Johnson & Johnson

Vaccine SHOULD NOT have been administered. When I took patient I did not know that the Janssen HAS NOT been approved for under 18 year olds. Nausea, tiredness, weakness, sweating, headache, shakes

SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; SORENESS IN THE ARM; TIRED AT NIGHT; This spontaneous report received from a parent concerned a 16 year old female. The patient's height, and weight were not reported. The patient was diagnosed with Lyme disease when she was 10 or 11 years old but no after effects and she is fine now. The patient have just seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, 1 total, administered to the left arm on 12-MAY-2021 (coded as inappropriate age at vaccine administration) for prophylactic vaccination. No concomitant medications were reported. After vaccination, the patient had soreness in the arm for a couple of days and felt tired at night which cleared in 24-48 hours. The patient work at a camp, where somebody came down with Covid and there have been couple of cases of Covid-19. The patient exhibited symptoms of Covid and was tested by rapid test on 13-JUN-2021, which was negative. Laboratory data included: SARS-CoV-2 test (NR: not provided) negative. The patient was subsequently tested twice on 14-JUN-2021, both positive (suspected clinical vaccination failure and suspected covid-19 infection). The patient's father did not know the specifics of the tests that were done. The patient was quarantined in the camp and was till under quarantine in the camp. The patient also presented with Covid symptoms such as Covid cough and pain in the chest for coughing. The patient felt fine now (as reported). The patient's father mentioned that the camp had to make a report to the health authorities but did not think that the patient visited a physician. Laboratory data included SARS-CoV-2 test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in the arm, and tired at night on 14-MAY-2021, and the outcome of suspected covid-19 infection, suspected clinical vaccination failure and inappropriate age at vaccine administration was not reported. This report was serious (Other Medically Important Condition). This case is associated with the Product quality complaint (PQC): 90000184104.; Sender's Comments: V0 - 20210660267- COVID-19 VACCINE AD26.COV2.S -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

nausea, headache, shakes, high fever 103+, 104+ for Thursday - Saturday, Health Department dispatched the nurse to inject the vaccine at the facility. My daughter?s COVID-19 vaccine card clearly states her birthday / age. Why did the nurse administer the unapproved COVID-19 vaccine, Janssen, to a minor? According to CDC, only Phfizer vaccine is approved to be administered to someone of age of 17?

severe body, muscle and joint pain/ache, fever, fatigue, weak, dizzy, fuzzy, nausea, headache, loss of appetite, unable to go to school Tylenol every 4-6 hours

Bad headache, fatigue. Started about 15 hours after vaccination. Fever 100.1. Normal ?shot hurt? pain in arm. Took Advil. Slight improvement. Submitting this form 17 hours after injection.

about 10-15 minutes after receiving vaccine pt complaine of dizziness, loss of vision, sweating, loss of consciousness, vomiting and of her left hand getting cold.

03/16/2021: At around 8:00 am my head and stomach began to hurt. A wave of drowsiness overcame me and I slept from 8:30 am- 1:30 pm. I then experienced body aches and extreme body weakness, thoughts were difficult to articulate and process, and I began to feel nauseated. This continued until 03/17/2021 in which I felt only nauseated, bloated. My headache was kept at bay with acetaminophen.

Pt started to feel hot and nauseous about 5 minutes after injection. Pt said her stomach 'hurt really bad' and started to vomit a few minutes later. After several minutes, pt started to pass out, so moved her to the floor for safety. Several minutes after that, pt started to feel better. Soon after she was sitting up, and later, able to tolerate an orange juice, then leave on her own.

At 1428, patient mother alerted medical staff, stating her daughter had a seizure. Upon arrival, daughter was sitting upright in passenger seat, mother holding her, eyes open, appearing pale. No convulsions , incontinence, or other seizure activity noted. EMS notified and arrived within a minute and evaluated patient. No medications or additional treatment given. Patient ambulated to EMS stretcher with one person assistance. Awake and talking. Patient transported via ambulance at 1437.

Minutes after I got the vaccine I started to lose hearing in my left ear (it sounded like I was under water) which slowly spread to my right ear as well. My hands and feet went numb and I started sweating all over. I felt sick to my stomach and I felt like I was above the whole situation-- I could hear the people talking but I felt like I was somewhere else. After resting my head on the table for about 10 minutes I felt better and was able to move to a cot where I rested for another 20 minutes or so until I felt pretty much back to normal. I was treated by the medical team at the site who cleared me to go home.

began with body aches in the knees, took Tylenol and went to bed @9:30pm. Woke up @12:30am with chills, a headache, soreness in the injection site, and body aches in the neck, back and legs. Got up and tried stretching and drinking water. Stoped drinking water when I felt nauseas. Did not throw up. Took Ibuprofen and melatonin before falling asleep about 30 minutes after taking the medication. Woke up @3:00am and chills were gone, only left with pain in the knees and injection site. Wasn?t able to sleep until around 4:45am. When I woke up @7:45 am, I still had slight pain in the knees, I took Tylenol @10:45 am. Pain was on and off throughout the day. I took a hot bath, that helped the pain tremendously. Fatigue throughout the day. After sleeping the day after the shot, all symptoms are gone, only soreness in the injection site.

Chills and full-body shaking starting about 2:30pm, going away for a few hours, and returning about 6:00pm?resolved by 7pm (this may have been anxiety, since I was working myself up, and this symptom was markedly similar to how I sometimes get during panic attacks). Fever (max temp 101.7F) starting around 8:30pm?broke by 2:30am 4/3/21 after taking ibuprofen 9pm on 4/2/21 (last checked temp 98.4F). Mild headache from 2:30pm to 8pm.

patient stated she began to develop blurry vision as well as arm soreness. began to breathe heavily due to panic and stated there was numbness going down her left leg. 911 was called and symptoms began to resolve as ambulance arrived.

Patient had seizure-like activity about 10 minutes after receiving the Johnson & Johnson Covid Vaccine. Nurse saw her eyes rolling back and struggling to breath. She was placed on her side until wheelchair was brought to her side and then transferred to wheelchair and taken to the ER. While in transit she regained consciousness and was lethargic but was responding appropriately to questions. Patient was checked by Dr. and his review was tachycardic and mild dyspnea. Skin was pink and warm. She was taken to the ER for further evaluation.

I felt completely normal after getting the vaccine. Then at 8 pm (5 hours after getting it) I felt heat rushing to my head and face. I became very weak in my legs and I had to lay down. I took ibuprofen at 9 pm because my body aching was very intense. I woke up at 11:30 pm with such terrible body aches I could not sleep and I was crying from the pain. I had freezing chills and a throbbing headache. When I tried to stand up, I almost fell over because I felt so light-headed. I thought I was going to faint. I was so concerned about the amount of pain I was in that I called my doctor and public safety came and checked on me. I couldn't get out of bed for 3 hours. I drank Gatorade and took more ibuprofen. I was able to check my temperature. I had a 101-103 degree fever. The entire next day (Tuesday) I took ibuprofen every six hours. My body was still very weak and aching everywhere as well as a headache. I stayed in bed the entire day. Today (Wednesday) I feel much better??both of my arms still ache a lot and my body feels exhausted.

Approximately 8 hours after injection, I woke up after sleeping for an hour with excruciating pain in all of my limbs, especially the injection site. I could not move any of my limbs. Not because of pain, I simply could not move them. I had a fever (temp not recorded, I could only tell because I was burning up.) I was very nauseous, but never vomited. I was shaking very hard and had the chills despite being covered by a blanket and simultaneously burning up. Both of my ankles that I had suffered a running injury to several weeks ago (I have an upcoming doctor's appointment to get them checked out) were pulsing with pain. I developed a minor headache. Eventually I either drifted back to sleep or stayed awake, because I don't remember anything up until around 5am when I was able to get up and take Tylenol and water. All symptoms were gone except for the minor headache.

Pt passed out after getting vaccinated. Her BP and pulse were normal. Pt stated that she did not eat anything since morning breakfast around 9am. Paramedics were called to verify that Pt was doing ok. Gave pt both orange juice as well and some food ( chicken nuggets). After 30 minutes pt was calm and stated that she was feeling well. Called pt on 4/7/21 at 9:05am to verify that she was doing all right. She stated that other than sore arm she was doing fine and did not go to the hospital.

Patient awake at 2:50AM shaking and sweating. She began stuggling to breathe around 3:00AM. Mother took her to the ED where she received the medications listed in #19 & felt relief about an hour later.

Dizziness, difficulty sleeping, headache, irritable skin, muscle pain, joint pain, disorientation, difficulty breathing, uncontrollable shaking, nausea; most just lasted from evening day of to next morning, muscle aches and sensitive skin lasted for a few days

Systemic: Fainting / Unresponsive-Medium, Systemic: Vomiting-Medium, Additional Details: Patient was administered vaccine per protocol. Prior to injection patient was complaining of being nervous, and permission was sought to proceed with the shot. Patient fainted about 10 seconds after the completion of the injection and was stabilized in the chair. When the patient came to she was complaining of nausea and proceeded to vomit several times. Mother of the patient was present at the time and said that she had a crippling fear of needles.

Patient went to ER later that day after receiving the Jansson Vaccine at AFC Bessemer. She was watched for 15 minutes and had no contraindications to the vaccine. At the ER, she c/o severe left leg pain and difficulty walking due to pain. The ER called to report this and spoke to a medical assistant at who then gave the message to me.

RIGHT AFTER THE SHOT, THE PATIENT SAID THAT SHE FELT LIGHT HEADED AND TIRED. SHE STARTED TO SHAKE AND SLUMPED OVER AGAINST HER FATHER THAT WAS NEXT TO HER. SHE STARTED TO SNORE, WOKE UP AND THEN PASSED OUT AGAIN. HER FATHER SAID THAT SHE REACTS TO SHOTS THIS WAY. SHE DID NOT RECEIVE ANY TREATMENT. SHE WAS IN THE PHARMACY FOR A TOTAL OF 25 MINUTES.

Patient fainted within minutes after receiving vaccine. Fell out of chair and blacked out. She woke up immediately but felt very confused and shakey. 911 was called and vitals were taken by EMTs. Patient was picked up by her parents.

Side effects of the Johnson & Johnson shot I?ve had...weakness , fever, muscle pain, body aches, headache, cold sweats, dizziness, chills.

Janssen COVID-19 Vaccine Chills, muscle aches, mild headache, a sudden reduced ability to hear and see, cold sweat, lightheadedness, disorientation Starting at approximately 1:00 am on 4/08/21 I woke up with a throbbing left arm, muscle aches, a very mild headache, and chills accompanied by bouts of uncontrollable shivering. I experienced these cold like symptoms throughout the night. At around 6:00 am, I woke up with a very mild headache and muscle aches. I took my temperature, and had a 101 degree Fahrenheit fever. I rested, and took my temperature multiple times that morning-- which had been gradually decreasing. At around 11:30/12:00 I experienced a sudden onset of extreme fatigue followed closely by a greatly reduced ability to hear and see, along with extreme lightheadedness and the feeling like I was going to pass out. I suddenly became cold, and my body was drenched in sweat in a matter of seconds. I think the whole experience lasted around 10 minutes, before it eventually began to pass. I could see clearly again and began to regain my hearing, however I still experienced some lingering auditory complications for an additional three- five minutes ( it sounded like a throbbing white noise). After that, I felt a little disoriented and tired. My aunt had taken me to Urgent Care, but they turned me away, saying I needed to go to the ER. However, by that time my symptoms had passed and I was feeling ok. So I went home and rested. By the next morning, I felt I had completely recovered

Patient had blank stares, nonverbal, loss of vision, cold/clammy hands, stomach tightness, and headache. BP fell to 55/26, 83/48, and 79/42, HR 57 and 62. Patient stabilized and released with father, advised to follow up with provider

Pins and Needles Sensation in fingers- Pt suspects it might be due to anxiety that was exacerbated by the stress of getting an injection - Pt also stated cold feeling in localized to left arm similar to tickling - Continued medical elevation by Doctor and EMT. Pt Parent stated that Pins and Needles Sensation disappeared after the pt arrived at home - As per mom Pt also presented with fever and "pretty bad body aches"

After about 4 hours of having the shot, I got extremely light headed and nauseous. About the same time I got really bad chills and was shaking aggressively from the cold and got very bad pain in my joints, back, neck and injection site. My skin felt very sensitive and hurt to touch. I took medication and felt a little better but was unable to eat due to the nausea. A few hours later I still had very sensitive skin and nausea but I was very hot and couldn?t cool off. The following morning at about 8am on April 9 I woke up with hives on my ears, back of my neck up to the top of my head and the center of my chest. I still had severe body pains and my hives spread throughout the day to my face, inflating my forehead, nose and lips. I was still unable to eat because of the nausea and I was still taking ibuprofen which usually eliminates my hives. My body pain, nausea and hives stayed consistent the entire day despite taking the proper medication precautions. At about 12:30am on April 10 I checked my temperature at 100.3 degrees. At 2:30am it dropped to 98.9 degrees. The first meal I was able to eat was at about 7:30am on April 10 while take over the counter anti-nausea medication. It?s currently about 5:15pm on April 10 and most of my hives have reduced to redness, my body pain and injection site pain is still consistent and my nausea has barely reduced.

Initially: Severe arm pain at the site immediately and then within minutes of vaccine: hearing loss and then tunnel vision to vision loss to feeling that could pass out: Hearing and vision came back in about 5-10 min and with taking off sweatshirt at that time 12 hours later: 101 fever and chills

Patient head tilt back and seized, not responsive and gasped for about 30 seconds, then became responsive. Talked with patient who know date and time got water. EMS was called and arrived within 10minutes.

I got the vaccine at 3:45 arm was sore but I wasn?t worried Later that night around 6 I started feeling disgusting from vaccine so I took an Advil. Around 8-10pm my body started getting chills, I started shaking, I had a headache my muscles were sore, and I started getting a fever. Around 12am all of the previous symptoms got worse my fever was at about 101 and rising and I was extremely tired. At 1am I felt the worst I have ever felt in my entire life. I could barely walk because my muscles and joints hurt and my fever was over 102.5 and I felt like my veins were on fire. At 2 am I moved to my bathroom because the floor was cold and I didn?t want my roommate seeing me cry from how much pain I was in. I have a high pain tolerance but this was the worst pain I?ve ever been in. In the bathroom I was at the peak of the pain of the vaccine. My fever was over 103 all of my previous side effects were worse than ever I felt weak and a little dizzy. I also was having a hard time breathing, my breathing was weak and I felt like I wasn?t getting enough air. I tried looking up on my phone if I should go to the hospital but I could barely pick up my phone to type or look. I dropped my phone and fell asleep in the floor for 20 minutes before I woke up. I walked slowly over to my bed and took a Tylenol and then had a sip of water and felt like I was going to puke. I tried to use my inhaler and I couldn?t hold my breath to use it. I crawled into bed and slept until 11 the next day and was too sore to walk to class all of my joints still hurt and I had a fever of 101 and a headache . I took a Tylenol and around 6pm my fever broke and I was feeling better. The next day I was still too sore to walk to class and had a headache. Today I am still sore but better my lungs still feel a little tight, I feel unfocused , and I still feel dizzy occasionally. I have no appetite and I feel nauseous when I eat so I?ve been eating in smaller portions . Every single day since the shot I?ve felt very tired. I hope these symptoms get better and Looking back on the night of vaccine I should have gone to the hospital.

Weak, sensitivity, whole body aches, incredible spine and shoulder pains, migraine-type aches, sore throat. Felt these symptoms from about 4:00 PM until about 11:00 PM when I went to sleep. The next morning, 24 hours after receiving the vaccine, my head still ached/throbbed, and my back still felt incredibly awful. My left shoulder was also still very sore. As of now, almost 60 hours after the vaccine, the only symptom still remaining is the very sore shoulder. I cannot extend it fully without immense pain, but it still hurts otherwise.

All around 2pm of the day i got the vaccine i got a fever, cold sweats, could not move, was very tired, and it hurt to touch my skin.

My whole body got tingly and then I was freezing and had a fever of 105 my head hurt so bad it made me nauseous I was weak I couldn't even keep my balance to walk I couldn't sleep I woke up every 15 minutes because I was so uncomfortable

chills, hot flashes, feeling flushed, fatigue, mind fog, pain at injection site, extremely sore muscles

fever, body aches, muscle cramping, left arm and hand numbness, shaking, loss of bladder control multiple times

Patient immediately complained of shoulder pain and not feeling well. Within a few hours patient had a fever of a 102+, chills, body aches, nausea, dizziness, feeling faint,shortness of breath, severe headache, severe shoulder pain in both shoulders, severe back pain, loss of sensation in right hand.

Patient complained immediately of shoulder pain and not feeling well. Within 6 hours, Patient had a fever of 102+, body aches, chills, severe headache, shoulder pain, lower back pain, nausea, dizziness, and loss of sensation in right hand. Symptoms continued for approximately 36 hours.

She felt totally fine after the shot and many hours after. She felt fine to go to a horseback ride lesson at 4. Half way through the lesson she acutely felt like she was going to faint/nauseous (she had a ton to eat that day, had a bottle of water just before lesson, etc. so she knew it wasnt those kinds of things) and then had a crushing headache with a lot of "pressure behind her eyes", dizziness, and a really "strange" feeling like out of body, bawling crying, and started FREEZING. I got there 15 minutes later and she was under lots of blankets, white as a sheet, freezing, said her spine was sore from the top to bottom... just tons of symptoms. When I got her, she moved to my car and had seat heater on high and I had to put all the clothes from a suitcase I had in my car on top of her bc she was so cold and her skin was burning up. I gave her 3 200 advil and a bottle of water. ½ hour later i had a thermometer and even after that she still had 102.3 fever. She was rambling some nonsense and seemed very disoriented for a while. She went straight to shower and laid on the floor of the shower for ½ hour, took cold medicine, and evnetually went to sleep. In the night she was freezing again and the fever had spiked and she took more advil. The next day she felt much better in the morning and fine by lunchtime. She was VERY sick/uncomfortable with basically every symptom under the sun.

Dizzy: continuous Nausea: 1 day Hot flashes: continuous Chills: continuous Body aches: continuous Injection soreness: continuous Tired: continuous

Around 5:00 PM the day I got the shot I started to get a slight headache. Shortly after the headache appeared I started to get the chills, I was wrapped up in multiple blankets and started shaking uncontrollably. I then checked my temperature and at this time it was 100.3. I then ate dinner and decided to try and fall asleep. When I lied down my heart began to beat very fast. I tracked my heart rate via a watch and my resting heart rate was around 140 bpm. My fever had also increased to 102. My head ache continued to get worse and I began to have bad neck and lower back pains. I was also having muscle spasm in my calfs. The entire night I could barely sleep because of my high heart rate, body aches, shakes, and the constant change from freezing cold to hot and sweating.

Patient collapsed 2-3 minutes after vaccination. The whole body was pale and irresponsive. She was laid down on the floor. 911 was called. Within a minute, her skin color became pinkish, and breathing was detected. She became aware of her environment. While we waited for the paramedics, her breathing and skin came back to normal. She reported of no breakfast or lunch before getting the vaccine. We gave her some chocolate and water. Her family later reported that she passed out after a flu shot a few years back. Her family refused to take her to hospital after the paramedic's advice.

Fainted and hit head, ,fever, threw up, bad headache, nausea, body aches so bad that it hurt her to touch her anywhere, chest heavy, mouth felt like something in it Lasted for about 36 hours and then weak for another 12 hours Took Tylenol and Motrin after calling Doctor

Patient arrived to clinic to receive Janssen COVID-19 vaccine. Patient was accompanied by father. After consenting to receive vaccine, vaccine was given to left deltoid muscle. After about eight minutes, patient started to express feeling strange, reporting that she felt like she was going to pass out. Patient became clammy and pale. Clinic MD was called for assistance. After a few minutes, patient started yawn, with head nodding back. Patient was slow to respond for approximately 30 seconds during syncope. There was no loss of pulse or no s/s of trouble breathing. In clinic emergency response called, along with 911. Paramedics arrived to clinic, received report from MD and nurse about situation. Patient was assessed by paramedics, EKG done and was NSR, blood glucose done, and VS several times throughout incident. Patient was initially hypotensive with BP 80s/60s, with BP returning to 116/62 within a few minutes. Patient was taken home by parents following incident, electing not to go to hospital with paramedics. Patient was in good condition when leaving clinic with directions from clinic staff and paramedics to seek emergent care if needed.

Adverse event: Day after vaccination, experienced severe dizziness, nausea, and fever. Fell over and experienced loss of vision and loss of control of limbs, difficulty talking. Loss of normal color in skin, instead had greyish/blue tint. Treatment: Cold compress, juice, rest laying down Outcomes: After 10 min of having a cold compress and juice, regained vision and ability to talk. 30 min later, regained ability to move limbs. Still could not stand up without falling over for a couple hours. After 6 hrs, only remaining symptoms were slight fever, fatigue, and some dizziness. After 2 days experiencing fatigue, headache, and dizziness, returned to normal health.

Mild case of Bell's Palsy in which the left side of my face became numb and muscles were unable to move. Was treated with steroids and most function came back within 7 days.

Day 1: Fatigue, headache, feeling hot and then cold, fever, fast and shallow respirations, muscle pain, cold extremities, difficulty sleeping for more than a few hours. Day 2: nausea, fatigue, fever

4:30- chills, headache 5:00- chills worsened, headache, pressure in my head when I moved 6:00- hurt to breath when laying down 6:30- 101 degree fever 7:30- pain in my head worsened when I moved 8:00- bed *woke up every 10 min* *next day* 6:00- 100 degree fever, still hurt to stand, nauseous, really really weak, chills 7:00- chills and hot flashes (with same symptoms as before) 12:00- started to feel a little better- still cold and headache 8pm- feeling okay *next day* Clammy but good

HEADACHE; PAIN IN ARM; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch no was not reported ,The company is unable to performed follow up to request batch /Lot numbers No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and pain in arm. This report was non-serious.

Chills, shortly followed by shivering and chattering. The shivering is so intense it essentially renders the patient in a state of involuntary writhing; muscles across the body, even if not in movement, may be tensed to the point of pain. Muscles affected lie in the legs, arms, and torso. An observer might mistake the event for a seizure, though the patient is fully conscious for the duration. The episode lasts only a few minutes; such an episode has only occurred once.

Systemic: Body Aches Generalized-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Additional Details: patient was taken to er after having a seizure. patient has been feeling sick ever since injection and has missed her period. The physicians at the Emergency room said they could not find anything wrong with her. But mother is convinced something is not right. she is seeking a second opinion from different hospital

AROUND 11PM STARTED GETING THE CHILLS, LEGS SHAKING AND HAD FEVER OF 104. AT 1:30AM, EYES HURT TO THE TOUCH. MOM ENDED TAKING TO ER AROUND 3AM. THEY GAVE HER TYLENOL AND IBUPROFEN. SHE GOT HOME AT 6AM AND SLEPT AND TOOK TYLENOL AND IBUPROFEN ON AND OFF. FEVER FLUCTUATED FROM 101 TO 104 AND BACK, TYLENOL TOOK FEVER DOWN TO 99.7. BUT UPTO TODAY, SHE STILL HAS BODY ACHES.

Around 9pm on date of vaccine severe chills, teeth chattering, nausea, headache. Saw HCP. Next day PT felt no better. Went to two urgent care that would not see her. Went to Med center. She had severe back pain and ringing in her ears at this point. They left her in a room for 30 minutes to go consult with a doctor after she told them she had the J&J vaccine. They came back and told her she had fluid in ear from pollen and back pain was caused from the chills and shaking. She still has a sharp pain in her ear and ringing in ears is still present.

HARD TIME CONCENTRATING; SHORTNESS OF BREATH.; SEVERE SHAKING; FATIGUE; HARD TIME MOVING; HEADACHE; EYE PAIN; FACE BRIGHT RED; FEELING LIKE BOTOX ON FACE; SEVERE BODY ACHE; ARM HEAVY; NAUSEA; This spontaneous report received from a parent concerned an 18 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced face bright red. On 07-APR-2021, the subject experienced feeling like botox on face. On 07-APR-2021, the subject experienced severe body ache. On 07-APR-2021, the subject experienced eye pain. On 07-APR-2021, the subject experienced arm heavy. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced severe shaking. On 08-APR-2021, the subject experienced hard time moving. On 08-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced shortness of breath. On 12-APR-2021, the subject experienced hard time concentrating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from face bright red, and feeling like botox on face on 08-APR-2021, and nausea on 09-APR-2021, was recovering from arm heavy, headache, severe body ache, and shortness of breath., and had not recovered from severe shaking, fatigue, eye pain, hard time moving, and hard time concentrating. This report was non-serious.

She got her J & J vaccine around 4:30 on April 7th ,2021. She was feeling fine up until around 10:00 that night when she began to have some of the regular side effects in addition to some unusual ones that were more concerning. She had chills was feverish and nauseous with flu like symptoms of her body aching. However, at around 10:30 that night she reported having difficulty breathing and having chest pains with pain when she would take breaths. She noticeably was taking very small but frequent breaths due to the pain. She described a pressure on her chest as if there was a bowling ball sitting on top of her chest. She was crying from the pain and her difficulty breathing. She also reported that her throat felt like it was smaller/ constricted. At that time, she was given Acetaminophen and later around 12:00 she was given Benadryl. When she went to bed that night, she was in pain but she also reported that her heart was racing and her resting pulse at the time was 110 bpm. She had the flu like symptoms into Thursday evening but by Friday she looked a lot better except for her difficulty breathing with complaints of chest pain when she breaths with continued pressure on her chest. She rested in bed for most of Friday and on Saturday she got dressed in the afternoon and took a walk around half a mile at which time she was exhausted and felt out of breath. When she walked back from her destination about a half mile, she needed to rest in bed to recuperate. The pain while breathing lasted into Sunday. Monday morning, she attempted to run and became winded from running a short distance of ¼ of the block and could not catch her breath having difficulty breathing and throwing up with a lot of subsequent chest pain that day. She was taken to the doctor by 10:00 that morning to run lab tests and get an examination. She is slowly getting better and taking it easy but Tuesday she still had some pain and by Thursday she is reporting that while the chest pain is still there it is more of a discomfort that she feels when breathing as compared to pain. She continues to report the discomfort when breathing till today 4/16/21 and is still limiting her physical activity but going about her daily routine.

FELT WARM; CRAMPS IN LEG AND BUTT AREA; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 12:45 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced cramps in leg and butt area. Treatment medications included: acetylsalicylic acid/caffeine. On 13-APR-2021, the subject experienced felt warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cramps in leg and butt area, and had not recovered from felt warm. This report was non-serious.

severe chills, shaking throughout the day. Severe right arm pain and lethargy ongoing at time of report.

In the observation area for 5 minutes and started to feel light headache and hot. transported to observation with medics. In observation for 30 minutes. 12:50 PM sitting and eating a granola bar. 1:00pm went home on her own.

Janssen COVID-19 Vaccine EUA 10Pm Night of Vaccine: Extreme chills - shivering and teeth chattering , fever of 101.7 degrees, weakness, lower back and body muscle aches, headache, dizziness and spinning sensation Morning After Vaccine: Fatigue, nausea, loss of appetite, headache, fever of 100.3 degrees

SPASMS ON LEGS, ARMS AND HEAD; SLIGHT HEADACHE; EXTREME TIREDNESS; SLIGHT FEVER; NAUSEA; BODY ACHES; PROFUSE SWEATING; POSSIBLE SEIZURE; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included food allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: unknown) dose was not reported, 1 total administered on 11-APR-2021 around 11:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, after vaccination patient had done lower body workout. On 11-APR-2021, the patient experienced nausea, extreme tiredness, slight fever, slight headache, body aches, and profuse sweating by evening. She took some children's liquid paracetamol (Tylenol). On 12-APR-2021 about 02:00, she also had spasms of her arms, legs, and head that lasted about 20 minutes. She took paracetamol (Tylenol) at about 03:00 and was pretty out of it. The patient's mother was concerned that it could had been a seizure (possible seizure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spasms on legs, arms and head on 12-APR-2021, and the outcome of nausea, extreme tiredness, slight fever, slight headache, body aches, profuse sweating and possible seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210423951-Covid-19 vaccine ad26.cov2.s-seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

FELLING TOO HOT OR TOO COLD; STOMACH PAIN; BODY SORENESS; CHILLS; HEADACHE; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's past medical history included birth control, and concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included the patient have allergies. but no allergies detail provided. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025,expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body soreness. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced severe headache. On 02-APR-2021, the subject experienced stomach pain. On an unspecified date, the subject experienced felling too hot or too cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body soreness, stomach pain, and severe headache on 13-APR-2021, felling too hot or too cold, and chills on 02-APR-2021. This report was non-serious.

NUMBNESS LIPS; FELT COLD AIR IN THE NECK; WEAKNESS IN THE LEFT ARM; INJECTION ARM HURT; MIGRAINE (DIZZY, HEADACHE, NAUSEA, FELT LIKE SOMETHING WAS RATTLING IN HER HEAD, FELT LIKE THERE WAS A HOLE ON HER HEAD); This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient had no medical history. 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, 1 total administered on 06-APR-2021around 10:30 in right arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, around 5 pm, the patient was dizzy, and had a headache and her injection arm hurt. On 07-APR-2021, the patient experienced numbness lips, and reported that "felt like something was rattling in her head, felt like there was a hole on her head, felt cold air in the neck", weakness in the left arm, nausea for which she was put on IV. On an unspecified date, the patient experienced migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness lips, injection arm hurt, felt cold air in the neck, and weakness in the left arm 08-APR-2021, and was recovering from migraine. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210419870-covid-19 vaccine ad26.cov2.s-Migraine, numbness lips, felt cold air in the neck and weakness in the left arm. 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). 20210419870-covid-19 vaccine ad26.cov2.s-injection arm hurt. This event(s) is labeled per RSI and is therefore considered potentially related.

SEVER SHAKING; COLD; DIZZINESS; FEVER; NAUSEA; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient was previously treated with amoxicillin/clavulanic acid for covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sever shaking. On APR-2021, the subject experienced cold. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 103 F, 102 F, 101 F, 99.8 F. Treatment medications (dates unspecified) included: ibuprofen, dimenhydrinate, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever shaking, dizziness, fever, and nausea on APR-2021, and the outcome of cold was not reported. This report was non-serious.

During obs, member became pale, felt faint, appeared to be hyperventilating and was obviously very anxious. Adult emergency called. Moved to holding room. BP 80s/40s O2 sats 60%, patient hyperventilating, c/o numbness in her hands and fingers. Alert and oriented, talking the whole time and very anxious. Member improved with O2 sats 100% BP 120/56. Observed x1 hr.

Dizziness immediately upon standing, followed by nausea and painful deep breaths. Symptoms subsided and patient went home approximately 30 minutes later. Several hours later, patient developed severe vomiting, back pain, and experienced numbness in her leg that lasted through the night. She contacted pharmacy next morning and was advised to go to ER, which she did. She received treatment of IV fluids for dehydration and steroid treatment and was sent home.

Was was pain in calf area and having a hard time breathing and very tired.. went to doctor on 4/20/2021 Doctors Diagnosed with Pulmonary Embolism

ARM HURT; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned an 18 year old female. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 01-JUN-2021) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced arm hurt. On 02-MAY-2021, the subject experienced fever. On 02-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt, fever, headache and fatigue on 03-MAY-2021. This report was non-serious.

Patient was waiting the 15 minutes after her vaccination and lost consciousness. She began to shake slightly which concerned me and we called 911. She came to within a minute and was aware of her surroundings. She stated she felt ok but her head hurt from hitting the floor. We gave her an ice pack for her head. After about 5 minutes she got back in the chair and was here until EMS arrived. While they were there questioning her she lost consciousness again two separate times and displayed potential seizure activity again. They put her on the stretcher and took her to the hospital. She reported she has not had seizures in the past but has fainted from a vaccination in the past but was younger and received 3 immunizations.

Systemic: Dizziness / Lightheadness-Mild, Systemic: patient stated that she couldn't see-Mild, Systemic: Nausea-Mild, Additional Details: Patient stated that she was feeling dizzy and lightheaded. She was sweaty and clammy. She stated that she couldn't see, but now she can see and seems to be fine. I gave her a bottle of water as well.

About 10-15 hours after injection - Came down with headache, fever, body aches, fatigue, and night sweats. Recovered fully 24 hours after injection. May 5th, 2021 ~7:30 am (4 days post-vaccination) I stood up from a seated position and then collapsed moments later and had, what my brother described as, a seizure which was followed by confusion, nausea, and fatigue.

PAIN IN ARM; ELEVATED HEART RATE; FEVER; BODY ACHES; DIFFICULTY SLEEPING; This spontaneous report received from a pharmacist concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, non-alcoholic, and drug allergy, and other pre-existing medical conditions included patient had no significant medical history. 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 03-MAY-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride. On 03-MAY-2021, the subject experienced body aches. On 03-MAY-2021, the subject experienced difficulty sleeping. On 03-MAY-2021, the subject experienced fever. On 04-MAY-2021, Laboratory data included: Heart rate (NR: not provided) 105-120 bpm, 110 bpm. On 04-MAY-2021 02:00, the subject experienced elevated heart rate. On 04-MAY-2021 02:30, treatment medications included: paracetamol. On an unspecified date, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty sleeping on MAY-2021, was recovering from body aches, had not recovered from elevated heart rate, and the outcome of fever and pain in arm was not reported. This report was non-serious.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: resolved after about 10 minutes (reaction developed within 5 minutes of vaccine administration)

Within 5 minutes of receiving vaccine, patient was hot and covered in a full body sweat, seeing spots, kept losing consciousness, nauseous. I couldn't get a reading on the BP monitor at that time as it was too low to read and she couldn't move her limbs. While waiting for EMS she could breathe fine, I could feel a faint pulse, but I had to keep taping her leg and talking to her to keep her awake. She was able to tell us her name and how many fingers I was holding up. I kept trying to get her to squeeze my hand, but I could only feel the tips of her fingers twitching and the whole time she was unable to move her feet/toes. I was able to look at her HR on her watch right before EMS arrived and it was at 62 and by that time her body temp seemed to be back to normal as her Mom said she felt cool and clammy. The BP reading by EMS was 100/60 and they tried to get her to stand but she couldn't and she still kept wanting to roll her head back and sleep.

LOSS OF APPETITE; VOMITING; SLEEPING; CHILLS; LOW FEVER; SEVERE HEADACHE; STOMACH PAIN ON RIGHT SIDE; BACK ACHE; BODY ACHES; HOT/COLD SENSATIONS; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included birth control. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included etonogestrel for birth control. On 03-MAY-2021, the subject experienced stomach pain on right side. On 03-MAY-2021, the subject experienced back ache. On 03-MAY-2021, the subject experienced body aches. On 03-MAY-2021, the subject experienced hot/cold sensations. On 03-MAY-2021, the subject experienced chills. On 03-MAY-2021, the subject experienced sleeping. On 03-MAY-2021, the subject experienced low fever. On 03-MAY-2021, the subject experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 97 F. Treatment medications included: ibuprofen. On 03-MAY-2021 05:00, the subject experienced vomiting. On 04-MAY-2021, the subject experienced loss of appetite. Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach pain on right side, severe headache, back ache, body aches, hot/cold sensations, chills, and vomiting, and the outcome of sleeping, low fever and loss of appetite was not reported. This report was non-serious.

HEART RATE WAS 130/ RAPID HEART RATE; FEEL DIZZY/ FEEL VERY LIGHTHEADED; WHOLE BODY FEVER/ BURNING UP REAL BAD; NAUSEA; FELT WEAK WHEN WALK; HEADACHE / MIGRAINE; This spontaneous report received from a patient concerned an 18 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced headache / migraine. On MAY-2021, the subject experienced felt weak when walk. On 04-MAY-2021, the subject experienced heart rate was 130/ rapid heart rate. On 04-MAY-2021, the subject experienced feel dizzy/ feel very lightheaded. On 04-MAY-2021, the subject experienced whole body fever/ burning up real bad. On 04-MAY-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 130. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel dizzy/ feel very lightheaded, nausea, whole body fever/ burning up real bad, and heart rate was 130/ rapid heart rate, and the outcome of headache / migraine and felt weak when walk was not reported. This report was non-serious.

On 4/20 at 5-6 AM mother found patient in bed moaning with a decreased level of consciousness/ altered mental status. She was not handling her own secretions. She could not talk. Mother tried to scoop secretions out of her mouth and stimulated her. She appeared very pale and could not hold her own head up. She called 911. She was taken to a local ED. The appropriate amount of carbamazepine pills were found in her pill bottle. She denies overdosing. Mother noted no mood issues or findings that make her think she would overdose. ??Potential interaction between antiepileptic and covid 19 vaccine immune response?? Reduced expression of cytochrome P450 enzymes??

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe

Deep venous thrombosis involving the common femoral vein and central portions of both superficial and deep femoral veins. Thrombus is also present within the saphenous vein. symptoms- leg swelling and pain since 5/2/21

The night of the vaccine: body aches, intense chills, fever, night sweats, headache, insomnia The morning after: Passing out/fainting (loss of consciousness for a couple seconds), body aches, chills, headache. *Symptoms improved with sleep throughout the afternoon of the the day after. Body aches and weakness continued for about 4 days.

At first once I received the vaccine I felt completely fine. Later that evening I started to lose my breath and had a fever. By 9:00pm I was unable to move the left side of my body, had sharp pains throughout my body, and involuntarily urinated and vomited. This continues until 12:00pm Friday, the vomiting and urinating involuntarily stopped but the high fever, body pains, and numbness continued until Sunday evening. Now I still am experiencing random sharp pains and numbness on the left side of my body to the point where I cannot move it at all. I am throwing up occasionally (which has never happened before), and I have had a headache and insomnia since I got the vaccine. Pains behind my eye, loss of appetite and weight loss have occurred since.

Staff member received the first dose of the Moderna vaccine on 4-15-21 and was scheduled to receive the second dose on 5-13-21. The nurse administering the vaccine on 5-13-21 administered the Janseen vaccine instead of the second Moderna vaccine by mistake. She reports that she had a fever, stomach ache/cramping, muscle cramps, lightheadedness and fatigue X 3 days following administration of Janseen vaccine.

MIGRAINE; DIFFICULTY SPEAKING (STUTTER WITH A SLIGHT SLUR); This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use the patient did not have any no known allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced difficulty speaking (stutter with a slight slur). On 13-MAY-2021, Laboratory data included: CT scan (NR: not provided) Clear, EKG (NR: not provided) Negative, and Toxicologic test (NR: not provided) Negative. On an unspecified date, the subject experienced migraine. Treatment medications (dates unspecified) included: escitalopram oxalate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty speaking (stutter with a slight slur), and the outcome of migraine was not reported. This report was non-serious.

Grandmother explained on 5/21/21 that pt had rare sickness called Panda disease that can lead to seizures, twitching, and tics. States pt had to go to ER in the evening after due to severe seizure onset, vomiting, and increased swelling in injection site.

Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient had trouble walking 5 minutes after vaccine injection. Sat patient down. She fainted and was unresponsive for over 1 minute. 911 called and emergency team came to check vitals. NP on duty also assisted checking vitals. Patient became conscious 1 minute after fainting. Her and her mom stayed in the store for an extra 30 minutes and decided to leave. Patient feeling normal.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient has vasovagal and experiences syncope somewhat regularly. 911 was called when she did not immediately regain consciousness, however she came to within 1-2 minutes. After 45 minutes of rest, reporting she felt normal again and being evaluated by EMTs she was cleared to leave on her own.

About 10 minutes after the vaccine, pt's father signaled he needed help. Pt was cold and had chills. She did not speak English well, and she said she couldn't hear. Then she stated that her throat was closing up. Then she stated she couldn't see.

syncope: Immediately after receiving the vaccine, patient complained of being dizzy, weak, 'turning black' and pale. Her mother said that she had a similar reaction to her HPV vaccine. It looks like this was primarily due to anxiety to vaccine. Patient was instructed to lie down on supine with feet elevated. Patient never lost consciousness. After 2-3 min of lying down, patient was able to get up by herself and was instructed to take a seat in waiting area for 15-20 more min. AFter 15 min, the family left and patient was feeling normal.

Patient reported being dizzy 2 minutes after vaccination. Upon going out and attending to patient, eyes starting rolling a bit and patient shook awkwardly a few times..as if was about to slip to unconsciousness. Tapping patient and repeating name she came out of this very shortly (4 seconds or so), and stated feeling lightheaded and dizzy. Patient was brought water, a cold pad, and some crackers and had her feet elevated . Patient was continuously monitored and continued to improve after initial episode. Blood pressure was taken twice during event, and was 109/61 and 109/62.

Patient received vaccination seemed okay went to get a drink of water. Sat down in waiting room and said she was going to pass out. I ran out she passed out for 30 seconds. She was completely out I shook her arm called her name several times. She came to and was very clammy and sweating. Her skin went pale. She vomited. I laid her down on the floor.

DIZZINESS (WHEN WALKING); FEVER; SORE ARM; SEVERE HEADACHES; This spontaneous report received from a parent concerned an 18 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, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced sore arm. On 07-JUN-2021, the subject experienced severe headaches. On 08-JUN-2021, the subject experienced dizziness (when walking). On 08-JUN-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from sore arm, and had not recovered from severe headaches, dizziness (when walking), and fever. This report was non-serious.

