Johnson & Johnson

SWEATING; DRY MOUTH; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; FEVER; This spontaneous report received from a patient concerned a 17 year old male. 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. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced sweating. On 31-MAR-2021, the subject experienced dry mouth. On 31-MAR-2021, the subject experienced inappropriate age at vaccine administration. On 31-MAR-2021, the subject experienced off label use. On 31-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from off label use, and the outcome of sweating, fever, dry mouth and inappropriate age at vaccine administration was not reported. This report was non-serious.

seizure about 2 hours after event, per mother also with increase in salivation and groaning. Benadryl has helped, is being monitored

Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient reported sweating, chills, feeling lightheaded/dizzy with visual disturbance (blurry, narrowed vission) for about 20 minutes post vaccination. Blood pressure taken 15 minutes after vaccination 105/68. Monitored patient for 30 minutes post. Symtpoms resolved significantly after drinking some fluids and patient left with Father. Followed up with patient next day and patient reported feeling feverish/chills not taking any medication to manage.

Fever Chills Terrible muscle and joint pain that Tylenol did not help with Headache that Tylenol did not help with Mouth sores Tired Still feels sick 4 days after the shot

Patient at Vaccination table, just received dose of vaccine when patient's arm went limp. Also developed generalized weakness. Mother stood in front of him and held his head with both hands. Patient then passed out with eyes rolling in back of head. Also had convulsions for a few seconds that mimicked seizure. Patient soon became alert. Vitals obtained with BP 92/52, HR 34, O2 96% on RA. Patient also diaphoretic to touch. EMS activated and arrived at 1:30pm. Placed in reclining wheelchair and taken to private area. Started to feel better after given cold water. Suggested ER due to having seizure first time. Declined ambulance but mother will take to ER in private car. Patient and mother left with no further incident.

Perfectly healthy, fit, thin 18 year old young man with no allergies and no previous reactions to vaccines or medications... immediately upon receiving J&J injection his eyes rolled back into his head and he was unconscious for two to three minutes, then in and out of consciousness for another eight to ten minutes. He convulsed for around ten seconds after about two minutes of being unconscious. Four to five healthcare workers attended to him, asking him to "stay with us." They called an ambulance, and the medics monitored him for awhile. Heart rate dropped to 34 bpm, clothing drenched with perspiration. Blood sugar was slightly low, although he had eaten a late brunch of two fried eggs, sourdough toast and fruit salad. The last thing he remembers is a cold sensation shooting down his arm and into his left hand. He tried to talk to say he wasn't feeling well, but he couldn't form the words, so he raised his arm and then fainted. He felt generally unwell the rest of the day, and today he is still not fully recovered.

Within 4 hours of vaccine and lasting 12-24 hours: Injection site pain, then severe chills followed by fever (99.9 degrees F), nausea, vomiting, joint aches/pain, shivering, loss of appetite, difficulty sleeping, GI pain, headache, severe light and sound sensitivity, fatigue; At 24-48 hours, headache, joint aches, fatigue, light sensitivity, decreased appetite, increased pulse; 48-72 hours - 2 pound weight loss, joint aches in major joints, fatigue, unable to perform physical work >72 hours - feeling better, but tired

The patient started feeling very dizzy and losing his vision within minutes of receiving the vaccine. The patient was conscious and slowly responded to questions. Memory intact. Patient recovered quickly after EMS arrived and didn't require any medical assistance.

Patient had the injection, reported that is wasn't bad and then within a few minutes when in the waiting area, he reported feeling very light headed, nauseous, and lost his vision and hearing was fuzzy. He was cold and clammy. He never lost consciousness. It took him a couple minutes to "come back" to alertness and feel better. Severe headache, chills starting and began asthma symptoms (wheezing) at 11;30pm the night of the injection.. 2 extra strength Tylenol did not help. He was very cold and the headache did not let up after several hours. Eventually he had a bout of sweats and he reports he was soaked. In the morning, at 8 am the headache was still severe...was sensitive to noise, light and touch. He was given 2 extra strength Tylenol at 8 and then 2 Advil at 10am, which finally began to reduce symptoms. He was not hungry, felt weak, and finally by late night he was feeling better. In the morning on Saturday he awoke with a swollen left eye and blood shot in that eye.

Symptoms: light headed, pale, dizzy, seeing stars Vitals: BP 100/60, RR 16, Pulse 73, O2 96% BP 115/70, RR 18, Pulse 60, O2 95% Intervention/treatment: assessed vitals, gave patient juice, water

This spontaneous report received from a parent concerned an 18 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced high fever. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced pressure in ears. On 08-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, diarrhea, headache, chills, pressure in ears and injection site pain was not reported. This report was non-serious.

In about a minute, ears "closed off", quickly became dizzy, feeling like going to "pass out". Some nausea. Indicated he had never experienced this with any other injections.

Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: DURING SYNCOPE EPISODE, PATIENT STATED HE "COULDN'T SEE". VISION RETURNED AFTER LESS THAN 1 MINUTE. PATIENT WAS UNCONCIOUS FOR LESS THAN 30 SECONDS. AFTER LAYING DOWN FOR 1 MINUTE, I RETURNED PATIENT TO CHAIR AND MONITORED BLOOD PRESSURE. PATIENT WAS HYPOTENSIVE FOR 20 MINUTES. PATIENT BECAME HEMODYANMICALLY STABLE AFTER 20 MINUTES USING 4 SEPERATE READINGS 5 MINUTES APART EACH. PATIENT'S FATHER ACCOMPANIED PATIENT AND OPTED TO TAKE HIM HOME AFTER HE WAS STABLE.

Suddenly felt dizzy and loss of hearing, sweaty and arms and legs felt tingly. He turned pale. We laid him down and placed ice pack on his forehead and neck. BP initially was 84/50 repeat in 10 min was 105/54. He felt better after 10 min. Felt back to normal at 30 min when he was released to his mother

Upon standing post-vaccination, patient fell into the floor, eyes rolled back into his head, and was convulsing. Upon regaining his whereabouts, patient stated he did not recall anything that had happened. He had impaired vision, tinnitus, and was ashen in color. I was able to get the patient into a chair and he experienced two more episodes within 5 minutes. 911 was called. Patient requested water and it was provided. Paramedics arrived and conducted multiple tests (blood glucose, blood oxygen, blood pressure, heart monitoring). Patient refused referral to the local hospital and left the pharmacy within 30-45 minutes after the incident without any further problems.

as soon as needle went in patient's arm patient turned white and sweaty. never lost consciousness. pt said ears were ringing and that he couldnt see patient's mother wanted us to call squad. we did. they arrived shortly after. they determined it to be an allergic reaction and administered epi and gave pt IV fluids patient was stable enough to leave a little before 7 pm

Patient fainted approximately 30 seconds after vaccine. Eyes closed and patient did not respond for approximately 30 seconds but still had pulse. When patient's eyes opened he stated his vision was slightly blurred; also pale and sweating. After elevating feet and providing ice packs patient began to feel better. Blood pressure and pulse stable 30 minutes following. Patient felt fatigued but otherwise back to normal when leaving pharmacy.

Patient was told to have a seat in the waiting room for 15 minutes after vaccination. Against medical advice, he left immediately. Employee called the pharmacy and informed us patient was in the bathroom feeling like he was going to throw up, his vision was going black and he was tingling. Our pharmacist brought an epi-pen to the bathroom immediately, however, patient had left the building before pharmacist could evaluate him.

Immediately post vaccine administration, patient experienced syncope (fainting). Eyes rolled back, sweating, lost consciousness. 15-20 seconds later regained consciousness as if nothing happened. Provided patient 4 glucose tablets and sat/spoke with him for an additional 15 minutes

Approximately 2-3 minutes after vaccine administration patient began having a seizure (convulsing/uncontrolled movements, random eye movements, unresponsive but conscious) in observation area chair. The paramedics were called immediately. The seizure lasted about a minute. The father was insistent that he get up and walk around. After 2-3 minutes he returned to his seat. Pharmacist attempted to take blood pressure reading. During blood pressure check the patient complained of fatigue and nausea and then began having another seizure. This also lasted about 1 minute. About 2 minutes later the paramedics arrived and took patient to ER.

Patient had slight queasiness/stomach discomfort and slight blurry vision before administration of vaccine. Both intensified within a couple minutes after vaccination, and 5 minutes after administration patient fainted/lost consciousness. He regained consciousness 10 seconds later and was ambulatory afterwards. Patient exhibited no difficulty of breath or cognitive impairment. Pharmacist had patient sit and drink water for a half-hour afterwards with observation. Patient left store on own ability and left afterwards.

Patient said he couldn't hear. He felt dizzy, nauseas, and was sweating. Blood pressure was taken it was low. Gave patient water to drink. Took blood pressure repeatedly. Gave patient something to eat (said he hadn't eaten & that could be cause of nausea). Patient's blood pressure went back up to normal. Patient felt fine before he left. I had patient sit longer than the 15 minutes, it was at least 30 minutes.

Patient felt like passing out, got very white in the face, eyes rolled back into head. Then he was ok.

Temperature of 103.6 - Vomiting, Lower abdomen pain, Cold Sore outbreak on 7/27 at eyes, nose, mouth Complaint of ear ache. Cold sore eruption increase to around both eyes, under nose, bottom lip. Bottom lip swollen, eyes puffy

Puffy eyes and face, swollen, but no other symptoms. Vaccinated at 4;45 pm and had mild inflammation 3 hours later, woke up today at 1pm with eyes and face completely swollen

Janssen COVID-19 Vaccine EUA Dry throat and dry cough. Painful cough. Discomfort eating and drinking. Drinking lots of water and using a humidifier has not helped. First started experiencing around 8:00 AM, and has been ongoing sicne.

Almost immediately after Johnson & Johnson Covid Vaccine was injected into patient, he passed ouit. He was in chair and his head went backwards with his eyes rolling back. called for help and I responded. Patient was coming to but proceeded to pass out 2 more times. Epi Pen was ready to inject if needed, but did not appear to be an allergic reaction. 911 and a code white were called. Blood pressure was taken and was low. Patient was warm and clamy. Ice was placed on his neck. Paramedics arrived and checked his vitals. Blood pressure had come back up. Pulse ox 99. blood sugar was normal. Paramedics told patient to hydrate and eat. Water was given to patient after paramedics cleared it. Patient eating in store and then checking in with Pharmacist. Patient will be called tonight at closing time.

I have had widespread soreness and pain over my entire body, I woke up at 3:30 AM and couldn't go back to sleep, I had light sensitivity, and a massive headache.

Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Mild, Additional Details: na

About 5 minutes after the patient was vaccinated, he felt weak and faint. His pupils dilated and he began to profusely sweat. He then blacked out for about 15-20 seconds. By the time EMS arrived within 10 minutes , he was coherent and felt fully recovered.

Pt received vaccine and they started to feel dizzy and then passed out in his chair momentarily. Pt began to feel better and then patient fainted again. Pt also complained of ringing in his ears. EMS was called to the bedside where they found patient to be hypotensive. Pt was resolved quickly. Once he began to feel better he was sat up at the side of the bed and monitored for a short while. Pt no longer had any symptoms or concerns and went home with his girlfriend

Patient about 3 minutes after receiving vaccine felt light headed, vision blurred, and felt like he was going to black out. Pharmacist had patient get down on floor to bend knees and get them above heart level and he started feeling relief. Patient quickly recovered.

Total loss of taste on the tongue. The (very few) taste buds in the other areas of the mouth remained minimally functional. For a point of reference, I can barely taste anything when I swish mouthwash around in my mouth. Pre-existing minimal chest pain (related to history of vaping) flared up to an extreme extent the night of the day I was vaccinated. Hurt more than the joint pain or headache I also have (but those are common side effects).

Patient experienced fainting spell. He complained of visual disturbance, blurry, twice within 5 minutes. His parents gave him a piece candy and drank some warm water. He was resting on a chair crouching over for about 5 minutes and feeling ok. I was going to call 911 for an ambulance and he refused. He was totally fine after 15 minutes of rest.

Janssen COVID-19 Vaccine, arms and legs were fully numb and cold, chest and back were hot, fever, headache, could not look to the edge of my vision, could not hold down food or water, intense pain in the lower back, bad balance, chills, aches,.

Started with a low fever 6 hours after vaccination, with slight muscle ache symptoms. About 4-5 hours later it evolved into a high fever (104 at peak), muscle aches on the whole body, and ringing in my right ear. The next day the symptoms were more mild, but still present (other than ringing in ear) with a lower fever, and the day after the symptoms were gone except for tenderness at injection site.

Severe arm pain/low swelling in arm area. Nausea. Pain near liver area. General fatigue. Mental cloudiness. Random bouts of tinnitus in both ears, switching off, never both ears at once. The arm pain and swelling in shot area lasted about two days, but the nausea, ;over pain, and fatigue continued for the better part of 4 days after the shot. The tinnitus only happened a couple times about 1-3 hours after the vaccination then ceased. I did not get this verified by a doctor, but I suspect my liver pain was related to an inflammation in the liver associated with the vaccine, as in the past, pain around my liver area has been associated with inflammation of my liver during minor flare ups.

