before. It is always the same and has not improved any with each cycle. The last time it was dormant for longer (10 days) but it seems to be worse with a bigger gap.
55 2021-06-09 feeling abnormal Two days after I got my vaccine started to not feel good, so I went to the doctor office. At the doc... Read more
Two days after I got my vaccine started to not feel good, so I went to the doctor office. At the doctor?s office they told me I got tested for Covid and was positive. I came back home and infected my husband with Covid. I also noticed my left foot and from my knee down to my foot, there is inflammation and are doing exams for blood clots and arteries to check why my foot is inflamed. I also have upper palate is also inflamed and my gums and upper palate bleeds out which I have gone to a dentist and gave me some antibiotics to see if my inflammation and bleeds go down. I would like an explanation of why this symptoms are happening to me. My doctor thinks my symptoms are related to the J&J vaccine.
55 2021-06-15 confusional state Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficu... Read more
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Pt became unresponsive to verbal stimulus and sternal rub within 5 minutes of vaccination. Person immediately called 911 (witness in line at the pharmacy) while (another patient in the pharmacy; a nurse) assisted the RPh and a technician in laying the patient on the floor and elevating her feet, providing ice packs for syncope symptoms, and damp towels for sweating. Patient became responsive prior to EMS arriving and transfer of care initiated upon EMS arrival.
55 2021-06-15 feeling abnormal At the moment of injection, I was in the middle of saying that the shot wasn't that bad to the pharm... Read more
At the moment of injection, I was in the middle of saying that the shot wasn't that bad to the pharmacist when I started to get very lightheaded. When he pulled the needle out of my arm quite a bit of blood ran down my arm even though I wasn't on any blood thinners. Fortunately, the pharmacists got me through it and I started to feel better in a few minutes. I ended up bruising very badly at the site of the shot. It took several weeks to go away completely. Three months later in June 2021, I have been experiencing prolonged unexplained pain in my left leg. Ultrasound showed no blood clots.
55 2021-06-16 impaired work ability The night of the vaccine I got a headache that got worse and I had to call into work. I also felt ex... Read more
The night of the vaccine I got a headache that got worse and I had to call into work. I also felt exhausted and the headaches came and went. It has been twelve weeks and I am still getting headaches every day. They start in different areas of my head sometimes in the front and sometimes in the front or on the side. They vary in intensity and they are sometimes very painful and sometimes mild. The only thing that seems to help is Excedrin. It is random which time of day it starts and the more intense ones last longer. The length of time that the headaches last is between 30 minutes to 4 hours.
55 2021-06-29 anxiety HORRIBLE experience!!! Felt faint the second the shot went into my arm, and for about 20 minutes af... Read more
HORRIBLE experience!!! Felt faint the second the shot went into my arm, and for about 20 minutes afterwards. (I practice meditation, and I can assure you this was NOT a panic attack or based on nervousness). Felt heat in my neck and ears, and immediate arm pain. After 30 minutes, drove home, and felt "spacey" the entire ride home. Ate some breakfast to see if that would help. Within 3 hours, I was getting a high fever, muscle aches (EVERYTHING hurt...including the tops of my hands...absoltuely miserable!!), fatigue, dizziness. THE WORST SIDE EFFECT WAS HEART PALPITATIONS. MY HEART WAS BEATING OUT OF MY CHEST (ELEVATED BETWEEN 90-120 BPM) FOR A STRAIGHT 36-HOURS!!!!! HOW COULD THIS BE NORMAL????? I THOUGHT I WAS GOING TO DIE. I WORK OUT EVERY DAY...SO MY HEART RATE IS NORMALLY MUCH LOWER...SO THIS WAS EXTREME FOR ME. It took FOUR DAYS for all of my symptoms to subside. FOUR DAYS!!!!! This vaccine is NOT safe, despite what you are telling the general public. I am an extremely healthy person...I eat healthy (no processed foods), do not drink or do drugs, meditate daily...this was an extreme reaction. Then, about 5 days later, news broke that the CDC was halting distribution of J+J due to blood clots. For two weeks, I developed severe anxiety, thinking that I would be a blood clot victim. Next to my breast cancer experience, this was the WORST health experience I've had in my entire lifetime. I WOULD NEVER GET ANOTHER VACCINE AGAIN!!!
55 2021-07-07 mental impairment DEATH; COMPUTERISED TOMOGRAM HEAD ABNORMAL; MULTIPLE ORGAN DYSFUNCTION SYNDROME; HYPOXIA; HYPOTENSIO... Read more
DEATH; COMPUTERISED TOMOGRAM HEAD ABNORMAL; MULTIPLE ORGAN DYSFUNCTION SYNDROME; HYPOXIA; HYPOTENSION; CONTINUOUS HAEMODIAFILTRATION; ENDOTRACHEAL INTUBATION; DEEP VEIN THROMBOSIS; ULTRASOUND DOPPLER ABNORMAL; LUNG ASSIST DEVICE THERAPY; DYSPNOEA; PAIN IN EXTREMITY; PERIPHERAL SWELLING; HYPOXIC-ISCHAEMIC ENCEPHALOPATHY; BRAIN INJURY; BRAIN OEDEMA; ACUTE KIDNEY INJURY; MENTAL IMPAIRMENT; HEPATIC STEATOSIS; THROMBECTOMY; PULMONARY EMBOLISM; PULMONARY INFARCTION; RIGHT VENTRICULAR DYSFUNCTION; ANGIOGRAM PULMONARY ABNORMAL; WITHDRAWAL OF LIFE SUPPORT; This spontaneous report received from a health care professional via a Regulatory Authority, VAERS (Vaccine Adverse Event Reporting System), concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included ethyl alcohol abuse, and concurrent conditions included hypertension. The patient had no known drug allergies. The patient had no known other illness at the time of vaccination. The patient was not pregnant at the time of vaccination. The patient had not taken any prescriptions, over the counter medications, dietary supplements or herbal remedies at the time of vaccination. The patient had no adverse event following any previous vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 21-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the patient's laboratory data included CT (computed tomography) angiography of chest showed severe burden of acute pulmonary embolism (PE) with severe right heart strain, small early infarct posteromedial left lower lobe (LLL), hepatic steatosis and interventional radiology (IR) thrombectomy procedure showed large bilateral pulmonary emboli. On 09-MAY-2021 (approximately 3 weeks after vaccination), the patient was presented to the emergency room due to progressively worsening shortness of breath. The patient also had pain and swelling in the left calf and leg. On the same day, the patient experienced brain injury, brain oedema, acute kidney injury, hypoxic-ischaemic encephalopathy, mental impairment, pain in extremity, peripheral swelling and had lung assist device therapy. The patient was hospitalized on an unspecified date. On 10-MAY-2021, the patient's ultrasound venous Doppler showed complete thrombosis left femoral, popliteal, posterior tibial, peroneal and anterior tibial veins, partial thrombosis of left common femoral vein. The patient underwent urgent thrombectomy, however, on 11-MAY-2021 (the next morning), she became more hypoxic and hypotensive and was intubated and was urgently placed on extracorporeal membrane oxygenation (ECMO). The patient developed multi-organ failure and was started on continuous veno-venous hemofiltration (CVVH) for oliguric renal failure. On 13-MAY-2021, CT computerised tomogram (CT) scan of the patient's head showed diffuse cerebral edema, which was most likely a result of hypoxic encephalopathy. With no improvement in her mental status over the course of the next few days, the patient was taken off life support and died on 15-MAY-2021 due to unknown cause. The patient was in hospital for 7 days. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death, multiple organ dysfunction syndrome, hypoxic-ischaemic encephalopathy, brain injury, brain oedema, acute kidney injury, mental impairment, deep vein thrombosis, pulmonary embolism, pulmonary infarction, hypoxia, dyspnoea, pain in extremity, peripheral swelling, hepatic steatosis, hypotension, right ventricular dysfunction, continuous haemodiafiltration, endotracheal intubation, thrombectomy, lung assist device therapy, withdrawal of life support, angiogram pulmonary abnormal, computerised tomogram head abnormal and ultrasound doppler abnormal on 15-MAY-2021. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210542597. Additional information was received from patient on 01-JUN-2021. The following information was updated and incorporated in to the case narrative: Patient demographics (race, ethnic origin), added patient history, added ethyl alcohol abuse in disease tab, added batch number, added facility type and other identification numbers updated.; Sender's Comments: V1: This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System), concerns a 55 year old female patient, who was noted to experience acute pulmonary embolism (PE), with severe right heart strain, 18 days after receiving the Janssen Covid-19 vaccine. The patient sought consult at the emergency room due to worsening of the shortness of breath. The patient also had pain and swelling in the left calf and leg. Computed Tomography Angiography (CTA) of chest showed acute pulmonary embolism (PE) with severe right heart strain, small early infarct posteromedial left lower lobe (LLL), hepatic steatosis. Venous doppler showed complete thrombosis left femoral, popliteal, posterior tibial, peroneal and anterior tibial veins, partial thrombosis of left common femoral vein. The patient underwent urgent thrombectomy. However, she became more hypoxic and hypotensive, was intubated and was urgently placed on extracorporeal membrane oxygenation (ECMO). Later, she developed multi-organ failure and was started on continuous veno-venous hemofiltration (CVVH) for renal failure. Nineteen (19) days after receiving the vaccine, Computerised tomogram (CT) scan of the patient's head showed diffuse cerebral edema, which was most likely a result of hypoxic encephalopathy. With no improvement in her mental status, life support was said to be taken off which resulted to death. It was unknown if autopsy was performed. Patient's height and weight were not reported. The patient's past medical history included ethyl alcohol abuse and concurrent conditions included hypertension. The patient had no known drug allergies. The patient was not pregnant at the time of vaccination. Information is limited in this case. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and the relationship is considered indeterminate. Additional information has been requested.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
55 2021-07-08 restlessness, insomnia Restarted Menses (menopause for 2yrs prior), reversal of hair from gray to black by root, increase i... Read more
Restarted Menses (menopause for 2yrs prior), reversal of hair from gray to black by root, increase in energy, restless, can't sleep.
55 2021-07-11 sleep disorder Redness, swelling, bruisig and a hard knot at the injection site which lasted for 6 weeks. Pain in ... Read more
Redness, swelling, bruisig and a hard knot at the injection site which lasted for 6 weeks. Pain in right neck and shoulder, bad enough to wake me from sleeping, still experiencing. Approx. 10 days post injection right thumb and wrist went numb. Still numb today.
55 2021-07-13 sleep disorder, insomnia The next morning after the vaccine my fingertips went numb at 10 am. This numbness persisted approx... Read more
The next morning after the vaccine my fingertips went numb at 10 am. This numbness persisted approx 8 hours despite my pumping my arms and flexing my fingers, which would normally get circulation pumping and alleviate "asleep" finger feeling that might occur on a rare occasion. The numbness in my digits came back a week later on Tuesday, July 13, and was later followed about an hour later by a tingling burning feeling in my hands late Tuesday night. It was uncomfortable and kept me from sleeping much the night. Now it is Wednesday, July 14 and my hands are better and I don't feel that prickly sensation at this moment of writing this report - just a bit of fingertip numbness. I would like to be contacted regarding what step I can and should take regarding my numbness and prickly hands. I also had injection site soreness for 5 days after the vaccine on my left shoulder. That is now better.
55 2021-07-15 insomnia I have had muscle pain in my legs for over a month. About a week after I got the shot I thought I ha... Read more
I have had muscle pain in my legs for over a month. About a week after I got the shot I thought I had pulled a muscle from mowing.But it is well over a month and the pain is still there. In the first week it started around the groin area, I could not take full steps, I could not pull my legs up without severe pain. I have had to sleep in the recliner because it was too hard to roll over with my legs. It is very hard to sit and get back up because of the pain in my legs.I do not know if my problems are from the shot, but I Have always been a very active person, The last couple of days my legs have actually felt better, still a little pain, but not like before.
55 2021-07-17 impaired work ability The adverse reaction began within hours of the vaccine. It began with flu like symptoms including c... Read more
The adverse reaction began within hours of the vaccine. It began with flu like symptoms including chills, fatigue, and aches (no fever but Patience rarely runs a fever even if very ill). Aches included sharp pains in her right calf muscle. Flu like symptoms persisted for 5 days and began subside on the 6th day. Patience was able to return to work on the 9th day, although pain in her right leg persisted. Over the next several weeks she had a VQ lung scan, bilateral Doppler ultra sounds of both legs, and chest x-ray as well as an array of blood work which were all negative. The pain continued to worsen to the point where she was not able to walk or drive. She visited an orthopedic urgent care center for evaluation, where it was suggested a nerve in her back was causing the pain. She was prescribed Gabapentin and refereed to Physical Therapy and a back specialist. Because there was a long wait to get an appointment with the back specialist, and the pain was worsening, she went to a different orthopedist who took x-rays and MRI of the leg, as well as additional blood tests. The X-ray showed no breaks or injuries to the bone, and the MRI showed no soft tissue damage but it did show some minor inflamation of the muscle. Her labs were all normal except for a slightly elevated C-Reactive Protein and slightly low Hemoglobin. The orthopedist prescribed a boot and recommended rest and continued Gabapentin. Over the next three weeks the pain subsided. With the MRI results showing no bone damage, she discontinued the boot, and with no remarkable spine abnormalities she discontinued the Gabapentin, and is currently taking a combination of Tylenol and Advil, and has returned to work on a reduced schedule. The pain has subsided but is still present and flares up at times. She is starting to experience similar symptoms on the left leg. The treating Orthopedist has referred her to a Rheumatologist, appointment is pending as of this date
55 2021-07-23 feeling abnormal BLOOD PRESSURE INCREASED; BURNING LIVER; EXACERBATION OF REFLUX; SHARP PAIN IN STOMACH; FELT LIKE KI... Read more
BLOOD PRESSURE INCREASED; BURNING LIVER; EXACERBATION OF REFLUX; SHARP PAIN IN STOMACH; FELT LIKE KIDNEYS WERE BURNING; SHARP PAIN IN CHEST; FELT THE VACCINE GO TO HEAD 10 MINUTES AFTER GETTING SHOT; RIGHT SHOULDER THROBBING; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy, alcohol use, non-smoker, and hypertension, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 14:10 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, Laboratory data included: Blood pressure (NR: not provided) 144/80 mmHg. On 18-JUN-2021, the subject experienced felt the vaccine go to head 10 minutes after getting shot. On 18-JUN-2021, the subject experienced right shoulder throbbing. On 19-JUN-2021, the subject experienced sharp pain in chest. On 19-JUN-2021, the subject experienced sharp pain in stomach. On 19-JUN-2021, the subject experienced felt like kidneys were burning. On 19-JUN-2021, the subject experienced exacerbation of reflux. On 19-JUL-2021, the subject experienced burning liver. On 20-JUL-2021, the subject experienced blood pressure increased. Laboratory data included: Blood pressure (NR: not provided) 165/105 mmHg. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 100/70 mmHg. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp pain in chest, sharp pain in stomach, felt like kidneys were burning, felt the vaccine go to head 10 minutes after getting shot, and right shoulder throbbing on 21-JUN-2021, and burning liver on 21-JUL-2021, was recovering from exacerbation of reflux, and the outcome of blood pressure increased was not reported. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
56 2021-03-04 feeling abnormal within a minute of receiving the vaccine I started feeling dizzy and woozy and like I was floating. ... Read more
within a minute of receiving the vaccine I started feeling dizzy and woozy and like I was floating. Then my blood pressure went up and my heart started beating faster. I had tightness in my chest and I got a tickle like feeling at the top of my chest. I got nauseous. BP was elevated (140/85) normal 107/65. I stayed for an hour. I was very very sleepy the whole time. 3/5/21 I still have the tickle and tightness and pressure on my chest and I am having vertigo attacks. I got a headache and pain and stiffness in my neck where I have had nerve pain injections and ablations.
56 2021-03-06 feeling abnormal I started to experience symptoms around noon time on the day of vaccination. It started with a low-... Read more
I started to experience symptoms around noon time on the day of vaccination. It started with a low-grade fever. Slowly over the course of the day, I started to experience body aches, chills and headaches. My left arm where I received the vaccine felt strange. My fever got up to 100.4. During the night I had chills. It felt like my fever broke early in the morning. I woke up okay and I feel like I could go about my day with no problem. I no longer have a fever.
56 2021-03-07 disorientation I had immediate pain at injection site, which is still tender to the touch. I have experienced extr... Read more
I had immediate pain at injection site, which is still tender to the touch. I have experienced extreme fatigue over the past three days. I had diarrhea multiple times starting at 12AM on 03/07/2021. I became extremely weak, dizzy, disoriented, and broke out into a cold, clammy sweat. My skin was very ashen/pale. Did not administer body temperature at time of incident but had cold chills.
56 2021-03-09 confusional state, excessive sleepiness Muscle Aches & Fatigue Muscle Aches = Approximately 1 hour after taking the vaccine, I started to ... Read more
Muscle Aches & Fatigue Muscle Aches = Approximately 1 hour after taking the vaccine, I started to feel a little crook in my side (like I had been running). As time went on, the pain spread. My entire stomach muscles tighten up (feels like I'm recovering from abdominal surgery) and then spread to the rest of my body. Couldn't move without feeling pain. Fatigue = I dozed off around 7 pm and slept like I was in a coma. Woke up around 2 am and was very confused. Muscle Fatigue = March 9th - The pain has subsided considerably Muscle Fatigue - March 10th - Still just a little sore - Can't laugh or cough without feeling pain and my back is killing me
56 2021-03-09 feeling abnormal, disturbance in attention Immediate headache, pains in legs/feet after 5 hours, low grade fever after 8 hours, pain in hands a... Read more
Immediate headache, pains in legs/feet after 5 hours, low grade fever after 8 hours, pain in hands and fingers after 10 hours, skin felt bruised and sensitive to touch starting 10 hours after vaccination and skin sensitivity/pain remained until 30 hours after vaccination, fever rose to 104.5F as measured at 2AM overnight (17 hours after vaccination), day after vaccination fever never dropped below 102.0F, day after vaccination all but unable to eat due to nausea, total loss of appetite, mind foggy with difficulty concentrating, difficulty in forming detailed sentences. Pain in feet was agonizing, especially while attempting to walk. Husband?s assistance required to walk to and from bathroom, unable to walk by self most of day of vaccination, and entire day following vaccination. Two days after vaccination fever still present, 99.5-100.0F, appetite returning, mental fog clearing, Still ?really exhausted.?
56 2021-03-14 insomnia The day I received the shot, my arm got warm and sore. The soreness traveled to my shoulder and nec... Read more
The day I received the shot, my arm got warm and sore. The soreness traveled to my shoulder and neck. I got headachey, alternating between hot and cold chills, a little bit of nausea and extreme tiredness. This continued for the next 5 days which seemed like they were considered mild reactions according to the CDC website. Most concerning though, is on day 5, (3/14/21) in the evening as I was getting into bed, I started getting a red, extremely itchy rash on both my arms, my lower back and my upper legs, to the point that I could not sleep because it was so itchy and had to take Benedryl. I have not changed anything in my diet or in the products I use on my body, so I can only attribute this reaction to this vaccine. I am still a little itchy on my arms today 3/15/21. I am also still getting the hot and cold chills and still have a little bit of nausea, not bad, but enough to be "off" certain foods.
56 2021-03-15 hallucination About 9 hours after getting vaccine, during the night I developed chills, shakes, extreme fatigue, l... Read more
About 9 hours after getting vaccine, during the night I developed chills, shakes, extreme fatigue, later had temporary hallucinations (weird!), the following day I had debilitating fatigue I could hardly get myself out of bed, severe headache, body aches and then slowly got better but Day 3 I got stuffy head and slight shortness of breath (I blamed that on seasonal allergies), but then I developed itchiness over my ENTIRE body. I took Benadryl and itch is subsiding. I hope this is the end of side effects!
56 2021-03-22 feeling abnormal Client complained of being light headed and feeling "funny" in her throat. alert and oriented x 3 ... Read more
Client complained of being light headed and feeling "funny" in her throat. alert and oriented x 3 . Respirations unlaboured . Blood pressure 170/100 pulse 96 RR 16 and 02 saturation 96%. at 12.57 pm by EMS on site. Rechecked at 1300 pm blood pressure 142/98 Pulse 98 and o2 saturation 98%. Released by Dr and released home with instructions to follow up in Emergency department if symptoms worsen or do not improve later.
56 2021-03-23 sleep disorder I received my J&J vaccine on 03-13-2021. On 03-16-2021 I woke up and the left side of my shoulder, b... Read more
I received my J&J vaccine on 03-13-2021. On 03-16-2021 I woke up and the left side of my shoulder, both knees, both legs and both feet are inflamed. I also have cramps to both of my shoulders. On Saturday 03-20-2021 when I woke up my right eye was also inflamed but only lasted one day. I have spasms to my calves with leg cramps. I can not sleep at night due to the inflammation. I went to see my PCP this morning who prescribed a leg cream for the cramps, but I do not know the name. My blood pressure today in the morning was 154/96. My doctor said it was a reaction to the vaccine.
56 2021-03-28 insomnia Very slight sore throat around 7:00pm; resolved in a couple of hours. Around 9:00 pm developed deep... Read more
Very slight sore throat around 7:00pm; resolved in a couple of hours. Around 9:00 pm developed deep, intense body chills that lasted at least 3.5 hours. No fever. Once the chills were gone, I got an intense headache around the back of my head and in my forehead between my eyebrows. Difficulty sleeping through these symptoms. Woke up the next day and those symptoms were gone. Fatigued the next day. Took a two-hour nap Saturday afternoon and felt normal afterwards.
56 2021-03-31 anxiety The patient was screened and was found to have multiple medical allergies but no allergies to any of... Read more
The patient was screened and was found to have multiple medical allergies but no allergies to any of the components to the Janssen vaccine. As a precaution, the nurses advised a 30 minute observation. She received the vaccine without complication and then was being observed and they called me over and the paramedics were also with the patient. About 17 minutes into observation, the patient started developing chest pressure (4/10), lightheadedness, and nausea. No shortness of breath, stridor, diaphoresis, back pain, abdominal pain, vomiting, neurologic changes, and any signs or symptoms of anaphylaxis. She was very anxious. Further history revealed that the patient had been discharged from the hospital 6 week prior. She initially went in for an abdominal laproscopic surgery and woke up to having 32 staples closing an abdominal incision. They had to change from a laproscopic approach to an open abdomen approach due to complications. She ended up with sepsis and a colostomy and was hospitalized for 2 weeks getting antibiotics. She lives by herself and was overwhelmed before coming into the clinic for her vaccine. The paramedics did a 12-lead ECG that showed sinus rhythm. Vital signs and blood glucose were within normal limits. The paramedics recommended that she go to the hospital to be checked out but she was very resistant and was tearful because she was traumatized from her previous hospitalization. After some time, the paramedics convinced her to go to the hospital. The paramedics hung around the emergency department and then came back once they found out that she was fine.
56 2021-04-01 anxiety Here, client received Janssen vaccine at 11:32 and while in the recovery area, @ 11:37 began to c/o ... Read more
Here, client received Janssen vaccine at 11:32 and while in the recovery area, @ 11:37 began to c/o palpitations, feeling clammy, dizzy and feeling faint. VSS @ 11:37: 110/78, HR 109-88, O2Sat 99%, skin wnl, very anxious, requesting to lie down, was lowered to the floor, placed in supine initially then feet elevated on chair, breathing easily but expressed feeling anxious. VSS @ 11:39: 102/61, HR 73, Sats 99%. Symptoms ongoing, 11:40, monitoring continued by recovery team, 911 called, Engine 340 arrived @ 11:47. EMS Assessment: EKG, Blood Glucose 92, VSS@ 11:59: 150/83, HR 76, continued to monitor. Following EMS assessment, refused EMS transport stating feels better, able to stand w/out incident, assisted to chair, monitored for add'l 15 minutes. Son was contacted and request to assist client w/ride home, drove to site independently, not safe to drive back alone. 12:13 Sone arrived, stand by assist to vehicle by recovery nurse, stable for dc to home.
56 2021-04-01 feeling abnormal Started with burning muscles throughout my body. Around 9 PM I started to get a headache. Then chill... Read more
Started with burning muscles throughout my body. Around 9 PM I started to get a headache. Then chills followed by intenses fever and sweating. All night and through to the next morning I had a high fever, though I didn?t take my temperature. I was achy all over, had an incredibly horrific headache which strong migraine over the counter pills did not help, I would go back and forth from shivering to sweating (my body would be drenched in sweat) and just feeling miserable. I slept off and on until about noon. Then all symptoms slowly went away. By about 2:00 I was up and around though tired. By early evening I was perfectly fine.
56 2021-04-04 feeling abnormal Patient reported to her doctor's office today with symptoms consistent with Bell's Palsy. She state... Read more
Patient reported to her doctor's office today with symptoms consistent with Bell's Palsy. She stated that the facial symptoms started mid morning today on 4/5/21. Last week ( week of 3/28 to 4/3) she reports that she felt "weird". She felt as if there were cool water running under her skin at all times. She also states that when anything touches her skin, it feels very cold. For example, when running her hands under warm water, it feels like ice water on her hands. When setting her bare arms on her desk, it feels as if they are being set on ice and when her pants rub against her legs it feels as if they are wet and cold. She also stated that the top 1/3 of her back was tingly and felt as if she had applied Biofreeze to it, but she had put nothing on her back. Her tip of her tongue feels as if it is "burnt" and she can not tasted anything on the front part of her tongue. She needs to get things way in the back of her mouth before she can taste them. On 4/3/21 she states that her lips began tingling as if they were having numbing medication wearing off from a dental visit, but she had done nothing different. On 3/31 her lower back also felt as if it had a pinched nerve. Today on 4/5/21 she has the Bell's Palsy on her face that started mid morning and she complains of her nose feeling tingly also. She also feels as if she is retaining fluid.
56 2021-04-05 irritability, insomnia Close to 24 hours after my vaccine I started to have goosebumps and then chills. Soon after the sev... Read more
Close to 24 hours after my vaccine I started to have goosebumps and then chills. Soon after the severe tiredness kicked in along with a cough. Then I started running a fever. I was hot with chills and when I wasn?t under a blanket I was shaking uncontrollably. I took ibuprofen which helped a little. Ended up taking an Ativan to sleep. The next morning I felt like I had the flu. Still feverish with a deep cough. Groggy, lethargic and tired. Took a two hour nap around 4. Starting to feel better but I?m exhausted and very irritable.
56 2021-04-08 excessive sleepiness Weds April 7th at 2 p.m. at the fairgrounds I was given the J & J 1 dose shot by retired Dr. The s... Read more
Weds April 7th at 2 p.m. at the fairgrounds I was given the J & J 1 dose shot by retired Dr. The second the shot went in I felt extremely light headed and felt like I was going to pass out. They got me by both arms and got me in a wheelchair and wheeled me to recovery with 30 minute wait. The staff member at recovery asked me if I had eaten anything that day. I had not eaten anything by 2 p.m. in the afternoon. They gave me apple juice and I instantly felt better. The next morning starting at 8 a.m. 1" welt at pin needle site on left arm, low grade headache all day, nauseous all day, tired. At 4:30 p.m. the next day Thursday, 4/8/2021 I went to sleep at 4:30 p.m. and slept until 8 a.m. Friday morning 4/9/2021. Friday, 4/9/2021 I feel pretty good today.
56 2021-04-08 loss of personal independence in daily activities, impaired work ability Yesterday after the shot, Heart racing after 40 minutes of injection, shortness of breath, dizzines... Read more
Yesterday after the shot, Heart racing after 40 minutes of injection, shortness of breath, dizziness and nausea. then later moderate headache and tiredness. Today, diarrea, weakness, tiredness , headache, body aches, Trying to do my daily routine has been hard, I was not able to work, haven?t talk to a doctor yet
56 2021-04-08 loss of personal independence in daily activities Body aches, chills, joint pain, fever between 100.4 and 101.8; headache, fatigue, eye burning/wateri... Read more
Body aches, chills, joint pain, fever between 100.4 and 101.8; headache, fatigue, eye burning/watering; stayed home in bed, hydrating, still not feeling well today; fever down to 99.8
56 2021-04-09 anxiety RINGING IN THE EAR; ANXIETY; SORE ARM; This spontaneous report received from a patient concerned a 5... Read more
RINGING IN THE EAR; ANXIETY; SORE ARM; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced ringing in the ear. On 01-APR-2021, the subject experienced anxiety. On 01-APR-2021, the subject experienced sore arm. Treatment medications included: ibuprofen. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and had not recovered from ringing in the ear, and anxiety. This report was non-serious.
56 2021-04-10 irritability, confusional state 4.8.21 4pm. Feeling tired and irritable. 530pm. Muscle aches in back and chest. Headache, no appeti... Read more
4.8.21 4pm. Feeling tired and irritable. 530pm. Muscle aches in back and chest. Headache, no appetite. Took 2 Advil. 9pm. Very achy and suffering from chills. Teeth chattering. 130am 4/9/21. Woke up in confusion. Couldn't find bathroom in my bedroom. Stood for a long time trying to figure out what to do. Found bathroom. Sweating profusely and took 2 more Advil. 4/9/21 7am tired and a little achy. Fever of 99.5. By 1130am fell into bed bed freezing and exhausted. Slept until 4pm. Woke up felt 80% better. Totally back to normal self by 4/10/21. Arm soreness did not start until 4/10.