WITHIN 3 MINUTES OF ADMINISTERING VACCINE, PATIENT ALERTED ME THAT SHE FELT DIZZY; SAT HER BACK DOWN IN IMZ BOOTH; WITHIN SECONDS SHE FAINTED; CALLED EMS; LOWERED HER TO THE FLOOR; POSSIBLE SEIZURE (NOT CONFIRMED) BUT LOOKED AS THOUGH HER ARM STIFFENED; PT HAD NO HX OF EPILEPSY; MADE GURGLING NOISES B4 SHE REGAINIED CONSCIOUSNESS; ROLLED HER ONTO HER SIDE SO SHE WOULDN'T ASPIRATE; SHE STATED THAT SHE WAS IN A DREAM STATE WHEN SHE WAS SITTING IN THE POST VACCINATION SEATING; BODY FELT NUMB& THROAT FELT TIGHT BUT BOTH RESOLVED WITH NO NEED FOR EPIPEN; FELT QUEEZY FOR CONTINUING OBSERVATIONS; EMS ROLLED HER OUT ON THE STRETCHER TO CONTINUE OBSERVING HER IN THE TRUCK & THEN RELEASED HER INTO HER FATHER'S CARE;

18 yo Male client received Janssen vaccine at 12:54. Immediately following injection, client slumped over in chair and began seizing. Seizure lasted 2 seconds, client immediately became alert and responsive. Client stated he got ?cloudy? but feels normal post event. Client assisted to floor to lay down. After 20 seconds client wanted to get up stating he was feeling normal. Client escorted to observation area where he was observed for full time without further events. No EMS called Ambulatory upon leave with his family

Around 8pm on the day on my vaccination, started having chills and a fever. These were the worst chills I have ever had. My whole body was shaking. I think that the chills ended around midnight. I lost my appetite the evening that I got my vaccination, haven?t regained my appetite yet, and I became somewhat nauseous. I haven?t thrown up yet. The morning the day after my vaccination I woke up and my abdomen was hurting a little bit. I was hot most of the night into the next day.

Right after getting the vaccine, patient got dizzy and experienced blurry vision. I had patient lay down on the floor and elevated her feet. Gave her an ice pack because she complained of sore arm. I also gave her some orange juice to drink after about 10 minutes when she started feeling better. after about 25 minutes patient felt fine and ended up leaving the pharmacy area with her mother. Called patient after about 2 hours and patient was back to normal.

TINY BLOOD SPOTS ON THE LEFT THIGH, LEFT SIDE OF FOREHEAD AND NEAR BOTH EYES; CHEST PAIN; SHORTNESS OF BREATH; PERSISTENT ABDOMINAL PAIN; BLURRED VISION; LEG PAIN; MUSCLE ACHE; FEVER; FATIGUE; HEADACHE; SORENESS IN RIGHT ARM; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and allergic to pineapples. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced soreness in right arm. On 16-JUN-2021, the subject experienced tiny blood spots on the left thigh, left side of forehead and near both eyes. On 16-JUN-2021, the subject experienced chest pain. On 16-JUN-2021, the subject experienced shortness of breath. On 16-JUN-2021, the subject experienced persistent abdominal pain. On 16-JUN-2021, the subject experienced blurred vision. On 16-JUN-2021, the subject experienced leg pain. On 16-JUN-2021, the subject experienced muscle ache. On 16-JUN-2021, the subject experienced fever. On 16-JUN-2021, the subject experienced fatigue. On 16-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.8 to 100.2. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness in right arm, headache, fatigue, muscle ache, fever, chest pain, shortness of breath, blurred vision, persistent abdominal pain, leg pain, and tiny blood spots on the left thigh, left side of forehead and near both eyes. This report was non-serious.

Sudden sharp pain in the right leg under the knee. Making it difficult to walk and move. Noticed three small bruises in the same area appeared around 1 hour after the pain started. Also some swelling around the area. And the area around the bruises is pale (white) This happens today at 2:30 pm June 24 The vaccine was administered June 21 11:30 am

Woke up day 12 could not get out of bed, extreme joint pain in arms, wrists, shoulders, fingers, neck, legs, ankles, toes... joints "locked" ongoing joint pain, swelling and locking to the point of not being able to walk or use arm and fingers on days. Pain is significant adn affects every day activities.

Patient passed out momentarily. She was sitting and fell back in chair and had convulsions. Eyes remained slightly open, breathing not affected in any way. Patient was awake, alert and responsive within a minute. 911 called and patient taken to hospital.

SHOOTING PAIN DOWN THE ARM; HEADACHE; FEVER; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced shooting pain down the arm. On JUN-2021, the subject experienced headache. On JUN-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shooting pain down the arm, headache, and fever on JUN-2021. This report was non-serious.

3 BRUISES IN THE AREA LINED UP VERTICALLY ON RIGHT KNEE AND FEELS HARD TO TOUCH; A LITTLE SWOLLEN RIGHT KNEE; PAIN IN RIGHT LEG SPECIFICALLY BELOW THE KNEE; GENERAL BODY WEAKNESS; A LITTLE TIRED; CHILLS; GENERAL BODY DISCOMFORT; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included motor problems specifically to legs ( weakness in bilateral legs due to being born premature), non smoker, and non alcoholic, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281 and expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the subject experienced general body discomfort. On 21-JUN-2021, the subject experienced chills. On 21-JUN-2021, the subject experienced general body weakness. On 21-JUN-2021, the subject experienced a little tired. Treatment medications included: acetylsalicylic acid. On 22-JUN-2021, treatment medications included: ibuprofen. On 25-JUN-2021, the subject experienced 3 bruises in the area lined up vertically on right knee and feels hard to touch. On 25-JUN-2021, the subject experienced a little swollen right knee. On 25-JUN-2021, the subject experienced pain in right leg specifically below the knee. Laboratory data included: Pain scale (NR: not provided) 7-8 on a scale of 1-10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general body discomfort, chills, general body weakness, and a little tired on 22-JUN-2021, and had not recovered from pain in right leg specifically below the knee, a little swollen right knee, and 3 bruises in the area lined up vertically on right knee and feels hard to touch. This report was non-serious.

SHORTNESS OF BREATH; CHEST PRESSURE; STOMACH PAIN; BACK PAIN; NECK PAIN; NUMBNESS IN CALVES; TINGLING IN FEET/SKIN FEELS STRANGE; SORE THROAT; BUBBLED EARS/RINGING IN EARS; PALE HANDS AND LEGS; RESTING HEART RATE WAS 99-110; SHOULDER PAIN; RIGHT LEG PAIN; HEAVINESS IN LEGS; CHILLS; PAIN AT INJECTION SITE (DURING ADMINISTRATION OF VACCINE); FEVER; HEADACHE; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight was 153 pounds, and height was 65 inches. The patient's concurrent conditions included positive for lupus anticoagulant factor (anti-phospholipid factor), non smoker, non-alcohol user, latex allergy, rubber allergy, allergic to silicone, and resting heart rate runs high. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 05-JUL-2021 11:15 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, Laboratory data included: Heart rate (NR: not provided) 99-110, and Oxygen saturation (NR: not provided) 96-99%. On 05-JUL-2021, the subject experienced shortness of breath. On 05-JUL-2021, the subject experienced chest pressure. On 05-JUL-2021, the subject experienced stomach pain. On 05-JUL-2021, the subject experienced back pain. On 05-JUL-2021, the subject experienced neck pain. On 05-JUL-2021, the subject experienced numbness in calves. On 05-JUL-2021, the subject experienced tingling in feet/skin feels strange. On 05-JUL-2021, the subject experienced sore throat. On 05-JUL-2021, the subject experienced bubbled ears/ringing in ears. On 05-JUL-2021, the subject experienced pale hands and legs. On 05-JUL-2021, the subject experienced resting heart rate was 99-110. On 05-JUL-2021, the subject experienced shoulder pain. On 05-JUL-2021, the subject experienced right leg pain. On 05-JUL-2021, the subject experienced heaviness in legs. On 05-JUL-2021, the subject experienced chills. On 05-JUL-2021, the subject experienced pain at injection site (during administration of vaccine). On 05-JUL-2021, the subject experienced fever. On 05-JUL-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 06-JUL-2021, Laboratory data included: Body temperature (NR: not provided) 101.1 F, Heart rate (NR: not provided) 117, and Oxygen saturation (NR: not provided) 97 %. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) high, and Lupus anticoagulant (NR: not provided) positive, slightly high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pale hands and legs, had not recovered from neck pain, and the outcome of fever, pain at injection site (during administration of vaccine), headache, sore throat, chills, heaviness in legs, tingling in feet/skin feels strange, shortness of breath, bubbled ears/ringing in ears, stomach pain, back pain, numbness in calves, chest pressure, right leg pain, shoulder pain and resting heart rate was 99-110 was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.

VOMITING (NOTHING CAME OUT); DIZZINESS; HAND SORENESS; WEAKNESS; FEVER OF 104; NAUSEA; HEADACHE (FELT SHE COULD SCREAM); This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced vomiting (nothing came out). On 09-JUL-2021, the subject experienced dizziness. On 09-JUL-2021, the subject experienced hand soreness. On 09-JUL-2021, the subject experienced weakness. On 09-JUL-2021, the subject experienced fever of 104. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced headache (felt she could scream). Laboratory data included: Body temperature (NR: not provided) 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 104, nausea, vomiting (nothing came out), weakness, headache (felt she could scream), hand soreness and dizziness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210724637.

I began feeling weak and fluey around 8:30 or 9:00 pm. I decided to go to sleep around 10, noticed my fingers had turned yellow and lost all circulation. I went downstairs to ask my dad what to do, and immediately felt like I was going to faint. Sat down on a chair and put my head between my legs, but passed out as I was doing so, and fell on the floor. According to onlookers (brother and sister, who is an EMT) I was convulsing and stopped breathing for about thirty seconds, and my eyes were glassy and rolling. I woke up to my sister telling me to breathe. There was blood on the floor (I had hit my face on the way down) and I was trembling uncontrollably and had wet myself. I was awake and aware of my surroundings, and remembered everything up to and including sitting sitting on the chair before I passed out. My brother had called 911 while I was out and an ambulance came within five minutes. The paramedics put me in the ambulance and took me to the hospital (they would have taken me to local except there was risk that it was a seizure, which I guess local isn't equipped to handle). They measured my vital signs, made IV ports in my arms and drew some blood. My blood pressure was super low and my heart rate was super high, and I had a temperature of 102. When I got to the hospital they put two liters of saline drip into me to rehydrate me, did a CAT scan, and some bloodwork. They discharged me around 3:30 AM on Monday morning, told me to stay hydrated and get a lot of rest. I slept all day yesterday (Monday) and was feverish and weak. By today (Tuesday) I think I have mostly recovered.

Patient describes an acute episode of difficulty breathing, tingling in hands and feet and tension in arms and legs. This occurred after the vaccine (woke her from sleep) and has occurred a few more times since then. It goes away after about 45min. Has never occurred before getting the COVID vaccine

patient passed out shook a couple times and slid down in the chair then a few seconds later woke up scared and unaware of where she was. She was warm and clammy plus felt like she was going to vomit. All complete symptoms of syncope. I stayed with patient and placed ice pack on her back neck area and offered her a drink of water. after about ten minutes she was completely back to norm and i continued to watch her for 30 minutes. she states that she faints every time she receives a flu vaccine as well. she went home with mother after the waiting period.

Approximately 2min after injection patient slumped down in chair and fainted. She came too briefly then fainted again with snoring resperations. I immediately placed her on the floor and opened airway. I got more help and elevated her feet. Patient came too. Her face was flushed but no other rash on body. No signs of difficulty breathing or cramping. Vitals were b/p of 92/60 with pulse of 88. I placed an ice pack behind her neck and gave her something to drink I monitored her for about an hour. She was able to sit in a seat with no dizziness or difficulty and b/p came up to 96/72. Patient ended up walking out with dad feeling better.

Fever began around 11pm 3/6/21 and went to 102.3 at about 2:00 am 3/7/21. She had chills for several hours during this time. She felt nauseous, had skin sensitivity, a dry mouth and muscle pain, and felt exhausted. No fever this morning but still some skin sensitivity, nausea and feeling tired, muscle pain, dry mouth, and hot/cold back and forth.

9 hours after the vaccine, the patient was extremely fatigued, experiencing hot flashes, muscle aches, and a fever. Treated with 1000 mg Tylenol. The patient felt relief at hour 26 after vaccination

patient experienced tiredness and fainted for a few seconds after injection, a few seconds of twitching occurred before waking up. Paramedics were called, once arrived, patient was evaluated and denied transport.

Around 7 hours after receiving the vaccine I started to get a fever. It was 99.6 at 11:30pm, 102.2 at 2:15am, 102.7 at 3:25am. It started going down at 4:00am after taking 1000 mg naproxen and Tylenol. Fever came back around 1:15pm today at 100.7 and has been up to 101.7 as of 5:30pm. The fever has come along with relentless shaking due to the chills. A migraine has also persisted despite taking NSAIDs to help with that as well.

extreme headache and dizziness about 4 hours after the shot at around 4:00 PM. migraine continued to get worse and i was seeing spots, vertigo and loosing balance and that lasted until 7 pm on 3/13

I received the Janssen COVID-19 Vaccine EAU at 1:45 PM. I was very tired around 8:30 PM, so I went to bed. I never fell fully asleep and began feeling worse at 11:00 PM. I had a fever of 101.5 F, chills, muscle spasms, anxiety, shortness of breath, and could not stop crying. This lasted until approx. 4 AM when I finally fell asleep. The next morning I woke up feeling much better. But, for the next 5 days, I have had on-and-off low-grade fevers between 99F and 100F.

National Guard Nurse Note: "1323: approx 10 minutes after Janssen covid 19 vaccine was administered patient c/o feeling 'lightheaded, hot, dizzy, sweaty and shakey'. Pt vitals were taken b/p 100/60, ox/ra 97%, p 70, r13. Assisted to stretcher in a seated position. Pt denies headache, vistion changes, or sob. shis is aox3. Communication is appropriate, no slurred speech. Pt able to smile w/o facial drooping. Given water to drink and ice pack placed behind her neck. 1338 vitals takend b/p 110/60, ox/ra 96%, p 73, r13. Pt states she does have a history of anxiety and 'afraid of needles and coming to the clinic today'. 1345: Pt states 'I feel better'. offered pt a snack but declined. pt denies sob or difficulty breathing. 1400: pt states she feels well enough to leave. Pt denies dizziness, lightheadedness, shortness of breath, headache or feeling of being hot. 1401 Pt assisted to her vehicle, her friend will be driving. Pt adn her friend advised if symptoms return, difficulty breathing or sob, hives, rash or any other unusual symptoms occur to call 911 immedicately." RA BSN 3/15/21 @ 1412

Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: she fainted shortly after administration. when i went back to her..she was conscience and breathing ok. She felt like it was typical to what she experiences with vaccines and did not blame the vaccine at all. She was responsive and did not seek additional help. she refused an ambulance. she had a friend pick her up so she didnt have to drive home.

Pt had a fainting spell. At first it appeared as if she was potentially having a seizure. After about 3 minutes she came to and was fine. She was examined by EMS and was released to going home own her own with her friends.

Violent uncontrollable full-body shaking for an hour with a high fever, shooting pain throughout the body for a day or so.

5:40pm - vaccine given 5:50pm - patients arm and legs begin itching, slight tingling of the tongue 6:00pm - Diphenhydramine injection given IM/RA 50mg/mL. BP 135/95, O2 Sat 96-97%. Dr was contacted via telephone (and continued on the phone until patient left the facility.) 6:25pm - Patient states that itching of extremities seems to be getting a little better, but tingling of tongue seems to be getting worse and now throat is tingling, voice sounds "raspy". Epinephrine 0.3mg was administered via EpiPen to the left thigh, at the direction of Dr. 6:40pm - Patient was transferred via ambulance to ER for observation.

Roughly six hours after receiving the vaccine, I began to get the chills, and I couldn't stop shaking. Roughly an hour to an hour and a half later, the chills/shaking stopped, only to be replaced by a fever. My temperature shot up, my ears began to ring, and my head began to pound. When I tried to eat, I felt sick to my stomach. My fever lasted for the entire evening, and I spent most of the night alternating between chills and heat flashes. My head continued to pound, and whenever I tried to sit up, I felt dizzy. At around 4am, I awoke with an upset stomach, diarrhea, and further dizziness. By around 8-9am, my fever had subsided, and I was beginning to feel a bit better. However, I have been feeling physically drained and a little achy today (03/26).

Exhaustion, headache, fever, chills, nausea, weakness, pain in injection site, pain in joints/muscles (neck and back)

Janssen COVID-19 Vaccine EUA. Symptoms: fever of 103.4, chills, headache, ringing in ears, nausea, sore arm, dizziness (started same day as shot approximately 8 hours after shot) Still felt sick next day with fever of 100 with all the same symptoms that I listed above 1 week later my arm is still sore from injection site

SEIZURE; DEHYDRATION; This spontaneous report received from a pharmacist concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dehydrated, anxious, non alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient did not had history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the patient had an seizures with in 1 minute after vaccine administration which was lasted for 10 second. The patient did not had history of seizure. The patient was taken to hospital via ambulance and they found that she was dehydrated and was given fluids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure on 16-MAR-2021, and the outcome of dehydration was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210332197 -JANSSEN COVID-19 VACCINE Ad26.COV2.S-Seizure, Dehydration. 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).

A few minutes after the vaccine was administered, the patient appeared to have a seizure for a few seconds. Her eyes rolled back, stiff arm, and she urinated herself. Her mom was holding her hand and after a few seconds, she was able to talk and said that she thought that she fell asleep for a few seconds. We called an ambulance and they are taking her to the hospital for a CT scan.

Within a few hours of getting the vaccine started with Flu symptoms of severe body aches, chills, headache, fever. Day 2 a bit better but still low grade fever of 101 degrees, nausea, weak, body aches but not as bad. In the evening around 5pm noticed ears starting to enlarge but didn't think much of it, by morning today at 7:30am I felt my face was swollen and numb on the right side. Now both ears were swollen and the area in my face was red. When I took my temperature on my forehead I was normal however the swollen cheek was 102 degrees. At that point I went to urgent care to get it looked out. Currently at 6:30pm on 4/3/2021 the redness in my cheek has turn back to normal however the face is still swollen but not as bad.

At 0830, RRT was called for a 19 y/o F with c/o dizziness, lightheadedness, pain in neck area, and difficulty with vision. At initial meeting, client was pale and stated she had difficulty breathing and had blurry vision, per client, like in ?hyperspace?. Head-to-toe assessment completed. Client was diaphoretic and cool and clammy. Pulse was thready. AA0x4 and tachypneic but has clear breath sounds. PERRLA. Vitals: BP: 100/60, HR: 55, 02: 95% on RA. Mother and father present during this time. No PMH, NKA. Did not take any medications today, only ate a small breakfast. Not pregnant. Client states she had a similar reaction like this with the HPV vaccine 1 year ago. During monitoring/observation time, client?s status improved. Client insisted for EMT/ambulance assistance. 911 called. EMT arrived at 0845. During EMT evaluation, client vomited about 70 ml of clearish/yellow emesis. After paramedic explained options of going home or transportation to the hospital, client opted to be transported to the hospital. Client left facility with paramedics (AMR 332), accompanied by mother and father. Patient transported to Hospital via ambulance.

Within 10-15 minutes after receiving the vaccine, the patient complained of nausea and was very white and clammy. When observing her, she appeared like she was going to fall over so I had her mom help me put her on her back. 911 was called and I took her blood pressure and it was 80/49 mmHg. She remained conscious and EMS took her to ED for observation. She was given liquids, discharged and told to come back if she had any other symptoms. Per her mother, she had not ate or drank anything prior to receiving the shot.

Patient became dizzy and lightheaded shortly following vaccination. Other symptoms included paleness, partial loss of consciousness, momentary loss of vision, diaphoresis and slurred speech. Patient was given a cold compress for the back of her neck, some peanut butter crackers to eat and water to drink. She had not eaten anything today with the exception of candy and coffee. Feet and legs were elevated and patient began to regain some color in her face and started feeling better after a few minutes.

Patient stated she was feeling dizzy and cold. Her pulse felt strong and regular but she was cold to the touch. She was given water and laid down while being monitored. After approximately 20 minutes after the event she said she was feeling better and left without assistance.

Immediately after the vaccine, my left arm was shooting pain and cramped up. That faded after a couple minutes and I felt fine afterwards. Starting at 7:00PM (April 6/same day), I suddenly felt extremely dizzy, nauseous, and my entire body is aching to the point of tears. My lower abdomen and spine/hips are also in terrible pain. I?m in too much pain to sleep even though I?m exhausted and for a little while, I was struggling to catch my breath. I also have chills and feel that a fever is not far off.

I?ve been fevering and shaking since 4am on 04/6/2021 and it is now 8:51 on 04/6/2021. I have dizzy spells, a runny nose, aching joints, a pounding headache, my eyes ache and burn, I constantly feel like throwing up, and I haven?t been able to sleep at all.

101.3 fever by 6 pm, 101.1 fever the next morning (6 am) intense shivering and aches in afternoon of 4-06 and intense heat evening of 4-06 and morning of 4-07. I took Tylenol and ibuprofen throughout it which definitely helped and my fever would break but then once the medicine wore off the fever would come back. Symptoms ended around noon today (4/07).

11:16 am Shortly after receiving vaccine, complained of pressure in chest, dizziness, body shaking, lightneaded. Offered water and granola bar and ate the bar. Blood sugar checked by EMT on site at 115 at 11:20 am. BP=98/60, 99 O2 sat, 60 pulse and regular. After about 10 minutes, recovered fully and was able to leave the clinic. Roser is from Spain and limited English, so Spanish interpreter was used to communicate.

Within the hour after receiving shot, migraine formed along with fatigue. Both progressively got worse through out that day(4/7/21). On 4/8/21 I woke up many times through out the night with a migraine that felt as though my brain was burning and sinus pressure, causing immense eye sensitivity. Throughout the night I became increasingly more sweaty, but didn?t have the proper thermometer to take my temperature. I took ibuprofen (at 6:45 AM on 4/8/21) which helped those two side effects subside (around 8 AM). Fatigue has been constant throughout both days. Around 5:00 PM on 4/8/21 I ate broccoli and rice for dinner, small amounts, and encountered bad diarrhea. It lasted for about half an hour. Migraine is reduced significantly (at 6:41 PM), but there is slight nausea, weakness, and fatigue.

The day after i felt tired and weak, headache and body/joint pain, i started to feel better but then i woke up today feeling very dizzy and lightheaded

I got my shot at 1:00 pm and my side effects started to begin at 8:30pm. It started off with a slight headache and body aches with pain in my injection spot. My whole body started to shiver uncontrollably. My body aches focused on my spine and I started to become dizzy and nauseous. Around 4:00 am, the worst migraine, I have ever had that encased my whole head, lasted for about 12 hours with hot flashes. After the migraine, my body and head is sensitive to rapid motion and loud noises.

My school, hosted a clinic and pressured students to receive the vaccine, threatening them with an email saying we may not be able to return to school the next semester if we did not receive the vaccine in the next day and a half. I felt extremely dizzy after recieving the vaccine, and I've never felt like that after any shot before, sho I was concerned. Within five hours, I started feeling really weak, and I developed a fever. In an hour, my fever rose to 104, my hands and feet were blue, and I felt so cold my fingers and feet were numb. I couldn't breathe, and I started coughing every time I took a deep breath. My entire body ached and I had stabbing pains in my abdomen. This was the worst pain I had ever felt in my life.

Janssen COVID-19 Vaccine EUA Immediately after getting the vaccine, I experienced severe nausea for 10-20 minutes. I experienced no symptoms for 3-4 hours afterward, but then began to develop a low-grade fever, muscle aches, a headache, and became nauseous again. Around 12 hours after getting the vaccine, I developed a fever of 102 F, I began to experience severe muscle aches and cramps in my calves and abdomen. I also began to develop a much worse headache and lost partial vision in my right eye for a few hours. This is when I became violently nauseous, but I was unable to throw up, or defecate. I was unable to sleep during this time, and at 2 am, my nausea peaked, and I threw up incredibly violently and incredibly suddenly. It was so violent, it caused me to pop a blood vessel in my eye, and gave me a sore throat. However, after throwing up, most of nausea subsided. At this point, the vision began to return to my eye. 20-40 minutes after throwing up, I began to experience chills that lasted for up to an hour. Eventually, I slept at 4 am, but slept fitfully, and woke every 40 minutes to 2 hours. At 7 am on the 9th, the nausea was completely gone the day after my vaccination, but the muscle aches and headaches were back. My fever was down to 101, and I took some Tylenol and slept fitfully until 2 pm when I woke up feeling significantly better.

Symptoms started around 9:15pm on 4/8 ??Mild Arm Soreness initially ??Fever of 100.0 at 10pm. 101.4 at 11:30pm, 99.6 at 4am ??Chills/Tremors: Stop and Start after a couple minutes. Did not stop until 2am ??Hot Breath; Felt like fire after cold water ??Extra Discomfort on lower back/sides ??Jaw Pain after chills stopped around 11:50pm. Took Advil to help Symptoms for 4/9 ??Sharp pain in chest when breathe in too hard at 4:50pm ??Fatigue all day. Only got out of bed to pick up mail and use the bathroom ??Diarrhea at 6pm. Couldn't keep anything solid down except oranges and bone broth ??Chest Pain after 8:30pm: Put ice pack on chest and it relieved pressure. It feels like something is stuck down my esophagus, even though I have not been able to eat anything solid.

Janssen COVID-19 Vaccine EUA About 8 hours after the vaccine, I developed a fever and chills. Then when I went to bed at 9:30 pm I had extreme thirst. I tried falling asleep but my fever got worse, chills worsened, I developed body aches, and I got a massive headache. I ended up not being able to get any sleep at all during the entire night because I was in so much pain. I felt tightness in my chest, stomach pains, super sore joints, and my body aches and headache kept getting worse and worse. When I got up to go use the bathroom I could barely walk because I felt so weak and was super dizzy. Later into the night my legs felt like pins and needles as if they were starting to go numb. I still have a fever, body aches, and a headache.

About 3-4 minutes after I vaccinated the patient, while she was in the 15 min observation seat, she lost consciousness, her fiance caught her from falling out of her chair. I ran over, and as soon as I got there she started to convulse, therefore appeared to be having a seizure. I help her fiance get her onto the ground safely and placed her on her side, then called for my tech to call 911. The seizure/convulsions only seemed to last 10-15 seconds. She then came to, and was disoriented. Then she felt nausous, and threw up a small amount. The paramedics arrived, checked her out. She said she was felt fine, and refused to go with them to the hospital.

passed out 2 minutes after moving from vaccine seat to observation area 20 ft away, very brief mild, seizure less than 30 seconds. regained complete alert and consciousness

Patient received the vaccine and approximately 5 minutes later, patient passed out and fell out of her chair onto the floor. 911 was called. Patient was unresponsive for approximately 30 seconds. She came to and was very disoriented and her pupils were extremely dilated. The paramedics came and did blood pressure checks and several other evaluations. They advised her to go with them by ambulance to the ER to be evaluated due to falling directly on her face/head. Patient went outside and was evaluated further in the ambulance but was not willing to go to the ER.

vaccination with the one dose Covid-19 vaccin Johnson & Johnson at 11:40am. Around 6pm patient began having headaches and a bit of fever. By 9pm patient had high fever, body aches, nausea, head spinning, bad headaches, and very fatigued. Mother gave her some pain and fever medicine. By 10pm she began complaining her chest felt like being squeezed. Mother applied some camphor essential oil on her chest. Seemed to bring a bit of comfort. Mother prepared her few bottles to drink throughout the night. Next morning 6am, patient still had a high fever throughout the day and evening, nausea, headaches, body pains but no more chest squeezing! Friday morning: patient's fever is gone. Yet she still has head aches and tired.New symptoms are sore throat and a blue toenail! Saturday morning: still some headache, sore throat, a bit of pain in the chest between the breasts, her arm where the injection took place is swollen as big as a grapefruit and painful to the touch as well as warm. You can clearly see the spot where the neddle was inserted.

The patient called the pharmacy today reporting that she has muscle aches and headache following her Janssen vaccine on 4/8/21. She states she developed numbness in the left cheek starting on 4/9/21. For reference she says the vaccine was given in the left arm. The numbness comes and goes. I encouraged her to register for VSAFE and report her symptoms and to notify us if anything else develops.

Patient experienced tingling in both arms and began what appeared to be a panic attack. EMT's were called and took the patient to the hospital where she received IV fluids and was discharged.

Fast heartbeat within 3 minutes of injection, slight swelling of face and mouth, weakness, numbness and pain of injection site, red rash on arms and legs, difficulty breathing, losing breath walking short distances, 10 hours later I developed muscle pain all over my body, chills, 102° fever, extreme shaking, difficulty sleeping due to muscle pain/aches, and fatigue.

Thursday I got extremely nauseous, muscle weakness as well as muscle pains, started vomiting throughout the night. Friday, I was still extremely weak and had muscle pains and nauseousness, struggling to get up for very long because I felt like I was going to pass out. Still have been nauseous through the weekend and very weak.

By 9:15 pm I developed a splitting headache, I could not look at any light. I tried wearing sunglasses but that didn't help. I was dizzy. I had taken Advil at 8:30 and my temperature was still 100.5. (I kept taking Advil and my temp remained at 100.5.) The pain in my head was the worst I had ever felt and was intense and stabbing .I had waves of nausea, and had extreme chills. I had severe hot and cold flashes. I also had a stomach ache. I tried to watch TV but it was too painful. I was really scared and I did not think the night would end.

While in observation area, patient started to feel dizzy/lightheaded, sweaty/numbness to hands/feet, "static" vision. BP after laying supine: 107/68, Pulse 58, repeat BP 10 minutes later after rest/hydration/snack: 120/83, Pulse 84. last meal/snack/drink: 2.5 hours prior to vaccine- fruit smoothie Prior history of syncope from tooth extraction/flu illness Patient gradually recovered after rest/hydration/food.

i started to have severe muscle pain in my thighs/legs , shooting pain throughout my legs and lower back. My heart was racing majority of the night , upwards of 100 at all times.

Patient received her vaccine and was being observed in the observation area upon becoming diaphoretic, pale, clammy and not looking well. RN approached asked if she was having difficulty breathing and pt reported yes. initially unable to obtain pulse or 02 reading. BP 58/38 and Epi injection was administered to the right outer thigh. Patient color and vitals started to improve and breathing was better. patient also was placed on cot in supine position initially. Last set of vitals prior to EMS arriving was BP 84/72, p-71, 02-99% and respirations are 22.

That night, around 9 pm - from the time I got the shot until then I was fine. At 9 pm, I came to my dorm and I got hot and woozy. My friend told me that my forehead was puffy (swollen). I laid down and I realized I was really really cold but skin was hot to touch. I think I had a fever. I was shaky and shivery and trembling. I tried to take a nap. Fell asleep for an hour - don't remember that time at all - but my friend told me I went to sleep. My smart watch was telling me my heart rate was 120s and 130s while I was sleeping. I debated whether I should go to the Dr. and I called the school police and they took me to the ER - at 03:00 am on the 8th - and they told me to rest for day and wait it out. I still feel like I have a lot of adrenaline - my watch says that my heart rate is way to high for what I'm doing. It's usually in 70's and 80's but it's in the 120's and 130's every day and I am really shaky with adrenaline. I have had a headache since Wednesday night and it hasn't gone away. If it goes past Wednesday, I will go to my primary care doctor but otherwise no treatment at this time.

Patient has felt Blurred vision, extreme nausea. Numbness in hands and legs. sweaty and most imp. Felt CHEAST PAIN from it.

Patient states received vaccine on 4/9/2021. States she had symptoms of body aches, headache, and sore arm 4/9/2021 -4/10/2021. She noticed a full body rash without itching on 4/11/2021 and slight shortness of breath with rest and exertion on 4/12/2021 morning. Patient took benadryl after speaking to her pediatrician. HR 86, BP 118/82, RR 24 O2 sat 96%. Labs for CBC, CMP, urine dip, and chest xray done on 4/12/2021. Patient given 4m IM decadron injection in clinic and started on zyrtec. Follow up appointment scheduled on 4/13/2021.

101.8 fever Muscle pain in neck Shooting pains in spine, hips, and legs, focused on the joints Lasting headache Brief sore throat

Received the vaccine at around 7:15pm. Left the vaccination site and about 2 hours later experienced extreme tiredness and extreme head pain. Head pain progressed and got worse and worse. A fever was present by 3am (99.0) and went up every hour reaching the highest of 102.7. I experienced violent chills and shaking, extreme nausea, extreme muscle aches and pains, extreme light sensitivity, dizziness, lethargy, and extreme weakness. I took extra strength Tylenol every 6 hours to control fever and other symptoms. All symptoms subsided within 24 hours, except for headache, tiredness and aches and pains. All symptoms went away by 8pm on 4/13/2021.

Weakness/Fatigue starting the evening of the injection and persisting for about 48 hours. Chills/fever, nausea, and lightheadedness starting the next morning. Loss of consciousness (Uncertain if it was vasovagal syncope or seizure) 10:30 pm the next day.

4/11/21 fatigue weakness slept 5 hours 4/12/21 chefs pain, clammy dizzy, fainted Headache 4/13/21 trouble tracking, time. Clammy, dizzy, fainted, headache, vomit, body aches, fatigue, tingling, shaking, cheats pain

At about 6PM the same day, I began violently shaking and experiencing severe pain in my hips, back, neck, and all of my leg muscles felt like they were about to cramp. I started having a very severe headache. Today, the next day, I still feel severe joint pain but my headache has been lessened by tylenol. I feel nauseous, am experiencing diarrhea, and am very cold and sweaty.

Flush immediately after shot Severe sweating evening of shot Severe headache 2 days after shot Lump at injection site 3 days after shot

Patient presented to hospital on 4/9/21 - 4 days post vaccination - with new onset left sided weakness. Brain CTA showed a M1 branch occlusion. Patient was given TPA and transferred to Medical Center for further management and mechanical thrombectomy. Successful thrombectomy done. Etiology of stroke cryptogenic but suspect emoblic event. Questionable moyamoya disease - notes state "if moyamoya suspect, patietn will get neurosurgery survice on board/appreciate neuro recommendations"

Janssen COVID-19 Vaccine EUA Numbness on left side of body, numbness in fingers, chest feels heavy, no shortness of breath

About 4 hours after the injection I began to feel extremely tired and took a nap for a couple of hours. When I woke up at 5 pm I noticed body aches and chills, and a migraine that would get substantially worse and became throbbing when I would sit up or stand. After taking some Tylenol (300 mg) I thought I was able to walk for small periods or time (aka walk to the bathroom) but I fainted on the way back

pt experienced weakness, nausea, and near syncopal episodes within 10 minutes of receiving vaccine. Symptoms resolved within minutes, pt was monitored in clinic for an additional 30 minutes with stable vitals and no further episodes. Pt left clinic in good condition, brother drover her home.

Cold chills, sweat, nausea, vomiting, horrible headaches, dizziness, and lightheaded, burning sensation around abdominal area, difficulty breathing.

A few hours after I got home from getting the shot, my lower body started to ache super bad. My skin started to hurt like I had rug burn, but I wasn't surprised because that happens to me when I get the flu. My legs and groin region started to hurt more and more and I got the chills. It was extremely bad and I was sort of writhing but I told myself I was overreacting. At around 8 or 9, I decided I would sleep it off and went to bed. At 1:00 am, I got up to use the bathroom and I began feeling lightheaded. I thought I had just stood up to fast so I continued. As I walked, i got more and more dizzy and I couldn't hear well. When I sat on the toilet, I realized I wasn't going to be able to get back up, so I sat and waited. I started to get super hot so I took my shirt off. I finally was able to get up and walked towards the sink but I collapsed before I got there. I started drinking the sink water and ran my shirt under the water and put it on my head to cool off. This really helped so I went back to my room to call my mom. I have never fainted before or come this close to fainting. For the rest of the night I had the worst migrane of my life that gave me aura in my left eye and made my left arm and left side of my face go numb, as well as pulsing in my head. The pain on my skin, and in my legs and head was still there for two days after but it was manageable enough for me to go about my day. I tried to exercize to ease the muscle pain but this did not work.

Patient presents headache, lower backache, chills, N/V, photophobia, weakness x 7 hours. Patient reports symptoms have been worsening after being sent home from work at 1430. Received J&J COVID vaccine at 0800.

Insomnia first night, fever lasting a few hours beginning 12 hours after the shot. Body aches and exhausted muscles the next day. Night sweats lasting four days (ongoing), swollen lymph nodes in neck. Left lymph node is the size of an egg, right node the size of a grape. Nodes are getting so swollen it is affecting ability to eat, drink, swallow and talk. Feels as if it is restricting throat. Taken single acetaminophen dose night of the vaccination (4/11/21), and one 4/15/21.

Patient claims she felt dizzy after vaccination and lost consciousness near checkout lane approximately 10 minutes after vaccination. She was assisted by asset protection staff and pharmacy staff. She left the store under her own power. She reported that she has had headaches and dizziness after the vaccination and was seen at an urgent care that did not provider her with a diagnosis, but felt her symptoms may have been caused by a concussion. She was advised by clinical team to contact her primary care doctor to follow-up, especially with recent reports of thrombosis linked with the J&J vaccine.

19 year old, female patient received the J&J vaccine on 4/12/21. Today, 4/16/21 she reported chills (the night of), headache and abdominal pain since then, and also that she cannot feel the right side of her face. Went over the EUA information for J&J such as side effects, etc and recommended for patient to contact her health care provider/seek medical attention as a precautionary measure.

nausea migraine- alternated ibeuprophen and tylenol arm pain- took tylenol kidney stone- nausea medication along with oxycodon

Very severe migraine continuously for four days. I checked my temperature the day after and had a fever of 99. I also have headache on and off almost every day for the last few weeks. My arm was moderately sore for the first three days on and off but the pain wasn?t unbearable.

VOMITTED BEFORE LEAVING THE PHARMACY (15 MINUTES AFTER INJECTION) FREEZING CHILLS (6 HOURS AFTER INJECTION LASTING 12 HOURS) MUSCLE SPASMS (6 HOURS AFTER INJECTION LASTING 24 HOURS) MUSCLE ACHES (6 HOURS AFTER INJECTION LASTIN 6 DAYS) SHORTNESS OF BREATH CAUSING ASTHMA SYMPTOMS NEEDING RESCUE INHALER EVERY 4 HOURS (17 HOURS AFTER INJECTION LASTING 4 DAYS) HIVES (17 HOURS AFTER INJECTION LASTING 4 DAYS AND NOW REOCCURING) CALLED PHARMACY MORNING FOLLOWING THE INJECTION TO REPORT PROBLEMS, PHARMACY STATED TO CONTINUE TO USE ADVIL/TYLENOL. CALLED PHARMACY TO REPORT HIVES, PHARMACY STATED TO TAKE DIMENHYDRINATE 50 MG EVERY 4 HOURS PRN UNTIL HIVES DISSAPATE TO GO TO ER IF OBSTRUCTING AIRWAY.

DIZZY; HEADACHES ON RIGHT SIDE BY EARS; GROGGY; FELT OUT OF IT; SOARED AROUND ARM; TIREDNESS; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight was 380 pounds, and height was 71 inches. The patient's concurrent conditions included pre-diabetes, high blood pressure, pollen allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced groggy. On 02-APR-2021, the subject experienced felt out of it. On 02-APR-2021, the subject experienced soared around arm. On 02-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced dizzy. On 07-APR-2021, the subject experienced headaches on right side by ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soared around arm, and tiredness, and had not recovered from groggy, headaches on right side by ears, dizzy, and felt out of it. This report was non-serious.

BURNING NEEDLE IN INJECTION SITE; STOMACH ACHE; FEELING HOT INSIDE; THROWING UP; HAVING THE RUNS; CHILLS ON AND OFF; HEADACHE; This spontaneous report received from a patient concerned a 19 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 03-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 stomach ache. On APR-2021, the subject experienced feeling hot inside. On APR-2021, the subject experienced throwing up. On APR-2021, the subject experienced having the runs. On APR-2021, the subject experienced chills on and off. On APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced burning needle in injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, headache, feeling hot inside, chills on and off, throwing up, and having the runs, and the outcome of burning needle in injection site was not reported. This report was non-serious. This case, involving the same patient is linked to 20210435721.

STOMACH ACHE; FELT HOT INSIDE; THROWING UP; STARTED HAVING RUNS; CHILLS ON AND OFF; HEADACHE; This spontaneous report received from a patient concerned a 19 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 03-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On APR-2021, the subject experienced stomach ache. On APR-2021, the subject experienced felt hot inside. On APR-2021, the subject experienced throwing up. On APR-2021, the subject experienced started having runs. On APR-2021, the subject experienced chills on and off. On 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 stomach ache, headache, felt hot inside, chills on and off, throwing up, and started having runs. This report was non-serious.

BODY ACHE; NAUSEA; CHILLS; VOMITING; HOT FLASHES; MIGRAINE; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced hot flashes. On 12-APR-2021, the subject experienced migraine. On 12-APR-2021, the subject experienced chills. On 12-APR-2021 18:00, the subject experienced nausea. On 13-APR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and the outcome of vomiting, hot flashes, body ache, chills and migraine was not reported. This report was non-serious.