PATIENT'S MOM INFORMED US THAT PATIENT WAS "SCARED OF NEEDLES". PATIENT APPEARED CALM IN VACCINATION OFFICE AND DID WELL WHILE VACCINE WAS BEING ADMINISTERED. PATIENT SAID HE FELT GOOD, STOOD UP WITH NO ISSUES, AND WALKED TO OBSERVATION AREA TO TAKE A SEAT. FIVE OR SIX MINUTES ELAPSED AND I WAS CALLED OVER WHEN PATIENT WAS "GOING DOWN". I RAN OVER AND NOTICED THE PATIENT PALE, COLD, WITH CLAMMY SKIN. HIS EYES WERE ROLLING INTO THE BACK OF HIS HEAD AND HE WAS BARELY RESPONDING TO HIS NAME. PATIENT'S MOM WAS CALLING HIS NAME AND I RAN TO GET THE BP CUFF. COULD NOT GET A PULSE OR BP ON PATIENT, CALLED 911. PATIENT WAS RESPONSIVE BUT BARELY. PATIENT RESTED, SITTING, WITH ARMS ON TOP OF A GARBAGE PAIL BECAUSE THE THOUGHT HE WAS GOING TO VOMIT. MOM TOLD US THIS HAS HAPPENED TO HIM IN THE PAST WITH OTHER VACCINES. HE HAS "VACCINE ANXIETY". THE PATIENT WAS TAKEN ON A GURNEY BY EMS, WAS AWAKE AND RESPONSIVE. EMS TOOK CARE OF HIM IN PARKING LOT IN AMBULANCE AND WE SAW PATIENT HEAD HOME IN CAR WITH MOM.

Aches and pains outside of arm 15 minutes afterwards. Subsided largely, but chills started and became more heightened after strenuous exercise later in the day. After 3 hours of sleep, awoke the next day with chest pain and difficulty moving. Heart rate (normally 60) spiked to 140 and could not see fit five seconds, had to call ambulance. Ambulance determined much of it was due to anxiety (multiple exams and significant work were due soon), and recommended medical supervision to ensure it did not escalate. Went to urgent care and was supervised until 1 pm, 24 hours after the vaccination, by which time symptoms had subsided

Patient reported feeling dizziness, his vision went black and he lost hearing within 5 minutes of receiving the vaccine. He was sweating and felt cold and tingling. Patient states the tingling started in his feet and worked its way up his entire body. Paramedics were called.

Adverse Events: Lack of muscle strength, thought capacity, sore eyes, sore left elbow. less coherent thoughts, headache, woken up from sleep. starting at 0230 all lasting approx. 6 hours. Treatment: 3x ibuprofen tablets taken approx 4 hours in. all events completely faded by 1000.

Pt was sitting in observation chair after his vaccination--a little slumped over and twitching as if he were having a seizure. He did not respond to me calling his name. Pt gained consciousness and was a little frightened, not understanding the situation or remembering where he was at. He felt a little better after some water. About 4 minutes later, he said he was losing his vision and seeing flashes of light. He was told to lie on the floor with his feet up. Within a few minutes, he said he was feeling a lot more like normal.

HPI This is a 19-year-old male that presents for complaint of witnessed seizure-like activity. He arrives by EMS. Patient is currently awake alert and oriented ×3. Today, he was out on the golf course with friends. It was a normal day and he returned home. When he got home, he was complaining of a headache to his mother. She gave him Motrin. Mother then heard a noise from the other room and found the patient on the floor unresponsive, displaying tonic-clonic activity, and eye rolling into the back of the head. This lasted for 4-5 minutes per mother. EMS arrived on scene he was postictal. Patient is never had this happen before. He denies any illicit substance, alcohol or medication use. Review of Systems Constitutional: Negative for chills, fatigue and fever. HENT: Negative for facial swelling and trouble swallowing. Respiratory: Negative for cough, shortness of breath and wheezing. Cardiovascular: Negative for chest pain and palpitations. Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting. Genitourinary: Negative for dysuria and frequency. Musculoskeletal: Negative for back pain and neck pain. Skin: Negative for rash and wound. Neurological: Positive for seizures and syncope. Negative for weakness, light-headedness and headaches. Psychiatric/Behavioral: Negative for confusion. The patient is not nervous/anxious.

Immediately following administration of the vaccine, the patient reported lightheadedness, tinnitus, and paresthesia of extremities. Patient experienced these symptoms within 15 seconds of vaccine administration. Symptoms persisted for approximately 15 minutes.

numbness/tingling in lower legs, fatigue, severe headache, eye pressure pain, nausea, hot/cold chills, low back and leg pain

SHORTLY AFTER VACCINATION WITHIN MONITORING TIME, PATIENT ASKED IF IT WAS NORMAL "NOT TO FEEL WELL" POST VACCINATION. PATIENT WAS LEANING ON A COUNTER AT THE TIME. THEIR EYES ROLLED BACK, I BROKE THEIR FALL AND GRABBED THEM. AFTER SITTING THE PATIENT CAME TO WITHIN A FEW SECONDS AND THE PATIENT HAD NO RECOLLECTION OF WHAT HAD HAPPENED DURING OR LEADING UP TO THEIR SYNCOPE. I APPLIED A COLD COMPRESS ON THE BACK OF THE PATIENT'S NECK AND THEY QUICKLY RECOVERED. THEY HAD NOT RECIEVED ANY RECENT VACCINATIONS BUT TO THEIR KNOWLEDGE NEVER EXPERIENCED SYNCOPE.

Patient was clammy, getting tunnel vision, and hearing was "tightening". Blood pressure was 101/56. this happened roughly 5 minutes after administration

After I administered the vaccine the patient's pupils became dilated right after I finished injecting vaccine. On my question whether he was doing ok he answered yes, then stood up and walked out of the immunization room. While walking he walked directly into the end cap of the aisle. I rushed to him and with another customer and his mom was able to handle to make him sit on a chair. I kept talking to him while tried to keep him alert waiting for EMT. Another customer turned out to be EMT healthcare professional so he was helping me to keep the patient alert as he was losing his conscience, and we tried by any means to prevent this to happen. I pour a cold water on the back of his neck and put on the fan. His pulse was slow as well as his blood pressure as his whole body became very pale and cold to touch. However, he was alert as he was able to answer questions of how old he was, what type of education he was about to get and at what location he was pursuing his career. So, it was sort of a "zombie" state of mind which scared me the most. I have been practicing as a Pharmacist for six years as well as immunize people according to NYS Department of Health authorization and I never ever saw such a reaction before.

I fainted while sitting in a chair about 3 minutes after receiving the dose. When I was woken up I was disoriented and had patchy vision as though due to low blood flow to my brain. I laid down on the floor with my feet in the air for several minutes to regain blood flow, then slowly got to my feet.

Patient received dose of vaccine. About 2 minutes later he started coughing. A minute later he started to hunch over in his chair. I went over to make sure if he fainted that he would not fall. He described numbing and tingling in both arms and face. He was having difficulty seeing complaining of seeing white. We took his Bp it was 116/70 and pulse of 63. Ge appeared pale and white. We called for ems, and by the time EMS arrived he was feeling better his color had returned in his face. Patient was able to walk and leave store under his own power and didn't need to be transported.

Patient expressed having anxiety to getting vaccines. A few minutes after administering the vaccine the patient reported feeling like he was going to faint. His vision got blurry and he stated that he couldn't see and that he was nauseous. He also said his hands were tingling. He sat in the pharmacy counseling room. He was given water and orange juice. After a few minutes he started to feel better. He called his mother to come and pick him up. He was in the store for about 40 minutes and his symptoms had resolved by the time he left.

PATIENT CAME IN WITH HIS MOTHER, I ADDRESSED ALL CONCERNS AND QUESTIONS REGARDING JANSSEN VACCINE AND ALLERGIES PATIENT HAD. MOTHER STATED THAT THEY DISCUSSED WITH PCP ABOUT ALLERGIES AND VACCINE OPTIONS, MOTHER STATED SHE HAS HIS EPIPEN ON THEM INCASE OF EMERGENCY. VACCINE WAS GIVEN TO PATIENT, HE SAT DOWN AND WITHIN 10 MINUTES OR SO PATIENT LOSS CONSCIOUSNESS, BEGAN DROOLING, AND COULD NOT BE WOKEN UP AFTER REPEATED ATTEMPTS. EPIPEN 0.3MG (IM) WAS ADMINISTERED TO THIGH AND PATIENT REGAINED CONSCIOUSNESS. 911 WAS CALLED AND PARAMEDICS ARRIVED WITH 5-10 MINUTES. PATIENT VOMITED TWICE, AND WAS SWEATING PROFUSELY. ONCE AWOKEN, HE WAS AWARE OF HIS SURROUNDINGS, WHO I WAS AND HIS MOTHER, APOLOGIZED FOR THE INCIDENT. MOTHER AND SON THEN LEFT WITH PARAMEDICS TO HOSPITAL.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt nearly fainted/passed out. Had some tunnel vision/nausea/loss of hearing. Recovered after water and sitting for 15 minutes. Had some numb/tingling hands/arms.

Night of 3/06/21 -headache -severe chills -high fever -body aches -fatigue Above symptoms disappeared on 3/09/21 3/09/21 -began tasting/smelling a very strange taste, almost like dog food, when eating most foods -taste either completely masked over the normal taste of the food or mixed with it -taste made it unbearable to eat certain foods that were my favorite foods before -foods that are affected -meats -flour based foods(tortillas, pancakes, cookies, etc.) -fried foods -foods that aren't affected -fruits -sweets/sugars -liquids(that I've tested such as tea, coffee, milk, water, flavored water, etc.) -this taste severely limits the foods that I can eat and is still present as of 3/16/21

Tired slight h/a 3 hrs post. Took nap, better. About 8 pm went to bed. Now, h/a severe, photophobia, wants to go to hospital, afraid. Fever of 100.8. Can?t lay down, get comfortable

Patient became lightheaded with blurred vision, pale, and nauseous within 5 minutes of administration of the vaccine. Called ambulence, EMT's performed vitals. Patient was given water to drink and refused transport to the hospital. Symptoms resolved between 30-45 minutes post vaccination.

Janssen COVID-19 Vaccine EUA 4/11/2021 1-3:30 AM: Chills, muscle spasms 4/12/2021 10 AM: Fever 4/12/2021 11:30 AM: Lightheadedness, muffled/impaired hearing, fainted

Experienced syncopal episode; ground level fall; PHN witnessed from vaccination station and provided assistance along with NP on-site. Recipient was lying on side and assisted to supine position; assessed skin pallor, bilateral hands cool to the touch; denied SOB, denied chest pain; no swelling noted; alert & conversing; stated "I can't hear from my right ear"; d/t fall skull examined and small raised area noted with no skin break. Spanish interpreter utilized.911 called. Denied any h/o of allergies or medical condition; remained alert until arrival of emergency responders. BP taken supine WNL; informed by responders hypotensive standing. Reported hearing returned back to normal. Recipient was taken to local ER for further evaluation. Patient returned to mobile vaccine site after discharge from ED to discuss vaccine and stated ER physician indicated episode was possibly d/t vaccine.

Fri 4/9/2021- Immediately upon receipt of vaccine, reported prickliness of soft palate and ?heaviness in throat?. Was observed for ~ one hour due to these symptoms q 10 assessments of vital signs, all of which remained normal at each measurement (100/60, o2 sat 97-99%, RR 12/min, HR 66). Provided with water to drink. Later that day (fri 4/9) ? c/o of headache, tiredness, chills, low gr temp (100.5). No resp c/o. no body aches. Sat- 4/10- slept most of day. Drank fluids (water, soup), nml urine. Began advil 400 mg bid-tid. When awake, c/o Persistent headache, Sun 4/11- c/o persistent headache, now with pain behind his eyes, and photophobia. No blurred vision. Denied sinus pain, nasal d/c or any visual changes. Applied cold spoons to his eyes with minimal relief. No sinus, nasal, or visual c/o. Continued motrin 200 mg po bid-tid. Mon 4/12- vaccine symptoms abating, eating normally, still tired and with HA (unchanged) and eye pain (unchanged). Noted eye worse when looking t upper and lower extreme corners of visual fields. No sinus, nasal, or visual c/o, EOM intact but w/ pain when looking at superior and lateral fields (r&L). (said this optic complaint was true all along, but only at this point was able to describe it). Tues 4/13- Because of the unusualness of complaint and the "J&J Pause", patient given given 1 adult aspirin & evaluated by (optometrist). Exam (including dilation) Nml optometric exam ( normal visual fields, visual acuity, color vision, eye pressures (14 bilateral); normal range of extra ocular movements, though pain reproduced at the extreme corners of the visual field; normal vessels and discs; NO evidence of optic neuritis)

The most severe headache I had ever experienced, as well as pain when I move my eyes around, lastly pain in the injection site for 4 days since

Patient was given vaccine and was told to wait in the monitoring area for 15 minutes post vaccination. Shortly after, the patient reported "feeling pale" and was told to remain seated. The patient then fell over from the chair and lost consciousness. We immediately called 911 and went to the patient's side with epinephrine. However, he recovered within seconds and was able to sit up and drink water. He reported feeling "pale [...], weird [...]" and said he felt like his "ears are sweating." He did not want epinephine and remained seated and responsive. When asked, he said he had never received any adverse reactions to any vaccines in the past. A pharmacist then cleaned and disinfected his right temple that was bleeding, which he seemed to have hit when he fell. He later reported feeling chest pain and slight difficulty breathing but did not want epinephrine at that time. Emergency services arrived about 20 minutes after and assessed the patient and removed him in a gurney.

PT presents with global headache that awoke PT from sleep with sensation of pressure behind eyes bilaterally. denies visual changes. reports receiving JJ vaccine 10am.

pt presents to the ED for "cold sweats, fever, headaches and soreness, and eye pain" that began yesterday after receiving the J&J COVID vaccine, has not attempted to take tylenol or motrin for fever and headaches

Apx 10 minutes after vaccine administration, Patient became non-responsive, his eyes rolled back in his head, and appeared tonic. His mother said this has never happened to him before. When he recovered he was disorientated and complained of blurred vision. He later said he thought he fell asleep. It is unknown if this is related to the vaccine. We took his pulse (apx 50 bpm) and gave him water. We called 911 and the paramedics evaluated him in the ambulance.

Syncope - patient experienced lightheadedness, sweating, paleness, blurred vision and cold extremities. I reassure patient that he will be okay and this is the body's response to pain/anxiety. I also provided patient with water and make sure he was seated so he does not fall. His vision return to normal after 5 minutes or so and he started recovering within 15 minutes.

