Johnson & Johnson

On March 11th at around 10pm I experienced severe shaking, fever, headache and delirium. The next day I improved but had a fever on and off of 99.1. I felt like I was stable, but felt dizziness increasing, and was lethargic through the weekend. Then on Monday the 15th, I had a noticeable cramp in my right abdomen. At around 8pm CST I began feeling like I needed to burp and that I had GI problems. The problems increased that night at around 10pm I had pain where the cramp started. Two hours later I started throwing up because of the pain and feeling of too much air inside of me. I could not stop vomiting after 2 hours so went to the Hospital ED at around 2:30 AM Tuesday the 16th. I was admitted after a CT scan showed and white cell counts confirmed and infection and drastically enlarged appendix. I was diagnosed with an appendicitis and they immediately scheduled me for surgery.

Dizziness and light headed, with confusion, fatiuge, with head ache. Very severe just after injection. 3 days post vaccine and still feeling dizziness and headache with mild fatigue. Symptoms are similar to a hang over. The symptoms are slightly better than the day of vaccination but still exsist. Symptoms do seem to come and go and are not constant. Little relief is given by tylenol.

Headache starting 1 hour after injection, lasting 36 hours. Light fever. Trouble sleeping. Trouble concentrating.

Approximately 9 hours after injection, and in mid sleep, intense body heat and severe chills woke up me up every hour for 5 hours(midnight to 5am). My body felt incredibly hot but I did sweat at all. If I would move the bed covers and any part of my skin below my neck felt the air I would get chills the would shake my entire body for a few seconds. Later that morning; body aches all over, a fever reaching 101.3, fatigue. Over the counter medicines, napping, and a shower helped reduce symptoms. All was gone by the next morning.

I started to feel really tired around 7:30pm and got a head ache so I went to bed early. I couldn't sleep well because I got the chills and a fever. I went to use the bathroom around 3am. All of a sudden I got really nauseous, the room spun, everything went black and I fainted in the middle of my bathroom. My wife woke up and helped me back to bed. The next day I was very weak and tired. The chills and fever faded the next afternoon.

"Janssen Covid-19 Vaccine EUA" flu like symptoms, body aches, running fever, makes you feel like you been hit by a big truck.

Employee did not have immediate post-vaccination reaction within 15-30 minutes. Employee reported that his wife found him wondering in the street at 2 AM on 3/27/21, confused with high fever of 104. Also reported nausea, vomiting, diarrhea, chills, myalgia, fatigue, headaches.

The day I got it my mouth started having a metal taste. For the past weeks I?ve been lethargic, can?t sleep, body ache, soft palate is itchy as well as my throat. The metal taste is still there and gets more intense with exercise or stress.

Patient reported burning sensation shortly, ~10 minutes, after receiving vaccine that carried across back of shoulder. Patient reported feeling "loopy/drunk". Patient refused all treatment and EMS. Around 40 minutes or so, patient vomited. Patient left with friends an hour after vaccine given.

Heart racing the next day after vaccination. I went for a walk in the park and i noticed my hear rate jumped up to 165bpm on my fitbit for a period of time even though i just began walking. I wasnt running or anything. I was foggy and very jittery. I also experienced the same symptoms today, 4.12.21 while also heading for a short walk. Im an athlete and in great shape and ive never had my heart jump to 165bpm just walking. That would happen normally after a sprint or long run, but not just walking.

I had the worst headache of my life on 3/22 but assumed it was a migraine and treated it as such. On 3/23 while playing hockey, nearly immediately after starting, the headache returned even stronger than on 3/22 and forced me to stop playing as I could not concentrate or focus. The headache lasted for several days. The following morning I went to my standard physician who immediately sent me to the ER because he was concerned about a potential aneurysm. No cause was ever determined as the tests were inconclusive but it was suspected to potentially be a pinched nerve. However, I never had any pain in my neck or elsewhere besides the headache.

Unusual exhaustion within an hour of the vaccine. Had to go to bed and slept into the evening developing a fever of 103, severe thirst and chills. The fever lasted until 10:00 a.m. the following day, but weakness, thirst, chills and body aches continued for 3 more days intermittently. I would feel like I could finally exercise and then be too weak and tired to go back to routine. My appetite declined for 4 to 5 days as food didn't taste appealing. On Thursday, April 8, I announced to my mom in the morning that I finally felt like I was back at almost 100% and later in the afternoon felt nauseous, incredible pain in my chest and had dry heaves. I finally vomited some and was once again overcome by a fever of 101 and all I could do was sleep from severe exhaustion. I am against medication, but finally agreed to taking ibuprofen and tums. After sleeping into the next day around noon, I finally was able to eat some breakfast but the pain in my chest continued and I could rid it for another day. I intermittently had to sleep and gave up my exercise routine until my body has had time to recuperate. I have not fully recovered, but my appetite is picking up. I still require more sleep than normal.

Got injected, didn?t hurt much. Was told to wait 15 minutes in case of reaction. They walked away and left me sitting in a chair in a public space with everyone else who was waiting. I texted my wife to check in, when I started tearing up and crying for no real reason, then started feeling nauseous so I closed my eyes. Suddenly I felt like I had been given a shot of adrenaline out of nowhere so I?m just trying to figure out if it?s nerves or a physiological response to something. I?m trying to control my breathing but having a hard time breathing. Then the fever hit. The most intense flash of heat. I was hyperventilating. I couldn?t open my eyes or move or make a sound, I could just sit there struggling to breathe. My phone was in my hand and I couldn?t lift it. I just simply didn?t have the strength or energy to move. At some point I legit thought I was about to die. I managed to angle my wrist so I could check my heart rate with my watch. It was 47bpm. I was fading away but I made myself get control of my breathing and forced myself to take long deep slow breaths. It hurt, and I felt like passing out, but I kept doing it. Fever turned into chills and then I soaked through my jeans and T-shirt in under a minute. I was finally thinking clearly and breathing and getting oxygen. Everyone else near me was fine. Nobody checked on me the entire time including the 3 people who sat there and watched me suffer through this. I told the pharmacist about my reaction and asked if it was normal and didn?t receive any indication that I should be concerned, so I went home since I felt better. It wasn?t until my friend pointed out that this sounds like anaphylaxis that I thought I should report it. So here I am. Hopefully I?ll be okay.

I experienced a severe headache later the same day as my vaccination. I took some extra strength acetaminophen at the regular intervals that day/night, but by the bed time (~9:00PM) I was unable to sleep. I experienced chills/sweating throughout the night as well as body ache and nausea. By morning (5/11/2021, ~9:00AM) I began vomiting and soon could not keep down any liquids. After this continued unabated, I went to the emergency room at ~11:00AM I checked myself in and the nurses triaged me and gave me IV fluids. The wait times that morning at the ER were very long, in excess of 2 hours, and after the first full bag of saline my nausea was gone and I felt amazingly better. Realizing I wasn't going to be seen for several hours and concerned about my own Covid exposure/general risk sitting in the waiting room for most of the day, I decided to leave without being seen. I ate lightly that day and drank lots of Pedialyte. By the next day I was ready to eat normally and went about my day. Later that week I went to see my primary care doctor just to establish that nothing more was going on, as the Johnson and Johnson pause was announced that week.

1. 40 y/o male with no past medical hx c/o lightheadedness and dizziness 8 mins after receiving the Johnson and Johnson vaccine. He reported that he came directly to site after a 12 hrs flight and he last ate earlier this morning. He was assessed and monitored by NP, EMT, and paramedic. BP - 103/68, HR- 62, resp 14, O2 sat 95% on RA, had mild anxiety. He was given H2O and granola bar, allowed to lie down, instructed on relaxation measures. He was kept at site until he reported that he felt better, calm and had no complaints. He was given the Vaccination information sheet, reinforced instructions on ADRs SEs to call 911 and go to the ED and that symptoms may occur up to 3 wks after receiving the vaccine. He verbalized understanding and willingness to comply. He noted that he will be returning to on 6/8/2021. He left site in no acute distress, awake alert and oriented to person place time and situation, calm.

Very ill feeling started on the following morning from the vaccination. Joint and muscle ache, chills, headache, stomach ache and fever. The symptoms were severe on the first day, and they were gradually fainting during the next two days. Was unable to work on the next day following the vaccination.

Headache, fatigue, muscle ache (mainly in back), joint ache (legs), soreness at injection site. All of these started within 6 hours of having been vaccinated. Alternating ibuprofen and acetaminophen provided good relief for muscle/joint ache. This also reduced the severity of the headache, but did not relieve it. Headache, muscle ache, and joint ache resolved by 40 hours post-vaccination. Mild fatigue/tiring more easily gradually improved over the next 48 hours. I took one day of sick leave from my job to rest.

Insomnia, starting on night of vaccination. Persisting until last night (6/20-6/21). I did not have serious insomnia issues prior to vaccination, and I haven't been able to sleep more than a few hours per evening since.

After receiving the vaccine around in the afternoon, I developed extreme body aches, fatigue, night sweats, headache, dizziness, and chills around 10pm. Along with these side effects I also developed an extreme ringing in my ears. The ringing is so constant that it's difficult to sleep and even think. The ringing has shown no signs of improvement and can best be described as a high pitch sibilant sound.

Extremely painful headache still ongoing 6 days later. Difficulty in sleeping. Cough developed and has not resolved

INSOMNIA (COULD NOT SLEEP FOR THREE TO FOUR NIGHTS); COUGH; BODY ACHE; SORE THROAT; FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight was 169 pounds, and height was 66 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug usage and no pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JUL-2021, the subject experienced injection site pain. On 11-JUL-2021, the subject experienced sore throat. On 11-JUL-2021, the subject experienced cough. On 11-JUL-2021, the subject experienced body ache. On 11-JUL-2021, the subject experienced fever. On 15-JUL-2021, the subject experienced insomnia (could not sleep for three to four nights). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 09-JUL-2021, and fever on 14-JUL-2021, was recovering from body ache, and insomnia (could not sleep for three to four nights), and had not recovered from cough, and sore throat. This report was non-serious.

Patient reports that as soon as he received he experienced tingling through out the his body - to the tip of his toes; experienced light headedness and slight nausea. Shortly after experienced tightness of throat, though denies having difficulty breathing. Patient described as, "having a knot in my throat." Denies experiencing hives, nor itching, no nasal drainage, no cough. States he waited 50 minutes post receipt of vaccine to ensure he could drive. Reports on 03/17/2021 he again experienced tightness of throat; denies difficulty breathing; states it felt like, "my throat was swollen." Again patient denies having difficulty breathing, no hives, itching, no cough. Advised should he experience difficulty breathing to please call 911 since that could be a life threatening emergency; or nearest ER. Denies tightness of throat today, no shortness of breath, nor difficulty breathing.

From about 1am to about 7am I felt like I had the flu or a bad cold. Headache. Feverish (but no fever when measured at 8am). Body aches. I took three ibuprofen at about 4am. Now I feel fine. Maybe just a little tired. But that could be from sleeping poorly last night.

Pt was sitting in chair for recovery. Fell out of chair from sitting to lying position face down on floor. Pt immeditaly sat up on his own. A/Ox3. Sat up in a daze for a few seconds. V/S obtained with b/p 98/56 HR 47 O2 98%. EMS notified. Upon EMS arrival pt was lying back down but a/ox3. Pt refused EMS for further care. Monitored pt for extra 30 min and sent home with wife at side.

Started feeling a little off a few hours after the vaccine but it was manageable. Around 8 hours after the vaccine my symptoms had gotten worse to the point i couldn?t leave the bed. Extreme chills, headache, fatigue and nausea were the primary symptoms. As of this writing, 27 hours after the vaccine my symptoms have significantly reduced but haven?t gone away.

Patient received vaccine and was instructed to sit for 15 minutes as required for monitoring. About five minutes in, another patient who received the vaccine together with patient told us the patient had fainted. Patient was slumped over to the side when I came to check on patient. I called the patient a few times and patient started to come to. I asked the patient how he was feeling and if he had any difficulty breathing to assess for anaphylactic shock. Patient was breathing normal, but was sweating and a bit confused. Patient reported feeling dizzy. I explained to patient that he fainted for a few minutes and instructed to sit as I did not feel comfortable having patient lay down in the state he was in. Patient was given water and a fan to help cool him down and legs elevated (patient reported feeling much better with the fan blowing on him). Patient sat at the pharmacy for over 30 minutes before heading to the bathroom. At this point, patient were no longer dizzy and I instructed him to get up slowly and assessed that patient was no longer dizzy before letting him go to the bathroom.

Shot on Friday at 7pm, Immediate arm soreness (fairly severe), then I woke up at 4am sweating and shaking and vomiting. I threw Up 8 times between 4am and 3pm the following day (Saturday), and it is now Sunday morning at 9:30 and the sweating and shaking seems to be subsiding. I would Describe Saturday as ?violently ill?. These were not minor side effects.

FEVER OF 102-107F; SHAKINESS; VOMITING; SENSATION OF COLD; CHILLS AND SHIVERING; HALLUCINATIONS; WEIRD TASTE IN MOUTH; This spontaneous report received from a patient concerned male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, acid reflux, and heat burn. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 around 1-1:20 pm to the left arm for prophylactic vaccination. Concomitant medications include blood thinners, medication for heart burn and acid reflux. Patient did not take his medicines on the day of his vaccination and few days after the vaccination. On 01-APR-2021 23:00, the patient experienced chills and shivering, fever of 102-107F, sensation of cold, vomiting and shakiness. Patient had not contacted his MD and had not taken any medications to manage those symptoms. At the time of calling (on the day of reporting), patient was feeling better but was having weird taste in mouth. On the same night of the vaccination (01-APR-2021), patient started experiencing hallucinations. The person who took this report on call recommended patient seeing his doctor regarding hallucinations. There were no hallucinations at the time of reporting. Laboratory data included: Body temperature (NR: not provided) 102-107 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucinations, shakiness, sensation of cold, chills and shivering, and fever of 102-107f on APR-2021, had not recovered from weird taste in mouth, and the outcome of vomiting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210406953-COVID-19 VACCINE AD26.COV2.S-hallucination. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 2021040695300-COVID-19 VACCINE AD26.COV2.S-fever. This event is labeled per RSI and is therefore considered potentially related.

I started get chills and sweating around 6pm when I woke up from a nap. I was still tired so I went back to sleep after a hour or two. I woke up again in a few hours with worse chills, minor headache, and minor joint pain. I took over the counter medication, felt a little better and went back to sleep after a few hours. I woke up around 4am to use the bathroom and still had the worse chills, sweats, minor headache and was very dizzy. I decided to lay down on a rug rather than try to make it back to my bed and laid awake for a few hours again I woke up again in a few hours a little better and repeated everything until Sunday night when all my symptoms were very mild. I eat and drank water regularly and took over the counter acetaminophen a few times.

I received the dose at 5:35am on 3/6/21 went home slept most of the day woke up and felt tired, 8:00pm on 3/6/21 I left for work drove a few miles up the road and fainted and crashed my vehicle.

Extreme fatigue that just won't stop. Headache and body aches. The fatigue is over whelming to the point it almost caused me to crash my vehicle on the way to work twice. It has caused me to miss work because the tiredness is overwhelming. It just doesn't seem to stop.

Injection Friday. No issues Friday, Saturday, or Sunday other than slight pain at the injection site and slight body aches on Sunday. Monday morning at approximately 0230 i woke up to what i can only describe as lightning pains in my legs. It was a very intense pain shooting from my upper thighs to my knees and slightly bending around to the top of my calves on the outside of the leg. Monday all day i did not feel well. Had a dull pain in center of chest, and my left arm from the shoulder blade to the elbow had what i can only describe as a slight warm sensation. I was also very "foggy" and light headed. On Tuesday the pain in my chest worsened. My left arm kept going numb (and still does today 04.21.2021), my jaw hurt, i was light headed and again very foggy. On Wednesday it was the same thing and I called the VA and they told me to come to the ER for evaluation.

FEELING BAD; LAZY; SLEEPY; This spontaneous report received from a consumer concerned a 41 year old male. The patient's height, and weight were not reported. The patient's past medical history included rheumatic fever, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient have no known drug 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced lazy. On 13-APR-2021, the subject experienced sleepy. On an unspecified date, the subject experienced feeling bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lazy, and sleepy, and the outcome of feeling bad was not reported. This report was non-serious.

Bloody nose Left leg / foot pain Entire left side of body not correct Chest pain Shortness of breath Blurred vision Can't sleep

Acute exacerbation of paranoid ideation, phobia and obsessive thoughts to a level leading to a constant panic state. Although he patient has had some occasional background fears that never necessitated intervention or affected his daily function, he has never experienced such intense and constant symptoms.

5/5/21: "Good morning sorry to bother you had a question about this shot (Janssen Covid19 vaccine). I have been checking in with that website (V-safe App) you gave me no one has contacted me. Monday (5/3/21) I missed work due to me not feeling good and still today (5/5/21) I'm at work but feel like I could fall asleep, no energy, nausea still, and like I haven't slept in weeks even though I get good sleep. My breathing has gotten to the point that it hurts to take a deep breath. I believe this is all due to the shot but didn't know what you thought."

Two days after the heart rate went up to 135 and I went to the ER. It was better the next day. By day 13 I started to get intermittent headaches that are very sharp. I am still getting them after three weeks. I have tried muscle relaxants and anti-anxiety medicine but they did not help. At night I am able to sleep but, in the morning, when I get up, I get sharp pains that are like ice picks and last for 3-5 seconds. Some of the headaches are more electric and as the day goes on it gets worse. I have tried taking Magnesium and Vitamin B-Complex and the headaches have changed to where they are starting in the afternoon instead of the morning. The headaches are a seven on a scale of 1-10. Sometimes the headaches come with a low grade fever.

Tingling in arms/hands/legs/feet. Headaches and dizziness and brain fuzziness. Can?t focus and head hurts constantly. Tingling still comes and goes. It?s been 5 weeks after vaccination.

The next morning I felt feverish. lethargic, cranky, more so that usual. wanted to lay around and sleep for approximately 24 hours

Felt severe burning/stinging pain in injection site upon injection. Left pinky and ring finger were pretty numb shortly thereafter for about a day or two. Numbness still comes and goes, but not as bad as after the initial injection. After about day 2 started to have severe pain in joint of left shoulder along with impingement, popping. Uncomfortable to sleep on left shoulder as it starts to hurt and "feels" as if it will pop out. Range of motion seems pretty normal, but still getting some pain, popping, and impingement with certain movements/actions throughout the day. I believe it to be SIRVA.

Strong headache at back of head and body aches from about 10 hours after vaccination until about 28 hours after vaccination. Body ache cleared up and headache lessened but off and on present since (now 17 days). I don't normally get headaches. Head has felt cloudy as well. About 4 days after vaccination I had itchy red bumps on my left arm between elbow and wrist for an hour or two then that cleared up. The next day I had the same itchy red bumps on the right arm, also clearing up on its own after a couple of hours. Day 7 or 8 after vaccination I had the same thing on my left leg between knee and ankle. The next day it was on both legs. Always clearing up within a few hours.

Tingling in hands/arms/legs and head. Also have headaches and pressure in head, mostly on left side. Elevated heart rate and fatigue. Dizziness and lack of focus. Overall feeling that something is wrong.

Body aches, headaches, chills, sleeplessness, tiredness. Treated with Ibuprofen, and rest. Took roughly 24 hours to subside to manageable levels.

My arm started getting soar that nigh and persisted the next day followed by two days after that (headache, fatigue, fever). It gradually decreased in pain and on Wednesday it was gone (felt as though I had a rigorous workout). I slept all day Sunday after taking the shot on Saturday! The tele-doctor asked what were my symptoms (allergies and sinus trouble with a cough all the time). He had me to switch allergy medications and my eyes were no longer watering (switched from Zyrtec to Claritin. My eyes were watering so much until I could barely do anything.

5/21/21 10:00pm shortness breath, chest pain, shoulder pain, jaw pain, metallic taste, fatigue ?mini heart attack? symptoms 5/26-5/27 trouble breathing, fatigue, light headed 5/29 pain in left arm 5/30 night - second ?mini heart attack? symptoms General fatigue, hard to breath, overall feeling bad 6/2 - bruise on arm and lump Extreme headache, fatigue, chest pain, arm pain Emergency room visit = blood clots

DIARRHEA; STOMACH FELT BIG; UPSET STOMACH; NAUSEA; FEELING BAD AT NIGHT; This spontaneous report received from a consumer concerned a 41 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: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 30-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced feeling bad at night. On an unspecified date, the subject experienced diarrhea, stomach felt big, upset stomach, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach felt big, diarrhea, feeling bad at night, upset stomach, and nausea. This report was non-serious.

SHAKY HANDS AND LEGS; CANNOT WORK; CANNOT EXERCISE; MUSCLE PAIN ON FEET AND LEGS; MUSCLE WEAKNESS/WEAKNESS ON FEET AND LEGS; NUMBNESS ON NECK, CHEST, ARMS, FEET AND LEGS; STOMACH PAIN/BURNING SENSATION; COLD SENSATION COMING FROM INSIDE OF BODY LEADING TO HEART; PAIN AROUND HEART, SHOWING UP INTERMITTENTLY; DIZZINESS; HOT SENSATION OVER FEET AND BODY; BACK PAIN ON KIDNEY AND LUNGS AREA; PAIN ON FEET AND HANDS/ PAINS WORSEN AT NIGHT ON FEET, HANDS, LOWER PAIN, AND UNDER ARMPITS; BURNING SENSATION ON FEET AND HANDS; MUSCLES SPASMS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 134 pounds, and height was 155 centimeters. The patient's past medical history included covid-19, and covid-19 like symptoms, and concurrent conditions included tomato allergy, alcohol use, non smoker, and gum infection, and other pre-existing medical conditions included the patient has no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced muscles spasms. On 17-APR-2021, the subject experienced pain on feet and hands/ pains worsen at night on feet, hands, lower pain, and under armpits. On 17-APR-2021, the subject experienced burning sensation on feet and hands. On 18-APR-2021, the subject experienced stomach pain/burning sensation. On 18-APR-2021, the subject experienced pain around heart, showing up intermittently. On 18-APR-2021, the subject experienced dizziness. On 18-APR-2021, the subject experienced hot sensation over feet and body. On 18-APR-2021, the subject experienced back pain on kidney and lungs area. On 18-APR-2021, the subject experienced cold sensation coming from inside of body leading to heart. On JUL-2021, the subject experienced numbness on neck, chest, arms, feet and legs. On 01-JUL-2021, the subject experienced muscle weakness/weakness on feet and legs. On an unspecified date, the subject experienced shaky hands and legs, cannot work, cannot exercise, and muscle pain on feet and legs. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, Stool culture (NR: not provided) Unknown, Tuberculosis test (NR: not provided) False-positive, and Urine culture (NR: not provided) Unknown. Treatment medications (dates unspecified) included: omeprazole, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness on neck, chest, arms, feet and legs on JUL-2021, dizziness on 19-APR-2021, headache on 13-APR-2021, and fever on APR-2021, had not recovered from stomach pain/burning sensation, pain on feet and hands/ pains worsen at night on feet, hands, lower pain, and under armpits, muscle weakness/weakness on feet and legs, pain around heart, showing up intermittently, muscles spasms, hot sensation over feet and body, back pain on kidney and lungs area, shaky hands and legs, burning sensation on feet and hands, and muscle pain on feet and legs, and the outcome of cannot work, cold sensation coming from inside of body leading to heart and cannot exercise was not reported. This report was non-serious.

Brain Fog /confusion since shot.. Arm (left) the shot was administered is still lacking in strength (just holding a cell phone wears it out). 2 weeks to the date, after the shot, I experienced extreme pain in all joints in left arm ( elbow, wrist, finger joints) The pain extruded to the middle of my rib cage from the left side. Shot site still mildly sore.. Brain fog still continues.

After the initial 12 hour period, I experienced night-time chills followed then by being too warm and night sweats. This happened both the first and second night. During the day I was taking Tylenol every 6 hours for aches and pain. Mainly my neck and back have been what hurts, although my knees, elbows, hips, etc. also were achy. The third and fourth days I still continued to have chills, no fever throughout as far as I am aware (took my temp 2-3 times). The fourth day I was very faint and somewhat unbalanced, felt shaky and light headed and I ended up having an anxiety attack. I mention the last symptom as I have never had an episode like this previously in my life. Today is day 5, still feel tired, slightly nauseous, neck and back pain, headache, difficulty focusing.

3/13/2021 began having right forearm wrist was sensitive to touch and skin clammy. 3/14/2021 still clammy in both hands. 3/15/2021 whole body clammy and sticky. Both shins and ankles had burning sensation. 3/17/2021 both ankles painful mostly at night. 3/18/2021 both ankles, shins and legs painful all day. Unable to sleep at night. 3/19/2021 left work early due to nauseated, headache and pain and burning both legs. Blood pressure elevated. 3/20/2021 head pounding and elevated rate and nauseated. Went to ER for continued leg/shins burning and pain. ABI was normal. Diagnosed with neuropathy. 3/23/2021 blood pressure elevated due to pain 3/24/2021 pain to legs and shins continue below know. pain scale 5. 3/26/2021 pain to legs and shins pain scale 7 3/27/2021 pain to legs and shins pain scale 3 3/29/2021 burning and sensitive legs. Sensitivity now present in both arms. 3/30/2021 burning to forearms and legs 4/1/2021 pain scale 3 burning pain to forearms and legs. 4/4/2021 improved pain 4/5/2021 tingling resumed to legs and calves. Pain scale 4. 4/6/2021 sensitive/burning bilateral forearm and wrist and bilateral legs. 4/7/2021 left leg burning more and feels warm. Back ache began 4/8/2021 both legs still burning and tingling. Heart rate elevated. Back pain continues.

DID NOT SLEEP; FEELING HOT; This spontaneous report received from a vaccine facility concerned a 42 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included unspecified medical history from military service. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 31-MAR-2021, the subject experienced did not sleep. On 31-MAR-2021, the subject experienced feeling hot. The action taken with covid-19 vaccine was not applicable. The patient recovered from did not sleep on 01-APR-2021 and the outcome of feeling hot was not reported. This report was non-serious.

Headache: Moderate headache 6 hours after injection. Became intense 8 hours after injection and disrupted sleep. Stayed intense for 24 hours after injection before moderating. Headache disappeared after 36 hours. Used Tylenol (acetaminophen) 1000 mg every 6 hours. Fever with chills: 8 hours after injection until 24 hours after injection. Fever between 100 and 101 degrees. Treated with Tylenol. Nausea: Again 8 hours after injection until 18 hours after injection.

My initial symptoms were light swelling a region around the shoulder of my injection arm and excessive sweating in the armpit on my injection arm side. Following this, symptoms similar to being on a hallucinogenic gradually manifested over the next several hours, including euphoria, a persistent urge to grind teeth, and some mild-to-moderate visual and physical effects. Following the date of the injection, the primary symptom has been a bruise/cramp hybrid pain in the upper arm of the injection site that is gradually receding (but still ongoing), along with random light bouts of nausea and headaches, random light pains throughout my injection arm, and occurrences of coldness in my injection arm (lasts about an hour)

NIGHT SWEATS; PAIN IN ARM; EYES PAIN; EYES SENSITIVE TO LIGHT; FELT LIKE FLU; FEELING BAD; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced eyes pain. On 06-APR-2021, the subject experienced eyes sensitive to light. On 06-APR-2021, the subject experienced felt like flu. On 06-APR-2021, the subject experienced feeling bad. On 06-APR-2021, the subject experienced pain in arm. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 07-APR-2021, the subject experienced night sweats. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eyes pain, and eyes sensitive to light on 06-APR-2021, felt like flu, and feeling bad on APR-2021, and pain in arm on 07-APR-2021, and had not recovered from night sweats. This report was non-serious.; Sender's Comments: V1: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

Started feeling dizzy and started to respond slowly to things and felt weak around 8pm. Shortly after these symptoms I begin to have uncontrollable chills followed by a fever and Nausea. The whole time starting around 8pm I had pretty bad muscle aches as well. I took a warm shower and bundled up the whole night because I had a fever, aches, chills, and nausea. It was impossible to sleep because of this and sometimes my heart was beating fast as well. The next morning I had a headache that would not go away until I took Tylenol. The whole next day I felt exhausted as well and very weak. I began to feel better on day 3 but still feel somewhat foggy from the shot. I would not recommend this vaccine to anyone and would never get it again and hopefully the foggy sensation goes away.

Arm pain, excessive fatigue, nausea, confusion, dizziness, sweats, cold, pain in joints. started Monday and continues today, 5 days later

First 2 days after vaccine I had the expected slight sore arm, some minor headache, some muscle aches. Nothing major that kept me from working or sleeping. Some time after, maybe 3rd or 4th day, I noticed a shortness of breath. This I did not expect since it's not a listed side effect for the vaccine but it is one for Covid. I notice it everyday while sitting/working. It does not keep me from being active (running/yard work) but I notice I'm not 100% healthy feeling. It feels like the shortness of breath is closer to the top of the chest/throat area if that makes any sense. If I breathe deeply it feels like I may want to cough although I don't usually cough from doing so. It's mostly just a constant feeling of a very slight shortness of breath.

EARS RINGING; VOMITING; TIREDNESS; FEVER; DIZZINESS; DISORIENTED; This spontaneous report received from a patient concerned a 42 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: 207A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Body temperature (NR: not provided) Over 100 (unit unspecified). On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced disoriented. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced tiredness. On 12-APR-2021, the subject experienced vomiting. On 14-APR-2021, the subject experienced ears ringing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 13-APR-2021, and had not recovered from dizziness, disoriented, tiredness, ears ringing, and fever. This report was non-serious.

Brain feels foggy or groggy, as if I am depressed, or really tired, no matter if I get enough sleep or not. Have not been able to attain or maintain an erection in two weeks, my sex drive is 100% dead. I used to have an extremely strong sex drive until 2 weeks ago. Something is very, very wrong with me.

5 hours later. Terrible Headache, so bad could not sleep the entire night. Chills, aches, small fever. 10 Days later. Rash and bumps all over both arms, neck and upper back

Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: patient was given jassen vaccine. during 15 minutes observation. patients appeared to black out for 3 seconds. patient can breath ok. no epipen injection was given. after 30 min. patient is coherent. BP 117/75. normal sinus rythm. 911 was called. Patient stated that he doesnt want to go to the hospital and doing fine. Patient had pee himself.

Patient wasn't feeling well after the shot. He said he had a couple episode where he spaced out. He mentioned afterwards that he doesn't do well with immunization shots. He was sweating and seemed dehydrated. We gave him water and to monitor. Fire dept came and asked if he requires urgent care and he said no. He felt better afterwards.

Current ongoing symptoms in order of severity include: lethargy/brain fog (daily since), thick mucus buildup (nose and back of throat throughout the day), regular headaches, depression, loose stool, eye redness, and tonsil stones (couched up daily). Events/symptoms after vaccine: tonic-clonic seizure (twice admitted to Hospital last event on 5/31/2021), petite-mal seizure (not admitted to hospital but noted by others in household), severe pounding headache (on and off in middle and back of cranium)

A month after I received the vaccine, I started having symptoms of forgetfulness, became foggy, had severe exhaustion, intense headaches, loss of appetite, issues with balance, vivid dreams and apparent hallucinations. My PCP had me see a neurologist and a rheumatologist. I had blood work drawn, tested for COVID and x-rays done. I have a CT scan in the next three weeks. We are going to come up with a plan after my CT scan.

BEGINNING ABOUT 1 WEEK AFTER VACCINATION PATIENT BEGAN EXPERIENCING MUSCLE WEAKNESS AND TINGLING IN THE LEFT ARM, HAS PROGRESSIVELY GOTTEN WORSE AND HAS IMPACTED DAY TO DAY ACTIVITY

The first day after the vax was fine, but towards the end of the day I felt strange. Half way through the second day, my pancreatitis came back with a vengeance for about a month, along with whole body inflammation for about a week, resufacing of neuralgias and other pain also. The first week was the worst. The whole body inflammation went away after a week. But the pancreatitis flare up was worse than experienced before, and the amount of pain increased since the injection of the pancreas has increased by about 10 to 15 %, and has not returned to pre-vaccination levels. I am taking more tramadol than ever now. I WILL NEVER GET A COVID VACCINE AGAIN.

I did not have any adverse events initially, but on the evening of 7/4/2021 I had a fever and had trouble sleeping, I just chalked it up to a day in the sun. On Monday, 7/5/2021 I had a sore throat; Tuesday, 7/6/2021 small cough; Wednesday, 7/7/2021 it moved into my chest; Thursday, 7/8/2021 loss my sense of taste. Thursday night I purchased an over the counter Covid test and it came back positive. On Friday, 7/9/2021 I went to my doctor on Friday morning and on Monday 7/12/2021 I was informed from my doctor's office the test was positive. Today on 7/14/2021, I feel pretty good, I am not doing too bad, I have a cough every so often and my taste has returned.

5/17/21 - general body soreness, didn't leave bed 5/18/21 - Extreme abdominal pain, couldn't eat, didn't leave bed 6/9/21 - Severe side pains and bloating below rib cage 6/16/21 - Woke up to 10/10 pain in my abdominal region, felt like knives were being stuck directly under my rib cage, around this same time, I noticed that both of my inner legs, from roughly my ankles up was going numb to the touch, severe stomach bloating as well 7/6/21 - Everything described for 6/16/21 progressively getting worse to the point where my legs were so sore that I can barely climb up stairs, can't eat much so went to the ER. During the visit they didn't address my leg issues, released me with diuretics to deal with bloating (which have not helped). My stomach is generally bloated anywhere from 50-75% and I have pain in my stomach , legs, and shoulders and seem to be losing muscle and a rapid rate. I'm a healthy eater so all of this is very unusual and extremely concerning. I cannot work as well.

Patient has history of MS well controlled with Cosentix injections. Patient reports approximately one week after taking vaccine he began experiencing pain in his feet and ankles. Reports the pain has ascended to lower back and reports he can no longer lift heavy objects and cannot perform required duties for his occupation. Denies numbness, tingling, burning. Difficulty with walking, especially distances or stairs. Reports pervasive fatigue and sleeping until late in the day but waking up exhausted.

Patient became anxious and upon assessment patient described as ?room is black.? Paramedics over to access at 1112. 1114 vital signs 82/47 BP, 75 HR, 98 on RA. Blood glucose 113. Paramedics gave 500ml Bolus of NS, BP now 112/74. Patient declined transport to ER, will have wife take him.

MDM-43-year-old man presents wit syncope versus near-syncope. Differential diagnosis includes vasovagal reaction versus dehydration versus anxiety versus arrhythmia.

Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient did experience fainting with Janssen, though important to note that patient said he has fainted before in past with vaccinations. He said he is fearful of them and it is more \"mental\" and does not attribute it to the vaccine itself.

client complained of feeling "foggy and strange " after receiving vaccine. He was reclined in his seat and monitored for confusion. He was released when symptoms improved. Blood Pressure 128/87 Pulse 84 and oxygen saturation 100%

Chills/Rigors for ~2+ hours starting before bed. ~1:30 am had high fever (102.2) and lack of mental clarity. Took 1g tylenol for fever which broke in the early morning. Also had severe headache during this time. Day 2 after the vaccine, lack of mental clarity and mental "fog" all day.

PATIENT RECEIVED VACCINE ON 4/4/21. ON 4/7/21, WAS AWAKENED DURING SLEEP WITH SHARP, STABBING PAIN IN LEFT LEG CALF MUSCLE. PAIN LASTED FOR 30-40 SECONDS. FOR THE NEXT 2 DAYS, PAIN IN THIS AREA REMAINED SORE, IRRITATED, AND TENDER. RATED PAIN 1-2/10 IF NOT TOUCHING THE AREA, BUT UP TO A 3/10 WITH TOUCHING THE AREA. IN ADDITION, FELT BREATHING HAS BEEN HEAVIER AND LITTLE WORSE THAN HIS NORMAL BASELINE (BASELINE DUE TO HISTORY OF ANEMIA/LOW IRON), AS WELL AS FEELING BRAIN FOGGY SINCE RECEIVING THE SHOT.

felt tired and sleepy on the same evening; then went to bed; woke up at night feeling a mild headache; took two pills of Acetaminophen; no fever; a few sneezes

COULDN'T SLEEP LAST NIGHT; TINY HEADACHE; LEFT ARM HURTING; LEFT SHOULDER HURTING; This spontaneous report received from a patient concerned a 43 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, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 at 14.30 to left deltoid at 14:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced couldn't sleep last night. On 07-APR-2021, the patient experienced tiny headache. On 07-APR-2021, the patient experienced left arm hurting. On 07-APR-2021, the patient experienced left shoulder hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiny headache, left arm hurting, and left shoulder hurting, and the outcome of couldn't sleep last night was not reported. This report was non-serious.

Numbness and weird feeling in left arm (injected in left arm) started like 8pm got worse. Also still felt awful comes and goes cold and feverish again. Felt good a day and a half. Then bad again but was at work. Woke up 2am with pain in chest and arm felt numbness and very strange and pain in chest - which did subside but almost called 911. Will go to urgent cate today to get checked out. Took BP at home and it was normal/ took an aspirin at 2am as well/

(1) Fever 2 days 100.3 - 101.1 (took tylenol every 6-8 hours). (2) Fatigue (slept most of day after injection). (3) Heart rate elevated (woke up 7hrs after injection with feeling of heart pounding in my chest; heart rate over 90 while trying to sleep; believe reducing fever with tylenol helped settle heart rate). (4) Muscle aches 2 days (previously injured muscles/joints became very sore 1-2 day after injection [left hip, right foot, left quad, lower back] - believe tylenol reduced inflammation) --symptoms ended 3-4 days after injection; slight fatigue remains 7 days later.

The day of the vaccination 5 hours after receiving the vaccine I started to get bruises the size of my hand on my left leg then I kept getting more on the upper part in the leg and in the buttock I take photos to have the record then I started to feel dizzy that I couldn't walk and I was going to faint, I had to call the rescue to come to my house because I felt very bad I could not move then I went to the emergency room to the hospital with the same symptoms I couldn't move it seemed that if I get up I was going to faint, I was under observation the bruises did not continue to appear, but I have been left with nervous tic symptoms in the left eye and in the left arm I have involuntary reflexes in the muscles of the left arm

Began to develop extreme exhaustion throughout day following shot. At approximately 5:00pm, began to develop a headache, severe joint pain throughout body. Approximately 2 hours later, began to develop a fever that rose to 102.5. Immediately took Tylenol. Fever last for approximately 24 hours as did joint pain. tiredness and washed out feeling lasted approximately 5 days.

I received the shot on 4/10. First 24 hours I had a slight fever and headache. Treated with Acetaninophhen. Since that time, I had relatively mild symptoms 4/11 - 4/13. Mostly fatigue. On 4/14, I had a sudden increase in heart rate, dizziness, tingling sensation in all arms and legs and weakness in my limbs/grip. This prompted me to visit the ER. They ran numerous blood tests amd scans on me but found no abnormalities. Various unusual symptoms have continued to persist since 4/14. For brief moments I feel fine. At other times I have experience fatigue, diziness/vertigo, rapid heart rate, pins and needles feeling in my left hand and left leg. Left leg numbness/tightness and heaviness. The fingers on my left hand sometimes move involuntarily. And my anxiety has also gone up during this time. Tonight it has migratee to my left foot, where I have numbness in several of my toes. I'm looking for advice. Should I be concerned? Should these symptoms still be occurring 11 days after receiving my shot? It has been very distressing and there seem to be very few people who have knowledge on this subject. My care providers keep saying to self monitor and contact them if symptoms worsen. The problem is symptoms don't necessarily worsen, they just migrate from one area of my body to another. The numbness comes and goes in maybe 1-2 hour intervals.

COUGH; DIFFICULTY SLEEPING/STRUGGLING TO SLEEP; LOSS OF ENERGY/ESPECIALLY NO ENERGY; SHIVERING; FATIGUE/FEELS VERY TIRED; COLD SYMPTOMS; HEART RATE INCREASED/FAST HEART BEAT; VERTIGO; BRAIN FOG; CHEST PAIN; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included pneumonia, and concurrent conditions included covid-19, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 (vaccinated at left deltoid) for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced cold symptoms. On 19-MAR-2021, the subject experienced heart rate increased/fast heart beat. On 19-MAR-2021, the subject experienced vertigo. On 19-MAR-2021, the subject experienced brain fog. On 19-MAR-2021, the subject experienced chest pain. On 19-MAR-2021, the subject experienced difficulty sleeping/struggling to sleep. On 19-MAR-2021, the subject experienced loss of energy/especially no energy. On 19-MAR-2021, the subject experienced shivering. On 19-MAR-2021, the subject experienced fatigue/feels very tired. On 20-MAR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold symptoms, and shivering on 20-MAR-2021, and was recovering from heart rate increased/fast heart beat, fatigue/feels very tired, vertigo, brain fog, chest pain, loss of energy/especially no energy, cough, and difficulty sleeping/struggling to sleep. This report was non-serious.

CONFIRMED COVID-19 INFECTION; FELT TERRIBLE; This spontaneous report received from a patient concerned a 43 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 allergies. 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 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced felt terrible. On 14-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) POSITIVE. On 15-APR-2021, the subject experienced confirmed covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of felt terrible was not reported. This report was non-serious. This report was associated with product quality complaint: 90000176502. The suspected product quality complaint has been confirmed to be this report indicates a medical adverse event for the patient. while a positive covid test result was received after vaccination, insufficient time (14 days) had elapsed for the patient to achieve immunity therefore this report is not considered a lack of effect. approval to void this record due to no pqc identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious

EXTRA SALIVA PRODUCTION; LETHARGY; HOT AND COLD SWEATS; UPSET STOMACH; WASN'T FEELING HIS SELF; GAS PAIN; ARM PAIN AND TENDERNESS; NAUSEA; HEADACHE; FEELING VERY TIRED; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included kidney stones. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced extra saliva production. On 08-APR-2021, the subject experienced lethargy. On 08-APR-2021, the subject experienced hot and cold sweats. On 08-APR-2021, the subject experienced upset stomach. On 08-APR-2021, the subject experienced wasn't feeling his self. On 08-APR-2021, the subject experienced gas pain. On 08-APR-2021, the subject experienced arm pain and tenderness. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced feeling very tired. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extra saliva production, hot and cold sweats, upset stomach, gas pain, nausea, and headache on APR-2021, lethargy on 10-APR-2021, and arm pain and tenderness on 11-APR-2021, and the outcome of feeling very tired and wasn't feeling his self was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

patient reports pain and pressure in ears lasting about 4 weeks and currently resolved, and low pitch constant tinnitus that was severe and very distressing for the first week or so to the point that he considered harming himself. The tinnitus persists but is less distressing. He was treated at Urgent Care with a steroid dose pack, a course of prednisone 40 mg/day x 5 days, 10 days of augmentin 875 mg po bid and a week of cortisporin ear drops. None of the treatment helped the tinnitus. He refused an audiogram to evaluate the tinnitus and denies preexisting tinnitus.

BLAH; CHILLS; FEVER; HEADACHE; SIDE EFFECTS; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 7/18O/U/V/8978 expiry: JUN-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. On 12-MAY-2021, the subject experienced blah. On 12-MAY-2021, the subject experienced chills. On 12-MAY-2021, the subject experienced fever. On 12-MAY-2021, the subject experienced headache. On 12-MAY-2021, the subject experienced side effects. The action taken with covid-19 vaccine was not applicable. The patient recovered from blah, chills, fever, headache, and side effects on 14-MAY-2021. This report was non-serious.

Case received vaccine at 10:30AM and at approximately 10 minutes into recovery stated he "feels a little dizzy" Case requested a drink of water. Vital signs stable at temp 97.6 Pulse 88 Respirations 16. Pulse ox 99% BP 128/70. He denied any shortness of breath, chest pain, difficulty swallowing itching or scratchy throat. He was advised to be observed for another 15 minutes and stated he was feeling better and returned to work at 11 AM At approximately 11:50 AM patient returned to clinic with boss stating he vomited in the rest room. Patient taken to recover room cot was placed in supine position on cot vital signs continued to be stable with 97.6 88 16 120/70 He complained of funny feeling in his throat. He was give Benadryl Liquid 50mg PO and continued with stable vital signs 97.6 88 20 120/70. He continued to complain of the funny feeling in his throat he was given Epinephrine IM .5ml, He did appear anxious and tearful after speaking with his friend on the cell phone. Vital signs remained stable of 99% SAO2 Pulse 83 Respirations 22 BP 128/70. Throughout entire event he was able to speak in clear sentences with the interpreter assistance. Patient was advised to go to ED for further evaluation and observation. He consented and 911 was called. EMS arrived at approximately 12:30 PM and report was given to EMT on patient event at clinic along with written information on vaccine and vital signs.

Patient stated that starting 3 days after vaccine he started with pain in his left arm and chest, pain in his joints to his bones. He says he has trouble sleeping. He did go to the Emergency Room and was evaluated. He says he still currently has the pain.

Received vaccine, sat down as advised, 3-mins later felt nauseous (about to vomit), got up and walked away from people around me. Fortunately my wife was there, I called out to her because I was getting dizzy, she came over as I was passing out, I grabbed onto her and we both fell to the floor (I used her to cushion my fall). I passed out on her as she screamed for help. Two male customers assisted me into a chair as I was disoriented, my wife asked me what her name was and I didn't her name as I was pale, trembling, and sweating. The pharmacy tech thought I was going into convulsions and called 911. The paramedics arrived and fortunately I was breathing and slowly coming back. Paramedics remained there and took all my vital signs and stayed with me. Since my vitals were okay and my color came back, I felt much better and was coherent again. This event was at least 30-minutes or more. I declined going to the hospital with ambulance and the paramedics told me to call 911 if it happens again.

INTENSE PAIN; DIFFICULTY THINKING STRAIGHT; INTERMITTENT, INVOLUNTARY MOVEMENT OF LEFT FINGERS; SPELLS OF STUTTERING; SLURRED SPEECH 2-3 TIMES A DAY; DIFFICULTY SEEING; MIGRAINE "WORST PAIN IN LIFE"; RINGING IN EARS; NON-CONTAGIOUS MENINGITIS / BRAIN SWELLING / UNABLE TO MOVE NECK TO THE LEFT / STIFF NECK RADIATED TO SHOULDERS AND LEFT ARM AT INJECTION SITE / STIFF NECK TO THE LEFT SIDE; LIME DISEASE / CHILLS / MUSCLE ACHE / MILD FLU LIKE SYMPTOMS; HEADACHE; TIRED/ FATIGUE; COULD NOT SLEEP ALL NIGHT; KNEE SWELLED UP; LEFT KNEE PAIN; SPINAL CORD SHIFTING FROM BASE OF SKULL TO TAILBONE- POPPING AND CRACKING; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and penicillin allergy at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: unknown) dose was not reported with frequency 1 total administered on 25-MAR-2021 at 16:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the patient did not have any side effects initially and he was fine after vaccination and suddenly he felt tired an hour after arriving home, also could not be to sleep all night, mild flu-like symptoms including chills, muscle aches, fatigue and a headache. He took ibuprofen 200 mg via oral route (frequency unknown) for headache or pain. On 26-MAR-2021, the patient experienced headache again. On 02-APR-2021, the patient experienced headache which continued to get worse, brain swelling, non-contagious meningitis, lime disease (Lyme disease), migraine "worst pain in his life", difficulty seeing, ringing in ears. Then, he took more ibuprofen (frequency unknown) as the migraine was unbearable for him and had mild relief. The patient went to the hospital and was admitted on 02-APR-2021. At hospital he received morphine (indication unknown). On the same day, the laboratory testing or data of patient included CT scan reported as brain swelling reduced in size and spinal tap reported as unknown chemical found, positive for lime disease and meningitis. Laboratory testing revealed the meningitis of patient was non-contagious. The patient started on blood thinners and antibiotics (drugs name unknown). The patient got followed-up with (Centers for Disease Control and Prevention) CDC disease specialist who said that it could not be clearly revealed whether it was related to the vaccine or not. On 05-APR-2021, the patient experienced difficulty thinking straight, intermittent, involuntary movement of left fingers, spells of stuttering, slurred speech. The patient hospitalized for 4 days and got discharged from hospital on 05-APR-2021 at 20:00. On the night of 06-APR-2021, it was reported that in the middle of the night the patient woke-up at 01:00 as his spinal cord was shifting from base of skull to the tailbone, it was popping and cracking, no pain, just moving. It was gone when he work-up that morning. On 08-APR-2021 at morning, the patient experienced stiff neck to the left side / stiff neck radiated to shoulders and left arm at injection site as unable to move neck to the left side and the stiff neck got progressively worse each day and by 09-APR-2021, the stiff neck was more severe and radiated to the shoulders and to the left arm where he received his vaccine, not the right side, unable to move neck to the left side. However, this lasted until 13-APR-2021. On 26-MAY-2021, the patient woke up with pain and swelling in the left knee. On an unspecified date, the patient experienced intense pain. Treatment medications (dates unspecified) included: ibuprofen several times, morphine, antibiotics and blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lime disease / chills / muscle ache / mild flu like symptoms, migraine "worst pain in life", difficulty seeing, and ringing in ears on 05-APR-2021, non-contagious meningitis / brain swelling / unable to move neck to the left / stiff neck radiated to shoulders and left arm at injection site / stiff neck to the left side, spinal cord shifting from base of skull to tailbone- popping and cracking on 07-APR-2021 and knee swelled up, and left knee pain on 30-JUN-2021, had not recovered from tired/ fatigue, headache, spells of stuttering, intermittent, involuntary movement of left fingers, difficulty thinking straight, and slurred speech 2-3 times a day, and the outcome of could not sleep all night and intense pain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210718928-covid-19 vaccine ad26.cov2.s-spinal cord shifting from base of skull to tailbone- popping and cracking ; non-contagious meningitis / brain swelling / unable to move neck to the left / stiff neck radiated to shoulders and left arm at injection site / stiff neck to the left side; lime disease / chills / muscle ache / mild flu like symptoms; difficulty thinking straight; migraine "worst pain in life"; ringing in ears; intermittent, involuntary movement of left fingers; spells of stuttering; slurred speech 2-3 times a day; difficulty seeing; intense pain; could not sleep all night. 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). 20210718928-covid-19 vaccine ad26.cov2.s-headache; tired/ fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.

Within hours I quickly became extremely sore, fatigued, and had difficulty breathing. I was unable to eat until the breathing issues subsided late afternoon Sunday since I felt as though I was choking when I attempted to eat. The fatigue and body pain was pronounced enough for me to have to call off work Monday, but they gradually diminished. I am submitting this on 3/11, and I am still experiencing some body aches though the constant feeling of exhaustion is no longer present.

Immediately tasted a metallic taste in my mouth. Within 12 hours experienced body pains (not aches...true pain) just like I had with Covid at Christmas. We are now almost a week later and the body pains have only gotten worse. Tylenol and Motrin have not helped. I don?t have a primary care doctor or insurance so I can?t follow up with a doctor, but I feel terrible.

Patient was given shot and asked to wait in pharmacy area at least 15 minutes. Within about 5-10 minutes his girlfriend comes to the pharmacy window and tells me he's feeling bad. By the time I get to his chair he is very lethargic and slumped over. I sit him up in the chair and his head rolls back and his eyes have rolled back in his head. I place him on the floor and instructed my staff to call 911. The patient presented with sweats and was unresponsive for about 10-20 seconds. When he came to he asked how he got on the floor. The patient never had any trouble breathing heart rate was steady the entire time. When EMS arrived they checked him out and was fine. He refused transport to the hospital. He walked out of the store after about 30 minutes from the point of his passing out.

PT ARRIVED VIA POV WITH WIFE DUE TO COMPLAINING OF HAVING JOHNSON AND JOHNSON VACCINE REACTION THAT HE RECEIVED YESTERDAY AT 1130 AM. PT VOICED HE WAS NOT ABLE TO SLEEP MUCH, HAD FEVER, CHILLS; WOKE UP WITH SWOLLEN UPPER LIP, RASH OVER HIS UPPER EXTREMITIES; RASH AND WHELPS SEEN TO HIS RIGHT RIB REGION-MODERATE AMOUNTS. PT ALSO VOICED, FEELING ITCHING ALL OVER HIS BODY. DENIED OTHER SYMPTOMS. PT IS STABLE. ER PROVIDER NOTIFIED. TX: FAMOTIDINE, BENADRYL, SOLU-MEDROL, DECADRON.

Janssen COVID-19 Vaccine EUA - Fever & Insomnia 10 hours after injection. Fever & Lethargy 20+ hours after injection.

pt fainted, the pt was sitting in the chair and fell off. the pt immediately woke up after falling. the pt said he was ok. he said he just wanted to lie down. he did so for about 10 minutes and then sat back up in the chair. we said he was feeling ok. he said he fainted because he was nervous. he did not think that it was because of the covid shot.

- Arm Sore at injection site from 4-6-21 to 4-9-21 - Passed out at 1:00am 4-6-21, and fell to floor with disorientation. - Severe Chills, uncontrollable shaking of body/teeth, 4-6-21 to 4-7-21 - Feverish 04-6-21 to 4-8-21 - Heart Arrhythmia, causing abnormal breathing and inability to breath and sleep 04-6-21 to 4-7-21 - Dizziness 04-06-21 to 04-09-21 - Food/Water/mouth tastes of metal 04-7-21 to 4-8-21 - Loss of Appetite 04-06-21 to present - Bloating, feeling full when haven't eaten 04-06-21 to present - Brain fog, not able to concentrate - 04-06-21 to 04-09-21 - Excessive sweating 04-06 to 04-08-21 - Tired 04-06 to 4-10-21 - Irritability, 04-09-21 to 04-10-21 - Emotional, crying for no reason sporadically 04-06 to 04-9-21

-fever -body aches -head ache -abdominal pain -extreme dizziness/lightheadedness -dry cough -incresed tinnitus -nervous system disorientation -tiredness -weakness All lasting ~36+ hours.

I felt fine all day and went to bed at 9:30pm. I woke up to my body shaking uncontrollably and I was freezing at 10:30pm. My wife felt my skin and she said I was burning up. Unfortunately our thermometer wasn't working so I don't know my temperature, but I have never in my life shaken so badly with a fever. I couldn't control myself and I was shaking so hard that my muscles were sore from it, but I still couldn't stop. I then began vomiting every 45 minutes or so. This happened for nearly 4 hours until 2:18am. Then very suddenly everything just stopped. No more feeling cold (actually I then felt very warm and couldn't cool off. I was sweating quite a bit). No more shaking. No more vomiting. I did get a wicked headache, but I figured it was due to dehydration and took two Advil. The Advil didn't do anything and I was awake until 5:59am because my head hurt too badly to sleep. Finally I slept for about 4.5 hours. Then I just felt worn out for most of the day on the 10th, and couldn't shake the headache. Then on the evening if the 10th, I started getting a sore throat and a slightly runny nose. I went to bed that way. When I woke up on the 11th (today) I still had the sore throat and slight runny nose. The headache was gone, but I felt tightness in my chest. As I went throughout the day, I've noticed that I'm short of breath with doing most things. I have two young children, so even taking care of them I feel like at times I'm struggling for breath. I'm not in bad shape and am a runner, so my cardio isn't bad. So I was surprised by this.

Extreme fatigue. Feel better when lying down. Can only be upright and active for about an hour or so before needing to lie down again.

I had difficulty to think all friday afternoon(2 days after injection). After going to bed around 9:30 PM and therefore lying down I suddenly started to cough. It last for about 10 minutes, I could not stop. I also started to sweat. At this time I believed I got COVID-19 at the vaccination site and moved to another room to avoid to expose furthermore my wife. I did not cough anymore since then. Today after reading the news and symptoms of blood clot in the lung, I prefer to report this incident.

Received shot at 9:20 am. Came home and went to bed. Woke up at 3pm and felt worn out. Then about 5:30pm I got super uncomfortable and then my skin got hypersensitive. To the point I couldn't even touch it. Then I felt like I had a fever but when I checked I did not. Went to bed at 8pm still with the hypersensitive skin. Could not get comfortable to sleep but when i eventually fell asleep I slept for 10 hours. Thats about 5 more than I normally do. The next day the hypersensitive skin was gone just felt a little wore out.

Patient reported to medical clinic 24 hours after COVID 19 injection (03/19/2021) with symptoms of visual hallucinations, myalgia, rigors, headache, nausea, vomiting and dehydration. At the time of arrival to the medical clinic, he had refractory nausea and vomiting after receiving Zofran earlier in the day at another clinical site. Medical treatment consisted of IV Fluid bolus with maintenance fluids, IV Phenergan for the nausea and vomiting, and IV Ketorolac for headache pain. His symptoms resolved and he started to feel better so a clinical decision was made to discharge him home in the care of a close friend. He planned to follow-up the next day. The patient returned to medical Clinic on 03/22/2021 with no specific symptoms. Previous symptoms from initial encounter resolved according to medical chart. Patient returned on 03/28/2021 with right upper arm DVT proven on U/S. He was seen at Primary Care Clinic beforehand where diagnosis of DVT was made. He was then started on anticoagulation therapy by MD in clinic after specialist phone consult, and will be closely followed. He was sent to Evacuation to home station due to the complexity of the condition, medications, etc.

At injection muscle spasmed, nurse stated never seen that before. Within 1-2 hours had runny nose and felt stuffed up, thought it could be allergies or something and didn?t really attribute to vaccine. 4-5 hours after injection felt something across the top of my brain ... felt as though something had been stuck in a blood vessel and became unstuck allowing blood to shoot through. Was certainly freaked out by this, but was at an event and head of the ER department of the local hospital was also attending - so figured I had quicker access to medical care there if needed, than at home. 30-60 minutes later congestion completely cleared up. 9-12 hours after vaccination had extreme chills. Day after vaccination had pain below the injection site... injection was 2? above pain. Also neck pain. Day 2-8 since vaccination, on/off muscle pain or injection site pain. Today, day 9, have muscle pain in wrist of injection arm.

The following day I get very disoriented and brain fog, severe difficulty paying attention, it?s almost a week later and I still feel off

Severe chill followed by low grade fever(98.2 F; normally I am about 97.5), mild headache that lasted about 12 hours, very dry mouth, and metallic taste in mouth. Accompanied by a feeling of mild intoxication / indifference / being unmotivated which lasted most of the next day. The lack of motivation with a slight tiredness seems to still be slightly present 11 days later.

Starting 8 days after injection I will go into a brain fog for several hours mid morning. Difficulty concentrating and motor function seems mildly impaired. Visuon is slightly blurred. Also slight pressure across sinuses.

Patient reports seizures on 4/25/2021 requiring 911 call, ambulance, and hospitalization stay. Patient mental status changed to violent and resulted in a dislocated shoulder when hospitalized. Patient has no history of seizures or violent behavior.

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Severe

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted after receiving covid vaccine (Janssen). He was sitting for the required 15 mintute interval and collapsed from his seat after about 5 to 7 mintutes. I quickly help position pt. against the wall. He was disoriented and slighlty confused. He was conscious and alert but dazed. I immediately had by technician call 911 and the paramdeics attended to pt. After doing thorough evaluation of symtoms, pt. declined further treatment. His friend picked him up

Patient approached pharmacy staff during 15 minute observation to report feeling of overheating and anxiousness. He was brought into the consultation room where blood pressure was taken which was normal. Patient was given water and a dose of Benadryl as well as provided direct cooling with table fan. He mentioned getting a taste in his mouth prior to the flushing and anxiety as well as blurred vision. He was observed for an additional 45 minutes with symptoms subsiding and was advised to seek medical attention if symptoms reappear as he refused any further medical intervention. Patient was called several hours after vaccine at home where he said he was feeling improvement but was resting.

12 hrs after shot felt exhaustion, mental brain fog, mild nausea and migraines. In the weeks following vaccine, exhaustion and migraines have persisted at an interval of several times a week. This is abnormal for me - i do not have headaches regularly or migraines. It has almost been 2 months and I am still having exhaustion and migraines.

Pt became diaphoretic, looked dazed, confused, and about to faint within 10 seconds of vaccination at 1pm. Pt's BP was 110/50, pulse 50. After 10 mins, pt seem to recovered from his symptoms. Later stated that he's had these vasovagal symptoms in the past with other injections. Said he was ok with the previous flu vaccine and didn't think to mention it to vaccinator. Pt stayed until 1:30pm (30 mins after vaccination) and reported he was ok to drive home. Pharmacy f/u in 2 days on 5/12/21 @ 9;15, who stated he is doing well and recovered from all symptoms.

For about 4 days after the vaccine I had chills, vertigo, fatigue, loss of appetite, hot flashes, and general malaise. Then, after the first week of having the vaccine, I began to have these symptoms about once a week. Last week, it was on 5/6 when I gradually become colder regardless of layers and my stomach was repelling the idea of food (no vomiting or actual nausea). I went to bed and I was better by morning. Yesterday (5/12), I had the same thing. Chills and the inability to stay warm, loss of appetite, and a sort of sleepy vertigo.

HEAD PRESSURE; ABDOMINAL PAIN; STUCK THROAT; DIZZINESS FOR APPROXIMATE HALF A DAY BUT GONE ON THE NEXT DAY; NAUSEA; MILD HEADACHE; HALF OF MY HEAD TO THE NECK IS SO STIFF AND GIVING HEADACHES AND DIZZINESS; CHEST FELT LIKE A TIGHT SQUEEZE; HEAD FELT LIKE A TIGHT SQUEEZE, COMPRESSION AND GIVING ME HEADACHES; This spontaneous report received from a patient concerned a 44 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. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced half of my head to the neck is so stiff and giving headaches and dizziness. On APR-2021, the subject experienced chest felt like a tight squeeze. On APR-2021, the subject experienced head felt like a tight squeeze, compression and giving me headaches. On 06-APR-2021, the subject experienced head pressure. On 06-APR-2021, the subject experienced abdominal pain. On 06-APR-2021, the subject experienced stuck throat. On 06-APR-2021, the subject experienced dizziness for approximate half a day but gone on the next day. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced mild headache. On 03-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not provided., Chest X-ray (NR: not provided) Not provided, EKG (NR: not provided) Not provided, and MRI (NR: not provided) Not provided. Treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine was not applicable. The patient recovered from dizziness for approximate half a day but gone on the next day on 07-APR-2021, had not recovered from head pressure, abdominal pain, stuck throat, nausea, head felt like a tight squeeze, compression and giving me headaches, and half of my head to the neck is so stiff and giving headaches and dizziness, and the outcome of mild headache and chest felt like a tight squeeze was not reported. This report was non-serious.

WOKE UP WITH PAIN AND BODY ACHES IN BACK AND LEFT SIDE AND FEELS LIKE THE PAIN IS ENLARGING; FEELING BAD; FELT FEVERISH; DIZZINESS; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart valve replacement, and concurrent conditions included abstains from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient has history of no drug drug abuse or illicit drug usage. the patient was taking blood thinning medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the subject experienced dizziness. On 04-JUN-2021, the subject experienced feeling bad. On 04-JUN-2021, the subject experienced felt feverish. On 05-JUN-2021, the subject experienced woke up with pain and body aches in back and left side and feels like the pain is enlarging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt feverish, dizziness, and woke up with pain and body aches in back and left side and feels like the pain is enlarging, and the outcome of feeling bad was not reported. This report was non-serious.

At 12:30am 04/06/21, I was wakened to a nauseous feeling in my stomach, and on my way to the restroom I passed out. My head hit the floor and that is when I woke up and had Diarrhea. Went back to lay down, and I had trouble the rest of the night breathing with intense arythmic activity. It caused me to not be able to breath as my heart was skipping beats very aggressively. This lasted into the morning of 04/06/21, and did not cease until 7-8pm that evening. Symptoms lasted approx 5 days, and dropped off in severity. Other symptoms included the following the day of the 04/6 -4/10/21: - dizziness - metal taste in my mouth - nausea - mental confusion - fatigue - loss of appetite - severe shakes/chills/sweats

Patient presented with wife 6/18/2021. Patient requested Janssen covid-19 vaccine. The immunization was administered at 6:55pm. After 7 minutes of sitting in waiting room, patient started to complain of dizziness, "spinning in head", heavy breathing, and sweating. Patient was very sweaty, pale, and uneasy. Patient then fell to the ground with wife next to him, and lost consciousness briefly. 911 was immediately contacted. Patient did not hit his head or other body parts. Patient was able to be picked up and brought back into his seat. He did lose consciousness again in his seat very briefly but was able to speak to me and answer questions as I spoke with 911. He was very pale and sweaty, but answered questions to check for mental status. 911 police and ambulance arrived and checked his pulse, blood pressure, and asked several questions to examine his mental status. Patient declined going to hospital. Patient did walk out with wife, more color apparent on face, and able to answer questions. Patient and wife were advised to stay home and relax post-vaccination and call 911 if symptoms arise.

9:48am during his 15 minute wait time, reported having a tingling in tingling in his throat, feeling flushed, and light headed. Declined us calling 911. He reported that he has a lot of allergies to foods and has experienced this reaction after having exposures to poultry products. Patient was brought in the nurses office and vital signs checked and stable. Lung sounds clear on auscultation. Given benadryl 50mg and monitored in office. Once patient reported feeling back to normal he asked to leave and went home. We called patient to verify that he got home and continued to feel fine.

Nine hours after receiving vaccine I started "trembling, shaking." Not convulsing, more like really cold. My temperature read 97.2 degrees. My normal temperature is 98.6 degrees. Shaking stopped around 11:30 p.m. I woke up at 3:15 a.m. very hot with my heartbeat racing. I did not measure heartbeat rate. I woke up this morning at 5:30 a.m. with no side effects.

About five hours after I received the vaccine I began to run a fever that averaged 102 degrees fahrenheit. At that time I also developed chills and extreme fatigue. These symptoms persisted until I fell asleep at 10:00 PM 3/13/21. I was awakened at 1:00 AM with severe muscle spasms in my left bicep and a fever of 102.5 I started taking tylenol to begin reducing the fever. I also lost my appetite around that time. Things were pretty much the same all day 3/14/21. I went to sleep at 10:00 PM I got up every four hours to take tylenol. I woke up at 7:00 AM 3/15/21 to prepare for work my bed sheets and shirt were soaked with sweat but my fever was gone. I ate breakfast and drank a cup of coffee. When I got to work I begin having stomach problems. When I started working I noticed that I was having a lot of trouble concentrating. I decided to leave early to go home and rest. Things have improved since then but I do have a headache that won't go away.

After the shot, I was feeling fine for 12 hours, I worked out at the gym, helped my roommate carry a desk up a flight of stairs. Then 12 hours into the shot I started getting chilly and immediately statrted shaking for 20 minutes, no warning, head to toe, more than just the average chills. So I took two tylenol and hoped in bed with a few blankets. The next day I felt like crap, but ok

Mach 24 1700-1730 feeling odd with some joint pain in knees. Injection shot pain normal as most injuections. 1900 achy 2000 chills started 2100 fever of 99.8 March 25 0015 sweaty and hot fever of 102.5 entire body aches, joint pains knees and arms. Musclar aches all over felt slight nausea 0700 aches continued fever down 100.2, fatigued slept most of the day. Injection site tender. Drank water ate toast. 1300 fever subsided 98.6 (my normal is 98.2) Took motrin for aches. Rest of day and night slightly achy stiff joints fatigued. March 26 Still achy and stiff. No fever. Took Motrin. By midday had more energy and able to get around and walk. Noticed taking deep breaths was hard to do with out slight pain. Was gone by the 28th.

At 3am I woke up with: Chills Fever Headache Body aches Throughout the day the symptoms persisted and included: Brain fog Dryness / dehydration Dizziness

At 5:45 I suddenly felt weak all over and had to lay down. Within 15 minutes I started shaking uncontrollably from body chills. Within a half an hour I had a 102.5 fever. After 2 hours the chills had dissipated but my fever was at 103.5. I took acetaminophen and slept fitfully all night. The next morning at 6:00 my fever was still 102 and I felt weak. By mid morning the fever was finally gone and I was exhausted and mildly nauseous for the rest of the day.

chills and restlessness sleeping Sunday / Monday night, Tuesday 9A: quick onset of severe flu like symptoms: dizziness, significant fatigue, loss of any concentration, nausea, lack of appetite. Dimished quickly after 400mg advil taken in afternoon. Mostly gone by 4:30P. Wed 4/7 most symptoms gone.

nausea, faint, migraine, chills, fever, muscle pain, shortness of breath, joint pain, weakness, fatigue, dizziness, heart acceleration, lots of sleep, anxiety, drowsy.

Pt. received the vaccine at approximately 2:44pm. Before I could hand him his card, his hands began trembling and he looked pale. I asked how he was feeling. He reported feeling shaky, dizzy, and very hot. I asked him if he was having any difficulty breathing, had tightness in his throat/airways, or even felt a tingle. He said no. Noting the time, I asked if he had eaten lunch. I asked if he has ever felt this way before. He said he had when he gets a "hypoglycemic attack." While not diabetic nor on any medications, he said he will occasionally get very low blood sugar. He said he had not eaten since early that morning. Another employee brought some juice I requested. I again asked him about symptoms related to anaphylaxis, to which was not an indication of an anaphylactic reaction. I gave him the juice to sip. I asked him again about symptoms. Because he was still dizzy, I took his blood pressure/heart rate. His BP was 160/119 and heart rate 96bpm. His color became more gray over the next several minutes. He was still too dizzy to stand, felt hot, shaky, and now nauseous. He handed over the juice and was given a receptacle if he vomited. We suspected a vasovagal response, but was still symptomatic after 10 minutes. Meanwhile, the other pharmacist tried to call his doctor's office. We learned his doctor had moved away and he had not yet come in nor selected a new provider. We asked him if he felt he needed to be seen by a doctor. He said he did and agreed to us calling an ambulance. The ambulance arrived around 3:10. The EMTs took his BP. It had come down, but he could not stand up without his knees buckling. The EMTs got him on the stretcher and took him to the hospital.