She has a history of Bipolar II, dx about 2 years ago. She has been in counseling for the past 5 years. She just changed from effexor to lexapro about 1 month ago. She has been on abilify 10mg for the past ~6months. On 4/8/21 she went to bed around 11pm and awoke on 4/9 around 8:30am. She had her JJ covid vaccine on 4/9/21. She had 2 handfuls of goldfish crackers on the way to her vaccine appointment around 11am. She had ~6-8oz of water when she awoke. She arrived at the Clinic on campus. She sat down for ~5 minutes and then the staff came to get her. She had the shot administered in left deltoid. When she first felt the pain her vision started to go black and she felt like she was going to pass out. She denies feeling hot or dizzy prior to event. Her vision went completely black, then when she "came to" she was bent over in her chair with arms drawn up to body and fists clenched. Immediately her body relaxed and she felt very confused. She was told she just had a seizure - bend forward and had whole body shaking for ~30 seconds. She felt extremely nauseated and had some dry heaving. Someone helped her to the floor and put up her legs. She was told she looked very pale. She felt much better within 5 minutes. Vitals were checked and were stable. She was given granola bar to eat and drank ~12oz of water. No one sided weakness, no incontinence, no tongue bite. She stayed there for ~45 minutes for monitoring. Someone walked her to her car, asked her if she was ok, and then she drove herself home. Of note, the room she was in was warm and they were going to open doors to get some air. She was not ill or tired at the time. After the event she drove for 5 minutes to her home. Once in her room she felt extremely tired and then slept until 7pm (~6-7 hours). She then called Mom. Mom reports that patient sounded different on the phone. Speech was slow and she seemed "off." Mom drove to her and was at her room by around 7:40pm. At that time, patient looked very pale to Mom. Mom took her home, gave her chicken soup. She did not have an appetite. She just wanted to go to sleep. Mom tried to have her stay up until around 10pm. She had ~8oz of water and then went to bed. She slept through the night. She awoke the next morning and reports that her brain felt like it hurt to work. She had chills, body pain, shakiness during the day on 4/10/21. This was easily managed by tylenol q4. Of note, she did have covid19 in 8/2020. She was ill for ~1 week with lack of smell/taste, febrile, shakiness, headache. She had an odd event on 4/19/21 while giving a presentation at school. She had sudden onset of left pinky numbness/tingling with radiated up the side of her forearm. This lasted ~1-2 minutes. However, her left arm hurt for a few hours afterward. She denies any fatigue after event. She has a Mirena IUD. She smokes nicotine via vape numerous times per day. She smoke weed up to 3X/day but not every day. She drinks beer a few days per week.

Patient stated she needed to go to hospital for adverse reaction of pain in leg. After asking MD to check her leg, they discovered a blood clot per patient. She is now doing well per her.

Started with shortness of breath (still have it) and high heart rate with little exertion. Extreme migranes lasting uo to a week.

Patient has been feeling ill with persisting nausea, headaches, malaise, generalized abdominal pain. She has intermittent shortness of breath with chest discomfort. She is not sure if this related to panic attacks. For the last 3 days she has had left posterior neck pain with radiation of pain to her head and left upper and lower arm. Her left arm feels numb and limp at times. She received the vaccine in her left arm.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: 5 minutes after vaccine pt felt lightheaded and blurred vision. then passed out. patient advised to sit down then passed out again and started to shake head (seizure like symptoms) for a few seconds. patient was pale, confused and started sweating, fingers were cold to touch. Then her fingers started to get numb and tingly. she was having a hard time seeing colors and she started having ringing in ears. Ambulance was called and they took over.

NUMBNESS AND TINGLING IN ARM; IT STARTED IN HER LEFT PINKY AND RADIATED UP THE LEFT ARM. IT HURT FOR A FEW HOURS; BRAIN HURT; SHAKINESS; BODY PAIN; CHILLS; EXHAUSTION; SEIZURES; This spontaneous report received from a health care professional concerned a 19 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, 1 total, administered on 09-APR-2021 on left deltoid for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 09-APR-2021, the patient experienced seizures, confusion, pale appearance and nausea after forty five minutes patient was okay. The patient was drove back home and slept for 7 hours then experienced exhaustion. The next morning on 10-APR-2021, the patient's brain hurt to work and experienced body pain, shakiness, chills. Ten days later on 19-APR-2021, the patient experienced numbness and tingling in left arm. It was started in left pinky finger and radiated up the left arm. It was hurt for a few hours (just 1 episode). health care professional has ordered tests but they had not been completed yet. The patient was seen by a pediatric neurologist on 22-APR-2021 for evaluation of seizures. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizures, exhaustion, chills, body pain, shakiness, brain hurt, numbness and tingling in arm, It started in her left pinky and radiated up the left arm, It hurt for a few hours was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210450038- JANSSEN COVID-19 VACCINE Ad26.COV2.S-Seizures. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Severe arm pain, headache, swollen cheeks, periorbital rash, lip angioedema, and shortness of breath all within 1 hour of receiving the vaccine

After about 6 minutes post-injection, she started feeling really dizzy and briefly passed out. After a couple minutes she was responsive, but still really weak and tired and said she had blurry vision. We called 911 and they came in and monitored blood pressure and heart rate, which was really low when they started, but did come back up into normal range and patient was feeling much better after about 15 minutes, but still tired.

PATIENT IMMEDIATELY FELT DIZZY AND PASSED OUT A FEW SECONDS LATER. THE VACCINATOR WAS NOT ABLE TO CATCH HER FALL AND SHE FELL OUT OF THE CHAIR AND HIT HER FOREHEAD. PT WAS IN AND OUT OF CONSCIOUNESS Q5 MIN, UNRESPONSIVE TO PAINFUL STIMULI, AND MUCOUS MEMBRANES WERE BLUE FOR 30 SECONDS BEFORE JERKING AWAKE AND COLOR RETURNED TO NORMAL. SHE DENIES NECK PAIN, HEADACHE, AND SPINE INTACT. SHE REPORTED DIZZINESS, BLURRED VISION, AND RINGING IN THE EARS FOR Q15 MINUTES UNTIL RESIDED. PT PRESENTED WITH DIAPHORESIS UNTIL HER REPORTED SYMPTOMS RESIDED. VITALS, CLEAR LUNG SOUNDS, AND GLUCOMETER WERE DONE. MEDICS GAVE ORAL GLUCOSE. VITALS MONITORED UNTIL STABLE. PATIENT STAYED WITH FIRE Q1H AND SIGNED AMA WITH FIRE TO GO HOME. SCHOOL SECURITY WALKED HER HOME.

c/o fever, chills, lightheadedness, and generalized body aches after receiving J&J COVID vaccine yesterday. Pt states she is currently feeling better than last night with OTC medications.

Pt's throat and tongue and jaw felt like it was swelling. She had extreme pain in her arm and her hands started swelling. She got a rash on her arms and on her hands. I took her to the urgent care facility and they gave her a shot of Decadron and a shot of Benadryl. They also Prescribed steroids. She was very sick like she had a severe flu. I was very worried as her mother. She was weak and slept constantly. Her arm could barely move and It almost appears as if she had had a stroke. She had brain fog and she wasn't remembering her days like she was missing memory. After five days, the reaction started up again so we took her to the emergency room. They did a variety of tests including a urinalysis, CT of the brain, ECG 12 lead, peripheral venous duplex of her upper arm. Everything checked out OK so they put her on more steroids and sent her home. Pt is still having arm pain a month later but finally feels better.

shortness of breath, pain in legs specifically hip and knee joints. fever of 103. cold sweats, body aches. extreme headache. hallucinations

BACK OF NECK WARM TO TOUCH; PAIN ON BACK OF NECK; HEADACHE; FEVER; This spontaneous report received from a parent concerned a 19 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: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, treatment medications included: acetylsalicylic acid, and ibuprofen. On 06-MAY-2021, the subject experienced back of neck warm to touch. On 06-MAY-2021, the subject experienced pain on back of neck. On 06-MAY-2021, the subject experienced headache. On 06-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever on MAY-2021, and had not recovered from headache, back of neck warm to touch, and pain on back of neck. This report was non-serious.

Patient got really hot, blurred vision, dizzy and threw up once. Gave her water and a fan. Offered her crackers, but didn't want to eat anything. Symptoms lasted for about 5 to 10 minutes. Observed her for 50 minutes after and felt fine. Her aunt came to pick her up. Patient stated she has a history of adverse effects such as this with vaccines.

Patient bleed more than usual when got the vaccine. Has couple of drops fall on the arm. After that patient waited for 30 minutes to check if everything is ok. During waiting patient complained of feeling nausea and getting hot. Patient had some water to drink and after a few minutes patient said she was feeling better. Kept watching the patient for 30 minutes and after that she left the pharmacy area without any problem.

Patient said she had ringing in ear, and was nauseous immediately after immunization. Patient appeared pale, sweaty, and shaky. I told the patient to put her head between her knees. She regained color within minutes. She felt better but we called 911 just to be safe. The patient and the EMT decided the she would be driven home bu her mother to rest.

patient started bleeding at the site of injection. During her wait time initial felt hot and was seeing spots. The patient also was sweating and didn't feel well. Patients blood pressure did drop. We gave the patient an ice pack and water. Patient refused 911 and refused Benadryl. We took the patients blood pressure and had the patient wait for 30 /40 minutes after the vaccine. the patient felt better

Immediately after receiving her vaccination client developed blurry vision and R arm pain. Denied cp/syncope/dizziness. She reported that she had not had breakfast in the AM. She was offered water and her symptoms resolved within 15 minutes of being observed.

Shivering, cold, sweating, dizziness, stomachaches, nausea, headaches, soreness, loss of appetite, extreme exhaustion, drowsiness.

Sudden drop in blood pressure (systolic dropped to 80s, unsure of exact number), vertigo and lightheaded-ness, increased heart rate, fading vision and changes to hearing, tingling in extremities. Nurses started checking bp, apple juice to increase blood sugar, symptoms started to abate after 5-10 minutes. Free to go 30 minutes after vaccination.

PATIENT WAS ADMINISTERED THE JANSSEN COVID-19 VACCINE AT 11:03AM ON 5/27/21. LESS THAN 10 MINUTES LATER, PATIENT STARTED COMPLAINING OF SEVERE ABDOMINAL CRAMPS, LIGHT HEADDEDNESS, AND BLURRY VISION. SHE RUSHED TO THE RESTROOM WHEN THE CRAMPS OCCURED, WHERE SHE VOMITED AND EXPERIENCED DIARRHEA. WHEN PATIENT CAME OUT OF THE RESTROOM AROUND 15 MINUTES LATER, SHE WAS GIVEN WATER AND A SNACK BAR TO SNACK ON. SHE REPORTED FEELING BETTER, NO NAUSEA OR STOMACH CRAMPS, BUT STILL VERY WEAK. SHE WAS ESCORTED TO HER CAR VIA MOBILITY CART, WHERE HER DAD WAS ADVISED TO TAKE PATIENT TO URGENT CARE FOR FURTHER EVALUATION AND POSSIBLE FLUID THERAPY FOR DEHYDRATION.

Patient reports receiving Jansen vaccine around 5:30 pm at the pharmacy. The patient then went home and went to bed. She woke up around 1:00 am on 5/27/2021 with numbness/tingling/pain in the left arm and in both legs. She states "it hurts to even stand on my legs". This has persisted all day and is not getting better. She has contacted her PCP and the pharmacy and they informed her to call us. Other symptoms include headache, jaw pain, dizziness body ache (mostly lower back) and cough. None of these symptoms are normal for her.

Patient recieved vaccine and in appoximately 5 minutes stated she didn't feel right. Momentary loss of conciousness then "I feel sick going to throw up" proceeded to vomit. Staff called 911. She was shaking and upset. EMTs arrived and checked pulse and other vitals. After observation for approximately 30 minutes from time EMTs arrived, patient , her father, EMTs and pharmacist agreed she did not need to go to the ER.

Systemic: Dizziness / Lightheadness-Medium, Systemic: patient said her ears felt like she was under water-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: within 5 minutes of vaccination, pt said she felt like she was going to pass out, her vision was blurry/weird & her ears felt like she was under water. She was sweating & felt clammy and I asked if she ate/drank today and she said she had about 2 hours prior. I helped her to floor % put her in recovery position. after 2 minutes pt stated she was starting to feel better. After 10 minutes patient was able to get off the floor and back into a chair. Had her drink gatorade, her bp was normal.

The night of vaccination I had fever, aches and body chills that lasted for 4 days. On the 6th day after the vaccine the chest pains started. I've been seen in the ER three times now. A stabbing pain under my left breast that is continuous.

With in 5 minutes of receiveing the vaccine, the patient developed shock-like symptoms. Patient presented with pale, cold, clammy skin. Then her vision became blurry and her arms shook when she moved them. After 15 minutes she began to feel better and the symptoms completely resolved after 30 minutes.

GRAND MAL SEIZURE; This spontaneous report received from a parent concerned a patient of 19-year-old female. The patient's weight was 210 pounds, and height was 170 centimeters. The patient's past medical history included seizures, drop blood pressure, and pulse drop, and concurrent conditions included borderline personality, bipolar disorder, cigarette smoker, non-alcohol user, marijuana user, and memory loss, and other pre-existing medical conditions included patient had no known allergies. The patient had 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: 207A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 03-JUN-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, at 7 pm the patient complained of being very tired, she felt that she was passing out and nauseated. At 3 am in morning (04-JUN-2021), patient started to have a grand mal seizure, lied on the floor, totally confused, her eyes went all over the place, she did not remember all the people around her. Based on description patient had memory loss, she could not remember the last 3 years of her life and she was on year between 2017 and 2018. Patient had a history of seizure last 2017 when she was on a psychotropic medication (Topamax) which she was taking because of her bipolar disorder. Medication which was taken for bipolar disorder causes her to drop her blood pressure and pulse which resulted to seizure. Patient was planning to visit doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from grand mal seizure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210611850-COVID-19 VACCINE AD26.COV2.S-Grandmal seizure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE

Patient experienced vasovagal syncope about 4 to 5 minutes after vaccine. Patient was unresponsive for about 50 seconds and then came back for a minute then was unresponsive for 10 seconds and then came back for good. the paramedics we called and patient was checked out. they gave her the ok to leave.

Patient was fine receiving vaccine as well as during the 15 minute mandatory waiting period, however later that evening upon going home she complained of headache and leg pain. Patient was instructed to contact PCP as soon as possible.

Passed out 2+ times for at least 30 sec and more over the course of about an hour. Signs were feeling light headed, dizzy, nauseous, chest pains, and clammy.

8 hours after receiving vaccine I began to shake and get super cold. A pounding headache began. Legs were crampy. This continued through the night but was better in the morning.

was sitting in a chair in the waiting area and within 5 minutes of receiving her vaccination she experienced an episode of syncope and her head and upper body slumped over to the side. A customer in line noticed and rushed over, then the pharmacy technician running the register noticed and pharmacy staff ran out to assist. The syncope only lasted for a couple of seconds before she jerked herself awake. I brought her into the consultation room and she declined to lie down but requested to sit. She drank water but refused any other food or drink. She said she felt better but was visibly shaken up from the incident and was crying. She refused any medical treatment and declined when I offered to call EMS. She called her dad and asked him to pick her up. Then she sat in the consultation room for a few more minutes and left.

104 fever, hands shaking, extreme chills, headache, dizziness, exhaustion, sensitive to light. This came on quickly, less than three hours after receiving the vaccine. Drinking lots of water. I dod not get sick when I got covid. Was not comfortable getting vaccine but had to get it to participate in collegiate sports.

- severe body aches - high fever (102.6 peak before taking Tylenol) - headaches - tingly sensation in skin - muscle soreness

5 hours after the vaccine, I started having a sore arm at the injection sight and a low grade fever of 100.0 with chills and I was uncontrollably shaking. I took ibuprofen at 8:00pm. That night at about 9:00 my fever was 100.8 and I felt extreme fatigue. I woke up at 3:30am feeling both extremely hot and cold with a bad headache and my temperature was 101.5. I took ibuprofen again at 3:30am. I then woke up at 5:15 am with a horrible headache and was very hot and sweating. I put cold compresses on my forehead and back of my neck which helped. The entire night, my arm with the injection site was very painful and stiff to move.

100.9 fever, horrible migraine (can't touch chin to neck), chills, sweats, stomach hurts, shivering, body aches, brain zaps, bad neck pain, nauseous Took Tylenol

Patient received the vaccine at 1500 and at 1510 she began complaining of numbness to tongue and throat. No shortness of breath, O2 saturation 100%, BP 126/84. Paramedics were on scene assessing another patient she they assessed this patient. She was medically cleared and stable. Patient was released to the care of her mother. She ambulated without difficulty to her car. Her mother drove her home.

Flu like symptoms 8 hours after injection, bad headache, body chills and shaking, felt both cold and hot, couldn't untense legs or relax, body aches. Lasted around 4 hours until falling asleep. Mild headache the next day.

Patient was flushed, could not hear, was feeling nausea, and fainted for few seconds. I administered Epi 0.3mg and called 911. Paramedics arrived and patient was taken to the hospital.

Took the vaccine at 6:00 P.M. the night before, no side effects besides occasional dull throbbing pain Woke up at 7:30 A.M., right arm is sore and hurts to lift, experiencing chills, fever of 101.3

Immediately after receiving vaccine, a cold, tingling, transient sensation was experienced radiating from the site of the injection up into the neck. Roughly 6 hours after injection (1 a.m., 3/9/2021) severe chills were experienced for approximately two and a half hours, preventing sleep. Patient experienced dizziness. spO2 was within normal limits. Temperature was measured w/ oral thermometer to be 101.3 degrees farenheit at 4:55 a.m. in the morning on 3/9/2021. Treatment was a single dose of ibuprofen at roughly 8 a.m. (3/9/21). Pt. continued to experience fatigue and sporadic chills, with gradual abatement of symptoms over the course of the day. Pt. had no symptoms the following Wednesday (3/10/21). Pt. experienced symptoms the following Thursday (3/11/21), with a sudden onset of intense stomach pain (8/10 on NRS) starting at approximately noon. Stomach pain was more similar to muscle cramps (with aching quality) than nausea. Other symptoms included fatigue and some feverish experiences (such as chills). Treatment was conservative (ginger tea, peppermint candies, rest). Temperature taken that evening via oral thermometer (roughly 7pm, 3/11/21) was 101.4 degrees farenheit. Symptoms were significantly reduced the following morning, Friday 3/12/21. Temperature taken approximately 10 a.m. was within normal limits.

Extreme fatigue, headache, sweating, chills, shaking, nausea, muscle cramping, difficulty breathing, and dizziness beginning approximately 6 hours after the vaccination. It was so bad that it caused me to stay in bed all day the day following the vaccine and I had to stay home from school and work. Today I am still extremely fatigued and have a bad headache and dizziness. This was not relieved by the maximum dose of Tylenol.

Vaccine at 3:10 pm March 18, arm pain and nausea began about 7:00 am on March 19. Nausea lasted about 18 hours. Sore arm was significantly less the morning of March 20th.

Fever reaching a high of 101.7 degrees F, whole body muscle aches and pains, migraine, shivers, fatigue, unable to get comfortable enough to sleep, severe facial pain and headache

Patient reported flu-type symptoms on 3/15/21 but states lumps in armpits started 3/16. Large lump left axillary area starting on 3/16/21.. On exam he had several small mobile tender axillary lymph nodes in left axillary area palpable. The right axilla had a small single mobile tender node. Both axillary areas had superficial follicular pustules and redness. On the Left axillary there was a larger carbuncle that was red and tender and inflamed consistent with boil. Patient described never having had any rash, bumps, or soreness prior to the vaccine. He was treated with Doxycyline and warm compresses to the left axillae and his symptoms resolved quickly within 48-72 hours.

Patient's housemate, called pharmacy 3/26/21 to report pt patient's sx. 3/25/21 approx. 11:00pm fever up to 100.9 F 3/26/21 approx. 9:00am severe abdominal pain, approx. 12:00pm vomiting x2, approx. 3:45pm pt clammy Pharmacist reviewed literature on FDA website regarding Janssen Vaccine ADE's. There was a very small percentage of pts that had appendicitis following vaccine. Although pt is 19.5 yrs old, here sx were also consistent with those experiencing MIS-C due to the virus. Pharmacist recommended pt to contact doctor immediately and follow his/her advice as to the need of further medical care. At 4:30pm 3/26/21 Pharmacist contacted pt to see how she was doing. Pt admitted feeling a little better and able to keep down soup. Pt stated that her provider told her sx were normal s/e of vaccine and that she received the vaccine too early, following 3/8/21 dx of COVID. Pt stated provider ordered meds for abdominal pain. Names unknown and not sent to our pharmacy.

Was really tired, ran a 100.6 fever, chills, couldn?t get warm. Had neck pain. Had a headache, felt tingling in my fingers, was super sore all over. Soreness at injection sight. Symptoms only lasted 36 hours.

12:50PM PT WALKING TO AFTER CARE AND BECAME WEAK. FELT DIZZY. PLACED IN WHEEL CHAIR. GIVEN JUICE AND WATER. BP 110/70, HR 60, SP02 95%. COLOR PINK. 1PM SITTING IN WHEEL CHAIR TALKING WITH FAMILY. STATES NO FURTHER DIZZINESS. MONITORED FOR 30MIN. FEELS BETTER. TAKEN TO DOOR - HOME WITH PARENTS. 4-2-21 9AM TC: 'FEELS FINE NOW'.

Patient experienced swelling of the face, eyes, and lips, and a burning sensation in her throat and chest. We called 9-1-1 to check vitals and they recommended going to her doctor or the hospital in case of additional swelling. We called the doctor and they told us to try Benadryl. This worked a little bit, but she is still in a lot of discomfort today (Saturday after Thursday shot).

It started with my teeth chattering and chills, but no fever yet. All of the muscles in my body had a severe tremor, and I had trouble with simple tasks like filling my nasal rinse bottle, because the tremor was so bad. My jaw was smacking the entire time, so hard that the headboard smacked against the blinds. Then I checked my temperature and it had gone from 97.5 to about 99.5. The symptoms got worse, and added in excessive thirst, pain at the base of my head where it meets my neck, pressure under and behind the eyes, severe lower back pain, muscle pain escalating on the right side of my body only, nausea, pain across the top of my forehead, and a weird heat sensation under my fingernails? Maybe and hour or so passed, and my fever rose to above 101, and I tried to go back to sleep. By this point the tremors were over, but slight chills and every other symptoms remained. I took my temp later and it was 102.7, and I again had all symptoms except the initial tremors. I also had tachycardia (super rapid heartbeat) and got dizzy for a second and have a little trouble focusing my vision when I sat up in bed.

Patient was given the injection and then she started feeling dizzy right after administration. She sat with her head against the wall and dropped her phone and passed out for just a moment. She had a slight tremor/shake for a few seconds. (I did not witness, unsure exactly what happened or how long) She came too fairly quickly after being yelled at, are you ok? When she regained consciousness she complained of being hot all over for a bit. We gave her ice packs to cool down. She felt hot for maybe 10-15 minutes, but felt relief with the ice packs. She also drank some sips of cool water which seemed to help her cool down.

6:00 headache, exhaustion 7:30 chills/hot, skin sensitivity, headache, exhaustion Headache and exhaustion have lasted 2 days. Chills/hot and skin sensitivity were only the night of the vaccine.

Head started feeling groggy at 3:30 pm. At the time of writing this it is about 6:30 pm and it feels like I have a mild flu?chills, headache, general body aches, pressure when sitting up. Chills in particular started at about 3:45 pm. Around 4:15 I had to lay down because I believe the shivering was exacerbating my aching.

Systemic: seizure-Medium, Systemic: Seizure-Medium, Additional Details: Patient was fine for apprxo 5 min after vaccination, fell off chair with seizure, paramedics were called and came, watched her for any sign of further problems, she did not require a trip to the hospital, they left and she remained for approx 20 more minutes, during which time she slept for a little while

FELT LIGHT HEADED; HOT AND COLD SWINGS; BODY ACHES; CHILLS; WEAK; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 31-MAR-2021 11:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102.5 F. On 31-MAR-2021 17:00, the subject experienced felt light headed. On 31-MAR-2021 17:00, the subject experienced hot and cold swings. On 31-MAR-2021 17:00, the subject experienced body aches. On 31-MAR-2021 17:00, the subject experienced chills. On 31-MAR-2021 17:00, the subject experienced weak. On 31-MAR-2021 17:00, the subject experienced fatigue. On 31-MAR-2021 17:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, felt light headed, fatigue, weak, chills, hot and cold swings, and body aches. This report was non-serious.

Started sweating after I got my shot for about 3 minutes. Felt fine for the next few hours. At 9:00 pm I was shaking I was so cold, I was achy. A few hours after that around 10:30-11:00 I was sweating. My arm has been sore the last 3 days. I have/had a mild headache. And yesterday I felt lethargic and tired.

At first I had no side effects other than a sore arm. However, later on the same day, I began experiencing severe cold chills. The next morning I experienced hot and cold flashes and had a fever.

After receiving her vaccine, she sat with her friend that she came with and told her that she felt lightheaded. She placed head between her knees initially, then sat up and leaned over to her left where she landed prone unresponsive. PCPH staff attended and turned her supine and noted that she was having a seizure like movements, not breathing for 10 sec., incontinent of urine, gurgling at one point. While assessing for need for CPR and with stimulation of sternum, regained consciousness and took deep gasp, asking "did I pass out?" "I usually get dizzy and sometimes faint with shots." VSS initially 98/60-71 hr-16-99% ox reading. EMTs summoned by Director of PCPH on site encouraged her to call her parents as s

When I got the vaccine, I had almost passed out and felt like I needed to vomit. Later, I started getting really cold and shivering, and there was nothing I could do to make it stop. I started getting a headache, nausea, and weakness around that time too, maybe a bit sooner, like 3:00pm. The chills started at around 5:00pm.

Patient felt light-headed and dizzy immediately following vaccine. She also started to feel warm and clammy. The symptoms progressed over the next several minutes and were not improving. Store management was called to the pharmacy as a precaution. After about 10 minutes, the patient stated her symptoms were improving. At that time, she agreed to walk to a waiting chair outside the pharmacy and was watched by pharmacy staff for the next 25-30 minutes. She said she felt fully back to normal by the time she left with the person she came with (her mom).

Patient received vaccine at clinic but unsure as to the time. She left the clinic feeling fine, but shortly after started to develop a rash. EMS was called to assess and felt it did not warrant ED visit, however, she went to softball practice and began to have lightheadedness, trouble speaking, in and out of consciousness, trouble breathing, clammy. A rescue squad was summoned and taking patient. Awaiting further word on her condition

Elevated heart rate. Fever. Body aches and pain at injection site. Chills, hot cold flashes. Weakness and fatigue

Felt pain in left arm immediately followed by difficulty breathing, sweating, nausea, loss of hearing and vision. No treatment given. Suddenly felt ok after a few moments. Went home, got full body aches, chills, tiredness, inability to sleep, and diarrhea

Severe headache starting around 2 am that only got worse as the day went on and ending around 6 pm. When I woke up at 7 am I became very faint about 10 minutes after getting up and walking around; it sounded like I was underwater, I had tunnel vision, I could not speak coherently, and I was sweating. This subsided about 15 minutes after laying on the cold floor with a cold towel. The faintness completely disappeared after an hour

uncontrollable laughing and crying, nausea and vomiting especially when standing, feeling of going to pass out and lightheadedness, very red, swollen, and flushed face and ears, eyes were droopy, barely had feeling in face and had a hard time moving jaw. Extreme back pain and facial pain, feeling of shakiness, face turned white like was going to vomit or pass out. Very cold feeling all over but was drenched in sweat. Very tired.

The Patient was in observation and felt faint and weak. She advised the Medic and an assessment was started. The patient was noted with a low BP. She was laid down and a response from the local ems system was started. The patient felt better, refused RX and TX, and signed out AMA.

Last night (around 9:00 pm) I became very nauseous and had a severe headache, chills and nausea. I took 2 Tylenol pills and went to bed. At 11:00pm I became extremely ill with a fever of 103 F and vomited 4 times consecutively. I went back to bed, still with a fever and chills. At 12:30 am (April 9th) I again started vomiting again (around 3 times). I then went back to bed and fell asleep. I woke up around 8am (April 9th) still feeling feverish, with chills and a severe headache. I have no appetite and no energy to get out of bed as of right now (11:00am).

Night of vaccine: severe chills, fever, severe headache Following Day: fever, chills and hot flashes, headache Symptoms mostly subsided on the 3rd day, only a minor headache remained which was progressively better.

I began feeling a migraine at 3pm. I took a nap and woke up at 6pm feeling extremely ill. My temperature was 101.5F and my entire body was in pain. I took two Tylenol as suggested. Over the course of the entire evening, I was vomiting profusely; I vomited approximately 10 times. By around 10pm my extremities became numb and I could not walk without assistance. I could not think or speak straight. I nearly fainted every time I tried to sit up. I tried to take ondansetron for vomiting but proceeded to vomit the medication as well. I wanted to go in to the ER because I felt like I was dying, but I do not feel financially comfortable doing so. All symptoms remained consistent until about 3am when I was able to sleep until 7am. I woke up with several bouts of diarrhea, intense nausea, and head to toe muscle and joint pains, as well as numbness and tingling in my arms and legs still. It is now 5pm the next day and I still can't eat or stand for too long without feeling faint. I still have diarrhea and strong migraine.

Fever, chills, sore/tender arm. Fever lasted about a day, and went down after taking ibuprofen and did not return. Arm was sore for about a week. Symptoms were overall mild

Hives on my arms and stomach developed within 15 minutes of receiving the vaccine at 2:16. I left the facility after 30 minutes because the hives did not get any worse and I did not experience any other symptoms. At home about 8 hours later, I started feeling exhausted, weak, and my body was literally shaking whenever I stood. Overnight, I felt feverish, I had the worst nightmares, and woke up every few hours. On Friday (next day) I felt dizzy whenever I moved, nauseous whenever I stood, and once when I was standing too long I started vomiting. On Friday evening I went to a local ER (all the urgent cares were closed) at my primary care Dr?s suggestion to ensure that I wasn?t having an allergic reaction to the vaccine. The ER determined that the hives were likely an allergic reaction but all other symptoms were reactions due to the vaccine.

While the vaccine was going in my arm it was stinging and burning. I fainted about 30 seconds after the injection. I waited at my vaccination site for about 30 minutes after that. My vision was blurring and turning black and white and my hearing went out. I felt lightheaded and fainted for a few seconds. Afterwards, I was lightheaded for quite some time and my blood pressure was a bit low.

About 3 hours after vaccination, intense headache began. My head felt like it was being pounded with a hammer, and the pain was so intense it traveled down from my forehead to my jaw bone. At around 3:00 pm on April 8, I began to develop a fever which first started at 100 degrees Fahrenheit. By around 5:00 pm, the fever had progressed to 102 degrees Fahrenheit, and the 700mg of Tylenol I had taken was not breaking the fever. I started to get body chills, muscle pain, joint soreness, and cold sweats. Again, Tylenol was not helping. I had no appetite and was having trouble keeping fluids down. Around 11:00 pm on April 8, I took more Tylenol and the fever began to break but did not fully break until 36 hours after the vaccination. It is now April 10 and I am starting to feel like myself again, but for a full 36 hours the pain was so intense that even a light sheet covering my body was painful.

Patient fainted 1 minute post vaccination. Patient said experienced arm pain and felt off immediately after vaccine. Patient came to within one minute of fainting. Blood pressure was checked and was in range at 119/90. Patient was slowly given water and started feeling better. Patient was also given orange juice and crackers. Blood pressure was taken again at 122/82. Patient experienced feeling cold and some yellowing of hands as well. Patient has a history of fainting when giving blood and is afraid of needles. After 50 minutes patient felt much better and left pharmacy. Followed up with patient after 2 hours and patient stated felt fine.

Client reported feeling "hot and light headed" approx 2 minutes after receiving vaccine. She was led by EMT to zero gravity chair. 12:31 V/S: HR 67, O2 99, BP 98/60. V/S @ 12:46 BP 118/80, HR 82, O2 99, AOx3 EMT observed client's to have pallor color. V/S @ 12:56 BP 92/58, HR 72, O2 100, RR 20 and client report of "feeling much better." Client reported having hx of syncope with nose piercing. At 1312, client left site unassisted and with a steady gait.

Jansen COVID-19 Vaccine EUA was given to me on 04/09/21 and later in the evening of 04/09/21 I started to feel sore in my arms and legs and did feel tired but not very tired but I don?t know if it?s from the vaccine because I came back from a walk when it started to happen.

Began with a head ache and slight dizziness followed by shaking/chills, after a while with those side effects I took ibuprofen. Later that night I had a fever, body aches and I woke up nauseous in the middle of the night. Other than being very tired and sleeping very late the next day all side effects subsided by Sunday March 14th.

Numbness in wrist and arm that was vaccinated after running and then while using a computer (this has never happened to me before). Also, I had digestive pain.

Pt stated that she has vasovagal syncope when she has needles and stresses. Pt received vaccine lying down on recovery cot. Friend was at her side providing support. Ice to back of neck, feet elevated. status post receiving vaccine approx 30 sec while talking to pt she had syncope unable to recover with verbal nurse provide sternal rub pt came to alert and oriented smiling and laughing. She stated this happens and is normal for her to pass out due to vasovagal syncope condition that it happens all the time. refused to go to hospital. She has had all kinds of tests (cardiac, neurological, ENT per pt it has been dx as vit def, NA def, nutritional def ) While talking to her she had a 2nd syncopal episode used ammonia salts to recover pt awakened immediately. VS 110/72, HR 84 reg strong, resps 12 reg nonlabored, SpO2 98%. Provided water for hydration. Friend stayed a side the whole time. after 20 min sat pt up, no LOC again, no SOB no N/V. Sat in recovery 30 minutes. Pt stated I feel fine . OK'd to exit

Patient fainted and had seizure like symptoms with eyes rolling back in head, clamminess, sweating, severe stomach cramps, blurred vision, and temporary loss of hearing

Weakness/heaviness of the right side of the body, headache only on the right side of the head - lasted ~30 mins. Flulike symptoms, fever, general headache - lasted 24 hours. Extreme fatigue - lasted 4 days.

My arm swelled up about 30 minutes after the injection near my shoulder. I started feeling pain in my forearm and the facility nurse gave me an ice pack. I stayed an hour after the shot and the nurse said I should be fine, so I went home. Around 10 pm I started having a really bad reaction, worse than normal flu symptoms. A fever of 102 and body chills that lasted for about an hour. Heart rate also consistently stayed above 130 bpm. I drank a lot of water and took an Advil. I then was advised to take a warm shower, and this helped bring my fever to a 99. After the shower, I became really nauseous and started throwing up. I was debating going to the ER. I also drank chicken broth and a lot of water and did not go to sleep until 4 am. The next two days I had a low fever and bad muscle aches throughout my body, the flu symptoms ended in 4 days.

Within 1 minute of receiving the vaccine, patient reported not feeling well. Administrating technician called for assistance from the pharmacist. Patient was breathing but was unresponsive. Pharmacist instructed store manager (also on scene) to call 911, and gently laid the patient on the floor. Within one minute the patient became responsive, and remained on the floor per instructions received from 911 over the phone. Shortly thereafter EMS arrived and assessed the patient. Patient refused to go with EMS for further medical assistance. She agreed to stay in a chair in front of the pharmacy for further observation for 30 minutes. After the 30 minutes lapsed, patient left the store under her own volition.

At 5:30 PM she was feeling nauseous and weak. She passed out, had a headache, chills, and intermittently experienced profuse sweating. She had a fever at 12:30 AM that evening (next day). She was a little nauseous and took it easy the next day and was fine after a day passed.

At 2:30am on April 13, I woke up with a 101-degree fever. Throughout the rest of the day I have felt chills, a headache, soreness all over my body, dizziness and overall weak. My temperature had fluctuated around 99.5-100 degrees all day.

Vaccine side effects. Pt c/o muscle spasms and pain in lower back and abd x4 hours. Pt recieved J&J vaccine at 0845, began having discomfort at 0930, fell asleep until 1500 and symptoms began around 1600. Pt is dry heaving and has not been able to eat or drink since AM. Pt notes ''fuzzy'' vision.Re-Assessment@ 2330: pt calm and feeling much better. no abdominal pain per pt; abdomen soft, NT, w/o guarding. no neuro deficit and able to ambulate in ER. no source of focal infection identified and symptoms likely due to J&J vaccine. will d/c with mother.

After getting the Janssen vaccine my hands have been constantly cold. They only get warm after I sit on them for about 10 minutes. Sticking them under blankets/etc doesn?t help.

Within 10 minutes of administration, patient reported feeling poorly. Reported lightheadedness and chills. EMS was present and assisted. On exam, elevated BP 180/118. SpO2 98% on RA. Patient was given juice and water and assisted to a quiet area to lay down. EMS stayed with her and continued to monitor. After 30 minutes patient reported feeling better and left vaccine area with her friend. She was feeling better by her report in the afternoon. Received a call at 9:30pm that evening. Reported same symptoms she had initially. She was advised to go to the ER for further evaluation but she declined. She took benadryl 25mg and rested. Reported feeling better the next day. Fatigue and mild headache. I saw her in the office for a BP recheck on 4/12. BP 120/70. She reported feeling much better with just some mild residual fatigue.

Janssen COVID-19 Vaccine I felt okay until 2:30. I started to get very bad body aches and the chills, later on I developed a headache and I couldn?t move out of bed because I felt so sick. My temp reached 102 at 8:15 even after taking a 500mg tylenol earlier. I had to stay sitting up because I got nauseous when I tried to lay down completely. I also kept getting very hot then very cold. It?s 4/13 and I?m feeling a bit better but still feel kinda weak and get exhausted easily.

At about 8pm the night of the day I got the vaccination, I began to experience pretty bad muscle & joint pains from my hips down to my ankles. I was also going back and forth between being very cold and very hot. I have not gotten a fever so far. The pain was so bad that I wasn?t able to sleep at all. The following morning, today, I am still experiencing pain in my hips, thighs, and knees, as well as a faint headache every so often.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: patient experienced nervousness.

April 7th 6pm - April 8th 10am: nausea and fever (reached 103.5°), did not go down with acetaminophen and lowered slightly with ibuprofen April 7th - April 11th: sore arm

Extreme pain in left leg all night on 4/8, turned to more gradual coming and going pain since then Headache every night since 4/8, located in back of head between the ears area Dizziness/feeling like I may faint on 4/8, comes and goes since then Shortness of breathe, unsure of exact start date but has been around a week

Systemic: Fainting / Unresponsive-Medium, Additional Details: Regained consciousness quickly (less than 30 seconds)

After receiving J & J Covid vaccine, client stated she felt weak and dizzy. After sitting for a few minutes, assisted client to lie down on couch. Client was diaphoretic. BP 88/68. Legs elevated and given a few sips of juice. BP rechecked at 100/70. Client was well enough to transfer to observation area. Client waited another 15 minutes and left on her own with no further complaints.

Around 5:00 PM after having gotten my shot, I arrived home from a drive down to meet my sister. Precautions were taken, masks were worn, safe social distance was maintained and I have no reason to believe any of the symptoms I experienced upon returning home were related to anything other than the vaccine, particularly since first that is how vaccines work and second one of my friends who was vaccinated at the same time as me at the clinic was going through similar pains. It started as a discomfort in my intestines or possibly just below my stomach in general. I thought my pants were too tight but just in case I let my mom take over driving the rest of the way home. When I got to the house, I had about an hour of usable time left before I went into a complete state of delirium. We're not sure how high my fever actually got before my mom woke up and checked in on me at 9:00 PM, but after having pulled the covers away I registered at 102.5° F. I was screaming in a half-awake and half-asleep nightmare, trying to get someone to come help me and unable to get anyone's attention. I would, as a result, like to insist that it be added to recommendations to not be alone after getting the vaccine! For the whole first night! I believe that I genuinely could have died. My brain was melting for lack of more proper medical terminology, and I stopped being able to understand and speak my own first language in an incredibly confused state. This was entirely a result of two simultaneous factors: Fever and Chills. First, the fever made my skin ache. Wearing any clothing hurt. But once I took off my pants in exchange for some breezy shorts, I was covered in goosebumps and feeling frozen even though it was solidly in the 70s. I claimed under blankets and still couldn't get warm enough. The backs of my thighs were insanely hot in comparison to the fronts of them, so I just warmed my body under 3 layers of blankets trying to get the chills to go away. I did that for about four hours during which time I was basically constantly screaming incoherently.

LOOKS PALE; FEELING SICK; HEADACHE; TEMPERATURE 102.4C; DIZZINESS AND WHEN TRIED TO SLEEP DIZZY; BODY ACHES; FEELING COLD; SWEATY; PRESSURE IN HEAD; PRESSURE IN EARS; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's past medical history included dehydration, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 08:40 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 102.4 C. On 08-APR-2021, the subject experienced dizziness and when tried to sleep dizzy. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced feeling cold. On 08-APR-2021, the subject experienced sweaty. On 08-APR-2021, the subject experienced pressure in head. On 08-APR-2021, the subject experienced pressure in ears. On 08-APR-2021, the subject experienced feeling sick. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced temperature 102.4c. On 09-APR-2021, the subject experienced looks pale. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness and when tried to sleep dizzy, feeling sick, body aches, headache, feeling cold, sweaty, pressure in head, temperature 102.4c, looks pale, and pressure in ears. This report was non-serious.

Started out with a headache and dizziness within a few minutes of the vaccine, along with nausea. I stayed put laying down with a lollipop and water bottle along with ice packs on me for about an hour until I was well enough they thought for me to drive back to my dorm. Once I started driving the headache was back but I was driving so I couldn?t do much. Almost pulled over because I was getting over whelmed but ended up making it back to my dorm. Once I got back I changed and laid down in bed hoping to fell better. Things started getting worse from there. Throughout the rest of the day my head ache and dizziness got worse to the point where I was pretty unsteady on my feet. Chills and body aches also started and progressed rapidly despite no fever. My nausea was present in waves but eventually dissipated around 8 PM. I tried to go to bed around 11 hoping to sleep off the symptoms. I began tossing and turning. My chills were really bad and it got to the point where my skin was so sensitive that the clothes I was wearing touching and rubbing against my skin were hurting me. I was so dizzy and light headed to the point where it didn?t matter if I was laying down or sitting up, I felt the same, extremely dizzy and lightheaded as if cotton were in my brain or as if it were working too slow. It was like trying to process thoughts through molasses. Then around 1:30 I couldn?t take it anymore and thought maybe a quick shower would help me to at least feel better so I could sleep. When I got in the shower I immediately knew things were worse. My vision started going black at the edges and black spots in the middle to the point where at certain moments I couldn?t see. I was fighting to stay on my feet and conscious and it was hurting to breathe. I knew I needed to get help so I stumbled to my dorm and collapsed when I got in the doorway to my room. My vision was spotty, my chest was hurting and I could barely breathe. My hands and feet went numb as well, I was shivering, and my body temperature was a little down to about 98.1 degrees Fahrenheit. I was transported to a hospital via ambulance my vitals were normal except elevated heart rate and O2 and was admitted at 2:40 in the morning. I received a chest x ray and my heart rate was better. The dizziness was under control by then. I was discharged at 4:50 in the morning.

