Johnson & Johnson

PT ARRIVED IN OBSERVATION AREA, AND STATED THAT SHE FELT TINGLING AROUND HER LIPS. VS WERE INITIATED. 3:52PM HR 90 BP 126/64 O2 96%. MONITIORED VS EVERY TEN MINUTES. PT WAS ADMINESTERED 25 MG OF DIPHEHYDRAMINE 0.5 ML AT 4:05PM. AT 4:30 PT STATED THAT THEY STILL FELT TINGLING. ANOTHER DOSE OF 25MG OF DIPHENHYDRAMINE WAS ADMINESTERED. MONITORED PATIENT FOR AN ADDITIONAL 30 MINUTES. PT WAS ESCORTED BY SPOUSE STABLE.

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.

Within 45 minutes lightheaded, within an hour extreme fatigue and chills, ear ache. Several hour after skin hyper sensitivity, nausea. The next day fatigue , nausea and mild cold symptons, migrane.

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.

My tongue started feeling itchy, I have a metal taste in my mouth. It has been this way since about an hour after I got the shot. Itchy has turned into like a tingling but also the feeling it you "burn" your tongue. It is not uncomfortable but a symptom that was not listed on the affects

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

Per HCW, she developed flu-like symptoms on 3/13/21 @ 0720 am. (Approx. 17 hrs post vaccination). Other symptoms include itching to face, headache, fatigue, pain behind the eyes and sore neck muscle. Took Motrin and Benadryl. Per HCW, symptoms worsened. On 03/14/21 @ 03:30am she noted swollen lips, injection site swelling, fever of 102 and shivering. She denied SOB, Chest pain. Had mild nausea and diarrhea (resolved). On 03/15/21, Sought treatment via PCP and was prescribed Alegra 180 mg by Mouth everyday and Ibuprofen 600 mg PO every 4-6 hours. OUTCOME: Began feeling better on 03/16/201 at approx. 1130 am. Continues to have a "knot" at injection site. Intermittent neck soreness and pain behind the eyes.

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

I got a broken blood vessel right eye contacted my doctor stated it was (subconjunctival hemorrhage). I'm not certain if this is related to the vaccine however this happens during the timeframe. I still exp redness in my eye.

Janssen COVID-19 Vaccine given in Lt-deltoid without incident. Patient placed in observation room for 15 minutes without incident. 5 minutes later patient return to observation room from the waiting room c/o numbness and swelling of Top Lt upper lip. Evaluated by Dr and instructed to give Benadryl 50 mg IM and given in Rt deltoid. Patient observed for 30 min., no further swelling or numbness noted. Previous reaction subsided Reviewed all possible side effects with patient and husband. V-safe instructions also reviewed again. All questions answered. Patient to call with any further concerns. Contact information provided.

On Friday evening after the injection: Within minutes of injection: pain in arm - injection site. Continued for several days afterwards. Within 10 minutes: tongue tingled and went numb. Continued for several days afterwards. Within 20 minutes: upset stomach for the remainder of the evening. Within an hour: Fever, chills, full body muscle aches, fatigue. Slept for several hours over 2 days. Resolved by Sunday evening (roughly 48 hours).

Typically symptoms plus those out of the ordinary: numb lips and face to cheeks, extreme ear pain, headache, dizziness, light headed, difficultly swollen for short periods of time.

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.

SHORTNESS OF BREATH; THROAT SWELLING; TONGUE SWELLING; UNCONTROLLED SHAKING; LEG NUMBNESS; 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: 1805022, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. Vaccinated on Left arm. No concomitant medications were reported. On 09-MAR-2021, the subject experienced shortness of breath. On 09-MAR-2021, the subject experienced throat swelling. On 09-MAR-2021, the subject experienced tongue swelling. On 09-MAR-2021, the subject experienced uncontrolled shaking. On 09-MAR-2021, the subject experienced leg numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat swelling, and tongue swelling on 14-MAR-2021, and uncontrolled shaking on 11-MAR-2021, and had not recovered from shortness of breath, and leg numbness. 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.

Extremely Swollen eye on right side of Body. Pain on right buttocks and back of leg. All over achy. Stuffy and flu like symptoms

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

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

Patient reported having puffy lips, numb and tingling sensation of tongue and mouth and subsided nausea Patient seen by medical team, blood pressure 185/105 and heart rate 97 Patient stated symptoms improved Patient refused medical transport and signed ama form

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

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.

left shoulder was the injection site- very swollen, red, the size of a fist, hot to the touch, very sore- a lot of pain. Hot, cold, chills, extreme body aches, blinding head ache, loss of clear site in left eye, vomit, nausea, tired, loss of taste, sores on the inside of mouth.

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

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

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

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.

Pt states she recieved the Johnson and Johnson vaccine on 4/8 and started have L sided pain from her shoulder to her foot, nubness in her L hand, vision is blurry, and "feels like her blood isn't circultaing correctly". pt states she tried to take bayer asprin today and felt some tingling in her L hand.

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

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.

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

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

states her vision had been somewhat blurry before the vaccine on 3/15/2021, but became more blurry the day of the vaccine. She states a doctor has stated that she has "blood spots on her retina."

Chills, fever up to 102.5, headache, fatigue, mild nausea, muscle aches, joint pain, minor shortness of breath, feeling of lightheadedness/dizziness, feeling like my vision was off/blurry and was... crowded, like the edges of my vision weren't entirely there?

Blood pressure 50/40 heart beat 50 fever body spasms eye spasms diarrhea short breath lot headaches skin burning when showering skin very dry and swollen

48 hr fever, 72 hr muscle pains, headache, eye pain ( severe flu symptoms) slight cough with asthma symptoms

First day - debilitating chills, fever, sweats, weakness Day 7 started experiencing light sensitvity, loss of central vision, dizzyness, headache Note: I have never had anything like this happen before (not prone to migraines etc.) Now in Day 13 and still have headaches light headedness and sensitivity to heat and light

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

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.

Started getting a blurry circle in my vision around 11am. It kept bothering me. I kept closing my eye and thinking it was just something bright I looked at that made the circle appear, but then I couldn?t really see and there was a white line that snaked around and started strobing a few different colors and my eye felt lazy and heavy. This lasted around 25-30 minutes. I have never experienced this before in my life and really freaked me out thinking I had a stroke, but could walk and talk fine and

Within 48 hours of vaccine, I developed Parosmia: distorted smell. Many things smell very, very foul, like a rotting compost. Garlic, onions, coffee, all body odors, and many other things have this smell. No sign of letting up.

- 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.

BLURRY VISION; DIZZINESS; HEADACHE; 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 abstains from alcohol, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced blurry vision. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, blurry vision, and dizziness. This report was non-serious.

Approximately 30 minutes after receiving the vaccination, the patient returned to the pharmacy and stated her upper lip felt tingly and larger than normal and she was having generalized itchy feelings around her face. We gave her diphenhydramine 25 mg and observed her for an additional 20 minutes. At that time, she stated she felt fine and left the pharmacy area.

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

I AM EXPERIENCING BLURRED VISION ON THE LEFT EYE CURRENTLY BUT IT DIDN'T START RIGHT AWAY - ALSO EXPERIENCED A THROAT INFECTION 3 WEEKS AFTER VACCINE AND WAS PRESCRIBED ZYTROMAX ANTIBIOTIC

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

The first 48 hours I experienced chills, fever, sweating, vomiting, severe headache, and body aches. Then 2 days later I experienced severe congestion, sore throat, fatigue, coughing and plugged ears.

I experienced occasional ringing in the ears after receiving the vaccine, but no other noticeable side effects during the first 48+ hours. However, soon after the 2-day mark had passed, I developed tinnitus (ringing in the ears) that has now been continuous for 24 hours.

I have been having terrible dry mouth and cannot fix it, I've tried every over the counter product and even drink triple what I was.

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.

MULTIPLE BLOOD CLOTS ON BOTH SIDES OF THE LUNGS/NAUSEA(THREW UP BLOOD TWICE)/BLACK STOOL (WAS LIKE DIARRHEA)/FEVER/OXYGEN WAS ON 80S/; WEIRD TASTE (AWFUL); BONE PAIN/BONE PAIN AS BONES FELT LIKE A GLASS/PAINFUL (ANYTHING THAT TOUCHED WAS HURTING); SORE ARM; POSITIVE COVID TEST (RAPID TEST)/CAME POSITIVE BOTH TIMES; HEADACHE; This spontaneous report received from a patient concerned a 40 year old White and Non Hispanic or Latino 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, expiry: unknown) dose was not reported,1 total dose administered on 10-APR-2021 on left arm as prophylactic vaccination. Batch/Lot number was not reported and has been requested. No concomitant medications were reported. The patient was not pregnant at the time of reporting. On 10-APR-2021, 5 hours after the vaccination, the patient started experiencing headache. On an unknown date the patient experienced sore arm for about a week. On an unknown date the patient experienced bone pain as felt like a glass, painful and anything that touched was hurting. On an unknown date the patient experienced weird taste that was awful. On 16-APR-2021 the patient tested positive for covid-19 (rapid test) (coded as: suspected covid-19). On 17-APR-2021 the patient was again tested positive for covid-19 (rapid test) on both time tested as positive. On 17-APR-2021 the patient experienced 2 episodes nausea (threw up blood twice) before visiting hospital and at the hospital. On an unknown date the patient experienced black stool (was like diarrhea). On 18-APR-2021 the patient had body temperature 100.8 to 100.9 and went to hospital again there diagnosed with multiple blood clots on both sides of the lungs. On an unspecified date the patient was taken with tums and pedialyte for an unknown indication. The patient was treated with tylenol (for an unknown indication), nausea medicine, steroids, blood thinner and oxygen (for oxygen level in 80s). On 21-APR-2021 the patient was discharged from hospital. The patient was hospitalized for 4 days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. On 26-APR-2021 the patient was recovered from headache. On an unknown date the patient was recovered from sore arm and not recovered from multiple blood clots on both sides of the lungs/nausea(threw up blood twice)/black stool (was like diarrhea)/fever/oxygen was on 80s/, and the outcome of positive covid test (rapid test)/came positive both times, weird taste (awful) and bone pain/bone pain as bones felt like a glass/painful (anything that touched was hurting) was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000179162 The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20210521944.; Sender's Comments: V0: 20210520244-Covid-19 vaccine ad26.cov2.s-multiple blood clots on both sides of the lungs. 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).

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

6 weeks after vaccination developed severe diffuse oral ulcerations (>50 ulcers) present on buccal mucosal margins, lips, gingivitis, oropharynx.

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

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

Constant headache x10 days after vaccination (HA starting day 1 post-vaccination). Visual changes with aura type arc in middle of visual field lasting 30 minutes prior to resolving spontaneously- this occurred twice after vaccination date with 1st episode occurring at 1 week post-vaccination and 2nd episode occurring at 2 weeks post-vaccination. Facial shingles at V2 dermatome (near Left eye) diagnosed 6/21/21; pending repeat eye exam 7/12/21 to follow this.

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

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

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

The patient had been in the post vaccine area close to 15 minutes. The patient said it felt like she could feel the vaccine going thru her arm and across her face and up the side of her face and she felt a little dizzy. I asked her if she wanted a water and I would check on her in 5 minutes. She then said her tongue felt a little funny, but that she could swallow. I had her wait approximately 15 minutes longer to see if it would pass. She stated that the dizziness had passed but the tongue/throat felt a little swollen but it had not progressed. There was no redness/flushing. I offered her a dose of Benadryl. Pt accepted the dose. I asked her to call me when she arrived at her destination. The patient called to say that she had arrived and was feeling some better.

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

Loss of peripheral vision, blurry vision, numbness to face, migraines, loss of balance for several months, intermittent

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

When I woke up the next, I had severe muscle pain for the whole body, chills, nausea, headache, sharp pain to the back of the head. Today (3/10/2021) I don't feel muscle pain for the whole body, chills, nausea but I have sharp pain inside left ears, headache and dizzy.

I woke up with an excruciating headache (with light sensitivity) that did not initially respond to Tylenol. Although I did not have a fever, I had temperature regulation issues all night - alternating between hot and cold - and woke up sweaty. Headache responded to Advil in the morning but I still have a minor lingering headache a few hours later.

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.

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

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

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

She got the vaccine she was fine, had a mild cramping in her stomach. She wakes up at 5:00 AM in the morning for work and on Friday she could not put her feet on the ground for pain in her legs. She also had a bad headache on the left side and took Advil for that, and then the headache switched to the right side. She then took another Advil, and that was all she took that day and was that way the whole weekend. She had pain all weekend and could not touch herself as the pain was so bad. She also had chills, nauseated, her vision was going in and out as if she was at the eye doctors office. Her uncle brought her mother over to her as she could not take care of herself or drive to take care of her cousin who she takes care of. She went to go work on Monday 3/26/21 then she started having difficulty breathing and her employer called the EMT's, they checked her heart rate which was high and did her oxygen level which was fine, and were afraid she may have gone into cardiac arrest, and told her to rest. She called her doctor who told her that it was a bad reaction to the vaccine. She is still having difficulty breathing after walking so far, she weighs 115# and has always been a small person. She was not given any medications by her doctor and told her to rest and if it worsened to call her back. She had been seen two weeks prior by her doctor for a sinus infection and was given an allergy shot and some other injection of which she does not know what it was, possibly a steroid.

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.

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

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

Patient complained of feeling as if something was stuck in her throat and she could not swallow, that her throat felt "fat". As the minutes passed, the feeling of fullness was more pronounced. We offered EPI-PEN and to call 911. Patient wanted 911 only. We called 911, took her blood pressure (188/119). Paramedics arrived within 1 minute. After examination, patient was transported to hospital at 1:30p.m. accompanied by family members. At 3:55p.m., I spoke to her fiancé to inquire about her well being. She was still at ER at 3:55 p.m. She was given Benadryl, EpiPen, and Prednisone. Fiancé said she was breathing better but there was a rash and itching at injection site which was being treated with Benadryl and Prednisone. Fiancé said patient was frustrated at having to be at emergency room.

localized reaction/induration initially ten minutes after vaccine administration. vaccination at 2023 first symptom at 2033. Benadryl 25mg given half at 2033 and the remainder at 2036. pt c/o tingling tongue at this time. no difficulty breathing or visible swelling. VSS. new complaint of dry throat and given water at 2038. by 2045 pt reporting improvement in symptoms. 2053 VSS and no complaints from pt. induration/localized reaction decreased substantially and symptoms relieved. pt disposition home with family.

I experienced slight nausea, awake all night, felt like a stimulant to me, fever, chills, sweating, migraines. I felt super tired but my body would not let me sleep. I also had muscle aches and cramps with lower back and leg with a throbbing sensation. This was within 12 hours. About 5 days later, my eye started to hurt, went to se my eye doctor and they found out I have ocular herpes. I am on now on some antiviral eye medication. I could tell after the vaccine I had a viral type infection. I still have not recovered and I will see my eye doctor tomorrow.

Patient received IM injection at 1:00. Patient noted to start having reddened cheeks and rash to chest. Patient stated her front of her tongue feeling tingling. Two 25 mg Benadryl given at 01:18. Patient stated she was breathing ok and able to talk and drink water without any problem. B/P 134/90, 98% O2,80 R. Patient monitored for additional 30 min. Patient admits to decreased tingling sensation to tongue at 1:30. Patient able to talk and drink no slurring of speech or problems swallowing Declined EMS to local hospital.

Headache - severe Tinnitus Diarrhea Fever 102 Joint pain - hips Muscle pain - whole body Shaking Chills Feeling of dread/hopelessness

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.

About 45 minutes after I got vaccinated I started to feel a strange sensation (a kind of tingling) in the right side of my head, inner ear, and jaw. Then about 15 minutes later I felt the sensation in the right side of my tongue. The best way I can describe it is similar to the same sensations I feel when the Novakane is wearing off after having a cavity filled. It's Monday (4/12/21) and I can still feel it a tiny bit in my right ear, where my jaw connects (right side), and my right cheek. Hopefully, it will go away when the stiffness in my shoulder goes away. Also, during my 15 minute waiting period I had the same tingly sensation going down my arm to my fingertips, but I was told that some people experience that sensation as the vaccine moves throughout their body. Other than that I experienced the stated side effects.

Ear ringing, ear pain and feeling fullness in ear. Dizziness. Sensitive to loud noise for the past four weeks since the start of the vaccination

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

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

Chills with violent shaking for an hour, then regular chills, fever on and off for 11 hours, headache, shortness of breathe a few times (each about 10 minute episodes), extremely thirsty, nausea, dizzy, body pain & cramps

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.

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

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

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

within 4 hours - pain at the injection site, tired, full body chills with uncontrollable teeth chattering, headache, entire body aches of the joints, eye pain. Effects lasted 36 hours then acutely dissipated.

Fever of 101, chills, body aches and headaches. Fever and chills lasted about 8 hours and the aches for about 16.

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.

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.

I developed what appears to be contact dermatitis around both eyes. Treated with oral steroids, prednisone eye drops, antihistamine pills and drops. Once I stop treatment it comes back

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.

Fever, Chills, headache, body aches. Severely Stiff neck Severe Headache Locked Jaw-unable to open and close Vomitting

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

March 9, 2021: 3:30am: Woke up with chills and feeling very cold 7:00am: Woke up with fever of up to 103F and extreme fatigue and headache which lasted during the day. To ease the symptoms I took Tylenol every 6 hours. 10:00am: Started noticing hives, first on my left shin and continued to manifest in my torso/back as well as forearms. I called my physician via telehealth and I was advised to take Benadryl as needed. Took Benadryl twice (6 hours apart) and the hives calmed down and eventually went away during the course of the day. March 14, 2021 1.30am: Woke up with itchy hives on my torso and back. Took Benadryl once again. I called my physician and was instructed to take Cetirizine for the next couple of days (10mg at 1x per day). Symptoms subsided. March 23, 2021 4:00am: Woke up with itchy hives on the left side of my torso and across my back and my groin area and upper thighs. Called my physician once again who instructed to take Cetirizine for a course of 2 weeks. No symptoms while taking Cetirizine. Stopped taking Cetirizine on April 2. April 6, 2021 6:00am. Woke up with itchy red patches (with very small bumps) in localized areas of the body (ie on my hand, on my right leg, and areas near my armpits. These lasted a little while with intense itchiness...would subside to just having red patches, and another area of the body would manifest red itchy patches. The above lasted several days as I wanted to see if this would go away on its own. On April 9th, called my physician to advise of the continued itchy patches which seem to come and go in different areas. Advised to take Cetirizine once again for another 2 weeks once a day.

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

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

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

No pain at site of injection. (A) Onset around 8:00 pm on day of injection: chills, shaking, fever (no thermometer was available -- legs, stomach and head were very hot to the touch for about an hour, despite strong chills); strong migraine; sensitivity to light, sound, touch; mild body aches. (B) Menstrual cycle began on time about 2 days after injection, but persisted for 3 days longer than usual. Normal bleeding occurs over 2.5 days, but light bleeding occurred much longer than any time in the previous decade. TREATMENT: (A) Tylenol, warm blankets, heat pad; (B) Ibuprofen 400mg, heat pad (normal treatment)

NECK STIFF; HEADACHE; NAUSEA; FEVER; EARS HURTS; DIARRHEA; EARS FEEL MUFFLED; EARS RINGING; This spontaneous report received from a consumer concerned a 41 year old female. The patient's height, and weight were not reported. The patient's past medical history included cervical cancer, and concurrent conditions included seasonal allergies. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced ears hurts. On 09-APR-2021, the subject experienced diarrhea. On 09-APR-2021, the subject experienced ears feel muffled. On 09-APR-2021, the subject experienced ears ringing. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced neck stiff. On 10-APR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.9. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and fever, and had not recovered from headache, ears hurts, neck stiff, diarrhea, ears ringing, and ears feel muffled. This report was non-serious.

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.

I immediately began to feel my arm asleep, it wastes the ring finger and the little fimger. then i was taking iboprofen ) sr, order to me, the was eors and he gave me diclofenacoy take it 5 day but i star havin ptoblems with my eyes and legs. my my sensory nervous systerm is very devilite. I ca"t smell and I have no Taste this week i did an MRI and x ray

PATIENT REPORTS: DIZZINESS 2 WEEKS POST-INJECTION, SEEING STARS ON SIDES OF VISION 2 WEEKS POST-VACCINATION, AND EXPERIECING FEELING OF "SHOOTING PAIN" OR "BURNING PAIN" INSIDE OF HEAD 2 WEEKS POST-INJECTION. NOT TYPICAL SYMPTOMS FOR PATIENT.

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

4pm severe peri orbital eye pain and severe headache 4:30p Severe ear pain with light sensitivity 9pm fever, severe chills,with excessive uncontrollable shakes that appeared to look like a convulsion, uncontrollable teeth chattering, hot flashes, diaphoretic , elevated blood pressure and teeth nerve pain, severe body aches and lasting muscle soreness

About 25 minutes after receiving vaccine patient said she had ringing in the ears. She said she has had before but this seemed louder/ higher pitched then before. Patient felt okay otherwise and decided to go some after another 10 minutes. She was informed to follow up with her doctor if it does not go away or gets worse.

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

Patient started feeling "dizzy", "woozy", "seeing spots" approximately 1 hour after she received her vaccine. She stated that she was very tired. She appeared to be very sweaty and said that she "felt hot" when she took a deep breath. EMS was called and patient went to ambulance with EMTs.

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.

when I first started feeling symptoms, I was achy, I wear a pain patch for my syndrome, achy all over, muscles felt like they were cramping, headaches, nauseated , tickle in my throat, and then a cough I couldn't get rid of. I gradually got sick and tested positive for Covid 19 on April 6 . I couldn't breathe, I couldn't walk. I had bilateral pneumonia

Patient complained of tongue and jaw feeling "numb and tingly". Vital signs stable. Numbness resolved but throat feels slightly swollen. No wheezing, or difficulty breathing, speaking in full sentences. Doctor onsite consulted. Patient observed for additional 30 minutes. Symptoms resolved. Discharged from clinic with doctor's approval.

