Johnson & Johnson

Immediate burning in both arms. Unable to hold a pencil to fill out card after receiving vaccine. Weakness in upper extremities. Tingling, pain and numbness in both arms, red streaks appeared on the left arm going further up on to the shoulder, the were visible and painful for about 90 mins. Sweating. Nausea. Blurred vision. Loss of consciousness. Headache behind the eyes.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient complained of nausea/dizziness followed by blurry vision. He felt like he was going to black out. I took his vitals at 11:43 am and his BP measured 78/53 with a pulse of 45. He was also sweating profusely. The paramedics came within a 5 min time frame and patient was stabilized within 10-15 minutes later.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient has history of fainting with IVs but never to vaccinations. He said he gets stomach aches with sugar derivatives. First BP taken was 107/93 with a low pulse. 5 minutes later it was 165/93 pulse 99. We called the paramedics and they came within 5 to 10 minutes. Patient stabilized after.

Janssen COVID-19 Vaccine EUA .. Super sore for over 24 hours. Lost sense of smell and taste for a short period of time. Cotton mouth and wasn't dizzy but had a weird feeling in my head I never felt before.

Quick onset of nausea, stood up and hearing was lost and felt ready to faint, drank a Gatorade and water and sat on the ground. Hearing came back after 5 minutes, but moderate body shakes began and lasted an hour. Got very cold feeling and began to feel fever like. Took acetaminophen and covered up with blankets and drank water. Took a couple hour nap and woke up sweating with terrible migraine and light body shakes. Fell asleep for a few more hours and woke up not feeling feverish, but migraine and body aches. 22 hours after onset I have a light headache and body aches and am mostly feeling recovered.

Immediately after standing up experienced ringing in the ears and faintness. Was helped back to nurse who laid me for 15 minutes for observation. When I laid down I became very flush and sweaty. Then at 12am experienced fever of 101, body aches, and sharp stabbing chest pain which has lasted 18 hours so far.

NAUSEA, BLURRED VISION, SWEATING, FELT LIKE PASSING OUT - SUSPECTED PANIC ATTACK - PATIENT FELT NORMAL AFTER 20-30 MIN

Starting last week I had cold symptoms, massive headaches, and this week I no longer can smell or taste. I got a covid test to ensure i did not get sick in the meantime but it came back negative..

I woke up with hives over my arms and chest. My left eye was nearly swollen shut and my hands were swollen and in a lot of pain. Whole body is very itchy and sensitive to touch. I took sudafed because it is all I had available at the time.

Initial symptoms of visual impairment, later diagnosed as visual snow, occurred on Sunday 3/28 along with a headache. Assumed it was a migraine, but after it continued on Monday 3/29 I called advise nurse and scheduled exams for my eyes. The eye doctor confirmed it seems to be experiencing symptoms of visual snow. My vision is currently still looks like static. It has not gone away. Google search showed potential side effect of astrazeca vaccine in their report so am assuming it is also a side effect of the Johnson and Johnson vaccine as this occurred as a result of receiving it. I never had this before.

patient presented with Covid vaccination related complications. Onset sx around 2-3 pm yesterday after J&J strain given. One dose. Pt noticeably very nervous, admits blurred vision and lower lumbar/spine feelin on "fire".

I took the vaccine around 4pm in 9th of April, it was ok that day , then i slept at 12am and i woke up shaking after 3 hours having sever chills and fever , after that the other day i had really bad fever and muscle pain , the severity was 8/10 , I couldn?t do anything that day .. but the interesting thing that i have CIA and it?s under control by taking loratidine everyday , but since i took the vaccine my rashes flared up , i got lip swelling, rashes all over my body regardless of taking loratidine as usual , and it?s getting worse at night time now since i took the vaccine.

J&J vaccinated @1030 today. HA, chills, fever and bodyache started @1600. Took tylenol 325mg po x4. Denies difficult breathing, chest pain or cough. History: pt here for fever of 104F at home since 1600. Had J&J COVID vaccine in the morning today. Has body ache, headache, light sensitivity, slight nausea. Denies any symptoms before vaccine and denies vomit/diarrhea, rash, cough, runny nose, ear pain, recent illness/injury, recent sick contact, recent procedure, prior co-morbidities. Took 4 tylenol pills at around 1830. Ibuprofen or NSAIDs make pt's throat swell up.

Janssen COVID-19 Vaccine EUA. When I was going to bed, I had very bad chills, leg cramps, shortness of breath, and a pounding headache. my vision was a little blurry at times too.

Arm pain immediately after the shot. 3:45 PM. Headache, eye soreness, sinus pain - 11:30 PM. Chills and shakes - 2:30 AM. Sweats - 4 AM. Continued tiredness throughout the day.

Initial adverse reaction was a headache and impaired vision. My vision has continued to be impaired with it being similar to static and has caused headaches. After research I saw AstraZeneca had this in their files as a possible side effect. I understand it is different but made with similar technology so it may or may not be true for J&J vaccine, but this has continued for almost a month so I am concerned.

THE PATIENT STARTED SWEATING WITH SHAKES FOR A FEW MINUTES THEN STARTED FILLING COLD HE STATED IT FELT LIKE SEIZURE NOT SURE IF THAT'S WHAT HE HAD. HE STATED HIS CHEST FELT TIGHT. HIS EYE MAY HAVE ROLLED BACK NOT SURE AFTER A FEW MINUTES(5-10 MINUTES) HE STARTED FILLING BETTER WE CALLED 911 AND THEY CAME WITHIN 5-10 MINUTES HE WAS OBSERVED FOR A WHILE HE SAT ON THE CHAIR TILL BETTER AND WENT TO ER FOR FURTHER OBSERVATION

The patient wanted to go to the restroom after getting the vaccine. He said he felt a little nauseous and had a slight headache but felt ok to walk to the bathroom. After returning from the bathroom, the patient informed he gotten a little dizzy in the bathroom and passed out. His head was bleeding. Patient informed his head was hurting at hit sit, feeling nauseous, vision a bit blurry and did throw up a bit. He was able to state his name, address, DOB, and was cognizant. There was no signs of SOB or allergic reaction. The EMS was called and it was detected his BP was a little low. Patient did feel a little better but it was advised to go to the hospital to make sure he did not have a concussion. Patient was then escorted by EMS to the hospital.

Patient got vaccine and sat down for observation. He reports that after 1 minute, he was shakey, sleepy, and very tired. Then he felt like he fell asleep until the person checking him called at him. He had some vision and hearing impairment at the beginning, then after 10 minutes he was better. His arm was hot, he was sweating, his skin was turning white color. His mom came (she was shopping) and said the patient is usually an anxious person, so it was overwhelming to be at department store and getting the shot. After another 10 minutes, he was drinking water, his senses were back, he was fine.

Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient went unresponsive approximately 30 seconds after vaccine administration, was unresponsive for a total of 30 seconds, his neck and face were flush, pupils were dilated and his eyes wandered. He woke up confused.

About 2 minutes after injection patient became pale and he verbally says he is feeling dizzy. I quickly grabbed an ice pack and placed it behind his neck to keep him awake. He started leaning forward and told me he is loosing his vision. He leaned forward and I had to support his chest with my arm all the while trying to talk to him. He dropped his phone and wallet on the floor. He seemed to be loosing conciousness. I had an epinephrine 0.3 mg in my hand but because he was speaking I did not inject him. After about 20 seconds he started gaining his vision back but he said his vision is still fuzzy. After about 2 minutes he felt better so I asked him to position himself at the blood pressure machine. It was 86/65. He does not take any medications or has any health issues. After 10 minutes he took blood pressure again and it was around 129/91. He used the restaurant during the 10 m inute break.

Pt got J&J vaccine around 1:25pm. After shot administered, while talking to me, patient suddenly slumped over into my arms and eyes rolled back and lost consciousness for about 10 seconds and he was making some gurgling noise. Some excretions came out of his nose and he came to and was able to lie on floor to elevate his feet, but still was very dizzy. First responders showed up and his vitals were WNLs, but pt continued to look pale and struggle to come to upright position for another 15-20 min. Pt's friend showed up to pick him up and he was able to walk out to the car without issue.

Received shot and waited for the 15 minutes as required, feeling no good with no symptoms. While driving home after leaving the pharmacy, I started experiencing light headed ness and dizziness. This eventually turned into tunnel vision which I thought was going to result in me fainting. This led me to start pulling over, but then the tunnel vision went away. During my short 10 minute drive home, this happened to me twice. After getting home, I had about 3 similar episodes during which similar light headedness happened. These all felt like they were getting close to fainting, and at one point while walking up the stairs in my house I could not stand. All of these symptoms started approximately 20 minutes after leaving the store, and then took place in a 20-30 minute timespan. Roughly 4-5 episodes in total, including the drive home and short time spent at home. No issues after lightheadedness stopped, besides feeling tired. I do not have a history of anxiety attacks due to needles. Donated blood and plasma in college, and have recieved many vaccines and never had this happen.

Medical evaluator reports: profuse sweating, delayed response, near syncopal. EMS reports: Pt feeling dizzy with Blurred vision after receiving shot.

Regular symptoms from the shot, EXTREME back pain (lower) headache, felt cold and exhausted, on first day. The second day I had blurry vision and all those symptoms so I went to doctor. They said I was having a reaction and also gave me Toradol for the back pain. I started to feel better symptom wise but the following day I started to poop blood. That only happened for one day then went away after a day. But I?ve had one or two more bloody stools since then. The ER said that it?s likely from the Toradol but to keep an eye on it. I have had 2 episodes since but it?s been random. Haven?t taken any more ibuprofen at all, was told to take omeprazole for a month and see how my body recovers

Soon after administration, patient got hot, sweaty, and had tunnel vision/ blurry vision. Checked blood pressure and was 54/40. Called EMS for support. Patient was light headed and shaky, would respond to questions and commands but a bit slow. Eyes seemed to be rolled back in head, but never lost consciousness. 2nd BP check was 94/62. EMS arrived at 11:25, patient began feeling a bit better at 11:30. paramedics arrived at 11:34. Patient moved to ambulance for observation until picked up to return home. Was not transported to the hospital. Checked in on patient at about 4:30 and was feeling well.

Day of-Within 5 minutes I went unconscious. I was sweating profusely and my vision began blurring I could feel my heart rate and had haggard breathing. After I came by to I had extreme light sensitivity and nausea. After 1 week-Still experience fever, chills, muscle ache, headaches, nausea, fatigue, winded easily, and hot flashes. 2 weeks- Still experience excessive fatigue, nausea, hot flashes, persistent mild to moderate headaches with occasional overwhelming migraine, light-headed, dizzy, loss of coordination and balance. 3 weeks-Same as 2 weeks out.

Fatigue, chills, slight fever headache- within first 24 hours Nodule felt on right temple area- 8 days after vaccine Headaches on both temples- 8 days after vaccine Slight blurry vision left eye- 1-2 weeks after vaccine Headaches left temple- 2-4 weeks after vaccine Left sided chest pain with difficulty taking deep breath lasting 2-3 days- 3 weeks after vaccine

Pt. tol vaccine well and was moved to observation room. He was given water and apple juice--both of which he quickly finished. Appx. 3 minutes after vaccination, pt reported feeling dizzy. 1 minute later, became diaphoretic and reported losing his vision. CNP was called in and pt. was moved to a lying position in our recuperation area. As he was being lowered, pt fainted. After 5 seconds, he became cogent and said he felt fine. Cool cloths were applied. He remained lying for about 20 minutes before sitting in a chair for another 10-15 minutes. He finished 2 bottles of water and 2 boxes of juice in this time period. Pt. left with friend feeling better. He was instructed to continue drinking water.

1000 vaccine recieved and pain started after he felt a pop, (instructed him this was the vanish shield needle most likely) followed by numbness and tingling. When he walked to chair become dizzy and light headed. 1005 reported issues to recovery staff. b/p 132/78, p-99, 02 sat 97%ra, r-18. 1019 cont to be dizzy and light headed, tingling wrist down, pain is gone @ this time. 1023 starting to get sleepy per report. 1045 c/o of vision alterations, blurry vision. B/P 152/80, p-99,02 sat 96%ra, r-18. 1100 b/p 140/86, p-99, r-18, 02 sat 97%. Reports cont to feel the same. 1105 Site lead instructed pt to call MD, go to urgent care or we could call EMS. Pt and significant other opted to drive via their car to urgent care.

PATIENT HAD A SEIZURE ABOUT 45 MINUTES AFTER GETTIN THE VACCINE. PATIENT'S EYES ROLLED BACK AND STARTED FOAMING AT THE MOUTH. PATIENT HAD BEEN SEIZURE-FREE FOR 3 YEARS PRIOR TO GETTING THE VACCINE.

Single Dose Janssen - one minute after injection - lightheadedness - inability to focus/concentrate - ringing in both ears -,tingling in hands/feet. Time now is approx 25 minutes post vaccine and he is feeling mostly better

Chest pains and shortness of breath started within an hour from vaccination. 3 hours after shot dizziness and chills began. The following day symptoms progressed and lasted all day. Severe dizziness, blurred vision, muscle aches, headaches, chills , shortness of breath, chest pains, sore throat, cough, fatigue, fever(up to 102.5).

Diziness, Sweating, Visual disturbance, Heavy arm, Pale, Hearing disturbance (hearing voices), Nauseated

vasovagal episode / syncope with subsequent fall to ground, striking head. lightheaded, clammy, loss of vision prior to episode. Brought to Emergency Department, discharged to home in stable condition within 5 hours.

1 pill of acetaminophen was taken around 5 PM for arm and lower back soreness. Shivering, chills, radiating pain behind eyes started around 11 PM. Patient was kept warm and rested. May have developed fever throughout the night. Was given acetaminophen around 3 AM for headache. Adverse symptoms had ceased. Patient is now fatigued.

Tinnitus in both ears since day after vaccination. April 15 left ear tinnitus mostly subsided but right ear still noticable and preventing sleep.

Johnson & Johnson Janssen COVID-19 Vaccine EUA Since 4/11/2021 I have had reoccurring headaches which are persistent. Minor vertigo, nausea, light sensitivity have accompanied each headache series. In healthy condition, rarely ever have headaches. Have had more headaches in the past week than I've had in many years combined. No treatment outside of consuming adequate hydration

High grade fever, multi hour severe migraine, light sensitivity, sharp abdominal pain, confusion, coordination/balance problems and severe flu like symptoms. Treatment was self administered and comprised fluids and bed rest.

On day 1 (April 15) of noticing my body was very off after the vaccine I had Leg pain and severe headaches, I say severe because though I rarely get headaches and stay hydrated I could tell this headache really hurt and lasted the full day and several days after (something I have never had happen to me) Also on April 15, I had leg pain, If I took a step off a few inches curb or stair step I felt sharp pain shoot up my leg. On April 16th I still had the headaches and leg pain , but also while driving I began loosing my vision and started to pass out/faint. I Pulled over and waited at least a half hour. during that time I. noticed I couldn't type or read anything on my phone as I was trying to reach a friend to help me. eventually after time had passed I was able to drive myself to a friends where I thought the best thing would be to sleep it off. the headaches and leg pain lasted a couple more days and I thought it was going to go away, but it is now May 5th and today and last couple days the leg pain feels more like someone has been punching my left leg. five had chest pain and headaches return. I do not have medical insurance and have avoided going to the hospital or primary care because I am afraid. today the pain is so irritating and sore I wish I could escape my body.

Systemic: Dizziness / Lightheadness-Mild, Systemic: other-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Additional Details: Transient lasting about 10 minutes then was able to leave on his own

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Medium

Patient recieved J&J COVID vaccine, after 1 minute was transitioned to the 15 minute waiting area. Upon arriving at the chair, patient fainted and fell to the floor, patient was out for approximately 20 seconds and came to. I then asked the patient if he hurt or felt injured, assessed his alerteness he was alert and oriented x 3. He transitioned to chair under own power and was speaking with me, his eyes then rolled back in his head for approximately 10 seconds went out again. At this time we called the ambulance, they came to assess patient, patient refused transport to hosptial and left under his own power.

After injection, patient jolted and eyes fluttered. He seemed to be having a seizure like reaction. He then slumped to side and head hit side of wall since we had chair with side rails positioned against wall. He lost conscious for maybe 30 seconds and then eyes opened. I asked if he was OK and the first thing he asked for was water. He said he felt light headed and dizzy. I had my intern who was working grab him water from the deli and had him sit and rest. He started sweating and asked for paper towels. I grabbed him a couple of towels so he can wipe his face. I continued to check on him while doing my work. He seemed fine after that. After 30 minutes, I checked his blood pressure. It read 100/63. I continued to monitor him and he left after that. He did have friend with him the entire time who helped him.

While the patient was being observed after his vaccine, he informed me after close to 10 minutes that he was starting to feel dizzy and couldn't see clearly because of the dizziness. He was moved to the floor, lying on his back, and his legs were elevated on the chair. I informed the patient to take slow, deep breaths. The patient said he immediately started to feel better once moving to the floor. He remained in this position for about 10 minutes, feeling better the entire time. He slowly sat up to a seated position for about a minute, and upon feeling fine, he stood up and felt normal. The patient informed me that he has a history of dizziness and fainting with different vaccines in the past and this is not an unusual reaction for him.

I experienced a weird taste in my mouth shortly after the shot and the day was fine I just felt kind of drained and that night is when it started I was puking my eyes were watering my throat hurt and I couldn?t hardly sleep the next day I?ve experienced a lot of body aches

No more than 60 seconds or so after vaccine was administered, patient stopped responding verbally then his head tilted backwards (seemed to be vasovagal response). Held patient's head upright so that he did not hit his head on wall and applied ice pack to the back of his neck. Patient twitched, sneezed, then muscles tensed and then relaxed. He came to not 45 seconds after initially losing consciousness. Patient was very pale and sweaty. He asked for water and sat for 5 minutes or so. Patient said he was then feeling a bit lightheaded so we gave some orange juice. 5 more minutes passed and he said he was feeling much better. Patient described feeling very dizzy and not being able to hear clearly before losing consciousness

Patient complained of throat tightness and dry mouth, pale. Heart rate- 88 Respirations-30. Epi given, Benedryl given 50 mg PO. Instructed CO's to watch patient closer with 5 min checks X 3 hours. Patient stated signs and symptoms had improved and vital signs stable.

About two weeks after the shot I started noticing the following symptoms: Dizziness/lightheadedness, brain fog, loss of balance, ears ringing, pressure behind the top my nose, neck pain/tightness running up to my head, nausea,

Muscle aches in armpits began a few hours after receiving the dose. Within 8 hours of dose, a mild fever and chills began (around 100 degrees F). I attempted to take a bath to soothe aches but it did not help, and instead tried to go to sleep at 8:30 pm. A slight red rash appeared on chest and arms around this time. I was woken up at 10:30 pm feeling disoriented and hot, with a fever of 104.5 degrees F. My wife noticed slurring of words and that I seemed unstable and confused, and symptoms were severe enough we considered going to the emergency room. I experienced ringing in my ears and a severe headache. I took 2 extra strength Tylenol, put a cold cloth on forehead, and drank fluids to fall back asleep. Fever dropped to around 102 but continued throughout the night. I woke up at 6:30 am and took two more Tylenol. The severe headache continued and I vomited twice. I attempted to take a shower and rinse off, and continue to rest. Fever is reduced to 99 degrees F with help of Tylenol.

Frequent urination Insomnia ( unrelated to frequent urination) Feelings of severe dehydration Muscle ache Headache

Broke into cold sweats when I went to the bathroom. Went back and sat in the chair and blacked out. Eyes rolled into the back of my head. Stiffened up and rolled out of the chair. Then I slowly came out of the black out.

fever, headache, chills, body aches, burning eyes followed by nausea and burning chest when taking deep breaths

07:40 patient reported to mother that he was "lightheaded and dim vision" then mother witnessed syncope. Nurse assessed patient LOC but breathing was recorded at approximately 1 minute with pallor, cool, and clammy skin. ED was notified of patient transport. Vitals were obtained BP - unobtainable, HR - 44 faint and thready, Resp -10. Patient regained consciousness and informed nurse that he had "white coat syndrome and history of fainting with blood drawn and doctor visits" he apologized for not notifying nurse prior to vaccination. 07:43 patient has second witnessed syncopal episode after reporting "dim vision", patient was lowered to floor with assistance from 3 nurses and bystanders. Vitals obtained - BP - 117/76, HR - 46 Resp - 12. LOC lasted 30 seconds, patient was pallor, skin was cool and clammy. Patient regained consciousness and was alert and oriented x 3. 07:48 patient was assisted to sitting position and then assisted to W/C and escorted to the ED with a nurse, CNA and family for examination and further treatment. Upon leaving patient had pink color, skin was warm, but diaphoretic. Pt entered ED at 07:55 VS BP - 141/83 MAP - 102 HR - 66 RR- 20 SPO2- 96% Temp - 97.9. Pt was observed in ED for an hour and was provided food and liquids after report of not eating or drinking since previous night.

13 days after the vaccine I developed tinnitus in both ears (3-27-21). The next morning, one ear was better, but my left ear still has ringing and I can barely hear out of it. I got my ears flushed at doctors and that did not help the issue either. I have never had tinnitus or any other ear issues in the past. Left ear is still ringing as of 3-30-21.

The patient passed out after receiving the vaccine. The patient received one dose of ammonium as the second time he passed out his eyes rolled back in his head. He has a history of fainting with vaccines. An ambulance was declined by the patient and the female who came with him. He was instructed to wait for 30 minutes at the pharmacy . A phone number was obtained to check on him later on.

Headache, diarrhea, fever 102 - 5 days after receiving vaccine, body aches, loss of sense of smell, L arm pain, fatigue, cough, congestion

Employee came at 1:30 to get vaccinated. Three to five minutes after administering the Johnson & Johnson vaccine, I asked the patient if he is feeling ok because he seemed nervous and sweaty. He responnded "yes, but I have a mental anxiety from vaccines, needls, doctors". one minute later he started complaining of pain in his left arm and feeling weak. . He then asked to sit on the floor and said that he can hardly breath, and lost vision. I administered Epipen injection to his left thigh while the store director was calling 911. He then complained about not being able to move his hand fingers. The ambulance came and took him to the ER. later in the day, his manager said that he spoke to hid family and they told him that he has been having anxiety from doctors, needls, and shots ever since he was little. He is feeling better now and the hospital will keep him for tomorrow.

approximately 15 minutes after vaccination patient had elevated blood pressure, pulse,. He appeared very flushed, pale and sweating profusely. He was complaining of chest tightness, dizziness, ringing in ears, nausea. Continued to monitor blood pressure and pulse, after approximately 5-10 minutes heart rate, pulse and appearance back to normal. Patient stated at this point he was feeling back to normal.

?Janssen COVID-19 Vaccine EUA" About 3 minutes after administration was experiencing lightheadedness, dizziness, and blurred vision. Turned very pale and heart rate dropped to 47. About 8 hours after administration body aches and body temperature began to rise.

Patient vaccinated by nurse and nurse reported patients eyes rolled back, patient appeared diaphoretic and pale Patient seen by medical team, vitals were stable, patient provided water and stated symptoms resolved Patient refused medical transport and signed AMA form

On 04/07/21, 28 yo presented to clinic for immunization. Pt's documented allergies include codeine (rxn: rash; severity: low) since 02/06/2018. Pt had no previously documented encounters. Pt was seen at another institution on 02/06/18 for Generalized Anxiety Disorder and was prescribed sertraline 25 mg PO daily. Unknown if pt continues on this medication. On 04/07/21 at 1141, pt was administered COVID-19 J&J (Janssen) Vaccine 0.5 mL in left deltoid (Lot #043A21A; Exp: 6/21/2021; NDC #59676-580-15). Immediately after injection, pt became lightheaded, dizzy, diaphoretic and "felt like his vision was closing in". Vitals assessed at 1145 were BP: 94/55, P: 42, O2 sats: 98%. Pt placed in Trendelenburg position with vitals BP: 116/75, HR: 43, O2 sats: 98%. Pt denied any chest pain, shortness of breath, throat swelling, skin itching or hives. Pt reported no previous reactions to vaccines and no h/o anaphylaxis. Pt did report a similar event during a previous blood draw. Pt remained in Trendelenburg x 10 minutes. At 1159, pt was repositioned to sitting with BP: 120/80, HR: 48. Pt reported a low baseline HR. After a total observation of ~20 minutes, pt was reassessed by MD and permitted to leave. Event noted as "Symptoms are most consistent with a vasovagal reaction after J&J Covid vaccine."

Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild

Patient has felt Extreme nausea, mild to moderate sweating, gittery feeling and blurred vision for about 2-3 minutes.

ED NOTE is as follows...from 4/21/21 @ 21:47 a 28 y.o. male who to the emergency room with reports of a headache for the last 48 hours. He reports this as being one of the worst headaches he has ever had. He was seen at urgent care and given Toradol, Zofran and Benadryl and still rates his pain an 8 out of 10. He does feel pressure behind his eyes. And reports vomiting in the parking lot at urgent care. He denies abdominal pain back pain, neck pain, shortness of breath, chest pain, numbness or tingling or any other worsening concerns. Reports that he did receive a recent Johnson & Johnson vaccination. Patient states he does vape. He occasionally drinks alcohol he denies any illicit drugs. Patient denies any head trauma. Diagnosis management comments: This is a 28-year-old male arrives to the emergency room with reported migraine headache for the last 48 hours. He did report that he was go to urgent care in which he received a migraine cocktail of Zofran, Benadryl and Toradol. Patient reported that his headache was not resolved so urgent care sent him on for further evaluation. Patient upon arrival had a negative neurological exam however he did report that he had pressure behind his eyes. Was unable to see any papilledema on funduscopic exam. Check patient's pressures bilaterally and they were 21 and 18. Patient did report to me that this was the worst headache of his life. I did administer IV fluids here as well as Tylenol and morphine. Patient did report some improvement. Patient did report in his past medical history had a recent Johnson & Johnson vaccination. A CBC and CMP was obtained. Did have thrombocytopenia with a count of 66. Since my exam was PERRL with normal extraocular movements. He had no eye redness or eye pain. Of low concerns for any iritis or uveitis. Patient's patient CT of his head did show a abnormal CT that had a dense appearing superior sagittal sinus that was representing a venous thrombosis. Radiologist did recommend a MRI MRV. An MRI and MRV was ordered. Patient MRI MRv did show findings are consistent with a venous thrombosis involving the right jugular right transverse sinus and superior sagittal sinus there is also a patchy edematous change within the subcortical white matter areas bilaterally and symmetrically. There was no CVA. With patient's reported migraine headache. Reported blurred vision, low platelets, recent vaccination I do believe patient has vaccine induced thrombotic thrombocytopenia. With this finding I did converse with my overseeing physician Calls were made out to neurology and then a call out did prefer to have patient started on IVIG at 1 g/kg daily for 2 days and blood thinner Xarelto 15 mg p.o. twice daily. These orders were initiated. Internal med services was consulted and with conversations of family, internal med services out possible transfer that an interventionalists could be available if patient needed it. Report was given at 2100 upon my end of shift.

Patient returned to site 30 mins after observation as he felt short of breath, difficulty swallowing and dry throat. Patient was evaluated by RN and EMS. No swelling noted. Vital signs obtained. Patient hydrated and was closely monitored. Patient was also evaluated by PA and PA. Patient was then had some complaints of left arm tingling. Patient provided with water to hydrate. Patient felt better after 30 mins. Patient instructed to contact PCP if any worsens Symptoms or if any medical emergency to call 911 or to ER. Patient also advised to report any symptoms using the VAERs online on card.

Patient fainted 4 minutes after vaccine given. Patient was able to talk but described "eyes in back of head". Blood pressure reading taken 132/76 pulse 72 then 128/82 pulse 85.Patient was responsive to our questions sitting on floor for 5 minutes. We then we observed him for and additional 15 minutes in our waiting area before he left.

Systemic: Throat felt itchy, but he never had any swelling.-Medium, Systemic: Shakiness-Mild, Additional Details: Pt waited 15 minutes, left. Then felt throat tingling and tightness on his drive home. Came back to the pharmacy, drank some water, we opted to give him loratadine instead of benadryl since he had a 2+ hour back home. He stayed in the pharmacy for another hour and was able to drink water and eat a snack with no issues and wanted to continue on his trek home. He called us when he arrived home and was feeling fine.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Medium

One week after receiving the vaccine I woke up on 5/21 with a mild rash. As the day went on the rash progressed and swelling of lips and uvula occurred around 5pm. I was taken to an urgent care who transferred me to a hospital via rescue. I spent the night at the hospital receiving multiple epi pen injections, and fluids. I was discharged 5/22 with a dose of prednisone. I was fatigued all day. On 5/23 I woke up to swollen eyes and lips and covered in hives again. I went to the ER where I was given steroids and fluids again. The hives went down but did not go away. One 5/24 I took multiple doses of Benadryl and dose of prednisone and in the evening time the hives progressed. Today 5/25 I woke up with swollen lips and checks and hives. I went to my doctors office to be evaluated.

Approximately 3 minutes following administration of vaccine, the skin on the patients face, arms, and legs turned red and the patient began to sweat profusely. The patient reported that he was feeling dizzy and had blurred vision. The patient did not report any shortness of breath or swelling of the face, throat, or lips. Physical assessment confirmed patients report of no swelling of the face, throat, or lips. The patient was treated with an ice pack to the back of the neck and was advised to place his head between his legs. The pharmacy student remained with the patient for 30 minutes after the reaction occurred. During the 30 minutes, the patient reported that his dizziness and blurred vision were improving and he was no longer sweating. Physical assessment of the injection site found that there was no redness, swelling, or rash developing. After 30 minutes had elapsed since the reaction, the patient reported that he was no longer dizzy, experiencing blurred vision, or sweating. Assessment of the injection site at this point was the same as above with no redness, swelling, or rash occurring. At this point, the patient was cleared to leave the pharmacy and was advised to go home and rest for the night and not perform any strenuous activity.

Patient reported sudden vision impairment, started palpating and had profuse sweating with shortness of breath; patient was administered one dose of Epipen; 911 initiated per protocol. By the time ambulance arrived, patient was already feeling better; for safety and evaluation , they took him to emergency.

Janssen COVID-19 Vaccine EUA Bruising and soreness around injection site, low-grade fever (~100.25 degrees Fahrenheit), muscle aches mostly along posterior chain from shoulders/neck to legs, sleeplessness, mild headache behind eyes. Symptoms first appeared approximately 12 hours after injection. Patient self-treated with 400 mg of Ibuprofen at approximately 9:00 AM on 7/8/21, roughly 19 hours after injection. Symptoms were minimized.

patient developed sore throat, headache, and new loss of taste / smell on 07/14/21. He tested positive for COVID on 07/18/21.

The patient was given a Janssen Covid-19 vaccine. About 5 minutes after receiving the vaccine, while he was waiting in his car, he began to experience light headedness, roaring in the ears.

Chills woke me up at 5am, kept me up for at least an hour. Headache, pain in eyes, fever continued through the day. Muscle pain in back significantly worse than previous days

First three days 102 fever, legs were in so much pain I could not walk or get up. The fourth and fifth day my lips and face would become tingly/numb and my left arm would get weak and I would feel a little disoriented, my sleep has been pretty disturbed. It felt like I was having a stroke. I did not have a stroke, I continue to occasionally feel the above symptoms, a little less potent than they were, they might be going away, I can't tell. I will be calling my doctor if it continues.

At 9pm (3-13) I began feeling sore and cold with some shivering. Couldn't get warm in bed, continued to shake harder. Slept until 11:15pm and woke up to violent shivering, pounding headache, full body aches, sore skin, achey joints, nausea, swelling tongue and throat. Took 1 dose of nyquil and then tossed and turned all night, very little sleep, symptoms persisted into the next day, but shivering stopped in the night. By morning (3-14) registered a fever of 100.3 which persisted most of the day along with remaining lessening symptoms. By evening I was still very sore, bad headache, and very lethargic/fatigued. Next morning (3-15) low temp of 97.1 degrees, headache, fatigue, lightheaded. Still feel headachy and tired.

Monitored for 30 minutes after injection, no symptoms, released back to housing (cell). Approximately one hour later, presented to Health Care Unit with c/o itching, nasal congestion, watery eyes, lightheadedness, nausea, "hard time breathing". Very anxious. Administered 50 mg Benadryl IM without any relief. Patient was sent to local emergency department as precaution. Given epi SQ and additional Benadryl in the emergency department

Patient reported at 1210 feeling lightheaded, vision blurred, had syncopal episode and fell from chair hitting L temporal region of head. LOC approx 1 min. VS at 1219 were 134/78 and HR 61, SP02 97%; all while sitting. patient was assessed by nurse and reported a hx of passing out with blood draws. VS at 1225 BP 135/70 and HR 72. Left returned to normal.

03/24/2021 - Mild sore throat in the evening. 03/25/2021 - Moderate sore throat, moderate fatigue and muscular pain. 03/26/2021 - Mild sore throat and mild fatigue. 03/27/2021 - Moderate sore throat, moderate fatigue and muscular pain. Low grade fever of 99.1F. 03/28/2021 - Moderate sore throat, mild ear pain, eye pain/pressure. Fever spiked to 102.4F during the night. 03/29/2021 - Severe inflammation of the right side tonsils, severe ear pain, severe eye pain/pressure, fever of 101.9F. Consulted a doctor on MD Live who felt it might still be a reaction to the vaccine and prescribed Ibuprofen 600mg to manage symptoms. 03/30/2021 - Extremely severe inflammation of the right side tonsils, severe ear pain, severe eye pain/pressure, low grade fever of 99.5F. 03/31/2021 - Symptoms same as 03/30/2021. Consulted a doctor at the local Urgent care clinic. Prescribed amoxicillin-clavulanate and predniSONE.

Patient received vaccine at 2:20 PM and showed no symptoms initially. His wife was having syncopal symptoms and he helped care for her while paramedics were on their way. After they arrived he experienced lightheadedness and blurry vision. He was evaluated by they team and they determined the cause to be vasovagal syncope. He recovered and declined transport. He left on his own accord after 40 minutes feeling back to normal.

Patient became very pale, reported feeling dizzy and having blurry vision after immunization, patient was given a cold pack to apply to neck and gradually felt better, patient remained at pharmacy for 30 minutes for monitoring

Symptoms similar to days of positive COVID-19 but in 'fast-forward': intense chills/shivering (12:30-2AM), low-grade fever of 99.5-101.1 (3-6AM), moderate fever of 102.1 (7 AM) broke around 9-10AM. Followed by intense headache/migraine, photosensitivity, difficulty sleeping, and mild nausea (until 12PM). Headache finished around 230 PM. Loss of appetite all day. Still not feeling well at time of submission. Treating with Tylenol and forcing fluids.

Felt fatigue 6 hours after shot and went to sleep for two hours. I started running a temp of 102 10 hours after shot. I started throwing up about 12 hours after shot until about sixteen hours after shot. I had hot and cold chills and would wake up with night sweats for about 40 hours after shot. Had a pounding headache also for about 24 hours after shot. Was thirsty for about 12 to 16 hours just couldn?t drink due to having to throw up. Still have hot and cold chills and feel weak and have no appetite now 45 hours after the shot. Only been able to eat soup since the shot.

once the person recieved the vaccine within a minute he felt dizzy, dry mouth, blurred vision, kept sweating he asked for water but he lost control of his muscle and the water spilled on his pants. We called 911, then after about 6 minutes he felt ok even before 911 arrived.

Discomfort in throat due to swollen lymph nodes. Additionally, swollen lymph nodes under left armpit.

All times in format HH:MM:SS after injection T+00:05:00: Heaviness, weakness in left arm. Gradually cessated over four hours. T+08:00:00: Interrupted sleep; insomnia lasting four hours; visual disturbances (flashing lights, geometric patterns). Ceased within 2 hours. T+18:00:00: Fever of ~1.5 degree F above normal; injection site reaction (soreness); weakness; fatigue; chills; all symptoms ?flu-like?. Slowly resolved over next 18 hours.

Headache: 4.5 days - current Nasal Congestion: 4.5 days - current Fatigue: 4 days Sensitive Skin: 2 days Nausea: 8 hours Muscle soreness: 1 day

12:21pm 115/60 51 16 O2 96%; 12:27pm 124/80 66 16 O2 96%; 12:37pm 118/70 66 18 O2 99%; 12:42pm 124/80 66 18 O2 97%; 12:47pm 110/72 66 18 O2 98%; 12:52pm 114/70 67 18 O2 97% C/O dizziness, blurred vision. 12:52pm Pt. denies any complaints; left with family member.

SHORTNESS OF BREATH; EYES BURNING; EXTREME FATIGUE; HEADACHE (PRESSURE IN FOREHEAD) FOR THREE DAYS; TROUBLE LOOKING AT THINGS FOR A LONG TIME/PATIENT COULD NOT OPEN HIS EYES; This spontaneous report received from a patient concerned a 29 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: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced trouble looking at things for a long time/subject could not open his eyes. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced eyes burning. On 07-APR-2021, the subject experienced extreme fatigue. On 07-APR-2021, the subject experienced headache (pressure in forehead) for three days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eyes burning on APR-2021, had not recovered from extreme fatigue, shortness of breath, and headache (pressure in forehead) for three days, and the outcome of trouble looking at things for a long time/patient could not open his eyes was not reported. This report was non-serious.

The night following my vaccination I ended up with a fever of over 100 degrees Fahrenheit and also suffered from a severe headache and sore throat. The fever and headache subsided after 24 hours, but the sore throat and ulcers on my gum line remained for the next 3-4 days. 9 days after I had gotten the vaccine, I started suffering from what I thought was a significant MS relapse. The left side of my face went numb and started drooping, my legs went completely numb, and my vision went blurry.

CHILLS; FEVER; LOST MY VISION; CLOSE TO FAINT; PALENESS; DIZZINESS; UNABLE TO STAND; SWEATING; LOSS OF ENERGY IN LEGS/BODY WEAKNESS; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced lost my vision. On 09-APR-2021, the subject experienced close to faint. On 09-APR-2021, the subject experienced paleness. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced unable to stand. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced loss of energy in legs/body weakness. On 10-APR-2021 14:00, the subject experienced chills. On 10-APR-2021 14:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost my vision, close to faint, paleness, dizziness, unable to stand, sweating, and loss of energy in legs/body weakness on 09-APR-2021, and fever on 14-APR-2021, and was recovering from chills. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe

On Day 2 after getting vaccine, fluid buildup in ears spiked and persisted, causing a range of symptoms. Symptoms include ear pressure, popping, crackling, and high-pitched tinnitus. Urgent care and PCP all saw fluid behind eardrums in two weeks prior, during week 3 saw an ENT who said fluid was not present anymore, however the audiologist confirmed that negative pressure still exists in both ear tubes. Tinnitus and symptoms persist through week 4 (at present).

about 15 minutes after receiving the vaccine, the person that accompanied the patient yelled for help. She states his eyes rolled back and then slumped over and arms flailed a few times. The patient didn't know it had happened. He stated he felt dizzy and looked pale. We gave him a water bottle and after a few minutes he felt better.

Patient states getting JandJ vaccine yesterday, was seen in the ED for same s/s except stating lost of taste and smell starting today. Denies contact with Covid-19

The patient received the COVID-19/Janssen vaccine at 12:33pm. Approximately, 5 minutes after receiving it, the stated that he was feeling dizzy and had ringing in his ears. I had him lie down with his knees elevated. He stated that he felt better in the supine position. I attempted to take his blood pressure, but was unable to get a reading after two tries. After a few minutes, he stated that he no longer had any ringing in his ears, but felt some numbness in his arms. His fingers were cold and I had a difficult time finding his pulse. While he was resting, he stated that he had anxiety to needles and "white coat" syndrome. He felt that he was okay to sit up, so he did without any adverse reactions. He drank some water and stated that feeling was returning to his arm. I asked if he had eaten anything this morning and was told, just a cup of coffee. We speculated that low blood sugar could have possibly compounded the situation. At approximately 12:55pm, he felt well enough to leave. I had him contact his mother who was in the store to accompany him out at around 1:00pm.

Systemic: see comments below-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: patient became faint, sweating, with decreased vision. He sat down on a chair, heart rate in 52-57/min, BP 100/56, rr 20, O2 sat 100%. Took about 10 minutes to fully recover, and all sympotms resolved, HR returned to 61-67/min. He declines EMS, says he will follow- up with PCP regarding drop of heart rate. His girlfriend picked him up and he went home.

Almost immediately after receiving the vaccine pt went rigid and was unresponsive. He came to within a minute. He was very panicked and stated he thought it was a dream. He was extremely pale and very sweaty. We gave him some water and an ice pack to cool down. We checked his blood pressure. He then lied down on the floor and we elevated his feet. He then stated he could not move his hands and his lips were tingly. We then gave him some liquid benadryl and continued checking his blood pressure and called EMS. They arrived and he left with them. I tried contacting him later without success. Will try again tomorrow.

patient had not eaten all morning and was dehydrated ( we were told this after the fact) . patient received vaccine and was fine upon immediately receiving vaccine. patient stood up and headed out the door of vaccination room in good spirits. Once patient got outside of the door to waiting area , patient began to feel dizzy and sat down in the chair. Patient began to sweat and show signs of impaired vision (spots) and discomfort. Pharmacist immediately ran to get the patient soda and a bag of chips to get patient's blood sugar up. patient immediately began to perk up. patient later stated he had not ate all day leading us to assume low blood sugar and abrupt movement was the cause of his dizziness.

Gastrointestinal issues including severe nausea, diarrhea, and loose stools. Difficulty eating due to tightness of stomach and feeling full after only a few bites. Sharp chest pains, including racing heartbeat and pressure which induces coughing. Various sharp body pains, mostly in the chest and torso. Uncontrollable shaking, and a buzzing electric feeling throughout body. Flashing in eyes when closed. Head feels heavy with constant vertigo and brain fog. Muscle spasms all over and twitching in left index finger. Insomnia due to listed issues. Nystagmus and feeling of eyes vibrating.

March 11: fever, headache, pain fatigue, arms turned bright red for about 10 minutes March 12:fever, headache, fatigue, nausea March 13:fever, pain, fatigue March 14:fever, pain, chills, fatigue, nausea, vomiting March 15: fever, chills, headache, tinnitus March 16: fever March 17: March 18: fever March 19: fever March 24: fever March 25: fever Last week or so: chest pains, really high heart rate

Approx 10 mins after receiving vaccination, the patients significant other reported that the patient was not feeling well. Pharmacist checked on the patient who reported loss of vision and a feeling of dizziness. Pharmacist contacted 911 and EMS came in to evaluate patient. Patient refused transport to the Emergency Department, reported feeling better after EMS evaluation, and left store under own power.

Had intermittent pulsentile tinnitus that turned in to traditional tinnitus ie ears ringing all the time

Tinnitus, some "whooshing sounds" about a week later, then on 6/23/2021 - ringing in both ears, loud, seems to get worse every morning, a little better through out day.

Patient was seated in the passenger seat of the car. We talked for a few minutes prior to administration and I actually administered a vaccine to the person in the driver's seat first. I walked over to give his shot and he then tells me he "doesn't do well with vaccines." He later told me he felt sick to his stomach after getting the shot and had a metallic smell similar to a bloody nose. About 1 minute after administering his vaccine, the patient's head went back, his muscles went very stiff, and he appeared to convulse. We called 9-1-1. His mom was sitting in the back seat and placed an ice cube on the back of his neck which seems to have pulled him out of it. During the episode, he reports "blacking out" without orientation to time or place. After the episode, he was dizzy and lightheaded for a few minutes. Soon there after he was jovial. I took his BP and HR about 5 minutes later BP 100/62 and HR 48. Paramedics also took vitals which were a bit higher than these. He reported having a small cereal bar for breakfast and 2 cups of coffee.

Swelling of Tongue and headache after receiving the vaccine, patient was given Benadryl 50mg PO BID x 3days and Prednisone 60 mg PO daily x 3 days

LOSS OF TASTE; LOSS OF SMELL; EYES ARE BURNING; ARMS ARE VERY SORE; EXTREME TIREDNESS; FEVER; MASSIVE HEADACHES; ARMS ARE VERY COLD; SHORTNESS OF BREATH; CHEST PAIN; BODY IS VERY HOT; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included had a surgery on the finger, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with paracetamol for surgery on the finger. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUL-2021, the subject experienced shortness of breath. On 21-JUL-2021, the subject experienced chest pain. On 21-JUL-2021, the subject experienced body is very hot. On 21-JUL-2021, the subject experienced arms are very cold. On 21-JUL-2021, the subject experienced eyes are burning. On 21-JUL-2021, the subject experienced arms are very sore. On 21-JUL-2021, the subject experienced extreme tiredness. On 21-JUL-2021, the subject experienced fever. On 21-JUL-2021, the subject experienced massive headaches. On 22-JUL-2021, the subject experienced loss of taste. On 22-JUL-2021, the subject experienced loss of smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, chest pain, body is very hot, arms are very cold, eyes are burning, extreme tiredness, fever, and massive headaches on 21-JUL-2021, was recovering from arms are very sore, and had not recovered from loss of taste, and loss of smell. This report was non-serious.

After shot, pain/soreness at injection site lasting up to 1 week after shot. Same night around 11:00pm vaccine symptoms include: fever/chills, headache, diarrhea lasting up to 10hrs. Reduced with aspirin. 9-13 days later increase in nightly symptoms including: Headache, stomach pains (upper stomach) Rashes/hive like bumps itching on body spreading to different parts each night ( 3-17-21, rash/swelling on both feet including white bumps that mostly went away with Benadryl (Diphenhydramine) and aspirin), ( 3-18-21, Rash spread to throat and face over night, numbness in upper lip mostly went away with Benadryl (Diphenhydramine) and aspirin), (3-18-21 rash moved to lower back left side, itchiness and sore throat.

Patient got dizzy around 5 minutes after dose; and began shaking a bit 1 minute later and staring into distance. Sweaty, continued dizziness. responsive at 1 minute after side effects began. Patient drank some water as able, and reported ears were ringing. Ambulance was called and reported all vitals looked good and patient likely experience syncopal event rather than seizure.

Patient received vaccine and reported approximately 5 minutes later that he needed help. Within just a few seconds following him calling for help he was not able to talk and his eyes had rolled into the back of his head. His body was rigid but he did not lose consciousness. A technician called 911. He was sweating profusely so his jacket was removed and a cold rag applied to his head. He finally came to after approximately 1-2 minutes and reported that he was feeling very dizzy. His blood pressure was 118/80 and temperature was 98.5 degrees Fahrenheit. He was examined by an EMT, and they found a very similar blood pressure. Patient reported feeling much better and was fine to go home. Treatment occurred over a 15 minute window.

About 8 hrs after injection while at work I started to notice a dry sore throat and that I was kind of feverish. 5 hrs later when getting ready for bed I got chills that lasted almost an hour as I attempted to warm up. Upon waking up next morning felt very lethargic while still being sore in the arm and very feverish. That lasted all day, feel much better this morning but retained a persistent cough

03/11/2021 3:05 pm Patient observed in chair pale with stiffened body and eyes rolling on back of head. Patient initially unresponsive V/S 97.2 20,71, 96/50, O2 sat@ 98% on room air. Blood glucose monitored @ 105 mg 1d1. 911 called patient responsive to verbal and tactile stimulation. Legs elevate, patient stated that he only ate breakfast for the day water and snacks offered and consumed. BP rechecked 80/50 Legs remains elevated. Awaiting for 911 to arrive close monitored is in progress. 3:20 pm The Fire Department arrives and assesses the patient. 3:30 pm BP 110/70 Patient awake and verbally responsive. Patient lift facility with rescue via stretcher en route to the hospital.

the nerves in my Teeth and Jaw are hurting. The pain comes in waves. It is keeping me up at night. I average about 3 hours of sleep every night.