Sudden fever of 101.7 with severe headache, severe chills, and shaking. Some nausea. Arm only slightly sore from injection. Took 2 Advil which did not seem to help much. Could not sleep all night and held cold pack on head to try to help headache. At 4:00 am was due to take 2 more Advil, and that finally seemed to help so he finally stopped having chills and could sleep. Woke up in the morning tired, but feeling better, symptoms pretty much gone.

3/21 - Felt like a sinus infection/Ear infection. Swollen lymph nodes. No congestion. 3/27 - Went to urgent care. Was given antibiotic/steroid to combat sinus/ear infection type symptoms. Tested neg. for strep. 3/29 - Went to PCP for continues pain in head and starting to have pain in lower back and down both legs. Some pain in arms too. 3/31 - Went to PCP for increased pain, weakness and numbness in legs and arms. Took blood for tests. COvid test 4/3 - Went to ER with intense pain/numbness/weakness/ restlessness in legs and some in arms/hands. Head still hurts too. More blood work, given Hydrocodone/Ibuprofin to help manage pain. 4/5 - Returned to PCP. Was given Gabapentin to help with the pain. Was referred to neurologist. 4/8 - Initial exam at neurologist. Plan to complete MRI and Nerve Conduction studies. 4/9 - Had MRI completed of brain and upper spinal cord.

Started with chills and muscle fatigue at 8pm. Once chill subsided felt feverish and could not fall asleep at about 1 am on 4/8. Sweating followed by better rest until waking at 6am for day, but felt fatigued from lack of restful sleep during night. Was able to nap during day (4/8) and felt much better by evening.

Beginning two days after getting the vaccine, I completely lost my appetite and developed severe abdominal pain, my blood pressure and heart rate were elevated and my stomach continued to hurt. I also had chest and back pain, muscle aches, insomnia and cramping. Finally went to the Emergency Room on the third night.

Patient does not remember most of the adverse event. Patient's partner reports that patient started feeling a tingling sensation on his left arm about 10 minutes after vaccination. Partner also reports that patient was hallucinating and sending her confusing text messages during his 15 minute observation period. The patient did not report feeling any adverse symptoms at the checkout station after his 15 minute observation period and before leaving the vaccination clinic. After patient returned home, his partner reports considerable swelling on his left arm, continued hallucinations and trying to dismiss her concerns. Subsequently, that same day, partner reports the patient had a severe migrane and began to lose feeling on his left arm and leg, at which point the patient also lost consciousness. Also at this point, the partner calls 911. After arrival of emergency personnel, the patient regains consciousness, but does not remember name and complains of continued pain on his arm. He is transported to hospital where he spends 3 nights and receives treatment and care for stroke symptoms. Patient reports that he does not remember much of anything 1.5 days after vaccination. After returning home from hospital, patient complains of memory lapses and begins seeing neurologist for minor seizures during his sleep. Wife reports that patient now lashes out and easily loses temper due to the fact that his memory is foggy.

This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 test positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unable to go work. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 06-APR-2021, the subject experienced warm throughout right arm at injection site. On 06-APR-2021, the subject experienced severe headache. On 08-APR-2021, the subject experienced stomach/abdominal pain. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach/abdominal pain, and warm throughout right arm at injection site on APR-2021, had not recovered from severe headache, and fatigue, and the outcome of unable to go work was not reported. This report was non-serious.

5 minutes post vaccination, client left an "adrenalin rush" and "tightness on his chest and tingling and tense all over his body." Client felt very anxious today and he reports having history of anxiety. His BP is 155/97 p 101, after 5 minutes manual BP is 142/90 p 110. 911 was called and medics performed an EKG on site. Client indicates that his symptoms are improving and was not transported to the hospital.

Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Additional Details: Patient Refused epi-pen. Most likely anxiety-related event per patient and wife/observation. EMS showed up to store within 20 minutes; patient was discharged to home and did not follow up with ER. Spoke with wife at 5PM --patient has been fine all afternoon and went shopping after AE.

Started with nausea, then it followed. Migrane, unable to talk, unable been awake ,I even fainted I don't know for how long but when I woke up was on the floor and sweating, chills, fever, shortness of breath, tireness, muscle pain and cough. Did not go to the doctor or hospital, I have no insurance. Even until today I still have a light cough and shortness of breath. All this stopped me from going to work for 2 weeks, and unenployment did not pay.

Started in the middle of night- awoke to my arm I got injected in being completely numb. Moved my arm around, got circulation and feeling back went back to sleep. Then the next day all day my back was sore and all my joints felt sore including my ankles, wrist, neck, knuckles, elbows, knees. Just soreness - NO FLU LIKE SYMPTOMS - but sorness all over. I left message with Doc's office. Next day my joints felt better but I awoke with splitting headache. Took aspire and all improved.

Before receiving the vaccination the patient mentioned he had a fear of needles. Patient was asked if he ever fainted after getting a vaccination or injection and patient reported no. The vaccine was administered to the patient and patient appeared to be fine for the next few minutes after getting vaccinated. Patient was told he could take a seat in the waiting area and wait until his 15-minutes were up and he could go. Patient was seated in the waiting area for about a minute but then got up to walk down one of the isles. When walking down the isle patient fainted and collapsed. This occurred approximately 10 minutes or so after he received the vaccine. Patient was helped to a chair and once seated appeared to shake/convulse (almost like a seizure) for approximately 5-10 seconds before snapping out of it and regaining consciousness. Afterwards he was alert and talking but didn't remember fainting. 911 was called and he was checked out by paramedics. After observing him for 15 minutes or so and determining his heartrate and blood pressure were normal and he appeared to be ok, the paramedics told him they can take him to the hospital to be evaluated further, or he was free to leave on his own without going to the hospital. The patient said he felt fine and declined being taken to the hospital. After another 10-15 minutes the patient left under his own power. Patient mentioned he would possibly be calling his physician and alerting them to the episode.

Tinnitus level 8/10. Bad swelling / inflammation. Brain fog. Diarrhea. Ear pain. Treated with large doses of Antronex with recommendation from Chiropractor. Antronex helped reduce swelling. Treated sinuses with Xlear nasal spray. Helped reduce swelling. Tinnitus still at level 4/10 after 9 days.

slight fatigue anxiety slight but weird tingling lips (if it gets worse ill go to the urgent care but im not concerned at this time. its been tingling for about 12 hours now and i can feel the tingle going away slowly now. just teporting my findings.

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

Stomach pain, extreme diarrhea, nausea. Got so dehydrated they put me an IV fluid at doctor's urgent care walk-in on 6/11/2021. My kidneys were hurting. Ciprofloxacin 500 mg 10 days, 1 tablet by mouth twice a day. Could have been a stomach virus. I still don't feel back to 100%. I still feel a little queasy every now and then. She wanted a stool sample, but I was too dehydrated for that.

CHEST PAIN; NUMBNESS IN FINGERS ON LEFT HAND AND LEFT ARM; FELT WEIRD; PAIN; PAIN IN NECK; PAIN IN ARM; PAIN IN HEAD ON LEFT SIDE; LACK OF ENERGY WHEN WALKING OR WORKING; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight was 175 pounds, and height was not reported. The patient's concurrent conditions included glaucoma. The patient experienced does not feel good when treated with metoclopramide. 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 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced numbness in fingers on left hand and left arm. On 18-APR-2021, the subject experienced felt weird. On 18-APR-2021, the subject experienced pain. On 18-APR-2021, the subject experienced pain in neck. On 18-APR-2021, the subject experienced pain in arm. On 18-APR-2021, the subject experienced pain in head on left side. On 18-APR-2021, the subject experienced lack of energy when walking or working. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, numbness in fingers on left hand and left arm, lack of energy when walking or working, and pain in head on left side, and the outcome of felt weird, pain, pain in arm and pain in neck was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.

After receiving the vaccination I experienced headaches, face drooping on the left side possible Bells Palsy. I also experienced panic attack symptoms as well.

Within about 5 hours of the vaccine, started to feel skin sensitivity all over my body. It felt like every pore on my body was open and hyper sensitive to touch. My scalp was very sensitive to touch and there was a strange sensation when my clothes touched my body- I've never been hyper sensitive like this before. Within about 12 hours, developed a fever, chills and inability to get warm. Symptoms persisted for about 36 hours.

On Tuesday, June 8th, I'm driving a car on the highway and a dizzy spell hits me hard with no warning. I got the car pulled off the side of the road but my world was spinning for 2-3 minutes. It scared me enough to go the ER an hour later where I had blood drawn, EKG, CT scan of brain, overnight monitoring, and an echocardiogram. All were normal, but over the course of the next week, I felt the full force of the following symptoms: lightheadedness to the point of almost fainting, brain fog, nausea, neck tightness, headaches, anxiety, and fatigue. I had so many lightheaded moments where I felt I would pass out. My life was affected because I couldn't do anything without feeling like I would pass out. Driving more than a mile is out of the question. Fortunately, I'm a school teacher and all this started on the 2nd day of summer vacation. I certainly would not be able to teach if school were in session. How bad was my brain fog? I have kids who love to play board games like monopoly. I play 5 or more times a week. My brain fog prevented me from playing monopoly with him. It was too complicated for me to roll the dice, count the dice, move my piece the number of spaces, figure out money amounts, etc. . My family was really worried because they noticed how I couldn't think. I felt like a 90 year old man with dementia. As far as my lightheadedness, I never actually fainted, but there were many times I had the "sense of doom" feeling where I was going to die. I visited the ER again a week later and they did another EKG with normal readings again and ordered a holter monitor to be worn for 24 hours, which came back normal. When I finally got into my primary care physician on June 17th, he suspected something terminal, so he orders a brain MRA the very next day. That came back clean, so he orders me to see a neurologist. Once I received news that the brain MRA was normal, my anxiety went away for the most part--I was not going to die! The neurologist prescribed gabapentin 100 mg daily (which is anti-migraine/anti-seizure meds) and a carotid artery ultrasound, which came back clean. (Notice a pattern?) Because of the neck tightness/pain/uncomfortability, I visited a chiropractor thinking neck alignment was off. Chiro realigned me but I didn't feel any better or worse. I have had 2 visits at the chiropractor, specifically for the neck pain and seeking relief. Today, I am 6 weeks from the June 8th out-of-the-blue dizzy spell that changed my life. If I gave a percentage of how good I am today, I would give a 75%. During all this time, I've never had a fever and my blood pressure has been normal every time it's been taken. According to all these tests, I'm the healthiest man in the world--my heart, brain, bloodwork is all great. My episodes are less and less frequent, and I drove today for about 5 miles! Yay! I feel like there's light at the end of the tunnel. In the last week, I've been playing board games much better with less brain fog, but I have my moments with brain fog and lightheadedness. My neurologist and my primary care physician feel like there is no correlation to the vaccine, but the chiropractor I visited has said that he's treated multiple patients like me who are looking for relief from these symptoms in the past 4 months.

MEMORY LOSS (SOMETIMES CAN'T REMEMBER THINGS); SORENESS THROUGHOUT THE BODY; INSOMNIA/CAN'T SLEEP; PAIN IN RIGHT ELBOW IS GETTING WORSE; CHILLS AFTER WIPING AWAY SWEAT AT NIGHT; HEAVY SWEATING AT NIGHT (DESCRIBING IT AS LITERALLY SWEATING BUCKETS, HAVE TO SLEEP ON TOWELS AND CAN'T SLEEP); This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no medical history, 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: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUN-2021, the subject experienced heavy sweating at night (describing it as literally sweating buckets, have to sleep on towels and can't sleep). On 27-JUN-2021, the subject experienced soreness throughout the body. On 27-JUN-2021, the subject experienced insomnia/can't sleep. On 27-JUN-2021, the subject experienced pain in right elbow is getting worse. On 27-JUN-2021, the subject experienced chills after wiping away sweat at night. On 13-JUL-2021, the subject experienced memory loss (sometimes can't remember things). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy sweating at night (describing it as literally sweating buckets, have to sleep on towels and can't sleep), memory loss (sometimes can't remember things), soreness throughout the body, insomnia/can't sleep, chills after wiping away sweat at night, and pain in right elbow is getting worse. This report was non-serious.

HR 126-67; SPO2-98; BP 154/80; pt. was fine after vaccine then got out of car to use bathroom and as soon as he stood up from the car he lost balance and stated feeling dizzy, light headed and didn't feel right. he Slumped over and was caught by an observer and guided to the ground. Hypoglycemic but not diagnosed. B/S 107. pale, nauseaous. care transferred to the paramedics.

Body shaking and aches 5 hours after vaccine, fever started 6 hours after vaccine, along with headache and inability to sleep, fever lasted for almost 36 hours, nausea which led to vomiting 16-17 hours after vaccine, vomiting off and on for the next 8 hours, 3 days later and still have headache and some dizziness and brain fog and some moments of nausea, day 2 had some itching on legs, day 3 and still don?t feel back to normal

Symptoms began immediately. I felt an aching pain in my left arm immediately after the vaccination. It then moved to my scapula. It persisted the rest of the day and all day Tuesday. I also felt soreness of limbs (both arms and legs) intermittently for the 48 hours. I had shortness of breath for the next day. I felt extreme fatigue for the next 48 hours. I felt my heart racing off and on for 24 hours, I felt a loss of strength in both arms and legs for the next 48 hours. Monday Night I woke up sweating as I had a fever. The fever persisted off and on for about 24 hours. I was irritable (probably due to not feeling well) for about 48 hours. My wife had to drive me home.

immediately felt tingling in left arm (like ben gay), then after about 10 min felt go into neck and and cheek. A little light headed. At 15 minutes asked nurse if normal. Then started sweating. left hand turned purple. Dont really remember anything else. Went unconscious. Remember them yelling Code something and Cardiac arrest. Taken to ER. Think they may have said anaphalatic shock. I think they gave me epinepherine. Had paralysis in left hand when i woke up for a few minutes. Blood work and EKG were normal. Went home within a couple of hours. Light-headed two days later still. Saw doctor two days after. Blood pressure is high. Little bit of fatigue and brain fog.

Same day/evening: chills, severe headache, sleeplessness, chest pain Next morning/afternoon: fever, muscle soreness, worn down

I received the J&J shot after work on Friday around 5:30 p.m.. Around 3 a.m. Saturday morning, I woke up with a fever and chills. My head was hot. My body was cold. I had a pretty severe headache as well. My body ached all over. Muscle and joint pain. I took Tylenol, but it didn't seem to do much. I spent all day Saturday in bed or on the couch. I ran a fever of 100.9 to 101.6 all day Saturday. My body ached making it hard to go up or down stairs. I was weak feeling and I was exhausted just going to refrigerator to get juice or water. Not much of an appetite all day. Also, arm was sore and bruised at the shot location. That was the least of my issues. Today is Sunday and I am feeling better now. I feel like the worst is absolutely behind me, but I felt so terrible yesterday, I thought I should report my issues.

day after, was severe nausea, body aches, low grade fever. headache. 2nd day I was fine, about a week later I had a relapse without the nausea. I have felt off ever since, low grade fever comes and goes 99-100 degrees. My skin feels constantly hot and has become extremely sensitive, scratching my head is painful. I am more shakey in my hands than normal, my head is foggy and cant concentrate at times, insomnia. Which is essential for my work. My heartbeat is rapid at times but my blood pressure isn't up. All of my bloodwork looked fine except for weak anemia which is new for me. the last thing is a rash appeared on my feet and legs but doesn't itch and I started getting shooting pains in my legs, this is new, started about a week ago.

Client was getting ready to leave after 15 minutes observation and he attempted to get up, felt dizzy, fell backwards and fell to ground. He appeared dazed for less than 30 seconds. No difficulty breathing, no shortness of breath. Able to answer questions appropriately, alert, oriented x 3, stated he felt okay. 911 called. B/P 139/82 right arm, HR72, RR18. Pt continued to feel fine, answering questions. appropriately. No history of vaccine reaction. Medication for stomach taken. Per client no heart, or diabetes history. Client stated he last ate breakfast and had a little bit of coffee. He refused medical treatment and his son drove him home.

I received the vaccine at 10:45AM on 04/08/2021. At around 4:30PM, I began experiencing waves of nausea and lethargy. By 7:00PM, I had a fever of about 101 F. By 8:30PM, my fever was exactly 103.46F. It was then that I took medication to bring the fever down. The fever broke overnight while sleeping. Since then, I continue to experience episodes of annoying brain fog. With hope, this will pass soon.

3AM woke up with high fever, headache, muscle ache from shoulders up. Treated with Tylenol to reduce fever, symptoms continued through the day. 2PM discovered large patch of hives on back from right shoulder to waist approximately 4 inches wide at the top and narrowing to 1 inch wide at the bottom. Treated with my go-to allergic reaction kit: Xyzal, Benadryl, Prednisone, and Pepcid. Hives started fading after 1 hour and were mostly gone within 3 hours, followed by 12 hours of sleep.

Fever, sever chills for 2 hours, sustained heart rate around 90~100 for more than 4 hours, intermittent headaches 24 hours, mild confusion for 4 hours, loss of appetite for 48 hours

I could not report March 15 when this occurred because Vaers HHS did not have the Janssen listed as an option to report against at that time. Unusual for me hour long nosebleed resulting in use of a half of box of tissues. It occurred at 3am so doing anything other than homecare didnt seem necessary. After getting this vaccine I felt a brain fog for approx 15 days especially after being awake for about 8 hours, unusual for me as well. The nosebleed was of most concern and with the recent pause I saw on todays news about blood clotting issues. I felt it was important I report my experience on day 8 of vaccine and days 2 thru 15 of vaccine. I would not go back in time and take this vaccine based on my side effects.

HIGH BLOOD PRESSURE; BRAIN FOG; FATIGUE; ANAPHYLACTIC SHOCK; PARALYSIS IN LEFT HAND; LIGHTHEADED; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pre-diabetic, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. The patient had no illness 30 days prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) 1 total dose was administered at left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021 at 14:35, the patient immediately felt tingling in left arm (like ben gay) after vaccination, 10 minutes later he felt tingling in neck and cheek. His left hand turned purple. He became unconscious (he did not remember anything). He had cardiac arrest (patient remembers yelling code). He was taken to emergency room. He thought people in emergency room said anaphylactic shock and gave him epinephrine (patient was not sure). He had paralysis in left hand when he woke up for a few minutes. His blood test and Electrocardiogram were normal. He went home in couple of hours (on 31-MAR-2021). On 02-APR-2021 (two days later) he was light-headed, he went to his doctor. His blood pressure was high, he felt little bit of fatigue and brain fog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheaded, anaphylactic shock, paralysis in left hand, high Blood pressure, fatigue, and brain fog. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210443005-covid-19 vaccine ad26.cov2.s- anaphylactic shock, paralysis in left hand. 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).

Starting day of, fever of 102, lasting 2 days, despite taking Advil throughout. Chills, fatigue. The next day, started experiencing BPPV. This last 2 days. This was helped slightly by Hallpike maneuver. Sense of haziness, inability to concentrate/focus, irritable, difficulty sleeping, tired, which are all still here to the time of this reporting.

Patient fainted post vaccination. Patient was seated in our post vaccine area in a chair with arms. Within a few minutes patient collapsed into the floor, was hot/sweating and a little disoriented. Patient regained consciousness, applied wet compress and tested in a seated position with head down. Began feeling better. Patient provided with a bottle of water. Patient remained on our site for another 30 minutes until felt better and stable.

Patient became non responsive within 2 min of receiving shot. Was lowered to the floor, diaphoretic and pale, revived within 1 min, confused. States he has had this effect during previous shots/ blood draws/ being around ?sick people?. Patient given water and crackers (has only some green beans at noon today). Feels fine 10 min later.

4/28/2021- Patient presented to ED for evaluation after a syncopal episode with fall and head injury, severe headache; loss of consciousness; bradycardia with early repolarization without acute ischemia. 6/3/2021- continued confusion, disorientation; Brain MRI shows early chronic infarct 6/14/2021- Patient presented with continued syncopal episodes, significant confusion ongoing for weeks, diagnosed with large left MCA stroke.

One or two minutes after administration, patient said we was feeling light-headed, and then that he didn't feel well. He was instructed to focus on his breathing. He did this for a moment (maybe a minute) and then his head fell forward and he slumped forward in the chair. He was held stable in the chair by the pharmacist. After a short time (less than a minute) the patient's upper body (bilateral arm and hand) muscles contracted (maybe a seizure?) and then he relaxed and sat up. He was alert, a little disoriented initially and had no recollection of his reaction other than feeling light-headed and unwell. He then became sweaty and felt a little nauseated. The pharmacy called 911 and the patient left with the medics. At that time he was alert and oriented, but still not feeling well.

Shingles in throat. Vertigo, dizziness, half of head numb. Disoriented, Throat and ear pain, eye pressure on face and in eye, tinnitus, tired. Most symptoms since April 12th. Took two doses of antiviral because I got sores in my throat twice three to four weeks apart. Vertigo, dizziness, disoriented persists.

Unexplainable dizziness, lightheadedness, body tingling, ringing in ears, fainting, rapid heart beat, unable to focus. All began a few weeks after shot and have not gone away.

The vaccine gave me quite severe side effects (COVID symptoms). I think this is because I had COVID twice previously (last time in Dec 2020). About 8 hours after injection, I had sudden onset of high fever, chills, aches, headache - the symptoms were worse than full blown COVID itself (without the breathing problems) and lasted about 4 full days. I was so sick I took 2 days off work, which is very uncommon for me. My arm was quite sore for about 5 days. I've never had any reaction to a vaccine before and thought I should mention this. I didn't have any anaphylaxis or allergic reaction that I know of, just very, very severe COVID symptoms.

Client received the J& J Covid vaccine injection at the Health clinic and within 40-60 seconds had c/o "feeling funny" and felt like he was going to pass out. Client started to have a seizure-like activity, and loss consciousness two times. Ice packs and cooling clothes were applied to clients forehead and neck after client seizure-like activity stopped, feet elevated. Client was diaphoretic, gray, started twitching (which he said is normal when he gets nervous.) BP was low at 86/64. EMT called and client evaluated. Client refused transport to hospital. Client recovered from episode after an hour and left with his wife from the health department able to walk and communicate on his own.

Got vaccine at 12:30am, was home asleep by 2:30. Head was insanely stuffy when I woke up around 8:30, my ears hurt on the inside and I couldn?t hear well. My lungs felt kind of funny, as if I?d taken too much asthma medication. By noon my lungs were burning with every breath, my eyes were hot and weepy, the fever and muscle/joint aches had gotten really bad, and I had pain in my neck under my jaw between chin and ears.

Day 1: Saturday morning March 6 at 5:00am I was shaken out of my sleep with a nasty migraine, sour stomach, intense body aches, stuffy nose, fever (102f). Classic flu like symptoms. I was extremely sick all day Saturday (level of sick: 8/10). Day 2: Sunday morning March 7 I awoke again extremely sick, just as sick as Saturday. All same symptoms (level of sick: 7/10). Sunday night I was incredibly miserable, all flu symptoms, I did not sleep Sunday night, up all night and up all day the next day Monday. Day 3: Monday I continued to be sick, all same symptoms, all day long. This time the blood shot eyes & bloody nose came on, fever was steady at 101f (level of sick: 6/10). Day 4: Tuesday woke up still stick, same flu like symptoms. I feel the headache has gotten worse, in fact way worse. Fever steady at 101f all day. Overall I'm not as sick except the headache and fever (level of sick: 6/10). Day 5: Wednesday I was really hoping I'd make a full recovery but still still sick, fever dropped for a few hours then came back, fever peaks and bounces around at 101f. Headache is absolutely nasty, I feel intense pain in the back of my neck and head, hard to sleep or lay down. (level of sick: 5/10). Day 6: Thursday I feel like I'm just about kick this sickness, feeling way better. I dont have a fever today but I still have an incredibly nasty headache, really intense, my eyes hurt, back of my neck hurts. (level of sick: 3/10). Day 7: Friday, no flu symptoms, finally!! But the headache continues, really bad. It sort of disables my ability to function with the headache. Back of my neck and back of head hurts, inside my brain hurts. Ugh! Day 8: Saturday, no flu, no fever, although still bad headache. I've been taking Advil all week to help reduce the headache. It helps, but after about 6 hours later the headache returns. Late in the evening Saturday my head was pounding. Day 9: Sunday headache not that bad, mild headache lingered throughout the day, tolerable. Day 10: Monday no headache!! Today was the first full day of full happiness!! *NOTE*: In July 2020 I got COVID extremely bad, spent 4 days in the ICU, couldnt breathe!! I had a fever of 103 for 6 days straight before calling 911 to come and get me. I was in bad shape, lost 30 lbs, had respiratory breathing issue for about 2 months after hospital stay. Most sick I've ever been, total game changer, I will never be the same. To this day I feel my respiratory is at 90%, fatigue still comes around every so often. --- Thank you ---

Started with sore throat and mild cough. By 11:00 PM I had body aches and chills. I could not sleep at all due to chills and body aches. I then had a horrible headache and a fever of 100.4 at 4:00 AM. I still have a headache and body aches at 10:00 AM the next morning.

Day 1: Saturday morning March 6 at 5:00am I was shaken out of my sleep with a nasty migraine, sour stomach, intense body aches, stuffy nose, fever (102f). Classic flu like symptoms. I was extremely sick all day Saturday (level of sick: 8/10). Day 2: Sunday morning March 7 I awoke again extremely sick, just as sick as Saturday. All same symptoms (level of sick: 7/10). Sunday night I was incredibly miserable, all flu symptoms, I did not sleep Sunday night, up all night and up all day the next day Monday. Day 3: Monday I continued to be sick, all same symptoms, all day long. This time the blood shot eyes & bloody nose came on, fever was steady at 101f (level of sick: 6/10). Day 4: Tuesday woke up still stick, same flu like symptoms. I feel the headache has gotten worse, in fact way worse. Fever steady at 101f all day. Overall I'm not as sick except the headache and fever (level of sick: 6/10). Day 5: Wednesday I was really hoping I'd make a full recovery but still still sick, fever dropped for a few hours then came back, fever peaks and bounces around at 101f. Headache is absolutely nasty, I feel intense pain in the back of my neck and head, hard to sleep or lay down. (level of sick: 5/10). Day 6: Thursday I feel like I'm just about kick this sickness, feeling way better. I dont have a fever today but I still have an incredibly nasty headache, really intense, my eyes hurt, back of my neck hurts. (level of sick: 3/10). Day 7: Friday, no flu symptoms, finally!! But the headache continues, really bad. It sort of disables my ability to function with the headache. Back of my neck and back of head hurts, inside my brain hurts. Ugh! Day 8: Saturday, no flu, no fever, although still bad headache. I've been taking Advil all week to help reduce the headache. It helps, but after about 6 hours later the headache returns. Late in the evening Saturday my head was pounding. Day 9: Sunday headache not that bad, mild headache lingered throughout the day, tolerable. Day 10: Monday no headache!! Today was the first full day of full happiness!! *NOTE*: In July 2020 I got COVID extremely bad, spent 4 days in the ICU, couldnt breathe!! I had a fever of 103 for 6 days straight before calling 911 to come and get me. I was in bad shape, lost 30 lbs, had respiratory breathing issue for about 2 months after hospital stay. Most sick I've ever been, total game changer, I will never be the same. To this day I feel my respiratory is at 90%, fatigue still comes around every so often.

Headache, Fever, Chills, Joint Pain, Kidney Region Soreness, Lethargy, Confusion and Difficulty in Expressing Thoughts Very similar to Malaria "type" symptoms without ringing in the ears. (Had malaria in 1997) Symptoms tempered by 40% day two.

Transferred from Hospital on 4/1/21 for fever and altered mental status, suspecting adverse reaction from Janssen COVID vaccine given 3/30/21, symptom onset 3/31/21 morning. Sepsis with unknown source of infection: This is evidenced by leukopenia, tachycardia and fever. Acute metabolic encephalopathy, likely secondary to possible sepsis versus effects of COVID vaccine. Encephalitis and meningitis ruled out. Acute nontraumatic rhabdomyolysis: evidenced by elevated CK levels 1700 on admission, likely secondary to sepsis. Acute renal failure, hypothyroidism, transaminitis, elevated troponin likely associated with rhabdo. On sepsis protocol (vancomycin, meropenem and acyclovir) Disc

PATIENT LOOKED AT WIFE AND SAID I DON'T FEEL RIGHT, AS I WAS CALLED BACK TO THE CAR HIS HEAD BEGAN TO ROLE FORWARDS, THEN IN A CIRCULAR MOTION. HIS EYES ROLLED BACK IN HIS HEAD AND HE MADE A GASP FOR BREATH THEN PASSED OUT. EPI PEN WAS IMMEDIATELY ADMINISTERED. PATIENT BECAME MORE RESPONSIVE, LAID SEAT BACK IN CAR. PATIENT SWEATING , COULD NOW SPEAK TO ME BUT STILL SOMEWHAT DISORIENTED. VERY FAINT PULSE. 911 WAS CALLED AND COOL WET PAPER TOWEL PLACED ON HIS NECK AND OBSERVED UNTIL 911 ARRIVED WITHIN 5-10 MINUTES. PATIENT TRANSPORTED TO ER DUE TO VERY LOW PULSE EVEN AFTER EPI ADMINISTRATION. PATIENT REMAINED AT ER UNTIL 1:30 PM FOR MONITORING. THEY TRULY FELT IS WAS A VASOVAGUL REACTION. PATIENT WAS OUTSIDE WORKING IN YARD AT 6:30PM WHEN I CALLED TO CHECK ON HIM, HAS NO RECOLLECTION OF RECEIVING SHOT OR EPI PEN, JUST SAID HE REMEMBERS MEDICINE FEELING "HOT" GOING DOWN HIS ARM.

Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Medium, Systemic: Seizure-Severe

When injected after about 60 seconds semi severe achy-burning feeling in my arm that subsided in a few minutes. After 15 minutes slight tingling/numbness on the tip of my tongue and slight tingling in the upper lips of my mouth. I was not worried. I took 1 Benadryl and 2 Ibuprofen (400 ml) at that time for symptoms. I took additional 1 Benadryl and 4 Ibuprofen about 6 hours later as a precaution. Day 2 after about 36 hours I had slight soreness, and some sweating as I slept the 2nd night. Treated with 4 ibuprofen. Also I woke up with a feeling of uneasiness in the middle of the night on the 2nd night. Day three, just a general feeling of tiredness. Day 4 and 5 still slight ache in the injection sight if pressure is applied. Other than that I feel normal as of day 5.

04/09, ~11:15 a.m.: Received injection in left arm, released at 11:30 a.m. 04/09, ~1:00 p.m.: Mild headache, dizziness and fatigue, mild pain in left arm 04/09, ~7 p.m.: Moderate headache, dizziness and fatigue, mild nausea, spasms in muscle around injection site/itching/redness 04/09, ~8 p.m.: Went to bed and slept 04/10, ~2 a.m.: Awoke with severe headache, fatigue and dizziness, chills/fever, moderate nausea, sleeplessness, moderate pain in arm, moderate joint and muscle pain all over body 04/10, ~3 a.m.: Symptoms progressed to include delirium and hallucinations, rapid heart rate, itching in extremities, neuropathy and hyperesthesia 04/10, ~8 a.m.: Symptoms began reversing in order of occurrence over next 36 hours, starting with delirium and hallucinations; unable to concentrate or function properly 04/12: Lingering mild dizziness and headache, fatigue

I would like to report what happened with all the facts. One week after I had vaccine, I had very serious nose bleeding in the morning. I said very serious because I felt it cannot stop by itself. I called 911 and went to ER. First time, I use 911 and ER. All previous nose bleeding is very minor and it will stop in a minute. But this time, I just felt the blood just pouring into my mouth. So I was scared and asked my wife called 911. After 2-3 hours, the bleeding stopped and I back home. To be cautious, I made an appointment with family doctor on next day (24th). But the bleeding happened again in the evening ( cannot remember exactly, but around 9pm). This time I just used the clipper for my nose and it took another 2 hours for the bleeding to stop. I had a very rough night while sitting on bed and had very little sleep. The next morning (24th), the bleeding come back after I used the restroom. The same feeling as the two bleeding before. I rushed to doctor's office even not my appointment yet. The family doctor said he cannot do anything since he cannot observe the place of blooding and he does not have instrument needed. I was referred to a specialist. And luckily I had the same day appointment. We rushed there and after roughly several hours waiting, I was the specialist and finally he did the treatment. Since then, my nose is ok and no serious bleeding again. After I saw the side effects of JJ vaccine, I think it is better for me to report you what happened. I strongly suspect that my serious bleeding was caused by the drop of platelet which was side effect of the vaccine. I will have one blood work today. And will let you know results if you are interested. Again, I never had such serious bleeding before and that is the reason for my suspect. All the best

About 10 hours after shot I had uncontrollable shakes, restlessness, and insomnia. Fever between 101-102 all the following day. Fever between 100-101 all the day after that. Along with the fever I had body and head aches.

Five minutes after injection I broke into extreme sweating, hot flash, nausea, fatigue and head ache. I was at work and requested to go home early. I fell asleep one hour into my arrival and slept for 17 hours. Up to and including today I am having headaches, pain in my legs on left side only, nausea, lack of sleep and a continued smell similar to dried blood after a injury. I have also have and continue to have shortness of breath and chest pains resulting in two panic attacks within the last three days. This has led me to report this and I have doctor visit scheduled for 4/22. I also reported today based on internet search of reactions.