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.

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

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

It first started with fatigue and chills, I woke at 1 am with a slight fever and felt like bone aches in my big joints such as my legs and hips. I had very mild soreness of the injection site. I had a headache the next day. I had a canker sore as well that lasted over a week. Most of the symptoms were gone with 24 hours. I also got diagnosed with breast cancer but I am not sure it is linked with the vaccine.

Intense, shooting, intermittent pain in/below left inner ear/jaw area that came and went for about 3 days along with a mild sore throat Acetaminophen 500mg seemed to help eliminate for about 2 hours after taking, then didn't help My left inner ear would pop every once in awhile on its own and a dull pain persisted for a couple more days in my inner ear and back of my neck area. Seemed to go away for a couple days, then the right side of my head felt swollen and stuffed--but no mucous or anything. No intense shooting pain, just a constant dull ache in my inner ear that also could be felt on the right side of my face and back of my head/neck area. Lasted for close to a week. Doctor ended up prescribing antibiotics and diagnosed me with sinusitis. All symptoms went away after about 2 days of antibiotics.

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

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.

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.

My arm was in terrible pain. I could not move my arm at all. I was experiencing excruciating pain. My face, tongue and arm were numb. I went to a doctor and they suggested a neurologist. I was told by my regular doctor that I was deficient in iron & vitamin D. I took multiple tests. They said there was no nerve damage, but that the vaccine was making its way through me. But both my arms and both sides of my face feel like its on fire. The pain does come and go. It shows up in random moments.

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

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

The patient experienced a metallic taste shortly after vaccination. The patient then experienced a severe headache and nausea about 13 hours after vaccination .

Headache, jaw ache, other minor body aches, chills, 99.4 F fever, mild fatigue, initial soreness of arm on day of injection

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

Patient reported tingling in the throat and slight dizziness about 5 minutes after injection. Vitals stable. 10 mg Zyrtec given as per nurse practitioner order. Throat continued to feel tingly. No shortness of breath/swelling/rash noted. Dizziness resolving, transferred to a doctor's office nearby for further observation.

Pt dizzy after IM shot @ 1200. Felt hot and tingly in legs. 1215 - Nausea, BP 143/90. 1230 - increasing dizziness and headache. 1300 - vomited x 7. 1309 - pt complained of throat pressure and increased vomiting. 50mg IM benadryl given. EMS called and Pt taken to hospital for evaluation.

Janssen COVID-19 Vaccine EUA Approx 7 p.m., I noticed moderate pain in my lower back, hips, and legs. Around 7 30, I felt very cold and began covering up with several blankets and turning up the heat. Husband and kids reported the house was not cold at all. Within 15 minutes, chills began and increased quickly to an almost violent state. I was shivering so badly, it became painful and scary. My husband added three blankets on top of our down comforter and sent me to bed. It took approx 15 minutes to warm up, stop shivering, and slow teeth chattering enough to relax and fall asleep. Awoke around 1:30am feeling incredibly thirsty and in desperate need of water. Upon standing, the pain in my body was excruciating which made it extremely difficult to walk. Finally in the kitchen, I took Ibuprofen 800mg and filled a large bottle with water. I began to feel incredibly dizzy and needed help from my husband to get to the couch. It took approximately 2 hours before I began to feel any relief from the ibuprofen. Around 6:30 a.m., about 60 to 65% of the pain had abated and I had finished around 100oz of water. The remainder of the day was spent feeling extreme fatigue and a general sense of unwell. Appetite was poor throughout entire event. This all continued into the evening until bedtime at 11pm. Experienced moderate insomnia overnight, falling asleep around 2:30am. Could not fall asleep due to constantly thinking about the stress of the previous 24+ hours. Upon waking this morning, I feel almost back up to 100%.

Myalgia, Arthralgia, Fever, NauseaVomiting, photophobia/ "red, tender, chapped lips" Narrative: Other Relevant History:

Received vaccine on 3.12.2021; began to have tearing of R eye with erythema on 3.24.2021 at approx 20:30; awakened 3.25.2021 with swelling of R eyelid, inability to blink, R side facial numbness, R side tongue numbness; Diagnosis: Bell Palsy; Rx Prednisone taper, Neurontin, Valacyclovir, moisturizing eye drops, eye patch.

First two days fever up to 103, extreme body aches and chills, excessive sweating, fatigue. Days 3-6 runny nose, body aches, extreme dehydration, fatigue,. Days 7-16 continued feeling of dehydration/dry mouth, sporadic body aches, shakes and dizziness with strenuous activity, and dry crusty painful nose ongoing currently.

about eight hours after receiving the injection, I started to feel strong aching in my muscles and joints (most strongly felt in neck, hands, jaw, inner ear, but also including legs and feet). I also felt chills. My temperature was 98.8 F. Over the course of the next three or four hours, I have felt strong sensations of aching and throbbing in my chest, back, hands, inner ears, and neck. I also felt pins and needles all over but most strongly in chest, back, hands, inner ears, and sides of my neck.

Ringing in left ear and hearing loss in left ear started on 4/2 and continues to persist. For the first 24 hours after receiving vaccine I sweated and had severe muscle cramps which have now resolved. The ringing ear and hearing loss hasn't stopped and is very concerning.

Patient received her vaccine at 11:30 AM. Immediately after receiving the Jansen vaccine, the patient reported feeling lightheaded as she stood up. She sat in our waiting area for about 10 minutes, and reported that she felt as though her tongue was swelling. We contacted EMS at this point, and provided a dose of Benadryl to the patient at her request. We brought the patient into our vaccine room where she began to break out into hives. She vomited several times. EMS arrived shortly thereafter and checked to see if the patient was experiencing an allergic reaction. EMS took the patient to the hospital. At about 2 PM, the patient called the pharmacy to let us know that she was okay. She said that it was confirmed as an allergic reaction at the hospital. She indicated that she had received a steroid injection at the hospital and was feeling much better. We encouraged the patient to call us at any time if she had any further problems or questions.

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

Started around 7pm with massive headache and light sensitivity, then by 10pm started running fever that lasted until morning and ranged between 100.7 to 101 F. Fever broke around 4:30am and gradually returned to normal temp by 9am. Since fever started and continue to have: chills, skin sensitivity to touch, nausea, headache, fatigue, and body soreness.

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

pt stated minor redness/ hives reaction and puffy eyes when she got home but subsided with benadryl . woke up at 130 am on 4/8 with fever of 104 f . fever broke and pt sweated profusely-- had headache and run down feeling most of 4/8. fever is down but still feeling tired

Fevers and shaking chills, nausea, and some dizziness started about 7 hours after the vaccine. I lost hearing in my left ear at about the same time. The hearing came back a few hours later but was muffled and echoed in the left ear for about 48 hours following the vaccine. I tried decongestant medications and tylenol without improvement in the hearing issue. The left ear has mostly resolved at this time but the ear is popping at times with muffled hearing intermittently. All other symptoms are resolved.

I experienced blisters/ mouth ulcers within 24 hours of being vaccinated and lower back ache + abdomen discomfort (akin to period pain) within 48 hours.

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.

By 8 pm Thursday I had chills and a fever. Poured sweat the whole night. Nauseous most of that day and the next. Very low energy and spent quickly the whole day on Friday. I?ve been shakey. Vision blurred at times. Body aches constantly

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

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

I had a very bad case of Covid in January 2021 and have not regained my taste or smell. I was in bed for 2 weeks and had a prolonged fever up to 105 degrees--so high that I had visual and auditory hallucinations. I had hair loss in the following months and I also continue to be fatigued. I received the vaccination on 4/6/21 around 11am; a slight headache and face flushing occurred about 30 minutes after shot, but generally felt ok. Woke up at 4am on 4/7/21 with chills, extreme joint pain, body aches, migraine headache, and a fever of 101.5 degrees. Took Tylenol around 6am and went back to bed. The migraine headache, chills, body aches, and extreme joint pain continued. I was dizzy and extremely fatigued. Woke up around 9 am and fever was at 102.7 degrees. Joint pain and headache were almost unbearable at this point and I took a hydrocodone. Took temperature around 12 pm and it was 103.5 degrees. Fever continued rising to 104.4 degrees at 2:30 pm. Took another Tylenol and went to sleep. The next day, my fever had fallen back down to 102.5 degrees. I continued with Tylenol to control me fever to around 101 degrees. My fever persisted for 3 days. I still have extreme fatigue, joint pain, burning scalp (which will likely mean more hair loss), zero appetite and weight loss, dizziness, blurred vision, etc. The side effects are exactly how i felt when I got Covid in January.

4-12-2021 Facial tingling & numbness, tightness/swelling of throat, difficulty swallowing, Given Prednisone 40 mg, 2 Benadryl and 1 Pepcit at ER visit. Prescribed Prednisone 40 mg /5 days, Benadryl & Pepcid for as long as symptoms are present. 4-13-2021 Headache, itchy eyes, sneezing, small red blood blister like areas on arms, chest, back and thighs. When Benadryl wears off throat tightness returns. Visited ER on advice from nurse hotline to check out the red blood blister like marks as she thought it was a new rash type symptom. ER recomended remaining on previously prescribed course of meds and to watch for further symptoms.

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

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.

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

Tinnitus started on the third evening following the vaccine. It's so loud that it's preventing me from sleeping.

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

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.

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

Severe headache, fatigue , twitching eye lid, itchy face, pain in legs , sharp pain in left side of abdomen. Blurred vision (comes & goes). Various muscle spasms, excessive thirst, sores under tongue, ringing in ears.

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.

Patient with intractable headache not relieved by OTC Tylenol. Presents today with right calf tenderness on palpitation. Headache, visual disturbance.

started getting a strange throbbing head pain under my right eye. then a few days later excruciating pain in my lower tooth radiating throughout my entire mouth and jaw. on the right side. it was the worst pain in my life. unrelenting, throbbing, radiating pain. I almost went to the emergency room since the pain continued for 48 hours without relief. I googled symptoms and found trigeminal neuralgia but ended up at a dental office and required an emergency tooth extraction in tooth #30. I had a root canal there prior so at first I didn't connect the two but the pathology found that I had periapical granuloma, which is inflammation. I do not know if the vaccine caused the inflammation but I believe the vaccine hastened inflammation rapidly in that area. the dental surgeon nor dentist believe there is a connection, but interestingly my mom had a similar experience right after her vaccine. I noticed there is a study testing on "Oral side effects of COVID-19 vaccine" https://pubmed.ncbi.nlm.nih.gov/33483637/

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)

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.

TASTE METALLIC; DRY COUGH; SORE THROAT; LIGHTHEADED; NUMBNESS OF FINGERS ARMS LEGS AND LIPS; BODY ACHE; TINGLING OF FINGERS ARMS LEGS AND LIPS; FEELING COLD; FEVER; FINGERNAILS BEDS TURN PURPLE; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included hashimoto's disease, and concurrent conditions included allergy to sun, aloevera, latex, and bees. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced fingernails beds turn purple. On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced tingling of fingers arms legs and lips. On 08-APR-2021, the subject experienced feeling cold. On 08-APR-2021, the subject experienced lightheaded. On 08-APR-2021, the subject experienced numbness of fingers arms legs and lips. On 08-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103-104 F. On 12-APR-2021, the subject experienced dry cough. On 12-APR-2021, the subject experienced sore throat. On 13-APR-2021, the subject experienced taste metallic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheaded on 09-APR-2021, and fever on 10-APR-2021, had not recovered from body ache, tingling of fingers arms legs and lips, feeling cold, taste metallic, dry cough, sore throat, and numbness of fingers arms legs and lips, and the outcome of fingernails beds turn purple was not reported. This report was non-serious.

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.

I had severe headaches and very sharp sight on the first day. The next day I experienced a strange leg numbness in the middle of the night. A week later as I was traveling I had a very bad allergic reaction that required me to call 911, as the throat swallowed. I am still experiencing leg pain when I walk. Sometimes the face feels tight also and I?m not sure this is something from the vaccine.

6 days after shot, I got what seemed like an Aura migraine, unable to see well out the front of my eyes, sides of my eyes had lights and line of geometric patterns. No pain in my head at this time. Lasted for 1-2 hours. For the next 2 weeks, I had light sensitivity and felt light headed on and off throughout the day with some fatigue. I had a headache a few times.

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

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

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

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

A few minutes after the vaccine I had a lot of heat and pain in my left ear. My left ear is still painful after four weeks. I am scheduled to see an ENT doctor today. I had to go to the emergency room because I was throwing up starting two hours after the vaccine and I was in pain all over my body. I became extremely fatigued, and I could not stop throwing up. I was given Reglan, to stop the vomiting, and I am still taking it twice daily after four weeks. I was also given Benadryl which seemed to help. I tried to stop taking the nausea medicine after three weeks and the vomiting returned. I threw up eight times that day. I still have aches in my legs and ear pain every day after four weeks. My fatigue has improved a little.

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.

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.

PATIENT REPORTS SORE SPOT ON INNER ASPECT LEFT LOWER LIP, LEFT HAND TINGLING (WENT TO ER FOR THIS COMPLAINT 05/05/2021 PRIOR TO VACCINE AND DIAGNOSED WITH CARPEL TUNNEL), ITCHY NOSE AND FACE

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.

12 hours of expected side effects (fever, aches, flu-like symptoms) followed by persistent and constant bilateral tinnitus. Originally treated for ear infection (antibiotics), then with steroids and anti-histimine. No improvements

high fever 102.6 for 24 hours , severe body aches 24 hours , long lasting Tinnitus ever since my fever broke

I received the shot Saturday at 1pm. The next day, late-afternoon Sunday, I experienced the expected flu-like symptoms: low fever (99.4 degrees F.), fatigue, aches, slight arm pain on left side, and fatigue. Monday morning (5/10) I woke up in a sweat; my fever had broken. But I had a slight headache and tinnitus. This headache and tinnitus has continued to the present day (5/17). Both have lessened in severity, and they were never crippling (I could still work and go about my business) but the constant, low-level pain is annoying. I also experience bouts of lightheadedness. Before the vaccine I had never had headaches or tinnitus.

Injection site immediately, pain and swelling. Starting the next day with onset of rapid symptoms including severe headache, extreme full body muscle aches and chills that felt painful as if had the flu, no fever, then the extreme tiredness hit where i had to lay down and sleep. I had to have my mom come get my young son because i couldn't even stay awake. muscle twitching in my calf muscles and my right thumb pad, post nasal drip started then stuffiness and that smell you smell when you are sick. So i slept hard for about 5 hours and when i got up i felt 80% better. The headache had been so bad when i opened my eyes it was very painful. My arm still is very tender and sore and swollen, but these symptoms were weirdly short lived. The most scary was the sleepiness that i couldn't control.

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

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

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

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

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

Extreme headache on left side of head, accompanied by eye twitching. Headache started a few days after getting vaccine and hasn?t gone away sense than. Went to doctor and got a ct scan and mri but couldn?t find anything. Even got three injections on left nerve on head and the pain did not dissipate. Pain medication only dulls pain once in awhile. Most of the time pain medication has not effect. I?ve had this pain for months and it?s not a coincidence that it started after getting the vaccine.

Left eye became swollen and red, then the eyeball (sclera) started to swell and bulge out and a vessel popped causing a red spot to the white of the eye.. Was significant for several hours, then slowly subsided over the course of the day.

At approxiamtely 1655 observation nurse reported 42 year old female with allergy to aspirin complaining of throat swelling and tounge swelling after receiving Janssen vaccine ( Lot # 204A21A) at 1653. Patient assessed, no visual swelling noted on evaluation. Patient denies difficulty breathing or difficulty swallowing. Vitals stable BP 130/80, HR 78, RR 18, O2 Sats 98% on room air. Patient was alert and oriented and in no visible distress. 1702- EMS called for further evaluation. Patient monitored while awaiting EMS arrival. 1720 EMS arrived. Patient assessed by EMS. Pt stable and refuses transport. Patient states she "feels better" and ?I don't feel it getting worse, I am OK". Patient discharged in stable condition in care of spouse. Patient educated to seek medical attention for any difficulty breathing, difficulty swallowing or any concerning symptoms.

I experienced ringing in my ears, pulsating ringing in my ears. I saw a doctor yesterday and I have an appointment with an ENT in two weeks.

In April I fell in the dollar store and I thought I cleared the shelf and fell. After that I had the balancing issues, after that I had eye pain. I did a CT SCAN and it was normal. I went to a eye doctor he thought the trulicity is what was making my eyes hurt. I called my PCP and told me to not to take it anymore. So, basically I was told it takes 3 weeks for it to get out of my system and it's been over a month and I'm still having the issues.

Developed a full feeling in left ear and tinnitus about 6 days post-vaccination. It felt like I needed to pop my ear, but it wouldn't.

Tinnitus - loud ringing in both ears. Have apt with hearing specialist this week. Ringing started as mild but has progressed to relatively loud ringing.

See description previously mentioned Saw practitioner May 24, treated for sinusitis w prednisone and antibiotic for 5 days. Cough returned on June 1. Saw practitioner again on June 7, treated with zpack and a prednisone for 5 days. Cough returned June 15 and I have not been back to the dr; waiting to be seen by PCP

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

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

First day nothing. Second day: tired; skin all over body was sore (like when you have a fever); headache. Third day: previous symptoms are gone but I have sinus pressure in my cheeks and my teeth are sensitive.

45 minutes after receiving vaccine, patient experienced numbness of her upper posterior palate and down her throat. This lasted about 4 hours and resolved without further treatment. No shortness of breath, rash or swelling noted per patient report.

Day of vaccine - Throat felt like someone was pushing on either side, numbness in sinuses (nose, cheeks, upper jaw, tongue), bad headache (almost immediately) Next day - congestion, bad headache, body aches, chills, coughing, more throat symptoms, numbness in sinuses

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

Roughly 8 hours later, mild headache that increased, followed by fatigue and sweating. Roughly 20 hours later I have a burning right eye that has continued into the day 3/17/21.

Headache, Myalgia, Arthralgia, Fever, metallic taste in mouth, dry mouth, loss of appetite, photophobia, fatigue Narrative: Other Relevant History:

Patient c/o "numbness et tingling" to lower extremeties. States she does not feel SOB at this time, states she has own EPI pen but has not given herself a dose. Nurse evaluated said person, noting HR is tachy, lungs clear et person states "I can breathe" Person then states, "My lips feel a little numb." Person asked for a bottle of water. Nurse asked the person is she felt she needed Benadryl or possibly an ambulance. Person stated, "If you tell me how to get to the ER, I will go there and get checked out." Nurse led person to ER where she states she no longer needed nurse's services.

hx of allergy to pineapple. Person started with itching to lips the same feeling she gets when eating pineapple. Urticiaria progressed to arms, legs, no visual hives. Person was given 50mg Benadryl PO by facility. 30 minutes later she was still itching. Person returned to work, but closely monitored.

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

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

30 minutes After receiving the vaccination, pt. right eye started to swell and pt c/o headache and tiredness, States swelling lasted about 2 days as well as the HA. Pt. took Benadryl and Tylenol both days.

Patient received Janssen vaccine and immediately reported feeling dizzy and blurry vision. Vital signs were monitored and were stable. Patient taken to private area to rest. Given juice and after 30 minutes reported symptoms were resolved.

Metal taste and smell immediately after injection First evening, chills and headache, sore swollen arm Next morning chills and headache, sore swollen arm Second evening, fever 101.4, chills, headache

Headache, chills, fever, congestion, cough, sore throat, loss of appetite, loss of taste and smell. Treated with acetaminophen and ibuprofen.

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

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

After 20 minutes the patient began to feel swelling in her mouth. EMS checked all vitals and they were all good. They looked inside her mouth and saw some swelling. At 2:05 the EMS gave a shot of Benadryl to patient. Patient was seen fine and working after.

At 1403, RRT was activated for a 43 y/o F with c/o feeling dizzy, ringing in the ear, vision spots, and stating, ?I?m about to pass out.? Very diaphoretic. Vaccinated at 1355 on the L arm. Vitals: BP ? 112/68, HR ? 72, RR ? 18, 0/0 pain. Head-to-toe assessment completed. No PMH, NKA, and did not take any medications today. During monitoring period, client?s condition improved. At the end of observation period, client did not experience what she was experiencing initially and felt much better. Client left vaccination clinic at 1432 ambulatory, in stable condition, accompanied by her family (Husband and daughter).

Metallic taste in mouth 14mins after injection. Minor tongue swelling, increased saliva production. Resolved within 3hours. No treatment or other medical intervention required.

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

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.

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.

I got the vaccine in my right arm and 8 minutes after getting vaccine I developed hives to my whole body and a scratchy throat. immediately was taken to my dr office and given benadryl

Normal adverse events right after initial injection: Headache, fever, chills Day 3: Tinnitus - ongoing Day 12: rash (looks like cigarette burns) in multiple locations- ONGOING. Currently one rash on each interior elbow, one on left ankle, one on left upper thigh, one on left glut. VERY itchy. Zyrtec and hydrocortisone being used as treatment.

March 13 & 14 - fever, fatigue, headache March 15 -18 headache (migraine like) March 19 - current date 1. severe debilitating headache, non-responsive to: immitrex migraine medication, Vicodin, flexaril, excedrin, or butalbital/acetaminophen/caffeine tablets 2. Blurry vision 3. Extreme light sensitivity April 7 - injection of Toradol (4 hours of relief) April 8 - current (4/13) Toradol every 6 hours with Tylenol supplements as needed between doses

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

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

Tingling in lower lip, bilateral lower extremity tingling & muscle aches, right forearm with tingling & muscle aches

Within 4 hours I experience chills, fatigue and a headache. Within 8 hours I had a fever and slept for the next 24 hours. I broke out in buckets of night sweats. The following 2 days I was generally fatigued and had sniffles. After that I was fine, until Monday night (Day 10). I suddenly experienced a sudden onset of a painful and raised red rash at the base of my spine on my lower back. Within hours it migrated up to my head, face and then to the front of my torso. My eyes and throat closed. I took benadryl with no relief. I called Dr. on Demand and they urged me if the symptoms got worse to head to urgent care/ER. The next day (Tuesday 4.13) I went to the ER where they gave me a steroid shot, and prescribed me predisone and Prilosec to block the histimines. I am still having rash symptoms,itchiness and burning. While I have a history of seasonal allergies they've always been stuffy nose at the most. We had no new dietary introductions or new habits.

