Johnson & Johnson

Post-injection patient reported feeling hot, sweaty, dizzy, and flushed. Blood pressure was low. Patient began vomiting. Patient was transferred to a nearby doctor's office for further observation. Patient's symptoms resolved.

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.

Chills, headache, bodyaches, nausea, and tiredness started overnight on 3/19 and lasted throughout Saturday. Woke up fine on Sunday, March 20th. The injection site was also sore for 2 days after vaccination, but is better now too. I did have Covid-19 in August of 2020.

Experienced moderate debilitating flu symptoms day after vaccination and recovered the following day. Over one week later (3/25) developed skin sensitivity on the neck which later spread to back, torso, and legs. Skin sensitivity persists still one week after onset, is a severe chafing feeling when skin comes into contact with clothing. No rash or any visual signs. Along with the skin sensitivity, mild to moderate chills from day to day as well as muscle fatigue and upper/lower back pain. Symptoms varied in severity day to day; used ibuprofen and it seemed to offer limited, temporary relief. Concurrent with second onset of symptoms, noticed gradual abdominal inflammation and developed sensation similar to UTI but urine dip and lab test results were all normal. Doctor concluded immune reaction to vaccine as no other allergies or changes in routine as well as no prior medical history of any of these symptoms. Prescribed daily prednisone for three days to calm immune response; after one day symptoms were greatly improved. Abdominal inflammation has improved and UTI sensation improved. Still experiencing slight chills and skin sensitivity unchanged.

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.

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.

Fever (100 F at 11 pm, 4/3/21, 7 hours after vaccine; 101.9 F, at 11 am, 4/4/21, 19 hours after vaccine: fever fell to normal 98.6 F by 7:30 am 4/5/21. Severe chills, uncontrollable shivering for about 10 minutes at about 11 pm 4/3/21; chills and hot flashes, sweating, on and off all day 4/4/21. Moderate body aches 4/3/21 and 4/4/2 Slight nausea 4/3/21

Fever, Chills, Body aches. Worst symptoms resolved in a few days. Still feeling fatigue a week after vaccination. Have moments of light nausea.

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.

ACHING BODY (INCLUDING THE CHEST AND AROUND THE AREA OF THE VACCINATION); NUMBNESS IN LEFT FINGER; CHILLS; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 40 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: 042A2A and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021; 13:16 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced aching body (including the chest and around the area of the vaccination). On 06-APR-2021, the patient experienced numbness in left finger. On 06-APR-2021, the patient experienced chills. On 06-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, chills, and aching body (including the chest and around the area of the vaccination), and had not recovered from headache, and numbness in left finger. This report was non-serious.

Within 8 hours of the shot, patient developed Chills, severe headache, fever (101-102) and vomited four times between 12am-7am. Note that he has had COVID infection in April 2020

severe headache, fever, chills, body aches (including in testicles), severe coughing, nausea, difficulty breathing

First evening of the J&J vaccine (4/1/2021) I had a fever, chills, headache, and was lethargic. This lasted for 2 nights. These symptoms I anticipated. What I didn?t anticipate was my abdominal pain. I still feel as of today (4/14), pain in my abdomen. The areas of the discomfort are all over my mid-section. I was so worried that I went to ?Urgency Care? doctor on 4/5/2021 and the nurse had me go for a ?CT Scan?. I also went to my Primary care physician on 4/13/2021 and described my concern and abdominal pain but didn?t get a diagnosis.

Patient was vaccinated at Pharmacy. Patient had COVID vaccine on 03/29/2021- Janssen vax, was administered at Pharmacy at 11:20 am. He had headache "almost migraine like" and nausea started 03/30/2021 lasted about 24 hrs. He states that he was just calling to report HA since he has heard the news about the Janssen vaccine. I informed him that I would take down this information and that most likely he was having side effects to vaccine which is pretty common for those symptoms. I also informed him of the adverse effects that would require immediate medical attention (severe HA, abd pain, leg pain and SOB). He states that currently he feels fine and does not have any symptoms. I informed him that would document this information for him and if he started with any other symptoms to come into clinic.

DIARRHEA; This spontaneous report received from a patient concerned a 40 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: 206421A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210427520.

Rash on both arms, started the next day, still there a week later. no treatment Sore throat, next day still happening. Nausea started next day. went away two days after Fatigue. day after and went away after that.

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.

LOSS OF APPETITE; FEELING WARMER THAN USUAL; FEELING ACHY; FEELING SICK; WEAKNESS; CHILLS; HEADACHE; WOOZY/DIZZINESS; This spontaneous report received from a patient concerned a 40 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced woozy/dizziness. On 13-APR-2021, the subject experienced loss of appetite. On 13-APR-2021, the subject experienced feeling warmer than usual. On 13-APR-2021, the subject experienced feeling achy. On 13-APR-2021, the subject experienced feeling sick. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling sick, headache, chills, loss of appetite, weakness, woozy/dizziness, feeling achy, and feeling warmer than usual. This report was non-serious.

Called Connections on 4/20/21. Pt c/o feeling swollen throat glands, hard to swallow, dry/sore throat, also random dizziness not constant, feeling body aches, tired, runny nose but pt denies sob, difficulty breathing, chest pain. Speech seems comfortable, AO X 3. Pt stated these sx started on 04/13/2021 after he got his Janssen(J&J) covid vaccine on 04/12/2021,he stated sx not getting better its getting more from then. This writer recommended pt to go to ED/call 911 for further evaluation and treatment. Pt took covid test yesterday awaiting for his result. Denies any past medical Hx

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.

A little after two weeks after vaccination I developed a extremely disgusting metallic taste in my mouth. I can no longer eat food without being disgusted and wanting to spit it out and it has not gone away

patient became diaphoretic and dizzy, mild nausea hands went tingling and numb. pt was moved to well ventilated area and recovered quickly. regained color and dizziness diminished.

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.

Patient within a few minutes indicated he felt dizzy and sweaty. I sat him down within minutes his eyes rolled back and he lost consciousness. He bagan to make gurgling noises as if trouble breathing. His color was grey and he was sweating profusely. 911 was called by a technician and I gave one dose of Epinephrine 0.3 mg into lateral right thigh at approx. 9:40 am. Within this period of time he began seizing. He regained consciousness prior to EMT's arriving and was brought to the hospital.

patient received the Janssen injection and at one minute became vagal and began vomiting at 2 minutes had a temporary loss of consciousness, EMS arrived at 4 minutes and patients heart rate was alternating between 20bpm-40 bpm. EMS transported to ED. Patient was discharged home at a later time.

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.