Syncope reaction - IMMEDIATE REACTION. DROP IN BLOOD PRESSURE, FAINTNESS, PROFUSE SWEATING, BLURRED VISION, COLOR DRAINED FROM FACE, NEVER LOST CONSCIOUSNESS. WAS UNABLE TO GET BP DUE TO SMALL SIZE OF HIS ARMS. I HAD TROUBLE LOCATING THE PEDIATRIC CUFF. WHEN EMS ARRIVED THEY TOOK BP AND IT WAS 58/40. EMTS HUNG FLUIDS AND TOOK PT TO EMERGENCY DEPARTMENT. Pt called pharmacy at 8:30p reporting leaving emergency department feeling fine after fluids administered.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient nodded off into a faint when I went to get him a snack, he remained in his chair but dropped his water. Patient said he was feeling sweaty and seeing black. He rested with head down & on the floor. Had some water and a snack. Side effects lasted 5-6 min, patient remained in pharmacy for an additional 15 min without any further events.

Following vaccine administration, pt claimed to feel a little "dizzy." had him lie down on the floor. he refused a yoga mat. mother requested to put some paper towel that was wet to cool his forhead. patient was very communicative and cognizant the entire time. had his feet elevated. observed him for 20 minutes. Checked pulse and it was 75. After sitting for approximately 15 minutes, he was able to sit up without problem. He was not dizzy and I observed no restriction in movement to indicate hypotension. While laying down he stated the inside of his mouth felt tingly which happens when he is nervous. At about the 15m mark, patient was able to drink fluids (mother purchased a drink from cafe) and felt immediately better. Prior to administration, hestated that he has never had a vaccine reaction. He did state following injection that he felt the needle. He tensed his arm muscle as I was about to vaccinate. He said he felt the needle which made him feel a little nervous. I asked to observe him for another 15 minutes, but mother wanted to take him home. Offered to get him a scooter, but patient and mother refused. Techincian offered to walk him to the door to make sure he was safe and had no issues walking while mother brought car around. He was under constant observation.

Pt got lightheaded and dizzy 30 to 60 seconds after getting immunization. Blurred vision, pale, nausea. Had stay seated leaning back and gave OJ and water, observed for about 30 minutes. Pt walked away after rest and fluids.

3:30 pm Received the vaccine 3:40 pm Lost vision, gained a loud ringing in the ears, hands went numb, and passed out for over a minute 3:45 pm Vision was regained, hands were still numb and I could not hear due to the loud ringing in the ears 3:55 pm All Symptoms subsided, went to urgent care and I checked out

20 year old, male patient came in for his appointment for Janssen COVID vaccine. Patient filled out the vaccine questionnaire, and we discussed patient questions and common side effects. Patient did not state any adverse reaction to previous vaccine or fainting history on the vaccine questionnaire. Patient was given vaccine in left arm. Shortly after receiving vaccine, patient states, "uh-oh it's happening again." I asked patient what was happening and he stated, "this happened to me when I got a blood draw. I fainted." I told patient to take some deep breaths, patient started to stare off to the ceiling and his pupils were dilated and his head fell back in the chair towards the ceiling. His legs body became stiff and he lost consciousness in the chair. I called for help and she came to assist me in the immunization room. I ran to get him a water while the pharmacy called for 911. He regained consciousness quickly, within a minute. Emergency response came quickly and attended to him and took his blood pressure and vitals. He was able to drink water and respond to all questions. He refused to be taken to the hospital and did not think he needed any additional medical attention. He was advised to follow up with his primary care physician. He was advised to sit and stay and get a ride home, which he did. An incident report and VAERS report will be reported today.

LETHARGIC; FELT PAIN IN HIS ARM INSTANTLY; HEADACHE; PAIN BEHIND EYES WHEN LOOKING LEFT AND RIGHT/STRAIGHT; This spontaneous report received from a parent concerned a 20 year old male. 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: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced pain behind eyes when looking left and right/straight. On 02-JUL-2021, the subject experienced felt pain in his arm instantly. On 02-JUL-2021, the subject experienced headache. On 03-JUL-2021, the subject experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, and felt pain in his arm instantly on JUL-2021, and headache on 04-JUL-2021, and had not recovered from pain behind eyes when looking left and right/straight. This report was non-serious. This case, from the same reporter is linked.

Patient came to counter approximately 5 minutes after receiving vaccine stating he felt like he may pass out. He was instructed to have a seat in the waiting room and the pharmacist was notified. Pharmacist immediately went to the waiting room to check on the patient and observed the patient drop his paperwork and lean back in the chair and his eyes rolled back. Within 30 seconds he sat up and began talking to me. He was able to tell me about feeling light headed and sitting down. We gave him water and he immediately began to feel better. He stayed in the store with supervision for approximately one hour before going home.

Patient reported feeling near syncope and sat down in his vehicle at 09:17. Patient had previously had Janssen COVID-19 vaccination on his right deltoid via intramuscular injection at 09:11. Patient was found awake, alert and oriented to person, time, place and event however was sluggish in response. Patient was observed pale, skin was dry to touch. Vital signs were obtained and patient was monitored every 5 minutes during incident. Patient reported progressively feeling better during interaction however patient stated that initially he experienced dizziness, a ?white-out, like a flash bang? to his vision, and feeling of near syncope. Patient stated not having any food intake that morning and to have previously used marijuana over night. Patient was offered EMS services on his behalf but patient stated he felt better after 15 minutes of monitoring and was well enough to drive home on his own. Patient was educated to stay hydrated and to have meals to compensate for his incident and informed to call 911 if his condition worsen or continued.

Patient got Janssen vaccinc , 5 minutes later his sister told us he was getting head ache ..got him water , headache he stated was getting worse throbbing pain, gave ice pack. as he was drinking bottle water , pt started leaning over as if sick, noticed blood coming from right nasal and he was actually about to pass out.got him sitting up while sister sat with him on phone with mother. Called 911 .pt was soaked with perspiration.He told EMT his vision was blurry but slowly coming back. After EMT assessed him he was starting to feel better and started walking and his oxygen was back up. Mom met with EMT later.

When injected, felt the burn of the vaccine. A few minutes later started sweating, dizzy, blurred vision, ears ringing and sound start fading.

flu symptoms. Pt received Covid J&J vaccine at 0920. At 2100ish stared to have ha/blurry vision/body aches, cough, chills, nausea. History: pt received J&J COVID-19 vaccine this morning and after 2100 or so tonight, pt developed body ache, nausea, non-thunderclap headache, and cough, here for eval. Denies any symptoms prior to vaccination and went to the area once over the weekend in the past 2 weeks and no recent travel/COVID-19 hotspot visit, no sick contact, and denies also ear pain, sore throat, runny nose, SOB, focal abdominal pain, vomit/diarrhea, rash, prior co-morbidities, use of any meds.

Following administration of vaccine client complained of blurry vision, a heavy arm and that he felt his heart rate was pounding out of his chest. EMS and Dr on site. Pulse 58, Blood pressure 104/65 and 100% 02 saturation. Client was reclined in his car seat until he started feeling better. He reported reactions to previous vaccines but no elaboration. Released by Dr and advised to seek medical attention later if needed. Client verbalized understanding.

headaches that have stayed for more than 12 hours, fainted at pharmacy minutes after receiving vaccine, blurry vision for around 8 minutes, dehydrated before fainting, a little difficulty breathing

Adverse event(s): Hives/red swollen skin(arms, legs, abdomen, back), fever, swelling of lips, fast heartbeat, high blood pressure, dizziness, weakness, headache Treatment: Prescribed Medrol (Pak) 4mg tablets, OTC antihistamine Zyrtec daily x 2 weeks, Benadryl at night Outcome: N/A. side effects have been reduced, occasional flare of hives.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Syncope, light head, blurry vision.

5 minutes post vaccination client had vision changes, lightheadedness, mild nausea, sweating. Symptoms resolved after 10 minutes. Client's treatment was elevating legs, applying cold packs to neck and staying close to client and not allowing client to leave until he was 100% normal per client's report of normal.

About 10 min following vaccination, patient's father yelled for help. Patient was sitting on a chair and pale looking. He said his vision turned black, felt dizzy. His breathing was normal, but blood pressure dropped. During the 2 min observation time, his breathing was fast at some point. He said he wasn't nauseous. He asked for water. I gave him some warm water. He finished the whole cup of 6 oz of water. We continued to monitor his blood pressure every 2-3 min. His blood pressure was going up every time we checked. He continued to ask for water, and he drank another cup of warm water. After about 10 min, he felt better and able to walk without dizziness.

1. Vasovagal syncope almost immediately after vaccination, little to no warning of oncoming syncope 2. Extremely fast acting fever (temperature went from 98.6 to 100.5 in roughly 30 minutes) followed by nausea, pounding headache, and body aches/chills. Remedied by alternating very high doses of ibuprofen (800mg) and acetaminophen (1000mg or 1g) every two to three hours. This did not ever bring down the fever below 100 degrees. 3. Blurred vision around 29 hours after vaccine - advised to go to ER by triage nurse. ER doctor determined not to worry about, likely due to headache but not 100% sure.

With in 5 minutes, Patient went from usual reddish complexion to pale, white. Complained of extreme dizziness, and that his sight was ?fuzzy?. Remained this way for approximately 10 minutes. Had him remain sitting and place head between knees. After 15 minute observation, he had regained some color, was able to stand, and left the pharmacy. He has a very sore arm today(4/10/2021), stated he is tired and feels feverish.

Minutes after receiving the vaccine, the patient started feeling dizzy and had blurred vision. He also started vomiting after drinking water. The patient recovered quickly after the arrival of the EMS and didn't require any medical assistance.

My head collapsed in on itself. I could not see, move, or think. I was more incapacitated than I have ever been in my life. I believe I nearly blacked out. This lasted for about two minutes, then slowly cleared up.

Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: patient experienced temporary blindness, sweating ,syncope- which is ultimately why we call the ambulance

4/8/21: Vaccine Received - 6:oopm By 9:00pm, patient begins suffering from intense headache, hearing loss in both ears, and blurred vision. For the ears, it was as if someone had taken ear plugs and coated the ear drum with them, making it hard to hear. Headache was treated with an ice pack on the temple for immediate site relief. Began to feel tired and worn out while in bed, loss of vision begins to occur as well. Body aches begin. 4/9/21: Patient is woken up from intense body spams throughout the entire body. Once awake, the entire body was spasming, causing the patient to be unable to control his body, and all extremities. After sipping some water for about an hour, the spasms subsided in all areas of the body except for the legs and shoulders. 4:00pm patient begins to feel extremely nauseous, begins having increased bowel movements including rapid diarrhea, and extreme stomach cramping. Deep body aches and pain continue. 4/10/21: 10am: patients body begins to become covered in hives all across his skin, inside his mouth, under his feet, and in his hair. Hives continued to grow, with no reddening of the skin however. This was treated with Benadryl for the remainder of the day; hives subsiding around 6:15pm. Dehydration also occurred, and hospital treatment for IV saline bag was soon to be utilized had the patient not been able to rehydrate himself. Body aches continue

Eye Muscle strain when moving eyes to look in any direction (up/down, left/right). No strain when looking straight. Lasted for roughly 4-5 days from day after injection, worst on first 3 days

The adverse events that occurred after this vaccination include the following: Severe headache, vision issues (i.e., loss of clarity, focus), muscle aches/cramps, chills, stomach/abdominal discomfort, upset stomach, loss of taste, loss of smell, sore throat, swelling of lymph nodes (underarms, groin region, and behind the ears), tiredness / loss of energy, and nasal congestion. The most adverse event, a headache, led to some dizziness, loss of clarity/focus (vision), and pain behind the eyes. The only treatment taken to lessen the severity of these events were acetaminophen and ibuprofen. The adverse events still occurring today are (as of now 04/14) include: stomach discomfort, muscle aches/pains, and discomfort under the arms (armpit area) near lymph nodes.

HEAD HURTS; FIRE SHOT DOWN ARM TO ELBOW WHEN RECEIVED THE VACCINE; SORE AND ACHY FEELING/ SORENESS EVERYWHERE; FEELS LIKE CRAP; SENSITIVE TO LIGHT; FEVER OF 102.5; This spontaneous report received from a parent concerned a 21 year old male. 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: 201A2119 or 201A211A) dose was not reported, administered on 08-APR-2021 10:50 on right arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced sore and achy feeling/ soreness everywhere. On 08-APR-2021, the subject experienced feels like crap. On 08-APR-2021, the subject experienced sensitive to light. On 08-APR-2021, the subject experienced fever of 102.5. On 08-APR-2021, the subject experienced fire shot down arm to elbow when received the vaccine. Laboratory data included: Body temperature (NR: not provided) 102.5 F. On 08-APR-2021 17:30, the subject experienced head hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fire shot down arm to elbow when received the vaccine, was recovering from fever of 102.5, and sensitive to light, and had not recovered from sore and achy feeling/ soreness everywhere, feels like crap, and head hurts. This report was non-serious.