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

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

Initial burning and pain left arm that subsided- try local chills/fever etc. But about four days after: severe throat ache, Full sinus infection and full asthma attack episodes. Lack of air

SWOLLEN EYES; HIVES IN THE EYES; ITCHY EYES; FEELING JITTERY; CONGESTION; This spontaneous report received from a patient concerned a 43 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: D41A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feeling jittery. On APR-2021, the subject experienced congestion. On 10-APR-2021, the subject experienced itchy eyes. Treatment medications included: diphenhydramine hydrochloride. On 11-APR-2021, the subject experienced swollen eyes. On 11-APR-2021, the subject experienced hives in the eyes. Treatment medications included: diphenhydramine hydrochloride. On 12-APR-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy eyes, swollen eyes, and hives in the eyes on APR-2021, and had not recovered from feeling jittery, and congestion. This report was non-serious.

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."

The patient was vaccinated at an outside clinic. She reports severe HA, tingling sensations in her tongue and face, mild exertional SOB, and fatigue.

Nueropathy (numbness weakness tingling) on right side. Loss of vision 30 minutes right side. Headaches, temple pain, sinus pain. Shots of random pain throughout body.

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

Numb left arm, intense headaches, inability to coordinate a fraise, pinches on the brain, blurred vision, problems to be focus. (attention problem)

First week after vaccine: fatigue, body aches, congestion, chills, loss of appetite. Ever since vaccine: chronic fatigue, body aches, joint pain, knee pain and swelling, tension and tightness in legs, tension and pain in neck, jaw, and head, headaches.

Developed ringing in the ears about 2-3 days after the COVID vaccine. Did not have ringing in the ears prior to getting the vaccine.

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

Tinnitus in the left ear started two days after the vaccine on April 12th. At the moment of this report, I have had constant tinnitus for 5 weeks. For treatment, I originally took homeopathic remedies and then switched to Sudafed for 10 days. While the condition has improved a bit, it's persisting. I have no history of tinnitus more than airplane ear/fullness when I feel tired or not hydrated enough.

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

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

I developed Covid after my J&J vaccine. I experienced cough all night, felt cold, runny nose and stuffy nose, congestion, felt low energy, and felt very tired. Then after two days later after my cold, I lost my sense of taste and smell. My symptoms lasted four-six days. I went to the doctor I got tested for Covid and was positive and within a week my symptoms started to go away. I have no symptoms today.

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).

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.

10 day long migraine headache located behind the left eye and left temple. Throbbing, recurrent pain. Accompanied by dizziness and visual changes.

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

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.

Mouth soars. Blisters that are in the back of my mouth started to come up in a few hours after the shot. Large in size.

head congestion, sore throat, severe cough, chills,low grade fever, lower back pain and fatigue. I had been having these symptoms that started with the sore throat on 6/24 and by 6/30 it was getting worse so I went to Urgent care and received a negative covid and strep test. Diagnosed with sinus infection and double ear infection. Antibiotic and cough syrup given. Felt better by 7/6 or 7/7 and cough nearly gone by 7/12 and returned to office. By 7/6 husband had same symptoms with same start with sore throat and congestion/cough that got worse. Family member visited with inside his home for 2-3 hours reported he became sick around 7/5 or 7/6 and was beginning to feel better by 7/10 when I checked on him. He also had the J&J vaccine he mentioned during that visit.

Uncontrollable shaking and teeth chattering, extreme weakness, fever starting at approximately 9pm the night of the injection. Shaking stopped when fever started. Fever broke by about 11am the following day. Weak and tired for 4 days following vaccine. Very thirsty.

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

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.

Approximately 24 hours after receiving the vaccine I felt like I had a mild flu with achy body and chills, I was tired and slept. This lasted for about a day. 48 hours after the vaccine my eye sight became blurry, my ears began ringing and my face became tingly around mouth and cheeks. The tingling is intermittent but the ear ringing and blurry vision has been fairly constant.

injection site pain/soreness: immediately during dose until 5 days after tinnitus: 22-36 hr post dose nausea: 22-36 hr post dose joint aches: 22-36 hr post dose tiredness: 36-72 hr post dose low grade fever (99.5 - 100.5 F): 37-72 hr post dose delayed or skipped menstrual period

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

Janssen COVID-19 Vaccine EUA swelling of lips, itchiness of palate and eyes; occurred within 15 minutes of vaccine administration and took Benadryl Allergy Liqui-Gels at vaccine site medical station

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

About 24 hours after shot, started having a headache. Took Tylenol, it helped Around 28 hours after shot, had fatigue, flu like symptoms- chills, felt warm feeling throughout body, nausea, headache. It lasted for about 8 hours. Had a taste in my mouth for about 12 hours after shot.

Relates "This was the worst Migraine I have ever had in my life" Reports she had chills and temp of 100.0 Had dizziness and sensitive to light Reports she was told not to take any Tylenol or Ibuprofen for 3 days Phone call to her provider and was told she could take something for her HA

Recipient call the employee health office approximately 24 hours after receiving vaccine stating that they had gone in to an emergency department for evaluation of symptoms. symptoms reported include fever, headache, chills, body aches and blurred vision. Recipient reports that ED physician evaluated her and sent her home with instructions to return in 72 hours if symptoms persist or sooner if symptoms worsen.

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

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

At 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

Treatment: Benadryl IM 25mg, Decadron 8mg IM Patient started feeling tingling in face about 40 minutes after injection, throat was scratchy and felt like closing off air. Tongue felt thick, eyes felt like they were swelling .

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

Johnson and Johnson vaccine. Dizziness, numbness and tingling left side of face, arm and hand. Ringing in ears.

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

Tongue whiter than usual with a reddish round patch near back of tongue. A little raw feeling on the reddish patch but not much discomfort. I did not burn my tongue or anything out of ordinary other than shot. I don?t know if it started this evening, but I noticed as I was brushing my teeth before bed. Left arm also still tender at injection site.

Pt received her vaccine at 1725 and proceeded to the monitoring area for her 30 minutes of monitoring. At 1755 pt c/o to RN of feeling itchy all over body. RN provided pt with diphenhydramine 25mg PO x 1 with water. No other c/o offered and pt's symptoms improved after taking diphenhydramine. Pt feeling better and discharged home at 1825.

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

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

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.

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

Had Janssen shot on April 2, 2021. No issues whatsoever until April 9, 2021 when I began having a horrible blinding migraine. Sensitive to light and noise. No over counter headache medicine was helping. Same night, a painful blue line, (like varicose vein) formed in left calf. On Tuesday, April 13, 2021 went to Dr. office who agreed that these reactions are a concern and went to Hospital.

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.

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.

12 hour flu symptoms starting ~8 hours after vaccine; headache and canker-sores appeared 1-2 days later and have lasted 1 week (as of now)

Dry throat immediately. Sinus pain, ear pain, teeth pain, and neck pain increasing. Injection site pain

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

Within 15 minutes of receiving my J&J vaccine, I experienced diarrhea. 12 hours later I ran a temperature of 37.5 and also had chills. On Sunday morning 04-11-2021, I had horribleheadaches and I took a Tylenol but it did not help. On Monday, Tuesday and Wednesday I again woke up with headaches and I felt extremely fatigued. I went to see my PCP who performed blood tests and also did a D-dimme test which the tests came back as being okay. I also experienced a full body rash and was having slight breathing issues. I also went to see an allergist on Monday 04-12-2021 due to my whole body rash, patchy skin, red and white bumps on my forehead. I was also concerned because at the inside of my mouth and upper pallet I had red bumps which lasted three days. I took me a whole week to recover from these symptoms.

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

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

Severe headache the day after injection, body aches, chills, dry mouth, fever, fatigue, dizziness, loss of taste, no appetite, quarter size bruise on L hip. Dr. advised that these are common vaccine side effects and could indicate possible viral exposure otherwise.

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

Tinnitus in both ears, worse in the left ear. The condition began as a periodic whooshing sound in one ear that lasted for a day or two, after which it became a constant ringing in both ears. I have not had tinnitus previously. Prior to the condition, I was not exposed to any loud sounds. I work from home at a desk in a quiet room and have done so for years.

Within 5 minutes, I felt like I couldn't swallow. My tongue got so big that it filled my entire mouth; throat closed. I started choking on my own spit. My hands got really big. I couldn't talk. The pharmacist told my friend to take me to the ER. I could kind of spit out stuff. She took me to Urgent Care. They gave me an epi-pen and instantly my tongue got small. Through an IV they gave me: Prednisone, Benadryl and fluids - by the time the IV was done I felt 90% okay. Four about 4 or 5 days - I would get fat fingers and itching. I would still have trouble swallowing - kind of choked when I swallowed. About 5 days after the event the allergy part was gone. I had three days of an oral steroid I was suppose to take and two weeks of Zyrtec. I did have flu-like symptoms also on the night of the vaccine. I had COVID in December 2020.

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

to Avoid Future Similar Events (EQUIP: note BEC, serial #) Pt received vaccination J&J at 12:58pm, within five minutes pt began to complain of itchiness and burning in her throat. Writer offered pt water, pt denied shortness of breath. Pt denied dizziness, no swelling or inflammation noted. Respiratory Rate 18/min. 1:10pm pt continued to complain of "dry and itchy" throat. Writer administered Benadryl 50mg via IM injection to right deltoid. Pt stated the itchiness and burning went away. Continued to monitor patient for thirty mins. Pt stated she felt better.

I experienced 12 hours later, had chills, body aches and then my feet were super cold but the rest of my body was super hot. I did not receive any treatment. I took OTC Tylenol for pain and by the next morning I felt about 80% better and then a few days later I developed a cough. I was then tested for Covid and tested positive on 04-12-2021. My symptoms with Covid lasted about 4 days, in bed was super tired. I also lost my sense of taste which lasted two weeks. I can say I am 90% better today just feel fatigued.

At day 9 after receiving the vaccination I started to have extremely itchy skin around mi mid area( thighs). At day 10, I was very dizzy/faint in the am. My eyes felt weird and The skin rash /itch was now at my thighs, hands and feet. In the pm my lips started to swell up and I noticed tiny red spots all around my stomach and back( lower and upper back). At that point i went to the ER.

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

Woke up next morning with buzzing/ringing in left ear. Thought it was from headache I had. Now every time I?m in silence I hear it.

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.

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.

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.

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

My tongue started tingling within one hour, I has a headache for a day and a half. I slept almost all day after the first 24 hours. My eyes started getting blurry, burning after 4 hours and are still bothering me. My tongue has been burning ten days after the vaccine on Saturday on June 26th. I need to see an opthalmologist now for my eyes. My appointment is on July 8th. The healthdepartment did not give me a information sheet about the vaccine or even put their sticker on my vaccine card. I have tried to call the health department and they are blowing me off.

HIVES LOCATED ON RIGHT AND LEFT BUTT CHEEKS WERE MILD AND ITCHY; MILD CHILLS; MILD FATIGUE; TINNITUS; BODY JERKING; FELT LIKE SHE WAS FALLING; CLOGGED SINUS FELT SUPER CLOGGED IN BILATERAL EARS; BODY ACHES WERE MILD AND LOCATED IN THE NECK AND SHOULDERS MOSTLY; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 125 pounds, and height was 64 inches. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no history of known drug abuse/ illicit. patient is not taking any medications, reports that patient is healthy. patient is not pregnant at the time of vaccination. The patient experienced drug allergy when treated with azithromycin. 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 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced body aches were mild and located in the neck and shoulders mostly. On 13-MAY-2021, the subject experienced tinnitus. On 13-MAY-2021, the subject experienced body jerking. On 13-MAY-2021, the subject experienced felt like she was falling. On 13-MAY-2021, the subject experienced clogged sinus felt super clogged in bilateral ears. On 13-MAY-2021, the subject experienced mild chills. On 13-MAY-2021, the subject experienced mild fatigue. On 14-MAY-2021, the subject experienced hives located on right and left butt cheeks were mild and itchy. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body jerking, and felt like she was falling on 08-JUN-2021, clogged sinus felt super clogged in bilateral ears on JUN-2021, body aches were mild and located in the neck and shoulders mostly on 25-MAY-2021, mild chills, and mild fatigue on 14-MAY-2021, and hives located on right and left butt cheeks were mild and itchy on 12-JUN-2021, and was recovering from tinnitus. This report was non-serious.

102 fever for two full days. Uncontrollable shaking in my body, intense headache, body aches, ringing in left ear, twitching in left hand, poor eyesight. . Extreme fatigue for 1 week after the shot.

Day after - headache and sore arm. Almost one month after began noticing taste changes with Certain foods, which then began to be smells of favorite things, and now more and more foods are tasting like detergent and things that I once loved smell like burning plastic.

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.

One month after vaccine was received, an allergic reaction began on 4/27/2021. Symptoms included swollen lips and mouth area, blistering and peeling of the skin on and around the mouth, pain and heat in the agitated areas. The symptoms appeared to be trigged by the use of a Chapstick with SPF but continued for 4 weeks after the initial response. A clean diet, OTC Zyrtec allergy medication in addition to a prescribed Anti-Inflammatory Montelukast prescribed for 4 weeks. A follow up is recommended once the medication regimen is complete and/or if additional symptoms appear.

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.

Rash consisting of red bumps on arms, face, between breasts, and a little bit on legs and feet. Also a terrible migraine-type headache on the left side with an unusual (for me) ocular disturbance. The rash seemed to appear first on my left arm, and the rash was worse on my left side (left arm worse than right, left side of face more covered than right). I cannot say exactly when on Saturday I noticed it. The bumps on my face itched terribly. I took Benedryl at night, by Tuesday morning it began to fade. The migraine appeared at approximately 2 PM on Saturday, July 10. I took my usual migraine medication, Sumatriptan. The headache presented with a sudden blurring and sense of pressure in the left eye. This headache and change in vision also persisted until Tuesday morning, July 13.

Body feels heavy like lead Very tired Minimal pain at injection site 2:18pm hands twitching and my right eye feels like it's swollen and burning closer to my cheek and then started twitching uncontrollably. Very dry mouth. Moments later body tremors and vomiting. Ended up being taken to the emergency room will elaborate later. Drink Sprite on the way home vomited it up as soon as I walked in the door. Not the feeling of nausea just the vomiting is coming. Took temperature have a fever of 101.0 DAY 2 Tremors while walking Headache Body aches Minimal taste Tingling around eye No real desire to eat Managed to keep some noodles down Today is Day 3 5:00am Still unsteady on feet when walking Still have headache and body aches

At 9:30 am felt warm, lower lip started to itch/burn, and scratchy throat. Flushed in face, ears, neck, upper chest, and shoulders. Was given .3mg Epinephrine IM with immediate results. Flushing and itchiness went away.

Systemic: Flushed / Sweating-Mild, Additional Details: Patient stated they felt sweaty and thirsty and said they felt like they were going to pass out, then said they felt fine once they took their sweater off and were given some water. EMTs were called and escorted patient out of the pharmacy. She refused epinephrine injection and did not want EMTs called.

10 hrs afterwards I had the worst chills I have ever had for 2 hrs then my body was on fire for 2 hrs. I was drenched in sweat had to change my clothes twice and a severe headache. I felt some mild discomfort in my breathing and I was extremely thirsty. All of this lasted about 5 hrs

The evening of the vaccine (I guessed around 6:00 p.m.), my ears felt like they became stopped up, especially the left. I still feel pressure. I feel like I can?t hear quite as well as before. I hear a high pitch sound when everything is quiet.

Extreme chills, body aches, headache, ear pain. Not accompanied by fever. Began 5.5 hours after injection . Chills subsided 10 hours after onset. Headache treated with ibuprofin 10 hours after onset.

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.

About 6.5 hours after injection I started to feel achy, fatigues, and weak. Chills and joint ache started about 8 hours after injection along with fever. Migraine type headache with sever teeth pain/ache. This all lasted until about 3-4am when my fever broke. Highest temp 101. This morning (day after injection) I feel better but still fatigued and weak. Injection site arm still sore.

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

I had burning with the actual injection. It burned as it went in and went down a small ways into my left arm. The rest of the day I had the normal symptoms- Pounding headache, nausea, horrible body aches (couldn?t lay down or stand to be comfortable). That night around 11:45pm I got up to let my dog in and I started seeing small black dots- blurry vision. I felt nauseas. I ended up falling on the floor. I was able to get up. I then ended up waking up in the bathroom on the floor and had no idea how I had gotten there. My hands were vibrating. I called my husband from work to come help me up. I was able to sleep and didn?t seek medical attention. I am not sure if it was low blood pressure or what could have happened I have never experienced that before. I did contact my doctor?s office this afternoon via (online) but haven?t had a response yet. I have been in bed all day today. - Body aches, nausea, pounding headache

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

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

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

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

Ear pain comes and goes, tingling and numbing body left side - is now gone. (vaccine was left side as well)

Initially started as nausea and dizziness within 20 minutes of the shot. I started running a fever that reached 100.4 that night. The fever continued the next day and stayed around 100.3 and went down to 99.4. Today (4/9) me fever has subsided. In addition to the what is listed I had, and continue, to have muscle soreness and pain in my stomach. I also have pain in my joints. I have also noticed that my vision is not clear is blurred and that continues. My stomach pain and pain in my legs continue at this moment and I am very tired.

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

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

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

Patient received her dose of vaccine and was in the waiting area for 5-10 minutes when she started to feel lightheaded and weak. She moved from her chair to lay down on the floor. I saw her do this and went over to check on he She reported being able to breath alright, but saw spots in her vision, very weak and had a full body sweat. After 5-10 minutes laying down she was able to sit up and drink some water and reported feeling tired but getting better. She was fully recovered from the episode after 20-30 minutes. No long term effect reported.

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

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

worse headache, neck pain, bodyache, chills, sweats, jaw pain, nausea, upper body rash, dizziness, lightheaded, insomnia,

Headache, leg pain, stomach pain and diarrhea and fatigue. Loss of appetite but Cravings for fruit...? So strange. Very thirsty.

Ringing in ears, dizziness, clogged ears started 7 hrs after vaccine and has not resolved. Please tell me this will go away and it?s not permanent!!

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

By 10 pm Saturday- severe joint/body aches, chills, headache ,exhaustion , pounding headache. Sleepy from 4pm Sat til 11:30 sun am Showered on Mon evening, Notice rash on injected arm Tues woke 630am feeling bit better then got exteremely dizzy 830am to the point I was stumbling cause it affected my vision. Became nauseous and had a severe headache Called doctor

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

The day of vaccination: Chills, temperature and severe headache. The next day: Blurred vision and dizziness for a few seconds. At 11 days: Blurred vision and dizziness for a few seconds

Approximately 24 hours after receiving the Janssen COVID-19 vaccine, patient experienced central vision loss or "white out" vision as she described it. She could still see things in the periphery, but her central vision went completely blank. This lasted for four to five hours and over time her symptoms gradually improved. She still has some double vision and difficulty focusing. Of note, she saw the eye doctor last month and had her prescription updated but has not picked up her new glasses. She only wears her glasses for driving and occasionally at work. She has chronic headaches and has not had any new/different headaches than before. No weakness, but her right leg did feel heavier than normal after receiving the vaccine.

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

BUMPS ALONG THE SIDE OF THE TONGUE; STRANGE MARKINGS UNDER FINGERNAILS; HEADACHE; DIZZY SPELLS; 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 was healthy individual at the time of reporting. 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 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 02-APR-2021, the subject experienced dizzy spells. On 02-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced bumps along the side of the tongue. On 04-APR-2021, the subject experienced strange markings under fingernails. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy spells, bumps along the side of the tongue, and strange markings under fingernails, and the outcome of headache was not reported. This report was non-serious.

Non stop joint pain in legs. Daily migraine unable to open eyes at times. Seeing silver waves constantly and vision has become worse

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

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

ALLERGIC REACTION; SWOLLEN EYELID; VERTIGO; RASH ON NECK; NAUSEA; EYES PUFFY; ITCHY EYES; EAR CLOGGED; EARACHE; RINGING IN EAR; SLEEPY; TIRED; HEADACHE; This spontaneous report received from a patient via Social media concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and pneumonia, and concurrent conditions included asthma, and high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNNOWN) dose was not reported, administered on 08-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced sleepy. On 08-MAR-2021, the subject experienced severe headache. On 08-MAR-2021, the subject experienced tired. On 21-MAR-2021, the subject experienced earache. On 21-MAR-2021, the subject experienced ringing in ear. On APR-2021, the subject experienced ear clogged. On 05-APR-2021, the subject experienced eyes puffy. On 05-APR-2021, the subject experienced itchy eyes. On 12-APR-2021, the subject experienced swollen eyelid. On 12-APR-2021, the subject experienced vertigo. On 12-APR-2021, the subject experienced rash on neck. On 12-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced allergic reaction. Treatment medications (dates unspecified) included: triamcinolone, ibuprofen, ciprofloxacin/dexamethasone, azithromycin, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing in ear, was recovering from earache, and nausea, had not recovered from, swollen eyelid, rash on neck, tired, and headache, and the outcome of vertigo, eyes puffy, allergic reaction, sleepy, ear clogged and itchy eyes was not reported. This report was non-serious.