STOMACH HURT; VOMITING /THREW UP BROWN LIQUID; CAN'T EAT OR DRINK ANYTHING; FEELING COLD; BODY CHILLS; WEAKNESS; LEFT ARM PAIN; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non smoker, and non alcoholic. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced stomach hurt. On 21-MAY-2021, the subject experienced vomiting /threw up brown liquid. On 21-MAY-2021, the subject experienced can't eat or drink anything. On 21-MAY-2021, the subject experienced feeling cold. On 21-MAY-2021, the subject experienced body chills. On 21-MAY-2021, the subject experienced weakness. On 21-MAY-2021, the subject experienced left arm pain. On 21-MAY-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting /threw up brown liquid, left arm pain, and nausea on 21-MAY-2021, had not recovered from headache, body chills, stomach hurt, weakness, and feeling cold, and the outcome of can't eat or drink anything was not reported. This report was non-serious.

Patient felt nauseous and lightheaded within 2 minutes of vaccination administration. He threw up once and felt better. VSS. Observed him for approximately 30 minutes. Patient reported he felt back to normal. Left in stable condition, without any symptoms. He did report he thinks that he had a reaction because he had not eaten all day. He is not a diabetic.

Shortly after receiving the Janssen vaccine, he saw his wife also receive the vaccine after which he felt extremely nauseous and looked very pale. His blood pressure was checked and measured 120/66, he said he was starting to feel warm but did not have any chest tightness, difficulty breathing, or swelling. After about 2 more minutes he said he was starting to feel better and then after 5 more minutes his blood pressure was 120/81, and he was starting to show more color to his face. He said he felt fine to leave. In hind-sight he stated that he has fainted in the past after seeing his wife receive a previous immunization as well.

06/10/2021 Pt, per EMS report pt had his second covid vaccine shot, started having bad reaction, ems on scene, pt GCS 10, spo2 92% RA, hypotensive. at home pt having bad reaction, vomiting, defecated. Pt on gurney moaning, shaking answering questioning. Per MD, CT results show multiple Pulmonary emboli

After 3 weeks, small rashes along the arms, minor coughing, occasional breathlessness, and mild diarrhea began appearing. Currently about 4 days of these symptoms. The week immediately after the injection, only minor itching about the body and nothing else. This might all just be a delayed response, but I'd like to note this occurred.

Main lingering adverse event is loss of sensation in the median nerve in both hands. Waited over two months hoping it would go away but hasn?t. Brought it up at annual check up with doctor who ran labs and has recommended EMG.

Chills, fever over 102.1 for 5 hours, extreme burning sensation in stomach, cramps in stomach for over 24 hours. Extreme fatigue for over 24 hours. Pain, soreness, and raised area at injection site.

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.

The effects started off as a general weakness, then progressed into nausea and, by the end of the day, chills. I did not have a fever. I took my temperature and it was normal at 98.1. I describe it as having a cold without the congestion and runny nose. I was fine by the next morning.

At 12:05 am client came to the staff office treatment facility stating he feels sick and has been throwing up. He stated he had the Johnson & Johnson vaccine Tuesday 4/6/21 in the morning and around 6 pm on Tuesday he started to feel sick. The staff took his temperature and it was 100.9 degrees. The client was dry heaving and red in the face and having cold sweats. Staff monitored him while 911 was called and paramedics showed up within 10 minutes. The Program Manager was notified and the client was given instructions for when going to the hospital.

Fever as high as 103.7, normal fever in 100-101.5 range, hot and cold flashes, sore arm and swelling in left hand, diarrhea, head aches

Fever of 102, body chills, nausea, headache, body aches, pain in lower back/kidneys, frequent nighttime urination. Headache and body/ kidney aches persisted until 1pm the following day, chills, fever frequent urination, nausea persisted until 7am the following day.

Chills, nausea and headache at 9pm, fever at 10pm peaking at 107.1° at 4am, blood pressure peaking at 216 over 103 at 8am. Fever persisted 41 hours, headache persisted 38 hours, nausea persisted 34 hours.

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.

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.

Patient was feeling warm and light-headed at 15 minute mark, so we kept for further observation and gave water to hydrate. At about the 17 minute mark patiently suddenly fainted in his chair for 15-30 seconds. He then began to vomit and woke up in the process. Once he fully came back to, he said he felt remarkedly better and no longer felt light-headed or clammy. Following this episode he reported feeling back to normal and that he had just ate a large breakfast before coming in for the shot, but did not feel bad in any way anymore. We observed for another 30 minutes and patient showed no further sign of issues. He was released with his wife.

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.

BODY ACHES AND CHILLS NIGHT OF VACCINE ADMINISTRATION, THEN STARTED EXPIRIENCING SHARP STOMACH PAINS LOWER ABDOMEN A COUPLE OF WEEKS AFTER VACCINE. DID NOT KNOW WHAT WAS CAUSING IT AND DID NOT THINK IT WOULD BE CAUSED BY THE VACCINE, STILL HAVING STOMACH PAINS.

About seven (7) days post vaccine injection I began to experience pain and numbness in both arms, numbness and swelling in my lips and face area and a feeling of indigestion/heartburn. I presented to urgent care and subsequently the emergency room on 03.27.2021 with those symptoms and was treated and released. The following day, the symptoms continued, specifically the pain and numbness in the bi-lateral arms and additionally began to experience pain in the chest area and increased resting heart rate (125+ bpm). Again presented to emergency room on 03.28.2021, treated and released.

I had chills the first night after the vaccine. In addition to that I have continuous pain in the legs, feeling of dizziness and fatigue even after sound sleep in the night. I am having feeling of nausea and vomiting on a continuous basis which have not gone away even after four days have been complete since vaccination.

On April 2, 2021 around 8:00 p.m. I begin having chills, body aches, fever ,nausea, etc. This continued until Monday April 5, 2021, minus the chills. My urine became very dark brown for a few days, then changed to a light pink color.

pins & needles sensation and "twitching" in muscles of bilateral lower extremeties, chest discomfort, abdominal pain, headache

CHILLS; FEVER (101.2 AND 103.5F); NAUSEA; 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 concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced fever (101.2 and 103.5f). On 20-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101.2 F, 103.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever (101.2 and 103.5f), chills, and nausea. This report was non-serious.

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."

COULDN'T TAKE A DEEP BREATH; FELT COLD; WHOLE BODY ACHY; DIZZINESS; WEAKNESS; CHILLS; EXTREMELY TIRED; NAUSEATED; EYES GOT HEAVY; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type2 diabetes. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. Concomitant medications included metformin for type2 diabetes. On 18-MAY-2021, the subject experienced whole body achy. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced weakness. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced extremely tired. On 18-MAY-2021, the subject experienced nauseated. On 18-MAY-2021, the subject experienced eyes got heavy. On 19-MAY-2021, the subject experienced couldn't take a deep breath. On 19-MAY-2021, the subject experienced felt cold. The action taken with covid-19 vaccine was not applicable. The patient recovered from nauseated on MAY-2021, was recovering from couldn't take a deep breath, had not recovered from extremely tired, whole body achy, weakness, and chills, and the outcome of dizziness, eyes got heavy and felt cold was not reported. This report was non-serious.

Symptoms of diarrhea and growth in abdomen following vaccination in otherwise healthy person. Diagnosed with Diffuse Large B-cell Non-Hodgkins lymphoma and 3b follicular lymphoma, >20 cm lymphoma mass in abdomen

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.