Patient felt dizzy and lightheaded, had slight blurred vision and was seeing spotty. He was given water/snacks/candy. We had him lie down and complete a couple of breathing exercises for about 15-20 minutes. Was complaining of dizziness intermittently in between lying down and sitting up. Vitals were checked by nurse, pulse ox and heart rate were normal. Patient felt better after about 30 minutes, EMTs were called and checked vitals - completely fine. Patient did not feel the need to go to the hospital.

Joints began feeling achy and body felt tired within a few hours of vaccination. About 10 hours later body began to feel warm and then within an hour began uncontrollable shivers and aching in testicles followed shortly after by a throbbing headache and pain behind eyeballs. I put on extra clothing and jumped into bed as symptoms persisted. Later in the night I began sweating profusely and removed the clothing. The headache and pain behind the eyes persisted. I also began feeling nauseous and almost vomited when I went to the bathroom. My body was so tired and achy I could barely move. I tried to wake up for work but my headache and pain behind the eyes was so bad I went back to bed for another four hours. I did not have any appetite for the rest of the day. My headache subsided that afternoon and I went for a walk that night and my body still felt incredibly tired and achy. The pain behind my eyes persisted. The following day I felt somewhat better and could work. That night I went for a jog and my body felt extremely heavy, my joints ached, and I could not catch my breath. My symptoms continued to improve but I have had no sex drive for a week.

I had received the Janessen vaccine around 3:30pm. Around 1 am I woke up to shivering and chills. My head felt extremely pressurized inside. My eyes felt like they were being pushed out of their sockets. My body hurt. It hurt to move. My neck , knees, ankles and back were in shooting dull pain. It took everything I had to stand up. I couldn't get to sleep. I had a fever. I started to shiver. My thought raced. It began to hurt to breath. My lower chest is sore on the inside where the lungs meets the rib cage. I could not to go class or do any work. Was easily one of the worst nights of my life.

Vaccine was administered Wednesday 4/7/21 at 8:00am, 24 hours later, woke up with a sore throat. By Friday 4/16 pain in the throat reached a level 10. unable to talk, open mouth, or swallow without being in severe pain. 4/16 made an appointment at clinic because the pain was unbearable. did a strep test and COVID test. Results: strep test: NEGATIVE COVID test: POSITIVE pain in throat continued to increase with all of the same symptoms as previously stated previously. started on amoxicillin 4/11 for infection in his thorat

Patient felt a reaction on his tongue that presented as tingling and his throat was hurting. He used liquid Benadryl and then felt completely fine.

So my right eye was swollen and had hives under my eyebrow and inside of my nose on both sides and on my mustache above my mouth. I had a headache. My throat was hurting.

around noon - legs went numb and weak - couldnt walk around 1 - took 2 tylonol and had sharp pains up and down the spine around 2 - face lips jaw were swollen around 4 - rashes on neck and back and welts on arms around 5 - went to emergency room around 6 - doc claims hes allergic to tylonol customer does not believe him and things dont make sense - pain in legs comes and goes

PERIODIC RINGING IN HIS EARS, EPISODES LASTING ABOUT 30 SECONDS AT A TIME; 4-5 TIMES/WEEK; This spontaneous report received from a patient concerned a 30 year old male. The patient's weight was 166 pounds, and height was 65 inches. The patient's concurrent conditions included penicillin allergy, alcohol use, non smoker, and rash. The patient had no relevant medical history. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced periodic ringing in his ears, episodes lasting about 30 seconds at a time; 4-5 times/week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from periodic ringing in his ears, episodes lasting about 30 seconds at a time; 4-5 times/week. This report was non-serious.

Friday night, Got a migraine and I had it all Saturday to night. I felt nauseous that night. It went away on Sunday. The following Saturday, I had a migraine and it lasted a full eight days - hanging out in my left eye (it was all in that eye - when I moved that eye from left to right, I would feel it) . I had taken Tylenol and ibuprofen but it didn't do anything. Some days it was intense and some days it was in the background. I did see and talk to a someone at my doctor's office - over video chat (on April 15th - that was day eight of migraine) and she told me to start taking Tylenol that night and I've been taking it one time in the morning since that day and it hasn't come back. I think the migraine went away on it's own. I haven't had a migraine ever in my entire life so it was very unsettling.

Patient raised hand and noted to be pale. Was asked if okay and noted that eyes rolled back and became diaphoretic . Paramedics called. Patients legs lifted and ammonia applied. Patients color started improving and patient started speaking. Patient stated " I want to lay down". Patient was taken by paramedics on stretcher

Severe headaches after four days. Continued mogranes to this date ( 14 days). Pain in right eye. Numbness and tingling throughout body. Waking up at 1 AM with 110 bpm heart rate. Easy bruising. Blood spots

SENSE OF SMELL DECREASED FROM NORMAL; SENSE OF TASTE DECREASED; LINGERING AFTERTASTE AND AFTER SMELL SENSATION; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcohol use (2 per week), 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 experienced ulcerative colitis when treated with adalimumab for ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced sense of smell decreased from normal. On 10-MAR-2021, the subject experienced sense of taste decreased. On 10-MAR-2021, the subject experienced lingering aftertaste and after smell sensation. On 26-APR-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache on 10-MAR-2021, and had not recovered from sense of smell decreased from normal, sense of taste decreased, and lingering aftertaste and after smell sensation. This report was non-serious.

During the observation period, pt was seen trying to take off his jacket, and proceeded to pass out and fall out of his chair. Pharmacist rushed to help him up and he complained of feeling very hot and sweating profusely. He did not have any swelling/itching of throat/facial area. Patient was provided cold water, and told to remain seated. Pt was asked questions such as name, what day it is, to establish if patient was alert and oriented. Patient complained of experiencing tunnel vision while passing out. He proceeded to pass out once more, while seated, this time the pharmacist was able to support him in his chair. After the water and rest, patient said he felt much better and his girlfriend came to escort him home. He stayed for about 30 minutes before leaving and staff made sure he was feeling alright.

The patient received their vaccination and before my immunizing technician could apply his bandaid he fell straight back while seated in his chair. She was able to catch his fall and lie him on the ground. I went into the immunization room to assist immediately and he was apologizing for scaring. I asked him to lie there for a few minutes and take some deep breaths. He was talking and aware of his surroundings. I asked him about his medication history which was null. I asked him if he had been nervous and he said he didn't think so. She said that he did mention he did not like needles. He had not eaten since the morning (a bagel) and it was late in the afternoon. After a few minutes I asked him if he would like to sit up so I could see how he was doing. Management arrived and observed while I went to get a cold cloth for his neck/face. Management asked him if he would like to sit in a chair. He sat in a chair and before I came back after just a few minutes, he had slumped over to the side with his eyes rolling back. Management was concerned so they immediately called 911. fire department and EMS arrived. They tested his blood pressure, etc and said they believed he had just passed out. They asked him if he wanted to go to the hospital. He declined. He called a family member to pick him up who arrived about 45 minutes after his vaccination. He was walking around and coherent when he left.

After 45 minutes to 0100 hours, numbness in side of face opposite from injection site. Persistent for 1-2 days. Pain in jaw when chewing. After 18-24 hours, tremor in hands worse than prior to vaccination. Can not raise glass of water to mouth without a significant tremor. The greater the weight of the item being lifted, the more significant the shaking of my hand

LOSS OF TASTE; This spontaneous report received from a pharmacist concerned a 30 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced loss of taste. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from loss of taste. This report was non-serious.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: Patient felt dizzy, lightheaded and then began seeing spots and proceeded to faint about 5 minutes after receiving vaccine. He attributes it to getting worked up just before vaccine.

Two days after vaccine, flue like symptoms. Third morning couldn't hear out of left ear. Few days it cleared up but now has ringing in left ear and worse ringing in the right ear. Now gets a rash when skin is exposed to the sun. Still very fatigued since the vaccine and has been sleeping 10 to 12 hours a night.

About 2 minutes after administering the vaccine to the patient, the patients fiance notice that the patient began to roll his eyes and slump over. Upon accessing the patient I notice that the patient was unresponsive to my calls, at which point I motion for my technician to call for emergency; then I proceeded to try to move the patient from the chair to the floor with the aid of his fiance. The patient became responsive a second before we go him to the floor and he seemed responsive and was breathing pretty well. The patient was unresponsive for about 35 second at which point his eyes were rolled backwards, his head was sweating profusely as well as his muscles seemed to become very rigid. Thankfully within 5 minutes emergency personal was at the scene and they took his blood pressure and heart rate with both values being on the lower end. The patient objected to going to the hospital, at which point they offered to roll him outside for him to get fresh air and observes him before leaving with his fiance

Patient reported in his consent form and verbally that he has a prior history of Vasovagal Syncope, but is manageable and definitely wanted to get his Covid 19 Vaccine at the pharmacy. Patient received his vaccine on his right arm, remained seated in his chair. A few seconds later, he decided to lie down on the floor, removed his mask and started taking deep breaths with his eyes closed. About 3 minutes later, his eyes got dilated, skin started flushing red, started with mild seizure like twitching and patient became unresponsive. So I quick put some ice cold water (from his water bottle) on his face, patted his cheek, put an ice pack on his face and neck and while I was asking his father (who was with him) to call 911, the patient regained consciousness and said he was okay. He continued to put the ice pack on his neck and forehead and in a few minutes the flushing stopped, in about 5 to 8 minutes, patient was able to sit up, lean back against the wall, take a few sips of water and the eat a granola bar. Patient then proceeded to wait in our waiting area for another 15 minutes and then decided to leave , since he was feeling much better.

Immediately upon administering the vaccine, the patient loss consciousness. I was able to catch him. He was unresponsive for approximately 5 minutes. His eyes rolled back in his head and he made seizure like motions. By the time EMS arrived he was responsive.

APPROXIMATELY 10 MINUTES AFTER THE VACCINE WAS ADMINISTERED TO THE PATIENT, THE PATIENT BEGAN SWEATING AND FEELING LIGHTHEADED/DIZZY AND WAS THIRSTY AND APPEARED PALE IN COLOR. THE PATIENT WAS GIVEN 50MG OF LIQUID DIPHENHYDRAMINE BY MOUTH AND BEGAN TO HAVE IMPROVEMENT IN SYMPTOMS APPROXIMATELY 5 MINUTES LATER. THE PATIENT WAS OBSERVED FOR 30 MINUTES AFTER, AND WAS GIVEN WATER TO SIP.

Injection was around noon, felt fine until dinnertime At around 5pm I started feeling a little groggy, lack of appetite By 7 pm I was experiencing moderate chills and shakes and tingling fingers and tongue, shakes subsided around 830p 9pm I went to sleep, 11pm woke up disoriented having been tossing and turning, elevated heart rate (approx 120 bpm) and temp (101.5) which lasted until around 12:30 am Resolved with symptoms of pressure headache until mid morning, made it difficult to sleep Treatment was ice and water, cold compress, hot shower, then in the morning two tylenol Day2 only effects seem to be those lingering from the night before (tired from lack of sleep, muscle soreness from shakes) The main fear was the high heart rate which was only listed in my side effects packet as something to look out for shortly after the injection as sign of an allergy, not something that would come on later

Fainting, dizziness, blurred vision, sweating, feeling clammy, blood pressure dropping and sugar dropping.

Fever, headache, body aches, light headedness and nausea causing me to pass out while trying to walk to the bathroom. Upon standing up from the laying down position, I got lightheaded, started profusely sweating, became nauseous and ultimately lost consciousness. When I regained my consciousness, there was a loud ringing in my ears and my hands were numb. I took some Tylenol, laid down and it subsided shortly after. I did not experience any symptoms as severe as this at any point again.

Following vaccination patient reported feeling dizzy, lightheaded ,visual changes. Paramedic and writer evaluated patient. Patient is alert and oriented. Able to verbally respond to questions. VS = 138/68, 73, 17, 98% RA. Patient states he has a history of anxiety and low BP untreated. Patient states he believes this is an anxiety related event. Declined further medical evaluation offered by writer. Patient waited in monitoring area another 15 minutes with Paramedics on standby. Left vaccination site with friend.

About 30 seconds after the shot, became faint, dizzy, and ears started to lose hearing and became fuzzy. Sat down and drank some water, vitals showed lowered BP. Recovered after 15-30 minutes and some water.

Fever greater than 103 Dry heaving Diarrhea Extreme headache Chills Sweats Extreme fatigue Dizziness Blurred vision Lethargic

BITTER TASTE ON MOUTH (CHEMICAL TASTE); AN INTERMITTENT SENSE OF CHEMICAL SMELL; FEVER; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 05-APR-2021, the subject experienced bitter taste on mouth (chemical taste). On 05-APR-2021, the subject experienced an intermittent sense of chemical smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from bitter taste on mouth (chemical taste), and an intermittent sense of chemical smell. This report was non-serious.

Chills, fever, sweating, fatigue and insomnia started within a few hours of vaccine and resolved within roughly 24 hours. Tinnitus started within a few hours of vaccine and is unresolved one week later.

Got J&J vaccine at our clinic on 4/9/21. Notes that several hours later he developed HA and hives over his abdomen. Sx got worse overnight, and by the next morning he noticed additional sx of tongue numbness/tingling, so went to the ER. ER diagnosed him with allergic reaction and discharged him with a short course of steroids and Rx for Banophen. He notes that the symptoms returned again on 4/24/21, and again this morning 4/28/21. Went back to ER on 4/24, got more steroids and sx went away. This morning bought OTC Benadryl and sx went away when he took 50-100mg.

Twenty-four hours after the vaccine I got fever, chills and body aches. Three days after the vaccine I had irritation in my right eye. The next day my eye was more irritated, and it was uncomfortable. I had a telehealth visit and they gave me antibiotic drops. I was diagnosed by an optometrist on the five days after the vaccine with the Shingles virus. The Shingles are still present on my eye after three weeks and I am taking steroids for that.

3 days later I started having sever shooting and stabbing pain on the entire left side of my face that would not go away. The pain started in my teeth, jaw, temple, eye and ear. The next day I went to the dentist thinking it was my wisdom teeth, they checked my teeth, did ex rays and checked for infection but found nothing. Went to my primary care flight doc and she was un sure what was going on. Then I went to the Emergency room and I was diagnosed with Trigeminal Neuralgia of the face.

After administration patient was sitting in post vaccination chair and was passing in and out, sweating very much, pale, high blood pressure, and experienced dizziness and tunnel vision. after about 30 mins patient was feeling much better.

Pt got J&J vaccine yesterday around 0900. and woke up w/ swelling of lower lip. No issues with breathing, chest pain. Denies pain but discomfort. c/o slight headache

Immediate side effects: Heavy brain fog, odd soreness all over my body in my muscles/vascular system (sore neck, wrists, lower back), I felt a pressure in my heart like it had swollen or something, ringing in ears, muscle twitching like I had just gotten off of a long run. Ejaculation was yellow for about a week with a different texture than normal texture (which is back to normal seemingly now). Longer side effects: Overall it took about 2 weeks before I felt back to normal. Lingering issues are some slight inter-muscular pains that didn't exist before.

Pt got J&J vaccine yesterday around 0900. and woke up w/ swelling of lower lip. No issues with breathing, chest pain. Denies pain but discomfort. c/o slight headache.

Patient (myself) experienced lightheadedness, blurred/starry vision, clammy palms, intense cold sweat and almost fainted approximately 10-15 minutes after receiving Janssen COVID19 vaccine injection. I was provided a small bag of cookies and a bottle of water while sitting in a chair. These symptoms manifested a second time approximately 10 minutes after the first on-set and I was laid on the floor with feet elevated.

Beginning on May 29, 2021, symptoms began with persistent headache and numbness in legs and feet. By June 2, 2021, severe pain in legs, arms, abdomen with throbbing headache, barely able to stand up or walk. Went to emergency room evening of June 2, 2021, but was released with suspected viral infection and was told symptoms should subside. Symptoms got worse, with the addition of full facial paralysis and revisited same emergency room on June 6, 2021. Admitted to hospital and diagnosed with Guillian-Barre Syndrome. Spent six days in hospital receiving IGIV treatment over five nights. Released on June 12, 2021 with severe upper body weakness, limited leg weakness, constant headaches, Bell's palsy and deteriorated vision. After two weeks of recovery, including doctor's visits and physical therapy, still weakness in limbs and Bell's palsy with deteriorated vision.

LOST MY TASTE BUDS A LITTLE BIT CINNAMON STICKS PUT IN MOUTH BUT COULD NOT TASTE IT AT ALL; BODY ACHES OCCURRING HERE AND THERE THEY COME AND GO; LEFT ARM SORE/ACHES IN LEGS; TEMPERATURE OF 101.9-102.1; FELT HOT; FEELS UNDER THE WEATHER; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 180 pounds, and height was 67 inches. The patient's concurrent conditions included non-smoker, and alcohol user, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug usage and no past medical history not with covid or anything like that.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 30-JUN-2021 18:00 for prophylactic vaccination. Concomitant medications included ibuprofen, paracetamol, tramadol, and venlafaxine. On 30-JUN-2021, the subject experienced felt hot. On 30-JUN-2021, the subject experienced feels under the weather. On 30-JUN-2021, the subject experienced temperature of 101.9-102.1. Laboratory data included: Body temperature (NR: not provided) 101.9-102.1. On an unspecified date, the subject experienced lost my taste buds a little bit cinnamon sticks put in mouth but could not taste it at all, body aches occurring here and there they come and go, and left arm sore/aches in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm sore/aches in legs, and body aches occurring here and there they come and go, and the outcome of temperature of 101.9-102.1, feels under the weather, lost my taste buds a little bit cinnamon sticks put in mouth but could not taste it at all and felt hot was not reported. This report was non-serious.

One minute after vaccination patient began to develop urticaria on his upper anterior chest. Patient complained of dry mouth and throat and "not feeling well". Patient was given 50mg of PO benadryl. Rash on chest resolved but swelling began in face around eyes, and blanchable redness developed on forehead and patient complained of itching scalp and nausea. 24 mg of methylprednisolone and 8mg of Zofran was administered. Patient maintaining a normotensive state throughout events, hr in the 70s and oxygen saturation 96%. at 0910 patient had returned a normal state, no signs of swelling or difficulty breathing. Fire team was called for evaluation and patient was observed for one hour. No return of symptoms.

Employee had shortness of breath, diarrhea, vomiting, fatigue and hypoxia and was taken by ambulance on 7/17/21 where he was given IV fluids and sent home. He returned to Emergency Room on 7/22/21 due to excessive thirst, frequent urination, blurred vision, and nausea. Employee was hyperglycemic with a blood sugar of 600. IV fluids given.

Clusters of mouth ulcers formed on lip, tongue and cheek. Some very deep and painful, in the 3 days since I?ve experienced these, new ones have sprung up and none have healed

Approximately 5 minutes after receiving the injection, I became dizzy and lightheaded. My eyesight became blurry and my hearing very "tinny". I felt nausea and thought I was going to throw up. I sat down in a chair and was given a granola bar and some water. After about 3 or 4 minutes the majority of these seemed to fade, but I still felt slightly "off". Approximately 9pm that evening I felt very fatigued, so I went to bed. At approximately midnight, I woke up shivering, extremely cold, and sweating. Around 2am I had a fever of 102.3. I took some Tylenol to try to bring my fever down, which seemed to help. Around 9am the next morning my fever was gone, though I still felt extremely fatigued. Later that evening, after several naps, I started to feel a little better. Most of these adverse events were resolved by 28 hours after injection. I had arm soreness at the injection sight that felt like having been punched in the arm for about a week after the injection.

After receiving my Johnson and Johnson COVID vaccine I experienced a lack of motor function in my throat. Approximately 40 minutes after having received the shot, I lost the ability swallow. A tingling sensation took the back of my throat and eventually felt as though it moved into my head. The whole experience lasted a couple of minutes. Since that time all other symptoms have been normal, sore, slight fever, etc.

Initial: 12 hours following - fever, chills, nausea, diarrhea, dizziness Following (since vaccination): extreme dizziness, eye pressure and blurry vision, tingling in scalp and face, back pain, hearing loss, and tinnitus

My vision has been affected. Starting 4 days after the shot, I had discomfort while driving. I was wearing contacts and had my prescription renewed 2 days before my vaccination so I don't think my contacts are the issue. I The discomfort feels like my eyes are having trouble focusing even though I can see fine. It's as if my eye muscles are strained. It also feels like I've been trying to look at something very close to my eyes for a long time even though I haven't. I'm not certain, but I think the discomfort is on top or behind my eyeballs. My optometrist told me to stop wearing contacts for 2 weeks and that's helped but I still have slight discomfort still, especially when driving or having to focus on near and far objects.

Patient endorsed unilateral eye twitching with subsequent development of generalized unilateral facial droop. Seen by provider the evening of 1April2021 where he was diagnosed with Bells Palsy.

Rash all over the body that causes itching more intensely on the legs, arms, and hands; Inflammation of the lips and loss of sensation in the lips, and inflammation of the hands.

Patient reported feeling dizzy, nauseated, Loss of hearing and lightheaded ness Patient seen by medical team, refused medical transport, stated symptoms improved, signed AMA form

Patient had an episode of fainting about 10 mins after vaccine administration. after regaining consciousness he had rolling eyes and seizure and 2nd episode of fainting. The fainting episodes were for few seconds (30-45 sec). Patients feet were elevated and paramedics were called. while waiting for the paramedics we had patient drink water and orange juice as he was on diet and had taken only 300 calories per patient. Used cold compress on his face and neck, patient was comprehending well afterwards. paramedics arrived and examined the patients vital and asked if he would like to go to the hospital even though patient seemed fine. Patient denied going to the hospital and paramedics left afterwards. patient waited for 30 minutes afterwards and then left. we called the patient later and he was doing fine.

allergic reaction. Patient reports blurry eyesight, headache, fever, feels like he cant think clearly, patient reports balance has been off, and back pain x 6 hours. Received J&J vaccine at 1800 last night. Denies vomiting and diarrhea.History: pt had J&J COVID-19 vaccine yesterday evening and here with headache, lack of balance (but able to walk), blurry vision with loss of peripheral vision, fever, back pain, some nausea, here for eval. Says he was in his usual state of health before vaccination and no recent sick contact or COVID-19 hotspot visit. No prior co-morbidities and denies recent illness/injury, use of any meds.

Patient is employee's son. Employee reported that he woke up at 3 a.m. c/o difficulty breathing, face and lips swollen. They gave dose of Benadryl and he seemed comfortable. Visit to Urgent Care in the morning, they administered a steroid shot. By Thursday afternoon, unusual looking rash all over. Visit 4/9/21 to PCP advising good possibility that it is delayed reaction to vaccine, since patient has not had anything different to eat or have contact with.

Approx 5 minutes post-immunization patient reported momentarily blacking out and dizziness. Patient was instructed to sit back down and was given a cold compress to apply to back of neck. Patient reported visual disturbances and shortness of breath. Patient was instructed to lay down with his feet elevated. Patient reported some numbness in left arm and hand (arm that vaccine was received in). Patient remained laying down with feet elevated for approx 10 minutes until he began to feel better. Patient then moved to sitting position on chair, with feet resting on second chair, where he remained until he began to feel back to normal. Patient was monitored for additional 15 minutes before patient left. Patient was feeling normal when he left the pharmacy area.

Systemic: Tasting iron in mouth-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Numbness at injection site

Approximately 2 minutes after the patient received the vaccine, the patient had other questions and while talking about the vaccine, the patient's eyes rolled back and he experienced a vasovagal reaction (syncope). Although he was sitting in a chair, his head fell to the left and his forehead bumped the table. The patient's legs were elevated and his upper body was laid back. Ammonia inhalant was crushed and immediately placed under the patient's nose. The patient came back to consciousness approximately 30 seconds after passing out. Patient was asked what symptoms he felt leading up to passing out. He said that he suddenly felt dizzy and does not remember much after. Patient states that he did not eat breakfast prior to receiving the vaccine and has a history of not doing well with needles or vaccines. He states that he now feels completely fine, however, the patient was advised to stay 30 minutes for monitoring, and once he felt comfortable standing up, a nurse walked with him to the observation area. Patient was provided an ice pack for his forehead. Observation nurse was notified of the adverse event and is now monitoring the patient.