RIGHT EYE CLEAR LIQUID SECRETION; RIGHT EYE WAS SWOLLEN SHUT; ARM SORENESS; REDNESS OF FACE; SWEATING; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced redness of face. On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced arm soreness. On 12-APR-2021, the subject experienced right eye clear liquid secretion. On 12-APR-2021, the subject experienced right eye was swollen shut. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right eye clear liquid secretion, and right eye was swollen shut on 12-APR-2021, and redness of face, and sweating on 11-APR-2021, and was recovering from arm soreness. 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.

DIZZINESS; FELT SLEEPY; MODERATE HEADACHE; NAUSEA; FELT TIRED; FEVER; BODY ACHES; MILD BONE PAIN; SENSITIVITY TO NOISE; NERVES ON NECK FEEL VERY TENSE; This spontaneous report received from a patient concerned a 45 year old female. The patient's past medical history included covid-19 infection, and concurrent conditions included high blood pressure, hypothyroidism, low vitamin d level, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no drug or non-drug allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 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 sensitivity to noise. On APR-2021, the subject experienced nerves on neck feel very tense. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced mild bone pain. On 10-APR-2021, the subject experienced felt tired. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced felt sleepy. On 11-APR-2021, the subject experienced moderate headache. On 11-APR-2021, the subject experienced nausea. On 13-APR-2021, treatment medications included: caffeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from moderate headache, and the outcome of body aches, fever, mild bone pain, felt tired, nausea, dizziness, felt sleepy, sensitivity to noise and nerves on neck feel very tense was not reported. This report was non-serious.

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

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.

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.

FELT RED STREAK UNDER ARM FROM SHOULDER; EAR PAIN ON RIGHT SIDE; HOARSE VOICE; LOOSE STOOLS; HYPERGLYCEMIA; SWEATING; LEFT BREAST BURNING; PALPITATIONS; LEFT ARMPIT BURNING; FELT RUN OVER BY A TRUCK; LEFT ARM SMELLS AND LOOKED LIKE AN AVACADO UNDER THE ARMPIT; TEMPERATURE 99.7-100.4; LEFT ARM DELTOID SORE/LEFT ARM SORE; This spontaneous report received from a patient concerned a 45 year female. The patient's height, and weight were not reported. The patient's past medical history included tick bite, and concurrent conditions included obesity, type 2 diabetes mellitus, hypertension, and anxiety. The patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 to left arm as prophylactic vaccination. Concomitant medications included fluvoxamine for anxiety, furosemide for hypertension, insulin degludec for type 2 diabetes mellitus, liraglutide for type 2 diabetes mellitus, sitagliptin for type 2 diabetes mellitus, and rosuvastatin. On 09-APR-2021, the patient experienced left arm smells and looked like an avacado under the armpit; she also felt run over by a truck. She had a temperature of 99.7-100.4 (unit unspecified) and had pain in left deltoid arm. On 10-APR-2021, the patient experienced palpitations, left armpit burning and left breast burning. On 11-APR-2021, the patient blood sugar was high 258 (unit unspecified) and experienced sweating and loose stools. On 12-APR-2021, the patient experienced ear pain on right side and had a hoarse voice. The patient had done lab tests at her physician's office; her blood sugar was 230 (unit unspecified), had palpitations at 144 (unit unspecified) and blood pressure was 157/95 mmHg. She was tested negative for covid-19 and had a sedimentation rate of 51(unit unspecified); her magnesium was at low level. She also did an unspecified lab test for lyme disease and was negative. The patient was prescribed with Nystatin cream and nystatin powder and she also took paracetamol (Tylenol) with no relief. The patient felt that she had a red streak under her arm from her shoulder and was going back to her urgent care; she also called her endocrinologist regarding her hyperglycemia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temperature 99.7-100.4 on 10-APR-2021, was recovering from left breast burning, left arm deltoid sore/left arm sore, sweating, and felt run over by a truck, had not recovered from left armpit burning, palpitations, hyperglycemia, ear pain on right side, loose stools, and left arm smells and looked like an avacado under the armpit, and the outcome of hoarse voice and felt red streak under arm from shoulder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210425219 -COVID-19 VACCINE AD26.COV2.S-Hyperglycemia .This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE

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

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

03/09/2021- I started to have mild sinus pain, headache and body ache 03/10/2021- This day my headache turned unbearable like a migraine, the pain shifted in my head, I had preasure around sinus, felt nausea and had body ache.. I took Advil cold and sinus multiple time b/c the pain was so bad. Inhaled menthol rub to try to fine soothes. Used ice to help my throbbing head ache. It lasted all day long. My mom took care of me massaging my head. Had I known know what I know I would have gone to the ER but I didn't at the time thinking the adverse reaction time for the vaccine had subsided. 03/11/2021- felt much better but weak and my vision seemed a bit off. I had a hard time reading things close to me as it was blurry. Current- I feel fine but my close range vision is blurry

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

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.

Developed tinnitus in my right ear that has not gone away. Onset of that condition happened around April 26-27. I do not normally have this condition. Also, received allergy shots in each arm since my vaccination, and both have resulted in large welt and subsequent bruising which has not occurred in the past year of having the same injections.

Shingles - zoster Headache , rush , severe pain , blisters in right side of torax, fatigue, diarrhea, sensitivity to light

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.

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

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

My arms became really sore and jaw started hurting. I also had a tingling feeling throughout my body and the migraine was very intensed. By the April the 12 and 20th had go to the ER. The symptoms did not sub-sized on the 21st of April.

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.

RASHES THAT BURN; RED ITCHY RASH; BURNING EYES; BUMPY RASH ON WHOLE BODY EXCEPT FOR FACE AND VACCINATION SITE; FELT VERY HOT ( LIKE HAD A FEVER); FELT TIRED; FELT A BIT QUEASY; MUSCLE ACHES; ACHES AND PAINS; 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 non-alcoholic, non-smoker, fibromyalgia, and allergic reactions to antidepressants, and other pre-existing medical conditions included patient had allergic reactions to antidepressants. the patient had no drug abuse or illicit drug usage. The patient experienced swelling of throat due to allergy when treated with erythromycin, and paroxetine hydrochloride. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included pregabalin for fibromyalgia, hydrochlorothiazide, and naproxen. On 16-MAY-2021, the subject experienced aches and pains. On 16-MAY-2021, the subject experienced felt tired. On 16-MAY-2021, the subject experienced felt a bit queasy. On 16-MAY-2021, the subject experienced muscle aches. On 18-MAY-2021, the subject experienced felt very hot ( like had a fever). On 19-MAY-2021, the subject experienced rashes that burn. On 19-MAY-2021, the subject experienced red itchy rash. On 19-MAY-2021, the subject experienced burning eyes. On 19-MAY-2021, the subject experienced bumpy rash on whole body except for face and vaccination site. The action taken with covid-19 vaccine was not applicable. The patient recovered from aches and pains, felt tired, felt a bit queasy, and muscle aches on 16-MAY-2021, had not recovered from bumpy rash on whole body except for face and vaccination site, red itchy rash, rashes that burn, and burning eyes, and the outcome of felt very hot ( like had a fever) was not reported. This report was non-serious.

- 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

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

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

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

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.

Cyst under right arm pit, Knee/toe/back pain, right arm tingling (falling asleep) at night, red painful bumps on legs, bumps in mouth, tired. Doxycycline started on 09Jul21. X-rays and bloodwork scheduled.

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.

Muscle pain (up to 7 days after vaccination) Joints and body pain (up to 11 days after vaccination) Weakness and dizziness (after vaccination until now) Tiredness (after vaccination until now) Chills (after vaccination until now) Headaches (after vaccination until now) I took Tylenol Eye pain (after vaccination until now) A blood vessel burst in my left eye on 7/7/21 and I still recovering from that.

PATIENT CAME TO THE PHARMACY ON 7/14/21 TO REPORT THAT HER RIGHT UPPER EYELID IS RED AND SWALLEN AND ON 7/9/21 HER PHYSICIAN TOLD HER ON VIDEO CONSULTATION THAT IS AN ALLERGIC REACTION TO THE COVID-19 VACCINE. PATIENT DID NOT SEEK ANY MEDICAL ATTENTION, SHE WAITED UNTIL 7/12/21 FOR HER PHYSICIAN TO MAIL HER EYE DROP (TOBRAMYCIN/DEXAMETHASONE). PATIENT STARTED TREATMENT ON 7/12/21. ON 7/14/21 WHEN PATIENT CAME TO THE PHARMACY TO REPORT THE INCEDENT, SHE WAS ALREADY GETTING BETTER.

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

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

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.

Fever, skin irritation/sensitivity, fatigue, brain fog, sore throat, gunky throat, headache. Significantly sore arm (going on 5 days)

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

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

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

my reaction was my left lower eye swollen, itchy after three hours shot. I had a fever, shivering, headache, body ache especially backache the first night, and then just healed up for my eye today.

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

Blurred vision dizziness nausea headache arm pain Extreme fatigue low-grade fever and chills. Have knot the size of a quarter on my arm at the injection site along with redness and pain. This was the one shot vaccine.

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

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

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

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).

8 hours of uncontrollable chills, shaking; terrible 8/10 headache, low grade fever, body aches, muscle spasms in legs and back, nausea and thirst

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

Several days after the J&J Vaccine I had a rash on my face and my lips became very swollen and turned a blueish gray color. Under my top lip there were several large dark red marks that were tender and swollen.

Patient received Johnson & Johnson 0.5ml Covid vaccine IM to left deltoid. While in observation area, patient reported nausea and "tingling throat." BP 170/120, HR 98. Patient began vomiting, observed to be scratching arms. She reported feeling itchy everywhere. 911 called. Patient reported tongue "felt funny" and throat felt tight. Epinephrine 0.3mg administered IM to left thigh at 10:50am. Patient reported almost immediate relief in symptoms after receiving Epinephrine. She was transported to local ED via EMS.

April 6: sore at injection site and left shoulder April 7: sore at injection site and left shoulder, headache, fever, chills, muscle aches, fatigue April 8: fatigue, intense pain in left arm- tricep/bicep/armpit area, sore in muscles & joints on left side only including left temple, jaw, arm, hip, thigh, ankle, and toe

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.

LEFT EYE SWELLING; LEFT EYE REDNESS; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a consumer 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: Unknown) dose was not reported, administered on 25-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced left eye swelling. On 25-MAR-2021, the subject experienced left eye redness. On 25-MAR-2021, the subject experienced body aches. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left eye swelling, left eye redness, body aches, chills, and fever on 01-APR-2021. This report was non-serious.

Fever, chills, diarrhea, sweating, muscle pain, fatigue, ringing in ears, pins and needles feeling in hands and feet. Very dizzy on day two accompanied by profuse sweating

Patient reported around 3:15pm that her tongue felt dry, tingly and had metallic taste. She denies trouble breathing. Gave patient a bottle of water and gave her a dose of Allegra 180 mg which she declined to take but agreed to keep with her. Observed patient over the next 30 minutes and during that time the patient reported a gradual improvement of symptoms. She spoke on the phone with husband whom is a physican and he told her to drink the water and thought she was fine. Patient declined EMS and going to the hospital across the street. Upon leaving she states that she is feeling normal and I advised her to call 911/md if any worsening of symptoms.

in about 5 hours after the shot, I started having very strong chills, body aches, headache, nauseous, eyes hurt, abdomen pain. Symptoms continued for about 20 hours (bed rest, not capable to do anything). horrible headache at night time. No fever. Felt chills and feeling hot sweating during the night. Took Tylenol 2 times. dull pain in the shot area, pain distributed under arms around breasts. tender breast and nipples on 3rd day (Sun) after the shot. Lost appetite for about 2 days (body weight 3 pounds less).

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

I immediately started exp symptoms asked to pull parking lot for observation. Then my arm left arm started throbbing to fingertips, metal taste exp no nausea I left. By that afternoon my joints, body throbbing, fever,chills, headache and extreme fatigue. For about 4 days I dint feel like doing my normal activities exp stomach cramps (feels like effect if on a rollercoaster almost sinking feeling) diarrhea and night sweats (full body under my boobs, back of my hair, at his point I have to sleep naked constantly changing bed sheets).I have never had night sweats don't know if it was hormones. I went to doctor did blood work for menopause I was recommended to follow up with doctor for my Ulcerative colitis. Also my doctor told me I'm in stroke level now I'm back on blood pressure medication haven't not any issues since 2 years ago.

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

In a few minutes are going to be 72 hours after the shoot. I had been experiencing severe headache many times during this days. I had take advil and acetaminophen for this condition. Also, I had experienced articular pain in arms and legs. Pressure in my chest yesterday in the afternoon. Muscular pain, pain in my left arm. And I had felt an unusual sweep in my hands and body. And I had felt a non normal condition of my nose, I feel like if I smell diferent, medicine or something like that. For that reason, I schedule an appointment for Covid test Tomorrow at 4 pm, to discard I don´t have the COVID. If somebody contact me please in language. Thank you.

Severe headache, muscle ache, nausea, tiredness, lack of appetite, extreme thirst, high fever for first 2 days. Could not get out of bed. 5 days later, still moderate tiredness, mild headache.

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

About a half an hour after injection my lips and tongue started tingling and swelling. Benadryl was able to control this. An hour after the injection I started to hurt and ache, which was expected. But it soon eclipsed the achy miserable feeling one normally gets with a flu shot. The left side of my body started having fibromyalgia nerve pain that was so severe I had no option but to lay in bed and endure it. The lightest touch felt like touching raw nerve endings similar to getting sugar into a severely bad tooth. I experience pain on a daily basis and this was something above and beyond any fibromyalgia pain or nerve pain I have experienced in the past. It was so bad, I would not have wanted to live the rest of my life in that level of pain. I took a Phenergan like I do for my chronic migraines and it allowed me to get some rest and thankfully in the morning it had mostly abated. I continue to have worse than normal fibromyalgia pain for 5 to 6 days after the injection.

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

Non-stop tinnitus. all day, everyday - I cannot concentrate. Horrible headache that won't go away with Advil.

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

LOST ALMOST COMPLETE FEELING IN ARM, PARTS OF FACE, EAR LOBES, CHEEKS, TIP OF NOSE,; LOST ALMOST COMPLETE FEELING IN OUT SIDE OF LIPS; 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: 201A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced lost almost complete feeling in arm, parts of face, ear lobes, cheeks, tip of nose. On 06-APR-2021, the subject experienced lost almost complete feeling in out side of lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost almost complete feeling in arm, parts of face, ear lobes, cheeks, tip of nose, and lost almost complete feeling in out side of lips on 06-APR-2021. This report was non-serious.

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

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

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

Patches of extreme dryness started inside front lower lip and left and right upper lip where lip touches gums 04/03/21 to present. Pain and ulcer appeared inside lower lip/gum 04/09/21. Dry areas of lip tissue sticking to gums. Red left eye on 04/09/21 for about 4 days. No itching or pain. Joint pain in hands, knees, and ankles starting approx. week after to present. Dry eyes and nasal passages for last week. Saw Dentist on 04/09/21 for dry mouth patches and mouth pain. Miracle mouthwash prescribed. Mouth symptoms improved not eliminated to date.

PATIENT SAID DAY AFTER SHE FELT DIZZY, HAD BLURRY VISION, NAUSEAM AND BAD HEADACHE. THE NEXT DAY SHE WAS FINE. A WEEK LATER ON DAYS 8 AND 9 POST VACCINE THE ABOVE SYMPTOMS RETURNED WITH A VENGENCE. PATIENT WAS UNABLE TO GET OUT OF BED, COULD NOT READ A BOOK DUE TO BLURRY VISION. OVER THE COUNTER MEDICATION DID NOT RELIEVE HER PAIN

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

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.

Middle of the night woke up with chills, sweats. Lasted for the night. Took Tylenol. I no longer have a fever. Headache that started at 4am on 4/13/2021 and lasted throughout the day. I have been having headaches on and off throughout the week. I have had a metallic taste in my mouth for about a week with increased heartburn. I am still having these symptoms. Increased fatigue.

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

I have no sense of smell, and taste. I had a great sense of smell before the vaccine. Now I cannot smell anything

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

Around 2 pm that day (Friday, April 9th) I got an extremely bad headache and ringing in my ears. By 4 pm I had a fever of 100.7, really bad shaking chills, body aches, and nausea. My chills went away by the next day. My fever, bad headache, and ringing ears continued. My fever reached 101 but never went over. It lasted until Sunday evening. It has been 2 weeks and 1 day and my headache has never gone away, though it is manageable and mild now, although it was really bad last night. My ears/head continue to ring non-stop. Nothing helps with that.

Injection received around 10:45 AM on 4/12/2021. By 10:00PM that night I noticed the development of Tinnitus. It has been constant and nonstop sense.

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

Right after the vaccine I had a metallic taste on my mouth it went away till midnight. Later on that day I also had lost of taste and smell that went away about 3 days later. I also experienced fatigue and a sever headache. My headache has not gone away. I contact my neurologist this morning and they will do an MRI on me they will call me back with my appointment information.

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

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

Site: Pain at Injection Site-Mild, Systemic: Fever-Mild, Systemic: Pin the throat/ear and back (only on right side) , coughing -Mild, Additional Details: patient complaining of pain in the back on the right side since Day 1. Fever developed on 2nd day, but recovered. Also pain in throat/ear, stuffy nose, and coughing, but minor.

I experienced extreme teeth and jaw bone pain for a couple days after the vaccination, until I started taking antibiotics. It might be unrealted.

TREMENDOUS HEADACHE LIKE MIGRAINE; MILD PAIN IN THE INJECTION SITE; MILD ALLERGY; TIGHTNESS OF CHEST; FLU LIKE SYMPTOMS; THROAT FELT FUNNY; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to dust, and acid reflux. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced tightness of chest. On 08-APR-2021, the subject experienced flu like symptoms. On 08-APR-2021, the subject experienced throat felt funny. On 08-APR-2021, the subject experienced mild pain in the injection site. On 08-APR-2021, the subject experienced mild allergy. Laboratory data included: Body temperature (NR: not provided) 102.5 F. On 09-APR-2021 03:00, the subject experienced tremendous headache like migraine. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tightness of chest, throat felt funny, tremendous headache like migraine, mild pain in the injection site, and mild allergy on APR-2021, and flu like symptoms on 2021. This report was non-serious.

3/28/2021 12:45pm Shot received as part of 1200 had gotten access to. It felt like fire in my arm at the point of the shot and moving down toward my wrist. It was cold and rainy, and I had taken my arm out of my sweater and the sleeve had gotten a little damp. I put my arm back in the sleeve and the cool damp sleeve made my arm feel better while I was observed and then drove home. 3/28 3pm I got home and the arm the shot had been given in was sore ? the aches seemed to move across my shoulders and all over my body. 3/28 10pm ? 7:30 am, Over the course of the evening, the aches seemed to get worse and I developed a headache, so, I took 2 tylenol and went to sleep.overnight I had severe chills. 3/29 7:30 am I took 2 Alkseltzer Cold & Sinus (tylenol and decongestant) and laid back down. Around 9am I had a glass of juice ? I was extremely thirsty and this helped. 3/29 11:30am The headache and body aches continued, but the chills seemed to break with a trade to cold sweat. I took 2 more Alkseltzer Cold & Sinus (tylenol and decongestant) and got up. 3/29 3:30pm The headache and aches continue, I took 2 aleeve to manage the headache and body aches. 3/29 6:30pm the body aches and headache are better but not gone. Cold sweats starting again 7:30 ? 2 more tylenol. 3/29 11:30 2 tylenol for bed ? slept through the night no problem. 3/30 ? 8am: Woke up still achy, but the headache is significantly reduced, started feeling a little dizzy and periodic cold sweat 3/30 ? 6:30 pm still a little dizzy and marginally achy 3/31 ? 8am: mostly back to normal. The spot on my arm is still raised and tender, but in general, I feel like I did before the vaccine, suffering seasonal allergies sinus congestion and headaches. My eyes are very tired, I?m having a hard time pulling things into focus or looking at screens ? the headache on Monday was a migraine complete with severe light sensitivity. Wearing readers with blue light blocking helps my eyes feel better. 4/1 ? arm still sore at location of shot, going to continue using scar cream on bump where shot was given. Eyes still a little weak/tired. 4/3 ? arm finally quit hurting ? still sore, but not actively in pain at site of injection.

On the night of the 17th, I couldn't open my jaw very well. The next morning, it had worsened and I could only open my mouth about a half an inch. It only hurt on the left side, under my ear. I called and talked to the advise nurse. The doctor told her I could wait until the next day to be seen. The next morning, I could open my jaw and it was getting better, so I canceled my appt. By Tuesday, it was gone. I've never had this to happen before.

DIZZINESS; NAUSEA; LOSS OF SMELL; LOSS OF TASTE; JOINT PAIN; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid19, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known drug allergies and had no breastfeeding. The patient had emergency room for an allergic reaction 10 years ago. The patient took an unspecified high blood pressure medication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1820095 and expiry: 04-JUL-2021) dose was not reported, administered on 28-MAY-2021 18:30 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: COVID-19 (NR: not provided) Positive. On 29-MAY-2021, the subject experienced loss of smell. On 29-MAY-2021, the subject experienced loss of taste. On 29-MAY-2021, the subject experienced joint pain. On 30-MAY-2021, the subject experienced dizziness. On 30-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from loss of smell, loss of taste, and joint pain on 29-MAY-2021, and had not recovered from dizziness, and nausea. This report was non-serious.

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

Moderate (RA) pain flared in multiple joins approximately 6-7 hours after injection (given on 6/3). This is unusual because I typically do not get pain in a lot of joints at one time. Individual knuckles on fingers, wrists, hip, neck, shoulder, knees and ankles. Morning after injection (approx. 16 hours): joint and muscle aches, low grade fever (99; I typically am at 97.4-97.8), moderate malaise and fatigue. Headache, eyes ached, mild nausea, stomach upset and diarrhea. Could not stay awake. Symptoms subsided greatly 30-32 hours after vaccination. Fatigue persists, but is minor; goes away with short rest.