I received the vaccine March 15 and just shy of 2 months later; May 10th, 2021 I woke up at 8am with a severe headache. I had a fever as well as the chills. I was nauseous and dizzy all throughout the day. The same symptoms continued on for 1 week. Then they eased up. I didn't think too much about it, but then the headaches have continued. As well as the nausea and dizziness. The symptoms are erratic. They last for 2 days at a time. Then they disappear for a few days. Then the cycle repeats. This has been on going since May 10th.

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.

When I got the vaccine I got an instant pain in my arm and into my neck, then an intense headache between my eyes above my nose, I was flush and sweaty, nauseous. Then had a bad headache on the top of my head, then soon I had left side facial numbness . Light sensitivity

About 8 hours after the injection I felt chills, night sweats, headache, lethargy, dizziness, muscle aches, pain in my entire right arm and loss of appetite. Lasted about 36 hours.

(Janssen COVID-19 vaccine EUA) Day of vaccine - soreness in shoulder at the site of the injection. Day 2 - continuing soreness of shoulder, along with general aches, chills, and sleepiness. Day 3 - continuing soreness in shoulder, but no aches, chills, or sleepiness. Began feeling nauseous, but still had appetite. Day 4 - continuing soreness in shoulder, as well as nausea, but both are somewhat diminished.

Approximately 10 hours after receiving the injection, I experienced extreme chills, nausea, elevated heart rate. The last time I experienced symptoms like this was on the first day I started chemotherapy and had an allergic reaction to one of the chemo drugs (bleomycin). I had a delayed reaction hours later and went to the ER. It was determined it was an allergy. So I took Claritin D 24 H and saw the symptoms I was experiencing last night dissipate.

Around 8pm I became very cold and tired. I took a bath, which is out of character, and tried to sleep. By 9 pm I was alternating between hot and cold sweats. By 10 pm I was vomiting and defeating uncontrollably while still alternating between hot and cold sweats. I dry heaved until around 3 am and then finally passed out. My fever never exceeded right about 100 degrees. For the next 2 days I was incredibly exhausted with muscle aches and a minor headache. I didn?t return to baseline for approximately 6 days after the shot.

Severe Headache, Extreme inflammation in already injured neck and upper body bringing current pain level to 10. Fever, chills, naseau, dizziness, tiredness.

Woke up 8 hours after receiving vaccine. Violent chills. Light headed. Nauseous. Fever spiked to 103. Headache. Fever broke after 24 hours. All symptoms vanished after 48.

KNOT ON LEFT ARM; OFF LABEL USE; INAPPROPRIATE ROUTE OF VACCINATION; INCREASED BP; INCREASED HEART RATE; DIZZINESS SUNDAY AND MONDAY; PAIN IN ARM; DONT FEEL WELL; SOME NAUSEA; TINGLING OF HAND; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 239 (unit unspecified), and height was 5 (unit unspecified). The patient's concurrent conditions included allergy, thyroid, sinus infection, elevated growth hormone, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tingling of hand. On 27-MAR-2021, the subject experienced off label use. On 27-MAR-2021, the subject experienced inappropriate route of vaccination. On 27-MAR-2021, the subject experienced increased blood pressure. On 27-MAR-2021, the subject experienced increased heart rate. On 27-MAR-2021, the subject experienced dizziness Sunday and Monday. On 27-MAR-2021, the subject experienced pain in arm. On 27-MAR-2021, the subject experienced don't feel well. On 27-MAR-2021, the subject experienced some nausea. On 28-MAR-2021, the subject experienced knot on left arm. Laboratory data (dates unspecified) included: EKG (NR: not provided) clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness Sunday and Monday, and had not recovered from knot on left arm, tingling of hand, pain in arm, some nausea, increased blood pressure, increased heart rate, don't feel well, inappropriate route of vaccination, and off label use. This report was non-serious.; Sender's Comments: V1: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

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.

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)

Upset stomach, mild nausea for about 36hrs, extreme fatigue for about 72hrs- rest and eating start by foods were only treatments (self care)

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.

Severe leg pain first, then trouble breather. Shortness of breath and tightness in chest. Thought it was severe congestion... delayed going to the ER. Finally went in due to vomiting trying to get breath. Had LAD 90% blocked and blockage in the right leg still in hospital receiving treatment. Will Catheter scope the right leg to very clots and severity.

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 hypertension, 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced body aching. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced pain at injection site. Laboratory data included: Body temperature (NR: not provided) 101.2 F. On 12-APR-2021, 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 was recovering from fever, and pain at injection site, and had not recovered from dizziness, headache, body aching, chills, and nausea. This report was non-serious.

SORE ARM; CHILLS; FATIGUE; NAUSEA; FEVER; TOTAL BODY MUSCLE ACHES; 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) UNKNOWN. On 08-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced total body muscle aches. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, nausea, fever, and total body muscle aches on 10-APR-2021, and had not recovered from fatigue, and sore arm. This report was non-serious.

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

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.

Severe full body rash roughly 36 hours after vaccination. Took Benadryl 48 hours after rash started which resolved the rash. Minor recurrence of rash in patches across body persisting for the past two weeks. Additional symptoms 12 hours after vaccination: heartburn, fever, chills, headache, tiredness . All resolved within 48 hours of vaccination and haven?t returned.

CHEST IRRITATION; ACHES; CHILLS; NAUSEA; FEVER; This spontaneous report received from a consumer 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chest irritation, aches, chills, nausea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, fever, chills, aches and chest irritation was not reported. This report was non-serious.

THE PATIENT RECEIVED JANSSEN COVID 19 VACCINE IN THE LEFT ARM. I RECOMMENDED TO SIT FOR 15 MINUTES TO OBSERVE THE PATIENT. PATIENT REQUESTED TO USE THE BATHROOM IN THE PHARMACY RIGHT AFTER VACCINE. PATIENT CAME BACK FROM THE BATHROOM SAYING THAT HE FAINTED AND FELL IN THE BATHROOM AND SLASH OPEN THE LEFT SIDE OF HIS CHEEK WAS BLEEDING A LOT AND HE FELT DIZZY AND NAUSEA. HE FAINTED THE SECOND TIME ON THE FLOOR. 911 WAS CALLED PROMPTLY. POLICE AND AMBULANCE CAME TO GO TO THE HOSPITAL.

on the 2nd i had the shot in the left upper arm .. two days later i woke up to violently upchucking pure water after that i when to hospital and was admited i was told after a ekg that i was haveing a heart attack after that have no recolectiom of anything i wake up to a doc telling ,e it was a bad heart attack and had delovped about 5 blod clots in left lung and microcaditis i have been trying since then for a doc to talk to me but so far i been avoided

Pt reported a headache since the day after getting the vaccine but did not report until 4.22.21. Pt was seen on unspecified date and found to have elevated blood pressure which was already being monitored. Lisinopril was started per MD. Headache improved and patient was using Ibuprofen and Tylenol which also helped. Headache worsened with vomiting episodes and MD changed med to Excedrin Migraine. Pt was tested for COVID-19 - negative antigen test but positive PCR NP swab. - Pt sent to ER due to continued vomiting/headache. Pt was also COVID-19 positive in October 2020 and had tested negative with nasal swabs (not NP) until completed on unspecified date

4/27/21 pt started to have nausea and upper abdominal pain, 4/28/21 presented to the clinic due to nausea, vomiting and abdominal pain. Examination showed elevated BP, mild upper abdominal distention and pain. Pt given Zofran 4mg for nausea, sent home to rest. Pt reported the next day to be feeling better, but got worse that night 4/29/21, went to the ER, diagnosed with a bowel obstruction.