RIGHT SHIN PAIN; ANXIETY; DIFFICULTY CONCENTRATING; HEAD FELLS FUZZY; POTENTIAL SHINGLES; SEVERE LEG PAIN IN RIGHT LEG/RIGHT THIGH PAIN; RIGHT HIP PAIN/RIGHT ANKLE PAIN; LOWER AND MID BACK PAIN; SENSATION IN HEAD AND NECK; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included inflammation, blood pressure, abstains from alcohol, and smoker (1 pack/day or a little less), and other pre-existing medical conditions included the patient had no known allergies and there was 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: 1808978, and expiry: 13/JUN/2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included chlortalidone for blood pressure high, and ibuprofen for inflammation. On 26-MAR-2021, the subject experienced sensation in head and neck. On 27-MAR-2021, the subject experienced right hip pain/right ankle pain. On 27-MAR-2021, the subject experienced lower and mid back pain. On an unspecified date, the subject experienced right shin pain, anxiety, difficulty concentrating, head fells fuzzy, potential shingles, and severe leg pain in right leg/right thigh pain. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) 271 (units unspecified). Treatment medications (dates unspecified) included: cefalexin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe leg pain in right leg/right thigh pain, right shin pain, difficulty concentrating, head fells fuzzy, and lower and mid back pain, and the outcome of sensation in head and neck, right hip pain/right ankle pain, anxiety and potential shingles was not reported. This report was non-serious.; Sender's Comments: V0- Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

TINNITUS; BRAIN FOG; PRESSURE BEHIND RIGHT EYE (WHERE HEADACHE PAIN WAS) ON AN OFF; ACHY BODY; INSOMNIA; HEADACHES; FEVER (LOW GRADE); LETHARGY; This spontaneous report received from a patient concerned a 47 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced lethargy. On 07-MAR-2021, the subject experienced achy body. On 07-MAR-2021, the subject experienced insomnia. On 07-MAR-2021, the subject experienced headaches. On 07-MAR-2021, the subject experienced fever (low grade). On 09-MAR-2021, the subject experienced pressure behind right eye (where headache pain was) on an off. On 10-MAR-2021, the subject experienced brain fog. On 07-APR-2021, the subject experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, headaches, and fever (low grade) on 08-MAR-2021, achy body on 07-MAR-2021, and brain fog on 15-MAR-2021, was recovering from insomnia, and had not recovered from pressure behind right eye (where headache pain was) on an off, and tinnitus. This report was non-serious.

BLOOD SHOT EYES; BLOODY NOSE; DID NOT SLEEP DUE TO FLU SYMPTOMS; FEVER; NASTY MIGRAINE/ INTENSE PAIN IN THE BACK OF NECK AND HEAD, EYES HURT; SOUR STOMACH; INTENSE BODY ACHES; STUFFY NOSE; FLU LIKE SYMPTOMS; EXTREMELY SICK; This spontaneous report received from a patient via a company representative concerned a 47 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 heart coronary artery disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 05-MAR-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included atorvastatin, hydrochlorothiazide, and losartan. On 06-MAR-2021, the subject experienced extremely sick. Laboratory data included: Body temperature (NR: not provided) 102 F. On 06-MAR-2021 05:00, the subject experienced nasty migraine/ intense pain in the back of neck and head, eyes hurt. On 06-MAR-2021 05:00, the subject experienced sour stomach. On 06-MAR-2021 05:00, the subject experienced intense body aches. On 06-MAR-2021 05:00, the subject experienced stuffy nose. On 06-MAR-2021 05:00, the subject experienced flu like symptoms. On 06-MAR-2021 05:00, the subject experienced fever. On 07-MAR-2021, the subject experienced did not sleep due to flu symptoms. On 08-MAR-2021, the subject experienced blood shot eyes. On 08-MAR-2021, the subject experienced bloody nose. Laboratory data included: Body temperature (NR: not provided) 101 F. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasty migraine/ intense pain in the back of neck and head, eyes hurt on 15-MAR-2021, sour stomach, intense body aches, stuffy nose, extremely sick, did not sleep due to flu symptoms, blood shot eyes, and bloody nose, flu like symptoms on 12-MAR-2021, and fever on 11-MAR-2021. This report was non-serious.

FLUSHED; MINOR GOUT SWELLS; SORE ARM/THROBBING ARM; TIRED; SHORTNESS OF BREATH; ANXIETY; DIARRHEA WITH BLOOD; This spontaneous report received from a consumer concerned a 47 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic gout. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205ANA, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAY-2021 vaccination at left arm 16:30 for prophylactic vaccination. Concomitant medications included allopurinol for gout. On 08-May-2021, The patient experienced Shortness of breath shortly after vaccination, but this resolved in 15 minutes. He waited for 20 minutes after getting the vaccine. Patient noted that it could have been anxiety driven. On 08-May-2021 night (10 hours after), patient experienced diarrhea in the middle of the night and progressed to blood in the stool. The patient also very tired. Patient slept for almost 24 hours from Saturday to Sunday night, but now feels better. Patient felt very flushed, also experienced arm super sore for 1 day after vaccination, and throbbing for about an hour. The patient suffers from chronic gout and experienced minor gout swells (unsure if it is related to the vaccine or not) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and anxiety on 08-MAY-2021, and sore arm/throbbing arm, and tired on 09-MAY-2021, was recovering from diarrhea with blood, had not recovered from minor gout swells, and the outcome of flushed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210522256-COVID-19 VACCINE AD26.COV2.S-diarrhea with blood. 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).

PT HAS A PANIC ATTACK AND FELT DIZZINESS AFTER THE SHOT. HE WAS SWEATING PROFUSELY BUT COGNITIVE. WE LIED PT DOWN FOR ABOUT 5 MINUTES AND HE WAS FINE.

PT WAS VERY NERVOUS, DIAPHORETIC, PALE, PARAMEDICS ON SITE, BP 99/64, HR 63, SX RESOLVED, REFUSED TRANSPORT, AMA SIGNED.

RESTLESS SLEEP; FELT COLD; INJECTION SITE SORENESS; TIRED; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced restless sleep. On 15-MAY-2021, the subject experienced felt cold. On 15-MAY-2021, the subject experienced injection site soreness. On 15-MAY-2021, the subject experienced tired. On 15-MAY-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99.4 (unit unspecified). On 16-MAY-2021, Laboratory data included: Body temperature (NR: not provided) normal. The action taken with covid-19 vaccine was not applicable. The patient recovered from restless sleep, felt cold, and low grade fever on 16-MAY-2021, injection site soreness on 19-MAY-2021, and tired on 17-MAY-2021. This report was non-serious.

FEELING KIND OF LETHARGIC; FEELING VERY ANXIOUS; FEVER; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included azithromycin allergy, high blood pressure, broke back, and broke neck, and other pre-existing medical conditions included patient got disabled from physical injuries. patient was not able to keep up the metabolic energy with exercise. patient was steadily getting better from the injuries. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced feeling kind of lethargic. On 03-JUN-2021, the subject experienced feeling very anxious. On 03-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 03-JUN-2021, had not recovered from feeling kind of lethargic, and the outcome of feeling very anxious was not reported. This report was non-serious.

CHILLS; GENERAL MALAISE; FEVER; TIRED; ACHY ALL OVER/YUKINESS; SLEEPING A LOT; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hiv positive. 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 28-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced sleeping a lot. Laboratory data included: Body temperature (NR: not provided) 99.6. On 28-MAY-2021, the subject experienced achy all over/yukiness. On 28-MAY-2021, the subject experienced chills. On 28-MAY-2021, the subject experienced general malaise. On 28-MAY-2021, the subject experienced fever. On 28-MAY-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the general malaise, fever, chills, achy all over/yukiness, tired and sleeping a lot was not reported. This report was non-serious.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Pt had syncopal episode but recovered quickly

Jansen J & J Vaccine- Intermittent Dizziness & Vertigo. I have been out for work for 1 week which recommended by Dr. I still experience dizziness up until now on and off.

Within 30 minutes post vaccine administration, patient started having seizure like symptoms (Altered mental status, clenched jaw, non-verbal, right sided headache) - V/S WNL, Ambulance called and patient was taken to ED for evaluation. Responsive during transport to ED. Patient reported back to baseline after 1.5 hours.

Fever started approximately 6 hours after injection. Symptoms included high fever, sweating, chills, shaking, entire body aches and pains, headache and disorientation. Fever peaked about 11pm and began for the most part subsided by morning with a persistent headache.

rapid heart rate, excessive sweating, chills, muscle aches, pain all over body, chest pain. Weakness, brain fog, out of sorts, flu like symptoms, break outs on face, trouble breathing. These conditions have lasted over 5 days so far.

pt says he developed a fever, was shaking with chills, and he had trouble sleeping. He still has fatigue and headache but is feeling about 70% better today 4/8/2021.

Just before going to bed I started feeling very cold, shivering, I had similar sensation in the past when fever went up extremely quick. I did not measure my body temperature because I immediately ran under the blanket. Icy-cold hands and feet, even after my body temperature seemed to stabilize. I fell asleep but not a restful sleep. I woke up after 2.5 to 3 hours with the feeling that it was morning, but in fact it was between 2am and 3 am. At that point I felt the worst part had gone, I felt weak and with muscle aches but I could drink water and go back to bed. I did not have a restful sleep all night and I woke up may times. By the morning I was tired but no fever.

Full body aches, fatigue, mild euphoria/delerium. Periods of chills and hot feeling though no fever. Symptoms started 24 hours after injection, 90% resolved at 42 hours post. Took low dose of Ibuprofen and drank liquids.

I received the Jansen 1808978 vaccine on 03/25/2021 at pharmacy , on the following day 03/26/2021 at 8:30 pm I became disoriented / dizzy along with severe tinnitus and for the first 30 minutes I lost hearing in my right ear but it?s been over two weeks and the ringing is still going on .

Extremely bad headache, shortness of breath, dizziness lump in throat, chills followed by getting hot flashes and very lethargic and fatigued. Shot was administered at 11:45am on the 9th and by 03:00am on the 10th felt the above symptoms. Today date I am feeling better with minor unsteadiness here and there and a slight pain deep inside the middle of head almost like a headache for a few seconds then goes away, So far so good I think. I did call doctor to note on chart. Thank you!

EXTREME DIZZINES; BRAIN FOG; VERTIGO; NAUSEA; MUSCLE PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was not reported and height was 175 centimeters. The patient's concurrent conditions included alcohol use 1-2 drinks, and non-smoker, and other pre-existing medical conditions included the patient had no allergies and no history of drug abuse. no prior history of dizziness or vertigo. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced muscle pain. On 09-MAR-2021, the subject experienced extreme dizzines. On 09-MAR-2021, the subject experienced brain fog. On 09-MAR-2021, the subject experienced vertigo. On 09-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme dizzines, nausea, brain fog, and vertigo, and the outcome of muscle pain was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided. did not meet pqc criteria. based on the PQC evaluation/investigation performed. Additional information was received on 11-MAR-2021.The following information was updated and incorporated into case narrative: investigation result added. Additional information was received on 12-MAR-2021.The following information was updated and incorporated into case narrative: reporter telephone number and zip code, event (vertigo, brain fog) and treatment, product (batch number, vaccination time and site), patient history, event description were added.

TIGHT BURNING FEELING IN UPPER RIGHT BACK AND RIGHT ELBOW; CRIPPLING CONSTANT PAIN; MUSCLE WEAKNESS TO THE RIGHT ARM; TIGHTNESS ON UPPER RIGHT SIDE ON BACK NEAR RIGHT SHOULDER; INJECTION SITE PAIN; INITIAL BURN WHEN VACCINATED; DISCOMFORT; DID NOT SLEEP WELL AT NIGHT; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced discomfort. On MAR-2021, the subject experienced did not sleep well at night. On 11-MAR-2021, the subject experienced muscle weakness to the right arm. On 11-MAR-2021, the subject experienced injection site pain. On 11-MAR-2021, the subject experienced tight burning feeling in upper right back and right elbow. On 11-MAR-2021, the subject experienced crippling constant pain. On 11-MAR-2021, the subject experienced tightness on upper right side on back near right shoulder. On 11-MAR-2021, the subject experienced initial burn when vaccinated. Treatment medications (dates unspecified) included: ibuprofen, naproxen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 12-MAR-2021, was recovering from tight burning feeling in upper right back and right elbow, crippling constant pain, did not sleep well at night, discomfort, initial burn when vaccinated, and tightness on upper right side on back near right shoulder, and had not recovered from muscle weakness to the right arm. This report was non-serious. Additional information was received on 19/Mar/2021. The following information was updated and incorporated into the case narrative. Reporter details added, patient information (date of birth, sex, ethnic origin, race) added. patient allergy details, batch number of suspect, site of administration, Vaccine facility details, events: injection site pain and muscle weakness to the right arm were added.; Sender's Comments: V1:Medical assessment comments not required as per the standard procedure as the case is considered non serious.

on 4/9/21 around 8pm extreme cold chills , headache , body aches fever all night , flu like feeling for 3 days body ache and little sleep , consistent headaches . Had out patient knee surgery on 4/14 . Continues nasty headaches and body aches after . on saturday 4/17 bad headaches all night , bones in upperbody and skin hurt , from waist up felt like i had sunburn including on top of head , little sleep again . Went to Emergency room on 4/18 am . Tested for blood clot in leg and was negative , they gave me something for headaches and i was dehydrated , tongue was white and continues to wake up everyday white and feeling like dehydration , continues head aches from front to back with some continues neck pain in back . Havent slept more than 2 hours at a time . wake up with headache everyday and at night headaches are bad . i drink plenty of fluids all day , should not be feeling dehydrated . its now 15 days since vaccine and have no answers , i need to be able to sleep to do my job , vaccine was a mistake

Headaches? nothing helps Fatigue Right side body pain?especially joints, wrist shoulder and hip and knee Two bumps on right side chest Loose stool General achiness No energy Bad sleep Intermittent nausea Higher bp

LEFT EYE WITH BLOOD SPOT IN THE EYEBALL; PAIN IN THE CENTRAL PART OF THE CHEST; DIFFICULTY BREATHING WHEN DOING ACTIVITIES; HEADACHE; LEFT ARM PAIN WHERE SHOT WAS ADMINISTERED; COULDNT SLEEP THE DAY OF THE VACCINE; BODY TREMBLING; This spontaneous report received from a 48-year-old, male patient The patient's weight was 184 pounds, and height was 74 inches. The patient's past medical history included gallbladder removal. The patient was non-smoker, social drinker (only in holidays mostly), and the patient had no known allergies. The patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A and expiry: 23-JUN-2021) dose was not reported, 1 total administered on 14-MAY-2021 around 13:15 to left arm for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the patient experienced left arm pain where shot was administered, body trembling and couldn't sleep on the day of vaccine. On 17-MAY-2021, the patient experienced headache which had diminished, but suddenly they were like stabbing, left eye with blood spot in the eyeball and pain in the central part of the chest, which on occasions varies from right to left with breathing difficulty when doing activities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body trembling, couldn't sleep, and left arm pain where shot was administered on 18-MAY-2021, was recovering from headache, and left eye with blood spot in the eyeball, and had not recovered from pain in the central part of the chest, and difficulty breathing when doing activities. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210555889-COVID-19 VACCINE AD26.COV2.S -Left eye with blood spot in the eye ball. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

SKIN ABRADED; AWAKE LAST NIGHT BECAUSE OF INTENSE ITCHING; ITCHING OF KNEECAP, QUAD, LOWER QUAD ON BOTH LEGS, BOTH SIDES OF HIP NEAR PELVIC BONE, BICEP, LOWER ABDOMEN; REDNESS OF KNEECAP, QUAD, LOWER QUAD ON BOTH LEGS, BOTH SIDES OF HIP NEAR PELVIC BONE, BICEP, LOWER ABDOMEN; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 178 pounds, and height was 69 inches. The patient's concurrent conditions included alcohol user, non smoker, and eczema, and other pre-existing medical conditions included the patient had no known allergy. The patient was normally healthy, had no medical conditions. The patient took no medications. The patient did not have any history of drug abuse or illicit drug use. The patient took vitamin b for men. The patient was previously treated with alprazolam, and zinc. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced itching of kneecap, quad, lower quad on both legs, both sides of hip near pelvic bone, bicep, lower abdomen. On 12-JUN-2021, the subject experienced redness of kneecap, quad, lower quad on both legs, both sides of hip near pelvic bone, bicep, lower abdomen. On an unspecified date, the subject experienced skin abraded, and awake last night because of intense itching. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching of kneecap, quad, lower quad on both legs, both sides of hip near pelvic bone, bicep, lower abdomen, and redness of kneecap, quad, lower quad on both legs, both sides of hip near pelvic bone, bicep, lower abdomen, and the outcome of skin abraded and awake last night because of intense itching was not reported. This report was non-serious.

Night sweats and overall feeling tired. Hot flashes. Low grade fever. Missed 60 hours of work in the 2 weeks following the vaccine due to not feeling right

Around 14APR2021 noticed small rash on top of right hand, used cortisone cream to treat it, did not help 24APR2021 I went to urgent care for a rash that spread to my biceps, I saw Dr., prescribed prednisone for 5 days 2x a day, but the rash never cleared; 03MAY2021 I saw Dr., because the rash spread from biceps to the back of my elbows, he prescribed me Mometasone cream. This helped a little, but I quickly ran out of the cream,. I communicated through patient portal online to Dr., they prescribed more Mometasone cream. The cream seemed to help but the rash kept spreading. 11MAY2021 I went to see Dr., the rash spread all over my arms, with slight signs on my body. I was feeling fatigue because I was not able to sleep. I remember Dr. mentioning a possibility of an allergic reaction to the Johnson & Johnson vaccine, because I never really had a history of allergies. My body was rejecting something though, prescribed prednisone for 9 days. Rash still spreading. 24MAY2021 the rash was all over my body.. arms, legs, torso, it had a sensation of heat, stinging, and intense itching...could not get in to my doctor until the next day...I called in sick to work. 25MAY2021 I went to see Dr. He put me on medical from 24MAY2021 through 07JUN2021 and recommended to see Dermatology for diagnoses and testing. 26MAY2021 I went to Dermatology to see DR. She said it looked like Chronic Urtacaria, but needed to take a biopsy from my skin to confirm she also ordered a blood test. I was instructed to take two over the counter medications. XYZAL and ALLEGRA, and prescription Montelukast 4 Xyzal 2Allegra and 1 Montelukast a day totaling 7 pills, 02JUN2021 I Had my blood drawn. 07JUN2021 I went to Dermatology to see Dr. I had the stitches removed from my arm. My rash was better but still present continued medication; 10JUN2021 I went to Hospital ER, for severe muscle cramps and dehydration...was later released; 10JUN2021 after discharge from the ER, I went to see Dr. at my doctor office. I told him I feel overmedicated and have depression and was having severe leg cramps and could not sleep, he told me to immediately stop taking the MONTELUKAST medication. 28JUN2021 dermatology called me and said my blood test result from my 02JUN2021 blood draw was STREP positive. I was instructed to take AMOXICILLIN 2x a day for 10 days the rash was slowly subsiding, and by 05JUL2021, I was happy to see the rash was gone from my skin, 07JUN2021 I finished AMOXICILLIN; Dr. told me to start up meds again if rash were to return.

After the injection I felt fine. After falling asleep that evening, I awoke around 12:30am with body aches and slight amount of nausea. It lasted for a few hours through the night in which I did not sleep.

Was in his USOH until this morning whilst he was at work. He noticed that he was having difficulty finding his words and that he felt spaced out. Decided to schedule appointment see his PCP early afternoon. He was brought to the emergency room for further evaluation due to concern of an underlying stroke. On further questioning, he has a history of atrial fibrillation for which he has been on Cardizem. Not placed on any anti-platelet or anticoagulants. Does mention that he has a family history of this. Recently had the COVID-19 vaccine. Notes that he did have some body aches and fatigue. The symptoms cleared up by yesterday was went to work. He was feeling normal today until he began to develop the above symptoms. He denies any weakness today however he does recollect that last week, as he was walking the dog, he fell. He was able to get up unassisted. About a year ago in August, he had a similar episode of falling, came to the emergency room the following day and was found to be in atrial fibrillation with a rapid ventricular rate. States he has been diagnosed with atrial fibrillation since his early 20s. He is unaware of any history of hypertension. He states that he is on Cardizem for treatment of atrial fibrillation

9 hours after shoot woke up feeling very poorly and feverish. Went to take Tylenol and passed out. Came to with wife shaking my arm. Suffered trauma to noise and back during fall as a result of passing out including laceration from hitting face on counter. After coming to sever body shakes. Temperature was taken twice and recorded 92.5 and 93.0. Blood pressure and pulse after moving to couch to lie sit down was normal. Next day couldn't do much and was very tired. By second day I was recovered but sealing with injuries from the fall.

Extreme anxiety since day 3. Dry sinus since day 2. Inflamed sinus. Off and on rapid/hard heartbeat since injection. Insomnia. Rapid weight loss. Dry mouth. Loss of appetite. Ongoing chills (10 days after shot). Depression. Lack of energy.

I received the shot at 1:11 pm. I felt sorta drunk and not safe to drive by 3 pm. Sorta woozy. By 7 I was home and fell asleep and did not wake up until 4 pm the next day. I was sleepy and felt terrible nausea and was sweaty three nights in a row. By the 2nd night I had a headache that was unbelievable. I eventually took Tylenol 48 hrs after the shot and it barely helped the headache. I never ever get sick never have headaches. It was bad. I was also super super irritable and I am generally a happy person. I was so bothered by everyone I was sorta angry at them it was weird. By Sunday night my headache was even worse so bad in my neck on my left side that I had the shot, I could barely move my head. I took Tylenol recommended dose. I finally fell asleep on Sunday night 3 days later midnight sweaty again. Monday morning I woke up and I never felt better. On top of the world amazing. I felt not just good but extra good. Ready to go for it all. It was a very strange experience for over three days. I typically get the flu shot, I stay healthy and never had an experience like this, I don?t get sick luckily. Any I wanted to share this because it was so strange and no one warned me really. . I have felt great since and am thankful I had the shot.

6 hours after shot, body started shaking involuntarily for 3 hours. I was extremely cold, 3 layers of clothes and 3 layers of blankets. Unable to sleep all night. Got up 6 am, had major headache, swollen nodes in neck, all over body aches and still had chills. After 24 hours I may have been 50% to normal, after 48 hours approx 75%, 72 hours about 85%. Headache was gone unless cough or sneeze. On third day. I did not take any over the counter Medicine after the shot at all in fear of affecting the vaccine.

Janssen COVID-19 Vaccine EUA: patient presents to emergency department with altered mental status and confusion three days after being discharged from a different hospital for COVID-19 infection. In emergency department diagnosed with stroke, left ventricular thrombus, subacute anterior myocardial inferction with totally occluded mid LAD, and COVID-19 infection. Underwent cardiac catheterization and transferred to current facility for higher level of care and testing- currently remains hospitalized on anticoagulation and oxygen.

Injection at 9:30 am on 4/8. Dizziness and euphoria beginning at 1:30 pm, 4 hours post-injection. Dizziness became severe at 5:30 pm, 8 hours post-injection with fever, chills, and nausea. Severe headache beginning at 7:30 pm, 10 hours post-injection, becoming severe migraine headache lasting for 24 hrs until ~7:30 pm on 4/9, 34 hours post-injection. Mild headache persisted until 2:00 am on 4/10, 40.5 hours post-injection.

Pt was in the waiting room in his motorized wheelchair when he complained that he feels like he's going to pass out. He also c/o being dizzy. His skin was cold and clammy. This happened about 5 minutes after the vaccine. We assisted him to a room where he laid down flat and I applied ice pack to his head and chest. Pt felt better after about 30 minutes. Pt stated he had never had this reaction before. Pt was discharged from the clinic with his father, in stable condition.

Patient received vaccine and about 2-3 minutes after vaccination began sweating profusely. His wife was with him and alerted our staff that something was wrong. Our staff pharmacist, immediately attended to him and noticed that his tongue looked enlarged. He was not speaking for himself and was very disorientated. , RPh administered and Epi-Pen 0.3mg injection in the patient's thigh. The patient quickly stopped sweating, became more oriented and began talking. EMS was called and came to the pharmacy. EMS observed him for a short time then took him to the ERD

received Janssen J &J shot 9:15 am on April 7th approx, 24 hours later had to leave work for home because I became incredibly weak, tired and without energy. struggled at driving home had to repeatedly slap my face to stay awake. checked my temp. when arrived home, had a low fever (100.1) went to bed slept for 4 hours, checked temp (100.1) went back to sleep. woke 9 am on 4/9/2021 checked temp. (normal) fever broke on 4/9/2021 used restroom at 11:01 am 4/9/2021 large amount of bleeding from rectum LARGE AMOUNTS of blood clots in stool (shaped like Candy) Contacted medical provider. Spoke to a triage nurse, explained my concerns about bleeding from rectum and blood clots in stool... she dismissed that my restroom issues were related to the vaccine,

ELASTICITY ON BACK OF HANDS UNRESPONSIVE; TIREDNESS; BACKACHE; NIGHTMARES; DIARRHEA; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included herniated disc, and concurrent conditions included penicillin allergy, high blood pressure, smoker, back pain, plantars wart, diabetes, and alcohol user. The patient experienced drug allergy when treated with Cleocin (clindamycin hydrochloride). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes, losartan for high blood pressure, salicylic acid for plantars wart, and Wellbutrin (bupropion hydrochloride). On 08-APR-2021, the subject experienced nightmares. On 08-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced backache. On 10-APR-2021, the subject experienced tiredness. On 16-APR-2021, the subject experienced elasticity on back of hands unresponsive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elasticity on back of hands unresponsive, and the outcome of backache, tiredness, nightmares and diarrhea was not reported. This report was non-serious.

I told the doctor at the Clinic immediately that it hurt very bad. The shot was given high up on my left shoulder. I continued to feel pain. Now Its been a month and I struggle to dress myself. My shoulder hurts really bad. On a scale from 1-10 its usually a 3-4 during the day and sometimes a 9 at night. The only thing that helps is Aleve and my family doctor told me I can't take Aleve anymore because I'm on blood thinners. She said take Tylenol. I followed her advice and It doesn't work. She said if it keeps hurting, to come back in 2 weeks.

Tinnitus and diminished hearing in the left ear only 5 minutes post injection. Pain at injection site lasting 1 week. Anxiety prior to receiving vaccine and post lasting 1 hour. Fatigue, body aches starting 5 hours post injection. Chills starting 12 hours post injection and lasting 2 hours. Headache lasting 24-36 hours. Elevated temp at 98.4, normally 97.4

He got the vaccine, He felt as if he was breathing shallow on the bus to get to work, within 15 minutes of the vaccine. He came home and collapsed due to the fatigue which is not normal for him. About 12 hours later his throat got scratchy, achy but doable. He went to work and had to leave early due to flu-like symptoms, felt feverish. Really bad aches now, and his breathing and heart rate are elevated right now. Achy-like headaches. He did take some Ibuprofen 800 mg and seems to be helping. He has had the typical soreness of getting the vaccine in the left shoulder, but otherwise ok. He also has a stuffy nose, scratchy throat and his eyes are a little red and glassy. He was directly exposed to somebody for 25 hours that was positive for COVID, but nobody else in the car got COVID in January.

Never felt "right" after receiving vaccine. Occasional dizziness noted, especially upon standing. Deterioration in health 5/16/21: Was on a bicycle ride in the morning and HR monitor read 180 BPM. Rested briefly, did not feel well, rode home. Continued to not feel well throughout the day. Went to the emergency room at 6:00 PM with irregular HR, fatigue, and chest tightness. Heart rhythm irregular with ventricular ectopy. Admitted to the hospital, cardiac catherization done 5/17 8:00 AM, no evidence of CAD, diagnosed with non-ischemic cardiomyopathy. No risk factors and all probably causes ruled out. Non-smoker, healthy lifestyle, no excessive alcohol use.

The day after I had flu like symptoms. Tuesday morning I was dizzy light headed and went to the doctor, I started stuttering and the doctor sent me to the ER because he was concerned I had a stroke. I developed headaches they believed to be tension headaches. I couldn't finish sentences without stuttering. Nauseous, light headed, and dizziness for some time.

CONSTIPATION; PROBLEMS WITH BOWEL MOVEMENTS; DIARRHEA; PANIC ATTACK; HOT FLASHES; PAIN IN KNEES; PAIN IN CALVES,LEGS AND RIGHT ARM; COULDN'T SEE WELL; FELT CONFUSED; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included patient has taken tylenol.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 25-MAY-2021 for an unspecified indication. The batch number was not reported and has been requested Concomitant medications included paracetamol. On 25-MAY-2021, the subject experienced couldn't see well. On 25-MAY-2021, the subject experienced felt confused. On 25-MAY-2021, the subject experienced pain in calves, legs and right arm. On 26-MAY-2021, the subject experienced hot flashes. On 26-MAY-2021, the subject experienced pain in knees. On 01-JUN-2021, the subject experienced panic attack. On 02-JUN-2021, the subject experienced constipation. On 02-JUN-2021, the subject experienced problems with bowel movements. On 02-JUN-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't see well, and felt confused, had not recovered from pain in knees, hot flashes, problems with bowel movements, and pain in calves,legs and right arm, and the outcome of panic atack, diarrhea and constipation was not reported. This report was non-serious.

Resting heart rate increased from 58 to 77 over the course of 7 days. racing heart rate, not correlated with activity, tired, fatigued, unable to sleep, loss of appetite, headache

I've experienced 8 what appear to be seizures/body tremors since being vaccinated. The first beginning on the Saturday May 22, 2021 at around 1:00pm. That being the longest and most intense of the 8, which actually brought me to the ground. I generally have a few seconds to prepare as i can fill when they are about to come on. The most recent was on Sunday June 6, 2021 at 4:23am. It woke me up out of sleep and only lasted about 3 seconds, where as the first one i had lasted at least 15-20 seconds. The others in between have decreased in size and time since the one i experienced on Sunday morning. I've also experience cold spots or chills in strange areas, like behind forearms or one side of shoulder one day and the next side the other day. the top of my hands get the chills and there has been times that my waist and lower back will have it. I have experienced blurred vision occasionally but mostly it seems to be at night and seems to be not as bad like when it first started, which was Sunday May 23, 2021. I've experienced my teeth being very sensitive to hot and cold, and a tooth ache from time to time, and the most recent thing to experience has been an ear ache in my left ear, that started on the Monday June 7, 2021, that seem to happen when i first wake up in the morning and again when im about to go to sleep. They last for about 10 minutes and build up in intensity and then just stop. Those I've been have daily to this day or this morning i should say. Other then for the usual side effects of feeling fatigued and fever, those have went away, but other than for that... I guess i fill normal.

Tired and sleepy - for the next couple of days right after the vaccine. June 14, I started getting on my right side - from cheek to toes - and my whole leg and is still in pain today. For the last three weeks - the pain level was from 9 or 10 out of 10. I missed work for three weeks. I can barely sleep at night - maybe for three to four hours because the pain would wake me up. Today was my first day after three weeks that I was able to go to work. Today the pain is 5 out of 10. No treatment at the hospital. They prescribed me with 800 mg of Ibuprofen - two pills at night. The medicine was not strong enough. The prescribed me cream on my neck. The day I went to pick up my prescription to the pharmacist advised me to take another brand - so found a generic brand for $25 instead of $525. The cream doesn't numb my leg or make me fill better. I was applying hot water in the shower on my neck and that helped a bit. Told me to watch videos to stretch and exercise my neck every day.

49M with PMH significant for anxiety and depression; unmedicated due to lack of health insurance presenting with vasovagal syncope 15 minutes after Janssen vaccine administration in left arm. Pt reported feeling nervous prior to vaccine administration with remote history of fainting one time due to needle phobia, pt was offered to prophylactically lie down in a cot to receive the vaccine, he refused. Pt stated that he began feeling flushed and sweaty when he lost consciousness falling from a seated position, hitting his face and head. Pt was lying in prone position unconscious for 10-15 seconds, EMS was notified and pt was turned using C-spine precautions and transferred to stretcher. Pt was placed in trendelenberg,

PLATELET COUNT WENT DOWN TO 96; NEUROLOGICAL SYMPTOMS; ANXIETY; DIMINISHED QUALITY OF LIFE; LOSING INTEREST IN LIFE; DIFFICULTY IN WALKING/ DIFFICULTY GETTING OUT OF THE CAR; GENERALIZED HEAVY MUSCLE PAIN ALL OVER THE BODY ESPECIALLY ON ARMS AND HANDS; FEELING OF ELECTRIC SHOCK ON LEFT SIDE OF BODY ESPECIALLY UNDERNEATH THE LEFT FEET AND LEFT INDEX FINGER; SEVERE HEADACHE MOSTLY ON LEFT SIDE AND TOP PART OF HEAD; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, pre-diabetes which the patient controls with exercise and diet and no medications, alcohol user (had been drinking vodka for the past few weeks), and non-smoker. The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 27-MAR-2021 for prophylactic vaccination. Concomitant medications included olmesartan for blood pressure. On an unspecified date before vaccination the laboratory data (dates unspecified) included: Platelet count (NR: not provided) 160. On 18-APR-2021 (3 weeks after vaccination), the patient experienced severe headache mostly on left side and top part of head and ended up in the emergency room at 01:00 AM in the morning. In the emergency room, the patient had a brain scan and he was told that the brain scan showed no blood clot and that his platelet counts were good. After these tests the patient was sent back home. On 27-JUN-2021 (for the past 2 weeks prior to this report), the patient experienced generalized heavy muscle pain all over the body especially on arms and hands and difficulty in walking and getting out of the car. On an unspecified date in JUN-2021, the patient experienced feeling of electric shock on left side of body especially underneath the left feet and left index finger. On an unspecified date, patient reported that his platelet count went down to 96 after the vaccination, had anxiety and had been drinking vodka every night because his quality of life was diminished and he refused to go back to the emergency room. The patient was irritated and he was losing interest in life. The patient had not experienced any fever or nausea. The patient had scheduled an appointment with the physician on 26-JUL-2021 due to his concern about the neurological symptoms. It was reported that, the emergency services were called and informed about the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache mostly on left side and top part of head, platelet count went down to 96, generalized heavy muscle pain all over the body especially on arms and hands, difficulty in walking/ difficulty getting out of the car, anxiety, losing interest in life, feeling of electric shock on left side of body especially underneath the left feet and left index finger, diminished quality of life, and neurological symptoms. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738395-Covid-19 vaccine ad26.cov2.s-Platelet count went down to 96. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY

LEFT ARM WEAKNESS; PAIN ON LEFT ARM AND FINGERS; CAN'T SLEEP BECAUSE OF PAIN; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included kidney stone surgery, and concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced can't sleep because of pain. On 20-MAY-2021, the subject experienced pain on left arm and fingers. On 15-JUN-2021, the subject experienced left arm weakness. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: gabapentin, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm weakness, can't sleep because of pain, and pain on left arm and fingers. This report was non-serious. This case, from the same reporter is linked to 20210760712.

Starting approx 7 hours after injection I started to feel run down. I then played tennis for about 45 minutes. I got home around 8:30 and started to experience extreme chills, fever of 100.4, joint aches in feet, hands, neck, wrists, shoulders, hips. Headache. I did not take any additional medication - toughed it out. This morning is approx 22 hours after vaccine. I could not sleep more than an hour or so, I was very chilled and achy. I am currently feeling a little better but still have aches in my back and wrists and ankles, have a headache

Fatigue, body ache, chills, headache. Chills starting Monday night/Tue morning while trying to sleep. Restless through night, then very tired Tue. Took Tue off from work and spent at home. All largely better by Tues evening. Wed morning, left arm still tender at injection site, but nothing serious.

