Johnson & Johnson

Aches in both arms (mostly in arm that was vaccinated), backache, restlessness, insomnia, headache, overall body fatigue. All of these things caused me to wake up in the middle of the night around 3:30 AM the day after vaccination.

Saturday night: bad headache which started around 7pm and lasted the wholel night Sunday: headache persisted, then ended around noon. Around noon became bloated and then by 5pm I had the runs and was using the bathroom for about 6 hours

Patient complaint of fatigue/(sleepy) and sensitive to light immediately 15 minutes after getting Janssen & Janssen vaccine

Janssen COVID-19 Vaccine EUA Side Effects: - Nausea - Head ache - Body aches - Chills - Very sore arm

Significant body aches and pain all over body, fatigue, headache, injection site pain the night after getting the vaccine

Janssen COVID-19 Vaccine EUA About 6 hours after receiving the vaccine: - headache - muscle aches - chills - fever The next day, after receiving the vaccine: - mild headache - mild muscle aches - fever and chills have subsided Immediately after receiving the vaccine and continuing the next day: - sore arm in the arm receiving the injection

Fever, aches, chills, sweats, racing pulse, swollen ears, vomiting. Fever and aches continuing to the next day. Unable to sleep due to pain and getting up several times at night to vomit.

Severe joint pain, severe muscle pain, fever 100.5, swelling in joints, and headache started at around 2pm of the same day of vaccination and continued into the night. Took 600mg of ibuprofen every 4 hours to control pain. After second round of ibuprofen pain was tolerable. Day 2: when going off of ibuprofen severe pain returns with limited mobility again. Will continue ibuprofen for day 2.

Headache began 4 hours after injection, body aches began 5 hours after injection, both became progressively worse over the next 5 hours. Took Tylenol and Advil in order to fall asleep. Symptoms gone next morning

Fever, sweating, chills/body aches (upper and lower body). Symptoms started around 3 am (woke me from sleep). Fever broke after taking 2 Advil liquid gels. Chills/aches contributed through out today.

Janssen COVID-19 Vaccine EUA Six hours after I received the vaccine I began to feel full body muscle aches and shivers. I took 2 Advil. I went to bed at 9:30 p.m. and woke up at 11:30 p.m. feeling as though I had slept 8 hours because I had a 102 fever. My face was burning from the heat and I was shaking. I took two more Advil. About 30 minutes later I threw up. I waited 30 more minutes and threw up again. As a result, of having Addison's disease, I have an emergency steroid injection that I use during crises such as this. I took my shot and immediately began feeling slightly better. I was able to go back to bed and at some point the fever went down overnight. I am currently feeling weak and with no fever. I also have a slight headache.

Around 8 pm (about 6 hours after receiving the vaccine) I started to feel typical flu symptoms such as chills and aches, and I had some body shaking as well. I was in bed that night and the symptoms kept getting stronger, and around 11 pm I started to feel tingling throughout my body, mostly in my hands and feet. It was very uncomfortable to lay still and I felt I'd never be able to fall asleep if I couldn't lay still. I took 10mg of Z-Quil around 11:30 pm. My body and skin was also starting to get very hot, I never took my body temperature but I probably had a fever. I put a cold compress on my forehead. I also took 1000 mg acetaminophen and 400 mg Advil. I got up to use the bathroom and I could walk but my balance was off and I felt tingling up my legs. I laid back in bed with the cold compress again and the tingling in my hands and feet increased. I tried walking around again and again felt tingling up my legs. I sat on the edge of my bed moving my feet around which helped the tingling, but when I laid down again the tingling kept coming back. I took another 10mg of Z-Quil and 0.25mg xanax (prescription for anxiety). I finally decided to move to a chair with lots of pillows so I could sit upright since that helped reduce the tingling. I finally fell asleep sometime after 12:30 am. I woke up in the chair around 2 am and was feeling better - no tingling, no body shaking, chills and aches were reduced and body temperature didn't feel as high. I was then able to sleep in bed for the rest of the night. The next day I still had aches and chills and a fever but it was manageable with Advil or acetaminophen, and by Monday (March 8) I was able to go to work.

I felt dizzy, nauseous, massive headache, it felt like my brain was swelling. hips and joints where so sore. dehydrated. i was exhausted all day and night. these symptoms lasted up untill today.

I had my J&J COVID vaccine on Monday 3.8.21 On Monday night I developed a fever of 103 which lasted all night despite Advil and Tylenol. I had diarrhea, injection site pain and severe shaking. On 3.11.21 I have developed a very red swollen injection site which is large and extremely painful to the touch. My fever did go away at around 3AM on 3.11.21 but still have the body aches. This was not listed in my possible side effects this far out and some side effects were not even listed in my hand out

I am 6 months pregnant (28 weeks). Approximately 8 hours after the injection, I developed a fever of 103 degrees. Other symptoms were severe body aches, tremors, and chills. I took two 500mg Tylenol pills, but the fever remained at 103 degrees for 12 hours. After 12 hours, the fever reduced to 100 degrees for another 6 hours. Body aches, tremors and chills decreased in severity along with the fever. After 18 hours, my temperature returned to normal and tremors and chills subsided completely. I remained very fatigued with some body aches and general soreness for another 24 hours.

After vaccination patient developed fever and chills lasting though today as well as severe GI issues.

Janssen COVID-19 Vaccine EUA. Mild body aches and chills. Injection site tenderness. Three 200 mg ibuprofen taken around 10 pm relieved symptoms

Around 1:00 am I started having chills and body aches. At 5:00 am I woke up with a headache and cold like symptoms, sore throat, headache, waves of nausea, soreness.

Janssen COVID-19 Vaccine EUA 12:15pm (3/10/21)- initial injection 12:20pm- excessive bleeding from arm 6:45pm- chills, inability to get warm, headache 7:45pm- low grade fever (100.3F), took Tylenol Overnight- inability to sleep, constant chills and sweating, muscle aches, felt very horrible 2:30pm (3/11/21)- fever breaks, only arm is still sore

My symptoms started at 4:30pm on Friday, March 12 and lasted until about 5:30pm on Saturday, March 13. My symptoms included headache, pressure in the ears, body chills, fever of 100.3, fatigue, loss of appetite, and body sweats.

Janssen COVID-19 Vaccine EUA. Fever 3/14 from 7:30pm-11:30pm. Fever 3/15 6:30-7:30am. Headache 3/14 starting at 7:30pm-3/15, ending at 9:00pm. Fatigue starting 3/14 at 6pm. Arm pain at injection site.

Fever Couldn't talk Sharp join & chest pains Painful to move eyes Fatigue Bedridden- couldn't move on my own Shortness of breath Lasted 7 hours; took 3 Tylenol @ 500mg each; lots of fluids

Intense chills started about 5 hours after vaccine injection and lasted on/off through the night. Fever at 9 pm was 102 degrees. Felt tired but chills and fever were gone by morning and felt relatively back to normal.

first started with severe migraine and chills and then experienced difficulty breathing and shortness of breathe. Had to go to the ER because I was unable to breathe when laying down

Dizziness, Pallor and pre faint feeling, diaphoresis then syncope for 20-30 seconds with inconstancy.

- Pain in injection site on left arm - redness, swelling (knot), warm to touch (still continuing, worsening) - Mild nausea for over 36 hours (still continuing) - Headache for less than 36 hours - Minor body aches for less than 36 hours - Slight chills on second day

12 hours after receiving the vaccine, I woke up in the middle of the night with severe chills, fever-like symptoms, a headache, and aches all over my body. I also was experiencing a heavy chest and shortness of breath. All but one of the adverse events went away after 24-36 hours - the shortness of breath and shallow breathing have persisted up through today. I am very aware of my breathing and how my chest feels tight, like I'm not getting enough air.

Hi, I received the Johnson and Johnson vaccine one week ago, Thurs March 11. On friday, I experienced the typical flu like symptoms - chills aches pains and fever. These have slowly gone away, but a week later I still have chills and constantly shake, and diarrhea. The most significant side effect I want to report is extreme vertigo and dizziness and headaches. These have been present for a week now and have prevented me from working and doing daily activities. I constantly feel like Im going to fall over and cannot see clearly. I previously had vestibular migraines, but these have been mostly gone due to going to the chiropractor and taking my supplements. The vaccine brought them back now in full force. I read that this is becoming a commonality among other people and need answers on this. I want to make sure its not permanent or that I will have this as a serious side effect.

30 minutes after leaving the site, got a mild reaction where my face got tingly and red but then it subsided but then 4 hours after receiving the vaccine I began getting a low grade fever (100.6) by 5pm that same day, I began having flu like symptoms, body aches, headaches, fatigued, chills, sweating and fever had risen to 101.7. Took ibuprofen to help with the symptoms but fever kept rising. By 8pm., fever was at 102.9, headache worsen, sweats throughout the night and felt dizzy. Next morning 3/18, fever was low grade by 7am (100.4) by 9AM, fever was gone, felt tired, with mild body aches and moderate headache and felt exhausted the rest of the day. Symptoms are getting better with rest.

Right after shot, within minutes, began mild cough. Persisted throughout next days. Two days later on Friday, suffered major asthma attack with trouble breathing, major coughing. Have had coughing and trouble breathing with more asthma attacks in the following days. Used albuterol nebulizer, asthma inhalers to cope.

102 degree fever, severe chills, severe muscle / body aches, severe headache exacerbation, severe diarrhea for 36 hours and hypovolemia, severe exacerbation in chronic abdominal pain, severe exacerbation in chronic joint pain, severe fatigue, insomnia, exacerbation in nausea and food intolerance

Started to experience nausea and chills about 8 hours after the shot. A few hours later I had a low grade fever of 100.7 and a headache. My body became very sore and weak and my heart was racing. Woke up around 4am with a headache, fever, and racing heart. My chest feels heavy and I?m very tired and weak. The shot was given to me at a local clinic.

Nausea day 1 accompanied with loss of appetite and hot flashes, Day 2 rash and itchiness at injection site, chills while sleeping, muscle aches, headache, fatigue, Hot flashes after chills went away

before vaccination person reported that she had n/v everytime she had recived a flu vaccine. It was discussed with her and she insisted on taking the vaccine so she could keep working. 10 min after taking vaccination she had headache. Brought to observation area and progressed to n/v. Monitored for 30 min and then called for EMS. She was given Benadryl. She reported only 4 hours of sleep and not eating anything after waking up. transported via EMS for on site observation

Janssen COVID-19 Vaccine EUA: patient received vaccine in the morning then later that afternoon developed fever, chill, backache, upper abdominal pain, malaise. Presents to emergency department (ED) with vital signs within normal ranges. Temperature 37.7 degrees Celsius. Patient received ondansetron and intravenous fluids. Discharged home medically stable with symptom improvement.

I started to feel tired once I got the shot, I got the shot at around 1:15 pm. About 5 pm, I started to feel really cold and my whole body was shivering and vibrating. My whole body also started to ache and my bones felt heavy. At about 10 pm I started to get really high fever and felt so cold. I could not sleep even with a winter jacket on, I had a really bad headache in the center of my forehead, lower back pain and felt extremely sore and weak. I found it difficult to stand or walk. I woke up at 2:30 am from bed, to get a snack and took 2 ibuprofen to ease the symptoms. Woke up at about 10 am next day, felt slightly better. Fever has gone down slightly but not completely. Still feeling really cold and shivering.

stomach pain. pt presents to the ED for severe abdominal pain x 8-10 hours, pt states she has left flank pain that radiates to her upper back, chills, denies N/V/D, denies any recent stools and endorses frequent eructation. 26 yo f w/spouse at bedside c/o ongoing intermittent episodes of diffuse abd pain/cramping (hypogastric > epigastric) w/additional nausea w/o vomiting x 2wks, worsening over past 24-48hrs, states latest onset largely R-sided in nature x8hrs; Pt denies any fevers/ns/chills, urinary sx's, vaginal bleeding/discharge, prior hx of abd trauma/surg/procedure

HA, vertigo dizziness started ~10am 3/21 with nausea - dizziness worse with walking - though also every 30min and lasts for seconds at a time - vomiting last night; + cold chills - also worsened reflux with epigastric pain with nausea; no cp or sob - no fever - + h/o vertigo in past - 3mo after delivery (suspected migraine/ anxiety - better with topamax and lexparo) -Denies dyspnea, no painful respirations, no loss of taste or smell

Headache, fever, chills, muscle aches, fatigue. Started 14 hours after vaccine and lasted for 12 hours. I took Tylenol and Ibuprofen and rested til it went away.

Patient was administered vaccine and told to wait the 15 minute monitoring period. After about 4 minutes, I heard her say "I'm not feeling right." I went to where she was sitting and asked "are you ok?" and had her take some slow, deep breaths. I then saw her eyes roll back and she lost consciousness. Thankfully, I was there and grabbed her as she toppled from the chair. I told the staff to call 911 and supported her neck and body in the chair. I could tell she was breathing and she was sweating profusely. I held her and spoke to her, and after about 15 seconds, she began to come out of it. After about a minute she was alert and orientated again. I had her slowly sip a little water. The EMTs arrived in about 5 minutes and the assessed her vitals. She indicated that this was the first time anything like this had happened to her. They advised that since she had fainted, she should go to the hospital for observation, but she declined, stated that she felt fine at that point. Since she was driving, I insisted that she remain another one-half hour before leaving. During that time she drank more water and alternately sat and walked around the pharmacy. She did indicate that she had drank a protein shake that morning, but not eaten. I advised her to in the future, tell her doctor and/or any immunizer about the event. She left, stating that she was feeling fine, and I called her several hours later to make sure that she had indeed gotten home ok. She again said that she felt fine.

Minor arm pain in the injection arm. Severe headache about 10-12 hours after the shot lingered for a few days fluctuating in severity after the second day. Body chills night of vaccine. Slight Fever night of vaccine.

Pain and swelling at injection site becoming hot and red at injection site, becoming very swollen in upper arm and some swelling in forearm. Became very hot in upper arm. No fever when taking temperature. Also some mild headache and mild body aches

Severe drowsiness 45 minutes after injection, slept 12 hours straight during day/evening, awaken for one hour then slept til 6 am. Awake 4 hours then slept 6 more. Chills noted from 2100on 4/1/21 til present.Fever of 100.5 noted at 1830 on 4/2/21, took ibuprofen 600mg po. Pending results. Still 100.5F-101.3F. Keeping fluids down. Body weakness/fatigue noted since 1100 am on 4/2/21.

Within 6 hours of getting vaccine I had flu symptoms- chills, aches, headache, fever, tiredness. By 9pm I had a fever of 104 degrees and was dropping sweat, shaking, and very weak. Within 24 hours, I developed a rash on my chest ans torso area of little red bumps that were itchy and spreading throughout the day. The fever came and went on the second day. Terrible flu symptoms have lasted over 24 hours now.

Received the vaccine on a Thursday evening. 9 hours after I received the vaccine I woke up with chills, fever, headache, body aches, and a sore arm around the injection site. These symptoms lasted a full day (all of Friday) with the body aches being the most intense. When I woke up Saturday, these symptoms were gone with the exception of the sore arm which took another two days before getting back to normal. I took one 500 mg Acetaminophen on Friday to relieve the symptoms which didn't seem to help.

Janssen COVID-19 Vaccine EUA - Muscle aches starting within 3 hours of vaccination, growing worse for 24 hours before receding after 36 hours - Headache starting within 5 hours of vaccination, ending by 20 hours post-vaccine (upon waking next morning) - Fever of up to 100.6 F starting 7 hours after vaccination, gone by 20 hours post-vaccine (upon waking next morning) - Fatigue starting within 3 hours of vaccination, lasting ~48 hours - Nausea off and on between 7 and 10 hours post-vaccine

At approximately 3:30 am on 4/2 I began experiencing moderately-severe muscle aches and muscle cramping throughout my body including hips, knees, fingers, thighs, and back. Accompanied with fever, cold sweats, and hot flashes. These symptoms lasted through 10 PM 4/2. Headache present from 7 am to 12 pm 4/5. Arm soreness and fatigue present from 4/2-present. Poor appetite from 4/1-4/5.

Patient has a fear of needles. After her injection, she tried to stand up to tell me she does not feel good but fainted before getting to the counter. She hit her head at some point. We gave her some water and called the paramedics. After checking her out she was instructed by the paramedics to go to hospital. She went to the student health center and given information regarding head injury. She later return to collect her Vaccine record card.

4-5 hours after vaccine - slight nausea 8-10 hours after vaccine - heavy head/headache/slightly feverish 18-24 + hours after vaccine - headache/feverish/weak body/pain at injection site

Janssen COVID-19 Vaccine EUA. Headache, fever (99.5 degree F), fatigue, sore injection site, sore left arm, forgetfulness,

Admitted 4/3 with a cerebral sinus venous thrombosis, portal vein thrombosis and pulmonary embolus. Pt received covid vaccine 3/18. Symptoms began 3/26 which started with chills and body aches. Then on 3/27- developed a severe headache in the back of her head with associated nausea. On 3/28 she had the most severe headache on the right side of her head. She was vomiting from 3/28-3/30. On 3/30 she went to the ER for evaluation of her severe headache. She was given a "migraine cocktail", no imaging was completed and she was sent home. Appetite improved on 3/31 and she had a small headache relieved with Excedrin. Then on 4/1-4/2 she had severe bloating , abdominal pain and fever of 100.4. She had been visiting her mom for the holidays and came to the ER. Imaging revealed cerebral sinus venous thrombosis, portal vein thrombosis and pulmonary embolus. She was started on a heparin drip and brought to ICU for monitoring.. She is not on any oral contraceptives and does not have any family history of clotting disorders.

The following two days I had a low grade fever, extreme fatigue, dizziness, and light headedness. This was intermittent throughout the two days. By day three it was done. I also have noticed (three weeks later) that there?s still swelling at the injection site, similar to a boil

Fever, body/joint aches, chills, cold sweats, all lasting until the afternoon on the following day. After it passed, muscle soreness and feeling very warm for another full day.

-Fever over 104 degrees approx. 10 hours after injection, Tylenol successfully lowered fever -Body aches and skin sensitivity for 24 hours following fever, resolved on its own -Multiple canker sore flare ups in mouth approx 3 days after vaccine, has not yet resolved (5 days post vaccine)

3/30/21- Chills, inability to sleep, nausea 3/31/21 - Chills, Headache, severe Muscle/body aches, runny nose, fatigue 4/1/21- chills, headache, muscle/body aches

I started to feel weird around 7pm, like the feeling of being "off" right before you get sick. By 9pm, I had the chills and a fever. For the next hour, I experienced nausea, headache, and worsening fever. I was shaking, had body aches and intense chills. I went to sleep at 10:30pm with a fever of 101.4 and had a fever until 8am the next morning. I experienced a terrible headache throughout the next day and felt extremely exhausted.

A few minutes after being vaccinated patient was sitting for her 15 minute observation period and walked over to the pharmacy counter stating "I just got my vaccine and I really don't feel well" the pharmacist approached the patient and caught her under both arms from behind her back as the patient fainted. Patient did not hit the ground or injure herself-she did not lose consciousness she was flushed and sweating. Pharmacist sat on floor with patient for 2-3 minutes and gave her water, patient was then able to stand up with little assistance and brought to sit down. Patient stated she felt nauseous and may vomit she was given a trash can but did not vomit she was able to drink a bottle of water and was given a soft pretzel. After about 10 minutes she stated she was feeling much better was no longer flushed or sweating she called her boyfriend for a ride home.

J&J COVID-19 Vaccine EUA Fever around 100 F (about 6 hours) Muscle aches (about 12 hours) Headache (about 12 hours) Diarrhea (about 6 times over the course of 8 hours) Vomiting (about 4 times over the course of 1 hour)

Within 5 to 10minutes of receiving vaccine, pt was visibly red, reported feeling hot all over with scratchy throat. Over the next few minutes mouth became numb. Medics evaluated pt, and after 30-40 minutes, pt left pharmacy with a family member. (medics came to pharmacy)

Vertigo Lightheadedness Chills Exhaustion Trouble sleeping Slight fever Muscle aches Injection site pain Headaches Nausea Swollen lymph nodes in shoulder, neck, and armpit

Headache and fatigue one hour after the vaccine. Terrible chills where I could not get warm starting two hours after the Vaccine. Also starting three hours after the vaccine I had extremely painful muscle aches and pains. Bruise at injection site and swollen arm. Excruciating pain in both arms and both knees. When the leg pain started, it started behind my knees. I was in tears for about 14 hours in excruciating pain due to the muscle aches and I am still having random hurts of sharp muscle and joint pain.

My symptoms came on very suddenly around 5:30 in the afternoon - I?ve described it like getting his by a truck. My symptoms include intense full body aches, moderate fever, chills/sweats, headache, and fatigue. It has now been 23-hours since my vaccine was administered and my symptoms have now subsided.

Janssen COVID-19 Vaccine EUA 12 am - 1 am: Chills, shivering, couldn't get warm. Temperature 98.9 degrees F 3:30 am: Woke up feeling very hot. Temperature 100.6 degrees F (Fever). Slight headache/muscle aches, and shortness of breath but those could be due to the fever. Took two 500 mg Tylenol tablets. 7:30 am: woke up due to alarm, temperature back down to 98.6 degrees F. 10:00 am: still feeling a little ache-y, shortness of breath, and tired. No more fever.

Chills, body aches, and headache that lasted about 24 hours after symptoms first started at 3 pm which was approximately 8 hours after receiving the vaccine.

Fever, chills, nausea, fatigue, blinding headache, body aches. Took 2 ibuprophin because the headache was unbearable.

Ache in injection site, muscle aches in joints throughout body, fever of 102 throughout night, loss of sense of taste, headache, chills

Woke up at midnight with chills, fatigue and nausea. I took 3 Advil (generic version) and after one hour symptoms subsided.

Experienced light headedness ( started before time stated but not sure when exactly). Around 6:30pm-7pm I began feeling dizzy, going between dizzy and light headed. I was drinking plenty fluids and did eat. A few people noted that I looked very out of it, and I felt very out of it. I tried staying seated and this did not have any effect on the dizzy feeling. I went to lay down and before going to sleep around 10pm-11pm, laying in bed I felt like the room was spinning. I also had typical symptoms, soreness as injections site and arm (starting immediately the day of vaccine), fever at it's highest was 102 (starting at 100.5 that morning, not peaking until Motrin wore off*see below*), feeling tired and very heavy.. like everywhere was waited down by something (starting early in the morning). I was given Motrin by my coworker in the morning as I was had a headache and was feeling sore and moving sore due to heavy feeling. Wednesday waking up the dizziness and lightheadedness were gone. A slight feeling of being out of it however, fever was about 99-100 throughout the day (99 being my typical temp). As of today only a feeling of sore arm and tiredness which sometimes feels like I and out of it but I feel both from later yesterday and today is due to the tired feeling that comes common.

VOMITING; FEVER; POUNDING IN HEAD; NAUSEA; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's past medical history included irritable bowel syndrome, and concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included patient do not have known allergies, patient do not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 13:30 for prophylactic vaccination on right arm. Concomitant medications included cannabis sativa for irritable bowel syndrome. On 02-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101 degree F. On 02-APR-2021 14:30, the subject experienced pounding in head. On 02-APR-2021 15:30, the subject experienced fever. On 02-APR-2021 17:30, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 02-APR-2021 17:30, and pounding in head, was recovering from nausea, and had not recovered from vomiting. This report was non-serious.

Janssen COVID-19 Vaccine EUA - 102 Fever - Chills - Aches - Headache - Bloody Nose - Pain in legs and back

Vaccine at 9 am. By 1 pm getting mild headache and nausea and fever symptoms including chills. By 6:30 pm, severe headache and nausea. Felt extremely hot and chills at the same time. May have had fever. Slight stomach ache. Would not have been able to work and notified work that may have to stay home next morning if felt the same way. Headache improved after Advil. Took hours to fall asleep and woke up several times throughout night. Woke up with slight but improved chills in the morning and back to mild headache and nausea. Very minor nausea and headache rest of day but back to mild headache and nausea the next day at 8 pm.

4/8/2021 3:00pm, 1 hour after vaccine stomach ache, drowsiness, and dizziness/lightheaded 4/8/2021 8:00pm, 6 hours after vaccine numb tongue, swollen face - allergic reaction -- took 1 25mg Benadryl 4/8/2021 10:00pm, 8hours after vaccine swollen face, throat tightness, swollen face, sore throat- allergic reaction -- went to ER given Pepcid, Benadryl, and steroid -- also prescribed these items for next 3 days. 4/9/2021 6:20am - following morning lips swelling - took 1 25mg benadryl

12 hours after vaccine around 3:30am on Saturday I woke up with sever chills, shaking uncontrollably for an hour or 2. I fell back to sleep and woke up about an hour later burning up and sore head to toe. I threw up and had a migraine that lasted the rest of the day. I was able to fall asleep around 6:30am and when I woke up around 9 I was just exhausted, sore all over, nauseous, with a headache. This lasted about a day. On sunday afternoon my toddler lightly hit my right arm where the vaccine was and it became sore, red, and swollen. By the late evening that day the soreness and redness increased. Monday-Thursday the redness and swelling increased to about 2 inches round and felt very tight with a lump in the swelling and it was warm to the touch. By friday the redness and swelling reduced to about an inch, but there is still an inch small lump at the injection site and hurts when anything touches it. The redness has faded and there is no visual bruising.

I received my vaccine in the morning and was fine with slight discomfort in that arm. Between 6:30 -7pm I started to get chills which turned into minor body aches that come and go and don't last very long. The chill sometimes starts between my shoulder blades where my back and neck meet then expand. I also feel tired.

About 6 to 7 hours after injection I began to have chills. Chills led to a fever and muscle aches. I?ve had a headache as well. Fever has last 12 hours even with medicine.

Janssen COVID-19 Vaccine EUA Severe chills/shivering, fever, headache, muscle ache/soreness, fatigue. Chills and fever lasted off and on for 4 hours. Headache lasted for 6 hours. Muscle ache/soreness and fatigue lasted 24 hours.

Janssen COVID-19 Vaccine EUA Initial pain in injected arm (left) that dissipated after 20 min. Roughly 5hrs. after vaccination: -Fever of 102.5 degrees F, nausea, eye sockets sore, intense throbbing headache, chills, felt like skin was over heating, dizziness, disorientation, intense body aches all over (arms, legs and back felt too sore to move) -Fever broke roughly 24 hours after injection -Treatment involved drinking lots of water, ice compress on forehead, and 1 Tylenol pill

About 12 hours after injection, I started feeling achey 13 hours later, I had a spell where I could not hear anything and felt as if I wasn?t in control of my body- in talking to medical personnel they say what I?m describing is what happens right before one passes out. I came out of it within 10 minutes. 16 hours later I had a 102 fever. Took Tylenol Felt fine 24 hours later 32 hours later I started to get a headache and light sensitivity. Fever back to over 99- low grade for me. 35 hours later I had such a bad headache and light sensitivity. I couldn?t watch tv, be on my phone, or look at a computer screen. I also started to get bouts of nausea. 38 hours later, I vomited for the first time. Same symptoms as what I described last. 42 hours later, I vomited again. 48 hours later - 5 days later, light sensitivity and migraine symptoms continued , but improved slowly each day. 6 days later, all previous symptoms were gone. I woke up with a bump in my inner eye. Slowly went away throughout the day, then developed a itchy, red bump in between my lips and nose, that progressively got bigger throughout the day and made my lip swell. Bump was about 2 inches in diameter at its biggest. Took Claritin, cleaned face with alcohol, and by 24 hours later it was not noticeable. 8 days later, the bump appeared again in between lip and nose on the opposite side of my face. Took Benadryl, bump slowly went down throughout the day. By 24 hours later it was gone

Pt is 6 weeks gestation, taking prenatal vitamins, and has not yet had 1st OB appointment. Pt c/o upper lip swelling and itchiness in throat within 30 minutes of vaccination. Pt given Benadryl 25 mg PO and evaluated by MD.

Tingling in left hand and left side of face starting aprox 20 min. after injection and subsiding ~1 hr later with no treatment fever and chills starting 2-3 hrs after injection & subsiding 4 days later treated with ibuprofen severe body spasms starting ~7hrs after injection & subsided 2 days later treated with ibuprofen, heat and rest Nausea starting ~7 hrs after injection and subsiding 4 days later with no treatment Migraine starting ~4 hrs after injection, treated with ibuprofen and rest, subsided 2 days later

This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anemia, alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and drug abuse illicit allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 09:30 on left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced throwing up. On 05-APR-2021, the subject experienced swollen arm. On 05-APR-2021, the subject experienced itchy at the injection site. On 05-APR-2021, the subject experienced arm pain. On 05-APR-2021, the subject experienced nausea. On 05-APR-2021, the subject experienced fatigue/ tired. On 05-APR-2021, the subject experienced red at the injection site. On 05-APR-2021 15:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, fatigue/ tired, arm pain, swollen arm, red at the injection site, and throwing up, and the outcome of itchy at the injection site was not reported. This report was non-serious.

For the entire day of 4/10/2021 I experienced fatigue, nausea, dizziness, sensitive skin, headache and left arm soreness. Now on 4/11/2021 I feel completely fine, except my arm still hurts a little.

Had the vaccine 11:30am. Beginning around 5pm, I began to feel nauseous and have extreme chills. I took Tylenol and felt better until about 8pm. I then began to feel nauseous again and get extreme chills. I vomited multiple times, and was curled up in a fetal position crying from the nausea, headache, and a feeling of pressure in my chest. I ended up going to bed to sleep it off, waking up in a pool of sweat. I felt better the next day.

Within 7 hours had chills, muscle and body aches, fever, severe headache, abdominal and kidney pain, nausea. Within 27 hours of dose got my menstrual period 2 weeks early with a very heavy flow, despite being on birth control.

Nearly immediate after administration of vaccine- stood up to move to a waiting chair & experienced dizziness to the point of near syncope, heart pounding, nausea, sweating- pharmacy brought juice and watched me. Drank juice but was disoriented enough to spill a bit- sat for about 30 minutes until symptoms cleared up enough to walk around and got a ride home.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild

11-12 hours after the vaccination: Severe chills began, inability to stop shaking or get warm. Inexplicable fear of being paralyzed and dying ( somewhat delirious overnight)- inability to sleep the evening after the shot. The full day after the vaccination, body temperature rose--couldn't stop sweating and had a searing headache. Took tylenol to reduce the symptoms. The following day (today) had severe dry mouth and very sore throat. Felt about 60% back to normal health. I am a very fit 26 year old (run and exercise daily)

Had no side effects whatsoever for many hours. Felt completely fine until about 7:30 pm, while I was making my plate of dinner. Felt lightheaded, dizzy, and hot. I began to black out, so I sat down, which helped for a few moments to subside lightheadedness. I was still feeling hot, so I walked a few feet to my back door and sat down on the steps outside to cool off. Within minutes, my vision blurred completely, I saw stars, and completely blacked out. My mother, who was nearby, heard me fall on the steps. She said my eyes rolled back, my body was completely limp, I was not breathing but rather making gurgling noises from my throat. She propped my head up, which allowed me to breathe properly, and I came to. If my mother had not been nearby, I am convinced I would be dead right now. I saw the light, saw the other side, saw my relatives. I have had a near death experience once before, and this was exactly like that.

General sleepiness, fever lasting about 12 hours recorded highest at 101.6 measured under the tongue. General feeling of being hit by a truck and headache.

Intense full body aches, starting 10 hours after shot. Fatigue, weakness. Chills. Fever. Heart racing. Body aches and fatigue lasted 24 hours. Chills and fever lasted 12 hours. Redness, swelling, and itchiness at injection site starting 48 hours after shot.

same day and the 2 days following Left arm/shoulder/side of neck had major joint pain, headaches, tiredness, sensitivity to light, brain fog, and felt extremely anxious to the point where my heart was racing and i was shakey. As of today (4/12/2021) I am still feeling extremely anxious (as if my anxiety medicine is not working at all) and have headaches and trouble focusing or remembering things, making it very difficult to work. Also having trouble sleeping because of the anxious feeling.

Syncopal event falling off chair striking forehead onto floor. Loss of consciousness about 10-15 seconds. Denies neck pain. Pt reports felt dizzy walking to seat post injection. Complains of headache. Pt declined to have driver pick her up. Left under her own power.

Within 2 hours of getting the vaccine, I developed a severe migraine, fever(100.1-100.4), chills, dizziness, extreme body aches, nausea and was very weak. Once the bulk of the symptoms subsided, a little under 48 hours after the vaccine was administered, I was able to resume to my daily life. I still have a lingering migraine, arm pain, body aches and a low grade fever of 99.9 now almost 72 hours later, but it is bearable unlike the immediate 48 hours following the vaccine. Over-the-counter medications usually take the edge off of my migraines, though they didn?t even come close to helping the one I currently have. I have been rotating Tylenol and ibuprofen since developing the side effects.

Immediate pain around injection site, has persisted until now 9:30pm began feeling nauseous/ experiencing stomach pain all night: muscle soreness, joint soreness, body aches, clamminess/feverishness Next day 4/11: weakness, fatigue, body aches, muscle and joint soreness, diarrhea, nausea (no vomiting), clamminess/feverishness intermittent-- confined to bed for 24 hours after side effects began

Fever of 101.1+ lasting 10 hours, on-and-off low-grade fever for 48 hours Headache, including eye and jaw pain, lasting 3+ days Dizziness; inability to stand or walk due to head pain and fear of fainting (dizziness lasted ~24 hours) Nausea and loss of appetite (ongoing) Body aches, including spinal pain and hip pain lasting 48 hours

Previously has covid last June - Severe body aches, migraine, fever starting 11 hours after vaccine and lasting almost 48 hours. Muscle fatigue lasting 6 days after vaccine. Migraine lasting up to 4 days after vaccine. Night sweats lasting 7 days after vaccine. Felt way worse than the flu and when I had covid and was bed ridden for two days.

Around 11 PM on April 8th after receiving the Janssen vaccine around 4:50, I woke up with intense chills, nausea and a fever. I also experienced an intense stomach pain that came and went that would make it difficult to move without severe pain. I felt extremely disoriented and confused and had a strong headache throughout the intense period of symptoms. Around 7 AM on April 9th the next day, the symptom's severity decreased and I experienced all of the symptoms mildly along with drowsiness. On april 10th I did not experience any stomach pain, body aches, or chills but, still experienced drowsiness, intermittent headaches and a mild fever. On april 11th, drowsiness and a headache continued. Today, april 12th, I am still experiencing a mild headache and slight drowsiness.

I received the vaccine at 12:30 PM on 4/9/21 and began feeling ill around 8:00 PM that same day. It started with my body freezing and then I started shaking because I felt so cold and I covered up in blankets and a heating pad and still felt extremely cold. Then, the body aches began, and my whole body was very tired. After an hour of sleep, I took my temperature and it was 100.8. That is the highest that it rose to. My normal body temperature is 97.4. This lasted all through the night up until Saturday afternoon around 3:30 PM on 4/10/21.

*Fever above 102 degrees and as high as 103.2 - utilized acetominophen, ice packs and could get it down to 100 degrees *Sweating *Intense spells of extreme cold with shivers *Extreme fatigue *Sleepiness *Muscle aches *Generalized pain *Vomiting TREATMENT: Acetominophen; Heating pad for aches and to warm self up; cold cloth for sweating; ice pack for fever; Slept alot; had mother (nurse) taking care of me - pushing fluids, BRAT diet and constant supervision for need to go to ER or PCP. Since mother is a RN we handled my symptoms at home. Symptoms continued for 3 days (I missed 2 days of work). Fever subsided on Day 3; other symptoms were milder day 4-10.

noticed 99F Fever started at about 5pm day of dose (day 1); fever rose to 103F by 7pm, 101F with 500mg acetaminophen lasting until next morning (day 1-2); chills started at about 1pm and went away with fever (day 1,2); pain during injection (day 1); injection site soreness day of and on (day 1+); headache (pain moving eyes, pain during coughing/sneezing) started a few hours after vaccine, worsened with fever (day 1-3); next day slight raised tender bump at injection site (day 2); quarter-sized raised bump with hardness and tenderness surrounding the raised bump at injection site, minimal redness if at all, slightly warm to touch (day 3,7)* bump is half-dollar size and itchy (day 4-6); pain moving eyes side-to-side and background headache that is obvious when moving quickly (day 1-8); slight dizziness (day 1-4) afterimages (day 3-4) *the pharmacist administering the vaccine was not wearing gloves and did not clean my arm with alcohol prior to vaccination.

A temperature of 103.8 for more then 5 hours, excessive tiredness, swelling of the face and neck area. Extreme weakness

Within 20mins of injection: Right arm tremors and twitching resembling dystonia, brain fog, nausea, extreme thirst, difficult swallowing, jaw pain, increased heart rate, and fatigue. Drank water and rested. Resolved within 120mins. After 12 hours if injection: nigh sweats, chills, fatigue, headache, and fatigue. Resolved with 600mg ibuprofen. After 48 hours of injection: Muscle tightness and twitching, limping, tachycardia, extreme fatigue and loss of strength. (Resembled POTS flare) Drank water, laid down, and rested. Resolved within 120minutes.

I had the common symptoms within 24hrs of receiving the vaccine, including headache, body aches, body chills, fever, and tiredness, which lasted approximately 24hrs. I had taken both Adderall and Allegra that day. 4 days after receiving the vaccine, I took Adderall and Allegra and had an adverse reaction (I hadn't taken Adderall the prior 3 days). I experienced palpitations and vertigo/dizziness plus slight nausea. The next day, I took a much lower dose of Adderall and decided to continue taking approximately 1/3rd of my typical dose after an E-visit with my primary care Dr. During the week of 4/5, I was able to increase the dose by a little bit without any adverse reactions. Starting on 4/11, I was able to take 2/3rds of the typical dose without adverse reaction. However, I am still experiencing vertigo/dizziness, which may or may not be sinus-related due to seasonal allergies.