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.

Cold hands and feet, blood pooling in hands, blurred vision, loss of appetite, palpitations, excessive urination, and pain around left shoulder blade area of back.

After about 5 minutes patient became light headed and became prone on the floor. Patient became nauseated and vomited.

VOMITING; HURTING ALL OVER; SEVERE HEADACHES; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 42 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: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced vomiting. On 09-JUN-2021, the subject experienced hurting all over. On 09-JUN-2021, the subject experienced severe headaches. On 09-JUN-2021, the subject experienced nausea. On 09-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headaches, nausea, vomiting, hurting all over, and fever. This report was non-serious. This case, from the same reporter is linked to 20210619423, 20210619407 and 20210619408.

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.

Waited over 20 min without resolution of nausea .Patient with hx of Gerd on PPI . Patient without cardiopulmonary symptoms . Patient encouraged to take PPI and make dietary changes x 24 hrs .Patient reported dizziness during questioning (mild) . Ambulance.

In the beginning, my feet and hands had poor circulation and became discolored, cold, and painful (like Reynaud's syndrome). I was able to get the circulation going by exercising. This lasted for a couple of weeks. I had cold sweats and chest discomfort, which I thought were symptoms of WPW. I went to the cardiologist. An EKG was done and I was put on a 2-week halter monitor. Everything checked out as not being a heart issue. Blood tests were done, and the results were normal. After the cold hands symptom, I developed palmar erythema. I also developed a lot of abdominal pain. I became really gassy, and my bowel movements became a light yellow. I had frequent urination. My weight dropped from 191 to 180, and I lost my appetite completely; the appetite loss happened for a week and a half. I had to force myself to eat. My hunger is now back, and I currently weigh 187. The gassiness, yellow stools, abdominal pains, and the frequent have all largely subsided. The stools are now a normal color. The palmar erythema is still present, though.

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.

MUSCLE LOSS TO THE ARMS AND SHOULDERS; BITES MARKS TO THE INSIDE OF THE THIGHS; NUMBING SENSATION TO BOTH LEGS FROM TOP OF CALF TO BOTTOM OF QUADS AND PAIN WORSEN AND SPREAD EVERY DAY; DIFFICULTY EATING DUE TO ABDOMINAL DISTENTION; SEVERE PAIN TO BOTH SIDES OF THE ABDOMEN AND IT IS PAINFUL TO TOUCH; DISTENDED ABDOMEN; NUMBNESS AND TINGLING TO UPPER BODY, UP TO NECK AND DOWN TO THE ANKLES.; FELT LIKE "PINS AND NEEDLES IN ALL ORGANS"; CURLED UP IN THE BED; GENERAL BODY ACHES; 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 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: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced general body aches. On 18-MAY-2021, the subject experienced felt like pins and needles in all organs. On 18-MAY-2021, the subject experienced curled up in the bed. On 08-JUN-2021, the subject experienced severe pain to both sides of the abdomen and it is painful to touch. On 08-JUN-2021, the subject experienced distended abdomen. On 08-JUN-2021, the subject experienced numbness and tingling to upper body, up to neck and down to the ankles. On 08-JUN-2021, the subject experienced numbing sensation to both legs from top of calf to bottom of quads and pain worsen and spread every day. On 08-JUN-2021, the subject experienced difficulty eating due to abdominal distention. On 03-JUL-2021, the subject experienced bites marks to the inside of the thighs. On 06-JUL-2021, Laboratory data included: Laboratory test abnormal (NR: not provided) Elevated liver enzymes, diagnosed with ascites, and Sonogram (NR: not provided) Free fluid in the abdomen. On 09-JUL-2021, the subject experienced muscle loss to the arms and shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from curled up in the bed on 19-MAY-2021, and bites marks to the inside of the thighs on 09-JUL-2021, recovered with sequelae from felt like pins and needles in all organs on 19-MAY-2021, and had not recovered from general body aches, severe pain to both sides of the abdomen and it is painful to touch, distended abdomen, numbness and tingling to upper body, up to neck and down to the ankles., muscle loss to the arms and shoulders, numbing sensation to both legs from top of calf to bottom of quads and pain worsen and spread every day, and difficulty eating due to abdominal distention. This report was non-serious.

Around 24 hrs after getting vaccine I started to get dizzy when moving around. The dizziness and Nausea has continued for now 9hrs since started.

- severe chills - lasted about 4 hrs - severe headache - lasted about 24hs - body ache - joint pain - nausea - lasted about 18hrs

103 degree fever, uncontrollable chills/shaking, headache, nausea, body aches, dizziness, weakness. Fever lasted 36 hours, aches and headache lasted 48. Felt like the worst flu of my life. Sickest I've felt in 10+ years.

Fainted about 7 minutes after receiving the vaccine. Came up to consciousness again after 1-2 minutes, but felt lightheaded and nauseas. Vomited 45 minutes after receiving the vaccine.

Patient became dizzy and had a vasovagal response. His heart rate dropped between 40-50 and did not increase how EMS had expected. Patient began to vomit and was transported.

While waiting 15 minutes after receiving the shot patient suffered a seizure roughly 5 minutes after receiving the vaccine. Seizure lasted approximately 10 seconds. Paramedic was on site and assisted in monitoring the patient until ambulance arrived. While waiting patient was sweating, nauseas and 'didn't feel well'. Patient suffered a second smaller seizure before the ambulance arrived. Patient was monitored and taken to ER.

PATIENT RECIEVED VACCINE 9:49 AM, MOVED TO POST VACCINATION AREA. BECAME DIZZY AND FAINT, WAS MOVED TO FLOOR FROM CHAIR. PASSED OUT AT 9:50 AM. CAME AROUND 9:55AM WITH NAUSEA THAT DID NOT RESULT IN VOMITTING. PATIENT SAT FOR AN ADDITIONAL 30 MINUTES WITH WIFE UNTIL FELT FINE TO LEAVE POST VACCINATION AREA AROUND 10:30AM. NO INJURY RESULTED. PATIENT ADMITTED AFTER VACCINATION THAT THIS IS A COMMON REACTION TO VACCINATION AND NEEDLES IN GENERAL.

sharp pain in arm starting approximately 5 minutes after injection, lasting about 5 minutes. dull ache in arm at injection site for four days after injection. flu-like symptoms including body ache, tiredness, weakness, fatigue, loss of appetite & general malaise starting approximately 24 hours after injection, lasting about 12 hours.