Headache started Sunday night, but controlled with Tylenol. Monday the headache was intermittent. Tuesday 4/12 the headache and leg craps started in the afternoon. 4/14 She was sent home from work with nausea, headache not letting up after taking Tylenol, numb hands. I called Occupational Health and they suggested having her report to Backus ED today.

About 10 hours after receiving my vaccine- I became extremely ill. I had migraines, fever of 101, chills, nausea, tightness of chest, abdominal pain, difficulty with my stool / bowl movements, and body aches. I could not move, and most effects subsided after laying in bed for two/three days straight. However, continuing up to today (three weeks later) I have still had tightness of chest/throat, bowl difficulties, and abdominal pain. I also noticed that for the past 2/3 weeks I have also had blood spotting with clots alongside my abdominal pain. It has not yet subsided.

Started with B leg achiness and pain the day after vaccination. She was having difficulty walking. the second day began having arm pain L>R to the point she could not lift her left arm. Also has severe headache unable to be treated by otc medicine, chest tightness and some difficulty breathing.

Patient was working and fell on the job due to what was perceived to be a seizure. Paramedics were called, and patient was taken to the emergency room. Initial reports from the hospital are that patient has clotting in the arm around the injection site. Patient is still at the hospital at the time of this report.

Nurse administered vaccine, within 1-2 mins the patient became drowsy, drooping head forward, closing eyes, and slurring speech. Patient lost consciousness and slumped into chair, EMS on site, administered IV fluids and transported to hospital.

c/o dizziness, cough, cold/hot, headaches, body sore since J&J vaccine on 13 Apr. denies v/d/, abd pain, chest pain, or sob. last Tylenol 0900. 20 yo f c/o ongoing diffuse nausea, bodyaches, and ha w/o visual changes x24hrs s/p receiving J&J covid vaccine 24hrs pta; Pt denies any sore throat/neck pain, fevers/ns/chills, abd pain, nvd, ear sx's, cp, sob, dyspnea, rashes, prior hx of vaccine rxn

Developed dull headache within 2 hours of vaccine with fatigue. By 6-7 hours later, her headache escalated to a severe migraine and she had chills, nausea, vomiting and a temp of 101. Severe symptoms lasted for 24 hours and she didn't feel better until 4 days later. By 5th day felt fine.

6 hours after I got the vaccine I had High fever 102.5 for about 3 days, vomiting and diarrhea as well for 4 days. That went away the. developed Headache and leg pain and abdominal pain for about 4 days. Injection site still hurts

Starting less than 12 hours from the injection, the adverse effects started with a bad headache and light sensitivity. Within an hour the adverse effects evolves to severe chills, fever, body aches, fatigue and nausea. A few hours later all symptoms continued and worsened. Fever spiked to 102, nausea turned to vomiting, chills made the skin hurt from any touch/pressure, muscles aches made pain continually radiate all throughout the body, headache turned to a migraine. Symptoms persisted throughout the night and into the next day resulting in no sleep. The following day ibuprofen was able to manage symptoms enough where patient was able to sleep. Fever decreased, but chills, headache, fatigue, and vomiting continued. Patient was forcefully vomiting bile after not being able to keep anything down. Patient broke capillaries across the face. Extreme tiredness pursued, but symptoms dwindled over the course of three days.

Johnson and johnson covid-19 vaccine eau March 20th - allergic reaction to covid vaccine Johnson & Johnson. Allergic reaction started approximately 2 minutes after receiving shot. It started with itching and redness on my arms and upper chest. After approximately 10 minutes, I knew something was wrong and I signaled an attendant. They immediately brought me over to the EMTs on site, where they looks me over and started drawing up IV Benadryl. In the time it took for them to draw up IV Benadryl and insert the IV, the hives on my chest started to turn into burning and ice sensations intermittently. As soon as they administered the IV Benadryl, the itching redness and hives on my arms went away within a couple minutes, and I was left with only redness on my upper chest. They felt comfortable with me getting a ride to the ER from my dad and not getting emergency transport. At the ER, they gave me pepcid and prednisone. About an hour and a half later, I started developing chest tightness and hives and redness on the side of my face. They decided to administer more Benadryl and start epinephrine. I was discharged a couple hours later. March 22nd - I went back to the hospital, with complaints of severe stomach pain. The stomach pain lasted approximately 24 hours. March 20th to march 26th - I experienced extreme fatigue. I was exhausted to the point where on Wednesday I took a ten minute shower and by the end of it I had to lay down again because I was shaking from exhaustion. Symptoms improved slightly until April 5th where it started taking a turn for the worse. April 5th - I started noticing black spots in my vision that wouldn't go away. They didn't move and they stayed in one spot for hours until I fell asleep and then they'd be gone the next morning. They usually started around 8:00 or 9:00 at night. Sometimes a couple hours earlier. They came every day until Friday April 9th when they did not come. April 5th to present - I also started noticing light-headedness, motion sickness when I stood still or sat in a chair, nausea, neck pain, and periods of muscle weakness in the neck. These symptoms have not stopped. Friday April 9th around 6:45 p.m. I started having a bad migraine, I noticed in the bathroom at work my eyes were dilating over and over and over again rapidly. The pain was very high. I ended up leaving work early and going to the emergency room. While at the emergency room they treated my migraine with a cocktail of Benadryl, toradol, and compazine. It reduced the pain at the time, however it did not take away the migraine. Friday April 9th to present - My migraine has continued from April 9th and is still happening. I have been having severe light sensitivity, sound sensitivity, and trouble reading. The rapid dilation of my eyes stopped April 10th, however my eyes stayed dilated until April 12th. In addition to all of my other symptoms, there are others that I am not as positive are relevant. I have asthma and it has been worse over the past couple of weeks, it it is not usually worse this time of year. I've been also been having quite a bit more light bruising than normal over the past two weeks and over the past one and a half weeks I have noticed red spots all over my skin. I was not sure if these red spots were normal or not because I do have them on occasion however these are darker than normal.

Janssen Covid 19 Vaccine clinic held at(Onsite Employer Services)Lot # 1808980 exp. 6/20/2021 As reported on Episode Note: Client returned to vaccination area c/o lightheadedness, dizzy, warm, chest discomfort. BP 114/74, HR 80 C/o centralized chest pain, pain level 5/10, sharp stabbing pain. "Feels like I swallowed water and it's stuck." Pain began when she walked down from the observation area. 1154- approximate time EMS called d/t continuing chest pain. 1156 BP 122/68, HR 84. continued dizziness, increasing fatigue. Applied ice pace to nape of neck. After ice pack applied, client c/o numbness/tingling of Right arm. Ice pack removed. 1158 Patient requested RN call father. Father notified of client status per client request. 1207 Reports feeling chilled, continued chest pain and fatigue. EMS arrived. Vital and 12 lead EKG completed by EMS. Patient denied transportation to hospital. 1215 EMS left. Patient requested RN to notify father to pick her up from employers. HR met with client to complete incident report. 1219 Father contacted to pick up patient. Client voluntarily walked to main entrance of building with HR contact.

Symptoms began evening after receiving vaccine. Patient reports headache which progressed into the next day to fever, fatigue, intense chills, chest pain. Patient had these symptoms over 2-3 days and had began to experience arm tingling in arm where vaccine was administered, which then spread to both arms. Patient reports arm tingling will come and go. Patient reports taking OTC medication (ibuprofen). Patient called a nursing line and was told to go to the ER. Patient went to ER on 4/14 and was admitted for observation. Chest X-ray was done with no remarkable findings. According to patient, additional testing was done. Patient was discharged on 4/15 and was told to return if arm tingling returns and does not go away.

-Burning nerve pain, crepitus, muscle tightness to where chest wouldn't expand fully for breathing - Resolved on own by next morning

Stabbing pain in muscles and skin, severe aches in joints, especially knee pain, jaw locked in open position, hallucinations, nausea, weakness. All lasted for entire night until around 4am. Joint pain, aches, weakness continued for another day. Knee pain continues now.

Nausea, vomiting, severe headaches, chest pain, SOB (only occuring at night), slight leg pain, and upper back pain

Pt was anxious prior to the vaccine administration; became dizzy, pale ,clammy, weakness. Evaluated by paramedic, HR increased to 134, no shortness of breath or tingling/numbness noted. Paramedic called, patient declined, called brother to take her to her apartment, agreed to keep an eye on her.

SWELLING BEHIND HER KNEE, CALF AND THIGH; PAIN BEHIND HER KNEE, CALF AND THIGH; CHILLS; NAUSEA; FEVER; INJECTION SITE PAIN; DIZZINESS; DIFFICULT TIME GETTING UP AND MOVING; HEADACHE/COULD NOT MOVE OR TALK; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, non smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced difficult time getting up and moving. On APR-2021, the subject experienced headache/could not move or talk. On 01-APR-2021, the subject experienced dizziness. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced injection site pain. On 11-APR-2021, the subject experienced swelling behind her knee, calf and thigh. On 11-APR-2021, the subject experienced pain behind her knee, calf and thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 04-APR-2021, injection site pain on 03-APR-2021, and headache/could not move or talk on APR-2021, was recovering from nausea, and dizziness, had not recovered from pain behind her knee, calf and thigh, and swelling behind her knee, calf and thigh, and the outcome of difficult time getting up and moving was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

LEG PAIN; SEVERE HEAD PAIN; This spontaneous report received from a consumer via a company representative concerned a 20 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, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced leg pain, and severe head pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe head pain, and the outcome of leg pain was not reported. This report was non-serious.; Sender's Comments: V0- Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.

Lupus butterfly rash on nose and cheeks, headache, hands/fingers - feet/toes tingling, skin itchy and burning

About a week after vaccination I started to feel a tingling, burning, almost itching feeling in my thighs and calves. It is not very uncomfortable but very noticeable.

severe fatigue, headache, chills, body aches. low grade fever, hot flashes, sweating, chest pains, shortness of breath, sore throat, stomach pains, congestion

WORSE ASTHMA; RED SPOTS ON ARMS/LEG/CHEST/CHIN/NECK; CONSTRICTING PUPILS; DILATED PUPILS; SEVERE MIGRAINE; BLACK SPOTS IN VISION; NECK PAIN; LIGHT-HEADEDNESS; NECK WEAKNESS; NAUSEOUS; LIGHT BRUISING ON LEG/ARM; FELT LIKE HIT BY MACK TRUCK; SEVERE ABDOMINAL PAIN; FATIGUE; ALLERGIC REACTION; This spontaneous report received from a patient concerned a 21 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: 1808609, and expiry: unknown) dose was not reported, 1 total administered on 20-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included omeprazole for abdominal pain. On 20-MAR-2021 two minutes after the vaccination, the patient had allergic reaction started with itching and redness on arms and upper chest. After ten minutes, the patient felt something wrong and consulted onsite EMT(emergency medical technician). Later the redness turned to hives with itchy to burning sensation. The EMT (emergency medical technician) was given intravenous Benadryl to the patient and hives got disappeared and redness remained. On the same day the patient went to the Emergency Room(ER) and stayed around seven hours. Pepcid and prednisone was given to the patient in ER (Emergency Room). The patient experienced chest tightness and warm and again Benadryl administered to the patient. The patient was also given Epipen while going home. On 21-MAR-2021, the patient experienced fatigue. On 22-MAR-2021, the patient had severe abdominal pain with 7-8 on pain scale, the abdominal pain was lasted for 24 hours and went away. The patient has been on Prilosec for the abdominal pain since a month. On 26- MAR-2021, the patient felt like hit by mack truck and fatigue. On 29-MAR-2021, the patient experienced light bruising legs far more easily than usual and had a bruise where she wore watch, but it was not deep bruising. On 05-APR-2021, the patient experienced black spot on vision in both eyes around 18:00-19:00 at night until went to bed, and lasted for 4 days. On 05-APR-2021, the patient experienced lightheaded and motion sickness when sitting or standing still; the patient also had neck pain. The patient's neck weakness was felt like the patient's head was going to fall off. The patient experienced neck weakness about once in a week around 15 minutes and also felt nauseous. On 09-APR-2021, the patient had severe migraine with light and sound sensitivity and had rapidly dilating pupils. The patient administered cocktail of medicine Benadryl, Toradol, and Compazine and this medicines helped the patient little bit with the pain. On 9-APR-2021, the patient experienced trouble reading for 2 days due to the dilatation of the both eyes. On an unspecified date, the patient experienced worse asthma than usual, and red spots on arms, leg, chest, chin, and neck. The spots were darker and shinier than usual. Other treatment medications (dates unspecified) included: Medrol for migraine. The patient had visited emergency room for allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from black spots in vision on 09-APR-2021, constricting pupils, and dilated pupils on 10-APR-2021, and severe abdominal pain on 23-MAR-2021, had not recovered from fatigue, light-headedness, nauseous, neck pain, severe migraine, light bruising on leg/arm, worse asthma, red spots on arms/leg/chest/chin/neck, and neck weakness, and the outcome of allergic reaction and felt like hit by a truck was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210436540-covid-19 vaccine ad26.cov2.s-Allergic reaction. This event(s) is labeled per RSI and is therefore considered potentially related.

Systemic: Dizziness / Lightheadness-Severe, Systemic: patients feels hot then an hour later feels cold-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Medium, Additional Details: Patient said she felt light headed and feels weak. Pharmacist had patient lay down with two legs slightly elevated. Patient was given water to drink since she said she feels hot and need water. pharmacist check vital signs 3 times.

patient was administered vaccine as per EUA/standin order. Approx 30 seconds after the vaccine was injected, the patient who was seated,stated she didnt feel well, fainted and slumped forward in chair. RPH who administered shot was able to catch her, keep her from further injury. Approx 10 seconds later, she came to and was disoriented. RPH explained where she wasand what had occured. She complained of nausea, feeling hot and sweaty and numbness in fingers. 911 was called, and while waiting for EMTs to arrive she stated that she had had some similar reaction during a previous blood draw. EMT arrived and transported her to local ER

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Tachycardia-Medium, Additional Details: Loss of hearing for a few minutes. EMTs came to store monitored pt and BP for additional 15-20 mins. BP increased to over 100. PT had water, crackers and chocolate. Pt felt fine and refused to be taken by ambulance but had a friend pick her up. I explained situation to friend and pt was told to take it easy for the rest of the day.

FEELING COLD/HOT SENSATIONS IN LEFT ARM; RASH ON ARM; NAUSEA; REALLY BAD STOMACH ACHE; DEHYDRATION; NERVE PAIN; FELT COLD RUSH DOWN HER LEFT ARM/ FEEL NUMB FOR A MINUTE/ NUMBNESS FIZZLED OUT; EXTREME ARM PAIN/ BURNING ARM PAIN/ FELT LIKE A REALLY BAD SUNBURN/ ARM SORENESS / ARM BEGAN TO SHAKE/ INNER ARM AND ARMPITS SORE/ FEELING WARM, FUZZY PAIN IN LEFT ARM; INJECTION SITE SORENESS; CHILLS; HIGH FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included born with cleft palate, non alcohol user, non smoker, pollen allergy, and mild cat allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced felt cold rush down her left arm/ feel numb for a minute/ numbness fizzled out. On 31-MAR-2021, the subject experienced extreme arm pain/ burning arm pain/ felt like a really bad sunburn/ arm soreness / arm began to shake/ inner arm and armpits sore/ feeling warm, fuzzy pain in left arm. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced high fever. On 31-MAR-2021, the subject experienced injection site soreness. On 01-APR-2021, the subject experienced nerve pain. On 07-APR-2021, the subject experienced dehydration. On 10-APR-2021, the subject experienced really bad stomach ache. On 10-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced feeling cold/hot sensations in left arm, and rash on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt cold rush down her left arm/ feel numb for a minute/ numbness fizzled out on 31-MAR-2021, rash on arm, chills on 01-APR-2021, and high fever on 02-APR-2021, was recovering from injection site soreness, had not recovered from nerve pain, and extreme arm pain/ burning arm pain/ felt like a really bad sunburn/ arm soreness / arm began to shake/ inner arm and armpits sore/ feeling warm, fuzzy pain in left arm, and the outcome of dehydration, really bad stomach ache, nausea and feeling cold/hot sensations in left arm was not reported. This report was non-serious.; Sender's Comments: V0 Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild

Chest pain immediately after receiving the vaccine described as a 6/10 on pain scale. (10 being the highest) Patient also reported her arm feeling numb after receiving the dose.

Shortly after receiving the Janssen vaccine, patient complained of shakiness and hot. Has history of migraines, Cerebral Palsy with brain injury at birth sustained. At 1 pm, BP=160/100, Pulse=71 and regular. Sp O2 reading 100% on room air. She was concentrating on not succumbing to seizure possibly and by 1:06 pm, her blood pressure is 140/80 and feeling better. Was stating she was feeling better and blood pressure was 140/80. Encouraged to drink 2 water. She was able to ambulate with friends after 30 minutes of recovery. Encouraged to drink fluids and rest.

Immediately following vaccination extreme injection site pain and soreness. Five hours after vaccine was received a minor headache and chills started, some nausea/loss of appetite was present. Six hours after vaccine was administered headache and chills had progressed to being extreme, extreme muscle and joint aches were felt throughout entire body, nausea was extreme and worse when in upright position, low grade fever was noted, some weakness was present, polyuria, thirst, and minor photosensitivity were all present within seven hours of vaccine being administered. All symptoms were persistent throughout night until 20 hours after vaccine was administered. Muscle aches, chills, thirst, and nausea/loss of appetite persisted for first 48 hours after vaccine was administered. Pain at administration site persisted for 2 weeks after vaccine was administered with limitation to use of left arm. Muscle soreness returns with increased use over extended period of time of left arm still at a month after vaccine was administered.

Systemic: Seizure-Severe, Additional Details: Pharmacist was informed that she was uncomfortable with needles and blood, but had not had a severe reaction to any vaccine previously. RPh checked if she had fainted before and told her to sit for 15 minutes then will check on her and if she is lightheaded or dizzy extend to 30 minutes. RPh administered Janssen shot to patient and asked if she was okay. She confirmed then patient got up. Patient moved to another chair & started seizing. RPh and mother took care until well enough to get up.

Systemic: Seizure-Severe, Additional Details: Patient seized for 1-2 minutes after being given vaccine. Pharmacist had patient sit/lay down for 30 minutes and mother took care of patient until she recovered. Pharmacist checked in every 10 minutes. Patient was offered but did not request any ambulance or further medical assistance.

PT presents with generalized weakness, HA and chills x this morning. reports she received JJ vaccine 1845. took 650mg tylenol PTA.

Patient felt faint, headache, arm/throat/tongue became numb, blurry vision, felt cold, feel tired and nausea. Patient BP and HR was initially high, lied patient on ground with legs elevated and cold pack and patient eventually felt better and BP and HR eventually normalized. Patient had already eaten prior to coming in.

After 5 minutes of receiving the COVID-19 Vaccination J&J/Janssen, the patient began to feel warm and experience hot flashes. She reported brief hearing loss and numbness throughout her body. 911 was called and they arrived 6 minutes later. Her blood pressure and pulse was taken and she was taken to the hospital on a stretcher.

Patient passed out and body started to shake. within less than a minute patient regain consciousness.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient has history of asthma, and had have same reaction with other vaccines before

Patient had a seizure and vomited. The seizure lasted a couple of minutes. She feel from the chair that she was sitting in when she got the vaccine. A gentlemen that came with her picked her up and sat her on a chair. He was holding her from there on. We called code Blue on the intercom and called the ambulance. Once she came back from seizure she was fully conscious and aware of her surrounding. She knew her name, address, where she is , etc. The ambulance took her away to Hospital. (She did mention to the ambulance that she had a seizure about a month ago because she took medicine and alcohol that she was not suppose to.)

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: immunization given on 5/12/2021 at pharmacy at approximately 5:25p. about 3 minutes later patienst complained of lightheadedness and black spots covereing her vision. in an attempt to help her lie down, when patienst was reposistioning, she went limp and passed out for a few seconds. vitals were checked by rph. 911 was called. patienst was cleared and went home on her own record. patienst has driver friend

After patient received Vaccine she started immediately to look very pale and stated she was not feeling well. Patient reported feeling numbness in her right arm and radiating to her left arm . Patient given oxygen via nasal canula , vital sign taken and offered orange juice to drink. patient stated has no breathing concerns or chest tighten. She continued to complain of numbness to both arms and now radiating to her face. patient also displayed cramping of both her hands. Ambulance notified and patient transported to local hospital. Patient was orientate, responsive and alert .

Patient had a vasovagal response and fainted a few minutes after her injection. She was unconscious, not breathing for a few seconds as her head fell to her chest, but resumed breathing when we opened her airways. Her body seized upon taking in air and 911 was called. She regained consciousness before the paramedics arrived and her vitals were within normal limits when they checked her. Pt went home on her own with mom.

BACK PAIN; NECK PAIN; BUTT HURTS WHILE SITTING ON THE RASH/BRUISE; INFLAMMATION IN BLOOD; NOT BEEN NORMAL; LEGS HURT; BRUISY ON LEFT BUTTOCK; RASH LOOKING LIKE BLUE/PURPLISH DOTS ON LEFT BUTTOCK WORSENED; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 20 year old. Initial information was processed along with the additional information received on 18-MAY-2021. 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, expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, next day after vaccination, the patient experienced bruisy rash on the left buttock. The rash looked like a little blue/purplish dots, it started coming back and worsened. If the patient does anything with impact it comes back. On 04-MAY-2021, laboratory data included: COVID-19 antibody test also called as Abbott Chemiouninesent Microparticles Immunoassay SARS COV-2 IgG test (NR: not provided) no antibodies. The patient experienced confirmed immunological vaccine failure. On an unspecified date, the patient experienced back pain, neck pain, butt hurts while sitting on it if she has rash/bruise, legs hurt, inflammation in blood and not been normal since she got it (unspecified). Laboratory data (dates unspecified) included: Blood test (NR: not provided) inflammation. The patient had been to the hospital and saw like 6 healthcare professionals and nobody knew how to help her/fix it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise on left buttock, back pain, neck pain, legs hurt, butt hurts while sitting on the rash/bruise, rash looking like blue/purplish dots on left buttock worsened, and not been normal, and the outcome of confirmed immunological vaccine failure and inflammation in blood was not reported. This report was serious (Other Medically Important Condition). This case is associated with Product quality complaint number 90000179797.; Sender's Comments: V0: 20210530406--Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Left side numbness. Tests pointed to possible blood clot. Still don?t have feeling in left arm. Having to continue to see neurologist.

I feel inclined to file this report in hopes that someone could study how receiving this vaccine affected my endometriosis. Please understand that I?m a proponent of vaccination and building herd immunity; however, women?s health is important and we have a right to be AWARE of ALL side effects. I?ve done my best to research this topic and was able to find very few sources on how COVID-19 vaccines impact menstruation. Aside from the lack of statistics, I found forums on social media platforms with women explaining how their menstrual cycles became irregular some way or another. I did experience the common side effects of fever, nausea, vomiting, diarrhea, soreness, and fatigue. In addition, I experienced severe cramps, back pain, thigh pain, groin pain, and nerve pain associated with the sciatic and obturator. I?m happy to be vaccinated because my immune system is far from the best, but if I were to have known that I would be unable to walk from the pain radiating from my back, pelvis, and thigh I would?ve opted for Moderna or Pfizer. At this point in time, I would NOT recommend the Janssen vaccine to someone with endometriosis. At that, this vaccine should be nowhere near as political as it is! My healthcare providers should be more willing to validate my symptoms, rather than saving face with the validity of the vaccine. I was told since my menstrual cycle is irregular I must coincidentally be getting my period, BUT I have not experienced any bleeding nor even spotting. I have no idea what the vaccine did to my body, I have no clue why it would induce such severe pain. I?m glad that the ?normal? symptoms have subsided by the second day, but the nerve pain complicates walking long distance or carrying heavy objects. I think I?ll eventually make a full recovery in the upcoming days, but this experience was so frightening. I laid on the floor for hours crying after I vomited up everything I had eaten. I couldn?t sleep because I couldn?t bear to lay down for long durations of time- and by that I mean more than ten minutes. It genuinely felt like I was getting my period, but whatever it was led to no external bleeding. Again, I?m grateful for the scientists who dedicate their lives to such integral work. I just wish I would?ve known about what was internally happening to my body beforehand, I would?ve chosen a different vaccine.

There were no symptoms until much later in the evening. Around 8:30 PM, I felt fatigued. A little later I had chills for about 30 minutes. Then I felt nauseous and went to the restroom down the hall (I was living in a dorm). I did not throw up, but I had a pounding headache which only got worse. I also felt very hot and the cold floor was welcoming. I laid on the floor in the bathroom but felt too awful to sit up. Someone found me in the bathroom around 10:00 PM and called campus safety, which came about 20-30 minutes later. She determined that she could not give me medication on the spot and that she had to take me to the hospital. We arrived at the ER around 10:45 PM. The nurses and doctor took my temperature and found I had a 103-degree fever. Because of my pounding headache, I couldn't hear very well. The doctor gave me a shot of 60mg of Toradol at 10:56 PM. He then gave me instructions to alternate tylenol and ibuprofen every 3 hours, increase my fluids, and only do activity as can be tolerated. I left the hospital around 11:25 PM with a huge headache, but better than when I initially walked in.

I got extremely sick. I was hot and cold. I was nauseas and threw up. I lost feeling in both of my legs. I had shocking pain in both of my legs.

SKIN FELT HOT TO TOUCH; SWELLING OF THROAT; SWEATING; BODY ACHES (UPPER CHEST, BACK AND LEFT HIP AREA); FELT FREEZE COLD; HEADACHE IN OCCIPITAL LOBE; This spontaneous report received from a patient concerned a 20 year old female. The patient's weight was 168 pounds, and height was 60 inches. The patient's concurrent conditions included post traumatic stress disorder, social anxiety, avoidant personality, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 294A21A, expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2020, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. On 28-MAY-2021, the subject experienced skin felt hot to touch. On 28-MAY-2021, the subject experienced swelling of throat. On 28-MAY-2021, the subject experienced sweating. On 28-MAY-2021, the subject experienced body aches (upper chest, back and left hip area). On 28-MAY-2021, the subject experienced felt freeze cold. On 28-MAY-2021, the subject experienced headache in occipital lobe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating, and had not recovered from felt freeze cold, skin felt hot to touch, swelling of throat, headache in occipital lobe, and body aches (upper chest, back and left hip area). This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non serious.

approximately two minutes after administration of vaccination patient had sat down in waiting area and became lethargic/dizzy/blurred vision. She had passed out with face pale and lips turning blue, minimally responsive. Called 911 and while awaiting for ambulance patient had recovered from all symptoms with the exception of "spotted visions." Observed patient for over an hour while a family member came and upon the time of departure there was resolution of all adverse events.

Patient said she felt ill. became unresponsive. Would fallen if we didn't support in chair. It appeared her eyes rolled back. Airway breathing was monitor. and fine. Called 911. She started to come to but was extremely clammy and complained of ring in ears. she was glad EMT's checked out but declined to go to hospital with them. We kept checking he till a friend came to pick her up.

Immediately after the vaccine was administered, the patient stated that she felt sick and light headed. I instructed her to remove her mask, place her head between her legs and take some deep breaths. Before she had completely bent over she lost consciousness and began seizing. She remained in the chair for the duration of the event and until the paramedics took her out of the pharmacy. I made sure she did not injure herself or fall out of the chair and when the event was over I called ED. I continued to monitor the patient until she was taken by paramedics.

patient was seated when received vaccine. she was led to main waiting area to wait for observation. about 5 to 10 min after the shot patient was seated and began to pass out. she came to after a few min and put into lying down position with feet up. appearance was and clammy skin. 911 was called. her blood pressure was normal. heart rate normal. 911 call- based on my answers to their questions they decided to come to the pharmacy. patient stated that she did not have much to eat and that she has passed out from a nose piercing in the past. her color came back by the time she left. ems checked her out. she signed a form stating that she did not want taken to hospital.

6/1 She woke up with a severe headache and vomiting. She went to the urgent care and was treated for migraine headache and nausea. She was giving medication for pain and vomiting. Slept until the next day. Felt somewhat better the next day and continued meds. She went to work on 6/3 and towards the end of her shift she told her boss about the severe headache and sat in her car outside and then became unresponsive. The paramedics were called and she was transferred to the hospital and diagnosed with a brain blood clot and brain bleeding. She was flow by air car to another hospital and admitted to ICU. She was in Neurology ICU until 6/6, and then transferred to a normal neurology bed and released on 6/11. Diagnosis of left venous sinus thrombosis and hemorrhage in the left temporal lobe.

Patient was nervous about getting the vaccine and was experiencing anxiety even before the shot. After receiving the shot she remained seated and coherent for a few minutes, then became non responsive and slumped in her chair. I elevated her legs and after about 30 seconds came around.

STOP BY AIRPORT OFFICER PT HAVING SEIZURE IN TERMINAL D WHO JUST GOT VACCINATED. I ARRIVED TO TERMINAL D PT IS TREMBLING CRYING CAN BARELY STAND FIRE RESCUSE KEEP SAYING SHES FINE JUST A LITTLE PANIC ATTACK PT CAN BARELY STAND. PT AND PT BOYFRIEND HAS NOT EATEN SINCE YESTERDAY WILL GET SOMETHING TO EAT CLOSER TO FLIGHT GATE. DOES NOT HAVE MONEY TO TAKE LATER FLIGHT. PT REFUSE ANY FURTHER MEDICAL CARE DUE TO MONEY

Extreme fatigue (rest, lasted 48 hours) Extreme muscle pain (Advil every four hours, lasted 24 hours) Extreme joint pain (Advil every four hours, lasted 18 hours) Fever (started 12 hours after shot and broke 4 hours after it started) Hot/cold flashes (lasted 36 hours)

RAPID HEARTBEAT; SORE ARM; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 20 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced rapid heartbeat. On JUL-2021, the subject experienced sore arm. On JUL-2021, the subject experienced headache. On JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) not reported, and Heart rate (NR: not provided) rapid. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, headache, and fever on JUL-2021, and had not recovered from sore arm. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.

Patient felt dizzy, was pale, cold, and diaphoretic after the injection. She lost consciousness for about 30 seconds in the vaccination chair. Vitals were taken. BP was 90/55. EMS was called

PASSED OUT; SURGES OF HEAT THROUGHOUT THE WHOLE BODY/HEAT ATTACKING THE HEART; PAIN IN THE BACK OF THE NECK UP TO THE SKULL; WHOLE BODY BURNING; LEFT ARM NUMB; LEFT ARM PAIN; PAIN ON THE LEFT SHOULDER BLADE; 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 penicillin allergy, and other pre-existing medical conditions included the patient reported that the patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 14-MAY-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the patient experienced left arm completely numb and painful where she got the shot, pain on the left shoulder blade, her whole body was burning. The patient also experienced surges of heat throughout the whole body, the heat started attacking the heart of the patient. Then the patient started experiencing pain in the back of the neck up to the skull. On the same day, the patient passed out and went to the hospital however, they could not find anything and advised that it was basically from the shot. The patient was discharged from the hospital after five hours. All of those symptoms lasted for three weeks and then everything resolved. As of 14-Jul-2021, the patient still had random pain and numbness in the left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, surges of heat throughout the whole body/heat attacking the heart, pain in the back of the neck up to the skull, and whole body burning on JUN-2021, and had not recovered from left arm pain, pain on the left shoulder blade, and left arm numb. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210730970 - covid-19 vaccine ad26.cov2.s -Passed out- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Midnight - I got a fever - my face was very, very hot. Fingers and toes were very, very cold. Unable to regulate body temperature. So fever and chills. Those lasted for a good four hours before it let up and then it happened again the next day and the day after that. I had about four days straight where I was not well and I don't remember a lot. On the fourth day, I was okay until the evening and I had really painful diarrhea. I couldn't keep anything in my body and I was in the restroom for about four hours. I was scared as to what was going on. I ended up calling telemedicine. The nurse I talked to over the phone and she said wait 7 days and that I should be okay. I was still slow and lethargic for the following week after but I did feel significantly better on the 8th day after the vaccine. In February, (before the vaccine) I had an UTI that I didn't go to doctor for. I drank a bunch of cranberry juice and I was fine afterwards. I do have an IUD- and on July 12th, I noticed the presence of a UTI and I had painful and really constant urinating. I was unable to hold on to anything at all and I went to Urgent care of the 14th. And they told me that I had deteriorated my bladder walls until I had come to a point where I couldn't hold on to anything. I had collapsed for lower back pain on the 16th of July and made an appt to go to doctor. I ended up speaking to someone on the 17th, and I got the medication that day for a kidney infection due to the lower back pain that I was having. And they said that the UTI had gotten so bad it had gone to the left kidney. I was first prescribed (on the 14th) - Cephalexin and had me take something called Uristat - an OTC cranberry aid and then on the 17th - they told me to stop taking the Uristat so it wouldn't be stressful on the kidneys and they gave me a different antibiotic - Ciprofloxacin and Extra Strength Tylenol. That helped with my symptoms. I had to go back in to the doctor today because for the past three days I have been having the same kidney pain again. I will get the lab results back sometimes this week. I either have another UTI or I didn't get rid of the kidney infection yet completely.

MIGRAINE; CHEST PAIN; PAIN AT THE INJECTION SITE; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: OU3A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain at the injection site. On 19-APR-2021, the subject experienced migraine. On 19-APR-2021, the subject experienced chest pain. On 20-APR-2021, Laboratory data included: EKG (NR: not provided) Normal, and X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 23-APR-2021, chest pain on 22-APR-2021, and pain at the injection site. This report was non-serious.

Heart rate 160+ beats per minute, chest pain, heart palpitations, low blood pressure, dizziness, shortness of breath, dehydration, migraines, hallucinations, COVID-like symptoms, chills, muscle spasms, fever of over 103 degrees Fahrenheit, vomiting, diarrhea, POTS. I have gone to the ER 5 times since the date I received the vaccine on April 6, 2021. Symptoms are ongoing. I have been referred to and seen by a cardiologist, gastroenterologist, and mental health practitioners as a result.

From about 4:00 p.m. until about 10:00 p.m., Patient had a headache, extreme chills, and a fever. From about 11:00 p.m. until 5:00 a.m., with varying intensity where she was able to sleep for an hour or so and then get woken up by the symptoms, she had at least a 103.5 degree fever, intense chills that caused her body to aggressively shake, excruciating pain throughout every part of her body that caused her to cry out in pain (she said it hurt more than anything she has ever felt), an intense migraine that was so bad it felt like her head was splitting open and her eyes torn out, shortness of breath and hyperventilating that caused her to repeatedly black out and weave in and out of consciousness, and extreme weakness to the point she could not move at all. She also said her muscles were aching and cramping and that her heart was pounding so hard it felt like it was hitting her rib cage. She wanted to call 911 because she didn't know how much longer she could hold on to consciousness, but was too weak to grab the phone, and her calls for help were weak and indecipherable. (Also, only her sister was home at the time, and she went to bed with earplugs in and couldn't hear patient.) From 5:00 a.m. to 7:00 a.m. many symptoms subsided, but there was still an agonizing pain in her kidneys (or adrenal glands?) that pulsed through her whole body. At 7:00 a.m. she woke up, and all the symptoms were gone, except for the area around her heart feeling strained. Two days later she called the nurse hotline and took ibuprofen as directed. The area around her heart gradually improved and seemed fine about two weeks later. Patient thinks she may have had Covid over a year ago because she remembers losing smell and having some chest pain that, for a couple of months, prevented her from exercising as she usually did. However, she never got tested because her symptoms were very mild. For her, getting Covid was a much better and less life-threatening experience than getting the Covid vaccine.

I got the vaccine at 10:30 am and began to notice side effects at 7:30. My symptoms are fever, malaise, and migraine.

Chills Fever/flush Periods of being cold then being incredibly hot Weakness/soreness of muscles Dizziness Headache/sinus pressure

Janssen COVID-19 Vaccine EUA Body aches and pains (specifically on left side of body and in lower back), lasted for ~14 hours. Migraine-like headache, currently ongoing but started 11 hours ago. Unable to sleep due to these moderate-severe amounts of pain (woke up at 3am unable to go back to sleep).

Chills and shivering that resulted in uncontrollable shaking, extreme full body pains especially in lower back that were debilitating, fever, extreme fatigue and weakness, headache, pain and soreness and injection site. All lasted for approx. 32 hrs.

Janssen COVID-19 Vaccine EUA fever of over 101°F, dry cough, shortness of breath, chills, muscle aches, weakness, headache

Had fever and headache but the event that occurred at the indicated time was uncontrollable movements - almost as if the chills except much more exaggerated movements and higher paced. This was very scary and lasted for an hour or two

On Tuesday at 12:20 PM Johnson & Johnson Vaccine was received in my left arm After Vaccination until bedtime (around 11 PM) was sleepy but no other symptoms presented themselves. On Wednesday at 01:07 AM woke up to a terrible migraine, nausea, and cold sweats. Could not go back to sleep. On a scale of (least)1-10(most) was a pain level of 6 or 7. I also could not stop shaking. At 2:03 AM developed a fever of 101.3 F. Sat in a cold lukewarm shower until the fever broke. Was able to go back to bed. Spent all of Wednesday inside. Migraine and nausea still present. Intensified with bright lights.

24 hour sickness, but adverse reaction has been a growing red circle on my arm. It is raised, itchy, painful, and hot.

vaccine at 1246. 1248 arm started to hurt, light-headed, nauseated, SOB followed by emesis. B/P 78/42, HR-55, 02 sat 99%, r-18. Pt given crackers and water. Pt reports only eating banana today. 1313 hr-64,02 sat 98% ra, b/p 88/60. Pt states she is starting to feel better. 1329 had pt stand up cont to be slightly dizzy. Instructed to f/u with MD as needed. 1335 escorted to her parents car who came to get her and updated of the situation per pt ok.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Pt fainted wile seated. emergency services were called. she recovered quickly. we gave some candy and water. her bp was normal and osat was normal. mother drove her home

patient was weak and pale . could not sit . low BP 91/44 HR; 43 . sever arm pain on injection site .

Severe chills at 11:30pm to 3am. Woke up at 4:30am and vomited several times. Felt weak and dizzy. The next morning, had severe headache and pain from behind my eyes to the back of my head.

Around 10PM I was on the phone and felt the body aches start. About an hour or so later it started to get pretty painful, my joints. I was trying to go to sleep and I started with chills. I had a heating pad and 2 blankets and was still shivering, I took my temp and it was 102.4F. I took some Tylenol and was able to sleep and woke up in the middle of the night sweating. Next morning I was again with 102.7F fever. I slept most o the day, and when awake I noticed the body aches were still present. Kept taking Tylenol. Next day my left ear started feeling to hurt and it felt like fluid. I decided to go get checked and that is when they told me I had an inner and outer ear infection. After meds were prescribed (oral antibiotics and ear drops) the swelling has been going down a lot and it is not as near as painful.

9 hours after the vaccine I had a sudden onset of flu-like symptoms. I had a fairly severe pounding headache, muscle aches, and felt very hot and cold. I was warmer than normal but did not have a full fever. I was extremely fatigued. Most of these symptoms subsided in about 24 hours with acetaminophen. I am still having occasional (every other day) mild headaches and shortness of breath, heaviness in the chest, and a couch that have persisted 5 days so far.

At around 11 Pm 10 hours after I took the vaccine, I experienced chills, then a fever, and extreme fatigue. The chills lasted for around 4 hours, and eventually my fever went away with it. I shook so hard my back, and my joints started to ache. I couldn't sleep because I was having hallucinations from the fever and the pain would wake me up every hour, I also had a headache. The next day my back still hurts, my head still hurts despite medication, the shaking has subsided. Yet I'm sweating, I'm still very weak, I can't stand up without getting super dizzy or experiencing extreme fatigue. If I think of food I feel as if I'm going to vomit just drinking too much water can make me ill.

FEVER 101.5, and EXTREME CHILLS, and EXTREME FATIGUE. Was really hot. Started not feel good before bed, then extreme chills, and then fever and was really fatigued. Stayed in bed all day the next day, was thirsty and also felt sick to my stomach in the morning but did not get sick and that went away. I started feeling better 24 hours later and was totally fine.

EXTREME FATIGUE, chills and fever of 101.5, upset stomach and wanting to get sick. Got shot in afternoon and felt bad before bed, then was really hot, had extreme chills, had a fever, and upset stomach the next morning. Stayed in bed for the day, was thirsty and really hot. Within 24 hours I felt completely fine...but just felt hot still and then that went away after 2 days.

Known patient to center here for covid vaccination present with father at 1030 Patient tolerated well vaccine and after waiting 30 minutes started to depart and states felt jittery at 1100. Patient resume in supine position with legs elevated. Patient states had not ate all day was going to lunch after appointment. Patient conversant and BP taken Right arm 132/78 at 1105 VS @ 1110 BP 165/99 100 02 sat and 92 HR. Ice paks applied. VS @ 1115 BP 148/96, 02 sat 99% 91 HR, Rep even 16 encourage deep breathing Patient drank juice x 2 , water and crackers without problems and felt better. Continue to monitor with Dr at bedside Patient HOB elevated in sitting position. Mother at bedside. Patient denies chest pain or difficulty breathing, denies throat swelling or itchy. noted eyelid tremors when shut. Discussion ensued on continued to monitor. Patient states feels better. BP 130/90 manual to right are. 149/101 Pulse 97, Resp 16 and even without problems at 1130. Patient amb in hall with assistance and tolerated well, no complaints. Patient escorted to car with out problems.

At around 10:30pm on the day of the vaccine until I feel asleep after 2:00am, my heart hurt, my whole body ached, I was so cold my skin was red. My head hurt. I felt like I would pass out. Today, 4/1, I feel better but go from hot to cold and still feel aches with my head hurting earlier.