2-3 Minutes after receiving the vaccine, the patient was seated in the waiting area for his 15 minute wait time. We heard a crash and the yell of his wife and 3 children. Found the patient laying on his back on the ground. Patient was breathing, but non responsive to tapping and shouting. 911 was called. Patient regained consciousness after about 15-30 seconds. He complained of being hot, thirsty, having to go to the bathroom and feeling out of it. He appeared pale. We did record a BP of 95/57. He remained conscious until EMT's arrived. He was attended to and taken to the ER by emergency personal.

3-4 days after the one dose shot i have been getting random welts of itchy/swelling over my body..most recent is very swollen lips. actively swollen at this moment.. Benadryl does not seem to help. 1 day after shot i had a 102.5 degree fever for 36 hours.

April 9 Morning: woke up with a mild headache. April 9 Afternoon (12 pm): feeling fatigued and headache grew worse. Plus chills. April 9 (5pm): feeling very cold and tired (worse than noon) April 9 (11:30pm): This time was the most severe for me in respect to side effects. I believe my headache woke me up. The headache was so bad that my eyes hurt as well (swollen almost). I think my fever broke. I felt very ?heavy? all over. The main concern was that around midnight I was having sharp pains on the right side of my body, near where my Liver is located. That was one effect that I did not read about. The sharp pains happened once every few minutes. I considered going to the ER but wasn?t sure. I ended up just changing my shirt, got some water, and went back to bed. April 10: My appetite was not normal, I ate but very little. The sharp pain on my right side went away but I had a minor headache for the rest of the day.

Started with slight tingling feeling in my fingers. Then I became tired and starting shivering aggressively. Then got the chills pretty bad as I laid down to go to bed. Became really sore all over. Couldn?t stay asleep for more than an hour. Later in the night I started sweating and felt really hot. Also became quite thirsty. During the entire night I also had horrible dreams. After about 5am things started improving. Had some light sensitivity in the morning for a shot bit. By noon I was almost back to 100%

I typically faint when getting shots or blood drawn. I did faint about 10 seconds after the initial shot injection. I was conscious throughout but was not able to speak clearly or control my body even though I could hear everything going on around me. After 30 minutes, I was feeling back to normal. The remainder of the day I felt drowsy and a little out of it. At 12:15am I began to get severe chills and shakes. This lasted throughout the night but was the worst from about 12:15-1:00am. I woke up at 4am with a fever and sweating. My entire body was stiff and in pain with aches specifically in my arms and legs. Very sore pain in my left deltoid where the shot was injected and is still slightly sensitive. It felt like my veins were stiff and in pain and it hurt to move. I had what I can describe as flu like symptoms (i.e. my teeth hurt, my body ached, fever, shakes, body stiffness and overall tiredness and weakness). These all lasted until about 6:30am at the worst and were relieved over the next few hours. I started to feel back to normal around 3pm later that day. That was April 11th. Last night, April 12th, I had trouble sleeping because my left arm was in pain from my elbow to fingers. It was a lingering pain that went away by this morning and is mostly gone now (morning April 13th).

Was sitting in chair, fell over. Hit head on cement floor. Seized for 35 seconds. Eyes rolled in to back of head and foaming at the mouth. Awakened suddenly to confusion. Escorted off floor to wheelchair. Reoriented.

Immediate loss of consciousness. I lost color in my face (pale white) I experienced chills and cold. My hands were shaking for about 4 hours following. From the fall, I developed right shoulder pain, right hip pain, jaw pain, right eye pain, right chest pain, right back pain, and a black eye. All symptoms have lasted a week.A I also had fever for about a day, along with generally feeling weak/unwell.A I

About 15 minutes after the injection I felt light headed and my chronic back pain was completely gone. Around 5 hours after injection I was overcome with extreme lethargy and had to sleep. 8 hours after injection I woke up very nauseous and could not stop salivating, however I never puked. I woke up again 18 hours after injection and felt nauseous and my chronic back pain had returned. I also had a weird throbbing pain in the right side of my neck and in the lower left side of my left leg. All symptoms were gone by ~36 hours after the injection.

(URGENT) MULTIPLE - severe, sharp shooting pain up from left side of neck to upper chest. - Lasted 3 weeks and still will come every now and then. - 2 day neck stiffness (normal) - complete immune system break down: Lost partial taste in tongue, developed oral thrush that was resistant to diflucan and nystatin. - 2 day stint with allergies (Sneezing, stuffy nose, no yellow mucus or fever) - Periodic headaches - swelling of tongue - fatigue lasted weeks. - easily bruising or bleeding under skin after getting minor scratches. Never healed properly (As in disappear) -glossy watery, red eyes with swollen nasolacrimal duct (inside pink corner of eye. Puffy and red.)

I experienced a sudden onset of symptoms approximately 7 hours post-vaccination. Symptoms started with severe chills, elevated heart rate, fever (~102), and progressed into muscle and joint soreness, severe migraine with sensitivity to light, and strong fatigue, coupled with insomnia. The symptoms were severe enough that I considered going to the hospital, but ultimately did not. Fever, chills, and elevated heart rate subsided by the next morning (~12 hours after onset), but muscle soreness, migraine, and fatigue lasted for another 12-24 hours, along with a loss of appetite. I am an otherwise healthy, male adult with no outstanding medical conditions whatsoever. This was one of the most severe immune responses I have ever had, including actual illnesses. I have received other vaccinations in the past and never had any response nearly as severe. I was significantly concerned for my overall health during the height of the vaccine response, and I wanted to report this to ensure that is aware of these types of responses, and can help prepare others by informing them adequately of the types of responses to expect from the vaccine. This response very much took me by surprise in terms of severity -- I had to call out of work at a critical time.

4/7/21 symptpoms began tired & aches. Nighttime severe swelling of face, lips & throat. Gave Benedryl 4/8/21 Visit Urgent Care, swelling slightly less, slight rash appears on arms & body. They gave a Cortisone injection & continue Benedryl. 4/9/21 Visit to PCP Doctor, swelling much less, rash became defined circles & trail lines over arms, knees & upper body. He determined allergic reaction to Covid Shot due to no exposure to other new factors. Determined the rash to be "Erytthema Multiforme". Give Allergra allergy medication. 4/10/21 swelling gone, rash only slightly visable, still some body aches. 4/12/21 swelling, rash gone, pretty much back to normal. This whole event began one week after shot.

This is a comprehensive neurological evaluation for a very pleasant right handed 32 year old gentleman who denies any past medical history who presents to the hospital with several day progressive visual changes and facial weakness. Patient reports he noted on Saturday that he had somewhat of a headache, he does get headaches from time to time in particular while looking at screens the television, he did have some associated blurring of his vision as well. This was not the worst headache of his life. He had no other associated symptoms. He went to bed on Saturday, he awoke on Sunday and went out to eat and noted that he couldn't form his mouth around the utensil, his face and lips and mouth felt weak. He still did have an intermittent headache and perhaps some neck pain as well at this point. His vision was still blurry. He denies any recent trauma, no car accident no whiplash no falls. He did go to an outside facility where a CT brain was performed and was normal he was told. He has noted yesterday that he could not close his eyes unless he did it manually, also he notes the way his voice sounds is different to him. He has not appreciated any weakness of his arms or legs. He is able to lift up his head off the bed without trouble. He does not think he has a hard time swallowing or breathing per se however he does describe that he is more "aware" of his breathing. He describes paresthesias of his face and around his mouth. No recent URI or diarrheal/GI illness, he did receive the Johnson & Johnson COVID -19 vaccine March 31st. Seen and evaluated in the ED with ed staff. He does report he recently ran a virtual type marathon over the course of 16 days. Clinical context and exam most consistent with that of GBS type variant (?Miller Fisher). Treated with IVIG. Symptoms improved after 1 dose. 4 more doses pending.

Patient had standard side effects (fever, fatigue, muscle soreness) day 1 and 2 after vaccination. Starting approx. 3 days after vaccination, patient started noticing altered smell and taste, which has gotten worse in the 14 days since vaccination. Patient also has fatigue and has been experiencing weakness since vaccination. These symptoms are identical to the symptoms the patient had with COVID (starting ~3 weeks after contracting COVID and lasting over a month). The patient contracted COVID in December 2020 and had fully recovered prior to vaccination. Recrudescence of symptoms appears to be due to immunological response to the vaccine.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Numbness, tingling in hands/ mouth/ tongue. History of similar reactions with other vaccinations per patient. Patient has a phobia with needles.

loss of consciousness two times, light headed and dizzy. Throat felt uncomfortable but not swelling or closing

Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Tingling of Lips and Tongue-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium

On 03-04-2021 I started to experience respiratory problems, my nose was clogged up with mucus, had some difficulty breathing and was having like an asthma attack. I do not suffer from asthma prior to this vaccine. I experienced headaches, fatigue, congestion, my ears were plugged and I also developed a rash on my arms and I also noticed a lymph node in my neck that I did not have prior to the vaccine. When I went to see my doctor my symptoms were not as prominent and the lymph node in my neck is decreasing in size.

Patient received a Johnson & Johnson vaccine today. Shortly afterwards while waiting in pharmacy area, we were alerted that the patient was unresponsive by his wife. Immediately responded to patient. Code white called and management responded. Tried to get him to wake up, he opened his eyes but immediately closed them again. I attempted to keep him alert and eyes open. This proceeded to go on for several minutes. Ice packs were placed on neck and wrists. Feet elevated. Once patient was alert and oriented, water was provided and patient was instructed to take small sips. Patient was kept in pharmacy area for additional 15 minutes once he was back to normal. Patient stated that when he passed out, he felt tired, couldn't see or hear.

6 days after receiving the vaccine I began to feel I'll. My arms were numb, I was sweating profusely, and was having a bad headache while at work. Suddenly I began to get tunnel vision and felt as if I was about to pass out. I was transported via ambulance to Medical Center where I was given IV and medication to treat vertigo and massive head pain/migraine. Since that day I have continually dealt with severe neck and head pain leading to migraines causing visual issues (auras and blind spots), vertigo, and nauseau.

Patient reports feeling dizzy spells and tunnel vision. Was not temperature related. As he was working, he felt dizzy enough that he may fall down. Started 24-32 hours after dose, and is still going 5 days later. Referred patient to care or emergency room.

APPROXIMATELY 4 MINUTES AFTER ADMINISTRATION, PATIENT REQUESTED TO LAY ON THE FLOOR DUE TO DIZZINESS AND BEING HOT. I ACCOMPIONED HIM TO THE FLOOR, AS PATIENT LAYED DOWN, HE LOST CONSIOUSNESS, EYES ROLLED TO BACK OF HEAD,SWEATING AND UNRESPONSIVE TO MY VOICE OR TOUCH. DEEP SNORE. 60-90 SECONDS, LIFTED HEAD, THEN SLIGHTLY BUMPED BACK OF HIS HEAD. AS PATIENT WOKE UP, HE ASKED WHAT HAPPENED. INSISTED AND REPEATED HE WAS ALRIGHT. I KEPT HIM ON THE FLOOR FOR APPROXIMATLY 7 MINUTES UNTIL FIRST RESPONDERS ARRIVED. THEY SAT HIM IN THE CHAIR, ASKED SEVERAL QUESTIONS AND TOOK VITAL SIGNS, AND EXAMINED BACK OF HEAD. HE SIGNED OFF WITH THE AMBULANCE ATTENDANTS AND REFUSED TO GO WITH THEM. HIS MOTHER ARRIVED AND STAYED WITH HIM FOR ANOTHER 7-10MINUTES. PATIENT LEFT WITH FAMILY MEMBER, SIGNED OFF AT THE REGISTER .

The patient had reported itching to his arms and legs, ears were swollen, lumps on his chest. and was getting lightheaded 6 to 7 minutes after he had received the covid-19 vaccine. The patient reported his cousin had an epi-pen, which he used and felt better afterward.

About 4 weeks after my J&J vaccine I noticed blurred vision along with (what I can best describe as) ?neon colored eye floaters?; followed by an intense headache that lead to violent vomiting; after that day stopped; but headache, muscle ache (at base of skull and neck /shoulder area), mental fog / inability to focus, mild to intense vertigo all continue to today. A week after chest pain started occurring.

MEMORY LOSS; DISORIENTATION; EYE PAIN; FEELING WEIRD; FEVER; VERY INTENSE HEADACHES/ PRESSURE IN THE HEAD; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies, drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced memory loss. On 23-MAY-2021, the subject experienced disorientation. On 23-MAY-2021, the subject experienced eye pain. On 23-MAY-2021, the subject experienced feeling weird. On 23-MAY-2021, the subject experienced fever. On 23-MAY-2021, the subject experienced very intense headaches/ pressure in the head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eye pain, and fever on 24-MAY-2021, had not recovered from very intense headaches/ pressure in the head, disorientation, and memory loss, and the outcome of feeling weird was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

After about 13 minutes, patient stated that he started to have blurry vision about 80% of it was gone, he felt nauseous, and starting to sweat a lot. Then patient threw up a little bit. After that we gave gave him some water and glucose tablets. Patient hasn't eaten all day either.

33 yo M with NKA, history of fainting in the past and anxiety about vaccines and needles was in the drive through clinic to receive COVID-19 Janssen vaccine on 3/12. After receiving the vaccine at 0943 (lot # 1802070) in right deltoid, the patient began to feel anxious. He had been or was watching EMS working with another patient who had experienced an ADR. He began to feel "floaty" and noted he was blinking uncontrollably. He reported some tunnel vision/blurred vision. He states he recalled a nurse rubbing on his chest and placing a cold pack on his neck and at this point he began to feel better. He states he was trying to "fight" the feeling and was tensing up his extremities but denied convulsions or any loss

Patient with orolabial swelling on both upper and lower lip with hives present over forearms, thighs B/L, and right upper eyelid. No pharyngeal edema. Normal Breath sounds. Patient administered two rounds of EPI autoinjector along with IV Benadryl and solumedrol. Improvement in Hives and Swelling after medication administration

Pt reported tingling, swelling in lips and tingling in arm 32min post vaccine. Administered epi 0.3mg and 50mg IM Benadryl and called 911. Pt transported to local ER awake, alert and breathing on his own. Called ER 5 hours later. Pt continued to be observed. No more epi had been administered.

I first felt the usual dead arm feeling and then that quickly progressed into a full-blown hot flash/feverish feeling accompanied by a splitting headache that I had last all of last night. Now I still have a minor headache and a dead arm after taking Tylenol (Rapid Release). I also felt very weak and fatigued all night with a dry mouth and plugged up sinus. Felt like I was going to be knocked out for 24 hours. I can hardly do these basic task on my work laptop.

Approximately 12 hours later i developed a rash under my bottom lip, The following day approximately 24 hours later I developed more rashes on my left cheek, right cheek and under my right eye. Approximately 33 hours after vaccination i developed another rash just to the right of the corner of my mouth. The rash is itchy and is slowly getting worse.

I received the vaccine on 3/13 and my wife developed COVID symptoms on 3/23 and received a positive COVID result on 3/25. I felt fine the entire time and the morning of 4/6 I couldn't taste or smell. I was given a nasal test and it came back positive for COVID. It's likely that I contracted it from my wife before the full two weeks were up, but I thought it best to report so any information that could be helpful could be used. My symptoms have not changed and I don't feel near as bad as after the vaccine or as my wife who didn't have the vaccine was!

It was a drive thru shot facility. They gave me a shot in my left arm and asked me to pull around to park. I parked my vehicle and didn?t feel well so I switched seats with my girl friend. As soon as I got into the passenger seat I was out. She said My eyes rolled back in my head and I started shaking and eyes at this point she said where going up down and side to side . She ran for help and after about 1-2 minutes I woke up. I thought I passed out so I instantly put my feet on the dash of my car and the pharmacist gave me water and chocolate milk. He then checked my heart rate it seemed good and after 20 minutes he let us go home.

Injection +8 hours: strong headache, full body sensitivity, body fatigue, flush neck and face, full body chills, full body shivering. +9 hours: hands pale, thumb capillary refill L: no refill, R: 6 seconds. HR98 +10 hours: Temp: 101.4, thumb capillary refill L:2 R:2. Eyes bloodshot, headache over eyes/temples +11 hours: Temp 102.5, HR 109, SpO2 95 +12 hours: full body chills transition to full body slight flush/damp. Headache pulsing behind/above eyes and temples. +18 hours: Temp 100.2, HR 87, SpO2 99, headache continues.

After administration of Janssen vaccine 0.5mL, pt reported arm was hurting and he began moving arm. CMA noticed that continued to shake arm after 5 minutes but patient was alert and oriented x 3. CMA thought the way he was shaking his arm seemed irregular so she advised pt he would be taken to an observation area for further observation. Half way to the observation area, pt reported to CMA that he was seeing spots and felt like he was going to get sick. CMA called for help. Patient experienced a syncopal event just as he made it to the chair. Several staff was helping to support patient. Legs were lifted to another chair. Patient was not responsive for a short time, very diaphoretic, breathing regular and unlabored. Patients eyes then rolled upward toward the ceiling and patient's entire body began shaking uncontrollably while staff managed to keep patient from falling to floor from the chair. Once patient was conscious, he was able to state his name but reported he was very confused and could not think clearly. He was able to sit upright. In the meantime while patient was shaking uncontrollably, staff sought urgent care provider to come and see patient. Patient was then taken over to the urgent care side of the building to evaluate and treat patient.

Saturday, 10 Apr 2021, 01:00AM MT: Woke up with substantial upper back pain and slight nausea. Took Alieve + hot 30min shower with water directed at upper back. Went to sleep at 04:00AM MT same morning. Sunday, 11 Apr 2021: Woke up with some degree of conjunctivitis (pink eye) in right eye. Eye was red and experienced pain due to sensitivity to light. No water or other discharge. Additionally, upper back discomfort still experienced. However, such went away with Tylenol. Monday, 12 Apr 2021: Some form of conjunctivitis continued in right eye. However, light sensitivity lessened greatly; eye minority affected by sunlight and no longer affected by indoor bright house lights. No water or other discharge. No back pain. Tuesday, 13 Apr 2021: Right eye is getting better. Eye is still somewhat red. No more pain due to light sensitivity. No water or other discharge. No back pain.

33yr old patient with unknown PMH and allergies, presented to office for COVID-19 injection on 4/10. CMA administered JANSSEN COVID19 VACC (LOT # 207A21A, exp 6/23/21) IM to patient's right deltoid at 0841. Immediately following injection, patient's arm began to shake which continued past 5min. Patient endorsed seeing black spots, then nausea. Patient denied shortness of breath, difficulty swallowing, chest pain or other symptoms. Patient noted to be pale, diaphoretic, and fainted upon sitting down. Reporter observed patient shaking. Patient admitted to urgent care for further follow up. At 0904, BP 136/82, HR 79, 98% RA. At 0947, BP 93/61. Patient given NS 500mL bolus IV. At 1025, patient denied dizziness, weakne At 1025, patient denied dizziness, weakness, or nausea. Patient changed to sitting position with mild nausea. VS remained stable. At 1035, patient ambulating without issues. Patient discharged home in stable condition. Patient noted he had not eaten prior to injection. Urgent care provider indicated per physical exam consistent with vasovagal reaction to vaccine. POC = 142, given crackers and water x 2.

Noticed headache bottom left back of head before bed. Woke up at 2:30am with right leg fully asleep. Attempted to wake leg up, lost equilibrium, stumbled, lost hearing, couldn't put words together to tell wife what was going on and ended up on the floor to regain composure. Had difficulty putting on clothes to go to hospital. Went to ER, had severe diarrhea there, they did blood work and EKG, sent me home saying maybe I feinted. Had high blood pressure at ER, 150/86. Felt weak and 'off' sense the event, felt tightness in chest and odd limb pain past 72 hours. Woke up at 3:30am on 4/15 with left arm asleep, went back to bed fine. Never had these symptoms before.

Day 1 of getting the vaccine, i felt great, seemed to have a lot of energy. Day 2 and since day 2 (today is 4-15-21) I have had ear infection symptoms in left ear, foggy hearing in that ear, pain, and low grade fever ranging between 100 and 99, and fatigue. (this stayed the same even taking Acetaminophen)

SEVERE CHILLS; BEING INCREDIBLY HOT; GENERAL LIGHT HEADEDNESS; THIRSTY ALL NIGHT; URINATED (PEED) A LOT AT NIGHT; PAINFULLY CHAPPED LIPS; TIREDNESS; HORRIFIC HEADACHE; MAYBE SLEPT FOR 4 HOURS; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's concurrent condition included obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) .5 ml, administered on 07-MAR-2021, around 11:30 am for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced maybe slept for 4 hours. On 07-MAR-2021, the patient experienced severe chills. On 07-MAR-2021, the subject experienced being incredibly hot. On 07-MAR-2021, the subject experienced general light headedness. On 07-MAR-2021, the subject experienced thirsty all night. On 07-MAR-2021, the subject experienced urinated (reported as 'peed') a lot at night. On 07-MAR-2021, the subject experienced painfully chapped lips. On 07-MAR-2021, the subject experienced tiredness. On 07-MAR-2021, the subject experienced horrific headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, severe chills, horrific headache, general light headedness, and being incredibly hot, and the outcome of thirsty all night, painfully chapped lips, urinated (peed) a lot at night and maybe slept for 4 hours was not reported. This report was non-serious.

I received the vaccine Saturday 4/10/21 at 9 am. By 8 pm of the same day I had fever, chills, headache and body aches. For about 30 minutes I saw a white spot on the peripheral view of my left eye. By Monday, I felt dizzy and bottom right part of my chest hurt when taking deep breaths. The dizziness and chest pain lasted all week, still feel feel it today 4-18. My doctors office told me vertigo was a common side effect. On Thursday 4-15 every time I bent down and tried to get up, my right leg hurt as if I had exercised. At the moment I haven?t gone into work since Monday 4/12 since my job requires a lot of physical work. I have mostly been home resting but don?t feel ready to go back to work. If someone calls can it be a Spanish speaking person please.

2-day history of ringing in his ears, spikes of pain throughout his body, and dizziness; did not require treatment and symptoms resolved, has not had any additional symptoms.

SWOLLEN LEFT EYE; HEADACHE; INJECTION SITE SORENESS; TIREDNESS; This spontaneous report received from a patient concerned a 33 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: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection site soreness. On 09-APR-2021, the subject experienced tiredness. On 21-APR-2021, the subject experienced swollen left eye. On 21-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness, and tiredness on APR-2021, and had not recovered from swollen left eye, and headache. This report was non-serious.

Patient received vaccine at 545pm. Administration noted as normal per pharmacist (rph), pt walked to waiting area chair. Approximately 7 minutes later pt asked for water. Pharmacist brought water to pt and asked if he was feeling okay. Pt stated he was having trouble hearing the rph. Rph walked back to pharmacy and continued to observe patient. approx 2 min later, pt passed out from seated position. rph did not see fall. both technician and rph ran out to pt. pt face down and water bottle spilled. assistant store manager reported as well. pt came to immediately and sat up on floor. He attempted to stand to sit in chair, but rph asked him to remain on floor. rph went to get emergency kit while tech observed patient. rph came back with instant ice pack. First pack did not activate but second pack did and had patient hold to his head as there was a visible red spot. Patient continued to be observed and was texting on phone during observation. Patient came up to pharmacist at 6:15 to ask to leave and Rph asked if pharmacy representative to could walk him to his car. Patient denied and Rph asked him to wait additional 5 minutes for observation. After 5 minutes, patient left. Today I called patient. He said he is feeling better and still has mild pain and a headache today.