56 2021-04-10 loss of personal independence in daily activities headache, chills, muscle ache, fever, dizziness, extreme fatigue began I day after vaccine. All thes... Read more
headache, chills, muscle ache, fever, dizziness, extreme fatigue began I day after vaccine. All these persisted for two days. It has been 5 days since injection and dizzyness is worse. Fatigue is less, but still present and keeping me from performing normal activities. Feesl like blood pressure is low. Tingling feeling in body. Heachache. I am a woman who weighs 105lbs.
56 2021-04-10 sleep disorder, feeling abnormal In the middle of the night of the 10th of April I started having what seemed like normal side effect... Read more
In the middle of the night of the 10th of April I started having what seemed like normal side effects---muscle aches, headache, fatigue.. and then all day on the 10th the same side effects. Then last night I slept 9 straight hours but woke up sweating a couple times in night and in morning woke up sweating but my aches and headache seemed better than the day before so I went downstairs to make tea. After pouring a glass of orange juice and having a couple sips I started to feel strange --dizzy and oversome with a strange feeling that was not quite like the feeling before fainting -- my back had a weird pain and i was a little nauseous as well. ..it was more overwhelming -- more loss of control like a huge wave of dizziness and ringing. I made my way to a couch to try to regain balance -- but was still very dizzy-- something happened to make me try to get up and go upstairs so I remember walking 12 feet or so then told myself to sit down. Before that happened I must have blacked out. I faintly remember moving myself across the floor but then must have blacked out again. I woke up at the base of the stairwell and then was able to walk upstairs. I had collapsed the first time onto a hard floor as my orange juice glass had spilled all over and when I got upstairs my sweatshirt was covered in juice. I don't remember any of that. Once upstairs I drank water and have been fine since then. I had eaten dinner the night before but maybe it was the sweating in the night that dehydrated me and i cramped up and had a strange pain in my back---i don't know. I am a very healthy 56 yr old woman 5'3" 105 lbs so maybe the Johnson and JOhnson one dose was a lot for my body or maybe my body was just doing what it's supposed to do to react to vaccine.... i also may have had asymptomatic covid in the last year so my body was overreacting. This happened 7 hours ago and I seem fine aside from slight headache and continued weakness from vaccine but I thought I should report the incident in case there might be something more or in case others had similiar responses.
56 2021-04-10 sleep disorder At 10;30 pm starting running a temp of 99.9, started shivering uncontrollably. Took 2 advil 200mg. e... Read more
At 10;30 pm starting running a temp of 99.9, started shivering uncontrollably. Took 2 advil 200mg. ea. woke again at 1:00 am with a temp of 101.6. My heart was beating fast so I took my blood pressure and it was 164/85, my heart rate/pulse was at 125 per min.. Took 2 more advil. kept checking my rates. at 2;30 am. it was 136/73 with a heart rate/pulse of 117. Temp 100.9. stayed awake till 4;30 am. thinking about going to hospital. When i woke at 7:00 am my BP had gone to 121/77 with heart rate of and temp of 99.9. I took more advil and slept most of the day. Was very fatigued. this lasted until that evening of the 8th. On the whole, it was a 24hr reaction period. From 10:30 pm. on the dosage day to 10:30 pm on the day after.
56 2021-04-11 confusional state, amnesia Confusion. Memory loss. Difficult time with word retrieval. Difficulty articulating
56 2021-04-11 insomnia I can barely move my left arm. I believe the injection was injected high upon my arm (almost my shou... Read more
I can barely move my left arm. I believe the injection was injected high upon my arm (almost my shoulder) and hit a nerve or bone. I al unable to have full range. It is painful to use and I am unable to sleep at night. My whole upper left side has seized up.
56 2021-04-11 sleep disorder Vaccine very painful-burning when injected Arm sore and tender for full week following injection Ap... Read more
Vaccine very painful-burning when injected Arm sore and tender for full week following injection Approx 15 hours following injection was woke from sleep with full body aches, chills, fever (100-101) - this continued for approx. 24-48 hours
56 2021-04-12 confusional state Got very dizzy, confused, could not speak. 911 was called and was transported to hospitol for stroke... Read more
Got very dizzy, confused, could not speak. 911 was called and was transported to hospitol for stroke sysmptons
56 2021-04-12 feeling abnormal About 24 hours after shot, experienced flu like symptoms-chills fever all over fatigue lasted 3-4 ho... Read more
About 24 hours after shot, experienced flu like symptoms-chills fever all over fatigue lasted 3-4 hours. After these symptoms passed, massive headache for 3-4 hours. The next morning, light headed upon standing and felt faint, then brain fog began tingling in feet/legs arm/hands and head. This continues but now having pain in legs and arms and brain fog is increased 12 days going and getting more pain in legs more brain fog. Contacted primary care on 04/12/2021 and had office visit 04/13/2021.
56 2021-04-12 excessive sleepiness FOR 3 WEEKS FOLLOWING THE VACCINATION: I had aches in all of my joints (elbows, wrists, and knees)... Read more
FOR 3 WEEKS FOLLOWING THE VACCINATION: I had aches in all of my joints (elbows, wrists, and knees). I thought maybe i am developing arthritis. This lasted for approx 3 weeks and then suddenly stopped. Was it joint inflammation? I had no other symptoms. I did not visit the doctor. Within 5 hours of the vaccination, symptoms started with pain in both of forearms. Overnight I developed fever, lethargy , aches and pains. Took Tylenol. Slept for approx 36 hrs. I felt much better after 40 hrs. I was not concerned. I would say my symptoms were moderate or worse. In March of 2020, I had shortness of breath in my left lung . It lasted for days. I was concerned but I did not visit the doctor. It eventually went away. Could I have had Covid then? A sure possibility but I will never know!
56 2021-04-12 nervousness at 6:00 pm. i started with light headedness and eyes blurred. by 830pm,started get cold and hot swea... Read more
at 6:00 pm. i started with light headedness and eyes blurred. by 830pm,started get cold and hot sweats together. i felt like my bones were going to break especially in toes. i was afraid to stand up, also it felt like my breathing was effected if i laid down, id cough and than get a sharp headache pain, so around 1230am, with still freezing and sweating started with sharp pains in left lower stomach and top left chest stabbing pains, felt like i have to vomit and go to the bathroom. ended up just vial vomit .this lasted until 0700am took a hour nap woke up sweating was drenched, continuing day on with left side stomach and chest pains and back shoulder pain. with nervousness. on 4-13-21 woke up to diarrhea and shaking still
56 2021-04-12 sleep disorder, insomnia I did not feel anything except the injection area right after the Janssen shot. It was great. Within... Read more
I did not feel anything except the injection area right after the Janssen shot. It was great. Within the past week and a half, I feel a little tired and light headache. Sometimes, I had trouble sleeping at night. But, starting end of the second week, the symptoms got worse. I am suffering from a sleep disorder. I felt exhausted, bigger and longer headaches, joint pain, muscle pain. My Blood pressure went up. I visited my family doctor today.
56 2021-04-12 sleep disorder The evening following the shot - chills, sweating, muscle achiness, headache, fatigue approximatel... Read more
The evening following the shot - chills, sweating, muscle achiness, headache, fatigue approximately the week prior to March 27 I was very very very fatigued. the following week still fatigued. I felt a weird sensation near my heart that was only momentarily - like a bubble or something about 1/4 inch in length move through a vein near my heart - I think I felt it again near my stomach a few days later - weird. and then my face felt like I was losing sensation - like it was tingling . that lasted a little longer, like a sagging. I thought maybe I put on weight. i was concerned and went to pharmacy to get my blood pressure taken - which I have never done in my life. I am 56! They no longer do that bc of COVID - so I asked a nurse friend to take it. She measured 124 over 60 something. that is high for me. I am typically 106/62. I checked my records. I started running then - in case I have put on weight. I am 155 (high). But now I started getting a constant headache about a week ago. I am in a new job - so have thought it was due to stress or I reactivated a concussion headache. i started taking Ecotrim 2 everyday now. I am NOT an aspirin taker and I do not get headaches. I try not to take ibuprofen for the headache. I am not sleeping. I have slept well ALL my life up to now. I go to bed late now like 11;30 and I don't sleep. I have a lot on my mind. so it could be that. Under a lot of stress. this just started the last week. A very new pattern. I started a new job 3/15/21. I was drinking coffee for the first 2 -3 weeks and now am not drinking it. I don't drink much alcohol but I have had 1 glass of wine on the weekend or beer. I run about 3 miles 2-3 times a week.
56 2021-04-12 sleep disorder Five days 18 hours after receiving the Janssen vaccine shot, I awoke with an unusual and very painfu... Read more
Five days 18 hours after receiving the Janssen vaccine shot, I awoke with an unusual and very painful headache. Having only been asleep for about two hours, I didn't want to get up and tried to rearrange myself for relief. Getting slight relief, I did fall asleep again after moving around and drinking water over about an hour. I awoke two hours later (about 10:00 AM) with almost unbearable head pain throughout my head, not localized to one area. I drove to fast food restaurant, having a difficult time driving due to pain, and got a half-sweet tea. Tea, having caffeine and some sugar, can often relieve a headache. It didn't offer the relief I expected and about 30 minutes later, I vomited up the tea. I was at that same time ordering a sandwich and detox smoothie, thinking the detox smoothie may help. It seemed to after a couple more hours, but I continued to feel like the headache was still barely there and waiting to return. I ate very well and clean all day, but even late in the evening, I cod feel remnants of a headache. The next morning, 4/12, I awoke again with that same horrible headache, but maybe just slightly less excruciating than the day before. I did not vomit. After a few hours of eating, drinking water, and taking aspirin with Tylenol, the headache subsided.
56 2021-04-13 disturbance in attention Headache, fatigue, joint pain, leg weakness and numbness, concentration issues, shortness of breath.... Read more
Headache, fatigue, joint pain, leg weakness and numbness, concentration issues, shortness of breath. Conditions improved by Saturday but are still ongoing as of today 4/14/2021
56 2021-04-13 feeling abnormal Left arm and left neck/face tingling, decreased sensation with subsequent Bell's palsy like facial a... Read more
Left arm and left neck/face tingling, decreased sensation with subsequent Bell's palsy like facial asymmetry on the left side, brain fog, dizziness with position changes, pressure in head when bending over behind the left eye, aching pain in left arm, fullness in the anterior lower right neck, episode of visual stars, food and drink dripping/falling out of left side of mouth, Pain in left rib cage/chest into the left back causing her to breath shallower. ER evaluation confirmed CT finding of right superficial vein thrombosis just above the sternoclavicular joint - see imaging report info.
56 2021-04-13 feeling abnormal LOSS OF SMELL; LOSS OF TASTE; BRAIN FOG; JOINT PAIN; HEADACHE; PAIN AT INJECTION SITE; FATIGUE; MUSC... Read more
LOSS OF SMELL; LOSS OF TASTE; BRAIN FOG; JOINT PAIN; HEADACHE; PAIN AT INJECTION SITE; FATIGUE; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced brain fog. On 23-MAR-2021, the subject experienced joint pain. On 23-MAR-2021, the subject experienced headache. On 23-MAR-2021, the subject experienced pain at injection site. On 23-MAR-2021, the subject experienced fatigue. On 23-MAR-2021, the subject experienced muscle aches. On 28-MAR-2021, the subject experienced loss of smell. On 28-MAR-2021, the subject experienced loss of taste. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, pain at injection site, fatigue, and muscle aches on 25-MAR-2021, and fever, and had not recovered from joint pain, loss of taste, loss of smell, and brain fog. 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.
56 2021-04-13 excessive sleepiness, memory impairment Terrible body aches and headaches. Felt like couldn?t even walk at times. Extreme tiredness. Slept f... Read more
Terrible body aches and headaches. Felt like couldn?t even walk at times. Extreme tiredness. Slept for 20 hours straight. Took 3 Tylenol. Lasted about 30 hours total. Ended abruptly the next day but tired like symptoms seem to be remaining as well as some forgetfulness. Did not go to hospital or go for treatment.
56 2021-04-13 insomnia Pain, swelling, redness, bruising, tenderness, hot to touch, unable to sleep on left side due to pai... Read more
Pain, swelling, redness, bruising, tenderness, hot to touch, unable to sleep on left side due to pain
56 2021-04-13 loss of personal independence in daily activities Day 1 & 2 after shot - left arm hurt around injection site. Day 2 I felt very tired and some body a... Read more
Day 1 & 2 after shot - left arm hurt around injection site. Day 2 I felt very tired and some body aches. By Day 5 or 6 - full body aches and my arms felt like there was pressure on them. I was feeling very tired. As more days passed; I was feeling tired, could not raise my arms, legs were weak and hurting. If I did anything (shower or carry a simple laundry basket) my arms would hurt so bad, I was out of breath and my heart was pounding so hard. By the week of March 29th - I was laying down in the middle of the day, no energy at all. Called the doctor and because of the shortness of breath & Body aches, they would only schedule a video visit for Monday, April 5th. After talking to me, they schedule to see me that day at 11:45 AM. I had weak muscle response in my arms, pale, and out of breath. They did blood work. Two hours after getting home; they called and said I needed to get to the emergency room. My red blood cell count was dangerously low, and they ordered a blood transfusion. I sent 6 days in the hospital.
56 2021-04-14 irritability, crying, impaired work ability Client reports that she received the vaccine at approx. 11 AM on 04/10/2021. At approx. 2 PM that da... Read more
Client reports that she received the vaccine at approx. 11 AM on 04/10/2021. At approx. 2 PM that day, she states that she felt very irritable. Throughout the week she states she felt very "weepy" and emotional along with irritability. Today the client states she has become very shaky. She states it's "not uncontrollable but I was having trouble holding a pen and using a keyboard, and I had to leave work." Recommended that she call her PCP and report these things to them as well. She voiced understanding.
56 2021-04-14 memory impairment, feeling abnormal Dizziness, Vertigo, Leg pain, memory issues (patient reports as "brain fog")
56 2021-04-15 feeling abnormal, memory impairment, impaired work ability - headache, mild fever, brain fog, dizziness on 4/11 - on 4/13 admitted with intractable dizziness a... Read more
- headache, mild fever, brain fog, dizziness on 4/11 - on 4/13 admitted with intractable dizziness and continued brain fog (requiring questions to be asked multiple times to answer. Taking a long time to remember current year and month) - still dizzy on discharge and unable to drive or work
56 2021-04-15 feeling abnormal Severe headache at approximately 3:330 am on Sunday April 11th, took two extra strength excedrin, ... Read more
Severe headache at approximately 3:330 am on Sunday April 11th, took two extra strength excedrin, (day after vaccine). didnt help much. Stomach pain started on Monday 4/12. nausea, felt like I was in a fog, very very tired. Called primary on Tuesday the 13th and was instructed to go to ER. Waited 8 hours and was unable to see MD for another 10 hours due to ER was 20 hours behind. I left and continue to have stomach discomfort, nausea, headache, chills, body aches, shortness of breath on exertion, lethargy, and brain fog.
56 2021-04-15 insomnia, feeling abnormal PALM OF HANDS ARE RED; CONGESTED; BOTH LEG MUSCLES HURTING; CHILLS; NAUSEOUS; BOTH EARS STARTED RING... Read more
PALM OF HANDS ARE RED; CONGESTED; BOTH LEG MUSCLES HURTING; CHILLS; NAUSEOUS; BOTH EARS STARTED RINGING; VOMITING; COULDN'T SLEEP; HEAD FEELS LIKE IT IS IN A FOG; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced both ears started ringing. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced couldn't sleep. On 08-APR-2021, the subject experienced head feels like it is in a fog. On 08-APR-2021, the subject experienced both leg muscles hurting. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced nauseous. On 09-APR-2021, the subject experienced palm of hands are red. On 09-APR-2021, the subject experienced congested. Laboratory data (dates unspecified) included: Rhesus antigen (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from both ears started ringing, vomiting, couldn't sleep, both leg muscles hurting, chills, and nauseous, and had not recovered from head feels like it is in a fog, palm of hands are red, and congested. This report was non-serious.
56 2021-04-16 hallucination, feeling abnormal Headache, fever, weakness, and hallicunations from 12 to 36 hours after receiving vaccine. Weakness... Read more
Headache, fever, weakness, and hallicunations from 12 to 36 hours after receiving vaccine. Weakness, shortness of breath, spaciness, and body aches from day 2 to 6 after receiving vaccine. Chest pain, back pain, and indigestion beginning around 2 weeks following vaccination and continuing until present day.
56 2021-04-19 feeling abnormal, sleep disorder At approximately 2AM on Thursday, a severe headache (I would term a migraine based on prior experien... Read more
At approximately 2AM on Thursday, a severe headache (I would term a migraine based on prior experience) woke me. I had no apparent fever, but my body was stiff and I felt my heart rate was elevated. I drank some water, in case it was dehydration-related, but was unable to fall back asleep. I also experienced some nausea at breakfast but ate toast and had some (caffeinated) tea about 6 AM. Around 7 AM I took two (2) ibuprofen, which dulled the headache slightly. However it persisted into early/late afternoon hours on Thursday. (My customary activities were curtailed somewhat.) Since I have had migraines in the past, I treated this as I treated those: hydrating, taking pain medication as required, remaining quiet, reducing exposure to light and sound, etc. I continued taking two (2) ibuprofen periodically as I felt the need through bedtime Thursday night. Friday I had periodic headaches (again, attributed them to rebound migraines or just headaches), felt tired, and been a bit 'out of it'. But my systems did not prevent me from functioning. I did repeat the two (2) ibuprofen on Friday night at bedtime.
56 2021-04-19 feeling abnormal At the time of the vaccine, I felt fine, soreness at the injection site but nothing. For days later,... Read more
At the time of the vaccine, I felt fine, soreness at the injection site but nothing. For days later, I began to feel, ill all over and could not get out of bed. I had severe abdominal pain, aches and pains all over my body. Particularly in places where I had pre existing conditions. As the day progressed, I continued to have severe GI issues, could not eat (pain like food was stuck) heart burn, constipation (clamy like flu). Shortness of breath, I could not walk far. I took 3 trips to the ER where they treated for the abdominal spasms, UTI, and pain. By the end of the week I had a slight fever. I tested negative for COVID during that time. For two weeks I was unable to eat, get out of bed. I had several petite mal seizures. If felt like my body was fighting the vaccine and the vaccine was attaching all of me weak or any preexisting conditions. Eventually, after 3.5 weeks I was able to sit up, and walk. I still have shortness of breath, some fogginess, Muscle strain, walking with a cane and a lump at the injection site.
56 2021-04-19 impaired work ability Patient's husband awakened patient from seizure like activity and sweats day after vaccination. Sin... Read more
Patient's husband awakened patient from seizure like activity and sweats day after vaccination. Since then, patient has cough, body aches, fatigue to the point that she remains unable to return to work
56 2021-04-19 insomnia Headache - immediate upon sitting down in waiting room after shot & on-going through today. Mild Hiv... Read more
Headache - immediate upon sitting down in waiting room after shot & on-going through today. Mild Hives - started approx. 45 minutes after shot. Lasted 2 days. Sleeplessness - can fall asleep - however, jerk away after 25-30 mins. Sleep challenges continue Tinnitus - both ears - on-going
56 2021-04-20 confusional state, insomnia RUNNY NOSE; SLIGHT CONFUSION; HOT FLASHES; HEADACHE; NAUSEA; TIREDNESS; INSOMNIA; EXTRA ENERGY; INJE... Read more
RUNNY NOSE; SLIGHT CONFUSION; HOT FLASHES; HEADACHE; NAUSEA; TIREDNESS; INSOMNIA; EXTRA ENERGY; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced insomnia. On 12-APR-2021, the subject experienced extra energy. On 12-APR-2021, the subject experienced injection site pain. On 13-APR-2021, the subject experienced runny nose. On 13-APR-2021, the subject experienced slight confusion. On 13-APR-2021, the subject experienced hot flashes. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from insomnia, slight confusion, hot flashes, and nausea on 13-APR-2021, and extra energy, headache, and tiredness on APR-2021, was recovering from injection site pain, and had not recovered from runny nose. This report was non-serious.
56 2021-04-21 confusional state WORSENING GRANULOMA ANNULAR; CONFUSION OF DAYS; JOINT PAIN; BACK PAIN; BODY PAIN; BONE PAIN; HEADACH... Read more
WORSENING GRANULOMA ANNULAR; CONFUSION OF DAYS; JOINT PAIN; BACK PAIN; BODY PAIN; BONE PAIN; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 56 year old. The patient's weight was 213 pounds, and height was 69 inches. The patient's concurrent conditions included azithromycin allergy, tetracycline allergy, sulfa allergy, dye allergy, shell fish allergy, bee sting allergy, wasp sting allergy, non alcohol user, non smoker, and granuloma annular, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced bone pain. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced back pain. On 03-APR-2021, the subject experienced body pain. On 03-APR-2021, the subject experienced confusion of days. On 03-APR-2021, the subject experienced joint pain. On 06-APR-2021, the subject experienced worsening granuloma annular. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bone pain, nausea, headache, back pain, body pain, and joint pain, and had not recovered from worsening granuloma annular, and confusion of days. This report was non-serious.
56 2021-04-21 feeling abnormal, confusional state, disturbance in attention FALL; DIZZINESS, FEELING FAINT FELT LIKE BLACKOUT, LIKE FALLING DOWN, LIKE PASSING OUT; TINGLING; SH... Read more
FALL; DIZZINESS, FEELING FAINT FELT LIKE BLACKOUT, LIKE FALLING DOWN, LIKE PASSING OUT; TINGLING; SHAKING; SKIN REACTION ON LEFT SIDE UPPER ANKLE AREA; FUNNY FEELING; NUMBNESS; HAND SWELLING; UNABLE TO FOCUS; BODY ACHES; FACE SWELLING; CONFUSION; BODY CHILLS; LIGHT HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included black plastics color allergy, and other pre-existing medical conditions included the patient had no known allergies and the patient was not pregnant at the time of event reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 121001A, expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced body chills. On 28-MAR-2021, the subject experienced light headache. On 29-MAR-2021, the subject experienced body aches. On 29-MAR-2021, the subject experienced face swelling. On 29-MAR-2021, the subject experienced confusion. On 29-MAR-2021, the subject experienced hand swelling. On 29-MAR-2021, the subject experienced unable to focus. On 31-MAR-2021, the subject experienced funny feeling. On 31-MAR-2021, the subject experienced numbness. On 31-MAR-2021, the subject experienced skin reaction on left side upper ankle area. On 04-APR-2021, the subject experienced fall. On 04-APR-2021, the subject experienced dizziness, feeling faint felt like blackout, like falling down, like passing out. On 04-APR-2021, the subject experienced tingling. On 04-APR-2021, the subject experienced shaking. Laboratory data included: Blood test (NR: not provided) normal, Computerized tomography (NR: not provided) normal, and Urinalysis (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body chills, body aches, numbness, face swelling, confusion, shaking, dizziness, feeling faint felt like blackout, like falling down, like passing out, light headache, funny feeling, fall, hand swelling, and unable to focus, and had not recovered from tingling, and skin reaction on left side upper ankle area. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
56 2021-04-21 insomnia Intermittent shortness of breath a few days prior to presenting on 4/22/2021. Patient also c/o bila... Read more
Intermittent shortness of breath a few days prior to presenting on 4/22/2021. Patient also c/o bilateral lower leg pain, hand pain, and difficulty sleeping. Evaluation by CTA revealed Pulmonary Emboli.
56 2021-04-21 sleep disorder Heart is beating fast for approx the past week. Wake up between 4-5 a.m. and can?t go back to sleep... Read more
Heart is beating fast for approx the past week. Wake up between 4-5 a.m. and can?t go back to sleep. On day of shot only had mild symptoms.
56 2021-04-22 confusional state, feeling abnormal brain fog, extreme mental confusion,
56 2021-04-26 feeling abnormal SENSITIVITY AT THE TOP OF THE HEAD; PRESSURE IN THE HEAD; OVERWHELMING AMOUNT OF HEAT COMING FROM HE... Read more
SENSITIVITY AT THE TOP OF THE HEAD; PRESSURE IN THE HEAD; OVERWHELMING AMOUNT OF HEAT COMING FROM HER BODY; UNSTEADY; ITCHING RASH; STABBING HEADACHE; DIZZINESS; FOGGINESS; BRUISING; FLUSHED FACE; EXTREME RIGHT KNEE SWELLING; LEG PAIN; DISTENDED VEINS; BALANCE IS OFF; PULSATING SENSATION; HIVES TO ARMS; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included sulfa allergy, and other pre-existing medical conditions included the patient had family history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A214 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced balance is off. On APR-2021, the subject experienced pulsating sensation. On APR-2021, the subject experienced hives to arms. On 07-APR-2021, the subject experienced extreme right knee swelling. On 07-APR-2021, the subject experienced distended veins. On 07-APR-2021, the subject experienced leg pain. On 08-APR-2021, the subject experienced bruising. On 08-APR-2021, the subject experienced flushed face. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced fogginess. On 10-APR-2021, the subject experienced stabbing headache. On 11-APR-2021, the subject experienced unsteady. On 11-APR-2021, the subject experienced sensitivity at the top of the head. On 11-APR-2021, the subject experienced pressure in the head. On 11-APR-2021, the subject experienced overwhelming amount of heat coming from her body. On 11-APR-2021, the subject experienced itching rash. On 12-APR-2021, Laboratory data included: CT scan (NR: not provided) Unknown, and Diagnostic ultrasound (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching rash, distended veins, dizziness, stabbing headache, fogginess, flushed face, and overwhelming amount of heat coming from her body, had not recovered from extreme right knee swelling, leg pain, unsteady, bruising, sensitivity at the top of the head, and pressure in the head, and the outcome of hives to arms, balance is off and pulsating sensation 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.
56 2021-04-27 anxiety Staff received incoming call at clinic. Patient states s/p J&J vaccination 4/12/21 at EVC. C/O conti... Read more
Staff received incoming call at clinic. Patient states s/p J&J vaccination 4/12/21 at EVC. C/O continuous HA that is worsening even with Tylenol 500 mg PO PRN. HA is worst at 8/10. C/O mild intermittent lightheadedness. C/O anxiety. Denies hx of HA, dizziness, anxiety. No other complaint. Advised to go to the nearest ED.
56 2021-04-30 anxiety LIGHTHEADEDNESS; HEADACHE; ANXIETY; VISUAL DISTURBANCE; This spontaneous report received from a pati... Read more
LIGHTHEADEDNESS; HEADACHE; ANXIETY; VISUAL DISTURBANCE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included hiccoughing, and concurrent conditions included speech slurred, non alcohol consumer, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included iron for used for unknown indication. On 07-APR-2021, the subject experienced anxiety. On 07-APR-2021, the subject experienced visual disturbance. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced lightheadedness. On 22-APR-2021, Laboratory data included: Lab test (NR: not provided) No results available (units unspecified). Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from visual disturbance, lightheadedness, and headache on 08-APR-2021, and had not recovered from anxiety. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure since case is assessed as non-serious.
56 2021-05-02 feeling abnormal Light headed. Feeling like I am in a tunnel
56 2021-05-02 sleep disorder Since receiving the J&J covid-19 vaccine, I have experienced severe joint pain in my hips, my knees,... Read more
Since receiving the J&J covid-19 vaccine, I have experienced severe joint pain in my hips, my knees, and sometimes ankles. I have not contacted my Dr yet, but I am concerned about the joint pain not going away. I also googled it and I saw that there are other people experiencing the same joint pain after the covid-19 vaccine. Please let me know what to do.
56 2021-05-10 impaired work ability I experienced had recurrent headaches 04-02-2021 lasting to 04-22-2021. I did not work 04-02-2021, ... Read more
I experienced had recurrent headaches 04-02-2021 lasting to 04-22-2021. I did not work 04-02-2021, 04-03-2021, 04-04-2021 and also on 04-14-21 and 04-15-2021. I also had some nausea that came and went in the time I experienced the headaches. n 04-08-2021 had a telehealth visits about my headaches and recommended I take two Benadryl tablets to break the cycle of the headaches and try it for 3 days. On 04-13-2021, went to urgent care, they gave me tramadol and more migraine medicine and I got sick for the next couple of days and could not hold any water or food. I also had a CT scan which did not demonstrate blood clots. I also had lab work performed. I take Furenell which I take for my migraines.
56 2021-05-13 anxiety Follow up report to first VAERS report (1248256) - Entire (all over) breast tenderness (the nipple t... Read more
Follow up report to first VAERS report (1248256) - Entire (all over) breast tenderness (the nipple tenderness has been there since within a couple day after the vaccine - and that hasn't gone away). Dr said I'm having an inflammatory response to vaccine and they have referred me to a rheumatologist (gave me a referral) - joint pain and itching hasn't gone away at all. (The really bad rash on my neck, upper chest and torso and back on day three - that rash is gone but that tingling and itching of having the rash hasn't gone away.) I'm working still but I'm working from home - so that has been okay - although some days I feel worse then others. I noticed yesterday that my breasts were swollen/lumpiness. Was born with fiber cystic breasts - since menopause that has gotten better but now this feels like it did back then - feels like it did when I was going to start my period. I haven't had a period since five years ago. Eye sensitivity: Normally have dry eyes but it's worsened. I have to put drops in multiple times of day. I literally wake up in the middle of the night with almost a sandpaper feeling in my eyes and have to put drops on them. I have been doing acupuncture - it will be my third time today - it helps with stress and the anxiety from these symptoms. They wanted me to take steroids - I'm trying not to do something like this because I am so sensitive to these types of things.