Dizziness started around the second day after receiving the vaccine. Today is the 4th day after and I am still having bouts of dizziness. It's not enough that I need to sit down, although it is somewhat disorienting.

Chills, mild fever, joint aches, skin sensitivity. Fatigue but difficulty sleeping. Similar to onset of flu, but milder.

Chills started around 11:30pm on 4/2/21; woke with fever, aches and sweats at 3am on 4/3/21. Fever, aches and fatigue persisted throughout 4/3/21. Took tylenol to manage fever and pain. Most symptoms had subsided by by mid-day on 4/4, but aches and fatigue persisted. Woke up on 4/5 feeling fine.

At time of vaccination patient felt fine. Morning after: patient stated he had a fever. At presentation to pharmacy(11:00am) , temperature checked any no fever was present. Patient stated he felt tired and couldn't catch his breath. Patient was encouraged to go home and rest as most of the described symptoms were to be expected. He did not. He reported back to pharmacy after 5:00pm and stated at around 2:00pm he felt dizzy and then went unconscious for a brief time (he did not know exact time frame but stated not long. Again temp was checked and was normal. He stated that his breathing was improving, but he was taking rest of day off.

Pain and swelling in my throat and severe tightness in my chest thirty minutes after the ijection. Severe ringing in my ears, could not sleep at night up to now. Went to ENT yesterday.

Patient presented to pharmacy feeling anxious, drank energy drink prior to vaccine, and had not slept the night before. He said he had a lot going on at home. After the vaccine he felt dizzy. Patient stayed in pharmacy admin area and then in the waiting area for over 20 minutes to see how he felt. he felt much better after waiting some time. We provided a gatorade to keep him hydrated.

Fever (100.5), cold chills, aches, headache, joint pain, fatigue, confusion, sore arm started 24 hours after shot and progressively got worse for two days. Symptoms have got better, but still lingering. A few red scabs appeared on upper arm of arm shot administered to, but not sure if related or not.

I received the Johnson and Johnson Covid 19 vaccine on 4/6/21 and the dose code is 041AZ1A. I received it at the Community Center. I'm writing because beginning with the evening after I received the Johnson and Johnson Covid 19 vaccine I've been having abdominal / stomach cramps and stomach pain. Sometimes it is on the top of the abdomen / stomach, other times it's at the bottom. Sometimes it hurts to the point of waking me up in the middle of the night. This morning it started moving into my chest. Do you know if this pain will subside shortly or what is known about this potential side effect? Is there anything I can do to mitigate the issue? I'm contacting my Dr for a visit.

Patient felt ok the day of the shot, next day got very sick. Said he felt terrible, felt like the vaccine was going to "do him in." He complained of weakness and shortness of breath. He was dehydrated and worried about his kidney function. Said he had a hard time going to the bathroom with stomach pains. On Mar 31, 2021, said he had fever, but didn't go to doctor. Was taken by ambulance April 3 to ER, admitted that night, transferred to ICU on April 4, on ventilator, proceeded to experience multiple organ failure and died on April 11, 2021

Immediate onset with pre-syncope. Persistent profound fatigue, diaphoresis, nausea, foggy, weak legs, muscle aches. Improving after 8 days.

FEELING VERY TIRED/ FATIGUE; DIDN'T SLEEP THROUGH THE NIGHT; BODY ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a consumer concerned a 50 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 207A21A 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 didn't sleep through the night. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced feeling very tired/ fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 10-APR-2021, had not recovered from headache, fever, body aches, and feeling very tired/ fatigue, and the outcome of didn't sleep through the night was not reported. This report was non-serious.

CHILLS; LACK OF SLEEP; TIRED FROM LACK OF SLEEP; This spontaneous report received from a patient concerned a 50 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 09-APR-2021 12:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced tired from lack of sleep. On 09-APR-2021, the subject experienced lack of sleep. On 09-APR-2021 20:30, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lack of sleep, and chills on 10-APR-2021, and the outcome of tired from lack of sleep was not reported. This report was non-serious.

Pt was admitted to the hospital on 3/31/21 and diagnosed with stroke. Pt states that doctors told him it looked like the stroke may have occurred about one week prior to hospital admission. Pt started experiencing daily headaches after receiving the vaccine, then a couple of days later started experiencing chest tightness, panicky feelings, feeling like he was going to pass out, and some tingling sensation in his hands. Pt states that although he has been released from the hospital, he is still feeling like he is going to pass out multiple times a day and still experiencing tingling in his hands. Pt states that he is still having minor headaches.

Patient was given Janssen vaccine on 05/11/21 at 3:02pm. Patient was asked to be seated for 30 minutes after receiving the vaccine, because he had food allergies. Immediately after administration, patient started complaining he felt dizzy. Pharmacist checked patient's vitals. Pulse was at 46. He was sweating profusely, drowsy, dizzy, not coherent, tingling in right hand, trouble seeing, blacking out. Paramedics were called to the scene by pharmacy technician. Upon arrival, they also checked his blood pressure, pulse, and blood glucose. Patient refused to go to hospital and signed a form provided by EMS. Before leaving, patient was alert and able to walk and carry a conversation on his own.

I started having random hives all over my body with severe itching about a month after the vaccine. It made me highly uncomfortable to where I was unable to go outside. I never had hives before. These were very unusual and happened at random times, at night, in the morning, when outside, in the afternoon at home. There was no common theme to these. I had to shower multiple times a day to get some relief but was short-lived.

?Janssen COVID-19 Vaccine EUA? Severe shoulder pain at injection site in muscle and joint that has worsened over time. Currently unable to sleep because of pain.

Pt was vaccinated with the Johnson and Johnson Vaccine on 5/3/21. he presented to the emergency room with a stroke on 5/15/2021. 50-year-old male presents emergency department with difficulty finding words and difficulty getting his hands to do what he wants. Last known normal was 1030 the previous night when he went to bed. He has a past medical hx sign for controlled HTN, seasonal allergies and obesity with a bmi of 48. Family members noticed him having difficulty finding words the morning of admission and it got slightly worse throughout the day. According to his wife he was holding the phone and could not dial the right numbers. His hands were working but they could not follow instructions from what his brain wanted to do. On evaluation the patient felt as though he was stuttering and could not get the right words. No numbness or tingling. No weakness on one side or the other. wife and pt reported no prior problems with word finding or memory in the past and other than obesity and controlled HTN he was healthy. He does not smoke. he had no prior hx of atrial fibrillation. telemetry monitoring showed no atrial fibrillation. His LDL was 109, chol 167,trig 119, hdl 34. No prior hx of covid 19 infection. echo with normal EF, no thrombus. He received Physicial therapy and Occupational therapy and speech therapy. He was discharged home on 5/17 on an aspirin. He was called on 5/22 and is still experiencing expressive aphasia and word finding difficulty. He previously worked full time as a machinist and has not been able to go back to work. He is also complaining of fatigue still.

Severe headache for 48 hours Mild headache for one week Severe fatigue for 48 hours Fatigue for one week Loss of appetite for 24 hours Night sweats and low grade fever for 72 hours Loss of concentration for one week

After receiving vaccination patient became incoherent, began having difficulty breathing and was audibly wheezing. Skin became extremely pale. Epinephrine was administered and 911 was called. EMS evaluated the patient and patient declined further medical attention.

left shoulder pain immediate but expected some...thought little odd got the shot more in back part of shoulder than upper arm.....pain from shot hurt more than any flu shot I ever got.......would not go away...had to stop lifting light weights after about 9 days, still did not go away, putting on and taking of shirts hurt, sleeping movement hurt in shoulder, was not getting better so saw ortho on 5/19...ortho prescribed 9 advil a day, ice and volentrane ...if not better in 2-3 weeks come back and will take next step...in between that now....pain less cause advil but feel not getting better and will probably see dr again ....have not lifted weights since ( I can't read hand writing exactly for lot#

After receiving Janssen vaccine, I experienced feelings of fatigue, ringing in ears, blurry vision, migraine type headaches. I had not suffered from any of these symptoms prior to the vaccine. On 6/2/21, I was feeling similar symptoms, and particularly a severe headache and some fatigue. I was driving to the gym, to see if perhaps, doing a little walking or exercising may make me feel better, when I experienced a seizure while driving, lost control of vehicle and ended up, off the road and hit a tree, I do not remember anything from the crash. I awoke in an ambulance, and was taken by helicopter to Hospital. I received emergency care and was admitted to the hospital.

Patient said they were passed out and blacked out for couple times while he was in his chair. Patient looked disoriented and sweating. We asked if he would require medical attention and he said yes. We gave him water to hydrate himself. Fire dept. came in and took a look. He did not require hospitalization as he was fine afterwards.

I received the inoculation against the SARS-CoV-2 at around 9:40 a.m., CDT as of FRI., Jun. 11, 2021. Later that night, at approximately 12:00 a.m., CDT, as of SAT., Jun. 12, 2021, I began experiencing what I feel to be adverse side-effects due to the inoculation I received earlier in the day. I began experiencing sharp pain in the brain, due to pressure in a blood-vessel in the brain, as if a blood-vessel in the brain were being clenched due to a blockage, and I also experienced a narcotic-like "high", due to the fact the inoculation, i.e., the Covid-19 vaccine, includes in its formula of chemical compounds a narcotic which sedates the nervous-system as a narcotic would do, such as alcohol. My view is due to the fact the vaccine never underwent proper FDA-approval, the vaccine will incur serious side-effects in individuals receiving the inoculation form healthcare professionals which did not result in clinical studies in patients receiving the vaccination in clinical trials prior to its introduction to the public, due to the fact the company did not have the time necessary to determine as to whether or not the vaccine would adversely effect individuals receiving it in certain sectors of the population. The company failed to factor in all necessary factors in the test population of vaccine recipients in tis phase of clinical trials, hence, the vaccine, could prove to have serious side-effects on certain members of the population. And the vaccine itself might prove to have long-term side-effects for patients receive the inoculation which will only be discovered in years to come, as these health issues emerge in recipients of the dosages, if the vaccine indeed proves to have an adverse effect on any individuals health-status.

I received the vaccination at approximately 09:40 a.m., as of FRI., Jun. 11, 2021. Later that night, at approximately 12:00 a.m., CDT, Jun. 12, 2021, I began experiencing what I would deem to be adverse side-effects due to the injection of the Janssen Covid-19 vaccine I received at the health-clinic earlier in the day from the healthcare-staffer onsite. I began suffering sharp pain in the head due to what appeared to be the clenching of a blood-vessel in the brain, as if I were experiencing a blockage, or blood-clotting in a blood-vessel in the brain, due to the injection of the Janssen Covid-19 vaccine which I received earlier in the day at the health-clinic building. I also, began experiencing chest pains on that night due to, again, what I trust would have been the injection of the Janssen Covid-19 vaccine at the health-care building by an onsite-agent administering the inoculation on my behalf. I also began to experience what appeared to be a "narcotic"-like stimulation of the central nervous-system due to a a particular chemical-compound appearing in the formula in use by manufactures to develop the vaccine itself. I experienced what to me appeared to be a "narcotic"-like high as one would experience after consuming a substance high in narcotic-content, such as cocaine or alcohol, which triggered a stimulation, as I said, of the central nervous-system on that occasion. Such side-effects are due to the fact the manufacturers in developing the inoculation did not utilize a wide sample-population for study in clinical trials of the dosage in order to determine side-effects caused by the vaccine in certain members of the population who could have an adverse reaction to the formula of chemical compounds appearing in the medication due to its effect on them physiologically. I.e., the need to quickly introduce an antiviral inoculation into the marketplace put pressure on the manufacturers to disregard lengthy clinical trials which would prove the vaccine to have very negative side-effects on certain members of the population who receive it as a vaccination against Covid-19.

PAIN IN THE RIGHT LUNG; DID NOT SLEEP WELL; FELT LIKE ON FIRE; FELT DOWN; CHILLS/FEELING COLD; SWEATY FEVER; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included chemical exposure, and concurrent conditions included morphine allergy, smoker, and chantix allergy, and other pre-existing medical conditions included patient said that the symptoms were similar to what he experienced in 25-JAN-2020, he thinks that he might have had covid back then, he thinks he was asymptomatic and didn't take covid test. The patient experienced drug allergy when treated with varenicline tartrate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, one total administered on left arm on 22-JUN-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the patient experienced sweaty fever, felt like on fire, felt down, chills/feeling cold and On 23-JUN-2021, the patient experienced pain in the right lung and did not sleep well. Laboratory data included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty fever, on 23-JUN-2021, was recovering from chills/feeling cold, and pain in the right lung, and the outcome of did not sleep well, felt down and felt like on fire was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210651442-Covid-19 vaccine ad26.cov2.s-Sweaty fever. 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).

Within two weeks of vaccination: energy level down, muscle ache, diarrhea, congestion, extra gas (intestinal). Ongoing: extra gas (intestinal); cold flashes that course quickly through body; tingling in arms, hands (like a buzz or very fine pins and needles); irritability; itchiness (upper body, face and head); numbness on front of tongue; stiff finger joints; brain fog; quick onset of fatigue; sudden faint feeling; feeling of weakness in muscles; bruise on right upper arm which remained for a couple weeks; apparent reduced allergen/pollen resistance. Also, it seems I may now be having novel allergic reactions to peanuts. I had long consumed peanuts and peanut butter without incident before taking the vaccine.

migraines, vision issues within 12 hrs. On 4-29 I had a TIA (complete loss of right side and couldnt speak for 10 min). I went to hospital and had CT, ekg, blood work, all were ok. Cardiologist determined I did have a TIA and after an Echocardiogram discovered a Patent Ovale Foramen (hole in heart) and recommended immediate closure. Surgeon also said to get the procedure but as of now my insurance has not approved payment. I have been having numbness and pain in hands and feet (mostly left side) along with vision issues, dizzyness, problem finding words and concentration, fatigue. I went to Hospital again on 6-27 due to pain and numbness in left hand and foot and doctor said he could admit me but I did'nt stay. I have gone from a healthy person who is very active to someone who is always tired and is constantly worried about having another TIA.

RIGHT HAND FELT GREASY AND THEN FELT STICKY NEED TO CLEAN HAND SEVERAL TIMES A DAY; INSECURE FEELING DUE TO MUSCLE WEAKNESS (DIFFICULT TO TAKE A DECISION TO WALK FROM THE DINING TABLE TO THE BATHROOM OR OTHER AREAS); WEAKNESS INVOLVING WHOLE BODY; HAD PROBLEMS WHILE SPEAKING; RIGHT HAND AND LEG NUMBNESS; PARALYSIS RIGHT HALF OF THE BODY; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included back injury, and pain due to back injury, and concurrent conditions included symptoms of covid-19 (runny nose). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: unknown) dose was not reported, 1 total administered on 03-JUN-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, at 21: 30 the patient experienced paralysis right half of the body and paralysis of the right leg. Did not feel any pain of previous back injury once the paralysis happened. On 16-JUN-2021, at 05:30- 06 the patient had problems while speaking, right hand and leg numbness and at unspecified time patient had trouble walking, hesitate difficult to get up from the couch or bed, insecure feeling due to muscle weakness (difficult to take a decision to walk from the dining table to the bathroom or other areas), tongue numbness, right arm weakness and sometimes left arm weakness and weakness that started on the right side and then involving whole body. On 19-JUN-2021, the patient felt right hand greasy and then felt sticky need to clean hand several times a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paralysis right half of the body, and paralysis of the right leg on 15-JUN-2021 lasted about 15 minutes, and had not recovered from had problems while speaking, weakness that started on the right side and then involving whole body, trouble walking, right hand and leg numbness, right hand felt greasy and then felt sticky need to clean hand several times a day, hesitate difficult to get up from the couch or bed, insecure feeling due to muscle weakness (difficult to take a decision to walk from the dining table to the bathroom or other areas), right arm weakness and sometimes left arm weakness, and tongue numbness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210731397-covid-19 vaccine ad26.cov2.s-Hemiplegia. 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).

5-6 hours after the shot I got chills and could not get warm. I went to bed and had mild aches and had to wear a jacket to keep warm. Woke up 4am because could not sleep and was ok with only mild aches

Chills, Fever (101.0), Achy, Sore muscles, Stiffness, injection site pain, mental fuzziness, Headache

2 hours after vaccination I noticed left arm started hurting . Went to bed at my usual time and woke up at 2:00 am with the chills I could not get warm late that night around 5:00 am I started having joint pain and fatigue with a headache and hot skin. I had taken my temperature and it was 100.7. I tried to wait out symptoms but I seem to bee get worse throughout the morning. Around 10:00 am I was in terrible pain and my body hurt all over. I once again took my temperature and it had gone up to 101.9. I had to call of work because I was so ?out of it?. I started taking Tylenol ever 4 hrs for my fever and I was trying to hydrate. My temperature slowly went down but still had body pain. I then started thank ibuprofen to help. Later that night around 9:00 pm my temperature was 99. The next day I called off work for fatigue and body pain. Today my temperature is normal and I?m starting to feel like my self again

March 17 at 6pm - Experienced chills and fatigue. March 17, during the evening - experienced pain in left arm, right arm, nausea, chills, hot flashes, restless feeling, unable to get comfortable to get to sleep. Woke up several times during the night. Woke up, took up to 4 Tylenol, still could not sleep. March 18 - Woke up - Fatigued, dry mouth, and in a fog. All I wanted to do was sleep. This is what I ended up doing most of the day. By the end of the day, felt a little better. March 19th - Feeling a little better, but still weak, but still somewhat dizzy. March 20th - Same as the 19th. March 21st - Finally feel 80 - 100% better.

Chills on the same day starting approximately 9 hours after vaccine injection. Little to no sleep that same night. Very restless, tossing and turning, not tired - very awake (which is unusual). Next morning, arose at 5am with moderate chills, moderate all over body aches, and moderate headache - very symptomatic of the regular flu. Felt bad enough to call out of work. As of this moment, roughly 33 hours later, it seems to be subsiding, but unsure if that's just the Advil. * Note: Vaccine is "Janssen COVID-19 Vaccine EUA Lot # 1805031 administered.

Patient became anxious and passed out. ambulance called and performed evaluation of patient at that time he informed EMT that this had happened with previous vaccine

The night of the vaccine I could not go to sleep. I was up all night. Insomnia. My wife had the vaccine the same day also and had the same side effect.

Almost immediately I felt extremely dizzy and lightheaded. Which put me in a state of panic. I did not ask for medical treatment. I will say that the typical side effect from this vaccine is very intense and should be looked at further. I was alarmed to say the least.

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium

Slight fatigue in the afternoon. Was a little chilled at 10PM. At midnight, I had severe chills and could not get warm. Around 1:00 AM, I had fever followed by sweats. Then more chills and fever and sweats. Then more chills and fever and sweats. Symptoms were gone by morning except for fatigue that could have been from lack of sleep. Was tired most of that day (day after shot). Had slight chills and sweats the next night. By morning two (3/27. shot was received on 3/25) symptoms were gone.

At 10 pm I had the chills and went to bed earlier than I normally do. Around 2 am, I was experiencing an irregular and racing heartbeat. My resting heartbeat is normally around 68 to 70. When monitoring my heartbeat through my Watch, I experience a heart rate of 100 to 120 beats per minute and I could feel it was irregular too. I had a very restless night, elected not to go to the ER and the symptoms were gone by about noon, although I did have a terrible headache all morning long.

The day of the shot my lips and tongue were numb until the next morning. The next couple of weeks my tongue would go numb often. I was also feeling tired and unsteady. 12 days after the shot I became very sick for 10 days with severe diarrhea, no energy, stomach pains, weak, shaking, no more motivation. I saw a doctor and was given antibiotics to stop the diarrhea. Now 1 month after I have no diarrhea but still get nausea and shakes . I feel very anxious and will see a therapist and prescribe medication for my anxiety that I have due to the vaccine reaction. I took the vaccine so I can travel abroad much easier but now afraid to travel because of my symptoms. I will get blood tested tomorrow to see if all is ok. This vaccine is very dangerous as it has affected my DNA.

HIGH BLOOD PRESSURE; SLIGHTLY DISORIENTED FROM THE SHOT; FELT ANTSY TO GO FOR WALK; This spontaneous report received from a patient concerned a 51 year old white, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure monitoring, overweight, non-smoker, and no alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 in morning, the patient reported his blood pressure was 170/100 which he felt high for him. It was stated that, usually patient's blood pressure was 125-138 systolic blood pressure. On 10-APR-2021, when he first woke up in the morning patient measured his blood pressure as 109/75 and was therefore concerned about the increase. Patient visited physician office for high blood pressure. Patient felt slightly disoriented since he received vaccination and felt antsy to go for a walk. It was stated that patient did not have any fever and felt okay. Laboratory data included: Blood pressure (NR: not provided) 170/100, 109/75. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 125-138 systolic blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure, slightly disoriented from the shot, and felt antsy to go for walk. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210421042-covid-19 vaccine ad26.cov2. s-High blood pressure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Patient presented on 4/21 with 2 weeks of generalized fatigue, abdominal pain, and weight loss with multiple lab derangements concerning for acute liver failure. Patient on 4/22 is tachycardic and change in mental status. Acute liver failure likely due alcoholic hepatitis. Cholestatic etiologies will be considered. Acetaminophen toxicity treated with acetylcysteine. Started on methylprednisolone 32 mg daily. RUQ: biliary sludge within gallbladder. No sonographic evidence of acute cholecystitis. Acute respiratory failure secondary to COVID pneumonia. Chest pain and elevated troponins. Alcohol withdrawal on treatment protocol. Sepsis and Community acquired pneumonia. Thrombocytopenia and elevated INR. Macrocytic anemia and AKI.

Headache Confusion/Lethargy Dysarthria and Ataxia Subsequent presentation to ER and Admission to medical ICU (see below)

Approximately 10-11 hours after receiving the vaccine injection I developed severe flu like symptoms. I developed a fever of 102 F, a headache, chills and severe joint and muscle pain. The majority of the symptoms resolved within 36 hours of onset but I am still experience severe joint and muscle pains, headaches, fatique/exhaustion and difficulty thinking clearly.

FELT LIKE CRAP; CHILLS; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 51 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: 043A21A, expiry: 21/JUN/2021) dose was not reported, administered on 07-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced felt like crap. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced low grade fever. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like crap, chills, low grade fever, and headache. This report was non-serious.

R41.82 - Altered mental status R53.1 - Left-sided weakness R47.9 - Speech difficult to understand I63.9 - Cerebral infarction, unspecified

Patient presented to hospital on 4/23 after experiencing stroke-like symptoms the evening of 4/22. Symptoms included slurred speech, confusion, and repetitive grasping of his L hand. Patient was diagnosed with DM2 and HTN during his hospital admit, but had not previously received treatment.

(@ hr 12 Nausea, Fever) (@ hr 24 Mental Confusion) The mental confusion was concerning enough to prompt this report. I could not remember where I got the vaccine. I could not remember where my son lived. Once a friend reminded me I remembered but still struggled with details for about one and one half hour.

SHORTNESS OF BREATH; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 51 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: 1808609, expiry: 09/JUN/2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced shortness of breath. On 09-APR-2021, the subject experienced trouble sleeping. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Signs of Pneumonia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and trouble sleeping. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Intense headaches, back and hip pain and right arm pain. The pain got so bad and lasted for a few months ultimately landing me in the Emergency Room for 3 visits in 2 days. I also had Bells Palsy. They were pumping me full of morphine and it did not take away the pain. Treatment was pain management - vicodin and prednisone for the bells palsy. Severe pain is gone , but now have joint pain, weird skin sensations and dealing with fatigue and some depression. This is vaccine related - I had no issues with any of this prior to the shot.

Light headedness, Muddy thinking Ringing ears Difficulty concentrating Sleep disruption Depression Irritability General feeling of being unwell

Had the expected fever within 24hrs which okay. But 5 days later out of the blue I felt shaky, disoriented, sweats, fatigued hardly had the energy to stand or even speak, I was fearing I was having some kind of heart attack or stroke. Something in my body was telling me something was very wrong, I have never had a feeling like this before in my life it was pretty scary. I went to a place to be alone and sit since I could hardly stand, I sat for an hour and started to feel some relief. It took almost 4 hours until some sense of normal was back. I came home and went to sleep for the event tired me out immensely. Since that days event and still ongoing I have been having random dizzy spells, I have days with absolutely not enough energy to walk out of bed and have called out of work because of it. I get the feeling I am unplugged and then plugged back in as far as energy goes almost every day. I have worse and better days with that. About 2 to 3 times a week I experience sudden pains and tingling that can go anywhere on my body but seems to focus more on all my extremities and back. Feels like fire/pins/needles and it stays with me for a few hours to an entire day the pain ranges from a 5 to an 8. My legs feel stiff every day now and at times sore yet I have done nothing exertive to cause that. With the stiffness I have trouble getting my shoes and socks on, and getting up from sitting. All these symptoms I didnt have until I took the shot.

Shot was given at max vaccination site in a shopping mall store. Shot was given in upper rear of shoulder. Continuing shoulder pain that got gradually worse over time. Pain also eventually felt from shoulder down arm. Restricted range of motion. Affects daily activities and ability to sleep. .

BELL'S PALSY; AFFECTING ABILITY TO THINK CLEARLY; DEPRIVATION OF SLEEP; PAIN IN THE BACK; TINGLING SENSATION OVER THE BODY BUT MORE IN THE EXTREMITIES; PERCEPTION OF HEAT AND COLD REVERSED OR DELAYED; MIGRAINE HEADACHES; MUSCLE WEAKNESS IN THIGHS AND LOWER BACK; CONTINUOUSLY EXHAUSTED WHICH IS AFFECTING ABILITY TO THINK CLEARLY; MUSCLES PAIN IN THE THIGHS AND LOWER BACK; This spontaneous report received from a patient via a company representative concerned a 52 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: unknown) dose was not reported, 1 total, administered on 11-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. After several weeks of vaccination on an unspecified date, the patient developed muscle pain and muscle weakness in his thighs and lower back, and the pain extended to his back. Patient experienced tingling sensation over the body but more in the extremities. He experienced perception of heat and cold reversed or delayed. The development migraine headaches increased dramatically, but as per reporter it was possible to had consequence of exhaustion from being sleep deprived. While brushing teeth patient discovered that he had partial paralysis of the left side of face and he was unable to spit, purse his lips, whistle, smile, twitch nose, or raise his eyebrow and the face area was mostly numb. Patient went to emergency room and where he had been told that he had Bell's palsy, but they did not know what to think about the non-facial symptoms and asked him to see a neurologist. The patient was prescribed with prednisone and an antiviral. By the end of the same day, he lost most sense of taste. Patient later saw a neurologist who ordered Magnetic resonance imaging (MRIs) of brain, sinuses, and upper spine to look for signs of neuronal demyelination, but there were not any significant findings. During follow up appointment on 15-JUL-2021 with the neurologist, they discussed potential association between vaccine and Guillain barre syndrome. He ordered patient to do nerve conduction test to look for evidence of peripheral nerve damage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the back, and muscles pain in the thighs and lower back, had not recovered from deprivation of sleep, tingling sensation over the body but more in the extremities, bell's palsy, lost most sense of taste, continuously exhausted which was affecting ability to think clearly, and muscle weakness in thighs and lower back, and the outcome of perception of heat and cold reversed or delayed and migraine headaches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210739148-COVID-19 VACCINE AD26.COV2.S -Bell's palsy and affecting ability to think clearly. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

nausea set in that night, sleepless night, pain in joints, nausea and pain in joints is continuing the day after.

J&J vaccine, Monday at noon. About 6 1/2 hrs later I got bad chills & severe shaking, temp dropped low. Then had severe diarrhea & vomiting for the nxt 12 hrs. Temp also went up to 102.5, body aches & severe fatigue. Tues morning I had to call online dr for prescription nausea meds. Then got a bad headache. Then wed, thurs & fri he just felt like i?d been hit by a truck. Was still foggy headed yesterday. Today I feel tired out easily.

FELT BILATERAL LUNG CONGESTION (Lung congestion, Pulmonary congestion) BILATERAL SIDE PAIN (Flank pain, Flank pain) VOMITING (Vomiting, Vomiting) LEFT ARM PAIN (Painful L arm, Pain in extremity) DIFFICULTY BREATHING (Difficulty breathing, Dyspnoea) MISSED WORK TODAY (Loss of personal independence in daily activities, Loss of personal independence in daily activities) PAIN WHEN BREATHS (Painful respiration, Painful respiration) FEVER OF 100 F (Fever, Pyrexia) FATIGUE (Fatigue, Fatigue) This spontaneous report received from a patient concerned a 52 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, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021 (mentioned as yesterday), the symptoms of the patient started, and he missed work today (loss of personal independence in daily activities) and left arm pain (painful L arm) because he was not feeling well. The reporter advised him to contact his primary care provider, but he said he called and they are not able to see him without an appointment also advised him to seek medical attention by going to the emergency room. The patient agrees to go to the Emergency Room. On 11-MAR-2021, the patient experienced bilateral side pain (flank pain) , vomiting, felt bilateral lung congestion (lung congestion), difficulty breathing, fever of 100 F, fatigue, pain when breaths (painful respiration) . Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 100 f, had not recovered from bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, and pain when breaths, and the outcome of missed work today was not reported. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, pain when breaths, fever f 100 f and missed work today as possible. Company causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, pain when breaths, fever of 100 f and of missed work today as possible. This report was serious (Other Medically Important Condition).

Feverish chills and vomiting on day 1. On 4/1/21 at 1:00 am patient fainted and had incoherent speech and then went ?lights out? for less than a minute. He was taken to ER. They gave him fluids anti nausea medicine and ran many blood tests. Patient still feeling dizzy and groggy on day 2

Patient started sweating and said he felt he was burning up about 13 minutes post vaccination. He was slightly disoriented. We quickly checked his temperature however it was within normal range. We applied cold packs to his wrists, forehead, and face for about 12 minutes. I checked for normal capillary refill and asked him questions to assess his mental status. About 20 minutes after starting the treatment, patient started improving. He returned almost back to normal in about 30 minutes.

Started not feeling well, then some headache. Could not sleep well and woke up with congestion, body pain, headache. Woke up in the morning and had chills. During the day I continued feeling headache and general discomfort and tiredness. I got an Advil and It is helping so far. I am still in the middle of this process. Nothing I cannot tolerate. I know I have a very sensitive immune system that reacts to any minimal aggression. to my system. I trust J&J and I want to provide this information to help with the statistics.

I was fine Saturday after the shot. Sunday I was completely enervated. I had a bad headache and zero energy and a little bit of nausea. I started feeling better around 6:00 pm, but went to bed at 8:30 pm and slept 9 hours (which is very long for me).

Mild to medium fever for approximately 5 hours. I was attempting to sleep at onset of fever and had difficulty sleeping.

CHILLS WITH SEVERE TREMORS/CONVULSIONS . EXTREME HEADACHE AND DEHYDRATION. DISORIENTATION. CONTINUED OCCASIONAL CHILLS

3/30/21, Tue. Got up and felt dizzy. Went to bed a few times to have a sleep. 3/31/21, Wed. Got up and felt better. Went to work but felt no idea of work related material. 4/1/21, Thu. Got up and felt good, but could not speak too much because of some loss of words. Called for PTO for Thu and Fri. 4/2/21, Fri. Mindset went back but still could not speak too much. 4/2/21, Fri night. After bible study at night, almost all bro & sis said that was symptom of stroke, and suggested us to see emergency doctor. On 11pm, we were at emergency room. 4/3/21, Sat. I was admitted 1-2 am into impatience room. CT diagnosed a big gray area in between speech are and spine. 4/3/21, Sat afternoon. MRI and MRA had been tested. Cardiologist said he could not rule out the last option, which was due to slow heart beat 50-60. But I have slow heart beat since I remembered things from 4-5 year-old. He suggested wearing a heart monitoring device for a 4 weeks after discharged. 4/4/21, Sun noon. Doctor admitted to discharge. They could not find cause, and would like to follow up within 1 to 2 weeks after discharging. 4/13/21, Tue night, I started wiring body monitoring device.

RESTLESSNESS; FEVER; ACHY THROUGHOUT THE BODY; HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pre-diabetic, hypertensive, and rheumatoid arthritis, 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: 1808978 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 achy throughout the body. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced restlessness. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from restlessness on 10-APR-2021, and fever on 12-APR-2021, was recovering from headache, and had not recovered from fatigue, and achy throughout the body. This report was non-serious.

Severe headache. Full head headache, not a simple sinus headache. I felt like I was hungover. Lasted for 2 days. Tylenol, Advil both helped. Pushed fluids to make sure I was not dehydrated. Had some coffee to make sure it wasn't caffeine withdrawal. Headache became less severe over time. By the third day it was pretty much gone. Possibly unrelated, starting 04/11/2021 through 04/15/2021 I had severe insomnia. I could not sleep longer than 1-2 hours. Very active mentally while trying to fall asleep. My brain was constantly churning over thoughts, emotions, work, not work, etc. I struggled to just calm my head and go to sleep. The night of 04/15/2021 I slept 3.5 hours. I was very physically active on 04/16/2021 and slept 10 hours that night (last night). Active today, but back to having trouble going to sleep.

Onset with severe headache, nausea, diarrhea, vomiting, shortness of breath, difficulty concentrating from 4/3 -4/8. Went to urgent Care on 4/8 where treated for severe dehydration and stomach aligment. From 4/9 - 4/14 continued to suffer from same symptoms and then began to have heart taching, feeling as if there was a bubble in my chest. Went back to Urgent Care on 4/14 and was again treated for dehydration. Outcome is that no one knows why I have been feeling this way except for that it is a direct result of receiving the vaccine.

COVID 19 PNEUMONIA; BAD FEELING; VERY CONFUSED; DOING THINGS THAT WERE NOT NORMAL; This spontaneous report received from a consumer via social media concerned a 52 year old Hispanic or Latino 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 06-MAR-2021 for prophylactic vaccination. The batch number was not reported ,per procedure no follow will be requested for this case.No concomitant medications were reported. On an unspecified date, the patient was very confused and doing things that were not normal (coded- abnormal behaviour). On an unspecified day in APR-2021, the patient experienced bad feeling, had a sore throat, stuffy, coughing, fever, feel fatigue and chills (subsumed under covid-19 pneumonia). On 01-APR-2021 the patient tested positive for Covid-19 and advised to quarantined for 10 days. The patient experienced difficulty breathing (subsumed under covid-19 pneumonia) and condition worsened and call for ambulance. The patient treated with oxygen and admitted to hospital via ambulance. The patient was in critical condition and hospitalized and treated for pneumonia. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid 19 pneumonia, bad feeling, very confused and doing things that were not normal was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is linked to AER No. 20210439435, same reporter.; Sender's Comments: 20210424004-covid-19 vaccine ad26.cov2.s-COVID 19 Pneumonia. 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).