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

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

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

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

REQUIRING NAPS ALMOST DAILY; WOOZY FEELING/BROWN OUT; DEPRESSION; DOES NOT FEEL LIKE HERSELF; LACK OF ENERGY; HEADACHE; LETHARGY; HARD TO TAKE A DEEP BREATH; WEIGHT GAIN; METALLIC/NUMB TASTE IN MOUTH; SWELLING; LOWER BACK PAIN; STOMACH CRAMPING; BODY SORENESS; ALMOST PASSING OUT; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause. The patient experienced anaphylaxis when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 005A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced lethargy. On 15-MAY-2021, the subject experienced hard to take a deep breath. On 15-MAY-2021, the subject experienced weight gain. On 15-MAY-2021, the subject experienced metallic/numb taste in mouth. On 15-MAY-2021, the subject experienced swelling. On 15-MAY-2021, the subject experienced lower back pain. On 15-MAY-2021, the subject experienced stomach cramping. On 15-MAY-2021, the subject experienced body soreness. On 15-MAY-2021, the subject experienced almost passing out. On 15-MAY-2021, the subject experienced woozy feeling/brown out. On 15-MAY-2021, the subject experienced depression. On 15-MAY-2021, the subject experienced does not feel like herself. On 15-MAY-2021, the subject experienced lack of energy. On 15-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced requiring naps almost daily. Laboratory data (dates unspecified) included: Weight (NR: not provided) 16 pounds gained. Treatment medications (dates unspecified) included: caffeine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from woozy feeling/brown out, headache, lower back pain, stomach cramping, body soreness, depression, and hard to take a deep breath, had not recovered from lethargy, weight gain, metallic/numb taste in mouth, swelling, lack of energy, does not feel like herself, and requiring naps almost daily, and the outcome of almost passing out was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious

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

Intermittent tinnitus. Previous to injection, would experience 5-10 second high-pitched ringing sounds in ears once or twice a year. Since the vaccine, I've experienced them 5-10 times per week. It's not causing problems, but it's been noticeable and began a couple days after the vaccine. 6 weeks later, and this pattern continues with only a small drop-off in frequency. Again not a disruptive problem, but if this information can assist in finding patterns or helping others with more disruptive issues, I felt it my responsibility to report this side effect.

BURNING HEADACHE; BLURRY VISION; DIZZINESS; This spontaneous report received from a patient concerned a 46 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: 1821288, expiry: UNKNOWN) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced dizziness. On 20-JUN-2021, the subject experienced blurry vision. On 02-JUL-2021, the subject experienced burning headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning headache, blurry vision, and dizziness. This report was non-serious.

NUMBNESS IN RIGHT HAND AND FINGERTIPS; TINGLING IN RIGHT ARM AND FINGERTIPS; TINGLING IN LEFT ARM AND FINGERS; DRY MOUTH; COULD NOT EAT MUCH; FELT LIKE A TRUCK HIT; INJECTION SITE WAS RED AND RAISED FOR 3-4 DAYS; BAD HEADACHE; NAUSEA; INJECTION SITE WAS RED AND RAISED FOR 3-4 DAYS; WHOLE BODY ITCHED; INJECTION SITE WAS ITCHY; BIG HARD LUMP AT INJECTION SITE LIKE A MOSQUITO HAD BITTEN; 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. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced big hard lump at injection site like a mosquito had bitten. On 02-JUL-2021, the subject experienced injection site was red and raised for 3-4 days. On 02-JUL-2021, the subject experienced whole body itched. On 02-JUL-2021, the subject experienced injection site was itchy. On 02-JUL-2021, the subject experienced injection site was red and raised for 3-4 days. On 02-JUL-2021, the subject experienced bad headache. On 02-JUL-2021, the subject experienced nausea. On 04-JUL-2021, the subject experienced tingling in right arm and fingertips. On 04-JUL-2021, the subject experienced tingling in left arm and fingers. On 04-JUL-2021, the subject experienced dry mouth. On 04-JUL-2021, the subject experienced could not eat much. On 04-JUL-2021, the subject experienced felt like a truck hit. On 05-JUL-2021, the subject experienced numbness in right hand and fingertips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site was red and raised for 3-4 days, injection site was red and raised for 3-4 days, bad headache, and nausea on 04-JUL-2021, and tingling in left arm and fingers on 07-JUL-2021, was recovering from whole body itched, and injection site was itchy, had not recovered from big hard lump at injection site like a mosquito had bitten, numbness in right hand and fingertips, and tingling in right arm and fingertips, and the outcome of dry mouth, could not eat much and felt like a truck hit was not reported. This report was non-serious.

5 min after shot became starting feeling unwell became faint had to lay down , was very hot, hearing was impaired , could not sit up for a few minutes.

Pt complaint of numbness and tingling to upper lip area 30minutes after vaccine given. Pt did complete 15+ minutes of observation in the waiting area at the vaccine site. Pt did go to her car then came back into the vaccine site to report her symptoms. O2 @ 2L/min applied. Deep breathing encouraged. No s/s of anaphylaxis occurred. Respirations easy, skin warm and dry. Pt did present with increased anxiety prior to receiving the injection. No worsening of symptoms. Family on site to transport patient home. EMS was on site. No transport to local ER needed.

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

Started with a cramp feeling next to my left shoulder blade, Then the feeling moved up my left side of my neck (like I had slept wrong) and began giving me a headache. Because of this, I was getting nauseous and fever spikes. Then about 3:30am, I had water like diarrhea. After that, I started to feel dizzy (I was fine as long as I still) with cold chills along with being very tired. When I got home, I took some Ibuprofen and took a nap (4 hour nap). Began to feel much better. When I woke up, I felt better but still had a stiffness in my shoulder blade area and left side neck.

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

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

Severe fatigue 36 hours after injection Within 48 hours of the injection, I regained my sense of smell, which I lost 20+ years ago due to chronic sinus infections and polyps. On 04/03/2021, I could smell water, shampoo, soap. I have not had such an acute sense of smell in decades.

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

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

On night of vaccine (4/6) she reported severe body aches and fatigue. On 4/7, she also had her ears and collar bone hurt. Then 4/8, She had numbness to forehead and back of head with shoulder pain.

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.

The next morning after the vaccine I woke up with my ears ringing, a bad headache, was really tired and not feeling well. My arm was so super sore I couldnt lift it over my head. On 3/10 the headache was still there but I felt a little better. But the ringing in my ears has been since day one and the headaches have been off and on as well since then also and on 3/25 I couldnt take it anymore so I went to see my PCP who referred me to an Audiologist but that appointment isnt until 4/29

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

About 20 minutes after the injection, I had numbness in my lips and cheeks (it felt like pins and needles). Over the next 10 minutes, I noticed swelling in my throat (swallowing felt somewhat obstructed). These persisted for an hour or so until I took Benedryl which seemed to ease the numbness but the swollen throat persisted..

Lips and jaw felt significantly numb and tingly, dizziness and faint feeling, approx. 30 minutes after injection. Symptoms lasted about an hour. Pharmacist had instructed me to wait 15 minutes after injection in case of a reaction, which I did. I felt fine when I left the store and got into my car, but while driving home, I began to have the symptoms described above. I pulled into a hospital ER parking lot and stayed in or near my car until the symptoms subsided. I called my GP and talked to a nurse, who said if I could breathe and swallow, I was safe to go home. I did not enter the hospital ER or seek medical treatment because the symptoms did not get worse. After returning home and waiting about another hour, facial numbness completely subsided.

SWOLLEN ALMOND SHAPE SPOT UNDER RIGHT EYE; INJECTION SITE PAIN; 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 allergy to contrast dye. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced swollen almond shape spot under right eye. On 06-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain, and had not recovered from swollen almond shape spot under right eye. This report was non-serious.

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

Weirdly despite a right arm injection - left arm ache and left thigh muscle spasms started a few hours afterwards. At 7pm heavy sweat and slight fever. During course of evening nausea, neck, shoulders and lower jaw severe ache by morning. Small sores (the little bubble kind) similiar to mild food allergy broke out on inside bottom lip only and passed only when soreness left lower jaw near late afternoon. Felt better by 5pm. Slight muscle aches in left arm, shoulders & tiredness remained through following day April 2. As of today, 4/12 - I'm having the heavy flow menstral cycle of a freaking teenager. Not fun. I'm accustomed to a very light period at my age not the uteras ripping heavy flow of those first 20 years. Hoping this is a one time deal.

Sudden sensorineural hearing loss (SSNHL) in left ear, beginning 8-9 days after vaccine on March 19th Friday. Symptoms of fullness, muffled hearing, sensitivity to sound. This was coupled with increased/exacerbated tinnitus in both left and right ears. Hearing test and physical exam done by ENT on March 22 Monday showed a loss of hearing in low frequencies in left ear of up to 40 DB. Treatment with steroids was initiated (prednisone 50 mg for 7 days, 30 mg 1 day, 25 mg 1 day). Follow-up visit to ENT on March 31 showed improvement in hearing nearly back to levels prior to the SSNHL; however tinnitus remained elevated. Prednisone was continued at 40 mg for 1 week with taper.

Patient complained of subjective lip swelling and throat feeling itchy. Physical exam unremarkable, no rash, no difficulty of breathing no stridor no lip or tongue swelling VS 97% O2, HR 91 Given 25 mg of Benadryl, watched for one hour and had complete resolution of symptoms. Discharged home

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

Since receiving the vaccine, I have had severe tinnitus and also developed vertigo. Two bouts of vertigo since the vaccine was given. Severe dizziness, nausea, vomiting.

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.

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

Initial symptoms on days 2-3 were fatigue and mild dizziness. Starting yesterday, 6 days after treatment, my ears began clogging. It comes and goes, but is noticeable. Given the current events it made sense to report since it is also accompanied by mild cold symptoms affecting my sinus area. No headache or other pain currently. Breathing is normal.

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

Janssen COVID-19 Vaccine EUA. I had a red spot appear in my left eye on 4/10. On 4/11 my fever increased to 101 and it felt as if I had a severe case of the flu. On 4/12 I felt fatigued, no fever. No appetite each day. 4/13 the injection site is still sore, red, and swollen.

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

Leg pain; Charlie horses in both legs & severe headache & fatigue. Leg pain started the evening I received my injection around midnight. It has lasted for over a week. Let pain continually through out the day & Charlie horses at night in both legs more my left and as the week progressed in my feet as well. Severe headaches on the right side of my head beginning started around 48 hours after the injection. Throbbing, stabbing pain radiating down my temple, side of head down my neck and into my shoulder blade. Rest, lots of fluids & migraine medication at the highest dose allowed to take.

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.

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

Chills: uncontrollable shivering for 2 hours (started 6 hours following vaccine) 103.6 fever max (fever varied) lasted 9 hours (started 7 hours after vaccine) Muscle/joint aches lasting for 16 hours (started 11 hours after vaccine) Severe migraine: extreme sensitivity to light and forehead pain lasting for 22 hours ( started 12 ish hours after vaccine) All symptoms disappeared in order of appearance 34 hours after vaccine.

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

About 4 days after I started having abdomen pain, it was like having contractions, then bleeding and spotting, and it was a different type of color instead of a period color, more burgundy. it lasted 26 days, when I'd eat it would start again, I started having headaches, and had vision problems, then SOB started and I used the inhaler to help. I also had a low grade fever of 99.8 - 100 that lasted up until about 5 days ago. I started having bruising and leg pain, the bruising would be if someone helped me get up, I have little bruising dots over my body. I went to the ER 3/16/2021 because the stomach and headache pains, they did a MRI and Ct and said it was acute stomach pain and migraines and told me to see a OBGYN for the bleeding and gave me meds for stomach pains. Bentel for stomach and Floraset for headaches but it never worked. I had a nerve block on my head for the migraines but it didn't work. The GYN gave me something to stop the bleeding and she's wants to do a D&C. I'm waiting to see my PCP on the 19th. I still have the purple dots and headaches, I still get the contractions and the stomach issues have settled some.

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

The inside of my mouth felt scalded starting about 20 mins post injection. The roof of my mouth was numb, my tongue felt burned, and my lips were slightly numb. I had no swelling or airway restriction. My tongue still feels slightly burned. I also had terrible heartburn and digestive problems the first 5-7 days. I am still very fatigued and the injection site is still tender (the injection felt like I was having a marble injected into my arm).

Lightheaded immediately and almost passed out. Felt a tingling in both hands. Metallic taste in mouth for about an hour. 8 hours later had the chills, body aches, headache, sinus pressure, and blocked ears. I developed tinnitus in both ears 24 hours after the shot and it still hasn't resolved 16 days later.

BODY ACHES; TINNIUTS; HEART RACING; TACHYCARDIA; DIZZINESS; SWEATING; CHEST TIGHTNESS/CHEST PRESSURE; BRUISING AT INJECTION SITE; HEADACHE; MYALGIA; FATIGUE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to bees.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced tachycardia. On 01-APR-2021, the subject experienced dizziness. On 01-APR-2021, the subject experienced sweating. On 01-APR-2021, the subject experienced chest tightness/chest pressure. On 01-APR-2021, the subject experienced bruising at injection site. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced myalgia. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021 14:00, the subject experienced tinniuts. On 01-APR-2021 14:00, the subject experienced heart racing. On an unspecified date, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, sweating, chest tightness/chest pressure, bruising at injection site, myalgia, and fatigue on 04-APR-2021, dizziness on 01-APR-2021, and headache on 03-APR-2021, was recovering from heart racing, had not recovered from tinniuts, and the outcome of body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

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.

Headache 1st day-6pm to 11am, Feverish off & on since shot,. Headache 3rd day-12pm to 3pm , Headache 7th day-5pm to 10pm. 7th8th9th day- leg pain from hip all the way to foot. Could not stand or put pressure for very long. Vision blurry after 2nd day. Still blurry.

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

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.

BLURRY VISION; WEAKNESS; FELT SICK; TIRED; COULDN'T MOVE; DIZZY; 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 non-alcoholic, non-smoker, no cholesterol, and varicose veins, and other pre-existing medical conditions included no known drug allergies and had a watch on eating. family history of varicose veins, thrombosis and blood clots. patient is healthy and exercise regularly. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced couldn't move. On 16-MAR-2021, the subject experienced dizzy. On 16-MAR-2021, the subject experienced felt sick. On 16-MAR-2021, the subject experienced tired. On 18-MAR-2021, the subject experienced blurry vision. On 18-MAR-2021, the subject experienced weakness. Treatment medications (dates unspecified) included: ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't move, felt sick, and tired, had not recovered from dizzy, and the outcome of blurry vision and weakness was not reported. This report was non-serious.

Client received Jansen Covid 19 vaccine, while heading to the car client developed a "tingling" feeling on lips and down her throat and some tingling on he hands. client evaluated by nurse and on-site EMT. Vitals signs BP 140/100, 162/95 p 69. Client reported a history of anxiety and hypertension. 911 was called, EMT evaluated and client was not transported to the hospital.

Fever, chills, shakes, burning sensation, body and backache, headache day of vaccine. Migraine day 2. Muscle pain x 10 days. Fatigue Day of vaccine x7 days. Alteration of smell day of vaccine to current date.

Persistent severe headache along with blurred vision. The headache has not resolved since a few days after getting the vaccine.

Approximately two weeks following vaccine, constant tinnitus. Previously had occasional tinnitus but since vaccine, it is constant

May 8, 2021 - in addition to headaches, fatigue, dizziness. Left ear pain started at 3PM, and left cheek/face became numb. (Like novocaine wearing off) May 9 - same symptoms as above, but left neck became numb May 13 - same symptoms as above dates persist on Day 8 post shot.

LIGHT SENSITIVITY TO EYES; BLURRED VISION; VISION CHANGES; 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 connective tissue disease, polyglandular failure (type 2), and raynaud's disease, and concurrent conditions included fibromyalgia, chronic hashimoto's disease, chronic lyme's disease, hypophosphatasia, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with clindamycin, codeine, lansoprazole, and glycopyrronium bromide. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced light sensitivity to eyes. On 10-MAY-2021, the subject experienced blurred vision. On 10-MAY-2021, the subject experienced vision changes. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from light sensitivity to eyes, blurred vision, and vision changes. This report was non-serious.

I had a blood vessel in my right eye rupture. The white of my eye is blood red. I did not have any event which would have potentially caused this. I do not know if it is related, however I thought it was worth mentioning.

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.

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.

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.

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

I started itching and found hives on my ankle. It started at my ankle and it moved all the way up to my head and face. My eyes became swollen. I was told to take Benedryl by my doctor. It took three days to clear. It returned a week later. I followed the previous request and took more Benedryl. It cleared and returned again last week. I called the CDC and they informed me that the hives may come and go.

Day 1 *Shot rec'd at 1:10pm *10-15 minutes later tip of tongue started tingling & started sweating - told provider I was either having a reaction to shot or anxiety attack (felt quick drop in blood pressure, profuse sweating & thirst, felt faint) - provider offered water & a fan & asked me to wait another 5-10 minutes under observation to see if it passed * Intense reaction diminished by 2:30, but tongue & fingers and toes remained tingling * Headache & body aches started almost immediately after injection, but didn't increase until about 6:30p * Around 6:30p, went to bed with sudden spike in fever, chills, body aches (joints, back, neck), intense headache * Fever spiked between 99-104 & intense side effects through the next 6-7 hours (usually run about 97.4 on current thermometer) * Vomited twice * Two ibuprofen slightly relieved discomfort & pain and fever didn't spike as high after 10p Day 2 * Improvement - Side effects more in-line with what I'd expected - slight fever spiking throughout the day, headache, muscle aches, arm pain, fatigue, lack of appetite Day 3 * Improvement from day 2 - no fever, lessening headache & muscle ache, increased arm pain

May 8, May 23, May 27 and June 4th, 2021 I have experienced random, severe lip swelling. The swelling varies in the upper and lower lip and the tissues above and below the lips. The swelling will last a day or two. Eye swelling also occured on 5/27. I take Benedryl to decrease the symptoms. I have not had lip injections, and have never had this swelling prior to the vaccine. It does not seem to be related to any food allergy. I have photos of the occurrences.

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

Muscle aches - entire body - 36 hours Jaw pain - 36 hours Headache - 36 hours Nausea - 12 hours Vomiting - 6 hours Fever/chills - 24 hours

SUBCLAVICAL LYMPH NODE SWELLING ON THE LEFT SIDE; RAISE AND TENDER ON THE RIDGE OF JAW; TENDER ON THE NECK WHEN PRESSED HURTS; LITTLE BIT WARM SWELLING ON THE RIDGE OF JAW; WARM SWELLING ON THE NECK; FATIGUE; BODY ACHES; FEVER OVER 101 DEGREES; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced body aches. On 07-JUN-2021, the subject experienced fever over 101 degrees. Laboratory data included: Body temperature (NR: not provided) Over 101 degrees. On 08-JUN-2021, the subject experienced subclavical lymph node swelling on the left side. On 08-JUN-2021, the subject experienced raise and tender on the ridge of jaw. On 08-JUN-2021, the subject experienced tender on the neck when pressed hurts. On 08-JUN-2021, the subject experienced little bit warm swelling on the ridge of jaw. On 08-JUN-2021, the subject experienced warm swelling on the neck. On 08-JUN-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 09-JUN-2021, and fever over 101 degrees on 08-JUN-2021, and had not recovered from subclavical lymph node swelling on the left side, raise and tender on the ridge of jaw, fatigue, tender on the neck when pressed hurts, little bit warm swelling on the ridge of jaw, and warm swelling on the neck. This report was non-serious.

June 5 - Trigeminal Neuralgia like pain in left lower jaw June 10 - Sores developed on lower left gum - started regimen for Shingles

Rash all over hands, arms and chest area that appeared the next day and has remained. Also since the vaccine I have had no taste or smell.

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).

SHAKING FROM THE HANDS; VISION SEEMED TO BE BLURRED; SPASMS IN UPPER ARM REGION; 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: 1808980 expiry: 04-AUG-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced shaking from the hands. On 12-APR-2021, the subject experienced vision seemed to be blurred. On 12-APR-2021, the subject experienced spasms in upper arm region. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking from the hands, vision seemed to be blurred, and spasms in upper arm region. This report was non-serious.

Within 2 minutes of administering patient reported feeling lightheaded. Before I could get patient laid down she slumped over in her chair and then became unresponsive. Patient does have history of seizures but there was no tonic clonic activity, this was more of a syncope type event. Patient was laid down and become aware and responsive within a couple minutes but pupils remained dilated. Patient reported continued to feel nauseous, had a headache, shaky and blurry vision. Vitals were taken Pulse- 84, Spo2 - 99 Blood pressure-124/70 Blood Sugar-99. Patient was monitored for 2 hours before feeling well enough to leave.

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

Severe flu-like symptoms, including chills, ache, and headache Metallic taste in mouth Injection site swelling and pain

1 minute after vaccine received, patient reports feeling mild tongue numbness. Patient denies respiratory distress. Patient given Certirizine 10 mg 1 tab oral. Pt able to hydrate with water. Patient advised to follow up with primary care provider and to call 911 if symptoms persist or experience respiratory distress. Patient instructed to take Acetaminophen/Ibuprofen, to have food/fluid, and to rest. Patient ambulatory and reports symptoms resolved after 30 minutes. Patient reports able to return to work. Patient declined transportation to hospital for further evaluation. BP128/82, HR 84.

She got home and did not have any reactions until last night around 10:00 PM when she got a bad headache, fever last night that was 100.1. Her back is killing her, her legs hurt and her left arm hurts as well. Her eyes are also watering. She has not taken anything for the symptoms. She tired to go to work, her husband said that she did not look good. She was sent home from work, she went to the nurses station at work, had a fever of 100.2 who told her to go home, it was a reaction from the vaccine, and to call us.