56 2021-05-17 feeling abnormal Chronic dizziness continues 3-10 times a day Brain fog improving Static in ears constant Speech inte... Read more
Chronic dizziness continues 3-10 times a day Brain fog improving Static in ears constant Speech interruption improved Continuing under doctors care for dizziness and brain fog... waiting for therapy for balance and prescribed meds that did not help
56 2021-05-20 feeling abnormal Immediately after the shot my arm started hurting. The next day I started getting a headache and nau... Read more
Immediately after the shot my arm started hurting. The next day I started getting a headache and nausea, chills and muscle ache. My bottom lip was swollen by the third day and I was not feeling right. I had numbness going up to my right eye and I could not speak clearly.
56 2021-05-24 mental status changes Patient stated that she has been suffering from Altered Mental Status, General Malaise, Near Syncope... Read more
Patient stated that she has been suffering from Altered Mental Status, General Malaise, Near Syncope, Weakness
56 2021-05-25 feeling abnormal My brain fog has been really bad but I'm not sure if that is related to my fibromyalgia. Left arm is... Read more
My brain fog has been really bad but I'm not sure if that is related to my fibromyalgia. Left arm is locking in place and I am unable to move it.
56 2021-05-26 nervousness Chills, Fever, Shakes, Aches & Headache after vaccination. almost 2 months later severe joint/muscle... Read more
Chills, Fever, Shakes, Aches & Headache after vaccination. almost 2 months later severe joint/muscle pain in calves.
56 2021-06-09 memory impairment pt was seen on may 7, 2021 for the following Aphasia, weakness, impaired memory. pt states this sta... Read more
pt was seen on may 7, 2021 for the following Aphasia, weakness, impaired memory. pt states this started 2 weeks prior to coming to see provider. all symptoms are worrisome for stroke. dr ordered the following ct scan, MRI, and Lumbar puncture.
56 2021-06-15 loss of personal independence in daily activities She got her vaccine, within the first 24 hours her feet went completely numb and can't feel them at ... Read more
She got her vaccine, within the first 24 hours her feet went completely numb and can't feel them at all, and now the numbness have traveled up her legs and she is unable to balance due to the weakness. She went to her PCP on 5/6 and then went to an orthopedist twice as they felt it may be a compressed vertebra, chiropractor and is scheduled to a neurologist in July. She cannot walk a straight line and leads a very active life, has horses and not able to care for them at this time as she is "completely useless", cannot stand on her feet, cook or anything due to this debility. She was already having problems from the first vaccine, and now has gotten progressively worse every day and since the 2nd vaccine. Her feet are cold to touch where they weren't before. Her PCP said that there was nothing else she could do for her and told her to contact us to report her symptoms.
56 2021-06-16 feeling abnormal MUSCLE SPASM; BURNING SENSATION STARTS LIKE BEING ON FIRE; TINGLING; TENDERNESS MOVED DOWN TO ELBOW ... Read more
MUSCLE SPASM; BURNING SENSATION STARTS LIKE BEING ON FIRE; TINGLING; TENDERNESS MOVED DOWN TO ELBOW AND BELOW IT; LITTLE WARM TO TOUCH; FEELS LIKE SOMETHING IS IN IT LIKE A BB-GUN; INJECTED ARM TENDER TO TOUCH /INJECTION SITE SORENESS; BUMPS; NAUSEA; HEADACHE; FATIGUE; ARM SORENESS; BODY ACHE /HURTS; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included seizure, and migraine, and concurrent conditions included allergic to bees, non-alcohol user, non-smoker, allergic to wasps, penicillin allergy, and allergic to sulfa drugs, and other pre-existing medical conditions included no drug abuse or illicit drug usage. patient is allergic to seizure and pain medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced body ache /hurts. On 11-MAY-2021, the subject experienced arm soreness. On 11-MAY-2021, the subject experienced nausea. On 11-MAY-2021, the subject experienced headache. On 11-MAY-2021, the subject experienced fatigue. On 16-MAY-2021, the subject experienced little warm to touch. On 16-MAY-2021, the subject experienced feels like something is in it like a bb-gun. On 16-MAY-2021, the subject experienced bumps. On 16-MAY-2021, the subject experienced injected arm tender to touch /injection site soreness. On 17-MAY-2021, the subject experienced tenderness moved down to elbow and below it. On 17-MAY-2021, the subject experienced muscle spasm. On 17-MAY-2021, the subject experienced burning sensation starts like being on fire. On 17-MAY-2021, the subject experienced tingling. Treatment medications (dates unspecified) included: ibuprofen, menthol, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from body ache /hurts, nausea, headache, and fatigue on 15-MAY-2021, and had not recovered from injected arm tender to touch /injection site soreness, little warm to touch, feels like something is in it like a bb-gun, muscle spasm, burning sensation starts like being on fire, bumps, arm soreness, tingling, and tenderness moved down to elbow and below it. This report was non-serious.
56 2021-06-19 sleep disorder, loss of personal independence in daily activities Received Johnson and Johnson Covid19 shot in left arm. Left arm was very sore next day, March 31, 20... Read more
Received Johnson and Johnson Covid19 shot in left arm. Left arm was very sore next day, March 31, 2021 along with mild sore throat, no fever. Same with my husband who received shot at same time as myself. On April 1, 2021 his arm was slightly sore then went away. My left arm remained extremely tender for a few days at the injection location. That started to fade slowly but arm was sore in joint area and has remained so even now. It aches and is hard to use at times. Example: when taking shirt off over my head, I cannot lift arm up to this without extreme pain. I cannot lay on left arm when sleeping and when I reach over to turn alarm off in morning with left arm, I must use right hand to help use arm. It is a constant ache, just hurts bad even now. I feel like at times I cannot move arm. I ride a stationary bike to exercise and most of the time cannot use arm on handle because of the extreme pain. I cannot take pain medication due to my stomach issues.
56 2021-06-22 feeling abnormal 56-year-old very pleasant female with a known history of alcohol dependence and cirrhosis along with... Read more
56-year-old very pleasant female with a known history of alcohol dependence and cirrhosis along with tobacco dependence and underlying nonoxygen dependent COPD who presented to the ER on 6/16 with uncontrolled diarrhea that started suddenly 2 weeks after getting her johnson and johnson vaccine on 5/5/21 associated with significant weight loss and persistent nausea and acute renal failure. She initially presented to her PCP on 5/25 complaining of urinary urgency for the past few months. She denied any frequency or dysuria but reported that her urine had an odor and an orange color. During that visit urine was positive for nitrates and leukocyte esterase she also had bilirubin in her urine and was given a 7-day course of Macrobid. There was not enough urine to send to the lab for culture. She then went to the emergency room that evening because her PCP contacted her that her potassium was low and she was sent to the emergency room during that visit she reported developing diarrhea she was given potassium and discharged home. She followed up with her PCP on 6/1 to follow-up on her ER visit and reported that the antibiotic was helping her urinary tract infection she continued to complain of some urinary urgency and it was recommended she have a urine culture done again which showed pansensitive E. coli which despite being sensitive to Macrobid she did not respond so she was prescribed 5 more days of Cipro. She reported that she quit drinking alcohol on 5/19/21 but admitted to drinking a beer now and then. Patient had her Johnson & Johnson COVID-19 vaccination on 5/5 and reports she was tired for a day or 2 afterwards and then felt better but then 2 weeks thereafter she felt terrible with associated development of nausea, weight loss, new diarrhea which has continued to progress to developing significant diarrhea and weight loss and fatigue for which she presented back to the ER on 6/16 with acute renal failure, uncontrolled diarrhea, hyponatremia and hypokalemia and metabolic acidosis. Imaging showed pancolitis, colonoscopy performed show diffuse bowel wall edema. She remains hospitalized as of 6/23/21. Stool pathogens panel and stool C. difficile x2 are both negative but the diarrhea is persistent and severe. Pt reports gi symptoms bagan 2 weeks after receiving her J and J vaccine associated with nausea, abd pain and development of diarrhea. CT of the abdomen pelvis showed a pan colitis and enteritis. colonoscopy was normal other than showing sign mucosal edema. Pathology negative for malignancy but the terminal ileum shows prominent peyers patches which are the immune sensors of the intestine.. stool o and P neg. Lactoferrin/fecal leukocytes is neg. fecal fat pending. stool ob neg. esr and crp markedly elevated.- budesonide 9mg was started, Added imodium q6h and acidophilous qid. rheumatoid factor neg, antinuclear and antimitochondrial antibodies neg, antineutrophilic cytoplasmic antibodies neg, anti-Saccharomyces cerevisiae antibodies neg and antithyroid peroxidase antibodies neg ,celiac ds panel neg. stool ob neg.. renal failure is felt due to acute tubular necrosis from severe diarrhea and poor po intake. She remains hospitalized in serious condition as of 6/23/21.
56 2021-06-27 sleep disorder Extreme migraine headache began within 12 hours of injection. Within 24 hours severe lower leg pain ... Read more
Extreme migraine headache began within 12 hours of injection. Within 24 hours severe lower leg pain (calves) began. Reached out to my primary care and they said this was normal. Headache lasted for 60 hours and dissipated. However lower leg pain continued for weeks, with pain waking me up in the middle of the night. It took 4 weeks for the leg pain to resolve. I was very concerned about the leg pain because of the blood clot issue. But I did read it could last for weeks.
56 2021-07-04 feeling abnormal Having a lot of Stomach issues, brain fog and headaches
56 2021-07-06 impaired work ability Itch on webbing of fingers (between 3rd and 4th), severe fatigue, severe headache. Missed work due t... Read more
Itch on webbing of fingers (between 3rd and 4th), severe fatigue, severe headache. Missed work due to side effects
56 2021-07-07 excessive sleepiness, confusional state, amnesia Fever or chills ( 3 weeks off and on, chills - I did not get feverish) Cough (fits of coughing, stil... Read more
Fever or chills ( 3 weeks off and on, chills - I did not get feverish) Cough (fits of coughing, still) Shortness of breath or difficulty breathing (still have this) Fatigue (still) Muscle or body aches (still) Headache (still) New loss of taste or smell I got smell back, though it is different. I have trouble tasting savory foods. I hardly eat. Sore throat (off and on) Congestion or runny nose (yes, still) Nausea or vomiting (nausea, yes, vomiting, no.) Diarrhea (horrible, weeks and weeks) Trouble breathing (yes, still) Persistent pain or pressure in the chest (on and off) New confusion (yes, and short term memory loss) Inability to wake or stay awake (for a solid month) water in lungs, (felt like) joint pain (severe, still have it, although it has diminished) eyesight worsened
56 2021-07-12 sleep disorder ***PATIENT STATED THAT HER VACCINATION CARD IS FADED AND SHE CAN NOT SEE LOT NUMBER FOR VACCINE!!***... Read more
***PATIENT STATED THAT HER VACCINATION CARD IS FADED AND SHE CAN NOT SEE LOT NUMBER FOR VACCINE!!*** 3 days after getting vaccination, I felt tired and weak. I also had a cough. I laid around for 2 days, I was aching, after those 2 days I was okay. But everything started happening again in April. I have medications for my cough. My body is stiff, and it's a little hard for me to walk. I have headaches, and I can barely eat. I have problems sleeping now. I also have a pain in my leg, and numbness in my right hand. Irritated eyes, and chest pains/ tightness, and these symptoms have been coming and going since April. I've tried to take tylenol for my pains. Patient stated that has not seen a doctor for reaction.
56 2021-07-15 sleep disorder I woke up at 3 am with extreme vertigo, the room spinning, very nauseous, for the next 24 hours I co... Read more
I woke up at 3 am with extreme vertigo, the room spinning, very nauseous, for the next 24 hours I could not keep anything down, I went to the ENT that afternoon and they gave me some medications. For the next 2 days I continued with extreme vertigo. I kept throwing up. For the last 12 days I still have dizziness and ear pressure, my balance is bad, I have trouble seeing, I have terrible head ache. Its almost been 3 weeks since I started having symptoms. I have never been this sick in my whole life. They did a brain MRI but it came back normal. I also saw my PCP and they gave me a 5 day prednisone pack but it did not really helped.
56 2021-07-19 impaired work ability About a month after the vaccine, I started getting sores inside of my mouth. An my gums have started... Read more
About a month after the vaccine, I started getting sores inside of my mouth. An my gums have started bleeding and teeth started hurting. Now I have to go to the dentist to see what's wrong. Than my eyes starting hurting and now I have blocked tear ducts. Went to the eye Dr. 4 times and I have had six blocked tear ducks. I have to go see a Retina doctor. I have to sit in the dark and put my steroids eye drops in. I haven't been able to go to work. The doctor said I might need to go see an Auto immune disease doctor.
56 2021-07-19 sleep disorder My arm started to hurt in the area of the vaccination about 2 weeks after the injection. It doesn't ... Read more
My arm started to hurt in the area of the vaccination about 2 weeks after the injection. It doesn't really hurt much as long as I am active. The pain is the worst in the early hours of the morning after I have been resting. The pain caused me to wake up often in the night. ibuprofen and acetaminophen did not help at all. I have started taking gabapentin at bedtime and probably 5 out of 6 nights it allows me to sleep all night.
56 2021-07-21 insomnia, feeling abnormal, feeling drunk OXYGEN WENT DOWN TO 92 PERCENT; CHEST TIGHTNESS; SWEATY; COUGH; ARM PAIN; SLEEPY; BRAIN FOG; FELT DR... Read more
OXYGEN WENT DOWN TO 92 PERCENT; CHEST TIGHTNESS; SWEATY; COUGH; ARM PAIN; SLEEPY; BRAIN FOG; FELT DRUNK; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, chronic obstructive pulmonary disease, seasonal allergy, non alcohol user, and smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 12-MAR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced trouble sleeping. On 12-MAR-2021, the subject experienced brain fog. On 12-MAR-2021, the subject experienced felt drunk. On 13-MAR-2021, the subject experienced sleepy. On 15-MAR-2021, the subject experienced arm pain. On 26-MAR-2021, the subject experienced chest tightness. On 26-MAR-2021, the subject experienced sweaty. On 26-MAR-2021, the subject experienced cough. On APR-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. On an unspecified date, the subject experienced oxygen went down to 92 percent. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) 92 %. Treatment medications (dates unspecified) included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen went down to 92 percent, chest tightness on 02-APR-2021, sweaty on 28-MAR-2021, trouble sleeping, and brain fog on 13-MAR-2021, cough on 02-JUN-2021, felt drunk on 12-MAR-2021, and arm pain on 19-MAR-2021, and the outcome of sleepy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210432473, 20210738839 and 20210739000.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.
56 2021-07-27 feeling abnormal Dizziness, tinnitus, brain fog, speech diffiulty
57 2021-03-06 confusional state Person received the Covid vaccine at 9:50 am and within 1 minute after the injections, patient appea... Read more
Person received the Covid vaccine at 9:50 am and within 1 minute after the injections, patient appeared confused and was shanking, had a 2 convulsions while sitting in the chair that lasted 1 second each. Patient stated " I don't know where I am". Patient lowered to the ground, face mask removed. Patient systolic blood pressure was 110 during the episode with HR 56, pulse O2 98% room air. After approximately 4-5 minutes patients stated "I'm feeling ok now" is alert and oriented to self, place and time. Dr. assisted the patient, orange juice given to the patient. At 10:30am patient back to her baseline, no distress noted and discharged home, no distress at the discharge time.
57 2021-03-08 anxiety, feeling abnormal I experienced body aches, headache, anxiety in my chest (once), tiredness. One other thing that hap... Read more
I experienced body aches, headache, anxiety in my chest (once), tiredness. One other thing that happened that may not be related is that my secondary implant eye socket became very sore and swelled up. It could of been for another reason but the timing was uncanny. I am feeling fine now and none of my reactions were that troubling. I have experienced about 3 times a sudden feeling in my body that made me think I wonder if that was the vaccine but I am feeling great now and all is good. Thank you so very much for all the research and production of these life saving vaccines.
57 2021-03-08 anxiety Patient received vaccine at approximately 10:50 AM. She proceeded to the observation area where she ... Read more
Patient received vaccine at approximately 10:50 AM. She proceeded to the observation area where she began to feel light-headed. On-site EMS from was summoned. EMS placed the woman on their gurney and began assessment (vitals and EKG). A copy of the PCR has been requested, but may not be available.
57 2021-03-09 impaired work ability 3-09-2021-4:30 am,Immobility, felt like I took a muscle relaxer, sever muscle and joint pain, blindi... Read more
3-09-2021-4:30 am,Immobility, felt like I took a muscle relaxer, sever muscle and joint pain, blinding headache, chills, I felt frozen all day. Some diarrhea and felt severely fatigued. Was unable to work I took a sick day. 3-10-2021 Another sick day still had symptoms.
57 2021-03-09 mental impairment Very tired for three days. Difficulty thinking for three days. Fever and chills the next day.
57 2021-03-11 feeling abnormal About 10 p.m. I started with bad chills, nauseau, and fever. Felt like I couldn't move at all. Th... Read more
About 10 p.m. I started with bad chills, nauseau, and fever. Felt like I couldn't move at all. Then developed bad headache -- couldn't get out of bed for about 12 hours -- almost went to the hospital I felt so bad. Didn't have any breathing issues -- just severe flu symptoms.
57 2021-03-14 anxiety Hives, itching, anxiety Tx. Benedryl 50mg IM Epinephrine 0.3mg IM Outcome: Transport to ED by EMS
57 2021-03-14 feeling abnormal On-set of severe chills started at 10:00pm with a 103 degree fever. I had tightness in my chest and ... Read more
On-set of severe chills started at 10:00pm with a 103 degree fever. I had tightness in my chest and my heart was beating irregular. After 4 hours the fever subsided as quickly as it came on and my heart returned to normal functioning. When the fever subsided I was left with a severe headache for approximately 6 hours. Once the headache subsided I felt lethargic and foggy headed. On the second night (3/14/2021) the fever returned but was only 100.4 degrees. I took an Aleve before going to bed and when I woke up this morning I felt back to normal.
57 2021-03-20 sensation of foreign body At about 23 minutes broke out in a cold sweat. At 26 minutes, became hoarse (always my first symptom... Read more
At about 23 minutes broke out in a cold sweat. At 26 minutes, became hoarse (always my first symptom of anaphylaxis). Progressed to coughing and feeling a lump in my throat and then tightness in my chest. My blood pressure elevated to 152/100. At that point I self administered epi pen and paramedics called 911. This provided relief but after about 5 to 10 minutes the tightness in my chest and the feeling I couldn?t get a deep breath began to return and the paramedics administered two puffs of an albuteral inhaler and transported me to the hospital. At the ER, they did an EKG, started an IV and administered fluids, prednisone and Benadryl. I was discharged about 90 -120 minutes later with a prescription for 3 days of prednisone (50mg) and instructions to continue to take 25 mg oral Benadryl every 4 hours. The next morning my face and chest were red and looked like I was sunburned. My face was also swollen.
57 2021-03-22 feeling abnormal I got the shot in my left arm and shortly after right above my right eye I could feel a reaction goi... Read more
I got the shot in my left arm and shortly after right above my right eye I could feel a reaction going on. Almost like something effected the muscle, I didn't say anything and went to the wait room I mentioned it before I left and they said it sounded like a migraine and I went home. When I raise my face on the right side of my eyebrow area feels like I have spasms. When I got home it moved to my cheek area as well and felt strange. I got a rash on my right cheek that evening and a super bad headache. I took a Benadryl and went to sleep. I didn't have a fever. By the morning the rash was gone, the only thing that bothered me was my eyebrow area ( muscle area) I went to the Dr the following day and she said it sounded like it was my sinuses. Prior to this I was having allergy / sinus issues.
57 2021-03-23 anxiety, delirium High fever, delirium. Body aches, joint pain in every joint of body, headache, nausea, sore throat, ... Read more
High fever, delirium. Body aches, joint pain in every joint of body, headache, nausea, sore throat, cough. I am now suffering with kidney stones, water retention and gained 15 lbs since I had the injection. Puffiness, bloating. Puffiness in hands, ankles, stomach. I have shortness of breath with sever anxiety that wakes me up. My heart races over 120 beats per minute during these anxiety attacks.
57 2021-03-23 feeling abnormal Received injection on Sunday. Monday was nauseated and had chest pressure. Nausea and CP came in wa... Read more
Received injection on Sunday. Monday was nauseated and had chest pressure. Nausea and CP came in waves and occurred about 10 times. Then stopped. Felt "off" for 4 days. Felt fine on Friday and through Wed 3/23/21 until 9:10 PM. Developed visual changes in left peripheral bilat. Appeared like waves in an arc. Then began to not be able to breathe. I had to tell myself to breathe. Called squad, arrived 9:45pm. BP 170/110, HR 118. By 10pm, the visual changes disappeared BUT developed chest pressure in same area as the MOnday after the vaccine. Then became extremely nauseated, almost vomiting. Nause came in waves for next 6 hours until it calmed down. Then returned Wed am for several hours, again in waves along with hollow chest feeling and pain. Continued with headache off and on with brain fog the remainder of Wednseday 3/23/21. Discussed with hospitalist at Hospital and was told to report it to the CDC as likely an adverse effect to the vaccine. Was still in the 14 day window. Thank you, RN, PhD, MSN, MS, BSN
57 2021-03-24 anxiety History of mast cell activation and patient stated she "usually has reactions to everything." Patie... Read more
History of mast cell activation and patient stated she "usually has reactions to everything." Patient experienced tachypnea and anxiety immediately following administration of dose of vaccine. SxS persisted for approximately 45 minutes. EMS was called to the scene to evaluate patient. symptoms decreased after 45 minutes and patient stated she did not want to go to the hospital. Reference EMS Incident for full PCR. Advised patient to contact her primary care physician for follow up.
57 2021-03-26 insomnia 8 hours after injection got cold, then shakes and fever, 12 hours post vaccine I had severe!!! pain ... Read more
8 hours after injection got cold, then shakes and fever, 12 hours post vaccine I had severe!!! pain in any area that I had any type of chronic pain - lower back, right hip, and recently fractured 2nd metatarsal on left foot, this was not myalgia this was severe uncontrollable pain unrelieved with NSAIDS, Tylenol or Tramadol. it lasted for 16 plus hours where it hurt to move, I broke a fever 3 times, severe thirst, after the pain subsided I had a severe left sided headache. The whole time I was fatigued but unable to sleep due to pain. Now three days later I have developed, to the site of my injection , a 1 cm by 1 cm oval shaped, extremely tender red raised nodule. I am still very tired and having low grade temps with sweats and chills.
57 2021-03-28 excessive sleepiness Body aches/fever to the point of going to bed for 24 hours
57 2021-03-30 feeling abnormal pt states that later in the day after taking the vax she developed a rash both arms, neck and chest.... Read more
pt states that later in the day after taking the vax she developed a rash both arms, neck and chest. Left hand was swollen and the vein was very enlarged in her left hand. The left arm has a hard knot around the injection site. The next day she was extremely tired and slept an entire day. the second day she got body aches in her lower back, hips and knees. the third day she had fever and chills. on day four she is still very fatigued and has no energy. Pt says she just has an odd feeling and does not feel like herself anymore. Pt will call her PCP for medical advice.
57 2021-04-02 sleep disorder Muscular pain, more than just aches. It was as if all of the muscles in my legs had shortened. It ... Read more
Muscular pain, more than just aches. It was as if all of the muscles in my legs had shortened. It wasn't like a sudden cramp that just went away after a few minutes. Nothing I did seemed to help, walking around, stretching,. It got progressively worse. This started around 9 pm. I took three (200 mg) ibuprofen at about 10:30 p.m.. That didn't help much, unable to lay down and sleep, too uncomfortable in any position. . Finally around midnight I took a muscle relaxant, and that worked. When I woke up this morning, I felt fine. No muscle pain or aches.
57 2021-04-03 sleep disorder, feeling abnormal, disorientation 16 hrs after vaccine (4:30 am Thursday) woke up needing to urinate, went to stand up, collapsed via ... Read more
16 hrs after vaccine (4:30 am Thursday) woke up needing to urinate, went to stand up, collapsed via legs folding in, fell into window, went to bathroom, realized I had nausea, headache, checked temp 101.1, felt beginning aches and pains all over, up all night with crazy frequent urination, every 15-20 minutes, freezing chills, burning up at the same time, disoriented, wobbly, runny nose, up and down all day and night urinating and diarrhea began, Friday 6 am fever 100.3 still aching all over, still frequent urination and diarrhea, freezing chills, Friday 7 pm fever 99.3, still feeling awful, started sneezing, Saturday am, sneezing attacks , low grade fever of 98.9- mine is usually 97.3 avg., started feeling better, started Pedialyte and Imodium, still have hardly any voice from sneezing attacks, still aching in back, feel wobbly and disoriented, Saturday afternoon 4 pm, woke up soaking wet, fever gone, still feeling nausea, disoriented, wobbly, Sunday, slowly getting better, back hurts really bad and I am still shaky
57 2021-04-04 disturbance in attention Patient had a blank stare on her face and did not respond to stimulus. She went limp slumped back, s... Read more
Patient had a blank stare on her face and did not respond to stimulus. She went limp slumped back, she was pale, hypotensive, and unable to follow directions. We called 911 and the Medics took her to hospital where she was released around 5pm
57 2021-04-04 feeling abnormal SHINGLES; FEELING LIKE CRAP; ITCHING ON LEFT ARM; NECK WAS VERY STIFF; NECK WAS SORE; HEADACHE; MUSC... Read more
SHINGLES; FEELING LIKE CRAP; ITCHING ON LEFT ARM; NECK WAS VERY STIFF; NECK WAS SORE; HEADACHE; MUSCLE PAIN; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s on left arm (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced feeling like crap. On MAR-2021, the subject experienced itching on left arm. On MAR-2021, the subject experienced neck was very stiff. On MAR-2021, the subject experienced neck was sore. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced muscle pain. On 23-MAR-2021, the subject experienced shingles. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck was very stiff on MAR-2021, was recovering from headache, had not recovered from shingles, muscle pain, itching on left arm, and neck was sore, and the outcome of feeling like crap was not reported. This report was non-serious. Additional information was received from patient on 30-Mar-2021. The following information was updated and incorporated into case narrative: Reporter (details), due diligence, events (neck was sore and neck was very stiff), outcome (shingles and headache), shingles, muscle pain and neck was sore (treatment information), product (neurontin), labeling and causality updated, narrative updated.
57 2021-04-04 feeling abnormal -felt faint upon receiving vaccine and vomited immediately after -felt sleepy -diarrhea at about 8:3... Read more
-felt faint upon receiving vaccine and vomited immediately after -felt sleepy -diarrhea at about 8:30 pm same evening, took Imodium AD and it stopped -next day dull headache, low-grade fever, extremely lethargic -repressed appetite -foggy head -slightly sore arm
57 2021-04-06 excessive sleepiness Difficulty taking deep breaths, dizziness that felt more like vertigo (the floor and ceiling spinnin... Read more
Difficulty taking deep breaths, dizziness that felt more like vertigo (the floor and ceiling spinning whenever I stood or sat up), exhausted to the point that I could not sit up without falling asleep. I slept 14hrs straight for two days after the shot. Tired after walking down the driveway and back. Entire body aching with excruciating pain but not the left arm where the shot was taken. Headaches were bad as well. No appetite. The 3rd day afterwards I felt better but still very tired. The 4th day still tired but better. Tylenol, caffeinated coffee and lots of water seem to help me get through this. The fifth day afterward, I am almost 100% but dealing with running nose and eyes which may not be related to the shot.
57 2021-04-07 sleep disorder Bad headache started middle of the night, body aches, unable to sleep, nausea 14 hours after vaccine... Read more
Bad headache started middle of the night, body aches, unable to sleep, nausea 14 hours after vaccine.
57 2021-04-08 feeling abnormal They did not have me stay at there store and wait a few mintues. I got in my car to drive home. I li... Read more
They did not have me stay at there store and wait a few mintues. I got in my car to drive home. I live 2.9 miles from the store. After about 5-6 minutes in the car, I started to feel bad, and I felt I should pull over. I was on the road and traffic was super busy. I did pass out in front of a store on the road while driving my car. I came too and saw a restaurant. I pulled into their parking lot and texted my husband to come and get me. When he got there, I could barely stand. I layed down in the back of his truck because I could not sit up. My arm went number but I could wiggle my fingers. We did drive to the hospital because I was so weak. but after the 15 minute drive to get to the hospital, I was able to sit up and walk again. I did not want to pay the $500 deductible so I my husband drove me home where I am sitting on the couch resting now. My husband is a Chiropractor, so he has a lot of medical background.
57 2021-04-09 disorientation Patient said she felt like she was going to pass out. Was advised to sit down immediately. Patients ... Read more
Patient said she felt like she was going to pass out. Was advised to sit down immediately. Patients breathing was fine, but she was extremely lethargic/limp. Was coherent but slow to answer questions, excessively sweating and pale, small amount of vomit. At one point, patient said that she did not know where she was. Said that her fingers felt numb and tingly (could not pick up water or orange juice...we had to put water and juice to her lips to drink). She said that she needed to lay down. Per patient she had oatmeal with very little sugar for breakfast and coffee. Believe the reaction was a vasovagal response.
57 2021-04-09 disturbance in attention Nausea and my head didn?t feel. I felt out of it and couldn?t concentrate on anything.
57 2021-04-09 feeling abnormal passed out. felt funny before passing out. tongue felt weird prior to passing out
57 2021-04-09 impaired work ability Day 2 with fatigue, chills, body aches, headache and body aches with more nausea. No treatment thu... Read more
Day 2 with fatigue, chills, body aches, headache and body aches with more nausea. No treatment thus far and unable to work today.