Rash on arm, then bad headaches, real bad headaches, When driving this last Monday. I would pass out at the wheel. At least 4 times I jumped the median. Got lost in a nearby neighborhood. Once I figured out what was going on I went straight home.

Roughly 21 hours after vaccine was administered: Fever 100.3, Chills, Sweats, Extreme Fatigue Treated with Tylenol 500ml every 6 hours. Felt better the next day after sleeping most of the day after vaccine administered. As of 4/28 still experiencing extreme fatigue randomly/ previously not experienced Very active, goes to gym every day, eats healthy otherwise.

7:00 pm feeling tired 8:30 pm forehead warm to touch but thermometer said temp normal. Went to bed. 10:40 pm, cannot sleep, 99.7 temp, headache, chills, warm, nausea. Brain constantly active therefore unable to distract to go to sleep 2 am head cool to touch, no covers, very warm 3 am started getting little bursts of sleep 4 am slept, not soundly, until 8 am

Patient became sleepy, light-headed, and confused within minutes after vaccination. He was nodding off in the observation area. He was difficult to wake up and confused when he did. We called 911 and paramedics came to check him out. They monitored his blood pressure and pulse. His pulse was high (120-130bpm), so they thought it would be best to take him to the hospital so he can be checked out.

Patient became dizzy after receiving vaccine and at the five minute mark, patient became unresponsive. His eyes rolled back in his head but stayed open. His jaw became very clinched. He was sweating profusely and not aware of anything goin g on around him. This lasted somewhere between 3-5 minutes.

Tinnitus in left ear started the Monday after the vaccination, I have also had what I can only describe as "fuzzy brain" indicated by a difficulty concentrating on complex projects. I have also been experience intermittent headaches and pressure in my head. My left eye started watering and feeling irritated.

Within 2 minutes of receiving vaccine, patient became hypotensive, diaphoretic, pale, altered consciousness. Recovered within 35 minutes after monitoring

Patient presented to the pharmacy today 06/26/21 with a rash that started about 4 days after the vaccine was administered which was on 06/08/21. He also says that he has some radiating pain that wakes him up at night on the same arm and his arm feels hot. I recommended diphenhydramine at night to help him with the rash.

Customer did not feel right within 7-10 mins after receving the Janssen vaccine. He complained of vision changes, "seeing dots". When he tried to walk, his legs buckled, but customer was slowly assisted to the floor. While on the floor, my technician heard grunting noises coming from him and his left arm was rigid and bent at the elbow. But within 5-10 seconds, he slowly sat up and said that he "doesn't remember being on the fall" and complained of being sweaty and "seeing dots". Paramedics were contacted and took him the hospital. Contacted the customer later in the evening and was informed that he was resting at home after spending half of the day in the hospital. He mentioned that the paramedics treated him with Epipen and bendadryl and then he felt better. He was treated "other things" but don't recall.

5/15: Two days after vaccine: feelings of paranoia, unable to complete work, up all night, had to miss two days work. 6/18: Feelings of numbness on right side (hand, foot) while going through security at Airport. Weakness in right leg. 6/23: Went to urgent care facility. Was told it sounded like a stroke, sent to hospital for treatment. After imaging at hospital patient was told he had a minor stroke.

2 weeks from the day of the vaccination, 04/16/2021, I had heavy ringing in my ears, started feeling vertigo, nausea, dizziness and lightheadedness and just started persisting on ever since. At least 2 weeks after that, I was trying to wait it out, but it persisted on and I made a tele-doc appointment. The tele-doc prescribed me Prednisone. The tele-doc felt it might go away but set me up with an ENT. A week after that I saw the ENT. The ENT did a hearing test but didn't find anything. I am still having the Nausea and ear ringing, they are the 2 most persisting symptoms. I feel it's pretty detrimental to my quantity of life. I just try to keep going and tolerate the symptoms as much as possible.

Within an hour to two after my vaccine I felt extremely exhausted. The next day (Thursday), I couldn't read anything. For the whole weekend I could not read anything. Not blurry vision, just could not read. Also on Thursday, I started to not be able to concentrate. To this day I still have trouble concentrating. I also experience dizziness after my vaccine. For the next two weeks I have had bad bout's of just feeling swimmy and weird. It has made me stay close to bed. I have been unable to do projects, I have had multiple migraines. For treatment, I have taken muscle relaxers and my migraine medicine as needed. I am going to see Dr. on 07/14/2021. I did see a doctor during a health fair on 07/09/2021 who recommended I see my doctor as soon as possible.

Neuropathy, painful burning sensation in feet, restless leg has gotten worse and is all day long. Painful electric shock type pains from feet up calf muscles. Sensation of no circulation in legs when elevated in recliner. Stumbling/tripping, lack of coordination and balance issues. Lack of mental clarity at times. Heart palpitations or PVC sensations. Difficulty urinating, in that the flow stops and starts as if I'm involuntarily doing Koegle exercises.

FEELING TINGLING IN RIGHT LEG AND LEFT KNEE/ TINGLING MOVED TO THIGH AREA, STOMACH AND CHEST; FEELING WEIRD AFTER EACH EPISODE OF TINGLING AND WEAKNESS; FEELING WEAKNESS IN RIGHT LEG AND LEFT KNEE/ WEAKNESS MOVED TO THIGH AREA, STOMACH, AND CHEST; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pre diabetes, and other pre-existing medical conditions included he had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced feeling tingling in right leg and left knee/ tingling moved to thigh area, stomach and chest. On MAY-2021, the subject experienced feeling weird after each episode of tingling and weakness. On MAY-2021, the subject experienced feeling weakness in right leg and left knee/ weakness moved to thigh area, stomach, and chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tingling in right leg and left knee/ tingling moved to thigh area, stomach and chest, feeling weird after each episode of tingling and weakness, and feeling weakness in right leg and left knee/ weakness moved to thigh area, stomach, and chest. This report was non-serious.

The morning after he received his vaccine he started feeling sick and then started to run a temperature. By evening his temperature was 102.9. Then the seizures started, first his "left" hand up his arm and down his left side. His right hand and arm was shaking rapidly. His left leg stiffened and his toes pointed down and then the seizure traveled to his right side. He remained conscious but somewhat dazed. This went on all night. By 10:00 the next day, Thursday the seizures stopped. His temperature went back to normal Friday morning.

1) immediate pain 1/2 through injection - fully dissipated within 5 minutes. Felt great all day. 2) Fever conditions (chills, body aches) about 10 hours later and pain in both shoulders that evening (difficulty sleeping). Next day feeling lethargic due to rough night`sleeping (?) and/or body's response to vaccine

Vaccine administered at noon on 3/14/21. Felt fine until 7;30 pm, suddenly became very tired, went to bed. By 9pm, experienced severe chills, by 1:00 am, had fever of 101.3, fever down to 99 by 8 am following morning. On 3/15/21, temp stayed normal, had mild headache and was just tired most likely due to lack of sleep.

Swelling and pain at injection site Itchy and. irritated skin tingling and numbness through body fatigue in both legs and back restlessness

Pain in the legs and feet. Same with my hands and fingers. Fatigue. Night sweats. Unable to sleep. Muscle pain in the back and chest area. This started at bedtime around 11:00 pm, approximately 12 hours after the dose. Symptoms lasted a full 24 hours. Fatigue being the symptom lasting the longest. As of now, all symptoms have subsided.

Fever started around 6:30 pm and progressed to chills and shaking. Took two tylenol, which helped with the chills and shaking. Experienced aches and flu-type sweats throughout the night, with sleep disrupted many times. Recovery staryed the next morning, but took day off of work due to slight headache and lingering slight fever.

Lightheaded about 5 minutes after injection. Medical team took HR and BP and was normal Took about 20 minutes and light headedness went away Later that night at around 12:30 am, felt very cold and shivering with severe headache Did not take temperature Had a hard time going back to sleep Got up around 1:00 am to take 800 mg of OTC Advil When walking back up stairs had severe muscle pain in arms and legs Was fine after that Seemed to get better by 2 am No issues next day About 7-10 days later developed severe frontal headaches/sinus pressure No other symptoms Used Neti Pot with saline solution and did nothing Took OTC allergy meds and Advil and did nothing Say my primary care Dr and he prescribed Flonase, Singular and Allegra + continue Neti Pot and Advil as needed Not much improvement on this regime after 3-5 days of use About a week later developed severe pain in bottom right jaw Took OTC Advil and again no improvement Went to Dentist and said not tooth related but probably TMJD Recommend dental appliance to help with grinding About a few days later after this jaw pain developed, developed sharp stabbing pain in bottom of left knee cap. No recollection of any insult that would cause this All three of these pain sites were perfectly fine prior to getting J&J vaccine. No history of pain or injury to these areas prior All of these incidents to me seem to be inflammatory/immune in nature and could be related to J&J vaccine based upon how I reacted to injection. Curious if others are seeing the same thing and if so what should be done or how long should this last?

about 3 hours after injection i noticed i was flushed neck ears face, about 5 to 6 hours my ears started ringing, trouble sleeping legs pricing over night., 2 degrees elevated temperature from normal. this lasted for almost exactly 24 hours. my leg pain is in the same location as a severe blue of shingles i had two years ago. it is now 96 hours after injection and my legs are still tingling and occasionally feel prickly and painful. this is manifesting into right toes. there is an odd numbness to my right thigh. i was worried somehow i might have triggered another shingles type outbreak.

Patient was scheduled for an appointment for a Johnson &Johnson covid-19 vaccine through a drive thru Thursday April 8, 2021 @12:45pm. We arrived early and he received the vaccine at 12:15pm, waited 30 minutes for reaction and he was feeling fine. Later that same evening, the patient was driving to work on the freeway when he felt a dry throat so he coughed hard, at that cough he felt a massive pain in his head, like his "head was going to explode." He immediately had tunnel vision closing in on him, so he pulled over and later woke up in our parked car with flashing emergency lights on, parked on the shoulder of the freeway. Disoriented and confused why he was there, he looked at his watch and saw he lost 15 minutes when he had passed out. MY HUSBAND COULD HAVE BEEN SERIOUSLY INJURED OR KILLED IF HE HAD NOT PULLED HIMSELF OVER WHEN PASSING OUT. Today we reported this to our doctors office and to you!

NIGHTMARES; TALKING IN HIS SLEEP; RESTLESSNESS AND THRASHING ABOUT/ ASLEEP, HE THRASHES AROUND LIKE FISH OUT OF WATER; NO ENERGY; FEVER; FATIGUE; This spontaneous report received from a consumer concerned a 53 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 02-APR-2021 15:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced nightmares. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced talking in his sleep. On 03-APR-2021, the subject experienced restlessness and thrashing about/ asleep, he thrashes around like fish out of water. On 03-APR-2021, the subject experienced no energy. Laboratory data included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nightmares, fatigue, talking in his sleep, restlessness and thrashing about/ asleep, he thrashes around like fish out of water, and no energy. This report was non-serious.

Lost his vaccine card would not give him a new one. He got his vaccine, had burning sensation immediately after the needle was pulled out. About 5-10 minutes later he started sweating, and seemed to have calmed down and felt OK. He was observed for 30 minutes there and went for observation for another 30 minutes. He went to another doctors office and at about 15:00 started feeling light headed and weak. He drove back home, picked up some stuff at a grocery store, and outside the grocery store in 80 degree heat he felt the need to put on a jacket as he had the chills. he went home, went to bed feeling bad, his shoulder was still burning where he got hte vaccin.e He had a little bit of site pain, applied topical and the pain went away. He woke up the next morning feeling really bad, felt like a major flu, his head felt like it was going to explode, but no problem with sinuses, no cough, no sneezing. His eyes were watering from the pain, and chills on and off. He had to change his sheets a couple of times due to sweating. He then developed a fever of 99 degrees at about 18:00 that night, and about 19:00 he went to 102 when he checked it. After that it went to 103, and about 15 minutes after that it was 104, and then higher at 104.+. He took some vodka, honey and lemon juice and took an alcohol bath and the fever had not broken yet. He called the clinic and they told him to call 9-1- 1 and to go to the ER. He went to the ER at about 10:00, gave him fluids, did a chest x-ray and released him about midnight. He apparently disoriented and tried to walk off and didn't remember this. They took him back to the gate and called his son. He went home, took another bath and woke up in sweat and was in bed for the entire weekend. He got up Monday morning, 4/13/21 feeling a little bit better and went to see his doctor, who does not believe he was having any side effects and that the information that is being reported is true. He is still feeling a little weak and still fatigued and on bedrest. He was taking Advil besides his regular medicines every 6 hours with 500 mg of Tylenol for the intense pain as every joint in his body ached, and the worst headache he had ever had, as well as the high fevers. His fever subsided on Saturday morning, and still had some sweats following that. Did have hot/cold flashes on Saturday and Sunday. He was given a COVID test in the ER and he was negative, but did not give him any other information regarding his lab work.

Bad headache in morning. Very unusual for me. In my eyes. Hard to concentrate on work at computer. After an hour took a short nap and completely went away. Several days before had sharp pain in my calf but thought it could be a muscle cramp. That was also very unusual.

HARDLY MOVE; VERY SORE OR PAIN IN THE ARM; CAN NOT SLEEP; This spontaneous report received from a consumer concerned a 53 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 04-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 can not sleep. On 04-APR-2021, the subject experienced hardly move. On 04-APR-2021, the subject experienced very sore or pain in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very sore or pain in the arm, and hardly move, and the outcome of can not sleep was not reported. This report was non-serious.

I believe this vaccination adversely affected my kidneys. the day after the injection I was drinking lots of water to help overcome the side effects (flu like symptoms) and was not using the bathroom very much and when I did, very little urine would come out. very tired, I went to sleep around 8 PM and by 11 PM woke up because I needed to urinate. several times that night I urinated after waking up with a very full Blatter. this tells me that my kidneys may have been negatively affected and once the flue like systems started to subside the kidneys were returning to normal and clearing out the excess water my body had taken in during the day.

COVID INFECTION; STOMACH GURGLING; BURPING; SLEPT ALL DAY; BRAIN FOG; 2 NIGHTS OF BAD DREAMS; TALKING IN SLEEP; BROKE INTO A SWEAT/ SWEATED TERRIBLY LAST NIGHT; VIVID DREAMS; This spontaneous report received from a patient's wife concerned a 53 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 to right arm on 02-APR-2021 around 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the patient experienced 102.7 fever, some dry cough. Laboratory data included: Body temperature (NR: not provided) 102.7 F. On 04-APR-2021, the patient experienced chills, broke into a sweat and had vivid dreams. Laboratory data included: Body temperature (NR: not provided) 102 F, 101 F. On 05-APR-2021, the patient also had brain fog, two nights of bad dreams, talking in sleep, back pain, fatigue, slept all day. Laboratory data included: Body temperature (NR: not provided) upto 102.7 F. On 06-APR-2021, the patient experienced stomach gurgling, diarrhea, weakness, burping, body ache. Laboratory data included: Body temperature (NR: not provided) 101 F. On 06-APR-2021 03:40, Laboratory data included: Body temperature (NR: not provided) 102 F. On 07-APR-2021, the patient experienced muscle aches, back ache was at level 9, sweated terribly at night and the patient went to urgent care and they did flu test. Laboratory data included: Rapid influenza diagnostic test (NR: not provided) Negative. On 08/Apr-2021, the patient had stomach still gurgling, back ache was at level 9, tiredness, weakness, achiness, brain fog, fever was back at a 100F and diarrhea. On the same day, the patient was tested positive for Covid-19 (coded to confirmed Covid-19 Infection: chills, fever, muscle aches, joint pain, diarrhea, back pain/ back ache, dry cough, fatigue/ tiredness, weakness, and body ache/ achiness). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-Apr-2021 he was hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, Covid infection, stomach gurgling, and broke into a sweat/ sweated terribly last night, and the outcome of 2 nights of bad dreams, talking in sleep, vivid dreams, slept all day and burping was not reported. This report was serious (Hospitalization Caused / Prolonged). Initial information was received on 07-APR-2021. With additional information obtained via telephone follow up from a wife on 15-Apr-2021 case was assessed as serious.; Sender's Comments: 20210413330- Covid-19 vaccine ad26.cov2.s- Covid infection. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

According to his wife, patient received the Janssen COVID-19 vaccine at the Center on a Friday afternoon in March; she could not recall the exact date and could not locate his vaccination card. Several hours later, patient began stuttering and was unable to put his thoughts together. Later that evening, he began experiencing muscle aches, nasal congestion, nausea, and was unable to get out of bed. He took some Advil and by the next morning he felt fine and was back to normal. It should be noted that he died suddenly and unexpectedly on 05/05/2021, and an autopsy showed his death was caused by hypertensive heart disease and cardiomyopathy.

Adverse Events: Tinnitus, Veritgo, Nausea 36 hours post injection there was a significant increase in volume of bilateral tinnitus which has been constant for 40 years with left side being louder and right side occasionally pulsating. Vertigo and nausea also set in 24x7 for the first week before reducing somewhat. Now 3 weeks post injection my tinnitus has increased from what was a volume of 4 out of 10 for 40 years to a solid 7/10. The vertigo is present although not triggering nausea until I am lying on my back looking up in activities such as lying back to read a book, work under a car, read a phone/Kindle device. The increased tinnitus volume has made falling asleep in a quiet room or focusing on my work where I wear a headset for virtual meetings extremely difficult at times.

Best use date recorded by HD as 3 months from receiving. Received on 3-2-2021. Marked to discontinue use on 6-2-2021. Maintained in cold chain management 36 to 46 degrees F. Administered on 6-1-2021 Vial opened for the client. The other 4 doses were discarded at the end of the clinic. On 6-2-2021 an e-mail from DH was noted with expiration of Lot 1802068 on 5-25-2021. Johnson & Johnson was contacted and reported to Pharmacist. Reference ID EZR20210078918(VO) case # 02242111. Client has a Developmental Disability. His guardian (mother) was contacted expiration date reported. The mother states that client c/o sore arm 6-1 with difficulty sleeping. Today he is feeling back to normal. No problems or concerns.

I went to Pharmacy on Aril 10 2021, after the vaccine I got fever for three days in a row, then four days with pain in my left leg. On the 19 I was not able to move my left leg with a lot of pain and a little discomfort on my right leg. Rush to the hospital and right away the found blood clots on my left leg, The ER did not check my right leg and two weeks later they found clots on the bottom part of my right leg. They gave me blood thinner and now Im taking Eliquis twice a day. Symptoms continue, I have the same pain, I dont see any improvent. I did went to work yesterday and I realize that I can do any lifting or be sitting down for at least one hour.

Massive headache for 8 days. I believe it was encephalitis. Dizziness, fatigue, nausea, terrible neck pain, pain allover skull. Completely out of it. Disoriented, Fever, rash, missed work. Now I have a purple spot on my inside of left leg, found this morning 6/14/21 7:30 am.

Pt.'s sister states after receiving the J&J 06/01/2021, started experiencing nervousness, nauseous, vomiting, anxiety, memory loss, and constant shaking. Weight lost (estimated 15lbs), loss of sleep. Physician visit (07/15/2021) Blood test ran still awaiting results. Cognitive Test 07/15/2021, recommendation for MRI.

Vaccinated at approx 1300 hrs. I began feeling chilled 6 hours later. Chills continued for hours. I developed a significant headache. Also experienced some body aches. Took my temperature via oral thermometer at 10:00 PM and it was 101.5. Went to bed at approx 11:00 PM wearing all my clothes and under a quilt and two wool blankets. Chills continued, but then I also began sweating profusely. I did not rest well and was up approx every hour drinking water and urinating. I noticed an elevated heart rate for several hours through the night. cont'd below

Severe chills for several hours, then high temps for several hours, then racing heart rate for 3-4 hours, tightening of chest, inability to sleep . Onset took 6 hours from shot. Conditions lasted about 18 hours.

i received the vaccine at 5:30 pm no side affect but at midnight 12:05 I woke u with massive headache around my head and muscles pain with temp and shivering cold i could not sleep all night after also with stomach pain too and at one time i felt short of breath i did not take anything until 12:00noon the day with tylenol and i drank lots of Gatorade, i night sweat a lot and i slept all night after taking another two pills of tylenol 500 mg each, i sweat all night and I woke up good thanks god i feel much better

Fever (100.0-100.2); headache/foggy head; muscle aches; pain at injection site. Symptoms lasted 36-48 hours.

About 18 hours after vaccination, I began to feel myalgias and burning skin while in the shower; I began to feel "hot" and very fatigued. Then my temperature went up to 101.9 degrees F, taken by an electronic touchless digital thermometer. Then, the L Deltoid vaccination site began to feel very sore. As the day went on, I felt increasingly fatigued and exhausted, and had trouble concentrating. I felt better the 2nd day after vaccination, but felt intermittent myalgias, increasing L Deltoid soreness, and hot and chilled at the end of the day. Today, I felt better in the morning, exceptfor persistent L deltoid soreness, and fatigue. This evening, I am feeling cold, tired, and myalgias again.

Patient stated feeling little light headed, strange, weakness, feeling warm, sweaty, without visual problems wanted to lay down. Patient awake and alert without anxious. Does not like needles/shots. Felt better after 15 minutes. Patient better after 15 minutes. Patient did not have SOB without swelling without rash. Breathing ok without nausea. 11:45 am- 126/90 HR 59

Arm pain and swelling began immediately. Later in the evening on same day of shot, I began to experience nausea. Next morning pain, swelling and nausea persisted. Medium intensity body aches and headache began late morning. By mid afternoon body pain increased to the point that I was no longer able to function and needed to lie down. Took a 4 hour nap. Side effects persisted after waking up. At time of writing, 28hrs after vaccine, I am still feeling the side effect although less severe. Ibuprofen and Tylenol do seem to help.

Severe Tinnitus flare up and dizziness started approximately 12 hours after vaccine administered. No tinnitus or dizziness in prior two weeks before receipt of the vaccine on April 8th at 2:00 pm. Dizziness resolved after about 72 hours. Tinnitus still present 24 hours a day, every day. Moderately disruptive to sleep and ability to function.

INTENSE HEADACHE. SCALE FROM 1 TO 10: 8 TOTAL INSOMNIA. IMPOSSIBILITY TO FALL ASLEEP ALL NIGHT VERY HIGH BODY TEMPERATURE NAUSEA DIZZINESS I TOOK ACETAMINOPHEN 500mg FROM 10 PM UP TO THIS MOMENT EVERY 6 HOURS SELF-PRESCRIBED REST. NO ACTIVITY OF ANY KIND

Blood pressure rose throughout the morning the day after vaccination. I currently take 5mg Lisinopril daily to manage high blood pressure and maintain a morning average around 118/80. The morning after the vaccination my blood pressure rose throughout the morning to 158/115. At noon, I took an additional 2.5mg of Lisinopril (in a addition to the 5mg I took before bedtime the night before). Also, to manage anxiety, I took 0.5mg Alprazolam. My blood pressure returned to normal by 5pm; and has been normal up to the day of this report.

Evening after getting vaccination I developed fairly loud tinnitus in both ears. The ringing was loud enough to keep me awake, even though I felt pretty weak and achy from the vaccine. It subsided after about a week but is still present to some extent. I've noticed it off and on before the vaccination, but never so steady or strong. About one month after the vaccine I'd say it's a little worse than before, but not terrible.

death. Patient had inactive cirrhosis from successfully treated Hepatitis C. He had chroinically low platelet from cirrhosis and was also a clotter as evidenced several year ago with portal vein thrombosis travelling down to his mesenteric veins causing a similar lower GI bleed by clotting his colonic veins. He required several months of anticoagulants with blood thinner at that time. One week prior to his COVID-19 vaccination there ia picture of deceased with evidence of bilateral suborbital bleeding. Patient told family that he felt poorly after injection. The day he was found there was evidence of significant GI bleeding. His corpse is currenly at medical examiner's office with no plans for autopsy.

FEELING HORRIBLE; BLOOD CLOT; BODY ACHES; JOINT PAIN; SPAMS ALL OVER BODY; TOE SWELLING; KNEE SWELLING/ ANKLE SWELLING; This spontaneous report received from a patient concerned a 54 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 expiry: unknown) dose was not reported, 1 in total administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. After getting the vaccine, the patient had immediate joint pain and body aches. He had spasms since day one. After two weeks, he developed swollen toe looked like a bunyon, then it moved up to the ankle then it moved up to the knee being swollen. The patient was sent to the imagining center. He had following imaging tests done, bilateral Lower extremity Doppler Exam. On 30-APR-2021, he was recommended to go to the emergency room (ER) and was admitted. He was diagnosed with blood clot and stayed overnight. He was prescribed on Xarelto (rivaroxaban) 15 mg twice a day (BID), titrating to 20 mg once a day. The patient was hospitalised for 2 days. He got another follow up on 14-MAY-2021, gave him another prescription for blood thinner to be on for two months. On 18-MAY-2021, he was given tramadol 7 pills for spams which had helped with his pain and currently patient was feeling horrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, body aches, toe swelling, knee swelling/ ankle swelling, spams all over body, and blood clot, and the outcome of feeling horrible was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210540030- Covid-19 vaccine ad26.cov2.s- A 54 yearold male presents with Blood clot, Body aches, Toe swelling, Knee swellng /Ankle swelling, Spasms all over body, feeling horrible. 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). 20210540030- Covid-19 vaccine ad26.cov2.s-Joint pain. This event(s) is labeled per RSI and is therefore considered potentially related.

BREATHING DIFFICULTIES; CONSTANT COUGH; LUMP IN THE THROAT; FEEL LIKE HE IS DYING; SWALLOWING DIFFICULTY; AIRWAY BLOCKAGE; This spontaneous report received from a patient concerned a 54 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: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced breathing difficulties. On 01-APR-2021, the subject experienced constant cough. On 01-APR-2021, the subject experienced lump in the throat. On 01-APR-2021, the subject experienced feel like he is dying. On 01-APR-2021, the subject experienced swallowing difficulty. On 01-APR-2021, the subject experienced airway blockage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breathing difficulties, constant cough, lump in the throat, feel like he is dying, swallowing difficulty and airway blockage was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.

During the 15-minute observation period, the patient had a fainting episode. He was briefly not aware of his surroundings and felt cool and sweaty to the touch. After a couple minutes, the patient slowly started regaining his mental status and was able to tell us his name, date, and the name of his kids. The EMTs arrived and did a thorough assessment; they determined that because the patient had not had anything to eat or drink all day up until his vaccine appointment, coupled with the fact that the patient had walked 5 minutes to the pharmacy and the weather was warm, the patient's blood pressure and sugar likely bottomed out and caused him to faint. The patient was given an ice pack to cool down and orange juice to normalize his blood sugar. After waiting in the pharmacy for another 15 minutes, the patient was deemed fit enough to walk back home. He was advised to have something to eat and take a cool shower.

To begin, I have always been a healthy, middle-aged male, with no history at all of neurological problems. What follows is a comprehensive summary of all that happened to me shortly (7 days) after getting the Janssen COVID vaccine and the supporting documentation to support the diagnosis of my having developed Guillian-Barre' Syndrome (GBS) as a direct and obvious consequence of the vaccine. THURSDAY, 5/13/21: Received the J&J vaccine at 10:00 AM (LOT NUMBER 205A21A). FRIDAY - THURSDAY, 5/13 - 5/20/21: No obvious reaction to the vaccine, at all. FRIDAY, 5/21/21: During the day, I noticed deep-muscle pain/soreness in both shoulders (deltoid muscles) that increased throughout the day. It felt as if I had been doing heavy-weight presses with the resulting soreness. I attributed it to a delayed reaction from the vaccine (as I'd heard muscle pain, particularly in the shoulders, is a common reaction symptom), as I had no injury or other possible cause and chose to ignore it. It may have even started a day or two before Friday, but wasn't of such consequence as for me to recall it; the only vivid memory I have is the discomfort on Friday, 5/21/21. SATURDAY - SUNDAY, 5/22 - 5/23/21: I had continued shoulder pains, but ignored them because they were not acute and just attributed them to a short-term vaccine reaction. MONDAY, 5/24/21: In the evening, while sitting in the bleachers attending a sporting event, I noticed my buttocks was pretty sore. The bleachers are not normally comfortable, but this was a dull, serious ache across my entire buttocks. I didn't know to what to attribute it (not yet at that time associating it with the shoulder pain), so ignored it. In retrospect, I realized later that the soreness I was feeling at that time was similar to the shoulder pain and was the pain felt from a deep numbness across the buttocks, akin to when a body part (hand, foot, etc) "falls asleep" so deeply that it's numb, but is still very, very sore. Later that night, my upper back began to feel sore, from shoulder to shoulder, down to my mid-back. As the night progressed, this pain increased exponentially to a "Level 10", leaving me unable to sleep but in 15-minute increments, wandering the house to find a spot -- sofa, chair, floor, anywhere -- to give me some comfort to sleep; I slept 2 hours, total, that night. The pain across my back felt equivalent to someone beating me with a baseball bat all over my upper back -- it wasn't an acute, localized pain, but very deep and broad across the area. Normally, Aleve quickly resolves any pain issues I have, but overnight, it did nothing to reduce the pain. TUESDAY, 5/25/21: I began to piggyback Aleve and Extra Strength Tylenol, and that seemed to help abate a little of the most intense pain, but it was still painful and precluded sleep and much of my working. I think it was at this time that I began to notice the pain and numbness going beyond my buttocks, down the backs of my legs, and into my feet, leaving my feet (and toes, in particular) numb and tingling. I also began to notice a problem with balance and gross motor controls (stumbling when walking, nearly falling several times in the shower) -- all symptoms I have never experienced in any capacity. Additionally, I had considerable pain down the backs of my legs, leading me to feel as if my calves and hamstrings had been through a heavy workout the day before and desperately needed stretching -- however, any attempts to do so led to excruciating, stabbing pains in those muscles. I also noticed that the pain in my upper back was becoming more acute and localized in my cervical vertebrae area. Having taken care of a father who has had many back surgeries and suspecting I have my own degenerative cervical disc issues (I've had past neck pains), I began to believe that all the pain and numbness throughout my body might be due to a cervical issue (e.g., bulging disc, stenosis, etc), and so tried to treat the area as such, with hot shower, heating pad, better neck support, etc. I continued to piggyback the two pain meds that day, but the upper back and neck pain and numbness and gross motor issues came back in full that night, again leaving me no relief for sleep -- I could only doze in 15-minute increments and found no position or place to sleep that was comfortable; I was in tremendous pain 10) across my entire back and down my legs. By 2:00 AM, I knew there was going to be no relief, and I couldn't wait until the morning; I drove myself to the nearby ER, again still believing/expecting at the time that this was a spinal issue. In the ER, I was met by a PA who reviewed my situation, determined that cervical imaging was unnecessary, and prescribed Percocet. My blood pressure was recorded at 160/94. I was released after two hours and returned home. Despite the meds, I was still in considerable pain that night and found myself unable to sleep in more than 10- to 15-minute increments. WEDNESDAY, 5/26/21: During the day, the Percocet seemed to abate the pain, somewhat, although it tended to flare up much more at night during the prior 2 nights, anyway. However, I noticed I had an upset stomach by midday, and as the day progressed, the pain in my abdomen grew considerably. By the evening, the pain across my abdomen was unbearable, as bad as it was in my back and legs. Late in the evening, I researched Percocet and saw that abdominal pain and nausea are two prominent side effects. I stopped taking the pain medication immediately, knowing that my back pain would return in full through the night; again, I slept in 15-minute increments in considerable back and abdominal pain for a total of about 3 hours. It was also during the day Wednesday that I noticed considerably worse gross motor skills (e.g., walking, ascending/descending stairs, standing up straight, writing), balance, and increased numbness and tingling in my legs, feet, and hands. At one point, I tried to walk by my daughter in a hallway in the house, and in trying to go around her, I fell against the wall. She thought I was joking; I wasn't. It happened several more times that week. Also, this day or the next, I started noticing additional problems with urinating and defecating. It felt as though I had no control over my abdominal muscles, so could not strain or push when going to the bathroom. When trying to have a bowel movement -- and I knew needed to -- I felt as though I had no control to push; when urinating, I had no muscle support for pushing out the urine. THURSDAY, 5/27/21: Still believing these pain, numbness, and other neurological, problems to be related to cervical vertebrae/disc issues, I had an appointment with a spine orthopedist. He ordered cervical X-Rays and confirmed that I do have disc compression/degeneration, but not excessive and nothing that could explain the pain and numbness persisting all over my back, down to my hands, across my buttocks, and down my legs to my feet. The message: the cervical discs were not the problem. This is when I reconsidered all I had been through, tying back to the initial pain I felt in my shoulders the prior Friday. This is when I realized that my body had been reacting to the vaccine. Never before in my life had I had neurological problem. Never before had I experienced pain, numbness, and tingling across my entire body that way, so until that moment, I hadn't considered the vaccine to be a possible vector for all that was going on with me. The coincidence of these events was FAR too great to be anything but a causal relationship. The likelihood of these symptoms arising on their own is infinitesimal in comparison to a causal effect. The vaccine had triggered a serious and painful neurological response in my body. The orthopedist, knowing I had responded poorly to the Percocet, prescribed oxycodone. I took that pain medicine that day and into the evening, but once again, my stomach and abdomen began to bother me and the abdominal pain returned. Once again, I looked at the side effects of the medicine, and the first two I saw were stomach pain and nausea. I stopped taking the pain medicine immediately. That night, I slept a total of 2.5 hours. FRIDAY, 5/28/21: I was still in considerable pain, and that combined with very little sleep (and none of it good) for 4 days led me to having trouble thinking clearly. My wife insisted I needed to go back to the ER in the morning to see what could be going on. My blood pressure upon being seen was initially approximately 185/140, but what was finally recorded after a second test was 191/112. I waited to be seen for about 2 hours, but I finally met with the ER physician and described my history of problems that week, including my then-belief that this was a vaccine reaction. She ordered full bloodwork, chest X-Ray and CT scans (without contrast) of lumbar and thoracic spine and CT scan with contrast of chest/abdomen. Nothing strikingly abnormal was found in these scans, but doctors (ER physician and neurologist) noted bliteral weakness in lower and upper body. The doctors wanted to order MRIs, but I am unable to have an MRI due to a piece of metal in my left eye. The morphine I was administered helped reduce my pain and my blood pressure upon leaving had abated, somewhat (don't recall my final BP). Both doctors seemed not to believe that these symptoms could be the result of an adverse vaccine reaction, but they were unable to explain a cause. On my inquiry, at my friend's recommendation I ask to verify, the neurologist disagreed that these were symptoms of a presentation of Guillian-Barre' Syndrome (GBS). The ER doctor asked if I was interested in being admitted, but I felt some of my more extreme symptoms (blood pressure and pain -- thanks to the morphine) had abated sufficiently to allow me to leave. After 8 hours in the ER, I left and returned home. My numbness, tingling, some pain, balance, and motor skills issues persisted, but were blunted somewhat (probably from the morphine?). It was either this day or the next, that I was standing outside, and knowing I had problems walking and with balance, I decided to try to run a few steps to see how weak my legs were and bad my motor skills and balance were. Immediately, it was clear that things were worse than I had considered. I had very poor control of my legs -- they flew off to the sides, out of control, as I tried to step; I stumbled a couple times and almost fell; and I couldn't proceed in a straight line, veering off at an angle. I earnestly tried several times, with the same results each time. That night, while the pain was still there, it was tolerable enough that I was able to sleep for a total of about 5 hours. SATURDAY, 5/29/21: Early in the AM, I noticed I was unable to smile. Having a friend who had had Bell's Palsy, I recognized the signs immediately. The left side of my face sagged, I was unable to smile (left side of my mouth sagged), and I was unable to close my left eye. My wife took me to the ER, and we were met by the same ER physician who had seen me the day before. She was shocked about my return so soon after my prior visit. My blood pressure, on being admitted, was 151/102, but as with my other visits, asymptomatic other than the problems described before (pain, numbness, and tingling, in my back, arms, legs, and abdomen; gross motor movement; lack of coordination; and lack of clarity in thinking); no other signs of infection or illness. The Dr ordered a CT scan (without contrast) of my head and other bloodwork. Of note, the CK came back at 712 U/L. The CT scan came back normal. Again, I was administered morphine, which abated my pain and allowed me to relax. After 3 hours, I was released, with prescriptions for Amlodipine for the high blood pressure and Prednisone and Valtrex (Valacyclovir) for the Bell's Palsy. The morphine helped reduce my back and abdominal pain and give me some comfort, such that I could sleep another 5 hours that night, although all other symptoms persisted. SUNDAY - WEDNESDAY, 5/30/21 - 6/2/21: I continued to experience the numbness and tingling in my back (primarily), abdomen, legs/feet, and arms/hands, but my severe pain began to abate, such that I could sleep a bit more easily. I taped my eye shut at night, as my Bell's Palsy eyelid would not close fully, and it teared constantly. WEDNESDAY, 6/2/21: Not having a GP, I finally found an Internist to review my case and symptoms, but primarily to extend my meds (Blood Pressure and antiviral and steroid for the Bell's Palsy), as the ER doctor had only given me a 5-day prescription. The doctor review my situation and continued the meds. Having been prompted regularly by my friend to confirm a GBS diagnosis, I asked this doctor about a possible GBS-vaccine link and after a cursory review, he said he did not think so. THURSDAY, 6/3/21: With the weakness in my left eyelid, my desire to find a resolution to it, and my concerns about its effect on my vision, I had an appointment with my opthamologist, who recommended eye drops until the eye improved and instructed me to stop taping the eye shut. She noted no other problems with my vision. FRIDAY - MONDAY, 6/4/21 - 6/7/21: During this time, the medicines for my Bell's Palsy seemed to take effect, and the paralysis symptoms abated mostly (with some residual weakness in my left eyelid). I continued to experience the other neurological symptoms, however. TUESDAY, 6/8/21: Having been unable to get a timely appointment with a trusted neurologist, a friend with a contact at medical school head of neurology was able to get me an appointment with a neurology faculty member. I met with Dr. that afternoon, and he was the first to really listen to the symptoms I had and understand some of the possible triggers and consequences of them. I started the conversation explaining that I'm a reasonable, rational, and science-based person, an engineer by training and career, and that I firmly believed all the symptoms I was presenting were a direct consequence of my getting the vaccine. Additionally, at my friend's continued urging, I asked if these symptoms could point to a Guillian-Barre' diagnosis. He was at first skeptical of my proposition of the vaccine cause, but was quick to say he was glad I had raised the question of GBS, because he had that diagnosis in mind, as I discussed my symptoms. He believed that the symptoms I had and the way and speed with which they had progressed pointed to a likely GBS diagnosis. He scheduled a follow-on appointment to have an Electromyogram (EMG) and Nerve Conduction Study to assess the extent of the neurological damage and prognosis for resolution, as I am unable to get an MRI and he seemed to feel a lumbar puncture was unnecessary. FRIDAY, 6/11/21: I had my scheduled EMG and Nerve Conduction Study with Dr. The results showed some abnormal neuropathy, but mostly normal in my extremities and indicative of some recovery from symptoms. Although I still had considerable numbness, tingling, and some pain down my legs into my feet and down my arms into my hands, my most prevalent issues at that point were numbness and tingling across my entire upper back and abdomen, but the doctor indicated these tests don't identify issues very well, that they are better designed for testing neurological issues in the extremities. We agreed to reconvene over the phone in several weeks, unless problems worsened. TUESDAY, 6/29/21: During a follow-up appointment with the doctor, I indicated that some of my neurological issues were abating and that my blood pressure had returned to near-normal range. My energy was returning to a degree and my motor skills and balance and control had improved. However, I continued to have significant numbness and tingling across my back and abdomen, and of greater concern, I had increasing tingling and pain going down my left arm to my index finger when I stretched out my arm. This was a new symptom and increased in pain in frequency in the following days and raises the question of what other symptoms might arise. AS OF 7/8/21: CURRENT STATUS: I have continued numbness and tingling in my feet and hands and back and abdomen, although they are reduced from their earlier state. However, I have increased shooting pain in my left index finger when stretching out my left arm. Additionally, I have a mild increase in weakness in my left eyelid, after prior improvement from the Bell's Palsy. My dangerously high blood pressure at the early onset of these symptoms has returned to near-normal levels, although my GP continues to keep on blood pressure medicine (Amlodopine) for now. Finally, a lot of the issues I had thinking clearly and regularly making mental mistakes, all noticeable and commented on by my family, have lessened, although I still find myself making mental mistakes and forgetting information that would have been MUCH less likely prior to this adverse GBS event caused by the J&J vaccine.