Shot was at 1:50. At 8:00PM I started getting chills and body continues to shiver. Was able to fall asleep and got up to use the restroom around 2:00AM and had dizziness, headache, Nausea and felt faint. Same occurrence happened around 4:00AM as I got up to use the restroom again. By 8:00AM I could slowly get up and move around with out feeling faint or nauseous. Left with fatigue

Extreme exhaustion, shakes and freezing cold, splitting head aches- most terrible head ache I have ever had. Weak feeling,

started as lethargy, progressed to moderate/ marked body aches- full body joint based aching. also febrile, headache from 10pm until around 8am on 4/9. Injection site pain until 4/11

Vomiting, Blurred Vision, Hard time catching my breath, numbness in arms, chest pressure, ear pain, headache, muscle aches, fever, dizziness for about 3 hours starting at 11:00 p.m. Ambulance was called around 2:00 a.m. taken to Hospital Seen by MD tests: Imaging XR CHEST AP PORTABLE MD Apr 12, 2021 The result is abnormalLab CBC WITH PLATELET AND DIFFERENTIAL MD Apr 12, 2021 The result is abnormalLab COMPREHENSIVE METABOLIC PANEL MD Apr 12, 2021 Lab PT-PTT MD Apr 12, 2021 Lab TROPONIN MD Apr 12, 2021 Lab CKMB W/TOTAL CPK MD Apr 12, 2021 Lab P-NATRIURETIC PEPTIDE, MD Apr 12, 2021 The result is abnormalLab MAGNESIUM MD Apr 12, 2021 Lab ESTIMATED GLOMERULAR FILTRATION RA MD Apr 12, 2021 Lab SARS-CoV-2 RNA RT-HDA MD Apr 12, 2021 Lab POCT PERFORM URINE PREGNANCY MD Apr 12, 2021 Pt seen and examined. Workup ordered. IVB, zofran, pepcid, toradol 15mg iv ordered. Reassess. Magnesium 1.4. repletion ordered. covid19 -ve. Upon reevaluation, pt feels better. VSS. Pt is clinically stable for d\c from ER. D\c to home per d\c instructions Strict d\c instructions and parameters when to RTER d\w pt, all of which pt verbalized understanding and agreement.

My heart started fluttering even after almost a month after the vaccine but it did start to happen less over time but still happens. After the vaccine for about for days I had intense headaches and body aches throughout my body.

The next day after I got the shot, I was very sick. I just felt very out of it. Then about three weeks after the shot I puked up blood. It was a lot of blood.

20 mins after injection felt dizzy and face numbness. 12 hours after injection felt nausea, chills, fever, fatigue. Fatigue persisted for 36 hours. 48 hours after injection, face numbness returned and persisted for about 3 hours. Localization around the eyes and nose.

Received shot at 4:00 PM, 2 AM that night symptoms started: fever, chills, nausea, vomiting, headache, body aches. Took Tylenol and all symptoms were gone in 48 hours

Started out with bad chills and a fever. Whole Body ache. Around 9-10am I broke out in hives all over my body that lasted all day. Now they are coming and going

Headache X 24 hours. Rigors, low grade fever, nausea X 1 hour 12 hours after injection. Improved with tylenol. Fever of 101 at hour 36.

After receiving the Johnson & Johnson vaccine at noon on April 9, at around 11:30 that evening, symptoms of muscle pain and fever began to appear throughout the body. When lying down in the middle of the night, I experienced severe shortness of breath. The above situations lasted for 2 days. It began to ease on April 13, and there are still fever symptoms now.

Had typical post vaccine symptoms right after - nausea, muscle aches, chills, fatigue. 5 days after vaccine those appeared to have dissipated. Went for a light walk in the morning. Completely lost vision in both eyes extremely blurry. Stumbled my way home running into trees, cars. Vision came back, thought it was migraine (had them before but nowhere NEAR as bad, never had vision completely blocked) Excurtating headache behind eyes and nausea, feels like pressure in head. Worst headache of my life, went to ER. Gave morphine (did not help pain at all which was horrifying) got a head CT scan which came out clear and discharged because clotting ruled out. It is now day 6 and my headache is persistent and still excruciatingly painful. I?m also extremely nauseous. I?m terrified because I know something is very wrong. ER doc said might be lingering side effect from vaccine but those effects felt very different.

Severe body aches, nausea, dizziness, headaches, rash/skin reaction on back for 3-5 days Pain, hardness and scabbing at injection site. Bump still present 4/14/21

Patient's mother called on 4/14/21 to report that her daughter have been having severe headaches, severe abdominal and leg pain since getting vaccine on Monday night

Patient was experiencing convulsions the evening/night of the vaccine administration. She also experienced shivers and had back pain. However, it was reported the patient is prone to back pain. Post convulsion, the patient was experiencing extreme sweating.

Felt okay until around 6:30pm that evening when I began to feel achy, fatigued, as well as pins and needles all over my limbs. I was extremely tired and the aches had significantly increased so I went to bed at about 8:00pm. When I couldn?t sleep around 9:30pm I took 1000 mg of acetaminophen. I woke up at around 11:00pm and felt extremely feverish (shivering, entire body extremely soar. My joints hurt so badly that I couldn?t get comfortable) and nauseous. I then had 4 or 5 episodes of violent vomiting throughout the night every 2 or so hours. After, I would be drenched in sweat. When I got up *crawled to trash can next to my bed* at around 2:30/3:00AM I took 200mg ibprofin. Felt fatigued and no appetite the next day then was fine

Sudden onset back pain on 04/09/2021, localized to the center of my spine, so bad i thought i was going to vomit. Tylenol was unhelpful but I had also taken my anxiety medication and 25mg of Benedryl, so the fact that it lasted roughly 4 hours is an estimation because i did eventually fall asleep. Chest pain on 04/10/2021, ongoing but only sometimes excruciatingly painful. Had costochondritis about a year ago, it eventually went away. This pain is the same as that. I was told that people who get costochondritis are likely to get it again, so may be unrelated to the vaccine, but thought i would list it anyways. General unwell feeling lasted until 04/13/2021 Unrelenting nausea lasted until 04/13/2021 Diarrhea started today 04/14/2021

Uncontrollable itching all over body, fever, bruises all over body. Itching started within hours of receiving the vaccine. Took Claritin, took hot bath and tried sleeping but was difficult. By Sunday, 4/11, rashes and bruises began to go away.

The night I got the vaccine I felt like my body had been put through a cheese grater and I had been half-heartedly put back together. I had a severe fever, chills, headache, muscle spasms in my neck, and whole body aches. This was over the course of 7 hours where I woke up every couple of minutes and thought I was dying. I feel better now though.

Lightheadness from Day1-present (Day 7). I feel dizzy and lightheaded all the time. Mild headache occurred from Day 1-4.

Around 8:00 pm on Tuesday April 13, 2021 I started to get a really bad headache that was like sharp stabbing pains that would come and go. The next morning I woke up with sharp stabbing pains in the left side of my head and numbness/tingling in the left side of my face. As the day went on I started to feel worse so I went to the emergency room. The doctor there checked me out and stated that I had Bell's Palsy and prescribed me three different medications. I am currently on these medicines trying to get better.

Obtained J&J vaccine on 4/4/21 Signs/symptoms started 4/12 and continue today Has intermittent severe headache that ranges in pain from 2-7/10 Current pain is 2/10 Intermittent abdominal pain that radiates to back Pain is mainly in shoulder blades just under her bra line Hurts when she takes a deep breath in Pain rated at 2/10 current but can range as high as 7/10 at times Denies Shortness of breath or difficulty breathing or speaking, states pain only when taking in deep breathing Sometimes the pain will shoot down her back to her hips Intermittent pain across the front of her upper chest States she does not know how to describe it but it is not severe Sore all over Fatigued Afebrile

Received shot around 10:00am April 12th, by 12:00pm (beginning of work shift)I experienced a headache and took Advil, figured it was menstrual related since it started the same day. By 5:00 my body started to feel aches and chills but was very mild. By 5:30-5:45 I took a midal for the pain I was experiencing, more severe muscle/ back aches and chills. By 6:30 I went home early from work because symptoms were getting worse and it was hard to continue my shift. Once arriving home around 8 pain continue to progress but I figured I just needed to lay down and rest. By 9 I had soup but could barley finish due to pain. I continued to monitor my temperature because I was experiencing chills even though I had my heater on etc. by 10:00-10:30 my temperature went all the way up to 101.2 and I was concerned so I called 911. They sent an ambulance to come take me to the hospital. On the way there I believe my temperature went down. The paramedics took my temp and it was 99.5 before they took me to the hospital. And when the nurses took my temperature it was 97.8. This happened in the course of about 30-40 minutes of my phone call and arriving to the hospital. Either way I was concerned about the pain because I know there would be symptoms following the shot but I didn?t think it would be so severe. After waiting to be checked in and evaluated they proscribed me Tylenol and ibuprofen. But at a location that was closed for the day. I asked if I could just take more pain killers for the pain (midal and Advil) and I was told i could. Once arriving home by 11:30 I took two midal pills and the pain reduced within an hour. So I was able to sleep. The next day I still experienced pain but took pain killers to help with it.

BODY ACHES; JOINT PAIN; HEADACHE; INJECTION SITE PAIN /SEVERE ARM PAIN; PASSED OUT AT INJECTION; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vonn willebrand's disease, non-alcoholic, non-smoker, and needle phobia, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug. 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 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced passed out at injection. On 12-MAR-2021, the subject experienced injection site pain /severe arm pain. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced joint pain. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, joint pain, and headache on 15-MAR-2021, had not recovered from injection site pain /severe arm pain, and the outcome of passed out at injection was not reported. This report was non-serious.

LOST VOICE; VOMIT; HARD TO FOCUS; HEADACHE; LITTLE FEVER; FEELING UNCOMFORTABLE; DIZZY; SWEATING; WEAKNESS; This spontaneous report received from a patient concerned a 26 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, administered on 09-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 09-APR-2021, the subject experienced feeling uncomfortable. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced weakness. On 09-APR-2021, the subject experienced little fever. On 11-APR-2021, the subject experienced lost voice. On 11-APR-2021, the subject experienced vomit. On 11-APR-2021, the subject experienced hard to focus. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fever on APR-2021, had not recovered from dizzy, lost voice, hard to focus, and feeling uncomfortable, and the outcome of sweating, weakness, headache and vomit was not reported. This report was non-serious.

4/11/2021: Fever range 99-102.4+, body aches, chills, headache 4/12/2021: fever range 99-100, body aches, headache

SYNCOPE; MIGRAINE; WHOLE BODY TREMORS; VOMITING; NUMBNESS IN HAND AND FEET; WHOLE BODY ACHES; 105.0 F TEMPERATURE; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight was 120 pounds, and height was 60 inches. Obstetrics history included gravida 1 para 1 (gave birth to a daughter 8 weeks ago). Concurrent conditions included penicillin allergy, non-alcohol user and non-smoker. The patient was not pregnant at the time of vaccination and had no history of drug abuse/illicit drug use. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on left arm on 03-APR-2021 for prophylactic vaccination. The product was stored properly from receipt to administration. No concomitant medications were reported. On 03-APR-2021, the patient experienced migraine, whole body tremors, vomiting, had a temperature of 105.0 F (required emergency room visit/urgent care), numbness in hand and feet, and whole body aches. On the same day, she recovered from whole body tremors. On 04-APR-2021, the patient experienced syncope. On the same day, she recovered from syncope, vomiting, and numbness in hand and feet. On 05-APR-2021, she recovered from whole body aches and 'temperature 105.0 F'. The patient was breastfeeding her child at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope, vomiting, numbness in hand and feet, 105.0 F temperature, whole body aches and whole body tremors, and was recovering from migraine. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210412341.; Sender's Comments: V0:20210411086-covid-19 vaccine ad26.cov2.s-Syncope. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Chills 12 h after receipt of vaccine followed by low grade fever (101 F) and body ache with minor headache. Symptoms subsided by the end of the following day. 1st menstrual period post-vaccination was noticeably heavier with more clots than usual.

Night of shot Friday 4/9I got chills for 2+ hours, then was over heating body aches nausea. Saturday 4/10 body aches continued headache, exhaustion and the chills hot flashes continue but not as intense as the day before. Sunday 4/12 I was exhausted but I also noticed a lump in my vagina. I called my Mom who is a nurse who told me to go see a doctor. On Monday 4/13 it was worse I went the the doctor they thought it was a barcilan abcess. It was sore all week I was soaking it. On Friday I went back to the doctor and they diagnosed it as Lipshultz Ulcer, like I had when I was 12 from Zithromax

It has been 8 days and I still feel weak and my head feels heavy. This started the day after the vaccine. It feels like a mild headache where moving makes it worse, or as if I had a hangover but I don't. I feel tension in my head. Lying down makes me feel better, as does any position where I'm resting my head. Yesterday I also had a weird feeling in my throat that came and went rhythmically.

Day1(4/8) I had a high fever (104 *F) and it hurt all over my body at 10.pm. Day2(4/9) I didn?t have that symptoms at the morning(about 8:00-11:30.am) But I was getting hurt all over my body at 12:00-19:00.pm. And I was getting head headache and had a high fever (104*F) at 8:00 pm Day3 I have had no symptoms.

Illness duration post injection: 30 hrs., High fever of 101.9 began 6.5 hrs post injection, sustained high fever for 24 hrs, treated with Tylenol PO during this time, fever then after 24 hrs converted to a low grade fever for an additional 6 more hours. During this whole time, had a persistent headache, general malaise., 5 hrs after the start of the fever, developed NUMBNESS IN FEET, ANKLES, CALVES, which then, 1.5 hrs later evolved into HOT & SWOLLEN & REDDENED FEET, ANKLES, CALVES, KNEES, HANDS, & FACE, this was treated with 50 mg PO of Benadryl, which did provide relief and was followed up with 10 mg of Zyrtec 20 hrs after the Benadryl was initially given, as a precautionary measure.

5 Blood clots coming from right nostril, headache, fatigue, stomach pains Nose bleed with clots lasted 15-20 minutes. Headache, fatigue, stomach pains lasted throughout the day.

SWOLLEN AT INJECTION SITE; INJECTION SITE GREENISH PURPLE BRUISE COLOR; ABDOMINAL PAIN AND PRESSURE; INJECTION SITE SORE/TENDERNESS AT INJECTION SITE; FEVER; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 test. 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced abdominal pain and pressure. On 11-APR-2021, the subject experienced injection site sore/tenderness at injection site. On 12-APR-2021, the subject experienced injection site greenish purple bruise color. On 12-APR-2021, the subject experienced swollen at injection site. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, abdominal pain and pressure, injection site sore/tenderness at injection site, swollen at injection site, injection site greenish purple bruise color, and headache. This report was non-serious.

The side effects began the night following my vaccine and lasted the entire next day. It began with fatigue/brain fog, then chills and soreness at the injection site. Once the chills began I was very ill with a fever (100-101), severe aches and pains in my body from head to toe, and experienced occasional shooting pains. Once the fever went away about 30 hours after my vaccine, I still felt pain and heaviness in my body and had a bad headache. The next day (day 3) was much better- I had no fever but still felt some brain fog, drowsiness, and slight muscle soreness (but no pain). Two weeks after my vaccine (4/20/21) I had a very similar experience but am not certain it was related to the vaccine. I developed chills, fatigue, and a headache for the majority of the day. In the evening, it progressed to muscle/joint pain, a severe headache, extreme fatigue, and a 100 degree fever. The next day (today 4/21), the fever has subsided and I feel slightly fatigued. Though I am not sure this was related to the vaccine, it mirrored my initial reaction to the vaccine two weeks prior. It is very unusual for me to get a fever in the 100 degree range and typically only happens every two years or so.

4/8-4/9: arm pain, chills, chattering teeth, fever, sweating, dehydration, insomnia 4/9: fatigue, brain fog/confusion 4/8-4/22: random muscle pains mostly in legs, ankles, feet 4/17: insomnia, sweating, neck pain, nausea, dizziness, fainting, muscle pains, dehydration, anxiety/elevated heart rate -> went to ER at 4am on 4/18, tests found no abnormalities 4/17-4/22: neck pain and upper back, fatigue, muscle pains, anxiety/elevated heart rate (intermittent chest pain/sensitivity), insomnia, general discomfort overall and thus depression from not feeling normal for so long

FEVER; HEADACHE; FELT TERRIBLE; BODY ACHE; SWEATING; CHILLS; FATIGUE; This spontaneous report received from a consumer concerned a 26 year old female. The patient's weight was 190 pounds, and height was 59 inches. The patient's concurrent conditions included asthma, non alcohol user, and electronic cigarette user, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced felt terrible. On 12-APR-2021, the subject experienced body ache. On 12-APR-2021, the subject experienced sweating. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, felt terrible, body ache, fever, and sweating, and had not recovered from fatigue, and headache. This report was non-serious.

VOMITING; SEVERED LEFT LEG PAIN; HEADACHE; CHILLS; DIZZINESS; This spontaneous report received from a patient concerned a 26 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: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced dizziness. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced severed left leg pain. On 15-APR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on 06-APR-2021, was recovering from severed left leg pain, and vomiting, and had not recovered from dizziness. This report was non-serious.

SEVERE HEADACHES; This spontaneous report received from a parent concerned a 26 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe headaches was not reported. This report was non-serious.

I woke up at 04:00 am with severe migraine; fever and chills. Migraine left 01:00 or 02:00 that afternoon. The fever and chills lasted through the next day - body ache and soreness throughout both of those days. For those two days I did not work. (Ended the 8th when it was time for me to go to bed.) I did have heart palpitations the night of the 9th that I did go get ER -they gave me a dose of Ativan and they sent me home. That took care of the heart palpitation symptoms. I followed up with my provider the following week.

Twenty four hours after the shot I had a high fever ,body aches and nausea which lasted 48 hours. I felt better for a few days and five or six days after the shot I started to get headaches again. The headaches got progressively worse and more frequent. I don't normally get headaches. It was pain at the lower back side of my head which was dull but got worse and throbbing in periods. My pain level was an eight or nine. They lasted most of the day. I am still getting a few headaches after three weeks. I have been taking Tylenol and Ibuprofen and it is starting to get better. It is still every day and the mornings are worse before I take a pain reliever. My pain level with the headaches is more like a 3-5 range level of pain.

VOMITING; DECREASED APPETITE; 106 DEGREE FAHRENHEIT (F) FEVER; FATIGUE; STOOL ODOUR ABNORMAL; REDNESS OF LEGS; BRUISING OF LEG; PYLORIC SPHINCTER INSUFFICIENCY; PSORIASIS; This spontaneous report received from a consumer concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe adult crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1139170) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. No concomitant medications were reported. On APR-2021, the subject experienced stool odour abnormal. On APR-2021, the subject experienced redness of legs. On APR-2021, the subject experienced bruising of leg. On APR-2021, the subject experienced pyloric sphincter insufficiency. On APR-2021, the subject experienced psoriasis. On APR-2021, the subject experienced 106 degree fahrenheit (f) fever. On APR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 106 F. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced decreased appetite. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, had not recovered from stool odour abnormal, redness of legs, bruising of leg, pyloric sphincter insufficiency, and psoriasis, and the outcome of 106 degree fever, vomiting and decreased appetite was not reported. This report was non-serious.

HEADACHE; FEVER; NAUSEA; TONGUE TINGLING; SKIN SENSITIVITY; BODY ACHES; This spontaneous report received from a consumer concerned a 26 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 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced tongue tingling. On MAR-2021, the subject experienced skin sensitivity. On MAR-2021, the subject experienced body aches. Laboratory data included: Body temperature (NR: not provided) 99.6. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, nausea, tongue tingling, skin sensitivity and body aches was not reported. This report was non-serious.

FEVER; This spontaneous report received from a patient concerned a 26 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 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-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 12-MAR-2021, the subject experienced fever. On 12-MAR-2021 11:45, Laboratory data included: Body temperature (NR: not provided) 103.7 degrees F. On 12-MAR-2021 22:00, Laboratory data included: Body temperature (NR: not provided) 104 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.

I woke up at 3 am Friday with cold sweats and body aches. Took 1000 mg Tylenol. Woke up again at 10:30 am to a fever still and this odd extremity feeling. Felt like I had a compression body suit on and weight of 50 pounds around my arms and legs, Mild shortness of breath. I felt like I was swollen but did not see any. I called my PCP and vaccine line and both nurses said go to the ER. I went to the ER they ran tests. The time of the ER I started getting leg cramping and spasming. Those symptoms continued to the weekend. On Sunday the weight and swelling feeling went away. I still had bad muscle cramping and swelling. I did telehealth on Tuesday with PCP and was given muscle relaxer which helped some throughout the rest of the week. Thursday night I have a temp pf 99.6 and went up to 100.6 on Friday morning. On Friday I became shortness of breath and fatigued. It became difficult to go up and down stairs or walking about 20 ft without difficulty breathing. I now have a lower right leg muscle twitch/spasm that comes and goes. I switched to a different PCP, he ran more blood work on Wednesday 4/21. And discussed the next steps for treatment and monitoring.

Nausea/vomiting/diarrhea, abdominal cramping and pain, headache, body aches (specifically pelvis and shoulders), fever of 101.2, chills

Reaction after Janssen vaccine (1805031), in right arm, at 1:20pm 3-16-2021: - Within 15 minutes: nothing - Within an hour or two after: itchy right hand, pulsing in right side of head behind eye, dizziness - About 8pm, onset like a wall: severe anxiety/impending feeling of doom, shortness of breath slightly, increased heart rate, tiredness, muscle aches, sore skin, feeling of sharp pains in ?blood stream?, chills, nausea - 12pm after sleeping for about half an hour: flushing of face, slight shortness of breath, facial swelling and blotchiness, swollen lips, fast heart rate, feeling of impending doom, nausea, tongue swelling, slight difficulty swallowing, nasal congestion, groggy voice, sinuses full of moving fluid, ear pressure, hot with chills, eye redness, achy body and sore skin, feeling of sharp pains ?in blood stream? - 1am, in addition to previous symptoms (peak of symptoms): Fever 101.4 F, puffy feet that hurt, dizziness - 1:30am, after eating a little: temp 100.8 F, puffiness went down slightly and severe symptoms improved a bit. Still chills - 2:45am woke up drenched in sweat and hot, 100.7 F. Chills mostly gone. Nose very stuffy. Eye pressure/pain. Feel improved. Chest feels exhausted. Still body aches but improved. Ear pressure. - 8am: 99.4 F. Feel better mostly overall. Head feels like a cinder block. Eyes and ears hurt. Body aches mostly gone. Pain at injection site. Chills gone. Sweats gone. Skin still sore. - 1pm: 98.3 F. - Only remaining symptom for next couple days is tenderness at the injection site. -Following a few days: completely recovered. no symptoms, back to 100%

I was on day 5 of my period when I got the vaccine. It lasted another 15 days after the vaccine and I am still spotting. Also the normal aches and fatigue.

Exactly one week after my shot (4/14) I felt a headache in the evening. It felt like it was sinus related so I figured it was allergies. However it continued the next day so I tried Advil. It kept going. It has now been 2 weeks and a day since the headaches started and I still have them. They go away late at night and return shortly after I wake up. They feel like tension headaches in the back of my head and also sinus headaches. I was concerned about clots so I went to the dr on 4/19. She did not think it was clots because the headaches were not severe and I had no other symptoms. She had me do different tests and concluded I had no neurological issues. She gave me a prescription for butalb-apap-caf50. This did not help. She also told me not to drink alcohol so I didn?t. I started feeling better on 4/24. I had a little to drink and my head hurt really bad. My headache was practically nonexistent 4/25 so I had one glass of wine. Not even half way through that glass, the head feeling from last night came back. The next day my headaches were back and have now continued since. I stopped drinking and have not felt that bad feeling in my head at night since. The headaches aren?t severe but they really suck. They make it hard to do things and all I want to do is lie down even though that doesn?t help. Exercise and walks sometimes help. No medication has made any noticeable difference.

SHAKING; HEADACHE; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-APR-2021, the subject experienced shaking. On 26-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shaking, and had not recovered from headache. This report was non-serious.

At 3 am the night of the vaccine, I woke up with flu like symptoms, including a headache and shortness of breath. Two days later, I had a severe manic episode that lasted for three days (bipolar was well managed with medication at this point and I had not had a manic episode in months). Along with the manic episode, I developed chest pressure and shortness of breath, along with dizziness and a pounding sensation in my chest. Any physical activity or even a sip of coffee sets my heart off. I am still experiencing these symptoms to this day and caused me to lose my job because I am not able to perform the required tasks. I had a premature atrial contraction prior to the COVID vaccine, but it had cleared up and I had been off of the medication for months with no problems. I have been to the doctor's office (primary care physician-4/15/21 and 4/20/21) twice, the emergency room once (4/26/21), urgent care (4/14/21), and now am seeing a cardiologist for this condition (first visit 4/29/21).

The first 2 days had awful headache and muscle aches, could not leave the bed. Then a week later, I got a horrible rash all of my body, worse at my hands and feet. The rash included many blisters. Loss of appetite and cannot sleep. I still have the rash now, and it is even getting worse in some parts, while other parts are better due to a steroid cream prescribed by my dermatologist. On April 26, I felt very dizzy and weak and went to urgent care. I have since recovered from those symptoms.

Immediately agter receiving the shot I broke out into a sweat and began to feel lightheaded. My eyes started to blur like I could pass out. The pharmacist/doctors at CVS gave me some water and told me to elevate ny legs. After 10 minutes they checked my termperature and blood pressure. I stabized somewhat and when home. I was sure it it was my nerves but something did feel right. I had a slight burning in my chest and felt queezy on/off throughout the day. Chills and hot flashes followed. I was anxious and paranoid about the possibility something serious coukd be wrong with me. I felt shooting pains in my lower left abdomen that nught and the next day. The following day I still felt very weak. My arm hurt. My muscles felt like jello and I?m unhappy. I wish I never got the shot and I?m worried about my body?s reaction to it.

Around 4 pm I had flu like symptoms. Headache, back pain, fatigue, chills, sweats. Around 5:30 I started feeling light-headed. I got out of bed and fainted on the floor. Laid there for a few moments. Got water. Laid back into bed and my body completely locked up. It felt like there were pins and needles coursing through my entire body. I couldn?t bend or move my legs. My wrists were bent down and my fingers all locked together. I could not move them at all. I was screaming out in pain. It was the worst pain I?ve ever felt. My roommate called 911. Paramedics arrived and took my temperature and blood pressure. They tried calming me down. eventually I did. And my fingers and legs unlocked but I continued having a severe headache, back pain, muscle aches and nausea. I woke up every hour of the night and threw up several times. It?s been 24 hours after the shot and I am still having headaches fatigue and muscle spasms.

BACK ACHE; MUSCLE SPASM; HEAVY DARK CLOTTY PERIOD; PARALYSIS; PINS AND NEEDLES SENSATION; NUMBING; SWEATS; SORENESS; NAUSEA; This spontaneous report received from a consumer concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included birth control implanted in arm that is old and needs to be taken out, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug allergies nor illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-MAY-2021 at 09:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 3-May-2021 at 09:00, the patient was vaccinated. At 17:00, the patient had pain, nausea, sweats, and soreness. At 18:00, she had pins and needles sensation, numbing, and paralysis. Later, she had sweats. Paramedics had checked the patient blood pressure and heart rate and they were within normal limits. The patient was still experiencing backache, muscle spasm, pain and heavy dark clotty period which was unusual. The patient had birth control implanted in arm that was old and needed to be taken out. Laboratory data included: Blood pressure and Heart rate was found normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness, back ache, muscle spasm, and heavy dark clotty period, and the outcome of nausea, sweats, pins and needles sensation, numbing and paralysis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210511206-COVID-19 VACCINE AD26.COV2.S- Paralysis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Tachycardia-Mild

So the 28th, early in the morning, I started getting a fever until 06:00 pm that day. Then I felt fine. Monday, the 29th, I had a small rash on my jaw area. It was pretty small but it kept spreading - face, ears , neck and then on to my chest, arms - it was very itchy. Thursday, I went to Immediate Care. I was prescribed prednisone. On Friday, my face was swollen to double the size. They gave me five days worth of doses which I got from the pharmacy on Friday, the 2nd.. I started April 2 with the prescription. It didn't offer immediate relief. I was still taking Benadryl in addition to prednisone. My rash still lasted for another week and a half to two weeks. I think there are still sometimes traces of it - it appears in small patches - I still get a rash on my neck. It has not fully gone away.

My symptoms starting the night I got the vaccine and lasted for 2 weeks after. I had a fever, chills, severe headache, nausea, shortness of breath, muscle aches, fatigue, and pain in my left leg. We ended up going to the emergency room the week after because of fear of blood clots.

Fever of 102.3, severe body and muscle aches aches, throat pain, chills, confusion, headache, fatigue

The right side of my body felt completely heavy as we walked out of the pharmacy. My right side continued to be right side continued to be tingly heavy for multiple hours. My headache was only on the right side as well. I was instructed to go to the emergency room who didn?t even examine the leg that was numb and tingly. Told me to take some baby aspirin, Benadryl and come back if it became hard to breath. I came home and have had the worse sharp pains in my legs, there have been some things I expected like headache and body aches, sore site. It?s weird because my site isn?t even that sore it?s mostly my legs, and now back , and ahead.

Bodyache, headache, vomiting x2times and fever after J&J shot 2days ago. Denies abdominal pain, difficult breathing or chest pain.

I have been extreme fatigue without specific reason, no energy, weakness, muscle and body aches, exhaustion. All started from the day I received the vaccine and continues to this day.

04/14/2021, experienced leg cramps, fatigue, body aches. Visited ER on 04/15/2021 05/10/2021, experienced chest pain, rapid heart beat, exhaustion Visited ER 5/11/2021

103 fever,, dizziness, weakness, unable to walk or lift arms, shortness of breathe , severe headache Stayed at doctors office for 1.5 hours, took ibuprofen to lower temp and had to have my husband leave work to come and get me as I was unable to drive. Woke up in the middle of the night with same symptoms and had to take more ibuprofen

Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: Pt told us she tends to faint when she gets shots. gave her the janssen shot and in 5 mins she told us she was about to faint. she became confused and started walking. technican went after her and she layed on the ground. called 911. took her bp. told them she did not eat today and most likely why she fainted. pt rested for additional 30mins. had some water and food. Felt better and left for home. called her back at 5pm to follow up. states she is feeling better just a sore arm.

At 10pm on 5/18/2021 I started having side effects, 9 hours after vaccination. My face and ears were hot and my body was cold, I felt very fatigued. I took Tylenol before bed and woke up in the middle of the night drenched in sweat. I woke up officially at 8am and felt my face and eyes were swollen, I also had chest tightness. I looked in the mirror and it looks like I was punched in the face. My left eye (the side I was vaccinated) is significantly more swollen than my right side. Since 8am, the swelling and puffiness hasn?t gone down in my face, however, the chest tightness went away. I took Benadryl. It is now almost 4pm on 5/19/2021 and I still have the same amount of swelling and puffiness in my face. It?s extreme enough that I can?t go out in public like this or else someone will think I got beat up. There isn?t any bruising, rather, under each eye there are very prominent dark circles with almost a reddish tint. It seems like this possibly could be an allergic reaction but after reading online it seems like allergic reactions would have happened right after vaccine. I noticed this side effect 19 hours after vaccination when I woke up on 5/19/2021. If it?s not better when I wake up tomorrow on 05/20/2021 I will goto urgent care.

VOMITING; DIARRHEA; SLEEPINESS; NAUSEA; LOW GRADE FEVER; SORENESS, ACHY KIND OF LIKE WHEN HAVE THE FLU; A LITTLE BIT OF SWELLING; This spontaneous report received from a patient concerned a 26 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced soreness, achy kind of like when have the flu. On MAY-2021, the subject experienced a little bit of swelling. On MAY-2021, the subject experienced low grade fever. On 12-MAY-2021, the subject experienced vomiting. On 12-MAY-2021, the subject experienced diarrhea. On 12-MAY-2021, the subject experienced sleepiness. On 12-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient recovered from soreness, achy kind of like when have the flu, a little bit of swelling, vomiting, and low grade fever on MAY-2021, and had not recovered from nausea, diarrhea, and sleepiness. This report was non-serious.

BODY PAIN; HEART PALPITATIONS; VAGINAL BLEEDING; FEVER; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and was not taking any medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 27A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced body pain. On 15-MAY-2021, the subject experienced heart palpitations. On 15-MAY-2021, the subject experienced vaginal bleeding. On 15-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, body pain, heart palpitations, and vaginal bleeding. This report was non-serious.

Experienced 2 days of worsening fever, chills, myalgias, mild chest pain, fatigue and malaise. Went to the ER after having a low grade fever, chills, shortness of breath, mild chest pain, and an elevated resting heart rate. Was diagnosed with SIRS as a response to the covid vaccine and hospitalized for observation. Was discharged the next day. Diagnosed with SIRS, possibly due to the COVID vaccine with a secondary diagnosis of asthma.

The patient broke out into a sweat and became lightheaded and dizzy just a couple of minutes after receiving the vaccine. We evaluated her pulse, blood pressure, and respirations which were all normal. She laid down with her feet raised for about 10 minutes before the paramedics arrived and she left with them for further evaluation.

Patient felt light headed and was dehydrated and need to sit down. Lost color and we elevated her feet.

Fever, chills, joint paint, muscle pain for 48 hours after... A few weeks later - back muscle spasms, intense back pain, shooting pain down legs ... I haven't had any issues with my back since my spinal fusion (in June 2013), and I called my surgeon who thought it was related to vaccine.

During injection, felt pins and needles from injection site to fingertips which faded to tingling and stopped entirely after about 7 minutes. Intense nausea and sweating beginning 1-2 minutes post injection; unable to sit up. Lasted approximately 7-10 minutes before clearing up 2 hours later (7:10 pm), arm at and above injection site felt hot to the touch and had mild dull pain at every movement. Slightly dizzy and nauseous. Arm periodically ached without movement. By 7:26 pm, arm pain from movement was a sharp pain, though still pretty mild. Around 9:30 pm, gently pressed at site of injection and a jolt of pain went all the way down to my fingers Nausea increased at 10:13, still mild. Decided to go to sleep. Woke up at least 5 times before 12:30 am in various states of pain and discomfort, including nausea when attempting to sit up; dry throat/mouth; pins and needles throughout my glutes and thighs accompanied by pain in my left hip, knee, ankle, and jaw; and mild to moderate arm pain at the injection site. Took about 15 minutes to be able to get up due to nausea and got some water. Was cold so wrapped myself in a blanket. Nausea and arm pain with movement remained but I was able to go back to sleep around 1:15 am. Woke up at 2:53 am - arm pain minimal and nausea gone, blanket felt nice but unnecessary, went back to sleep Woke up at 5:34 am with pins and needles in glutes and thighs and pain in my right jaw, knee, hip, and ankle (all sites of previous moderate injuries) along with a low grade headache. Went back to sleep. Woke up after an hour or so feeling relatively normal, arm pain and headache returned after sitting up. Got out of bed but ended up taking another nap. Woke up after another hour with just a headache and brain feeling fuzzy, but strong tingles began returning to my glutes and thighs like they had fallen asleep (referred after this point as tingles). Arm hurt. Drank some more water and took another nap. Woke up around 9:15 am with a low grade headache and slight tingles; fuzzy brain feeling was gone. Legs wobbly when I walked. Realized that tingling got worse anytime I was sitting down or lying on my back. Around 10:20 am started crying - no known cause. Couldn't stop for a few minutes. This is not normal for me. Around 1 pm realized I had a pretty high fever; unsure how high it was or how long I'd had it. Took another nap at 1:30 pm and woke up at 2:20 pm feeling much less hot so I thought it had broken, but I was told by my friend who dropped by that I was still feverish just much lower. Slept from about 2:45-3:55 pm; headache was much better when I awoke; tingles and sore arm remained. Realized at 4:13 pm that I'd had no appetite the whole day. I'd also barely been able to force myself to drink water; too cold and it hurt, room temperature didn't feel right. No times, but felt periodic stabbing pain in my left ear until about 6:30 pm. Much else also recovered by 6:30 pm: felt well enough to drink cold stuff, tingles were low grade, fever was present but low. Arm was still sore. 7:08 pm headache was gone. 8:49 pm felt much better and able to do things and take care of myself with minimal discomfort, but felt a little lousy overall - low grade headache, head felt like there was some pressure in it, periodic tingles, achy arm. 9:29 pm felt exhausted and slightly achy but otherwise mostly normal. Felt some hunger twinges for the first time that day but nothing felt appealing (realized I had only eaten about 5 spoonfuls of soup the whole day). Fell asleep getting ready for bed; woke up at 10:49 pm and finished getting ready for bed then went back to sleep. Summary: Friday: Symptoms: mild to moderate nausea, mild dizziness, mild to moderate injection site pain, pins and needles in glutes and thighs, joint pain Treatment: drinking water Saturday: Symptoms: mild to moderate pain at injection site, headache, fever, nausea, tiredness, glute and thigh tingles, lack of appetite, periodic stabbing pain in left ear Treatments: ice/cold pack on arm (helped with arm pain while on), drinking water, sleeping

I experience respiratory issues, coughing, running nose, sinus pressure, coughing up film. I treated with Mucinex, cough syrup, throat spray. Pretty much over the counter medications. And a migraine that caused me to throw up. Getting more frequent headaches. And also feeling fatigue.