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

8hrs after vaccination started itching all over and moments after that shivering, then shaking very strongly. Got high fever. Shakin lasted for over 2hrs at which point I took 2 Tylenols. After 20min the shaking decreased. The shaking came back about 1.5hrs later. At that point I took 2 ibuprofens. The shaking went away. The entire following day had mild fever. have been tired physically for a week now after receiving the vaccine. Lost sense of smell and taste on the 3rd day after vaccination. It has since slowly improved. Botox injection sites (received Botox injection for migraine on March 4, 2 days before the J&J vaccine) are still slightly red a week after the vaccine. My facial skin is breaking out also. Vaginal yeast infection started 4 days after receiving the vaccination. I feel slower than usual in my thinking processes since the vaccination.

Woke up with severe chills around 3:45 AM the morning after my vaccine. Temp was low grade at first but then climbed, max was 102.2°F. All over body aches, no appetite, weakness, fatigue, headache, nasal congestion, burning eyes, ataxia, lightheadedness. Took my AM meds including hydrocodone-APAP which caused the fever to break but stayed low grade until the following afternoon around 2 PM. Helped with the body aches somewhat as well. Appetite started to return this morning, 3 days after the vaccine but the fatigue, weakness, muscular pain and a general unwell feeling continues.

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

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.

I had chills, fever, headache, extreme tiredness, almost passed out and tingling on right side arm/leg. When I almost passed out felt like tunnel vision.

Allergic reaction began 3/25 at 3:30pm and continued to get worse overnight. Rash on hands, arms, and back of knee. Swollen lips and itchy head. Patient took benadryl 50mg and applied benadryl gel topically to affected limbs at night and in the morning. Patient did a teleconference visit 3/26 at 11am with ARNP and he prescribed Levocetrizine 5mg q pm and a Medrol Dose Pack as customarily prescribed. Medication began at noon on 3/26. As of 4:30pm patient rash and lip swelling have subsided.

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

Less than 24 hours after the shot, I have severe body aches to the point I'm stiff. My entire left side is in a tremendous amount of pain. I have a severe headache and my eyes are hurting. The body chills are almost unbearable.

Burning feeling at injection site immediately. Spread to fingers within one minute and lasted over 24 hours. Within two hours, burning sensation also felt in feet, calves, and knees, lasting at least 12 hours. Weakness in legs. Faint feeling. Increasing body aches over 12 hour period and still on-going 48 hours after injection. Within 12 hours, nausea, diarrhea, stomach cramps and on-going 48 hours after injection. 12 hours after injection, developed runny nose, sore throat, slight cough, watery eyes, headache. Runny nose, watery eyes on-going 48 hours after injection. Severe pain at injection site. Tenderness and redness continues 48 hours after injection. Within 6 hours of injection developed traveling itchiness starting at feet but moving to shoulders, scalp, hips, and hands.

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

Patient is GCS 15, A&Ox4, with skin that is flushed, warm, and dry and a strong radial pulse. Patient is coughing. Patient states she received her vaccine about 30 minutes ago. She states 20 minutes after the vaccine was administered she began to feel itchy and as if something was stuck in her throat. Patient denies any allergies or respiratory history. The Vaccine Clinic standby units have already administered 50mg Benadryl PO prior to arrival. Lung sounds are clear in all fields. No stridor noted to auscultation. No redness or angioedema noted to patient's airway. Patient's skin is flushed on the chest. No urticaria noted. Patient denies and GI symptoms. An 18G IV is established in the RAC. 125mg Solumedrol administered IV. Patient requests transport to Rex ER. Transport is initiated non emergent to Rex ED. Enroute 0.3mg IM epi is administered. Patient reports her itchiness is gone after Epi administration but is still coughing and states she still feels like something is in her throat. Upon arrival to the ED care is transferred to the RN at triage.

upper lip tingling, tongue, no SOB, palpitations, edema 12:03 25mg Benadryl given 12:12 numbness subsided 12:24 asymptomatic Walked around for approximately 5 minutes. Denied sleepiness and stated "I am fine to drive"

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.

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.

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

* 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.

Four hours following the vaccination the patient developed Numbness; Tingling of the back of her neck with extension to the back of her head; Headache; Dizziness; Fatigue; Arm pain; Rash at the injection site; Blurry vision for one day. All symptoms except the rash and the blurry vision were still present after one week when seen in the Medical Centers ER.

Tired,body felt as though it weighed 500#,vertigo,muscle pain on off,restless legs, visual disturbances

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.

Janssen COVID-19 Vaccine Taste of mental after 30 minutes with tingling on tongue. Tongue has been numb on the tip/front since injection. It has slightly decreased since the first day but still remains 1 week later.

8-year-old female presents with right-sided headache onset earlier this morning. Patient states headache has been gradual onset throughout the course of the day. Is in the right frontal right occipital region. Patient does have migraines but this is more severe than usual. No focal neurologic deficits but patient states eye discomfort. Acuity remains intact. Nontoxic-appearing initial and evaluation the emergency room. Patient received her Johnson & Johnson Covid vaccine about 2 weeks ago..

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.

I am not sure if my event was caused by the vaccine I received on April 8, but I have a very strong feeling it is, as never in my life have I experienced anything like it. My day began normally, and I just had returned home from an appointment. I had some lunch, and a few minutes later as I was standing in my kitchen, I began sweating terribly, heart was racing, and I felt like I was going to pass out. I managed to make it to a large living room chair, and once I say down and put my head back, I passed out. My daughter witnessed everything and said when I passed out, my arms were trembling and my eyes rolled back. This lasted for about 30 seconds. She was unable to arouse me for a bit, but when I came to my speech was slurred. I did not know what had happened. My daughter called 911. By the time medics arrived, I was feeling much better and aware of everything happening. The checked for signs of stroke, vital signs, blood sugar, and everything was normal. I was transported to the ER, and my work up there was normal, including EKG and blood work. The physician that I saw diagnosed me with vasovagal syncope and did not feel the event was related to the vaccine. I completely recovered, and like I said I?m not sure if it was related to the vaccine I received or not. I just feel that it may be worth noting since I?ve never had an experience like this and I?m pretty healthy with really no medical history.

My wife was feeling great and then woke up with massive sinus pressure from her face cheek bones and up. Blocked nasal passages. Swollen, aching eyeballs with eye muscle pain. Extremely dark circles below eyes. Headache and nausea. Continued for 36 hours and then went away. We thought we would let you know as there now is a hold on administering this vaccine.

vaccine was administer at 9:07 am patient started complaining at 9:09 am numbness on the lips , tongue , it was having difficulty of swallowing . nausea . vitals were check every 5 min . patient started emesis . per Dr order i administer epi -pen at 9:13 am 911 was call .

*** Symptoms - Headache - 30 mins after shot - lips tingling some - fatigued and body aches ***** Shortness of breath that gradually became severe over a 24 hour period. Referred to Emergency Department by physician for evaluation. Pulmonary embolism ruled out - diagnosed with reactive airway disease with acute reaction exacerbation due to virus and dyspnea at Emergency Department. Been severely SOB unable to talk without gasping until 4/14/21 - Eliquis was increased to 5mg twice - along with the Prednisone and Ventolin inhaler - Now able to talk small conversations, but walking short distances still causes respiratory problems and strain on body.

FELT VERY THIRSTY; CHILLS; FELT LIKE GOT A HIGH FEVER; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight was 255 pounds, and height was 69 inches. The patient's concurrent conditions included seasonal bronchitis, heat intolerance, and seasonal asthma. 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 16-MAR-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amoxicillin for chronic bronchitis. On MAR-2021, treatment medications included: naproxen. On 16-MAR-2021 22:00, the subject experienced felt very thirsty. On 16-MAR-2021 22:00, the subject experienced chills. On 16-MAR-2021 22:00, the subject experienced felt like got a high fever. On 16-MAR-2021 22:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt very thirsty, chills, felt like got a high fever, and headache on 18-MAR-2021. This report was non-serious.

Patient had symptoms of a cough and congestion reported on 03/29/2021. Symptoms have been continuing since. Loss sense of taste and smell, cough, congestion, and shortness of breath.

Loud tinnitus left ear, clogged/numb feeling left ear, headache, head pressure, increased dizziness. Have pre-existing mild tinnitus left ear - much worse after vaccine. Have pre-existing head symptoms - much worse after vaccine. Symptoms appeared within a few days of vaccine, still here two weeks later. Volume of high pitched tinnitus and clogged/numb sensation in ear is very distressing, Ear doctor gave me rx for prednisone which I've started. Also had fever of 101, chills, pain in both legs but these resolved by day two.

Pt. reports L arm numbness from elbow down to fingertips and cotton mouth while in observation after receiving vaccine. Shortly after she c/o of pain in L hand and L hand drawing up. Vital signs assessed and EMS called. Tingling went away briefly but came back 2 minutes later. Pt. is allergic to Trumpet and Morrell mushrooms(anaphylaxis), she carries an EpiPen. Pt. refused to go with EMS and stated she would seek treatment on her own. Pt was monitored for additional time and released. She stated she felt much better and denied any symptoms other than still experiencing a "claw hand" .

NUMBNESS ON LEFT SIDE OF THE FACE; TINGLING ON LEFT SIDE OF THE FACE; PRESSURE BEHIND THE LEFT EYE/THROBBING PAIN BEHIND LEFT EYE; 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 12-APR-2021, the subject experienced numbness on left side of the face. On 12-APR-2021, the subject experienced tingling on left side of the face. On 12-APR-2021, the subject experienced pressure behind the left eye/throbbing pain behind left eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness on left side of the face, and tingling on left side of the face on APR-2021, and had not recovered from pressure behind the left eye/throbbing pain behind left eye. This report was non-serious.

ARMS FEEL SLEEPY/FACE SENSATION; DIZZY; DROWSINESS; HEARS A BEEP IN BRAIN; HEART BEATING FASTER THAN NORMAL; TONGUE SENSATION; FEVER; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.8 F, and Heart rate (NR: not provided) heart beating faster than normal. On 10-APR-2021 19:00, the subject experienced arms feel sleepy/face sensation. On 10-APR-2021 19:00, the subject experienced dizzy. On 10-APR-2021 19:00, the subject experienced drowsiness. On 10-APR-2021 19:00, the subject experienced hears a beep in brain. On 10-APR-2021 19:00, the subject experienced heart beating faster than normal. On 10-APR-2021 19:00, the subject experienced tongue sensation. On 10-APR-2021 19:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arms feel sleepy/face sensation, dizzy, fever, drowsiness, hears a beep in brain, heart beating faster than normal, and tongue sensation. This report was non-serious.

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.

The night after my vaccination I had pain in my ears and had a headache as well as fatigue and overall not feeling well. By April 8th my symptoms we greatly reduced. My vaccination spot remained red and wam for the retainer of that week. I have had a headache since April 13, 2021. On April 24th I noticed a rash the softball size at my injection site that included lots of red dots all around. There was also warmth in the rash area. I went to unspecified pharmacy with my headaches and rash. Due to my symptoms I was referred to emergency department.

Patient tested for COVID on 4/27/21 via PCR and results positive. Symptoms include: body aches, headaches, dizziness, loss of taste and smell, cough, runny nose

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

Pt received the injection and within 10 minutes she started to feel lightheaded and nauseous. She also stated her tongue felt a little tingly and numb. She was taken into our immunization room and she started out seating then decided she would feel better laying down. We gave her a half of a Benadryl to help with the nausea. She was given cold compresses, water and some ice to suck on. Her blood pressure was taken and was 122/70 mmHg, heart rate was 58 bpm. She was laying down for approximately 20 minutes, then stated she was feeling better and moved to a sitting position. She was felt she was improving, and after a few minutes of sitting decided she felt well enough to leave. She did state as she was leaving that she has a similar reaction when she gets blood drawn and that she had been nervous about getting the shot.

3/13/21 at 1145 redness (flushing) to the face, 2000pm: fever 101 F, chills, body aches until morning, leg pains, Ibuprofen 800mg every 6hrs 3/14/21 0800am fever 100.1 F, body aches, gum pain through out the day, Ibuprofen 800mg every 6 hrs 3/15/21 0600am temp 99.6 F, vertigo, nausea all day 3/16/21 no more symptoms

2 minutes after receiving the vaccine pt began to feel itching to bilaral arms and left rib area. Itching progressively became worse. 50 mg benadryl given. No relief. 16 min after receiving vaccine pt complained of lips swelling and throat tightening and feeling swollen. Lips swollen. 0.3 mg epi auto injector given in left thigh. 911 called. 1-2 minutes after epi throat felt less swollen, itching began to decrease. Pt remained alert and oriented x3 and no evidence of respiratory distress. Ambulance arrived. pt left on stretcher

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

Pain in left leg... progressive. Called doctor weeks later to verify if clot. I still have pain in my leg. Dr sent for X-rays and made a referral to orthopedic dr. Also extremely tired, and occasional pain in left breast area/chest. Also locking jaw and headache that does not go away

Monday-Feeling like ants crawling under my skin. Headache, present even with Tylenol Tuesday- Ant feeling subsided, headache and neckache. Lightheadedness and loss of balance. Went to ER Thursday 5/20- Lightheaded and loss of balance Since 5/4, lightheadedness comes and goes. Light and sound affect the ability to focus. I have never felt like this before.

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.

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

Symptoms lasted for at least 16 days. Pretty much every symptom in the book. Everything from shortness of breath to congestion to headache to muscle ache neck ache, dizziness and chest pain. I had extreme muscle weakness and ringing in ears. Dizziness, ringing in ears and chest pain around heart are still present.

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.

Fatigue, Diarrhea, Headache with head pressure, Numbness on left side of face, Chest pressure, Abnormal heart rhythm, Loss of peripheral vision on left eye

1.) Severe constant headache top of head - Time onset @ 16:15 to present time Took Tylenol 500mg no relief 2.) Burning of eyes like if you are developing fever - Time onset between 17:44 to 18:30 Apply cold compress to eyes 3.) Headache covering top of head now to back of head. Treatment already took Tylenol so no other recourse Will drink plenty of Gatorade and water and rest the night

I developed Shingles on May 25th, 2021. Not sure if related but Ive heard of several other people getting shingles recently. Feels relevant to report.

pt started feeling nauseous, dizzy, gagging and blurry vision within 5 minutes of administration. Healthcare provider assessed patient and advised ER. Clinic staff escorted patient to the ER.

Very dry throt, chocking, chill. body shacking, chest tightness, twinging in arm and legs, Visit Emergency room for 3 time ( around every 8 days) test - X-ray for chest, Neck, CTC - chest, neck, head CTA- neck, head MRI - neck, head telescope to check throt by ENT visit to - ER 3 time, admitted to hospital at 3rd time, visit to ENT, GI, Polemology, Neurology, Symptoms still as is, little better than before.

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

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.

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

Sore on both arms, painful to hold anything and to reach to get anything. Lung pain. Headache. No smell. Tired.

43yo Female collapsed into husband?s arms after receiving Janssen vaccine at 08:46. Observation nurses responded, assisted client to ground and determined client was having a seizure and was not breathing. Pupils dilated, non-responsive, not breathing, initial carotid pulse not found, immediately began chest compressions and called 911 at 08:49. At the start of first chest compression client inhaled and carotid pulse returned. Client continued without responsiveness and atypical grunting for about 20 seconds before regular breathing returned at 08:50. Pupils returned to normal size and client alertness returned 08:50. Client remained flat, was very diaphoretic and clammy and hand and arms remained in contractures; BP 90/72 Client able to state her name and location and identify husband. Repeat BP 110/72; client remained diaphoretic 09:02 Client hands and arms remained in contractures until 09:03 Client reported similar event has happened in the past but unable to state details of prior event EMS arrived at 09:11; BP 110/70, HR 122, SpO2 98%, blood glucose 145 Client began vomiting at 09:16, assisted to her side. EMS assisted client to chair Client refused transfer to hospital. EMS left at 09:47 Wheelchair called for transport Client left with husband via wheelchair at 10:06

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

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

Raynauds on day 2, then Migrating shooting pains/spasm 2-3 seconds, easy bruising, intermittent skin rashes, cognitive dulling, joint pain, blurry vision, hand stiffness, excessive, dry mouth and dry eyes, headaches. Tachycardia and palpitations

I started getting bad headaches soon after shot and went to dr. to be told was a migraine. Woke up blind after a week in my right eye went to dr said I had blood clot and stroke in my eye. I lost my right eyesight. One week after that I started having horrible joint pain which I had never had before and they believed the vacine was attacking my immune syste. I spent 6 days in Hospital to stop symptoms with no real relief. MY blood sugar and blood pressure were severly high and I couldnt function. I am still dealing with all of this.

LOSS OF SMELL; WARM; LOSS OF TASTE; CHEST COLD; HEAD COLD; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight was 145 pounds, and height was 64 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and the patient had no known allergies. The patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 to left arm as prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, the patient had head cold and chest cold. On 10-JUL-2021, the patient had loss of smell, taste and was warm. On 13-JUL-2021, the patient was scheduled for COVID test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from head cold, loss smell, warm, chest cold, and loss of taste. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210725918-COVID-19 VACCINE AD26.COV2.S-chest cold. 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).

26 hours after the shot I developed a fever of 102+. Fever was gone the next morning. On the 13th day (05/24/21) after receiving the vaccine I had significant pain on the left side of my face, head and neck. By 7pm that day the left side of my lip was numb. I went to the hospital about an hour later where they conducted tests to rule out a stroke as my blood pressure was extremely high. No signs of stroke showed in the MRI scan. Nausea hit that night. On the morning of 5/26/21 I returned to the same hospital because my face was numb and I was still in a lot of pain and was still nauseous, unable to eat or drink anything. Another doctor ran another MRI focusing on different nerves in my face and neck and she consulted with the on call neurologist who concurred that my symptoms were consistent with Bell's Palsy. The nausea finally disappeared 5/27/21 but the pain continued for about a month. As of today I still have no movement in the left side of my face. It is difficult to speak clearly, eat certain foods, and drink fluids without spilling from the left side of my mouth.

My left ear went deaf and I went to a walk in and told me to take antihistamines. I waited 5 days and made an appt to see an ENT doctor. I went Tuesday morning and he said there was no fluid in my ear, it was nerve damage, SSHL hearing loss and they did a bunch of audiologist tests. He is proceeded to give me shots in my ears and giving me steroids to see if I can get my hearing back.

I CHEST TIGHTNESS; TENDERNESS TO LEFT ARM EFFECTING ROM/TENDER TO TOUCH LEFT UPPER ARM; FEVER OF 101F; NAUSEA; HEADACHE; PAIN AT INJECTION SITE (LEFT ARM); FACIAL FLUSHING; FEELING LIKE BLOOD PRESSURE IS HIGH/BLOOD PRESSURE ELEVATED AS HIGH AS 150/100; CANNOT MOVE LEFT ARM UP; INFLAMMATION TO THE LEFT UPPER ARM; VISION DISTURBANCES; 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 pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for premedication. On 24-MAR-2021, the subject experienced feeling like blood pressure is high/blood pressure elevated as high as 150/100. On 24-MAR-2021, the subject experienced facial flushing. On 24-MAR-2021, the subject experienced cannot move left arm up. On 24-MAR-2021, the subject experienced inflammation to the left upper arm. On 24-MAR-2021, the subject experienced vision disturbances. On 24-MAR-2021, the subject experienced tenderness to left arm effecting rom/tender to touch left upper arm. On 24-MAR-2021, the subject experienced fever of 101f. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced pain at injection site (left arm). Laboratory data included: Body temperature (NR: not provided) 101 F. On 25-MAR-2021, the subject experienced chest tightness. Laboratory data included: Blood pressure (NR: not provided) elevated as high as 150/100. Treatment medications (dates unspecified) included: metoprolol succinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 101f, nausea, and headache on 25-MAR-2021, was recovering from feeling like blood pressure is high/blood pressure elevated as high as 150/100, vision disturbances, and chest tightness, and had not recovered from pain at injection site (left arm), facial flushing, tenderness to left arm effecting rom/tender to touch left upper arm, cannot move left arm up, and inflammation to the left upper arm. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case is assessed as non-serious.

SHORTNESS OF BREATH; BLURRED VISION; LEG SWELLING; TACHYCARDIA; EASY BRUISING; LEG PAIN; HEADACHES; INJECTION SITE PAIN; WEAKNESS; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication. On 28-MAY-2021, the subject experienced shortness of breath. On 28-MAY-2021, the subject experienced blurred vision. On 28-MAY-2021, the subject experienced leg swelling. On 28-MAY-2021, the subject experienced tachycardia. On 28-MAY-2021, the subject experienced easy bruising. On 28-MAY-2021, the subject experienced leg pain. On 28-MAY-2021, the subject experienced headaches. On 28-MAY-2021, the subject experienced injection site pain. On 28-MAY-2021, the subject experienced weakness. On 06-JUN-2021, Laboratory data included: Duplex ultrasound (NR: not provided) Negative. Treatment medications (dates unspecified) included: tramadol, and naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, blurred vision, tachycardia, easy bruising, headaches, injection site pain, and weakness, and had not recovered from leg pain, and leg swelling. This report was non-serious.

Client stated her lips felt tingly and her throat felt itchy. Airway clear, respirations even and unlabored, heart rate within normal limit. Patient in no acute distress. No angioedema noted. Patient was administed Benadryl 25mg PO X 1 dose.

High Blood Pressure, Jaw Pain !0/10, headache, nausea, involuntary leg movement We are deeply concerned about getting patient the care she needs. There is a lack of urgency on the part of the hospital staff in acknowledging a connection to her receipt of vaccine and onset of adverse symptoms.

After about 15H after the vaccine I strayed to feel very tired and started having severe body aches, chills, sweating and my teeth were hurting. By 2pm I had 102.5F /103F which lasted all day. At 1am I was in unbearable body ache and 103F that I took Tylenol and finally got some relief. The following morning I felt better still with 100F and body aches but better.