57 2021-04-09 insomnia My legs are very achy....making it difficult to sleep most nights
57 2021-04-11 sleep disorder 20 minutes after the patient was inoculated with Covid Vaccine, the patient experienced severe nause... Read more
20 minutes after the patient was inoculated with Covid Vaccine, the patient experienced severe nausea, lightheadedness. Left-arm was sore at the site of injection immediately after inoculation. To alleviate extreme nausea, that patient contacted her primary care doctor. Doctor immediately prescribed, meclizine to be taken 4x a day. The patient was not able to sleep that night. She was still dizzy and the headache set in. The patient experienced chills and was lethargic. Nausea and headache lingered for 2 1/2 days.
57 2021-04-11 sleep disorder First 24 hours I was fine no symptoms, woke at 2:45 AM and was dizzy and spinning. Low grade feaver ... Read more
First 24 hours I was fine no symptoms, woke at 2:45 AM and was dizzy and spinning. Low grade feaver of 99.7 on 4/10 and dizzy. Dizziness still on 4/12/21.
57 2021-04-12 altered state of consciousness Light headed, nausea, syncope, vomited, Level of consciousness was diminished prior to leaving after... Read more
Light headed, nausea, syncope, vomited, Level of consciousness was diminished prior to leaving after receiving her vaccine. > First VS: 140/83, Pulse 88, RR 18, Oxygen 97% > Second VS: 123/74, pulse 76, RR 18, Oxygen 93% Transport checked VS in the ambulance and she refused transportation.
57 2021-04-12 anxiety Day of -light headed approx 1/2 hr after vaccine lasting a few hours, anxious, palpitations Next day... Read more
Day of -light headed approx 1/2 hr after vaccine lasting a few hours, anxious, palpitations Next day, tired, headache, feeling like "coming down with something" Fri: headache, sore throat, chills, runny nose, sinus congestion Sat: COVID PCR test, same symptoms with cough Sun: Negative Covid result, same symptoms, headache worse
57 2021-04-12 feeling abnormal Palpitations immediately after shot was given (Wednesday evening).. Approximately 17-18 hours after ... Read more
Palpitations immediately after shot was given (Wednesday evening).. Approximately 17-18 hours after injection (by noon Thursday), muscle & joint aches began (hips, shoulders, hands, neck), with chills, fatigue, and low-grade temp (99.6). Tylenol helped, but brain fog was severe. By 9:00pm, my temp was 101 and I felt severe body aches & miserable. Only very mild symptoms the next day (Friday) and by Saturday I was fine. It was like a 24-hr flu.
57 2021-04-14 feeling abnormal headache, vomiting, diarrhea, fever, joint pain, lethargy, body aches, tinnitus, chills, blueness in... Read more
headache, vomiting, diarrhea, fever, joint pain, lethargy, body aches, tinnitus, chills, blueness in fingers and toes, cheeks flush, brain fog. onset of all symptoms other than fever, vomiting and diarrhea began 3/8/12. additional symptoms began 3/15/21 (lasted 3 days) all symptoms have subsided with the exception of tinnitus, cheeks flush, headache. They continue, are constant, not helped with ibuprofen or tylenol, have not changed in severity.
57 2021-04-14 feeling abnormal Started having a headache on Tuesday afternoon, took migraine pill (excedrin) with minimal improveme... Read more
Started having a headache on Tuesday afternoon, took migraine pill (excedrin) with minimal improvement. Went out to dinner later that night and couldn't finish dinner d/t HA. Describes head pressure, pain, and pounding sensation. On Wednesday worked from home, felt like she was in a fog and continued to have pain/pressure in the back of her head. Pt took a nasal decongestant which pt is unsure if made any better. Thursday continued to have headache but improved compared to Tuesday and Wednesday. Had taken benadryl at school which was somewhat helpful. Saw PCP today via telemedicine visit. PCP prescribed steroid; had not started taking this because started feeling worse and came into the ED for this. Earlier today, had worsened HA and felt like she was going to pass out (did not pass out). She felt like her left hand was numb/pins/needles as her son was taking her BP; lasted for a few minutes. Later, her right hand started feeling numb/pins/needles and had difficulty picking up objects. 57-year-old female presented with a headache and found to have a subdural hematoma of unknown etiology. Neurosurgery was consulted. Patient was initiated on Keppra 500 mg b.i.d. for seizure prophylaxis. Serial CT scans were done Which showed stable subdural hemorrhage. Blood pressure was monitored during her stay but did not require any as needed medication. Further imaging including MRI and MRV were performed to assess for aneurysm or venous malformation however nothing was seen. Bleeding disorder workup was not performed. Neurology was consulted. EEG was ordered to assess for seizure activity however this was negative.
57 2021-04-15 amnesia After the injection about 15 minutes afterwards I was getting dizzy I was having trouble breathing. ... Read more
After the injection about 15 minutes afterwards I was getting dizzy I was having trouble breathing. Was given a Benadryl. An ambulance was called. I do not remember being transferred to the hospital. I was given solu- Medrol (methylPREDNI solone succinate 125mg IV and 20 mg Pepcid IV for an allergic reaction to the vaccine. I was prescribed an EpiPen. I am still having side effects from the vaccine. Migraines, dizziness, hives, swollen lymph glands.
57 2021-04-15 feeling abnormal CHEST PAIN; LEFT SIDE HAND AND FOOT BURNING PAIN; SHAKING; HEART RACING; FEEL HORRIBLE; JOINT PAIN; ... Read more
CHEST PAIN; LEFT SIDE HAND AND FOOT BURNING PAIN; SHAKING; HEART RACING; FEEL HORRIBLE; JOINT PAIN; CHILLS; NAUSEA; FEVER; SEVERE HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chest pain. On 07-APR-2021, the subject experienced left side hand and foot burning pain. On 07-APR-2021, the subject experienced shaking. On 07-APR-2021, the subject experienced heart racing. On 07-APR-2021, the subject experienced feel horrible. On 07-APR-2021, the subject experienced joint pain. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced severe headache. On 07-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, chills, and fever on 08-APR-2021, had not recovered from severe headache, chest pain, fatigue, joint pain, left side hand and foot burning pain, nausea, and heart racing, and the outcome of feel horrible was not reported. This report was non-serious.
57 2021-04-15 sleep disorder Woke up around 2:00 am on 4/14 with leg pain on left side of lower left leg above the ankle in the c... Read more
Woke up around 2:00 am on 4/14 with leg pain on left side of lower left leg above the ankle in the calf area. Felt like pain was moving up leg. Pain was strong enough to wake me up and was something I never experienced before. Leg is still tender in that spot but there is no bruising or discoloration.
57 2021-04-16 nervousness Since the day 12, I feel bad with headaches, neck, accelerated palpitations, I feel nervous, my hand... Read more
Since the day 12, I feel bad with headaches, neck, accelerated palpitations, I feel nervous, my hands go numb, my left foot hurts up to the calf, I do not feel much improvement despite the medication, I do not have peace of mind
57 2021-04-18 emotional distress, amnesia, confusional state, disorientation Adverse event: "Transient Global Amnesia" starting appx 1:30pm Wed Apr 7 2021; confusion, distress, ... Read more
Adverse event: "Transient Global Amnesia" starting appx 1:30pm Wed Apr 7 2021; confusion, distress, loss of short/long term memory Taken to Medical Center Emergency Dept appx 4pm 4/7/2021 Conducted Cat scan, x-rays, MRI, Urine, Blood tests, stroke protocols and admitted for the night Started to regain memory appx 9:00pm 4/7/2021; memory continued to improve, discharged appx 2pm Thurs 4/8/2021 Follow-up EEG Apr 15, awaiting results. Felt fatigue and somewhat disoriented for appx 5-6 days following 4/7/2021 Transient Global Amnesia episode, which was only 4 days after 4/3/2021 Janssen vaccine.
57 2021-04-18 insomnia Muscle pain in both shoulders, neck and both arms and fatigue that has lasted since the day after th... Read more
Muscle pain in both shoulders, neck and both arms and fatigue that has lasted since the day after the vaccine was administered. Prior to vaccine, I was energetic and worked out vigorously every day for 60 min (20 mile bike ride and weight lifting). Typical muscle sored prior to vaccine was a day or 2 after increasing weights. Now, I can only work out 2 days a week. Muscles ache constantly and I cannot sleep because of the pain. Ibuprofen only helps a little. Prior to the vaccine I slept 7-8 hours a night. Since the vaccine, I am sleeping 10 hours and am still tired.
57 2021-04-19 excessive sleepiness, impaired work ability I felt stomach issues and fatigue on 4/3/21. I left work early and slept the rest of the day and mos... Read more
I felt stomach issues and fatigue on 4/3/21. I left work early and slept the rest of the day and most of 4/4/21. Headache started 4/8/21 I also had nausea. I tried Tylenol but it did not help. I had to leave work and slept from noon thru the next day.
57 2021-04-21 feeling abnormal, sleep disorder Started to feel tired around 7:00 Pm the night after getting the vaccine. Went to bed thinking I cou... Read more
Started to feel tired around 7:00 Pm the night after getting the vaccine. Went to bed thinking I could sleep through any discomfort. Woke up at 8 pm with shooting pains in my head and sever joint pain. Temp was 101.5. Took a motrin PM. could not sleep for more than 10 min at a time. At 10pm took 2 reg motrin. tepm each hour after reduced by0.5. Still with server headache and body aches until 4AM. I have never felt as bad as I did for those 8 hours, even with the flu
57 2021-04-26 insomnia SWELLING OF FACE, TONGUE, ARMS AND HANDS; VOMITING; NAUSEA; ABDOMINAL PAIN; SWELLING OF FEET; COULDN... Read more
SWELLING OF FACE, TONGUE, ARMS AND HANDS; VOMITING; NAUSEA; ABDOMINAL PAIN; SWELLING OF FEET; COULDN'T SLEEP; ITCHY RASH; DIARRHEA; PAIN ALL OVER; SORE THROAT; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no underlying medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced pain all over the body, sore throat. On 12-APR-2021, the patient experienced rash. On 13-APR-2021, the patient experienced diarrhea, itching. On 14-APR-2021, the patient experienced abdominal pain, swelling of feet, could not sleep. On 15-APR-2021, the patient experienced swelling of face, tongue, arms and hands, nausea and vomiting. She went to clinic to see a doctor and doctor told the patient to go to ER. In Emergency room, they gave her intravenous fluids and medicine for the nausea and vomiting. All her symptoms were improving but she was worried that she will still have swelling and rash with the itching. She only slept for about 4 hours at night. She did not have insurance and medical bills got expensive and was worried. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea on 15-APR-2021, was recovering from abdominal pain, diarrhea, pain all over, sore throat, and couldn't sleep, and had not recovered from swelling of face, tongue, arms and hands, swelling of feet, and itchy rash. This report was serious (Other Medically Important Condition). .; Sender's Comments: V0;-covid-19 vaccine ad26.cov2. s-swelling of face, tongue, arms, hands and abdominal pain. This events are considered unassessable. The events had a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
57 2021-04-27 feeling abnormal Foggy - this has not gone away Tired Headache Arm soreness
57 2021-04-30 amnesia, incoherent, feeling abnormal within 2 minutes having the J and J covid vaccine, patient became pale, clammy and almost fainted. ... Read more
within 2 minutes having the J and J covid vaccine, patient became pale, clammy and almost fainted. She was non verbally communicative to her spouse and I, she was "zoned out and incoherent" . Paramedics were called, but after 10 minutes she became sick, vomited and then color came back and then she was fine. Patients says she doesn't remember even getting the shot.
57 2021-04-30 feeling abnormal TRANSIENT ISCHEMIC ATTACK (TIA)/STROKE; FELT LIKE GOING TO DIE; This spontaneous report received fro... Read more
TRANSIENT ISCHEMIC ATTACK (TIA)/STROKE; FELT LIKE GOING TO DIE; This spontaneous report received from a patient concerned a 57-year-old Asian and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, and numbness. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: 042142114, and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 to left arm for prophylactic vaccination. On 15-APR-2021 the patient called paramedics due to right side felt numb. Paramedics diagnosed her wrong as having a panic attack. On 17-apr-2021, the patient started feeling numb and disoriented and close to midnight she felt like going to pass out. She also felt right side was not working and she called paramedics again and was taken to emergency room. Her blood pressure was at 172/111 and she was shaking a little. She underwent the laboratory test magnetic resonance imaging (MRI), computed tomography scan, magnetic resonance angiogram and blood work was performed. On 18-Apr-2021, At 17:00, the patient was informed that she was moved to another hospital since she was diagnosed with and she was diagnosed with transient ischemic attack (TIA)/Stroke. The patient described that her side was still numb so they performed magnetic resonance angiogram (MRA). No Damage was found hence she was discharged from the hospital on 20-Apr-2021. The patient was hospitalized for 4 days. The patient was prescribed with amlodipine for blood pressure and clopidogrel bisulfate for a blood thinner. Patient reports continuing to "feel a little numb" intermittently. She describes the initial symptoms as "feeling like I was going to die". She stresses that she "has never been to an emergency room in her life". The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient had not recovered from transient ischemic attack (tia)/stroke, and the outcome of felt like going to die was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0: 20210453183-COVID-19 VACCINE AD26.COV2.S-transient ischemic attack (tia)/stroke. 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
57 2021-05-02 nervousness Dose given at 1:43pm. Symptoms started around 1:50pm. Symptoms include arm numbness and chest pressu... Read more
Dose given at 1:43pm. Symptoms started around 1:50pm. Symptoms include arm numbness and chest pressure. Pulse ox: 98 Bp: 168/95 Heart rate: 89 Pain: 8 of 10 chest pain moving to left Arm Pt reports numbness in the left arm all the way to shoulder & in the right arm numb to elbow. Pt states having breathing problems. Gave pt oxygen. Pt reports pain with inhalation and exhalation. Pmh: diabetes, no cardiac hx, thyroid problem Per pt, took medications today, ate quesadilla for breakfast, & was feeling good before vaccine administration. Pt has never felt these type of symptoms. No fever, no cough Medications per pt: glipizide, synthroid Recommended to go to the hospital; sounds like anxiety but pt wants to go to the hospital. Pt feels tightness of throat, but o2 is sat is 99@2:02 Pt was very nervous and didn't want to get the vaccine. Her legs are numb/falling asleep 2:05pm Nauseous at 2:08pm but dry heaving, no actual vomit 911 called at 2:10pm. Chest pain @ 2:11pm is 8 out of 10 and numbness is still present in hands and feet, per pt. o2: 99 and pulse: 87 at 2:13pm Temp: 36.0 BG 8am before breakfast: 118 Ambulance arrived @ 2:19pm and transported pt to hospital
57 2021-05-05 depressed mood, feeling abnormal My issues initially started about an hour after the vaccine. I became very subdued, no appetite and... Read more
My issues initially started about an hour after the vaccine. I became very subdued, no appetite and "foggy" for a lack of better words. I attributed this to what others stated were "typical reactions" and did not make a fuss over it. The following day I was VERY tired and stayed in bed and then about half way thru day 3, I became alert and resumed normal activity. At day 13 I began to have upper thigh pain in my left leg and began to feel winded as I was would walk up steps and do housework which had not happened previously ever.. On 4/14/21 I requested an appointment with my primary care doctor, however he was booked for 2 weeks and I was referred to an associated PA where I received a virtual consult. He told me that I was "over the age" of the women that were having reactions ,even though I had requested a Doppler. He only ran bloodwork, and in fact never even called me back on the bloodwork, and just posted it in the online profile. My ankles are VERY swollen and have bluish pitting and my feet do have considerable pain. I do have right side abdominal pain everyday since the 13th of April. I now need to find a doctor that will run diagnostics and respect my concerns
57 2021-05-05 disturbance in attention, feeling abnormal I tracked my symptoms in a notebook because they were so severe on Day 1. Day 1-3: sore arm, headach... Read more
I tracked my symptoms in a notebook because they were so severe on Day 1. Day 1-3: sore arm, headache, dizziness, shortness of breath, foggy brain, unable to focus, chills/uncontrollable shaking for several hours, body aches. Day 4: Same symptoms as above but milder. Bleeding gums when brushing teeth on left side of mouth (this NEVER happens). Painful gums (does happen when very sick with a virus). Day 5-6: Feeling better, but tired. Day 7: Tired, headache, nausea following exercise. Day 8-12: Mild feeling of discomfort while peeing. Tired every day. A bitt foggy every day but this happens with pollen season. Day 18: tired, trouble breathing on treadmill- I attributed this to pollen as it went away the next day when I closed the window. Day 20 (May 1): While out with friends, after having lunch and a glass of wine, I jumbled a few words and could not say them correctly. There were just about two words in two sentences. I tried a few times and they kept coming out wrong. It was nothing I have ever experienced before. We laughed it off but I felt very unsettled and a bit concerned about driving home. I drove home and was fine. I remain tired and feeling foggy which could be due to pollen. I have scheduled an appointment with a clinician today and hope to have some blood work done.
57 2021-05-11 anxiety, confusional state, thinking abnormal 15 to 20 minutes after the shot I got very hot/clammy, weak and confused the employee health nurse ... Read more
15 to 20 minutes after the shot I got very hot/clammy, weak and confused the employee health nurse came to check on me and told me to come to her office and I passed out. I was taken to the ER and kept there approx. 5 hours. I was extremely weak, could not lift my head and had trouble forming thoughts and words. They gave me medication via IV's and observed me. I started to feel better after about 4 hours after the vaccine, but have had more headaches than usual after receiving it. I still have some issues with being upset and anxious about the reaction and if it will have long term adverse effects on me. I will never get another vaccine of any type again.
57 2021-05-11 loss of personal independence in daily activities, insomnia Vaccine high up in left shoulder joint area & sideways towards body. Immediate severe burning pain, ... Read more
Vaccine high up in left shoulder joint area & sideways towards body. Immediate severe burning pain, flushing, dizziness, faintness, chest pain, BP 180/115. Incident report was filed by nurses. Paramedics onsite attended patient; documentation was signed by patient. Felt like arm ripped off and put back on. Severe pain left shoulder to elbow, neck, scapula: continunous for 6 weeks, no sleep. Moderate pain at 8 weeks. Pins & needles top-trunk 4wks. 2 weeks out: lump on top of L shoulder for 1 week. 2.5 weeks out: burning rash in armpit for 1 week. 8+ wks of numb/tingling in L hand pinky & ring fingers, limited range of motion w/popping, crunching in shoulder when move left arm. Headache, nausea, muscle aches for 5 days post vaccine. On 3/29/21, 3/30/21, 4/16, 4/19, 4/30/21 sought medical attention @ internal med. doctor & orthopedic doctor.
57 2021-05-12 sleep disorder Arm/Shoulder is getting worse with pain. Unable to put my coat on as usual. Compensating for the p... Read more
Arm/Shoulder is getting worse with pain. Unable to put my coat on as usual. Compensating for the pain using caution to lift. The pain is progressively getting worse to point of tears at night and waking me throughout the night.
57 2021-05-20 insomnia She got her vaccine, her arm stayed sore for about 4 days and didn't notice it anymore. She was tir... Read more
She got her vaccine, her arm stayed sore for about 4 days and didn't notice it anymore. She was tired feeling, just yucky feeling, no energy to do anything. Then after that it was more of not sleeping well, tossing and turning all night. Then about 2 weeks after that she had noticed that her hair was coming off out of the brush and then her brush was full of hair. A friend looked at her head and said that she had a bald spot and then realized that there were spots. The one started at about the size of a half dollar and now are the size of a grapefruit. The other three are larger than a 50 cent piece. She has lost about 40% of her hair, and it is very thin especially straight down on the middle, and the others are to the side and one to the corner, which this hair loss has not stopped. Most of them are in the back of her head but does have one coming in the front as well . She also has had a headache that she wakes up with every day and takes Ibuprofen and Tylenol alternatively which she did not have before the vaccine. She went to her doctor when she noticed the hair falling out and has run blood work, urine screening and the only thing came back was that her blood was too thick and she was started on a baby aspirin. Her doctor wants to do additional testing, CAT scans, and other blood work.
57 2021-05-23 feeling abnormal My arm was in uncomfortable pain, sore, tender, and swollen for a week. The next day I started feeli... Read more
My arm was in uncomfortable pain, sore, tender, and swollen for a week. The next day I started feeling hot but it was not a fever, my head started hurting and I was just feeling blah. I called the County Hotline and they said that they have heard that before. I felt like I was getting the flu, but it never turned into the flu. I was very fatigued and out of sorts for about a week and then everything went away.
57 2021-05-24 impaired work ability A few hours after the vaccine, began having a headache. The next day had severe body aches and chil... Read more
A few hours after the vaccine, began having a headache. The next day had severe body aches and chills, which continued for another 4 days. I missed 4 days of work. I began feeling better a week after the vaccine. 24 days after the vaccine, I was awaken with excruciating pain in my left abdomen, and had severe diarrhea. The diarrhea lasted most of that day, the pain continued. I went to an Emergency Room on 4/1/21, and a CT scan revealed what appeared to be a stomach ulcer, a kidney stone and a post-menopausal ovarian cyst, all of which were causing the pain. I have been through many tests and seeing a variety of doctors, and currently am awaiting results and treatment plans for the stomach problem and the ovarian cyst. The cyst has grown and is causing continued pain. The stomach issue is being treated with Sucralfate 1 g 4 times per day and Pepcid 20 mg.
57 2021-05-25 feeling abnormal Violently Ill, bodyaches, brain fog, rash in the left groin to knee area. Raised D-dimer test. Musc... Read more
Violently Ill, bodyaches, brain fog, rash in the left groin to knee area. Raised D-dimer test. Muscle aches and weakness. Joint pain and frequent headaches. Bladder leakage and her blood pressure has been elevated since vaccine.
57 2021-05-25 excessive sleepiness, feeling abnormal about 10 pm, the same day of the vaccine. I had migraine headache, body aches, the whole body ache... Read more
about 10 pm, the same day of the vaccine. I had migraine headache, body aches, the whole body ached, chills, 103 fever, shaking so bad could not have called 911 if I wanted to. At 2 am, I did not take any medications bc the instructions said not to take any thing any relief. At 6 am I went to the ER, I felt like I wanted to die I felt so horrible. I was given ibuprofen and benadryl. I was given IV fluids. I was discharged at 1:00 pm. I slept for 3 days straight. and I still had the side effects. I still had low grade fever and fatigue. Migraine headache was the worst, it just continued and the fatigue. Even now I am still tired.
57 2021-05-26 anxiety Received vaccine on 4/7/2021. Starting next day-intense all over body itching...increased a few days... Read more
Received vaccine on 4/7/2021. Starting next day-intense all over body itching...increased a few days. Skin flushes-arms, stomach, chest, lower back. Eye twitches. Pressure under left rib cage. Unexplained bruising-legs and arms. Inflamed veins..arms, legs, mouth. Vasculitis? Increased anxiety. Waking up in cold sweats. 2 weeks post vaccine-tongue started swelling up and develope pasty white coating, mouth lesions and blisters. Increased inflamed veins in mouth-Ongoing.
57 2021-05-26 impaired work ability On April 23rd, I noticed a sore on my left ear that evening. It was very tender. It finally occurred... Read more
On April 23rd, I noticed a sore on my left ear that evening. It was very tender. It finally occurred to me on the 27th. That's when I went to the dr's office because I thought I might have shingles. The dr started me on valtrex for a week. I was told because I work in a cancer center that I could not be at work with shingles. They thought that I might be contagious and I had to work from home for four days before they cleared me to come back to work.
57 2021-05-27 impaired work ability 3-19 vaccination 3-20 I started to have hives, low grade fever. 3/21 I went to church. I left betwe... Read more
3-19 vaccination 3-20 I started to have hives, low grade fever. 3/21 I went to church. I left between services due to being dizzy, fever chills, achy, body aches. 3/22 didn't go to work. But by midday felt better. *Every week for a month, the hives would disappear and reappear in another place. *6th week I went to urgent care as the hives were around stomach. Prednisone. Rash/hives went away. 5/11/2021 I went to work first part of the day. I left work at 11:00am. The cough started. 5/12 my results showed second strain positive for COVID. 5/18 Cough persisted and boss advised to go seek medical attention as been sick for a while. I went to urgent care. He put me on an antibiotic and pill that makes me stop coughing . The dr. didn't seem to think that I had COVID as I had been vaccinated. I had a low grade fever. He did the COVID test. I was able to access the records online the following day. *Off from work, could go back after my fever had left. My fever left on 5/22 *I missed approximately 6.5 days of work. I missed another day after vaccination, as well.
57 2021-06-02 anxiety Patient received vaccination, became anxious and lightheaded. lost control of her bladder. opened an... Read more
Patient received vaccination, became anxious and lightheaded. lost control of her bladder. opened an ammonia inhalant and patient felt better.
57 2021-06-07 feeling abnormal HOT FLASH LIKE SYMPTOM; BLURRED VISION; IMPAIRED VISION; WEIRD FEELING; This spontaneous report rece... Read more
HOT FLASH LIKE SYMPTOM; BLURRED VISION; IMPAIRED VISION; WEIRD FEELING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included carpal tunnel surgery, deviated septum surgery, and rectal seal surgery, and concurrent conditions included sleeping trouble, penicillin allergy, alcohol user, and non-smoker. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced hot flash like symptom. On 26-MAY-2021, the subject experienced blurred vision. On 26-MAY-2021, the subject experienced impaired vision. On 26-MAY-2021, the subject experienced weird feeling. The action taken with covid-19 vaccine was not applicable. The patient was recovering from blurred vision, had not recovered from impaired vision, and the outcome of hot flash like symptom and weird feeling was not reported. This report was non-serious.
57 2021-06-16 insomnia INSOMNIA; PAIN IN HIP JOINT; This spontaneous report received from a patient concerned a 57 year old... Read more
INSOMNIA; PAIN IN HIP JOINT; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 198 pounds, and height was 63 inches. The patient's concurrent conditions included epilepsy, non-smoker, non-alcohol user, depression, and seizure, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the 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, intramuscular, batch number: 205A21A, expiry: 18-JUN-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. Concomitant medications included escitalopram oxalate for depression, and phenytoin for seizure. On 06-JUN-2021, the subject experienced insomnia. On 06-JUN-2021, the subject experienced pain in hip joint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in hip joint, and had not recovered from insomnia. This report was non-serious.
57 2021-06-18 nervousness, feeling abnormal, sleep disorder Arm pain the first week. Then on the eighth day, I had twitching (whole body) like I was having a se... Read more
Arm pain the first week. Then on the eighth day, I had twitching (whole body) like I was having a seizure but it wasn't. It only happens when I lay down. Then I had a headache, maybe a little that first week after, but when the twitching the headache got worse. When the twitching was severe it was every couple of minutes. The headache could be associated with other problems. I wasn't sleeping. The headache gets worse at night time. If I lay on the left side where the headache is on it gets way worse. Then my hip hurts if I lay on other side because I had hip replacement. My blood pressure got so high, went up to 212/110. I went by ambulance to ER. At one point, 240 over 110 (the ambulance guy told me it got up that high). But then at hospital it was back down to 212/110. I had been taking my blood pressure was not going down and that's why I called. I got to the hospital and they took all types of tests and blood and x-ray of my chest. Then they gave me one shot in the IV of Ativan. That helped a lot. It stopped the twitching for 24 hours. But now the twitching is back but it's less often. The next day after the hospital I slept all day and didn't twitch. Just last night I couldn't sleep at all. Not just the twitching but I was just restless. I have a headache today, too, and have been in bed all day. I'm trying to stay calm because I don't want the blood pressure to go up. No new meds after the hospital. I still feel pretty bad and will see my doctor on Monday follow up. I'm nervous to take blood pressure reading, trying not to take it.
57 2021-06-23 impaired work ability I have NO INSURANCE and NO MONEY to go a doctor. VERY SWOLLEN LEGS FOR 14 DAYS,, low to high grade ... Read more
I have NO INSURANCE and NO MONEY to go a doctor. VERY SWOLLEN LEGS FOR 14 DAYS,, low to high grade headaches AND STILL ON GOING, I HAVE TO TAKE PAID DRUGS EVERY DAY TO WORK AT ALL. I HAVE NOT BEEN ABLE TO WORK EVEN HALF TIME IN LAST 2 WEEKS - NO UNEMPLOMENT IS ALLOWED FOR THIS SO I HAVE ALREADY LOST 2 WEEKS of INCOME!!!
57 2021-06-29 loss of personal independence in daily activities Cramps, stroke like symptoms, headaches, quickly get tired, back aches, can't stand straight, knee p... Read more
Cramps, stroke like symptoms, headaches, quickly get tired, back aches, can't stand straight, knee pains, assistance with getting up and laying down, numbness, blood clot in left hand, left knee swells and pains , unable to do the things that she used to do
57 2021-06-30 impaired work ability, depression, depressed mood 2:00 after the vaccine - Chills and tired/fatigue (I noticed that I had to cover up more). I felt li... Read more
2:00 after the vaccine - Chills and tired/fatigue (I noticed that I had to cover up more). I felt like I was going to get a fever but I don't usually get a fever. In the morning, I had extreme light sensitivity. I couldn't read the computer and do my work. I went outside about noon and that is when I could first tolerate the light. I took the day off mostly. I was fatigued. I started getting achy and flu symptoms. And that went away. The 1st weekend of April, I had hip pain (and I normally don't have it). It was making me limp it was so bad - on the right side. That hip pain lasted two days. Around time of hip pain, I started feeling a dizzy, balance problem and had to really concentrate on my steps. I had a televisit with the NP in April. That lasted for about a month. I had difficulty walking around. My husband had the balance issue, too. I'm normally not ever dizzy. In May, it felt like my brain was inflamed. Like there was swelling in brain. The dizziness and balance issues continued into May. Those all lasted until the end of May. Around June 16th, I was starting to feel really sad for no reason, though. I realized I better get some depression meds again. I just started them this week. The one I take acts pretty quick. I had run out of refills and I had stopped taking them because I had been feeling fine all spring. I contacted my NP, and he got me a refill this week. And the medication seems to be helping with the depression. I don't have the balance thing anymore or the dizziness.