Severe chills within 5 hours of shot. Awoke at 2:30 AM (about 9 hours after shot) with fever of 101.5 that climbed as high as 101.8 by morning. Accompanied by body aches, mild headache. Took Acetaminophen occasionally over 24 hours, but lower fever (100.8) persisted each time after medicine wore off. Limbs are sore. Slight soreness at injection site but more soreness in ankles/lower limbs. About 24 hours in, I noticed 2 faint red splotches on my stomach and chest.

3 hours after vaccine started throwing up for the next 16 hours on and on for two hours. Next two days after she had diarrhea. First day she had a fever.

I woke up at three AM feeling like I had a fever. I had body aches. The next morning when I woke up I felt like I had a tourniquet on my arms and legs. I was also short of breath. I went to the ER and they checked for blood clots. I started to get lower extremity cramps and muscle spasms. Two days after I started to have some shortness of breath and I was out of breath if I walked any length. One week after the vaccine I ended up wit an ear infection in my right ear. The muscle spasms continued especially in my right lower legs with twitching which lasted for five weeks. Two weeks after the shot my Asthma, which is normally controlled got very severe. My inhalers didn't seem to work. Three weeks after the vaccine my Asthma got worse and I was having trouble breathing. I went to the ER again and there were more tests done. I was prescribed Prednisone, and I took one week off work. After multiple treatments I was prescribed antibiotics and switched my inhaler which helped. I have been trying to do some Cardio activity this weeks and I feel better after six weeks. I don't have to use my Nebulizer as much as I had been.

The day after my vaccine I woke up with a very bad headache stomach ache diarrhea fever and chills and all of my symptoms besides a severe headache have subsided I am on week eight of a constant headache I have had to ER visits one of which was because of my headache and elevated blood clotting factors

Pt developed sore arm, Tmax to 102, fatigue and headache ~5 hours post vax, but these symptoms mostly improved within 24 hours. Vax site swelling (Left arm) increased to size of palm of hand and developed pain shooting down legs (R>L) over the next few days. Today is 5 days post vax.

05/19/2021 Nosebleed and 20 to 30 to stop. Abdominal pain. 05/27/2021 Infection, hospitalized to prevent infection to shunt. 06/01/2021 Pneumonia

Leg pain. Started in left leg, moved over into right leg as well. Got xray on left knee- nothing came back. Got ultrasound on leg leg- nothing came back. My legs constantly hurting. Mainly behind my knees, side of my knee, and front of knee . My calves and ankles are also hurting. I feel pain, weaknesses, and throbbing. They are very tired. I visit a sports medicine doctor tomorrow. Also visiting a cardiologist tomorrow. I?ve been having chest pains (which are normal for me prior to vaccine). However, now my heart is feeling like I?m having palpitations. It starts beating faster then normal. I can feel my heart beating now, which I?ve never been able to notice prior. I?m having to catch my breath often, and have to take really deep breaths. This is the first time I?ve ever experienced these heart issues. Visits since vaccine- 2 visits to PCP, 2 visits to urgent care, ultra sound, upcoming sports medicine visit, upcoming cardiologist visit

Patient walked into the pharmacy trying to get vaccinated for Covid. Before anything patient was concerned about her previous Covid positive case (not a severe reaction, was eventually tested negative in April) and also her family history of asthma (Patient herself never had an episode so far). I told the patient it would be okay to get vaccinated, per CDC guideline. As patient filled out the consent form, I checked the screening questionnaire, which she answered "no" to everything except "don't know" to asthma related questions. As everything was set I brought patient into the consultation room, explained what vaccine she is receiving, how long it takes for the vaccine to be fully incorporated into her defense system (2-3 weeks), and what kind of side effects she can expect (muscle pain, elevation in body temperature, redness around injection site). I took extra moments to explain risk vs benefits for blood clotting issue. At this point patient was ready to get vaccinated. I wore gloves, asked patient to roll her sleeves up so I can proceed to wipe the right upper arm area with alcohol and give her an injection. she followed promptly so far to this point. As soon as patient received the vaccination, her body started to slide down the chair. Patient reported to feel dizzy and also reported that she had some "dreams." Fortunately while everything was happening patient's head did not hit anything and patient was in sitting position the whole time of the event. I asked patient if patient was feeling okay three to four times but I did not get any straight answer from the patient. I asked for help, and pharmacy technicians and store manager offered help. Patient wanted us to call her husband and 911, which we proceeded. In the mean time I also reached out to my district manager to report what was going on. Store manager offered a room temperature water to keep her fluid balanced, as she was sweating heavily. Once 911 got to the site, they measured her BP and HR, and it was a bit low. 911 offered a choice to take patient to ER, which PT and her husband first decided to use their own car, and later decided against going to ER. Husband reported that patient is feeling much better, drank a few ounces of fluid and taken a banana.

Body aches and muscle pain of arms and legs - lasted about 36 hours Severe headache - 7 days Fatigue - ongoing, started after vaccine, still persists Chills (no fever) Hypoglycemic episodes - sporadic (did not have prior to vaccine) Syncope - once (cause unknown, happened on 5/17)

6/28/21 A 26y/o female client 10:25 A client was given the following vaccines; Hepatitis A- Lot #G99R expiration date in the right deltoid; Hepislav B- Lot # 934599 expiration date in the right deltoid: and Johnson & Johnson Janssen COVID vaccine Lot # 202A21 expiration date 08/07/2021 in the left deltoid. 10:30A During routine observation noted client color was pale, skin warm and dry. Client initially states she is ?okay?. After questioning client again this time Client admits she feels ?dizzy?. Client denies any difficulty breathing and B/P 112/70 with a heart rate 76; pulse was strong and regular. 10:35A Client now c/o a ?dry mouth and dry throat?. Client given a minute sip of water was able to swallow without difficulty. Client continue to deny any difficulty breathing or swallowing so couple of minutes later client tried another minute sip of water, but this time had some difficulty swallow. Now client admits she is having ?pain in my throat? and ?chest pains? in the left side. Epi pen -Lot #G201104X expiration date 02/2022 was given in client?s upper left thigh without problems; repeat B/P 118/68 and 911 was summoned by nurse 10:40AM Paramedics arrived ? reported to Paramedics epi pen was given. 10:47AM Client B/P per Paramedics 107/73, heart rate 72; Paramedics report client will be transported to the Hospital ED for evaluation. 3:50PM Noted client was back. Client reports she is feeling ?okay?. Client states she was ?discharged from ED at 13:22? (1:22PM) with the diagnosis of ?allergic reaction?. Client resumed her routine scheduled chores and continue to report she feels ?okay?. RN CCM

1805 vasovagel, pale skin moist, put in reclining position, legs elevated. moist clothes applied to face & neck. pulse 80 strong regular, R 16. 1810 sitting up skin w/d. Patient made full recovery and left the clinic at 1830.

Covid-19 Ad26 Vaccine administered to Left deltoid muscle per standard IM injection protocol. Within a few moments after administration patient stated "Oh. I'm going to faint." Pt. was assisted to supine position and observed to be unresponsive to name calling, appeared pale and slightly diaphoretic with a weak thready pulse. Clinic staff was notified of vasovagal syncope, patient self-revived within 30 seconds. Afterwards cool compress was applied to forehead and pt. provided with water for hydration and was also offered crackers and juice, which she declined. Pulse re-checked approx 2 minutes after pt. revived found to be approx 65bpm and strong, 2+ color returned to pt. face and she stated she felt much better. pt. was observed by clinic staff for full 15 minutes following vaccine administration and vasovagal episode without further issue. Pt. left exam room and clinic under own power in stable condition.

FEVER; FELT NAUSEATED; FELT REALLY HOT; COLD; COUGH; BILATERAL EAR ACHE; FELT BURNING PAIN ON STOMACH MOSTLY ON THE MIDDLE AREA; SEVERE HEADACHE; BODY ACHE; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood clot, non alcoholic, occasional smoker, penicillin allergy, allergic to amoxicillin, and bee sting allergy, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. Patient's concomitant medication included: cemoxazine100 mg twice a day for anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. Concomitant medications included hydroxyzine for anxiety. On 02-JUL-2021, the subject experienced body ache. On 02-JUL-2021, the subject experienced cold. On 02-JUL-2021, the subject experienced cough. On 02-JUL-2021, the subject experienced bilateral ear ache. On 02-JUL-2021, the subject experienced felt burning pain on stomach mostly on the middle area. On 02-JUL-2021, the subject experienced severe headache. On 03-JUL-2021, the subject experienced felt really hot. On 03-JUL-2021, the subject experienced felt nauseated. On an unspecified date, the subject experienced fever. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) Headache, Body ache and Bilateral ear ache had pain scale of 10/10. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, body ache, felt really hot, cold, cough, bilateral ear ache, felt burning pain on stomach mostly on the middle area, and felt nauseated, and the outcome of fever was not reported. This report was non-serious.

Racing heart, highest recorded beat was 108, lasted from 7:45 to 8:45 pm Face/throat swelling, I treated with benedryl , lasted from about 8:15 PM to 8:45 PM Vomiting and nausea , I treated with anti-nausea med lasted from 7:15 pm to 9 pm Migraine-like headache , I treated with ibuprofen, started around 9 pm and finally decreased around 4:30 am. I still have a slight headache. Chills - started around 3 pm and lasted until around 6am this morning. Site pain - 10 Am until 3:30 am.

patient said she was nervous about getting the shot & needles. I told her to relax and she would be fine. After getting shot she fell over, started sweating & shaking. I called 911. She wanted to lay down. Paramedics took her BP and it was low but she started to feel ok. She refused going to hospital. A friend came and drove her back to work

Approximately 2-5 minutes after administration, she became sweaty, loss of color in her face, nausea and dry heaving, dizziness, tingling and numbness in all extremities, stiffness in lower extremities, difficulty talking and ability to catch her breath.

Pt has severe headaches with no specific area and problems with bright lights and noises. This started approximately 7/6/2021

I developed dysautonomia (elevated heart rate, chest pain, and shortness of breath upon standing. also GI distress) on June 12, 2021. I ended up in the emergency room and being admitted to the hospital twice over the next week and a half. I have been trialing medications, wearing compression socks, and drinking a lot of water and eating a lot of salt. My symptoms have improved a little but my doctors believe I will be managing this for life (or at least a while). Prior to this episode, I got the Janssen vaccine which caused me to have tachycardia for about 12 hours within the first 24 hours. I felt fine for a week but the second week I felt very fatigued and couldn't do much other than sit on the couch for the week.

FEELING NUMBNESS IN THE PALM OF HER RIGHT HAND AND IN RIGHT LEG AND FOOT; DIFFICULT TO MOVE FOR ABOUT 4 DAYS; FELT SEVERE PAIN IN BOTH THE HANDS, LEGS, AND ARMS; ABNORMAL HEART BEAT; HIGH BLOOD PRESSURE; FELT WEAK; SLIGHT HEADACHE; PAIN ON INJECTION SITE; LOSS OF APPETITE; SLIGHT CHILLS; This spontaneous report received from a patient concerned a 26 year old , female. The patient's height, and weight were not reported. The patient's concurrent conditions included nonsmoker, non alcohol use, and blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced loss of appetite, slight chills, weakness, slight headache and pain on injection site. After 2-3 weeks after receiving vaccine, on 01-MAY-2021, the patient experienced sever pain in hands, legs and arms and it was very difficult to move for about 4 days. Patient went to the clinic in May to seek help for her pain and new heart side effects. Patient noticed that her heart was beating abnormally, It would beat hard 10 minutes and then stop. On MAY-2021, Laboratory data included: Scan (NR: not provided) No abnormalities with heart. In clinic they also checked blood pressure and Laboratory data included: Blood pressure (NR: not provided) Abnormally high, Heart rate (NR: not provided) normal, Patient did an Magnetic resonance imaging (MRI) 3 days after the clinic appointment and had No abnormalities, results came normal. On 11-JUL-2021, the patient experienced feeling numbness in the palm of right hand and in right leg and foot and Patient said it's not serious but had been dealing with the symptoms continuously. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficult to move for about 4 days, and loss of appetite, slight chills, weakness, slight headache, and pain on injection site on 11-APR-2021, had not recovered from felt severe pain in both the hands, legs, and arms, abnormal heart beat, and feeling numbness in the palm of right hand and in right leg and foot, and the outcome of high blood pressure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210730598-covid-19 vaccine ad26.cov2.s -Abnormal heart beat. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

CHILLS; FEELS COLD AND CAN NOT SEEM TO SHAKE IT; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 26 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, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUL-2021, the subject experienced chills. On 21-JUL-2021, the subject experienced feels cold and can not seem to shake it. On 21-JUL-2021, the subject experienced fatigue. On 21-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and the outcome of headache, fatigue and feels cold and can not seem to shake it was not reported. This report was non-serious.

PAIN IN RIGHT ARM; PAIN IN KNEE; CHEST PAIN; TINGLING; NUMBNESS; FEELING LIKE SHE IS GOING TO FAINT; FEVER; FAINTING; This spontaneous report received from a patient concerned a 26 year old White, Non-Hispanic/Latino female. The patient's height, and weight were not reported. The patient's past medical history included birth control stopped 2 months ago, and concurrent conditions included pollen allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with benzoyl peroxide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-JUL-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 13-JUL-2021, after receiving the vaccine patient reported fainting and fever on the day of injection. On 14-JUL-2021, the day after vaccination patient had chest pain, tingling and numbness and feeling like patient was going to faint. Patient went to the emergency room on the 14-JUL-2021 and patient was told patient was ok. On 16-JUL-2021, patient started feeling pain on the right arm and knee (side of injection). Patient mentioned patient was travelling after few days on a long flight to Germany. Patient mentioned that patient was very healthy. Laboratory data included: Blood test (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, and Urine analysis (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, recovered with sequelae from chest pain, and had not recovered from fainting, tingling, numbness, pain in right arm, pain in knee, and feeling like she is going to faint. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738815-covid-19 vaccine ad26.cov2.s -fainting. 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).

lower extremity thrombophlebitis and fever on 07/04, elevated WBC. improved after antibiotics. US doppler pending

Coughing when not exercising, and that coughing prompting a gag reflex. Essentially, I feel like I'm going to vomit when I cough, and unlike in the past the coughing is not tied to exertion. This started sometime in June (I regrettably didn't record when I first noticed it). I have been tested by Dr., who is a respiratory specialist, as I originally believed this to be an odd development in my asthma. He currently theorizes that I have in fact outgrown my asthma (which first presented in 2005, at age 9), and this is some new, unknown issue. Our first move was to stop my asthma medications, positing that if this was asthma, my symptoms would worsen. They have not. Additionally, his first guess was that this may be related to acid reflux (which I have experienced mildly in the past), and he prescribed me Omeprazole 40mg/daily. However, around the sane time that I started the omeprazole (roughly a week ago), I began experiencing debilitating nausea, a worsening of the gagging sensation when coughing, and horrible stomach pain. As of today, at Dr.'s recommendation, I have reduced the omeprazole to 20mg to try to determine if it is the cause of my worsening symptoms, but it is too early to tell. I have also contacted the physician I see for Hormone Replacement Therapy, which I began about a month prior to my vaccination. Nausea is a noted side effect of estrodial, so I was advised to take that medicine at night instead of the morning. This advice also came mere days ago, so it is too early to tell if it will affect anything.

Later in the evening after receiving the vaccine, I experienced a very strong and pounding headache. I took some Ibuprofens and went to sleep around 9pm and the headache was resolved around 11:30pm. However, later during the night the headache came back. Also, my body aches all over and just generally uncomfortable feelings. The injection site felt warm to the touch and sore.

Patient stated she received her vaccine around 9:50 am and started having symptoms of fever, body aches, HA, chills and nausea around 3:50 pm that afternoon. States fever went as high as 106 degrees. She took tylenol initially for symptoms. As fever continued to increase she called her PCP who told her to take tylenol and motrin at the same time and if temperature did not drop below 103 to report to her local hospital. States her temperature decreased to 102 the next morning on 3/6/21 and then all symptoms resided by afternoon on the 6th.

Janssen COVID-19 Vaccine EUA Severe headache, body aches, fatigue for more than 24 hours after vaccine. Feels debilitating. Symptoms barely changed after taking 2 Advil pills.

No adverse side effects until 10:00 PM- chills began, fever until 2:30 AM, fever broke, then whole body aches with intense headache, high level of fatigue- with advil and mucinex- symptoms subsided- unknown if they will return once medication wears off

Nausea, cramping, soreness all over my body, headache, chills and fever. These have lasted so far for 10 hours.

Severe joint and muscle pain to the point of being unable to get out of bed alone. Difficulty taking deep breaths. Deep breaths cause coughing. Severe headache and nausea to the point of having trouble standing without feeling sick. Started with a few hours of getting that vaccine and is still present. Have missed two days of work so far as a result with no symptom improvement so far.

No symptoms after receiving the shot. Next day had a 102.8 fever, chills, body aches & head pressure.

Janssen COVID-19 Vaccine EUA Sore arm, woke up at 1:00am with chills but no fever. I went back to sleep. When I got up at 5:40am, I had a headache and my body was aching. I took ibuprofen. After a few hours, those symptoms are much milder.

12 hours post vaccine - muscle pain, difficulty moving, headache. A few hours later - chills, sweats, fever of 101.0, continued muscle pain and headache, throbbing pains

Extreme chills/shivering. Subsided after 1 hour with extra clothing for warmth, tylenol, and ibuprofen Headache neausea

start with arm hurt, and then headache, dizziness. and these symptoms getting worse along with time. I start to feel cold at night time, but the room temp was 70 which is not cold for me. I started to shiver with cold. my hands and feet were freezing cold. at the same time feel my body is so hot but cold. I started to sweat. after I feel less dizzy, I use an oral thermometer, it was showing 38.5 degrees. I was still boiling hot this morning. and then I took some Tylenol for my body ache and fever. and then i went back to sleep for 6hrs.

Janssen COVID-19 Vaccine EUA G1P0 at 33w5d by LMP, presented to L&D the evening of 3/10/2021 after experiencing fevers, chills, diaphoresis, and muscle aches beginning approximately 8 hours after vaccination. She has chronic headaches which is also present on presentation. She denies any cough, sputum production, nausea, vomiting, diarrhea, dysuria, hematuria, flank pain, abdominal pain, vaginal bleeding, rash or skin changes, no leg swelling or pain. On presentation she was noted to have a fever of almost 103F, was tachycardiac to 160s, BPs 90s/50s, and had fetal tachycardia in the 170s. Her exam was non focal with no evidence of infection. Sepsis workup was initiated which was negative. COVID-19 test was negative Discharged home in stable condition

Patient noted to be flushed, lightheaded and Diaphoretic. Treated with cold compress, gave water, juice and crackers. Patient observed for 60 minutes.

Starting at 8 pm on 3/11 I had flu symptoms; fever, aches, headache neck ache. Had fever through night chills and sweats. This morning I noticed around 9 am I started to develop hives on my shoulders/back/neck/face and my ears are red. I took 400 mg Aleve at 1:30 am 3/12, Tylenol 500 mg at 9 am and Benedryl at 11 am all on 3/12. My arms/shoulders/chest/neck feel itchy.

I took one preventative Tylenol at 7pm per a friend?s recommendation. I woke up at 11:55p (8 hours post vaccine, two hours after falling asleep) due to full body chills and shaking. I took two Tylenol. This lasted about 45 minutes. I felt cold but didn?t have a fever. I kept waking up throughout the night clammy. I woke up at 5:30a (30 mins earlier than normal) because I couldn?t sleep and had a headache. I felt sore and achy and very fatigued all day. I took the afternoon off work and came home and slept 3 hours. Still felt groggy and sore after. Felt more normal the next morning. My left arm is still sore two days post vaccination.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Patient became rigid, unresponsive, fixed eyes, dilated pupils, shaking (seizure-like movements), when patient was moved to floor, she became alert and oriented. Dizziness, shakiness, body slower to respond than normal...took some time to get back to normal. EMS called for monitoring and support.

Muscles aches and chills at 12:30am, then gradual fever that peaked at 101.4, taking acetaminophen at 4am

Received vaccine at 8am. Began feeling achy at 2pm. Fever reached 102F at around 4pm and was hard to control with Tylenol/Advil. 10/10 pain in the form of a full, throbbing headache that also didn?t subside with Tylenol or Advil. My headache is now down to 6/10 pain 28 hours later but is worse when lying down. Fever is down to 100.6 without medication.

flu symptoms. Pt received Covid J&J 1100 10MAR2021. Pt started having HA, fever, chills started midnight. Pt denies coughs, nausea, chest pain, respiratory problems, abd pain. History: pt received J&J COVID-19 vaccine around 10am and woke up around midnight with shakes/chills and mild non-thunderclap frontal headache with mild body ache, here for eval. Had work-out earlier and not sure if body ache is from work-out, per pt. denies any recent illness/injury or symptoms prior to the COVID-19 vaccine this morning. No visual deterioration, sore throat, cough, SOB, vomit/diarrhea, rash, sick contact, recent COVID-19 hotspot visit, co-morbidities, use of any meds, or chance of pregnancy, per pt.

I received the shot on 3/10 at 5pm 3/11 3AM - I woke up from my sleep with chills, body aches, fever, my left arm where I received the injection was twitching. I had to take tylenol to fall back asleep. 9AM - I wake up fatigued with a low fever 12PM - Fever goes up, chills and body aches return. I take tylenol and they go away. 3 PM - Fever goes away completely 3/12 - I wake up and my symptoms are gone

High fever (102), extreme headache, severe body chills, body aches, swollen lymph nodes in neck and groin. Onset at 2:00 pm, kept developing rapidly until I took 800 mg of ibuprofen around 6 pm and symptoms lessened within an hour. Symptoms still present but mild with the pain meds. Injection site pain as well.

Fever started at around 4:30 am the morning after receiving the vaccine. The chills woke me up, so I took Tylenol 1000 mg and my fever broke about an hour later. I had to keep taking Tylenol 1000 mg at 10:30 am and 4:30 pm to control my fever. Each dose worked well for the first 3 hours or so on the fever, but then it would come back. I also had muscle and headaches and fatigue, which made it very difficult to move around. The Tylenol also helped with that somewhat, but I spent most of the day in bed and on the couch (and I am normally very active). By around 5:30-6pm, the symptoms were fading slowly. I felt a lot less achy and my body temperature felt closer to regular by the time I went to bed at 9pm.

After several hours of injection, started to feel chills and headache during the whole night. Second day had fever 100-102F throughout the day and headache and tiredness. Third day the fever is gone, injection site still experienced mild soreness.

First Woke up at 2 am on 3/12/21 with a headache. Then at 5:30 am massive headache still present and a mild fever reading at 100.1. Fever broke later that day. Muscle aches in injection site for a few days. Slight overall muscle aches and feelings of tiredness persist as of 3/15/21.

After receiving the vaccine, I slept okay, the next morning about an hour after I woke up I had severe chills, body aches, and nausea. I had to go home from work due to these feelings. Eventually, developed into a fever. I went home and the chills and aches worsened. I could not get warm not matter how many layers or blankets I had. I took tylenol and fell asleep after several hours. When I woke up, I was profusely sweaty, my fever broke. I was able to eat a small lunch and continued to lie down the whole day. My symptoms lessened and were more minimal 24 hours after. After going to sleep the second night, I felt back to normal upon wake up.

Fever, muscle aches, tender skin, started the night of and passed by the next evening. Nausea lasted about an hour. Facial rash, bumpy and itchy started the 2nd day and is ongoing.

I noticed a very mild headache and slight coldness within 2 hours of my vaccine. Onset of my severe symptoms began around 10PM on 03/12/2021 with a stabbing headache (Felt like someone took an air pump and kept 'blowing up' my head. My eyes felt achy and heavy and every time I looked in a different direction I would get a zapping/electric feeling throughout my head that would cause my head and neck to spasm (longer duration) or twitch (quick jolt). This also caused dizziness). I got really cold and had intense shivering and shaking. Around midnight, my skin started feeling bruised all over my body (very sensitive to touch, including my bed sheets against my spine felt like rubbing up against a wound). At the same time, my joints (especially my neck, hips, and knees) got hot to the touch and were incredibly painful (induced tears). My muscles developed a deep ache that also caused significant pain. I felt very weak and confused. I didn't take my temperature until the early morning, and it was 102.9 at that time. I alternated taking Tylenol and Ibuprofen throughout the day, but my temperature stayed between 102 and 103.1 for about 24 hours, as did the previously noted symptoms. I noticed a gradual improvement of my symptoms over the next two days. On the evening of 03/14/2021, my headache worsened some, and I had an unexpected episode where I nearly passed out (dropped to the floor but stayed conscious). I also had intermittent foot tingling (very noticeable, not mild) over the course of a few hours. For 3 full days (but by far the most severe within the first 24 hours), I experienced some strange sound processing. Things like the sound of a car driving by or the ceiling fan felt like it echoed throughout my whole body and gave me an uncomfortable shivering feeling. As of today (03/16/2021), I am mostly recovered. I am still experiencing fatigue, a very mild headache, and some mild pain. My nausea has completely resolved, though that was never a chief complaint of mine. I realize that some of my symptoms are to be expected with this vaccine. But especially the level of pain I experienced throughout my entire body was very concerning and not something that I was aware could happen as a result of the vaccine.

Loss of circulation/feeling in vaccinated arm, onset within 40 minutes, lasting two and a half hours. Nausea, onset within one hour, lasting 30 hours. Severe headache, onset within 18 hours, lasting 54 hours. Body aches, onset within three hours, lasting 60 hours. Fever of 99.7F, onset within two hours, lasting 48 hours. Rash on vaccinated arm, lasting 60 hours.

-fatigue, fever, shortness of breath, vomiting, chills, headache Began at 6:00pm (about 9 and a half hours after vaccination, and lasted for about 6-8 hours). -soreness in arm, lump at injection site Continuous (3 days later and still sore).

high fever, chills and sweats throughout the night; extreme fatigue and weakness the next day in addition to sore injection site

Within 8 hours of receiving the vaccine, I started to feel weak and began to develop a fever. By that night I had a 102f fever. My muscles were very achey, and my heart was racing. I was slightly nauseous but still able to eat a little. By 24 hours after the shot my fever was down to 99f. I started to get diarrhea beginning the second day and has lasted until now the third day after vaccination day.

No side effects until 8 hours later. Started feeling dizzy occasionally, especially when I turned my head. Dizziness worsened over the evening to the point where almost any movement made me dizzy. Extreme muscle and body aches around 8pm continuing now. Feeling very weak and had chills throughout the night. These symptoms feel exactly how I felt when I had covid on 12/28/20.

Severe chills starting at 1:30 am 17Mar21 followed by fever/sweats at approximately 3:00 am 17Mar21, Headache and body aches 8 am 17Mar21, vomiting 10 am 17Mar21. Headache and body aches present until 10:30 pm 17Mar21.

Fatigue, fever, chills, headache and arm soreness beginning the same day as the vaccination date through to end of the following day

Approximately 1 to2 hours post 2 hives on top of each foot, treated with benadryl topical. Relief 5 hours post- chills, restlessness, and body aches, treated with Tylenol no improvement, clonazepam taken to help sleep, slept 3 hours. 9 hours post- low grade fever, restless, body aches, treated with Tylenol no improvement. 14 hours post- swelling of both lips and around the mouth, body aches, tried Tylenol again still no improvement. 20 hours post- lip and around the mouth still swollen still body aches low grade fever with PCP approval took benadryl and ibuprofen body aches improved fell asleep 26 hours post- body aches mild, no fever, lips and around mouth decreased a small amount, ibuprofen helped with body aches again. 27 hours 30minutes post- swelling still present took benadryl again and went to bed. Slept through the night. 37 hours post- feeling much better, very small amount of swelling with lips and around mouth, slight injection site soreness

Nausea , fatigue, weakness, headache , back and Neck pain, pressure behind eyes, headache, fever, intermittent hot then chills, rapid heart rate 110s, and shortness of breath at rest & w/ exertion. Vaccine @ 9:00am 3/13 ?> symptoms progressing at 4:00pm and lasting until next day 3/14 3:00pm

Strong chills set in around 2:30 PM. I ended up getting a fever that spiked at 103 and lasted on and off for 12 hours. The following morning the fever and chills were gone. I felt extremely fatigued.

Fever, chills, whole body aches, nausea onset 6 hours after injection. Fever reached 102 degrees overnight, came down to 100 by next morning at 9am. Body aches and nausea continue so far, 18h after injection (time of reporting is 18h post injection)

11:00 Feverish, headache 3:30 Headache 4:00 Extreme fatigue, back pain, extreme headache in front of head, chills 4:30 Chills, hard to focus, shoulder pain 5:00 Chills 9:30 Extreme chills, fever, back soreness Symptoms continued to March 11 with extreme headache, fatigue, fever, and chills March 12 symptoms included fatigue, congestion, headache March 13 symptoms mild fatigue and congestion March 14 symptoms included lip swelling around 2:00 as if allergic reaction, used Benadryl and it stopped swelling March 15-16, lip dryness and chapping, lips are numb and skin feeling tight

Janssen COVID-19 Vaccine EUA The day after the vaccine I experienced fever, headache, nausea, body pains, and fatigue for the entire day.

Headache, muscle pain, pain in the arm of the injection, chills, internal fever, nasal congestion, eyes pain.

Patient reports urticaria rash onset 22 hours after vaccine. No angioedema. Experienced fever (Tmax 101.6), bodyaches hours before that improved with tylenol. Did not take benadryl, any other antihistamine, rash persistently itchy 4 days after onset.

4 hours after injection: Nausea, slight fever, fatigue, inflammation in joints, headache, dizziness 24 hours after injection: Hives on skin on arms, legs, and torso 48 hours after injection: Hives remained, larger rash spread 72 hours after injection: Hives and rash had spread on entire torso and up the neck

Patient reports receiving the Janssen vaccine on 3/16/2021. She developed symptoms the same day of subjective fever, body aches, chills, diarrhea, nausea, and abdominal pain. Patient was prescribed loperamide HCL and Ondansetron HCl to treat her symptoms. Outcome unknown as of right now as treatment was initiated today.

lt thigh pain. Lt thigh pain x 4 days; became raised and tender yesterday, reports some drainage yesterday, increased pain today Reports fevers at home. 23 yo F w/ no known chronic medical conditions, p/w several days gradually worsening "boil" to L inner thigh. Initially thought it was an ingrown hair, so she pulled the hair out. A boil formed yesterday, which she attempted to "pop." The area drained a little bit of pus at the time, but since then area has grown since. Woke up and the lesion had doubled in size; now raised, red, warm, very tender. Hurts to walk; couldn't even put on her underwear this morning because it hurts so much to touch the area. Denies fevers/chills, n/v/d, lesions/rash elsewhere. No h/o si23 yo F w/ no known chronic medical conditions, p/w several days gradually worsening "boil" to L inner thigh. Initially thought it was an ingrown hair, so she pulled the hair out. A boil formed yesterday, which she attempted to "pop." The area drained a little bit of pus at the time, but since then area has grown since. Woke up and the lesion had doubled in size; now raised, red, warm, very tender. Hurts to walk; couldn't even put on her underwear this morning because it hurts so much to touch the area. Denies fevers/chills, n/v/d, lesions/rash elsewhere. No h/o similar sx.

Extreme body pain, vomiting, chills, migraine. Considered going to hospital as I could not keep any fluids down, including water.

Lips and tongue tingly/numb. Fever 101.4, body ache, muscle pain, headache, chills, pain at injection site, fatigue.

17 minutes after injection my left arm began to feel hot then the rest of my body did too and my throat stared to feel itchy. Dr. started to monitor me to see if symptoms worsened. Then 15 minutes later my chest felt hot and heavy and throat was more itchy. Dr. took vitals then administered epi , monitored throat became even more itchy then Benadryl was given and emergency services was called. Paramedics evaluated and symptoms began to get better, there was no transfer to the ER

Pain at injection site immediately, swelling around site, after about an hour, cold chills and a headache, body aches about 2 hours after

About five hours after the vaccine injection, at around 11 PM, I began to feel cold and achy, which soon led to body chills all over. It felt like I could not get warm no matter how many extra blankets I added. This soon led to a fever. I was in an out of sleep for the next few hours and woke up around 2:30 AM. At that point the fever had broken and I was sweating. I still had body aches, which I think was due to my body being tensed up for some many hours, and I had a splitting headache, as well. At around 4:30 AM, I woke up again, with a very sore arm a terrible headache still. I got up and took 400 mg of Ibuprofen and went back to sleep. At 7 AM my alarm went off and all adverse effects seemed to be gone other than a sore arm. The sore arm last for about 6 days.

3:30pm - shot given 7:00pm- fatigue and nausea 9:00pm- fatigue, nausea and fever 12:00am-3pm next day- fatigue, nausea, fever, chills, body ache, muscle pain, headache 3:00pm next day - fatigue, fever, body ache, headache 5:00pm- start to get energy back, slowly feeling better

Muscle soreness and light headed. Cannot sleep toes going a but numb. Feel like I got hit by a truck. Also head ache

Woke in the middle of the night to nausea and a low grade fever with chills. Took ibuprofen, fever broke around two hours later.

A few minutes after receiving vaccine patient began to have irritation in throat and tightness in the chest. 911 was called. 50 mg of diphenhydramine was given to patient with their consent and denied any allergy to benadryl. Counseled patient that benadryl could cause drowsiness. Patient denied any history of anaphylaxis in the past. The EMTs arrived and took over care. Vitals were good per EMT's. The EMTs escorted patient from the pharmacy. Per the EMTs, the patient was advised to self-monitor at home and seek medical attention if any worsening of symptoms, and they advised the patient not to drive home, and alternate transportation was arranged.

Chills started at 4:30am the next day - then I had nausea, then I had a fever of 101, then I had a headache

beginning 7-9 hours after injection, lasting for 24 hours (until 31hrs after injection): fever (99-100 degrees F), chills, headache, muscle aches in legs (quads, hamstrings)

Severe body and joint aches, fever, headache, cough, runny nose, injection site swelling and redness, sore arm.

Vaccine received by 9am. Start having fever at 4-5pm, 38.3 for 6-8 hours, chills, fatigue, pain at injection site, took 325mg Tylenol once , fever broke. Next day, temp 37.6, took another Tylenol 325 once. Symptoms resolved in the next 24 hours

I started having chills, light fever, and muscle discomfort starting about 10 hours following my vaccination. For the next 24 hours after that, I experienced chills, muscle discomfort, and injection site discomfort.

Headache & difficulty moving my eyes without pain (felt like migraine), injection site pain, pain in lower and upper back (very sensitive to touch too), extreme shivers and skin cold and hot to the touch, dizziness Drank water, used a lot of pain medication, heat pad for lower back

Fever, nausea, dizziness, migraine, chills beginning at 10 pm. Fever and migraine significantly reduced with Naproxen sodium. Continuing dizziness, fatigue for next 24 hours

Injection technique seemed poor as it was the most painful vaccination I've ever received, and upper arm became tight and achy immediately. Soreness lingered but the sharper pain went away shortly after. About 8-10 hours later I began feeling nauseous and lightheaded. 12 hours after vaccine I had trouble falling asleep, overcome with nausea and chills. This turns into sweating and insomnia the rest of the night. The following day I felt better, but the next night (and following one) I continued feeling a bit sick. Currently (3 days later) my upper arm is still very sore and I have lots of muscle/joint aches throughout my whole body.

At about 12:45AM on 4/2/21 I noticed I had a fever, a headache, chills, and injection site pain. My fever broke about 5 hours later and my headache and chills went with it. The injection site pain continues even now on 4/6/21.

BODY ACHE; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a female. The patient's height, and weight were not reported. The patient's concurrent conditions included mild hyperthyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 in left arm for prophylactic vaccination. Concomitant medications included thiamazole for hyperthyroidism. On 06-MAR-2021, the subject experienced body ache. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fatigue. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) NEGATIVE, NEGATIVE, and COVID-19 antigen test (NR: not provided) FALSE POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, and fatigue. This report was non-serious. This parent/child case is linked to 20210357033.

15 hours after I was vaccinated I woke up with a severe headache and also felt very hot/feverish. When I got up at 3:30 am to get some water/Advil I also felt light stomach pain and dizziness. It took me about an hour to go back to sleep. Currently the time is 11:00 AM on 07APR2021 and I am experiencing a light headache, but am no longer experiencing dizziness or stomach pain. Arm is still sore from the site of injection.

Day 1: body pain and tingly face that evening. No sleep Day 2: headache, extreme body pain, chills, fever (100.5-101 degrees), unable to work, last all day Day 3: moderate body pain, headache, chills, no fever though.

Patient was waiting in car after vaccine and returned to pharmacy at 1:40 (approx. 20 minutes after) stating she was okay now, but she originally felt faint, sweaty, heart racing, and dizzy. Patient didn't receive anything due to event ending before intervention could occur.

Two minutes after vaccination, pt reported feeling dizzy and became diaphoretic. Blood pressure measured at 63/22, heart rate of 60 bpm. Ambulance was called. Patient placed in supine position and reported feeling better, BP recovered to 98/66.

Vaccination appointment was at 1:30 pm on Monday, April 5. I received the shot at around 2:00pm in my left arm. It hurt going in, but quickly dissipated as I moved my arm. I felt fine for the rest of the day. I felt normal the following morning (April 6), but started to feel tired in the early afternoon. I took a nap around 3:00-4:30pm, and woke up feeling slightly hungry. I went to bed around 11:00pm. I woke up the next day (April 7) with a headache. I called in sick to work and stayed in bed as my headache grew worse and nausea began to appear. I threw up for the first time at 11:00am, then again around 11:30am. I emptied my bowels in between these bouts of vomiting, and my stomach was very obviously empty after the second bout. I took a nap from 12:00-2:00pm, after which I threw up at 2:30pm and then again at 3:00pm and again at 3:30pm. I took another nap from 4:00-5:00pm, then threw up again around 5:30pm. I threw up a seventh time around 6:00pm and saw a couple flecks of blood in my vomit. Each bout was sudden in onset and violent but quick. I think I burst some of the blood vessels in my throat, because it was sore. I called a friend to take me to the ER, and threw up once or twice more while waiting. On the way to the ER, I threw up for the last time. The ER gave me Toradol, Zofran, and two bags of IV fluids. This improved all my symptoms. The next morning, April 8, I felt much better until 12:00pm, when I laid down for a nap and couldn't get out of bed until 4:30. My headache had returned so I took Advil, then ate some rice. I felt better from 6:00pm onwards.