Chills, fever, headache, muscle aches, severe joint pain and swelling in knees, random acute pains in ear and abdomen, some mild nausea for about an hour after fever spiked. Fever went to 103 before I took fever reducing medication (ibuprofen). Temperature reduced to 101 after lukewarm shower and ibuprofen. Now 24 hours after vaccine, temperature is elevated slightly from my norm (hovering around 100), head ache and joint pain is persisting.

Bell's palsy symptoms within an hour after receiving vaccine injection: consisted of right-sided facial numbness, right-sided eyelid droop, right-sided mouth turn, right-sided tightness in neck muscle, pressure behind right eye, headache, loss of balance, difficulty speaking. The injection was at 3:15 pm and started with arm soreness and stinging, a slight headache, and some tingling in my right hand while waiting 15 minutes after the shot, I had also felt a sensation going up the right side of the back of my neck almost immediately after the injection. The Bell's palsy symptoms started by 4:00 pm. I had a low-grade temp that evening of 99.9. I emailed my neurologist who I see for migraines, of my symptoms. The following morning on 03-10-2021 I woke with a severe migraine, fullness in my right ear, more pressure behind my right eye and it is watery, with new ringing in both ears, louder in the right ear. Still residual numbness and drooping of right side of face and eye, tightness in right side neck muscle in front, and speaking better. Woke up on Thursday morning 03-11-2021 with flu symptoms and migraine gone. Eye pressure still there and now having significant pain moving my eye and now more feeling of fullness in my right ear. Eye pain was concerning. Dr advised me at this time if symptoms have continued or gotten worse to go to the emergency room. Today, Saturday 03-13-2021, I am still experiencing moderate eye pain behind/above my right eye with pressure. I am continuing to treat the pain with oxycodone prescribed by ER Physician.

"Janssen COVID-19 Vaccine EUA" Patient was diaphoretic, feeling faint and reported blurry vision. Patient denied dizziness, shortness of breath or chest pain. Patient was assessed by medical doctor and registered nurse . 911 was called , EMS responded , EMS assessed and treated patient . Patient was discharged in stable condition.

Sore arm up into neck, headache, racing heart that felt like I could pass out, fatigue, heart palpitations frequently, tongue went numb, and burning sensation in hands and fingers, with joint stiffness.

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.

Patient came back to vaccine area at 9:30 am reporting light-headedness, tingling at lips, SOB. Vital signs taken: BP 180/100, P-80. Treated with 25mg. Benadryl by mouth with vital signs every 5 minutes until BP decreased to 140/90. Patient placed in supine position with feet elevated. Patient remained under observation x 1 hour and left area without symptoms at 10:30.

The shot was given on 3/14/2021. At 1:45 am on 3/18/2021, I woke up with the area around my eyes itching and burning. When I got up, my eyes were almost swollen shit. The whole day of 3/18/2021, it felt like bees were stinging my eyes. I did have the corona virus in December and my eyes reacted the same way at the end of my sickness.

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

Approximately 40 mins mouth/tongue started tingling. Then an hour I developed a rash lower part of my face and hives on chest. I'm still exp symptoms taking Benadryl.

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)

"swimming" feeling in head -30 min after shot body aches - 30 mins after shot through day 1 Heart racing/palpitations - apx 7 hours after shot extreme exhaustion - 4 hours through day 1 chills - 30 mins through the end of day 0 (day of shot) gum pain - 30 mins through the end of day 0 (day of shot)

1st Nausea than severe cold chills, fever and the whites of my eyes turned red. I also felt a burning sensation in the veins in my hands and feet.

Onset of headache and fatigue around 8pm 4am: woke up and has extreme headache, arm so sore unable to move it w/o pain, whole body aches, chills, low grade fever 8am: extreme fatigue, fever, chills, body aches, body so heavy feeling unable to leave bed for any extended amount of time Sat. 4/2 Headache still present but not as extreme, arm still very sore but able to move it, fever broke, fatigue Sun. 4/3 Slight headache, sore arm, minor cough, dry throat, tired but not fatigue Mon. 4/4 Headache upon waking, Headache subsided, arm sore, dry cough, heavy feeling in upper chest/throat Tues. 4/5 *same symptoms Monday Wed. 4/6 *same symptoms Thurs. 4/7 *same symptoms

TOP LIP WAS SWOLLEN AS MY LOWER LIP; CHILLS; HEADACHE; RINGING IN EAR; 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: 1805020, expiry: not reported) dose was not reported, administered on 12-MAR-2021 14:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021 22:30, the subject experienced ringing in ear. On 12-MAR-2021 22:30, the subject experienced chills. On 12-MAR-2021 22:30, the subject experienced headache. On 13-MAR-2021 14:30, the subject experienced top lip was swollen as my lower lip. On 13-MAR-2021 15:30, treatment medications included: ibuprofen. On 13-MAR-2021 17:30, treatment medications included: diphenhydramine hydrochloride. On 30-MAR-2021 17:30, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing in ear, chills, and headache on 13-MAR-2021, and was recovering from top lip was swollen as my lower lip. This report was non-serious.

12:30 - Received J&J vaccine 13:00 - Started to experience lip/gum tingling and chest tightness. Given Benadryl 50 mg PO x 1 in vaccine clinic. Symptoms progressed to throat tingling, coughing, difficulty swallowing, lightheadedness, some SOB. 13:15 - Transported to ED. Received IM Epi x 1; improved within a few minutes. Also received methylprednisolone, famotidine, IVF. 19:00 - Monitored in ED. Discharged home with Epi pen, prednisone, famotidine, Benadryl.

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

About 20 minutes after vaccination, started to feel tingly sensation in mouth, tongue. About 1 hour after vaccination my lips felt numb. No blue lips, no rash/hive, no swelling of tongue, lips or face, no difficulty breathing or swallowing. Just numbness in lips and tingling feeling on tongue, all over mouth. The numbness felt like novacaine shot you would get if you were getting dental work done. Numbness in lips lasted about 3 hours but gradually reduced to just tingling feeling after. The tingling feeling in my mouth gradually got better every hour after that. It still lasted all night. It did not completely go away until the next morning. After the morning, numbness and tingling sensation went away.

30 min after shot my lips and fingers began to tingle. After 5-10 min there was a bitter taste in my mouth. Lips and mouth then felt numb and I had difficulty swallowing. At 10 hours post shot body aches, EXTREME headache, ringing in ears, blurred vision, dizziness, heart beat seemed fast and some times irregular, chills then sweating. 24 hours after shot the headache and body aches are mild. I am fatigued.

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.

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.

Chills, low grade temperature, headache, very tired, arm soreness for days, body aches, bloody nose(the day after vaccine I had pinkish discharge from left side of nose that lasted 8 days. On day 11 I had a bloody nose on right side that took approx 15 minutes to stop. Also starting day after vaccine, breast tenderness and fullness in both breasts..have had this everyday since and still have this.

4/10/2021- 102 temp by 10 pm. Aching in all joints especially ankles and wrist. 103 temp by 12am. 04/11/2021 severe headache.. light sensitivity.. fever 101-103 until 5pm. Nausea and diarrhea. 04/12/2021 temp and aching has subsided.. Major headache and nausea and diarrhea still on-going. Taking Tylenol 325x2 every 8 hours.

Received vaccine 4/1 at 7pm; woke up 4/2 at 6am with a sore back and shoulders. 11am: Severe nausea and excessive drooling, eyes watering. 11:30am: Extreme nausea with vomiting, eyes continued to water and drooling. Took Zofran for nausea, headache and severe body aches, joint pain in hips, feet and knees lasted for approx. 5 hours. Temp 100.2 and body aches throughout the night x 8-10 hours.

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.

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.

During my 15min wait (about 5 minutes after the injection) I started to become very hot and sweating profusely. My ears started ringing and the noise in the room sounded like it was in slow motion. I started to feel dizzy and clammy like I was going to pass out. I got up and walked over to the paramedic and he sat me down and took my vitals. All of my vitals were fine and I started to come out of the feeling of passing out. After waiting another couple of minutes I went outside to get fresh and was able to go home. I felt very tired and just not quite right the rest of the day and slept most of the day. I was ok after that with just a fatigue and headache in the following days.

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

headache, nausea shooting pain from back through neck up through back of my head, blurred vision, lightheaded and dizziness

Extreme breathing difficulty, veey bad cough.m, heavy mucous severe headache, blured vision. Had to have albuteral treatments in nebulizer every 4 hours, started on Adair inhaler and Augmentin 875 mg 2 times daily.

High fever, severe flu like symptoms, complete loss of taste and smell, being treated for severe sinusitis. Diarrhea, nausea. I have had covid before-these symptoms have been worse than when I had covid.

On April 9 in the afternoon, a severe headache began, which I had never experienced. This led me to vomit and even then the pain was unbearable. The pain persisted despite taking an analgesic and the next day still felt throbbing that was reflected in the head in general and in the eye area.

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.

Fever ranging from 103.8-106.6 for 3 days, chills, body aches, muscle cramping, nausea, severe headache, low back pain, red swollen painful arm at injection site, dizziness, blurry vision, and a large lump/infection under the arm near the armpit on the injection side with redness that extended about 6 inches.

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.

Numbness in left ear, side of face, and tongue Severe dizziness Pain in injection site, left arm, and shoulder Severe headache I took Benadryl and Ibuprofen and stayed in bed for two days. Symptoms lasted for 4 days. Extreme fatigue lasted for 10 days

Within 24 hours of the dose, a slight headache arose. Following the headache I experienced bruising on my thighs, tightness in my left arm, bruising oat the injection site for at least one month and a weighted feeling on my chest along with tightness and shortness of breath. Subsequently, I experienced blurred vision and loss of sight one month following injection. The loss of sight lasted close to 10 minutes.

SINUS HEADACHE; DRY MOUTH; 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced sinus headache. On 10-APR-2021, the subject experienced dry mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus headache, and dry mouth. This report was non-serious.

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

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.

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

Vertigo that started a few days after the shot has gotten progressively worse over the last two weeks and is ongoing. Metallic taste in mouth for the first two days immediately after the shot.

3d s/p vaccine symptoms started w/ SOB w/ exertion, itchy skin, metallic taste in mouth, left sided chest pain that went straight to back followed by heaviness and pressure in chest, and HA

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

Patient arrived to ED with C/O vision changes and dizziness after vaccine on Saturday (unknown) patient was transferred to Main campus for Occipital Stroke at neuro facility., This facility did not give the vaccine

FEELING FULL IN BOTH EARS; HISSING SOUND IN THE LEFT EAR; 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: Unk) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced feeling full in both ears. On 20-MAR-2021, the subject experienced hissing sound in the left ear. On 15-APR-2021, treatment medications included: bioflavonoids nos/vitamins nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling full in both ears, and hissing sound in the left ear. This report was non-serious.

SHORT OF BREATH; RAPID HEART BEAT; DIZZINESS; NUMBNESS OF TONGUE; TASTE METALLIC; FATIGUE; HEADACHE; FEELING UNWELL; PALPITATIONS IN ARM; SORE ARM; 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 penicillin allergy, prednisone allergy, flu shot allergy, and beta blocker allergy, and concurrent conditions included rheumatoid arthritis, and neuropathy in both arms. The patient was previously treated with methotrexate for neuropathy in both arms, rheumatoid arthritis; and experienced hydroxychloroquine allergy when treated with hydroxychloroquine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced palpitations in arm. On 12-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced feeling unwell. On 15-MAR-2021, the subject experienced short of breath. On 15-MAR-2021, the subject experienced rapid heart beat. On 15-MAR-2021, the subject experienced dizziness. On 15-MAR-2021, the subject experienced numbness of tongue. On 15-MAR-2021, the subject experienced taste metallic. On 15-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced headache. On 14-APR-2021, Laboratory data included: Platelet count (NR: not provided) unknown unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations in arm, short of breath, rapid heart beat, dizziness, feeling unwell, fatigue, and headache, and had not recovered from sore arm, numbness of tongue, and taste metallic. This report was non-serious.

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.

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.

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.

COULD NOT MOVE; CHILLS; HEADACHES- PIERCING ON THE RIGHT SIDE; NOT GOOD; TIRED; NAUSEAS; SHORTNESS OF BREATH; MOUTH WATERING; CHEEKS SORE; BODY ACHES; 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 asthma, and other pre-existing medical conditions included brio in am from 2015 due to overuse of pesticide at work. 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 22-MAR-2021 for prophylactic vaccination. Concomitant medications included salbutamol for asthma. On MAR-2021, treatment medications included: ibuprofen. On 22-MAR-2021, the subject experienced shortness of breath. On 22-MAR-2021, the subject experienced mouth watering. On 22-MAR-2021, the subject experienced cheeks sore. On 22-MAR-2021, the subject experienced body aches. On 22-MAR-2021, the subject experienced not good. On 22-MAR-2021, the subject experienced tired. On 22-MAR-2021, the subject experienced nauseas. On 23-MAR-2021, the subject experienced could not move. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced headaches- piercing on the right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move, and chills on 25-MAR-2021, shortness of breath, mouth watering, cheeks sore, not good, tired, nauseas, and headaches- piercing on the right side, and body aches on 05-APR-2021. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

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.

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.

SEVERE MIGRAINE; RIGHT ARM WEAKNESS; LOSS OF TASTE; LOSS OF SMELL; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 125 pounds, and height was 160 centimeters. The patient's concurrent conditions included migraine, history of concussion, post concussion syndrome, eye convergence inefficiency due to concussion, regelan and penicillin allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not had any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included gabapentin for severe migraine. On 17-APR-2021, the subject experienced loss of taste. On 17-APR-2021, the subject experienced loss of smell. On 22-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 23-APR-2021, the subject experienced severe migraine. On 23-APR-2021, the subject experienced right arm weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of taste, loss of smell, severe migraine, and right arm weakness. 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.

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.

Severe migraine, low fever of 100.6, burning eyes, chills, extreme body pains and aches, throbbing of socket from recently removed tooth. Loss of appetite. Localized injection site pain. Took Tylenol every 4 hours for first 8 hours then switched to Tylenol PM. Lots of liquids and sleep. Ice pack on injection site

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.

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.

I woke up at 02:00A with a bad headache, I took some Tylenol. On Thursday April 8th, 2021 around 02:00pm I had flu-like symptoms with body aches, fever, chills. The next day April 9th, 2021, I experienced fatigue, headaches and ringing in the ears. On the 4/10/2021, fatigue, headache and noise or ringing in the ears. On the 4/11/2021, fatigue, ringing in the ears. On 04/12/2021, dizzy spells which has continued. Feeling of lightheadedness and on the 04/14/2021 I went to see my doctor. Feeling of pressure in my ears with the ringing. For two weeks I struggled with the dizziness and lightheadedness. I also developed Tinnitus. I also had low back pain and pelvic pain.

Bells Palsy. Symptoms began on 4/21/2021 with alteration of taste. On 4/22/21, tingling on right side of the face began in the morning. At 2pm unable to talk, face drooping and eye tearing. Went to ER and testing ruled out stroke. Admitted for further observation and testing. Discharged on 4/23 with Prednisone 60mg x 6 days and Valtrex x 6 days

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

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.

COLD SWEATS; WEIRD FEELING IN THROAT; LEFT EAR POPPING LIKE GOING UP IN ELEVATION; SINUS CAVITY PRESSURE IN THE RIGHT EYE; STUFFY NOSE; FEVER 101.3 F; HEADACHE; LITTLE NAUSEOUS; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 165 pounds, and height was 63 centimeters. The patient's concurrent conditions included barrett's esophagus, high blood pressure, premature heart beat, hypothyroidism, sulfa drugs allergy, non smoker, and non-alcohol user, and other pre-existing medical conditions included the patient was not pregnant at the time of the 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: 201A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 27-MAY-2021 11:45 for prophylactic vaccination. Concomitant medications included amlodipine, carvedilol, levothyroxine, and losartan. On 27-MAY-2021, the subject experienced cold sweats. On 27-MAY-2021, the subject experienced weird feeling in throat. On 27-MAY-2021, the subject experienced left ear popping like going up in elevation. On 27-MAY-2021, the subject experienced sinus cavity pressure in the right eye. On 27-MAY-2021, the subject experienced stuffy nose. On 27-MAY-2021, the subject experienced fever 101.3 f. On 27-MAY-2021, the subject experienced headache. On 27-MAY-2021, the subject experienced little nauseous. Laboratory data included: Body temperature (NR: not provided) 101.3 F, 101.0 F, 97.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, weird feeling in throat, and left ear popping like going up in elevation on 27-MAY-2021, had not recovered from headache, stuffy nose, and fever 101.3 f, and the outcome of sinus cavity pressure in the right eye and little nauseous was not reported. This report was non-serious.

SORE THROAT; FEVER OF 104/LOW GRADE FEVER; DIZZINESS; BLURRED VISION; 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 high blood pressure, high cholesterol, alcohol consume 3 glass per week, and non smoker, and other pre-existing medical conditions included the patient had not known allergies to drug. 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 21-MAY-2021 for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure. On 21-MAY-2021, the patient experienced dizziness. On 21-MAY-2021, the patient experienced blurred vision. On 21-MAY-2021, the patient experienced fever of 104/low grade fever. Laboratory data included: Body temperature (NR: not provided) fever 104. On 23-MAY-2021, the patient experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 104/low grade fever, and had not recovered from dizziness, blurred vision, and sore throat. This report was non-serious

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

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.

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

UNABLE TO WALK; UNABLE TO GET OUT OF BED; BLURRED VISION; LEFT ARM PAIN; LEFT ARM WEAKNESS; FEVER; MUSCLE PAIN/ACHES; WEAKNESS; TIREDNESS; 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 ulcers in mouth due to medication, and concurrent conditions included psoriasis, psoriatic arthritis, high blood pressure, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with terbinafine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: 28-JUL-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included hydrocodone for pain, alprazolam, amlodipine, cyclobenzaprine, folic acid, hydrochlorothiazide, methotrexate, metoprolol succinate, secukinumab, sulfasalazine, and trazodone. On 24-MAR-2021, the subject experienced unable to walk. On 24-MAR-2021, the subject experienced unable to get out of bed. On 24-MAR-2021, the subject experienced blurred vision. On 24-MAR-2021, the subject experienced left arm pain. On 24-MAR-2021, the subject experienced left arm weakness. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced muscle pain/aches. On 24-MAR-2021, the subject experienced weakness. On 24-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to walk, unable to get out of bed, fever, muscle pain/aches, and weakness on 24-MAR-2021, and had not recovered from blurred vision, left arm pain, left arm weakness, and tiredness. This report was non-serious.

Day one: pain in arm, extreme fatigue, nausea, fever, blurred vision, heavy chest, headache, eye burning pain, pain in side of neck and intonarmoit, pain in right calf, runny nose, burning in nose and throat, oversensitive to touch like clothes Day 2: runny nose, fatigue. congestion, headache, injection site pain Day 3: scratchy throat, watery eyes, arm sore at infection site, naseua, low energy Over the next four days symptoms lessened. At day seven finally felt back to normal. Day 18 &19- spotting blood, period is 9 days early which is not normal. I'm never this early or irregular

Started with chills. I was freezing for almost three hours. I could not get warm-with tons of blankets, heater, heat cranked up. Then I was seating. I had a fever and am still fighting this fever. It was at 103 on Sat. It was 101 this morning. I feel fluish-body aches, headache, eye sockets hurt, exhausted. On sat, after the chills, my legs hurt and felt like they were 100 pounds.

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.

Immediate rash in chest and face. 20 minutes later entered ER with swollen eye and throat. 14 hours later re-entered ER with rash on chest and face, swollen tongue and throat

Immediate burning sensation traveled from left side of body: arm, shoulder, neck, back, left ear, and chest. Then traveled across entire face eyebrows, cheeks, and lips felt numb and irritated.

vaccine administration approx. 11:20 AM, at approximately 11:30 AM developed itching to buttocks and bilateral posterior thighs. patient notified nurse of symptoms at approximately 11:40 AM. Nurse assessed area of itching- no redness, rash, or hives noted. Nurse administered 50mg diphenhydramine and 20mg famotidine. At 12:00 AM patient reported the tip of her tongue felt tingly. EPI pen was administered immediately (12:00 PM) and EMS called. Patient denied any shortness of breath or difficulty swallowing.

Patient developed signs of syncope about 5 minutes after vaccine given - 7:50 dose and 7:55am she felt warm, dizzy and had blurry vision and a dry throat. We supplied ice packs and she felt symptoms subside by 8:11am. At 8:18am she felt a wave of symptoms back and had an itchy throat - she was given 50mg of oral benadryl and felt better - leaving the pharmacy with her husband at 835am. I called patient at 1:18pm 3/14/21 and she had just gotten home from the ER where she was treated with iv fluids, benadyrl and steroids per husband

Extreme tiredness/fatigued within the hour. A few hours later, chills and dull headache. By evening, severe body aches. Middle of the night, woke up extremely thirsty (dehydrated), and with a slight fever of 100.7. Took two Advil at the time. Following day, body aches, slight temperature (99.7), and intermittent headache. Dehydrated. No chills. Took two Advil by mid afternoon. Started to feel better by early evening, but still feeling sluggish; tired.

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.

Headache, Myalgia, HYPERtension, metallic taste/loss of taste appx 30 min after vaccine; bodyaches, headache, bp elevated. taken to ER for further observation; treated with toradol, pepcid, zofran, ivf. d/c same day. had an episdoe of emesis (per er note, might have beenn due to eating at outside restaurant the day before)

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

tingling down arm up neck (left side) pain in left ear then moving accross forehead into head pain extreme headache chills, fever shot up to 102 hands and face freezing for hours while high temp. Up all night in extreme pain and with fever weakness body aches internal pain, migraine. took some oxy and ibuprofen in the early evening when pain got too bad to bear around I think 7pm. That helped, fever went down to 99, then the meds wore off chills and pain returned. Started taking oxy and ibuprofen every hour on the hour from 2am until 2pm following day when I was then able to sort of sleep for 2 hours. Stopped taking meds. Took NAC to protect against all that ibuprofen. Took warm bath with bathsalts. Still feel sick but head pain and muscle aches have receeded.