-Fatigue, headache, fever, dizziness, burning sensation in head 4/9/2021 ~2AM-6PM -Fatigue 4/9/2021-4/20/21 -Fatigue, dizziness, fever, headache, dry eyes, shortness of breath 4/17/2021 5PM-12AM -Heart palpitations, fatigue, dizziness, fever, headache, dry eyes, shortness of breath 4/18/2021 3PM-4/19/2021 12AM (was hospitalized) -Resting heart-rate upon arrival to hospital was ~105

RESTLESS; LACK OF SLEEP; LACK OF MOTIVATION; FELT ROSY IN THE CHEEKS; FELT HOT; FEVER; BODY ACHES; DIZZINESS; WEAKNESS; INJECTION SITE PAIN; EXTREMELY FATIGUE AND TIRED, FELT REALLY WORN DOWN; FELT OFF; SENSITIVITY TO LIGHT; SENSITIVE TO SYMPTOMS OF A SEIZURE ONSET; CRAMPING STYLE PAIN THAT TRAVELLED UP AND INTO THE SHOULDER AND UP INTO THE NECK MUSCLE INTO THE BASE OF SKULL WRAPPING AROUND HEAD CAUSING A MIGRAINE; HARD AND HOT TO THE TOUCH GOLF BALL SIZES LUMP SLIGHTLY PROTRUDING; DISORIENTED; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included epileptic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 10-APR-2021, the subject experienced sensitive to symptoms of a seizure onset. On 10-APR-2021, the subject experienced cramping style pain that travelled up and into the shoulder and up into the neck muscle into the base of skull wrapping around head causing a migraine. On 10-APR-2021, the subject experienced hard and hot to the touch golf ball sizes lump slightly protruding. On 10-APR-2021, the subject experienced disoriented. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced felt off. On 10-APR-2021, the subject experienced sensitivity to light. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced extremely fatigue and tired, felt really worn down. On 11-APR-2021, the subject experienced felt hot. On 11-APR-2021, the subject experienced restless. On 11-APR-2021, the subject experienced lack of sleep. On 11-APR-2021, the subject experienced lack of motivation. On 11-APR-2021, the subject experienced felt rosy in the cheeks. On 11-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, weakness, disoriented, fever, felt hot, felt off, sensitivity to light, and felt rosy in the cheeks, and had not recovered from injection site pain, cramping style pain that travelled up and into the shoulder and up into the neck muscle into the base of skull wrapping around head causing a migraine, extremely fatigue and tired, felt really worn down, body aches, restless, lack of sleep, lack of motivation, sensitive to symptoms of a seizure onset, and hard and hot to the touch golf ball sizes lump slightly protruding. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.

after pt got janssen vaccine he suffer blurred vision, ear ringing, light headache, vomiting, dizziness and sweating for short time

Patient got vaccine and sat down. He felt tired, his vision and hearing was impaired, and his skin turned white. He was still talking to us and somewhat alert but felt very tired and lightheaded. After continuing to talk to him for about 5 minutes, he started feeling better and his skin color recovered. He was able to drink water and his senses came back. He kept sitting and staff member watched him longer till he was able to get up .

Vaccine administered 4/11/21. Patient developed loss of smell 4/23/21. Has improved since that time but has not completely resolved.

After receiving vaccine and during monitoring period, patient walked up to check out table and fall witnessed by RN at 16:25. Patient unconscious for 10 seconds, later reported feeling dizzy and having blurred vision prior to fall. Denied any other symptoms once conscious. Initial vitals obtained: BP 100/50, Pulse 80, O2 Sat 97%. Patient alert and oriented. Given gatorade and remained lying down. EMS called and arrived to scene to assess patient. Patient denied transfer to hospital, monitored for additional 30 minutes at vaccine site. Additional set of vitals obtained prior to patient exiting facility: BP 118/84, Pulse 75, O2 Sat 99%.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Got shot 2:09pm pt had vision loss, sweating, low bp after recieving shot. 1st bp: 120/50 pulse 51 at 2:23pm, 2nd bp: 97/56 pulse 52 at 2:34pm, 3rd bp:97/47 pulse 54 at 2:48pm. advised pt to not drivr had friend leave with him at 2:50pm

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient had a history of seizures from 2012-2015 but is no longer on medication of any sort. About 5-7 min after vaccine was given he had seizure like activity. He had cold sweats, low blood pressure, and was very pale. He complained of dizziness, nausea, tingling in hands, and blurred vision. 911 was called and he left with EMT

patient was in the observation area when his family told us that the felt dizzy. i got to his side and asked if he was doing ok but did not get a response. he was sitting on a chair with eye opened but not responding. so we called 911. then a few seconds later , he said i could hear you but was not able to see. then he said he felt hot so we gave him some water. Now dispatcher on the phone told us no water and have him lay on the floor. by now he had started to feel a lot better. then the parametic team came and took over . His vitals, blood sugar and EKG were all normal. then patient was offered to go to hospital for evaluation but he refused

patient received vaccine , looked at his arm , and started to freeze up, almost passing out , eyes rolled back and we got him to the floor and he came around saying he could move his arms (both) and his fingers were seizing up, we got ice packs, hewas clammy, but breathing fine , and hew was speaking and complaining about his inability to move. no issues breathing , we called 911

PAIN IN THE REAR OF THE RIGHT RIB CAGE; SHARP PAIN; SORE THROAT; NAUSEA; LIGHT RINGING ON THE RIGHT EAR; LEFT EYE DRYNESS; SLIGHT NECK STIFFNESS; BOTH EYES SENSITIVITY TO LIGHT; LEFT EYE IRRITATION; SLIGHT PRESSURE-LIKE FEELING ON THE NECK; SLIGHT PRESSURE-LIKE FEELING ON THE CHEST; DROWSINESS; HOT FLASH ON CHEST AND NECK; TOP LEFT OF THE ARM (AND SHOULDER AREA) FELT LIGHTLY NUMB; DIARRHEA; NERVOUSNESS; ANXIETY; SLIGHT LEFT SIDED CHEST PAIN; VERY SORE ARMS; LOSS OF APPETITE; ARMS AND LEGS FELT HOT TO THE TOUCH; HANDS WERE CLAMMY; SHORTNESS OF BREATH (UPON ACTIVITY - BUT WHENEVER LYING DOWN OR SITTING, THERE IS NO SHORTNESS OF BREATH); SMALL "HIVES" APPEARED ON HIS BODY; UPSET STOMACH; STOMACH PAIN; LIGHT HEADEDNESS; FATIGUE; HEADACHE; FEVER; CHILLS; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A - VHC 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 trouble sleeping. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.4 deg. On 12-APR-2021, the subject experienced light headedness. On 12-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced upset stomach. On 13-APR-2021, the subject experienced stomach pain. On 16-APR-2021, the subject experienced small "hives" appeared on his body. On 18-APR-2021, the subject experienced shortness of breath (upon activity - but whenever lying down or sitting, there is no shortness of breath). Treatment medications included: dexamethasone, and diphenhydramine hydrochloride. On 19-APR-2021, the subject experienced arms and legs felt hot to the touch. On 19-APR-2021, the subject experienced hands were clammy. On 19-APR-2021, the subject experienced loss of appetite. Laboratory data included: Body temperature (NR: not provided) negative for fever. Treatment medications included: paracetamol. On 20-APR-2021, the subject experienced very sore arms. On 21-APR-2021, the subject experienced anxiety. On 21-APR-2021, the subject experienced slight left sided chest pain. Laboratory data included: Blood test (NR: not provided) no abnormality, Chest X-ray (NR: not provided) no abnormality, and EKG (NR: not provided) no abnormality. On 22-APR-2021, the subject experienced top left of the arm (and shoulder area) felt lightly numb. On 22-APR-2021, the subject experienced diarrhea. On 22-APR-2021, the subject experienced nervousness. On 23-APR-2021, the subject experienced hot flash on chest and neck. On 26-APR-2021, the subject experienced drowsiness. On 28-APR-2021, Laboratory data included: Body temperature (NR: not provided) no fever. On 01-MAY-2021, the subject experienced slight pressure-like feeling on the neck. On 01-MAY-2021, the subject experienced slight pressure-like feeling on the chest. On 03-MAY-2021, the subject experienced left eye irritation. On 04-MAY-2021, the subject experienced both eyes sensitivity to light. On 08-MAY-2021, the subject experienced slight neck stiffness. On 09-MAY-2021, the subject experienced left eye dryness. On 14-MAY-2021, the subject experienced light ringing on the right ear. On 15-MAY-2021, the subject experienced sore throat. On 15-MAY-2021, the subject experienced nausea. On 16-MAY-2021, treatment medications included: ibuprofen. On 17-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. On 18-MAY-2021, the subject experienced pain in the rear of the right rib cage; sharp pain. On 19-MAY-2021, treatment medications included: azelastine hydrochloride, cetirizine hydrochloride, and methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 12-APR-2021, headache on 18-MAY-2021, and nausea on MAY-2021, was recovering from loss of appetite, very sore arms, diarrhea, and sore throat, had not recovered from upset stomach, fatigue, light headedness, small "hives" appeared on his body, arms and legs felt hot to the touch, stomach pain, top left of the arm (and shoulder area) felt lightly numb, hot flash on chest and neck, slight pressure-like feeling on the neck, left eye dryness, both eyes sensitivity to light, nervousness, anxiety, light ringing on the right ear, slight pressure-like feeling on the chest, and left eye irritation, and the outcome of shortness of breath (upon activity - but whenever lying down or sitting, there is no shortness of breath), hands were clammy, pain in the rear of the right rib cage; sharp pain, trouble sleeping, slight left sided chest pain, drowsiness and slight neck stiffness was not reported. This report was non-serious.

Patient received Janssen COVID19 vaccine (LOT#201A21A) in his left arm at approximately 14:43 on 5/25/21. During the 15 minute observation period, he expressed "I don't feel well" and endorsed dizziness/ lightheadedness, slight tingling feeling in fingers, and nausea. Shortly thereafter at approximately 14:50, he started to slouch and appeared faint while sitting in a chair with eyes closed. He did not fall or hit any part of his body. He was easily aroused with a touch on his arm and responded to verbal questions immediately. He denied trouble breathing, chest pain, palpitations, headache, muscle weakness, vision changes, skin reactions, swelling. He was oriented x3 and not exhibiting verbal or swallowing problems. His vitals were normal- HR 80 bpm and BP 105/80 mmHg. He was offered a receptacle to vomit in if needed; however, he did not vomit. This initial reaction was consistent with potential vasovagal reaction/ near-syncope after vaccination. Patient was encouraged and instructed to sit on the floor to prevent injury in case of fall but he refused. Staff offered him water, a fan, and opened windows while monitoring. Later while waiting for a ride at around 15:10, he endorsed headache (first above his eyes and then toward the back of his head) and clarified this did not feel like a typical migraine that he has had before. Then at around 15:20 he endorsed vision changes in his right eye- he could not see a portion of vision out of that eye except peripheral vision and described not being able to see writing on the right side of a whiteboard in front of him in the room. Later he described a resolution of that gap in vision but then had blurry vision out of that eye. He denied any vision changes in the left eye. Due to alarming symptoms of vision changes and onset of headache, patient was recommended to go to ER for further observation and evaluation. He was not in urgent distress and patient did not wish for EMS to be called but agreed to go to ER when his emergency contact picked him up. Patient's emergency contact came to pick up patient at approximately 15:40 and was recommended to take him to the ER. Patient and emergency contact were amenable to this plan. He was able to stand up and walk to the car without issues.

c/o no appetite,nausea,fatigue, weak, cold sweat, epigstric pain, redness on both eyes with visual change sicne 21May2021(s/p J&J Vaccination).

Patient developed painful blurry vision in left eye that progressed to painless blurry vision in same eye within 24 hours after onset of symptoms. Patient had edematous and pale retina with swollen optic cup. Patient has had complete vision loss in his left eye since.

Patient went to wait outside after 15 minute observation period. Came back inside at 1500 for family member. 1505 Started complaining of itchy throat, forehead, dry mouth/throat while sitting in observation. Nurse practitioner was called at 1507 and assessed patient. EMT was called at 1510. First set of vitals sitting position 136/93 99% O2 82 HR RR16. 1515 vitals 119/83 98% O2 HR 85 RR 16. 1515 NP performed physical assessment. NP instructed patient to open mouth and stick out tongue to assess throat. No signs of anaphylactic shock noted. Checked integumentary system for rashes. None noted. Provider does not believe allergy is related to vaccine. 1516 Patient feels dry mouth and throat has subsided. Patient continued to be monitored for 15 minutes. 1530 NP reassessed patient. NP instructed patient to open mouth and stick out tongue to assess throat. No signs of anaphylactic shock noted. NP cleared patient to go home. Patient left with family members.

RN to J&J vaccine about 3-5 min after delivery. Assuming Vasovagal response. His brother reports that patient was sitting there and his eyes rolled back in his head and he fell off his chair and hit his head/right eye. Employee got out there and he was a bit combative and saying "whats going on, whats going on". I asked him to sit down and employee called 911. We put pressure on his eye area to stop the bleeding. He was sweating, shakey, pale, and nauseous. Paramedics arrived quickly and eventually took him away on a strecher. Update: mom came back a couple of hours later to thank us and let us know that he is home and resting. He did get 3 stiches by his eye and the reason they took him via strecher was because his blood pressure was staying so low while they were here.

Patient was given a Janssen Covid 19 shot on 7/5/21 around noon. After the shot we talked about different side affects and he had a few questions about adverse reactions. I had him sit down for 15 minutes while I finished his paperwork. As i was walking back from the immunization room toward the pharmacy I saw him drop his phone and he fell to the ground. I tried to reach for him but was not close enough to break his fall. I saw his eye roll back and his face turn very red. He was breathing very fast and loud. He regained consciousness and I told him 911 way on the way and to please try to relax his breathing. His brother was with me the whole time talking to him and reassuring that everything was ok. The paramedics came and hooked up a monitor. They were asking all sorts of questions to everyone in the area. I went back into the pharmacy and he walked out to the ambulance with his family and was taken to the hospital.

Hives breakout all over face and arms - I've been taking Benadryl but still present, swelling on eyelids so I could barely open eyes - Been taking benadryl, Fever of 105.3 degrees - Been taking tylenol for 2 days but still have fever, Sore arm and body aches, Overall weakness feeling

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Near fainting episode. Pt did not lose consciousness but blacked out (visual disturbances, tinnitus/temporary hearing loss, nausea) occurred within 2-3 minutes of administration. First attempt to read BP was low (~80/60). Pt is an athlete, so I waited until after water was consumed to take BP again. 2nd reading was ~106/65. Pt felt better after drinking water and after sitting for 15 minutes under observation.

ringing in the ears, nausea, numbness in extremities BP: 124/62 HR: 70 Sp02: 98% Seen and cleared by EMS

Patient experienced nausea, vomiting, puffy eyes, itchy eyes, fever, chills, and abdominal pain. Patient was treated with Benadryl and Odansetron 8mg. Patient symptoms have sense stabilized and progressively resolving.