57 2021-07-01 loss of personal independence in daily activities FLARE LOWER BACK/ SCALP/EARS AND ON FACE; A LOT OF PAIN; MAKING DAILY ACTIVITIES DIFFICULT; This sol... Read more
FLARE LOWER BACK/ SCALP/EARS AND ON FACE; A LOT OF PAIN; MAKING DAILY ACTIVITIES DIFFICULT; This solicited report received from a patient via PPSIMM001960: Pharmacy concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included morphine allergy. The patient was treated with guselkumab (solution for injection, subcutaneous, batch number was not reported) 100 mg, 1 time every 8 weeks, from 25-SEP-2020 for psoriatic arthritis. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, Expiry : unknown) dose was not reported, 1 total, administered on MAY-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 naproxen for drug used for unknown indication, hydrochlorothiazide/triamterene, losartan potassium, metformin, and metoprolol. On MAY-2021, the patient experienced flare of Psoriatic arthritis in the lower back/ scalp/ears and on face. The patient was also experiencing a lot of pain, making daily activities difficult. The action taken with covid-19 vaccine ad26.cov2.s, and guselkumab was not applicable. The patient had not recovered from flare lower back/ scalp/ears and on face, a lot of pain, and making daily activities difficult. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and flare lower back/ scalp/ears and on face, a lot of pain, and making daily activities difficult was not related; and between guselkumab, and flare lower back/ scalp/ears and on face was related, and between guselkumab, and a lot of pain, and making daily activities difficult was not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210652721-covid-19 vaccine ad26.cov2. s- flare lower back/ scalp/ears and on face. This event(s) is considered not related. The event(s) has an unknown/unclear 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. V0: 20210652721- Guselkumab- flare lower back/ scalp/ears and on face was related. This event(s) is labeled per regulatory authority and is therefore considered potentially related.
57 2021-07-12 impaired work ability, memory impairment, feeling abnormal, amnesia One week after receiving the vaccine, my left arm became numb tingling and pins and needle feeling. ... Read more
One week after receiving the vaccine, my left arm became numb tingling and pins and needle feeling. It began at my shoulder and traveled down to my elbow down to my wrist to the tips of my fingers I had started my shift and the pain and numbness was so bad in my hands that I had to stop working and go to the ER. Once at the ER I was admitted for observation. I was released the next day upon my release, the pain numbness pins and needles tingling feeling travel to my right arm from the tips of my fingers to my elbow to my shoulder it then began in both feet from the tips of my toes traveled up to my knees eventually up to my thighs. It just progressed and progressed day by day eventually it hit my face my gums my tongue my lips and at that point I was afraid that it was going to go to my brain and I went back to the ER. I was released and told to go home and basically write it out. A few weeks later I had an appointment with a neurologist and it was determined that it was most likely a side effect of the vaccine. Prior to my neurologist visit I had had a phone appointment with my nurse practitioner. I had explained to her my symptoms of the burning numbness pain tingling pins and needle stabbing random feelings I was feeling in my entire body. She prescribed me the medication gabapentin. The gabapentin did help me and I also began to take vitamin B12 which I believe also help me eventually it all dissipated except for my hands and my feet it was minimal but still noticeable and aggravating. About a week and a half ago I started to get real bad numbness pain tingling burning stabbing pains in my feet and now my hands and now it is again began to travel from the tips of my toes to my ankles up to my kneecaps but I'm both sides. It's also worse now in my hands with burning and tingling and numbness which is traveled from the tips of my fingers to my wrists up to my elbows. I fear that it's recycling itself and it's going to happen all over again affecting my entire body. I did see my GP last week and I was prescribed more gabapentin I don't like taking the gabapentin and it's not really helping me this time around. I also experienced brain fog memory loss cognitive problems also. I'm thinking one thing but the words won't come out of my mouth. I forget things also. I have terrible memory issues. When I'm working and I'm talking to a member I forget what they called for and I can't remember. I sometimes can't talk or say the words right. I don't know what I'm going to do because I need to work but the numbness is so bad in my hands it makes it very difficult it also makes it difficult for me to talk because I can't say the right words and I can't remember things I forget very easily.
57 2021-07-23 restlessness, feeling abnormal, insomnia BRAIN FOG; WANT TO SLEEP DUE TO RESTLESSNESS; FEVERISH LIKE FLUSHED/HOT FLASH; TIREDNESS; LITTLE NAU... Read more
BRAIN FOG; WANT TO SLEEP DUE TO RESTLESSNESS; FEVERISH LIKE FLUSHED/HOT FLASH; TIREDNESS; LITTLE NAUSEATED AS LIKE A FLU BUG; HEADACHE; RESTLESS; LEFT ARM THROBBING/ACHY; DID NOT SLEEP WELL; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 165 pounds, and height was 62 inches. The patient's past medical history included cough, fever, and penicillin allergy, and concurrent conditions included low thyroid, alcoholic, non smoker, and seasonal allergy. The patient had no drug abuse or illicit drug usage at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287, expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. Concomitant medications included thyroid for low thyroid. On FEB-2020, Laboratory data included: Body temperature (NR: not provided) 103 temperature. On 21-JUL-2021, the subject experienced restless. On 21-JUL-2021, the subject experienced left arm throbbing/achy. On 21-JUL-2021, the subject experienced did not sleep well. On 21-JUL-2021, the subject experienced headache. On 22-JUL-2021, the subject experienced brain fog. On 22-JUL-2021, the subject experienced want to sleep due to restlessness. On 22-JUL-2021, the subject experienced feverish like flushed/hot flash. On 22-JUL-2021, the subject experienced tiredness. On 22-JUL-2021, the subject experienced little nauseated as like a flu bug. Laboratory data included: Body temperature (NR: not provided) 101.5 or 101.9 degrees Fahrenheit, 99 F, 99.8 F. Treatment medications included: ibuprofen. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish like flushed/hot flash on 22-JUL-2021, was recovering from restless, headache, tiredness, brain fog, and little nauseated as like a flu bug, had not recovered from left arm throbbing/achy, and want to sleep due to restlessness, and the outcome of did not sleep well was not reported. This report was non-serious.
58 2021-03-08 insomnia Chills, upset stomach, insomnia
58 2021-03-09 impaired work ability patient developed a rash and hives on head neck and face. Patient went to work and was identified t... Read more
patient developed a rash and hives on head neck and face. Patient went to work and was identified to have an adverse reaction to the Janssen immunization. Patient was sent to the clinic for treatment and was told to use Benadryl for the rash. patient did take two capsules for a 50 mg dose. Patient worked about two to three hours and was then sent home for high blood pressure which patient claims lasted three hours. Patient is feeling fine on 03/10/2021 and says they do not have a rash today.
58 2021-03-10 anxiety Heart rate 120 bpm, Blood pressure 170/110, lightheaded, feeling faint, tingling, anxiety
58 2021-03-10 sleep disorder Starting at 10:30 p.m. I experienced severe, shaking chills, fever, random tingling, some joint ache... Read more
Starting at 10:30 p.m. I experienced severe, shaking chills, fever, random tingling, some joint aches and a headache. I took advil p.m. and tried to sleep, but really couldn't sleep much. By 7 a.m. the symptoms subsided accept for a mild headache. I went to my teaching job that afternoon and felt pretty good. Now two days later, I feel completely fine.
58 2021-03-14 fear headache, chills, body ache, 101.4 temp/fever; none yet Adv ok to take some APAP PRN if this is some... Read more
headache, chills, body ache, 101.4 temp/fever; none yet Adv ok to take some APAP PRN if this is something safely taken according to dosing on the bottle, can try heat pad, stay hydrated. Call back if any issues worsen/persist provided number and PCC will FU tomorrow.
58 2021-03-14 sensation of foreign body Within a couple of minutes of vaccine administration, the patient began experiencing throat tightnes... Read more
Within a couple of minutes of vaccine administration, the patient began experiencing throat tightness and stated that it felt like "there was a lump in my throat". BP initially was 168/81 and then continued to increase to 217/94. O2 sats remained stable but Benadryl 50mg administered PO for potential allergic reaction. RN remained with pt for approximately 1 hour and pt eventually returned to baseline and was allowed to go home.
58 2021-03-16 excessive sleepiness Fatigue-48hrs but was worse the last 24 hrs- I slept for 18 of the 24 hrs Joint Pain-48hrs Body Musc... Read more
Fatigue-48hrs but was worse the last 24 hrs- I slept for 18 of the 24 hrs Joint Pain-48hrs Body Muscle Aches-48hrs Total Body Inflammation/Swelling- 24hrs All
58 2021-03-17 insomnia On 3-17-20201 at 9:45pm. Severe neck and muscle pain , SEVERE body shakes that lasted til 3am then I... Read more
On 3-17-20201 at 9:45pm. Severe neck and muscle pain , SEVERE body shakes that lasted til 3am then I was extremely hot with 102.9 fever did I not sleep all night. My hands would not work they were extremely painful. My sugar went to over 200 which was high for me. At 6am Motrin was taken and after 2 hrs temperature came down to 98.6. At 10am shakes started again and finally stopped at 5pm. My skin on hands and neck were burning. Unable to move fingers well until now at 5pm.
58 2021-03-21 hallucination The most concerning was hallucinations. I saw the tooth fairy and cried for santa. I had a fever, ... Read more
The most concerning was hallucinations. I saw the tooth fairy and cried for santa. I had a fever, chills so violent that I made the bed shake - lasted for hours; severe headache that triggered a migraine, exhaustion, and nausea. It's 2 days later and I still feel terrible. My husband gave me a tylenol PM that night and the next day as the headache was a full blown migraine, I took naratriptain. I still have a slight headache but want to avoid taking additional medicine if possible.
58 2021-03-22 impaired work ability Immediately after receiving the vaccine, I had stinging pain spreading like a wasp sting (to which I... Read more
Immediately after receiving the vaccine, I had stinging pain spreading like a wasp sting (to which I am allergic) traveling down my left arm. Within a half hour, sharp muscle cramps took place simultaneously on top of the "wave" of sting like pain. These waves of cramping pain changed in location, but were strongest in my arms and legs. Between these waves, sharp pinching nerve pain happens in specific spots which could be anywhere including scalp and between toes. I had one good day with little pain. Other days are not so bad if I keep ibuprofen consistently in my system. It has been 12 days, and these pains have lessened but not stopped. The remaining pains are more of the sharp isolated nerve pains. I have not had any flu like symptoms, and I've had very little pain at the injection site. I have not been able to work much of the 12 days since the shot. I worry that the nerve pain may not go away.
58 2021-03-29 excessive sleepiness Severe diarrhea accompanied with abdominal pain for several hours (began about 10:30 pm lasting 4-5h... Read more
Severe diarrhea accompanied with abdominal pain for several hours (began about 10:30 pm lasting 4-5hrs). Took an over the counter remedy for diarrhea...had to take repeated doses, and still had diarrhea. Also experienced chills for the same time period. Went to bed about 3am...woke up later in the morning and those symptoms were gone. Over next couple days experience fatigue, slept more often and for longer periods of time. Today is the first day I felt returned to normal.
58 2021-04-01 hallucination FEELING HOT; SWEAT; TOOTHACHE; HEART RACING; FEVER; POUNDING HEAD; TENSION IN NECK; SORENESS IN BODY... Read more
FEELING HOT; SWEAT; TOOTHACHE; HEART RACING; FEVER; POUNDING HEAD; TENSION IN NECK; SORENESS IN BODY; SORE ARM; FEELING ROOM ON FIRE/PARANOIA/SEEING SPIDER/POSSIBLE HALLUCINATION; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, high blood pressure, and depression. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: unknown) dose was not reported, administered on 27-MAR-2021 on right arm for prophylactic vaccination. Concomitant medications included tramadol for fibromyalgia. On 27-MAR-2021, the patient experienced possible hallucination, tension in neck, soreness in body, sore arm and pounding head. On 28-MAR-2021, the patient experienced heart racing, toothache, fever and feeling hot and sweat. Treatment medications included: amoxicillin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from possible hallucination, paranoia, heart racing, seeing spiders, tension in neck, soreness in body, feeling hot, felt like room was on fire, sore arm, fever, and pounding head on 29-MAR-2021, and sweat, and the outcome of toothache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210356720-COVID-19 VACCINE AD26.COV2.S-Possible hallucination. This event is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
58 2021-04-06 excessive sleepiness, sleep disorder I felt fine immediately after the injection - just a little pain in the arm where I got the injectio... Read more
I felt fine immediately after the injection - just a little pain in the arm where I got the injection and when raising my arm. By 6:30 pm I was achy all over and my legs were aching a lot. When I went to bed around 8:00, I hurt all over (achy and flu-like feeling, but no fever). I dozed off and on and about midnight when I woke up, I had a very rapid heartbeat. This went on all night and into the morning. It was hard to get any sleep at all. When I'd get up to go to the bathroom, I was slightly dizzy and unsteady on my feet. After I got up at 6:30 am, the highest my heartrate got was 113, then it finally began going down. I was still hurting all over, felt extremely tired, and now had fever - 99.8. The fever lasted off and on all day and into the next night. I was also very nauseated all day and I felt extremely bloated. I also had a bad headache. When I woke up on Friday, my fever and the headache was gone, but I felt extremely tired and weak and still nauseated. I slept most of the day and I still ached all over, but not as much. My lymph nodes were also swollen. On Friday afternoon, I walked up to the mailbox and I was winded and unsteady. On Saturday, I felt a little better, but was still extremely tired. By Saturday night, all the aches, pains and headache were back and I didn't sleep well at all. I rested most of Sunday and felt a little better Sunday evening. The aches and pains were going away, but I was still very tired and exhausted. I felt the same way when I woke up on Monday morning. It seemed like the vaccination made the aches and pains I normally had with Fibromyalgia about three times as bad as usual. And I was still very bloated feeling all over. By Monday afternoon the nausea finally went away. By Monday afternoon I was feeling a little better, but still tired. On Tuesday I felt better still and I noticed that I wasn't bloated as much. It seemed like I was getting back to normal.
58 2021-04-07 anxiety tachycardia, hot sweats, anxiety Patient was hospitalized
58 2021-04-07 sleep disorder My left arm started to sting immediately after getting the shot, then the stinging subsided. My lef... Read more
My left arm started to sting immediately after getting the shot, then the stinging subsided. My left arm started to hurt later in the day and I had pain all the way down my left arm and left side of my chest. This pain throughout my left side was not helped by Ibuprofen and made sleep very hard. I had intermittent sharp pain in my neck, shoulder, and left arm for days. The injection site turned red, hot, and a raised area the size of a silver dollar appeared and was med-red in color for about 8 days. The color is better/ almost normal as of today, but still a hard lump under the skin and a bit itchy. This has caused pain throughout my back and shoulders since I got the shot....but it has not been activity limiting. I had a slight bit of nausea for a couple of days as well. My husband had his shot just after mine and experienced Chills , headache, and nausea at about 9:00 P.M. His chills subsided at about 3:00 A.M. He continued with the headache for another day/ fatigue for 2 days/ and nausea for about 5 days. He has also had tingling in his left arm (about 7 days) and a funny tingling on his tongue for about a week.
58 2021-04-08 feeling abnormal, disturbance in attention Bones ache eyes out of focus extremely Dizzy nausea cannot keep any food or water down cannot focus ... Read more
Bones ache eyes out of focus extremely Dizzy nausea cannot keep any food or water down cannot focus or remember very foggy cannot walk forward in a straight line have to hold onto the walls and doors or crawl head aches right kidney aches knees don?t work
58 2021-04-08 feeling abnormal patient indicates she is starting to feel hot in neck area up to her arm. She had watery eyes. Pharm... Read more
patient indicates she is starting to feel hot in neck area up to her arm. She had watery eyes. Pharmacist assisted her and asked if she has any condition in her eyes : she said no. She said she felt weird and drowsy. Pharmacist asked if she was allergic to something and she said yes. Pharmacist administered 50mg of Benadryl IM on arm. She started to feel better.
58 2021-04-08 restlessness I had a number of side effects the same day...nausea, restlessness, migraine. Then the headaches & m... Read more
I had a number of side effects the same day...nausea, restlessness, migraine. Then the headaches & migraines continued. Previously I hadn?t had a significant migraine for over a year. So far I?ve had 3 that required medication, & several lesser headaches. Tjis is what is unusual, & due to recent reporting regarding possible,link to brain blood clots, I?m worried.
58 2021-04-09 feeling abnormal FELT SHE IS GOING TO DIE; GAGGED ALL OVER HERSELF; VOMITING; COULDN'T WALK/TRIED TO DRAG HERSELF TO ... Read more
FELT SHE IS GOING TO DIE; GAGGED ALL OVER HERSELF; VOMITING; COULDN'T WALK/TRIED TO DRAG HERSELF TO BATHROOM; CHILLS; FEVER; FEELING WEAK AND CAN'T DO ANYTHING; TIRED; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis, lupus, non alcohol user and non smoker and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A-HR, expiry: UNKNOWN) dose was not reported, 1 total administered on 30-MAR-2021 at 09:15 on right arm for prophylactic vaccination. The concomitant medications included immuno-suppressant medications. On 30-MAR-2021, the patient started experiencing chills which kept getting worse and got fever then started with vomiting and could not walk. The patient Gagged all over herself. The patient felt like she was going die and can't do anything so she called an ambulance. She was hospitalized on 30-Mar-2021 for all night. At hospital patient treated with medication for vomiting and was put on IV and blood test was performed. On 31-Mar-2021, At 13:00 , the patient was discharged from hospital but patient still experience weak, tired and can't do anything. The patient was hospitalized for 1 day. Hospital stated note for visit was Adverse Drug Reaction and instructed for follow up with treating physician in 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt she is going to die, and vomiting, couldn't walk/tried to drag herself to bathroom, chills, and fever on 31-MAR-2021, had not recovered from feeling weak and can't do anything, and tired, and the outcome of gagged all over herself was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0: 20210404324-covid-19 vaccine ad26.cov2.s -Vomiting, couldn't walk and tried to drag herself to the bathroom, gagged all over herself, felt like she is going to die. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210404324-covid-19 vaccine ad26.cov2.s -Fever, chills. These events are labeled per Agency and are therefore considered potentially related.
58 2021-04-10 insomnia Racing heart, tightness in chest, increase blood pressure: began after 18 hours still happening toda... Read more
Racing heart, tightness in chest, increase blood pressure: began after 18 hours still happening today but not as severe aches :began after 28 hours still happening but lesser degree fever up to 102 began after 24 hours finally broke after 48 hours Insomnia at night from aches and rapid heart. Hard to get comfortable from leg and hip aches. began first night and each night since.
58 2021-04-10 poor quality sleep POOR SLEEP; SENSATION OF SMELLING ROAST BEEF; CHILLS; HEADACHE FOCUSED AROUND EYES ,FORHEAD AND SINU... Read more
POOR SLEEP; SENSATION OF SMELLING ROAST BEEF; CHILLS; HEADACHE FOCUSED AROUND EYES ,FORHEAD AND SINUS; MUSCLE ACHE; INTERMITTENT FEVERS; SINUS CONGESTION; This spontaneous report received from a patient concerned a 58 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: 0U3A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On APR-2021, the subject experienced sinus congestion. On 05-APR-2021, the subject experienced poor sleep. On 05-APR-2021, the subject experienced sensation of smelling roast beef. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced headache focused around eyes, forehead and sinus. On 05-APR-2021, the subject experienced muscle ache. On 05-APR-2021, the subject experienced intermittent fevers. On 06-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache focused around eyes ,forehead and sinus, muscle ache, chills, intermittent fevers, poor sleep, sensation of smelling roast beef and sinus congestion was not reported. This report was non-serious.
58 2021-04-10 sleep disorder Vaccinated at 12:00pm Around 6:00pm started to get a really bad headache at the back of my head. T... Read more
Vaccinated at 12:00pm Around 6:00pm started to get a really bad headache at the back of my head. This lasted all night, preventing me from sleeping. Finally fell asleep around 5:30am still with a really bad headache. Woke up at 11:00am. Brushed my teeth and started to feel nausea. I went back to my bedroom and I got lightheaded to where my vision was blurred. Layed on the bed and felt really bad with a sweaty face and still nauseas. Had someone bring me grapes and some tea and layed there. I felt bad for about 45 min. then I fell asleep. Got up about 3:30 hours later feeling better, but not 100% Still a bit of a headache but nausea went away. Today I feel back to my normal self. I thought you'd like to know I did experience some of the side effects for your records.
58 2021-04-12 anxiety Symptoms: light-headed and anxious / cold & dizzy Intervention/treatment: assess vital signs, apple ... Read more
Symptoms: light-headed and anxious / cold & dizzy Intervention/treatment: assess vital signs, apple juice, granola bar/ fruit leather Vitals: BP 115/58, RR 18, Pulse 68, O2 100%
58 2021-04-12 feeling abnormal 4-9-21 The morning of I tested negative for COVID, took vaccine that afternoon. Following morning, 4... Read more
4-9-21 The morning of I tested negative for COVID, took vaccine that afternoon. Following morning, 4-9-21 woke up with 101 fever. Took Tylenol at 4 am. Did not take anything else since. Fever subsided in low 99's throughout that day. No other symptoms. 4-10-21 Woke up fine, no fever. Went to work at 7 am. Toward end of work day, vaccination site became sore and I felt out of sorts. 4-11-21 Woke up fine, no fever. Went to work at 7 am. By noon, feeling foggy. Very sore throughout my body, especially upper body and vaccination site. 4-12-21 Woke up ok, no fever but not quite myself. Went to work 7 am. At about 8 am began to feel a bit foggy , dizzy and almost past out. Blood pressure taken by medics was normal but high for me, after resting for 15 minutes it had gone done to my normal. Went back to work station sitting down but the foggy & dizziness continued off and on. Went back to my hotel to rest at 1 pm. While resting felt better but when moving out of bed sensations would come back. Some pain in left side vaccination and shoulder/neck pain but that may be related to chronic issues. 4-13-21 Stayed home to rest, fogginess continues, pain in vaccination site down arm.
58 2021-04-12 mental impairment Blood Clot blocked oxygen to the brain. Suffered a severe stroke Was hospitalized Suffered brain s... Read more
Blood Clot blocked oxygen to the brain. Suffered a severe stroke Was hospitalized Suffered brain swelling Lost brain function Died.
58 2021-04-12 sleep disorder On the night of March 18th, around 2am on the Friday morning, I woke up with a vicious headache -- ... Read more
On the night of March 18th, around 2am on the Friday morning, I woke up with a vicious headache -- a steady pressure and pain in my whole head. By far the worst headache I've ever had. I sat in the shower for about 40 mins trying to get it to go away, it didn't. I took a Tylenol when I got out of the shower which I immediately vomited up . After a while I was drained enough that I was able to go back to sleep. Headaches continued for more than a week, though not as awful (I was more or less functional). On March 26th I requested an appt and was seen right away.
58 2021-04-14 sleep disorder, impaired work ability Was stressed and run down in weeks prior to shot (taking care of mother dying of cancer who passed 0... Read more
Was stressed and run down in weeks prior to shot (taking care of mother dying of cancer who passed 04//01/21) so was not able to determine if experiencing side effects of just continued fatigue. Sore arm, bruised. Monday evening 04/12/21 felt sick, nauseous. Unusual for me. Continuing to feel sick each day since then and called in sick to work today. When I move around I feel worse. My chest feels like I am on the verge of getting really sick. I can breathe but just do not feel good. Feel worse when having a conversation with people. Feel better resting. I have no fever. My blood pressure and heart rate are normal. This is the sickest I have felt since before the pandemic. I called a nurses hotline yesterday and was told to call 911 is I had chest discomfort. I do not feel sick enough to call 911 and could drive myself if I need to go to the hospital. Best way to describe my symptoms is feel like I am on the verge of getting a bad chest cold. Had a headache last night and did not take anything. Woke up in the middle of the night with a very painful headache and took 2 Tylenol which made the headache subside. I have been feeling worse each day since Monday. Today is Thursday. Am wondering if I have COVID-19 and have called a clinic to schedule a COVID test that will be paid for by my work. Am waiting for a return call. All I know is that I feel sick and was not feeling this way before having the vaccine.
58 2021-04-19 poor quality sleep, feeling abnormal, sleep disorder Day 1- (April 1st - bearable arm pain & low fever that night (nothing bad) Day 2- @5:00PM - arm pain... Read more
Day 1- (April 1st - bearable arm pain & low fever that night (nothing bad) Day 2- @5:00PM - arm pain was unbearable hurt from the root of the arm to my elbow, including lymph nodes and all the part of the arm that touches the ribs, a headache that fluctuates from bad to my head is going to burst, from there it became a very weakening fatigue where I could hardly get around, lots of joint pain, nausea and I do not know if the vaccine provoked the diarrhea or if it triggered the Crohn's. To this day I am still dealing with the headache, the pain not just in the arm but allover, gastro intestinal problems. It has impacted my sleep tremendously because the level of pain is very high. The one thing that went away that very first night was the low fever. But this vaccine is like a Wish (cheap store) Vaccine. They SHOULD NOT give this to immunocompromised people and the "few days" rhetoric does not apply to us and that should be specified! Initially I thought this was to be expected when I heard a Doctor on the news say: "if you fell like you got ran over by a truck, that is normal." So, that is how I felt, so I thought it was normal.
58 2021-04-20 confusional state Intense muscle and bone pain, unable to stand due to pain on the bottom of feet, blisters on hands, ... Read more
Intense muscle and bone pain, unable to stand due to pain on the bottom of feet, blisters on hands, bad headache, joint pain, weakness, dizziness, fatigue, confusion.
58 2021-04-21 insomnia After vaccination on April 12 had nausea and vomiting, chills and headache, stomachache most of the... Read more
After vaccination on April 12 had nausea and vomiting, chills and headache, stomachache most of the day. At night had fever, pain at injection site, malaise. Same on day2 but milder and headache. Insomnia Day 3 -7chills at day and night time mild headache, sore throat, insomnia Day 7 nausea, chills and headache, tiredness, sorethroat, insomnia Day 8- 10 chills, mouth sores, tiredness, insomnia On eAch day took antihistamine cetrizine
58 2021-04-21 insomnia Approximately 6-7 hours after injection, all over my body, my skin was "tingling" and right thumb an... Read more
Approximately 6-7 hours after injection, all over my body, my skin was "tingling" and right thumb and lower back pain increased. The tingling all over my body was not really painful, more like the nerves were just very active. It was hard to get comfortable to sleep. The symptoms lasted approximately 6-1/2 hours. No other symptoms.
58 2021-04-22 feeling abnormal After vaccination, at 10pm I started feeling flu like symptoms, fever chills shakes feeling miserabl... Read more
After vaccination, at 10pm I started feeling flu like symptoms, fever chills shakes feeling miserable and this lasted 3 days straight, I also had diarrhea, nausea and vomiting. I woke up with a swollen juggler vein that ended up being a blood clot, 10 days later my arm was swollen up twice the size of my leg, the juggler was still swollen. I call the urgent care nurse they said to go to ER. I went to hospital got a CAT scan and ultrasound, I was given a shot of warfarin that was supposed to last for 12 hours. I went home and the next morning instead of going to the hospital, I went to hospital and they found 2 blood clots in brain, arm and leg and neck. I have had no history of blood clots and this all happened after the J&J vaccine. They did a procedure where they tried to put a balloon to relieve the pressure. The blood clots in the brain cannot be removed because of their location and it would be dangerous to remove and I am on blood thinners for the rest of my life. Multiple blood clots in body brain, arm and shoulder.
58 2021-04-22 sleep disorder The first symptom, on the 27th in a.m., I had chest pressure or pain for about 90 minutes. I couldn'... Read more
The first symptom, on the 27th in a.m., I had chest pressure or pain for about 90 minutes. I couldn't take a deep breath and I couldn't exert myself at all without it hurting in my chest. The 2nd symptom, I went to doctor (21 days after) and he checked my platelets. I woke up three times during the night with pain in my left calf. A couple of nights previously I woke up with those same pains in my left calf, as well. It was worse pain the second time. I went to the dr and he did bloodwork. I did not have any other pains after that.