I first started to feel weak and achy around 6 pm. Around 7 pm the body aches started to intensify especially in my lower back and thighs. I started to get chills and had a temperature of 102.8. The next morning I woke up with a low fever of 100 and was very tired and had a headache the rest of the day. My arm at the site of the injection was mildly sore for 3-4 days after the vaccine

SEIZURE/CONVULSION; LOW BLOOD PRESSURE; SORE ARM; FEVER; This spontaneous report received from a patient concerned a 21 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 16-MAR-2021 at 17:00 in the right deltoid for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 20-MAR-2021,The caller called to report that her daughter developed some rare side effects. The patient reported that she got the shot on 16-MAR-2021 and went home and went to bed at 23:15 PM experienced convulsing/seizure, chills, shaking, low blood pressure, heart rate increased. The police came to take her to the Emergency room. The patient was hospitalized on 16-MAR-2021. On an unspecified date in MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 70/20 mmHg, 80/30 mmHg, and Heart rate (NR: not provided) 110 OR 115 BPM. The patient has no fever then was given an unspecified IV. At 06:00 On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 98/38 mmHg, COVID-19 virus test (NR: not provided) NEGATIVE, CT scan (NR: not provided) NORMAL, Echocardiogram (NR: not provided) FINE, and Echocardiography (NR: not provided) FINE. Overall she took 6 Liters of IV fluid. The patient was discharged on 17-MAR-2021 at 14:00PM. The duration of hospitalization was two days. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 120/90 mmHg, and Heart rate (NR: not provided) 70 BPM. On an unspecified date, the patient experienced dizzy, lethargic, sore arm and fever. The patient gave permission to speak with her doctor who treated her there and was told to follow up with Primary Care Physician which she did on 18-MAR-2021. No medications were given at discharge. According to her, Blood pressure and Heart Rate was normal when she saw her Primary Care Physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking on 19-MAR-2021, low blood pressure and heart rate increased on 18-MAR-2021, was recovering from, chills and the outcome of, convulsing/seizure, dizzy, sore arm, lethargic and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210339790 - COVID-19 VACCINE AD26.COV2.S - Seizure, Blood Pressure Low. 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).

Began feeling lethargic and had a bad headache at 6pm on April 1st. I took ibuprofen to tame it. Began having cold chills 10pm. Took more ibuprofen to tame. Went to bed around midnight. Woke up at 10:30am feeling miserable. Very bad cold chills, painful headache, and body aches. I took Dayquil and covered up with lots of blankets and went back to sleep. Did not sleep well and sweated off the blankets. Woke up at 1:30pm feeling slightly better. The rest of the day I experienced mild headaches and slight chills in the evening.

Started with a headache 5 hours after the vaccine. Got worse and worse and got dizziness, weakness, fever (got worse and worse up to 103), and nausea.

Starting about 12 hours later I started feeling off, weak and achy. I wasn't able to sleep all night, sweating, aching. When I got up the next morning I had nausea all day and complete loss of appetite. My head hurt, my body was achy, and I fought throwing up all day on 4/3. When I woke up 4/4 my appetite wasn't fully there but I was feeling better. Now 4/5 and 4/6 I'm feeling normal.

Injection site soreness immediately after and continuing for days (to present at time of writing). At 12 hours after injection, feeling feverish, chills, crawling skin, full body aches. Feverishness and chills resolved after a night of sleep, and aches and crawling skin continued for one more day. Managed with rest, oral painkillers, and fever reducers.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted after standing up to move to the observation area, she opened her eyes almost immediately after falling to the ground and was responsive, ems was alerted to check and make sure she did not hit her head. ems assessed and patient was stable, refused medical care or transport to the hospital. left with boyfriend (she was not driving herself).

Janssen COVID-19 Vaccine EUA Headache started around 5:30PM and progressed into migraine by 7:30PM. Full body aches, severe bone pain (low back/neck), sensitive skin, hot/cold flashes, dizziness and sleep difficulties continued all night even after 1000mg of tylenol. Symptoms continue this morning (8:00AM) but to a far lesser degree. On a scale of 1-10, the level of pain was ~8-9, and unrelenting.

Chills and moderate to severe fatigue throughout the day of 04/07/2021; headache throughout the day escalating into a migraine at night (began at roughly 9:00 pm) that persisted through most of the night

Patient felt dizziness, shaking and light headed few minutes after getting the shot, forehead was hot to touch but temperature was 97F, upper lip was sweating and hands were turning blue, and patient reported temporary loss of vison, patient was conscious the entire time called 911 and patient was taken to Emergency Room, Patient was later discharged and 4 hours later patient came to the pharmacy to pickup the car and drove home.

After receiving the vaccine, patient started having dizzy and nauseous. He also reported tingling arm on the vaccinated one, weak leg, and hearing muffled. He was sitting down for at least 30minutes and felt better afterward. He was fully recovered.

Body aches, dizziness, insomnia related to the pain, nausea, weakness, restlessness, headache, injection site pain, chest pains.

About 12:30 AM on 04/09/2020 patient started shivering and the intensity has increased since then. She started feeling really cold around 12:45 AM and started having pain in both legs and the right side of her torso around that same time. We are currently headed to the ER.

Pt received her dose of Janssen Cover 19 vaccine administered to left arm intramuscularly by RN given at 06:54 PM. Pt was seated for observation when scribe noticed pt being pale and sweaty. Sribe asked pt how is she, pt stated that she is dizzy , warm and nauseous. Scribe called RN to assess pt. Pt is alert oriented to self, time, date and location. Initial vital signs was taken by RN at 07:00 PM and it was 145/110mmhg, PR 138 ppm, RR20 cpm, Temp 98.1, Oxygen saturation of 99% at room air. RN assisted pt to lay patient down safely. No SOB and chest pain noted. Pt stated feeling better upon laying down for couple of minutes and stated that her dizziness comes and goes. Pt had no allergic reactions to any other vaccination but pt also stated that she has been feeling dizzy couple of times as her history. No history of elevated BP as well was stated by pt. Pt continuous to complain on and off dizziness, NP assess pt and Called 911 for further assistance. Repeat vitals check done by RN BP 135/100 mmhm, PR 81 ppm, RR 20 cpm, oxygen saturation 98% at room air. EMT came at 07:45 PM came assess pt, checked her vitals, pt requested if she could walk and have the EMT assist her to evaluate herself, no complaints of dizziness reported. EMT offered to bring pt to hospital for further evaluation, pt refused to go to hospital. Pt was advised to go to hospital if episode of dizziness happens again. EMT walked the pt to her car and have her sister drive. Pt left facility at 08:00 PM without any complaints. VAERS was filed and education provider RN was reported.

Numbness in Left Side of face, so far has persisted for 6 days after the vaccine. Included Left side of mouth, left cheek/cheekbone area, and left eyebrow to midline. Felt like there was lidocaine in my face. Dizziness: still getting bouts of dizziness while sitting down and walking, world feels like its spinning Brain Fog: struggling to maintain train of thought, memory problems Fatigued Feels like there is a knot at the base of my throat, feel it when I swallow liquids, does not inhibit swallowing but is a nuisance Fever- lasted for 3 days Chills- lasted for about 24 hours Muscle pain and aching, soreness at injection site, intense shoulder and neck tension is still present but decreasing Headache- 4 days Ventolin Inhaler needed to be taken twice during the worst of the effects, asthma symptoms, specifically coughing and wheezing, have been continuing but decreasing Felt like vaccine exacerbated asthma symptoms Chest tightness, as though someone is sitting on my chest(not one of my usual asthma symptoms)

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: patient was taken by ambulance to ER

Patient briefly slumped over and appeared to pass out shortly after receiving the vaccine. This only lasted about 30 sec to a minute before she became responsive again. Patient reported that this has happened multiple times before when she has received vaccines and was anxious (crying) prior to receiving the vaccine. An initial blood pressure reading was 100/64 at 12:50. She was then able to sit up in the chair and began feeling a little better, asking for water. A second reading five minutes later was 94/54. The patient then chose to drink some water and eat some candy she had brought and this seemed to make her feel better. Lightheadness/weakness was the only symptom she complained of. By 1:03, 15 minutes after the vaccine, she reported "feeing much better." I continued to observe her, seated, for 15 more minutes and a final blood pressure reading at that time was 115/74. Patient reported feeling normal again and went home.

Received vaccine 04/09/2021 at 9:13 AM. Experienced light concentrated headaches around 11pm on the same day. Around 12:30AM 04/10/2021 when trying to sleep experienced cold and hot flashes. On 04/10/2021 4:00AM experienced more hot flashes. From 7:00AM till the time of filling this form (9:00AM) experiencing noticeable back pain (uncomfortable) - muscle pain concentrated on the back. As of 9:00AM 04/10/2021 no other side effects.

Headache started around 7 pm and progressively got worse. Took two Aleve which didn?t help in mitigating pain. Chills around the same time, eventually developing a fever around 10. Used ice packs to try and help bring the fever down. Woke up in the middle of the night sweating through my shirt. Dizziness upon standing, leg pain and chest pain.

Extreme chills and ultra hypersensitive skin. Extreme lethargy and pain in arm. I bundled up in many layers and laid in bed with the house thermostat set to 72. Chills and sensitivity have not abated in the 2 hours since onset.

Day 1- sore arm within 1 hr....8 hrs-vomiting and fever 9hrs through rest of night-vomiting Day 2-vomiting all day Day 3- fine all day until 11 PM-vomiting continues

CHILLS; HEADACHE; INJECTION SITE SORENESS; CHEST PAIN; SORE ARM; FATIGUE; SLIGHT FEVER; This spontaneous report received from a patient concerned a 21 year old female. The patient's weight was 190 pounds, and height was 158.49 centimeters. The patient's concurrent conditions included smoking, and alcohol user, and other pre-existing medical conditions included patient was not pregnant at the time of reporting and has no history of illicit drug abuse and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 16:30 to left arm for prophylactic vaccination. Non-company suspect drugs included: amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate ( form of admin, route of admin, and batch number were not reported) 15 mg, 2 times every 1 day, therapy dates were not reported for an unspecified indication; and drospirenone/ethinylestradiol ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 10-MAR-2021, the subject experienced chest pain. On 10-MAR-2021, the subject experienced sore arm. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced slight fever. On an unspecified date, the subject experienced chills, headache, and injection site soreness. 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 fatigue, slight fever, and chest pain, and the outcome of sore arm, headache, chills and injection site soreness was not reported. This report was non-serious.

Night one, feverish and chills. Day two, swollen and tender. Day three developed into a red bump the size of a dime and pain and swollen. I iced it. And took ibuprofen. Day four the redness has welted and increased in size to a 50 cent piece. Still hurts and feels hot, sometimes it tingles. Still taking ibuprofen.

Janssen COVID-19 Vaccine EUA- Had a 101 degree fever (with headache, body ache, and shaking) the day after vaccination, and a 99 degree fever (I'm usually about 96.5 degrees) the next two days. Left arm has gotten progressively sorer over three days and is currently (3 days in) swollen and feverish feeling in an area the size of a baseball around the injection site.

HIGH HEART RATE; CONGESTION; BODY SHAKES; VOMITING; FEVER OF 102 F; MUSCLE ACHES; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, 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, batch number: 043a21a, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at 17:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 01-APR-2021 01:00, the subject experienced high heart rate. On 01-APR-2021 01:00, the subject experienced congestion. On 01-APR-2021 01:00, the subject experienced body shakes. On 01-APR-2021 01:00, the subject experienced vomiting. On 01-APR-2021 01:00, the subject experienced fever of 102 f. On 01-APR-2021 01:00, the subject experienced muscle aches. On 01-APR-2021 01:00, the subject experienced nausea. On 01-APR-2021 01:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 102 f, high heart rate, muscle aches, nausea, vomiting, headache, congestion, and body shakes. This report was non-serious.

between 5 and 6 in the evening i started feeling a sharp throbbing pain in my right quad and then gradually my entire leg got tingly/numb feeling. in addition my symptoms of fever, headache, and body aches set in at this time too

Started to feel woozy and weak at 5:30pm, headache with sore muscles starting at 6:30pm, went to bed at 7:30 when couldn?t stand up anymore. At 8:00 chills started, along with a feeling of all my muscles contracting , lost the ability for fine motor control and fell asleep at 9.pm. Woke up at 12:45am covered in sweat feeling as if I was burning with a splitting heavy headache, had fever, don?t know temperature new house so no thermometer but it sucked. dunked head in sink. Legs could barely support me so I couldn?t go down the stairs for pain medication, went back to bed. Got cold washcloth at 1:00am pain felt pretty unbearable, couldn?t make it downstairs or move at this point so I spent night in and out of sleep unable to move. Muscles still feel like rocks and my head feels like it?s stuffed with a mixture of Vaseline and nitroglycerin, every time I move it feels like my brains smashing into my skull with little explosions. Recent development within the last 5-6 hours maybe?(3:00-4:00pm) centralized over my breast bone feels incredibly painful, hurts to breath and feels like something heavy is pressing it through my chest into my spine. Not sure what to do or if this is normal but it hurts really really bad. Accurate hours because I was lucidly texting my friends to make sure I wouldn?t pass out, so I have nearly exact hours when each symptom appeared till I could no longer use my fingers.

Minutes after shot: felt slightly faint, tingling in feet and fingers, nauseous, sense of taste was off. Nausea and altered taste lasted about 3 hours. Insomnia beginning 10 hours after shot. 14 hours after shot: headache, fever 101, pain on left side of chest/spleen area, severe left arm pain, pain in left shoulder and forearm, fatigue, loss of appetite.

Janssen COVID-19 Vaccine EUA 11 hours after shot I started to experience a fever with extreme chills and uncontrollable shaking. I felt light headed and nauseous and threw up multiple times. The following day (4/10/21) I was back to my normal self.

Immediately (a minute or two) after receiving the vaccine: lightheadedness, nausea, nearly fainted, vision started going blurry/black, sweating for about 5-10 minutes. Stayed seated until it mostly passed, then went outside for fresh air and to cool down. Put a cold rag on forehead/back of neck for half hour following symptoms. Drank water at soon as possible. For the next 36 hours after receiving the vaccine: sensitive skin, muscle weakness, tiredness, headache, body aches (including the sight of injection), chills, hot flashes. Took Advil every few hours to reduce pain, kept lights off, laid in bed to rest.

High fever that reached up to 103 degrees Celsius that lasted for 24-30 hours, dizziness that is still occurring almost 48 hours after, severe migraine, difficulty breathing at onset of fever

Started off with sudden chills not even eight hours after receiving the vaccine. Chills slowly processed into a fever. By 7 pm, the fever progressed to 103.7 deg F. By 11 pm, I started to have nausea. Throughout the night I continued to have chills and sweats with episodic vomiting. The next morning I had terrible body aches and restless leg syndrome. I still had a fever and a lack of taste. It wasn't until 48 hours after receiving my vaccine that my symptoms eventually subsided.

Several hours after getting the vaccine, my back spasmed out and the pain was continuous and I still have the upper back pain today. That same evening I developed the chills, stomach pain. The next day I began experiencing a fever, headache, nausea, light headedness, dizziness, chills, back pain, lock jaw, some numbness on left side of face, zoning out or spacing out. My period also came two weeks early. I had some throat irritation as well as the feeling of being weak and some neck stiffness. All these symptoms seem to have gone away by Sunday evening, if not Monday morning. Except for the back pain, the nausea, and the throat irritation and some head pain and some numbness in face seem to have persisted.

Chills: I had chills when I was trying to fall asleep. I was cold but I felt my body hot at the same time. I took 1 pill of DayQuil Severe + VapoCool (Acetaminophen 325 mg, Dextromethorphan HBr 10 mg , Guaifenesin 200 mg , Phenylephrine HCl 5 mg) It lasted about 40 minutes. Then I fell asleep. Fever, headache and nausea: I woke up an hour later with fever, mild headache and nausea. It lasted about 4 hours. I took 2 pills of tylenol and had a shower. Started feeling better afterwards but I was too tired because I wasn´t able to sleep. I was okay the whole day but too tired. Then, I got a fever and headache again around 6 pm. Fell asleep for around 3 hrs and woke up feeling better.

Patient fainted and, upon waking, was hot/sweaty and generally felt unwell with several random spells of nausea for about 45 minutes afterwards.

Pt was in the waiting room. Approximately 5 minutes after getting the vaccine, pt's mother called out and said that her daughter is passing out. Pt was found slump on the chair, slow to respond to my questions and diaphoretic. Pt stated she feels hot. Pt did not lose consciousness. Pt assisted to a room where she laid down. Mother stated she's never had this reaction to vaccines in the past. About 40 minutes later, pt sat up. Pt c/o feeling cold and shaky for a little while, but stated she feels better. Pt waited another 5 minutes and then discharged home accompanied by mother, in stable condition

PATIENT EXPERIENCED DIZZINESS, FEELING HOT, SCRATHY THROAT, FEELING ITCHIY AND LIPS TURNED BLUE WITHIN 2-3 MINUTES OF ADMINISTRATION. ADMINISTERED EPIPEN. PATIENT FELT BETTER. EMT TOOK PATIENT TO THE HOSPITAL. I CONTACTED THE PATIENT SHE IS OK AND WAS SEND HOME AFTER THE HOSPITAL.

At 6:30PM, I developed a headache and took acetaminophen. It didn?t subside after taking that, and progressively got worse as the night went on. I began feeling chills and feverish before I went to bed. I woke up sweating in the middle of the night multiple times with my headache getting even worse. At 5:30am, I woke up and it was as its worst, with a 101.2° fever, sweating, chills, and an even worse headache that felt like a migraine. The headache lasted until the next morning and lingered throughout the entire next day, although not as intense as it was at 5:30pm. I?m still struggling with some on and off fatigue from the vaccine, and my arm is still sore.

Nausea, fatigue, shortness of breath, shaking feeling in the body, headache all within the same week of the shot which was 4/5/2021. Shaking feeling still on going as of 4/13/2021

Patient stated that she had history of dizziness after she received birth control shot ( six years) ago, but she has been getting flu shots and felt fine. No known drug allergies per patient. On 04/04/2021, patient received her first J&J covid vaccine from one of our technician, her skin stated turn crimson. The technician reported to the on duty pharmacist. The pharmacist then found patient sat on a chair sideway and was unresponsive. A immediate 911 call was made. In the meantime, Patient sat up and was able to answer questions appropriately. Patient declined to call ambulance. Patient's BP was 135/86 and P was 48. We observed patient for an additional half hour until her ride came. Pharmacist also counseled patient to have some benadyl at home and seek PCP for medical evaluation. The pharmacist checked back patient twice after she left and she felt fine.

- weakness in my body - muscle aches - headaches - fever of 101.3 lasting for almost a full day after - confusion -chills - soreness around injection site - redness around injection site (all the above lasted almost 24hrs, from 7pm the day of the shot until the next day around 7pm) I also have a hardness under the skin at the injection site that has persisted a week after. It?s a hard lump, shallow and it?s sore to the touch, it used to be hot and red, now it?s just tough.

Pt exhibited s/s vasovagal rxn immediately after COVID vaccination. Stated she felt "hot and sweaty". Had several emesis and then stated she felt better. Was diaphoretic and pale. BP remained WNL. Denied SOB/dspnea. Pt given water and assisted to supine position on cot. Stated this has happened to her in the past with a blood draw. After about 10 minutes, pt assisted to sitting position and reported s/s resolved. Color had returned and pt less diaphoretic. Pt able to stand without difficulty. Was assisted to waiting area and waited for 30 minute period with 10 extra minutes. Discussed s/s to seek emergency care for. States understanding.

I did not receive immediate treatment following the vaccination. This occurred two weeks after my vaccine. My symptoms, nausea, dizziness, mental fog, severe and 11 out of 10 full body contractions and cramps. My heart rate was fast, tachycardia and trouble breathing. My doctor said that it is allergy symptoms but I did not have any difficulty breathing before my J&J vaccine. I saw Dr. , as well as Dr. and Dr. . I also saw a lead nurse. . I am still having respiratory issues, and pain when breathing and unable to fully respirate. My Sat O2, is 99-100 on average.

After about 7 hours of receiving the vaccine I started to shiver. My body felt extremely cold even though I was in 75 degree temperature indoors. I started getting goosebumps. That lasted for about 9 hours throughout the night. I also experienced nausea for about 30 minutes at 8:45 pm. I felt like I was going to pass out within that time period too. My head was also hurting throughout the night. My body was aching through the night as well. The only reason I am not sure if I had a fever is because I did not have a thermometer. My arm was sore for 3 days and I was also sweating throughout the first night.

Janssen COVID-19 Vaccine EUA The morning after getting the vaccine I woke up feeling very tired and sore/achey all over. I got to work (I lifeguard at the pool on campus) at around 6:15am and helped get the pool set up. When I sat down to try to do homework I started feeling very dizzy and nauseous. The pool deck is very hot, so I decided to try to go into the pool office where it would be cooler. I remember walking through the door and into the office, and then laying down next to the trash can because I thought I might be sick. One of my coworkers brought me some water and Goldfish, and I layed on the office floor for the rest of my 45 minute shift. Afterwards, when I was looking for my laptop, my other coworker said that when I had tried to go through the door into the pool office I had run into the door (I later got a small lump on my head from this) and that I had dropped my latptop. I do not remember either of these happening, so I believe that I blacked out for a moment, and it was likely hitting my head on the door that woke me up. A small scratch and some mild pain in my foot leads me to believe I dropped the laptop partially, but not completely, on my foot. I felt very tired for the rest of the day, and a little dizzy up until about mid-afternoon. I spent most of the day in bed sleeping. Waking up the next morning I felt completely fine, and was able to go about all of my normal activities with no side effects at all.

Strong shivers along with high fever and pain in legs until current day (04/14). Also shortness of breath

2:30 slight-mild symptoms: headache, body aches 4:20pm- 7am SEVERE flu symptoms: body aches, chills, hot flashes, headache, nausea, dizziness, sensitivity to light and sound, tinder, fever Treatment: Tylenol and cold rag

Patient passed out and we could not get her to come to. She was taken to the hospital by ambulance. Her blood pressure was very low. She became very weak. She had a horrible and very scary reaction to the vaccine. She was in the hall face down when we found her and we could not get her to wake up. When she did come to, we could not calm her. Patient normally lives by herself and luckily was with us when this happened. We can't imagine what would have happened if she was alone.

101 fever, Extreme Headache with pain to touch hair, left hand pain, and body twitching. VNS implant device for seizures constantly provided autostimulations, which is not a normal occurrence. Provided OTC Iburophen 800mg every 6 hrs and kept hydrated.

SYMPTOMS PRESENTED: SEIZURES, PALPITATIONS, FEVER, PULSE IN 125-130 FOR SEVERAL HOURS EVEN WHEN I WAS RESTING, BLOOD PRESSURE 86/66

SEVER COLD; FEVER; SHORTNESS OF BREATH; THROW UP; COUGH; SEVERE BODY PAINS; WEAKNESS; CONSTANT HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 21 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, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced shortness of breath. On 10-APR-2021, the subject experienced throw up. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced severe body pains. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced constant headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021 20:30, the subject experienced sever cold. On 10-APR-2021 20:30, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever cold, and fever on 11-APR-2021, and had not recovered from constant headache, cough, shortness of breath, nausea, severe body pains, weakness, and throw up. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Starting by 5:00pm in the evening, I started feeling faint and very exhausted. I had zero appetite and ate some noodles for dinner. I felt like I couldn't stand up. I started feeling the chills and joint/muscle aches by 8:00pm. I fell asleep at 9:30pm because I was so tired and woke up at 11:00pm feeling incredibly feverish, naseauish and weak. I couldn't stand in the shower I felt so weak. Then around 11:30pm I vomited all of the contents of my stomach. I didn't feel nauseous after I finished vomiting. The next day I still felt feverish and like I didn't have an appetite. I spend around 5 hours of the day sleeping. I felt more like myself by 7:00pm the following day.

MINOR COLD; SORE ARM; FATIGUE; CHILLS; FEELING HOT; This spontaneous report received from a consumer concerned a 21 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 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced feeling hot. On 10-APR-2021, the subject experienced chills. On an unspecified date, the subject experienced minor cold, sore arm, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling hot, and chills on 11-APR-2021, and minor cold, and had not recovered from sore arm, and fatigue. This report was non-serious. This case, from the same reporter is linked to 20210421646.

SWEATING; RASH ON NECK; SORE ARM; This spontaneous report received from a patient via a company representative concerned a 21 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sweating, rash on neck, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweating, rash on neck and sore arm was not reported. This report was non-serious.

BACK SORE; PAIN IN HIPS DOWN BOTH POSTERIOR LEGS; DID NOT FEEL GOOD; This spontaneous report received from a patient concerned a 21 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced back sore. On 12-APR-2021, the subject experienced pain in hips down both posterior legs. On 12-APR-2021, the subject experienced did not feel good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not feel good, and was recovering from back sore, and pain in hips down both posterior legs. This report was non-serious.

PAIN IN BOTH ARMS; HEADACHE; CHILLS; PAIN IN INJECTION ARM; FEVER; PAIN IN VEINS; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included thrombosis, and concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of report. The patient was previously treated with rivaroxaban for thrombosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pain in veins. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced pain in injection arm. On 18-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced pain in both arms. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, pain in injection arm, fever, and headache on 19-MAR-2021, had not recovered from pain in both arms, and the outcome of pain in veins was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.

SHAKY; HEART RACING; STOMACH PAIN; DIARRHEA; BODY ACHES/BODY PAIN; NAUSEA; FEVER 101F; This spontaneous report received from a parent concerned a 21 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced body aches/body pain. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever 101f. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021, the subject experienced heart racing. On 12-APR-2021, the subject experienced shaky. Laboratory data included: Blood glucose (NR: not provided) 120, and Heart rate (NR: not provided) 145. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, stomach pain, diarrhea, body aches/body pain, fever 101f, heart racing and shaky was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

Patient developed calf pain 4 days prior to her ER presentation on 4/22/2021. Found to have an occlusive DVT of the left posterior tibial vein.

4/17 Chest pain when she takes deep breath that spreads to her left arm 4/20-Follow up call second attempt - Voicemail not set up yet; unable to leave a message.

Severe Headache, left leg tingling, nausea, nerve pain in left leg and arm. All started on 4/13 in the PM and are currently ongoing.

CALF PAIN; ANKLE PAIN; HEADACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 21 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 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced flu like symptoms. On 07-APR-2021, the subject experienced headache. On 17-APR-2021, the subject experienced calf pain. On 17-APR-2021, the subject experienced ankle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms, and headache, and had not recovered from ankle pain, and calf pain. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious

A lot of bleeding at injection site when given the shot. The day of began 102 degree fever. Severe chills. Body aches. Sore throat. Fatigue. Swollen arm. Pain in arm. Nausea. Lasted about 5 days. 3 weeks later still have tingling and pain in right arm.

Yesterday pt reported sore arm, swollen/red arm, body aches, fever (102F), headache, difficulty swallowing, palpitations, shortness of breath, gets winded walking around. This was when she spoke to triage nurse. Advised to go to Urgent Care or ED and follow up with PCP Dr.

Hepatitis / Encephalopathy (seizures, ADEM, MISC/A) PRESENTING PROBLEM: Fever and chills [R50.9] Hepatitis [K75.9] Febrile illness, acute [R50.9] Acute nonintractable headache, unspecified headache type [R51.9] Seizure (HCC) [R56.9] MIS-C associated with COVID-19 (HCC) [M35.81] Active Issues Requiring Follow-up MIS-C/A - 2/2 COVID-19 infection vs idiosyncratic reaction to J&J vaccine -prednisone taper over 16 days as above -ID will be arranging follow up serial labs (CBC with diff, CMP, Ferritin level, CRP, LDH) -Bactrim prophylaxis while on steroids -Acyclovir 400 mg BID for prophylaxis (hx of recurrent HSV infection of eyelid) - duration to be clarified by ID at follow up -ASA 81 mg daily -TTE w/ normal coronaries. She will need cardiac MRI, to be arranged by adult congenital cardiology Generalized tonic-clonic seizures - witnessed and captured on EEG 4/9. No further events. Continue Keppra 1500 mg BID. outaptient f/u with neurology Abnormal MRI brain - diffuse T2 white matter hyperintensities - non-specific. She will need follow up MRI brain w/ and w/o contrast in 1 month and follow up with neurology clinic ADHD - given insomnia, Senthuri was recommended to avoid vyvanse for now. She will discuss with her outpatient prescriber Anxiety and depression - zoloft increased to 125 mg daily Insomnia - 2/2 trauma from critical illness. Improved with trazodone HS. Elevated EBV PCR - ID will continue to monitor. Nausea/vomiting - resolved. Likey 2/2 gastritis in setting of steroid use. PPI BID x 4 weeks DISCHARGE DISPOSITION: Home without services

My lips were burning and pulsating, my upper lip had gotten a dry bump. I had tried throwing up once but all I could do was gag. The next day my body felt tired and I had slept the majority of the day my arm had also hurted. My seasonal allergies were bothering me so I took Benadryl only one before bed. Today I woke up my arm is still hurting although not as bad. But I'm still tired I felt like I haven't slept enough but I had gotten about 7 or 8 hours of sleep.

Dizzy, Sweaty, Lost Vision Temporarily, Hearing muffled, Sensation of needing to urinate, Chills, overwhelmed, numbness in hands

Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Additional Details: light headed started to fall sweating called 911 paramedics took to hospital as blood pressure too long could not leave her

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: before vaccination, pt indicated that she doesn't do well in needles. she experiences panic attacks with needles. pt complained of lightheadedness, nausea,flushed, warm feeling. gave pt a trashcan but didnt vomit. gave a cool compress, and pt already had h20 to drink. after sitting over 30 minutes, pt boyfriend came to p/u pt. called pt. pt is doing much better also indicated she had some blurred vision also.

LEG PAIN; FATIGUE; FEVER; DIZZY; This spontaneous report received from a parent concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizzy. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced leg pain. On 16-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Not had clots. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, fatigue, and fever on 08-APR-2021, and leg pain. This report was non-serious.

Myalgias for 17 hours on day of vaccination that completely resolved. Myalgias and weakness started 4/15 and continued progressively for a week before presenting to the clinic. Lab results showed rhabdomyolysis with CPK of 204,900 U/L and elevated transaminases (see levels below). Referred to Emergency Department where she was admitted to the hospital for IV fluids. Creatinine never increased and CPK/transaminases trended downward until release from hospital. At clinic follow up visit on 5/6, patient reported resolution of pain and weakness although she doesn't quite feel 100%.

VOMITING; BODY ACHES; CHILLS; FEVER; NAUSEA; PAIN IN ARM; WEAKNESS; This spontaneous report received from a patient concerned a 21 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: 1821286, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 11:40 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced pain in arm. On 12-MAY-2021, the subject experienced weakness. On 12-MAY-2021 22:00, the subject experienced vomiting. On 12-MAY-2021 22:00, the subject experienced body aches. On 12-MAY-2021 22:00, the subject experienced chills. On 12-MAY-2021 22:00, the subject experienced fever. On 12-MAY-2021 22:00, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) Pretty high. The action taken with covid-19 vaccine was not applicable. The patient was recovering from fever, and had not recovered from chills, body aches, nausea, vomiting, pain in arm, and weakness. This report was non-serious.

pt received shot at 1107am at 1110am pt started feeling sweaty/claimy an severe headache, pt asked to wait a few before calling 911, we gave pt a wet paper towel and boyfriend purchased a water to possible give benadryl, at 1112am pt started feeling hot, and felt like throat closing, we called 911 at that time and monitored symptoms pt wasnt running a fever and no rash around injection site, ems and fire arrived and checked vitals all checked out ok we advised we could give a benadryl pt said they had some at home and would just take at home, pt refused to be transfered to hospital so we all signed off on ems sheet and pt left with parent and boyfriend.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Additional Details: patient fainted and vomiting after receiving vaccine, ambulance was called patient was evaluated and vitals were within normal limits. Patient was contacted 6 hours after event and stated she was feeling much better. patient was observed after vaccine for 1 hour

Symptoms started roughly five hours after receiving the vaccine. It began with cold sweats, where I was shivering but sweating. Then I began experiencing nausea overnight coupled with a headache.

The first symptom I experienced was a high grade fever that reached 103.5 degrees Fahrenheit. The fever lasted from 2:00pm on May 10th (the day it was administered) until 2:00 am on a May 11th (the early hours of the day after it was administered). Some weakness, as well as muscular soreness in the left arm persisted in the insuring days. The reason why I chose to report my experience is because something that I thought was abnormal happened. On the evening of May 15th, as I was putting on my pajamas, I noticed an irregular mass in my left breast. As I examined it further, I realized that this mass was not there previously and warning shots fired off in my head, immediately. I immediately asked my grandmother to do another examination of my breast, and she confirmed my suspicion that there was a foreign mass located above my nipple in my left breast. It was difficult for me to closely monitor this mass as it was difficult for me to think about it as it triggered emotional distress. I asked my mom to do an examination and she also noted the mass. A little more than a week later, I noticed that the mass shrunk. Since everyone in my family was on edge for nearly a week suspecting that a 21 year old female in their family could possibly have breast cancer, this caused my family to consult my grandmother?s doctor, and have her assistant contact me about what could potentially be happening. Her assistant spoke to me over the phone and communicated that it is important for me to have the mass formally examined and for me to receive a mammogram. She also mentioned that many women who have received the vaccine also noticed irregular lumps in their breasts after receiving the vaccine. I want women in my age range to be aware that they might notice lumps in their breasts after the vaccine and not to experience the same emotional distress of thinking that they have breast cancer when it could be inflammation occurring in their lymph nodes as a result of being administered the Covid vaccine.

Night of vaccine for 3 days, extreme chills and cold sweats, fever, cold symptoms. No medication administered. Numbness in left leg 1 week later.

21yo Active Duty female Navy Sailor currently deployed to UAE reports to Fujairah Detachment medical clinic with c/o bottom lip swelling x 96hrs, which began about 24 hours post receiving the J&J vaccine on 16May21 in Jebel Ali, UAE. Pt denies any pain, tingling, or numbness but does report a throbbing sensation in the lip. Pt denies any dyspnea, SOB, dysphagia, or difficulty eating/drinking. Pt states there is also a blister like red spot on the middle of the lip. Pt denies any fever, body aches, fatigue, n/v, or other skin lesions. Pt denies any history of cold sores/herpes labialis. Pt denies having anything like this from a vaccine in the past. No history of medication, food, or environmental allergies. Pt also reported HA, stomach ache, and feeling weak for 24 hours after vaccination then resolved, but lip then swelling began and persisted prompting medical evaluation. Provider prescribed 25mg Benadryl which significantly decreased the lip swelling over the following 6-8 hours.

Date of vaccination (4/28), fever of 102 F, resulting in loss of sleep. A week later (5/03), singular hives began to appear on arms and legs, resulting in loss of sleep. Much worse the next day (5/04)- clustered hives accompanied with burning rash all over arms and legs. Benadryl anti-itch cream only enflamed them more. Vomited the next morning (5/05) and made an appointment with healthcare clinic, despite hives and rash subsiding overnight. Doctor ruled vomiting as an effect of prescription medication, but rash and hives as a result of a reaction to the vaccine. Next day and the day after,(5/06-5/07), had a few single hives appear on body. Haven't had any more appear since then, and I've felt fine.

I woke up around 2 in the morning with body aches, chills, and nausea. I started having muscle seizures that made me unable to talk, but I was still somewhat aware of things going on around me. I went to the ER where they observed my pulse and oxygen levels. I was also completed a full blood panel and an EKG was administered. woke up aroound 2 am with body ached, chills nausea i started havieng mucle seizurs, where I couldn't talk .I went to the ER week to get better

Patient developed a deep vein thrombosis approximately one month after receipt of vaccine. Of note, was on an oral contraceptive prior to this. No other history of VTE or smoking, or other coagulation disorders in family.

SEVERE MIGRAINE; FLU LIKE SYMPTOMS; STOMACH PAIN; ARM SORENESS ON THE SURROUNDING TISSUE AROUND THE INJECTION; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, severe depressive disorder, generalized anxiety, alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. Concomitant medications included sertraline for antidepressant, ethinylestradiol/norgestimate for birth control, and salbutamol. On 25-MAY-2021, the subject experienced arm soreness on the surrounding tissue around the injection. On 26-MAY-2021, the subject experienced severe migraine. On 26-MAY-2021, the subject experienced flu like symptoms. On 26-MAY-2021, the subject experienced stomach pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe migraine on 26-MAY-2021, and flu like symptoms, stomach pain, and arm soreness on the surrounding tissue around the injection on 27-MAY-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

Patient states that in the first two days after vaccination, she experienced flu-like symptoms. Her symptoms progressed and became more severe with nausea, vomiting, fever, and "sleeping legs" (numbness, tingling). Pt's mother called pharmacy on 6/3/2021 to express concern and pharmacist advised her to take daughter to emergency department. Follow-up calls to patient have gone unanswered.

Right after I received the vaccine, I was ill to the stomach and the next day I had a burning stabbing pain and leg (specifically, my left leg and calf area). I considered going to the ER. I went to a friend's house and the pain from my leg and calf was extremely bad and 4:00PM in the afternoon, I drove to my parents house. My parents helped me out of my vehicle and took care me. I waited to see if the symptoms would go away or if they continued to persist and finally went to a Doctor after 3 to 4 weeks to find out what was wrong with me.

Patient was very nervous at the time of vaccine. After the vaccine was administered, the patient went to sit for 15 minutes afterwards and her whole body was shaking. We assessed the patient, provided her water and orange juice and monitored her. She declined for us to call the hospital and stated that she was nervous about getting the vaccine. She initially felt flushed but as we sat and talked to her, the shaking subsided and the patient felt fine to leave. She declined getting her blood pressure or blood sugar checked. We had her stand up slowly and assessed her gait to make sure she was feeling okay, and she appeared to be standing normally. She stated that she felt fine to leave. She said that she was not driving and that her husband was going to come and pick her up.

Systemic: Fainting / Unresponsive-Severe, Additional Details: pt fell off the chair, faced down after 5 minutes of vaccine injection. 911 was called and paramedics took her to ER.

Patient started to feel light headed , cold sweat, pale and nauseated about a minute after the injection. I had patient lay down on the floor with her feet up on the chair for about 15 to 20 minutes. After 20 minutes patient feels better.

Patient with no medical history, received dose of Jannsen and within 16min of the vaccination started having tingling to Left arm down to hand. No rash noted and experienced no other symptoms.

PAIN IN LOWER BACK; CHILLS; FEVER; HEADACHE; NAUSEA; OVERALL WEAKNESS; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies, no any history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204a21a, expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced pain in lower back. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced fever. On 25-JUN-2021, the subject experienced headache. On 25-JUN-2021, the subject experienced nausea. On 25-JUN-2021, the subject experienced overall weakness. Laboratory data included: Body temperature (NR: not provided) 102.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, nausea, chills, pain in lower back, and overall weakness. This report was non-serious.

WITHIN 3 TO 4 MINUTES OF INJECTION PT FELT DIZZINESS, HEADACHE, SWEATING, FEELING TINGLING ALL OVER BODY, AND NAUSEA . THE FIRE DEPARTMENT MEDIC CAME IN. MONITORED HER. TOOK HER OUTSIDE ON A STRETCHER, SHE FELT BETTER, WALKED BACK AND FORTH AND FELT BETTER AND DID NOT GO TO THE HOSPITAL.

21y/o female reported feeling dizzy and weak after receiving Janssen vaccine. patient assisted to the floor by observation nurses, legs elevated on chair. BP 100/65, patient awake and alert. Patient observed for additional 15 minutes and ambulatory with family upon leaving.

Rash across chest and neck (about three minutes after the shot, went away an hour later), fever 103.5 by 3pm that day, nausea and vomiting by 8pm, panic attacks and night sweats throughout the night and the following day. Fever wouldn?t break with Tylenol for two days. Cramping in left calf to present day.

Nurse was asked to come help a patient that felt dizzy after getting the vaccine. Nurse walked over and she was being held up by other nurses. Patient never hit her head but she lost consciousness and had jerky movements for about 10 seconds. After coming to, she could tell us her name and where she was accurately. Nurses took vital signs that were stable after event. She was taken to a holding area by wheelchair and given water/food. She said she felt much better and left 30 minutes later on a bus.

I first noticed that I was extremely cold and could not get warm at about 11 pm on the evening of my vaccine. I then realized it was getting worse, and I was shivering uncontrollably despite sitting in front of a space heater in warm clothing and wrapped in a blanket. I checked for a fever, but my temp was only 99. I fell asleep around 1 am, and woke up at 5 am (3/8/21) to a splitting headache, extreme thirst, slight nasal congestion, muscle soreness, fatigue, and nausea. These symptoms feel almost identical to the symptoms I experienced when I contracted COVID-19 in September 2020 at my university.

8 hours after getting the vaccine I started to get the chills and couldn't get warm. I took my temperature and it was 99.7. I wait a another hour and I still had the chills and started to have terrible body aches. I took my temperature again and it was at 101.3. This stayed the same until the follow day (03/07/2021) My fever finally went down around 2pm. And the body aches stopped around 4pm.

Muscle pain all over body, specifically glutes, lower back back, and arms. Fever above 99° F Chills and sweats at the same time Headache with pulsating nerve pain on sides and ears. Dryness in mouth no matter how much water intaked Treatment: tylenol and bed rest

The night of my vaccine date (6 hours after) I was fatigued and started a fever with chills and acheyness which kept me in bed all night. I got up to shower and get some food as I was going upstairs I grew very faint, my vision grew black and my hearing faded. I was able to make it to my bed then ask for some help. After taking Tylenol, my fever began to be very hot instead of chills. I was able to fall asleep until I woke back up to chills again and taking more medicine. The next morning, I was still dizzy when I walked around but the fever was gone. I was still very fatigued which made me unable to go to class or work. Day 3 I was back to my normal self.

patient reported feeling of hot flashes and head pounding; patient informed pharmacist about the reaction 2 hours after the vaccination. Pt felt better after taking Tylenol.