I got the injection then went and sat down in a chair at the back of the room and started getting light-headed about 3 minutes after I sat down, so I called a nurse over. Then the inside of my chest started getting really hot and my vision started going white in both of my eyes, it took about 10 seconds for me to completely lose vision. Then I passed out, I have no idea how long I was out for but when I came too I had a sort of epileptic-type seizure but I do not know how long it lasted. I woke up completely disoriented, had no idea where I was at and had a severe cognitive dysfunction. I still have moments where I just can't follow or complete a thought or just kind of go blank.

Janssen COVID-19 Vaccine EUA Soreness immediately after injection. Chills, dizziness, ringing in ears, nausea lasting from about 9pm to 3am.

Onset lower lip swelling 14 hours after vaccine. Urticarial rash 18 hours after vaccine. No respiratory associated S&S. Treated with Allegra and Zytrec with improved S&S. Also had fever 100.5 with HA, myalgia and fatigue.

It started with extreme fatigue and an extreme headache. The headache caused patient to have an extreme light tolerance causing them to wear sunglasses indoors with the shades drawn three hours after injection. As time progressed the patient began to become nauseous and contract a bone shaking chill. By 5 P.m. the patient was dry heaving and having trouble consuming liquid and solids then around 8:30 the patient vomited for 10 minutes. After that the next day the patients headache continued and they were extreme weak and fatigued.

At around 7PM the day of the J&J vaccine, I began to feel very fatigued and could tell that I was going to come down with a fever. I went to bed early that day around 10PM. Woke up around 1:30AM on the 4th. Felt terrible and took my temperature. It read 101.5. Got up to use restroom and when washing hands, everything started to go blurry, I thought i had just become lightheaded and that it would pass so i stood there leaning against the bathroom door.I ended up fainting and hitting my head on the cabinets. I was completely soaked in sweat. An hour later we drove to the ER to make sure everything as okay. IV was started, some test performed, and fever was gone by 5AM. Felt completely fine after going home and resting for a few hours.

The patient (self) felt a soreness around the site of the injection begin immediately and grow throughout the day. The soreness continued to at least April 12 (at the time of this report). The soreness was immediate unlike a tetanus shot but the pain the following days was 2-3 times less that of a tetanus shot. By 4pm the same day, the patient felt fatigue and tired and had difficulty staying awake. Around 6pm the patient took 200 mg of ibuprofen by mouth because of a strong headache. At 7pm the patient was experiencing the following: headache, warm head to the touch, shivering/shaking, fatigue, mild aching. The patients pulse was consistent 100-104 bpm. The patients temperature at 8:30pm was 100.4 F. The patient then went to bed at 9pm. Patient had trouble falling asleep due to fever, shaking, aching. The patient slept intermittently until midnight. At midnight, the patient noticed the fever and shaking had ceased but the headache and aching were still strong. The aching was all over the body. The patients eyes hurt to move. The aching was constant and at times was throbbing. At 3am the patient could still not sleep well so he took 650 mg of Acetaminophen by mouth. The patient began to notice some relief approximately 30-60 min after. The patient fell asleep after the relief began and slept soundly til 9:15 am, April 11th. The patient awoke feeling much better. All side effects had stopped with the exception of a feeling of weakness and slight dizziness. The patient was able to carry on normally and took no more medications.

Patient called the pharmacy on Monday, 4/12 to report an adverse reaction through the night on Friday, April 9 into Saturday, April 10. Patient reported had been taking ibuprofen following administration of Janssen vaccine on Friday at 9 AM. On Friday evening, patient reported that body temperature began to rise, going as high as 102.5 degrees F. Patient reported going to bed, then awakening early Saturday morning with a feeling of shortness of breath, intense pain in his left side that he described as "knives" in his chest, numbness in hands and legs, as well as body aches. He stated his jaw was locked up and he had bit his tongue. Patient's father called 9-1-1, paramedics arrived and were able to stabilize the patient at home. Patient stated his BP was elevated, however HR and 02 saturation was within normal limits. Patient reported to pharmacy on Monday, 4/12 and stated symptoms have resolved other than mild fever.

I took a nap after around an hour of receiving my shot at around 1:40pm. Once I awoke at around 6pm, I had irritated eyes, extreme nausea, extreme dizziness, insatiably low body temperature, extreme shivers, migraine because of my head uncontrollably shaking, and dry mouth. I felt like I was in 20 degree weather and nothing I could do would heat my body up. My body grew so tired from the uncontrollable shaking that I could not get out of bed to get my phone to call 911. Every symptom I was experiencing was not mild and was to the level of extreme. This lasted until around 9am. I have been slowly recovering since then (currently almost 9pm) and feel only 70% back to normal.

Patient reports history of passing out with lab draws and one other time with injection. Within 30 seconds of vaccine, patient reported dizziness, narrrowed vision, and diaphoresis; he also appeared very pale. As we attempted to assist him to the floor, his eyes rolled back and he lost consciousness. Patient became alert within 10 seconds of losing consciousness. When safe, he was assisted to WC and taken to clinic where he was observed for a few hours. Patient discharged home with his mother when he was feeling better.

Headache beginning shorty after vaccination persisting rest of day. Intermittent headaches of greater severity on right/top right of head starting 42 hours after injection. Currently 75 hours post-injection and intermittent headaches persist. Moderate light/sound sensitivity.

Sores in mouth starting about 36 hours after the vaccine. Some sores lasted a few hours. Others, especially those towards the back of the throat have persisted and caused pain.

Patient was administered the Janssen COVID vaccine at 403 pm. I returned back to the pharmacy to prep his partner's vaccine and when I came back at 405 pm, he was loopy with his head swaying. He wasn't responding to verbal communication by his spouse and me nor through touch as I shook his shoulder. He then lost consciousness and so I lifted his head to check for breathing and pulse which he had. I asked my technician to call 911, and asked my other tech to help me transition him to the floor so we can raise his legs to provide blood flow to his head. Mid-transition, he had a seizure. We brought him completely to the floor and just as I was about to turn him to his side, he regained consciousness. Pupils were dilated, breathing normal, pulse elevated. He also was able to speak immediately and confirmed feeling "okay". I then had my technician remain outside with him laying on the ground as I returned back inside the pharmacy to call management and my technician was still on the phone with EMS. Paramedics and management arrived within 10 minutes upon which patient was then taken to the hospital. Wife followed and we rescheduled her vaccine.

Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: pt had tunnel vison and lost his vision for a split second, he could not remmember me asking if he was okay. I gave his benadryl and checked bp that was 95/65, Encoraged pt to drink water and got a sucker for him. He was clammy and seemed worried. His bp started coming up within 5 minutes and was 105/80. His bp was 120/80 in 5min later, asked pt to get a ride and his wife came and got him. It had happened to him one time giving blood. pt had chills and ackes last night and is fatigued

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: About 2 minutes after receiving the vaccine the patient was complaing about being hot (flushed) with sweating. Patient asked for a glass of water. When getting the patient water my technician said she saw the patients eyes roll to the back of his head and that he was going to pass out. I went out to the patient and helped him to the ground and had him lay flat on his back with his feet elevated. After 3-4 minutes the patient was feeling better. Patient never lost consciousness.

WITHIN 5 MINUTES OF ADMINISTERING VACCINE, PATIENT WAS SEATED AND COMPLAINED THAT HE COULD NOT BREATHE.. HE BEGAN TO PANIC AND BECAME INCREASINGLY ALARMED, CRYING AND WAS HOLDING ONTO HIS CHEST. HE WAS CONSCIOUS BUT DID NOT RESPOND TO ME WHEN I KEPT ASKING IF HE WAS OKAY. I CALLED 911 AND GRABBED THE EPI PEN IN ANTICIPATION OF ADMINISTERING IT. PATIENT WAS DROWSY, CLOSING EYES AND SUDDENLY OPENING THEM. NO SIGNS OF BLUE LIPS. WHEN PARAMEDICS ARRIVED, IT LOOKED LIKE PATIENT'S BOTTOM LIP STARTED SAGGING TO RIGHT SIDE AND WAS SWOLLEN. PATIENT WAS TAKEN TO LOCAL ER AND WAS GIVEN EPI AND BENADRYL IN ER DEPARTMENT.

Patient received the vaccine and proceeded to walk to the front of the store. He describes the experience as his ears stopped hearing and he fell to his knees (passed out). Patient did not report that he had been hurt in any way. He came back to the pharmacy where we had him sit with his legs up. He already had a bottle of water and was drinking. Patient's blood pressure was a bit elevated 139/104. He declined a second blood pressure check. He stayed waiting for approximately 15 minutes then felt well enough to leave.

pt started feeling dizzy and blurry vision a few minutes after vaccination. Dr observing instructed him to rest on the floor. BP low, felt cold hands. His BP increased and he stopped feeling dizzy/blurred vision a few minutes after laying on the floor w feet elevated on chair. Police detail called resucue team, but patient was feeling normal by the time paramedics arrived. Was able to stand up and sat under observation for several more minutes before leaving clinic.

AFTER PATIENT RECEIVED THE VACCINATION, HE SAT DOWN IN THE WAITING AREA. AFTER APPROXIMATELY 1 MINUTE THERE WAS A NOISE AND I NOTICED THAT HE WAS SLUMPED TO THE RIGHT SIDE AND STARTED TO CONVULSE. I RAN OUT TO THE PATIENT AND ENSURED THAT HE DID NOT FALL AND HELD HIM IN PLACE UNTIL HE STARTED TO COME TO. AFTER ABOUT 30 SECONDS THE PATIENT STARTED TO BECOME AWARE AND COULD HEAR ME TALKING BUT WAS STATING HE COULD NOT SEE. AFTER ABOUT 30 SECONDS HIS SIGHT RETURNED. DURING THE TIME THAT I WAS FIRST WITH THE PATIENT, THE STORE MANAGER CALLED 911 AND THE EMS WAS ON SITE AFTER APPROXIMATELY 5 MINUTES. I HAD THE CUSTOMER SIT DOWN AND GAVE HIM WATER UNTIL THE PARAMEDIC ARRIVED. THEY TOOK A HISTORY OF THE PATIENT AND AFTER A FEW MINUTES TOOK HIM BY AMBULANCE TO THE LOCAL HOSPITAL FOR ADDITIONAL OBSERVATION.

Started off with extreme fatigue the morning after the vaccine, then throbbing intense migraine started around 11 am that lasted until the next morning after which a dull headache lasting till Friday, 102.3 fever, EXTREMELY painful body aches, metallic taste in mouth, thirst that could not be quenched, dizziness, blurred vision, confusing, nausea.

pt mom reports on Tuesday morning. PT HAS FEVER, SWELLING OF LEGS, SHORTNESS OF BREATHE, NO BLOOD FLOW IN EXTREMETIES. PT REPORTS FEELING NUMBNESS IF EXTREMETIES. CANT SEE OUT OF HIS RIGHT EYE, REFERRED TO hospital.

Pt received Johnson & Johnson vaccine on 6/12 @11:03 at the Vaccination Site. Patient started walking to observation area, reported feeling dizzy, lost consciousness, was assisted to the ground by staff at 11:05. When awakened, patient reported right elbow pain, headache, and was found to have a small amount of bleeding from his right ear. No preceding chest pain/palpitations/dyspnea, seizure activity, nor focal weakness. He was transported to the ED via EMS for further evaluation. In the ED patient reported previous history of syncopal episode with preceding dizziness several years ago but did not seek further evaluation. No nausea/vomiting. Evaluation revealed decreased hearing, drainage from ear, and right elbow tenderness. CT of head demonstrated right temporo-parietal bone fracture extending to skull base with blood within right mastoid air cells. Elbow x-ray showed no obvious fracture with right elbow contusion diagnosed. Trauma and neurosurgery further evaluated patient and recommended non-operative management of right temporal skull fracture extending into the auditory canal with no evidence of intracranial bleed nor depression. Hospital consulted and prescribed Ciprodex drops for 1 week with follow-up audiogram in 6 weeks. Patient to follow-up in trauma clinic or with PCP in 2-3 weeks. If hearing still muffled at follow-up, ENT will be consulted. Patient was discharge later in the evening on 6/12/2021.

About 10 minutes after the vaccine, pt began to feel bad, vision went black, hearing was muffled/ringing, sweating and dizzy. Pts mom requested an ambulance. He drank a few sips of water and we put cool, damp cloths on his neck. We considered laying pt flat but he refused saying he was feeling better. His vision cleared, hearing returned , sweating stopped and by the time the fire department arrived he was just shaky. His vitals were all normal by then. He then said now that he thought about it, he flet like it was a panic attack and he almost passed out. i checked on pt again today and he stated that he is now fine.

Pt c/o sore throat, congested/stuffy nose, on/off slight sob while walking not severe not continuous and loss of taste. Pt concerned its due to possible s/e of covid 19 vaccine J&J that he got on 06/09/21 as all these sx started same day and not getting better still. Pt speech clear, comfortable. Also denies emergency sx at this time. Advised to monitor his sx . was scheduled to speak with urgent care provider for consultation.. Notified pt if any emergency sx arises call 911 or go to nearest ED.

patient received J & J vaccine at 1050 am patient was talking with nurse and suddenly stiffened his body with clenching fists curled upward to chest. He had bright red skin color, and could not speak. this lasted 10 seconds at most. Afterward the patient was sitting in chair had turned very pale and did not realize what had happened. one of the other nurses asked him if he knew where he was, he stated "In the Hospital", the nurse repeated that he was not in hospital, that he was at the health department getting a Covid shot. He stated "oh yeah.. I forgot," patient stated he was going to be sick, patient grabbed garbage can that was sitting next to him Patient was hooked up to oximetry, reading was 99% on RA, attempted Blood pressure 3 times but was unable to attain a reading, patient was holding garbage can tightly. patient had emesis 3x's that was clear in color, cold packs were placed on the nape of the neck and under armpit, patient was sweating and white in color. patient stated he had blurred vision, and noted that he was unconscious for approx. 25-30 seconds. 911 was called at 10:57. Nursing supervisor was notified at 10:58. Patient stated that he had nothing to eat today, and his mother stated that he had been anxious about getting the vaccine and that she made her son get it. Epinephrine was available but not given. no issues with breathing. EMS came in did a quick evaluation and transported patient to the hospital. Mother was with patient during the entire incident.