58 2021-04-28 impaired work ability SPASMS TO LEFT HAND AND FINGERS; BUMP SIZE, PENNY SIZE TO LEFT UPPER ARM (INJECTION SITE); TENDENTI... Read more
SPASMS TO LEFT HAND AND FINGERS; BUMP SIZE, PENNY SIZE TO LEFT UPPER ARM (INJECTION SITE); TENDENTIOUS/ LEFT ARM WITH RADIATING PAIN TO LEFT HAND AND FINGERS/ LEFT HAND THROB; SOME FATIGUE; HEADACHE RADIATING TO NECK, FRONT HEAD AND LEFT SHOULDER; UNABLE TO WORK; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight was 175 pounds, and height was 63 inches. The patient's concurrent conditions included fatty liver disease, blood pressure, alcoholic, non smoker, and muscular skeletal pain in left arm, and other pre-existing medical conditions included the patient had no known drug allergy and did not have 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included valsartan for blood pressure, and tizanidine for muscular skeletal pain in left arm. On APR-2021, the subject experienced unable to work. On 09-APR-2021, the subject experienced tendentious/ left arm with radiating pain to left hand and fingers/ left hand throb. On 09-APR-2021, the subject experienced some fatigue. On 09-APR-2021, the subject experienced headache radiating to neck, front head and left shoulder. On 11-APR-2021, the subject experienced bump size, penny size to left upper arm (injection site). On 19-APR-2021, the subject experienced spasms to left hand and fingers. On 20-APR-2021, treatment medications included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from some fatigue, had not recovered from headache radiating to neck, front head and left shoulder, bump size, penny size to left upper arm (injection site), and tendentious/ left arm with radiating pain to left hand and fingers/ left hand throb, and the outcome of spasms to left hand and fingers and unable to work 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.
58 2021-05-03 insomnia Sleeplessness with no energy loss ,itching without rash. Strange taste. Self monitoring no treatmen... Read more
Sleeplessness with no energy loss ,itching without rash. Strange taste. Self monitoring no treatment.
58 2021-05-05 feeling abnormal pt stated she was watching TV about 10 days after taking the vax she had a stroke. She became where... Read more
pt stated she was watching TV about 10 days after taking the vax she had a stroke. She became where she couldnt talk and was speaking jibber jabber. Her eyes blurred. These symptoms went away and she felt better. On 4/23/21 she went to ER. Her BP was 212/117. She had multiple test. She was diagnosed w/ Stroke. She was prescribed water pills and sent home to FU w/ PCP. On 5/3/21 she saw PCP. He prescribed blood pressure medicine. She is waiting on them to call her back w/ appt date for a Carotid US. She feels better but says she has brain fog, has fatigue and right eye is still blurry.
58 2021-05-07 impaired work ability Very weak, worn out, tired, achy, fever lasted about 3 days, used ibuprofen, rested, couldn't go to ... Read more
Very weak, worn out, tired, achy, fever lasted about 3 days, used ibuprofen, rested, couldn't go to work, no medical attention.
58 2021-05-15 feeling abnormal She presented to Hospital for Johnson and Johnson Covid vaccine on 5/14/2021. Janssen vaccine was gi... Read more
She presented to Hospital for Johnson and Johnson Covid vaccine on 5/14/2021. Janssen vaccine was given at 1330. She was instructed by LVN to wait 30 minutes in the waiting area to be monitor for any allergic reactions. At approximately 1550, she presented to LVN reporting tingling sensation in the mouth, lips and tongue, stating "feeling funny". Then she was evaluated by an RN and Benadryl 50 mg was given by mouth at 1553. Her symptoms were increasing. 911 was called at 1606 and she was injected with EpiPen at 1610. Paramedics arrived approximately at 1618 and transported her to the Emergency Department. Patient remined alert during the entire encounter.
58 2021-05-20 feeling abnormal About a month later I started having odd symptoms. I notice changes in my urinary and bowel functio... Read more
About a month later I started having odd symptoms. I notice changes in my urinary and bowel functions. Having to void often and more wet bowels on a weekly basis. Shortly after I started to feel weakness in my thighs and periodically in my upper arms. Overall weakness and stamina are not normal. Also considerably fatigued. Not happening every day but multiple times within a week. Often 2 to three days feeling like above and 3 to 4 days of somewhat normal but stamina is slowly getting less than before. Typically I can walk 3 to 4 miles 5 times a week, lift bags for yard work, not get winded on stair.
58 2021-05-24 loss of personal independence in daily activities, feeling abnormal, impaired work ability I was at work and all of a sudden my lower abdomen started bloating and it was very painful. Within ... Read more
I was at work and all of a sudden my lower abdomen started bloating and it was very painful. Within seconds I started feeling nauseous and my mouth filled with saliva. I started to feel faint. I left work 30 minutes early. I had to take my pants off and put on pajama pants because that is the only thing that would fit me. The pain from my abdomen was around my female organs. I laid down and my quads started to ache and I developed a fever. I did take some Tylenol which helped with the pain. I took Tylenol all week. My abdomen was still swollen come Friday and I developed brain fog. I was really having trouble recalling my normal daily routines and people I work with. This lingered on for 3 weeks. My head feels clear now, but I am still having trouble remembering normal daily activities and recall.
58 2021-05-25 impaired work ability Sick with symptoms very similar to when I had Covid in April 2020, everything but the fever, so head... Read more
Sick with symptoms very similar to when I had Covid in April 2020, everything but the fever, so headache, body aches and fatigue on 5/8/21 the whole day. On 5/11/21 I experienced Vertigo, lightheadedness, inability to walk straight. Improved the next day, but I still had bouts of vertigo and developed nausea. I saw an ENT on 5/25/21 and he diagnosed Labyrinthitis and I started a 6 day course of Medrol today 5/26/21.
58 2021-05-26 sleep disorder I noticed the stiffness getting worse in my hands about April 17th. I figured it was because I had g... Read more
I noticed the stiffness getting worse in my hands about April 17th. I figured it was because I had gotten off my RA medication. When I got back on May 7, that first week of May (1st or 2nd) - my hands were waking my up 4-6 times a night because I couldn't used my right hand - had to use my other hand (my left hand doesn't have as much problem) to open up my hand - joints were stuck. I saw my doctor on May 18th and he prescribed me Prednisone for a week and a I did acupuncture for two weeks and I got back on the Methotrexate (I've only been back on it one week now) and now I can use my hands. I can sleep through the night without hand waking me up.
58 2021-05-28 feeling abnormal HALO VISION; HORRIBLE FEELING; COUGH; FAST HEARTBEAT; FEVER; FATIGUED/EXHAUSTED; THROAT TIGHTNESS; D... Read more
HALO VISION; HORRIBLE FEELING; COUGH; FAST HEARTBEAT; FEVER; FATIGUED/EXHAUSTED; THROAT TIGHTNESS; DIZZY; FEELS PRESSURE INTERMITTENTLY; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 58 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 (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced chest tightness. On MAY-2021, the subject experienced feels pressure intermittently. Treatment medications included: diphenhydramine hydrochloride, and ibuprofen. On 21-MAY-2021, the subject experienced throat tightness. On 21-MAY-2021, the subject experienced dizzy. On 21-MAY-2021, the subject experienced fatigued/exhausted. On 22-MAY-2021, the subject experienced fast heartbeat. On 22-MAY-2021, the subject experienced fever. Laboratory data included: Heart rate (NR: not provided) Fast. On 23-MAY-2021, the subject experienced cough. On 27-MAY-2021, the subject experienced halo vision. On 27-MAY-2021, the subject experienced horrible feeling. The action taken with covid-19 vaccine was not applicable. The patient recovered from fast heartbeat on 22-MAY-2021, and feels pressure intermittently on 23-MAY-2021, had not recovered from cough, and dizzy, and the outcome of chest tightness, halo vision, throat tightness, fever, fatigued/exhausted and horrible feeling was not reported. This report was non-serious.
58 2021-05-31 feeling abnormal On 04/21/2021, 12 days after I received the vaccine, I woke up with my entire left side feeling numb... Read more
On 04/21/2021, 12 days after I received the vaccine, I woke up with my entire left side feeling numb and I had a headache. I felt like I had pressure on my chest and I was really lightheaded. I got up for a little while and I felt like I was going to faint. I felt like I needed to eat something and I was very weak. I drank some juice and ate an orange. I was having a hard time swallowing and at times slurred my words. I realized that something serious was going on because I had pain like when I went through chemo. The base of my spine has been hurting every day since I received the vaccine and I have had headaches since as well. I was having heart palpitations and felt super weak. I didn't go to work for 2 days. That was 04/21 and 04/22. On 04/23 I had to do a zoom conference for work, for an hour, and my eyes starting hurting really bad like my eyes had been open for 24 hours. The light from the computer screen was really affecting me. At 5pm I did a tele-video appointment with the NP. She told me that she wanted me to go urgent care because it was the closest urgent care to me. After going to Urgent Care on 04/24, the doctor wanted me to go to the Hospital by ambulance. At the hospital the performed an EKG, CTA and MRA and they said that everything looked fine. They couldn't validate that my pain was from Johnson and Johnson vaccine. I was release at 10:30pm PT, I called Dr., my Oncology surgeon, and he referred me to Neurology doctor. I got an appointment with Dr., 04/27, and she ordered a CTA and an MRA. I had the scans completed on 04/28, with and without contrast. The radiologist found something. I was sent back home, but I was told that right vertebral artery was completely excluded. In January of 2020, there was a CTA performed, and I didn't have any numbness and my vertebral artery still have a steady flow even though there was a tear. It also showed that I had more stenosis in my carotid artery. I have now been referred to a new Neurosurgeon. Dr. never saw me because they couldn't view my records. The doctor told me to take Crestor and 81 mg aspirin. I did not feel that those medications helped at all. If anything, I felt worse. on 05/15, I was in the passenger seat of my grandson's car and I ended up throwing up and there was blood coming out with the vomit. He took me the Hospital. I had a video appointment on 05/11, with an NP, and she told me to up my aspirin to 325mg and continue to take Crestor. She referred me to The Stroke Neurology Group and she referred me to get a CTA. She also referred me to a GI doctor. On 05/15, against medical advice, and was taken by ambulance to another hospital. I stayed there until 3AM 05/16. They performed an MRA, a CT, Stroke Angiogram, they MRI with and without contrast, a chest x-ray and a lot of blood work. They also performed are lactate test and at first it came back as 2.5, which made them think I had an infection, but they re-tested and it came back as 1.5 which they said to be normal. The results from the hospitals. On 05/19 I went to see a Cardiologist, and she took me off of Crestor and put on pravastatin. She order an echocardiogram and a treadmill test and an EKG. I did see a GI doctor and they told me that the aspirin that I was told to take is what was making me throw up blood. I do have a neurology appointment on 06/11 and I have an appointment with the neurosurgeon on 06/16. My last heart test came back normal.
58 2021-06-07 nervousness THROWING UP BLOOD; FEELING LIKE BEING CHOKED; HEAVY FEELING IN CHEST; FELT SHAKY; FELT SICK; STROKE-... Read more
THROWING UP BLOOD; FEELING LIKE BEING CHOKED; HEAVY FEELING IN CHEST; FELT SHAKY; FELT SICK; STROKE-LIKE SYMPTOMS; PAIN IN BASE OF SPINE; LEFT TORSO AND BOTH ARMS ITCHING; DEHYDRATION; This spontaneous report received from a patient concerned a 58 year old female. Initial information was processed along with additional information on 04-JUN-2021. The patient's height, and weight were not reported. The patient's past medical history included vertebral dissection of right vertebral artery in 2000, hiatal hernia, chemotherapy, radiation, vertebral tear, 5 years of cancer drugs and stroke-like symptoms, and concurrent conditions included 2 times breast cancer survivor, non-smoker, and sulfa drug allergy cause night time swells in mouth and tongue. The patient experienced pain in base of spine when treated with pegfilgrastim for breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 in total administered at left arm on 09-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, and pravastatin. On an unspecified date in 2021, the patient had elevated lactate level of 2.5 (unit unspecified) and was 1.5 (unit unspecified) on repeat and also had elevated chloride level was 110 (unit unspecified). The patient was dehydrated. On 09-APR-2021, the patient had left torso and both arms itching for 4 hours, started within half hour after received vaccine. On 10-APR-2021, the patient experienced pain in base of spine, which was exactly the same as when she received Neulasta during a previous cancer treatment regimen and patient experienced headache for 3 days. On 21-APR-2021, the patient woke up with left side numbness from head to toes, feeling like being choked as if like an allergy, felt heaviness in chest, within one hour patient felt shaky and like she was going to faint, felt dizziness/lightheaded and laid down for 2 days, later felt like her eyes were going to pop out of her head, was putting Refresh eye drops in her eyes and was having problems focusing her eyes (vision disturbances). The patient was only able to stay up for 2 hours, then had lie down because felt sick and weakness and had sever fatigue. All like stroke-like symptoms. The symptoms started on 21-APR-2021. The patient went to emergency room on 24-APR-2021 and discharged on same day. On 28-APR-2021, the patient had computed tomography scan and showed occluded right Vertebral artery. The patient had a computed tomography scan one year ago and there was no occlusion. They did a computed tomography scan that showed a same occlusion as on 28-APR-2021. On 28-APR-2021, the patient had stenosis of right carotid artery. The patient went back to emergency room on 15-MAY-2021 because she was throwing up blood and dizzy and she was told to go to emergency room. On 11-JUN-2021, she was going to see a stroke neurologist specialist a neurosurgeon 16-JUN-2021. On 15-MAY-2021, the patient went to emergency room and they re-performed a computed tomography scan and it showed an occluded right vertebral artery just as first scan did. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left torso and both arms itching on 09-APR-2021, had not recovered from pain in base of spine, and stroke-like symptoms, and the outcome of heavy feeling in chest, feeling like being choked, felt shaky, felt sick, dehydration and throwing up blood was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient concerned a 58-year-old female who experienced stroke-like symptoms and occluded vertebral artery 15 days after vaccine. Past medical history included vertebral dissection of right vertebral artery in 2000, hiatal hernia, chemotherapy, radiation, vertebral tear, 5 years of cancer drugs and stroke-like symptoms, and concurrent conditions included 2 times breast cancer survivor. Concomitant medications included acetylsalicylic acid, and pravastatin. On day 12 after vaccine, the patient woke up with left side stroke-like symptoms. The patient went to emergency room on day 15 and discharged on same day. On day 19, the patient had computed tomography scan and showed occluded right Vertebral artery. The patient had a computed tomography scan one year ago and there was no occlusion. She was discharged and evaluated by stroke neurologist. There is no report of thrombocytopenia to suggest thrombosis with thrombocytopenia syndrome. Given the pre-existing history of vertebral artery dissection, there is a plausible alternative explanation for the event.
58 2021-06-08 sleep disorder LOWER BACK PAIN; KIDNEY PAIN IN THE KIDNEY AREA; PROFUSE SWEATING; BODY ACHES; FREEZING COLD; VICIOU... Read more
LOWER BACK PAIN; KIDNEY PAIN IN THE KIDNEY AREA; PROFUSE SWEATING; BODY ACHES; FREEZING COLD; VICIOUS HERPES OUTBREAK (ANAL DISCOMFORT, PAINFUL BLISTERS ON LABIA, DISCOLORATION/PUFFY/YELLOW APPEARANCE OF ANAL AREA THAT GOT ITCHY/BURNY AND PAINFUL, HAD ANAL BUMPS, FEVER); DISRUPTED SLEEP (PAIN FROM THE BLISTER WAS KEEPING PATIENT FROM SLEEPING); This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included candida, and concurrent conditions included latex allergy, alcohol consumption, and non-smoker, and other pre-existing medical conditions included the patient had no history for drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced disrupted sleep (pain from the blister was keeping subject from sleeping). Treatment medications included: paracetamol. On 29-MAY-2021, the subject experienced vicious herpes outbreak (anal discomfort, painful blisters on labia, discoloration/puffy/yellow appearance of anal area that got itchy/burny and painful, had anal bumps, fever). On 01-JUN-2021, the subject experienced lower back pain. On 01-JUN-2021, the subject experienced kidney pain in the kidney area. On 01-JUN-2021, the subject experienced profuse sweating. On 01-JUN-2021, the subject experienced body aches. On 01-JUN-2021, the subject experienced freezing cold. On 02-JUN-2021, treatment medications included: fluconazole, and valaciclovir. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower back pain, kidney pain in the kidney area, profuse sweating, and body aches on 04-JUN-2021, had not recovered from vicious herpes outbreak (anal discomfort, painful blisters on labia, discoloration/puffy/yellow appearance of anal area that got itchy/burny and painful, had anal bumps, fever), and the outcome of disrupted sleep (pain from the blister was keeping patient from sleeping) and freezing cold was not reported. This report was non-serious. This case, involving the same patient is linked to 20210614700.
58 2021-06-10 impaired work ability Over the course of 10 days following the injection I had fever spikes (up to 102), fatigue, loss of ... Read more
Over the course of 10 days following the injection I had fever spikes (up to 102), fatigue, loss of appetite, muscle soreness and joint stiffness (more than normal), chills, sweating, heaviness in chest, diarrhea, I vomitted the day after, but that was just for a period of 4 hours. On the 4th day I woke up with stiffness in my left arm and underarm, and swollen glands. I went to the urgent care on the following morning, but the stiffness and swelling had started to retreat and has since disappeared. Soreness at the injection site for about two weeks after vaccine. It is still a bit tender to the touch, but does not bother me unless rubbed hard. There was also redness and tenderness and some itching at the injection site. I felt poorly enough (the fatigue, mostly), that I was not able to work for 10 days. At about the two week mark I finally had the feeling that I felt good! I occasionally feel fatigued, but have been able to resume normal activities.
58 2021-06-13 feeling abnormal Brain fog, eye floaters and ringing in the ears. Brain fog lasted about a month and a half, eye floa... Read more
Brain fog, eye floaters and ringing in the ears. Brain fog lasted about a month and a half, eye floaters and tinnitus still an ongoing nuisance. I saw my ENT on May 3 but he didn't see anything wrong with my ears.
58 2021-06-17 impaired work ability Sever pain in the lower abdomen. Unable to drive due to pain/ missed two days of work
58 2021-06-20 feeling drunk Right away after having the vaccine I felt dizzy and I told the staff that I was not feeling that we... Read more
Right away after having the vaccine I felt dizzy and I told the staff that I was not feeling that well and they took my blood pressure and it was high and they kept taking it every 10 minutes or so and it kept increasing. After 45 minutes it began to level down and they sent me home but even before getting to the parking lot I started shaking and I was out of breath. They gave me epinephrine and they called 911. They took me to the hospital, and they told me I have an arrhythmia. They did an EKG. They let me go my home. Since that day my blood pressure has been high and my doctor put me on blood pressure medication. The day before having the vaccine I had a physical done and my blood pressure has been always on the low side but now it is still high. Now I am being treated for new symptoms, which are chest pressure accompanied with shortness of breath and dizziness. The dizziness its scary because sometimes I drive and I feel like a drunk person driving which is not right and not safe.
58 2021-06-24 disorientation Immediate reaction, dizziness, ringing in ears, headache, disoriented, taken to ER, was not treated
58 2021-07-11 feeling abnormal, loss of personal independence in daily activities Received Johnson and Johnson vaccine on the 10 th of March, started having flu like symptoms early n... Read more
Received Johnson and Johnson vaccine on the 10 th of March, started having flu like symptoms early next Sunday morning, late Monday night my hands began to swell up and hurt when I was laying down. This got progressively worse and I started having pain when breathing, I called my doctor and was told my symptoms were normal for the vaccine and to go back to bed, and call after a day or so if no changes. The next day I called the advice nurse and was advised to go to the urgent care. I didn?t get any information on why this was happening to me, just a bad reaction to the vaccine, I was prescribed medication to help with my breathing, but the pain in my hands now includes my arms, legs and feet. I take a minimum of 600 mg of Advil liquid gels every 5 hours, I?m pretty miserable and cannot do normal life things.
58 2021-07-11 loss of personal independence in daily activities I had my vaccine on May 18, 2021. Prior to this date I was in good health. I was in remission from... Read more
I had my vaccine on May 18, 2021. Prior to this date I was in good health. I was in remission from Ankylosing Spondylitis and Rheumatoid Arthritis for a 3 year period of time. I was off all meds related to this. I was active and I am not over weight. ( I have HBP and thyroid issues....All controlled). After the vaccine, beginning around May 27, 2021 I started experiencing bi-lateral shoulder pain and my knees began to get stiff. within the next week and after the symptoms got worse and started affecting all major joints. I had a routine appointment with my Rheumatologist on June 21, but I called to been seen sooner because it was becoming difficult to stand, walk and the pain in my shoulders was severe and referred pain down my arms to my elbows. I had an appointment on June 14, 2021 and had a blood test on the 18th. The report came back with the highest numbers that I have ever had for inflammation. There has been a lot of confusion at my doctors office but they are finally getting me approved to go back on biologics. I have been unable to do any of my normal activities and the pain throughout my body is a solid 10 on a 1-10 scale. There isnt any relief currently and I am struggling.
58 2021-07-11 sleep disorder In April I started noticing bright red dots on my legs. The dots have spread to my stomach. In May... Read more
In April I started noticing bright red dots on my legs. The dots have spread to my stomach. In May I started experiencing achy legs when I went to bed, which was grown worse and now sometimes interferes with my sleep.
58 2021-07-21 loss of personal independence in daily activities, sleep disorder The MRI shows an adhesive capsulitis with a degree of synovitis. Severe pain with limited range of ... Read more
The MRI shows an adhesive capsulitis with a degree of synovitis. Severe pain with limited range of motion of the left shoulder. I am unable to dress, shower and tie my hair by myself. I have had to stop all physical activity and i am unable to sleep comfortably without waking up at night with the pain.
58 2021-07-25 impaired work ability extreme pain in neck, shoulder and arm is numb. Cant' work.
59 2021-03-08 feeling abnormal I had Covid in January. I felt fine after 12::30vaccine then awoke at 4:30an .. chills, earache, ho... Read more
I had Covid in January. I felt fine after 12::30vaccine then awoke at 4:30an .. chills, earache, hot neck, extreme tiredness... body aches.. lasted until 6:00pm that day
59 2021-03-09 anxiety Patient fainted in and out three times due to anxiety of needles
59 2021-03-10 feeling abnormal broke out in large red hives felt very poorly
59 2021-03-10 insomnia Flushed and sweaty after 20 minutes. Heart started beating fast and irregular. Went by ambulance to ... Read more
Flushed and sweaty after 20 minutes. Heart started beating fast and irregular. Went by ambulance to ER where given complete smattering of tests, 2 EKG's Chest xrays, Chest CAT scan, blood work and observation. Heart and BP continued to be elevated during stay. PB 168/85 down to 148/74. Heart rate 110 to 85 ish. Discharged from hospital. Bed at 10:15 feeling ok. During the night fever, chills, swollen glands, nausea, severe body aches, headache. fast heart rate, heavy breathing, general malaise, sleeplessness, painful injection site. Took tylenol at 5:00 AM and slept a few hours. Woke at 10 AM with body aches, but heart rate was down to 76 and BP down to 112/74. Continuing the tylenol and wiped out.
59 2021-03-12 irritability, feeling abnormal Immediately Saturday: spacey and throat feels strange; afternoon: body is cold/tired. Sunday: felt g... Read more
Immediately Saturday: spacey and throat feels strange; afternoon: body is cold/tired. Sunday: felt great! lots of energy until during a walk at 3pm started to feel spacey (hands feel weird) and spiked a short term fever. Tired and cold. Monday: tired, bottom of lungs burning like I inhaled campfire smoke for a week straight, stumbling over words. Tues: tired, more burning lungs but sensation moving to mid chest (NOT heartburn), feeling like I needed to cough but nothing in lungs, still tired, still struggling with full sentences, irritable. Weds: felt hot but temp was below normal, lungs burning. Took Covid test (negative), incredibly tired, got the spacey feeling and hands felt weird-lasted 30 mins. Thurs: tired, irritable, left side hurt, started having to clear my throat every 20-30 minutes, cold. Fri: still tired, felt like I needed to cough but didn't reduce the pressure in chest/burnin/aching. Slept 14 hours. Sat: woke up feeling awful. Short of breath, clearing throat all day. Went to urgent clinic. Lab/chest x-ray and EKG all negative. Dr:"Nothing we can do for you. This vaccine is too new and you are likely having a reaction. Come see us if it gets worse." I almost cried. When he had me take 4-6 deep breaths to check my lungs with his stethoscope I almost passed out. Now I'm home stuck on the couch under an electric blanket feeling like crap with no relief in sight. Hoping no one else has this ever.
59 2021-03-13 disturbance in attention Received the shot at a drive-thru event and then was directed to park in a lot with an EMT squad on ... Read more
Received the shot at a drive-thru event and then was directed to park in a lot with an EMT squad on standby to wait in my car case of adverse reaction. Due to a prior reaction to vicodin I was asked to wait 30 minutes. I began reading on my phone, and after 10 minutes passed I noticed I was becoming very short of breath and was having difficulty mentally focusing on what I was reading. As this was not an expected reaction, I decided to wait a bit before honking my horn to request assistance. After 5-7 minutes, the feeling went away and my breathing and concentration returned to normal. I waited an additional 30 minutes just in case, but have been fine for the past 6 hours without even a sore arm. Had anything been in bloom in the surrounding area, I would have presumed rolling down my window allowed me to breathe pollen that triggered my allergies, but it is still too early in the spring for that. Weather was 53 F, sunny and dry.
59 2021-03-15 feeling abnormal Fever of 100 degrees, naursea, headache, soreness at injection site and all over body, pain behind e... Read more
Fever of 100 degrees, naursea, headache, soreness at injection site and all over body, pain behind eyes and brain fog
59 2021-03-17 restlessness, hallucination, feeling drunk Shortly after I got home, within the hour; My husband told me when I got home I started acting lo... Read more
Shortly after I got home, within the hour; My husband told me when I got home I started acting loopy. by 5pm - it was if I was drunk, halucinating and talking jibberish. By 6pm I passed out but restless - no fever but knocked me out for over 10.5 hours (I normally sleep 6 hrs a night). Woke up the next morning with no other reaction but a sore arm.
59 2021-03-21 feeling abnormal Normal initial stick pain, but immediately intensified and went down my arm. I got up and walked b... Read more
Normal initial stick pain, but immediately intensified and went down my arm. I got up and walked back over to my waiting chair and my Husband got up and received his vaccine. Besides the pain in my left arm, I started feeling weird tingling sensations and spaced out. When my Husband sat back down next to me, my stomach had a burning sensation and I felt slightly nauseated. Then I felt like I was about to faint. My Husband and the Staff kept me from falling, The Staff brought ice packs to put on my neck. They said I turned white and profusely sweat. I don't remember all of it, my Husband filled in the blanks. I started feeling better and we left @4:30.
59 2021-03-21 insomnia OMG! I had covid and this was worse!!!! I got the vaccine at 9am. around 4pm that afternoon i sta... Read more
OMG! I had covid and this was worse!!!! I got the vaccine at 9am. around 4pm that afternoon i started feeling sick. by 7:30pm I was in bed thinking I was going die! By midnight, I got up and tried to walk to the stairs but i was to weak to walk. I could not sleep. I was up for 36 hours! I was nauseous, dizzy, weak, exhausted. Every inch of my body had pain!!! I was tingling all over. I had the chills until midnight. My heart would race and then stop... then race again... I was having difficulty breathing! I tried standing up but I couldn't. I would have driven myself to the emergency room but I couldn't walk. by noon the next day, my heart regulated, I was able to breath easier. I was still exhausted and full of pain and tingling. Today, I still have some pain, but no tingling.
59 2021-04-02 insomnia After getting the shot that afternoon at 3:00 a.m. I woke up in a flu state of chills, fever, heada... Read more
After getting the shot that afternoon at 3:00 a.m. I woke up in a flu state of chills, fever, headache, achiness. The headache lasted a solid 24 hours almost to the point of vomiting even while taking 4 tylenol every 4 hours then my stomach was empty so I ate a few crackers, but that next night it was hard to go to sleep. At night I suddently realized my forehead seemed larger than normal! It really felt bigger and swollen so I massaged it and could feel my layers of skin/dermis moving around I beleived it was the serum from the shot from all the prone position I was in for so long laying in bed. Thankfully the next day all syptoms went away gradually and by the third day I was back to normal....at least I THINK my forehead has returned to normal so far as I can see or feel.
59 2021-04-03 irritability, disorientation Body aches, joint pain, headache, fever of 102, lethargy, disoriented, cranky. I went back to sleep,... Read more
Body aches, joint pain, headache, fever of 102, lethargy, disoriented, cranky. I went back to sleep, drank a lot of water and took Tylenol. Felt ill until March 6th.
59 2021-04-04 feeling abnormal MUSCLE ACHE; FEVER; HEADACHE; FEELING OUT OF IT; This spontaneous report received from a patient con... Read more
MUSCLE ACHE; FEVER; HEADACHE; FEELING OUT OF IT; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history 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: 1808978 expiry date: unknown) dose was not reported, administered on 23-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced feeling out of it. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and headache on 25-MAR-2021 and feeling out of it on 24-MAR-2021, and had not recovered from muscle ache. This report was non-serious. Additional information was received from the patient on 25-Mar-2021. The following information was updated and incorporated into case narrative: Additional event added; outcome updated.
59 2021-04-08 feeling abnormal Immediate pain in the left arm below the injection site. Lump in the arm, below the injection side ... Read more
Immediate pain in the left arm below the injection site. Lump in the arm, below the injection side (3 inches below injection site). Pain into my neck and stiff neck immediately. Extremely elevated blood pressure (the next day) (173/103) My usual BP is around 118/75. Fuzzy head. Not dizzy, just fuzzy.