RASH ON TORSO; HIVES; A SLIGHT RAISE IN BODY TEMPERATURE; NAUSEA; MILD FEVER; LETHARGY; TIREDNESS; CHILLS; MUSCLE FATIGUE; INFLAMMED JOINTS; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, and other pre-existing medical conditions included the patient ha no known drug allergies. The patient was previously treated with omeprazole for acid reflux. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 20-MAR-2021, the subject experienced muscle fatigue. On 20-MAR-2021, the subject experienced inflamed joints. On 20-MAR-2021, the subject experienced lethargy. On 20-MAR-2021, the subject experienced tiredness. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced a slight raise in body temperature. On 20-MAR-2021, the subject experienced nausea. On 20-MAR-2021, the subject experienced mild fever. On 21-MAR-2021, the subject experienced rash on torso. On 21-MAR-2021, the subject experienced hives. On 22-MAR-2021, Laboratory data included: Body temperature (NR: not provided) a slight raise in temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle fatigue, inflamed joints, and tiredness on MAR-2021, and nausea, and mild fever on 20-MAR-2021, had not recovered from rash on torso, and hives, and the outcome of chills, lethargy and a slight raise in body temperature was not reported. This report was non-serious. Version created to amend previously reported information on 23-Mar-2021. Upon review the following information was amended: Event Lethargy Labeled Muscle fatigue labeled Hives labeled.

103.5 fever for 8 hours; violently throwing up for 4 hours; migraine, dizziness, and body aches for 24 hours after shot.

I had a high fever - for me a high fever is above 98.4 or 98.6. I was running a fever of 99.1-100.2 for three days. I didn't take anything for awhile for it. Thursday morning, on the first, my arm - at the injection site - was swollen to size of nickel. Over the next few days it grew to a size of a paper dollar bill - red, hot and swollen and very itchy. Saturday - 4/3/2021 - I went to a pharmacy where I get my meds and the pharmacist suggested I take anti-inflammatories and Benadryl. I did put ice pack on before taking those. I do still have a lump on my arm at the injection site - it's probably the size of a quarter now.

Day 1 (4/5/2021): extreme exhaustion and nausea Day 2 (4/6/2021): extreme exhaustion, nausea, fever (101), chills, sweating, whole body and muscle aches, vomiting, disoriented, unbalanced, light headed, head ache Day 3 (4/7/2021): extreme exhaustion, nausea, fever (101), chills, sweating, whole body and muscle aches, vomiting, disoriented, unbalanced, light headed, head ache, vertigo, injection site is a hard, swollen, and red Day 4 (4/8/2021): extreme exhaustion, nausea, vomiting, whole body and muscle aches, disoriented, unbalanced, lightheaded, head ache, vertigo, injection site is a hard, swollen, and red Day 5 (4/9/2021): extreme exhaustion, nausea, whole body and muscle aches, disoriented, unbalanced, lightheaded, head ache, vertigo, injection site is a hard, swollen, and red

Chest pain, disorientation, dizziness, nausea, brain fog, muscle spasms, inflammatory response in prior surgical sites (from 6 months to 2 years old), and fatigue

Very mild headache and mild chills that began around 3pm and got progressively more noticeable starting around 7pm. I took advil around 9pm. I woke up the this morning (4/9/2021) and feel completely better.

After I received the vaccine, during my 15 wait period, I started to sweat and feel like I was going to pass out about 3-5 min after getting the shot. I called for help and the pharmacist called EMTs who checked me out. After about 45 minutes, I felt better and requested to leave and NOT be transported to a local hospital.

I received the vaccine at around 5:23pm, and then about 11pm the same night I was awoken from sleep by terrible body shivers. I managed to doze off for about an hour before I was woken up again by a migraine at midnight; dozed off again, and woke up at around 2 am with a mild fever (around 99.3 degrees). Sometime between the migraine and fever I began to develop terrible body aches as well. The first 24 hours were the worst as I was completely bedridden. The next day, 4/8/21, was better, but the body aches and migraine persisted all day while the fever broke late morning. The third day (today, 4/9/21) everything is feeling better but the migraine is still a persistent issue.

Severe body aches began at 11pm on 4/8. Then, a high fever - the worst fever I?ve ever had in my life. That lasted until 8am on 4/9. Now, I have chills and nausea - still ongoing.

Started with a slight headache that worsened to a crushing headache that felt like my head was in a vice. Lower back started hurting, followed by all joints and eventually every part of my body was in pain. 103 fever, severe chills. Sweating, nausea, shakes.

At 3pm on 4/7 (the day of the vaccine), I started to feel ?out of it? with chills. At around 4pm, a mild headache started, and I was experiencing cramping from my chest down to my stomach. I had no appetite that evening. By 8pm, I had a 101.0 fever, and by 9:30pm the cramps were severe in my lower stomach. I was sweating profusely and shaking until I vomited, which helped to relieve some of the stomach pain. Before I vomited, I was in intense pain- possibly some of the worst pain that I have experienced in my life. The sweats and chills alternated throughout the night, and the headache was intense. The next day, the chills, sweats and headache persisted until mid-afternoon, in addition to the occasional stomach pain and diarrhea. The side effects slowly subsided, and I was feeling better by 4/9. The sweating was the longest lasting side effect.

BODY ACHES; TINGLING IN LEFT CHEEK; FATIGUE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced tingling in left cheek. On APR-2021, the subject experienced fatigue. On 02-APR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, and the outcome of fatigue and tingling in left cheek was not reported. This report was non-serious.

Starting on 4/8/21 around 9:00 PM my body started to feel slightly sore and I had a low grade temperature of 99.6. Throughout the night my body became extremely sensitive and sore especially in my lower back and neck. My temperature also continued to rise to 103.0. Throughout the day of 4/9/21 I was taking Tylenol and ibuprofen on a rotating schedule. My temperature went up and down throughout the day spiking at 105.7 and dropping down to 101.2. Around 10:00 PM it was around 102.9 and my body was becoming even weaker. This morning, now 36 hours after my symptoms started, I can barely lift my arm, my headache has worsened, my total soreness and weakness is no better and my temperature is 102.3. I have also had trouble with staying hydrated because my skin hurts if it is not covered from the air and I get heavy chills, but when I cover up I am profusely sweating constantly. The sweat is so bad, I constantly have to lay on a towel and change my clothes.

Chills, fever, fatigue, headache, body aches. Chills and fever lasted off and on for 6 hours. Ibuprofen helped. Headaches has lasted most of the day after receiving the vaccine, and ibuprofen didn?t help.

Remember to prep some pain killer!! I was ok in the first 4h. Didn't feel anything. Then my body started feel a bit lethargic. I went to sleep around 9pm but my body was so pain that I couldn't really fall asleep. The whole body was pain. I didn't have short breathe but I had to breathe heavily to catch myself. Until 2am my arms, legs, face and head started numbing and I couldn't even grab anything. My hand were like sprained. That's when my hunsband has to go buy pain killers for me. He also bought thermometer. I checked my Temperature it's was ~96F. I took ibuprofen and some milk, bread and egg. The pain and numbing was getting off after ~40min after I took Ibuprofen. Then I was able to sleep on bed.

Was administered covid vaccine J&J on left arm felt a burning sensation just after it which i knew it normal you just got a vaccine. Walked to the observatory area where we are supposed to wait 15min until you are released to go. Well less than 10 min in the observation area that?s when i started to feel un well my body started sweating excessively and thats when i felt numbness on my right side of my head with a tingling sensation couldn?t hear with my right ear and i freaked out when i started to get blurred vision thats when i knew something was wrong i got up to ask for water once i got up i felt like i was going to faint and felt really dizzy. Once i got to the lady that was there in the observation area she was shocked at how i looked she told me to go sit down and brought me water as she called the ambulance. Once i was sitting down and was brought water i drank like more than half of the water and the numbness was going down from my right side of my head but still had blurred vision and just felt disoriented and not my self. The ambulance took me to the ER once i got there i felt a little better but still disoriented and dizzy. So disoriented that i left the hospital with me actually realizing i had to stay there to get checked because they kept saying i was fine.

Around 6 PM (after receiving my shot at around 12:30 PM), I started to feel very tired and slightly achy. By around 9-10 PM, I had a fever of about 100.5 degrees with pretty severe chills, and my arm had started to hurt VERY badly. For almost the entire rest of the weekend (from Friday night-Sunday), I was very fatigued and achy and could not lay on my left side due to the soreness in my arm. The fever seemed to pass by mid-day on Saturday, though, and I was able to go back to work on Monday. It was not pleasant, but it was totally worth it and a million times better than actually being sick with COVID!

15 mins after Injection I had pain in my jaw 5pm I had a fever of 100.5 by 6:30 I had a fever of 101.5 which lasted for 15 hours. Starting at 5 I had a pounding f headache and pain in my teeth and jaw By 7pm I had my period which was not supposed to be coming until next month. The next morning I woke up with VOmmiting and stomach pain 10am the morning after the shot I was still in paid around my back neck and head. Still with a fever Fever subsided by 4pm the day after injection

Fever (101.6) and muscle aches and headache starting around 8 or 9 pm. Lasted through the night, took naproxen at 1 am, fever was lower (100) at 2 am. Fever gone in the morning at 6:30 am

In the evening while making dinner I noticed mild pain at injection site and began to notice increasing chills, and unusually intense tiredness, which were followed that night by a low grade fever, headache, and nausea which led to vomiting. Was unable to sleep that night and unable to eat most of the following day due to these symptoms, primarily the nausea. Symptoms began to resolve during the later afternoon of April 11th. No medical treatment sought as these were side effects listed on the fact sheet and expected to go away which they did. Still experiencing mild arm pain in injection arm but expecting that to resolve soon on its own.

Around 4/4:30pm I started to feel dizzy and by 5pm I grew worried I might faint (I?ve never previously fainted). Around approximately 8pm I was feeling very feverish, experiencing body aches, mental fog, intense shaking and chills, and within the next few hours threw up multiple times. I eventually fell asleep and sweated profusely, waking up multiple times (unusual for me). The next day I had low appetite, fatigue, and body aches, but other symptoms were reduced.

Fever, dizziness, weakness, trouble walking, full body aches, headache, wheezing, difficulty breathing, rapid heartbeat, high fever, cough, shortness of breath, vomiting, heartburn, earaches (pressure in the ear), chills, extreme night sweats

1p (Friday)- Received shot and felt normal rest of afternoon 7p - Started feeling lethargic and dizzy 8:30p - Started getting full body chills and shivers, felt freezing, headache and fever started 10:30p- Body shivers stopped. Fever 102 F 11:30p- Fever 104 F 12:00a- Extremely rapid heart beat, couldn?t slow it down with breathing. Fever still 104 F 1:00a - Fever 103F. No sleep 8:00a (Sat)- Temperature came down to 100F. Bad headache and body aches, worst in hips and legs/knees. By Sunday, temperature back to normal and headache subsided. Still aches in right hip/leg.

Dizziness, nausea, vomiting, diarrhea, arm pain, body aches, joint pain, headache, my period which is otherwise regular started two weeks early the day after the vaccine

Vaccine at 12:50 20 minutes after shot: fuzzy, drugged 35 minutes after: face and neck was red and blotchy and itchy. Tongue was itchy. Pain at injection site Drive home was bad. Slurring my words. Eyes were so heavy, hard to keep open. I felt weight on me. Pressure on my chest, heart was tight. Fatigue. Started hysterically crying. Got home, couldn?t walk normally. Sweating. Chills started at 8 Body aches at 9 Woke up with TERRIBLE body aches at 11:40. Skin was so hot, I was shivering cold. My legs hurt so bad. My knees mostly. My ankles. My inner thigh muscles. My lower back couldn?t handle any pressure. It hurt to lay. My left shoulder blade and upper arm hurt bad. Then my head hurt. My hips couldn?t move. My elbow felt weak and painful, like they would break. 12:40 headache got worse. I was shaking. I was nauseous. Chills were awful. Ears were ringing. No appetite for days. Sore joints, muscle pain and fatigue still 4/13

Patient became very pale, sweaty and felt like she was going to pass out approximately 5 to 10 minutes after vaccination. After drinking fluids she quickly recovered.

Approx 5 mins after vaccination patient reported feeling dizzy, lightheaded and nauseous (dry heaving), pt looked pale and diaphoretic - symptoms lasted approx 5-10 minutes. Left on her own, no EMS needed

Fever of 102 evening after vaccine. Took 1 Tylenol to combat it. Fever went down but remained low grade for 48 hours after vaccine.

event time started at 06:30pm of 04/12/2021. patient felt over at home. reported headache, increased heart rate, shortness of breath, chill, pain on head, back, leg, right leg numb. with no bleeding

24 hours post vaccine headache. 9 days post vaccine developed Covid-19 c.o fever, chills headache, cough, muscle aches. Complained of headache for the past 14 days. Past 48 hours headaches have worsened and not reileved by Over the counter medication

cold chills, low back pain, trouble sleeping, injection site pain, migraine, fever starting at 99.8 in pm and 101.7 in the AM.

Janssen COVID-19 Vaccine EUA Fatigue and chills, but no fever. These symptoms started about 6 hours post-vaccine and lastest for about 36 hours on and off. Arm at injection site is still sore to the touch, but manageable. Around 3 PM on Sunday, April 11th a small rash/hives broke out on the inside of my left arm opposite of my elbow. My vaccine was given in the right arm, but the right arm did not have any reaction. This rash lasted for about 12-24 hours and then was gone. It was never itchy.

About seven hours post-injection, I started feeling short of breath and chest tightness. I also had extreme nausea, headache, and fatigue. Fatigue continued for about one week. Nausea spells continued for about 2 days.

Fever and chills for 24 hours, hives for about 12 hours, body aches for 8 hours until Tylenol was taken. Fatigue and mental fogginess for 36 hours.

Fever 102 degrees for 6 hours Sore Arm 1 week Ibuprofen taken to lessen fever Extreme exhaustion 18 hours Pancreas pain day 2 and day 3 No medical care sought as symptoms went away on there own.

Vomited two hours after vaccine Aches and fatigue 4-24 hours after vaccine Ocular migraine two days after vaccine Ocular migraine three days after vaccine

Headache and chills started around 7:30pm on 06-Apr-2021 (about 8 hours after injection). Headache worsened so I took 2 Tylenol pills. The next morning, the chills were gone, though I felt slightly feverish and headache still remained. I took another 2 Tylenol and by 12pm on 07-Apr-2021, all symptoms were resolved and I felt ok. I've continued to feel ok since.

4:30pm hot flashes and chills begin 5:45pm sleepiness, fever, sweating, headache and abdominal pain begin 6pm nausea begins and laying down doesn't help Unknown time between 6 and 7:45 Advil is taken 7:45 - 9:45pm sleep 9:45pm headache pain has centralized to one spot, no more nausea, still sweating with fever 11:30pm all symptoms except fever, nausea, and headache are gone. Remaining symptoms are less than they were. Day after vaccine fever, nausea, and headache persist but are decreased by Advil and drinking pedialyte and sports drinks with electrolytes. Day 3, only headache and fever occasionally return. No need for medicine, just taking constant electrolytes.

Believe I may have passed a blood clot through urine or vagina early this morning. It appeared to be quarter sized. Non painful, one time event. Also have intense back pain and leg aching. Still feverish and have mild headache as well.

Woke up the following morning with severe headache and vomiting. Recommended follow-up immediately with MD.

reports she had dizziness, warm sensation, tongue numbness, decreased appetite, decreased sense of taste, vomiting x1, sore throat, myalgias, and intermittent shortness of breath and chest pain. of note had Covid in December 2020

patient received vaccine @ 6pm. waited the 15 minutes and was walking to her car with mom. Mom notified RN that patient was c/o nausea, vomiting, tremors, phlegm build up in throat. Nursing staff evaluated patient and per protocol gave 50mg IM Benadryl. Patient unable to have PO due to vomiting. Patient was aox4, lungs clear. 911 was called at 627. Benadryl given at 629. pt tolerated IM Benadryl. 911 arrived at 632 and assessed the patient and transported to medical center for further evaluation

Fever, chills, nausea, headache, body aches. Started around 10pm on 4/10 (day I received vaccine). Fever broke around 2pm on 4/11. The headache, nausea and body aches went away around 5-6pm on 4/11.

I got the J&J vaccine around 2:30pm on a Saturday and by 6 or 7pm I was experiencing a really bad headache. This headache extended down my back and around the back and top of my skull. By 8pm I had began experiencing chills, body aches, and nausea. By 9pm I had a fever and could not stand up without feeling like I was going to vomit. Walking to even get water in the other room gave me motion sickness. I was shaking and sweating with a fever all night, was unable to sleep, and experienced hallucinations due to the high fever. The next morning I still had a fever but could finally sleep. I still had a bad headache, body aches, and nausea. I slept most of the day and my fever went down but was still >100 degrees all day. On Monday, I had a mild fever in the morning which went away by afternoon. I felt weak all day Monday and still experienced body aches and a headache. By Tuesday, I was only experiencing fatigue and brain fog. This lasted about a week.

High fever of 103 the night of the vaccine Extremely painful headache two weeks following the vaccine.

I had sparkles in my vision 5 min. after getting my shot. They went away quickly, so I wasn't concerned. I had a little bit of hotness up my neck and a little itchy, but both also were quick to go away. I went home and went to bed without issue. I woke up at 4am crying and in a lot of pain all over my body. I had a crushing headache, my back, arms and legs ached down to the bone. I had a fever of 100.7, and had to call in sick from work. I took 3 ibuprofen and it didn't help stop the pain or fever. I cried myself back to sleep after wreathing in pain for 3 hours. Woke up again crying again and the pain and fever continued on. I drank 2 beers to see if that would help relax my muscles and back around 3pm and by 4pm I finally felt somewhat better, but still couldn't get up out of bed. I had to call my brother over to help me and considered asking him to take me to the hospital several times because the pain was so intense. The spot where I got my shot wasn't inflamed, or if it was I didn't notice. It did seem a little stiff. I managed to fall back asleep and by the time I woke up again the next day around 5am, I felt completely fine. Fever disappeared and the body pain was gone. It was like nothing had ever happened.

The morning after the injection I woke up with a slight fever (99.0 degrees), body aches, and a headache. The fever lasted for about 4-6 hours and the body aches and headache lasted until mid-day the following day.

Female with history of COVID-19 in January presents to ER with 1 day of shortness of breath. Patient reportedly received Johnson & Johnson COVID-19 vaccine last week, states postvaccination she had flulike symptoms for a few days that resolved. States this morning she woke up feeling short of breath. Reports associated feeling of anxiety/possible palpitations. Denies chest pain. Reports resolution of symptoms at this time. Patient reports history of ectopic pregnancy while on birth control pills, currently has hormone positive IUD. Denies smoking cigarettes.

Approximately 10:00pm, I started having mild body aches, general malaise, and mild fever/chills. Around 1:00am (4/11/21), my fever and chills escalated, my body was shaking until I wrapped up in several blankets. At 2:30am, I woke up with nausea. At 3:00am, I vomited. I continued to have fever and chills and body aches. At 9:30am, I had body aches and felt only slightly feverish. I took acetaminophen for the rest of the day and had no problems.

FEVER, ACHES, DIZZINESS, PRESSURE, TIREDNESS NOT AFFECTING DAILY LIFE, ABLE TO RUN ETC. HOWEVER STILL HAVING SOME DIZZINESS AND TIREDNESS. RECOMMENDED CHECKING WITH MD

Fever for first 3 days Body/muscle aches for 3-4 days Fatigue that has not gone away Random headache off and on Occasional dizziness/light headedness, has gotten better over time but still occurs Rapid heartbeat at times

I had a fever of 103.8 8-12 hours after the vaccine. After the first 24 hours all normal side effects went away. Yesterday (day 5), I started having leg discomfort and it continues today. Could easily be a pulled muscle but I?m also concerned about blood clots so I?m watching my symptoms and if anything worsens, I will get seen by patient first.

Friday evening I had what I thought was normal reaction: chills, aches, headache, nausea. Saturday it was mostly aches. Sunday was dizziness, aches, nausea and cramping in left leg. Monday was nausea, aches, tingling in hands and feet, headache, brain fog. Tuesday I woke up with major imbalance and needed to use walls to walk without falling over. Dizziness subsided after some time to only rapid movements. I had a warm burning sensation in left leg with tingling hands and feet. Moderate headache. Reports came out of stopping the Janssen vaccine so I contacted my doctor with my symptoms and they ordered blood tests for clots.

My temp gradually rose over the course of the day/night after getting the vaccine. By the 12 hour mark I had a 103.9 fever, chills, severe body aches, nausea, weakness, fatigue, and dizziness. Treated with Tylenol and Advil over the next 24 hours. Fever, aches and chills subsided within 48 hours. Weakness and fatigue lasted for 7 days after vaccination, then went away. General dizziness (constantly feels like when you have a cold/ear infection and get up and are dizzy) persists through date of this report (day 12 after vaccination). I feel completely better except for the dizziness.

BACK PAIN; PAIN IN BILATERAL ARM; PAIN AT RIGHT KNEE; CHILLS; HEADACHE; PAIN AT INJECTION SITE; FEVERISH FEELING; FATIGUE; This spontaneous report received from a parent concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included premature at birth, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced back pain. On 09-APR-2021, the subject experienced pain in bilateral arm. On 09-APR-2021, the subject experienced pain at right knee. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced pain at injection site. On 09-APR-2021, the subject experienced feverish feeling. On 09-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at right knee, chills, and feverish feeling on 10-APR-2021, was recovering from pain in bilateral arm, back pain, and fatigue, and had not recovered from headache, and pain at injection site. This report was non-serious.

About 1 hour after: sore arm, sore/enlarged lymph node in underarm About 8 hours after: chills, body ache, fever About 16 hours after: severe headache, fatigue

On 03/18/2021 at 03:30AM I had a lot of arm pain from my shoulder to my elbow in my left arm. This lasted until 03/31/2021. On 03/18/2021 I woke up with a headache that would not go away. Next, at about 03:15PM I was not able to walk for about 10 minutes. Then, at about 05:00PM I started menstruating. At 07:00PM I had severe pain in my pelvic area for an hour and a half. At approximately 08:30PM I passed a softball sized blood clot vaginally. I bled heavily through the night. On 03/19/2021 I still had a headache and no energy at all. I continued to bleed heavily all day as well. 03/20/2021 was the exact same as the days prior. 03/21/2021 I was still bleeding heavily throughout the day with no energy. I still had the headache as well. I started feeling dizzy while walking on this day. 03/22/2021 I went to work like normal. I was cold all day. I was still bleeding, headache and dizziness. It was hard to stand for 30 minutes. While climbing the stairs I got very light headed and dizzy. I could not go up the stairs at a normal pace. 03/23/2021 I had the same symptoms all day but I was getting short of breath walking short distances. I still had very little energy and a headache. I also lost all color in my face and hands. I was still cold all day. I noticed some slight swelling in my ankles. 03/24/2021 The symptoms were getting more intense. I was still cold. I finally took some aspirin for the headache because it was very severe. The medication didn't help with it. This routine went on for the next week and the symptoms intensified with each day. Throughout this time I was still passing clots that ranged in size from golf/ping pong ball to baseballs. They were very painful when they passed. The days from 03/25/2021 to 04/01/2021 were all the same as far as how I felt. On 04/02/2021 I woke up with the same symptoms but now I could not stay awake for anything. I slept on and off all day. I only ate one meal a day because I was so tired and I had no appetite. The headache was getting worse as the days went on. The bleeding was still happening. It was not as heavy as the weeks before, but enough to be painful still. I also started having abdominal pain. On 04/03/2021 I was seeing stars when I moved too quickly. My heart rate was elevated with shortness of breath along with the rest of the previous symptoms. My headache however was very intense. 04/04/2021 I still couldn't stay awake on top of all the other symptoms. The dizziness and stars were more frequent. I couldn't move my head without seeing stars. 04/05/2021 I couldn't get warm and I still felt the same way. I called and made a doctor?s appointment for Wednesday the 7th. I had all the same symptoms still and they were getting worse. I had to move in slow motion so I could try to function. 04/06/2021 I woke up drained of all my energy and color. I couldn't shower because of the pain in my body. I couldn't stand because I felt like I was going to fall down. I could barely stand up straight let alone walk very far. I was shaking from being so cold. I had all the same symptoms from the days prior. I was in severe pain. I couldn't sit because of the pain in my abdomen I couldn't stand because of the weakness in my legs. I could barely see anything because of the stars I was seeing. At this point I had no color and I was barely conscious. That is when my family took me to the emergency room.

Initially patient felt feverish with body aches after receiving the vaccination but this improved after 48 hours. Two weeks after vaccination patient presented to hospital with ascending paresthesias and urinary retention. MRI cervical/thoracic spine with evidence of longitudinally extensive lesion from C6 distally to throughout thoracic cord. Findings overall concerning for transverse myelitis v demyelination.

Hypothermic episodes (95.5) during periods of fever Extreme and persistent nausea Highly elevated neutrophil count (12.18 10*3/uL)

Red & swollen arm, fever, chills, headache, body tremors, weak, muscle fatigue; started 5 hours after shot, got worse over night, was very painful in the morning to the point of sobbing and having to call into work sick, ended within 30 hours of getting vaccine; arm still a little soar 1 week after shot (felt like a bruise)

I received my J&J COVID-19 vaccine at around 1:45 p.m. on April 7, 2021. The shot itself was hardly painful, and I felt fine in the wake of the vaccine. That same evening, I had a fever of around 100 degrees , along with chills and fatigue. My most notable symptom was a severe, pounding headache throughout my forehead. It seemed to be localized above my eyes, in the front of my head. This was surprising to me, as I never get headaches. I took some acetaminophen and went to sleep, and the next day the headache had subsided slightly. The headache did not subside completely until 3 days after the vaccine and even now, nearly two weeks after the vaccine, I still get a slight headache in the same location (above my eyes, across my forehead) unexpectedly. Again, I never got headaches until receiving this vaccine.

I began to feel shortness of breath when walking, tightness in my chest, for the same reason any physical effort made me feel like I was short of breath. (The day before I had presented the common symptoms such as fever, chills, arm pain, muscle pain) however this symptom was off the list, at 11:30 in the morning I had to go to an emergency clinic, they checked me with blood test, urine tests, medical exam, electrocardiogram, and chest X-ray. The doctor told me that everything was fine that I could leave. I had to pay a high bill at the hospital. The following 7 days the sensation was disappearing very slowly. However from day 8 it started again, until now on day 13, I still having sensation of shortness of breath when doing physical exercise, it is something that lasts and does not disappear.

After the shot I had a pasta lunch and then took a nap for about one hour. When I woke up ( 3-4 hours after the shot) I had a fever. I could tell because I was very hot and sweaty even though my room was air conditioned. I drank water and immediately was nauseous and vomited. I continued to have sweats, chills, and after about another hour body aches set in. My whole body was cramping up and my hands were shaky. I was very short of breath over short movements like to get to the bathroom, I would be out of breath and dizzy. Around 1700 (6 hours post shot) I took Tylenol and continued to take it every six hours. I was able to keep ginger ale and crackers down but didn't eat much else until the next morning. I think the fever broke in the night. The next morning I was just really tired and sore, but much less achy than the day prior. I was able to eat light meals and I stopped taking Tylenol sometime that mid-morning. I felt fine the next day (about 48 hours after the shot).

nausea, back pain possible uti foul odor, blood in urine ongoing for 2 weeks, urine urgency, abdominal pain unsure if related to period (Period doesn't typically last two weeks), chills, janssen vaccine small bump on arm where vaccine is, arm is warm to touch with redness around the area, headache comes ago did not have a h/a last week, chest pain

a 27 y.o. female with a history of Covid infection December 26, 2020, positive covid test December 29, 2020. She had approximately 2 weeks of symptoms including generalized body ache and generalized weakness. Fatigue and some headache. Had some persistence of symptoms after that time. Had some benefit from ibuprofen. Was seen at emergency room on January 27, 2021 stating that she felt that all her symptoms of Covid had resolved except for some chest pain which awoke her on January 27. She presented to the emergency room. Had sinus tachycardia at 113 but otherwise unremarkable physical exam, laboratory studies with white blood count elevated 16,004-20, hemoglobin 13.7 g hematocrit 41.8%, MCV 87.1, RDW 12.7%, platelet count 329,000, segs 72.8%, lymphs 20.6%, monocytes 4%, eosinophils 1%, basophil 0.6%. BUN 10.1, creatinine 0.8, AST 24, ALT elevated 56, alkaline phosphatase 68, total protein 7.6, total bilirubin 0.3, albumin 3.6, globulin by subtraction 4.0, troponin less than 0.02, D-dimer quantitative 0.22, urine pregnancy test normal. Chest x-ray normal. Chest pain appears to be musculoskeletal and was reproduced by palpation of her chest wall. No evidence of deep venous thrombosis or pulmonary embolism. D-dimer was normal. Heart rate returned to normal after some intravenous fluids. Patient discharged on Zithromax 500 mg day 1 and then to 50 mg days 2 through 5. Also continued on ibuprofen. Received Johnson and Johnson vaccine April 5, 2021. Over the next week patient started having increasing soreness. Her joints hurt more than usual and her headache was worse. She had a sensation that her legs were "numb and tingly" starting at her buttocks and extending down her leg. Because of reported incidence of cerebral sinus thrombosis or cerebral vein thrombosis patient appropriately presented for screening in the emergency room and was sent for appropriate imaging. April 16, 2021 CT scan of head with and without contrast no acute intracranial hemorrhage, no mass-effect or midline shift. On contrast-enhanced images there appears to be a lobular nonocclusive filling defect in the far lateral right transverse sinus. Lobular occlusive filling defect is also likely present in the mid to central right transverse sinus. Short segment filling defect in the medial left transverse sinus. Remainder of sinuses and internal cerebral veins are patent. Focal lobular filling defect within the confluence of the right and transverse sinus most likely related to arachnoid granulation. No edema hemorrhage of the cerebellum or cerebrum. No other significant findings. April 16, 2021 confirmatory MRI angiogram of head without contrast with no restricted diffusion to suggest acute or subacute infarct. Contrast void in the middle to central right transverse sinus consistent with occlusive thrombus. Nonocclusive thrombus in the far lateral right transverse thrombus. Narrowing of the medial left transverse sinus without complete occlusion. April 16, 2021 2345 hrs. inital hematology consultation. D-dimer and fibrinogen levels have been requested stat and are still pending. If fibrinogen level is low will replace with cryoprecipitate. If D-dimer is elevated barely confirms diagnosis of possible vaccine related thrombosis. The fact the patient is not thrombocytopenic at this time is encouraging, however despite the lack of thrombocytopenia she still has clearly documented symptomatic nonocclusive and occlusive thrombus in her cerebral sinus. From UPtoDate.com Ad26.COV2.S (Janssen COVID-19 vaccine, also referred to as the Johnson & Johnson vaccine) ? On April 13, 2021, the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) recommended pausing administration of AD26.COV2.S to further investigate rare cases of cerebral venous sinus thrombosis and thrombocytopenia [33]. As of that date, six cases had been reported, all in females aged 18 to 48 years with onset 6 to 13 days after vaccination; during this period, 6.8 million doses were administered (with 1.5 million doses in females of that age range) [121-123]. Since some vaccine recipients have not been followed for longer than the time frame over which these symptoms develop, the incidence may change with additional follow-up. Initial symptoms included headache, backache, chills, and fatigue, and progressed to focal neurologic deficits. Intracerebral hemorrhage and thromboses at other sites were also seen in some patients. All of the five patients who were tested for the anti-PF4 HIT antibody tested positive. Another case, in a young male who was a vaccine recipient in one of the pre-emergency use authorization efficacy trials, had been previously reported. These cases appear similar to those reported following ChAdOx1 nCoV-19/AZD1222, another adenovirus-vector vaccine. Although rare, the observed number of events exceeded the expected rate among females <50 years old. Given the extreme rarity of these events, the FDA and CDC acknowledge that they recommended the pause out of an abundance of caution and to ensure awareness of these rare events. ?Evaluation and management of possible thrombotic complications ? Recipients should be aware of the possible association and seek immediate care for signs and symptoms suggestive of thrombocytopenia (eg, new petechiae or bruising) or thrombotic complications (including shortness of breath, chest pain, lower extremity edema, persistent severe abdominal pain, unabating severe headache, severe backache, new focal neurologic symptoms, and seizures) [117]. In such cases, some experts suggest evaluation with complete blood count and differential (including the platelet count), quantitative D-dimer, HIT testing, and imaging of any suspected site of thrombosis [113,114,125]. Onset 4 to 20 days after vaccination, platelet count <150,000/microL, elevated D-dimer, and a positive anti-PF4 antibody (HIT antibody) suggest the diagnosis. Treatment with a non-heparin/non-warfarin anticoagulant (eg, argatroban or direct oral anticoagulant) and intravenous immune globulin has been suggested. The CDC recommends not using heparin in individuals with thromboses following receipt of Ad26.COV2.S unless HIT testing is negative [126]. (See "Cerebral venous thrombosis: Etiology, clinical features, and diagnosis" and "Clinical presentation and diagnosis of heparin-induced thrombocytopenia", section on 'Terminology and HIT variants' and "Management of heparin-induced thrombocytopenia", section on 'Role of IVIG'.) As stated above all the 6 cases were "all in females aged 18 to 48 years with onset 6 to 13 days after vaccination" this would certainly fit the timeframe that we are seeing in this case. Recommendations from national guidelines would be to start treatment with dexamethasone immediately while awaiting intravenous gammaglobulin. To pursue intravenous gammaglobulin treatment at 1 g/kg over 1 to 2 days. It is recommended to avoid heparin and instead use direct factor X inhibitor such as Eliquis, which this patient is already been started on. There is unfortunately considerable risk that even though patient's symptoms appear mild at this time, that she may deteriorate in the very near future and I would recommend treating her aggressively at this time with dexamethasone and intravenous gammaglobulin while we are awaiting further testing. Patient clearly has had unusual thrombosis, especially in a 27-year-old. With the fact that she had headache dating back to January, it is impossible to determine the acute versus chronic nature of her venous sinus thrombosis. Covid infection does cause increase in coagulation as well. However, given the small risk of tragic outcome with cerebral vein and sinus thrombosis in the setting of Covid vaccinations, we will proceed aggressively with treatment starting tonight with intravenous gammaglobulin and intravenous dexamethasone. Will require rapid fasting glucoses to evaluate possible hyperglycemia from high-dose dexamethasone. Will consider stopping dexamethasone at 48 hours. Current recommendation for gammaglobulin would be single 1 g/kg or 500 mg/kg over 2 days. No recommendations for treatment beyond this point. Current recommendations for gammaglobulin dosing would recommend using an adjusted dose for patients with greater than 125% of their ideal body weight. This patient at 122 kg on a 5 foot 2 inch frame does qualify for adjusted dose and her orders reflect that. I appreciate the opportunity see this patient this evening and consultation requested by Dr. We will follow patient in hospital. Hopefully she will have gradual improvement and avoid any serious or tragic complications of her cerebral sinus thrombosis. We will have pharmacy report possible adverse reaction to Johnson & Johnson vaccine to the FDA as required by law. April 17, 2021 follow up. No new events. Laboratory studies remained excellent. White blood count is further elevated, however, this may be secondary to high-dose dexamethasone with a white blood count of 16,060. Hemoglobin 14.0 g hematocrit 42.8%, MCV 86.8, RDW 12.9%. Platelet count is actually increased slightly at 374 as of 9:10 AM this morning. Differential shows left shift as expected with dexamethasone. Results from yesterday showed fibrinogen normal at 369 (180?415) pro time normal at 10.4 seconds with INR of 0.97, PTT 26.7. D-dimer 0.23 (0.19?0.50). With platelet count, fibrinogen and D-dimer normal I am inclined to believe that this is not an acute post vaccination HIT-like phenomena. If it were I would still expect to see some degree of thrombocytopenia elevated D-dimer and perhaps low fibrinogen. The other explanations for her cerebral venous sinus thrombosis are either idiopathic spontaneous and merely coincidentally associated at the exact same time as her Covid infection or more likely, cerebral venous sinus thrombosis secondary to hypercoagulable state secondary to her Covid infection from December 2020. Unfortunatly there is no way to accurately date the acuity of the venous thrombosis in her cerebral sinus. HIT Testing is still pending and most likely will not be available for 3-4 more days despite being ordered stat. Have called the laboratory and asked them to check with our outside reference lab what the expected return time is on this test. (LabCorp says "Tuesday April 20, 2021). Patient refused intravenous gammaglobulin infusion which has been ordered last night. Patient has been receiving dexamethasone which was a bridge until intravenous gammaglobulin could be administered. Current guidance from the expert hematology panel (EHP) on Covid vaccine induced thrombosis dated April 7, 2021 from the public health would state that a patient who has a reduced platelet count without thrombosis with a D-dimer normal and normal fibrinogen or thrombosis with a normal platelet count and D-dimer normal and normal fibrinogen are "unlikely cases". They recommend for probable cases who have D-dimers that are elevated to send HIT assay and then give immediate intravenous gammaglobulin while awaiting results. They recommend fibrinogen supplementation, if needed. They recommend a direct acting antithrombin agents such as the Eliquis this patient is receiving. They recommend steroids particularly if there is a delay in getting intravenous gammaglobulin delivered. With the fact that we now have 24 hours in the hospital with no evidence of thrombocytopenia, no evidence of increased fibrinolytic activity or active thrombosis, and no evidence of hypofibrinogenemia, I would argue that her presentation is subacute. In this setting, I do not feel intravenous gammaglobulin would be necessary and does involve a small risk as well as considerable cost. Dexamethasone also involves small risk and negligible cost. I have discontinued both of these medications. My overall impression would be that this was not related to her Johnson & Johnson vaccination which was recent, but rather her more distant Covid infection. It is impossible to definitively answer the question however. The next question is duration of anticoagulation. Risk of recurrent cerebral sinus venous thrombosis is relatively small but the morbidity can be high. Studies have been performed showing medications in the same class as Eliquis have been associated with a decrease in incidence of the recurrence. Most hematologist recommend 3 months of anticoagulation for provoked venous thrombosis including cerebral sinus venous thrombosis. I feel this patient's thrombosis is "provoked", with her association at the same time of her Covid infection (and possibly vaccination). I would recommend Eliquis (apixaban) 5 mg twice daily or Xarelto (rivaroxaban) 20 mg daily with food. I would feel comfortable in discharging patient for outpatient follow up IF Dr and other speciality services agree. Plan 3 months of full dose anticoagulation with direct factor X inhibitor. Circulation 2010 Jun 29;121(25):2740-6 "Long-term evaluation of the risk of recurrence after cerebral sinus-venous thrombosis", Background: The clinical course of cerebral sinus-venous thrombosis (CSVT) is largely unknown because prospective studies with a long follow-up and with the goal to assess thrombosis recurrence rate and predisposing factors for recurrence are lacking. Methods and results: One hundred forty-five patients with a first CSVT were followed up for a median of 6 years after discontinuation of anticoagulant treatment. End points were recurrent CSVT or other clinical manifestations of venous thromboembolism. CSVT recurred in 5 patients (3%) and other manifestations of venous thromboembolism (deep vein thrombosis of the lower limbs or pulmonary embolism) were seen in 10 additional patients (7%), for a recurrence rate of 2.03 per 100 person-years (95% confidence interval, 1.16 to 3.14) for all manifestations of venous thromboembolism and 0.53 per 100 person-years (95% confidence interval, 0.16 to 1.10) for CSVT. Nearly half of the recurrences occurred within the first year after discontinuation of anticoagulant therapy. Risk factors for recurrent venous thrombosis were male sex (adjusted hazard ratio, 9.66; 95% confidence interval, 2.86 to 32.7) and, for thromboses other than CSVT, severe thrombophilia resulting from antithrombin, protein C, protein S deficiency, anti-phospholipid antibodies, or combined abnormalities (adjusted hazard ratio, 4.71; 95% confidence interval, 1.34 to 16.5). Conclusions: The risk of recurrent CSVT is low and is higher in the first year after discontinuation of anticoagulant treatment and among men. Mild thrombophilia abnormalities are not associated with recurrent CSVT, but severe thrombophilia entails an increased risk of deep vein thrombosis of the lower limbs or pulmonary embolism. April 19, 2021 Follow up, no change in condition. Discussed case with Dr, will order Factor V Leiden, prothrombin gene mutation, anti phospholipid and anti cardiolipin antibodies, if she will allow draw. Expect Heparin Induced Thrombosis testing result tomorrow, but with no thrombocytopenia after given heparin, expect will be normal. Will await result. If discharged, would recommend 3 months direct thrombin inhibitor (Eliquis/Xarelto/Pradaxa) at full anticoagulation dose. Then stop, no taper. Overall still feel "provoked" thrombosis due to December Covid, unrelated to J&J Covid vaccine, but can not definitively prove that..