Patient had a very short seizure lasting a few seconds. Then was aroused and didn't have a postictal phase. Her skin color was pale, blood pressure was low at 106/70 sitting, and heart rate was slow at 60. She was evaluated by fire department paramedics and transported to ED.

headache and feeling ?high? about an hour afterwards. fatigue persisting. seven hours later (12 am) fever 100.5, severe chills and shakiness and a migraine type headache. nausea came sometime after 12 am.

Immediately after being vaccinated, patient's face and eyes began to swell and became red. Patient denied itching or shortness of breath, itchy throat. Patient given 50mg benadryl at 1900. Patient then complained her throat was itchy and her voice was becoming hoarse. She continued to deny shortness of breath. EMS was called at 1908. EMS arrived at 1920, evaluated patient. Patient found to be stable and was given option to go to the hospital via EMS or go home. Patient decided to go home with her friends.

Janssen COVID-19 Vaccine EUA I received the Janssen COVID-19 Vaccine EUA on 03/09/21 at 6:20AM. My arm started to ache maybe 15 minutes after and lasted throughout the whole day. Around 4:30:PM I started to feel more aches and chills. Then, by 7:00PM I had a fever. My temperature was 100 degrees. By the next day, 03/10/21 my fever and chills were gone, however, I felt very achy all over the body. It was not until the next day, 03/11/21 that I didn't feel achy anymore.

Originally, I started with random muscle aches in my left shoulder then it went down my back (a few hours after receiving vaccine). Then slightly fogginess and at night the muscle pain became worse making it difficult to sleep and started getting cold flashes. Once asleep around 12:30 I started getting muscle aches that felt like they were burning and in random spots on body along with a headache and would get random cold and heat flashes. Kept yelling out in pain all night and increased tremors in hands. Boyfriend noticed I had a fever as well and gave me ibuprofen around 3am since pain was unbearable and was difficult to sleep. Almost took me to the hospital due to the intense pain.. In morning slightly better but still frontal lobe pain and aches throughout body with raised heart rate. Cannot do much or else aches get worse including headache.

arm soreness within 12 hours persisting for 3 days. Fever after 1 day. Headache still occurring after 4 days. Swelling and redness at injection site after 2 days and continuing growth. On day 2, size of dime. Day 4 (today) size of tennis ball.

After receiving the vaccine, client lost consciousness and collapsed to the floor. EMS was summoned. Client had two separate seizures, regaining consciousness in between and after. Client was taken to local hospital for care via ambulance. Attempts to contact client on 3/21/2021 and 3/23/2021 unsuccessful.

Increased muscle pain and joint pain all over body....head/neck tics involuntary muscle movement, jerking of body...hands... taking Advil 200mg 2 tablets dose for pain and monitoring tics as they seem to be starting to subside today...

Dizziness, NauseaVomiting, Palpitations, near syncope/tingling in extremities Narrative: Employee presented to the ER for evaluation within 15 minutes of vaccine with dizziness, palpitations and feeling nauseated. She reported tingling in her legs as well. She was monitored-required IVF, pepcid and benadryl in the ER. Other Relevant History:

Severe chills, tremor approx. 6 hours after injection(8 PM). Initial episode of chills/tremor lasted roughly one hour before calming. Recurrent chills of lesser severity followed for approx. 4 hours after, on and off. Fever ranging from 99.4-101.0 followed. Skin sensitivity akin to "feeling like a sunburn", muscle ache, and brain fog followed the next 30 hours.

Involuntary shaking from 12:10 to 1:30 vomiting from 12:10-1:30 only stopped after I took Benadryl. But my body is still recovering from the shaking and vomiting and I am sore all over.

It started as chills and body aches at 2 AM then progressed to a fever, borderline migraine, and nausea. I am unsure about whether or not I should take medicine for it so I have remained unmedicated thus far.

Nausea, blurred vision, loss of vision, loss of hearing, out of it, heart racing, body became hot, ice packs were placed all over my body, in a couple minutes my vision came back and my heart rate started to slow

muscle pain in the back of the legs, chills, fever, headache, dizziness, tiredness. It started around 12am and went until 1pm when I took tylenol.

About 10 hours after vaccine, began to feel tired and fatigued and nauseous. Then I developed a fever and sore muscles. It progressed to the point where I needed assistance walking. I had extreme chills with uncontrollable shivering and muscle spasms. I felt very cold though I was burning up and sweating profusely. I went to sleep and woke up a few hours later with no fever but very sore muscles. When I woke up in the morning, I felt like nothing had happened, I was just a bit groggy.

Initial arm pain in injection spot for about 10 minutes. About 5 hours after vaccine, developed headache. About 7 hours after vaccine, developed convulsing chills. Throughout the first night after vaccine alternated between chills and hot flashes. About 15 hours after vaccine, still had headache and sore/tired eyes. Headache lasted for about 48 hours in all. Arm with injection site sore for 48 hours. Ibuprofen did not help with headache or arm pain.

Fever and chills (8:30pm-2:00am next day) Nausea / vomiting (3-4am next day) Extreme back pain (mostly lower back) (2am-7am next day) Red, hot, itchy rash on left side of back / abdomen (I just noticed at 11pm day after, not sure when it began) Extreme fatigue and mental fogginess (8pm day of - still continuing 11pm day after)

Patient experienced fainting approximately one minute following administration of vaccine. Patient reported hearing ringing in ears prior to fainting. Patient did not fall or experience any physical injury during fainting episode. Patient returned to consciousness and reported feeling hot and sweaty. Patient consumed apple juice and was monitored for thirty minutes. Patient denied the need of emergency medical care and reported feeling better throughout the 30 minute monitoring and prior to leaving the facility. Patient was given a ride home with family members. Patient blood pressure prior to leaving the facility was 113/69 with pulse of 61. Patient denied feelings of dizziness, lightheadedness, ringing in ears and difficulty with breathing prior to leaving facility.

Muscle pain, fever, and headache the day after the vaccine was administered and this lasted 2 days. Also I got inflammation in the injection area which is red, inflamed and causes a lot of pain as much as the movement of the arm as the touch of the area. It's like a "bump". This effect originated since the same day that vaccine was applied to me and even 6 days later I still have this symptom or adverse event in my left arm which is where I received the "shot."

Patient received Covid 19 Janssen vaccine, about 10 minutes after administration patient started to get really hot. We applied cold clothes to the neck and head and patient felt like she was going to vomit so we also gave her a bag just in case she got sick. She started looking very pale so we layed patient on floor. She started to panic that she wasn't going to go to work and eyes were rolling in the back of head. Called 911 for patient and I stayed with patient, I took her blood pressure which was normal. Patient became fully alert again and stated she was feeling a little better. The ems checked her blood pressure and blood sugar and released the patient.

Instant dizziness, pain in the neck area, loss of arm motion, Violent shaking at night, fever 101.8. Body aches, headache, sensitivity to light, low grade fever for 48 hours. Felt slightly better taking Advil for 48 hrs.

102 fever, extreme chill, sore and stiff neck, body aches, joint pain, very bad headache, restless legs, hot flashes later, nausea, weak, fatigue, and the next morning I still had a fever, fatigue, weakness, and joint pains.

Experienced chills beginning at 2am the following night, followed by a fever of 100.6 degree which peaked around 5am. Following this, I was fatigued and felt overall unwell and unable to do work until 4pm the next day (24 hours later).

102 degree fever (for 10+ hours), migraine, body aches, chills, nausea Treated with rotating Tylenol and ibuprofen for 24 hours

The night I got my shot, my entire body was freezing and I couldn?t sleep at all because my entire body was in so much discomfort and pain, especially near my rib cage area in the front and back. The following day was the exact same, except my front rib cage didn?t hurt anymore (only the back). I was extremely fatigued and I couldn?t sit down because my body hurt so much. The worst symptoms were the sharp ear and neck pain (by the ears). It was a sharp, sporadic pain, but it still hurts a lot. It?s now been 2 days since the shot and the neck and ear pain is now more frequent, though my fever and some of my muscle sores are now getting better. I also feel extremely nauseous, like I?m going to puke anytime soon.

Flushing, Sweating, Dizziness, and Fatigue. BP 141/88 HR82 RR 19. After monitoring in observation area, despite stable VS, patient continued to report dizziness, nausea, and headache, EMS called and patient taken to ED.

My daughter got the shot at 1 pm on the 8th of April, 2021. (My daughter & I both got the shot at the same shot at the same time). By 11:00 pm my daughter started complaining with feeling dizzy. She kept saying she felt like she was going to throw up, meaning she was nauseated. She was complaining with her bones hurting. We both got these symptoms at the same time. We both stayed in and out of the shower letting the shower water just run on us. I had to give her ibuprofen because she complained of a mild headache & the pain all over her body. She couldn?t sleep at all. She cried. It had her scared. I fully believe she?s having an allergic reaction to the Janssen shot. I have fully read the Janssen ?fact sheet?. My daughter was having hot flashes & cold sweats. She has ongoing symptoms & it?s been 2 days since receiving shot including fever. She was having what I thought heart palpitations. We both swelled up causing our bodies to feel tight. We both were healthy before receiving the shot. We?ve never had covid nor tested positive. We are currently going to receive a check up by a doctor. The side effects of this medication is dangerous & doesn?t compare to flu like symptoms.

Day After Injection: fever, chills, nausea, dizziness, light sensitivity, migraine, muscle aches, itchiness by injection Day two: swollen injection site, severe itchiness, muscle ache, dizziness Day three: 04/10/21 severe itchiness, redness size of golfball

Temporary paralysis in limbs and trouble breathing. Started as tingling and numbness in body. Both lasted for 5-10 minutes and then went away

Headache, fever, chills, Body aches , injection arm hurts, feels weak. Overall after Tylenol, arm still hurts and feels weak.

HPI: Patient is a * year old * who presents following administration of a single dose of J&J COVID19 vaccine in the left deltoid. About 20 minutes following administration of the vaccine, the patient started to experience numbness in the left shoulder to the left neck and post auricular region. Patient denies allergies to medication, food, and other vaccines. She states she has never had a similar experience. She declares a past medical history of asthma that is controlled with rescue inhaler and oral medication. She has not taken the medication for the past week and uses her rescue inhaler 2-3 times per week, particularly when she exercises or coughs too much. She affirms numbness of the left neck, left shoulder, She denies chest pain, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting. Exam (update as needed): GEN: Alert and oriented x 4, NAD. HEAD: NCAT EYES: PERRL, EOMI ENT: Decreased touch sensation in the left post auricular region and left posterior neck region. Normal ROM and 5/5 strength of the neck. Right ear normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD. CV: RRR, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: No rashes, skin warm and dry. No erythema or edema of the injection site. MSK: FROM of the bilateral upper extremities and neck, MS 5/5 bilaterally NEURO: Alert and oriented x 4, CN 2-12 grossly intact, no ataxia, gait steady. Decreased sensation of the left post auricular region, left posterior neck region, left shoulder, left bicep compared to the contralateral side. Clinical Impression/Field Tx: Possible peripheral nerve injury secondary to vaccine administration. Patient not displaying active signs and symptoms of anaphylaxis. Patient demonstrated ability to adequately control airway and secretions. The patient was experiencing decreased sensation on the ipsilateral side of the vaccine site compared to the contralateral side. Muscle strength was 5/5 bilaterally. CN II-XII were grossly intact. Patient offered further evaluation by EMS, however, patient declined as she has an appointment with her PCP on Monday and would prefer to address it there. Instructed patient to consult their PCP regarding the post-vaccination reaction. Patient states she has an appointment on Monday. Patient instructed to go to emergency department should the area of decreased sensation increase in size or if they develop chest pain, difficulty breathing, difficulty swallowing, swelling of the face/lips/mouth/tongue/throat, or cramping abdominal pain with nausea/vomiting, as these are signs of possible anaphylaxis that requires immediate intervention. Medications administered: None Disposition: Home

I started having a fever and headache around 7pm. At 10 pm my back was hurting badly, head hurting badly, and lots of chill shaking my body

chills, uncontrollable shaking, fever, fever dreams, headache, dizziness, nausea, loss of vision (momentarily), loss of hearing (upon waking up)

Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe, Additional Details: THis event happened approximately 30 sec after receiving the Janssen COVID-19 Vaccine. Patient was brought to the ER by firemen due to in and out consciousness. Patient was with boyfriend who caught her as she was falling. Patient did not hit her head. She did state that she has passed out in the pass once after receiving a vaccine, but not regularly. She states she does not have a fear of needles when asked by fireman.

Blood Vomitings, Nausua , knee pains, Chills, fever, headache, dizzyness, uncomfort.. 6 hours of sickness, next day body pains and uncomfort.

FIVE MINUTES AFTER ADMINSTRATION OF THE VACCINE, PATIENT BECAME VERY DIZZY,FELT EXTREMELY HOT, SWEATY AND BECAME UNCONCIOUS FOR ABOUT 2MINS.

Sore arm mild right after shot, then progressed around 6/7pm of following day. Fatigue remained constant after shot. Chills and headache appeared at 9pm of following day. No over-the-counter medication taken.

Light headed. Fainted. Shaking uncontrollably. Extreme fatigue and body aching. Extreme sweating. After 24 hours, all muscles very sore.

Starting at 9:00pm (approximately 6 hrs after vaccination) I experienced: Sudden exhaustion at end of day, lasting 24 hrs Chills/shaking for about 3 hrs Mild headache for 24 hrs Body aches, especially lower back pain, lasted 24 hrs Frequent urination (3 times) throughout the night Increased thirst, 2 days Wobbliness/loss of balance 18 hrs (worst symptom for me) Feverish symptoms (sweating but cold), 24 hrs

Around 6pm I started having normal mild reactions to the covid vaccine. Around 10pm I lost feeling in both arms and my lower legs, but otherwise was still able to move without pain. At about 10:30, the loss of feeling turned into partial paralysis and extreme pain where feeling had been previously lost. My hands refused to stay in any position except for a clenched fist or fingers completely extended. Moving my arms and lower legs was only able to be done with great difficulty. I was worried that it would spread to my chest, so I got up from where I'd been sitting at a desk and began forcing myself to walk up and down my apartment hallway. I was able to do this though my gait was stuttery and uneven, and my pain was about an 8 out of 10. I was alone in my apartment at the time and my hands weren't working well enough to handle my phone. After about 10 or 15 minutes the nerve pain and paralysis subsided and hasn't come back since, but my leg muscles felt incredibly weak the rest of the night and my partner had to help me to make sure I didn't fall over a couple of times. I didn't end up going to the doctor or seeking treatment because it didn't come back.

Tingling and numbness in face (lower half, along the jaw and lower half of cheeks), numbness in mouth and tightening of throat. Fever after 11 hours and extreme fatigue.

7:00pm- start to feel really cold, develop a high fever and chills and eventually go home to lay down. 8:30pm- uncontrollable shaking and high fever maintains and I develop I very bad migraine, I can't feel my arms or legs and everything sounds like my head is underwater (I think this might have been a migraine but I've never had one). When I stand up my vision goes black, and I develop joint pain, muscle aches, and very bad nausea. 9:00pm - I take 500mg of aspirin and all of my syptoms persist for ~30 minutes when suddenly my fever breaks and I'm sweating underneath my 3 blankets and I can think again as long as I don't move my head. Everything still sounds weird and my stomach and joints still hurt but I go to sleep. 4:00am- wake up crying from the headache and with a fever again so I take 500 more mg of aspirin and set an alarm to take more at 10am. 10:00am- I feel exhausted and really weird, I take only 250mg of aspirin and sleep the whole day. 4:00pm - I wake up feeling so much better. Kind of achy and still very nauseous, my ears still ring when I stand up. 4:00pm yesterday - now: I kept movement at a minimum and was still nauseous throughout the day but was able to eat at around 9pm. I think I may have had a low grade fever on and off last night but the headache has thankfully stayed away and other than a little bit of arm soreness and weakness I feel back to normal today.

103.5F fever, severe chills/sweats, joint pain, myalgia, eye pain, neck pain, headache, injection site pain, weakness, light headedness, axillary lymph node swelling and pain. still experiencing eye pain and lymph node pain

I woke up at 1am feeling fatigued. At 3am it hit my like a truck. My body was so weak I could barley move. I had an unbearable headache. I felt very nauseous. I had extreme chills and sweats. This lasted non-stop until 6am. I woke up around 10am with a bad headache and like my body had been through something traumatic. I felt even more nauseous and had very bad diarrhea . Anything I would consume would make my stomach go into a knot and come straight out. After 10am I felt dizzy and weak. I still had a bad beach ache; and medicine wasn?t doing anything. This lasted until I went to bed around 11pm that next night. When I woke up around 9am on Friday I still felt a little drained and a small headache. My stomach was the worst part after my episode on Wednesday night. Around 5pm medicine started to help with my headache so I would say my symptoms stopped about that time , not including my abdominal pain. My stomach pain lasted until Saturday evening.

About 9 hours after receiving the Janssen vaccine on April 9th, I started feeling ill. I had a fever of 102, difficulty walking/moving on my own, intense nausea, numbness in my left arm for about 2 minutes, and I spontaneously got my period (which was very regular up until then). I took Tylenol, went to bed, woke up with a 100 degree fever but feeling much better, and it soon dropped back to 98 degrees. Today, on April 13th, I started having pain in my left arm and leg. Specifically, in my left bicep (not the injection site) and my left thigh. This pain does not feel like muscle soreness, but almost like a knot? I'm not sure how to describe it, but I find it odd the pain in my arm increases a bit when I walk/move.

Janssen COVID-19 Vaccine EUA. Vaccine burned while being injected and for about 4 hours afterwards. Arm hurt for a good week after as well. Had a small red raised bump at injection site for about 6 days. Have not had a period for 4 years due to my birth control, got my vaccine on 03/30/2021 and then started a brown and clotty period on 04/01/2021. Period last about 9 days and seems to be gone now besides an odor. Had undescribable cramping in abdomen. Had some type of stomach bug (fever, vomiting, diarrhea) on 03/27/2021 that lasted about 72 hours. Then had another episode of diarrhea on 04/04/2021. Currently having bad headaches and right thigh cramps. Blood pressure and temperature seems to be running higher than my normal still.

pt reported had vaccine on wednesday, on thursday started feeling sluggish, flu like symptoms, friday started itching and achy arm, saturday went to urgent care with blister at injection site, urgent care filled out online form and gave pt benadryl. today tuesday, pt felt better, blister went away, still little achy arm but better.

High fever, chills, uncontrollable shaking, nausea, headache, extreme back ache, weakness, lightheadedness, faintness of breath, pain in the left arm, loss of appetite: these lasted for 24 hours, then gradually faded. It was one of the most severe flu-like episodes I have ever experienced. Now, 6 days later, I am experiencing lightheadedness, weakness, extreme anxiety, fatigue, and loss of appetite.

15 MINS AFTER SHOT I STARTED FEELING DIZZY, REALLY BAD HEADACHE, FATIGUE, AND ON AND OFF CHEST PAINS. HAD TO LAY DOWN. STARTED GETTING TREMORS, DIDN'T FEEL ANY BETTER AFTER ANOTHER 20 MINS AND THEN THE DOC CALLED THE AMBULANCE TO TAKE ME TO ER.

Right after the nurse administrated the vaccine to my daughter, she complained about having numbness on her feet, flurry eyes, was not able to hear very well, dizziness and fainted for a short time.

I?ve received the vaccine on Sunday and have been having nervous twitching ever since. It has now been over 72 hours since I?ve received the vaccine and the nervous twitching up until now is starting to get worse.

History of Present Illness This is a 22-year-old female who was previously healthy with no significant past medical history presenting to the emergency department after a syncopal event. She was getting her COVID-19 shot today (Johnson Johnson). After her shot she was texting on the phone with her mom, felt slightly dizzy and the next thing she remembers was lying on the ground. Witnesses reported that she syncopized and had some convulsive like behavior afterwards. She was not postictal or incontinent however. She reportedly hit the front of her forehead on the left side. She denies any chest pain, abdominal pain, hemoptysis, recent surgeries, immobilization or recent travel. She reports that when she woke up her hands felt a little bit tingly. When the fire department arrived they found her to be bradycardic however by the time the medics arrived her heart rate had resolved. Her blood sugar was 110 on the scene. Medics noted that she was orthostatic on the scene as well. She currently is feeling well, has no complaints. States that she has gotten dizzy before in the past with COVID vaccines.

Dizzy and nauseated when standing, Shivering beginning two hours after symptom start, Headache, Muscular pain at site of injection, mental inhebriation (brain felt drunk) getting increasingly worse. Three hours after symptom start unable to keep balance while standing, shaking in blankets. Next day, fever of 100.4 at 9am down to 99 by 12pm (after nsaid at 10am), fatigue, trembling, stiff neck

Shivers/shaking in the beginning, developed into full body chills (violent shivers) and all over body pain. This lasted for about an entire day, full body excruciating pain with constant chills/sweating.

Prolonged tingling/burning pain in left leg from above knee to toes. Could not be relieved by any position sitting or lying down. Movement of ankle, toes, or leg in general caused pain to extend up to the hip and become much sharper. Relieved by 3 Aspirins

About 7 hours after receiving the vaccine I developed a painful migraine. The pain was very intense behind my left eye like there was a needle being poked in from behind. Some nights the pain is so bad it hurts to lay my head on a pillow or I wake up all through the night because of it. I took tylenol the first 4 days then stopped. I tried to see an urgent care about it but they told me they couldn?t help me due to the vaccine type.

Patient presented to the ED and complained of bilateral posterior thigh and buttock pain. Reports the prior evening had cramping and a lump in left calf.

I had the Johnson & Johnson vaccine and had a bad headache two days after and still have a slight headache five days after. I also have pretty bad fatiuge. All symptoms started 4/5 hours after getting the vaccine including nausea, headache, chills, fever (of almost 103), chest pains, fatigue, body/arm pain, ear pain. The ear pain started 3 days after the shot. I tried calling one of the doctors in our network around and they both denied me even though the symptoms were from the vaccine...

PAINFUL HEADACHE; FAINTING/LOSS OF CONSCIOUSNESS; HEART RACING; APPEARED WHITE; FELT WARMTH IN EARS; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. The patient was not pregnant at the time of reporting. The patient had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: unknown) dose was not reported, 1 total administered on 07-APR-2021 14:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, around eight hours later after vaccination, the patient felt a warm in her ears and her heart was racing. She appeared as white as a ghost and the patient fainted with complete loss of consciousness for approximately less than a minute. She had regained consciousness and still had accelerated heart rate until she ate and drank water and then calmed down. On 08-APR-2021, the patient had a very painful headache when she wake up and a low grade fever. She wanted to know if she can take Motrin or Tylenol for her events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling of warmth in ears, fainting, complete loss of consciousness, and heart racing on 07-APR-2021, had not recovered from very painful headache, and low grade fever, and the outcome of appeared white was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210416890-JANSSEN COVID-19 VACCINE-Fainting. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

First day, 7th, had fever of 101.3 and was sore all over and was having hot flashes.. Next day, 8th, was a little sore and still having g hot flashes. On the 13th, I started getting the hot flashes so bad I had to keep my heat at 66. No more than that. After I would get a hot flash, it was followed by chills. That has been flip flipping until today. Two days ago, 14th, had migraine that wouldn't go away all the way until today, 16th, where I still have migraine and I still have hot flashes/ chills.

SORE ARM; SLIGHT FEVER; BAD MIGRAINE HEADACHE; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced bad migraine headache. On 11-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad migraine headache, slight fever, and sore arm. This report was non-serious.

Pt became lightheaded following vaccination, diaphoretic, then unresponsive, she then opened her eyes and began talking

Vaccine received 4/7/2020. On Wednesday 4/14/2020, pt went to the gym and did high intensity interval training involving body weight exercises, specifically an exercise called "v-ups". Exercise was not more strenuous than usual, and pt was well hydrated. Pt reports that she exercises often and this was not a new exercise. Soon after workout, pt began having muscular pain in the hip, radiating into her inner thighs bilaterally with associated tingling. On 4/15, pain worsened and pt had difficulty ambulating. Denies any edema, erythema in her legs or unilateral leg swelling. Presented to the ED on 4/16 and found to have elevated CK of 127,768 with UA significant for large blood and protein, without RBC, indicative of rhabdomyolysis. Pt did not have any known risk factors that may precipitate rhabdomyolysis. On admission, fluids were initiated with downtrending CK, LFTs, and renal function remained stable. er D&C was done at on 4/2 and she reports there were no complications during or after the procedure. Her BHCG was elevated at the time and she tried an oral abortion pill but still had some fetal remnants so went for a D&C. She had the J&J vaccine shortly after on 4/7 and she reports no complications around and shortly after getting the vaccine. Denies vaginal bleeding or odor. Denies fevers, chills, abd pain, diarrhea, constipation, dysuria, chest pain, palpitations, shortness of breath, nausea/vomiting.

per patients mother: pt had complained of dizzyness right after leaving clininc. Mother was driving, she said that about 5 minutes later pt started getting hot flashes and had developed a rash across chest, decided to drive to hospital on the way there she progressively got worse she started to complaine of chest tightness/pain. once at ER she double over from severe stomach pain-said it felt like she had to go to the bathroom. Mom said that things quickly worsened. She started to have throat swelling. Epinepherine was administered and IV benedryl, pt stayed in ER and was observed for several hours. Mom reports they were sent home around 4pm and around 7320pm that night pt started feeling tightness in her chest and difficulty breathing mom gave epinephirine and called 911. EMT's transported her back to ER. She was stablized and sent home. pt continued to have these episodes of Chest tightening and difficulty breathing resulting in several more visits to the ER and one over night stay. Last visit to the Hopsital was on 4/15/21

Patient contacted for follow up regarding post vaccine status. On day 2 patient reported feeling very tired, more so than usual, body aches, cough, and a decrease in taste. Patient agreed to come in to the clinic on Friday to be evaluated for COVID testing. On the day of testing mother called clinic and stated to cancel appointment, patient had gone to the emergency department the day before. Mother reports that patient began complaining of increased facial pain on 04-14-2021. Soon the facial pain increased, and the patient noticed she was having trouble chewing her food and talking, as well as a facial droop to the right side of her face. As the mother was driving the patient to the hospital the patient began complaining of edema to her lips and tongue, and that her right eye was hurting and was very dry. After being evaluated in the emergency department the patient was diagnosed with Bell's Palsy and sent home with the following prescriptions: Prednisone 20 mg, Valacyclovir 50 mg, and eye drops.

SORE THROAT; BURNING EYES; BODY ACHES OR BODY WAS PAINFUL TO THE TOUCH; MIGRAINE; NIGHTMARES THROUGHOUT THE NIGHT; DIZZY; FEELING COLD; SHAKING; CHILLS; INJECTION SITE PAIN; FEVER OR BODY WAS BURNING UP LIKE A FURNACE; FELT FATIGUED; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 15:50 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced body aches or body was painful to the touch. On 09-APR-2021, the subject experienced migraine. On 09-APR-2021, the subject experienced nightmares throughout the night. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced feeling cold. On 09-APR-2021, the subject experienced shaking. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced fever or body was burning up like a furnace. On 09-APR-2021, the subject experienced felt fatigued. On 09-APR-2021 19:00, the subject experienced burning eyes. On 10-APR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning eyes, nightmares throughout the night, dizzy, chills, fever or body was burning up like a furnace, and felt fatigued on 10-APR-2021, was recovering from injection site pain, body aches or body was painful to the touch, migraine, and sore throat, and the outcome of feeling cold and shaking was not reported. This report was non-serious.

Mother gave me lot # which is Moderna lot#201A21A, but the vaccination card says Janssen which does not match up with this lot#. Mother reports that she had the vaccine, had no symptoms, and then started with a fever that evening of 103. She was having cold extremities, numbness, tingling of the arms, face, legs. The fever dropped and went away and was having fatigue and getting winded doing regular activities. By Monday she continued with the shortness of breath and go increasingly worse as the days went on and also the. By Wednesday she was having chest pain, numbness and tingling of her extremities and shortness of breath. She went to the hospital, gave her IVs, says her BP was elevated and sent her home. Mother told her to sleep and see how she felt. By Thursday night 4/15/21 she screamed out because she was having chest pains and having chest and pains and not able to straighten out her hand and could not catch her breath. She was then taken back to the hospital and said that she her BP was high and said that she had the Janssen vaccine, and said that she was hyperventilation due to anxiety. Once they got her stable and released her again. Mother asked the doctor if he felt that this was normal, and could see her throat contracting and that she was stable and to go home, and he said yes and that it was anxiety and that sometimes we get ourselves worked up about things and that was causing it. The daughter has no history of anxiety, no breathing issues. They did labs and everything was okay, her counts were somewhat off but nothing felt to be abnormal. She then went to another Hospital as she was still not feeling well, and checked the other reports from the other hospital and they conferred with that information, gave her Valium and sent her home. As the evening progressed on Friday 4/16/21 she started having chest pains and her girlfriends mother is a nurse and came and saw her and called the mother and told her that she did not like how she was looking, and that her SOB and weakness in her extremities and the tightness in her chest was not right and that she felt that she had a PE. They took her to another location, she had extremely high calcium levels, and high blood pressure and her heart rate was high and she was admitted. She has been on flushes to reduce calcium, and her blood levels are improving. She is on Warfarin to prevent clotting. She has had a CAT scan and other studies and all were negative. She felt better yesterday, but she states today that she is not feeling as well, she is nauseous and gave her Zofran, has a headache, and they gave her something a little stronger than Tylenol. She is extremely fatigued and weak. Mother said that she saw her on Sunday 4/18/21 and that she was not able to walk, they had to put her in a wheelchair, and her grandfather walks faster than she can. They are presently getting her up to get her to walk and see how her strength is, 4/20/21. They are now waiting to get her levels under control and to see if she is strong enough to go home. Neurology released her from their standpoint as they did not see anything, but she is to FU with them afterwards and want to do EMG's as an out patient.

Nausea, headaches, leg pain (04/08 - 04/10) Nonstop headaches, pain in lower right calf (04/08 - Currently)

PASSING OUT; RUPTURED BLOOD VESSEL IN THE EYE; MIGRAINE/SEVERE VOMITING/INABILITY TO RETAIN FLUIDS/NAUSEA; TREMBLING; SWEATING; FELT SICK; FEVER OF 101F; This spontaneous report received from a consumer (father) concerned a 22 year old not Hispanic or Latino, white female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient reported no significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, frequency 1 total, administered to left deltoid on 08-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 20:00, the patient felt sick and was incapacitated by severe vomiting (coded as migraine/severe vomiting/inability to retain fluids/nausea), sweating, trembling, fever of 101 F that resulted in her passing out. Vomiting was so severe that patient was unable to retain fluids and ruptured a blood vessel in her eye (coded as Broken Blood vessel in eye). Patient was hospitalized on 09-APR-2021 at 12:24 am. During hospitalization she received IV fluids and medicines for migraine and nausea and multiple blood samples were collected. Patient was discharged on 09-APR-2021 around 6 AM. Patient was hospitalized for around 6 hours. Patient reported that symptoms had recovered except was still having nausea and ruptured eye vessel from severe vomiting. (it was Confirmed with patient that she had no past medical history of migraine and was referring to her headache as migraine.) Laboratory data included: Body temperature (NR: not provided) 101 F, Blood test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable The patient recovered from trembling, sweating, passing out, and felt sick on APR-2021, and fever of 101F, and had not recovered from migraine/severe vomiting/inability to retain fluids/nausea, and ruptured blood vessel in the eye. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-covid-19 vaccine ad26.cov2.s -Passing out, Ruptured blood vessel in the eye, Migraine/severe vomiting/inability to retain fluid/nausea, trembling, sweating. 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). 20210422127-covid-19 vaccine ad26.cov2.s -Fever, Felt sick. This event(s) is labeled per RSI and is therefore considered potentially related.

VOMITING; "EXPLOSIVE DIARRHEA"; DIFFICULTY BREATHING; UNABLE TO CHEW; WATER IN EARS FEELING; PAIN IN ELBOWS AND KNEES; HEADACHE; PAIN IN SPINE FROM "NECK TO BONES"; "FELT LIKE SKELETON WAS ON FIRE"; ALL TEETH ACHY; LOCKJAW; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's past medical history included insomnia, and anemia, and concurrent conditions included penicillin allergy, asthma, adhd, ocd, memory aphasia, auditory processing dyslexia, speech and language difficulties, reading disorder, difficulty learning math, anxiety, depression, aspirin allergy, and allergic to seafood. 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 pain in spine from "neck to bones". On 10-APR-2021, the subject experienced "felt like skeleton was on fire". On 10-APR-2021, the subject experienced all teeth achy. On 10-APR-2021, the subject experienced lockjaw. On 10-APR-2021, the subject experienced unable to chew. On 10-APR-2021, the subject experienced water in ears feeling. On 10-APR-2021, the subject experienced pain in elbows and knees. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced vomiting. On 11-APR-2021, the subject experienced "explosive diarrhea". On 11-APR-2021, the subject experienced difficulty breathing. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 11-APR-2021, had not recovered from pain in elbows and knees, pain in spine from "neck to bones", "felt like skeleton was on fire", lockjaw, and water in ears feeling, and the outcome of all teeth achy, "explosive diarrhea", difficulty breathing, headache and unable to chew was not reported. This report was non-serious.

minor soreness in near injection site (within fifteen minutes of injection, continuing for several days) severe chills, causing whole body shivering (eight hours after injection, for approximately forty-five minutes) interrupted sleep (nine hours after injection, then ten hours after injection) hot flashes (nine hours after injection, then ten hours after injection, each for approximately ten minutes) body aches (ten hours after injection, lasting until twenty-four hours after injection) elevated heart rate, hovering around 130 bpm while walking, standing, and sitting (ten hours after injection, lasting for approximately thirty minutes) dry heaving (ten hours after injection, lasting for approximately ten minutes) joint pain (ten and a half hours later, lasting until twenty-four hours after injection) mild fever of up to 100.7 (eighteen hours later, lasting until twenty-four hours after injection) Body aches, joint pain, and fever were successfully resolved with a dose of Tylenol, administered about twenty hours after injection. All other symptoms resolved on their own.

Nose bleed at work 12 days post vaccine, never had a nose bleed before in my life. Pain in left shoulder and right leg on day 11. Persistent headache for two days. Occasional light-headedness, blurred vision, slow cognitive abilities for 2 days since nose bleed.

FELT LIGHTHEADED; TINGLING IN HER FACE AND EXTREMITIES; UNABLE TO WALK; CALCIUM LEVELS WERE HIGH; ANXIETY; HYPERVENTILATED DURING SLEEP; BLOOD PRESSURE (BP) WAS OFF; HAND CONTRACTED; CHEST PAIN; CHEST TIGHTNESS; NUMBNESS IN EXTREMITIES AND FACE; SHORTNESS OF BREATH; FATIGUE; PAIN IN EXTREMITY; WEAKNESS; CHILLS; FEVER; MUSCLE ACHES; DECREASED ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING; This spontaneous report received from a consumer concerned a 22 year old female. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of report. The patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced decreased ability to perform activities of daily living. On 10-APR-2021, the subject experienced pain in extremity. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced muscle aches. On 11-APR-2021, the subject experienced numbness in extremities and face. On 11-APR-2021, the subject experienced shortness of breath. On 11-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced chest pain. On 12-APR-2021, the subject experienced chest tightness. On 14-APR-2021, the subject experienced hand contracted. On 14-APR-2021, the subject experienced blood pressure (bp) was off. Laboratory data included: Blood pressure (NR: not provided) BP was off, and Chest X-ray (NR: not provided) CLEAR. On 15-APR-2021, the subject experienced hyperventilated during sleep. On 16-APR-2021, the subject experienced calcium levels were high. On 16-APR-2021, the subject experienced anxiety. On 16-APR-2021, the subject experienced tingling in her face and extremities. On 16-APR-2021, the subject experienced unable to walk. Laboratory data included: Calcium increased (NR: not provided) Very High. On 18-APR-2021, the subject experienced felt lightheaded. Laboratory data included: MRI (NR: not provided) No clots in her chest or legs. Treatment medications (dates unspecified) included: warfarin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand contracted, and chills on APR-2021, and fever on 11-APR-2021, was recovering from shortness of breath, chest pain, chest tightness, hyperventilated during sleep, and calcium levels were high, had not recovered from numbness in extremities and face, fatigue, pain in extremity, weakness, anxiety, muscle aches and unable to walk, and the outcome of decreased ability to perform activities of daily living, blood pressure was off, tingling in her face and extremities and felt lightheaded was not reported. This report was non-serious.

New minor tingling in digits 1-3 and surrounding area of left foot starting 04-23-2021 approximately 09:00 AM, subsided approximately at 10:30 AM. Minor tingling returned in same area 04-24-2021 approximately 09:00 AM, subsided approximately 10:30 AM. Minor tingling returned in same area 04-25-2021 approximately 09:00 AM, minor tingling remains in sole of foot by 1st metatarsal as of this report (04-26-2021 at 10:00 PM).

4/2 vaccination 4/8 severe HA, leg, arm, lower back pain, chest pain, diarrhea, bad anxiety with shaking 4/9 PCM (NP) appt; CT scan of abdomen and blood panel 4/10 felt worse, nauseous. Diarrhea continued 4/11 At 11PM, pain right side of neck, to jaw, and toes turned purple. 4/13 PCM; vit D prescribed as they were extremely low, extra strength Tylenol release for leg and arm pain, ordered a D-dimer for possible blood clot. Doppler for right leg. COVID; neg 4/17 chest pain was extremely severe. Radiated to L arm. Went back to ER. EKG, CT Scan, BNP. All normal. Stated probably really bad heartburn. 4/19 Prilosec. I called my dr on 4/22 to follow up. They told me to keep eye on BP as been elevated thru this whole thing. 4/22 My chest, arm and leg pain with HA are still present despite Tylenol and Prilosec. My PCM said to come back in . She prescribed Prednisone and Pantropical and did a blood test to check for inflammation which was normal. I have been taking both medications since Tuesday. *My HA still present. My right side still has pain and I still have chest pain.

High fever, body aches, chest pains, back pain, fatigue, sweating, chills, shortness of breath, over sleeping, left arm pain.

Case had Covid-19 dx on 3/18/21. No SXS. Had Janssen vaccine administered on 4/7/21. Approx 2 wks later c/o fevers and a seizure on 4/26/2021. Was eval in medical facility then at another for seizure. Her fever was 102.7 about 1 hr prior to her seizure.

SEVERE CHEST PAIN RADIATING TO LEFT ARM; HEARTBURN; NECK PAIN IN RIGHT SIDE RADIATED TO JAW AND EAR; PURPLE TOES; FEELING WORSE; LOSS OF APPETITE; NAUSEA; CHEST PAIN; LEG PAIN; HEADACHE; ABDOMINAL PAIN; LOWER BACK PAIN; DIARRHEA; SEVERE UNEXPLAINED ANXIETY; SHAKING; LOW GRADE FEVER; ARM PAIN; COLD FINGERS / COLD TOES; LOW VITAMIN D; ELEVATED BLOOD PRESSURE; This spontaneous report received from a patient concerned a 22 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: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced low vitamin d. On APR-2021, the subject experienced elevated blood pressure. On APR-2021, the subject experienced cold fingers / cold toes. Laboratory data included: Pain scale (NR: not provided) HEADACHE (6 on pain scale), RIGHT LEG PAIN ( 5 ON PAIN SCALE), CHEST PAIN (3 ON PAIN SCALE). On 02-APR-2021, the subject experienced arm pain. On 02-APR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99 F. On 08-APR-2021, the subject experienced abdominal pain. On 08-APR-2021, the subject experienced lower back pain. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced severe unexplained anxiety. On 08-APR-2021, the subject experienced shaking. On 08-APR-2021, the subject experienced chest pain. On 08-APR-2021, the subject experienced leg pain. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced loss of appetite. On 09-APR-2021, the subject experienced feeling worse. On 09-APR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) NORMAL, and CT scan (NR: not provided) NORMAL. On 10-APR-2021, the subject experienced neck pain in right side radiated to jaw and ear. On 10-APR-2021, the subject experienced purple toes. Laboratory data included: COVID-19 virus test negative (NR: not provided) NEGATIVE. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) LOW VITAMIN-D. On 14-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) NEGATIVE. On 15-APR-2021, Laboratory data included: Ultrasound Doppler (NR: not provided) normal. On 16-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) NEGATIVE. On 17-APR-2021, the subject experienced severe chest pain radiating to left arm. On 17-APR-2021, the subject experienced heartburn. Laboratory data included: Blood test (NR: not provided) NORMAL, CT scan (NR: not provided) NORMAL, and EKG (NR: not provided) NORMAL. Other relevant diagnostics included: Mono test on 10-apr-2021 result - negative D-dimer test for blood clot on 13-apr-2021 result - normal l. On 19-APR-2021, treatment medications included: omeprazole. On 26-APR-2021, Laboratory data included: Blood test (NR: not provided) NORMAL. Additional treatment medications (dates unspecified) included: paracetamol, pantoprazole, and prednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and shaking on 15-APR-2021, loss of appetite, and nausea on 12-APR-2021, and arm pain, and low grade fever, had not recovered from headache, leg pain, severe chest pain radiating to left arm, and chest pain, and the outcome of abdominal pain, lower back pain, severe unexplained anxiety, neck pain in right side radiated to jaw and ear, purple toes, low vitamin d, elevated blood pressure, cold fingers / cold toes, feeling worse and heartburn was not reported. This report was non-serious.

PULSING AT INJECTION SITE; ARMS HURT; LEGS HURT; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 08-APR-2021, the subject experienced arms hurt. On 08-APR-2021, the subject experienced legs hurt. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. On 26-APR-2021, the subject experienced pulsing at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arms hurt, legs hurt, fever, and headache on 11-APR-2021, and chills on 09-APR-2021, and had not recovered from pulsing at injection site. This report was non-serious.