BRAIN FOG; CANT FOCUS; COULD NOT SLEEP; NUMBNESS AT THE BASE OF THE SKULL; SEVERE HEADACHE; BODY GETTING HOT; BODY ACHES; LEG PAIN; BODY FATIGUE; MUSCLE PAIN; NAUSEA; PALPITATIONS; FAST HEART RATE; This spontaneous report received from a patient concerned a 33 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: unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced fast heart rate. On APR-2021, the subject experienced palpitations. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced body fatigue. On APR-2021, the subject experienced muscle pain. On APR-2021, the subject experienced nausea. Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative, Not reported, Headache (NR: not provided) 6-7/10 pain level, Leg pain (NR: not provided) 9/10 pain level, 7-8/10 pain level, and MRI (NR: not provided) NORMAL. On 06-APR-2021, the subject experienced body getting hot. On 08-APR-2021, the subject experienced brain fog. On 08-APR-2021, the subject experienced cant focus. On 08-APR-2021, the subject experienced could not sleep. On 08-APR-2021, the subject experienced numbness at the base of the skull. On 08-APR-2021, the subject experienced severe headache. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) NORMAL, CT scan (NR: not provided) NORMAL, and ECG (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body getting hot on 08-APR-2021, and fast heart rate, had not recovered from severe headache, brain fog, cant focus, nausea, body aches, leg pain, muscle pain, body fatigue, numbness at the base of the skull, and could not sleep, and the outcome of palpitations was not reported. This report was non-serious.

Patient received vaccine in a drive up clinic and was waiting in his car during the 15 minute observation time. 10 minutes after the vaccine, he became lightheaded and alerted for medical attention. When we arrived at his car he was having tonic clonic seizure like activity which lasted about 20 seconds. Patient was reclined in his car seat, VS taken and stable. Oriented x4 but described feeling light headed, tingling in left arm and lips, and diaphoresis. EMS arrived and assumed care. Extended observation showed improving vital signs, and resolution of described symptoms. Patient was released from EMS care and was transported to the ER by a friend for further eval.

patient was feeling dizzy and head hurt about 5 minutes after administration. He took his bloop pressure which was high 160/98. I kept monitoring the patient and had slight rash on chest which went away and after 5 minutes time . Then started to feel itchy but no rash appeared. after about 20 minutes didn't feel better so gave 25mg benadryl capsule and called 911. EMS took patient to the hospital because patient said tongue felt heavy.

After 5 mins of getting the vaccine, pt had a syncope and/or seizure episode. Pt's eyes started to roll back and was only showing the white. His hands were flinching into fist and pt was unresponsive. This lasted about 20-30 secs. We called ED and got the operator on the phone. When we started to give the operator information, pt starts waking up. Pt's mom didn't want the ambulance to come since pt is now awake so we told the operator everything is fine now and hung up. Pt's forehead was sweaty and facial color was very pale. We gave pt some water to drink and asked pt to continue to sit there and relax. Pt has no idea of what happened he said he just remember one moment talking to his mom and the next moment she was holding him up. Pt sat there for a total of about 1 hour and he said he was fine so they left. We informed mom and pt to please go the UC or ER for follow up but they declined. They said they will have him rest and hopefully things will be OK soon. I checked his Blood pressure x 2 and both times they were good at around 128/87. Gave mom my pharmacy business card to call with any further questions or concerns

Patinet received his Janssen Covid Vaccine today. He was fine in the immunization room and he went to the waiting area. Patient lost conciousness and fell on his partner. We went to him when we heard from another customer. He said he was feeling really lightheaded and thirsty. He had Syncope (Paleness, excessive sweating, and Loss of Consciousness for few seconds). He mentioned he did not drink much water today before the appt and also worked outside in the sun. We had him wait for 30 mins and he was perfectly fine. Coach came to do an incident report and then he left. His partner was with him all the time.

PRESSURE PAIN FROM THE LEFT CROWN OF THE HEAD; SWELLING NEAR THE LEFT EYE; PRESSURE IN THE LEFT EAR CANNEL; SOFT TISSUE SWELLING AROUND THE CROWN/SOFT TISSUE LUMPS OR SWELLING/NEW BUMPS ON HEAD; PRESSURE PAIN IN THE LEFT EYE NEAR THE BROW; SINUS PRESSURE; SORENESS IN HEAD; SORENESS IN BACK OF NECK; SORENESS IN INJECTION SIRE; SORENESS IN THE LEFT ARM; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. takes blood pressure medications when necessary. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced soreness in the left arm. On 14-JUN-2021, the subject experienced soreness in injection sire. On 15-JUN-2021, the subject experienced soreness in back of neck. On 15-JUN-2021, the subject experienced soreness in head. On 17-JUN-2021, the subject experienced pressure pain from the left crown of the head. On 17-JUN-2021, the subject experienced swelling near the left eye. On 17-JUN-2021, the subject experienced pressure in the left ear cannel. On 17-JUN-2021, the subject experienced soft tissue swelling around the crown/soft tissue lumps or swelling/new bumps on head. On 17-JUN-2021, the subject experienced pressure pain in the left eye near the brow. On 17-JUN-2021, the subject experienced sinus pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in the left arm, and soreness in injection sire on 16-JUN-2021, and had not recovered from soreness in back of neck, pressure pain from the left crown of the head, swelling near the left eye, pressure in the left ear cannel, soft tissue swelling around the crown/soft tissue lumps or swelling/new bumps on head, pressure pain in the left eye near the brow, soreness in head, and sinus pressure. This report was non-serious.

4/13/21 33yo male presents to the ED for evaluation of general malaise after receiving COVID vaccine yesterday. Pt reports body aches, photophobia, headache and abdominal pain that started today. Assessment: 33yo male presents to the ED for evaluation of general malaise after the COVID vaccine. No chest pain or SOB. Differential diagnosis: Vaccine reaction, dehydration Plan: Offered labs and IV fluids vs PO hydration Pt prefers to go home and rest and take ibuprofen and tylenol for pain. Reassured that symptoms are normal after COVID vaccine. ED Course and Disposition: Discharge.

Became extremely weak and sick for 3 days after the shot. Had a grand mall seizure 19 days after vaccine. Also had a really bad headache and lost vision in my left eye for nearly 8 hours about 2 weeks after the seizure. Have had dizziness and been feeling week for nearly 2 months after vaccine and still cannot manage to get rid of the constant headaches and loss of thought due to these side effects.

Whenever I drink anything with caffeine, I get dizzy. I've had caffeinated drinks my entire life, but since getting the shot, I have gotten dizzy every time I have consumed caffeine. I generally feel a lightheadedness at the top of my head, and it makes it difficult for me to concentrate or work at the computer. I also develop vertigo sometimes whenever I try to move around. Also, whenever I have this dizziness, my ears feel full and stopped up. The symptoms persist as long as the caffeine is in my system; once the caffeine leaves my body, the symptoms cease. I am scheduled to see my doctor about this on 7/30/2021.

The left ear of the patient became red and swollen. The patient did have on a mask that was tight fitting. The mask was removed on that side and the swelling and redness started to subside. Patient did wait in the pharmacy for 30 minutes before leaving and said he was fine.

Patient received vaccine and five minutes after injection he began to see dots, slowly progressed to the floor and passed out. Patient reports hitting his head. After recovering patient states he woke up with healthcare personnel making sure he was ok. He describes his experience as taking deep breaths, he felt chills, sweats and nausated. He refused further treatment.

Patient given COVID J&J vaccine and within a minute complained of being dizzy/faint. While seated, patient fainted, eyes rolled, arms and hands clonic/tonic activity which caused him to fall from chair. Doctor was able to hold on to upper back of patient as both fell to the floor. Patient hit head on carpet with not traumatic injury. 911 was called and by time of paramedic arrival the patient was alert and oriented. Patient was assited to wheelchair and taken to ED for evaluation.

Sedation of tongue swelling approx 10 minutes after injection. VSS. Recommend transport to local ED for evaluation NAD at vaccine site prior to transport

Patient felt fine after vaccine until seated in observation area. Became very dizzy, vision became blurry, and patient started sweating. Laid patient on floor and elevated legs and feet. After about 10 minutes patient stated symptoms had resolved.

Immediate numbness of arm/hand. Burning pain, sweating, freezing and cotton mouth feeling within 10 minutes of injection Injection site was at top of humerus bone area

Muscle aches and severe shaking due to chills reported 8 hours after injection, fever of 102 and mild nausea reported 12 hours after injection, continued fever and muscle aches from 12 hours - 30 hours after injection, ocular pain and tenderness reported 30 hours after injection along with continued muscle aches

Sever Allergic reaction. Had hives on face, head, neck, shoulders, back, chest, rib cage, arms and hands. Moved to the mouth and lips. Self administered 25mg of benedryl at 1920. Symptoms worsened. When swelling moved towards mouth at around 2010, patient went to the ED. ED administered 25mg of benadryl and 20mg of pepcid. At 2130 swelling noticeably decreased patient discharged without seeing ED physician. As of 0700 next morning all swelling had dissapated.

dizzy, could not walk, talk, hear anything, popped blood vessel in eye. slurred speech We have ordered blood work and a ct scan.

SLOWING DOWN; ARM WEAKNESS; FEVER; FATIGUE; ARM TINGLING; PALE HANDS; HOT FLASHES; DROOPY EYES; LOW BLOOD PRESSURE; This spontaneous report received from a patient concerned a 34 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: Unknown) dose was not reported, administered on 07-APR-2021 13:30 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm tingling. On 07-APR-2021, the subject experienced pale hands. On 07-APR-2021, the subject experienced hot flashes. On 07-APR-2021, the subject experienced droopy eyes. On 07-APR-2021, the subject experienced low blood pressure. On 07-APR-2021, the subject experienced arm weakness. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021 20:30, the subject experienced slowing down. Laboratory data included: Body temperature (NR: not provided) 103.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm tingling on 07-APR-2021 19:30, and arm weakness, had not recovered from fever, fatigue, hot flashes, and droopy eyes, and the outcome of pale hands, low blood pressure and slowing down was not reported. This report was non-serious.

I have a constant high-pitched ringing sound that will not stop. I noticed it first in my bedroom/house, but it is still present when I travel outside my home into the community. It is really persistent and loud and worrying. Has been going on since right after I got vaccinated.

After patient received vaccine they reported they felt "off", said there was tingling and burning sensation down arm. After 5 minutes patient said they still felt off, 10 minutes no change, 15 minutes patient said they felt hot and their throat was dry, offered antihistamine (Benadryl) and asked if the patient could have someone pick them up, the called their physician on base and they physician stated for the patient to come in for observation. Patient refused Benadryl but arranged for a family friend pick him up at my request because I did not feel comfortable releasing the patient without observation. 45 minutes later the patient was picked up and they went to their physician to be observed. Called patient at 7pm to check in and they stated they "felt better but still off".

Sore arm muscle for over a week. Couldn?t raise arm without pain. Rest and heat helped. The other issue was development of mouth ulcers about 4 days after vaccination. Multiple mouth ulcers on bottom lip and gum (about 4-5) developed and spontaneously resolved within about 3 days.

I felt extreme fatigue and general malaise at 14:30. I took a Vicodin for my chronic back pain and lost consciousness at 15:00. I Went to bed and woke up at 16:25. 30 min later I slept again for about 90 min. Then I woke up and walked outside for some fresh air and got this extreme ice pick pain in the left side of my head for a few seconds. Then a few seconds later again. Now it just nags a bit behind my left eye and it feels a bit off in the left side of my brain. Bright lights hurt a bit. My back pain and Sciatica is also a lot higher than normal.

BURNING SENSATION ALL OVER BODY; RED EYES; HOT EYES; BODY ACHE; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 34 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: 202A218, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced burning sensation all over body. On 08-APR-2021, the subject experienced red eyes. On 08-APR-2021, the subject experienced hot eyes. On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation all over body, headache, red eyes, body ache, nausea, and hot eyes. This report was non-serious.

Could feel thickness of shot move down my arm and within 20 seconds I could feel it enter my heart. The second it entered my heart my face became numb. I was lightheaded within 5 minutes and that lasted about 30 more minutes of dizziness/lightheadedness. My left ear started ringing as soon the the lightheaded feeling started subsiding. About 2 hours later I had a small muscle cramp in my neck and the ringing stopped. My face was numb until about 2am.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Pt received shot, went to monitoring area, sat, leaned to right and passed out, pharmacist ran out, made sounds like gasping for breath/eyes rolled back/not responsive but breathing, asked tech to call 911, had bystander help lower to ground, pt regained consciousness, mother came around and said he has a history of doing this/phobia of vaccines, no one informed us

After my J&J vaccine, I experienced fever, chills and a left sore arm and those symptoms resolved in 24 hours. On 04-06-2021 I experienced headaches on and off and on 04-07-2021, I had light headiness, an air-filled pressure sensation to my eyes, forehead, more like a sinus headache. On 04-14-2021, I went to see my PCP due to my headaches continuing, the doctor ran complete blood panel test were performed along with a D-dimmer test to rule out blood clots and he told me to take Advil as pain medication. My D-dimmer test was normal. I noticed when bending down my headaches became worse. On 04-20-2021, an MRI of the brain was performed. On 05-01-2021, I experienced muscle body aches, fever and continued with headaches. I went to a walk-in clinic, where a Covid-19 test was performed and it was negative. I started taking antibiotics and the fever and muscle bode aches started to go away. I still have to this day headaches and an air-filled pressure sensation around my eyes and eyebrows. As of today, my headaches are consistent, and they come and go.

Vaccine was administered at 2:54PM, patient began feeling dizziness, feeling faint, sweaty, blurred vision at 3:00PM. Ammonia Inhalant was stimulated and was held near patient's nasal passage. Doctor was notified and assessed patient. Vitals: BP: 90/60 mmHg Spo2: 100% Pulse: 72 Provided Gatorade for hydration. Per Dr. monitored patient for additional 30 minutes. After 30 minutes symptoms were resolved . Had patient walk around and per Doctor ok to release patient. patient advised may go to ER for follow up if symptoms returned and do not resolve. Also notified may contact his PCP for further assistance and/or our office for any further assistance

Severe pain in jaw and ear on left side, identified 10 hours post injection and continuous Pain at injection site, continuous and not subsided since injection

Patient received the Janssen COVID vaccine then shortly after administration patient stated that their vision started to go blurry and the next thing their sight went dark, patient was seen falling out of chair head first after passing out.

Muscle aches, ocular pressure behind the eyes, chills, fever, soreness, gas and bloating, frequent urination, dizziness, faintness, difficulty moving, head ache, subocciptal pressure / muscle tightness, nausea.

2 days after the vaccine, my left eye became swollen and red. No pain, itching or other noticeable changes. Disappeared after 3 days onset, gradually getting better.

syncope right after vaccination, patient gained consciousness after few seconds. then he passed out again for few seconds, patient has phobia from needles , right after his second episode , he became extremely pale, started sweating heavily and his pupils dilated, the episode passed on its own, the paramedics still took him to the hospital to make sure he didn't hurt his head when he fell.

Patient received vaccine at approximately 10:55a.m. and started reacting at 10:57a.m. Patient stated that he started to feel like he was blacking out, alerted staff at the vaccination site. When staff got to patient he was incoherent and having body movements similar to a seizure, when staff spoke to patient he immediately responded as other staff went to get epi. Pulse was racing, breathing was normal, and patient able to communicate. Epi not administered, as soon as epi arrived to patient and 911 called at 10:58a.m. patient was talking normal, responding to questions, heart rate was returning. Staff stayed with patient to wait for EMS to arrive, police officer arrived pulse ox reading was 99% saturation, and heart rate of 59bpm. Applied oxygen with non-rebreather to help stabilize. Patient continued to improve, vision blurriness was the last symptom to fully return. Patient evaluated by EMS staff and released shortly after.

Rec'd vaccine at 1500, reaction started at 1505- pt observed to be stiff posture, eyes rolled to back of head and unconscious. Pt transferred to a gurney and heard to be wheezing. Epi x1 given and 911 was called. Pt became arousable after a few minutes as ambulance arrived. Pt breathing improved and able to answer simple questions. Transferred to nearest hospital.

Severe raised burning itching rash, severe headache, vision blurred, very tired fatigue, joint muscle pain, throat pain, mental fog slowness,severe pain at surgery site, increased tremor, pain in chest, itching keeps waking me up

Tremors, sweating, severe headache, vision flashes, pain in arm, fatigue, confusion, reduced consciousness, fainting, loss of balance, unable to ambulate or communicate, adrenal crisis, started in morning, treated at home with oral steroids for Addison's disease, doubled dosages for the next few days, pain and headache lasted beyond these symptoms.

Severe headache in upper right side of head with light and sound sensitivity followed by a shingles outbreak on right side of face and head.

Chills, fever, headache, fatigue. Muscle weakness and eye pain within 24 hours Continued headache with fatigue and eye pain. New symptoms include back pain, dizziness, Numbing and tingling of arms, legs, and faces within 72 hours

Vaccine was administered and 10 minutes later patient indicated he was getting dizzy with some vision changes and was sweating profusely. He was administered water and a snack and 20 minutes later was feeling better.

Tested Positive for Covid19 on 07/08/2021. Suspected Delta Variant Had Covid19 Symptoms, including headache, body pains, Severe lower back pain, Loss of smell, Low oxygen levels (83%), persistent cough, fatigue- Lasted 10days Recovered, but persistent cough, mild headaches and mild fatigue

**Uncertain if it this is related to the vaccine** On 3/14/21, a week after vaccine was administered, I had a fast food meal I've had several times before. Around 30-40 minutes later, I began experiencing a reaction I'm not prone to. I had severe heartburn throughout most of the night and my lips began to swell which made me mistakenly assume I have had a cardiac event. While in the morning the pain had subsided, the numbness in the lips hadn't and I went to the ER thinking it might've been a heart issue. No cardiac condition was noted at the hospital which leads me to believe I may have had a severe allergic reaction to foods or environmentals I've never had reactions to.

HPI: Patient is a 35 year old male who presents following administration of a single dose of J&J COVID19 vaccine in the left deltoid. Patient started to feel light headed and nauseous while walking to his car. About 20 minutes following vaccination, a vaccinator had walked passed his vehicle and noted that he was unconscious. Patient was still unconscious upon medical response team arrival and unresponsive to stimuli. Once the patient awoke about 30 seconds later, he continued to state that he was nauseated and ?did not feel good.? Patient was unaware that he had lost consciousness. He further disclosed that he had been working in the sun planting trees all day and had not consumed any food or beverage. He denied allergies to medication, food, and other vaccines. He relayed that he had passed out from vaccinations in the past as a child. He affirms lightheadedness and nausea. He denies chest pain, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, and vomiting. Exam (update as needed): GEN: Upon arrival, patient unconscious and not responsive to stimuli HEAD: NCAT EYES: pupils unreactive and mydriatic ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD. CV: RRR, no m/r/g, palpable strong radial pulse PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: Skin pale, cool, and clammy. No rashes. No erythema or edema of the injection site. MSK: FROM, MS 5/5 NEURO: Patient unconscious upon arrival. CN 2-12 grossly intact, no ataxia, gait steady Clinical Impression/Field Tx: Vasovagal syncope. EMS called immediately to respond to the site for further evaluation. Patient placed into a reclined position. Patient not displaying active signs or symptoms of anaphylaxis. Upon regaining consciousness, patient was alert and oriented x4. Once the patient demonstrated ability to control airway, he was given candy and water. EMS arrived and an EKG and BGL were performed, both of which were normal. Vital signs were stable. Instructed patient to consult their PCP regarding the post-vaccination reaction. Patient instructed to go to emergency department should they develop chest pain, difficulty breathing, swelling of the face/lips/mouth/tongue/throat, or cramping abdominal pain with nausea/vomiting, as these are signs of possible anaphylaxis that requires immediate intervention. Medications administered: None Disposition: FD EMS called to the scene for further evaluation. Patient elected to go home after evaluation by EMS.

Severe joint stiffness and pain, mild relief with Aleve. Severe Headache/ Migraine, so far with Aleve, Tylenol and Hydrocodene, no relief. Cold compress over the eyes seems to help with comfort but pain remains. Considering ER visit.

Fever (102 degrees)- started 04/08 in the afternoon and got worse at night. Went away next morning. Headache - Next day 04/08, lasted all day and went away next morning. Sore body - started 04/08 morning and persisted until next morning.

DURING COVID VACCINATION CLINIC, DIVISION 1 EMPLOYEE ASSISTING WITH POST-VACCINE OBSERVATION REPORTED TO PHARMACIST THAT A PATIENT WAS FEELING LIGHTHEADED. SHE IDENTIFIED PATIENT WHO WAS DISTRESSED AND APPEARED UNSTEADY. THE PATIENT REPORTED THAT THEY HAD TUNNEL VISION AND FELT VERY LIGHTHEADED. PHARMACIST ASKED THE PATIENT TO REMAIN SEATED AND TRY TO TAKE SEVERAL DEEP BREATHS WHILE THE PHARMACIST HELD THE PATIENT'S LEFT SHOULDER TO ENSURE HE WOULD NOT FALL IF SYNCOPE OCCURRED. THE PATIENT HAD FLUTTERING EYELIDS AND APPEARED IAPHORETIC AT FIRST, BUT AFTER SEVERAL MINUTES RECOVERED SOMEWHAT. THE PATIENT REPORTED THAT HE HAD RARELY HAD SIMILAR EPISODES IN THE PAST DURING SOME MEDICAL PROCEDURES, BUT NEVER ASSOCIATED WITH A VACCINATION. PHARMACY TECHNICIAN HAD A D1 EMPLOYEE RADIO FOR A CODE WHITE AS SHE CONTACTED 911 ON HER CELLULAR PHONE. PARAMEDICS ARRIVED AND ASSESSED THE PATIENT'S HEART RATE, SEATED BLOOD PRESSURE. AND STANDING BLOOD PRESSURE. THE PATIENT REPORTED FEELING SLIGHTLY LIGHTHEADED WHEN FIRST STANDING, BUT MUCH IMPROVED OVERALL. THE PARAMEDICS INDICATED THAT THERE DID NOT SEEM TO BE A MEDICAL EMERGENCY BY THIS POINT AND EXPRESSED CONCERN THAT THE PATIENT MAY BE DEHYDRATED BUT THE PATIENT REFUTED THIS POSSIBILITY. HE ALSO STATED THAT HE HAD NOT RECENTLY OVEREXERTED HIMSELF AND HAD EATEN LUNCH EARLIER THAT AFTERNOON. PHARMACIST PROVIDED THE PATIENT WITH GATORADE AND ICE TO IMPROVE BLOOD SUGAR, ELECTROLYTE, AND HYDRATION STATUS AND THE PARAMEDICS DEPARTED. THE PATIENT REMAINED FOR APPROXIMATELY 30 MINUTES UNTIL HE WAS FEELING CLOSE TO BASELINE AND FELT COMFORTABLE LEAVING.

Major symptoms, roughly 20 hours after vaccination, 10-15 minutes after waking, while walking and standing: - Extreme pain in right hip joint. Pain is sharp, stabbing, burning. Pain radiates down leg, and right foot numb and tingly - Overheating - Lightheadedness, blurred vision, confusion - Fainting or loss of consciousness, falling to ground Timeline of events: 2021-04-08 13:00 Injected with Johnson & Johnson 13:00 - 13:15 Very slight nausea 13:15 - 22:00 Very slight nausea and fatigue 22:30 Lymph nodes in neck feel swollen, ears feel slightly clogged (typical early cold symptoms) 23:30 Insomnia and chills 2021-04-09 00:00 - 07:30 Insomnia, poor sleep, and cycles of chills and overheating while trying to sleep or sleeping. Stronger nausea than before 07:30 Wake up, knees feel slightly weak when walking 07:35 - 07:40 While walking inside a market. Right hip joint begins to hurt with sharp, stabbing, hot pain. The pain radiates down right thigh. Right foot begins to feel numb and tingle. This pain increased over 5 minutes, to excruciating levels, with right leg feeling numb, and sharp stabbing tingles in right foot. Difficult to walk normally 07:40 - 07:45 Pain becomes overbearing, and market counter used for support. Begin to feel light headed. Begin to feel hot, and begin to overheat within ~2 minutes. Walk outside market (outside temperature 32 - 40F) to cool down. Lean on car hood for support, and become increasingly lightheaded. Vision becomes blurry. Stumble and fall onto face. Regain consciousness after unknown time, groggy and with blurred vision, lightheaded feeling. Attempt to stand and fall again onto face. Regain consciousness after unknown time. No longer feeling extremely hot. After roughly 1 minute, regain clear vision and lucidity. Pain in hip and leg completely subsided 07:45 - 09:00 Driven to hospital. Treated by hospital staff for laceration in forehead requiring 7 sutures. EKG reports normal. Concussion check negative. 09:00 - 00:00 Occasional nausea, fatigue, weakness (same as weak cold) 2021-04-10 11:00 While walking and standing in line. Right hip joint begins to hurt, with pain radiating down right thigh. Right foot begins to feel numb and tingle. Begin to feel warm. Hip Pain remains at manageable level, and walking normally is easy. Hip pain is roughly 1/3 of pain of 2021-04-09. 2021-04-11 07:30 - 11:00 Occasional slight pain in right hip and left hip joints. Hip pain is sharp and burning, and roughly 1/10 of pain from 2021-04-09.