59 2021-04-08 feeling abnormal About 6 hours after receiving the vaccine I started getting a headache and felt chills. I was on my ... Read more
About 6 hours after receiving the vaccine I started getting a headache and felt chills. I was on my way to a hotel before leaving for a flight the next morning and was driving. When I stopped driving and attempted to exit my car, I experienced dizziness and stroke like symptoms. My legs would not hold me up and I felt as if I would pass out in the road. I held on to the car for several minutes until the feeling abated somewhat. Then I made my way unsteadily into the hotel building and had to sit down for several minutes. My heart was beating rapidly and I felt strange so I took one of my nitroglycerin and also took an extra 12.5 mg Coreg. After being taken to my room, I laid on the bed and continued to feel weak, lightheaded and became very nauseous. I got out my pulse oximeter and my pulse was 95. I took another Coreg and it seemed to slow it down for a little while but again it started racing and I continued to be nauseous and broke out in sweats and my pulse got back up to 100. I took another nitroglycerin and a baby aspirin in case I was having a heart attack. Then I took another Coreg. My pulse rate finally slowed down. I slept intermittently until going to the airport at 5 a.m. I still felt weak and nauseous and very tired.
59 2021-04-08 insomnia Headache, diarrhea, fatigue followed by sleeplessness
59 2021-04-08 insomnia 6 hrs post-vax: muscle aches/headache/weak 9 -20 hrs post-vax: muscle aches/fever/extreme headache/w... Read more
6 hrs post-vax: muscle aches/headache/weak 9 -20 hrs post-vax: muscle aches/fever/extreme headache/weak/sleepless 9-44 hrs post vax: fever/weak
59 2021-04-09 loss of personal independence in daily activities, feeling abnormal FYI, Approx. 1:00 AM woke up with high fever and could hardly move. Whole body hurt very bad. Shakin... Read more
FYI, Approx. 1:00 AM woke up with high fever and could hardly move. Whole body hurt very bad. Shaking from chills . Bad headache. Very thirsty. Definitely flu like symptoms, but worse. Turned electric blanket on, very cold, and just tried to sleep. Only getting out of bed to use restroom and more water. Straight back to bed. I did not vomit, nor did I have diarrhea. Could not stand it any longer Saturday PM approx. 10:00 took two Advil. Woke up Sunday 8:00 AM felt much better. Still had slight symptoms, but I could do chores. My brother kept checking on me. Came to let my dog out. My brother wanted me to call 911 but I can not afford that. It was holiday weekend, I wanted to die, didn?t care. I get the flu shot every year. I have a high pain tolerance, very rare for me to be sick. If I needed a second dose. I would NOT get it. If I would have known it was that bad, I would not have signed up to get it. Thank you.
59 2021-04-10 feeling abnormal I had been drinking the night before. I woke up at 8:00 am with a blazing headache. (I've been havin... Read more
I had been drinking the night before. I woke up at 8:00 am with a blazing headache. (I've been having a lot of headaches lately.) My coffee didn't take right. By 4:00 pm, I wasn't feeling right. Became flushed, an elevated temperature of 99 degrees, with flu-like symptoms. I was terribly dehydrated. When I arrived home, I made a sandwich and 12 oz of seltzer water.
59 2021-04-11 abnormal dreams, sleep disorder Returned home around 4:30 PM from vaccine and felt a bit tired & not hungry for dinner. Iced my arm ... Read more
Returned home around 4:30 PM from vaccine and felt a bit tired & not hungry for dinner. Iced my arm and took 2 Tylenol as my head began hurting. I went to bed at 9:00 PM and woke up around 1:00 AM with an excruciating headache and felt nauseous I took 2 more Tylenol, but could not fall back asleep. I felt very nauseous and was unable to go back to sleep. Oddly, I was sitting up wide awake and for a period of about 30 minutes, I began seeing brightly colored images that looked like they were floating in front of me. It was extremely odd as my eyes were open and I was awake. I finally fell back asleep around 5:30 AM and had horrifying vivid nightmares. When I woke up around 8:00 AM my headache was still there and I felt somewhat nauseous but not as bad as during the night. My headache continued through the day on Saturday and I continued to take Tylenol about every 6 hours. I attempted to go to bed around 9 PM when I experienced horrible chest pain that radiated through my chest and into the left side of my throat. This was frightening because the pain did not let up for 7 to 8 hours, even after taking a Tagamet. I've never suffered from heartburn previously other than when I was 8 months pregnant with twins. I was lucky to have any medication at home and that was only because my husband suffered from heartburn frequently. I finally fell asleep around 6:00 am for just a few hours and woke up feeling tired, but no headache or chest pain. Other than feeling tired, the symptoms appeared to all be gone. On a positive note, my arm never became sore!
59 2021-04-11 feeling abnormal Within 25-30 minutes I felt a very sore area on my right side just up from the bottom of my rib cage... Read more
Within 25-30 minutes I felt a very sore area on my right side just up from the bottom of my rib cage. I reached for it and I could touch the exact spot with one finger. It was almost like if you had run into the corner of a table really badly. It came on fast. Within less then 10 min later it felt like a small balloon was getting inflated with the sore spot right in the center expanding. The soreness was not that big just this strange feeling like that area was expanding just like a balloon. I would say it was about an 8" circle. This strange feeling and soreness lasted all evening. It even woke me up in the middle of the night. It was slowly gone by the end of the next day. The next day I only felt a little tired and not well. Nothing major. I have not heard of anything like this. I have no doubt this was from the shot. I had only gotten in my car to drive home. As soon as I pulled in my garage it came on very suddenly. No other reason for this.
59 2021-04-11 feeling abnormal Patient reported an extreme burning sensation at time of injection. She described it as like "lighte... Read more
Patient reported an extreme burning sensation at time of injection. She described it as like "lightening", both electrical and heat that radiated from the injection site to her fingertips. Pain started with administration of vaccine. She felt "crumby" on Saturday. Today she no longer feels the burning sensation, but has a 1/2" ring around injection site that is swollen and bruised. She also reported feeling a knot under her skin. She did not seek medical attention and was quite embarrassed that she cried after her injection.
59 2021-04-11 insomnia Body aches; Did not sleep well; feeling woozy; BURNING AT INJECTION SITE WHICH STUNG; fever; Headach... Read more
Body aches; Did not sleep well; feeling woozy; BURNING AT INJECTION SITE WHICH STUNG; fever; Headache; very tired; Joint ache; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included arthritis, pre-diabetic, alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies, the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 04ZAZ1A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 11:30 on right arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced joint ache. On 06-APR-2021, the patient experienced body aches. On 06-APR-2021, the patient experienced did not sleep well. On 06-APR-2021, the patient experienced feeling woozy. On 06-APR-2021, the patient experienced burning at injection site which stung. On 06-APR-2021, the patient experienced fever. On 06-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning at injection site which stung on 06-APR-2021, had not recovered from fever, body aches, headache, and did not sleep well, and the outcome of joint ache, feeling woozy and very tired was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
59 2021-04-12 feeling abnormal Having had Covid19 in November 2020, I recalled the symptoms experienced to be the same. ONn 4/7 I ... Read more
Having had Covid19 in November 2020, I recalled the symptoms experienced to be the same. ONn 4/7 I experienced bilateral flank pain, fever and aches. 4/8 I experienced nausea, exhaustion, and dizziness 4/9 shortness of breath with lingering dizziness. I still feel brain fog and dizziness.
59 2021-04-12 feeling abnormal Eye pressure, blurry vision. Severe muscle aches, joint & body pain. Uncontrollable shaking. Terri... Read more
Eye pressure, blurry vision. Severe muscle aches, joint & body pain. Uncontrollable shaking. Terrible cold chills. Low grade fever. Extremely foggy brain. Extreme weakness. Above symptoms lasted for 36 hours. 5 days post vac still having cold chills fatigue sleeping all the time and brain fog.
59 2021-04-12 hallucination, delirium, insomnia, anxiety Extreme nausia & vomiting; insomnia; shaking (adrenaline); extreme anxiety; fever conditions: chill... Read more
Extreme nausia & vomiting; insomnia; shaking (adrenaline); extreme anxiety; fever conditions: chills; shortness of breath; muscle contractions; hallucinations; delrium; racing heartbeat; ?burning? feeling in muscles and bones. Loss of appetite. Symptoms extreme for first 48 hours - tapering off in days to follow; still some weak symptoms on day 7.
59 2021-04-13 delirium Sore arm, fatigued at first. Went to bed at 9pm, woke up around 11pm with fever, chills, body aches... Read more
Sore arm, fatigued at first. Went to bed at 9pm, woke up around 11pm with fever, chills, body aches (pain level: 7), delirious, slight rapid heart rate. This lasted for about 12 hours before tapering off over the next 48 hours.
59 2021-04-13 feeling abnormal Dizziness, Chills, Headache, Foggy thinking
59 2021-04-13 feeling abnormal Fever, chills, severe headache and fatigue. It was exhausting opening my eyes. Even after two week... Read more
Fever, chills, severe headache and fatigue. It was exhausting opening my eyes. Even after two weeks I would try to convince myself to pull over in my truck and take a nap! I am still extremely tired. My Heart was pounding, throbbing in ?my ears?. I could hear it so loudly . 2weeks of brain fog ? could not stay on task (due to dehydration?) I still can?t drink enough water and Gatorade to satisfy my thirst. Extreme Weakness, Nausea , especially when I would try to eat . Increased thirst/ urination . My ankles and feet swelled . My friend who is a pharmacist instructed me to take a Tylenol but I couldn?t even get out of bed to get one to take. ? any movement made my head swim and I felt like I would throw up. I slept most of that day and also the next day
59 2021-04-13 feeling abnormal Okay left voicemail with cdc and wrote this email I?m not sure how to report symptoms I had after t... Read more
Okay left voicemail with cdc and wrote this email I?m not sure how to report symptoms I had after taking the jannsen vaccine March 6. Because of the new reports I thought it may be helpful. To begin in late nov 2020 my roommate was confirmed covid. I was exposed tremendously and never tested because if I did not get it from him, I was immune. He was very ill. He talked of getting head pains as well. I got sick for a weekend but not super ill. Tired, headache and head pains in one spot. After my vaccine I felt the same illness but ran a fever with the shot. My main recognition was I had the exact same head pains, same exact spot I had when I?m sure I had Covid. 1 unusual symptom I had after the shot was I felt like I had a 4? metal plate wrapped around my arm where I got the shot for a half day. Hope this helps.
59 2021-04-14 feeling abnormal Began to feel poorly about 7 hours post injection. Basically like I was getting the flu but the ons... Read more
Began to feel poorly about 7 hours post injection. Basically like I was getting the flu but the onset was very fast. Within an hour I had severe chills, body aches, headache and shivering. This lasted for about 6 - 8 hours and then began to subside. I never registered a fever. The following day I just felt kinda blah, without a lot of energy but all symptoms were gone.
59 2021-04-14 excessive sleepiness Started off as muscle pain during the day, with severe headache. Evening during sleep, extreme muscl... Read more
Started off as muscle pain during the day, with severe headache. Evening during sleep, extreme muscle pain. Woke up the next morning with severe fatigue. Slept all day and couldn't get out of bed. Slept all through the night. Following day was fatigue all day. Mild fatigue the following day.
59 2021-04-14 sleep disorder for about 7 hours - fever, chills, body aches for about 12 hours - head ache and slight body aches ... Read more
for about 7 hours - fever, chills, body aches for about 12 hours - head ache and slight body aches Fatigue for about 24 hours leg pain for 4 days - bad for 2 days - making sleep difficult - sore all day but very painful at night. Day 3 was better as was day 4. they were gone by day 5
59 2021-04-14 sleep disorder Janssen COVID-19 Vaccine EUA Mild-Moderate ringing in the ears began on 4/7/21 at about 2:00 am (not... Read more
Janssen COVID-19 Vaccine EUA Mild-Moderate ringing in the ears began on 4/7/21 at about 2:00 am (not quite 2 days after injection). Ringing is mostly constant and tolerable and doesn't prevent day to day activities, although can make it harder to focus at work. Does affect my ablitiy to fall back to sleep once I've woken (at say 4 AM). Seems to be worse in early morning, when it is typically quiet. Haven't seeked medical attention so far.
59 2021-04-15 feeling abnormal ELEVATED BLOOD PRESSURE; NECK STIFFNESS; FUZZY HEAD; BUMP BELOW THE INJECTION SITE; PAIN IN ARM; Thi... Read more
ELEVATED BLOOD PRESSURE; NECK STIFFNESS; FUZZY HEAD; BUMP BELOW THE INJECTION SITE; PAIN IN ARM; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported. 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: 042A21A expiry: UNKNOWN) dose was not reported,1 total administered on 08-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the patient felt pain in the arm, stiffness in the neck 30 minutes after receiving the vaccine. She had a bump not where she got the shot but below the injection site and also had fuzzy head. She had elevated blood pressure (173/103) and her normal blood pressure was (118/75). It was reported that all the symptoms were still persisting. Laboratory data included: Blood pressure (NR: not provided) 173/103. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in arm, neck stiffness, bump below the injection site, fuzzy head, and elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420595-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Elevated blood pressure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
59 2021-04-15 feeling abnormal MALAISE; TIREDNESS; NAUSEA; BOWEL MOVEMENT IRREGULARITY IN TEXTURE; CHILLS; INTENSE HEADACHE; FELT R... Read more
MALAISE; TIREDNESS; NAUSEA; BOWEL MOVEMENT IRREGULARITY IN TEXTURE; CHILLS; INTENSE HEADACHE; FELT REALLY BAD; 3 OR 4 BOWEL MOVEMENTS EACH OF DAY; SOFTER TEXTURE THAN NORMAL STOOL; This spontaneous report received from a patient concerned a 59 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced 3 or 4 bowel movements each of day. On APR-2021, the subject experienced softer texture than normal stool. On 08-APR-2021, the subject experienced felt really bad. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced intense headache. On 09-APR-2021, the subject experienced bowel movement irregularity in texture. On 11-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced malaise. On 12-APR-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and intense headache on 09-APR-2021, and had not recovered from bowel movement irregularity in texture, nausea, malaise, tiredness, felt really bad, 3 or 4 bowel movements each of day, and softer texture than normal stool. This report was non-serious.
59 2021-04-16 excessive sleepiness, sleep disorder Started 2 days after shot (4/13): Extreme abdominal pain with diarrhea & headache through the night ... Read more
Started 2 days after shot (4/13): Extreme abdominal pain with diarrhea & headache through the night starting about 7:30pm. Never had anything like that & almost went to hospital but could not leave the bathroom to go. just laid on bathroom floor while my husband put cold washcloths on my head. Day 3 after after shot: on & off Fever, fatigue & slight headache throughout the day. Day 4 after shot: fever throughout day with slight Headache until about 9 pm, then extreme migraine & fever throughout the night with no sleep. Day 5 after shot: Extreme migraine headache, fever & loss of appetite. resting in bed since yesterday. doing survey so dont know on-going.
59 2021-04-17 feeling abnormal, agitation, mental status changes, mental impairment, delirium, confusional state At 23 hours post Johnson and Johnson vaccination, I began to have a 10/10 headache (which was the wo... Read more
At 23 hours post Johnson and Johnson vaccination, I began to have a 10/10 headache (which was the worst headache of my life), nausea and severe aura. I then became extremely confused and was taken to the emergency department by my husband. The following was reported to me the next day when I awoke in the ICU at Hospital: within an hour of arriving at the ED, I exhibited a progressive hyperactive delirium, agitation, slurred speech (word salad), combativeness, confabulation, word finding difficulties and an inability to follow commands. The neurologist in the ED said that she was seeing this adverse vaccination side effect in other patients at the 24-hour period. I received Haldol, Zyprexa, and Ativan to control the delirium and received a head CT angiogram in the ED, which was normal. I was transferred by ambulance to the main hospital due to acute metabolic encephalopathy/altered mental status. I was admitted to the neurological unit whereby I became critically hypotensive (60s over 30s) and was transferred to the ICU due to persistent hypotension unresponsive to IV normal saline. I was then transferred and admitted to the ICU and was given continued IV fluid resuscitation and Levophed vasopressor. I was eventually weaned from vasopressors and was discharged back home in three days exhausted, bruised, fatigued and with continuous clouded mentation. I have been told by all of the doctors that this was a vaccination side-effect, which caused cerebritis. I was subsequently treated as an outpatient at Hospital for intractable aura with IV Valporic Acid, Magnesium, and Lasix infusion on April 1, 2021.
59 2021-04-18 feeling abnormal, anxiety PATIENT STATES THAT 2-3 WEEKS POST RECEIPT OF VACCINATION SHE BEGAN HAVING SEVERE NECH PAIN ON THE R... Read more
PATIENT STATES THAT 2-3 WEEKS POST RECEIPT OF VACCINATION SHE BEGAN HAVING SEVERE NECH PAIN ON THE RIGHT SIDE (SAME SIDE OF BODY AS VACCINATION), BRAIN FOG, AND AN UNUSUAL TASTE IN MOUTH. SHE IS STILL EXPERIENCING THESE SYMPTOMS. SHE ALSO DEVELOPED DIFFICULTY BREATHING AND HAS BEEN PRESCRIBED SPIRIVIA RESPIMAT. (SHE WAS EVALUATED BY HER PHYSICIAN FOR THIS) SHE HAD SEVERE ANXIETY REQUIRING EMT EVALUATION ON APRIL 15, 2021.
59 2021-04-18 sleep disorder, feeling abnormal March 27 woke with severe headache lasted 24 hours. Monday tops of my legs hurt so much it was hard ... Read more
March 27 woke with severe headache lasted 24 hours. Monday tops of my legs hurt so much it was hard to lower myself to sit. Lasted till Thursday. April 11 woken by severe headache, couldn't see clearly. Very dizzy blurred vision threw up went to er was admitted. Had. Ultrasound, CT scan, EKG, MRI. Left hospital Monday evening, still dizzy till Thursday. Head still doesn't feel right.
59 2021-04-19 anxiety On 3/17/21 patient returned to clinic complaining of sudden onset of dizziness, weakness, shaking, s... Read more
On 3/17/21 patient returned to clinic complaining of sudden onset of dizziness, weakness, shaking, some SOB and anxiety. Patient reports this started suddenly at noon. She reports associated lightheadedness and difficulty with focusing her vision. She reports "feeling like I am going to pass out and not wake up". Denies nausea, vomiting, head injury, fall, slurred speech, confusion, or chest pain. Last meal was previous night, has not eaten that day. She denies recent alcohol use, did admit to smoking marijuana prior to episode starting. She did have the Johnson&Johnson Covid vaccine on 3/12/21, only has had a sore left arm, denies other side effects. Patient was sent to the emergency department via ambulance for further evaluation. Work up at the emergency department showed bilateral pulmonary embolisms.
59 2021-04-21 feeling abnormal COUGH; CONGESTION; FEVER; TINGLING AT INJECTION SITE; SORE ARM; SLIGHT HEADACHE; BRAIN FOG; HEAVY HE... Read more
COUGH; CONGESTION; FEVER; TINGLING AT INJECTION SITE; SORE ARM; SLIGHT HEADACHE; BRAIN FOG; HEAVY HEAD; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included coronary heart disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced tingling at injection site. On 01-APR-2021, the subject experienced brain fog. On 01-APR-2021, the subject experienced heavy head. On 01-APR-2021, the subject experienced sore arm. On 01-APR-2021, the subject experienced slight headache. Laboratory data included: Body temperature (NR: not provided) 101 F. On 01-APR-2021 19:00, the subject experienced fever. On 04-APR-2021, the subject experienced cough. On 04-APR-2021, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling at injection site, brain fog, heavy head, and slight headache on 01-APR-2021, cough, and congestion on 05-APR-2021, and fever on 02-APR-2021, and the outcome of sore arm was not reported. This report was non-serious.
59 2021-04-22 feeling abnormal, insomnia I got the JNJ vaccine on Wed 4/7/21 (a wk before FDA paused that covid vaccine). Initial response w... Read more
I got the JNJ vaccine on Wed 4/7/21 (a wk before FDA paused that covid vaccine). Initial response was Extreme Fatigue, but starting 11:45 pm on 4/18/21, I suffered headache, chest pain, short of breath. I could not sleep at all till 4/19/21 PM after asking my kids to pray for me. In case it's just heartburn, I took TUMS at 8:15 pm on 4/19/21 . Headache, short of breath comes and goes, but the chest pain persists, and I develop a hot flash. I never took birth control pills, but my OB/GYN prescribed daily Estrogen (to prevent osteoporosis) and every 3 month, Progesterone for 10 days (to prevent breast cancer). Estrogen & Progesterone happen to be the birth control pills' composition. On 4/17/21, I finished my 10 days Progesterone regime. I discontinued the Estrogen supplement on 4/19/21 or 4/20/21, now (4/23/21 1:20 am) no more chest pain, but still feel fatigue, feverish with a hazy/foggy head (not really a headache). I have a suggestion for JNJ, FDA, CDC on JNJ vaccine warning label. If indeed those 6 women are all on birth control pills which are composed of synthetic estrogen and progesterone, then the warning label should also warn people who take these hormone supplements, instead of just an age range.
59 2021-04-22 feeling abnormal LEGS SWOLLEN FROM THE KNEE DOWN; ARMS FEEL KIND OF WEIRD; FEELING OF LEGS KIND OF DETACHING FROM THE... Read more
LEGS SWOLLEN FROM THE KNEE DOWN; ARMS FEEL KIND OF WEIRD; FEELING OF LEGS KIND OF DETACHING FROM THE BODY; FEELING LIKE WHEN YOU PRESS YOUR FEET AND IT'S DIFFERENT, NOT PUFFY; ARMS FEEL SWOLLEN; TINGLING IN RIGHT ARM; WHEN GOING TO SLEEP LEGS FEEL VERY HEAVY/LEGS FROM THIGHS TO FEET, ENTIRE LEG, FEELS HEAVY JUST BEFORE FALLING ASLEEP; VERY TIRED; A LITTLE BIT OF HEADACHE; FLAVOR IN HER MOUTH LIKE ORANGE OR CHERRY; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was not reported and height was 64 inches. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies and medical conditions. the patient did not take medication regularly. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced flavor in her mouth like orange or cherry. On 08-APR-2021, the subject experienced very tired. On 08-APR-2021, the subject experienced a little bit of headache. On an unspecified date, the subject experienced legs swollen from the knee down, arms feel kind of weird, feeling of legs kind of detaching from the body, feeling like when you press your feet and it's different, not puffy, arms feel swollen, tingling in right arm, and when going to sleep legs feel very heavy/legs from thighs to feet, entire leg, feels heavy just before falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flavor in her mouth like orange or cherry on 08-APR-2021, and very tired, and a little bit of headache on 09-APR-2021, and had not recovered from legs swollen from the knee down, arms feel kind of weird, when going to sleep legs feel very heavy/legs from thighs to feet, entire leg, feels heavy just before falling asleep, feeling of legs kind of detaching from the body, arms feel swollen, tingling in right arm, and feeling like when you press your feet and it's different, not puffy. This report was non-serious.
59 2021-04-22 feeling abnormal DIZZY/LIGHTHEADED; RUBBER LEGS; HEART RACING; LOOKED WHITE; NEAR SYNCOPAL EPISODE/NEARLY PASSED OUT;... Read more
DIZZY/LIGHTHEADED; RUBBER LEGS; HEART RACING; LOOKED WHITE; NEAR SYNCOPAL EPISODE/NEARLY PASSED OUT; INTERMITTENTLY FEELING HOT; FLUSH; FOGGY; NOT FEELING WELL; BLURRY VISION; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced blurry vision. On 01-APR-2021, the subject experienced intermittently feeling hot. On 01-APR-2021, the subject experienced flush. On 01-APR-2021, the subject experienced foggy. On 01-APR-2021, the subject experienced not feeling well. On 02-APR-2021, the subject experienced near syncopal episode/nearly passed out. On 02-APR-2021, the subject experienced heart racing. On 02-APR-2021, the subject experienced looked white. On 03-APR-2021, the subject experienced dizzy/lightheaded. On 03-APR-2021, the subject experienced rubber legs. On 05-APR-2021, Laboratory data included: ECG (NR: not provided) UNKNOWN (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from near syncopal episode/nearly passed out on 02-APR-2021, heart racing on 04-APR-2021, and blurry vision on 30-MAR-2021, was recovering from intermittently feeling hot, flush, foggy, not feeling well, dizzy/lightheaded, and rubber legs, and the outcome of looked white 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.
59 2021-04-22 excessive sleepiness SLEEPING ALOT; RACING HEART; ABDOMINAL PAIN; STILL NOT GETTING HER ENERGY BACK/FEELING BETTER; DIARR... Read more
SLEEPING ALOT; RACING HEART; ABDOMINAL PAIN; STILL NOT GETTING HER ENERGY BACK/FEELING BETTER; DIARRHEA; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid irradiated, and concurrent conditions included aneurysm, and hyperthyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sleeping alot, racing heart, abdominal pain, still not getting her energy back/feeling better, diarrhea, fatigue, and fever. Laboratory data (dates unspecified) included: Investigation (NR: not provided) NOTHING WAS FOUND, and X-ray (NR: not provided) NOTHING WAS FOUND. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sleeping alot, and still not getting her energy back/feeling better, and the outcome of fever, diarrhea, abdominal pain, racing heart and fatigue was not reported. This report was non-serious.
59 2021-04-23 loss of personal independence in daily activities, impaired work ability On 04-12-2021 at night, I noticed blood in my urine. I saw my PCP on 04-13-2021. On 04-14-2021, I ag... Read more
On 04-12-2021 at night, I noticed blood in my urine. I saw my PCP on 04-13-2021. On 04-14-2021, I again had blood in my urine. I called my urologist and was seen on 04-14-2021. My blood platelets were extremely low. I was then referred to see a hematologist who sent me to the hospital. I was admitted at Hospital where they performed lab work, MRI's and CT scans. I stayed two days at the hospital. The hematologist who saw me said I have thrombocytopenia. Other tests were also performed and they checked me for stroke and I did not have a stroke. I am concerned due to my thrombocytopenia, if I get cut, I will bleed a lot and this is interfering with my job and to carry out my daily functions. I am still not recovered and my platelets are low. I still have to follow-up with my PCP and my hematologist has to check my bone marrow as the next step of treatment.
59 2021-04-25 feeling abnormal Shot arm swelling, pain and bruise, fatigue and loopiness for 5 days, then better for about 5 days. ... Read more
Shot arm swelling, pain and bruise, fatigue and loopiness for 5 days, then better for about 5 days. 10 days in upper body stestemic response with muscle twitching, pain and swelling. Shot arm and other arm pain, neck pain and pectoral muscle pain. Went to Dr who diagnosed on the 15th. He ran blood work which was normal other than cholesterol 220, ldl and hdl high and glucose was 102. Then twitching moves to lower limbs with lymph swelling behind knees at 21 days in. Went back to Dr. On the 22nd. He considered it still an inflammatory response. Now at 26 days out, still have some lower limb twitching and upper body muscle spams have begun again mainly on right hand side non shot arm.
59 2021-04-25 feeling abnormal Very fatigued for 4 days+, joint aches for approx. 7 days, headache on and off for 4 days, Brain fog... Read more
Very fatigued for 4 days+, joint aches for approx. 7 days, headache on and off for 4 days, Brain fog on and off for 3 weeks or more. Arm soreness. Lethargic on and off for a week or more.
59 2021-04-26 feeling abnormal BOTH KNEES SWOLLEN AND UNCOMFORTABLE; KNEES WARM TO TOUCH; HEADACHE; ICKY; WEAK; TIRED; LOW GRADE FE... Read more
BOTH KNEES SWOLLEN AND UNCOMFORTABLE; KNEES WARM TO TOUCH; HEADACHE; ICKY; WEAK; TIRED; LOW GRADE FEVER; PAIN; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included ankle replacement, and knee replacement, and concurrent conditions included penicillin allergy, nonsmoker, and non alcohol user, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with chloramphenicol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, 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 pain. Treatment medications included: paracetamol. On 10-APR-2021, the subject experienced icky. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced weak. On 10-APR-2021, the subject experienced tired. On 10-APR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) over 100 F. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 20-APR-2021, the subject experienced both knees swollen and uncomfortable. On 20-APR-2021, the subject experienced knees warm to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from icky, headache, weak, and tired on 18-APR-2021, and low grade fever on 11-APR-2021, had not recovered from both knees swollen and uncomfortable, and the outcome of knees warm to touch and pain was not reported. This report was non-serious.
59 2021-04-27 anxiety Experienced an unusual headache on about April 8th. It felt like it was behind my left eye, and in ... Read more
Experienced an unusual headache on about April 8th. It felt like it was behind my left eye, and in front of my left ear. Pain subsided in about an hour after resting. On April 28th, I experienced vaginal bleeding. I awoke to a dry cough and felt the leakage. The blood was bright red and I'd estimate 4-6 Tablespoons. I feel light-headed, concerned, but otherwise fine.