Patient states he was doing well until 419 when he had abdominal pain. Patient says abdominal pain started in the middle of his belly and radiated to his back. Pain is worse when he tries to eat and 8 out of 10. Pain is sharp. Patient has not had pain like this before. Pain improved when not eating. Patient has had watery non-bloody diarrhea for the past 2 days. Patient denies any fevers or chills.

INCREASED SEIZURES; THREW UP; INCREASED PHLEGM / INCREASED COUGHING; This spontaneous report received from a parent concerned a 43 years old white Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included cerebral palsy, mental retardation, and epilepsy, and concurrent conditions included seizures, cough, and phlegm. 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: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced increased phlegm / increased coughing. On 07-APR-2021, the patient experienced increased seizures. On the same day, he experienced threw up. The patient usually had a cough and phlegm. On the following day of vaccination, the patient's amount of phlegm and cough was increased and he throw-up and had 2 seizures. On 08-Apr-2021, the patient had 10 seizures. The patient regularly had seizures but the number per day increased after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased seizures on 09-APR-2021, and threw up on 07-APR-2021, and had not recovered from increased phlegm / increased coughing. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210428761-covid-19 vaccine ad26.cov2.s-increased seizures. 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

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.

Vasovagal episode. After receiving dose patient complained of feeling lightheaded, nauseous and was visibly sweating. Vitals were taken 10:10 106/60 97% HR: 52. At 1015 vitals were 118/10, 98% and HR 65. Patient was given wet towels around his neck and on his forehead. brought cot to patient and patient placed in trendelenburg position. pt given water and stated he was no longer lightheaded or nauseous but continued to have HA. Pt at that time was being evaluated by both doctors. Patient then walked to monitor area where was continuously checked on until 1100 when his vitals were rechecked (118/80, 68HR). Pt stated he felt better and was released and recommended not to drive. Pt says his brother would drive him home. - RN

PT COMPLAINED OF INTENSE PAIN IMMEDIATELY AFTER INJECTING, THEN NAUSOUSNESS, THEN WANTED TO STAND, AS I WAS PREVENTING HIM FROM STANDING HE BEGAN TO SHAKE AND THEN WENT LIMP, I USED SMELLING SALTS AND HE CAME TO, HE WAITED IN PHARMACY HIS BP WAS LOW, WE GAVE WATER AND AFTER ABOUT AN HOUR HE WAS ABLE TO WALK OUT ON HIS OWN

Received vaccine on 5-6-21. On 5-8-21, complained of headache, bloating, fever, and constipation. Last seen alive at 9 PM on 5-8. Found dead at home at 7 PM on 5-9.

Blood clot in superficial vein behind right knee as well as vertigo and nausea. Currently on 30mg/day of XARELTO blood thinner (I've been taking since diagnosis on 5/5/21). Will continue to take 20mg/day for the next 30 days. Background: I started to notice my right calf get tight and sore approximately ~3 weeks following my vaccination. I had been doing a lot of running and hill training so I assumed it was a muscle strain/aggravation. After approximately 1-2 weeks I noticed the tightness worsen and also noticed significant swelling around my lower calf/ankle. I went to the doctor on 5/4/21 and was given a D Dimer blood test which came back 1.27 mcg/mL FEU (over the recommended 0.5 mcg/mL). The next day I had an ultrasound of my right leg where they discovered the SVT clot behind my right knee in a superficial vein (but near a major/deep vein intersection). I was immediately prescribed XARELTO blood thinner - to be taken for ~51 days. ~21 days of 30mg/day (15mg twice/day) followed by ~30 days of 20mg/day 1x per day. The morning of 5/20/21 around 6:30am I started to feel nausea and vertigo after returning home from walking my dog. I finished a low-intensity exercise routine at my home and around ~7:15am my symptoms worsened. I went upstairs to my bedroom to lay down on my bed and the room started spinning. I then went to the bathroom and vomited clear fluid. I started feeling a little better after vomiting but was still slightly dizzy and light-headed. I made an appointment and went to the doctor around 10:30am. The doctor suggested doing further bloodwork and a CT scan of my head. Both tests came back normal. The doctor suggested the vertigo and nausea were inner ear related and that I should continue taking XARELTO and to also start wearing a compression sock (especially during exercise/activity).

PAIN IN STOMACH; SWEATS; REDNESS ON BODY LOOKS LIKE SKIN IS DISCOLORED; CHILLS; FEVER; NAUSEA; BODY PAIN; MIGRAINE; EVERY BEAT OF HEART HURTS; HYPERVENTILATION; COULD NOT GET A FULL BREATH; PASSED OUT'; FINGERS WENT NUMB; GOT A CHARLIE HORSE ON LEG; EVERY SINGLE JOINT AND ANKLES HURTS FOR NO REASON; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight was 135 pounds, and height was 66 inches. No past medical history or concurrent conditions were reported. The patient's concurrent conditions included migraine The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered, 1 total to right deltoid on 19-MAY-2021 around 10 am for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, around 7 pm patient started experiencing side effects. After 1 hour of shot patient had his heart hurt at every beats, hyperventilation. It lasted for 1 -2 hours. The patient also had fever, chills, nausea, sweats and had not taken any medication, as he was afraid of another side effects, had redness on his body which looked like skin was discolored and was like hives. The patient also had body pain appeared suddenly. The patient also had pain in stomach which felt like nastiest gas cramp patient had ever and it was continuous like a rock blocking in stomach, he did not know if it is pain or gas but was hurting. Patient had migraine which lasted long time and was continuous than he ever had. The patient was fine as he was speaking at the time of reporting. On MAY-2021 (dates unspecified) the patient experienced Charlie on his leg (muscle spasm) for which he stood up and didn't do anything on leg, he was passed out and fingers went numb, felt every single joint and ankle hurt with sharp pain like a stuffed knife (intermittent pain for 3-5 minutes).He could not get a full breath of air, and was breathing really fast. Then patient tried to slow down breathing as he didn't want to be hyperventilated but it happened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body pain, hyperventilation, migraine, pain in stomach, chills, fever, nausea, and sweats, and the outcome of passed out, could not get a full breath, redness on body looks like skin is discolored, got a charlie horse on leg, every single joint and ankles hurts for no reason, fingers went numb and every beat of heart hurts was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210540430-COVID-19 VACCINE AD26.COV2.S --Every beat of heart hurts, Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

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.

Extraordinary chills and body shakes, painful joints, burning sensation of skin all over, fever of 103.6, slight nausea - all lasting 12 hours and then subsiding.

Patient admitted to hospital with a platelet count = 0. Patient presented with fatigue, mouth sores and body rash and extensive bruising. Patient also tested positive for COVID 19.