Second day after vaccine shot I experienced extreme fatigue and pain. Third day I broke out in hives all over. Today I?m still in hives and have a pink eye.

LACK OF SMELL; LACK OF TASTE; NAUSEA; VOMITING; SEVERE METALLIC TASTE; This spontaneous report received from a patient concerned a 35 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, rare form of gout, and immunocompromised due to chemotherapy infusions., and other pre-existing medical conditions included atromyocin allergy. The patient experienced drug allergy when treated with vancomycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and 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 vomiting. On 07-APR-2021, the subject experienced severe metallic taste. On 07-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced lack of smell. On 08-APR-2021, the subject experienced lack of taste. Treatment medications (dates unspecified) included: ondansetron hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea on 07-APR-2021, and severe metallic taste on 08-APR-2021, and had not recovered from lack of smell, and lack of taste. This report was non-serious.

Strong Metallic taste, in mouth, within 10 minutes after injection, lasted over 30 minutes. Lightheaded within 10 minutes after injection, lasting less than 5 minutes. Mild, aching, posterior Headache that started within 1 hour after injection and has continued up to present time.

10 April 2021: 14:00 J&J Covid-19 vaccine. No issues whatsoever throughout day, neither muscle soreness at injection point, nor fatigue etc. 11 April 2021: Woke having had headache and left shoulder/neck muscle soreness affect sleep. Woke ~09:00. Headache became worse, & minor chills. Had breakfast (toast w/Vegemite). Drank lots of water. Through day, felt worse (notably headache, fatigue). Had lunch ~12:30 (salad and jerkey), but quickly felt unwell with it. Interrupted phone call at ~13:45 to go to bathroom, feeling nauseous Felt a bit dizzy, having to stabilize my walking around apartment a couple times, but mostly feeling mentally foggy/unclear. Struggled with some sentences on phone calls.

Increased ringing in both ears. Gradual but significant hearing loss in left ear. Started maybe on 4/12, but is noticeable on 4/14 and has gotten worse since.

SKIN PEELING BETWEEN INSIDES OF FINGERS OF RIGHT HAND; HEADACHES; NAUSEA; BLURRY VISION; SORENESS OF KIDNEY/LOWER BACK AREA; MASSIVE BODY ACHES; DIZZINESS UPON STANDING (HYPOTENSION); CHEST TIGHTNESS; FOGGINESS; FATIGUE; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Pain scale (NR: not provided) 5-6 out of 10. On 09-APR-2021, the subject experienced fogginess. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced blurry vision. On 10-APR-2021, the subject experienced soreness of kidney/lower back area. On 10-APR-2021, the subject experienced massive body aches. On 10-APR-2021, the subject experienced dizziness upon standing (hypotension). On 10-APR-2021, the subject experienced chest tightness. On 10-APR-2021, the subject experienced headaches. On 10-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced skin peeling between insides of fingers of right hand. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fogginess, blurry vision, fatigue, massive body aches, dizziness upon standing (hypotension), headaches, nausea, chest tightness, skin peeling between insides of fingers of right hand, and soreness of kidney/lower back area. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

History: pt got J&J COVID-19 vaccine on 4/5 and the next day, pt developed left-sided headache and body ache, like as if having a cold, per pt, and gradually the headache got better every day but it didn't go away completely, now steady for a week w/o daily improvement, bilateral, but also with left neck pain with certain rotation of neck, with vague intermittent bilateral blurry vision and bilateral intermittent non-pulsatile tinnitus (says pt heard some gobbled unclear noise during meeting thru the speaker earlier), w/o paresthesia/weakness in limbs, here for eval. Sometimes, pt has felt dizzy when standing up. Denies use of any meds currently and denies prior history of headaches, prior concussion/head injury.

Reporting a symptomatic positive COVID swab after the Janssen J & J vaccine administration on 3/18/21. Description of symptoms Loss of taste and smell Congested Cough Sore throat Shortness of breath-states he feels like he cannot draw out a full breath and feels short of breath even at rest Muscle fatigue

Patient initially reported symptoms of body aches to jail officer at 10:00 and requested ice pack. Jail nurse provided details of symptoms at 12:15 am 5/20/21 as the following report from officer "He (jail officer) said he had the following symptoms: severe body pain, muscles felt like they were burning, confusion, severe headache. Officers noted lip swelling, weakness, and confusion. They had to help him walk. According to ED notes he was given Benadryl, Ibuprofen and a bag of fluids. They (ED) did a CBD and Metabolic/Electrolyte Panel."

35 Y/O MALE WITH NO SIGNIFICANT PMH PRESENTED TO EMERGENCY ROOM WITH ACUTE DIFFICULTY WITH MOUTH MOVEMENTS STARTING 18 DAYS AFTER JNJ COVID VACCINE. REPORTS DIFFICULTY WHISPERING, SMILING, PREVENTING LIQUIDS FROM LEAKING WHILE EATING. PATIENT IS UNABLE TO WRINKLE FOREHEAD, HAS SIGNFICANT WEAKNESS OF EYE CLOSURE WITH INCOMPLETE EYE CLOSURE ON BOTH EYES. NEUROLOGY DIAGNOSED PATIENT WITH BILATERAL PERIPHERAL FACIAL NERVE PALSY THAT IS LIKELY DUE TO GUILLAIN-BARRE SYNDROME VARIANT.

Severe headache, weakness, sudden loss of energy, drowsiness, blurred vision, loss of balance. The day of vaccination, it was mainly the severe headache and some swelling in my face. Mainly along my jaw line and gums. Day 2 all of the other effects I mentioned above hit me when I woke up and persisted until today. Still feeling some of it, mainly a slight headache, some loss of balance and I still get hot and start sweating at random times for no obvious reason.

The night after receiving the vaccine I started to develop a fever and headache. It lasted 3 days for the fever. On Tuesday I felt something different in my body. On Thursday I went to see an Optometrist. While there he found that there was something going on in my eyes. He noticed there was blood clot in the back of my right eye. I did go to the ER because of the blood clot. At the ER I had a CT scan and bloodwork completed. I was told that everything looked normal and I was told to go to a different hospital. I was transferred to Medical Center. While I was there they performed an MRI, CAT scan and Lumbar function test. I was told that everything looked fine from the neurology point of view. I need to follow up with an Ophthalmologist. I have gone completely blind in my right eye and my left eye is not clear anymore. On 05/20 I had an appointment with the ophthalmologist. There was something wrong with my optic nerve as well. There was a test performed 05/21. I went back to the doctor on 05/26 he said that the reports he received are not making sense to him. My next f/u appointment with Dr. is 06/09 because the doctor asked to have2 weeks to read through my hospital reports. I saw a different doctor instead on 05/27, Dr. , and he said that this can happen from the vaccine. He said that there is a swelling and I need to see a different doctor about my retina. I was told that I need to see another physician. I saw Dr. . on 05/27 and he said that there are fluids there, but no one can confirm that this is because of the vaccine. He gave me the option to take prednisone 10mg and I feel that it is working, but it is very slow. It was moved to 3x per day. I can see objects now even though it's still not clear. I have a f/u with Dr. 06/03.

Coughing congestion,nose,chest ears runny nosy stuffy nose sore throat body pain fatigue muscle aches 5/26/21 - now

Right sided headache x 5 days. No thunderclap onset. Patient complains of nausea and sensitivity to light. Headache is throbbing in nature. Patient experienced tingling in right cheek the day before presentation. Patient is treated with diphenhydramine and prochlorperazine in ER and is given a prescription for Topamax to take at home for the next 5 days.

VERTIGO; RACING HEART; BLURRED VISION; CHILLS; FEVER; BODY ACHES AND PAIN; HEADACHE; This spontaneous report received from a parent concerned a 35 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: Unknown) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced headache. On 02-JUN-2021, the subject experienced body aches and pain. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. On 03-JUN-2021, the subject experienced vertigo. On 03-JUN-2021, the subject experienced racing heart. On 03-JUN-2021, the subject experienced blurred vision. Treatment medications (dates unspecified) included: amoxicillin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever, chills, body aches and pain, vertigo, and racing heart, and the outcome of blurred vision was not reported. This report was non-serious.

Symptoms started ~10 minutes after injection. I began to feel dizzy. I felt very warm and began to sweat profusely. My vision got cloudy. I was given water. The pharmacist measured my blood pressure, and I believe he said I was 70 over 50. I began to feel like I was about to pass out, so I laid down and gradually began to improve. I began to feel very cold instead of very warm. About thirty minutes later, I felt well enough to leave the pharmacy. After a couple hours, I began to experience what I think are more typical symptoms - stiffness and pain in the arm which received the shot, and chills. The next day, I experienced sore wrists, shins, and lower back; fatigue; headache; and hot & cold flashes with uncontrollable shivering or sweating at times. These symptoms were alleviated about 42 hours after the injection, except for persisting mild pain in the arm had which received the shot.

Side effects began few hours after receiving the Covid-19 Janssen vaccine. Side effects included suddenly freezing followed by full body shivers, hallucinations, extreme thirst, woke up feeling extremely hot as if overheating but no sweating, confusion, headaches/migraines, nausea, and muscle tightness.

felt like I had the flu a day after but went away then the Tingling fingers, Tingling/ numb feet, legs giving out, eyes contantly watering all started 3 weeks after shot

Consistent right sided headache with nausea and sensitivity to light. No thunderclap onset. Throbbing headache on left side. Tingling in right cheek. Patient is treated with diphenhydramine and prochlorperazine. Patient discharged home with prescription of topiramate x 5 days for any lingering headache.

During 15-minute observation period, patient said he was thirsty and want to get a bottle of water. Atfer getting water, patient felt dizziness and was about to faint. We called 911 and monitored him until EMT team came. Patient was still conscious and said he felt dizzy, sweating due to potential low blood sugar and asked for a sip of gatorade. Then he started felling better after that and he said it happened before during his MRI and other procedure. EMT team accessed his vital signs and symptoms inside their vehicle and finally released him home. His family took him home

2021-03-20 07:30 PM - chills, 11:00 PM - vomited, 11:30 PM- seen in the Emergency Department 2021-03-21 11:30 AM - fatigue, somnolescence, nausea 2021-03-22 08:00 AM - nausea, 11:30 AM - altered mental status, vision loss, headache, balance problems, numb left arm and hand, hypoxia (SpO2 < 50%), 01:00 PM - seen in the Emergency Department, 03:00 PM Creatinine > 6.8, eGFR < 10

near immediate cold sensation in left arm, nausea, and light headedness approx 3-5 minutes later hearing loss and blacked out

102.2 degree fever. Tremors and shaking for hours and hours. Insomnia. Diarrhea. Nerve pain. Joint swelling. Loss of taste

Cold sweats, Severe bodyaches, headache, Loss of taste, and high fever. Symptoms occurred approximately eight hours after injection and lasted for about 12 hours.

Extreme headache and high fever, numbness in face, tingling fingers, impaired vision and loss of balance, very confused. Fever and worst of symptoms lasted approximately 6 hours. After major symptoms subsided, nausea, confusion , and generally sick feeling lasted 24 hours additional.

While exercising on the morning of 4/11, received a sudden, severe headache on the left side of my head. It started in my neck, moved up through my skull, and ended above my left eye. The feeling gradually improved with time, stretching, and acetaminophen. For more than 24 hours, a mild feeling persisted. On 4/13, the left side of my neck is still stiff and my left eye has a light throbbing.

Started with headache on 3/20 3/21 am - flu like sx 11:00 became unresponsive, disoriented, started having hearing & vision problems, left hand wasn't working. Problems worse upon standing, dx w/ hypovolemic shock

Systemic: Dizziness / Lightheadness-Mild, Systemic: EXTREME THIRST AND PROFUSE OVERALL BODY SEATING-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: GAVE PATIENT GLASS OF WATER AND TURNED ON FAN , HAD PATIENT REMAIN SITTING FOR 30 MINS, REVIEVED SHOT AT AROUND 2:08PM AND COMPLAINED OF SYMPTOMS OUTLINE ABOVE AT 2:15PM. TOOK 1ST BP AT 2:26PM WAS 118/74 PULSE=70, REMAINED SEATED FOR ADDITIONAL 15MINS (TOTAL 30MIN OBERVATION PERIOD) TOOK 2ND BP AT 2:41PM WAS 129/79 PULSE=72, PATIENT OPTED TO LEAVE AND ADVISED PT TO HAVE 24 HR URGENT CARE ON SPEED DIAL IN CASE ANY OTHER SYMPTOMS MAY ARISE AND GAVE PT EUA FACT SHEET WITH SYMPTOMS TO WATCH FOR.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: this may be duplicate: pt recieved shot 2:10pm at 2:15 complained of profuse sweating and blurred vision, asked for cup of water and turned on fan for patient, no other symptoms except for say felt the med injected to arm, at 2:39pm bp was taken and was 118/74 with 70 pulse, pt remained seated for additional 15mins, total 30 min observation time at 2:41 pm took 2nd bp reading was 129/79 pulse of 72, pt doesnt have pcp and Advised to have urgent care thats 24 hrs on speed dial in case

light headed, dizziness, sweating, anxious, vision blur saw yellow, had him sit extra 15 minutes until felt better took temperature - low registered 95, drank juice had a granola bar , stayed seated until felt better was with friend who was able to help when left temperature was at 96

Patient developed cranial nerve 7 palsy, facial numbness, and non descript visual changes. Was treated with prednisone for Bell's palsy. Also developed joint pain

After I received the vaccine and was waiting 45 minutes, I had a weird taste in my mouth and I texted my mom to tell her that I wasn't feeling good. While texting her, I started experiencing color distortions and the next thing I knew was the Pharmacist was asking if I could breathe and they laid me down on the floor and called 911. The Fire Department arrived and took my blood pressure and I tried to walk out and the next thing I knew was that I was weak; therefore, the Ambulance transported me to the hospital. In the ER they examine me and ended up giving me a nausea pill after observing me for two hours.

Later that eveing around 10pm I developed muscle pains and chills. A headache came about 2 hrs after and a little later I developed a fever and the headache went from light to mild. Throughout the night I could not sleep because the headache had gotten so severe and I had uncontrollable chills and shakes and a fever. 3/6 I did start around the clock Tylenol which did reduce the fever and make the headache less as intense but for about 2 days the headache so bad with pressure associated it felt as if my eyes were going to bulge out of my head. By day 3 I woke up feeling better but was in a fog which lasted the remainer of that day and by day 4 all symptoms had subsided

Pt received vaccine in LUE. Pt c/o pain in LUE, shortly after stopped responding and eyes rolled back in head, became diaphoretic and warm w/ seizure-like activity noted w/ hands contracted and UE/LE rigid and not immediately responsive. Pt was laid down on back and responsive shortly after. VS obtained and stable. Pt had no recollection of event. Continued to monitor and obtained stable orthostatic VS prior to allowing pt to leave. 1149 - lying down - BP 160/82, HR 59, O2 99% RA 1152 - lying down - BP 118/76, HR 75, RR 13, O2 99% RA 1159 - sitting - BP 121/80, HR 66, O2 100% RA Orthostatic VS Lying @ 1210 - BP 118/75, HR 63, O2 100% RA Sitting @ 1212 - BP 129/84, HR 55, O2 100% RA Standing 1215 - BP 120/84, HR 66, O2 98% RA

Pt. presented to hospital with worsening shortness of breath, dry cough, fatigue, loss of smell, and poor appetite for about 1 week on 04/06/21.

I received my vaccine this morning at 6:12AM and felt fine after. Around 7:45AM I started to feel slightly short of breathe, but figured it was just from the cold outside and my Asthma. The shortness of breathe feeling goes away. Later in the day sometime after 3 PM, I start to feel as if I am getting stuffy. I take a nap on the buss on my way home, and when I wake up I suddenly feel like I am freezing and have chills all throughout my body. I get home and jump in a hot shower to warm up, but it did not help. I then heat up some food to eat dinner, and I go to drink some soda, and I notice I have no taste. I figured the soda was flat, but even flat soda has some taste to it. I then drink a Cherry Gatorade, and still no taste. Now I check my temperature and it is at 101.4, and I have a slight cough.

Very dry/sore throat, intermittent lose of voice, low-grade fever, body shivering/chills, pressure/tension headache, hard spot at injection site, joint pain/stiffness, ringing of ears; all for around 40 hours and slowly clearing up. *Tylenol, ibuprofen, cold/flu meds had minimal effect.

Fever, Chills, Muscle Aches, Pounding headache, Fatigue, Malaise, Joint pain, stuffy nose, shortness of breathe, chest feel heavy, injections site pain (not red or swollen), sinus congestion, inner ear ache.

Patient was standing with hands on knees and stated that he was "going down". Paramedic was standing nearby. Patient's eyes rolled back into his head and paramedic helped to guide patient to the floor. Pt tried to crawl while on his hands and knees prior to rubbing his face into the carpet as he continued to crawl. Paramedic rolled patient over onto his back and patient rested there for about 10 minutes. Pt got up with standby assistance and sat in chair. After 5 minutes pt passed out again and was turned over on his back on the floor. Pt vital signs were taken and were stable. Ice pack placed on patient head. Pt had visible bruises to the face (nose, eye and forehead). Pt has a history of passing out with vaccines and stated that he had not taken his blood pressure medicine today. Pt placed in wheelchair and taken by EMS to the hospital.

03/18/21 @ 1008: After covid -19 vaccination, pt suddenly reported having tingling lips, dizziness, flushed face, nausea, palor. Assisted pt to laying position on floor. Applied cold wash cloth to forehead, turned on fan. Vitals: 110/69, 52, 18, 99% spO2 on RA. After laying, pt then reported symptom improvement. 03/18/21 @ 1015: Assisted pt back to sitting position in chair. Pt remained stable and feeling well. Vitals: 126/80, 723, 16, 97% spO2 on RA. Pt remained in clinic until 1023 then was discharged to home with driver in stable condition. 03/22/21 @ 1100: Called pt for follow-up. Pt reported he had another episode on the way home in vehicle, same symptoms as in clinic following vaccination. Driver took pt to nearest medical facility where they did 3 EKG's which should pt was in a second degree heart block and known vitals reported by pt was 102/60, and HR of 50's. Pt then went to another facility for further evaluation @ 1500. EKG performed then was normal and vitals were stable. Pt was set up for 24 hour heart monitor the next day, 03/19/21-03/20/21. Pt has not found out those results as of this conversation. Pt reports not having any further episodes and feels good today.

Got the vaccine around 10:30am, felt ok until around 7:30pm, when I started feeling some nausea and dizziness and weakness. Then progressed to severe shaking chills, fevers, headaches, tingling/electric shock feeling in back of head/neck, muscle aches, mild joint pain, eye discomfort associated with the headaches, poor appetite at first, trouble sleeping, and fatigue; all of which required doses of Tylenol and ibuprofen and cold packs. Symptoms lasted all night and fever broke overnight after finally falling asleep. The next day (3/17) took some more Tylenol and ibuprofen, but the fever and chills subsided. The other symptoms mostly resolved except was still quite tired and felt weak. Also, had cold sweats all day on 3/17. By around 3/18 most all of the symptoms resolved. Also, had mild soreness at vaccination site throughout. I?m a physician. If I wasn?t a physician I may have sought medical attention.

Seven days after vaccine was administered Patient started having symptoms of difficulty breathing, rapid heart rate, and breaking out in a rash all over his torso and upper arms. His lips also got quite swollen. The rash eventually spread down both his legs. He was taken to the emergency room at Hospital, as he was visiting there at the time. He was given benadryl, and prednisone once his Covid test came back negative. Blood work, chest x-ray, CT scan of both stomach and chest, EKG and blood work all came back normal. His resting heart rate was 120 and above, and he required two liters of oxygen to stay in the mid 90's saturation level. He spent five days in the hospital before the rash was mostly faded on his torso and his lip swelling had come down. He was discharged on 3/24/21 with the advice to see his primary care physician, and to be monitored carefully for oxygen saturation and heart rate. The family could not think of anything he had eaten or come in contact with that would have caused any reaction. At this time we think it was a reaction to his Janssen vaccine based on all the tests at the hospital coming back normal.

Patient went to School 4/1/21 to receive J&J vaccine. Patient came to see Dr. on 4/7/21 claiming his symptoms started on 4/2/21. His symptoms included erythema multiforme on lips and in oral cavity.

Loss of consciousness about 5 minutes following vaccine administration. Muscles contracted with arching. As patient regained consciousness he still had vision loss. Complained of nausea for about 24 hours but no vomiting. Dizziness and headache persistent for about 36 hours. Patient with severe fatigue for about 24 hours and gradually improving over next 48 hours.

within in minutes of the vaccine and while driving to the rest area almost fainted, started to black out, dizziness an hollow hearing/tinitus. Lasted for 10 mins and gradually subsided over 20 minutes

Patient had syncope, dizziness, ringing of ears, chills. BP 144/92 P73 RR17. Given water and recovered, discharged home in stable condition

Patient was administered the COVID vaccine and felt fine. He relocated to our pharmacy waiting area for observation. Once there he started to read the provided material (EUA, V-Safe) and started to feel anxious. He said the next thing he knew he was sweating and had tunnel vision. He wasn't 100% sure he passed out. A fellow associate helped him to the ground and elevated his feet. We got ice for behind his neck, and a cold cloth for his forehead. We took his blood pressure and it started to come back up. He waited for about 30 minutes before leaving. His color had returned and he stated he felt fine.

Immediately after, tingling in lips. Day after, HS exacerbation. Large sores on inside of thighs that created a burning sensation and weeping wounds. Have been present for 3 days

I have developed a constant low hum in my left ear, as if some machine is operating in my house, or always on the other side of the wall of whatever room I'm in.

Two days after having my one and only covid shot i began noticing ringing in my right ear and my hearing is not as good as is was previously. i am setting up a doctors appointment today to see what the issue is.

KIDNEY INFLAMMATION (RENAL DISORDER); LUNGS FILLED WITH FLUID; PANCREATIC PAIN; KIDNEY INFECTION; LEG PAIN; KIDNEY FAILURE; CAN'T MOVE; SEVERE BACK PAIN; KIDNEY PAIN; LOSS OF VOICE; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight, height, and medical history were not reported. The patient received two weeks ago covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total administered on 22-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAR-2021, the patient experienced kidney failure, can't move, severe back pain, kidney pain, loss of voice, leg pain. The patient didn't feel right and lied down and woke up with severe back pain. The left side of patient body was in excruciating pain and he was unable to walk. On 05-APR-2021, the patient experienced kidney infection and pancreatic pain. On an unspecified date, the patient experienced lungs filled with fluid and kidney inflammation (renal disorder). He addressed that his lungs were filled with fluid and he lost his voice which was later improved in few days. The patient required urgent/emergency care visit, for events back pain, kidney pain, leg pain, can't move, loss of voice, kidney failure, and kidney infection. The patient was experiencing as if he was dying and failure in kidney and not be able to understand to compensate the situation. The patient family was concerned about him and due to vaccine he was not able to work or to do anything. Considering severity he was asking for the compensation for the vaccine effect on him. The patient asked for a call back as he was not able to talk and he was on bus so could have got disconnected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of voice on 24-MAR-2021, had not recovered from back pain, kidney pain, leg pain, can't move, kidney failure, and pancreatic pain, and the outcome of lungs filled with fluid and kidney inflammation (renal disorder) and kidney infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0 This spontaneous report involves a 37-year-old male patient who experienced kidney failure, can't move, severe back pain, kidney pain, loss of voice, leg pain the same day the Janssen COVID-19 Vaccine Ad26.COV2 had administered. The patient didn't feel right and lied down and woke up with severe back pain. The left side of patient body was in excruciating pain and he was unable to walk. Apporxiamtelly two weeks later he had kidney infection and pancreatic pain. On an unspecified date, the patient experienced lungs filled with fluid and kidney inflammation. Medical history, concomitant medications, and details of the events were not reported. This case has insufficient information to make a meaningful medical assessment. The case will be assessed further when additional information is received.