Day 2 after getting the vaccine I went to the hospital over headache, tinnitus, chest pain and breathing problems. The pain never went away but it slowly got worse over time. 5-6 weeks and I am severely suffering from chest pain and shortness of breath. Airways feels very tight. Went to the doctors and got perscribed prednisone and an inhaler. I've never needed or used an inhaler before. I've never had breathing problems other than nasal congestion during flu season. Neither the prednisone or the inhaler help at all. The prednisone and inhaler do not help the breathing even a tiny bit and this is after using them for all 5 days that they were perscribed. Breathing never feels satisfying. I am constantly breathing deep breaths through the mouth for air but it never feels like I'm getting enough air. Whether it be stress, allergic reactions, or exercise, I have never had breathing problems like this before and I have not done anything else that could have brought these problems on.

Id say approximately 60 seconds after administration of the vaccine, I started to become the most lightheaded I've ever felt, like I was really about to pass out. I felt a very extreme pins and needles feeling in both my hands and my feet, and my vision began to fade. After about 30 seconds of that and beginning to panic, I stood up and knocked on the doctors door and asked for water and told him how I was feeling. After about a few minutes of sitting and drinking Gatorade my vision returned fully and I began feeling stronger again. Since then I only feel a slight pain around the injection site.

10 min. after vaccine - small pang of soreness through left arm, went away after a couple of seconds 7:30 PM the same day - Grade 3 fever (102.9 degrees), intense chills, joint pain, minor headache, loss of taste and smell, coughing fits. Threw on lots of blankets, drank some water, and took two Tylenol pills. 10:30 PM the same day - while on Tylenol, fever dropped to 101.9. Kept taking Tylenol until I went to bed at around 1 AM. 9 AM on Sunday 3/7 - 101.2 w/out Tylenol, no chills or coughing, minor headache. Symptoms faded away over the course of the rest of the day. Back at 100% on Monday 3/8.

Janssen COVID-19 Vaccine EUA Headache, nausea, extreme exhaustion, muscle/body aches, fever, dizziness, sensitivity to light and sound (headache), skin sensitive to touch, loss of appetite. Vaccine was administered at 10:38 AM. Symptoms began 10:00 PM 3/10/21. The worst of it was 8 AM to 6 PM 3/11/21. Some lingering mild headaches until 3/13/21.

On 3/12/21 day of injection The patient got the Johnson & Johnson Covid vaccine this afternoon around 1400, after which he noted a red, itchy rash on his chest, back, and bilateral upper extremities. He also notes a dry mouth and mild throat swelling, but denies shortness of breath, vomiting, lightheadedness, chest pain. He took benadryl about an hour after getting the vaccine without any improvement.. He states that amoxicillin is the only medication to which has had an allergic reaction. On 3/12/21 He was s treated with Vistaril 50 mg, Deltasone 50 mg, and epinephrine 0.3 mL. The medications relieve most of his symptoms for 2 hours before it returned along with having developed a sore throat and sensation of swelling to his throat. On 3/13/21 at 0139am patient returned to ED for further evaluation. Patient remedicated with benadryl, epinephrine and was given pepcid. On 3/14/21 at 1430 patient again seen in ED for further evaluation with worsening rash. patient that last night he had a severe allergic reaction and self administered epinephrine at 0440. This morning he woke up with a worsening rash that he describes as burning. He reports a sensation of throat swelling. He has had 3 episodes of diarrhea, but no nausea or vomiting. Yesterday, patient states that his heart was "racing" but denies any chest pain. He states that every time his rash is treated, it returns and is worse in severity

After the patient received the vaccine, he sat down in a chair for observation and less than 5-10minutes he slumped and dropped to the floor. the patient is able to respond to questions and felt very weak. he felt very thirsty and we gave him water drink. he slowly recovered while partially lying in the floor and being supported. when medics came in he was already able to sit in the chair and refused to go with the ambulance. he rested more and finally went out of the pharmacy.

Patient immediately started sweating, turned pale, complaining of dizziness and blurred vision. We observed him for approximately 30 minutes. Sweating stopped; coloring became better and normal vitals were seen before he left.

Later at night on the same day as my vaccine, the roof of my mouth began to feel almost numb. There is no pain or swelling that I am aware of, but there is a sensation that has not gone away since that time.

Dizziness right after and felt a numb feeling - felt like he could not hear - sweaty . Feeling better now - was initially very hypotensive but better after laying down. Feeling better now after sitting again

Patient was given the Janssen vaccine on 4/08/2021 at 4:25pm. Patient reported feeling faint, dizzy and hears ringing in his ears less than a minute after. Had the patient laying back on chair against wall with feet elevated. Patient turned pale and started to break out in cold sweats. No signs of swelling or redness around the injection area. Patient did not report any itching or swelling in throat/tongue. After 2 to 3 minutes from time that vaccine was given, patient started to recover, no longer feeling faint nor sweating. Over the course of the next 30 minutes, the patient?s condition stabilized with pulse returning to 80 beats per minute. Patient reported feeling fully recovered at 5:00pm.

About an hour after the shot, I began hearing a faint ringing in my right ear. It is very low volume, but it is there. It now occurs about every 2 hours and the ringing lasts for only about 15 seconds before going away again. This does not happen in my left ear. The tone of the ringing is equivalent to a C4 on a piano. It is not harsh, and sounds like a synthesizer tone.

Apart from the expected side effects (headache and chills, some soreness at injection site), I believe I'm experiencing tinnitus or a similar ringing in my ears. It appears to be concentrated in my left ear, although it's hard to tell. There's a consistent high-pitched tone that won't go away. I'm not entirely sure when it started (maybe 24-36 hours after receiving the vaccine), but it's gotten slightly worse since then and is more noticeable. I have not been able to go to the doctor yet.

pt presents to the ED for migraines and blurred vision that began last night which he is concerned is a side effect from the J&J vaccine, pt received the vaccine on 5/3/21.

Pt scheduled and appt for J&J vaccine and it was administered by LPN in his left arm. Pt waited in observation for 5 minutes and reported he felt dizzy. Pt loss consciousness while sitting in his chair. Nurse repeatedly called patients name with no response . Charge Nurse was called for assistance . Charge Nurse administered a sternal rub and patient woke up . Pt was able to state his name , DOB and location . Pt reported that he lost his vision , with a headache and everything was black. Laid patient in first aid area on a cot and took patients vitals which were WNL. After lying down for 15 min patients vision returned. Pt stated he walked 25 min in the sun to the vaccination clinic and only had 1 meal for the whole day. Pt was monitored for an additional 30 minutes , drank water and was provided some crackers. Pt refused EMS services and just wanted to lie down . medial director was notified immediately of the incident and felt comfortable releasing the patient to walk back home on his own . Patients Vitals were rechecked and within normal limits . Pt left after 45 minutes

Patient reported arm soreness, few minutes later left leg starting to feel numb, shortness of breath. Then he reported tight throat and tongue swelling. Immediately called 911 and activated ems. Vitals: 0xygen 100%, bp 230/130, HR 80. Symptoms seem progressing so epinephrine 0.3 mg was administered at 11:30 a. EMS arrived 2-3 minutes later after epi was administered . Epi lot: OFM242, exp 11/01/2021. Patient left with EMS on gurney

3:00 AM- Woke up with a headache, eyes hurting 3:30 AM- Alarm goes off for Saturday work, found self couldn't keep my balance, felt hot 3:38 AM- Temp read 104° F, drank 8 Ounce of water and some Gatorade, called in sick for work and laid back down. 3:40 AM- Vomiting, sweating, knees aching and felt weak and dehydrated. 7:13 AM- Arived at IU, got some meds to help with headaches and keeping fluids down

Severe headache, severe muscle pain, loss of taste, severe skin sensitivity on whole body, sleepiness, lethargic, sharp eye pains

MUSCLE PAIN; FEVER; HEADACHE; EYES HURT; RED EYES; This spontaneous report received from a parent concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced eyes hurt. On MAY-2021, the subject experienced red eyes. On 22-MAY-2021, the subject experienced muscle pain. On 22-MAY-2021, the subject experienced fever. On 22-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, headache, and muscle pain, and the outcome of eyes hurt and red eyes was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545645.

About 4 minutes after administering the vaccine patient was sitting down in the waiting area and stated that he was not feeling too good. I immediately went over to him, at which point I noticed he was sweating profusely and stated he felt a little light headed. Less than 1 minute afterwards, he stopped talking and his eyes began to roll back, at which point his upper body began to slide over to once side as if he was going to fall. I immediately caught him, motioned for someone to call emergency services and continued to call him name. He did not respond, was pale and blacked out for about 30 secs. He was still breathing thankfully. When he regain consciousness, he stated that he felt better but he felt some tingling sensation in his forearms bilaterally. Thankfully at this point emergency services were present and upon taking his vitals, realized that his HR and BP were significantly low for someone of his age.

23 YO male was given Janssen vaccine and started getting tired and leg shaking without respond for a few seconds 5 mins after he was given the vaccine. He was then responsive again and said he has blur vision and feeling hot in the ears. Ambulance was called when pharmacy staff noticed his reaction. He was awake and oriented x3 according to paramedics, bg 109, bp 77/57. He was then taken to the hospital via ambulance.

Please note patient did not receive vaccine at this organization. Submitting to VAERS following ED visit and admission. 23 y.o. male with no previous past medical history presented 6/10 with complaints of dizziness, presyncope and syncopal episodes. Initial fainting episode was in January 2021 upon receiving sutures the laceration on his his right index finger. At the time he reports that although he passed out he did not really lose consciousness as he was aware of his surroundings. Things seem to go fine for a while until the day after he received his J &J vaccine in April 28, 2021. Reports having the usual post vaccine symptoms such as myalgias and malaise but the following day while at the barbershop he reports having another syncopal episode. He reports a prodromal phase that includes shortness of breath, numbness of the lips and a generalized warm feeling. During this episode he denied any loss of consciousness, as he was able to unlock his phone and respond to the people around him. He denies any myoclonic movements or jerks. He denies any postictal symptoms. Patient has been seen in the ED 3 times within the last week. On 6/10/2021 while at the base clinic, he reports feeling like he was about to pass out and was brought to the emergency department for further evaluation. He denies any nausea, vomiting, headaches. He endorses some chest pain when he lays down flat that is relieved by leaning forward. He denies any recent illness. Denies any new medications or changes to his diet or hydration status. The day prior to admission, his ED visit for weakness and presyncope occurred shortly after PT eval at the base. He felt very lightheaded and he attributes that to not eating and drinking prior to the PT eval. Work-up in the ED included EKG which showed ST elevation in leads V3 and V4 in a biphasic pattern. CT chest which showed no PE or consolidation pneumonia or pleural effusion. CMP was remarkable for potassium of 3.4 serum bicarbonate of 21. CBC was normal. CK was slightly elevated at 913. Troponin was negative. Lactic acid was 1.9. UA with no concern for infectious process. UDS was negative. Due to EKG findings reported above, patient was discussed with cardiologist who recommended that patient be admitted for observation. Upon further discussion with patient, it was clear that his chest discomfort improved when leaning forward, and his EKG was consistent with diffuse ST elevation. With a clinical diagnosis of acute idiopathic pericarditis, patient was initiated on colchicine 0.6 mg twice daily and ibuprofen 800 mg 3 times daily. He is to continue his colchicine therapy for 3 months and his ibuprofen therapy for 1 to 2 weeks with a gradual de-escalation of that ibuprofen by 200 mg/week. He has follow-up with cardiology scheduled. Cardiology mentioned in their notes that they would obtain an echocardiogram to rule out structural heart disease and recommended a 2-week event monitor upon discharge with a 3-week follow-up with tilt table testing and exercise stress testing. Cardiology had high suspicion for possible vasovagal. Echocardiogram was unremarkable without pericardial effusion.

PATIENT STARTED TO PASS OUT AND LOOSE CONSCIOUSNESS 2 MINUTES AFTER GETTING HIS JANSSEN & JANSSEN VACCINE. HE WAS KEPT OUT SITTING ON THE CHAIR. HE HAD HIS JAW TO LOCK BUT I WAS TRYING TO KEEP HIS MOUTH OPEN IN ORDER FOR HIM TO NOT BITE HIS TONGUE. HIS EYES WERE ROLOONG OUT. IN ABOUT 20 SECONDES HE RECIVERED BUT HE WAS COMPLAINING ABOUT BLURRED VISION. WE CALLED 911. I TOOK HIS BP. FIRFIGHTERS & PARAMEDICS CAME INSTANTLY AND TOOK OVER HIM. THEY OFFERED HIM TO BE TAKEN TO THE HOSPITAL , BUT HE SAID HE WAS OK AND LEFT WITH HIS GIRLFRIEND. I DID A FOLLOW UP CALL AFTER 2 HOURS WITH HIM. HE SAID HE WAS FEELING MUCH BETTER.

Patient reported that 3-5 minutes after the injection his vision was gone and his hearing was diminished. He did not report this until 2:25. The symptoms resolved by the time he reported them to the nurse. Denied dizziness, shortness of breath, chest pain, or any other problems. Said he has a history of "passing out" if he gets overheated, but this episode did not feel like those other episodes. Released to the care of his mother at 2:35pm.