COUGH; COMMON COLD; EXTREME FATIGUE/ LEG FATIGUE; FUZZY MIND (FOR COUPLE OF WEEKS); BONES HURT; HEADACHE; FELT WEAK; HEAT GLOW (FEELING LIKE HASN'T SLEPT); This spontaneous report received from a patient concerned a male of unspecified age. 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced heat glow (feeling like hasn't slept). On 14-MAY-2021, the subject experienced felt weak. On 15-MAY-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced fuzzy mind (for couple of weeks). On 21-MAY-2021, the subject experienced bones hurt. On 21-MAY-2021, the subject experienced extreme fatigue/ leg fatigue. On 30-JUN-2021, the subject experienced common cold. On an unspecified date, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fuzzy mind (for couple of weeks), bones hurt, headache, felt weak, and extreme fatigue/ leg fatigue, was recovering from common cold, and heat glow (feeling like hasn't slept), and had not recovered from cough. This report was non-serious.

TROUBLE GETTING UP; COULD NOT FEEL ANYTHING; BRUISED HIPS ARMS AND BUTTOCKS BRUISES HAD SWOLLEN TO BE SIZE OF A FOOTBALL ON RIGHT BUTTOCKS AND HIP AND FEW SMALLER BRUISES ON RIGHT SHOULDER; DISCOLORATION ON THE BRUISES/BRUISES WERE EXTREMELY DARK; FELT WEAK FROM WAIST DOWN; AS WERE WALKING BUCKLED OVER/ FELTS LEGS BUCKLED COMPLETELY; FELL TO FLOOR BUT DID NOT LOSE CONSCIOUSNESS; BRUISED HIPS ARMS BUTTOCKS; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 245 pounds, and height was 76 inches. The patient's concurrent conditions included back issues, and spinal cord stimulator implant, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced as were walking buckled over/ felts legs buckled completely. On 19-JUN-2021, the subject experienced fell to floor but did not lose consciousness. On 19-JUN-2021, the subject experienced bruised hips arms buttocks. On 19-JUN-2021, the subject experienced felt weak from waist down. On an unspecified date, the subject experienced trouble getting up, could not feel anything, bruised hips arms and buttocks bruises had swollen to be size of a football on right buttocks and hip and few smaller bruises on right shoulder, and discoloration on the bruises/bruises were extremely dark. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from as were walking buckled over/ felts legs buckled completely, fell to floor but did not lose consciousness, and felt weak from waist down on 19-JUN-2021, and bruised hips arms buttocks, and bruised hips arms and buttocks bruises had swollen to be size of a football on right buttocks and hip and few smaller bruises on right shoulder on 04-JUL-2021, was recovering from discoloration on the bruises/bruises were extremely dark, and the outcome of trouble getting up and could not feel anything was not reported. This report was non-serious.

SHORT-TERM MEMORY LOSS; FEELS LIKE GOING SENILE; CAN'T STAY AWAKE; FELT IN A FOG/FELT LIKE SYMPTOMS HIT LIKE A BRICK WALL; FEAR OF DRIVING; NAUSEATED; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, and other pre-existing medical conditions included patient described himself as healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. Concomitant medications included metformin for type 2 diabetes. On MAY-2021, the subject experienced feels like going senile. On MAY-2021, the subject experienced short-term memory loss. On MAY-2021, the subject experienced can't stay awake. On MAY-2021, the subject experienced felt in a fog/felt like symptoms hit like a brick wall. On MAY-2021, the subject experienced fear of driving. On MAY-2021, the subject experienced nauseated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from short-term memory loss, nauseated, can't stay awake, feels like going senile, felt in a fog/felt like symptoms hit like a brick wall, and fear of driving. This report was non-serious. This case, from the same reporter is linked to 20210754945.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Pt presented with AMS. History provided by father at bedside. For 2 days after vaccine pt reported not knowing what he was doing and where he was. Father brought him to ED after having breakfast together and son didn't know how to pay or what foods he liked. Was unable to recall his father's name. Treatment: DAPT with ASA and plavix x21 days and then transition to plavix 75mg daily, atorvastatin 80mg (stroke treatment) Outcome: TBD

Patient states they received Vaccine on Monday, became confused at work on Tuesday and then presented to ED after multiple seizures overnight Wednesday and then was having trouble ambulating. also complains of left elbow pain

Around 7:00 P.M. on March 12, 2021 approximately 9 hours after receiving the Jansen COVD-19 vaccine in my left arm. I developed extreme fatigue, muscle aches, skin hurt to the touch of anything including clothing, headache, and fever 101.5. I had to go to bed and was very weak. I took ibuprofen and Tylenol for the discomfort. I slept 14 hours and was able to get up at 11:00 A.M. on March 13, 2021. The soreness at the site of the injection is not problematic. There were other odd symptoms overnight I would awake with strange nerve like sensations tingling and itching that occurred on the bottom of the left foot, upper lip, and neck. I also had several episodes of restlessness that was so bad that I had to stand for a few minutes before being able to lay down again. The worst is the skin hurting and headache. I have also had a few dizzy episodes since getting out of bed this morning. It passes if I sit down or hold onto something. None of these symptoms are normal for me and I cannot remember having a reaction to any vaccinations that I have received in the past. I hope this helps with your study.

Felt like passing out for 2 minutes. Patient states he was anxious because he don't like taking shot. He states he has history of passing out with shots. VSS: BP 92/61, Heart rate 86 bpm, 02 sat 97%, Blood Sugar 128

Body aches, tiredness, headache since the day after treatment. It's been 6 days since the injection and I am still feeling bad. Body aches worse in the afternoon. Headache for 2 days now (Friday and Saturday). Not as tired as I was Tuesday through Thursday and body aches are better with Acetaminophen. Headache does not improve with medication.

Severe leg pain onset approximately 7 hours after vaccination. Patient was unable to go to work today.

I shortly after the shot I having had random pains in arm, including joints [like when the pressure changes ... don't think I have arthritis]) but they only lasted a few minutes and then would go away. About 10 hours later I started feeling sick. One of the first things I noticed besides a headache was my heart rate jumped up to over 100 beats per minute (it is normally below 84). I started getting chills and fever. It was worse than any flu fever I ever had and I could not sleep. Worst part was my heart rate would not go down, remaining above 100 but below 110-115 beats per minute. I considered calling 911 but after looking online decided not to as long as it remained below 120 bpm. I don't know my maximum temperature - I did not think to take it until after the peak had passed by 20 minutes or so (was 99.4 at that point - normal temperature runs 97.2 (low 96.8, high 98.2)). Heart rate finally started to drop around 3:30 am.

Pt went unconscious walking to the sitting area immediately after receiving their vaccine. Pt came to and recovered quickly. Pt reports this happens every time he gets a vaccine of any kind and is due to anxiety, not allergies.

Within two and a half hours had diarrhea and vomiting. Body aches started right away me were severe by the night. Fever started the first night and continued through 4 days. Severe fatigue ongoing 5 days out. Trouble concentrating. No focus. Dizziness. Headache. Vomiting returned day 4.

The next day woke with worse headache of my life , nausea, pain behind my eyes,confusion, throwing up brown liquid, left work early came home , went to bed , next day still really sick , so missed work again , 3 days total missed , thought it should be know men are having bad reactions too

Fatigue for several days, very mild rash, followed by dizziness and disorientation/unsteadiness on day 8

Day 1 / Wed.: Headache, slight dizziness (starting at 4 PM) Day 2 / Thurs: Headache (All day / night) Day 3 / Fri: Light headache (All day / night) Day 4 / Sat: Very bad body aches, muscle soreness, (All day / night) Day 5 / Sun: Extreme diarrhea, light body and muscle soreness (All day / night) Day 6 / Mon: Extreme diarrhea, light body aches / Stomach gurgling (All day / night) Day7 / Tues: Diarrhea stopped at AM. Stomach gurgling / cloudy mind (All day / night) Day 8 / Wed: Stomach still gurgling / cloudy mind. Still happening at time I write this.

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe

BLOOD CLOT IN LEFT LEG; DIFFICULTY SLEEPING; SOME LEG CRAMPS; SWELLING; This spontaneous report received from a patient concerned a 55 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, expiry date: unknown) dose, 1 total on an unknown date in APR-2021 (reported as about three weeks ago from the date of reporting) on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Since an unknown date in APR-2021 (reported as about a week ago), the patient experienced swelling and some leg cramps. It was reported that nothing (swelling and leg cramps) was dramatic initially, however, they worsened. On 28-APR-2021 (reported as last night), the patient had difficulty in sleeping. On 29-APR-2021, the patient was diagnosed with blood clot in left leg by his doctor. At the time of report (reported as currently), the patient was in transport to a hospital for further evaluation. The patient further mentioned that he did not have possession of the vaccination card, but his wife had it and she would be arriving at hospital later. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in left leg, swelling, and some leg cramps, and the outcome of difficulty sleeping was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -COVID-19 VACCINE AD26.COV2.S-Blood Clot in leg. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Starting approximately one week after vaccination I started to experience onset of loud tinnitus primarily in my left ear. I have experienced mild tinnitus for 8 years but this was much more severe. The night of 04/19/2021 I noticed the onset of dizziness which progressed to strong vertigo the morning of the 20th. It was so severe I was unable to work and stayed in bed for the better part of two days. It was accompanied by the increased tinnitus. I scheduled an appt with my primary care physician for 04/23 and by Thursday 04/22 the vertigo had decreased to a general dizziness with tinnitus in my left ear. Dr prescribed Meclizine 25mg to me which has not appreciably addressed the symptom which as of 05/21 continues to be a constant mild dizziness with pronounced tinnitus in my left ear. I am planning to see an ENT that specializes in AIED (auto immune inner ear disorder) which I suspect was triggered my my immune system response to the vaccine. I should note that 8 years earlier I had a milder but similar case of vertigo w tinnitus which was never diagnosed despite extensive testing (vestibular migraine as a diagnosis by exclusion). It gradually subsided over 2 years with only mild tinnitus remaining as a symptom.

FEEL STRONG IN THE MORNING; DIFFICULTY SLEEPING; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, hypertension, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had allergy to chloroquine (difficulty sleeping, itching, fast heartbeat). The patient experienced drug allergy when treated with chloroquine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 04-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 17-MAY-2021, the subject experienced difficulty sleeping. On 18-MAY-2021, the subject experienced feel strong in the morning. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty sleeping, and the outcome of feel strong in the morning was not reported. This report was non-serious.

The participant woke up with a severe migraine headache. He couldn't focus on anything everything looked blurry, He went to work and couldn't focus on numbers, every time he tried to read everything was blurred, He had a constant headache for 2weeks and his eyes are still experiencing blurred vision. He heard that several others also experienced reactions who were vaccinated at his job. He missed 2 days of work and went to urgent care, where he was advised to go to the ER immediately. He had someone take him to ER because he was advised not to drive. To this day he still has a hard time focusing on numbers, When reading the shelf tags at his job everything needs a lot more focus to help with blurriness.

My arm got sorer and stiffer. Followed by I could barely lift it and can hardly steer my car. Hard to put on and take off t-shirts. Hard to lift with my arm and it is weaker now.

SHORTNESS OF BREATH (FEELING CONSTRICTED BUT NOT COMPLETE LOSS OF BREATH); LEFT NECK LYMPH NODE SWELLING (NOW DECREASED IN SIZE, STILL PALPABLE AND INFLAMED); FEELS HYPOSTATIC; LIGHT HEADED; FEELING BACKED UP; CLOUDINESS IN URINE; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included fever, tinnitus, and drug induced hypertension, and concurrent conditions included autoimmune disease -psoriatic arthritis, and other pre-existing medical conditions included the patient had experienced many adverse experiences with other vaccines/medications in the past. the patient had received steroids that resulted in bright pink torso and was aware about the steroid allergy. the patient thinks he had covid-19 back in december because he loss his sense of smell for 2 to 3 weeks. patient received a vaccine 10 years ago that gave him a fever for 10 days straight. The patient experienced hypertensive when treated with salbutamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04A21A, and expiry: 05/AUG/2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced cloudiness in urine. On 21-MAY-2021, the subject experienced shortness of breath (feeling constricted but not complete loss of breath). On 21-MAY-2021, the subject experienced left neck lymph node swelling (now decreased in size, still palpable and inflamed). On 21-MAY-2021, the subject experienced feels hypostatic. On 21-MAY-2021, the subject experienced light headed. On 21-MAY-2021, the subject experienced feeling backed up. On 01-JUN-2021, Laboratory data included: Blood test (NR: not provided) all clear. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 111/63. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath (feeling constricted but not complete loss of breath), left neck lymph node swelling (now decreased in size, still palpable and inflamed), feels hypostatic, light headed, cloudiness in urine, and feeling backed up. This report was non-serious.

Could not walk for two days had to sleep in bathroom of home, had to crawl into shower to go to bathroom. Start on Thursday morning and last till Saturday morning. Then I was able to stand but slowly able to move

No effect for approx. 6-weeks; then, headache, complete body fatigue and muscle weakness developed overnight. A "charged-nerve"/anxious-energy feeling developed throughout body. Then- over the next couple-weeks- numbness in hands/fingers, feet/toes, tremors in head, neck, face hands and fingers and shakiness in arms and legs, developed and continue until today. The headache and charged-nerve feeling has continued, and pain in neck and mid/lower-spine has developed. Muscles in legs especially continue to be weak and some pain has developed in thighs. A ringing in ears is continuous and fasciculations have developed throughout entire body.

Patient stated he gets anxiety when getting any vaccinations or at the dentist office. Patient states he feels hot. He looked flushed and sweaty. His blood pressure at 12:48pm was 159/84. Two ice packs were used. One was placed on his neck while other one was used on his forehead. He was given couple of water bottle. Blood pressure was taken at 12:58pm 132/82. He stated ?I feel much better and this always happens to me when I get vaccinated? He was observed for additional 10 minutes.

two weeks after shot I starting having pain in my right shoulder. thought I over worked it, but week by week it continue to get worse. To the point that it wakes me up 4-5 times a night. While on vacation it hit a tipping point in pain and my pinky finger and ring finger started going numb on my hand. I started to research and thought it might be a nerve issue... from top of shoulder blade to my fingers I get pain. Pain to the point I have a hard time moving my arm in certain directions. two day prior to returning from vacation I called the doctor to have it checked out. On July 12th I saw my doctor (knowing nothing about J&J) and he thought I just needed a steroid shot for inflammation and was given the shot. watching news I heard about these nerve issue with J&J, men over 50 and everything they were saying fit me perfect. The next day I followed up with my doctor (Put a call into him) and a nurse called me back and informed me it probably had nothing to do with the J&J shot. I called the location that gave me the shot and they recommend that I complete this from. Today, 7/17/21 I am still in pain with numbness in my fingers.

Felt rush towards his nose and mouth right after he had the injection Then developed metallic taste in his mouth and altered sense of smell since then

Body aches hips and all joints, neck and jaw muscles on right side going up to my right temple. Light sinus headache. Depression. Tylenol has helped.

Extreme fatigue--slept for over 24 hours after receiving vaccine Shortness of breath Dizziness Irritable diarrhea the first day Had to leave work the next day as dizzy and unsteady and diarrhea

Pt presents following syncopal episode 5 minutes post vaccination of 1 dose Janssen vaccine to right deltoid. Pt?s wife states that he was sitting in the car when he started to complain of dizziness, lightheadedness, and nausea followed by +LOC x1 minute. He had no head injury or other trauma. On immediate evaluation he is conscious and endorses nausea and lightheadedness. He denies medical problems, medications, or any Hx of allergies. He states that he has syncopized multiple times in the past after getting vaccines and giving blood. He also states that he was nervous to get the vaccine today. Pt denies swelling of the face, throat tightness, difficulty swallowing, itching of the skin, SOB, or CP. Following repeat vital signs that showed improved sitting BP of 113/70, Pt refused medical transport and signed out AMA with EMS. Pt was driven home by his wife.

PATIENT BECAME DIZZY, SWEATING PERFUSELY, CONFUSED WITH A BP OF 154/144 AND A PULSE OF 48. LIED PATIENT ON THE GROUND AND RAISE HIS FEET ABOVE HIS HEAD. PLACED A COLD COMPRESS ON HIS FORHEAD AND GAVE HIM SOME WATER, CALLED 911. AFTER 5 MINS THE PARAMETICS WERE ON SCENE AND HIS VITALS BECAME NORMAL AND HE WAS TRANSPORTED TO THE HOSPITAL FOR OBSERVATION.

FLU-LIKE SYMPTOMS; LACK OF SLEEP; LOW GRADE HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included herniated disc, and nerve pain, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A211A, and batch number: 207A211A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for nerve pain, and herniated disc. On 12-APR-2021, the subject experienced flu-like symptoms. On 12-APR-2021, the subject experienced lack of sleep. On 12-APR-2021, the subject experienced low grade headache. On 12-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 13-APR-2021, had not recovered from low grade headache, and tiredness, and the outcome of lack of sleep was not reported. This report was non-serious.

At work while sitting at my desk I became dizzy, broke out in sweat, disoriented, blurred vision, slurred speech. Called plant nurse. She said my face was drooping, I couldn't smile or stand. She called Ambulance. Ambulance arrived and decided symptoms of stroke and called for helicopter to take me to medical center. When I arrived they did CT and I was later told it showed possible areas of no oxygen to brain. They gave me TPA drug and almost immediately I could see improvement - my headache cleared. Throughout the next couple hours I regained movement on right side and all functionality returned except weakness in right arm. I stayed in ICU for 24 hours as required after receiving TPA and while additional tests were ran then was discharged on Friday, April 16, 2021

I started having bad headaches the day after the vaccine. A few days later I saw blood in my stool. I have experienced blood in my stool seven times up to this point. I have been feeling slight numbness in my biceps and calves. I have also been very sleepy and fatigued. Another thing is also pain around my rib cage area. I have also experienced some shortness of breath.

Pain in the vaccination area began about 18 hours after injection. It has not abated in 3 weeks. General body aches - mostly in feet and in upper right arm, shoulder, and neck area (C1-down to mid-shoulder), fogginess of thought, and overall tiredness and lack of sharpness since about 2-3 days post injection.

Janssen COVID-19 Vaccine EUA. Fatigue, hypersomnia, painful white blisters on tongue and in throat, laryngitis, headache, difficulty breathing (more severe than pre-vaccine) Started 5 days after vaccination. Symptoms have not subsided 17 days after vaccination.

Significant stomach ache and loss of appetite, enough pain to wake from sound sleep, no eating the first day just Gatorade, second day broth with some noodles, third day fruit and bread and butter, fourth day 80% improvement and normal diet, 5th day 100% improvement.

BODY TREMBLING AND SHAKES; FEELING ELECTROCUTED; TINGLING ALL OVER THE BODY; INSOMNIA; BARELY ABLE TO WALK; REDNESS IN THE FACE; HEART FEELING WEIRD; WHOLE BODY ACHES; EXTREME SORNESS OF LEGS; EXTREME WEAKNESS; HEADACHES; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included there was no past medical history. the patient was overall healthy prior to the side effects after receiving the vaccine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body trembling and shakes. On APR-2021, the subject experienced feeling electrocuted. On APR-2021, the subject experienced tingling all over the body. On APR-2021, the subject experienced insomnia. On APR-2021, the subject experienced barely able to walk. On APR-2021, the subject experienced redness in the face. On APR-2021, the subject experienced heart feeling weird. On APR-2021, the subject experienced whole body aches. On APR-2021, the subject experienced extreme sorness of legs. On APR-2021, the subject experienced extreme weakness. On APR-2021, the subject experienced headaches. Laboratory data (dates unspecified) included: Scan (NR: not provided) No diagnosis, and X-ray (NR: not provided) No diagnosis. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from body trembling and shakes, tingling all over the body, insomnia, redness in the face, whole body aches, extreme sorness of legs, heart feeling weird, headaches, extreme weakness, and barely able to walk, and the outcome of feeling electrocuted was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious

CHEST DISCOMFORT; RADIATING FEELING OF PUMPING IN HEAD AND NECK; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-SEP-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 01-APR-2021, the subject experienced chest discomfort. On 01-APR-2021, the subject experienced radiating feeling of pumping in head and neck. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from chest discomfort, and radiating feeling of pumping in head and neck. This report was non-serious.

Chills & fever of 101.7 8hrs after shot. Fever rose to 102.1 during night. At daylight or 18hrs after shot, fever began dropping & was totally gone by 22hrs after shot. Just achy & wiped out the remainder of day 24hrs to 34hrs post shot. All gone by 42hrs after shot

About 8 hours after injection, minor chills started. One hour later, chills became severe. About 13 hours after injection, I felt like I had a full blown case of the flu...fever, chills, sweats, light heaviness, body aches and general nausea. Sleep was irregular. Next day, symptoms subsided, but still had body aches and fatigue, and I called in sick for work.

9 to 10 days post vaccine: Flu symptoms for 24 hrs, Fatigue the following day with headache and sinus discomfort. Monday the 29th, worked and arrived home feeling like I may have a sinus infection. Tuesday, no headache just extreme fatigue, left work early took a 2 hr nap and feel a bit better. Lower back discomfort during this time period, discomfort urinating. Feeling of constriction but no pain while peeing.

COVID-19 Vaccine EUA got J&J vaccine shot @ 2:00pm on Wed, April,7th woke up approx. 2:00am in trembling chills , woke up again @ 7:00a with fever , nagiated and feeling a flu like symtoms, headache , sore bones , been out of work two days now and starting to feel a little better but not anywhere near normal yet and don't have any alergies or alergic to anything.

Within 12 hours of getting the shot I developed severe flu symptoms with a fever of 102+, chills, severe headache, sweating, hallucinating, I recovered from that about 35 hours later but then about 2 days later I started having a lot of unusual anger, sleeplessness, racing thoughts, and ended up having a psychotic break. I was sent to the ER where they ran multiple tests on me to determine a cause. No alcohol, no drugs, no bipolar, no infection. It was determined that the vaccine was the cause of this really awful event.

extreme body ache, fever 103 at 2 in the morning, swelling of the face, extreme chills, felt like I was freezing.. Start about 7:00 pm 4/10/2021lasted until 6:30 am 4/11/2021..fever has broke, but body ache still remains

- general sense of feeling weaker than normal. - feeling of tense and restless muscles (especially legs), a sense that my body was struggling. - inability to sleep. That lasted about 30 hours. I realize this is probably a mild symptom, and probably a normal reaction. But you might need to know that.

After 4th day of receiving J&J Covid Vaccine to present, I have dull headache, fogged brain, equilibrium seems off, slight loss of balance, increased heart rate of 170-190 BMP, my normal rate is 70 BPM, I took 25Mg of Metoprolol which brought my rate down to 70 BPM. I have increased wheezing and feeling shortness of breath, whereby having to using my albuterol inhaler quite often and I also took 20MG of Prednisone after which my breathing has improved.

THROBBING PAIN; UNABLE TO WALK (AFTER 4 HOURS OF VACCINATION); WAKE UP IN MIDDLE OF THE NIGHT (AFTER 4 HOURS OF VACCINATION); PAIN IN HIS SHOULDER AND ARM JOINTS; SEVERE HEADACHE/DULL PAIN ON TOP OF HEAD (AFTER 4 HOURS OF VACCINATION); FEVER; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 182 pounds, and height was 165 centimeters. The patient's concurrent conditions included high cholesterol level, diabetic, high blood pressure, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included naltrexone for alcohol dependence. On 30-APR-2021, the subject experienced throbbing pain. On 30-APR-2021, the subject experienced unable to walk (after 4 hours of vaccination). On 30-APR-2021, the subject experienced wake up in middle of the night (after 4 hours of vaccination). On 30-APR-2021, the subject experienced pain in his shoulder and arm joints. On 30-APR-2021, the subject experienced severe headache/dull pain on top of head (after 4 hours of vaccination). On 30-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) burning, and Pain scale (NR: not provided) 10/10 pain level. On 01-MAY-2021, Laboratory data included: Pain scale (NR: not provided) 05/10 pain level. Laboratory data (dates unspecified) included: Blood glucose (NR: not provided) 160 mg/dL, and Blood pressure (NR: not provided) 145/110 mmHg. The action taken with covid-19 vaccine was not applicable. The patient was recovering from severe headache/dull pain on top of head (after 4 hours of vaccination), and fever, had not recovered from pain in his shoulder and arm joints, and the outcome of throbbing pain, unable to walk (after 4 hours of vaccination) and wake up in middle of the night (after 4 hours of vaccination) was not reported. This report was non-serious.

Extreme muscle weakness in lower extremities. Currently using a walker when previously never had a gait issue. Developed Bell?s palsy. Weakness and at times severe pain in shoulders and arms. Tingling sensations in hands. Decreased feeling in legs and feet. These weaknesses are bilateral. Started with general feeling ?off? approx April 1, progressed to severe back pain April 13, visit to ER April 16 diagnosed with pneumonia sent home with antibiotics. Back to ER April 21 with severe back pain and beginning to have difficulty walking and weakness. Sent home with naproxen and muscle relaxers. Back to ER on April 24 fearing a stroke due to face droop. Admitted. Several tests run to R/O stroke,myasthenia gravis, lymes disease. Diagnosed with Bell?s palsy. Sent home on April 28. Still extremely weak. Using a walker. Still in pain. Sent back to ER per physician for another brain MRI on may 4. Not done due to argument between ER staff and physician who sent him in.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: 3 minutes post vaccination patient was pale, experiencing diaphoresis, felt funny. Immediately he drank apple juice and right after still felt like he was going to faint. As he was sitting upright in chair talking his eyes rolled back in his head and he became unresponsive. I had him lie down and propped up his feet. Called 911 and took his blood pressure. He regained consciousness but was still not coherent. He attempted to sit in chair again and immediately felt like he was going to pass out

The day of the injection there was no reaction. Three days later I started getting a headache that would?ve been April 11 or 12th 2021. I do not usually get headaches I?ve had this headache since then it never goes away I?ve also experienced ear ringing , jaw joint pain In what feels like inflammation I?ve been to my ear canals. No present sinus infection or allergy type symptoms related to sinus pressure and pain.. Almost constantly. Over the course of week two and week three had extreme fatigue , tiredness, insomnia, And also very narrowly localized pain?s of which I?ve never had before. The fatigue tiredness insomnia and pains seem to be Diminishing but the headache and ear ringing now goes away. Headache has increased and then decreased but it?s always present. Ear ringing Constantly. Jaw joint pain Changes between mild to moderate.

DIZZY; HEAD SPINNING; NOT FEELING HIMSELF; HYPERVENTILATING; SWEATING; WEAK; NAUSEA; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 235 pounds, and height was 61 inches. The patient's concurrent conditions included smoker, and abstains from alcohol, and other pre-existing medical conditions included patient took water pills twice a day. patient had history of illicit drug use. The patient was previously treated with oxycodone hydrochloride/paracetamol. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for drug used for unknown indication, ergocalciferol for drug used for unknown indication, and metformin for drug used for unknown indication. On 10-MAY-2021, the subject experienced dizzy. On 10-MAY-2021, the subject experienced head spinning. On 10-MAY-2021, the subject experienced not feeling himself. On 10-MAY-2021, the subject experienced hyperventilating. On 10-MAY-2021, the subject experienced sweating. On 10-MAY-2021, the subject experienced weak. On 10-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from weak, dizzy, nausea, head spinning, not feeling himself, hyperventilating, and sweating. This report was non-serious.

Initially I experienced severe headache, fatigue, fever, tight chest and short breath and swelling in my hands such that I couldn?t get my ring off. I am still experiencing varying degrees of headache and fatigue that is at times preventing my working.

First few days severe headaches and neck aches. These were gone after a week. Intense pain in legs and knees. VERY difficult to walk and stand from getting up in the morning until mid day. Painful most of the days and evening. I wake up multiple times at night with pain. I wake up about 5 or 7 times/ night. Very difficult to walk up and down stairs.

Five weeks (05/16/2021) after receiving the Johnson and Johnson vaccine, my left leg just started feeling numb. I went into my kitchen and all of a sudden I started feeling dizzy. I lost all strength in my legs and in my left arm. I really couldn't move my arms or my legs and I felt really light headed. I had to have my 5 year old boys get me some water to drink. My son noticed that my heart was beating really strong and really fast. I saw water boiling over in the pot on the stove and I couldn't even get out of a chair to turn it off. I couldn't stand up. I finally managed to go back by my bed from the chair and slowly moved around. I tried holding my phone and it dropped out of my hands a couple of times because I couldn't hold it. A couple hours later, I felt a little better, but I had to fight to get around. We fell asleep and when I woke up, I still felt bad. I took my children to school and told them that I was going to the hospital to get checked out. At the hospital they performed multiple tests and they back showing I had stroke. I was treated for suffering from a stroke.