Narrative: 36 year old male with no pertinent pmhx who presented to ER on 4/19/21 with a four day history of headache and left eye visual blurring which began last night. Blurring peripheral in nature. Patient denied nausea, dizziness, no antecedent trauma. He reported no occupational exposure history nor migraine headache hx. Location of pain was the top of the head, intensity is 6/10, he had taken no medications to ameliorate symptoms nor had he endorsed any antecedent drug tobacco or alcohol use. Patient noted that he received the johnson and johnson covid 19 vaccine 4/7/21 (vaccine was not received from the specific facility). ER physician followed up with patient day after presenting to ED today, and patient reported he was doing well. ER presentation may represent a simple tension type headache given his single episode, relief with NSAID and the location that the patient described the pain.

HEAVINESS IN EYE; ABDOMINAL PAIN / STRANGE SENSATIONS IN ABDOMEN; LEFT EYE SWOLLEN AND PUFFY; STRANGE SENSATIONS IN FACE; LEFT ARM PAINFUL; NAUSEA; This spontaneous report received from a parent concerned a 37 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced heaviness in eye, abdominal pain / strange sensations in abdomen, left eye swollen and puffy, strange sensations in face, left arm painful, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heaviness in eye, abdominal pain / strange sensations in abdomen, left arm painful, left eye swollen and puffy, strange sensations in face and nausea was not reported. This report was non-serious.

FAINTING, SWEATING, EYES ROLLED BACK, ARMS AND LEGS JERKED. ABOUT 5 MINUTES OF SYMPTOMS, THEN RESTED FOR 30 MINUTES BEFORE LEAVING.

Lower lip swelling Presented to ED complaining of allergy to vaccine Treated with oral steroids and a dose of Benadryl and felt better so was discharged home

HEAD PRESSURE; HEART PALPITATIONS; FEELING OF A RUSH TO THE HEAD AFTER EATING; DRY EYES; RINGING IN THE EARS; MYALGIA; GI ISSUES LIKE BUBBLING STOMACH; FATIGUE; STIFFNESS IN THE NECK/ MUSCLE TIGHTNESS IN THE JAW; DROOPING RIGHT EYE LID; CHEST PRESSURE; ANXIETY; DIZZINESS AFTER GOING FOR A WALK; HEADACHE; This spontaneous report received from a patient concerned a 37 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: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dizziness after going for a walk. On 2021, the subject experienced anxiety. On 2021, the subject experienced headache. On APR-2021, the subject experienced drooping right eye lid. On APR-2021, the subject experienced chest pressure. On APR-2021, the subject experienced stiffness in the neck/ muscle tightness in the jaw. Laboratory data included: Blood test (NR: not provided) NOT REPORTED. On 07-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced gi issues like bubbling stomach. On 09-APR-2021, the subject experienced myalgia. On 18-APR-2021, Laboratory data included: Blood test (NR: not provided) did not find any specific signs causing his symptoms, and CT scan (NR: not provided) did not find any specific signs causing his symptoms. On 25-APR-2021, the subject experienced ringing in the ears. On 26-APR-2021, Laboratory data included: Blood test (NR: not provided) also found nothing unusual. On an unspecified date, the subject experienced head pressure, heart palpitations, feeling of a rush to the head after eating, and dry eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from gi issues like bubbling stomach, feeling of a rush to the head after eating, and dizziness after going for a walk, had not recovered from fatigue, myalgia, head pressure, heart palpitations, chest pressure, anxiety, and ringing in the ears, and the outcome of dry eyes, stiffness in the neck/ muscle tightness in the jaw, drooping right eye lid and headache was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.

1. Dizziness - Started on 04/10/2021. Continuing in 7th week since vaccination. 2. Tinnitus- Started 1 week after shot, continuing in 7th week. 3. Headaches and pressure behind the eyes - Stared 1 week after shot, continuing in 7th week. 4. Ear fullness and pressure in ears - Resolved 5 weeks after shot. 5. Off balance during walking- Started on 04/10/21. Continuing in 7th week.

SHORTLY AFTER RECEIVING VACCINE (APPROXIMATELY 1/2 MINUTE) PATIENT FAINTED. HE SLOWLY SLID OUT OF CHAIR AND I (PHARMACIST) CAUGHT HIM GOING DOWN AND HE LANDED ON HIS LEFT SIDE, ALMOST FACE DOWN. I SHOUTED OUT HIS NAME SEVERAL TIMES, ROLLED HIM ON HIS BACK, AND CHECKED FOR BREATHING. NO BREATH SOUNDS OR CHEST RISING, COULD NOT FIND A PULSE, AND THEN HIS EYES ROLLED UP AND BACK. A STORE CUSTOMER CALLED 911 AND I BEGAN COMPRESSIONS. AT COUNT 20 HE BEGAN TO MOVE AND TRIED TO TALK. STOPPED COMPRESSIONS, AND ROLLED PATIENT ON HIS LEFT SIDE. I WAS ABOUT TO CHECK BLOOD PRESSURE WHEN PARAMEDICS WALKED IN AND TOOK OVER. PARAMEDICS CHECKED VITALS, TEMPERATURE, BLOOD GLUCOSE AND RAN EKG. THEY SAID THEY COULD NOT SHARE RESULTSWITH ME, BUT STATED PATIENT REFUSED TO GO TO THE ER/HOSPITAL. AFTER ABOUT 30 MINUTES PATIENT WALKED OUT OF THE STORE ON HIS OWN.

Shingles outbreak on left side of face/ head beginning ~ 5 weeks after Janssen Covid vaccine (fever, inflammation, blisters, rash, swelling, nerve pain, headache, occular complications)

After receiving the J&J Covid vaccine I was awake all night with fever and chills, which I understand is completely normal. However the next day my upper lip and lower nose swole up in an allergic reaction. I took Benadryl and went to sleep and by the time I work up it had subsided. Two days after that incident I woke up (this morning) and my left cheek was swollen from another allergic reaction. During this time I had not eaten or taken anything out of the ordinary.

At approxiamtely 1716 observation nurse reported 37 year old male with no known allergies complaining of throat tightness and ?weird feeling in throat? after receiving Janssen vaccine ( Lot # 204A21A). Patient assessed, no visual swelling noted on evaluation. Patient denies difficulty breathing or difficulty swallowing. Vitals stable BP 108/65, HR 67, RR 17, O2 Sats 98% on room air. Patient was alert and oriented and in no visible distress. 1720- EMS already on scene for a different call and was called for further evaluation of this patient as well . 1724 EMS assessed patient. Pt stable and refuses transport. Patient states he "feels ok?. Patient educated to seek medical attention for any difficulty breathing, difficulty swallowing or any concerning symptoms. Pt discharged in stable condition.

Severe tinnitus, variable throughout the night, louder than the train horn 4 blocks away. Severity slowly lessened the next day, by evening June 2 it was at the steady state level it is still at now, 2 weeks later. It's extremely distracting and reduces my ability to focus or think clearly. I have a purely thinking job and this is an extremely disruptive and productivity reducing level of sound. Related but not what is being reported: Fever of 103F from about 7pm (6 hours after injection) to early morning. Down to 101F by 8am. 400mg ibuprofen taken at 9pm. I've never had any negative reaction to any other vaccine before.

Symptom onset 6/22/2021 of runny nose, nasal congestion, headache, fatigue, nausea, loss of smell and loss of taste. Tested positive for COVID-19 via PCR on 6/24/2021

FELT TASTE OF BLOOD IN MOUTH; FELT SORENESS; FEELING OF PAIN IN CHEST; NO ENERGY; DIZZINESS; This spontaneous report received from a consumer concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and gout, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced dizziness. On 25-JUN-2021, the subject experienced no energy. On 26-JUN-2021, treatment medications included: paracetamol. On 27-JUN-2021, the subject experienced felt soreness. On 27-JUN-2021, the subject experienced feeling of pain in chest. On 29-JUN-2021, the subject experienced felt taste of blood in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and no energy, and the outcome of felt soreness, feeling of pain in chest and felt taste of blood in mouth was not reported. This report was non-serious.

After about 3 days of flu like symptoms the flue like symptoms began to decline however late in the night, roughly 2am wednesday night/thursday morning, I woke up with a high pitched squealing in my left ear. The pitch started at 9,000Hz. After about 2 weeks I saw my family physician where I was prescribed corticosteroids orally. That slightly diminished the high pitch and changed it to more of a oscillating frequency however once one the steroids were complete the pitch continued to get worse and back to original levels. I went back again about 4 weeks later and was prescribed a second dose. Same outcome occurred. I then went to a ENT and was prescribed a different corticosteroid and again same outcome occurred. The frequency is so bad I can't sleep, read, and can barely do my job. Besides the tinnitus their is consistent pressure on my left ear and ear popping every time I swallow. I have taken Zyrtec-D however this only mildly works for the pressure. Although the pressure is consistently there it varies in intensity. This has been one of the worse experiences of my life and I hope the matter is taken seriously as both physicians correlate the occurrence with the vaccine but are unsure why it's happening.

Patient b/c diaphoretic, pale w/ facial flushing w/in 3 min of injection. He then c/o feeling dizzy and nauseous. Vitals were stable other than his BP being slightly low at 97/58. After ~10 min he c/o feeling his throat getting a little tight, at which time he was injected w/ 0.3 mg of Epinephrine w/ an auto-injector. His throat started to feel better shortly after, but still felt sick. He was given Cetirizine 10mg along w/ Pepcid 10 mg , but avoided benadryl d/t h/o severe sedation and wanted to keep him alert during the observation period. After 2 hrs of observation, he was feeling much better and all vitals were normal. However, he still c/o some discomfort w/ his throat, so another 0.3mg of Epinephrine was injected using an auto injector. He continued to recover and after another 2 hrs of observation, he was allowed to go home w/ his wife for close monitoring. He was called 1 hr later and confirmed that he continue to do well. He was advised to take 25 mg of Benadryl before going to bed. He was seen the following day and was back to normal.

Received vaccine on 6/5/21, next morning at 7:00 am mother heard a loud noise and found PT face down lying half way in bathtub unresponsive, attempted to lift him observing his eyes were rolled back in head, was unconscious for approximately 1 min trying to lift him out, then he blacked out a second time hitting bathtub a second time. Lifted him out and placed on floor, he was unresponsive - called 911, he came to slightly after 3 minutes. Ambulance took him to ER and we stayed all day receiving fluids and chest XR (clear). We were discharged in the afternoon with the doctor saying he has a syncopy episode. At 4:00 PM PT was going to the bathroom and he stated he didn't feel good. I stood in front of him because he turned white and eye rolled up into his head and he blacked out and stopped breathing for approximately 2 minutes while I got him on floor and gave CPR. Called 911 and he began breathing again . Back in ambulance to hospital and we stayed in hospital for 2 days.

Right after the vaccine was administered, patient complained about dizziness, temporary blurred vision & loss of hearing. Patient became pale, hyperventilating and complaining of shortness of breath. Soon after, he passed out for 20 seconds. When he gained consciousness, he felt tingling and numbing on both hands.

I've had skin rashes on hands and fingers (similar to a form of contact dermatitis in appearance) since April 11th. I've had what appears to be angular cheilitis since June. I've had irritation, itchiness, and skin peeling around both eyes since June.

FLU-LIKE SYMPTOMS/FEVER/BODY ACHE/CHILLS BUMPS/SLIGHT COUGH; SUPER DROWSY; EYES HOT/ON FIRE; COLD SWEATS; HOT SWEATS; THIRSTY; DRY THROAT; NO APPETITE LAST NIGHT AND THIS MORNING; BLOOD PRESSURE NOT HIGH; COULDN'T GET MUCH SLEEP LAST NIGHT; DRY MOUTH; HIVES; UNABLE TO SMOKE AS IT MAKES HIM NAUSEOUS; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JUL-2021, the subject experienced flu-like symptoms/fever/body ache/chills bumps/slight cough. On 20-JUL-2021, the subject experienced super drowsy. On 20-JUL-2021, the subject experienced eyes hot/on fire. On 20-JUL-2021, the subject experienced cold sweats. On 20-JUL-2021, the subject experienced hot sweats. On 20-JUL-2021, the subject experienced thirsty. On 20-JUL-2021, the subject experienced dry throat. On 20-JUL-2021, the subject experienced no appetite last night and this morning. On 20-JUL-2021, the subject experienced blood pressure not high. On 20-JUL-2021, the subject experienced couldn't get much sleep last night. On 20-JUL-2021, the subject experienced dry mouth. On 20-JUL-2021, the subject experienced hives. On 20-JUL-2021, the subject experienced unable to smoke as it makes him nauseous. Laboratory data included: Blood pressure increased (NR: not provided) Little high. Treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: tetryzoline hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from super drowsy, cold sweats, hot sweats, flu-like symptoms/fever/body ache/chills bumps/slight cough, eyes hot/on fire, thirsty, dry throat, couldn't get much sleep last night, hives, and dry mouth, had not recovered from no appetite last night and this morning, and unable to smoke as it makes him nauseous, and the outcome of blood pressure not high was not reported. This report was non-serious.

I fainted the following evening after my vaccination. I felt fine all day and after dinner started to feel flush, vision became blurry and had trouble hearing. Within 3 minutes I fainted. Felt fine after coming to, and have felt fine so far the next day.

No symptoms within first 2 hours of vaccination. At about 2 hours, became extremely sensitive to light and sound, severe headache/migraine (pain 7/10) to left side, and heavily fatigued. No discomfort at injection site. Temp 99.1°F, muscle pain, weakness, stiffness approx 5 hrs after injection. OTC Tylenol (700mg) taken around 7 hrs after injection with no relief of symptoms. Unable to stay awake, slept approx 12 hours from 21:30 on 03/08/2021 until 09:30 on morning of 03/09/2021. All symptoms still active, headache improved slightly (5/10) but muscle stiffness, muscle pain, and fatigue worse. Nausea and mild abdominal pain/cramping around noon. Fever of 101.2°F at 13:00 on 03/09/2021, 100.0°F at 16:00, and down to 99.1 at 20:00.

Patient described onset of ringing in the ears with intense headache beginning Sunday 3/21 in the afternoon and lasting until Tuesday 3/23 - Since Tuesday the ringing and headache has been episodic. Today (3/24) patient reports tingling, pins and needles on head/face and neck. Patient says he has normal sensation in those areas as well.

38 yo male with complaints of localized chest pain on the left side. Progressed to have chest tightness without breathing difficulty. Stated he had facial and oral numbness and numbness of top of L hand. Declined any intervention initially then agreed to take 25mg of benadryl solution orally. Lungs clear, tachycardic but regular rhythm, throat clear, uvula midline. Patient left with EMT's

Approximately 6 hours after the vaccination I started to experience minor flu-like symptoms including low grade fever & chills. By 12 hours after vaccination my symptoms were more severe and included fevers 101.5, headaches, severe body aches, chills, dizziness, nausea, and hearing sensitivity. By 36 hours after vaccination my symptoms had mostly subsided with just minor dizziness and nausea remaining.

3/28/21 started to have jaw pain. 4/2/21 a lump started to form in neck. 4/3/21 lump in the neck and evening broke out with lesions on the left side of forehead, nose and temple. Went to ER for evaluation, CT scan with contrast. CT confirmed lump was swelling of lymphoid. ER thought maybe shingles, but it crosses over slightly over to the right with lesions.They determined maybe a virus and follow up with a dermatologist. 4/4/21 lesions now on left eye lid. ER visit again to ensure eye is ok, the ER dr. believes its shingles. 4/5/21 visit to dermatology and swab of lesions on face taken (still waiting on results). Dermatology believes some kind of herpes, but not sure. Went to Eye specialist to ensure eye does not have virus on same day. Eye dr believes shingles. Virus is not in the eye, but on left eyelid.

Complaints of spotty vision and tingling in hands. Approximately 5 mins after receiving Janssen vaccine. Suddenly patient became pale but did not have loss of consciousness, During evaluation tingling sensation included abdomen and chest area. Denied facial swelling, throat/lip swelling, difficulty breathing, shortness of breath or difficulty swallowing. Able to take water at 4:38 pm. Tingling in abdomen or chest resolved at 4:45 pm. Tingling in hands resolved at 4:50 pm 1630: BP 131/78, Pulse 108, RR 12 O2 Sat 98% 1650: BP 134/86, Pulse 108, RR 12, O2 Sat 97% Medical history of anxiety/depression, has fainted with needles in the past

Within approximately five minutes of injection, I experienced increased sweating, light headedness, and difficulty seeing until I passed out unconscious for a minute or two. When I awoke I was still sweating and cold for the next five to ten minutes. Paramedics checked my vital signs onsite afterwards (blood pressure, sugar levels, and pulse) and everything appeared to be normal. I was able to drive home 30 minutes later after making sure that all side effects subsided. I have not experienced any other side effects from the vaccine.

Left-sided face numbness and tingling in tongue approx. 12 hours after receiving the shot Extreme fatigue, back pain/kidney pain, joint pain, extreme pain in both feet, vertigo, ringing in ears, stiff neck, back pain, heaviness in legs, difficulty sleeping, brain-zaps (forget my thoughts)

Left work early because Chills, sweating Fever, Headache, Muscle and body aches, Fatigue, Shortness of breath, Fast heartbeat, Blood pressure 150/86/98 at 4:10pm on April 11. Cyclobenzaprine 10mg at 5pm and slept under multiple blankets because I was cold and sweating. Woke up the next day fine just a sore arm.

patient received the vaccine janssen at 2:12 pm . At 2:13 pm patient complaint of experiencing dizziness , nausea, sweating , blurry vision dry mouth , difficulty swallowing saliva . per Dr order administer the Epi-pen . 911 was called . Paramedics transport patient to the nearest hospital

Ringing/pressure in left ear began within 4 hours of vaccine administration and continues almost 2 weeks later. Some varying degrees of intensity but continuous symptoms.

After receiving the vaccine, about 12:30am on 03/28/21 I felt a chills, shaky muscles around my neck/shoulders..the room temperature was at 80F but I felt cold like 35F. The next morning, I felt very tired walking up stairs from the basement to my room on the 2nd floor..barely made it to the 2nd floor, felt like my body hitting a wall/ no energy to lift my legs up. I made to my bedroom but felt very dizzy, using my hands holding myself up on my desk and realized I might faint any seconds..my vision was bright and blurry. I slowly moved myself to a bed and laid down for a while. Later that day in the late afternoon, my muscles were sore (legs, thighs, back) I could not walk more than 10-15 steps which I needed rest. These conditions lasted me for 6 days since receiving the vaccine and felt better on the 7th day. Currently I'm ok.

Chills, Muscle Spasms, Shortness of Breath, Fever, Sweating, Joint Pain, Muscle Aches, Severe Headache. Symptoms resolved within 24hrs except headache and fatigue. Headaches continue and new symptoms have emerged. Acute severe head pain, dizziness, mental confusion, difficulty speaking and visual affects of stars, dark spots and difficulty focusing.

MIGRAINE TYPE HEADACHE; PAIN IN NOSE; FEELING OF PIMPLE INSIDE NOSE; PAIN IN EYES; PRESSURE IN LEFT EYE; BLINKING LIGHT AURA IN LEFT EYE; NASAL PRESSURE; FEELING OF BUMPS INSIDE NOSE; PAIN IN FOREHEAD/A LOT OF HEADACHES; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included social drinker, and non smoker, and other pre-existing medical conditions included the patient have no known drug allergies, drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol. On 05-APR-2021, the subject experienced migraine type headache. On 05-APR-2021, the subject experienced pain in nose. On 05-APR-2021, the subject experienced feeling of pimple inside nose. On 05-APR-2021, the subject experienced pain in eyes. On 05-APR-2021, the subject experienced pressure in left eye. On 05-APR-2021, the subject experienced blinking light aura in left eye. On 05-APR-2021, the subject experienced nasal pressure. On 05-APR-2021, the subject experienced feeling of bumps inside nose. On 05-APR-2021, the subject experienced pain in forehead/a lot of headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in nose, feeling of pimple inside nose, and feeling of bumps inside nose on 07-APR-2021, had not recovered from pain in forehead/a lot of headaches, migraine type headache, pain in eyes, pressure in left eye, and blinking light aura in left eye, and the outcome of nasal pressure was not reported. This report was non-serious.

Symptoms: Fever, tiredness, body aches, joint pain, soreness around eyes, and soreness at injection site. Symptoms started approximately around 7:00 P.M. , which is approximately six hours after receiving the vaccination.

Tinnitus in left ear (shot received in left arm). It?s a constant tone. I?ve never had tinnitus previously. Tone was there when I woke up (9-apr, 0800) the morning following the shot (8-apr, 1400). The tone increased in intensity about a week later and was consistent after that. Based on surrounding conditions, intensity of tone can be a 1/10 with background noise and 6/10 in silence. Additionally, there is a degree of interference in sounds. If the sound is from a low quality speaker (phone/computer) the sounds generates a static sound, almost like interference or what music sounds like from low quality buffering. Also, music, even played at low volume in speakers, increases the intensity of the tone.

ED notes: 39 y.o. male with no significant medical history brought by EMS for dysarthria, RT arm weakness, and RT facial droop beginning at 2:05pm today. Sx acute onset, severe, constant, and have not occurred previously. Pt was driving just prior to symptom onset when he called his mother stating he did not feel well at 2:05pm. Upon arriving home, mother noticed he was dysarthric and called 911. EMS noted facial droop, arm weakness, dysarthria, and gaze palsy and transported him to the hospital. Initial glucose by EMS 110. Pt denies headache, recent head trauma, history of brain hemorrhages or prior stroke. PMH: None, PSH: None, Allergies: NKDA, Tobacco: Denies, ETOH: Social, Drugs: Denies Pt AAOx3, bib from home for weakness and facial droop. Stroke alert called en route. As per report, pt was driving home at 2 pm when he started to feel ""weird"". Pt called his wife and was able to drive himself home. Upon arrival at his house he ""collapsed"" on the couch and his wife noticed right-sided facial droop and weakness, more prominent on the right side. Upon arrival to ED pt appears pale and weak. R sided facial droop and right arm and right leg weakness noted. Dr. at bedside. Stroke alert called in ED. Hr noted to be in the 40s. As per wife, pt is an athlete 5/4/21 Critical Care Notes: Neurology- No hx of neurological disease but does have family history of blood clotting disorder in maternal uncles and cousins (factor 2 and factor 5 but unclear specific diagnosis)- Patient presented with R sided weakness, R facial droop, dysarthria, double vision, R CN 6 palsy; no prior history of similar events- CT brain negative for acute abnormaility - CTA brain/perfusion showed no significant stenosis, occlusion, aneurysm, no perfusion abnormality- MRI brain showed small acute ischemic infarct in ventromedial L thalamus and chronic bilateral cerebellar lacunar infarcts- Patient showing improvement in symptoms s/p tPA- Repeat CT showed new mild hypoattenuation suggesting evolving acute infarction with no bleed, herniation, mass effect, or midline shift- Echo with bubble study revealed patient PFO, No DVT on LE US- Lipid profile WNL, tox screen neg, RPR neg- Neuro checks per unit protocol- Check ANCA, Anti cardiolipin, anti thrombin III, antiphospholipid Ab, Factor V Leiden, Protein C and S, ANA, FTA, A1c; Dr. (H/O) consulted- ESR elevated- DAPT per neuro- DSA with NIR today Cardiology- Hx of sinus bradycardia: Patient is athletic, works out regularly. Had previous cardiac evaluation with no significant findings- EKG showing borderline 1st degree AV block- Troponin neg- BP well controlled - MAP goal >65mmHg- 2D echo with bubble study revealed patent PFO, No DVT on LE US Heme/Onc- CBC unremarkable - No active bleeding- Transfuse if Hgb < 7- DVT prophylaxis SCDs, patient ambulatory- No DVT on LE US- Workup as above for blood clotting disorders given stroke in otherwise young healthy patient with family history of clotting disorders- H/O consulted, pending eval 5/9/21 Neurology Note: Overall neurological assessment remains stable and unchanged overnight. Double vision on the right eye stable, improving as per patient's report. Will recommend to continue with DAPT as ordered. Follow up with neurology as an outpatient in 2-4 weeks. Follow up with Cardio as well. Ok to discharge patient home as per Neurolgy standpoint. 1. Left ventromedial thalamic CVA. 2. PFO - S/P closure 5/7/2021. 3. Congenital hypoplastic left VA, basilar trunk. 4. Remote cerebellar lacunar infarcts. 5. Family history of Factor V Leiden, factor II. PLAN: 1. Ok to discharge patient home as per neurology standpoint. 2. Continue ASA 81 mg and Plavix 75 mg Daily. 3. Follow up with neurology as an outpatient in 2- 4 weeks. 4. Follow up with Cardio as per their recommendations. 5. Medical management as per IM.