6-48h: joint pain, fever, chills, headache, nausea, sore arm and pain around injection site, extreme pain below knees 48h+: original symptoms subsided but developed numbness and weakness left leg and left arm 56 hours: left face partially paralyzed and/or swollen to the point where couldn?t move week. Prickly feeling left skull. Weakness and numbness in leg and arm persisting (decreased feeling on skin on left side of the body) 1 week: saw GP, neurologist, and sought emergent care at hospital for symptoms as doctors feared potential small stroke. MRI, chest X-ray, and blood works all clear. Discharged same day. 1 week+: partial facial paralysis gone, numbness and weakness in left side located to below the knee, but not present in both legs. Pain and uncomfortable feeling in both calves when lying down .

about 12 hours after I received the Janssen Covid Vaccine I woke up and had a really bad fever. I was nauseas, was drenched in sweat, and couldn't stop shaking. I went to the bathroom and began violently puking for 30 minutes and then I continued to shake continuously for 3 hours. I was also in a lot of pain and couldn't sleep.

Day after shot, I experienced flu-like symptoms. I experienced a high fever and body aches. On the 13th of April, I began to experience severe dizziness, vertigo, and blurred vision. I have been experiencing this everyday since the 13th of April. I was submitted to the hospital on April 16th due to severe dizziness and blurred vision. The diagnosis was BPPV (benign paroxysmal positional vertigo) and I received 0.9% NaCl (NS) and Meclizine (Antivert). I am still experiencing severe dizziness and vertigo.

Within one week of the vaccine I felt like I had pressure on my chest and chest pain and I was having a problem breathing. I had a cough and I had shortness of breath. I was really tired. I had that feeling of tiredness for one week. The shortness of breath and tiredness lasted two weeks. I used my inhaler when I needed it and after three weeks it feels better and I no longer have any symptoms.

INCREASING CHILLS; MILD PAIN AT INJECTION SITE; UNUSUALLY INTENSE TIREDNESS; LOW GRADE FEVER; HEADACHE; NAUSEA; UNABLE TO SLEEP; UNABLE TO EAT; VOMITING; This spontaneous report received from a patient concerned a 27 year old. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unable to sleep. On APR-2021, the subject experienced unable to eat. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced low grade fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced increasing chills. On 10-APR-2021, the subject experienced mild pain at injection site. On 10-APR-2021, the subject experienced unusually intense tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increasing chills, unusually intense tiredness, low grade fever, headache, nausea, vomiting, unable to sleep, and unable to eat, and had not recovered from mild pain at injection site. This report was non-serious.

Janssen COVID-19 Vaccine EUA Started 5 hours after injection and lasted total of 36 hours. Had fever of 102 degrees in the first 8 hours of the event, and a fever of 100 for remainder of the event. Had chills and uncontrollable shakes. Lips turned blue at the start of the event. Had a headache for almost the full time of the event. Had brain fog during the last 12 hours of the event. Had flu-like aches and pains for the duration of the event.

NUMBNESS IN CHEEKS; TINGLING PINS AND NEEDLES; GROGGY; FELT GROSS; SWEATY; NAUSEA; VERY TIRED; HEADACHE; CHILLS AND FEVERS; This spontaneous report received from a patient concerned a 27 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: 205A264, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 22:00, the subject experienced chills and fevers. On 10-APR-2021, the subject experienced sweaty. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced very tired. On 10-APR-2021, the subject experienced headache. On 10-APR-2021 10:00, the subject experienced groggy. On 10-APR-2021 10:00, the subject experienced felt gross. On 11-APR-2021 22:00, the subject experienced tingling pins and needles. On 12-APR-2021, the subject experienced numbness in cheeks. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty, groggy, felt gross, nausea, and headache, and chills and fevers on 10-APR-2021, had not recovered from tingling pins and needles, and very tired, and the outcome of numbness in cheeks was not reported. This report was non-serious.

HEAVY CHEST; ANXIOUS; STRESSED; CHILLS; HEADACHE; MUSCLE PAIN; TIRED; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A,and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced muscle pain. On 08-APR-2021, the subject experienced tired. On 12-APR-2021, the subject experienced stressed. On 13-APR-2021, the subject experienced heavy chest. On 13-APR-2021, the subject experienced anxious. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stressed on 13-APR-2021, chills, and muscle pain on 09-APR-2021, and headache on 11-APR-2021, and had not recovered from tired, heavy chest, and anxious. This report was non-serious.

Janssen COVID-19 Vaccine Symptom: vaginal ulcers appeared approximately two days after dosage. Chills one day after vaccine.

SEVERE HEADACHE; INABILITY TO SLEEP; This spontaneous report received from a patient concerned a 27 year old. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNWON) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced inability to sleep. On 02-APR-2021, the subject experienced severe headache. Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, and the outcome of inability to sleep was not reported. This report was non-serious.; Sender's Comments: V0: MAC comment is not required for nonserious case as per standard protocol.

On the 13th, I had a low grade fever and it never actually broke past 100. I spent most of the day in bed. Fatigued - and general was exhausted and tired .After that day, everything was pretty good. I had minor discomfort in my arm (that first day.) On the Friday, the 16th- my left arm - a third of my upper arm was bright red, swollen and hot to the touch and it was very painful. I reached out to a doctor for a chat with a doctor. The dr had me take 600 mg of Motrin and a Claritin and I took those based on the dosages allowed on the box, consistently for about 24 hours and after that it started getting a lot better. I'd say by Sunday the 18th, I was pretty much back to normal and everything resolved. Doctor chat but not a regular doctor visit.

Patient presented on 4/17 to urgent care afer significant vaginal bleeding (soaking through a pad every 1 hour to 1.5 hours) and petechia on multiple extremeties. She also had a nose bleed and bleeding in mouth earlier in the day that resolved spontaneously. After obtaining CBC, platelets were <1000. She was on oral contraceptives. She is a non smoker. She received work up for thrombosis, not indication of thrombosis. She did have some muscle aches and fever and fatigue the day after vaccine. Histroy notable for mild diffuse petechiae on all 4 extremeties. As inpatient received solumedrol 125 mg (then switched to prednisone 80 mg daily), IVIG 1 g/kg x 2 doses. she was discharged on 4/19 d/t rising platelets, Vaginal bleeding slowing and Petechia much fainter.

ANEMIA SECONDARY TO MENSTRUATION; TINGLING OF TONGUE; SORE THROAT; MUSCLE ACHES; FEVER; HEADACHE; This spontaneous report received from a physician concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included anemia secondary to menstruation. 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) dose was not reported, 1 total, 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 (same day after vaccination), the patient experienced tingling of tongue, sore throat, muscle ache, fever, headache and was hospitalized. On the same day, the patient experienced anemia secondary to menstruation as her hemoglobin was 6.2 (unit not specified) and was transfused. On 13-APR-2021, the patient had a mild headache at night and labile temperatures (her maximum temperature was 101.1 F in 24 hours prior to this report). On 14-APR-2021, the patient symptoms were improved and she had no thrombocytopenia to date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling of tongue, headache, muscle aches, sore throat, fever, and anemia secondary to menstruation. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210429348-covid-19 vaccine ad26.cov2.s- anemia secondary to menstruation. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE 20210429348-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Tingling of tongue, Sore throat. This event(s) are 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). 20210429348-covid-19 vaccine ad26.cov2.s - headache, muscle aches, fever. This event(s) are labeled per and is therefore considered potentially related.

while walking to the waiting area she was feeling sick and she lay down on the floor before passed out. Never pass out. BP and pulse were stable. Able to sit on a chair and observed for 10 minutes client voices feeling fine and sign the observation release form and went home in accompany of her mother.

SKIN SENSITIVITY; LIGHT SENSITIVE; BODY ACHE; CHILLS; NAUSEA; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 09:30 at left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced skin sensitivity. On MAR-2021, the subject experienced light sensitive. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the skin sensitivity, nausea, chills, headache, light sensitive and tiredness was not reported. This report was non-serious.

Initial severe headache after vaccine- this resolved in 24-48 hours. Had some LEFT flank pain for a few days. This resolved on its own. Then awoke on 4-17-2021 with LEFT calf pain that was constant and persistent. Called triage on Monday 4-19-2021 for guidance- came to Urgent Care. D dimer done and was positive. Was then sent to ER for imaging with + Doppler U/S LLE DVT- started on Eliquis.

Next day woke up at ~3am with; fever, hot and cold flashes, and weakness and fatigue. These symptoms persisted until end of the day 4/12.

Severe Headache. Pain from nose up throughout that half of the head from front, sides, and back of head. Excederin did not help. Nausea and eventually threw up everything in stomach. Went to ER, recieved fluids, toradol, Reglan by IV, and tylonal by mouth. After the ER visit, the pain went away.

The first night, around 06:00-07:00 pm, I had pretty intense muscle pain/myalgia. Joint pain; 101 degrees, chills and headache - these lessened but still continued into unspecified day- Fatigue and Muscle pain lasted the whole 12 days. (. Unspecified date in the night into the next day - I had stomach pain ,nausea, diarrhea, dizziness and I decided to go to unspecified hospital - symptoms were getting worse. They gave me an IV treatment. They provided my the IV because I was dehydrated and then told me to wait it out.

TINGLING; LIGHTHEADEDNESS; RANDOM SHARP PAINS AROUND CHEST ON BOTH SIDES PERSIST; NUMBNESS TO FACE; HEAVY FELLING; HEADACHE PERSISTS 2 WEEKS POST VACCINE PULLING, ON LEFT AND RIGHT SIDES; PAIN BEHIND LEFT THIGH; CHILLS ON HALF OF BODY; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient had no known medical history. the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, 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 pain behind left thigh. On APR-2021, the subject experienced chills on half of body. On 11-APR-2021, the subject experienced tingling. On 11-APR-2021, the subject experienced lightheadedness. On 11-APR-2021, the subject experienced random sharp pains around chest on both sides persist. On 11-APR-2021, the subject experienced numbness to face. On 11-APR-2021, the subject experienced heavy felling. On 11-APR-2021, the subject experienced headache persists 2 weeks post vaccine pulling, on left and right sides. Laboratory data included: Diagnostic ultrasound (NR: not provided) NEGATIVE. On 15-APR-2021, Laboratory data included: Blood pressure (NR: not provided) NOT REPORTED, and CT scan (NR: not provided) NEGATIVE. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache persists 2 weeks post vaccine pulling, on left and right sides, tingling, lightheadedness, random sharp pains around chest on both sides persist, numbness to face, and heavy felling, and the outcome of pain behind left thigh and chills on half of body was not reported. This report was non-serious.

Continued and persistent pain in hips, back of thighs, and down my calves. There is a cramping sensation in my calves. Head pressure and sinuses are filled. I do not have a history of allergies or sinus issues. My main concern is the leg cramping/inflammation. I am 22-days post vaccine and still have this symptom.

Fatigue almost immediately, lasting 36 hours Intermittent headaches, treated with ibuprofen lasting 36 hours Whole body aches starting 12 hours after injection, lasting 24 hours Injection site bruising and soreness

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Visual Changes/Disturbances-Medium

On Friday 4/23 I began experiencing a severe headache, chills, and body aches. I had trouble falling asleep because of these symptoms. I had bloody stool. On Saturday 4/24 I was still experiencing body and head pains and continued having bloody stool and by around midnight I had abdominal pains and went to the ER. My appetite was poor the prior week, and since this incident I have hardly been able to eat. I am constantly nauseous and dizzy. After days of not being able to eat, I ate some soup and vomited it back up. I still have abdominal pain, nausea, and am fatigued with a less intense headache.

Immediately after the injection I felt light headed. Soon I could not see (very blurry vision) and I could not hear (like drowning in water). I then started to sweat profusely from every inch of my skin. I couldn?t catch my breath. I was handed water and told to sip on it, which proved difficult when my throat started to feel like it was swelling up. After about a 15 minute ordeal, it was like nothing ever happened. The only symptom that remained, was sweat soaked clothes

April 10th - 6 hours post vaccine - chills, fever, and migraine 7 days post vaccine - fatigue and constant migraine, causing missed work 16 days post vaccine - After taking Rizatriptan, migraine is still debilitating, patient seeks help from the ER April 26th - patient receives Compazine, Toradol, and Benedryl in the ER. Patient starts convulsing after a dosage of Compazine. Receives IV fluid, and is sent home when migraine recedes. Pallete blood test taken in ER and results come back normal. April 29th - patient's migraine returns worse than before, patient works with a neurologist, takes 20 mg of Rizatriptan and then returns to Urgent care, receiving a 25mg shot of Phenergan, which relieves migraine temporarily. May 3rd - patient continues to have headaches and fatigue, neurologist has prescribed a protocol of 10mg of Propranolol 3x daily as preventative. Rizatriptans are prescribed to quell migraines.

Patient experienced hives/rash within first half-hour of receiving the vaccine. She took Benadryl and rash subsided. Pt woke up the next day (4/4/21) feeling ill with heart racing, hypertension, and headache. She was scheduled to have an infusion appointment 4/5/21, which was canceled when she was found to have elevated liver enzymes and very high blood pressure. Patient went to ED on 4/6/21 for high blood pressure, lightheadedness, and headache.

NARRATIVEPATIENT WALKED IN TO FIRST AID AND COMPLAINED OF NUMBNESS TO THE LEFT SIDE OF HER FACE AND COMPLAINED OF TIGHTNESS TO HER THROAT. PATIENT PUT HERDISCOMFORT AS A 3/10. SHE SAID THAT SHE WAS BREATHING FINE BUT HER THROAT FELT SCRATCHY AND BOTHERSOME. PATIENT WAS GIVEN ROOM TEMPERATURE WATER ANDSHE DID NOT HAVE ANY DIFFICULTY SWALLOWING IT. DR. ARRIVED AND VISUALLY CHECKED THE PATIENT'S THROAT WITH A FLASHLIGHT. PATIENT WAS OFFEREDTRANSPORT BUT DENIED IT. SHE STATED THAT THE NUMBNESS RESOLVED BUT SHE STILL FELT THAT HER THROAT WAS TIGHT. PATIENT CALLED HER MOTHER WHO IS AN RN ANDSHE CAME AND PICKED UP THE PATIENT. AMA FORM WAS FILLED OUT AND PATIENT SIGNED THE AMA.

Around seven hours after receiving the vaccination I was very fatigued. Nine hours post vaccine I had chills and a fever. Upon waking up the next morning I was nauseas, had a mild headache, a fever and chills, and very sore and stiff joints. Tylenol has been helping with the fever and the joint pain.

APPENDICITIS; CHEST PAIN; WEAKNESS; BODY ACHES; SKIN BLOTCHES; BRUISES; HEADACHE; This spontaneous report received from a consumer concerned a 27 year old white, hispanic or latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to aspirin (unknown reaction), no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no relevant medical history. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. It was reported that, the patient experienced side effects that developed after receiving covid-19 vaccine ad26.cov2.s. On 03-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced skin blotches and bruises. On 07-APR-2021, the patient experienced body aches. On 14-APR-2021, the patient experienced weakness. On 19-APR-2021, the patient experienced chest pain. On 27-APR-2021, the patient experienced appendicitis and had a hospitalization that resulted in surgery for appendectomy. The patient had visited emergency room/department or urgent care and doctor/healthcare professional office. The patient was hospitalized for 1 day and was discharged on 28-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skin blotches, bruises, and appendicitis, and had not recovered from headache, chest pain, body aches, and weakness. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210456304- COVID-19 VACCINE AD26.COV2.S-Appendicitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, alcohol user, and non smoker, and other pre-existing medical conditions included no illicit drug usage or drug abuse.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced nausea. On 11-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 nausea, and headache. This report was non-serious.

I had an adverse reaction 10 hours after getting the vaccine a month ago. I got a bad fever and started to uncontrollably violently shake for an hour and a half. I had sevier leg pain and soreness. I also had a terrible headache. The symptoms eventually eased after taking Advil and Tylenol after a few hours. The next day I still had all of those reactions again, but the shaking was not as bad and didn't last more than a half an hour. Symptoms continued to fluctuate, but generally got better over 4 days.

Patient presented with sweating and blurred vision 5 to 8 minutes after vaccination. No swelling of lips or tongue observed or shortness of breath reported. Patient reported having anxiety from vaccinations. Patient was sat down on the ground with her feet elevated, hydrated with water, instructed to take deep breaths, and blood pressure was taken every two minutes. Vitals will be reported as Time, BP, Pulse: 11:28, 78/62, 60; 11:30, 118/96, 121; 11:32. 107/69, 57; 11:35, 116/88, 65; 11:52, 107/73, 57. A pulse oximeter reading was taken twice reporting 96% and 97%. Patients reported feeling better after 2 minutes (11:30) and was given a glucose tablet at around 11:35, when she reported not having eaten yet. Patient reported feeling better and drove home after contacting family by phone. Follow-up phone call with patient at 12:10 showed that patient arrived home safely, felt normal. At another follow-up phone call at 5:45 patient reported that she was doing okay and no problems.

May 8 Immediately after vaccine: felt flush, very warm, sore arm. Hot feeling lasted for a few hours. PM: extreme chills, pounding headache Lasted 8pm-3am Headache is still dull as of May 9

Woke up at 2:36am, crying in physical pain with throbbing migraine and back pain down the spine [longissimus]. Fluctuated between cold finger tips to sweating.

Received my covid shot Wednesday, March 31st. Experienced a headache afterwards which was tolerable but lasted all day. Had a headache the next day as well, all day. Since receiving the vaccine, I have been experiencing headaches from what appear to be daily, I had experienced headaches before but not this often. It tends to be throbing pain on the right side of my head only.

Fever, chills, body aches, confusion, dizziness, neck pain, back pain. Symptoms were worst on 5/1 (1 day after shot), but none have gone away as of today (5/11).

Initially presented with 5 out of 10 chest pain (substernal, no radiation, no exacerbating or relieving factors), nausea, vomiting, diarrhea, dyspnea on exertion, and fatigue. Further history obtained included decreased exercise tolerance since four weeks prior to presentation (noticeable during runs). She was found to have an abnormal EKG at an urgent care and was sent to an outside hospital emergency department. She ultimately was found to have heart failure with preserved ejection fraction (56%), Stage C, Class III, and myocarditis. The highest suspicion for the etiology of her myocarditis is viral vs. autoimmune (given response to steroids) vs. genetically-mediated myocarditis. She was discharged on aspirin, a prednisone taper, colchicine, metoprolol, and Entresto with cardiology follow-up. Patient discharged with 4 week monitor to monitor for arrhythmia as per EP service. Infiltrative cardiomyopathy evaluation pending as well- plan for SPEP/UPEP, serum/urine protein electrophoresis, immunofixation, and alpha-galactosidase (not sent due to specific tube not available).

ABDOMINAL CRAMPING; BACK PAIN; DIZZY; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 27 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: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced abdominal cramping. On 07-MAY-2021, the subject experienced back pain. On 07-MAY-2021, the subject experienced dizzy. On 07-MAY-2021, the subject experienced headache. On 07-MAY-2021, the subject experienced fatigue. On 07-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal cramping, headache, back pain, fatigue, dizzy, and nausea. This report was non-serious.

So the first night, I had a fever, achy, near the injection site was warm and it hurt; stiffness there at the site and headache- a lot of flu-like symptoms - it was about 36 hours that they lasted. Thursday evening, 8th, I got hives - all over my body and that started on my left arm and then it didn't go in my mouth but otherwise all over. I went to my doctor - the ER at my doctor's site - on Saturday, 10th. He prescribed me some medicine - don't remember what plus I took Benadryl . I had to take a week and a half off of work because the medication was so strong. My hives lasted another week. It stopped growing after that week and then it started healing.

Fast heart rate and SOB w/HA and fatigue x 2 days, started 1700 yesterday after receiving J&J vaccine in AM yesterday, reports SOB upon exertion and "long-winded conversation"; denies any dizziness; last dose 325mg ASA with 500mg Tylenol at 0900.

EXHAUSTED; ACHY; LOW GRADE FEVER; This spontaneous report received from a parent concerned a 27 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 30-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-APR-2021, the subject experienced achy. On 30-APR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) Around 99.9. On 01-MAY-2021, the subject experienced exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, and low grade fever on 02-MAY-2021, and had not recovered from exhausted. This report was non-serious.

First 48 hours I felt normal flu like symptoms. Except after that the symptoms did not go away. Today is day 7 and the symptoms have changed. I have woken up the last 4 mornings with extremely dry mouth and throat. I feel nasally and extremely tired. The exhaustion lasts throughout the day and night. The dryness is only very bad in the mornings and then slowly goes away throughout the day, but I am still sniffly/nasally throughout the day.

On March 22 2021, I had leg cramps that felt like Charlie horses, I had a fever of 102 and I missed work. On March 24 I went to my doctor because my legs were still bothering me. That same night I ended up experiencing extreme dizzy spells, I fainted. On March 25 called my doctor I told them my symptoms were getting worse, the office made me a follow up appointment for April 2 for dizzy spells and fatigue. My symptoms continued to get worse, I had a tele visit April 5. Then, I started developing a dry cough. I called again that same day 4/5 for shortness of breath and went in to my doctors office 1:10pm. They did a chest xray. April 6th I had another tele appointment for anxiety Because I started developing anxiety from all my symptoms. April 7th I called again I had blood in my urine and back pain, It was very alarming because my last period was & years ago. April 7th I went to an Urgent Care . April 8th it got really bad. I went emergency room, I felt like I had a lump in my throat and experiencing some chest tightness, my pulse was 101 beats per minute, heart 118, BP was 143/106 I presented with unspecified Right Bundle Branch block and I ended up tachycardia, they did a CT scan of my chest. the doctor gave me Valium & Hydroxyzine. At the hospital I started dry heaving and vomiting. April 9th saw a new doctor still very nauseated and I was experienced nausea and heart palpitations, and rapid heart.

5/9/21: woke up disoriented and with a headache, fatigued and slept all day - took three ibuprofen 5/10/21: less severe headache on and off morning to afternoon, body aches all over, still fatigued and slept all day, felt queasy towards evening 5/11/21: no headache but body aches continued, couldn?t hold down water or food, drank half a glass of water around 5ish and threw it up a minute or so later; I stayed home and slept 5/12/21: body aches less intense but still felt weak all over, continued to struggle holding down liquids, fatigued; I slept it out 5/13/21: finally able to eat, body aches and fatigue continued, some queasiness on and off 5/14/21: felt weak and sore but not fatigued, some queasiness 5/15/21: felt better, but a little weak - would describe it as an ?in recovery? feeling 5/16/21: a little queasy in the morning, but otherwise on the mend 5/17/21: felt better in the morning and afternoon but drowsy in evening - not sure if it was vaccine related though 5/18/21: felt slightly queasy in the evening but puked around 11:45 pm - not a large amount

Headache, fever, tooth pain, restlessness, chills, nausea, joint pain, sore/heavy feeling arm, swelling at the injection site, loss of appetite, reoccurring dreams

CONFIRMED IMMUNOLOGICAL VACCINE FAILURE (NEGATIVE ANTIBODY TEST, VACCINE DID NOT WORK); BODY ACHES; FEVER; This spontaneous report received from a patient concerned a 28 year old. The patient's weight was 51 kilograms, and height was 150 centimeters. The patient was non-smoker, and non alcohol user. Patient had no known allergies, no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient experienced body aches and fever. Patient recovered from body aches on 10-MAR-2021. On 10-MAY-2021, the patient performed antibody test which was negative (confirmed immunological vaccine failure) and the patient reported that the vaccine did not work for her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, was recovering from fever, and the outcome of confirmed immunological vaccine failure (Negative antibody test, vaccine did not work) was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179393. The suspected product quality complaint has been confirmed to be not voided, based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210525073--Confirmed immunological vaccine failure (negative antibody test, vaccine did not work). This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

I had the usual side effects, sore arm, fatigue? then 2 days after the vaccine I had a panic attack, then continued to have them along the week. I believe that on the 17th I was taken to the ER with high heart rate, chest pain, tremors? but doctors ran test and believed to be another panic attack, they referred me to a doctor. The past month ive been struggling with extreme anxiety and panic attacks, ive been on escitalopram, weekly therapy. I had no prior history with mental illness.

Day after vaccine I had extreme nausea and head ache. Following day my lips went numb. Woke up the next day to Bell?s palsy (ER diagnosed) steroids seem to be helping. Currently still taking them.

I first noticed a sore throat on 4/16 that I attributed to the start of allergy symptoms. On Saturday, I began to get a headache and felt very lethargic. On Sunday, I was extremely lethargic and unable to leave my bed. I had no appetite, a headache, a sore throat, and a dry cough. My fever reached 101 degrees F. Monday morning I went to urgent care; I no longer had a fever but was still tired with a sore throat. As the week went on, my symptoms dissipated

CHEST PAIN; GENERALISED ACHING; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight was 132 pounds, and height was 177 centimeters. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse. The patient was not on any medication at the time of event. The patient had no illness at the time of vaccination, no past history of similar event, no adverse event after any previous vaccination, no history of allergy to vaccine, drug, or pre-existing acute illness 30 days prior to vaccination. The patient had no history of hospitalization in last 30 days and no family history of any disease (relevant to vaccination) or allergy. The patient was not breastfeeding at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 16:00 for prophylactic vaccination. Concomitant medications included calcium for maintain normal calcium levels. On 10-APR-2021, the subject experienced chest pain. On 10-APR-2021, the subject experienced generalised aching. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, generalised aching, fever, and headache on 12-APR-2021. 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

CHEST PAIN; DIZZINESS; SHORTNESS OF BREATH; SHE WAS UNABLE TO MOVE FOR WHOLE DAY; CRAWL TO THE BATHROOM; CHILLS; HEADACHE; FATIGUE; BURNING ARM; BODY ACHE; CHEST TIGHTNESS; LEFT ARM PAIN; LEFT SIDE OF BODY OUT OF IT; This spontaneous report received from a patient concerned a 27 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: 1806025, 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 left side of body out of it. On 15-MAY-2021, the subject experienced chest tightness. On 15-MAY-2021, the subject experienced left arm pain. On 15-MAY-2021, the subject experienced burning arm. On 15-MAY-2021, the subject experienced body ache. On 16-MAY-2021, the subject experienced she was unable to move for whole day. On 16-MAY-2021, the subject experienced crawl to the bathroom. On 16-MAY-2021, the subject experienced chills. On 16-MAY-2021, the subject experienced headache. On 16-MAY-2021, the subject experienced fatigue. On 18-MAY-2021, the subject experienced chest pain. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from she was unable to move for whole day, was recovering from crawl to the bathroom, had not recovered from fatigue, burning arm, headache, dizziness, shortness of breath, chills, left arm pain, and chest pain, and the outcome of left side of body out of it, chest tightness and body ache 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.

Patient fainted after sitting down in observation. Disoriented and scared once alert. Complained of nausea and headache. EMS called. Patient alert and agreed to go to hospital. Vitals @ 12:11p: 110/80 BP, 84 Pulse, 98% O2.

Started with shivers. Then appeared the fever 102F at 7pm. Treated with Tylenol 400mg but then I threw it up. I tried again and tolerated it. At 11pm the fever started to go down. At 00am, I took Tylenol again and at 8am the fever was 99F. In the course, I had joint pain, tiredness and a little headache.

I started with headaches. Then I went to the ER. I had leg and abdominal pain also. Back pain that won't go away either. The doctors are not finding anything and It is stressful.

I started to feel a little intoxicated 20 minutes after the vaccine. After about 30 minutes I had rashes on my face. I was unable to walk in a straight line. I was also very emotional. I took a nap and woke up with a headache, chills and sweating, I had body aches and pain in my back. My skin was hot to the touch. I was nauseous and weak with no fever. The next day I was having shortness of breath and I thought I had blood clots.

Immediately after receiving the vaccine, my left arm and left side of my neck and back became very sore and I felt very light headed and dizzy. 7 hours later, the back pain worsened and I started sweating a lot. Soon after my skin all over my body began to tingle as if I had bugs crawling all over my body and it was very uncomfortable. During the night I couldn't sleep because I was sweating so much, the back pain was getting worse and worse, and the tingly skin feeling turned into very intense skin sensitivity and hurt any time my body touched something or rubbed against my clothing. At some points I would be extremely hot and sweating a lot and then some points I was freezing cold and shaking uncontrollably. These signs all lasted 24 hours and slowly started going away after 48 hours. After 48 hours, I felt much better and back to "normal" but couldn't help but notice some strange reactions that I still have today, 3 weeks later... I have had acne which is uncommon for me. I have had period cramps and mood swings but am not on my period. I also have had crazy bloating in my stomach and all over my body... swollen legs, feet, hands, etc. I also have been experiencing brain fog where I loose my train of thought in conversation, I can't remember where I put things, I can't remember if I took my eye contacts out or not, or fed the dog... very strange and uncharacteristic of me to be so aloof and forgetful but to the point where I have zero recollection of doing such activities.

Pt had headache, lightheadedness, shaky and was hot about 25 minutes after receiving vaccine. Her blood pressure and pulse were normal. About an hour after the vaccine, she was still lightheaded. She because nauseous after her initial reaction and threw up.

Patient felt fine day of shot. Next day started to experience muscle tightening, flulike symptoms, scratchy throat, leg numbness, dizziness, cold sweats, shortness of breath and headaches. She was seeking care today, 7/15. I advised patient to go to hospital.

MATERNAL EXPOSURE DURING PREGNANCY; STUFFY EARS; VOMITING; FEELING UNWELL; CHILLS; FEVER; HEADACHE; NAUSEA; This solicited pregnancy report received from a patient concerned a 27 year old female. The patient was enrolled in a non-company sponsored study C-VIPER: COVID 19 Vaccines International Pregnancy Exposure Registry number: C00243). The patient's weight was 77.1 kilograms, and height was not reported. The patient's pre-existing medical conditions included the patient had multigravida. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ascorbic acid/calcium pantothenate/cyanocobalamin/ergocalciferol/nicotinamide/pyridoxine hydrochloride/retinol palmitate/riboflavin/thiamine mononitrate. On 09-APR-2021, the patient experienced maternal exposure during pregnancy. On 09-APR-2021, the patient experienced stuffy ears. On 09-APR-2021, the patient experienced vomiting. On 09-APR-2021, the patient experienced feeling unwell. On 09-APR-2021, the patient experienced chills. On 09-APR-2021, the patient experienced fever. On 09-APR-2021, the patient experienced headache. On 09-APR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stuffy ears, vomiting, feeling unwell, fever, headache, nausea, chills and maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and stuffy ears, vomiting, feeling unwell, chills, fever, headache, and nausea was related. This report was non-serious.

TWO LITTLE BLISTERS ON LOWER LIP; TINGLING SENSATION ON LOWER LIP; MILD DIARRHEA; PAIN ON THE INJECTION SITE LEFT ARM; TIREDNESS; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight was 190 pounds, and height was 195.58 centimeters. The patient's pre-existing medical conditions included the patient at the time of reporting was not pregnant .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the subject experienced pain on the injection site left arm. On 26-JUN-2021, the subject experienced tiredness. On 27-JUN-2021, the subject experienced mild diarrhea. On 10-JUL-2021, the subject experienced tingling sensation on lower lip. On 13-JUL-2021, the subject experienced two little blisters on lower lip. The patient visited to the Doctor/healthcare professional office for the blisters in lower lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild diarrhea on 27-JUN-2021, tingling sensation on lower lip on 11-JUL-2021, pain on the injection site left arm on 29-JUN-2021, and tiredness on 26-JUN-2021, and had not recovered from two little blisters on lower lip. This report was non-serious.

I almost fainted and was sweaty and felt an intense buzzing / vibration in my hands and I had a pain in the back of my throat (this throat pain was different than I?ve ever felt before from a sore throat) that lasted a few minutes

High fever, extreme body aches, extreme weakness, excessive thirst for next 24 hours extreme confusion and blurry vision for next 4 days. Extreme confusion to the point where I did not recall the names of my parents in the ~15 hours after the shot. delayed menstrual cycle for next two months

Extreme muscle aches and joint pain to the point of barely being able to move Chills Sweats Burning/Irritated Skin Nausea Thirst

Body aches and chills led to low-grade fever (100 degrees at peak) and headache over the course of midnight to 9:30 a.m. the following day. Treated by hydrating.

I had my vaccine at 12:15 pm. Five hours after vaccine, at 5 pm, I started to get chills. I took Advil and they went away. Once Advil wore off 5 hours later at 10 pm , I had a fever, very thirsty, shivers, and small headache. I took two more Advil at 11 pm and my shivers disappeared by midnight. By morning time my fever broke and I?m left with a small headache.

Sore at injection site. 5 hours after injection, i had an Increased heart rate, 101 fever, convulsing from the chills, body aches, poor sleep. splitting headache, fatigue, and fever continued to next day. Most symptoms were gone by 48 hours after injection, except soreness around arm. Took ibuprofen to help with symptoms.

I took the vaccine around 8:15 am at Hospital. They had a special event for Employees. After I was home I felt extremely tired and that improved after i laid down for a bit. However, around 7 PM I became very cold and had a temperature of 100.3 with chills/shakes. It has lasted into the next day with chills being on and off. I experienced muscle cramps as well has some chest discomfort.

Approximately 8 hours later, sudden onset of extreme chills accompanied by aches and fatigue; subsided after taking Tylenol. Next day, approximately 24 hours of fatigue, minor aches, headache, and fever.

Loss of consciousness, irregular heart palpitations, nausea. Loss of consciousness lasted less than one minute, recovery took about twenty minutes to become stable to leave the facility; lingering ?wooziness? throughout the day. This reaction was more likely due to vasovagal syncope than the vaccine. Patient has a history of vasovagal syncope. Arm soreness, fatigue, and headache presented the following day.

Janssen COVID-19 Vaccine EUA. Injection site on arm hurt immediately after injection and upper arm is still sore today (3 days later). Approx 7 hours after receiving vaccine I experienced a sudden onset of overall body aches and joint pain specifically in my knees. It was kind of severe- even my skin was hurting when I got goosebumps. A fever came on after that and I was shivering, cold, sweaty. Approx 11 hours after injection I began to experience a severe headache and sleepiness. Symptoms continued overnight and disturbed my sleep, but were relieved somewhat by taking ibuprofen. By the next morning (after sleeping 14 hours) I was only feeling tired, arm soreness, and headache (no more fever, chills, body aches). All symptoms except arm soreness cleared up rather suddenly, approx 24 hours after they came on (which was approx 31 hours after injection).