LOW LEVEL INFLAMMATION IN PERICARDIA; LOW LEVEL INFLAMMATION IN MENINGES; HIGH BLOOD PRESSURE; ACUTE INFLAMMATORY RESPONSE; MUSCLE CRAMPS (LEGS); COULD NOT SLEEP; MILD BRONCHITIS; HALF SIDE OF THE FACE COMPLETELY NUMB; END OF THUMB GOING NUMB; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 57 year old White and Caucasian male. The patient's height, and weight were not reported. The patient's concurrent conditions included cholesterol, and the patient always had healthy lifestyle, never had heart problems or blood pressure before, was not taking any medication. The patient experienced intolerance to medication when treated with Nurofen (ibuprofen) for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, 1 total, administered on 06-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included fish oil for cholesterol. On 07-APR-2021, around at 01:00 AM, the patient started having headaches and flu-like symptoms that he could manage without medication. On 14-APR-2021, in morning, he had severe muscle cramps (calves and feet), end of thumb going numb and left side of the face completely numb (bottom half of the cheek and underneath the throat). Also had severe headaches (scale 8/10), which was very unusual for the patient. The patient called his PCP who referred him to a local clinic, they drew blood and did a chest X-ray based on the symptoms. Chest X-ray revealed mild bronchitis. Doctor suggested him to go home and stay hydrated. On 14-Apr-2021 (during the night) , patient woke up with muscle cramps in legs and feet, could not sleep because of the severity of the cramps (scale 7 to 8/10) and severe headaches (scale 8/10), could not stay laying down. On 15-Apr-2021, patient visited physician's office. Physician prescribed him steroids (prednisolone) and told him he had an acute inflammatory response to the vaccine and now has low level inflammation in pericardia and meninges (verbatim "inflammation in the bag around the brain and bag around the heart"). Patient's blood pressure (BP) was at 148/130 (his BP baseline was around 120/75) and heartrate was around 96 bpm (baseline 52-55 bpm). Doctor prescribed propranolol. Heart rate went down with propranolol, but Blood pressure was still high, so Doctor switched to losartan 25 mg. He was diagnosed with tachycardia (heart pounding out of chest). On 21-APR-2021, Doctor has scheduled a MRI to rule out blood clots which was normal and also Fibrin D dimer, result was unknown. On 22-APR-2021, patient went to the emergency room, because blood pressure (BP) was 195/138. After receiving treatment, blood pressure was 130/85 and patient went home. Couple of days later, BP was high again, doctor added amlodipine 5 mg to losartan 25 mg and referred the patient to a cardiologist who then increased the dosage to amlodipine 10 mg. Patient now takes losartan 25 mg and amlodipine 10 mg. On 27-May-2021, the patient visited cardiologist and Scheduled Computed tomography scan and electrocardiogram on Monday. Primary care physician had prescribed magnesium supplement for the cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, had not recovered from muscle cramps (legs), and the outcome of end of thumb going numb, half side of the face completely numb, mild bronchitis, acute inflammatory response, low level inflammation in pericardia, high blood pressure, could not sleep and low level inflammation in meninges was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210608039 -covid-19 vaccine ad26.cov2.s- low level inflammation in pericardia, low level inflammation in meninges, high blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabelled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Got injection on Tuesday June 2. On June 6 in the evening I started to feel dizzy, faint, foggy feeling in my head. Almost like a stroke type symptoms. I was unable to ambulate. I got real tired and just felt like going to sleep. I laid down around 5 pm and got up at 5 am. I do not sleep more than 4 or 5 hours nightly. I went to ER due to not feeling any better. I was admitted to the hospital immediately.

ELEVATED HEART RATE; DISCOMFORT SLEEPING ON THE LEFT SIDE; 4 EPISODES OF CAPILLARY BURSTING, 2 IN EACH EYE; CHRONIC DIARRHEA 2-3 TIMES DAY; RIGHT HAND/FINGERS JOINTS ACHY; SEVERE HEADACHE; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 172 pounds, and height was 71 inches. The patient's past medical history included covid-19. 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 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-MAY-2021, the subject experienced right hand/fingers joints achy. On 12-MAY-2021, the subject experienced severe headache. On 12-MAY-2021, the subject experienced injection site swelling. On 15-MAY-2021, the subject experienced chronic diarrhea 2-3 times day. On 19-MAY-2021, the subject experienced 4 episodes of capillary bursting, 2 in each eye. On an unspecified date, the subject experienced elevated heart rate, and discomfort sleeping on the left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand/fingers joints achy, and injection site swelling on 15-MAY-2021, 4 episodes of capillary bursting, 2 in each eye on 29-MAY-2021, and severe headache on 12-JUN-2021, had not recovered from chronic diarrhea 2-3 times day, and the outcome of elevated heart rate and discomfort sleeping on the left side was not reported. This report was non-serious.

"When I woke up, I felt sick to my stomach, experiencing nausea, sharp pain in my back towards my right shoulder. I felt dizzy, and feeling in my head, detached fatigued, feeling like I kind of had a head cold, but didn't. Dull ache in my head on the (R) side. Strange transient pains in my body. My heart felt like it was racing, and I felt like someone had punched me in my lower stomach".

High fever up to 103, taking Tylenol to lower but goes right back up, headache, body aches and terrible chills the first few hours. Unable to function normally or go to work.

arrived to recovery stopped vehicle and became pale diaphoretic. pt stated and loopy. Assessment pt very diaphoretic, pale, no LOC near syncopal episode - N/V. able to answer questions. L Deltoid site benign. ice pack to back on neck, water to hydrate, medical called to assess. Pt stated he had not eaten all day. no further orders from medical. VS 122/70, HR 76 reg, Resps 16 reg non labored, SP 02 97%. After 5 min color back to facial area, stopped sweating was AAO. Refused to stay 30 min left 20 min stated I feel fine I would rather go. Explained V-safe site, OK'd to exit. RN

Received Janssen Lot 1808980 at 10:15AM on 4/1/2021. No symptoms at first other than missing appetite. Around 9:00pm started to feel chills and tired with low grade fever (100 C). Around 1:30am started feeling right side back pain in my kidney area that woke me up. By 2:15am the pain was almost unbearable, and I could no longer lay in bed. At 3:00am I took 2x 500mg Tylenol as I debated whether to call my doctor or go straight to ER. By the 3:45am pain was subsiding and was I able to get back in bed by 4am. Today no pain.

I became nervous and started shaking (no chills). The quaking/shaking lasted about an hour. My heart rate was accelerated for a few hours and I had difficulty sleeping.

Patient woke up on 4/3/2021 at 7:30am with the symptoms of Light Headedness, Dizziness, and not feeling like himself. He got up and continued with his normal daily routine until around 10:30 when his vision started to double and he was off balance on his feet. He was taken by ambulance to a Hospital at 11:15am upon arrival his vision trippled and his eye right started to veer outward. He was taken in for a CT scan immidiatly and then was transfered to another campus to have a MRI scan done. He was then admited to the hospital for evaluation where he stayed overnight and was released the next afternoon (4/4/21)

4/4/2021 - feeling off, somewhat run down /// 4/5/2021 - feeling more run down /// 4/6/2021 - exhibiting sore throat and swollen glands throughout the day then at 5:45 was eating cocktail shrimp when I lost function and control of my right arm as well as a slight problem with my gait. As soon as the event took place my sore throat and swollen glands stopped immediately. My wife took me to the hospital where I was entered into stroke protocol. I was subjected to a series of tests including: EKG, ECHO, Platelet Cnt, Lipid Panel w direst LDL reflex, Hemoglobin, MRI Brain w/o contrast, CTA Stroke Alert (head/neck), CT Stroke Alert Brain, ECG, Basic Metabolic Panel, CBC, Protime - INR, APTT, Troponin I, Covid19, Influenz Influenza A/B, RSV PCR, and POCT GLUCOSE. I was kept for observation and determined I had suffered a small stroke. Released from the hospital 4/7/2021.

4-2 headache, fever, fatigue, chills, light-headed, body ache 4-3-21 Headache fever(101 deg), fatigue, dizzy, nauseous 4-4-21 severe dizzy. headache, fatigue nauseous 4-5-21 Monday dizzy, miss work,nausious, headache 4=6=21 Tuesday headache, dizzy lightheaded, tested for Covid 19/negative 4-7-21 return to work but experience headache, nausea, lightheaded 4-8-21 dizziness and headache 4-9-21 some dizziness and headache 4-10-21 light-headed, headache, little dizzines 4-11-21 light-headed 4-12-21, headache 4-12 headach, lightheaded 4-12-21 lightheaded and headache at times 4-13-21 sharp pain in head/ headach

Patient was given vaccination and asked to sit in observation area for a minimum of 15 minutes. Within the first 5 minutes, the pharmacist was alerted to the patient dropping his phone and glasses to the floor and staring off into space. The pharmacist proceeded to make contact with patient by calling their name and giving them gentle taps on the shoulder and knee. The patient "came to" within a few minutes stating that they could hear and see but felt as though they were "off in space" . Once the patient "came to" they were coherent but perspiring a bit. The patient was offered water and a cool damp cloth. The patient was offered EMT services which they declined. The patient was made to wait another 15 minutes in the observation area. The patient did have a spouse with them who would be driving them home. The patient was called later in the day to by the pharmacist to see how the were feeling. The patient stated they were fine and appreciated the follow-up call.

This spontaneous report received from a patient concerned a 58 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: 180502D, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced didn't feel good. On 25-MAR-2021, the subject experienced tired. On 13-APR-2021, the subject experienced dizzy. On 13-APR-2021, the subject experienced pinched nerve. On 13-APR-2021, the subject experienced felt like hot fluid was running down the inside of his right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, pinched nerve, felt like hot fluid was running down the inside of his right arm, and didn't feel good on APR-2021, and tired on 28-MAR-2021. This report was non-serious.

After my J&J vaccine, I experienced left hip and joint pain. I could not lift my left leg up. The next morning after my J&J vaccine, my left leg started hurting more and I could not ambulate. My left hip was hurting so bad I could not sleep at night. I went to the doctor 03-17-2021 to get monitored and he said it could be arthritis. I was prescribed by Dr. cyclobenzaprine 10mg and naproxen 500mg. I feel that my pain is inside the joint, hip pain region and to this day, I still have sleeping problems due to my pain in my left leg and left hip pain since the J&J vaccine. I will have a follow up with Dr. in the coming weeks.

FELT LIKE SOMETHING ON CHEST; SKIN HOT; LITTLE BIT OF COUGH; FEELING HOT; CAN'T SLEEP AT NIGHT; DIZZY; BARELY COULD STAND; COULD BARELY WALK; PAINS IN BACK ESPECIALLY BACK UP NECK; CHILLS; VERY WEAK; FELT VERY HOT FEVERISH; NIGHT SWEATS; TIRED; This spontaneous report received from a patient concerned a 58 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced tired. Laboratory data included: Blood test (NR: not provided) everything was ok. On 24-MAR-2021, the subject experienced night sweats. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced very weak. On 24-MAR-2021, the subject experienced felt very hot feverish. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced barely could stand. On 25-MAR-2021, the subject experienced could barely walk. On 25-MAR-2021, the subject experienced pains in back especially back up neck. Treatment medications included: naproxen. On APR-2021, the subject experienced little bit of cough. On APR-2021, the subject experienced feeling hot. On APR-2021, the subject experienced can't sleep at night. On APR-2021, the subject experienced felt like something on chest. On APR-2021, the subject experienced skin hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 2021, was recovering from pains in back especially back up neck, and felt very hot feverish, had not recovered from chills, and the outcome of night sweats, little bit of cough, dizzy, barely could stand, could barely walk, very weak, feeling hot, can't sleep at night, skin hot and felt like something on chest was not reported. This report was non-serious.

SLEEP RESTLESS; This spontaneous report received from a patient concerned a 58 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: 043A71A, 04321A, and 043Z1A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced sleep restless. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleep restless on 04-APR-2021. This report was non-serious.

After my J&J vaccine, about 2-3 days after I developed flu like symptoms, chills and headaches. On the 6th day after my vaccine, I developed a lump on the right side of my throat which progressively got worse. I also experienced diarrhea which lasted three days. I went to see my PCP, Dr. who ordered a CT scan of my neck. The CT scan demonstrated I had an ulcer in my throat located in my larynx box. MY PCP doctor then referred me to an ENT doctor, Dr. The ENT doctor gave me antibiotics and a shot in my arm. My throat kept getting worse and the ENT doctor have me reflux medicine and Prednisone and Bactrum medication. Today I woke up feeling much better although the pain and swelling to my left side of my throat and ear has gone down but I still have a sore throat and ulcer and is being treated with medicine.

Patient flew from city to city through another city on Tuesday 3/16/21. He had a reaction on the flight where he coughed for 1.5 hrs and was hot in the airplane. He could not go to work and was required to get Covid tested on 3/18. Still coughing and having trouble sleeping (laying down). Rapid Covid test negative on 3/18. PCR test results negative on 3/21 from hospital. He continued to grow weak and cough from 3/16-3/21. At 3am on 3/22 he called and said that his feet were 2X their size and having difficulty breathing. Taken to hospital via ambulance. When transfered to ER bed, Dr said that he lost pulse. They intubated and got his pulse back. Died at 5:15am. Autopsy said cardiac arrest. Dr said that they could not maintain a heart beat. He asked me if the patient had a history of blood clots? No he did not ever has a blood clot that I know of. He had a chest xray post mortem showing fluid in his lungs from low circulation of blood.

BLOOD CLOT IN UPPER THIGH; NO PULSE FROM KNEE DOWN ON RIGHT LEG; RINGING AND BUZZING IN EARS; PURPLE TOE; COULD NOT MOVE; FEELING CRAPPY; TIRED; NAUSEOUS; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included Barrett's esophagus, and controlled high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular batch number: 1805031, and expiry: unknown) dose was not reported, 1 total administered in left arm on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included Nexium (esomeprazole sodium) for Barrett's esophagus, and lisinopril for high blood pressure. On 25-MAR-2021, the day after the vaccination, patient felt crappy and could not move, had tiredness and nauseous. After 10 to 12 days of vaccination on an unspecified date in APR-2021, the patient had ringing and buzzing in ears, pain in the bottom of feet on walking, and purple discoloration to front of the right toe. The patient had visited health care professional (HCP). The patient had undergone some tests and HCP identified no pulse from the knee down on his right leg and a blood clot in upper thigh. The patient had experienced pins and needles and buzzing on his leg. He has also has a ringing and a buzzing in his ears and the bottom of his feet hurt when he walked on them. The patient was scheduled for an appointment with cardiovascular surgeon on 28-APR-2021, prior to the visit the patient has to tested negative for COVID. The patient went to take test on 23-APR-2021 and results not yet received. Laboratory data included: Peripheral pulse absent (NR: not provided) no pulse from the knee down on right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling crappy, tired, nauseous, no pulse from knee down on right leg, blood clot in upper thigh, ringing and buzzing in ears and could not move was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to.This spontaneous report received from a patient concerned a 58 year old male.; Sender's Comments: V0: This 58-year-old male patient was found to have blood clot in upper thigh with no pulse from the knee down 10 to 12 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. Concurrent conditions include Barret's esophagus and "controlled" high blood pressure; concomitant medications includes Nexium and lisinopril. The symptoms reported were ringing and buzzing in ears, pain in the bottom of feet on walking, pins and needles and buzzing on his leg, and purple discoloration to front of the right toe that prompted consult with HCP, who advised the patient that there was no pulse from the knee down on his right leg and a blood clot in upper thigh. Prior COVID test was negative. No other details reported. The information available precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.

HEADACHE; SOMETIMES LOOSE MEMORY; HIGH BLOOD PRESSURE AFTER VACCINE; DIFFICULTY BREATHING; FEELING ABNORMAL; LOOSING WEIGHT; VOMITING; MY TONGUE WAS SWOLLEN; POOR APPETITE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included blood pressure abnormal, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known allergies or 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: 1200287383 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sometimes loose memory. On APR-2021, the subject experienced high blood pressure after vaccine. On APR-2021, the subject experienced difficulty breathing. On APR-2021, the subject experienced feeling abnormal. On APR-2021, the subject experienced loosing weight. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced my tongue was swollen. On APR-2021, the subject experienced poor appetite. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, fatigue, sometimes loose memory, high blood pressure after vaccine, poor appetite, nausea, vomiting, loosing weight, and feeling abnormal, and the outcome of my tongue was swollen and difficulty breathing was not reported. This report was non-serious.

DIDN'T SLEEP WELL; BODY ACHES; FATIGUE; HEADACHE WITH NO FEVER; FELT LIKE NOT ABLE TO TAKE DEEP BREATH; FELT LIKE HEAVY WEIGHT ON CHEST; This spontaneous report received from a patient concerned a 58 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, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced felt like not able to take deep breath. On MAY-2021, the subject experienced felt like heavy weight on chest. On 11-MAY-2021, the subject experienced didn't sleep well. On 11-MAY-2021, the subject experienced body aches. On 11-MAY-2021, the subject experienced fatigue. On 11-MAY-2021, the subject experienced headache with no fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from didn't sleep well, body aches, fatigue, and headache with no fever, and the outcome of felt like not able to take deep breath and felt like heavy weight on chest was not reported. This report was non-serious.

DEPRESSIVE EPISODE; IRRITABLE; BODY ACHE; INSOMNIA; FEVER; HEADACHE; INJECTION SITE PAIN; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included granule storage platelet disorder, early-stage prostate cancer, itch, face peeled, and huge sunburn like reaction, and concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with morphine, and articaine hydrochloride/epinephrine bitartrate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced depressive episode. On 30-APR-2021, the subject experienced irritable. On 30-APR-2021, the subject experienced body ache. On 30-APR-2021, the subject experienced insomnia. On 30-APR-2021, the subject experienced fever. On 30-APR-2021, the subject experienced headache. On 30-APR-2021, the subject experienced injection site pain. On 30-APR-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 F, running greater than 100 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache on 01-MAY-2021, and injection site pain on 02-MAY-2021, had not recovered from fever, headache, irritable, depressive episode, and insomnia, and the outcome of tired was not reported. This report was non-serious.

THROAT HOARSE; SNEEZING; COLD; BACK PAIN; ARM SORENESS/ARM FELT SORE/PAIN IN LEGS; MILD HEADACHE; MUSCLE ACHES; FEVER OF 100.4; FLU LIKE SYMPOTOMS; DID NOT SLEEP WELL; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 175 pounds, and height was 70 inches. The patient's past medical history included back surgeries, and concurrent conditions included cigarette smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 05-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced did not sleep well. On 06-MAY-2021, the subject experienced flu like sympotoms. On 06-MAY-2021, the subject experienced back pain. On 06-MAY-2021, the subject experienced arm soreness/arm felt sore/pain in legs. On 06-MAY-2021, the subject experienced mild headache. On 06-MAY-2021, the subject experienced muscle aches. On 06-MAY-2021, the subject experienced fever of 100.4. On an unspecified date, the subject experienced throat hoarse, sneezing, and cold. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.4 F, 99.8-99.9 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from did not sleep well, and flu like sympotoms, and back pain, arm soreness/arm felt sore/pain in legs, and muscle aches on 10-MAY-2021, had not recovered from mild headache, and fever of 100.4, and the outcome of throat hoarse, sneezing and cold was not reported. This report was non-serious.

I went to the vaccine shot and we were crammed in there. I got the shot and I went home and I felt fine and then 11 that night I started to get a fever and chills and I started ranting, yelling couldn?t get to sleep the next day everything was gone. I started to have a small cough on Sunday morning. On the Monday I went to a college visit when my daughter to and I didn?t feel bad at this time I was masked for most of the time. And Tuesday morning I woke up and had a sore throat and a cough that grew in to some body aches and I contacted the doc I lost my sense of taste and smell I contacted a doctor telehealth who set up and a covid test (positive) . From the time that I was not feeling well I did separate my self from everyone. The aches lasted for about 5/6 days and the body aches I did have a lingering cough. My instructions were to stay out 10 days starting 04/02 and I could go back to work on 04/12 if I was fever free and the other symptoms were improving

Received shot at 1:10pm and was asked to wait 15 minutes before leaving. At 1:20pm I became very lightheaded and anxious. I stood up to look for a drinking fountain then woke up on the floor surrounded by people. Blood pressure was 80/40. Spent next two hours in ER on an IV. I was released once BP came back up. After getting home, I developed chest pain on the left side which I still have after three days so far.

FELT LIGHT HEADED; DISORIENTED; SWELLING OF STOMACH; SWELLING OF ARMPITS; SWELLING OF HANDS; ANXIETY; FEELS LIKE VERTIGO; This spontaneous report received from a patient concerned a 58-year-old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 (took 6-7 months to clear), and concurrent conditions included smoking, fatty liver, high triglycerides, dieting, and seasonal allergies. Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered, 1 total to left arm on 09-MAY-2021 for prophylactic vaccination. Concomitant medications included loratadine for seasonal allergies. On 09-MAY-2021, 30 minutes after vaccination the patient felt light-headed and disoriented and he drove to the hospital where he consulted in emergency room and did blood work, and did X-ray of heart and lungs. They put him on IV (intravenous). Patient was admitted for 4 hours and discharged. On 09-MAY-2021, the patient also experienced swelling in both hand, stomach and in his armpits. Since after discharge patient felt disorientated sometimes. The patient felt nervous and also felt like vertigo. Patient was completely disoriented and felt dizzy when he was walking (prior day of reporting). He still had swelling on hands and recovered from swelling on stomach and armpits. Patient felt anxious sometimes and could not walk and he mentioned it could be partly due to unemployment and overwhelming medical bills. The patient mentioned that he had covid-19 in OCT-2020 which was pretty bad that made him decided to take vaccine. He was worried how long these symptoms will persist at a time and unemployment added to his anxiety. He also mentioned about seeing doctors to rule out other rational other than the vaccine. Patient had lab test during his emergency room visit. Laboratory data included: Blood test (NR: not provided) as Not reported, and X-ray of heart and lungs (NR: not provided) as Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of stomach, and swelling of armpits in MAY-2021, and had not recovered from felt light headed, disoriented, feels like vertigo, anxiety, and swelling of hands. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210556773 -Covid-19 vaccine ad26.cov2.s-Felt Light-headed, Disoriented. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY V0: 20210556773 -Covid-19 vaccine ad26.cov2.s-Swelling of stomach, swelling of armpits, swelling of hands. 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).

BILATERAL SWOLLEN LEGS FROM HIP TO FEET; SWOLLEN TESTICLES; DIFFICULTY AMBULATING UPSTAIRS; DIFFICULTY PUTTING ON SHOES; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included open heart surgery, and aortic aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included furosemide for heart surgery. On 04-MAY-2021, the subject experienced bilateral swollen legs from hip to feet. On 04-MAY-2021, the subject experienced swollen testicles. On 04-MAY-2021, the subject experienced difficulty ambulating upstairs. On 04-MAY-2021, the subject experienced difficulty putting on shoes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral swollen legs from hip to feet, swollen testicles, difficulty ambulating upstairs, and difficulty putting on shoes. This report was non-serious.

Overall flu like symptoms and extreme weakness now lasting 12 days. Insomnia for 8 days. Extreme pain from hips up back to neck, and ribs front and back still continue. Periodic cold sweat mainly in the mornings and sense of unsteadiness in my head.

COVID-19 PNEUMONIA; DEPENDENCE ON VENTILATOR; NOT ABLE TO WALK; COULD NOT WORK; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, alcohol user (not often), and non-smoker, and he had no chronic medical history. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: unknown) dose was not reported, 1 total, administered on 09-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. After vaccination on 10-APR-2021 (Saturday), he was feeling bad and 11-APR-2021 (Sunday) and 8 days later went to the hospital. He did a polymerase chain reaction (PCR) covid-19 test at the hospital on 16-April-2021 and result was positive. He went back home but on 28-APR-2021, because his oxygen levels dropped and had trouble breathing. He was ventilated for 18 days. He was hospitalized for Covid-19 pneumonia (pneumonia, feeling bad and lost 45 pounds) for 36 days. He was discharged from hospital on 03-JUN-2021. On an unspecified date, he was not able to walk. He had home therapy and nursing therapy to be able to walk again and he lost 45 pounds. Since unspecified date, he could not work for 3 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 pneumonia on 03-JUN-2021, and dependence on ventilator, and could not work, and had not recovered from not able to walk. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000182426. The suspected product quality complaint has been confirmed to be not voided. The patient received the vaccine on 09-APR-2021 and had a positive Covid-19 test on 16-APR-2021 with 7 days elapsed between vaccination and test. There was not sufficient time elapsed for the patient to achieve immunity; therefore this report was not considered a lack of effect for Janssen COVID-19 vaccine.; Sender's Comments: V0: 20210622074-covid-19 vaccine ad26.cov2. s-Covid 19 Pneumonia, Dependence on Ventilator. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

I am finding my ability to stand, walk, or hold my arms above my head for any period of more than a few minutes difficult. Yesterday I was unable to hold myself upright sufficiently to sit in a kayak (never got to find out for how long could I try to paddle). Mentally I am constantly having short-term memory challenges, for example just recalling the word fatigue to describe my situation I have had to write on a note paper as I repeatedly forget the term until I read it. Bringing groceries from our vehicle into the house I am finding near impossible (what used to take 1-2 minutes has taken me over 15 in the past 3 weeks on multiple occasions). I find myself falling asleep repeatedly during work, even though I am sleeping well at night. Some days are better than others, with a strong correlation to temperature.

TREMBLING; BODY ACHES; NIGHTMARES; SEVERE CHILLS; SORE / PAINFUL ARM; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, and other pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 28-JUN-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) Negative. On 28-JUN-2021, the subject experienced sore / painful arm. On 29-JUN-2021, the subject experienced trembling. On 29-JUN-2021, the subject experienced body aches. On 29-JUN-2021, the subject experienced nightmares. On 29-JUN-2021, the subject experienced severe chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trembling, nightmares, and severe chills on 29-JUN-2021, and body aches on 30-JUN-2021, and had not recovered from sore / painful arm. This report was non-serious.

Stroke, treated at hospital with blood thinners. Outcomes - 85% within a year. Patient has memory and speech issues. Facial paralysis on right side.

Awoke with the the room spinning, dizziness, headache, brain fog, vertigo, fatigue. I have had these symptoms for over 2 months now. Have reported it to my doctor and 2 neurologists. On going. Taking Tylenol, Naproxin, Aspirin, Motrin for relief. Also take Dramamine to help with dizziness.

Severe chills, sweating, low grade fever, intense headache, and pain in the back of my neck. Vaccination was at 10am and symptoms started at 7pm and lasted through the night. By 9am (23 hours later) all symptoms seem to be cleared leaving me very tired from lack of sleep.

Temperature peaked at 101.7, chills, little confusion, but the temperature is coming down due to vinegar and water on head.

Fever (reached 102.3) Fatigue Headache nausea Symptoms started about 8pm (7 hours after vaccine) and were in full force by 10pm. The fever and associated shivering kept me awake until about 4am. Woke up about 9am the next morning feeling much better. Fever was down to lower 99. Aside from being tired I was felling fine by noon.

moderate severe chills,(main symptom),,during bedtime,,,general body ache,,,unable to perform daily activity for 24 hrs,,,symptoms subsided rapidly after 24 hrs,,,also be noted ,alcohol was consumed 3 hrs after vac,,,2 beer,,,2 shot of vodka,,,ate normal dinner at 8pm.

Patient become diaphoretic, nauseous, and pale. There was no SOB reported. Patient's anxiety recovered--given juice and a snack and reported feeling better. BP 110/77, 94% SP02, Pulse 85. Patient went home in stable condition

Pt received dose of J&J vaccine (Janssen) on 3/13/2021. Symptoms began around 3/27 similar to COVID-19. Pt presented to ED at another local hospital 3/29/2021, tested positive for COVID-19 and was transferred to be admitted to our hospital for treatment of COVID-19. Notes from hospital admission H&P: Patient is a 59 y.o. male with history DM, Who presented to Urgent care then hospital ER with covid positive, PNA, Fever and a cough. Real tachycardic there to 117, temp to 103, confused, moving slow. Altered mental status (slow cognition), 94% on 2L"

Patient reports feeling spacy, difficulty focusing, light headed. Has been happening since he woke up at 3:25 am the day after getting the vaccine. There seems to be a lot of confusion for the patient. No fever present any day after getting the vaccine. Patient reports that he feels "High as a kite."

Started to feel weakened after about 6 hours. Woke up about 12 hours later with very sore muscles, headache, and significant cold shivering. Was unable to go back to sleep.

Went emergency after noticing one of my veins had turned red and was hardening. Vein pulsing in left leg. Emergency room doctor diagnosed "superficial thrombophlebitis." The pulsing in lower leg (calf) continues and in elbow and wrist joints. The pain is not an issue. I've been feeling a bit of but most of my discomfort has been anxiety about what's going to happen next and what are the throbbing. The vein is no longer red, is slightly hard, pain is a 1 on scale of 10. Doctors have not contacted me since the evening after I was seen and I reported to them I felt better than I did at the hospital.

FELT HUNGOVER; LOSS OF ENERGY/DIDN'T HAD GUMPTION TO DO ANYTHING; FELT-LIKE DRUNK/BUZZED; TROUBLE GOING BACK TO SLEEP; FEELING OF LIKE BEATEN UP/ FELT DEAD; TIREDNESS; INJECTION SITE BURNING; ARM SORENESS; This spontaneous report received from a patient concerned a 59 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: 1808978, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 12-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced injection site burning. On 12-APR-2021, the subject experienced arm soreness. On 13-APR-2021, the subject experienced trouble going back to sleep. On 13-APR-2021, the subject experienced feeling of like beaten up/ felt dead. On 13-APR-2021, the subject experienced tiredness. On 13-APR-2021 05:30, the subject experienced felt-like drunk/buzzed. On 15-APR-2021, the subject experienced felt hungover. On 15-APR-2021, the subject experienced loss of energy/didn't had gumption to do anything. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site burning, and arm soreness, had not recovered from tiredness, felt-like drunk/buzzed, felt hungover, loss of energy/didn't had gumption to do anything, and feeling of like beaten up/ felt dead, and the outcome of trouble going back to sleep was not reported. This report was non-serious.

(Hips) both left and right. Adverse pain making walking, standing and laying in bed extremely uncomfortable. Ibuprofen for action of course, 3ea 250 mill in AM again at PM. Before ibuprofen pain level 6 out of 10. After ibuprofen 4. NOTE: problems persistent to date...

No symptoms other than just a mild injection site pain. Didn't last long. On 5th of April I began to get: I had rigors (shaking, chills), sweats at night 3 or 4 times of night changes of bedding, acute Prostatitis and pain upon urination and pain from prostrate itself. fever spike as high as 102.2 and my blood cultures were positive for Staphauereus in my blood stream. Sepsis diagnosis. I was admitted to hospital on 7th April of Hospital I had a fever of 102. My prostate was enlarged to 131 grams and I was having difficulty urinating. The infection was Staphaureus Staphlicottis. I was initially treated at a walk-in clinic and they did a direct admit to the hospital for UT .and I stayed there for 7 days. They installed a PICC line for IV upper arm to vena cava up into my heart. I still have that in - for intravenous home infusions of antibiotic. Peripheral Inserted central Catheter. Up until Sunday, May 16, of this past week, I had extreme fatigue to the point of not being able to walk a normal amount for me - maybe 1/3 of the amount. I haven't been able to get back to my regular exercise. I was having headaches and brain fog and a lot of aches and pains throughout the body up until Sunday. Since then I have felt quite a bit better.

Client was seen by his doctor on April 13th related to severe headaches . He stated that he had headaches prevaccine and was given Tropromax for it which he only took for 2 days as it caused him dizziness. He had CT scan of Head and MRIs on April 13 and 14th and then again on April 27th. The scan on April 27th showd a blood clot with 80% blockage in carotid artery and was dxd with a blood clot via CT scan. . He was told to get to Hospital where he was admitted to ICU for 4 days Client was also dxd with Factor5 Leiden at that time. Per client he ha a stroke and is recovering. Per client still unable to work r/t poor balance and dizziness

Pt received shot, went home, within 1 hour of having shot he felt extremely high. The feeling escalated quickly, lasted about a 1/2 hour, and then subsided. He described his symptoms as feeling paralyzed, as he couldn't move, even to reach his phone to call for help, but his mind was alert. He felt tired and achy and slept for 3 hours.

PATIENT COMPLAINED OF LOW BLOOD SUGAR AND ANXIETY. PATIENT DRANK OWN ORANGE JUICE HE HAD BROUGHT WITH HIM. PATIENT STATED FEELING BACK TO BASELINE

Cubital tunnel syndrome in injected arm. Hands "fall asleep" occasionally, but this time it did not resolve, resulting in weakness in hand and arm that have only partially recovered in the weeks following. Unable to use left hand since onset to use most tools, turn a valve, etc. Uncertain at this point whether full recovery is possible, but progress seems to be stalled at perhaps 50%-75% capacity. Icing helps with pain, along with regular acetaminophen and occasional ibuprofen. Exercise (including ulnar nerve "flossing") helps with recovery but has plateaued.

TICKING SOUND IN THE BACK OF NECKTICKING SOUND IN SKULL; ANNOYANCE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, non-smoker, coronary artery disease, high blood pressure, anxiety, and depression, and other pre-existing medical conditions included the patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced ticking sound in the back of neck. On 12-MAY-2021, the subject experienced ticking sound in skull. On 12-MAY-2021, the subject experienced annoyance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ticking sound in the back of neck, ticking sound in skull, and annoyance. This report was non-serious.

Patient had stated that he tended to pass out after giving blood. After shot was given pharmacist stayed with patient in case something happened. Patient almost immediately said he didn't feel right. Patient started to lose color and was very hot. Pharmacist got up and stayed next to patient. Patient slowly lowered his head and started to breathe heavily. Pharmacy technician then came over with a cool towel to place on patients head. The pharmacist couldn't tell if patient had in fact passed out because patients head was down and pharmacist was holding patient in place so he didn't fall. The pharmacy tech was asked if patient passed out and she saw his eyes were open. Patient then asked how long he was out for. That was for a total of roughly 5 seconds. Patient then stayed at pharmacy for around 45 minutes. He regained his color and his body temp returned to normal. He did say he was drowsy but felt he was fine to go home. Patient was called later in the day and he said he was drowsy but feeling much better.

I did not feel well for several days following the injection. I was tired and had a headache. However as the days went bye I stopped exercising and did not feel like working or even leaving the house. On the night of May 24 I began to have the worst headache of my life, my heart was beating irregular. By the morning of the 25th I got up and passed out. I was sweating, heart pounding, nauseous, chest pain, shortness of breath, pain in my shoulder blades.

within 2 weeks of injection, patient feels he had worsening Fatigue, Weakness, Tremulousness, confusion.