More than 30 days after receiving the Janssen vaccine, I tested positive for COVID-19. Symptoms began as runny nose, sneezing, and sinus pressure/burning on April 6, 2021. Tested for COVID-19 on April 11, 2021 (nasal swab, PCR test) after a family member tested positive. Symptoms worsened on April 12, 2021, including shortness of breath, chest pain, complete loss of taste and smell. Sought treatment for breathing difficulty at ER on April 13, 2021 (Vidant Medical Center and was instructed to rest at home. Sought treatment for breathing difficulty at PCP on April 14, 2021 ( Medical Center) and prescribed Prednisone. Symptoms worsened on April 15, 2021, including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting. Sought treatment at ER on April 15, 2021 (Vidant Medical Center, Greenville, NC). Held for three days, treated with Remdesivir (3 doses) and supplemental oxygen. Discharged from hospital on April 18, 2021. Symptoms did not improve following discharge. Sought treatment for ongoing symptoms at ER on April 21, 2021, instructed to rest at home. Symptoms continued to worsen on April 24, 2021, including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting, and slurred/incoherent speech. Sought treatment at ER on April 15, 2021, admitted to hospital on April 25, 2021 diagnosed with probable TIA. Treated with Optiflow high-flow oxygen therapy, nebulizer, and steroids. Received a variety of tests and scans of head, neck, spine, chest, heart; none showed signs of any serious cardiac, vascular, or neurological problems. Transferred to in-patient rehabilitation on May 1, 2021 for physical and occupational therapy. Discharged from in-patient rehabilitation on May 6, 2021. Prescribed out-patient physical and occupational therapy to resolve remaining dizziness, balance, and endurance deficits.

ANGIOGRAM PULMONARY ABNORMAL; SCAN WITH CONTRAST ABNORMAL; SARS-COV-2 TEST POSITIVE; FULL BLOOD COUNT NORMAL; SARS-COV-2 ANTIBODY TEST NEGATIVE; ANGIOGRAM; ANGIOGRAM PULMONARY; BLOOD GASES; BLOOD MAGNESIUM; BLOOD PHOSPHORUS; BLOOD THYROID STIMULATING HORMONE; CHEST X-RAY; COMPUTERISED TOMOGRAM; COMPUTERISED TOMOGRAM HEAD; COMPUTERISED TOMOGRAM THORAX; ECHOCARDIOGRAM; ELECTROCARDIOGRAM; ELECTROENCEPHALOGRAM; FIBRIN D DIMER; GLOMERULAR FILTRATION RATE; GLYCOSYLATED HAEMOGLOBIN; MAGNETIC RESONANCE IMAGING HEAD; MAGNETIC RESONANCE IMAGING SPINAL; METABOLIC FUNCTION TEST; SCAN WITH CONTRAST; TROPONIN; LIPIDS; PULMONARY EMBOLISM; TRANSIENT ISCHAEMIC ATTACK; AGEUSIA; AMNESIA; ANOSMIA; BALANCE DISORDER; CHEST PAIN; COVID-19; DIZZINESS; DYSARTHRIA; DYSPNOEA; EXPOSURE TO SARS-COV-2; PRESYNCOPE; RHINORRHOEA; SNEEZING; PARANASAL SINUS DISCOMFORT; HYPOAESTHESIA; SPEECH DISORDER; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a Regulatory Authority, VAERS (Vaccine Adverse Event Reporting System) (VAERS ID 1347147), concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol. The patient had no known allergies. The patient had no current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced pulmonary embolism, ageusia, amnesia, anosmia, balance disorder, chest pain, dysarthria, dyspnoea, paranasal sinus discomfort, presyncope, rhinorrhoea, scan with contrast abnormal, sneezing, speech disorder, dizziness, hypoaesthesia, angiogram, angiogram pulmonary, angiogram pulmonary abnormal, blood gases, blood magnesium, blood phosphorus, blood thyroid stimulating hormone, chest x-ray, computerised tomogram, computerised tomogram head, computerised tomogram thorax, echocardiogram, electrocardiogram, electroencephalogram, exposure to sars-cov-2, fibrin D dimer, full blood count normal, glomerular filtration rate, glycosylated haemoglobin, lipids, magnetic resonance imaging head, magnetic resonance imaging spinal, metabolic function test, sars-cov-2 antibody test negative, sars-cov-2 test positive and troponin. More than 30 days after receiving the Janssen vaccine (on 06-APR-2021) the patient tested positive for COVID-19 (Confirmed COVID-19 Infection) and was confirmed Clinical Vaccination Failure, the patient experienced symptoms runny nose, sneezing, and sinus pressure/burning. Laboratory data included: Angiogram (NR: not provided) Not reported, Angiogram pulmonary (NR: not provided) Not reported, Angiogram pulmonary (NR: not provided) Abnormal, Blood gases (NR: not provided) Not reported, Blood magnesium (NR: not provided) Not reported, Blood phosphorus (NR: not provided) Not reported, Blood thyroid stimulating hormone (NR: not provided) Not reported, Chest X-ray (NR: not provided) Not reported, Computerised tomogram (NR: not provided) Not reported, Computerised tomogram head (NR: not provided) Not reported, Computerised tomogram thorax (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, Electrocardiogram (NR: not provided) Not reported, Electroencephalogram (NR: not provided) Not reported, Fibrin D dimer (NR: not provided) Not reported, Full blood count (NR: not provided) Normal, Glomerular filtration rate (NR: not provided) Not reported, Glycosylated haemoglobin (NR: not provided) Not reported, Lipids (NR: not provided) Not reported, Magnetic resonance imaging head (NR: not provided) Not reported, Magnetic resonance imaging spinal (NR: not provided) Not reported, Metabolic function test (NR: not provided) Not reported, SARS-CoV-2 antibody test (NR: not provided) Negative, SARS-CoV-2 test (NR: not provided) Positive, Scan with contrast (NR: not provided) Abnormal, Covid-19 virus test (NR: not provided) Positive and Troponin (NR: not provided) Not reported. On 11-APR-2021 tested for COVID-19 (nasal swab, PCR test) after a family member tested positive (confirmed covid-19 infection). Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) Positive. On 13-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (NR: not provided) Not reported, and EKG (electrocardiogram) was normal. On 12-APR-2021 symptoms worsened including shortness of breath, chest pain, complete loss of taste and smell. On 13-APR-2021 the patient received sought treatment for breathing difficulty at ER (emergency room) and was instructed to rest at home. On 14-APR-2021 the patient received sought treatment for breathing difficulty at PCP (primary care physician) medical center and was prescribed prednisone. On 15-APR-2021 symptoms worsened including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting and patient received sought treatment at emergency room. The patient was held in hospital for three days and was treated with remdesivir (3 doses) and supplemental oxygen. Laboratory data included: CBC (complete blood count) Not reported, Chest X-ray (NR: not provided) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, EKG (electrocardiogram) Normal, Magnesium (NR: not provided) Not reported, Phosphorus (NR: not provided) Not reported, SARS-CoV-2 IgG antibody test (NR: not provided) Negative, TSH (thyroid stimulating hormone) Not reported, Troponin I (NR: not provided) Not reported, and Urine analysis (NR: not provided) Not reported. On 16-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (complete blood count) Not reported, Computerised tomogram scan (NR: not provided) Not reported, Computerised tomogram thorax (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, HbA1C (Glycated hemoglobin) Not reported, Lipids (NR: not provided) Not reported, Magnesium (NR: not provided) Not reported, Phosphorus (NR: not provided) Not reported, Troponin I (NR: not provided) Not reported, and Vitamin D (NR: not provided) Not reported. On 17-APR-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Not reported, and Fibrin D dimer (NR: not provided) Not reported. On 18-APR-2021 the patient was discharged from hospital. The patient reports that the symptoms did not improve following discharge. On 18-APR-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Not reported. On 21-APR-2021, the patient undergone sought treatment for ongoing symptoms and was instructed to rest at home. Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (complete blood count) Not reported, Chest X-ray (NR: not provided) Not reported, Computerised tomogram thorax was found to be pulmonary embolism with contrast, EKG (electrocardiogram) Not reported, Estimated glomerular filtration rate (NR: not provided) Not reported, and Troponin I (NR: not provided) Not reported. On 24-APR-2021 the patient reports that the symptoms were continued to worsen including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting, and slurred/incoherent speech. Laboratory data included: Arterial blood gases (NR: not provided) Not reported, Chest X-ray (NR: not provided) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, Computerised tomogram head (NR: not provided) Not reported, EKG (electrocardiogram) Not reported, SARS-CoV-2 IgG antibody test (NR: not provided) Positive, and Troponin I (NR: not provided) Not reported. On 25-APR-2021 the patient received sought treatment at emergency room and admitted to hospital on the same day again, patient was diagnosed with probable TIA (transient ischaemic attack) and was treated with Optiflow high-flow oxygen therapy, nebulizer, and steroids. Laboratory data included: CBC (complete blood count) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, Computerised tomogram head (NR: not provided) Not reported, Computerised tomogram neck (NR: not provided) Not reported, Computerised tomogram thorax (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, HbA1C (Glycated hemoglobin) Not reported, Magnetic resonance imaging brain (NR: not provided) Not reported, Magnesium (NR: not provided) Not reported, and Phosphorus (NR: not provided) Not reported. On 26-APR-2021, Laboratory data included: CBC (complete blood count) Not reported, and Lipids (NR: not provided) Not reported. On 27-APR-2021, Laboratory data included: CBC (NR: not provided) Not reported, and electroencephalogram (EEG) (NR: not provided) Not reported. On 28-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (complete blood count) Not reported, Fibrin D dimer (NR: not provided) Not reported, Magnesium (NR: not provided) Not reported, Magnetic resonance imaging spinal (NR: not provided) Not reported, Magnetic resonance imaging thoracic (NR: not provided) Not reported, Phosphorus (NR: not provided) Not reported, and SARS-CoV-2 IgG antibody test (NR: not provided) Positive. On 30-APR-2021, Laboratory data included: CBC (NR: not provided) Not reported, and SARS-CoV-2 PCR test (NR: not provided) Positive. On 01-MAY-2021 The patient was transferred to in-patient rehabilitation for physical and occupational therapy, Laboratory data included: CBC (complete blood count) Not reported, Magnesium (NR: not provided) Not reported, and Phosphorus (NR: not provided) Not reported. On 03-MAY-2021, Laboratory data included: CBC (complete blood count) Not reported, Magnesium (NR: not provided) Not reported, and Phosphorus (NR: not provided) Not reported. On 06-MAY-2021 patient was discharged from in-patient rehabilitation and was prescribed with out-patient physical and occupational therapy to resolve remaining dizziness, balance, and endurance deficits. The patient was hospitalized for 16 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ageusia, amnesia, angiogram pulmonary abnormal, anosmia, balance disorder, blood gases, chest pain, dysarthria, dyspnoea, paranasal sinus discomfort, presyncope, pulmonary embolism, rhinorrhoea, scan with contrast abnormal, sneezing, speech disorder, transient ischaemic attack, blood magnesium, blood phosphorus, blood thyroid stimulating hormone, chest x-ray, computerised tomogram, computerised tomogram head, computerised tomogram thorax, covid-19, dizziness, echocardiogram, electrocardiogram, electroencephalogram, exposure to sars-cov-2, fibrin d dimer, full blood count normal, glomerular filtration rate, glycosylated haemoglobin, hypoaesthesia, lipids, magnetic resonance imaging head, magnetic resonance imaging spinal, metabolic function test, sars-cov-2 antibody test negative, sars-cov-2 test positive, troponin, angiogram, angiogram pulmonary, and scan with contrast, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). The case is associated with Product Quality Complaint number: 90000181966. The suspected product quality complaint has been confirmed to be not confirmed. The reported allegation was not confirmed and the root cause was determined to be not manufacturing related, based on the PQC evaluation/investigation performed. Additional information was received from Central Complaint Vigilance on 21-JUN-2021. The following information was updated and incorporated into the case narrative: Product complaint investigation result was added.; Sender's Comments: V1. The follow-up information in this version updates Product complaint investigation result. This updated information does not alter causality of previously reported events. 20210609990 -covid-19 vaccine ad26.cov2.s - Pulmonary embolism , transient ischaemic attack, Ageusia, amnesia, angiogram pulmonary abnormal, angiogram pulmonary , anosmia, balance disorder, blood gases, chest pain,dysarthria, dyspnoea, paranasal sinus discomfort, presyncope, rhinorrhoea, scan with contrast abnormal, sneezing, speech disorder, blood magnesium, blood phosphorus, blood thyroid stimulating hormone, chest x-ray, computerised tomogram, computerised tomogram head, computerised tomogram thorax, covid-19, dizziness, echocardiogram, electrocardiogram, electroencephalogram, exposure to sars-cov-2, fibrin d dimer, full blood count normal, glomerular filtration rate, glycosylated haemoglobin, hypoaesthesia, lipids, magnetic resonance imaging head, magnetic resonance imaging spinal, metabolic function test, sars-cov-2 antibody test negative, sars-cov-2 test positive, troponin, and angiogram. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210609990-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Muffled hearing in my right ear started a couple days after the vaccine, it got worse over the next 3-5 days. Then it?s just stayed at that hearing loss/muffled hearing state ever since.

Chest fluttering Dizzy/nauseous/fatigued 1st day Fever/chills/tension headache 2nd day Mild chest tightness 3rd and 4th day Sweaty/clammy hands and feet every day since vaccine Waking up sweaty every night Mild left ear Tinnitus 4th day Forehead Neck/throat/chest/stomach warm no fever 3rd and 4th day Some loose stool 4th day, vertigo Imbalanced feeling chest quivering elevated heart rate 4th day constipation 5th day and insomnia along with severe vertigo when lying flat severe tension headaches mild hearing imbalance and popping both ears 6th day mild tension headaches with pressure on head, stomach burn, heartburn weak legs vertigo 7th day mild tension headaches with pressure on head, stomach burn, heartburn weak legs vertigo 8th day pressure on head, stomach burn, heartburn weak legs vertigo 9th day

Arm pain, elevated temperature 99.5, head ache, light sensitivity. I couldn?t work or sleep and had to stay in a dark room the entire day after

Chest pain, fever, body aches, headaches, blurry vision. All seemed to last about 5 days. Pain at injection is still sore. Wife had same exact adverse effects.

Developed within 10 hours and lasted 36 hours Severe body aches Fatigue Metallic taste in mouth Injection site pain that lasted 1 week Fever of 104.3

EYES WATERY; BODY ACHES; FEVER/CHILLS; This spontaneous report received from a patient concerned a 39 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 21:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Pending at this time (units unspecified), and COVID-19 antigen test (NR: not provided) Negative (units unspecified). On 02-APR-2021, the subject experienced eyes watery. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced fever/chills. Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 03-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 12-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.4 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 05-APR-2021, and had not recovered from fever/chills, and eyes watery. This report was non-serious.

Hives, swelling in lips, face, metallic taste in mouth. Continuing even after ER visit at 4 am Wednesday morning and taking meds to control reaction

Chills and Fever the first day a few hours after injection along with Fatigue, Multi-day Headache, Slight Body Ache, and Injection Site Pain all for about 2 or 3 days. Some leg pain was noticed the 2nd or 3rd day. And I have experienced ear ringing randomly about a week and a half after vaccination. Those may or may not be related. Also I feel it important to note in March of 2020 (before testing was available) I experienced a very similar set of symptoms: fever, chills, fatigue, multi-day headache, body ache, 6 weeks of slight cough, leg pain, and a day a few weeks after the coughing started where I had shortness of breath. I wasn't tested back then as it was not available. But based on the symptoms I experienced, I truly believe I had COVID-19 last year prior to vaccination.

Dizziness, coughing, mild headache, and pain behind eyes - took Tylenol Daytime Cold Tablets twice during day - 4/25/21

Almost vasovagal syncope. Vaccine administered at 11:00. Vasovagal symptoms present at 11:03. Profuse sweating, decreased ability to see (tunnel vision), ringing in the ears (subsequent hearing loss). Fainting did not present, and symptoms completely subsided at 11:08.

Not sure when it actually started, as I had fever like symptoms the day after, but ever since I have had a ringing in my ears. With background noise or doing some kind of activity it sufficiently distracts me from it but it's quite clear in the morning and night. Hasn't gotten better or worse.

woke up to vomiting, loss of appetite, dizziness, severe tinnitus, head congestion and pressure, headaches. Went to emergency room 3 days after and got IV fluids and prescribed prednisone and anti nausea meds. still having nausea and extreme tinnitus that will not stop. appetite is getting better but nausea still comes and gos.

Three days and continuing since onset Fevers of above 100(Tylenol sometimes controls fever) 2 every 6 hours Muscle aches Extreme fatigue Dizziness Shivering /hot and cold flashes Loss of strength Mental confusion Coughing Shallow breathing Loss of taste and smell Loss of appetite Nausea Sensitive skin(pins and needles)

Three minutes after receiving a Janssen vaccine, patient was noted by this RN to be unresponsive in his chair located in the post vaccine observation area. The following observations were noted. His head was tilted back resting on the clinic trailer. Body positioned, slumped in the chair. His pupils were positioned back. Unresponsive to verbal or tactile stimuli. Respiration labored with an occasional agonal breath. Infrequent twitching of body noted. Patient was drooling, clear secretions. Pallor was noted on this patient's face. Time lapse for previous noted symptoms was one minute. Vital signs were assessed. Vital signs were normal. BP 120/60, left arm, manual assessment cuff. HR 56. RR 18. 02 saturation 97 % on room air. Blood glucose 97 mg./dl. 911 called for rescue. Patient gradually regained conscious. Patient vomited two times, small amount, clear secretions. Rescue arrived. Normal sinus rhythm. Patient was alert and oriented x 3. Refused transport to the hospital for evaluation. Home with family driving him home. Patient does not have a PCP. Patient encouraged to call 911 if symptoms return.

SWEATING; LIPS TURNED INTO PALE; VISION BLURRED; NO ENERGY; STRESSFUL HEADACHE; NUMBNESS IN THE GROIN AREA AND LEFT TESTICLES; SWOLLEN LEFT TESTICLE; FEEL EXTREME PAIN; FEELING SENSATION IN DEEP INSIDE BODY AND WAS NOT SUPERFICIAL/FEELING WAS GOING TOWARD LEFT SIDE OF PELVIS/FEELING BLOOD BEATS IN LOWER PART AREA; LEFT SIDE OF LOWER ABDOMEN AROUND THE WAISTLINE SWOLLEN; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgery, and concurrent conditions included non alcohol user, and smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced numbness in the groin area and left testicles. On APR-2021, the subject experienced swollen left testicle. On APR-2021, the subject experienced feel extreme pain. On APR-2021, the subject experienced feeling sensation in deep inside body and was not superficial/feeling was going toward left side of pelvis/feeling blood beats in lower part area. On APR-2021, the subject experienced left side of lower abdomen around the waistline swollen. On APR-2021, the subject experienced stressful headache. Treatment medications included: morphine, and oxycodone hydrochloride. On 03-APR-2021, the subject experienced sweating. On 03-APR-2021, the subject experienced lips turned into pale. On 03-APR-2021, the subject experienced vision blurred. On 03-APR-2021, the subject experienced no energy. On 30-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) no sign of infection, Physical examination (NR: not provided) no sign of infection, and Urine analysis (NR: not provided) no sign of infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vision blurred, and the outcome of numbness in the groin area and left testicles, sweating, swollen left testicle, lips turned into pale, no energy, feel extreme pain, feeling sensation in deep inside body and was not superficial/feeling was going toward left side of pelvis/feeling blood beats in lower part area, stressful headache and left side of lower abdomen around the waistline swollen was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.

I have had headaches every day since I received the vaccination that last most of the day. There is a constant pressure in my head that moves around all areas, from the back base of the head, to the sides, temples, forehead/sinus regions. It is from waking until sleeping. Not incredibly intense, but constant. I have difficulty sleeping through the night and have not slept well since, either. I have also experience blurred vision. I have also experience bruising on various parts of my body including my arm, abdomen, and toe nails. My quality of life has suffered tremendously and I wish I hadn't gotten the vaccine.

day followimg shot: i awoke to extreme pain in all muscles and joints, profuse sweating, blurred vision, headache just behind my eyes muscle/joint pain lasted approx 24 hours; ibuprofen offered some relief. sweating lasted 3 days and resulted in dehydration to the point where my kidneys ached; i drank as much water as i could but my urine remained dark headaches/blurry vision lasted 2 days 5 days after the shot, the soles of my feet began to feel itchy, and the itchiness has been ongoing even up to now (7 days after shot) 7 days after shot, itchiness has also begun affecting the palms of my hands

Immediately while receiving my shot my mouth went dry, I have had continuing dry mouth since them, It made my blood sugar go up and I'm now a diabetic. Soreness for almost 2 week in my arm, blurred vision. I was extremely exhausted, and had a headache. I ended up going to the ER

New onset headache, eye pain, paresthesias, and urinary retention 2 weeks after getting covid-19 vaccination on 5/14/21

He has s had severe pain in left shoulder that radiates pain up into his neck, causing some headaches and seeing black spots. He cannot put his arm behind him, raise it up very high, and interferes with everyday living which is causing a lot of frustration and depression! It's been about 5 weeks and has taken Advil & Tylenol with no relief; feels the same pain & lack of mobility each day with no improvement.

Night of the vaccination had a fever of 102., body aches, chills and fatigue one night tired for a couple of days then three weeks later three weeks after vaccination had a fever body aches, chills, fatigue lasted 9 days, 3rd short ness of breath, 5th day head aches,6th blistered and body swelling, face swelling lips, neck and antiphallic type. A week into the symptoms Tele visit was told to take Benadryl next day, Emergency room a week into the symptoms, after taking Benadryl and was not seeing relief. Right wrist blister and both arms and legs was swollen feet and ankle was swelling and over the weekend the swelling. 5lbs of water swelling. Cold sweats through the symptoms.

TINNITUS; CHILLS; HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included hypertension, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced fever. On 13-MAY-2021, the subject experienced fatigue. On 14-MAY-2021, the subject experienced chills. On 14-MAY-2021, the subject experienced headache. On 19-MAY-2021, the subject experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, and fever on 18-MAY-2021, and fatigue on 21-JUN-2021, and had not recovered from tinnitus. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.