High fever, muscle aches, shaking, nausea, shortness of breath. All of these lasted for 18 full hours, and slightly shortened breath is still present 5 days later.

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.

ive never been sicker throwing up,diarehaa,cold/hot flashes,super tired,and basically havent felt all trhe way well since taking shot i totally regret getting shot

pt stated that he got flu like symptoms including tight muscles, headache, body aches, chills, he was nauseated. He woke up feeling a little better but still has head ache, body aches and some nausea.

Myalgia, Arthralgia, Fever, Diarrhea, Fatigue Narrative: Reports fever on 3/5 at night into 3/6, diarrhea on 3/7. Myalgias, arthralgias, and fatigue on 3/5, 3/6, and 3/7. All resolved on 3/8.

3/12 4:30 pm started with frequent liquid diarrhea for the next 3 days but on 3/13 at about 9pm broke out in full body hives, very red and became flushed and hot

Fever, muscle aches, extreme fatigue, nausea. Used Advil and rest...left work due to symptoms. Symptoms lasted about 36 hours. Resolved.

Cold hands/feet, shivering, chills, fever, massive sinus-like headache, nausea and felt like vomiting.

Felt a little warm for first 30 minutes after receiving the shot at 1015am but then felt fine until about 6pm that same day. At that point, started getting chills, which progressed into mix of chills and hot spells, fever, headache, and frequent urination throughout the night (though was also hydrating a lot). Had fever the next morning still and Diarrhea. Still feel modest headache and chills the next evening (before bed where I had felt the worst overnight the first night of the vaccine) but feeling better than the first night. Per the form I received, I was told to include Janssen COVID-19 Vaccine EUA in this section of the form. I am reporting this on the day after the vaccination, so don't yet know final outcome, but again, improving and don't feel like I need medical attention.

Three hours after the vaccine I had nausea and tiredness, slept for five hours. After waking up, I've had muscle ache, high fatigue and weakness, soreness all over the body, headache, head pressure, and pain in my muscles when an area of my body is pressed or grasped. Yesterday at 4pm, had chills and temperature for a total of 4 to five hours.

TENSION; SHIVERS; HEADACHE; VOMITING; LETHARGIC; SORE ARM; MYALGIA; 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 concurrent conditions included high blood pressure. The patient experienced drug allergy when treated with ibuprofen. 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 27-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced lethargic. On 27-MAR-2021, the subject experienced sore arm. On 27-MAR-2021, the subject experienced myalgia. On 30-MAR-2021, the subject experienced vomiting. On 31-MAR-2021, the subject experienced tension. On 31-MAR-2021, the subject experienced shivers. On 31-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, vomiting, myalgia, sore arm, shivers, headache, and tension. This report was non-serious.

- 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.

Day 1 after shot: body aches, headache, blurry vision. Day 2 and beyond: excruciating abdominal pains, no appetite, inability to have a bowel movement or even pass gas. Had I known this level of agony would happen, I would have refused the vaccine, and I will NOT take the J&J again.

Left arm felt thick and stiff; fingers on same side began to tingle; became dizzy; sweaty; got up to ask for help as instructed, fainted and hit the top on my head on the counter, I believe; came to; threw up; laid on the floor for a while; moved to a chair; wife came to pick me up; slept for 2 1/2 hours after that; felt better in the evening; typical sore arm

Upper intestinal aches - on a scale of 1-10 I would give it a 4. It was bothersome but I was able to do normal activities. It lasted for about 4 days and I began to take Pepto Bismol to help with the aches. This was not a normal gassy event from food, the ache was different and not in a normal location. I never had diarrhea or constipation and my appetite never went away. However, I did cut my food consumption in half.

12 hours after receiving injection, I began to feel aches and chills. Went to bed. After sleeping, woke up (about 24 hours after receiving the vaccine) feeling nausea and my head was aching. After several hours of feeling nausea, I began to vomit. I had only drank liquids since dinner the night before. Several days after the vaccine, I had a headache for 24 hours, with pain focused above my right eye.

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.

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 declined any other treatment modalities or medications at the time of the discharge. The patient returned on 03/28/2021 with a right arm DVT proven on U/S. He was then started on anticoagulation therapy after specialist phone consult and will be closely followed.

6/11-6/14 : Extreme migraine, fever, extreme chills, fever, extreme body aches, extreme fatigue, diarrhea 6/14-present: moderate migraines, moderate fatigue, moderate body aches, moderate fatigue, diarrhea

BLOOD IN STOOL; STOMACH PAIN LIKE A CUT INSIDE; FREQUENT BATHROOM VISITS THREE TIMES IN A ROW; This spontaneous report received from a patient concerned a 44 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: 1805018, expiry: 25-MAY-2021) dose was not reported, once total, administered on 27-MAR-2021 at Left Arm as prophylactic vaccination. No concomitant medications were reported. On 11-Apr-2021, the patient experienced blood in stool (bleeding in feces). It was reported that bleeding was almost like hemorrhage, a lot of blood came out and patient felt like patient was bleeding internally. Patient described pain like stomach was cut inside. The patient felt bad on the side of his stomach all over midsection. He mentioned that it started all of sudden, on same day an hour later he went to the restroom and went 3 times after in a row, on the day of report patient did not use the restroom and the pain was less. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from frequent bathroom visits three times in a row on 13-APR-2021, was recovering from stomach pain like a cut inside, and had not recovered from blood in stool. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210426962-covid-19 vaccine ad26.cov2.s-Blood in stool. 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 MINUTES AFTER INJECTION WHILE IN THE CAR, I FELT HOT, NAUSEUS THEN FOLLOWED A STRONG SURGE OF DIZZINESS. IT HAPPENED TWICE WITHIN 15 MINUTES. 12 HOURS LATER, I WOKE UP WITH HEAVY LEGS AND SLIGHTLY FEVERISH. MILD FATIGUE PERSISTED THROUGHOUT THE DAY EVENTUALLY GOING AWAY AFTER A DAY OF REST.

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

Diarrhea-like soft stool 2.5 hours after inoculation; fatigue and general malaise for more than 36 hours after inoculation; sore left arm for more than 36 hours and soreness at the injection site.

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.

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.

Starting the evening of the vaccine, about 7 hours after receiving it, began feeling lethargic. Then 2 hours later, had strong chills, which lasted for a couple of hours. In parallel also had a fever (around 101F) and headache. Fever lasted for several hours into the night. Fever subsided in the morning (around 7AM on Saturday, May 8th). Felt lethargic throughout the day, had little appetite and light headache. By Sunday was feeling better. Monday was 100% again.

COLD SWEATS; COUGHING; DIARRHEA; TIRED AND SLEEP; NAUSEA; This spontaneous report received from a consumer concerned a 44 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: 1808982, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced cold sweats. On 14-MAY-2021, the subject experienced coughing. On 14-MAY-2021, the subject experienced diarrhea. On 14-MAY-2021, the subject experienced tired and sleep. On 14-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine was not applicable. The outcome of the cold sweats, tired and sleep, diarrhea, coughing and nausea was not reported. This report was non-serious.