3/6 3:30pm received vaccine. 6pm felt foggy, extreme exhaustion, irritable, nauseated, arm pain. Headache 3/7 12:30am restless in bed with muscle pain in thighs with burning sensation down into calves and up into lower back. 4:30am fever of 102 degrees Fever all day till about 8pm when temperature dropped below 100 degrees. Chills throughout day Extreme fatigue throughout day Headache 3/8 No fever in AM 8pm felt queasy & nauseated continued overnight. Extreme fatigue continued Slight cough Headache 3/9 Temperature over 100 Chills Queasiness and nausea continued throughout remainder of day. 6:30pm lesser sense of taste Headache

Fever, shakes, severe body aches and sharp pains throughout my body. Nausea and vomiting and constant use of the bathroom. Dizziness, and severe migraine, fatigue and trouble breathing that lasted 2+ hours.

Pain at injection site, headache, fever, fatigue, extreme pain all over body , skin is painful to the touch, nauseous, dizzy and difficulty walking, extreme perspiration while sleeping

Immediately experienced pain and soreness in arm upon administration of vaccine. Started experiencing additional side effects 9-10 hours after vaccine administration: at night I developed a severe migraine, nausea and chills. When I woke up the next morning, I still had a migraine, my nausea was less apparent, but I did begin to experience fatigue/exhaustion and muscle aches. I've experienced chills and hot flashes in waves throughout March 11th. I took my temperature for the first time at 4PM on March 11th and I have a low grade fever of 99.6. degrees Fahrenheit.

Fatigue, 12+ hours after vaccination Tachycardia, heart rate 130-140 resting,, onset 12+ hours after vaccination Nausea, onset 1 hour after vaccination Headache, onset 1 hour after vaccination

About 6 hours after receiving vaccine, I got very tired. Soon after, I had a bad headache and uncomfortable temperature issues (feeling hot and cold). My heart rate seems a little elevated and I am experiencing sensitivity and body aches. I have taken naproxen and acetaminophen. It is now 4 hours since symptom onset and I have not gotten much relief, if any. I would describe my symptoms as moderate.

** 35 weeks pregnant, due date 4/14/2021, 1st pregnancy * I had a fever about 8 hours after the vaccine. The highest I got to was 105, I also had really bad chills. The next day I had a low grade fever and just had a headache and fatigue. After 24 hours my symptoms went away.

Patient is a 29 y.o. female who received the Janssen COVID Vaccine Lot#: 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate of observation: Dizzines Diaphoretic Patient was treated/managed as follows: Pt was given Gatorade VS are as follows: 10:20: BP 108/76 HR: 76 RR: 18 O2: 98% 1034: BP 116/64 HR: 80 RR: 18 O2: 99% Pt reports feeling better Patient given educational material regarding vaccine and advised to continue to self-monitor. Pt escorted to car

Severe headache, body aches, chills, difficulty breathing, severe muscle aches, heart rate 140, extremely high blood pressure 158/91, dizzy, weakness, fever 103.7, swelling of throat, etc

Immediately after the vaccine I had extreme sleepiness and some dizziness. After taking a nap I felt better for a few hours. I did notice my Raynaud?s symptoms became way worse. At about 5:30pm I started to feel extremely cold. By 6pm I was having horrible pains and spasms in my lower back and hips. My muscles and joints became very stiff. This moved to my neck/shoulders, and down my thighs. I lost feeling in my feet and started struggling to be able to take in a full breath. I felt like my whole body was locked up. I started feeling nauseous, but part of that may have been from the nerves. The next morning I felt a bit more mobile but still nauseous and stiff. I have slowly gotten better throughout the day, but am still stiff and exhausted

bodyache. PT receive J/J vaccine yesterday approx 0930 reports onset of bodyaches, chills, HA and nausea since last night. denies feeling ill prior to vaccination. 28 yo F, no known chronic medical conditions, got the COVAX (J&J) at 0930 yesterday; at about 1900 she started to experience severe fatigue, chills, frontal HA, body aches, and nausea. No fever, neck pain, vomiting, diarrhea, urinary urgency/frequency, hematuria. No CP, cough, SOB, abd pain. Felt well prior to receiving the vaccine.

Janssen COVID-19 Vaccine EUA - had numbness and tingling in pinky and ring finger on left hand. Woke up at 1:40AM with skin hurting, fever was 100.9. Really bad headache, lightheaded

9 hours after the shot I became nausea and had the chills. About 11 hours after the shot I had a fever of 101 and then vomited. 18 hours after the shot my fever has gone down but I still have a headache and bodyaches. I?ve been taking Tylenol to treat the symptoms.

Patient stated prior to administration that she had a history of passing out when she had needles administered, specifically with shots, blood draws, and IVs. Patient stated she felt fine and appeared normal for the first 10 minutes. After approximately 10 minutes, the patient was sweaty, hot, and lethargic. Patient was able to respond to verbal commands but was dizzy and speech was slow. Patient stated she felt like she was going to pass out. No person witnessed patient actually pass out. Two EMS personnel and two nurses were present to assist. Patient was able to take sips of water and an IV with fluids was started by EMS. Patient stated she felt better after approximately 20 minutes and was transferred to Emergency Department by EMS.

AMI onsite Paramedics were approached by a 28 y/o female stating she was about to ?pass? out as she was kneeling approx. 10 mins after receiving the vaccination which was administered at 16:54. Pt was caught prior to losing consciousness for approx. 30 seconds post vaccination and presenting with sz like activity consisting of decorticate posturing and pupils dilated @6mm. Pt was carried onto available cot via two man carry where pt regained consciousness, coax4 of 4 GCS 15. Pt stated she felt lethargic and was diaphoretic and feeling nauseated, no emesis. Pt was placed left lateral and was placed on oxygen via N/C @2lpm while EMS responded. Pt denies allergies but states being hypersensitive to Augmentin, no meds taken, no prior medical hx but states she?s had similar episodes since the age of 17 being reported as sz like but never diagnosed and denies having a neurologist. Pt also stated that this was the worst episode. While awaiting EMS, pts nausea and diaphoresis had subsided but stated feeling ?heavy?. HEENT-unremarkable, Pupils now equal and reactive, neck-supple ,equal chest rise with clear equal lung sounds ,abd non tender, FROM to extremities x4 with equal weak strength. Upon EMS arrival, report was provided, EOR.

Fever and chills occurred 9 hours after injection and lasted for 4 hours. Mild fever the next morning with body aches and fatigue and moderate pain at injection site. Following day slight headache and remaining pain at injection site. Today very mild pain at injection site (3 days later)

By 930 that evening, i was experiencing arm pain at injection site and nausea then went to sleep. i woke up at 830 the following day 3/14, with the same symptoms as the day prior along with a migraine, light sensitivity, a fever of 100.6. i took 1000mg of tylenol and went back to sleep until 1pm. i awoke with a migraine and nausea still but fever had subsided to 99. went to sleep at 10:30, awoke today, 3/15 with headache, nausea but temperature at 98 flat. arm pain has persisted entire time and still continues.

I had some slight arm pain the day of the shot, but the morning after my arm that received the injection was in so much pain that I could barely even move it. Very little mobility, slight bruising and a red circle around the injection site about 1.5 inches. However, I felt fine most of the entire day besides that. Around hour 28 of getting vaccinated I started to get very bad chills that lasted for about 3 hours. Took my temperature, which stayed around 100 degrees the entire night, 100.5 at its highest point that I checked. The next day it was standing in around 99.9. Felt slight muscle soreness the last couple days, but no fever since then. My arm gained a little mobility on Sunday, 2 days since vaccination so I thought it was getting better. but Monday and today (Tuesday) my knot/lump in my arm at the vaccination site is back to hurting extremely bad and the swelling and size of the lump and red circle is actually growing and pain is starting to increase again. The red circle is around 4.5 inches now and the pain is sharper where the injection happened. I am starting to get worried something is wrong, but will give it another day or so before checking in with a doctor.

Fever up to 102° started around midnight - took Tylenol which lowered the fever and stopped the chills for a while Chills started at midnight Headache started next morning Muscle pain/tightness started around 3:00 AM first night Weakness started around midnight

Around 12:00 a.m. on Monday, March 15, 2021 (which was 12 hours after receiving the vaccination) I started to experience cold chills so severe I thought I was having a seizure. My husband stacked 10+ blankets on top of me trying to get me to warm up. I was running a fever of 103, and my heart rate was at 104 all night long. My fever didn't break until shortly before 8:00 a.m. on Monday, March 15, 2021 but my heart rate stayed between 95 - 102 most of the day. The body aches weren't too terrible, but I did have those. I have bruising, puffiness, and swelling at the injection site.

About 7-8 minutes later I started feeling pressure in the right side of my head. It went away a bit. I was walking after the 15 minutes and started feeling weird in my face, I just sat in my car and waited because I had to drive. I started feeling numbness under my eye and down the rest of my face. The thing that worried me the most I had so much pressure under my eye like it was inside my brain. The numbness and pain caused me to freak out. I went to back to the convention center to let them know, they brought the Paramedic to me they started checking me and doing a work up. They told me I wasn't a life threatening emergency and my vitals were ok. They offered to take me to the ER and I declined and I decided to leave because I have been there for 1hr 45mins. I felt like my symptoms were at 70%. When I got home I freaked out again because the numbness didn't go away and my face looked like it was a little lower and had a panic attack and went to the ER. They checked on me and told me I didn't have a stroke. They told me It was a side effect to the vaccine. They told me to follow up with the Neurologist if I have any more symptoms, I have an appointment with them in a couple weeks. I'm a little concerned because there is a minor pain that I didn't have before on my right side and it worries me.

Immediately after vaccination, pt was sitting in chair in clinic lobby, she states she felt like she was having a panic attack and that is the last thing she remembers. She fell out of chair and hit her head on the clinic floor. Staff responded to pt lying in the lobby floor with a quarter sized red knot on left side of forehead. Pt complained of a headache, was found to be diaphoretic and had nausea and small amount of emesis but had moderate nausea for 30 minutes after event. Vitals were obtained and WNL. EMS was called and pt agreed to be transported to ER for evaluation.

Early the next morning after the vaccine I woke up with chills, body aches and felt feverish so I took 2 tylenols and went back to sleep. Around 7am I woke up still with the same symptoms so I took another 2 tylenols. I remained up but started feeling bad so I laid down and took a nap. Around 4pm I took 2 more tylenols because I just didnt feel well. I didnt feel well the remaineder of the day and laid down for bed around 7pm and woke up the next morning and all symptoms had subsided. I was 16 weeks gestation at the time of the vaccine. EDD-8/25/2021.

Received vaccine at 3:40pm. Tiredness started around 7pm. Fever started at 11pm and lasted until morning. Terrible body aches, unable to sleep. Painful. Fever broke around 5am but then returned around 1pm. Finally broke fever around 4pm. Body aches lasted the rest of the day. Overall weakness and tiredness for a week.

Difficulty in breathing, shortness of breath, shivering, fast heartbeat, coughing, headache, blocked nose.

I had immediate soreness at the injection site. Later that evening around 9:30 I felt very weak and shakey. I had a bad headache, fever, chills, muscle aches, and nausea. I couldn't hold down water of food. At 10am the following day (3/21) I was able to take aTylenol and the fever came down. So far, I have taken Tylenol throughout the day and kept the fever down, however I still get bad night sweats and muscle aches. Today (3/23) I feel a little off, but much better.

At about 10:00 p.m. on March 10 patient lost her balance and fell, bumping her head in the process. Residential care staff called emergency services. EMTs detected somewhat elevated heart rate (140+ BPM) and temperature (approximately 102 degrees) and recommended she go to the ER. She was attended to and tests were administered to detect any underlying infections. Tests were all negative. Patient was kept overnight for observation. By Thursday, March 11, her heart rate and temperature were normal and she was discharged just after mid-day. She has had no lingering effects post-hospitalization.

intense tiredness and full body soreness starting about six hours after shot - symptoms got progressively worse over the course of the afternoon, and by 10-12 hours after the shot I had a fever and chills. after 24 hours, all symptoms except for some soreness in back and shoulders were gone!

Around 6 pm after receiving the vaccine, I had a massive headache (felt like my head was being compressed severely), chills and body aches all over, pain and swelling at the injection site, nausea, a fever of 100 F, and my bones feeling brittle/weak. I had blankets piled on me, an ice pack on my head, and two ibuprofen. The fever broke over night and the headache reduced over night as well. The oter symptoms became less severe over the course of the 28th and are only remnant on the 29th. The arm pain and swelling are still present and I have muscle tension and pain pulsing up the left upper back/ neck area.

March 31, 2021: 12:30pm: Headache and sore arm 3:30pm: Nausea and severe headache 4:30pm: Pain in joints and swelling in hands + headache continuing 7pm: Severe chills with temperature at 100.3 F + headache continuing 8:30pm: Abdominal pain and continuation of chills + headache. Quite a bit of abdominal gas April 1, 2021: 12:30am: Chills subsided and temp raised to 100.5F. Joints still still and sore. 6:30am: Sore joints but body temp back down to 98.3F and body aches not as bad 8am: Minor traces of blood in stool 10am: Took 2 advil for headache and other body pains 12pm: No more traces of blood in stool 11am: Headache minimized and body aches greatly reduced

Yesterday (3/31/21) after the shot (4:00pm) my arm at the injection site was sore. This has continued into today. No swelling or redness but my arm hurts to touch or move. Beginning this morning (4/1/21) around 7:30 am I started having a headache. I took an ibuprofen which slightly lessened the pain but it has not gone away all day. It worsens with activity. Starting around 8:30-9:00 am I started to feel nauseous and lightheaded. I didn't take any medication for these symptoms. They've stuck with me all day. Starting around 11:30am I started to feel cold chills and body/muscle aches. This has continued throughout the day. Starting around 2:45 pm I've felt feverish, with severe cold chills.

Low grade fever for 24hrs? still active: Full body muscle aches(primarily lower back, neck, and shoulders), pain at injection site, fatigue...

Pain immediately at injection site. Tiredness, chills to the point I was shaking, using hand warmers and comforters with heat turned way up, pain in my arm that goes to my fingers and into my neck, head pain, then getting so hot I felt like I was burning, then freezing again, nausea and multiple trips to the bathroom.

Janssen COVID-19 Vaccine EUA Received the shot at 11 am and started feeling tired with some muscle aches at 2:45 pm. I slept from 3:45 to 4:30 pm but was still tired and felt weak. I did feel hungry and made dinner over 30 minutes. However, this wore me out. I was even more tired and started getting dizzy. I almost fainted as I made my way to a chair to sit down. I couldn't eat because of slight nausea and cold chills. I was shaking for about 20 minutes. Eventually, I made it to my bed to lay down, but my legs were shaking as I walked up the stairs. At 6:00 pm, my temperature was 98.8 F. I was freezing a shivering for the next hour in bed under 3 blankets. My hands and feet felt like ice. At 8:00 pm, I had a fever of 100.2 F that lasted all night. My body ached all over, especially at the hips. I couldn't sit still and couldn't sleep until 4:00 am. I woke at 8:30 am with some milder aches and fatigue with a temperature of 97.6 F.

Started with muscle aches, then got a headache. Several hours later I had a low fever (99 degrees) and chills. I also experienced nausea. A few hours later my fever broke and the chills went away. The muscle aches are still there but are gradually subsiding.

Currently pregnant and due June 19, 2021. Experiencing: pain at injection site, body aches, lethargy, low-grade fever

Patient is a 28 y.o. year old G1P0 at 38w6d who presented for fevers, chills and decreased fetal movement. She received her first COVID vaccine 8 hours prior. No cough. She felt well before the shot. No bleeding or leaking fluid. Her COVID test was negative. She was tachycardic to the 140's and the baby was tachycardiac to the 180's starting at presentation. She was treated with oral tylenol and IV fluids. After about 90 minutes of monitoring a prolonged fetal heart rate deceleration was noted to the 60's for 6 minutes. This recovered with repositioning. After another hour a reactive tracing was noted with a normal heartrate for baby. In induction of labor was started.

High fever and chills starting 5 hours after vaccination. Took one ibuprofen 18 hours after vaccine. Symptoms lessened but remained. Fever persisted. Took one ibuprofen 42 hours after vaccine. Symptoms largely subsided.

4/02/21-body aches dizzyness, nausea 4/03/21-body aches, nausea, dizzyness, fever, chills, chest pain 4/04/21- dizzyness, nausea,worsening chest pain

Chills, low grade fever, body aches, fatigue, brain fog, skin sensitivity Use of Acetaminophen and Ibuprofen

Fever, fatigue, headache, body aches, weakness the day after injection. Fever lasted for two days. Arm soreness and fatigue was present for three days following injection.

About an hour after injection (~9:15am), I felt mild fatigue and a very mild headache. The fatigue progressed throughout the day and made me very exhausted. About 8 hours after the injection, I had chills, still fatigued, mild headache, and about an hour later I ran a low grade fever (about 99*). Took Tylenol to keep my fever down. Temp shot back up to 101* a few hours later (still having body aches, fatigue and chills, and some mild nausea at this point.) My fever broke about 19 hours after the injection. 24 hours after the injection, the injection site was sore and I had a moderate headache with mild nausea. This continued throughout the day so I rested. 48 hours after the injection, still soreness in my upper left arm from the injection with mild headache, mild nausea and small lack of appetite. 72 hours after injection, completely back to normal with some soreness in my upper left arm at injection site.

I awoke at 6:45 a.m. feeling a bit sore in my arm, but relatively okay. I was up for approximately ten minutes and then extended my arms over my head to stretch out some of the achiness and immediately regretted the action. I began to feel dizzy and nauseous and saw black spots encroaching on my peripheral vision. I washed my face to relieve some discomfort with no change. I walked toward the bedroom to grab my glass of water when the black spots increased, clouded my entire vision, and I collapsed on the bed. I then began to hyper-salivate and after waking my husband and catching my breath, I returned to bathroom, experienced diarrhea, and simultaneously vomited into the trash can. The vomit tasted chemical and extremely acidic. My body was also shaking uncontrollably during this time and I kept switching between chills and being too hot. After I felt comfortable leaving the bathroom, I crawled back in bed but was shaking so much that I couldn't stop my teeth from chattering and could not get warm no matter that my husband placed an extra blanket over me. I had taken my temperature before while I was in the bathroom and it read 94.6 degrees Fahrenheit. I took it again in bed about twenty minutes later and it read 99.4 degrees Fahrenheit. My head was splitting and my arm ached, but I was eventually able to go back to sleep. I felt better after sleeping for a few hours and drinking more fluids.

Approximately 12 hours after receiving the vaccine, I was running a fever of 101.7 F, with associated chills, muscle aches, and a pounding headache. Most notably, I was experiencing tachycardia with a resting heartrate of between 109-127 bpm which was sustained for at least two hours. My normal resting heartrate is between 60-70 bpm.

pt states that her arm was very sore after getting the vax. Her arm is still sore today but was severely sore for a week and half. She gets a chronic migraine every day since taking this vax. She says the headache comes on about 10 AM everyday and it may last about 30 minutes or it may last a couple of hours. She has bouts of vomiting that comes and goes. she says the vomit contains blood. When she vomits her face breaks out into a rash. Pt says she is not feeling well, has chills and very fatigued. These symptoms have been going on for almost 2 weeks. Pt will see her PCP next week for symptoms on 4/14 @ 10AM.

Around 4 pm I was starting to feel a little sore. By 4:30 pm I had some major chills that turned into hot flashes. At around 4:30 pm I took 400mg of Ibuprofen. For 1 hour I was fighting a fever and chill spells that rapidly changed during that 1 hour time period, ending at 5:30 pm. Within that time I had major acks in my back and neck. I also experience sinus pressure and pins and needs in my ears and behind my ears. After 5:30 pm I did feel significantly better and now are 8:00 pm I feel exhausted, my head hurts and my ears feel like they weigh a pound each. Hope that was helpful. Thanks for doing what you're doing.

Shot administrated at 11:45am 2:30pm Neck and Back became tense 4pm pain started spreading from neck and back into the rest of the body Bones began locking up and I couldn?t move my joints, Headache, Nauseous set in, pain was so intense over entire body I was just shaking and couldn?t walk without assistance. I wasn?t able to rotate my hips or spine, couldn?t not sit, lay down, or stand on my own. Pain continued like this until 8am April 6th when it then started receding into my back again. I am still very tensed up in my back and neck with pain in my spine. Headache is still present, and my jaw and ears hurt when moved.

Client received Janssen COVID vaccine @ 2:11pm, reported not feeling well @ 2:23pm. Stated, "I can't get enough oxygen". Client placed in zero gravity chair, was noted to be shaky and diaphoretic. Oxygen saturation 100% on room air, pulse 47, BP 122/68. At 2:28pm, client states she's not dizzy anymore, able to drink water, vital signs stable. Client also reports she has fainted before with other vaccines and blood draws. 2:37 pm, client states she feels better. 2:56pm, client able to stand and leave observation area with steady gait and fiancé present.

Patient felt dizzy right after vaccine administration and fainted and collapsed into vaccinating pharmacists arms. Patient immediately regained consciousness but still hot, dizzy, sweaty. 911 called immediately and paramedics arrived to assess vitals in the ambulance, patient walked out of the store to the ambulance with assistance.

Fever around102F for 3 hours, petered out slowly over the next 8 hours Headache Nausea/vomiting Chills Slight shortness of breath All symptoms resolved within 24 hours of onset

After receiving the shot, I was required to sit down for 15 minutes. About 5 minutes in, I started to become dizzy, my vision started blacking out, my hearing was muffled, I became clammy, sweaty, and experienced mental disorientation. It became harder for me to breathe, but I never struggled to take a breath. I drank some water and waited for the symptoms to subside. I remained seated and these symptoms went away within 5 minutes. After feeling better for about 5 minutes, I felt cold and was shivering. The woman sitting next to me was completely fine after her shot. I've since felt a slight burning sensation on my skin in areas that I have scratched lightly. I'm also experiencing strange feelings throughout my body- specifically my head, leg, and hand. It feels like I can feel something in each area for a bit and then it subsides after several minutes.

Fever & chills, temperature unmeasured, 1 AM following day Fatigue, 10 AM-10PM following day Dizziness, 3 PM - 10PM following day, 2 Benadryl taken

Chest pain, difficulty breathing within 3 hours of shot Body aches, chills within 6 hours of shot Tylenol and advil

Pt received vaccine and then began to feel nauseated and fatigue. Pt laid down on a cot, with small sips of water and less than 15 minutes later patient said the symptoms resolved.

4/5 8:30am -Pain at injection site immediately, sore left arm 1pm -Fatigure 2pm -Body aches and chills 6pm -100.4 degree fever (lasted 4 hours) 4/6 Sore left arm, fatigue, nausea, right armpit swollen lymph node 4/7 nausea and fatigue 4/8 nausea and fatigue

Chest Pain, shortness of breath, fever, chills (9:00pm-3:00am) chills, body aches (April 4th-April 5th)

Beginning on 04/06/21 I had pain at injection site, joint, and muscle pain, aches all over my body, chills, mild fever, and headache. Beginning on 04/07/21 I began having severe shoulder, and neck pain, unable to turn my head to the left (side of injection) and unable to lift my head upwards, pain at base of my head, mild fever, body aches, joint, and muscle pain, headache, pain at injection site. 04/08/21 fever has subsided, headache, pain at the base of the head, still experiencing pain in my shoulder and neck on the left side, and mobility is still limited. Still feeling achey, and sluggish.

I received the vaccine on 4/8/2021 around 8:35am. I felt fine all day, only soreness at injection site. Later that day (around 6:00pm) I started feeling lightheaded, chills and a headache. My hands, feet, nose and hands were freezing but other areas of my body were warm. I also felt body aches- my lower back started with the aches and it spread up to my upper neck. Around 9:00pm I started feeling very hot and this hot/cold changes continued throughout the night. This morning of 4/9/2021 I have less of a headache however, my body is still very sore and I continue to experience the hot/cold changes.

2:00 am woke up with teeth chattering, cold chills, body aches continued to wake up through the night almost hourly in extreme body pain 6:00 am woke up in severe pain, stomach cramping, lower back pain, nauseous, attempted to get myself water and had to sit down in the kitchen in fear of passing out, barely made it back to bedroom before almost passing out again and immediately broke out in a profuse sweat. Body pain and aches continue for rest of day and into the next.

Typical side effects of fever, chills, injection site pain began 12 hours after the shot. 24 hours after the shot, my breathing got gradually worse. It was like an asthma attack, but normally my asthma attacks are caused by a sinus infection. This was just shortness of breath and gasping for air. I used my rescue inhaler with increasing frequency over the course of the following week. By March 12, I had to use my nebulizer. I used the nebulizer once on March 12, twice on March 13, twice on March 14, and I finally went to urgent care on March 15 when the nebulizer stopped helping. Urgent care was unable to help due to covid protocols, so they put me on oxygen for 5 minutes and transferred me to the ER. At the ER, by the time I got to the ER, my breathing had normalized. I was given prednisone on site, as well as a prescription for 5 days. I had a chest xray done that returned completely normal.

Immediate arm pain at injection site and overall arm heaviness. Aches throughout body and exhaustion about 2 hours after. Headache and nausea about four hours after shot. Fever of 102.6 about 7 hours after shot accompanied by chills/shaking worse than any fever I?ve had. Tylenol was taken around time of headache which may have delayed the fever and chills. Tylenol and ibuprofen were taken simultaneously every 5 hours starting that evening and throughout the night and all the next day. Food consumption was minimal due to nausea but hydration was maintained.

Syncopal episode, flushed, sweating. Denies medical history, allergies or meds. 1630: BP 117/89, Pulse 82, O2 Sat 99% 1645: BP 129/93, Pulse 88, O2 Sat 99%

I had the Janssen covid shot yesterday. The shot stung a little and made my arm sore. Later on in the evening I became tired (so far nothing I didn't assume would happen) so I took a nap. When I woke up, my arm stung worse than when I had the shot and the pain kept shooting up my shoulder into my neck. I went back to sleep, thinking it was just normal vaccine stuff. When I woke up this morning, I had chills, a fever of 101.7, and muscle aches. My body feels like I have a sunburn all over it. My right arm feels like it was stung by a scorpion. I feel dizzy and nauseous, and I have head fog. I feel the exact same way I did when I had COVID19, but with my arm hurting so bad, anything that barely touches it (such as clothes) shoots a stinging pain up my neck

CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patiennt concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:30am in left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, chills and nausea was not reported. This report was non-serious.

Day of Vaccine: Slightly blurry distance vision, mild fever, chills, mild headache, injection site pain/soreness, One day after Vaccine: Mild fever, chills, injection site pain/soreness, red/raw tongue. Two days after Vaccine: Mild injection site soreness, red/raw tongue.

patient reported muscle cramping and shaking,, sharp headaches, fever 101.9 unresponsive to tylenol and ibuprofen for 8 hours, nausea, and back pain

Racing heart, mild fever, body aches - 12-24 hours after shot Nausea - 12-36 hours after shot Hives outbreak - 36 hours after shot

About 14 hrs after injection, I got really bad chills for a couple of hours, then got very hot and had a 3 timepoints of chest pains (I assume I had a fever at this time but didn?t verify). By 7am when I got out of bed, it felt like a truck hit me. I had a major headache, very fatigue, fever (checked at this point and it was 101), nausea, hotness/chills. By 12pm, I had an 100 degree fever, chills/hotness, and headache. By 6pm, I was only tired. Next day, I was back to normal with a little soreness in my injection arm.

Left arm injection. Read and white (left arm) Sore (left arm) Bruised injection site Diarrhea Fatigue

Patient experienced anxiety, SOB, clammy hands, vomiting, sweating, arm numbness. BP 108/77 HR98 R16, then 10 minutes later 103/67 HR82, RR18. Patient stable, released with instructions to f/u with healthcare provider

HEADACHE; FEVER; This spontaneous report received from a parent concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known allergies or drug abuse illicit allergy.. The Patient had reported no lingering effect. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 on left deltoid at 14:30 hours for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fever on 10-MAR-2021. This report was non-serious.

Janssen COVID-19 Vaccine EUA Approximately 9 hours after vaccine administration side effects of fever (101F) and severe muscle and body aches began and lasted approximately 24 hours.

Dose at 1:32 pm, low fever 99.5 at 8 pm high fever 102 at 9 pm. Dizziness, confusion, numbness, muscle aches, entire body skin pain, lower back pain, neck stiffness.

vaccine taken on right arm on Wednesday 4/7/21 at 12:30 pm -symptoms began at 3am in the morning with a swelling 5cm by 3.5 cm at the site that was painful firm and hot to the touch, I was also febrile (temp not taken) with chills, sweating and body aches. The swelling has persisted until Sunday 4/11/21 and I went to urgent care and was prescribed cephalexin. The fever lasted until the Saturday morning and was self treated with over the counter Tylenol.

About 6 hours after the shot, I started to have very bad chills followed by high fever and joints pain. All of these made it hard to sleep. I didn't have a thermometer to measure but it's probably the highest fever I ever had. There was a lower fever, headache, joint pain, and fatigue the next day. I didn't take any medicine just drank a lot of water and my body is back to normal the third day.

Severe body aches and pain, chills, headache, 102 degree fever, fatigue. Severe symptoms lasted about 16 hours, mild symptoms after 24 hours. Feeling almost back to normal after 48 hours except for a maintained arm soreness where injection was taken.

I experienced a low-grade fever (100), muscle and joint pain, pain at the injection site, and fatigue during the first 24 hours after receiving the vaccine. A little less than 24 hours after the vaccine, my fever broke, and I began to develop a rash on my legs, which consisted of small, itchy, bug-bite like red bumps. I consulted my primary care physician, who recommended I take Benadryl. The rash worsened and spread to my torso - stomach, chest, underarms, and forearms - but was never present at the injection site. The rash on my chest was significantly different than the rest of my body, and when I saw an urgent care provider (5 days after being vaccinated), she diagnosed the chest rash as a separate issue (Folliculitis) and prescribed oral antibiotics. I saw no improvement in any symptoms. A week after being vaccinated and symptoms not improving, I saw my Allergist, who prescribed a 10-day course of oral steroids (Prednisone). My symptoms gradually improved, but the rash did not fully disappear for approximately 3 weeks after the first symptoms appeared.

About 12 hrs later, strong headache, chills, sweating, vomiting, body ache. Next day mild headache and tiredness. Sore arm around injection site

Fever, headache, nausea, fatigue, shivering. Adverse effects: Throat and ears soar. Aligns timeline wise with the other reactions and is lasting longer. I haven?t been sick in a long long time so I believe it?s from the vaccine.

VOMITING; FEVER; ARM SORENESS AT INJECTION SITE; FAST HEART BEAT; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included patient had series of rabies vaccines last year., and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 14:00 in left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced fast heart beat. On 05-APR-2021, the subject experienced arm soreness at injection site. On 05-APR-2021 21:00, the subject experienced fever. On 06-APR-2021 02:00, the subject experienced vomiting. On 06-APR-2021 03:10, Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, vomiting, arm soreness at injection site, and fast heart beat. This report was non-serious.

Woke up shaking and very cold with chills sometime after 12:00am. After layering up it took about 30 minutes for shaking to fully subside and maybe 2-3 hours for body temperature to feel hot. Had headache and dry mouth the rest of the night into the early morning. Took 400mg ibuprofen after having a morning meal and experienced no other side effects going forward except some tiredness from not getting a full nights rest.

Janssen COVID-19 Vaccine EUA Felt light headed at 8pm. I laid down and then started to get terrible chills. Around 10pm the chills turned to muscle aches all over and a terrible headache. Had a fever of 99.9 at 3am. The headache and mild muscle aches have continued into the next day as of 9:30am. The site of injection has been sore to the touch ever since I got the shot as well.

High fever, shaking, chills, severe arm and neck pain, projectile vomitting, severe headache, body aches

About 10 hours after my Johnson & Johnson COVID vaccine, I had sever chills, teeth chattering, body tense and aching, and trouble breathing. These were severe symptoms that lasted for two hours.

MOM STATES THAT ABOUT 2 HOURS AFTER DAUGHTER RECEIVED THE VACCINE, SHE REPORTED A SPLITTING HEADACHE. DIARRHEA AND VOMITING SOON STARTED BETWEN 4/10/21 AND 4/12/21.

Fever began around 1-2 am on 4/9/2021. At the same time I began having chills & sweats. Fever lasted until 4/10/2021 around 1 pm. Ranging from 99.2-101.4. Aches and pains in my muscles that were felt all the way to my bones. The aches went away by about 10 am on 4/10/2021. I took about 5 or 6 doses of tylenol extra strength and motrin to help. Nausea and dizziness began on 4/10/2021 which I am still experiencing today 4/12/2021. I began my menstrual cycle 4/10/2021 and have noticed more shedding than usual.

Low grade fever, chills, body aches, headache, nausea, diziness/lightheaded. Felt like the full flu for 24 hours about 12 hours after recieving the vaccine.

Fever, extreme chills, extreme body aches, muscle weakness, headache, sore injection site; ibuprofen every 6 hours; symptoms set in within 5 hours of injection

Fever, throat closing, red hives all over body, swollen eyes, swollen jaw, swollen cheeks, muscle aches

Headache, chills, muscle aches, and joint pain that lasted through the night. By morning, it was a more mild headache and minor muscle ache.

- visual disturbances (black dot and blurry vision) on drive home from vaccine - Fever (102.5), chills, extreme shaking started at 10:15pm and is still happening (tylenol is helping with the fever) - body aches in all joints - dizziness and lack of coordination / feeling confused - went to pcp and they did a cognitive test and didnt see any reason for concern, although I am a healthcare provider myself (pharmacist) and I know something is very wrong. I might go to the hostpital, but dont have great insurance so am uncertain

Chest Pains 24 hours after vaccine. Lasted two days. No Treatment. Went away on its own. Sharp Stomach Cramps 48 hours after vaccine- 04/09-No Treatment. Ended 04/13. Irregular Menstrual Cycle. Period not due for 3 weeks and started in middle of birth control packet (Lo Loestrin Fe (doesn't usually have a normal flow of blood on birth control)- 04/11 coupled with fatigue and headache. It is 04/13 and am currently still bleeding.

Om March 26th I recieved the vaccine and then had a fever later that night. I recovered from the fever. On April 1st I was exposed to someone who had Covid 19 and contracted it myself. I became symptomatic with congestion, cough, fatigue which all last until the 9th of April. On April 12th a rash began to breakout on my skin and I began to experience nausea. Today, April 13th, the nausea has worsen and the rash spread to my whole body. I am unsure of whether it is related to Covid or the vaccine.

Achy joints and muscles, tiredness, back hurting, mild fever. I got the vaccine at about 12:15, and around 9pm I started to suddenly not feel great. I had COVID early December, and these symptoms felt similar to COVID, but less severe. Now, the next morning, I'm still not feeling great, but don't seem to have any fever.

left arm has bump on Injection site it?s also very warm and tender to the touch headaches left side very tired fevers nausea lost of appetite

few hours after vaccination, I started to have severe headache, dizzy and abdominal pain. The headache and abdominal pain reached to their peak at night on the same day, and I took extra strength tylenol. I felt better after two hours. I still took the tylenol the following day since the severe headache and abdominal pain came back. It was relieved after a couple hours. The following five days, I had minor headache, felt dizzy and very tired. I did not any more medicine. I got recovered a week since vaccination date.

vaccine given at 12:30pm on 4/12/21, around 6:30pm adverse reactions started including headache, fever (temp not actually taken), chills, achy all over. Reported to us today 4/13/21, has taken Tylenol to help relieve symptoms which has help some til it wears off.

Severe Headache for 4 days, constant. Triage RN advised ER now for disposition. No history of Migraines or severe headaches per patient statement.

SEVERE shaking all over, difficulty breathing, racing heart, headache, dizziness, muscle pain, and muscle weakness. I just tried to wait it out. The shaking (extremely bad, could not control my own muscles at all and I had to lay on my arms so they wouldn't flail out) and racing heart lasted about five hours. The headache and all over muscle pain finally eased up last night. Breathing aches and I am still experiencing muscle weakness.

Chills and fever were accompanied by sharp joint pains, severe throbbing and pulsating headaches (primarily on the upper right side) and migraines that developing into throbbing and pulsing in the entire body lasting for 10 hours; three fever cycles and the first lasted 10 hours before the fever broke in a sweat; I could not sleep the entirety of the first night and experienced hourly urination and intense dehydration. After first fever cycle I was alert for an hour before second cycle began; after third cycle symptoms changed to nausea and dizziness that prevented me from being mobile without assistance or upright for more than a few minutes, by Saturday evening symptoms went away and I could resume eating, drinking, and walking again

Within 3 minutes of getting the Janssen shot I started feeling really sick, lost my vision and all feeling in my hands. I sweated through all of the clothes and soaked the chair I was sitting in. That night around 7 pm I got a migraine and felt really fatigued I couldn't stay awake and I was really sore. My chest hurt and so did my head. I was nauseated to no end The next day was worse. All day I couldn't stay awake. I felt so sore and sick to my stomach and I coint move too much because I was super dizzy. The next day I was still sick and dizzy By day four I felt fine just dizzy.

Shot administered at 1:30 pm, onset of symptoms at 8:00pm fever, chills,, body aches, nausea. Severe for 10 hours, then just general soreness and feeling tired.