BODY ACHES; PAIN IN THE LEG; This spontaneous report received from a consumer concerned a 22 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 04-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, and pain in the leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the leg and body aches was not reported. This report was non-serious.

Severe nausea, cramps, fatigue, and muscle ache the whole next day. It was almost unbearable the morning of that next day.

Patient reported before the vaccine was administered that she had a history of fainting upon receiving vaccines in the past. As predicted, she fainted within seconds of administering the Janssen vaccine. While unconscious, patient had a few mild head/neck twitches which then progressed to 2-3 full body twitches/spasms before regaining consciousness. Total time unconscious with less than 1 minute. Once fully awake and alert, patient informed me that she had a history of a seizure once before. We gently laid her on the floor and I took her vitals. Vitals were low with BP 90/49, HR 49, and O2 90%. She continued to lay on the floor for approximately 10 minutes before checking her vitals again. At that time, vitals were better with HR 60 and O2 99; I was unable to retake her BP at that time, but patient claimed that it usually was on the low side. She called her mother who agreed to come stay with her to keep watch for more events at her home. A family friend was also called to come pick her up and drive her home. Before leaving, I strongly advised patient to see a doctor to check everything out. Patient just moved here and claims to not have a primary at either location.

SEVERE MIGRAINE; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a consumer/non healthcare professional (patient's mother) concerned a 22 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, frequency 1 total, administered on 07-APR-2021 Vaccination site was left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced body aches, chills, weakness. fever and severe headache with eye involvement. Patient was taken to the Emergency Room and was told that the vaccine caused a severe migraine. The reporter sought compensation of patient's medical bills. Patient was hospitalized and discharged on 30-APR-2021. Patient was hospitalized for 1 day. Patient was hospitalized on 30-APR-2021. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from body aches, chills, and fever on 2021, and the outcome of severe migraine was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210539285-COVID-19 VACCINE AD26.COV2.S- severe migraine, body aches. 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). 20210539285-COVID-19 VACCINE AD26.COV2.S- chills, fever. This event(s) is labeled per RSI and is therefore considered potentially related.

Seizure like shaking and jerking in my sleep since week after COVID vaccine, symptoms: shaking and jerking and difficulty breathing and can?t wake up

Currently can?t get warm with body chills/shakes but probably have a fever. Headache and nausea. Took 2 ibuprofen 200mg/ea at 0130

Initially had arm soreness that resolved expectantly after about 2-3 days. Then 2 weeks after vaccination arm became even more sore and she experienced pain with movements. No signs of infection from the injection site. No rashes, fevers/chills, signs of superficial phlebitis. This lasted for approximately 6 weeks.

HEADACHE; NAUSEA; FEVER; STOMACH CRAMPS; VOMITING; REALLY BAD SHAKES; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's past medical history included laparoscopic surgery, and concurrent conditions included endometriosis, and factor v leiden carrier, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: 01-JUL-2021) dose was not reported, administered on 22-MAY-2021 10:30 to the left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced stomach cramps. On 22-MAY-2021, the subject experienced vomiting. On 22-MAY-2021, the subject experienced really bad shakes. On 22-MAY-2021, the subject experienced nausea. On 22-MAY-2021, the subject experienced fever. On 23-MAY-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 22-MAY-2021, and fever on 23-MAY-2021, was recovering from nausea, and stomach cramps, had not recovered from headache, and the outcome of really bad shakes was not reported. This report was non-serious.

PATIENT RECEIVED THE VACCINE AT 9:00AM, SAT IN STORE FOR 15 MINUTES AND LEFT THE BUILDING. AT ABOUT 9:20 SHE CAME BACK TO THE PHARMACY SAYING SHE IS NOT FEELING WELL AND FELT WEIRD. PHARMACIST ASKED HER TO DESCRIBED THE FEELING, PATIENT SAID SHE JUST FEEL WEIRD LIKE NAUSEA AND NUMBNESS AROUND HER LEGS AND HER CHEST FELT TIGHT. PHARMACIST OFFERED HER TO SIT DOWN AGAIN AND ASKED HER IF SHE HAS ANY HISTORY OF ALLERGIES OR REACTIONS TO OTHER VACCINES BEFORE. PATIENT SAID NO REACTION TO HER YEARLY FLU SHOTS AND NEVER FELT LIKE THIS BEFORE AND STATED SHE'S ALLERGIC TO AMOXICILLIN ONLY. PHARMACIST OFFERED TO CALL THE AMBULANCE FOR HER AND GAVE HER SOME WATER. AMBULANCE CAME IN AROUND 9:40AM AND ASKED PATIENT SOME QUESTIONS AND TOOK HER TO THE ER.

WEIRD REACTION TO THE JANSSEN COVID-19 VACCINE; TINGLING NUMBNESS IN RIGHT ARM NON-VACCINATED ARM; SORENESS IN THE LEFT ARM; CHILLS; HEADACHES; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281 expiry: 30-SEP-2021) dose was not reported, administered on 22-JUN-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced weird reaction to the janssen covid-19 vaccine. On 22-JUN-2021, the subject experienced tingling numbness in right arm non-vaccinated arm. On 22-JUN-2021, the subject experienced soreness in the left arm. On 22-JUN-2021, the subject experienced chills. On 22-JUN-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weird reaction to the janssen covid-19 vaccine, tingling numbness in right arm non-vaccinated arm, soreness in the left arm, chills, and headaches. This report was non-serious.

On Saturday 6/26, I got the J&J vaccine at the clinic. That night I experienced whole body soreness/achiness, my entire left arm felt tingly and numb and restless, my back hurt a lot and I had a really bad headache. I felt dehydrated. I drank water but I still felt dehydrated. On Sunday 6/27, I was tired because I couldn't sleep well because my head hurt so bad the night before. My symptoms were the same as on Saturday night. On Monday 6/28 everything is the same except now I'm also throwing up, I'm not able to keep food or water down. I do not have a temperature.

Six hours after receiving the vaccination, I woke up with a high fever and severe, uncontrollable shaking in my whole body. Something like quivering shock waves started to radiate from the center of my chest and shuddered out through my entire body, causing every muscle to shake uncontrollably; the shaking became increasingly violent. My heart was racing. I took deep breaths and applied a cool, wet hand towel to my forehead/neck to relax, but none of it helped. After about 20 minutes, the violent shaking was only getting worse, so I took one Aleve. The shaking continued for another 20 minutes. Finally, it became less frequent and I could tell I had a little more control but was still shivering. My thumbs were also numb and tingly for the duration of the shaking (about 40 minutes) and afterwards. Eventually I completely relaxed and fell asleep, but I am now sore from being so tense. Still have slight fever and aches.

Patient voiced she was anxious and asked for water. Patient voiced she felt warm then became unconscious for few seconds. Her head was protected from injury. 911 called. No medication given. Ice pack given for cooling measures. Patient said she felt fine and refused further treatments and hospitalization. O2 saturation 99% room air. Heart rate 90bpm. No shortness of breath and no other abnormal findings noted.

Patient received vaccine dose at 4:43pm. At approximately 4:48pm, she stood up to tell staff that she was feeling ok and wanted to pick up an item in the store. A staff member saw that she looked unwell and asked if she was ok and she said no. She passed out at that moment. She was unconscious for approximately 5-10 seconds. Her body became stiff and her shoulder/arm trembled during that time frame of being unconscious. She refused an ambulance. She remained in the pharmacy for 30 minutes until she no longer felt light-headed. During the 30 minutes, she felt light-headed, hot and was sweating. She said she felt fine after the 30 minute wait.

At 10:44am, Fainting, drastic drop in blood pressure, blurred vision, numb hands. That evening, chills and vomiting.

Woke up in middle of the night freezing while being super hot to the touch. Realized I probably had a fever.

3/10 4pm: headache 5pm: took 2 Advil and drank a lot of water 6pm: worsened headache, nausea, body aches 6:30pm: took 1 more Advil, continued to drink a lot of water, ate peanut butter toast 7pm: all of the above became worse, difficulty breathing, feverish, chills, fatigue 11pm: vomited 3/11 9am: symptoms improved, lingering headache, ongoing nausea, body felt very weak and drained, fatigue 12pm: symptoms continue to slowly improve

Janssen COVID-19 Vaccine EUA Within the first 24 hours I had headache, fever, nausea, muscle aches, tiredness, weakness, dizziness, and difficulty breathing. That all went away after 24 hours though. Now, five days later, my tongue is swelling.

First pain in whole arm and across my chest. Then chills and all over body aches. I also have fatigue. It began around 9 pm and is getting worse at 11:15pm.

1305 - pt. found in post vaccination waiting area pale, diaphoretic, and slightly slumped over. RN notified. Rn arrived at pt's. side to find her pale and unfocused, staring with pupils slightly dilated. No LOC per medic in waiting area. medic described " 2 minutes of pt. with petite mal seizure activity". Rn did not observe any tonic seizure activity but pt. very slow to focus and answer questions. 911 notified and pt. placed in wheelchair and moved to Tx. area. Placed supine, BP 116 palp, HR 100, RR - 28. O2 started @ 6L by NC. 1310- Med Hx reveals pt. stopped oral Cymbalta 3/5/21. 1312 - Pt. more alert , focused and able to answer questions appropriately. 1315 - medics arrived and care transferred. BP - 138 palp Glucose - 95. 1320 - pt. remains stable and able to notify family by phone. !325 - Pt. transported to Hospital by ambulance in stable condition.

covid vaccine reaction J&J. c/o temporal h/a, generalized body aches, n/v, rhinorrhea, chills, and dizziness after getting J&J single dose COVID vaccine at 0830 this AM. Pt began feeling ill around 1000. History: Pt had COVID-19 J&J vaccine this morning and then felt lousy and started heaving some headache, non-thunderclap, behind eyes, with shakes, chills, nausea, and then vomiting, here for eval. Feels better now after ibuprofen/Tylenol and has bad headache at this time. No recent illness/injury, COVID-19 hotspot visit, sick contact, recent international travel, diarrhea, rash, photophobia, ear pain, cough, SOB, abdominal pain, dysuria, vaginal bleed/discharge, recent surgery/procedure/abx use, prior co-morbid

Woke up the next morning with a major migraine, suffered from body aches and fatigue, a slight fever (100.2), chills, and a lasting headache. Also pain at injection site. Janssen COVID-19 Vaccine EUA

Severe chills. Teeth chattering. Vomiting. Extreme discomfort and flu like symptoms for 2 days. Teeth chattering

The injection was painful going in. No other symptoms on the day-of. The following day, the injection sight was painful to the touch. I had body and muscle aches in my full body including neck, back, abdomen area, legs, and arms. I had a headache most of the day. I had the chills throughout the full day and had on and off nausea. I was extremely tired and stayed in bed almost all day. 2 days after the vaccine, all of these symptoms were gone except the injection sight is still slightly tender 4 days later.

Extreme fatigue, muscle aches, weakness. Sudden onset, accompanied by a 100.4 F fever, teeth chattering chills, and pounding headache.

Had the chills, body aches, headache, nausea, muscle pain and fever all happen at once about 8 hours after receiving the vaccine and continued throughout the night. Took 2 Tylenol to help with symptoms. Still feeling very weak and achey this morning but no chills, nausea or fever currently

Pain in arm immediately after injection, blacked out after 2 mins after injection, felt faint, shaking, very sweaty for about 15 mins after injection. Symptoms receded and felt better about 30 mins after.

Severe migraine started 4 hours after shot Uncontrollable chills began 6 hours after shot, accompanied with intense leg/ pelvic region aches and pain Nausea and vomiting Following morning: occasional stabbing pain to the head, slight dizziness, continued leg/ lower back/ pelvic aches, full body skin tenderness (like the skin had been over exfoliated)

Around 10pm on 3/26, I got a slight headache, but I am not sure if it was due to screen time or a vaccine side effect. Per the clinician that administered the shot, I took 2 tabs of Tylenol (one normal adult dose) with water and went to bed. At 1 am on 3/27, I woke up incredibly sore all over but especially in my joints. I was shivering badly and woke up in a tightly curled fetal position. I was unable to lie still or warm up. I eventually went back to sleep and woke up at 5 am, this time with extreme nausea and threw up everything I had eaten the day before. This went on for a couple of minutes. I was still shivering constantly and sore and achy everywhere. Especially in my knees, shoulders, and lower back. At 6 am, I was still awake and while I still had chills, my face felt hot and I took my temperature twice. First getting 100.74 then 100.86. Slept deeply for the rest of the night. At noon on 3/27 I woke up with no nausea, body aches but only in my joints but with general soreness everywhere (like after a good workout) and a temp still in the 100.7 degree range. I took 2 Tylenol tabs at 2pm. At 4pm, I only had slight body aches, a headache, and a slight brain fog left and my temp was at 98.7, so no more fever. No further problems showed up and when I woke up at 9 am on 3/28, I felt absolutely fine other than soreness at the injection site and a little chest tightness which last for about 2 days, through 3/30.

At 11pm I had an immediate onset fever and chills. Took Tylenol and it went away pretty quickly. Woke up at about 2am with a fever again, took Tylenol. Trouble sleeping the rest of the night with hot flashes. Migraine at about 7am, took migraine medicine, went away around 10am. Since then, major body aches and feeling out of it. Feeling better April 5th with only arm soreness.

Got slightly nauseous and had pain in my left arm around 6pm. Then when that subsided shortly after I began to have chills, body aches, and a headache. Still had some body aches the next day.

Janssen COVID-19 Vaccine EUA Onset ~9am Friday, April 2 Symptoms: excruciating headache in occipital & temporal regions of head, aching joints (especially knees & lower back), cold sweats Signs: decreased appetite, pale

The patient passed out for a few seconds about 5 minutes after the vaccine administration. She was very clammy, sweaty, and alert but very groggy when the pharmacists went out to her. She also stated that her throat felt swollen and sore and that she felt like she was going to throw up. We called the EMS, and she left in the ambulance about 25 minutes after being vaccinated. We don't have any further update at this time.

Temperature (not measured but most likely), shivering (could not get warm no matter how many covers), then later, felt very hot. Generally very exhausted and also felt my tongue numb.

Client received the COVID vaccine (Janssen, Lot# 1808980) complained of feeling dizzy at 1424, EMT and RN responded. The client was sitting in a chair with her head in her hands, stated that she felt dizzy and was having a "hot flash." The client stated that she is anxious around needles and has a history of syncope after blood draws. She also complained of experiencing tunnel vision and hearing. The client's vital signs were a temperature of 96.7, blood pressure of 122/82, heart rate of 92, and O2 of 99%. The client stated she did eat that morning, and refused a set of repeat vitals, but agreed to wait 30 minutes for observation after her symptom onset. Per the client, she has no allergies or medical conditions, and takes no medications. At 1435, the client accepted some water to drink. At 1440, the client stated that she no longer felt dizzy. The client's color had returned and she was no longer dizzy. She agreed to have repeat vital signs at this time: blood pressure of 118/82, heart rate of 90, respiratory rate of 16, and O2 99%. The client refused benadryl at this time. At 1454, the client's vital signs were as follows: blood pressure of 116/82, heart rate of 90, respiratory rate of 12, and O2 of 99%. The client stated that she felt "back to normal" and called her sister to drive her home. She was escorted to her car by the EMT, she ambulated with a steady gait. Education provided regarding emergency response, V-safe, and the importance of following up with a primary care provider.

Painful injection. Localized pain around injection site and general arm soreness. Soreness did not extend beyond arm. Headache morning after. Neck soreness morning after. Heavy fatigue and sluggishness.

At 11:32 patient noted to faint in chair and fall to the flood and begin seizing about 1 to 2 min post vaccine. Seizure lasted about 15 seconds. RN supported patients head at time of seizure. Patient was aware of where they were and noted that they were feeling nauseous and dizzy. Patient was eventually helped to a seated position where EMS transported patient.

I don't know exactly when they started. but I woke up at 1:30 AM on April 8, 2021 with chills, uncontrollable shaking, diarrhea, nausea, muscle fatigue, but no fever

Started with a slight fever and fatigue, evolved to intense chills and feeling very cold, got a 102.5 fever from midnight ~ 8am, milder fever until ~7pm day after vaccination. At the same time as the fever an intense headache started and lasted until ~ 10am. In that afternoon pain in the joints and muscles of the legs started and lasted all afternoon and early evening. Fatigue lasted until ~ 48h after vaccination. Muscle pain at the injection site started directly after vaccination and is still ongoing.

A vaccinator came to PHN to report a woman in the bathroom who was throwing up. PHN and vaccinator came to attend to the client. Client said she was feeling warm and her head was throbbing. Client said her name. Client was eventually able to sit up in a chair and said she was feeling hot and lightheaded. Client asked to lay on the floor and legs were placed on a chair. Client said she was feeling better after this. PHN came back to the bathroom with ice pack, fruit strip, water, and apple juice. Client seen throwing up again, vaccinator was standing by with client. Vital signs taken after episode of emesis. BP: 113/84 and HR: 75. Client asked to take deep breaths and slow breathing, which client was able to do. Client said she was still feeling hot so client was given another ice pack. Client felt cold after some time so both ice packs removed. PHN asked another PHN to come assess client and Dr. called in to assess client also. Client was throwing up for the third time, and Dr. suggested we call 911 to get her checked out. EMS called at 1808 by other PHN. Client said she is only allergic to an antidepressant but did not recall the name. Client continued to talk and be responsive throughout entirety of event. Client called someone she knew to pick up her truck as she knew she would be going to the hospital. PHN took down name of friend, his number, and client?s keys. PHN gave keys and information to client flow lead, who gave items to an employee to ensure keys were returned to trusted entity. EMS arrived. Client denied any swelling, throat closing sensation, sensation of a thick tongue, or itching. Client taken on stretcher to Hospital.

Very painful at time of vaccine administration. Woke up in the middle of the night (1am) feeling feverish. I would switch back and forth between being overwhelming hot to having chills. Nauseated, muscle aches all over, headaches, exhaustion, and slight dizziness when standing up.

Woke up feeling really nauseous and my whole body was sore. Really dizzy and had a horrible headache. My arm also got a huge knot in it. Lasted about two days. My arm is still killing me though and still has a knot in it.

Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Weakness-Mild, Additional Details: only welt at injection site

I had a headache around 9:30 am, but I did not think too much about it. I began feeling tired and started getting mild body aches in my ankles in legs. I woke up at 1:30 am with severe body aches from my head to my toes. I was experiencing nausea and sweating and cold chills. I could not sleep at all. These symptoms lasted 6 hours. I had a fever of 107 degrees Fahrenheit at 6am. I could not move without being in severe pain. Today, I woke up with a swollen face. I feel very weak and fatigued. I am experiencing body aches, headaches, and tiredness.

Had fever and chills beginning about 10 hours after injection. Could not get warm under blankets and socks, shivering for a few hours. Nausea started around same time. Vomited a few times. Couldn?t walk around house without feeling fatigued or nauseous. Symptoms subsided about 16 hours after they began. Still fatigued for another eight hours after. Symptoms completely gone 24 hours after injection.

Janssen COVID-19 Vaccine EUA. About 1am I woke up short of breath. I sat up in bed to catch my breath and immediately felt nauseous. I went to the bathroom because I thought I was going to throw up but only ended up dry heaving. After sitting for a minute to catch my breath again I started shaking really bad and couldn't stand up without having blacked out vision. Luckily I grabbed my phone when I went to the bathroom so my mom could come home to help me. Until about 5 am I was shaking going between being extremely hot and extremely cold. After that my body SEVERE:Y ached all day with off and on sweats and headaches. I took Tylenol all day. I started feeling better with just some fatigue around 6pm.

Approximately 5 weeks pregnant, estimated due date December 11, 2021. Symptoms after vaccine include; pain at and around injection site through right shoulder, tiredness and fatigue, chills, headache, nausea, intense dizziness and feeling faint. Pain symptoms started within 1 hour after injection, all other symptoms approximately after 8 hours.

FACIAL IS SWELLING; SLURRY WORDS; DIZZINESS; SWOLLEN TONGUE; HARD TO TALK; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known medical history. The patient had no known drug allergies at the time of reporting. 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: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 about 1 hour and 30 minutes ago (as reported) on for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the patient experienced facial is swelling. On 05-APR-2021, the patient experienced slurry words. On 05-APR-2021, the patient experienced dizziness. On 05-APR-2021, the patient experienced swollen tongue. On 05-APR-2021, the patient experienced hard to talk. On 05-APR-2021, the patient experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from facial is swelling, slurry words, dizziness, soreness at injection site, swollen tongue, and hard to talk. This report was non-serious.

I was perfectly fine after I got my shot (yay)! But then, I started around 9:30 PM when I was talking to my husband getting severe shaking/chills to the point where everything was shaking uncontrollably. I am also very weak, feel very cold, and have a headache. Pulse according to watch is 104 bpm. It is 11:00 pm now and I still have these symptoms. Warm blankets help.

Severe shaking and chills at 9:30pm. Very quick onset, and transient episodes. Fever related with chills.

At about 5 hours after receiving the vaccine at around 5 p.m., I developed a pounding headache. As the night continued, if I moved my head at all it would cause severe pain and a pounding headache. Additionally, I experienced shooting pains through my neck and back, I became extremely hot to the touch, yet I felt freezing cold and could not stop shivering. Then I developed severe aching and tingling from the top of my head to the tips of my toes, with excruciating lower back pain and I could feel my heart beating very fast. My entire body was tense and sore. These symptoms did not alleviate for 12 hours and I could not fall asleep due to the discomfort I was in. I finally was able to fall asleep at 6 a.m. after the aching/tingling/pain/hotness subsided (about 12 hours after side effects started).

Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Hyperventilation-Mild, Systemic: Nausea-Severe, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Systemic: Weakness-Mild, Additional Details: The first side effects of nausea and vomiting were reporting a few minutes after vaccination.The patient then reported some dizziness/lightheadness.Upon checking back,they changed their original report of dizziness/lightheadness to also include possible fainting.Blood pressure measurement was attempted 3 times with 2 different cuffs,but an error was displayed.It was sucessfully tested on a collaegue.EMS noted BP 120/81.Patient was coherent and conscious,albeit nervous,while conversing.

3 minutes after janssen covid vaccine, person was feeling nauseated and shaking a bit. later she was feeling like passing out and seeing blackout. she didn't pass out and didn't go to hospital. later she had a headache and took acetaminophen, which helped her a lot.

I got the vaccine Tuesday evening and felt fine until Wednesday morning when I got a migraine and a fever. Thursday I felt mostly fine just some tiredness and a little weakness. Friday evening I started to feel light headed and then by Friday night I felt a lump in my throat and my neck felt like it was burning. The burning continued into Saturday. I went to the pharmacist and he told me to take some Tylenol and an antihistamine. That helped a lot with the burning feeling. Sunday I felt very weak all day and felt more of a slight tightness in my throat. Monday the weakness and tightness in the throat continued just not as extreme.

Patient has reported having an issue with fainting with vaccines in the past. Approximately 1 minute post vaccine, patient reported feeling dizziness and nausea. Patient was laid down on the floor with her feet elevated and given a cold compress for the back of her neck and her wrists. Patient did not lose consciousness but did report dizziness, nausea, and numbness in her hands and fingers. Patient was able to hold conversation and reported feeling better after about 5 minutes. Patient was allowed to move to a sitting position and was monitored for any changes. Patient reported feeling better. Patient was monitored for an additional 15 minutes and reported feeling normal before she left.

-4 PM: intense headache -11:30 PM chills, uncontrollable vomiting -1:00 AM dizzy, fading consciousness, full-body tingling, paralysis and stiffness of legs, difficulty breathing -2:30 AM entered ER: blood tests, Tylenol, 2 IVs -7:00 AM discharged from ER -symptoms persisted the next two days, slept most of the day

Woke up in the night due to fever. When I woke in morning I had headache and nausea. Couldn?t sleep on right arm. Symptoms lasted until 8:00 pm the following night. My arm is still puffy and red and sore. I have a rash on injection site. Also bled when I got the vaccine which hasn?t happened before.

Woke up 12 hours after vaccine shivering uncontrollably. Got several blankets and dozed back off to wake up a couple hours later dripping in sweat. My body ached the day after the shot and then the evening after is when my symptoms became more severe. I was extremely tired and my entire body hurt. It hurt to even touch my hair, lay in bed, stand, and be covered up by blankets. The following day I just felt tired and my arm was sore. Three days after my vaccine I woke up with a sore throat and neck, but just on the left side. I slept the majority of the day and my body felt achy all day. Four days after my vaccine I woke up again shivering uncontrollably and my body felt sore all over.

Sore arm one hour after receiving immunization, around 5:00pm dizziness, tired, nausea. 9:00pm : 101.2 fever, body aches, fever subsided with 600mg Motrin. 4/12: 8am: normal temperature, body aches, tired.

8 hours post shot extremely cold, chills, severe body aches, severe headache, hives, skin felt on fire

I received the shot at 14:30, in which medical staff in the jail's medical center watched me for 20 minutes to ensure there were no immediate reactions. I went about my day afterward with no symptoms. At 21:30 when I went to sleep, I got some aches in my joints and took 1 dose of liquid capsule NyQuil to help with the pain and went to sleep. At 00:30, the 7th, I woke up groaning in my sleep to the extreme pain in my joints and feeling hot internally. I decided to get up and take a warm bath to ease the aches. I went and ran the bath and all of a sudden while it was running, I had a severe need to throw up, but could not naturally. Since this was concerning, I got up and walked out of the bathroom and all of a sudden in the hall I got a feeling of impending doom and that something was not right and I fainted. I laid on the floor for what I would approximate to be 5 minutes going in and out of consciousness waiting for the blood to fully return to the brain. After this, I instantly felt like I needed to survive and that I felt like I could be dying so I slowly crawled down the stairs to get to my military ID so I could call the military's nurse advice line. I had to take a break and lay on the concrete in my garage because I felt so dizzy and so hot and began to feel my vision disappear like I was going to faint again. I waited a few minutes before getting back up the stairs crawling to my phone to call. When I called them 00:58, they told me to call 911 because they believed I would be having a severe reaction, though I noted to them I did not have a rash or hives. I then called 911 at 01:08. They sent EMT's to my home which took my vitals. I had normal blood pressure, SPo2, and temp, but an elevated heart rate of just under 100 and a high respiration rate. EMT's made the decision for me to stay home since the hospital did not seem immediate in their opinion. After this I stayed on the couch for a few minutes and then felt very tired so I walked slowly to my room and fell asleep. I woke up at 06:00 for work, and arrived at 07:00. In the hour after waking up I was achy, sweating, and felt light headed. I got to work and my Sergeant told me to go home and sleep. I slept another 5 hours at 08:00 and when I woke up most of my symptoms went away other than aches and getting flush very easily for 5 days. At this current time all I notice is some random light headedness that quickly resolves and comes a few times a day at random and without cause.

Patient called on 04/13/2021 at 110pm reporting that when she woke up today, 04/13/2021 she had some blood on her pillow and said that the blood came out of her mouth. She did not think that she vomited the blood. She also reported some chills and worm feelings.

12 hours after vaccine - intense pins and needles feeling in arms and legs. Excruciatingly uncomfortable, unlike other pins and needles feelings/numbness I?ve experienced before. Could not stop moving.

Until 12:00AM 04/03 - 5:00PM 04/04: Extreme migraine symptoms so severe, was debilitating. Could not walk, move, or see light without extreme pain. Was forced to take acetaminophen due to severity. Pain was severe enough to cause nausea and jaw soreness from clenching. Patient suffers chronic tension headache and this was more severe than anything experienced - may have even been a cluster headache due to severity and location.

Around 2:30pm on 4/9/21 (one day after vaccination) I got a Charlie horse in my right calf. I didn?t think much of it. About 20 minutes later when trying to get out of bed I got another Charlie horse in my left calf this time. This one was much more painful and intense. After it let up I laid there for a little longer and tried to get up when my leg calf, again, got another Charlie horse in the same place. This happened a total of 4 times, back to back to back to back. Each Charlie horse I had in my left calf was especially intense and painful, worse than any Charlie horse I?d ever had before. I don?t get Charlie horses often, but I have been a lifetime athlete so I?m familiar with the feeling. I had not previously worked out in the days leading up to my vaccine. I?m not even sure this is an adverse effect of the vaccine, I just didn?t know if anyone had had a similar reaction and have been made aware that blood clots have also been a concern with the J&J vaccine. I?m also unsure if my Zoloft, which has a warning that it may cause dizziness, may have reacted with the vaccine to make me incredibly dizzy. But around 04:00am on 4/9/21 (I work night shift) I became increasingly dizzy making it difficult to perform the tasks at hand. Enough so that I had to sit down and even reading words off a computer screen made me dizzy. I couldn?t drive home from work at 07:30am that morning because I was concerned with my dizziness. It had subsided by the time I woke up at 02:00pm later that day.

Left leg tingle/pain. Went away after about 10 minutes but was unusual. Started while I was driving home and I got a slight headache.

FEELING VERY HOT; NUMB TONGUE; SHAKING; FEELING UNWELL; CHILLS/SHIVERING; FEVER; EXHAUSTION; This spontaneous report received from a parent concerned a 23 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced feeling very hot. On 08-APR-2021, the subject experienced numb tongue. On 08-APR-2021, the subject experienced shaking. On 08-APR-2021, the subject experienced feeling unwell. On 08-APR-2021, the subject experienced chills/shivering. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills/shivering, exhaustion, numb tongue, feeling unwell, feeling very hot, and shaking. This report was non-serious.

7 hours after the vaccine at 8pm, I had extreme chills, a fever started at 99 degrees, and my body started to hurt. At 11pm, my chills were so bad I was wearing a coat and stocking cap in my house under blankets, I was physically shaking, and my teeth were chattering. My fever was 100 degrees and my body aches were bad. From midnight until around 6 am, I was not able to sleep at all because I was so uncomfortable. My body went from having the chills to being extremely hot and couldn't cool down, my fever fluctuated between 101-102 degrees, and the muscle aches and headaches were the worst. My lower back and hip specifically hurt extremely bad to the point where I had to get up and try to walk around in hopes of making it feel better. My headache was horrible and it felt like my brain was filled with fluid and pressure. I cried on and off all night. At 2 am and again at 4 am my brain started to hallucinate and I was seeing things and having delusional thoughts. If I could have driven myself, I would have taken myself to the ER at this point but I knew in my condition I could not drive. At 6 am, my symptoms started getting a little bit better. I was not completely back to normal until about 36 hours after receiving the vaccine, but the first 12 hours were the worst.

Body chills, high 102 fever for about 10 hours, fatigue, body shakes, severe headache, redness of skin (likely due to high fever)

Approximately 4 hours after receiving the injection, I started developing a fever, within an hour it had reached 103.3 F. At this point I took 400 mg of over the counter ibuprofen which helped drop my temperature slightly to approximately 102.2 F. This fever continued into the night. I took another dose of ibuprofen before sleeping, about 6 hours after the first dose. Along with fever I experienced strong shaking/chills, muscle and joint soreness, headache, dizziness, confusion, and chest pain/feeling of pressure on the chest. The day after vaccination I continued to have a low-grade fever of approximately 100 F which subsided by evening. All other symptoms subsided as well except for the chest pain. On the second day post-vaccination my only remaining symptom is the chest pain.

Patient received 1 dose of the vaccine on 3/29/21. 13 days later on 4/10/21 the patient presented to Hospital with an acute stroke. Patient was working out with her mother and collapsed. She presented to the ED with aphasia, right sided weakness, right nick pain and a left gaze preference. CT in the MSU was negative therefore IV tPA was given. Patient is recovering but still admitted to the Neuro ICU.

After the vaccination approximately 3 hours later patient experienced severe leg pain that has since resolved. Patient had leg pain for one week. Patient also experienced fever for 1 day after the vaccine

I received my vaccine April 11th at 3 p.m and began to have a fever around 9 p.m. My fever did not go away until the next evening. On April 12th I had a fever and woke up with red little dots around my eyes. At night the fever went away. The following day April 13th I felt my chest tight and had shortness of breath throughout the day. I also had stomach pains at times. April 14th and 15th (today) my chest still feels tight and I get tired very easily. My arm is also still very sore and sensitive, I have a little bump where the vaccine was put in.

Headache started around 10pm. Went to sleep. Woke up at 4:30am with bad muscle aches in head, neck, shoulders, arms, hips and legs. I had no appetite. I got heart palpitations, was dizzy and had the chills. I didn't think to check my temperature. I didn't start to feel normal again until Sunday evening.

Headache in the middle of forehead (not a migraine), right leg cramps that are aggravated when touched, stomach cramps that worsen when eating, sore throat, lowgrade fever, general feeling of discomfort.

I experienced dizziness, a severe headache pain radiating from the right arm, Weakness and numbness on the right side of my body, fatigue and shortness of breath.

The night of 4/1, 12 hours after vaccine, I woke up with a fever of 103 and was having muscle spasms in my arms and legs, and felt like my whole body was vibrating. My fingers were frozen, I could not feel them. 2 weeks later (last night) 4/15/21, I woke up feeling the vibrating sensation again. It feels like my whole body, muscles, everything are vibrating. I had muscle spasms in my arms and legs.

MUSCLE SPASMS; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 23 year old female. The patient's height, and weight were not reported. The patient's past medical history included severe acid reflux, 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: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 18:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced muscle spasms. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. 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 was recovering from nausea, and had not recovered from fever, muscle spasms, and headache. This report was non-serious.

Immediate pain upon injection, body aches within 12 hours, massive headache, arm still sore after three weeks.

About a day after the vaccine I noticed my left hamstring was quite sore and cramping and a day or so after that I had intense twitching in my right bicep. Throughout the next week the pain had moved to both of my legs being achy and cramping and intense muscle spasms throughout all the muscles in my body. I have had no headache, vision issues, shortness of breath or swelling within my limbs.

3:00pm - immediately sore arm & feeling ?high? 5:00pm- feeling off, dull headache 7:00pm - severe chills, headache, fever 99 9:00pm - fever 103 9:15pm - fever 106, took aleve, vomiting, pulsing headache 9:45pm - diagnosed with hyperpyrexia, directed by doctor to take ice bath & place ice packs around joints while sleeping, fever dropped to 103 10:15pm - directed by doctor to take Tylenol Extra Strength, fever 103 10:40pm - fever 101 7am - fever 99, extreme body aches (feeling of being hit by a bus) 9am - fever 102, ice packs , headache, took Tylenol 5pm and thru night - nausea, chills, fever 100 Extremely fatigued, extremely sore, on/off nausea, on/off headache for 2 -3 more days. Started feeling mostly better by Sunday evening.

FLU-LIKE SYMPTOMS/HEADACHE/NAUSEA/VOMITING/FEVER/CHILLS; TINGLING SENSATION IN LEG; SWEATING; HOT FLASHES; EXTREME LEG SORENESS; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no other medical condition and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced tingling sensation in leg. On 09-APR-2021, the subject experienced flu-like symptoms/headache/nausea/vomiting/fever/chills. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced hot flashes. On 09-APR-2021, the subject experienced extreme leg soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling sensation in leg on APR-2021, had not recovered from extreme leg soreness, and flu-like symptoms/headache/nausea/vomiting/fever/chills, and the outcome of sweating and hot flashes was not reported. This report was non-serious.

SHOULDER PAIN; BODY WEAKNESS; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced shoulder pain. On 12-APR-2021, the subject experienced body weakness. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on 13-APR-2021, had not recovered from nausea, and the outcome of shoulder pain and body weakness was not reported. This report was non-serious.

ITCHING; SWELLING ON FACE; BURNING SENSATION; HIVES; RASH; BUMP; FEVER; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 17:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On NOV-2020, Laboratory data included: COVID-19 (NR: not provided) Positive. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.4 F, 98.8 F. On 09-APR-2021 02:00, the subject experienced body aches. On 09-APR-2021 02:00, the subject experienced chills. On 09-APR-2021 02:00, the subject experienced fever. On 15-APR-2021, the subject experienced itching. On 15-APR-2021, the subject experienced swelling on face. On 15-APR-2021, the subject experienced burning sensation. On 15-APR-2021, the subject experienced hives. On 15-APR-2021, the subject experienced rash. On 15-APR-2021, the subject experienced bump. Treatment medications included: cortisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever on 10-APR-2021, and itching on 16-APR-2021, was recovering from hives, rash, swelling on face, and bump, and had not recovered from burning sensation. This report was non-serious.

Around 5pm after getting the vaccine, I developed a fever of 101 and got chills, body aches, a migraine, and severe nausea (no vomiting). It lasted about 14 hours.

Patient fell to floor unconscious with seizure. Mucous was coming out of mouth. Patient was placed on side with cold gel packs place on neck and forehead. Patient regained consciousness in about 2 minutes. 911 was called. Dr. overheard page and came to assist. Patient refused ambulance when they arrived. Her boyfriend was going to take her to the ER to have the bump on head be looked at.

RAPID COVID-19 TEST POSITIVE; SLIGHTLY UNDER THE WEATHER; WEAK; NAUSEOUS; This spontaneous report received from a parent concerned a 23 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 16:45 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced slightly under the weather. On 06-APR-2021, the subject experienced weak. On 06-APR-2021, the subject experienced nauseous. On 26-APR-2021, the subject experienced rapid covid-19 test positive. Laboratory data included: COVID-19 antigen test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slightly under the weather, weak, and nauseous on 07-APR-2021, and the outcome of rapid covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: The suspected product quality complaint has been confirmed to be voided (no PQC was identified within the reported complaint reported) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Immediately after receiving the shot I began to have fairly intense pain at injection site. It continued in waves. I began to walk around the store for the allotted 15 minutes. I began to feel very dizzy and faint. My ears began ringing and I didn?t feel well. I stumbled back to the pharmacy to ask for help. At this point I was also feeling like it was very hard to breathe. I explained all these symptoms to the pharmacists on duty and they told me to just sit down. After sitting down I still felt faint but suddenly felt the need to vomit. I stumbled to the bathroom where I collapsed in front of the toilet and passed out twice, striking my head and throat on the bowl. After awaking I was very disoriented and felt very hot and clammy. The pharmacist then came and found me and told me to once again sit down and continue waiting. After sitting down for about 5 more minutes I began to feel less dizzy and was having an easier time breathing. I left the store as the pharmacist was ignoring me and didn?t seem concerned about my symptoms. After arriving home I was tired and week and very very cold. I noted my body temp was lower than usual. I took a nap and then these symptoms continued for about 24 hours. I am now feeling much better.

Patient received a Janssen Covid 19 vaccine at 3:15pm and was waiting in the observation area when she felt like she was going to faint (she claimed to feel really warm) so she laid down and within seconds a tech and pharmacist approached her where she was responsive. she said that she was just warm and did not want us to call 911 or anyone for her. She remained seated for another 20 minutes and felt fine so she left and shopped for the next hour and felt fine.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: patient passed out due to anxiety-Mild, Systemic: Flushed / Sweating-Mild

I had a red, hard, spot on my arm that lasted over two weeks. I also had a bruise that was changing colors. My arm was painful and the redness was spreading. I was given antibiotics for ten days afterwards. My mother also had a rash at the injection site, and was given same shot as me on same day. The lot number for my shot is 1808609. I have many pictures of the reaction if you want me to upload. Furthermore, the doctor said that my reaction would be aligned with a "moderna" reaction but is NOT typical of a J and J reaction (which is the shot that I had received and obtained a record of receiving from the Pharmacy). I got an ultrasound and blood test around two weeks after vaccine, no blood clot found.

Recipient felt lightheaded and dizzy immediately after receiving vaccine. Transferred individual to recliner via wheelchair and administered Gatorade. Initial VS @ 3:45p as follows BP 80/40, SpO2 98% and HR 54. Denies blurred vision, numbness, changes in hearing or vision or difficulty swallowing. Reports tingling sensation in hands. VS recheck at 4pm 100/70, 98%, 74 bpm. Reports feeling much better, no tingling or lightheadedness. Released after 30 mins observation

HEADACHES; HEART RATE INCREASED; FEELING HOT; SORE LEFT ARM AND LEGS ACHY; CHILLS; FEELING WEAK; This spontaneous report received from a patient concerned a 23 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: 207A212A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 18:15 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced heart rate increased. On 06-MAY-2021, the subject experienced feeling hot. On 06-MAY-2021, the subject experienced sore left arm and legs achy. On 06-MAY-2021, the subject experienced chills. On 06-MAY-2021, the subject experienced feeling weak. On 06-MAY-2021 04:00, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart rate increased, had not recovered from feeling hot, headaches, sore left arm and legs achy, and feeling weak, and the outcome of chills was not reported. This report was non-serious.

Patient received vaccine and fainted. Significant other was with patient at the time and reported patient "convulsing". Patient reported feeling numb and tingly at extremities and hyperventilating. Patient was sweating and extremely anxious. EMT arrived, assessed patient, and escorted patient out of facility.

patient passed out on floor and appeared to have seizure like symptom. Felt faint , dizzy, and flushed. called 911. Medical team arrived and patient proceeded to get nauseated and throw up.

Lower back pain started at approx 4:30. Muscle soreness through rest of body. Then skin began to feel tingly most everywhere, not painful but more so sensitive to touch? I feel physically fatigued. When I move too fast my ears start to ring in and out for a few times before settling. Headache.

When patient filled out the form she stated that she tended to have seizures with immunizations. About 3 minutes after the Covid immunization she did have a light seizure.

Pt presented to ER early the following am, with seizures. Pt reports having a small reactions immediately after vaccine administration. Pt reports muscle stiffness, eyes rolling back, shaking, diaphoretic. Pt also reports having a second episode of syncope when she arrived home.

HX VASOVAGAL EPISODE. AFTER RECD J AND J VACCINE, EYES ROLLED, UNRESPONSIVE X 30 SECS, THEN BECAME RESPONSIVE, BP 106/76 HR 59. CODE GREEN CALLED, SX RESOLVED, NO TRANSPORT.