Confusion, Headache, Myalgia, Arthralgia, Fever, Chills Narrative: Johnson and Johnson vaccine - Only upper body body aches and joints, bad headache with light sensitivity, nauseous, feeling a little disoriented - don't feel irrational but just foggy, forgetful--got home and left car running in driveway, fever 99.7, chills; taking Tylenol, but did not at first because she was told to wait at least 12 hours before taking anything.

Blurriness in the left eye and muscle fatigue continuing for more than 2 weeks after the vaccine. Reduced muscle recovery after physical activities, even 2 weeks after the vaccine.

patient's vaccine was administered at 3:40pm, he disclosed that he had passed out after a vaccine previously so I advised that he could wait 15 minutes in the post-vaccination area but not to drive for 30 minutes. At 3:44pm the patient was waving at me indicating that he felt dizzy so I ran out there and he asked for ice and said he was feeling lightheaded and seeing black spots. I asked him to lay on the floor with his feet elevated in a chair. He stayed that way for a few minutes and said he was feeling better, and we were able to get him a cool pack. He sat up on the floor and put the cool pack on his neck. After a few minutes he was feeling better so I allowed him to remain seated in the chair until 4:10pm. Store management came to get a statement from him and he ended up staying in the pharmacy area for approximately 1 hour post-vaccination. He waved and thanked us when he left.

Patient reported feeling sweaty, mildly nauseous, tingly in his hands and teeth/roof of mouth, flushing of the face and ears. Treatment included administering an ice pack for the patient's neck and a cool towel for the patient's forehead. Observed patient for 30 minutes, and he made a full recovery within 25 minutes of vaccine administration.

Tinnitus volume has increased significantly and is now present in both ears. This started a day or two after recovering from the flu-like side effects.

pt had a sore achy arm all of the way to his hand immediately after getting the vax. Later that day he became fatigued, extremely nauseated, had body aches, chills, profuse sweating, and headache. He took Tylenol 1000mg that night, the next morning and again twice the next day. The next day his eyes hurt, had headache, loss of appetite, fatigued with body aches and pain. On 4/3/2021 he still had a headache but the other symptoms were better and disappeared by the end of this day.

At 10:12am client received the Janssen COVID-19 vaccine and at 10:14am client the stood up and walked to the front of table waiting for his vaccination card. His eyes then rolled to the back and he fell backwards on the floor hitting his head. Onsite MD was called out to the floor for triaging. Client stated he did not have anything yo eat or drin today. Client was put in a wheelchair, paramedic arrived at 10:30am and client refused to go to the hospital. Client mother was present with him today and she drove client home.

Worst headache I?ve ever had (8 out of 10 pain scale), could not sleep due to the headache, very lightheaded, entire body ached (could barely move), eyes hurt, highest fever temp 102.8, nausea (at times I thought that I may have to puke). These symptoms lasted all night, but felt better in the morning. These symptoms were like COVID but x5. When I had the COVID-19 virus, my symptoms were not as bad as yesterday?s adverse effects from the vaccine. At 3 AM, I was considering going to the hospital and I have never been hospitalized before. I could barely open my eyes since the headache was so bad.

Began feeling delirious around 7:00pm - uneasy and strange. Upon walking to the subway station, I felt overwhelmed with sudden depressive thoughts and anxiety. On the Subway, I had a very severe, and disturbing panic attack. My vision became blurred and distorted, my heart rate spiked, and I became nauseous and extremely frightened. I sat down to try to maintain a sense of calm - but got off the subway after a few stops and met with a friend whom I had texted, to take care of me. From the point on, I was very shaken and agitated, and have been since the event. I have never experienced anxiety, depression, or any such symptoms in my life before, nor was I nervous or anxious about having received the vaccine. The onset of the event was sudden, and seemingly out of nowhere, without real purpose, hence my conviction that it may have been spurred as a side effect from the vaccination. I went to Urgent Care Sunday morning, April 11th, the morning after the event. My resting pulse was 97 BPM (normally 52-54) - and my blood pressure much higher than normal - 175/110. The doctor insisted I go home "and relax". I still feel uneasy and shaken from the event.

Patient had an initial response 2 days after the vaccine, with general malaise, dry mouth, headache and itching hands as well as local discomfort at the injection site that seemed to resolve spontaneously. On April 3rd he had non-specific changes in his hands that he attributed to cold weather that led to discomfort when running them under warm water. By monday APril 5th he was having worsening sensitivity in his hands and feet to heat, touch and experienced numbness. he also began to have difficulty walking. He went to the ER April 6th and was discharged April 7th after undergoing MRI of the brain and spinal cord, labs and lumbar puncture, with a presumptive diagnosis of early Guillain-barre Syndrome. His symptoms continued to worse, loss of gait was more pronounced as well as loss of balance and new off sensations in his tongue. He was admitted to the hospital, continued to undergo diagnostic workout. Results from tests on APril 6th came back positive for Anti nuclear antibodies and high protein in his CSF. He was treated with 3 days of infused Immunoglobolin therapy and was discharged on April 11th with a diagnosis of likely GBS. His symptoms continue to worsen slightly, but with less day to day decline

Starting 04/12/2021: Headache started at around 3pm; continued to worsen until the morning of 04/13/2021 when woke up at around 9am after falling asleep at around 3am with it significantly improving but still present as of the submission of this adverse event account at 3:40pm, 04/13/2021. Starting 04/12/2021: Stuffy ears started at around 6:30pm; continued to worsen until the morning of 04/13/2021 when woke up at around 9am after falling asleep at around 3am with it significantly improving but still present as of the submission of this adverse event account at 3:16pm, 04/13/2021.Starting 04/12/2021: Fever started around 9pm, 04/12/2021 at 99.3 degrees fahrenheit ( oral temperature); at 11pm worsen to 102.5 degrees fahrenheit ( oral temperature); took 650 mg of acetaminophen (Tylenol) at 12am 04/13/2021; temperature went down to 101.5 degrees fahrenheit (oral temperature) which continued until the morning of 04/13/2021 when I woke up at around 9am after falling asleep at around 3am with temperature at 9:47am 98.5 degrees fahrenheit (oral temperature). Starting 04/12/2021: Body aches started at around 7pm and continued to worsen until the morning of 04/13/2021 when woke up at around 9am after falling asleep at around 3am with it significantly improving but still present as of the submission of this adverse event account at 3:40pm, 04/13/2021. Starting 04/12/2021: Nausea started around 9:00pm, 04/12/2021 continued to until the morning of 04/13/2021 when woke up at around 9am after falling asleep at around 3am with it subsiding.

Patient had a brief syncopal episode w/flushing followed by muscle contractions. 911 was called. Blood Pressure 94/43. O2 sat was 98% on room air. Per patient, vision got blurry and then went black. Tingling in bilateral hands. Paramedics arrived and assessed patient. Per paramedics request patient was to wait another 20 minutes before leaving. 10:34am patient is alert & oriented x4. Walking and feeling back to baseline. patient was then walked to his vehicle and was informed that if he began to feel that way again, to call 911 immediately. from time of vaccination to time patient left was a total of 42 minutes.

Severe chills, High fever, shivering, headache, body aches, light sensitivity , blisters all over mouth

HA with light sensitivity and body aches since yesterday after getting J&J vaccine yesterday; Denies taking any meds; denies any noise sensitivity or any vision changes at this time. CC: headache and malaise HPI: 24-year-old active-duty male received Johnson & Johnson COVID vaccine yesterday and is having headache and generalized malaise today. He has no focal subjective neurologic deficits, headache is not first/worst/maximum at onset. He has no fever no other complaints.

PATIENT BROUGHT TO ED DEPARTMENT: HISTORY LIMITED TO PATIENT MENTAL STATUS CHANGES. PATIENT PRESENTS TO THE ED AFTER BEING FOUND ROLLING AROUND ON GROUND OUTSIDE OF APT. COMPLEX. SEVERAL HOURS INTO PATIENT STAY, HE BEGAN DROOLING. PATIENT HAD A RIGHT-SIDED FACIAL DROOP. CT ANGIOGRAM ORDERED WHICH SHOWED A THROMBUS IN THE LEFT MCA. VACCINATION OF JANSSEN VACCINE APPROX. 1 WEEK PRIOR TO PRESENTING PER PATIENTS MOTHER. UNKNOWN WHERE HE RECEIVED VACCINATION. PATIENT DIAGNOSED WITH ACUTE CVA

Patient administered Janssen Covid vaccine at 0943AM on 5/1/21 by pharmacist on duty. Patient had no prior reactions to vaccines but did admit being needle adverse prior to administering vaccine. After administration patient sat in waiting area within direct view of pharmacist. No sooner than 2 minutes post administration patient spoke up to pharmacist assisting customer at consultation window about feeling nauseous, and vision fading. Patient comfortable being assisted in taking two steps to immunization room to lie flat on ground after removing outer jacket. Patient was visibly sweating profusely and described hands feeling cool, dizzy, and lacking peripheral vision slightly. Pharmacist remained in immunization room talking to patient for 10 minutes, patient never fully lost consciousness and within 10 minutes recovered from all visual disturbances. Patient moved to seated position within immunization room and accepted offer for juice box. Patient remained seated in immunization room for additional 10 minutes under supervision from pharmacist through window. Patient comfortable moving to waiting area again for additional 10 minutes, afterwards he described feeling still slightly nauseated but no other symptoms. He called his ride from the waiting area and told pharmacist he was recovered and comfortable leaving. Pharmacist agreed to call patient later in the day to check in again. Pharmacist left message at 5pm 5/1/21. Appropriate parties notified and VAERS completed.

Started to get tired and thirsty the evening of the 30th a few hours after the vaccine. Went to bed around 10:30 and woke up about 3 hours later at 1:30. Had chills and was shaking when I got up. Could not really fall back asleep. Chills turned into a fever. That morning I started to get a headache. I sounded congested at one point, but no runny nose. I also had body and joint aches. I took Excedrin three times that day. Once in the morning, once in the afternoon, once before bed. I used zquil to sleep a little bit in the afternoon and again at night. I woke up Sunday and felt completely fine except for my arm still being sore.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild

Systemic: Bell's Palsy-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: OTHER-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild, Systemic: Weakness-Mild

A week and a half approximately after the initial vaccination of the J+J covid vaccine I started having a course of strange symptoms. Insomnia, inability to focus on things directly in front of me (a hand in front of my face would go out of focus automatically after a second), blurred vision, short term/long term memory loss, severe emotional issues, difficulty breathing, anxiety. Shortness of breath at a certain point was so bad I thought I was not going to make it. One very troublesome symptom that culminated after weeks of 4 hours of sleep was that my brain started feeling "funny". The best way to describe it was a brain "orgasm" which I have never experienced before. At the same time I experienced dry heaving for several minutes, and severe shortness of breath. After this experience my symptoms gradually improved over the next week or two. Prior to this it felt like my brain was not getting enough oxygen/blood, which could have been feeding my insomnia. When I would try to sleep, I would wake up at 4 am gasping for air, as I felt like my breathing was labored when sleeping. I could not focus on my computer screen to do my job at home. Large amounts of melatonin seemed to help my brain feel better and get some rest. I took hydroxyzine for unrelated reasons prior to the vaccine injection as needed, however not too often. During March I did not take it, as I had experienced disruptions in circadian rhythm due to the medication. I feel it is possible I had a blood clot that has been described in the news, although now there may be no way to know for sure. I talked with my primary care physician about this, and he did not think this was the case because I was male. However I have a BMI of 18.7 and some issues females have such as TMJ and inability gain weight/anorexia diagnosis when younger. I also was recently diagnosed with an only recently described actual medical issue called R-CPD, which is the complete inability to burp or belch. I felt like during the time when I experienced the side effects, that this condition was heightened (bloating/loss of appetite). I lost quite a bit of weight during March, I usually weigh 135-140, and was down to 115 at a certain point. I am now back up to 130. I now take sertraline at 1/4 pill dosage to treat the anxiety I experienced as a result of these symptoms as well as some other personal issues. I experienced severe side effects from the sertraline taking it at full dosage, and still experience some at 1/4 pill dosage.

Severe migraine headache with visual changes, aura, right sided numbness of face and arm, followed by pain. never had this before. lasted over 24 hours and necessitated trip to urgent care; CT scan was considered, but symptoms resolved with sumitriptan; recovered completely and no further symptoms

About week after shot, became extremely weak , fatigued , and am showing signs of vestibular neuritis (vertigo , feeling as though I would pass out, blurred vision , head ache , ear pain)

Patient received J&J vaccine at 4:09pm on 5/11/2021. Within 3 to 4 minutes patient's girlfriend stated that the pt was having difficulty seeing. Pt evaluated and he described complete loss of vision (lasting approximately 10 seconds) that returned. Pt was seated and was instructed to move to floor and lean against wall. Pt described numbness and tingling in both legs that resolved within 5 to 10 minutes. Pt stated he was anxious, shaking was observed, and he was hot and sweating. Vasovagal episode with loss of consciousness was immediate assessment. BP was 98/62 within 20 minutes of AE. 911 was called and EMS evalauted pt. Pt did not go to hospital AMA per EMS and pt stated he felt better. Patient was contacted on 5/12/21 at 3:25pm and he stated "I'm all good no further issues. I got a fever 8 hours after the shot. Other than that I'm all good". Inquired about temperature and pt stated "I do not have a thermometer". Pt instructed to contact primary care but he has not seen them in 2 year (She is primary care). Pt then instructed to contact cardiologist that he sees for his heart palpitations and heart rate control. Patient is prescribed metoprolol for this and he missed a dose the night of 5/9/21, took dose night of 5/10/21, and had shot on 5/11/21. Patient's physician office was called and information reported to her.

Tightness in chest and slight difficulty breathing hours before event. Event was an episode on the toilet including vomiting, diarrhea, dizziness, sweating, slight tingling sensations, and temporary loss of vision (5-6 minutes). Dehydration and headache occurred after the event.