Extremely high fever, light-headed, fainting, muscle aches, chills, nausea. Symptoms began at about 4 pm. By 8 pm, they were unbearable and fainting began. Fever broke at 11:30 pm after laying under cold towels and taking aspirin at 8 pm. Headache and fatigue lasted until noon Saturday (April 10)

About 2 minutes after vaccine I became very faint, nauseous and felt very hot. Sweating pretty bad as well. That night I had a fever going up too 103.5. Took Tylenol to get rid of that. Bad headache and body aches all until the next day.

I had the usual fever that began in evening around 8pm, but before that I started developing leg cramping like growing pains behind my left knee. The growing pains persisted behind the left knee for two full days (requiring me to take Tylenol to sleep), then it began behind my right knee, as well. That lasted another 24 hours before the growing pains expanded to both calves, as well. The pain persisted for an entire week and would wake me up in the mornings. I began stretching and working out and now the soreness from my work outs mostly masks the growing pains. I believe today is the first day I am not experiencing the growing pains.

I was fine for the most part after the vaccine. The only thing that hurt was my arm at the injection site. I started feeling nauseous about an hour later. Then at about 9:00 pm, I started to feel really sick. I felt very tired and my whole body hurt. I had a low body temperature, 95 degrees. Chills, fever, shaking, nausea. Very SEVERE symptoms. Felt very disoriented. I thought I was going to pass out and faint. Vision blurry and seen white. Pounding headache. Ears ringing. I could hardly walk that night, I was crawling on the floor. I felt out of breath. My heart was beating very fast. My left side of my chest hurt by my ribs. When I did wake up from sleep, I woke up with blood in my mouth and dried blood on my lips.

Vomiting for 48 hours, nausea, headache, chills, fever 102 for two days; period started and bleeding increases daily. Vaginal bleeding still heavy with dime size clots.

The week prior to delivery (3/22), I started feeling shortness of breath and a headache. I thought it was just normal pregnancy symptoms. That Friday (3/26), I noticed swelling in my ankles. I am a teacher so I asked my school nurse to check my blood pressure; it was high (for me) around 144/88. She said I should call my OB and let them know. I did, and they said to rest for the weekend and they'd see me on Tuesday for my 29 week appointment. We had a weekend trip planned. We took our son there. The next night, I didn't feel right. My belly felt hard to me and I wasn't feeling my daughter move as much, but soon after, I went to sleep. Our two year old son woke us up crying around midnight, and I noticed that I started bleeding when I went to the bathroom. My husband drove me straight to the emergency room. I was diagnosed with sudden and severe preeclampsia. My fibrinogen levels were 100% indicative of a placental abruption. They called the transport team in from hospital so they could transfer my daughter immediately after birth. At 5:57 am on 3/28, my daughter was born via emergency c-section. She is currently fighting everyday at the NICU in the hospital. On Friday, 4/2 I was readmitted for severe preeclampsia to hospital. My blood pressure was 190/115. I had to receive another round of magnesium sulfate. I was released from the hospital on Sunday, 4/4.

Severe headache, body aches, sensitivity to light and sounds about 9am-12pm on 4/10 Called pharmacy and was advised to take Tylenol, which seemed to help.

On Sunday, 4/11 my eyelids were tingling, it then went to my forehead, entire face and both of my arms. My muscles stiffened and my hands/thumbs were cramping inward. My hands were also red and blotchy during this time. My face was tight and hard to move or talk. This entire incident lasted in total around 20 minutes or so. I seem to be okay since that incident, I have had a headache off and on. Not sure if it?s related to the vaccine but I haven?t experienced anything like this before.

8pm - Severe body aches began and skin sensitive to touch 10pm - Temperature begins to climb and chills start 12am - Tylenol taken 1am - Temperature reaches 103.1 3am - Temperature begins to decline Next day: extreme fatigue, chills continue, low grade fever (99.5-100.4), pain at injection site, and vomiting (3 episodes)

The day I received the shot, I started to feel severe fatigue, headache, light-headed, and started running a fever about 6 hours after the shot was administered. The next day (4/6) was worse. Severe fatigue, muscle aches, headache, loss of appetite, fever (101.5 was the highest I notice but seemed to be around 101.1-101.3 all day), and general flu like symptoms. However, I also started experiencing abnormal menstrual bleeding. I am on the Depo shot and have been for some time. Due to this, I do not usually experience any menstrual bleeding so I found this to be a little odd. It was not heavy but it was noticeable and contained quite a few clots. Day 3 (4/7) was about the same except my fever came down and ranged from 99.8-101.1. Abnormal menstrual bleeding continued. New side effect this day included diarrhea. Day 4 (4/8) I started to see improvement. No fever (that I could tell). Remaining side effects included mild headache, fatigue, diarrhea, and abnormal menstrual bleeding. Day 5 (4/9), I had one of the worst nose bleeds I've ever had in my life. I apologize for the graphic description but it lasted about 20 minutes and my bathroom looked like a crime scene after. Blood was pouring out of my left nostril and I threw two large clots that were about the size of slug (or slightly larger than a fun size snickers... I wish I had a better way to describe it). I've had some bad nose bleeds, particularly when I was on Accutane, and this was worse! The rest of the day I felt like I was improving. Energy levels were better. No fever. Menstrual bleeding stopped. Only lingering side effect was mild headache and mild diarrhea. Since then I've continued to feel better and the diarrhea seems like it's improving. Mild headache persists. Only new item is an annoying twitch in my left eye that started on Monday (4/12).

Immediate injection site soreness, dissipated after a few hours by moving arm after injection Fever (100.5 degrees F), chills, body aches, headache began about 8 hours after receiving the vaccine and lasted for 12 hours after that Lethargy and headache remained for additional 12-24 hours Symptoms managed with 2 Tylenol rapid release gels, 500mg each; taken first night before bed and the following morning

High fever over 102°F, severe fatigue, severe chills and night sweats, severe body aches, lack of appetite for the first 48 hours after receiving the vaccine. Bad taste in mouth and bad smell in nose since recieving the vaccine and currently still experiencing (causing foods to taste or smell spoiled, sour or rotten , unable to enjoy things that I previously liked)- the taste and smell are like that of dirty, old, wet paper towels and are present all the time even when I'm not eating.

Lightheadedness and dizziness spell about an hour after injection. Nausea all night of first evening. Day after shot, felt tired and achey. This lasted for about 48 hours. On the second day, my arm began swelling near the injection site and turned red. It?s now been 7 days since my injection and my arm still has a large knot under the skin and is sore.

Felt tired the same day The next day I woke up with lower back pain. 4/8: lower back pain is increasing and a bump developed.

Friday 4/9/2021- Nausea, Upper Body Pains (arms, chest, upper back, neck, stomach), Dizziness, unable to walk, fatigue, headache. Saturday 4/10- Same symptoms with little to no improvement Sunday 4/11- Same symptoms with minor improvement Monday 4/12- Same symptoms with no improvement, increased pains, dizziness, fatigue with headache and facial pain in eyes, cheeks, jaw, ear, nose, and back of neck, primarily on left side of face. Tuesday 4/13- Same symptoms, No improvements, increased nausea with severe headaches and facial pains Wednesday 4/14- Same symptoms, with diarrhea. Thursday 4/15- Ongoing same symptoms, little improvement with Tylenol. Less upper body pains, and nausea. Off and on facial pain and headaches but with facial numbness when without the pain. Dizziness while standing. Diarrhea has ceased. Still weak/fatigue.

Atypical Headache 8 days post J&J vaccine. Woke up with headache at 7:30am and the headache got progressively worse throughout the day. Headache symptoms included head pressure, ear pain, and generalized full body weakness. Went to urgent care at 6:00pm. Due to ongoing health issues it was hard for the doctor to tell if it was a reaction to the vaccine or not at the time of exam. The doctor discharged me and recommend I go to ER if symptoms progress/get worse.

All over body aches, uncontrollable shivering and high fever recorded at 104.9 degrees for multiple hours beginning 6 hours after vaccination and lasting until 30 hours post-vaccination. Fever was not controlled well by acetaminophen or ibuprofen. Cold sweats, headache, shivering and body aches continued for 2 days post vaccination along with periods of vertigo and light headedness. Episodes of vertigo/feeling dizzy and lightheaded to the point of needing to sit down continue at least once a day now 10 days post-vaccination.

Janssen COVID-19 Vaccine EUA So after the shot I felt tired is but nothing big, then I went to bed around 9 p.m and I started getting chills, and I was freezing cold even under two blankets. I was wearing a fitbit and then noticed my heart Rate went up to the 90s and fluctuated between 90-110 bpm all night into the next morning. I woke up every 2 hours to a new symptom on top of what I was feeling already. It started with chills, then sweating, nausea and a headache. I had a fever of 99.5 at the highest. And then the last time I woke up at 5 my heart hurt so bad, my whole chest muscle hurt with a sharp pain and It hurt to breath. The next day I had a little headache and my body hurt, and I had cramping in my legs for a few days, but I also started my menstrual cycle on the 13th. The leg cramping continued for a few days but only when I sat on my legs for too long.

Initially had tingling in the lips (7 minutes after injection) The next day I had a fever of 104.5 with severe body aches, chills, lack of appetite, headache, weakness, productive cough and congestion. Have had severe body aches, chills, lack of appetite, headache, weakness, productive cough and congestion since the injection as of 4/15/2021

Aches started about 4-5 hours after the shot, and about 6 hours after the shot I had a 102 degree fever that lasted 12 hours. I also felt nauseous and had chills.

Severe fever (101.7) and abdominal pain began around 12am on March 27th, and persisted throughout the day and into March 28th. Symptoms were unresponsive to Acetaminophen 1000mg. Needed to consistently take 1000mgs every 4 hours to bring fever down to 100.7. I was 18 weeks pregnant at the time of vaccination, due on Aug 28th 2021, and 10 oz

Fever set in the next evening, on Saturday the 3rd. Lasted until Sunday the 4th. Injection site swelled up starting that Sunday, and lasted a week. Grew to be about grapefruit sized in diameter, raised out of the skin like a large lump. Was red, and painful to the touch. Shrunk slowly over the course of the week, while still remaining painful and red. Tomorrow will be 2 weeks from vaccination, a lump still remains in the arm. Redness is gone, and slight pain remains when touched.

VERY CHILLS; FEVER; This spontaneous report received from a patient concerned a 28 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: 1808982, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced very chills. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and very chills was not reported. This report was non-serious.

FEVER; HEART RACES; SHORTNESS OF BREATHE; CHILLS; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no history of vaccine allergy. 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 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced heart races. On 25-MAR-2021, the subject experienced shortness of breathe. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced tired. On 25-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart races, shortness of breathe, tired, and headache, and the outcome of fever and chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

FEELING A LITTLE SHAKY; NAUSEA; HEADACHE; MUSCLE ACHES ON THE LEFT SIDE OF THE BODY; VOMITING; SHAKINESS; HOT FLASHES; DIZZINESS; This spontaneous report received from a patient concerned a 28 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, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced shakiness. On 08-APR-2021, the subject experienced hot flashes. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced muscle aches on the left side of the body. On 10-APR-2021, the subject experienced feeling a little shaky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, shakiness, hot flashes, dizziness, nausea, and muscle aches on the left side of the body on 09-APR-2021, and had not recovered from headache, and feeling a little shaky. This report was non-serious.

Pt received J and J vaccine on 3/31/21. She had some initial reactions including headache and body aches that resolved 24 hrs post injection. She is now reporting new leg pain, it began behind her Lcalf, now is behind her L knee. Her L arm also aches. The pain in her L leg has been getting progressively worse. She has not tried OTC meds. Encouraged pt to go the ED for evaluation based on these symptoms. She understands, and agrees.

Fever at first. Then occasional shortness of breath. These have gone away but now have sudden and brief headaches. No treatment.

I had the regular symptoms (fever of 104, shaking, chills, headache) 6 hours after the shot. What is my new concern is leg weakness and pins and needle feeling in my legs that started a few days after the vaccine. My legs still feel weak and I have occasional pins and needles and muscle cramps all through my legs, but especially my left.

Got J&J vaccine on Friday at 3pm (April 9) and felt Body aches, Muscles hurt, Stomach hurt, Dizzy, Nauseous , Heart rate fast, Clammy Chills, Didnt sleep, Chest tightness, Upset stomach, Fever, Head hurt, Arm hurts and chest tightness feels in-line with where I got the shot, by Sunday (April 11) Flu like symptoms went away, but still have chest tightness uncomfortable and Feels like i have to cough When I take a deep breathe it it feels tight. Have diarrhea everyday since vaccine Still feel weak and dizzy Most of the flu like symptoms have gone away but chest tightness still concerning When I bend over or lay on my right side feels constricted and tight and uncomfortable. Bilirueben associated with liver is elevated and white blood cell count is low. On Wednesday, April 14th I started to get super congestion, runny nose and sneezing and Eyes a little red. Rashes and Hives that were red, blotchy and bumpy started Wednesday April 14 at 6pm and worse at 9pm. Continues to get worse and hurt throughout Wednesday and Thursday night. Developed all over body, legs felt hot. The hives and blotches would disappear and would then reappear at different areas of my body. Called Nurse Triage line and suggested I treat at home with Benadryl since hospitals had 6 hour wait and were full of COVID positive patients. Unable to sleep Wednesday and Thursday due to hives, very comfortable feeling. Diarrhea on Thursday morning , cough and felt shakey. Noticed on Thursday April 15th, some skin on right foot looked like it was pealing. Thursday night noticed some blotching and hives but not as bad as they were the night before. Friday April 16, No redness on legs at 1130am, but Lips feel dried out and Feel a little dehydrated . Bilirueben associated with liver is elevated still and will need to follow up with Doctore in two weeks. However, when laying on right side or bending down feels like something is stuck un chest and need to cough still, with chest tightness. Still had diarrhea until Saturday, April 17th. Chest is still tight and feels like something is stuck. Sunday, April 18th, went for short walk and felt uncomfortable breathing and not normal. This has not resolved still and does not feel breathing is normal.

Pain and soreness in left arm, upper back, and neck as well as nausea day of administration (12:30am). Ongoing on and off nausea since administration. Deep burning sensation on side left side between neck and shoulder. Mild joint pain. Ongoing fatigue (11 days).

28 y/o female with h/o obesity (120kg), anxiety and depression, received the J&J vaccine on 3/5/2021 (Lot 1805020). Home meds included only citalopram and an OCP which she had stopped on 3/10. On 3/15 she developed a predominantly R sided headache 9/10 pain, described as the worst of her life that didn't remit with over the counter analgesics and eventually became global in distribution, lasting 4 days. She was seen for this in urgent care on 3/19, given a shot of Toradol and then transferred to the emergency department where CBC showed platelets of 33, WBC 9.1 53% PMNs, 43% lymphs, Hgb 14.1, MCV 87, PT 15.7 INR 1.2. Chemistries were all normal. CT brain was unremarkable.

VOMITING; CHILLS; NAUSEA; FEVER; This spontaneous report received from a patient via a company representative concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient's medical history was unknown and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 03:00, the subject experienced vomiting. On 09-APR-2021 03:00, the subject experienced chills. On 09-APR-2021 03:00, the subject experienced nausea. On 09-APR-2021 03:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, nausea, and fever on 10-APR-2021. This report was non-serious.

I was tired the night of the shot and my arm was painful near the injection site, hard to move arm and touch caused great pain. My neck also started to lock up from my shoulder across to my spine and up my neck. This lasted about three days with occasional tension in the neck area coming back. Next morning I was very achy and my entire body felt like my muscles had a buildup of lactic acid. I did not have a fever but felt feverish that night. I felt the fever broke Saturday night/early Sunday morning (4/4) while I was asleep. I developed a slight cough for a few days and the muscle aches decreased by half each day. I felt mostly better after a week but occasionally felt tired and the cough lasted about a week. My arm developed a bolus at the injection site in the muscle that took about two weeks to go away, with occasional ice. The arm pain only lasted about 4 days before full range of motion was restored.

I received the shot on Saturday, March 6th. Flu-like symptoms developed 12 hours after (aches, chills, extreme fatigue) and lasted about 12 hours -- pain in left arm lasted a full five days. On Thursday March 11th I started to develop a cold sore on my chin which was followed by malaise and swollen glands. I treated it with Zovirax. On Wednesday March 17th I developed what looked to be a pimple in the middle of my left eyelid. There was a small white/ fluid filled head about the size of a pin head. Over the next three days, three more fluid-like blisters the size of a pin-head began to develop on upper eyelid. By Tuesday March 23rd, I had over half a dozen fluid filled blisters that were painful and began to crust. The blisters extended from upper eyelid to below the brow (only on left side of face). On Tuesday March 23rd I went to the eye doctor. The eye doctor had asked if I ever had shingles (I have had the chicken pox vaccine, but never had chicken pox nor shingles). I have had HSV-1 since childhood and get the yearly cold-sore when stressed or immunity is low, but I never have had cold sores appear anywhere else other than lip/chin area. The doctor had suspected the eye blisters were a form of herpes and prescribed me 14 days of Valacyclovir. The blisters only affected the skin-- not the cornea or inside eye. Within a day and a half of the antivirals medication, the blisters were fully crusted over and started to clear up.

Extreme fatigue and dizziness lasted 5 days. Constant metal taste in mouth, from 04/03/2021- currently. Sense on smell is now sensitive as in everything smells bad like b old burnt coffee, from 04/03/2021- currently

Day 1: Extreme fatigue / muscle ache / headache / dizzy. Day 4: Lost sense of taste Day 6: Took covid test, negative Day 8 + : Painful mouth ulcers forming all over tongue and roof of mouth. Currently on day 14 and the mouth ulcers are getting worse, not better. Tongue is extremely inflamed and red spots all over the roof of my mouth.

That night woke up in sweat, and freezing cold. Next 3 days I had hot and cold flashes. Day 6-currently(day 12) I have vertigo, headaches, fatigue, and extreme thirst/dehydration? Despite all the water I consume..

-Fever (102) and body aches for 1 day post vaccine (4/6). -On 4/11 at 11pm started having shortness of breath/wheezing and severe dry cough. Reminiscent of asthma attacks I had as a child (but haven't had in years). Used OTC inhaler with no relief. Wheezing died down after about 1.5h after starting and no chest symptoms after that. Headache/fatigue next day (4/12), then fine after that.

Patient received the Johnson & Johnson / Janssen COVID-19 vaccine on April 5, 2021. Patient woke up overnight with severe headache that was different than her typical migraines headaches. Headache was "like I never had before", "it's really painful." When I asked if this was the worst headache of her life she responded "probably." No photophonia, no phonophobia, no nausea, and no vomiting, which she gets every time she has migraines. "This is a different type of headache," she said. "I usually throw up and my headaches get better." This headache feels like a "balloon in my head." She reported vision changes (blurred vision) 45 minutes prior to our visit which started at 8:19 a.m. on April 21, 2021. ("I was having a problem with peripheral vision, about 45 minutes ago," but not so much now. Patient denies loss of balance (dizziness), seizures, focal weakness, radicular symptoms, saddle anesthesia, sensory changes, slurred speech, numbness, chills, and fever. She was sent to the emergency department for further evaluation. She is a female patient with new, severe headache that is between 18 and 48 years of age, and has received the Ad26.COV2.S (COVID-19) vaccine within 3 weeks of headache onset.

Minor fever 48 hours post injection; acne-like rash across upper back and shoulders 11 days post-injection. Rash almost gone 14 days post-injection.

DIZZY; LIGHTHEADEDNESS; PAIN UNDER THE LEFT ARM; CHILLS; SORENESS AT INJECTION SITE; FEVER; GENERALIZED ACHING; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient does not have any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 01:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced generalized aching. On 10-APR-2021, the subject experienced soreness at injection site. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced dizzy. On 13-APR-2021, the subject experienced lightheadedness. On 13-APR-2021, the subject experienced pain under the left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized aching on 12-APR-2021, chills on 11-APR-2021, soreness at injection site on 10-APR-2021, and fever on 13-APR-2021, and was recovering from dizzy, lightheadedness, and pain under the left arm. This report was non-serious.

Severe headache for two days. Extreme chills, nausea, cold sweats, fatigue for three days. On the third day previous symptoms went away and I got an extreme head cold, congestion, tiredness, lethargic. My varicose veins have been midly painful but it might be from laying all day for a week. On day five I started my menstrual cycle two weeks early, it was completely black and clumpy (not normal). It is now day 10 and I still have a slight cold, very tired, and am still on my period.

CHEST HEAVINESS; CHILLS; SORE ARM; FEVER OF 103F; DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced difficulty breathing. Treatment medications included: paracetamol. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced sore arm. On 06-APR-2021, the subject experienced fever of 103 F. Laboratory data included: Body temperature (NR: not provided) 103 F. On 11-APR-2021, the subject experienced chest heaviness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, sore arm, and fever of 103f on 08-APR-2021, had not recovered from chest heaviness, and the outcome of difficulty breathing was not reported. This report was non-serious.

WHOLE BODY HURTS; VOMITING; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 28 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: 1802068, expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 09:15 in left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, approximately at 16:00 the subject experienced whole body hurts. On 24-MAR-2021, approximately at 16:00 the subject experienced vomiting. On 24-MAR-2021, approximately at 16:00 the subject experienced fever. On 24-MAR-2021, approximately at 16:00 the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from whole body hurts, fever, headache, and vomiting. This report was non-serious.

FLU-LIKE SYMPTOMS CHILLS, MUSCLE SORENESS, HEADACHE AND ACHY SKIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included clotting disorder (unknown cause, with two episodes of clot prior), chronic migraine, celiac disease, penicillin allergy, cephalosporin allergy, sulfa drugs allergy, and social drinker (once every few months). The patient experienced drug allergy when treated with tetracycline, and vancomycin non-company 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 14:15 in left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced injection site pain. On 15-MAR-2021 22:00, the subject experienced flu-like symptoms chills, muscle soreness, headache and achy skin. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient was recovering from flu-like symptoms chills, muscle soreness, headache and achy skin, and injection site pain. This report was non-serious.

Janssen COVID-19 Vaccine fever that peaked at around 100 degrees and lasted for about 30 hours took Tylenol to keep the fever down tired and achey headache

I have severe, random, and unprovoked bruising covering both legs. I have abdominal pain that has persistent since being vaccinated. I?m dizzy. I?m bleeding in my urine, stool, and vaginally. Period came early (unrelated to previous vaginal bleeding) and is not clotting. Just significant amounts of red blood, soaking through one ultra absorbency tampon an hour. I have a headache. Went to the ER and my platelets were (345) and my blood sugar low. My bp was 145/90 which is high for me, from the bleeding. They said I have a ?higher chance of being bitten by a shark? than having a side effect. They diagnosed me with a single contusion and sent me home. Have been feeling worse since leaving the hospital.

I was seen on April 10th for the lump in my arm at the injection site. I was told I had ?covid arm? and that it should resolve over time. It?s gotten much better, but I still have a very small lump there. I was seen on April 19th for constant pounding in my left ear that started around April 12th. I was told I had pulsatile tinnitus, and I will be having a MRA scan on May 8th. I have felt some pressure in my head since then, and was told it may be related, but to just wait for the scan.

Fever over 105, chills, cough, soar throat. aches and pain for 2 days. Led patient to go to the ER on monday 4/12. MD found blood clot at that point. No treatment was given patient was told to follow up with her PCP. Did not go to PCP as yet.

Woken in the middle of the night to njection site pain, headache, profuse sweating for 8 hours+, nausea, projectile vomiting.

The day after the J&J vaccine, I experienced a high fever of 102.3, fever-like symptoms, chills, headaches, and fatigue. Symptoms lasted about 48 hours.

WHEEZING FEELING; WOOZY; HEAD FEELS TINGLY; LIGHTHEADEDNESS; FEELING OF PRESSURE ON HEAD; This spontaneous report received from a patient concerned a 28 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 10-APR-2021 for prophylactic vaccination. Batch number was not reported. The company has requested follow-up for batch number. No concomitant medications were reported. On 24-APR-2021, the subject experienced wheezing feeling. On 24-APR-2021, the subject experienced woozy. On 24-APR-2021, the subject experienced head feels tingly. On 24-APR-2021, the subject experienced lightheadedness. On 24-APR-2021, the subject experienced feeling of pressure on head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from wheezing feeling, woozy, head feels tingly, lightheadedness, and feeling of pressure on head. This report was non-serious.

4/5 vaccination. By 1pm, I felt fatigue, HA, light headed, feverish, loss of appetitive. 4/6 same symptoms but worsened; 101.5 fever. flu like symptoms. Abnormal menstrual period 4/7 fever was low. Diarrhea, upset stomach 4/8 low grade fever; 99. HA, fatigue, diarrhea. 4/9 really bad nose bleed with 2 really large clots. Continuing of flu like symptoms. 4/14 HA and flu like symptoms persisted till this date. 4/16 fever and HA stopped. 4/5-4/22 menstrual bleeding continued. *clots in nose bleeds and menstrual bleeding. Tele med on 4/14, 4/15 MRI. *still experiencing some intermittent spotting but not as much.

7:00 PM I started feeling tired and a little cold, by 7:30 PM I had horrible body aches and chills and was very tired. I laid down to go to sleep at 8:30 PM and dosed in and out of sleep. Around 10:30 PM I had a fever of 100.7 degree Fahrenheit. Around 12 AM my fever broke and by 1:30 PM I started feeling better. I had a really bad headache all night and into the morning, so bad I could feel throbbing in my teeth. I still have some soreness in my left hip joint and shoulder/neck. I have also had diarrhea once around 12:30 PM today. I did have COVID-19 at the end of December 2020 into January 2020. Not sure if that makes a difference.

Pregnancy: 24 weeks at time of vaccine, estimated due date: 7/27/2021. Second pregnancy but no prior live birth. Adverse effects: Woke at 2:30am the next morning with chills, low grade fever throughout the next 24 hours (99 degrees F), severe muscle and body aches, extreme fatigue, slight nausea. Outcomes: Completely resolved by the following day (4/9/2021). Pregnancy is uncomplicated with baby in 25th %ile for EFW. Baby healthy and active. No issues with cervix or placenta.

Arm pain immediately after injection - sore arm, whole arm felt heavy 4 hours later - headache At about 5:30pm - slight fever, slight chills 6:30pm-7:00pm - high fever, terrible chills, widespread body aches, delirium, nausea, extreme weakness, bed ridden The following day - weak, body aches, loss of taste

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient was unresponsive for 30 seconds and recovered quickly - orange juice was given.

Half hour after shot numbness and tingling on my face Fever of 101.4 starting about 4 hours after injection along with headache body aches nausea and chills, ringing in the ears and dizziness when laying down or closing my eyes Fever remained high with Tylenol and Motrin for about 24 hours. Around 24 hours the fever broke and for 3 days had a low grade fever of 99-100 the body aches resolved but the dizziness ringing in the ears nausea Continued for 5 day after the shot

9 pm post dinner in order of occurance -BAD back ache -Muscle aches all night -Chills -Fever of 102.5 -Vomiting Fever lasted through the night, 101 in morning - finally broke at 11 am next morning

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Minutes after receiving the Janssen vaccine, patient described feeling dizzy and light-headed. Pt put her head between her knees for some minutes; during that time she appeared clammy and described nausea, dizziness, and sweatiness. After some minutes she began to feel better. She stayed sitting in the pharmacy observation area for 30 minutes, after which she seemed to have fully recovered and was able to leave.

persistent headache. mild headache ~7 days after vaccine. increased severity leading to two emergency room visits to check blood and have cat scan in order to rule out blood clot.

patient was nervous while asking about vaccines, choose to take J&J covid 19 vaccine. After vaccination, she stated that she felt "woozy" then said she was feeling better so went to sit in designated seat. She then had her daughter come let us know that she was not feeling well. She was feeling clammy and laid in the floor with her feet propped up. BP was checked, she was clammy and sweaty. No issues with breathing, did ask for a Benadryl and it was given to her.

I had nervous sweats, I felt that my throat was closing. Once I got home, I had body aches, fever, and chills. It lasted about three days. I took Dayquil and nightquil

R facial edema and pruritus, headache, chest pressure, dizziness, cough. Treated with diphenhydramine 50mg IM in clinic, Benadryl at home.

COLIC ABDOMINAL PAIN; LIQUID STOOLS; NUMBNESS SENSATION IN THE LEFT ARM; HEADACHE; DIFFICULTY BREATHING; PAIN IN ARM; This spontaneous report received from a patient concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 02-MAY-2021, the subject experienced pain in arm. On 15-MAY-2021, the subject experienced difficulty breathing. On an unspecified date, the subject experienced colic abdominal pain, liquid stools, numbness sensation in the left arm, and headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from difficulty breathing, and the outcome of pain in arm, colic abdominal pain, liquid stools, headache and numbness sensation in the left arm was not reported. This report was non-serious.

Numbness is vaginal area and buttocks. She could not feel herself pee, tiredness, achy, fever, headache.

About 4 pm that afternoon I felt like I had the flu, I got really cold. At 6pm I had a 103 fever. I was completely immobile for 3 days. I started having low-grade fever and severe leg pain for about a week, Went to ER for dehydration. Ruled out blood clots. We back to ER a week later, couldn't find anything wrong. About a month later I still feel off, Dr. diagnosed me with spinal cord inflammation,

I had the normal arm soreness. I had rapid heart rate and it continued for about 24 hours. I had a fever of 103 and every part of my body was hurting. I had severe chest pains, severe migraines for abut a month and muscles aches for about 2 months.

Fever woke me up the next morning around 5 am. Sweating, chills, muscle soreness. Tired, weak, slight headache. Was fine after 24 or so hours.

On .4/19 I started to feel fatigue in my legs 04/20 it got worse in the legs 04/21 I came to work I worked through out the day with pain in my legs it hurt to walk it hurt to sit down the pain in my leg was getting worse 04/22 the pain got really bad I got up in the middle of the night to use the bathroom and I could feel my legs , my legs got really heavy and it felt like I had Charlie horses from my ankles up to the top of my thigh and I could not stand up. So I went to the ER and I got blood work done and I was told something about my CK levels were extremely high and that's when I was admitted. The day that I got the vaccine I got really dizzy during that 15mins that they make us wait and I felt very sick While I was admitted my CK levels kept going up the doctors told me that I had something rhapdomysosis , the pain got worse and the doctor increased my level of fluids and they did and ultra sound on my legs to check for blood clots and they kept increasing my levels of fluids and once I was let go from the doctor I did have to keep going back to keep getting my blood check. I did continue to feel muscle weakness in my legs while I was home. I did go back to the doctor 05/14 for muscle weakness I was given as bag of fluid.. After that any time I stand too long or I am working out I can no longer work out for as long as I can. I can no longer work out for longer then 15mins because of the pain in my legs. I suffer at night time now with muscles spams now they happen all throughout the night. I had very low potassium

Fatigue, weakness, Acute kidney injury, shock liver, thrombocytopenia, pneumonia, syncope, wide complex tachycardia over last 2 weeks

Very lethargic around 6pm day of shot Flu like symptoms from 7pm to 8 am Fever broke after that and started to feel better Still lethargic until 2 days later

8 hours after cold like symptoms - headache, body aches, low energy. 1st menstrual cycle (April 19, 10 days later) now heavy and 2 days longer 2nd menstrual cycle (May 18) continues to be heavy and 2 days longer Overall decrease in motivation and energy, slight weight gain, breasts appear slightly larger.

Constant daily headaches located at front of head, on/above eyebrows. Light sensitivity and pain when pressing around eyes. Headaches started on 4/12 and have continued daily since.

I had flu like symptoms, slight fever, body aches, felt clammy. My symptom persisted for about 3 days.

Review of ED notes show she received IV infusion of normal saline, and IV push of benadryl and compazine after going to the ER for severe headache on 04/17/2021. She first noticed pain when streching the arm shortly after the IV infusion but didn't pay attention to it, then 5 day later she noticed localized swelling and redness. Patient was sent for US doppler which left cephalic vein thrombus detected on duplex US. Was treated with aspirin and had follow up doppler of UE for follow up on LUE cephalic vein thrombosis-negative 5/13/21.

Pt states she felt fatigue and nausea the day after getting vaccine. 3 wks post vaccine, started feeling neck pain- April 27.

Fever, chills, tingling in the lips, throat swelling, hives, high blood pressure, coughing, asthma attack. The lip tingling was within 30 minutes of my vaccine, and continued for 2 weeks. Throat swelling lasted the first week. Hives lasted 1 week 4 days. Coughing started on day 3 and lasted 3 days. Asthma attack happened one time, during the coughing phase. High blood pressure started the evening of the vaccine and has continued. Doctor has prescribed a low dose of blood pressure medication to help combat it. Fever and chills started on the first day and lasted through the second day.

ITCHING; GOLF BALL SIZE SWELLING AT INJECTION SITE ABOUT 6 HOURS AFTER THE VACCINATION; PAIN; ABOUT 3 HOURS AFTER THE VACCINATION LOW GRADE FEVER AND TEMPERATURE; REDNESS; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy, and other pre-existing medical conditions included no illness or surgery to report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 12:00 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride for drug used for unknown indication. On 08-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 12-MAR-2021, the subject experienced itching. On 12-MAR-2021, the subject experienced golf ball size swelling at injection site about 6 hours after the vaccination. On 12-MAR-2021, the subject experienced pain. On 12-MAR-2021, the subject experienced about 3 hours after the vaccination low grade fever and temperature. On 12-MAR-2021, the subject experienced redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching, and redness, and had not recovered from golf ball size swelling at injection site about 6 hours after the vaccination, pain, and about 3 hours after the vaccination low grade fever and temperature. This report was non-serious.

WHITE PATCHES ON THE BODY/PATCHES WORSENING; BODY ACHES; FEVER; PAIN IN INJECTION SITE; INJECTION GIVEN TWICE BY VACCINE FACILITY; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included vertilligo in childhood.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and batch number: 043A21A expiry: 21-AUG-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced injection given twice by vaccine facility. On 05-APR-2021, the subject experienced body aches. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced pain in injection site. On 10-MAY-2021, the subject experienced white patches on the body/patches worsening. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 08-APR-2021, fever on 07-APR-2021, and pain in injection site on 19-APR-2021, was recovering from white patches on the body/patches worsening, and the outcome of injection given twice by vaccine facility was not reported. This report was non-serious.

It was nausea, vomiting, light sensitivity (migraine symptoms), pounding on the base of my skull. It hurt to open my eyes. I took my rescue medication Ubrelvy 100 mg at onset of migraine, it didn't work. I took another one two hours later. I sat in the shower trying to relieve the pressure. It took about 48 hours for it actually go away. It was lingering though. I could go about my day to day but there was this constant pressure in my head. That went on for about a week. I work with my physicians and he confirmed it was a migraine. Rest was what helped.

Hives, breaking out, flush, chills, faintness/dizziness Treatment was an injection of Benadryl and ice packs

I was 13 weeks and 3 days pregnant on my vaccine date, my baby is due 12/26/21. My vaccine symptoms started at 9pm with severe chills, body muscle aches, severe headache, pain everywhere. Then by midnight I was crying in severe pain, everything worsened plus I had severe nausea and diarrhea. My neck and back and every limb was throbbing, I was sweating profusely and had the chills, my headache has still persisted even now. I had to call out of work today. I stayed in bed until 11am and finally was able to shower. I?ve been lethargic, and in pain all day. Today more in my hands and head.

PATIENT WAS ASKED TO WAIT AT THE WAITING AREA FOR 15 MINS AFTER RECEIVING THE VACCINE. IN FEW MINUTES SHE SLOWLY WALKED UP TOWARDS MY WORKSTATION AND I QUICKLY RAN OUT AND GRABBED HER BECAUSE I COULD TELL SOMETHING WAS WRONG. A CUSTOMER STANDING BY GRABBED A CHAIR FOR HER AND WE HAD HER SIT DOWN. THEN SHE TOLD ME SHE GOT UP TO GET WATER AND SHE PASSED OUT. I TOLD HER ITS BETTER THAT SHE LAYS DOWN ON THE FLOOR TO PREVENT ANY FURTHER INJURIES AND I HELPED HER TO LAY DOWN. SHE WAS SWEATING AND SHE STATED THAT HAD TROUBLE WITH HER VISION AND HEARING. PARAMEDICS WERE IMMEDIATELY NOTIFIED. MEANWHILE SHE STATED SHE WAS ANXIOUS TO GET THE SHOT AND SHE DIDN'T HAVE BREAKFAST. SO WE GAVE HER WATER, ORANGE JUICE AND CRACKERS. BY THE TIME THE PARAMEDICS ARRIVED SHE STATED HER VISION AND HEARING IS BACK TO NORMAL. PATIENT ALSO WAS FEELING BETTER. PARAMEDICS CHECKED HER BLOOD PRESSURE AND ASKED IF SHE TAKES ANY MEDICATION AND SHE SAID SHE TAKES A ANXIETY MEDICATION AND I AM NOT SURE IF SHE TOOK ANY THAT MORNING. SHE WAS ASKED IF SHE WANTED TO GO THE HOSPITAL AND SHE SAID NO BECAUSE EVERYTHING WAS BACK TO NORMAL. PATIENT WALKED OUT OF THE PHARMACY FEELING BETTER.

I had side effects starting one hour after the vaccine - headache and nausea. Muscle pain started 12 hours after and it spread to my other arm - my entire upper body ached. I was nauseous and peeing a lot for 2 days. I did have a few hives, 2 on my arm and 1 on my face and I had not eaten anything high in histamine. The weather that week was stormy and lousy. On Friday-Saturday, I had an intense bought of allergies (plugged dripping nose) and that is very rare for me, regardless of the weather. By Sunday, I had shortness of breath, nausea, and shaking. I tried eating and playing a game to get my mind off it and that didn't help. Usually with my anxiety, I can just tell myself I'll be okay. I told myself I would be okay and if I got a blood clot I would be perfectly fine. It did not work at all. This kind of anxiety was unlike anything I've ever experienced. Nothing I did helped and it felt like everything was going a mile a minute. I decided to take a benadryl, telling myself that this was just the "impending sense of doom" that happens with food allergies. I slept for 12 hours and felt exhausted when I woke up, like I had just been through something tough. I tried to just move past it, but the anxiety got worse and worse. I saw a doctor 06/23/2021 and have started taking Prozac.