Ear (right) was a little uncomfortable - it gradually got worse - by Tuesday afternoon, I went to my fitness class but tapped out half way through and it was around 6 pm that I went to urgent care. Had an ear infection and was given a ten day regimen of amoxicillin. My ear is much better today.

Woke up to strong and painful diarrhea - almost passed out while sitting on the toilet. Had an odd white noise in my ears - not "ringing" but buzzing kind of sound. Lasted for about 3-5 minutes and I ended up lying on the floor for about 15 minutes before I could get back up. Felt like I may blackout. It's three hours later and I'm ok now.

Chills, headache, vomiting and fever during the first 18 hours. Tingling hands and feet from 3/16-3/26. Fluid behind eardrums 3/24 & 3/25.

Pt received J&J COVID vaccination during down time 3/30 approximately 7 minutes after receiving the vaccination at 1:50pm Patient reported feeling dizzy and having double vision. Pt VS remained stable and instructed Pt to take deep breathes. After a few minutes Pt still was feeling dizzy, instructed patient to lay back and elevate feet while taking deep breathes. Pt still feeling dizzy and faint per protocol administered 15L/min O2. At 2:05 patient started to feel better better and removed O2. Monitored patient for 10 more minutes. Pt stated she felt better and requested to leave. Instructed patient to take deep breaths and report to her doctor if she felt bad again. Patient reported she understood and left with her husband .

pt had chills, fatigue, 100.9 fever, weakness, and scratchy throat. Her arm is very sore and a little swollen around the injection site. She took Tylenol for her symptoms and seem to be getting better.

Within minutes of getting the shot, my throat became itchy and the roof of my mouth felt like it was burning. I started breaking out in hives , coughing and trying to clear my throat. I was taken to the medical area and given a dose of liquid Benadryl. Within 20 minutes it was easier to breathe and my blood pressure and pulse ox returned to normal. About 3 hours later I started to get itchy again around my throat and ears. Per the guidance of the nurse at the vaccine site, I took 2 - 25mg Benadryl tablets. By the next morning I felt better.

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

Pt complained of numbness in tongue. Benadryl 25mg given. Very anxious and diaphoretic. Pt left with husband.

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

First symptoms was swelling of lips a few hours after the J&J vaccine received on 04/05/2021. The 2nd symptoms was chills and then 3rd was severe dizziness around 2:30 am.

Dizzy, feeling light headed & nauseated 26 hours after shot, then by late Sunday evening I was running a fever of 103, Tylenol was able to keep it down but not for a long period of time, upset stomach, cold chills, and hot at the same time. Feeling very sore all over, like I had a bad flu. I was very fatigue, sleeping 18 hours straight. Extremely thirty, diarrhea and vomiting. By Tuesday night I was fine. I was still sore all over, but fever had gone back to normal & I was able to eat some chicken noodle soup. Wednesday morning I was back to me. Feeling well now.

headache, body aches, extreme fatigue, pain at injection site, fever under 100 degrees, itchy Eyes , sore throat

First symptom was moderate tiredness and dizziness that lasted all day and night. Excessive thirst, arm was very sore. Later that evening I experienced some difficulty breathing, severe muscle pain in my legs, arms and shoulders, and moderate to severe headache. Burning but no rash around my hips and back that felt like severe razor burn. Today, I am still experiencing leg pain, burning sensation and headache.

Client received vaccine and became dizzy and was "seeing stars". Sat for about 20 seconds right after being vaccinated and then passed out for 10 seconds. BP was unreadable, pulse 72, O2 saturation 98%. Was transported to hospital

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

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

C/O numbness lips and tongue. Cleared to leave @ 1215 Pt denies SOB or swallowing difficulty. Discharged at 1232.

Develop a blood clot lost vision in left eye due to stroke. I?m still in the hospital. I am 50 and had a stroke a week at getting that vaccine TPA shot. Given. Clot buster

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.

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.

onset within 7 hours of injection: Low grade fever, chills, uncontrollable shaking, thirst, muscle aches, joint aches, tinnitus, fatigue, headache, nausea, vertigo, dizziness.

Ringing in ears same day as vaccine was adminstrated…Joint pain, headache, dizziness, chills, fever, soreness at injection site and nausea. (Dizziness and nausea lasted 3 days) All the symptoms have gone away EXCEPT FOR TINNITUS IN BOTH EARS.

Extreme fatigue, increase in palpations, ears ringing off and on, tightness in chest (could be anxiety but am VERY concerned about my Cardiac Ectasia (Bulge) on my Aorta due to news of Serious Adverse Events reported by others who received J&J Vaccine.

Headache, all over body aches. Tired. Dizziness. Stuffy nose. Vision issues, I have to change between old glasses or take glasses off completely, takes longer to focus.

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

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.

Literally within a few minutes of receiving the vaccine my tongue started to swell a bit. That sensation lasted about 4-5 hours. About an hour after receiving the vaccine my lips also swelled a bit(that lasted about 2-3 hours). I did speak with a paramedic at the vaccination site (about the tongue) and we both felt like I was ok enough to go without further care. I was informed by him that if I felt worse during the day to call 911. The tongue and lips swelling was never severe enough to feel it warranted calling 911 or going to emergency room. I would classify them both as "slight" swelling. That evening I also suffered from the flu-like aches and pains that were expected as possible side effects. Those flu like symptoms went away 24 hours later. It was really the swelling that I felt important to properly report.

3/12/21 developed dizziness, redness all over, 20 min after the injection the redness resolved. Also c/o tinnitus and dizziness comes and goes. Went to the ed x2 and saw pcp for dizziness. Zofran was given for dizziness. Going to see a neurologist on the 4/20/21

4/5 - Fever and chills started also severe headache. 4/8 eyes started to burn, blurry vision numbness in extremities.

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.

ELEVATED BLOOD PRESSURE 200 PLUS; FLUTTERING HEART; DIFFICULTY BREATHING; DIZZINES AND LIGHTHEADED; AFTER STANDING GOT A RUSH AND STARTED TO STUMBLE; FLUSHED; FELT VERY THIRSTY; NAUSEA; 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: 1808980, and expiry: UNKNOWN) dose was not reported, frequency once total, administered on 31-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 31-MAR-2021, within 15 minutes, the patient experienced lightheaded, difficulty breathing, after standing up got a rush and started to stumble, fluttering heart, nauseous, dizziness, flushed and elevated blood pressure 200 plus. It was stated that all symptoms went away that evening. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, elevated blood pressure 200 plus, after standing up got a rush and started to stumble, flushed, fluttering heart, light headed and dizziness, nausea on 31-MAR-2021, and the outcome of felt very thirsty was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210415219-Covid-19 vaccine ad26.cov2.s-Elevated blood pressure 200 plus And Fluttering Heart. 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).

Dizziness, extreme nausea, headache, weakness about 10 minutes following vaccine. Still having severe headaches, dizziness, memory loss, blurred vision, fatigue, restlessness.

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.

Severe Headaches, Eye Pressure, and pain extended all the way to the back of my head. Joint pain is constant, especially in the legs.

SWELLING IN FILLER LIP ON LEFT SIDE OF UPPER LIP FROM MIDDLE OF LIP TO END OF TOP LIP.; BURNING PAIN ON LEFT SIDE OF UPPER LIP FROM MIDDLE OF LIP TO END OF TOP LIP.; HEADACHE; LOW GRADE FEVER; MUSCLE ACHES; FATIGUE; DIZZINESS; FELL DOWN; 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 panic attacks. The patient was previously treated with hyaluronic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included alprazolam for panic attacks. On APR-2021, the subject experienced fell down. Laboratory data included: Body temperature increased (NR: not provided) 99.5 F. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced low grade fever. On 09-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced swelling in filler lip on left side of upper lip from middle of lip to end of top lip. On 12-APR-2021, the subject experienced burning pain on left side of upper lip from middle of lip to end of top lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021, and low grade fever on 08-APR-2021, was recovering from muscle aches, and fatigue, had not recovered from burning pain on left side of upper lip from middle of lip to end of top lip., dizziness, and swelling in filler lip on left side of upper lip from middle of lip to end of top lip., and the outcome of fell down was not reported. This report was non-serious.

On Sunday she began to experience a feeling of tightness and tingling in her throat. This continued for three days before she returned to the pharmacy to report the reaction. Because of the throat involvement it was recommended to the patient to follow up with her doctor as soon as possible and report to the ER if she at any point has difficulty breathing. She reports that it is worse at night. She said that the reaction feels similar to her seafood allergy but she only reports tightness and tingling not difficulty breathing.

TINGLING TONGUE; RED RASH ON NECK, SHOULDERS AND CHEST; MUSCLE ACHES; HEADACHE; PAINS THROUGHOUT THE BODY; CHILLS/SHIVERING; 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 penicillin allergy. 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 11-APR-2021 14:15 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced pains throughout the body. On 11-APR-2021, the subject experienced chills/shivering. On 11-APR-2021, the subject experienced muscle aches. On 11-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced tingling tongue. On 13-APR-2021, the subject experienced red rash on neck, shoulders and chest. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pains throughout the body, chills/shivering, muscle aches, and headache on 12-APR-2021, and had not recovered from red rash on neck, shoulders and chest, and tingling tongue. This report was non-serious.

PATIENT REPORST DEVELOPING SOREES IN MOUTH 3 DAYS AFTER, REMAINED FOR ONE WEEK. rETURNED AGAIN IN 10-12 DAYS. REPORTS CHANGE IN PIGMENTATION OF TONGUE.

Pt called the office reporting injection site pain, headache, and right eye redness. Started with the red eye then injection site arm hurting/pain, and headache. Pt was told to go to her PCP and/or the emergency room to be seen and treatment.

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.

04/10/221-post vaccination-syncopy episode, supported fall to the ground, dizziness, blurred vision, nausea, high BP 194/118, stabilized at 187/110 ( already on propanol 10mg), BS 82, Pox 97,Medics responded, tx w/ Zofran, sent home wi/ family support/supervision. Instruc to be seen by MD on Mon 4/12, as ct has hx significant HTN, if increase H/A, dizziness or blurred vision to go to ER. 04/14/2021-4 days post vaccination-ct c/o pain, tingling, heaviness L arm (arm vaccine given in)numbness L side, fatigue, achy all over, instructed to go to ER r/t high BP, ER reported-EKG, blood work, ultrasound all negative. Instructed to take Ibuprofan alternated with Tylenol x 24 hrs for arm pain, and to make appt with

Immediate overwhelming metal taste in mouth Immediate prickles on head and face and went down to arms. 20 min after injection moderate dizziness and severe itching. Most severe on face, neck, head, arms, and hands but also on back and torso. Took 10 mg liquid Benadryl orally. Symptoms still bad after 15 minutes so another 10mg liquid Benadryl orally. Very nauseated so took ODT Zofran. Symptoms did not get worse after 10 mins so went home. At home: 5 hours after injection severe cold shivering profuse sweating, nausea, and stomach pain. 8 hours post injection violent vomiting and continued cold shivering profuse sweating. Now 11 hours post injection continued cold sweating, vomiting, and now persistent diarrhea with abdominal pain.

TACHYCARDIA; DRY MOUTH; DIZZINESS WITH STANDING AND INTERMITTENTLY WITH SITTING; PULMONARY EMBOLISM; FEELING OF DOOM/ FEELING OF PASSED OUT; FATIGUE; This spontaneous report received from a patient via a company representative via the VAERS (Vaccine Adverse Event Reporting System) concerned a 50 year old female unknown ethnicity . The patient's height, and weight were not reported. The patient's concurrent conditions included osteoarthritis, gluten intolarance, and diflucan allergy. The patient was previously treated with fluconazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: UNKNOWN) with unspecified dose on left arm, on 27-MAR-2021 11:00 for prophylactic vaccination. Concomitant medications included amino acids NOS, biotin, cannabidiol, collagen, ethinylestradiol/norethisterone acetate, and hyaluronic acid. On 07-APR-2021, the patient experienced dizziness with standing and intermittently with sitting, tachycardia, dry mouth, chest pressure, shortness of breath, and feeling of extreme doom. On an unspecified date, the patient was transported to the clinic. In the clinic the patient had heart rate of about 140 with irregular beats. The patient had undergone Electrocardiography test which showed ST Depression. The patient's symptoms were improved by taking nitroglycerin. As the clinic did not have the technology to provide care so the patient was emergently transported to the hospital. In the hospital the patient's D-dimer level was positive. Later the patient undergone Computerized Angiogram for lungs which showed pulmonary embolism. The patient undergone Dopplers studies of both legs which showed as negative. The patient had received Heparin treatment for several hours and then later switched to Eliquis. After 6 hours being on Eliquis treatment the patient had same original symptoms and for that again nitroglycerin was administered. The patient was placed back on heparin for a longer period of time. Later on the patient got switched to Eliquis 10 mg twice daily for 7 days and further to 5 mg twice daily for 6 to 9 months. The patient had undergone Angiogram of head and neck which was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, feeling of doom/ feeling of passed out and dry mouth on APR-2021, had not recovered from fatigue, dizziness with standing and intermittently with sitting and pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening). Sender's Comments: V0 -covid-19 vaccine ad26.cov2.s-Pulmonary embolism , Feeling doom, Tachycardia, Dry mouth, Dizziness with standing, Fatigue 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).

Extreme tinnitus, brain fog, dizzieness and stomach pain 1-4 weeks after. Extreme tinnitus has not resolved yet.

Approximately 10 minutes after vaccine administration, patient reported tongue tingling and throat tightness. Nurse reported flushing. After arrival to the ED approximately 10 minutes patient also reported voice hoarseness and sweating. On arrival to ED, patient received Epinephrine 0.3 mg IM, diphenhydramine 50 mg IV, famotidine 20 mg IV and methylprednisolone 125 mg IV Patient began feeling better shortly after. Currently (~2.5 hours after vaccine administration), patient is sleeping in ER. Anticipated discharge later today with a steroid taper.

Constant headache blurred vision dizziness pain in back of head numbness in left leg bp very high weakness tightness in right arm and pain in left arm where the shot was given sore throat face numbness

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.

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

Sick and chills and bodyache night of vaccine, horrible headache lasting for 2 days. On the third day, another headache. On the fourth day, mild headache. 5th day bad headache and that afternoon started tongue swelling and right gland in throat is sore/swollen. Hurts to swallow.

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

Migraine, followed by severe eye pain and a very bad broken blood vessel in right eye. Eye pain has continued over time.

POSITIVE COVID TEST AFTER VACCINE; SORE ARM; DRY THROAT; WARMTH WENT UP NECK; VERY THIRSTY; WATERY EYES; FEELING A LITTLE NASALLY; This spontaneous report received from a consumer concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A 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 feeling a little nasally. On APR-2021, the subject experienced watery eyes. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced dry throat. On 09-APR-2021, the subject experienced warmth went up neck. On 09-APR-2021, the subject experienced very thirsty. On 18-APR-2021, the subject experienced positive covid test after vaccine. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 25-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from positive covid test after vaccine on 25-APR-2021, and the outcome of sore arm, feeling a little nasally, dry throat, warmth went up neck, very thirsty and watery eyes was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be pqv management approval - confirmed no pqc was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.

I had Covid-19 in March of 2020. I lost the muscle function in my legs. I was in a wheelchair for two months at the time. I had side effects one week after the vaccine. I had headaches and I had no energy at all. I was tested for Covid-19 four weeks after the vaccine. I think I contracted it from my father a few days after the vaccine. My ear hurt and my jaw kept popping. I felt really bad. I was given antibiotics and steroids, but I still feel bad after two weeks.

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

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

04/08/2021- Day of shot, pain began and lasted over 4 weeks, went across my shoulder around my heart and down my arm, pressure, discomfort kind of pain. 04/11/2021 began having extreme dizziness. stabbing pains around hear while driving, lasted for 10 minutes. 05/04/2021 I woke and I had blurry spot in vision, more dominant in left but was in both eyes, then began to spread, last about half an hour, was left with headache, I went to ER. I started to get bloated, I am dealing with a lot of stomach issues. I have to see endocrinologist .

Significant but not extreme vertigo lasting about half an hour. Several weeks later, more moderate, more persistent vertigo returned and persisted for several weeks off and on, accompanied by extreme fatigue and tinnitus. Because I had had one previous, weeklong episode of severe vertigo in 2018, a specialist diagnosed me with probable Meniere?s disease based on this second episode that began about a month after my Covid19 Janssen vaccine. It is not my belief that it was necessarily caused by the vaccine, but I thought I should report the information.

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

Post menopausal woman. Period began again day after shot. 4 weeks later heavy period with bleeding soaking pads every hour with thick clots. Also experienced allergic reaction at time of injection. Swelling of lips and difficulty breathing. Took Benedryl.

BLURRED VISION; FLASHY THINGS AROUND EYES; NUMBNESS ON RIGHT SIDE; TINGLING ON RIGHT SIDE; PAIN ON LEFT SIDE DOWN TO THE BASE OF SKULL/SEVERE HEADACHE (HEADACHE UNBEARABLE); This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included contracted covid, and concurrent conditions included benign hypertension. The patient experienced drug allergy when treated with metformin, and amlodipine besilate for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAY-2021, the subject experienced blurred vision. On 27-MAY-2021, the subject experienced flashy things around eyes. On 27-MAY-2021, the subject experienced numbness on right side. On 27-MAY-2021, the subject experienced tingling on right side. On 27-MAY-2021, the subject experienced pain on left side down to the base of skull/severe headache (headache unbearable). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurred vision, flashy things around eyes, pain on left side down to the base of skull/severe headache (headache unbearable), numbness on right side, and tingling on right side. 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.

I received the Johnson and Johnson covid vaccine on 7 April 2021. Within 6 hours of receiving the vaccine, I experienced typical flu like symptoms. Though the majority of the symptoms subsided within 24 hours, I continued to experience headache symptoms for several days. On 12 April 2021, I woke up with a broken blood vessel in my left eye and red and black eyelid. The blood from broken blood vessel continued to get worse. I went to the ER to have tests run because the J&J vaccine was removed from use during this time.

First noticed double vision and blurry vision while driving. A few days later, someone noticed that my left eye was not moving outward and along with my report of having double vision it was decided that I should go to the ER. Tests conducted included CT scan of head with and without contrast, MRI of head, eyes, and neck, ultrasound of neck, EKG, and blood work. Also had two separate series of tests performed by a neurologist. Everything came back normal. Was sent home and visited an ophthalmologist a couple of days later. Several tests were made and nothing was out of the ordinary, but doctor suggest a left 6th nerve palsy. Referred to neuro ophthalmologist. Appointment is still a few weeks away. Double vision has largely gone away as well as blurry vision. Left eye movement outward is still limited.

Received vaccine on 07/02/2021 at 9:00am. Woke up on 07/05/2021 with hearing loss in right ear. Arm soreness starting 07/04/2021. Chills and full body aches started 07/02/2021 in the evening and again 07/03/2021 in the evening but only in the evenings.

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

Immediately following, patient reports that tingling sensation to her tongue, dyspnea and ?my throat feels tight.? Patient reports a similar prodrome to when she had an anaphylactic reaction to eggs. Ed medications-sodium chloride 0.9 % bolus 1,000 mL (0 mL Intravenous Stopped 5/7/21 1332) famotidine (PEPCID) injection 20 mg (20 mg Intravenous Given 5/7/21 1054) diphenhydrAMINE (BENADRYL) injection 50 mg (50 mg Intravenous Given 5/7/21 1055) EPINEPHrine PF (ADRENALIN) 1 mg/mL injection 0.3 mg (0.3 mg Subcutaneous Given 5/7/21 1044) methylPREDNISolone sodium succinate (Solu-MEDROL) injection 125 mg (125 mg Intravenous Given 5/7/21 1100) ibuprofen (MOTRIN) tablet 600 mg (600 mg Oral Given 5/7/21 1443)

BLURRED VISION; TOE CRAMPING; FACE BROKE OUT/PIMPLES; NIPPLE HYPERSENSITIVITY; JOINT PAIN; FLU LIKE SYMPTOM,FEVER,HEADACHE,CHILLS,FATIGUE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 18-AUG-2021) dose was not reported, administered on 28-JUN-2021 09:30:00 for prophylactic vaccination. No concomitant medications were reported. On 28-JUN-2021, the subject experienced flu like symptom, fever, headache, chills, fatigue. On 28-JUN-2021, the subject experienced joint pain. On 29-JUN-2021, the subject experienced nipple hypersensitivity. Treatment medications included: paracetamol. On 30-JUN-2021, the subject experienced toe cramping. On 30-JUN-2021, the subject experienced face broke out/pimples. On 03-JUL-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from face broke out/pimples, and had not recovered from joint pain, flu like symptom, fever, headache, chills, fatigue, blurred vision, toe cramping, and nipple hypersensitivity. This report was non-serious.

Within one day of vaccination experienced minor tinnitus, tingling in the left arm and significant stiffness in the left neck and left shoulder area. Stiffness in the left neck and shoulder lasted four days, tingling I the left arm on/off lasted eight days, and tinnitus lasted two days. On days seven and eight experienced weakness in the legs, especially first thing in the morning. On day nine my ?back went out? - this major lower back strain lasted five days to where it was difficult to move. On day 14-15 lower back pain still exists, but is more mild with limited mobility.

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

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

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

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.

Got J&J vaccine Sunday and have experienced every side effect listed. Had 103 degree fever, took tylenol, drank water. Fever broke @ 4am, still have excruciating headache, eyes hurt from the light, body aches, can't move right arm more than 90 degrees . Fever is now at 2pm 3/8 inching up, is 99.5.

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

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