Patient was very nervous about getting the covid vaccine. She sat for 15 minutes and after about 8 minutes she said she thought she was having a panic attack and felt hot. Tech administered vaccine and sat with her the whole wait time since she was nervous. Held an ice pack on her neck when she stated she felt hot. The 15 minute timer went off and she still felt nervous so she continued to sit. Rph also was present once the ice pack was given. She had a dry heave at about 12 minutes. After 20 minutes we moved her to the floor she said she was seeing light flashes. She was sweaty and hot. BP was taken at 420pm 162/109 and 98 pulse. Asked pt if we could call an ambulance, she felt she didn't need one. We got lead from Division 1, also suggested an ambulance and this time pt said ok. Now BP taken was 157/109 and pulse 108. Patient felt a dry heave and we put her on her side. Ambulance arrived and put pt on a stretcher.

I had severe body aches, tremors, headache, fatigue, fever of 103.4 that was controlled by Tylenol, these symptoms lasted for 30 hours. I still am experiencing vomiting, nausea and diarrhea

Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient informed us prior to vaccination that she is prone to fainting and this happens when she receives vaccine or gets blood draw.

I have an extreme fear of needles and we thought that the dizziness came from that and the nauseous came from that as well, that night I had a tough time sleep because my arm was so painful and over the next several days my arm had became inflamed and red we noticed that my sugar had started climbing. So I was kinda okay Monday still kinda sick and nauseous at 6:00 am that morning I started to throw up and I threw up at 6 times my mother had to call 911 and I was taken to hospital in the squad my sugar was 501 I was dka, I had to go without food and water for over a day. I had complications with the insulin and the shot was causing my sugar to rise and there were complication. I was not able to lay on my left for a week longer maybe a little longer. I think my shot was infected it started to leak white goop as well. I was on an insulin drip for a while, my pump was not working so I had to stay longer until a new pump came. I went into the er Tuesday morning and came out Thursday morning

Starting 5/20 at around 2PM, experiencing cough (productive), nasal congestion, sinus pressure, slight headache. 5/21 - 5/22 symptoms were cough (productive), chest congestion, sneezing 5/23 - cough (productive), nasal congestion, chest congestion, sneezing, very raspy voice 5/24 through present - cough (productive), chest congestion, raspy voice

Fine for 6 hours Then got flu like symptoms I was freezing cold for 24 hours with a 104 fever. Had body aches that caused me to scream. I had a head ache and stomach ache. The severe issues were better by Thursday morning but I still have upset stomach when anything is ingested and diarrhea. I am a healthy individual. With a high pain tolerance. This was the sickest I have been in 10+ years no exaggeration.

FEELING DIZZY; CLAMMY; TIGHNESS ON CHEST; NAUSEA WITHOUT VOMITING; This spontaneous report received from a parent concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included patient has no allergies, no drug abuse or illicit drug usage. patient was non smoker and consume alcohol sometimes.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and batch number: 207A21A) dose was not reported, administered on 27-MAY-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced feeling dizzy. On 27-MAY-2021, the subject experienced clammy. On 27-MAY-2021, the subject experienced tighness on chest. On 27-MAY-2021, the subject experienced nausea without vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling dizzy, clammy, nausea without vomiting, and tighness on chest. This report was non-serious.

About 8 hours after receiving the vaccine, my body started hurting, I got intense chills, and I became exhausted. 13 hours post vaccine, I had a fever of 101.6, I began vomiting, I was sweating, I was trembling, and had diarrhea. The vomiting lasted for about 2 hours. Also, I was vomiting up small amounts of blood. About 24 hours post-shot, my entire body was sore, I still had chills and sweats, I had a fever of 101.2, fatigue and a headache. Day 2 after the shot, I was still extremely fatigued and sore. Day 3, I began to feel better. I was still fatigued, but the only soreness was in the arm that I got the vaccine along with some redness around the injection site. I also had no fever. Day 4, my injection site was a little sore, I was slightly fatigued, and a small rash was on one of my arms for most of the day, but then the rash faded.

A LOT OF PAIN IN ARM; FEVER; This spontaneous report received from a parent concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. the patient had some allergies.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-MAY-2021, the subject experienced a lot of pain in arm. On 30-MAY-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 99.8 F. On 31-MAY-2021, Laboratory data included: Fever (NR: not provided) 101.8 F. On 02-JUN-2021, Laboratory data included: Fever (NR: not provided) 99.1 F, 101 F. The action taken with covid-19 vaccine was not applicable. The patient was recovering from fever, and a lot of pain in arm. This report was non-serious. This case, from the same reporter is linked to 20210604932.

CONSTANT TO BAD DIZZINESS (TO THE POINT WITH FEELS LIKE ROOM IS SPINNING); PAIN BEHIND EYES; MODERATE CONSTANT HEADACHE; NAUSEA; VOMITED 10 MINS AFTER FEELING NAUSEOUS; FEVER OF 102 CONSISTENTLY; FATIGUE; MUSCLE PAIN; LEFT ARM SORENESS; CHILLS BADLY; BODY ACHES EVERYWHERE; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, non alcohol user, cigarette smoker, bees allergy, and insect allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced body aches everywhere. On 28-MAY-2021, the subject experienced left arm soreness. On 28-MAY-2021, the subject experienced chills badly. On 28-MAY-2021, the subject experienced fatigue. On 28-MAY-2021, the subject experienced muscle pain. On 28-MAY-2021, the subject experienced fever of 102 consistently. Laboratory data included: Body temperature (NR: not provided) 102 (units unspecified). On 29-MAY-2021, the subject experienced vomited 10 mins after feeling nauseous. On 29-MAY-2021, the subject experienced nausea. On 04-JUN-2021, the subject experienced constant to bad dizziness (to the point with feels like room is spinning). On 04-JUN-2021, the subject experienced pain behind eyes. On 04-JUN-2021, the subject experienced moderate constant headache. On 07-JUN-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches everywhere, chills badly, fatigue, muscle pain, and fever of 102 consistently on 31-MAY-2021, vomited 10 mins after feeling nauseous, and nausea on 29-MAY-2021, and left arm soreness on 02-JUN-2021, and had not recovered from constant to bad dizziness (to the point with feels like room is spinning), moderate constant headache, and pain behind eyes. This report was non-serious.

APROX 20 HOURS AFTER IM INJECT PT HAS NUMBNESS AND SHARP, SHOOTING PAINS DOWN THE ENTIRE LEFT ARM TO FINGER TIPS. WEAKNESS TO THE POINT SHE CANNOT PICKUP HER CHILD. HER WRIST IS ACHING AS WELL.

102.3 9:00pm 06/11/21 102.8 10:00pm 102.5 11:00 pm 2 acetaminophen at 1222am 102.2 -1:30am 101.1 1:50am 100.3 2;07am 100.0 2:33am 98.3 3:49am 98.5 6:30am 2acetaminophen 6:35am 98.6 11:38am 100.4 1:28pm 100.5 2:15pm 101.0 3:00pm 2 acetaminophen 3:05pm HR & o2 96 3:06pm 100.2 3:33pm 99.5 4:01pm 98.3 4:36pm 98.3 5:09pm HR 74 o2 97 5:11pm 98.4 7:08pm 98.0 8:53pm 98.8 9:52pm 98.9 10:53pm 98.0 11:20pm 99.1 1:33pm HR 90 o2 98 1:34am 97.9 7:20am 96.8 8:54am 97.4 10:24 am sweating 96.7 10:22pm 98.2 11:38pm HR 65 o2 98 2:07am 97.3 2:09am 96.4 11:38am Fever Muscle ache/pain (lower back, arm and chest) Can barely move my arm Throbbing Headache Almost vomiting Slight dizziness Congestion Sneezing

A-Team member stated they didn't feel good this morning and last night after taking the J&J vaccine. Around 8 am looked for the employee health nurse to get medication for nausea and headache. She was then making tea and was noted not to be feeling well and fainted. Another employee found her on the floor, and her heart rate was 115, and BP was 112/64 with a 100-degree temp Fahrenheit. A couple of hours prior, her temp was 97 degrees Fahrenheit. She looked diaphoretic, hypoglycemic, and was too weak to get off the floor, there was a maxi lift used to transfer to a wheelchair, and she was very dizzy. The only medicine taken was Pepto Bismol for nausea.

Approximately 15 seconds after administration of the vaccine the patient passed out. The patient almost immediately regained consciousness and shook a couple of times. The pt. reported feeling dizzy so I moved her to the waiting area, with her mother, to wait to make sure she was feeling ok and that there were no more adverse reactions. After 5 minutes the pt. reported that her legs felt like jelly, that her head and legs felt like they were burning and that her throat was feeling dry/tight. I gave the pt. 25mg of oral diphenhydramine and immediately called 911. I monitored the patient and her breathing until the paramedics arrived. Upon arrival the paramedics took over the patient care, the pt. was eventually transported to the hospital.

Developed severe wrist pain and finger hyper extension pain over the course of several weeks after sudden onset. Was prescribed Meloxicam and told to stretch more and wear carpal tunnel braces and to come back in 2 weeks if not improved for bilateral x rays.

About twelve hours after the vaccination, I was unable to sleep and felt so nauseous I almost vomited. In the months following the vaccination, I have experienced increased IBS symptoms and joint pain and back/neck spasms. I have also felt just general malaise.

I was freezing with chills but had a fever. Muscle aches and a bad headache. It happened all night until about 4am. I only felt those side effects through the night.

Patient came in for Janssen COVID vaccine that was scheduled electronically online. All appropriate prescreening was done and patient had no previous allergies or issues. Patient was instructed to sit in one of the chairs designated for post vaccine observation for 15 minutes after her vaccine. Within a minute or so patient felt light headed and like she might pass out. She notified the technician who was right there and he notified me. I assisted her to a sitting position on the floor from her chair and I was able to ease her back to a lying down position from there with her head on the floor and feet elevated above heart on a chair. Patient was able to talk the whole time. She told us at that point when she was younger she was scared of shots and had fainted when having them, but thought she was past that and did not mention it during screening. She said she was surprised to feel this way because she was so excited about getting her COVID vaccine. She had not eaten much today (a small snack) and had rushed here for her appointment without getting food. I checked her blood pressure while she was lying down and it was 94/63 and pulse of 75. She said she normally had lower end of normal blood pressure. She was pale when I started checking her, but her color began to return to normal within minutes. After 5 minutes she felt well enough to sit up and we got her a granola bar and water. She remained this way for 5 minutes and felt good, so we moved her to sitting in a chair and got her a pepperoni and cheese snack tray from the cafe. She ate this and waited for 10minutes and felt good. We walked her to her car and she felt fine. I called to verify she got home fine and she did.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Additional Details: Patient fainted 10 minutes after administration of Janssen vaccine. Patient was unconscious for about 15 seconds before regaining consciousness. 911 was called and EMT arrived on scene to monitor's patients blood pressure and blood sugar. Patient still reported lightheadedness so was taken to hospital by EMT/ambulance.

Sudden onset of muscle cramps, light headed, uncontrollable shivering, abs fever at 8 pm. Fever got worse all night up to 101.8. Treated with ibuprofens and Tylenol. Still aching and chilled the next night. Exhaustion and fever continued but lower and comes and goes

Extremely weak, extremely tired, slight headache, nausea, chills, pain on the inside of my face, sore joints (shoulders, knees, ankles, feet and toes), sore muscles, minor soreness on injection site, eye pain/soreness

Janssen COVID-19 Vaccine EUA. I had the vaccine at around 4:00 pm and felt fine until I woke up around 12:30 am. I had severe chills and shakes, body aches, and a headache. It eventually turned into sweating. Around 8:30am, it's not as severe. I took tylenol around 8:30 am and do not feel like I have the chills anymore, just body aches and some fatigue.

Fever of 102 degrees, Vomiting, Diarrhea, Cold sweats, Headache, Body Aches, Sore Arm, Inability to sleep

Started experiencing mild fatigue and body aches ~5 hours after getting the shot. Over the course of the day these symptoms started increasing and I developed chills and a fever around 100F at about 7 hours. Took an ibuprofen when symptoms persisted and fever kept rising. Fever rose to over 101F while sleeping and woke me up once the ibuprofen ran its course. Did some wet towel compresses but did not help. Took another ibuprofen. Muscle aches and chills persisted into the next day. Developed another mild fever in the second day. Symptoms resolved on day 3. Soreness in arm where the vaccine was administered persists.

Night of vaccine, I woke up at about 4am experiencing chills and a headache. Headache and minor chills still remain as well as fever, aches, fatigue, and weakness.

Light headed, hot, dizzy. Started within 5 minutes of vaccination. Provided apple juice and water to patient. Felt better after 25 minutes.

After about 6 hours of receiving the shot, I woke up with uncontrollable chills, and hot flashes in between, where my chest, back and face felt hot but hands and feet were ice cold. I had a fever of 99.9 and had a headache across the front of the face and nauesa. All of this lasted together for about 6 to 7 hours. During this time I took Tyenol, used cold compress, wrapped up in blankets and sipped on water. After the chills and hot flashes subsided I continued to feel fatigue,and had head and body aches for the next 18-24 hours. During this time I continued with Tyenol and fluids. In all it last about 36 hours before I felt like myself again.

Felt cramps in my lower abdomen, then in my mid back. Put heat on my back. Then I started to feel very nauseous and light headed, dizzy. Shortly felt a burning feeling in my chest and collar bones, that spread to my head. My head started to burn, it felt like it was on fire, along with my neck and chest. I felt dizzy, like i was going to faint, the burning and dizziness lasted for about 5 minutes. Shortly after i felt like my throat closed up and I was having very labored breaths. The burning feeling in my body and dizziness came back, along with not feeling like i could breathe well. I went to an ER, they gave me an IV with Benadryl, and I started to feel well enough 2 hours later to go home.

vaginal bleeding. Pt reports LMP 28Feb and started having vaginal bleeding on 12Mar and has variable light to heavier bleeding since then. patient also received J&J COVAX yesterday and has fever,and headache, reports improvement with excedrin. 24 yo f c/o ongoing vaginal bleeding w/clots x1wk w/irregular menstrual cycle timing; Pt states LMP 28FEB2021, states was regular w/o heavy flow; Pt states approx 7d ago sudden onset of vaginal bleeding, however tapered off slowly over next several days, then increased again this AM, states has used 1x pad over last 4hrs; Pt states mild abd cramping radiating to lower back b/l, c/w sx's experience during child birth; Pt denies any fevers/ns/chills, nvd, urinary sx's

Symptoms started approximately 6 hours after injection. Felt chills, night sweats, headache, body ache.

Blurred vision, list of vision, intense shivering and tingling. Peripheral neuropathic tingling in feet and fingers. Patient reported similar incidents when younger.

Initially started with chills (uncontrollable shivering), then fever (never surpassed 101.9), joint and body aches, headache, arm soreness.

Patient reported feeling nauseated and lightheaded a few minutes after administration, then became extremely pale and head went backwards. Moments later patient's face became red and body convulsed once. Blood pressure and HR taken three times by nurse in the clinic. 2:15 pm 75/58 HR 94 2:20 pm 68/50 HR 88 2:40 pm 80/58 HR 88 Patient felt better and left 3:00 pm

I got hot and my throat started to close up before I got dizzy and nauseous. Then my heartbeat spiked and I got really loopy and uncoordinated while having trouble breathing. That night I got the chills and a fever of 102.

10 hours after shot developed fever 102. Shaking and holding chest. Was able to calm her down. Fever started to break in the afternoon on 04/01. Continued to vomit all day probably because of the fever. Gave liquids only. By 9:00 pm fever fluctuating 99 to normal. Hopefully by 4/2 all symptoms will have passed. I did not take her to the doctor for this although when the symptoms started I was very concerned because she does not speak and I didn?t know if she was having chest pains.

The patient described burning sensation as the vaccine was going in followed by numbness of the right arm and start of a migraine on the same side. The patient was told to put ice pack on the arm. The arm seemed to be experiencing localized injection site reaction. She was informed to take acetominophen when arriving at home and ibuprofen later to help with pain and inflammation

Janssen COVID-19 Vaccine EUA. 6 hours after injection (6pm April 1) I had full body muscle aches, major chills with low grade fever, loss of appetite, a little nausea, major fatigue, headache, prickly sensation on skin. Symptoms subsiding by 1pm on April 2, 2021.

I passed out in my bathroom the morning after the vaccine shot around 5:30am. I called the doctors and they said that was unrelated to the vaccine, but I had intense dizziness and tinnitis before I passed out. I was incredibly fatigued all day long for the rest of the day and had a migraine - both to be expected. However, I am 3 weeks post-vaccine (April 3) and have been having intense muscle cramping and fatigue in my legs during exercise. I wake up with muscle soreness that goes away throughout the day and then comes back during exercise.

Fever (101.4 highest measured at home), fatigue, body aches and muscle aches started about 12 hours after vaccination and lasted 24 hours. Pain in vaccinated arm started about 6 hours after vaccination and continues at 42 hours after vaccination.

At around 9:15 PM I started to feel nauseous and got out of bed to go to the bathroom. While using the bathroom I felt a very strong chill come over my whole body and started shivering and got directly back into bed and wrapped myself up in a thick blanket. For 45 minutes I laid wrapped up and was shivering constantly. At 10 pm I was brought extra blankets and a heating pad but moving to get situated caused dizziness. It was about 10:30 when the shivering stopped. I was able to sleep but got up to go got the bathroom around midnight and my entire body was drained of energy and I felt that I could barely stand and walk on my own. I was dizzy and my head hurt as well. I could barely hold my arms up to look at my phone briefly. Between 11 PM and 2 AM I had 5 or 6 high heart rate alerts (over 120) according to my Apple Watch but I did not wake up to them. In the morning (Sunday 4/4/21) around 9-10 am my head still hurt and my body was very achy and I felt very hungover. All day I continued to feel achy almost with a bad cold or a minor flu. Today has been better but I have still felt pretty drained. I?ve had continuous arm soreness in the arm I got the injection - but nothing too severe. 15 minutes after my vaccine on Saturday 4/3/21 I took 600 mg of ibuprofen and around midnight of that night I took 2 of pain relief PM acetaminophen (1000 mg of acetaminophen total snd 50 mg of diphenhydramine HCI total)

Was fine for about 8 hours, outside of a little soreness in arm. Then I started feeling cold chills, and had to lie down in bed for the rest of the day. Slight fever also occured and intense body aches. However, these slowly subsided after taking tylenol at about 6PM. I slept through the night and outside of feeling a little lethargic the next day, I was back to normal.

Brain fog; chills & shaking; skin feeling raw; headache; brain zaps; fatigue; sore muscle; slight bruising at injection site

At approximately 0945 this nurse witnessed patient sitting in the observation area with her head tilted to the left side and her body leaning to the left. The medical assistant was with her holding her body up. Her eyes were closed and she had no color to her face and lips. She was not able to respond to questions being asked. As her head was shaking she was making grunting noises. She was diaphoretic and tremulous. This episode lasted for approximately 60 seconds. Pt then opened her eyes and was able to respond to questions asked but with a delayed response. Pt was moved to the stretcher to lay down. Her color came back to her lips and her blood pressure improved. She was responding to questions appropriately. Pt was diaphoretic for approximately 10 minutes. Ice packs and water were provided. Pt was observed by the medical assistant for 30 minutes. Her HOB was elevated gradually until she was able to dangle her feet and sit on the side of the stretcher. Pt stated that she was feeling better and was ready to go be with her roommate. Vital signs were taken and BP 91/54, HR 70, O2 97%. At 0952 HR was 62. 1005 BP 102/67, HR 57 O2 99%.

Client complained of complained of flushed face, swelling to hands, headache, vision changes and dizziness after receiving Janssen Covid vaccine (lot 1808980 exp 6/20/21). Client was walking out of waiting room and approached the PHN to inform she was not feeling well. Client assisted to closest chair, EMT joined in and started vitals as PHN did assessment. Per client started feeling mild symptoms after 5mins and by 15 mins symptoms had progressed. Client did not alert anyone until her time was done and she began to walk at 1125. Client alert and oriented, flushed face, mild diaphoresis, per client spots in vision, swelling to hands, left hand more, and headache. Client denied shortness of breath, chest pain. History of allergy to penicillin. No other pertinent medical history. Vitals 1125: blood pressure 140/98, pulse 99, oxygen 100%. Client transfered to gravity chair and given water. Client wanted to call husband to come pick her up. 1134: pulse 97, oxygen 98%. Client stated pressure behind eyes. PHN offered client benadryl, flushed face continued, headache, swelling to hands. Client accepted as husband was on his way. Benadryl 50mg PO given at 1137. Vitals 1139: blood pressure 150/90, pulse 95, oxygen 98%. Per client dizzy, felt warm across face, headache, pressure around eyes, swelling on hands and flushed face. Client denied shortness of breath. Client asked if she wanted 911 to be called for further assessment, client denied, she stated she would continue waiting. Vitals 1144:blood pressure 130/90, pulse 97, oxygen 90. Per client headache gone, no flushing, felt tired. 1148 swelling on hands was improving. Vitals 1152: blood pressure 110/80, pulse 89, oxygen 96%. No headache, just pressure on forehead, no flushing, blurry vision improving. Vitals 1157: blood pressure 126/90, pulse 90, oxygen 97%. Per client all symptoms improving. Wanted to sit straight on chair. Client stated felt well enough to go home. Pressure on head was only symptom at this time. Client given ER precautions. Husband was going to driver her home. Last vitals at 1205: blood pressure 120/90, pulse 86, oxygen 97%. Alert and oriented, stood up with no complaints of dizziness. Client walked out of facility with steady gait

High fever, extreme dizziness, nausea and vomiting, diarrhea, feeling cold then hot, sweating, headache, extreme body aches, pain at injection site. This occurred after 5 hours after the vaccine.

Started with headache, fever, chills all at once. Two hours later my entire lower back hurt like crazy. The only thing that made it better was walking but lying down or sitting felt like the worst thing in the world. Nausea much later in the night and my heart rate was higher than normal for the most part. My resting rate is usually 57-62 bpm but this time it was ranging between 100-108bpm. Arm soreness Back pain was mostly felt on the left side and accompanied by leg pain. I?ve had back pain in the past but this was x100 worse to the point where I considered going to the ER. My final symptoms were nausea but waking up this morning I feel fine

The night after I got the shot I had a pulsating migraine, a fever of 103.9, really bad chills and was extremely nauseous and weak. Here it is 6 days later and I have developed a rash all over my body. On my back, my legs, my arms. It is very red and very itchy.

patient was cold and clammy about 5-10 minutes after vaccine and vomited x 2, she had not eaten anything before vaccine; she was moved to a chair, administered epi-pen dose x1 and wrapped a blanket around her to warm her up; she was alert and responsive and was monitored for about 1 hr with no other symptoms . Follow up call was made a few hours later and no further events reported

Started developing a headache about 2/3 hours after the vaccine. Took some ibuprofen, at 7:11am I still have a severe headache being treated by otc pain reliever. About 2:30am I woke up from my headache and realized I was freezing cold, dispute it being 74 degrees in my house. I did not have a fever but I had extreme chills, my entire body shivering and shaking at some points. This made it hard to stand or even get some water. These lasted about 2 hours or so. Once I was able to get warm again, under several blankets and a heated blanket they did go away and I did not experience them again.

Veteran reports that several of hours after her Covid vaccination, she developed chills, shaking, sweating, dizziness, nausea and vomited x1. Veteran has not taken her temperature. Due to her symptoms, her spouse had to come to her work and drive her home.

About 6 hours after vaccine injection I began to have weakness, numbness, tingling, and burning from my hips down. From the top of my legs all the way to my feet. Also numbness in my hands. Went to the ER approximately 15 hours after receiving my vaccination. Was discharged, awaiting on leptospirosis bloodwork and if conditions do not improve I will return to the ER to get a lumbar puncture to check for Guillain Barre Syndrome.

PATIENT HAD A SEIZURE AND FELL. SHE DID HIT HER HEAD. FALL WAS NOT WITNESSED BY THE RESPONDERS. VITAL SIGNS WERE TAKEN: BP 142/88, PULSE 98, O2 SATS 100%, RESPIRATIONS 20, BLOOD SUGAR LEVEL 84. HELPED PATIENT TO WHEELCHAIR AND SECURED HER TO THE FIRST AID AREA. AMBULANCE WAS CALLED AND SHE WAS TRANSPORTED TO THE ER.

Patient fainted right after receiving her shot. She woke up immediately after, though very pale and shaky. Patient stayed laying down for 15 minutes until she felt better and left under her own power with no problems.

Severe abdominal cramps, severe chest pain, neck pain and headache, severe joint pain, muscle aches and weakness and shakiness. Started 6 hours after receiving vaccine and is ongoing at 30 hours post vaccination.

Low fever (100.1 F), body ache, exhaustion, general discomfort. Symptoms first started the evening of the vaccination day (yesterday, 04/08/21). The symptoms increased day after the vaccination (04/09/21). Patient has been in bed since last night

Shortly after receiving the vaccine (04/05/2021), I became very tired, but otherwise had no adverse reactions. I went to bed around 9 pm, and at around 3 am the next morning (04/06/2021), I woke up with severe chills, body aches, a pressure headache, and some mild nausea (I believe caused by the headache) that lasted through until early afternoon. Taking ibuprofen seemed to help the body and headaches, but it seemed like it was difficult to regulate my body temperature. I couldn't tell if I was too hot or too cold, and trying to remedy one or the other made me either too cold or too hot, respectively. All effects completely cleared up by 04/07/2021.

Intense flu-like symptoms including muscle aches, chills, and piercing headaches lasting two days. Extremely sore arm and armpit continuing.

I started experiencing side effects about 6 hours after receiving the vaccine. I experienced chills, sweating, 99.5 fever, headache, head pounding, dizziness, nausea, tiredness, sore body, sore left arm, and had trouble sleeping. I took two Motrin pills and felt a little better and was able to sleep. In the morning, I woke up tired, sweating, had a sore left arm and sore body so I took two more Motrin pills and am feeling mostly better. Fever, headache, head pounding, dizziness, and nausea are gone.

High fever (104) for three hours. Vertigo, weakness and uncontrollable chills. Self treatment included 1000mg of Acetaminophen, fluids, ice packs, and 400mg of Ibuprofen four hours after the initial dosage of Acetaminophen.

Extreme chills that left me severely shaking for 3 hours. This also was accompanied by a fever until noon the next day. Chills and shaking started at 10:30 pm on April 1st 2021 and continued until 1 am April 2nd 2021. Less severe chills occurred next day. Severe aches and dizziness day after shot. Side effects subsided by approximately 2 pm April 2 2021

Fever, nausea, muscle aches and body pains, headache, weakness. Treated fever with ibuprofen and rest. Since 4:00am on April 11.

Almost immediately after COVID 19 vaccine administration, patient began experiencing warmth ,dizziness and faint, variable breathing shallow, deep etc. Cool compress applied to patient. Patient began to slump, tremors, and appeared to be passing out, eyes began to roll back. EPIPEN was administered and 911 was called. The 911 medics arrived and patient was transported to emergency room .

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: sweating-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Weakness-Severe

Patient began to feel dizzy around 10 minutes of waiting after the vaccine administration. Patient then began to vomit but could not get all of the vomit out of her throat. She then passed out. Patient was lethargic and difficult to arouse. Patient's blood pressure was 122/80. Medics were called and arrived on scene and took patient to the ER.

Fever ranging from 99.5 degrees F to 101.7 degrees F, severe headache, moderate chills, and moderate body aches for 48hrs after vaccine. Mild headache and body aches for 72hrs after vaccine. All symptoms disappeared after 72hrs from vaccine time.

At around 10:30 AM on 3/29/2021, I began to notice some irritation and phlegm build up in my throat, as well as some tingling and numbness in my face. This lasted for approximately 30 minutes before subsiding. At around 8:00 PM on 3/29/2021, I began developing a fever and somewhat severe body aches that lasted until the morning of 3/31/2021. I also developed a somewhat severe headache on the morning of 3/31/2021 that lasted through 4/1/2021. The injection site was tender to the touch from the evening of 3/29/2021 until 4/2/2021, and my arm was also very sore during this same time frame. I also noticed unusual exhaustion from the evening of 3/29/2021 until 4/5/2021. During 3/29/2021-4/1/2021, I was taking Tylenol Extra Strength (1 pill every 6 hours or so) to help alleviate symptoms, but it only helped for about 3 hours in the 6 hour interval.

Got the shot at 9:20am on Saturday (April 10th). By the time I sat down to do the 15min waiting period before I could leave. My arm from the back of my shoulder all the way down to around my thumb joint in my hand ached so bad. By around 3pm on the same day, I started to feel really tired and had a pounding migraine. By 4:30p I started to get really cold and everything started to ache. By 6p I was feeling hot but at the same time cold and shivering. My head was pounding. Every muscle ached all over my body, and by every muscle I mean even my eye muscles and pelvic floor muscles. My face had so much sinus pressure that it felt like it could explode. My skin, all over my body, was so sensitive that it hurt to the touch. On top of my skin being sensitive to the touch, off and on my skin would tingle, including the inside of my mouth and tongue. My lymph nodes were swollen enough in my neck that my throat ached. I was mentally confused and shaking. Everything got bad enough I started crying and hyperventilating. I felt sick to my stomach and felt digestive pain. My entire body felt so heavy. By the time it got to around 8p, my mom finally took my temperature, which at that point I had already been taking Tylenol all day and was no longer shivering, and I had a temperature of 101 degrees F. I finally went to bed around 9p. I was thirsty but my stomach felt sick. I still ached and woke up around 10 times throughout the night either feeling too hot or cold or hurting so bad. At 4am I took a Tylenol because it everything hurt bad enough to able to fall asleep. The next day. I mostly better. I was still tired and a little achy and my lymph nodes under my arm pits were swollen. At this point my lungs felt strange. Harder to breathe than normal. I was starting to cough. The day after that (today) I have felt fairly normal except I?m coughing and my lungs still feel a little strained. No more aches or fever or anything like that though.

Joint and bone pain in legs, right shoulder 12 hours after vaccine. Decreased pain, increased fatigue 24 hours after vaccine. Mild pain at site of injection.

Janssen COVID-19 Vaccine EUA Immediately after receiving the vaccine, I had no side effects. The following morning, my arm hurt and I felt a bit tired, but other than that normal. About 27 hours after I received the vaccine, I had severe stomach pain. I ended up vomiting and having diarrhea at the same time, for an hour. Immediately following this, I was very feverish, and I got the chills horribly for about an hour. I was very tired for the next 48 hours, but Tylenol alleviated the fever and headache.

Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted due to low blood sugar having skipped breakfast. Recovered within minutes after sitting down and drinking water.

Patient said she is scared of needles and has fainted after injections. Immediately after injection she said she felt dizzy then she slumped in her chair and closed her eyes was unresponsive and pale for about a minute. When she responded she was slightly confused for about 30 minutes sat up drank water and put cold paper on her forehead and her back of her neck. Rested for half an hour. Then walked assessed to observation area.

Alternating sweats/chills and headache beginning ~10 hours after vaccine administration, followed shortly by 100.2 degree fever lasting until ~21 hours after administration. Body fatigue/weakness for most of the next day. Tylenol taken ~27 hours after vaccine administration, which helped headache subside. All symptoms went away ~30 hours after vaccine administration.

Trouble breathing as the shot was administered. Vision began to black out after 3 minutes. Urge to vomit, extreme nausea. Passed out, unconscious within 5 minutes of receiving the shot. Could not sit up/dizzy for 30 minutes. Nausea, weakness, dizzy, poor mental acuity/memory. Later that night, and through the night for 10 hours, severe back pain. Nausea, severe weakness, dizzy, poor mental acuity and memory, sweats and chills. The next day (day immediately after receiving vaccine) symptoms continued but lessened by 5 pm. Each day since then, the symptoms have ALL remained in a more mild form. Today is day 6 and I still have moderate back pain and occasional sweats, weakness and fatigue.

The night of the shot I was unable to sleep while in excruciating pain all over by body. I had a fever for 6 hours. I was to week to move for hours and when I finaly could get up and move around I was unable to even open my contact case to take them out because I was to week. The pain continued until noon when it lessened some with tons of advil I was able to move around slowly but pain persisted throughout the day and into the next 2 days. I finaly woke up pain free 4 days after getting the vaccine.

Felt generally unwell 12 hours after the vaccination: onset of headache and body aches. During the night, fever spiked to 103 degrees, had uncontrollable shakes, chills, cold sweats, dizziness, and mild nausea. This lasted roughly 48 hours. After 48 hours, fever was reduced, body aches remained, but other symptoms subsided. I continue to feel generally unwell with body aches and a slight fever. In retrospect, I should have gone to the hospital.

The day following the vaccine (Wednesday 4/7/21), I woke up with body aches, a strong headache, feeling quite warm (no fever throughout the day, but I felt quite warm), and felt a lot of fatigue. There were no respiratory symptoms, but many of the body symptoms that I typically associate with a regular cold. I slept for much of the day Wednesday as the course of treatment - no medications were taken. The symptoms persisted all day, and were essentially gone when I woke up the next day (Thursday 4/8/21). I had varying levels of pain in my arm, where I received the shot. There was more pain than expected when the needle went into my arm, then all pain subsided by the time I went to sleep on the day the shot was received. The day of the cold-like symptoms there was significant pain at the injection site that persisted through Thursday. All pain resolved by Friday.

I have had headaches nausea lightheadedness/dizziness body chills every now and then hot flashes. I have gone to my personal clinic. I went to urgent care there and was seen by the doctor I had a CT bloodwork and urine test I?ll run and everything came back normal. I still get random spurts of headaches nausea they did give me some medications to help treat the symptoms but I still in continue to get the symptoms.

First day - Wednesday: Return home from work for lunch around 12am. - leg pain (really bad, muscular-like pain. Ache, sore. Would flare. Sometimes in knees, mostly in calves... continued until midway through the night) - fatigue (felt just a little more tired than normal, really tired by bed time: 9pm) - heightened heart rate (excitement from vaccine / apprehension for potential illness?) Second day - Thursday: - fatigue (tired all day, almost fell asleep through a couple meetings) - leg pain (reappeared in the morning, ached and throbbed. Made it difficult to relax. Was gone around 3/4pm) - headache (probably from dehydration, I was warm, but not completely a fever. Attempted to drink a lot of water, but too much made me nauseous) - chills (sporadic, barely noticeable except it agitated the headache) - nausea (I barely ate more than a granola bar and attempted to drink water and tea, but too much made me sick, especially if it had sugar - mainly drank water. Had some soup later in the day (6pm) and most of the nausea went away)

Within 5 minutes of receiving the shot I fell incredibly nauseous, staying nauseous for two full days and then periodically off and on. It has been 6 days since the vaccine and I have random muscle and joint pains, leg pains, nausea, and still have an extremely hard painful lump in my arm. The worst of symptoms is over.

Chills, fever , nauseous, sore arm, vomiting , nasal congestion, mild cough, headaches and body aches

Muscle and body aches sharp pains throughout body swelling at injection site short bouts of numbness and tingling in right arm from elbow down to fingers headache joint pain

I was running on the treadmill and all of the sudden my feet started tingling. I got off the treadmill to try to massage my feet. Then, I felt nauseous and vomited. After vomiting I could not move and I had very hard time walking. I noticed that my face had swollen, my throat was closing, and my vision was blurry. I also broke out in hives. Once I could get mobile (about two hours after the adverse reaction started) I took a Benadryl and that helped ease the swelling.

Prior to administration of Janssen Covid-19 vaccine the patient was anxious but was completely fine once the procedure commenced and concluded. After finishing explaining the possible side effects of the vaccine and handing the patient the V-Safe handout, she got up slowly and proceeded to our designated post vaccination monitoring seating arrangement. Upon concluding the vaccination process with the patient?s partner, she alerted the pharmacist that she does not feel well. To which he asked her to further elaborate on what she is experiencing. She began to say she thinks she?s going to faint as she is attempting to drink water. As she was having a drink of water she fainted. To which he responded by running over and catching her before she hit the ground, cradling her upper torso, specifically the head and laid her down on the floor with the assistance of pharmacist and her partner. In the midst of everything he instructed another pharmacy technician to call 911 for the paramedics. As she was in the process of drinking water I saw her other hand go to the region of the neck, thinking it was also an allergic reaction and administered a dose of Epi-Pen. He administered the Epi-Pen on the upper side of her thigh, directly to the skin not through clothing. There was a very brief moment where the patient began to convulse but gradually regain consciousness. The patient became lucid and was conversing with him, apologizing for the incident. He assured her there was nothing to apologize for and to which she told me she had similar incidents from vaccinations as a child. She did not mention this prior to administration of the vaccine and through conversation we believe the incident may be caused from high anxiety of needles / vaccinations. When the paramedics arrived, they assisted the patient from the floor and gave a warning that she believed she was going to faint again, and fainted in the arms of the paramedics.

shaking, chills, fever, muscle aches, fatigue, tinnitus (4/6) nausea, fatigue (4/7-4/9) tinnitus (constant since vaccine administration)

The night I got the vaccine 3/10 my arm was sore just like any other vaccine I?ve received. Two days later, I woke up and noticed a welt on my arm that was about two inches in diameter. It was itchy and painful. I could not lift my arms up. By noon it had doubled, and the slightest touch was unbearable. The ?Covid arm? was also hot in temperature. That night, it was at its worst at 5 inches in diameter and it was even more swollen. It stayed that way for three more days before it started to go down. A week after my vaccine a bruise developed where the welt was. Two weeks after my vaccination it was still bruised and swollen. It felt like a tide pod when I touched it. My mom encouraged me to go to urgent care. So on 3/26/21, I went to urgent care and was told it was a cyst. My arm is currently still squishy at the welt and bruised. I have an appointment on 4/19 at my dermatologist for further care.

Night of vaccine: sore arm, severe headache, dizziness, low grade fever (99), chills. Recovered the following afternoon. One week after vaccine developed tingling in left leg, two weeks after vaccine developed mild numbness/loss of sensation on left side. Went to urgent care and then to ER, they suspected complex migraine as I have a history of migraine (though had never had one lasting that long). Numbness has been intermittent since but seems to have mostly gone away.

Site: Pain at Injection Site-Mild, Systemic: Blood Disorder (diagnosed by MD)-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: blood clots in stool-currently under care of primary care physician for clot formation investigation-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Medium, Additional Details: patient reported blood clots in stool on 4/11/21 and 4/12/21. Patient was flushed, dizzy and faint after clot was found. Patient has no significant history of hemorriods or colorectal conditions.

About seven hours after vaccination (~5:30pm), felt slight chills. Over about a half hour, they escalated to severe chills and a 101.9 degree fever that lasted through the night. Chills subsided about 3am, but fever remained until following morning and slowly lowered until about noon the day after vaccination. That day, arm soreness increased, with sharp pain when arms raised or pressure applied, and soreness continued until five days after vaccination.

Tiredness, achy-ness, high fever (102.7°), mental fogginess, shivering/tremors from feeling cold, this went on for over forty minutes before I fell asleep still shaking. I had not taken Tylenol or any other forms of medication at this time to alleviate symptoms. That night I took two Tylenol 500 mg and symptoms from fever began to subside. Following day still experienced fatigue , low energy, and achy-ness.

Developed ulcers around my genitalia 48 hours after being vaccinated and experiencing severe muscle pain/ weakness, nerve sensitivity, migraine, fever/chills and dizziness. The ulcers were located on my labia; caused extreme pain around labia, intense pain while urinating, inability to use bathroom, dehydration. Ulcers lasted for 5 days, then the pain and sensitivity stopped.

Patient had a mild seizure several hours after receiving the J&J vaccine. She is epileptic and generally has two seizures a year that would last 30 minutes or longer. The seizure she had after receiving the vaccine only lasted around 40 seconds. She had her last regular seizure in January so she stated she was not due to have a seizure anytime soon based on her previous medical history. Her father was present and able to keep her safe during seizure so no medical treatment was received.

DRY COUGH; SORE LEGS; CHILLS; FEVER; SWOLLEN EYES; BODY ACHES; HEADACHE; This spontaneous report received from a parent concerned a 24 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: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced swollen eyes. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced sore legs. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced dry cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen eyes on 09-APR-2021, was recovering from body aches, had not recovered from fever, chills, sore legs, and dry cough, and the outcome of headache was not reported. This report was non-serious.

April 8th at 11pm I started to have slight body aches. I woke up at 3am with intense body aches/ chills/sweats, felt like I had a cabin fever for the entire day of April 9th. I felt dizzy, had a headache, my eyes aches and very very fatigued and couldn?t eat. Night of April 9th I started to not feel so dizzy but I was very very hot and could not cool down. Ever since April 10th I?ve have runny/stuffy nose/ body aches, sore throat, I developed a cough week of April 12th, eyes ached and very very fatigued. Today, April 21st, I am still a little fatigued, little soar throat, but runny/stuff nose still, and body soreness/aches.

COLD/MUCUS CONGESTION/COUGHING GREEN MUCUS/FEELING SICK/TIRED/NO ENERGY/SLUGGISH; MIGRAINE/SEVERE POUNDING HEADACHE; This spontaneous report received from a parent concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1A05031 expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced cold/mucus congestion/coughing green mucus/feeling sick/tired/no energy/sluggish. On 10-APR-2021, the subject experienced migraine/severe pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold/mucus congestion/coughing green mucus/feeling sick/tired/no energy/sluggish and migraine/severe pounding headache was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

RIGHT FOOT PAIN; FEVER; This spontaneous report received from a parent concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included scoliosis, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies. the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 06-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 15-APR-2021, the subject experienced right foot pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from fever on 12-APR-2021, and had not recovered from right foot pain. This report was non-serious.

6 hr after shot: intense chills 8-10 hr after shot: migraine (then took Tylenol) 12-24 hr after shot: lethargy, aches, migraines 48 hr after shot: lethargy, cold sore on left side of mouth, and beginning of rash on left eye 72 hr after shot: singles rash (diagnosed by ophthalmologist) on left eye, including discharge, pain, redness, and swelling

BODY ACHE; SORE ARM; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 24 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 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the patient experienced body ache, sore arm, chills and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, and headache, and had not recovered from sore arm. This report was non-serious.