20 hours after vaccine began having copious vomiting, 2 episodes of diarrhea, myalgia, fatigue, and tingling to BUE

Fatigue, muscle soreness, arm soreness from vaccine - Vaccine was placed in freezer upon receipt from manufacturer, then thawed prior to administration

Patient received the J and J vaccine June 20. For the next 4-5 days, patient had vomiting, fevers, chills. After that patient developed full body aches, cramps. Patient states that the initial pain was in the level of her spine and radiating down to her legs. She then states that she has and numbness difficulty with walking. She had walking difficulty especially when climbing up steps and initially later needed having help with ambulation. She also has reports that after initial symptoms 7 days after she started having some abdominal discomfort. Most recently she started having some urinary retention issues and was seen evaluated outlying hospital ER on 5th of July. Patient also states that on July 9 she presented a.m. to ER for facial numbness, right side of the mouth . She also has noticed some left-sided finger tingling because of were deficits patient present to ER. Neurology Consultation Note from 7/10/21. Pt is currently admitted to our facility currently. Right facial weakness new Paresthesias weakness Demyelinating process MRI brain with t2 flair hyperintensity differential ADEM vs CIS vs MS vs NMO spectrum disorder Left side ptosis hearing impairment chronic secondary to acoustic neuroma Low suspicion of GBS good distal strength 5/5 ankle bilaterally and knee except for left knee extension 3/5 intact distal reflexes ankle and patellar -Time of onset of symptoms was: Patient has had a progressive course of multiple neurologic complaints from June 20, 2021 when was reported that she received at a intake COVID vaccine -Had symptoms of: Initially had flu like symptoms, followed by bilateral lower extremity weakness, numbness, progressive to have urinary retention, facial weakness on the right side MRI brain Multifocal abnormal white matter T2 hyperintensities, most pronounced involving the subcortical white matter, left greater than right Abnormal signal within the upper cervical spinal cord. Diffusely low marrow signal on T1 imaging suggesting red marrow hyperplasia. Plan: LP ordered for tomorrow AM Follow up CSF results methylprednisolone 1gm x5 days will check blood sugars q.8 hours q4h neuro checks Message Lab for myelin oligodendrocyte glycoprotein (MOG) IgG autoantibody and the aquaporin-4 (AQP4) IgG serum autoantibody Follow up to see if sent.

In the past few weeks, starting at the end of June, when I bend over, viscous fluid pours out of my nose. It's persistent post-nasal drip that lacks the consistency of familiar snot. It isn't minuscule enough to ignore. It's like I am climbing out of a chlorinated pool. It only happens when I bend down to pick something up and whatever comes out keeps coming until it decides it is done.

The expected adverse effects of fatigue and head pain began immediately, but that evening chest and left arm pain started. I thought it would end, but the chest pain and palpitations continued daily for the next 2 to 3 months. Afterwards, they would happen on occasion and still do to this date. In the first 2 to 3 months after receiving the vaccine, I would get so winded after walking from the train station or up stairs that I would have to stop. Many times throughout the day I had to stop what I was doing and not only rest but sleep. I was exhausted and felt overwhelming pressure around my heart and increased heart rate daily.

Three day fever, extreme fatigue, swollen left arm (hot to touch, itchy, painful, fluid build up), rash down left arm. Received botox shot for migraines within ten days of shot, had extreme swelling in forehead for a few days. This has never occurred in prior botox shots.

I woke up that morning with a lot of sneezing, 24th of May 2021, coughing and sore throat etc. Those were like the main primary symptoms, I also was sneezing as well. Basically head cold symptoms. I contacted the DR on May 27, 2021. The DR gave me Prednisone and Fluticasone. The DR basically thought I was having allergies.

Two days after receiving vaccine, patient started to develop cold symptoms and swelling in her face that got progressively worse throughout the day.

Initial symptoms of chills and heart racing. Initial HR was 119 with slight dizziness. Reassurance, rest, granola bar. Return to normal HR, BP 02 sat normal, normal CV exam

I received my shot at 3:30 pm on Friday 3/5/21. Around 9 pm I started experiencing extreme body aches all over that felt like my body was "fighting" against itself. I also experienced chills. I had a hard time sleeping from the pain. The next morning a headache started and progressed into a migraine. I could not get up or open my eyes from how bad the migraine was. I took extra strength Tylenol for the pain with little relief. On Saturday evening the symptoms started to get better and turned more into a headache. I still had the headache on Sunday but it was better after taking the Tylenol. On Monday my arm is now sore (it wasn't sore prior).

At the time of injection, it was pretty painful and thus sent my body into a shock less than 5 mins after receiving my dose. My vision went white and I was very light-headed and hot/sweaty. A nurse came with me outside to monitor and I was feeling back to normal in 15 minutes. This is something that happens when I experience a high amount of pain, so just reporting for others who maybe have low blood pressure issues. At about 8pm, other side effects started to set in. I first experienced a headache, then experienced soreness/ache-y-ness in my back. Around 8:30, I started to feel light headed again and soon my whole body felt ache-y. I quickly developed chills where I felt so cold that I was uncontrollably shaking and felt very sore/stiff. I have been laying under a heated blanket for the last hour and a half and am finally feeling better with no more shaking or chills. I still have soreness throughout my body and a headache, but I took ibuprofen around 8:30pm.

Janssen COVID-19 Vaccine EUA Chills & fever for 3 hours, 6 hours post shot Entire body aches for 12 hours Headache Tiredness Muscle & joint pain/weakness

1:20am: woke up with full body chills and felt feverish. Temperature was 99.1 4:30am: woke up with full body chills. Temperature 101.7. full body aches. headache. 6:30am: took ibuprofen. 8:00am-4pm: fever went away. aches and headache remained. 12:00pm: took ibuprofen 4pm: diarrhea 7pm: achy and lethargic. took ibuprofen 8pm: went to bed. 6:00am: woke up sweaty. Felt 99% back to normal. Left arm still sore.

Around 3:15 in the afternoon, I began experiencing severe aches and muscle pains, combined with a growing migraine. Not realizing what it may be related to, I took two ibuprofen and I've acetaminophen. By the time I around home around 6:30, I could barely hold myself up. I ate dinner, which only helped minimally, and by 8 pm felt like death. My husband notice I looked red and felt my forehead, immediately going for the thermometer. I had a fever of 100.5. We eventually got me into bed after downing a lot of water, but the pain would not ease up. The pain was too excruciating. At 10:30 my husband came to bed and we took my temp again which was 101.6. To help me sleep I took another Tylenol. At 5:45 my work alarm went off and I checked my temp again; still 101.6. I got a cold pack for my migraine and went back to sleep. Slowly throughout the day my fever dwindled, until it finally broke in the early afternoon. By 4:15, as I am writing this, all that's left is done tiredness, thirst, and a small bit of achiness.

I got the vaccine around 12 pm went home and fell asleep at 1 woke up around 4 was felling very tired and my body was beginning to feel very sore fell asleep again and got up at 6 with a fever and awful migraine and chills and laid down until 8 when I stood up I started to feel very nauseous and started to vomit uncontrollably all throughout the night maybe 4 or 5 times and vomited twice the next day I?ve had a continuous migraine and fever soreness muscle aches in head, neck and back.

Arm sore after injection. Loss of appetite for dinner. Woke up around 2:00 AM with chills. Added more clothes and tried to go back to sleep. Felt hot and took temperature and had a temperature of 100. Body aches. Took Tylonel around 3:30 AM. Couldn't sleep. Tylonel helped and I was able to fall back asleep. Woke up at 6:00 AM for my day. Fever gone, aches still a little there, tired from lack of sleep and a little bit of chills. It was a rough night but overall feeling good today.

Vasovagal syncope a few minutes after vaccination. Fever of 101.8F 24h after vaccination (3/10/2021). Fever is continuing today (3/11/2021), but is lower at 100.4F. Tingling fingers on hand from vaccination arm (left), swelling from vaccination injection site, headache, and neck pain all developed on 3/10/2021. Headache and neck pain could be due to head trauma from vasovagal syncope. Tingling fingers were not observed on 3/11/2021. *I have had vasovagal syncope in the past, but never with vaccines. It always occurs when I see my own blood.

Body aches and chills through the night By 9 am Wednesday- 102 fever Severe headache / migraine through Wednesday Fever broke Wednesday night Still fatigued and sore arm (Friday morning)

Severe chills, fever of 100.7, vomiting, fatigue, weakness for less than 12 hours Chills, diarrhea, fatigue, weakness for three days

muscle aches, nausea, and fever in lower extremities; was not able to sleep ibuprofen taken within 12 hours of onset

5:50pm to around 8:30pm constant shivering no matter how many layers to heat up body. Fingers and toes tingling and numb from cold. (It was 70 degrees in the house). Fingers under nails discolored bluish. 8:30pm shivering stopped, started getting a fever and headache, vomiting around 9:30pm. Vomiting started and stopped within an hour. 9:30pm to 4:20am (this morning) fever, severe headache. 4:20am to 10:30am severe headache.

Woke up with chills, fever of 100, headache, muscle aches. Took Tylenol as advised by the nurse who administered the vaccine and it seemed to help a little bit with the headache.

Janssen COVID-19 Vaccine EUA Side Effects I encountered are Including Low Fever, Body Aches, Tiredness, Headaches, One day After injection. Body Aches and Headaches continued for 4 days after.

3/14: fatigue and nausea 3/15: severe headache (alleviated with Tylenol) and fatigue/flu like symptoms

Patient received vaccine on 3/13/21 in the morning. Later that evening she stopped by and said she felt tired but was well. I saw her today and asked how she was doing. She stated that by 6pm that evening at home she had body aches, fatigue, fever, nausea and at 2am her fever was at 102.4. Sunday continued with fever, down to 100.8, body aches, and fatigue, nausea, and diarrhea. Her temperature this morning was 99 and was she was feeling much better. Treatment was not needed.

Acute but intense fever, chills, and body aches. Had difficulty walking, sitting, eating, and using the restroom (physically, no internal issues like vomiting, constipation or diarrhea). Was more significant than any "real" flu I have ever had in the past. Could only sleep. Symptoms decreased by the next day, but still fatigued. Fully healed by third day. *For clarity's sake, I had tested negative for SARS-COV-2 the day prior.*

Headache and eyes aching around 10:30pm on 3/12/21 I went to bed and started aching around 4:00am on 3/13/21 by 6:00am 3/13/21 I had a fever of 101.5 and my body aches. I took two pills of extra strength Tylenol and water and laid back down to break the fever and help with the aches and pains. I woke up around 9:30am on 3/13/21 and did not have and appetite all day. I was extremely fatigued all day and had no energy to get out of bed or do much. On 3/14/21 I began to develop an appetite again around noon. I was still fatigued. My arm was very tender and itchy at the injection site and hurt to the touch. My 5:00pm on 3/14/21 I had more energy and the aches were gone but my arm was still hurting and sore.

Vaccinated at 3 pm on 3/14/21. At 12:30 am (3/15, 9 hours post) woke with chills. At 2:30 am, woke again overheated and with a bad headache. Could not sleep well. Some muscle aches in my upper legs. Checked temp at 6 am. No fever. Hot/chills resolved. Tired all day 3/15. Headache and muscle aches resolved by noon 3/15. Fatigue resolved when awoke on 3/16/21. Bruising and soreness at injection site. Still present.

Fatigue and high fever onset ~9 hours post-injection. Fever of ~101-102 F + chills, aches, etc. lasted 9-10 hours. ~20 Hours post injection, fever dropped to ~100 F; severe headache onset treated/relieved with 400mg ibuprofen; still fatigued and experiences aches and chills; fever broke around ~30 hours post-injection.

Felt faint/sweaty 15 minutes after the vaccine was given. Pale and moist appearing. BP 80/40 (pulse 66), O2 sat 99%. Given water and felt better after rest. BP 132/76 (pulse 74).

I started feeling subtle flu-like symptoms about 6 hours after receiving shot. At first I thought it was in my head but by the early evening I felt like I had a full blown fever even though I never actually had a fever at any point. I had chills, muscles aches, head aches, and extreme fatigue. My back hurt especially and overall I felt very weak. I also had pain at the injection site that got worse the following day. I had trouble even lifting my arm to reach a drink just a few feet away from me. The arm soreness lasted through the Monday following my vaccination (I received it on a Friday). All my symptoms were at their worst on Saturday. I felt much better on Sunday but still had the arm pain through Monday. Motrin did help relieve the worst my symptoms. I thought that was the end of my symptoms but that last week I have noticed what I believe to be a lingering fatigue from the vaccination. While it's not usual for me to feel tired at points throughout the day, I have been feeling a heavier and more full body fatigue than I usually experience. I have had to take naps more often, sometimes multiple times in a day. During these bouts of fatigue, my whole body feels heavy and somewhat weak. It's similar to the exhausted feeling someone might have after they've been crying for a while but I haven't been crying or emotionally taxed in anyway. Normally when I wake up in the morning, I might feel tired for the first 30 minutes to an hour but once I get moving, I feel better and more alter. I have been having a harder time feeling rested or awake in the mornings and even if I get more sleep than normal, I still feel exhausted. I did not change my routine or diet which I why I think this is related to the vaccine.

Chills/ sweating, fever (103) with Tylenol, muscle and joint pain/ burning, difficulty standing, difficulty walking, difficulty bending limbs, nausea, fatigue, headache, loss of appetite, lower abdominal pain, sensitivity to light, weakness

fever,vomiting. Got J&J vaccine yesterday @1400. Sx started since this morning. C/O cold sweats, headache and n/v. vomit x2 this morning. No blood in vomit. Had L temporal headache but not at this moment. No visual changes or dizziness. Not took medication.History: pt had J&J COVID-19 vaccine yesterday and started feeling sick this morning, with some muscle aches, intermittent headache, vomit x 2 this morning, and slight cough this morning (which stopped afterwards), here for eval. Pt was doing ok before the vaccine and lives off-post and denies recent COVID-19 hotspot visit or sick contact. No neck stiffness, runny nose, ear pain, sore throat, visual deterioration, chest/abdominal pain, diarrhea/constipation, History: pt had J&J COVID-19 vaccine yesterday and started feeling sick this morning, with some muscle aches, intermittent headache, vomit x 2 this morning, and slight cough this morning (which stopped afterwards), here for eval. Pt was doing ok before the vaccine and lives off-post and denies recent COVID-19 hotspot visit or sick contact. No neck stiffness, runny nose, ear pain, sore throat, visual deterioration, chest/abdominal pain, diarrhea/constipation, vaginal bleed/discharge, rash, prior surgery, prior co-morbidities. Has had implanted contraceptive since before 11/2020.

15 mins after receiving the vaccine, I began feeling nauseous. One hour after receiving the vaccine, I began throwing up. I could not keep anything down until 2 PM the next day. I was also extremely tired and slept most of the next day. I was 10 weeks pregnant at the time of receiving the vaccine. Had a terrible headache. I took Tylenol for the headache.

About 30 min after the vaccine, I started to feel symptoms. I had a fever, chills, vomiting, diarrhea. The next day, my arm swelled up at the injection site and was extremely tender, hot, and my whole arm was swollen as well.

103 temperature, seizures, vomiting, feeling like the bones were broken in my neck. I did not make it into the ER

8 hours after the vaccination, patient felt cold/chills along with ascending body temperature. Then, patient felt hot and had speeding and heavy heartbeat while body temperature exceeded 100 degree fahrenheit. Dizziness and fever persisted for over 24 hours until taking Tylenol and a night of sleep.

Around 8 hours after the shot I started to experience fatigue, body aches, uncontrollable body shakes, blueish lips and sweating (which to me indicated I had a fever). After taking some Advil my lips returned to normal and the body shakes stopped although it was hard to regulate my body temperature. I was sweating but felt cold. The worst of the symptoms seemed to last around 13 hours after they had started (so about 7pm on 3/25 to about 8am on 3/26). It's now been around 30 hours and I'm feeling better but still fatigued and have soreness in my left arm where I received the injection.

I received the vaccine at 1:30 pm in the afternoon on 3/22/21 and immediately afterwards I felt fine. I waited my 15 minutes and had no signs of a reaction and was free to go. Later in the afternoon, around 3:15 pm, I began to feel a little fatigued and my arm was sore. Around 6:00 pm that same night, I developed a low grade temp of 99.8, I was very fatigued, had achiness all over, as well as my arm was very warm and tender. I was unable to sleep through the night of 3/22/21 into 3/23/21 and got out of bed around 4: 30 am on 3/23/21 and had to call into work due to the pain. The pain was not an achiness but sharp throughout my whole body. Around 9:00 am, I took a pain reliever and was able to sleep for a few hours. Upon waking up around 1:30-2:00 pm, I was still hurting and was then nauseated as well. I tried to drink water and ate a few crackers to settle my stomach with no relief. At 5:15 pm on 3/23/21, I went to the bathroom and got in the shower to try to help with the pain. After a few minutes in the shower, I became extremely lightheaded and felt like I was going to be sick. I sat down in the bathtub and hollered for my mother to come help me because at this point, I felt like I needed to go to the hospital. Upon sitting down in the bathtub, I began to profusely vomit and started to lose feeling in my legs. My mother entered the bathroom and I explained what was happening and soon after my hands contracted and were stuck in an abnormal position. The pain was unbearable and I was unable to move them from that position. I was unable to get myself out of the bathtub so my mom then called for an ambulance. These symptoms occurred somewhere around 5:20-5:21 pm and EMS was called at 5:22 pm. After a few minutes, I was able to regain movement of my legs but my hands and fingers were still contracted and unmovable. I was able to help my mother enough to put my clothes on and to make my way outside to the front porch to get fresh air. After getting outside, I was accompanied by my mother and my neighbor whom is a nurse. My neighbor looked at my hands and noticed they were discolored and she attempted to straighten out my fingers to no avail. The pain in my fingers was sharp and excruciating but there was also a pins and needle type pain as well. I remained outside until EMS arrived. I was then transported to Hospital where I was seen in the ER for this. Upon arrival to the ER, the physician ordered labs and fluids and stated that apparently he had seen at least 2 other cases that day with a similar reaction to the vaccine. He explained that I was having an adverse reaction to the vaccine and that my hands should return to normal within 24-48 hours. I was then discharged home. As of 3/24/21, I was able to straighten my left hand out and my right hand, my fingers would straighten out, but they would return to a curled resting position. As of 3/25/21, I returned to work and I have some weakness in both hands with a slight discoloration of each hand as well. I am a nurse and work in an office and the physicians in my office commented on the color of skin upon seeing them. I was still very achy and fatigued. My arm was still sore and tender as well. As of today, 3/26/21, I am still achy as well as tired. My right hand has improved some but still returns to a curled resting position. The color of my hands has improved as well. I am a nurse and have seen many things throughout my career. This experience has been absolutely terrifying and I still have no answers as to why this happened to my body. I did my part by being vaccinated and was terrified that I was going to lose my life to it. I pray this does not happen to anyone else.

Flu-like symptoms beginning at 1:30 am with no fever, and vomiting at 4:30 am. Both arms were hot and anything that touched them felt like sandpaper, and a fever begins at 5:30 am and goes up past 100° at 9 am. Fever finally reduced and feeling back to normal by 7 pm that same day.

Injection site pain, weakness, fever, chills, disrupted sleep, body aches, joint pain, dizziness, headache, stiff neck, back pain

Pain at injection site, severe fatigue, feeling of passing out, drowsiness on the first day. Treated by sleeping and taking Tylenol. Second day: headache, muscle weakness and body aches on side of body injection was given. Facial weakness, weakness in right arm, headache persistent on third day as well as redness and swelling at injection site. Difficulty swallowing.

DEHYDRATION; CANNOT EAT DUE TO BLISTERS AND INFLAMED GUMS; CANNOT DRINK DUE TO BLISTERS AND INFLAMED GUMS; DIZZY/LIGHTHEADED; INFLAMED GUMS; MOUTH BLISTERS; INFLAMED, SWOLLEN AND SORE THROAT; SWEATS; CHILLS; FEVER; MUSCLE ACHES; NAUSEA; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user (Social once in a month), and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the patient experienced sweats, chills, fever, muscle aches, nausea. On 12-MAR-2021, the patient experienced mouth blisters, inflamed, swollen and sore throat and the patient was given steroid shot. On 13-MAR-2021, the patient experienced dizzy/lightheaded, inflamed gums. On an unspecified date, the patient experienced dehydration, cannot eat due to blisters and inflamed gums, and cannot drink due to blisters and inflamed gums. The patient was given IV for dehydration. Laboratory data (dates unspecified) included: Streptococcal sore throat (NR: not provided) Negetive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflamed, swollen and sore throat on 13-MAR-2021, and sweats, chills, fever, muscle aches, and nausea on 12-MAR-2021, had not recovered from mouth blisters, dizzy/lightheaded, and inflamed gums, and the outcome of dehydration, cannot eat due to blisters and inflamed gums and cannot drink due to blisters and inflamed gums was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210329079-covid-19 vaccine ad26.cov2.s -Mouth blisters, Inflamed Swollen and sore throat, Cannot eat due to blister, Cannot drink due to blisters, Dizziness, Dehydration, Inflamed gums, Sweats, Chills. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210329079-covid-19 vaccine ad26.cov2.s -Fever, Muscle aches, Nausea. These events are labeled and are therefore considered potentially related.

fever, chills, body aches, interrupted sleep, loss of appetite, fatigue, soreness at site of injection

Tiredness: started from 4pm 4/1; sore at the injection site, fever about 100 F: started from 10pm 4/1 till 2pm 4/2; sore in lower back and finger joints: 4/2 No treatment.

I began to feel bad 6 hours after the application of the vaccine with chills, stiffness, muscle and body pain. I already imagined that the fever was starting. 3 hours later I got home and took my temperature, it was 101 F. the fever lasted more than 15 hours. I didn?t take any medication. I put cold cloths on my head, bathed and rested. the headache was very intense. So far I have discomfort from that but the fever has already stopped. The most striking thing was the allergic reaction that I began to have around midnight and it continued until today. they were hives all over the body. swelling and itching and redness. Finally after 24hs after vaccine I took an anti allergy called levocetirizine cause itching won?t stop.

Almost exactly 6 hours later, I vomited, had body aches, ran a 102.3 fever, and had uncontrollable shivering. The fever and body aches lasted approximately 24 hours.

101 degree fever, cold chills, body aches, severe headache, body sweats, very tired. I drank a lot of water, slept, and took Advil every 4 hours to try to manage my fever.

Symptoms started around 7:00 PM and gradually increased. The first symptoms were chills and body aches which gradually increased and also led to a fever of 103 F, confusion and lower back pain level 10/10. The fever and chills subsided the next day however fatigue and soreness followed the next couple of days. I still have lower back pain that comes and goes.

I got my vaccine at 1220pm , and started experiencing side effects around 8pm . I was overly tired , cold sweats , fever , headache , nausea all for about 24 hours after the initial side effects began .

Headache, body ache, fever and chills, exhaustion, all experienced off and on for the two days following my vaccination.

Experiencing headache, nausea, body aches, fever approximately 10 hours after injection of J&J vaccine.

Patient stated feeling dizzy 1minute after sitting down in Post Vaccination. Pt felt sleepy, body felt heavy and she was about to fall. Pt did not fall but staff member stated her eyes rolled back. @ 2:20pm Pt is fully awake and feel back to normal now. Currently sitting in Post Vac eating and talking while being monitored by healthcare staff. Bp 122/76 Hr 66 O2 98 Patient stated that every time she gets vaccines and blood draws she feels this way related to anxiety of getting a vaccine. Patient is stable

I started feeling tired and achy around 6pm. My left arm is really sore. I have a temperature or 99.6 and a Headache

Pain and swelling at injection site immediately after and through the time of this report. Full body muscle aches overnight. Nausea, fever, fatigue, and muscle aches through time of this report (ongoing).

Fever accompanied by painful paresthesia most prevalent in extremities. Pain level is about a 6. Frontal lobe migraine, throbbing and pressure. Pain level 4. Extreme fatigue.

Facial tingling around 1:00 PM followed by drowsiness. Around 6:30 PM chills started followed by a headache. Drowsiness continued and then fever of 102 throughout the night. Headache at temples, in between eyes and eyes continued to get worse along with pressure in those areas. Full body aches also developed. Nausea also occurred along with grassiness. Around 9 AM the next day the fever broke but headache continued. Aches subsided but persisted in neck, shoulders and most notably middle to lower back along with stomach aches. Weakness in the arms and hands still noticeable. Dull headache still exists, aches, and weakness as of 9:00 PM.

Janssen COVID-19 Vaccine EUA - headache and muscle aches starting 5 hours after shot - fever starting 7 hours after shot, with headache, chills, nausea, fatigue - maximum temperature of 101 degrees, treated with ibuprofen - 24 hrs after shot: fatigue, muscle aches, no fever.

1:32p shot Less than 8 hours: Minor headache and nausea. Still able to do normal life activities. 12 hours: cold chills 13 hours: body aches 14 hours: random sharp pains, body aches, nausea 15 hours: major headache, nausea, weak 18 hours: took Tylenol 500mg 21 hours: woke up sweaty, but feeling ?better?, no appetite 24 hours: major headache, body aches, random sharp pains (not as bad), weak, nausea, somewhat dizzy. Still, no fever. 25 hours: Took Tylenol again, plus Ibuprofen. 30 hours: Began feeling better, had my appetite back. Light headache. 46 hours: (now) feel back to normal.

Janssen COVID-19 Vaccine EUA 4/5 - (from time of waking up in the AM) persistent migraine, joint pain, heart palpatations, soreness at injection site, nausea, dizziness, persistent lethargy and lack of appetite 4/6 - persistent headache, joint pain, light-headedness, lack of appetite. Noticed a red welt at injection site (bright red, hot to the touch, swollen) 4/7 - red welt inflamed, still hot, sore, became incredibly itchy, whole arm uncomfortable and hurting. All other symptoms gone 4/8 - Inflammation of welt partially faded but red irritation spread out like it was dispersing. Later became darker red, still itching, began to hurt so much that even light fabric brushing across the skin caused pain. Still very warm to the touch. Doctor diagnosed the welt as Cellulitis and immediately issued an antibiotic.

Headache began around 12:30 am Unable to sleep rest of night Nausea and vomitting occurred around 2:52 am General body soreness and muscle pain rest of day, plus prolonged headache Recovered next day

Woke up the morning after getting the vaccine and had these symptoms chills achy body Temperature was around 99.0 Headache no appetite lethargy I usually run about 97. The symptoms got worse in the afternoon. Anytime something touched my skin, I would get goose bumps and go between feeling cold and hot. My temperature is now 99.8.

Six hours after I received the vaccine the most intense pain I've ever felt in my life took over my entire body and has not stopped for a moment 20 hours later. It's particularly bad in my legs, knees, and elbows. There's also a fever but the pain is much worse. I have a high pain tolerance but I'm not kidding when I say this is unbearable. Breaking a bone hurts less. Actual COVID hurt less. This is agony.

Exhaustion about 5 hours after the injection. Extreme cold and uncontrollable shivering and chills about 6 hours after injection for several hours throughout the night. Sometimes interrupted by sweating. Ibuprofen helped to regulate the body temperature.

Starting 11:45pm on 4/6 woke up with severe chills lasting about 2 hours, severe muscle and bone aches all over body, headache, fever, nausea and dry mouth. All symptoms remained at same intensity for 12 hours and started getting better early afternoon on 4/7. Still had headache and muscle aches until around 6am 4/8.

About ten hours after receiving the vaccine I started to get a fever, chills, and muscle pain. The fever got worse overnight and I woke up repeatedly with a higher than normal heart rate and a severe migraine that lasted throughout the next day. I took Tylenol (two doses, 12 hours apart) to some relief.

After 8 hours: headache and fatigue (still experiencing after 24 hours) After 10 hours: Back pain, especially in lower back--unable to get comfortable or sleep (still experiencing after 24 hours) Nausea--couldn't lay on my back because it made me feel like I would throw up. Burping. Elevated heart rate--I felt like my heart was pounding out of my chest. My resting heart rate lying in bed was 90 bpm (I'm a runner and my resting heart rate is usually around 55 bpm). This lasted for 3-4 hours.

Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Shortly after administration of the vaccine (~3 min) pt started shaking, sweating, looking flushed, feeling clammy, dizziness, lightheaded and briefly fainted. Pt was put on the floor and legs were elevated, given water and a snack and started feeling better. 911 was called and an evaluation was done.

Syncopal episode, flushed, sweating. Denies medical history, allergies or meds 1630: BP 117/89, Pulse 82, O2 99% 1645: BP 129/93, Pulse 88

Patient was sitting down and started to feel dizzy and her vision was starting to become blurry. She got up to let us know that she was having a reaction and fainted. She was awake immediately after she fell and said that she was experiencing the blurred vision still, extremely sweaty/hot flashes, and ringing in her ears. She drank some water and sat down for a little bit and started to feel better.

Extreme chills (shaking uncontrollably) for at least half an hour. Freezing cold. This happened twice, about two hours apart, at 11pm and 1am. Low fever of 99.3. The following day I was extremely tired and had a headache all day. Continued to have headache the following day (Monday) and a fever of 99.5 at one point. Continued to have headaches for rest of week on and off (Tues, Weds, Thurs). Alternated taking tylenol and ibuprofen as needed.

Within an hour of receiving the vaccine I had lightheadedness and dizziness. I had mild bouts of nausea with this episode. The dizziness subsided close to 1 pm. At approximately 4 pm I was lethargic, and starting to run a fever with arm pain at the injection site. By 7pm I had no energy, small cough, fever (unknown), chills, and headache. This lasted until 10 AM the next day. Headache lasted until 5 pm the next day.

Nausea, vomiting, diarrhea, headache, dizziness, fatigue, low grade fever (100.8?F), body aches, joint pain, abdominal pain, chills, insomnia

J&J COVID-19 Vaccine EUA beginning 5 hours after vaccination, I developed nausea that lasted 2 hours, chills that lasted 12 hours, aches that lasted 16 hours, and a 104-degree fever that lasted throughout the night but was gone by morning. Acetaminophen helped alleviate these symptoms.

Standard side effects occurred within 24 hours, shivering, chills, body aches, fever of 100.3. Fever would not break until later that evening even when taking one Tylenol every four hours. Day two I couldn't tell if I was actually looking at myself in the mirror. I was dizzy and felt high. I could not remember simple tasks I just did like washing my face in the shower. I felt like I was hallucinating. I went to urgent care and they had no recommendations. I was to take the LSAT today, Saturday, April 9. I had to cancel it because I'm still not fully coherent. I still feel dazed and out of it. I tried to go to work yesterday and old lasted an hour. I had a COVID test performed yesterday on my own accord, not per the request of urgent care, just in case I caught it prior to the vaccine without knowing, and it was negative. I can remember things now at least but I'm still not mentally coherent. It's a scary feeling. I am about three and a half days post vaccine and slowly becoming myself again. I still feel dazed but I am able to have a conversation and remember it.

Fever, chills, body aches, sore throat, diarrhea, fatigue, continued swelling, redness, and pain at injection site

8 hours afters after receiving my Janssen vaccine, I woke up in the middle of the night with a 103 fever that was not well managed by taking Tylenol. I also suffered from extreme body aches, fatigue, nausea, upset stomach, diarrhea. This lasted a full 24 hours before my fever went away. The following day I still had an upset stomach. I also developed a red welt at the injection site which lasted for about a week, was red, swollen, bruised and itchy. 11 days later I tested positive for COVID19 and had full fledged symptoms of COVID19 as well.

I started shaking uncontrollably approximately 9 hours after injection. My teeth were chattering so badly they hurt. This maintained for 20 mins. I then had severe flu like symptoms overnight, including chills, and feeling hot and cold at the same time. I woke up with a headache. I had muscle pains through the entire ordeal. At 7am the next day, I took 600mg of ibuprofen and took a walk. I then felt fine.

Chills, fever, heavy breathing, body aches (began around 7PM 3/25/21 lasted until 3/26/21 night when they improved drastically, but did not feel all the way better until 3/26/21 from these symptoms) hallucinations (woke up in the middle of the night when this happened- 1x occurrence) dizziness (ongoing from 3/25/21 night and still continuing)

3:00pm sudden chills, felt extremely cold and shivering, muscle ache and fatigue 3:30 pm lightheadedness/dizziness to the point of almost fainting 5:00PM continued symptoms with added naesua 9:00PM extremely hot , 101.8 degree fever Following day felt much better except for headache and fatigue. Continued to have some much aches and pains Currently on day 3 and have some aches and lains, arm tenderness still, but no lightheadedness or naseau since the first day Treated with Tylenol, rest, ibuprofen

Fever and body aches beginning around 5pm, 7 hours after the vaccine. Nausea hit at 10pm and lasted until the next morning. I threw up 4 times throughout the night. I have red splotches all over my face from broken blood vessels I think. They are all around my eyes, but also on the rest of my face and neck. Fever of 100.4. Had a headache and was shaky all night. The next two days I have been fatigued.

Burning sensation in arm. Lightheaded. Dizzy. Nausea. Severe headache. Fever. Chills/Sweating. Elevated heart rate / Palpitations.

PATIENT FELT UNWELL AT 1230, BP 124/82, HR 73, RR28 1237 GAVE 25MG BENADRYL IM 1245 PATIENT STARTED TO SHAKE, INCREASED RESPIRATORY RATE, STARTED TO HAVE AIRWAY CLOSURE 1245 EPI PEN GIVEN IN LEFT LEG IN RESPONSE TO SOB, REPORTED NUMBNESS AND SWELLING IN THROAT, INCREASED RESPIRATORY RATE. 1246 PATIENT ABLE TO BREATHE BETTER AFTER EPI 1247 PATIENT TRANSPORTED TO ED FOR OBSERVATION 1257 EMS TRANSPORT TO ED

I had immediate soreness after the vaccine does. Then at 7pm of the evening after getting my vaccine, I began to feel weak, get chills, and run a low grade fever. At midnight, my fever had increased to 101 and I began taking Tylenol (recommended by Pharmacy). I had sever body aches, muscle fatigue, joint paint, chills and nausea through the night and the next day. In the morning, I had excruciating pain in my abdomen and began vomitting. Later that day, my fever increased to 102.7 (with Tylenol) and I called my regular doctor. She told me to continue to monitor and if my fever did not decrease by 7pm to go the hospital. Finally, my fever decreased to 101, muscle aches, chills and joint pain continued. I began vomitting uncontrollably for a short period of time. I was very dizzy and weak the remainder of the day. Saturday, my fever finally broke (I sweated all day) but my body was still weak and sore. I also had dizzy spells on and off. Sunday, I felt much better but was still very tired compared to my normal self. I had abdomen pain and burning on and off. I also got hive on my hands Sunday afternoon. After Benadryl, the hives went away but I still felt itchy all over. Today (Monday), I still don't feel like myself, but it is the best I have felt since receiving the vaccine. I have never experienced anything like this and was miserable Thursday night, Friday and some of Saturday. It truly was a terrible experience.

Sever chills and uncontrollable shaking 9 hours after injection (midnight). Symptoms lasted for several house and stopped around 5AM. Sever headache and fatigue upon waking 8AM and took Tylenol that reduced symptoms. Left arm sourness continued for several days. No fever throughout.

Janssen COVID-19 Vaccine EUA. Day after vaccination I had a slight fever and severe fatigue. I was only able to stay awake for an hour at a time. I also had a severe headache and pain and swelling at the injection site. The next day, the fever broke (about halfway through the day) and my fatigue lightened. I was still experiencing a minor headache and continued pain and swelling at the injection site. The third day, I woke up feeling normal, until I engaged in physical activity. The fatigue returned, however I am no longer experiencing a headache and the pain in my arm has lessened considerably. The swelling hasn?t reduced.

BACK PAIN; LEG PAIN; HEADACHE; ELEVATED TEMPERATURE; NAUSEA; This spontaneous report received from a consumer concerned a 29 year old female. The patient's weight was 82 kilograms, and height was 159 centimeters. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient has no known allergies. the patient had no drug abuse or illicit drug usage. the patient was not pregnant at the of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered at left arm on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced back pain. On 06-APR-2021, the subject experienced leg pain. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced elevated temperature. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain, leg pain, headache, and elevated temperature, and the outcome of nausea was not reported. This report was non-serious.

Dizzy, lightheaded, headache, chills, muscle and joint pain, weakness, extremely tired. Well I laid in the bed with two blankets and took tylenol. Once I was done freezing and with the fever it felt like my skin was on fire. I was in so much pain that night that I couldn't move without crying. After I slept that night and about 7 hours the next day I finally started to feel better.

7pm: Uncontrollable chills, nausea, muscle aches 12 am: fever (100.4 F), restlessness, muscle aches, headache, nausea 6 am: muscle aches, headache, lethargy 12 pm: no more symptoms

Starting around 8:00pm started to experience muscle and joint pain in lower back and hips and headache. Left arm became warm to touch and felt slightly swollen. Chills and fever started to set in. Chills lasted for about 3 hours. Fever with a high of 101.7 degrees F noted around 2am. Took tylenol, which brought fever down, and reduced headache and muscle aaches. Fever remained between 99 and 100 degrees F for most of the following day. Took another tylenol in the late afternoon. Fever finally broke by the evening on 4/10/2021. Still fatigued for all of 4/10/2021. Woke up on 4/11/2021 with out any other adverse effects. Fever, headache, and muscle aches passed. Still a little tired, but felt more energized.