59 2021-04-28 abnormal dreams, feeling abnormal VOMITING; DIARRHEA; THROWING UP BILE; HEADACHE; EQUILIBRIUM OFF; RINGING IN EARS; TREMORS IN LEGS AN... Read more
VOMITING; DIARRHEA; THROWING UP BILE; HEADACHE; EQUILIBRIUM OFF; RINGING IN EARS; TREMORS IN LEGS AND ARMS; WEIRD DREAMS; NAUSEA; HIGH BLOOD PRESSURE; DID NOT EAT MUCH; FELT LIKE GOING TO PASS OUT; LOOKED WHITE; FELT OF HAVING HEART ATTACK; SWEATING; BARELY GET OUT AFTER SHOWER; NOT FELT WELL; NIGHT SWEATING; LOST 16 POUNDS; HARD TO BREATH; RACING HEART; FELT LIKE PINS AND NEEDLES (TINGLING) IN MOUTH; BRUISING EVERYWHERE; FELL OUT OF BED; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included hemorrhoid surgery, and concurrent conditions included blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On10-APR-2021, the same day after vaccination the patient was doing fine. On 11-APR-2021, the next day after vaccination started to not feel so great and got worse as the day went on. The patient could barely reach her husband after shower and felt like she was going to pass out, heart racing, felt like pins and needles (tingling) in mouth and head felt very swollen, hard to breath, had a headache, night sweating (2-3 times per night) and weight loss (lost 16 pounds). The patient's husband called the emergency services almost 24 hours post vaccination. The patient did not feel herself and was sweating. The patient's heart was checked and was normal. The patient looked pale but decided to stay home. The same night remained on and off and patient felt of having a heart attack and her neck felt funny. On 12-APR-2021, the patient did not felt well and did not eat much, but was not as bad as the previous day even though it would come every 3-4 hours. On 13-APR-2021 at 03:00 AM in the morning, the patient experienced vomiting, and throwing up bile, diarrhea until 08:30 or 09:00 AM. On the same day the patient went to the hospital and had to spend most of the time in out-patients section with ongoing vomiting. The patient administered Zofran (ondansetron) and then experienced a worsening headache. The patient experienced high blood pressure on the same day. The patient's laboratory data included blood test and computerized tomogram (CT) brain scan without contrast which was normal and was given intravenous morphine. The patient was sent home with prescription for Zofran (ondansetron) 4 milligram and Butalbutal/acetamin/caffeine tablets and came home on the same evening by 4/5 PM. The patient experienced on and off headache and fell asleep at 03:00 AM and on 14-APR-2021 she woke up with diarrhea and started to experience nausea and vomiting. The patient's diarrhea resolved on 14-APR-2021 or 15 APR-2021, but she her nausea persisted. On an unspecified date in APR-2021, the patient experienced bruising everywhere, ran into wall one night and fell out of bed. On 15-APR-2021, the patient experienced tremors in legs (currently worsening) and arms (new onset) and had weird dreams. On 22-APR-2021, the patient experienced equilibrium off and ringing in ears and her blood pressure as normal. On 23-APR-2021, the patient again experienced ringing in ears. It was reported that, the patient did not feel well for 14 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throwing up bile, and diarrhea on APR-2021, vomiting, and high blood pressure on 22-APR-2021, hard to breath, and felt like pins and needles (tingling) in mouth on 11-APR-2021, racing heart on 15-APR-2021, lost 16 pounds on 23-APR-2021, and equilibrium off on 24-APR-2021, was recovering from headache, nausea, and ringing in ears, had not recovered from tremors in legs and arms, night sweating, weird dreams, bruising everywhere, and sweating, and the outcome of barely get out after shower, not felt well, did not eat much, felt like going to pass out, looked white, felt of having heart attack and fell out of bed was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210449836- COVID-19 VACCINE Ad26.COV2.S-Throwing up bile, Vomiting, Diarrhea, Headache. 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).
59 2021-04-28 feeling abnormal Patient called us today at approximately 1:20pm to let us know after receiving the vaccine on stated... Read more
Patient called us today at approximately 1:20pm to let us know after receiving the vaccine on stated date, she felt off all afternoon and had no appetite. Her stomach was upset and she wasn't right. That evening her friend drove her to the ER and she was hospitalized for 5 days. She was said to be dehydrated, put on dialysis and her Kidney function was 11 and creatinine was 95 according to patient. She stated MD told her she is lucky she went when she did. She just wanted to make us aware and I told her I would report the issue
59 2021-04-28 loss of personal independence in daily activities, sleep disorder When I received the injection, I experienced a sharp intense burning pain which shot up my shoulder,... Read more
When I received the injection, I experienced a sharp intense burning pain which shot up my shoulder, neck and behind my ear. This has never happened before. My shoulder/arm were sore for approximately one week which seemed typical to how I respond to a vaccine. After a week I began experiencing a sharp pain in my neck and shoulder area which has gradually worsened to where I am now icing it multiple times per day. There is also numbness and tingling down my forearm and into my thumb and index finger. The pain is unmanageable at times and I am unable to get a full nights rest and have near constant pain when keyboarding.
59 2021-05-12 excessive sleepiness 10 minutes after receiving injection felt body heating up like blood was boiling, sweating eventuall... Read more
10 minutes after receiving injection felt body heating up like blood was boiling, sweating eventually passed out. 8 weeks later still low energy levels and llengthy sleeping times
59 2021-05-24 mental impairment Shot received aprox. 12:30p.m. and by 6:30p.m. raised area at injection site. then feeling tired. T... Read more
Shot received aprox. 12:30p.m. and by 6:30p.m. raised area at injection site. then feeling tired. Then early a.m. of 5/25/21 woke with muscle cramps in right calf. As the day progressed, I had the following symptoms: fever ,chills, burning sting/watery eyes, muscle aches, severe head and neck ache, congestion in left cheek and brow bone(general feeling of the flu). On 5/26/21 still having feeling of muscle cramps, exhaustion, headache, and cloudy thinking/judgment.
59 2021-05-27 feeling abnormal SEIZURE; SLURRED SPEECH; LEG PAIN; HEADACHE; SORE ARM; FEEL WEIRD (NOT HERSELF); This spontaneous re... Read more
SEIZURE; SLURRED SPEECH; LEG PAIN; HEADACHE; SORE ARM; FEEL WEIRD (NOT HERSELF); This spontaneous report received from a patient concerned a 59 year old white and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroid. The patient did not do drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, 1 total, administered on 20-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the patient experienced sore arm the next day after receiving vaccine. On 22-MAR-2021, The patient had headache the following week that did not go away for about 5-7 days and nothing was relieving the pain. On 24-MAR-2021, the patient experienced leg pain and thought it was arthritis but she had never had leg pain like that before and her legs were really hurting. On 04-APR-2021,Sunday the patient was still feeling it. The next day woke up fine but still had leg pain and decided to take a hot bath and she really started to feel weird (not herself) and she was talking to the delivery woman and she was slurring her words (she did not do drugs) and was a healthy person. The patient laid down and her fiancé wanted to take her to the hospital. The patient's mom came over and she wanted to show her a new fridge and called it a fire place. 911 were called and the patient was taken to the hospital and admitted with seizure for 5 days. The patient had the seizure 15 days after the JnJ vaccine on 05-APR-2021, in the afternoon. The patient underwent 2 Magnetic resonance imaging (MRI) and a bunch of tests, computed tomography scan (CAT scan), electroencephalogram (EEG). No MD could claim this was from the JnJ vaccine. It was reported that the patient never had a seizure before in her life. A colleague told the patient that she read an article that said that she could have seizures and she was hypothyroid and thought that it a contraindication to the vaccine. The patient was admitted for 5 days and all tests came back normal. The patient was having speech issues but they were improving. The patient's mobility was fine and eye function was fine. The patient missed a lot of work. The patient had follow up with neuro in a month and would see another neuro and pen medicine and it was an ongoing situation. This was to make sure that everything was okay. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) Normal, EEG (NR: not provided) Normal, and MRI (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, leg pain, and headache on 2021, and sore arm, was recovering from slurred speech, and the outcome of feel weird (not herself) was not reported. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0-20210552079-covid-19 vaccine ad26.cov2.s -Seizure- This event is considered un-assessable. 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.
59 2021-05-27 sleep disorder, abnormal dreams 4-08-2021 Frequent urination 4x during night vivid dreams 4-22-2021 Muscle weakness, loss of muscl... Read more
4-08-2021 Frequent urination 4x during night vivid dreams 4-22-2021 Muscle weakness, loss of muscle tone , falling, red eyes, swollen wrist 5-1-2021 Went to Urgent care for adverse reactions was prescribed muscle relaxant 5-5-2021 Feel and broke wrist from muscle weakness
59 2021-05-27 sleep disorder One the third day is had an upset stomach. Then the next week, I started to feel tired but then I st... Read more
One the third day is had an upset stomach. Then the next week, I started to feel tired but then I started having a very weird heartbeat that kept me awake at week (during the day they came and made me feel super dehydrated).
59 2021-05-28 disturbance in attention, feeling abnormal 9 hours after the vaccination, I woke with seizure like sub-0 chills where I where I felt like I was... Read more
9 hours after the vaccination, I woke with seizure like sub-0 chills where I where I felt like I was lying in the snow without clothes on. Very hard shaking. Put on flannel pj's and wool socks, but could not get warm. The violent shaking lasted about 3 hours. Along with what felt like 12 migraines at the same time. My forehead was very hot, but that could have been from my hand being so cold. My thermometer battery was dead. The next morning, and for almost a week, I felt very lethargic as if I were watching myself from outside my body, hard to drive and focus, head felt like a giant bruise and I was incredibly tired. The tiredness has never gone away and I feel weaker every day here two (2) months later.
59 2021-05-28 disturbance in attention sore throat, gastritis, dizziness, lack of energy, headache, acne breakout, difficulty concentrating... Read more
sore throat, gastritis, dizziness, lack of energy, headache, acne breakout, difficulty concentrating, some joint pain
59 2021-06-02 impaired work ability, sleep disorder I felt pain in the arm, I could feel the shot going into my arm. Within an hour it got extremely pai... Read more
I felt pain in the arm, I could feel the shot going into my arm. Within an hour it got extremely painful, I could hardly move it, I could not raise my arm. For the next 3 days, I could not lay on my left side, I could not use my arm and was extremely painful. I also noticed my lymph nodes were all swollen and sore, the ones in my neck were the worst, I had a severe headache, I was extremely fatigued and body aches. The body aches were excruciating. I was bed ridden for 3 days . I also had nausea and completely lost my appetite. I remember being very thirsty. I had really sever fatigue, it took a week before I started feeling better. I had to take a week off of work. I'm having a really hard time with fatigue now. It seemed to cause what I would call is a huge flair up of my fibromyalgia .
59 2021-06-03 excessive sleepiness, feeling abnormal TIGHTNESS IN CHEST; Shortness of Breath; FEELS LIKE DRUGGED,FELT EXTREMELY WEIRD,FEELS LIKE A ROBOT ... Read more
TIGHTNESS IN CHEST; Shortness of Breath; FEELS LIKE DRUGGED,FELT EXTREMELY WEIRD,FEELS LIKE A ROBOT SHUTTING DOWN; RANDOMLY FALLING ASLEEP; WAKING UP FEELING RESTED; EXTREMELY TIRED; This spontaneous report received from a patient concerned a 59-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, thyroid issues, irritable bowel syndrome, latex allergy, and penicillin allergy, and other pre-existing medical conditions included patient was allergies to anything you can think of in Kansas could not name them all. The patient experienced allergic reaction when treated with nitrofurantoin for urinary tract infection. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 03AZ1A, and 03A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 15:00 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced tightness in chest. On 24-MAY-2021, the subject experienced shortness of breath. On 24-MAY-2021, the subject experienced feels like drugged, felt extremely weird, feels like a robot shutting down. On 24-MAY-2021, the subject experienced randomly falling asleep. On 24-MAY-2021, the subject experienced waking up feeling rested. On 24-MAY-2021, the subject experienced extremely tired. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from tightness in chest, shortness of breath, and extremely tired, and the outcome of feels like drugged, felt extremely weird, feels like a robot shutting down, randomly falling asleep and waking up feeling rested was not reported. This report was non-serious.
59 2021-06-05 excessive sleepiness, loss of personal independence in daily activities After about a month my Wife started to show signs of weakness and unable to do a lot of the daily ro... Read more
After about a month my Wife started to show signs of weakness and unable to do a lot of the daily routines and appreare to have no energy. We have been wondering why this was happening and I mentioned that all of this started happening about a month after the short and she agreed. She has continued to go down hill with little energy and sleeps a lot. Her voice has weakened. I decided to make a report for her as this is the only thing that I can think of that would have caused her health decline. Prior to the shot she was active and could do many routine things during the day.
59 2021-06-07 sleep disorder Janssen- lot #1805018] use for COVID-19 under Emergency Use Authorization (EUA): Since the time of v... Read more
Janssen- lot #1805018] use for COVID-19 under Emergency Use Authorization (EUA): Since the time of vaccination on 3/16/2021 patient reports dramatic increase in tinnitus above her baseline casusing issues with sleep and hearing people talking. Patient has had hypertension contolled with diet and exercise, however, since vaccination she is having erratic readings as high as 110/185 and now with diastolic readings reading high. Blood sugars have also been erratically high since vaccination. Morning sugars in past had been 110-130 and are now 140-190. Both HTN and NIDDM had been well controlled prior to vaccination. Diastolic elevations continue Erratic blood sugars continue to be elevated Tinnitus continues to be problematic for patient
59 2021-06-09 disorientation, impaired work ability She got her vaccine at about 6:30, and the bottom of her foot started swelling, then the to of her f... Read more
She got her vaccine at about 6:30, and the bottom of her foot started swelling, then the to of her foot, ankle, tingling of her feet (both), neuropathy pain came back which she hadn't had in a long time. The spinal stenosis pain came back very strongly and her fibromyalgia pain came back and they were all pretty well managed prior to the vaccine. She is still having that pain. She is on a pain management regimen to control her pain prior to the vaccine, and then it has worsened and was scheduled for an epidural spinal shot and not able to get off the Eliquis due to the vaccine and that has been postponed. She was on Duloxetine for the neuropathy pain and it had been being managed and then all of a sudden that pain has worsened and the medicine she was taking for that did not work anymore. She went to the ER on 5/5/21, and they gave her Morphine for the pain, and discharged her home with Tramadol. The 2nd ER visit was on 5/15/21, as when she woke up both of her legs were numb, and could not feel her legs from her ankle to her hip/waste area. When she opened her eyes she thought she was looking at the side wall and was looking at the ceiling and could not discern where she was, was disoriented and called her doctor and told to go to the ER. She went to the ER and they finally took it seriously and they suggested that she had inflammation in her system that was causing her other problems to flare up. She made appointments with her specialists to see where the inflammation was. She then saw a rheumatologist as when she went to the ER the 2nd time they wanted to put her on steroids and she did not want to be put on it due to her diabetes. She did have drug-induced lupus at one point from isoniazid. Her rheumatologist confirmed she did have inflammation on blood work and told her to take the steroids. The steroids have taken down some of the pain, but not completely. She did have a lumbar epidural steroid injection yesterday 6/9/21 at L4 bilaterally, which has helped as of today. She was put on Tramadol after the first ER visit by her pain management doctor and that did not work. After that she was switched to Hydrocodone which has helped her. Her cardiologist, rheumatologist and PCP told her that it hit things that impacted her nervous system and that she has inflammation in her system, does not know exactly where it is and it has impacted her system and caused intensity of her spinal stenosis, neuropathy and fibromyalgia. She is still undergoing treatment for these symptoms. She was not feeling her neuropathy pain hardly at all prior to the vaccine. On She woke up and both of her legs were numb, and could not feel her legs from her ankle to her hip/waste area. When she opened her eyes she thought she was looking at the side wall and was looking at the ceiling and could not discern where she was, was disoriented and called her doctor and told to go to the ER. She has not been able to return to work as a teacher due to the reaction she has been having. She wants to know what the efficacy is now that she has had a reaction or has it lessened or does she have any protection at all now.
59 2021-06-10 sleep disorder Severe burning pain from injection site to fingers at time of injection with continued pain in left ... Read more
Severe burning pain from injection site to fingers at time of injection with continued pain in left arm and tingling in fingers, within 8 hours developed 2 day period of fever ( not more than 100.2) chills, joint pain in hips, knees & shoulders, severe headache with scalp pain and piercing ringing in ears ( not able to sleep), severe nausea and stomach cramps. As of today 6/11/21 still have headaches with scalp pain and severe ringing in both ears preventing me from sleeping, pain in left arm with tingling in my fingers.
59 2021-06-11 feeling abnormal Daily persistent headaches, ear pain, hyperacusis, feeling like my head is under water, brain fog, l... Read more
Daily persistent headaches, ear pain, hyperacusis, feeling like my head is under water, brain fog, lethargy, balance issues: I had the J&J on April 12th. On the 20th I was awakened by fluid in my ears. I had a spot of blood from my left ear, and fluid from both. Then more ear fluid and head pressure and headache and head-cold symptoms developed over the next few days along with brain fog. By that weekend, I had a slight fever, symptoms worsened, and I was also sneezing and had a very runny nose. Took a rapid test and antibody test that Sunday, the 25th. Both Negative. On the 26th, I tested negative with a PCR test. Preplanned by my rheumatologist, I also had multiple labs drawn. Normal, except my Sed Rate had doubled from what it was on 3/23, and my Fibrinogen was high at 512. Phos, Mg, CMP, CBC, D-Dimer, were WNL. My daughter tested negative for Covid but positive for strep on 4/26, so my dr put me on Azithromycin for 5 days. He saw me the next day after confirming a negative PCR, on 4/27 to confirm that my ears were red, but my eardrums looked okay, and my throat was slightly red. On 5/4, I saw my PCP again and symptoms were unchanged. He put me on Neomycin/Polymyxin w/ HC Otic drops for a week, then steroids for a week after that when he saw me again on 5/14. At this point, occasional dizziness/light-headedness was increasing, added to the other symptoms. I tried 3 different antihistamines though I have no environmental allergies but that didn?t help either. I started the methylprednisolone 4mg pack on 5/17 after I had the CT scan that he ordered. That was normal. When I close my eyes, my balance is off. I used to have no problem with that, and would often walk to the bathroom in the middle of the night with the lights off and eyes closed. So I saw an ENT on 5/26, and my ears looked okay. Hearing and fluid tests were good too. Though the audiologist had to turn the left side volume down because it was too loud. I have developed hyperacusis, left ear. I had an MRI scan on 6/10, with a 1.5T machine, and that looks normal too. Now I will be seeing an Acupuncturist starting 6/14, and a Neurologist before the end of June as recommended by my ENT for suspected vestibular migraines.
59 2021-06-27 confusional state, feeling abnormal Patient reports that for the past two days (since date of vaccination) she has felt dizzy. She also... Read more
Patient reports that for the past two days (since date of vaccination) she has felt dizzy. She also reports ongoing confusion since her surgery for her cerebral aneurysm. She reports that for the past few days she has been bumping into walls and generally feeling off balance as well as experiencing word-finding difficulties. Patient is being admitted for MRI and neurology evaluation. CT and CTA of the head show no acute abnormalities.
59 2021-06-28 feeling abnormal I came home from work on the 14th and I was freezing cold. I laid on my bed and bundled up in 5 0r 6... Read more
I came home from work on the 14th and I was freezing cold. I laid on my bed and bundled up in 5 0r 6 blankets even though it was 110 degrees outside. I got up and took a couple of Tylenol and went to sleep. Got up the next day and went to work and worked through my day and took my grandchildren somewhere and I got home and I was freezing and miserable. I took a couple Tylenol. On Wednesday, my husband said "This isn't normal" and he took me to Urgent Care - and they tested for COVID it came back positive for COVID. Gave me a cough medicine prescription - but it was starting to upset my stomach. Had my husband to give me bananas and applesauce and when I eat that then I take the medication so it won't upset my stomach. And I can't breathe, I cough and have fevers and pain. I am pretty sure right now I have blood clots in my legs. I get up every once in a while to get something to eat and I'm really light headed and dizzy. Have to hold on to walls - don't feel stable in walking. And then I lay down in bed again. I did get my doctor to call in a large dose of Zofran. I've got Zofran now and two different cough medicines. Other than the cough medicine (which makes me dizzy when I call back) - it does prevent me from coughing. Symptoms ongoing. I've tried to force myself to get up more today and move around more to do a few things. I have had to take my work in small portions to fold three or four pieces of clothing and then rest a while. I don't have the energy to hardly do anything. I'm nervous to going back to work. I'm in the process of recovery.
59 2021-07-01 loss of personal independence in daily activities, feeling drunk I started feeling dizziness and thought I would give it a week or so, since I thought it was just a ... Read more
I started feeling dizziness and thought I would give it a week or so, since I thought it was just a side affect that would go away. It feels like I am intoxicated, but not having fun (how the dizziness feels). Heart palpitations, thumping on my heart. I had a phone conference with my doctor yesterday and then went to ER, tested heart, sodium was a bit low. I got a CAT scan on brain and they found no abnormalities in my brain. My blood work looks good. Thyroid was checked but have not gotten the results back for that. I had numbness and tingling in my feet as well. No treatment. I am still experiencing the thumping heartbeat last night and the night before I had chest pain on my left side and cramping in the chest. I added electrolytes to my drinks, trying to get my sodium back up again. I am still experiencing the dizziness and the numbness and tingling in my feet, as well. The dizziness is interrupting my daily activities such as cooking and cleaning the house.
59 2021-07-02 feeling abnormal fever and nausea at roughly hour 16 nausea and diarrhea by ~24 hours vomiting with intermittent feve... Read more
fever and nausea at roughly hour 16 nausea and diarrhea by ~24 hours vomiting with intermittent fever at hour ~42 headache at hour ~50 fatigue beginning at about hour 36 arm soreness thru hour 72 significant brain fog from about hour 42-72 all but arm soreness resolved by hour 72.
59 2021-07-11 feeling abnormal I had itchy, scratchy throat on the 12th in afternoon. Sunday, I woke up fully congested. I went to ... Read more
I had itchy, scratchy throat on the 12th in afternoon. Sunday, I woke up fully congested. I went to the pharmacy to get decongestant and I ended up going into the clinic, 13th, to get checked. There, they looked in my nose and she said it was stuffy and goopy. She wasn't convinced it was an infection so told me to wait until. On Monday, Tuesday and Wednesday, I worked all day and was exhausted when I went home and on Wed, 16th, I started taking the antibiotic, I just felt bad and felt really stuffy. Got a low-grade fever, was taking Tylenol. I felt went really bad and I went as a walk-in to my primary care doctor. She said to let whatever it was to take its course. I had a little bout of nausea that would come here and there (she said that was from the drip in the back of my throat). Thursday night, I got dehydrated because I wasn't drinking enough or eating enough, nothing sounded good, though. I had a really bad headache and I passed out, woke up very quickly though. I woke up and felt nauseated. Husband took me to ER. They did an EKG and other testing including COVID test, positive result. Zinc; vitamin D, I started taking it every day instead of three days a week and added vitamin C and the elderberry gummies with immune support. I drank 7-8 bottles of water with electrolytes in it a day. I was in bed for three days without getting up. I got a pulse oximeter (as instructed by nurse at ER), never got below 90. The virus never went into my chest of my lungs and I never had to use my inhaler one time. I have about 90% of taste back now; I have some of my smell back. I didn't go back to work until 29th of June and I was just working short days as I was still very, very tired. About 3PM the tiredness would hit. Into this week, I'm not as tired anymore. I don't have 100% of energy back for exercising back.
59 2021-07-12 confusional state new onset of R-sided facial drooping, slurred speech, and confusion. VS: 98.7, 120 (apical), 22, 90/... Read more
new onset of R-sided facial drooping, slurred speech, and confusion. VS: 98.7, 120 (apical), 22, 90/68, pulse ox 85% on room air. She was medicated with routine ASA and PRN Clonazepam. Pulse ox improved to 90%. . New orders received to send to ER via 911 for eval.
59 2021-07-14 loss of personal independence in daily activities On approximately March 27, two weeks after Janssen vaccine, patient began having pain in right hip a... Read more
On approximately March 27, two weeks after Janssen vaccine, patient began having pain in right hip and started to have difficulty with walking and using stairs. Between April 3 and 10th patient began having severe right hip pain. She was unable to do stairs and had pain with ambulation. She contacted her family physician but was unable to get in to see her until May 17th. patient was still having the severe pain in her right hip. Doctor ordered x-rays and blood work which did not have any unusual results. The doctor thought possibly sciatica or nerve pain. Pain in hip is slowly improving but now that info is out about guillain-barre syndrome she feels that could possibly be the cause. patient is contacting doctor to determine diagnosis.
59 2021-07-14 mental status changes 59 Y female with history of hypothyroidism presenting with fever, cough, and fatigue, admitted for c... Read more
59 Y female with history of hypothyroidism presenting with fever, cough, and fatigue, admitted for covid pneumonia. COVID PNA/ AMS/ Fever. Pt p/w fever, cough, fatigue, x1wk, found to be covid+ in ED (7/12), p/w mild leukocytosis, fever 101.4, and elevated inflammatory markers. Pt s/p 2L IVF, and started on decadron 10mg in ED given desaturation to mid 80s w/ ambulation. CXR: w/o acute disease. Pt also p/w and transient vision loss in setting of high fever (106), suspect symptoms 2/2 fever, no recurrent episode. Per neurology, no indication for further imaging or workup at this time. Given high fever 106 and tremulousness on admission concern for other etiologies of fever. TSH 0.4 wnl. Psych meds initially held given concern for serotonin synd, however given pt improvement w/ <24hrs of holding meds, and no recent dose changes, will restart. Pt w/ 1/2 Bcx + staph simulans, likely contaminant per ID, initially started on vanc (7/13-7/14), will dc. Worsening leukocytosis likely 2/2 known side effect of steroid use. Inflammatory markers downtrending. Overnight pt w/ episode of desaturation to 87% on ambulation to bathroom, this AM satting 94%. decadron 6mg daily for total tx 10d (7/12-); trend inflammatory markers every other day; Lovenox 40mg SQ BID (BMI>40) and hold for Plt <25k, Fibrinogen <100, active bleeding; Hypothyroidism Last TSH 0.4 on 7/13/21. On PTA levothyroxine 25mcg daily. continue PTA levothyroxine 25mcg daily
59 2021-07-21 insomnia FLARE UP OF CROHN'S DISEASE; CHEST PALPITATIONS; CHEST PAIN COMES AND GOES IT FEELS LIKE HAVING A HE... Read more
FLARE UP OF CROHN'S DISEASE; CHEST PALPITATIONS; CHEST PAIN COMES AND GOES IT FEELS LIKE HAVING A HEART ATTACK; SHORTNESS OF BREATH; STRESS; ITCHING; BLOOD DOTS UNDER SKIN; FELT HOT; NOT ABLE TO SLEEP WELL; HEART RATE WENT UP; KNEE JOINTS HURT MORE THAN BEFORE; HEADACHE; OVER EXHAUSTED; FEVER BETWEEN 99 F TO 102 F; RASH ON LEFT ARM SPREADING ON OTHER ARM, NECK, SHOULDER; FEELING SICK; COULD NOT MOVE; RASH LOOKS LIKE BLISTERS THAT ARE PEELING LIKE SUNBURN, BURNS MORE THAN IT ITCHES; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included joints hurt (knee), and concurrent conditions included Crohn's disease for 35 years, non-alcohol user, non-smoker, hypothyroidism, fibromyalgia, migraine, blood dots under skin. The patient was allergic to lot of medications and could not recall their names, but mentioned new migraine medications. The patient did not do well with steroid (unspecified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 07-AUG-2021) dose was not reported, frequency 1 total, administered on 26-JUN-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, 3 days after vaccination patient started feeling sick and could not move. The patient experienced rash that started on the same arm where she got the vaccine (left arm) then spreading under arm, to the other arm, neck, shoulder. The patient described as it looked like blisters that were peeling (like a sunburn), it burned more than it was itching. It was reported that when the patient's heart rate went up, it hurt more. It felt so hot. On unspecified date, the patient experienced chest palpitations/chest pain that came and went (it felt like having a heart attack). The patient was having headache that did not go away (she usually got migraine that went away) but since she received the vaccine, the headache did not go away. She was also having a fever that ran between 99 F to 102 F. The fever started couple of days after vaccination and still did not resolve. The patient had not been able to sleep well. She had been over exhausted (fatigue). The patient's joints hurt (knee) more than before. The patient had a flare up of Crohn's disease that had not flared-up for 15 years. The symptoms worsened with any activity (even like driving for 25 minutes). It was reported that the patient had shortness of breath (she was on the mountain, not much air). She could get her Hydrocodone prescription because she was away from home. The patient also had little blood dots under the skin on her arm. She was not planning to get the vaccine but got it because she needed to travel to care for her parents and people were bugging her for not being vaccinated. She usually avoided getting any new investigational medications because she was allergic to a lot of medications and had Crohn's disease. She still walked around wearing her mask and took all her precautions. The patient's father passed away recently and her mom was in Hospice so she had been going through a difficult time and a lot of stress. The patient went to the emergency room and spoke with a doctor at her mom's facility, they told her that there was not much they can do other than giving her a steroid shot and she did not do well with steroid. At present the patient lived from 25 minutes away from town and she could not drive far because she got exhausted. On an unspecified date in 2021, Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Fever 99 F to 102 F, and Heart rate (NR: not provided) went up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on left arm spreading on other arm, neck, shoulder, fever between 99 F to 102 F, headache, chest palpitations, knee joints hurt more than before, shortness of breath, over exhausted, flare up of Crohn's disease, rash looks like blisters that are peeling like sunburn, burns more than it itches, and blood dots under skin, and the outcome of could not move, not able to sleep well, feeling sick, chest pain comes and goes it feels like having a heart attack, itching, heart rate went up, stress and felt hot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210729164 -Covid-19 vaccine ad26.cov2.s-flare up of Crohn's disease. This event is considered not related. The event 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 than the drug. Specifically: MEDICAL HISTORY
59 2021-07-25 sleep disorder That evening at about 6 pm, I got up off the couch and had a sharp, shocking pain from my butt (scia... Read more
That evening at about 6 pm, I got up off the couch and had a sharp, shocking pain from my butt (sciatica) down my leg to my ankle. Could barely walk and was not comfortable in bed on any side. Came on all of a sudden the night of my shot.