MIGRAINE HEADACHE; PRONOUNCED FATIGUE; NAUSEA (NO VOMIT); This spontaneous report received from a patient concerned a 44 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: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On MAR-2021, the subject experienced migraine headache. On MAR-2021, the subject experienced pronounced fatigue. On MAR-2021, the subject experienced nausea (no vomit). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The outcome of the pronounced fatigue, nausea (no vomit) and migraine headache was not reported. This report was non-serious.

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.

FEELING NUMB ON RIGHT SIDE INCLUDING ARM AND LEG; WEAKNESS ON RIGHT SIDE INCLUDING ARM AND LEG; NAUSEA; COLD SWEATS; FEVER; CHILLS; This spontaneous report received from a patient concerned a 44 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: 207A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced cold sweats. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. On 03-JUN-2021, the subject experienced nausea. On 04-JUN-2021, the subject experienced feeling numb on right side including arm and leg. On 04-JUN-2021, the subject experienced weakness on right side including arm and leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, chills, and fever on 04-JUN-2021, had not recovered from nausea, and weakness on right side including arm and leg, and the outcome of feeling numb on right side including arm and leg 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

5 mins post administration of J and J vaccine, patient complained of flushing nausea and light headedness. Vital signs obtained 98% room air, post rate of 72, blood pressure 138/72 temp 97.1. Patient provided water and 1 cooling pack and observed for 10 mins. 2nd vital signs were obtained which was 98% room air 72 heart rate 130/70 and 98.1. Patient was observed until symptoms resolved. final vital signs showed 98 room air, 74 heart rate 126/78 BP 98.1 temp. Patient was safely discharge without further incident.

Fever of 101°f. Joint pain, Fatigue, Muscle aches. Beginning about 10 hours after vaccination. Lasting about 16 hours. Vomiting and diarrhea with fever of 99°f about 60 hours after vaccination.

Initially Fever, Fatigue, Joint Pain. 2 days later pain in right abdomen, diagnosed with Appendicitis and had emergency appendectomy performed.

Vaccine at 11:30, at 12:30 he started feeling faint, light headed, heavy legs, little nausea. Monitored blood pressure from 12:40 to 1:50, ranged 142/93 to 163/113. Pt has high blood pressure. Had he sit and recline until he felt better.

Symptoms: Nausea, Sharp Headache (Right Side), Body Ache, Fatigue. / Time: Bed Rest (two days), hospital visit on the third day. / Treatment: Bed Rest and Antibiotics.

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.

Fever of 102 degrees, body aches, chills, nausea, vertigo, fatigue - Rest, fluids, Tylenol - Recovering well 2 to 3 days

After I had the shot, I did get the chills, fever and achiness. However, it kickstarted a really bad bout of IBS/Diverticulitis that has continued on through today. The doctor has prescribed medication to help, but this is one of the worst bouts I've had.

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.

Chills at 7 hours post vaccine; temp taken at 11 hours was 103; headache and nausea; terrible body aches; Worst symptoms resolved at 17 hours post vaccine; low level fatigue still at 48 hours post vaccine

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.

Complaints of diarrhea, sweating, weakness suffered sudden cardiac arrest. CPR, AED, Lucas device applied ACLS protocol initiated by EMS. Efforts terminated. Patient pronounced deceased at 1003am.

At 0932, RRT was initiated for a 45 y/o M with c/o feeling dizzy, nauseous, and clammy. He also vomited about 50 cc of yellowish emesis. Vaccinated on the L arm at 0923. Vitals: BP - 128/58, HR ? 62, RR ? 18. Head-to-toe assessment completed. After vomiting, client states he felt so much better. He stated, ?I probably did not eat enough.? He has no PMH, NKA, and did not take any medications today. He has not experienced a reaction with any other vaccine, medication, or food product. Throughout monitoring period, client?s condition improved. By the end of monitoring period, client was in stable condition and did not experience dizziness or nauseousness anymore. He was no longer clammy. Client left vaccination clinic at 0948, accompanied by his family, ambulatory, in stable condition.

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

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.

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.

Onset Thursday, 4/08/21 at 03:00 am: Fever, Chills, Severe Body Aches and Joint Pain, Exhaustion. 09:00 am to 1:50 pm: Slept with profuse sweating. Friday 4/09/21 at 12 midnight: Fever with ears red and burning. Applied wet cold towels on body. Vomited once, followed by dry heaves. 10: 00 am Nauseous. Checked temperature with ear thermometer- afebrile. Checked oxygen saturation with pulse oximeter- 96% HR 35. Checked pulse manually with a range of 39-44 and irregular.

my husband has asthma and this shot made him very sick. today is day 4 and he still has fever, chills, is perspiring profusely. an hour after his shot was administered, he started to feel cold, shortly after, he was having chest pains, not long after his fever spiked to 104. his side effects were, fever, chills, vomiting, chest pains, perspiring, asthma attaches, sever body aches, head aches.

Spent 2.5 days off work feeling like a moderate severity stomach flu. Lower GI cramping, which moved higher on day 2, hot and cold flashes, sweating, extreme fatigue, upper back muscle aches (severe). Diarrhea, total loss of appetite.

Immediate intense internal heat with excessive sweating; nausea; light headed; faintish; severe dizziness. After 40 minutes, the lightheadedness, faintish and dizziness subsided. However, the intense heat, sweating and nausea continued. By the evening an intense migraine started and by 4/10/21 my sister vomited and started running a fever 100.5. Complete muscle aches, overall feeling extremely ill, totally bed ridden and a migraine that cannot be controlled at all.

States that he got the J&J COVID vaccine Thursday 4/8/21 States that he had immediate muscle pain right away and a cough right away Upper chest is painful and he is having trouble breathing Chest pain has started yesterday- reports the pain has gotten worse States that he exercises every day and ran this AM States that today the chest pain has gotten worse and his breathing has gotten worse as well States that he works around chemicals in a woodworking shop but doesn't think that this is the cause of his chest pain Chest pain is located at the top of his sternum States that he feels queasy and unwell over all Advised that with current symptoms that he needs to be evaluated urgently and advised calling 911 if he did not have someone to bring him in. Patient refuses 911 but agrees to be seen in the ER. Will go to his closest ER now.

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.

Developed acute severe abdominal pain and found to have splenic infarct, splenic artery thrombosis, celiac artery stenosis on morning of 4/14/2021 on CT abd/pelvis with IV contrast and presented to ED for symptoms. Started on apixaban.

I had mild pain radiating in my arm within 2 minutes of the vaccine. 1-2 hours later I developed unusual and intermittent pain on the volar surface of my wrist. 8 hours after the vaccine I developed chills, severe fatigue, myalgias, loss of appetite, and a fever up to 101. I was bedridden for 36 hours and then the symptoms gradually subsided by day 3. I then developed a sense of chest tightness intermittently for the next 4 days usually at night. I did not have chest pain, but had tachypnea at times with a respiratory rate up to 22/min. At day 7 this resolved.