Right eyelid started itching, turning red and swelling along with rash on neck within 30 mins of receiving vaccine. Fever, Body Aches

The first night I experienced pain on the injection site of the arm. Tongue was very swollen the next day. I went to the emergency room and was given medication.

Patient felt ringing in ears, darken vision, and feeling faint seconds after injection. After drinking water and breathing deeply, patient's symptoms resolved in about 5 minutes.

Patient informed paramedic of arm tingling, paramedic informed patient that he will check back with him in a couple minutes. 5 minutes after, paramedic witnessed the patient having a seizure for 10 seconds. During seizure, patient hit car in front of him. Paramedic stated that patient had flexion and eyes rolled back. Patient came to and asked paramedic what happened. Patient does remember seizing. Patient went into ambulance and was given snacks due to blood sugar of 95. Patient states he is currently on a keto diet. Patient informed staff that someone will be picking him up and refused to go to hospital with EMT.

while in post vaccination observation, client thrust head back into the wall, while in a seated position. Became unconscious. Left arm tremor- observed. diaphoretic, skin warm to the touch, sweating. When client became alert and oriented, he was fearful of the situation and began to cry. stating he didn't know what happened, he was scared, and he was dizzy and didn't feel well. Patient given emesis bag, given water and Ice pack. He also reports no ability to alert anyone prior he had no physiological indicators of what was about to happen. He urinated himself. He then had the second emesis and EMS alerted and on site to assess patient .

6 minutes post vaccination he reported feeling lightheaded. his BP was 147/77, pulse 60. About a minute later, he reported chest pain. 911 was called. They had him chew 4 81mg ASA until the paramedics could arrive. Around 15 minutes after vaccination, he reported chest tightness, he thought he was breathing at 80%, and light sensitivity. Around 20 min post vaccination, EMS arrives and escorted him outside. I never received further info on his condition from EMS. The next day, I tried to reach the patient twice via phone, but there was no answer and no voicemail.

Thrombocytopenia resulting in undetectable platelets that improved with 4 days of dexamethasone and IVIG with improvement in gum bleeding and petechial rash of bilateral lower extremities

After the vaccination, patient presented with an elevated pulse and blood pressure. He complained of blurry vision and requested to remain seated in the office. He sat in the office for 30 minutes and drank 3 cups of water. Ammonia inhalants were also administered as syncope was suspected. After 40 minutes, all of his vitals returned to normal and he no longer had blurry vision.

Woke up at 1:30 am with shivers and vomited. Felt dehydrated. Woke up one hour later sweating and vomited. Repeat back and forth cycle until 7am. Feeling much better now. Just achy.

15 (09:50) minutes post vaccination, pt approached healthcare staff and indicated eye itchiness and thickening in throat. Per pt, facial swelling was not present. Pt was observed closedly x 3 minutes, during which time pt indicated throat swelling was progressing. Diphenhydramine, 25 mg PO administered at 09:55. At 10:10 pt stated eye itchiness was worstening, and he was unable to swallow, could breathe comfortably thru his nose. At this time RN and MD decided to call for emergency support, and they arrived at approx 10:15. After initial assessment they determined the best course of action was to transfer to ER should airway management be needed Pt and EMS left facility at 10:25.

Systemic: Dizziness / Lightheadness-Severe, Systemic: blacked out immediately post vaccine administration (1-2 min)-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: PT stated passing out post vaccine is normal / occurs (why he used nasal flu shot in 2020 and not injection). blacked out post vaccination, RPh held patient at head and shoulders in chair to prevent fall from chair or injury to neck when as when he blacked out he fell back in his chair. post black out we provided water and monitoring. PT stated during recovery light headed, tingling in fingers / numbness. vision impared (like post concussion when hit in head/face).

Patient stated they didn't feel well at all and was sweating. I told him I should give him an Epi Pen, but he preferred receiving generic Benadryl. At approximately 12:50pm he was given 50mg of diphenhydramine since he wasn't having any swelling to inhibit swallowing. He drank half the bottle of water. He stated his vision was spotty, but getting better. I told him we should give him the epi pen and call 911. He asked us to call girlfriend to let her know he wasn't feeling well. After another few minutes he stated his vision was getting better and feeling much better. At 1:12 we took his blood pressure 102/67 pulse of 47. He stated the pressure and pulse were normal for him since he is a runner. (He had run a marathon the previous weekend). He was monitored for 30 minutes. After the 30 minutes, he felt fairly normal and was going to be with someone the rest of the day working at home. He was given more benadryl and advised to seek emergency medical attention if symptoms returned and were worse. Around 7;30pm I called to check on him. He had taken another dose of benadryl 50mg. He still felt comfortable not seeking er attention since he was going to be with friends the rest of the evening and night.

Thursday 4/8: 3:20pm: COVID injection given in right arm Friday 4/9: ~1:00 am: woke up shaking with chills and severely cold; had slight headache. Had insomnia all night. 6:00 am: woke up with bad headache, slight fever. 7:00 am: got out of bed and had vertigo and was running into walls trying to walk to my living room, along with the worst migraine I?ve ever had. Also had dizziness, nausea, chills, 100+degree fever, aches, skin sensitive to touch, and severe tinnitus. All of the veins were visibly popping out of my head. As the day went on, everything got worse. Any time I moved, my head would throb so bad that I thought I was going to have to go to the hospital. 3:45 pm: the headache started to finally go away. It would only hurt if I moved fast. At this point my fever was only slightly high, about 99 degrees. I was still unstable when I walked and dizzy. I went from being super cold, to being super hot and sweaty. And I was alternating between cold & hot and sweaty for the rest of the night. Was also having some memory issues, repeating things when I was having a conversation with someone over the phone. I was sweating all night when I was sleeping. Saturday 4/10: 7:00am: woke up with a slight headache; still out of it and dizzy. 8:00am: after being awake for about an hour or so, I looked in the mirror and my whole face (around the lips, cheeks, and jawline, and under the eyes) was really swollen and puffy. My face was even mis-colored. Under my eyes was purple and yellow, and my cheeks were white. Some confusion persisted throughout the day as well as dizziness.

I experienced all of the listed side effects (except, I didn't have an actual fever, I felt like I had a fever, but my temperature was normal). The chills and muscle pain were extremely intense 6 hours after I received my vaccine. I could not stop shivering, or get warm enough. That would be followed by a feeling that I was too warm and I would begin sweating profusely. I also experienced a few additional side effects I could not find listed: I felt especially sensitive to stimuli as if normal sensations were heightened (e.g. hot water in a shower felt painful, running fingers through my hair felt like I was having my hair pulled, I kept my eyes squinted because the sunlight through the windows felt too bright.) I was extremely irritable and became extremely frustrated easily. I mean frustrated to an embarrassing degree over small things that didn't matter. It was inconsistent with my day-to-day temperament. It felt like an adrenaline rush came in response to the most minor of inconveniences.

9 April 11:07am: got the vaccine 12:00: started feeling an underlying headache. 15:00pm: very fatigued, headache increased, slightly nauseous. 16:30pm: started feeling better, but still have an underlying headache. Appetite came back. 17:42pm: started feeling a fever develop. 23:30pm: temp. were normal 97?F. 10 April 03:30am: +102?F fever, body pain, Took one 500mg Tylenol, Stayed awake until 04:17 with elevate heart rate and it felt like my heart was pounding through my chest. Headache increased and I started to experience neck stiffness. 04:17: Temp 98.9?F. 04:39am: took another Tylenol 500mg and finally slept. 10:00am: woke up 11:31am: had breakfast and took Tylenol 500mg. Underlying headache, neck stiffness, light chills, ears are sensitive to sound. Elevated heart rate and increase blood pressure. Could feel my heart beating very strongly and intensely. 16:07pm: fever chills continued to be more severe. Latest temp is 102.2?F. Took another Tylenol 500mg. Heart rate is still elevated and beating very strongly. Headache and neck stiffness. 18:35pm: Temp 102.7 F. Heart, head and neck same as above. 18:42pm: temp 102.3 F. Heart, head and neck same as above. 19:30pm: Went to Urgent Care to seek medical assistance as my condition deteriorated. Received 975mg of Tylenol from Urgent Care unit. 20:00pm: Transferred to Hospital ER facility for further checks/tests. 21:20pm: Temperature gone done from fever levels. Still waiting for doctors to tend to my case. 22:05pm: Doctor came to see me and suggested an IV to hydrate me. 11 April 12:58am: Received the IV and pain medicine. 02:03am: IV completed, headache and neck stiffness reduced. Heart rate still very elevated and pounding strongly. 11:00am: Still had an underlying headache, dizziness and foggy mind.

A 25 y.o. male showed signs of respiratory distress and swelling around mouth about 15 minutes post Janssen COVID vaccine. We immediately called 911 and an Epipen 0.3mg was administered. His breathing quickly began to improve. The paramedics arrived and transported him to the ER. His mother was with him throughout the process.

VASOVAGAL: The patient stated he wasn't "feeling good," he felt very dizzy and his vision was blurry, he was sweating as well. I immediately grabbed another chair and raised his feet above his heart level. He immediately stated that he was "feeling better" and his vision was improving. I then offered him a cold bottle of water. He appeared very stable within a few minutes. We did call 911 as a precaution, they arrived a while later and deemed the patient was stable and their additional services were declined by the patient. I insisted the patient stay and finish the bottle of water. All together I believe the event was about 30 - 35 minutes before leaving. I encouraged the patient to drink plenty of fluids and electrolytes and to take it easy for the rest of the day.

In the span of about 40 minutes following the shot, I had severe reactions. I initially felt really warm in my arm and my heart started to race for a bit. That subsided pretty quickly. Then I got really dizzy, lightheaded and warm and sweaty while waiting the 15 minutes. Then my vision started to blur and I felt tingly in both of my hands and both of my legs. According to others with me, I also went grey. I was given a cool cloth and fanned which helped with a lot of the issues. I also had my legs elevated and was given some slightly sugary food and drink to help the vaccine disperse better. Paramadics and amabulance arrived to assess me. I was improving by the time they arrived and was deemed stable, so I did not go to the hospital for this incident

Fever that won't break for 3 days, chills, uncontrollable jerking, Horrible headache (couldn't lift head up), loss of taste (on day 2 only) (taste returned on day 3) day 3 soreness down the arm.

on the patients PQCF every question was a no,pt showed no fears for needles or signs of aversion,afetr administeru=ing the vaccine pt was waiting for 15 mins sitted ,after 5 mins or more he stated that he could not see,he went blind momentarily, would not blink after a waved my hands across his eyes,we initiated a call to 911 and made him comfortable no other signs of syncope was observed ,he was very aware and calm,after acouple more minutes he regained his sight and at this time he broke out in sweat and was clammy, he felt a lot better with the fan on him and drank some water and ate some chocolate and after a couple more mins he was good to go home,checked up him again the next day and everything is normal

Pt was lethargic, described blurred vision, tingling in both arms, sweaty, felt cold to the touch, BP at 7pm was 70/42, contacted EMS for help. EMS followed the pt home (came to pharmacy with his father), his BP had risen to 119/88 per call with father at 8:38pm. Father stated his symptoms had resolved and he was resting.

Full body ache, headache with sensitivity to light and noise, temperature of up to 101.7. Treated with Advil Or Tylenol Happened 8 hours after dose. Broke at 8 am that next morning. Came back at 8pm that evening as well (24hrs post initial symptoms)

Patient received vaccine and with in minutes, became very light headed, vomited and lost consciousness. Patient became alert but still had trouble hearing, seeing and speaking, and vomited several more times. Paramedics arrived and transported to hospital

I had the expected side effects for about two days after the vaccine. A week later I started to have pain and tightness in my jaw. I waited about a week and the pain seemed to be spreading into my face. I started to have a headache after that and consulted my doctor. The headache and pressure in my sinuses and cheeks has been persisting for eight weeks. It happens intermittently and some days it seems to come on later in the day. The tightness in my jaw has gone away and it is a nagging headache now. When I run it seems to be a slight tightness in my sinuses. I have been using some Allergy medication and they only hep a little.

ER care, spent 5-7 hours under treatment of lactic acid, saline IV, ivsoln IV and ceftriaxone vial after receiving multiple imaging tests, EKG, and other tests. He started feeling bad in the evening, went to sleep, and woke up around 11pm that night shaking uncontrollably, unable to see, had an extreme headache and was throwing up. His heart rate was close to 180 while sitting down and he could not stand up. Was taken to the ER and seen immediately. Afterwards for about 2 weeks he had bad chest pains and extreme shortness of breath. He could not exert himself at all.

At 12 Hours Post-Vaccination the following adverse effects were experienced for approximately 48 hours: Moderate Fever, Severe Fatigue, Moderate Chills, Moderate Body Aches, Mild Nausea, Mild Headache Onset 3 Days Post-Vaccination: Mouth and Tongue Ulcers

Pt at vaccination table after receiving first dose Johnson and Johnson vaccine. Nurse states she left table to get the lot # and upon returning pt stiffened up, eyes rolled into back of head. 1425 staff assisted in lowering pt to the floor where he began to demonstrate convulsions lasting no more than 30 seconds. Nurses and EMS responded. Pupils dilated , skin pale and stated "am I okay? Hello." Nurse told pt what had happened. A&O and able to tolerate water. Pt states no past medical hx. BP 118/62, HR 62, O2 97% and POC 108. Pt sat up, stated feeling nauseous and started to vomit. Pt assisted to stretcher at 1440. Pt educated on going to hospital for further evaluation. At this time pt is refusing transport and wants to wait.

Chest pain, lung heaviness, pressure behind eyes and in head, weakness, fatigue, joint pain, dry mouth, feeling of passing out.

Mild tinnitus that began the day following vaccination. I have never previously experienced ringing of the ears nor any other sort of ear injury or hearing issues. It has remained relatively constant since the onset.