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.

COUGH; BACK PAIN; CHILLS/SHIVERS; HEADACHE IN RIGHT TEMPLE, MALICIOUS HEADACHE; FEVER; LIGHT HEADEDNESS, DIZZINESS; VOMITING; This spontaneous report received from a patient concerned a 45 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced light headedness, dizziness. On an unspecified date, the subject experienced cough, back pain, chills/shivers, headache in right temple, malicious headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: oxycodone hydrochloride/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headedness, dizziness on 12-APR-2021, had not recovered from headache in right temple, malicious headache, and back pain, and the outcome of vomiting, cough, chills/shivers and fever was not reported. This report was non-serious.

CHEST PAIN; CHEST PAIN RADIATING TO STOMACH ON AND OFF; PAIN LIKE SENSITIVE TO TOUCH ON LOWER BACK OF LEGS BELOW KNEE (RIGHT LEG IS MORE SENSITIVE TO THE TOUCH THAN LEFT); 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 did not known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 17-APR-2021, the subject experienced pain like sensitive to touch on lower back of legs below knee (right leg is more sensitive to the touch than left). On 20-APR-2021, the subject experienced chest pain. On 20-APR-2021, the subject experienced chest pain radiating to stomach on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain like sensitive to touch on lower back of legs below knee (right leg is more sensitive to the touch than left), and chest pain, and the outcome of chest pain radiating to stomach on and off was not reported. This report was non-serious.

Patient was doing paperwork when he experienced the worst headache of his life on 4/17 with associated emesis. Patient found to have a Hunt Hess 3 Fisher Grade 3 Subarachnoid Hemorrhage with hydrocephalus s/p EVD, s/p cerebral angiogram on 4/18 negative for aneurysm/AVM. On the evening of 4/20, patient became acutely hypoxic with wheezing for which he required oxygen via 10L oxymask. During 4/21, his oxygen requirements continued to increase with increased work of breathing requiring high flow nasal cannula (HFNC) at 50L/60% + pulmonary congestion on imaging and he was treated with diuresis. On 4/22, oxygen needs increased requiring 70L/100% with worsening imaging. He was then started on steroids, antibiotics were broadened, epoprostenal started in addition to diuresis. On 4/23, patient reports improved breathing and is on non-rebreather. Antibiotics, steroids, and epoprostenal were discontinued as patient showed improvement of oxygenation without clear signs of infection. Of note, patient reports vaping in the past 2-3 months. Patient has also been intermittently febrile. Wife was concerned that these symptoms were possibly related to him getting the J&J vaccine on 4/11. Patient is currently still in hospital on day 6 of admission at this time.

VIRAL PERICARDITIS; LEFT ARM PAIN; SEVERE HEADACHE; ABDOMINAL PAIN; This spontaneous report received from a patient via a company representative concerned a 45-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and social alcohol drinker, and other pre-existing medical conditions included no known allergies and 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: 1808609, expiry: 09-JUN-2021) dose was not reported, 01 total, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient experienced abdominal pain. and severe headache. On 03-APR-2021, the patient experienced severe chest pain and left arm pain. On 04-APR-2021, the patient was admitted to the hospital and diagnosed with viral pericarditis and was discharged on 06-Apr-2021. Laboratory data included: On 04-APR-2021, Angiogram (NR: not provided) Not reported, CT (computed tomography) scan (NR: not provided) Not reported, EKG (electrocardiogram) (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, Troponin increased (NR: not provided) Troponin levels increased, and X-ray (NR: not provided) Not reported. On 05-APR-2021, Laboratory data included: Angiogram (NR: not provided) No blockages. On 06-APR-2021, Laboratory data included: Echocardiogram (NR: not provided) No blockages. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain, and left arm pain on APR-2021, and had not recovered from severe headache, and the outcome of viral pericarditis was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210436265-covid-19 vaccine ad26.cov2.s-Viral pericarditis, Abdominal pain. 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). 20210436265-covid-19 vaccine ad26.cov2.s-severe headache, Left arm pain. This event(s) is labeled per Agency and is therefore considered potentially related.

HYPOTHERMIA; LOSS OF TASTE; ARM WAS LIKE ROCK SOLID; RASH ON LEFT ARM AND WENT ALL OVER THE BODY; HURTING ARM; WEAKNESS; FEVER; FLUCTUATING BLOOD GLUCOSE LEVEL; LIGHT HEADED; DIARRHEA; 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 sinus surgery, and spine surgery, and concurrent conditions included type 2 diabetes mellitus, allergy to pecan walnut, allergic to pollen, allergic to lobster/oyster, allergic to molds, allergic to dust, and allergic to cat hair. The patient experienced drug allergy when treated with doxycycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 16:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, within 1-2 hours after getting vaccinated the patient experienced a rash on left arm where he got the vaccine and it went all over the body. On the same day, his temperature was 95.1 F On 05-APR-2021, he also experienced weakness that lasted for a week. His arm was hurting and was like rock solid for almost ten days. The patient was feeling light headed that started on the same day of vaccination and could be due to low glucose level. The patient had diarrhea that started the same day as vaccination and was still ongoing. The patient's blood glucose was going up and down since the vaccination. On 05-APR-2021 at 23:05, his blood glucose level was 249 mg/dl. On 05-APR-2021 around midnight the patient had a fever of 101.9F. The patient experienced fever for first three days after vaccination, for which he took Tylenol for three days as directed by his physician. The patient took Tylenol 500 mg for every four hours total he took 5 pills on day one. The next day he took 3 pills of Tylenol 500 mg. On 06-APR-2021 at 8:00, his blood glucose level was 349 mg/dl and then he took his medication and it went down to 169 mg/dl. The patient stated that since vaccination his blood glucose has been unstable and the blood glucose readings are between 47 to 389 mg/dl. On 06-APR-2021, his temperature reading was 94.3 F. The patient also experienced loss of taste on the day after vaccination which has resolved now. His taste came back about a week or 10 days. The patient was not sure if the loss of taste is due to his allergy or the vaccine. On 07-APR-2021, the patient's temperature was 99.7 F. On 07-APR-2021, he took 500 mg every 6 hours. The patient took Tylenol for only three days and fever stopped after three days. On 07-APR-2021 the patient experienced hypothermia of 94.3 F. On 18-APR-2021 at 6:30, his glucose level was 95 mg/dl. The patient said that he had such unstable blood glucose readings only when he had an infection going on. On Friday the patient was going to see his endocrinologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hypothermia, loss of taste, arm was like rock solid, hurting arm, and weakness on APR-2021, and fever on 07-APR-2021, had not recovered from diarrhea, and fluctuating blood glucose level, and the outcome of rash on left arm and went all over the body and light headed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210438172- COVID-19 VACCINE AD26.COV2.S- Hypothermia, Fluctuating blood glucose level. 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.

Dizziness, nausea and vomiting. Only reporting for what it?s worth to cdc. All manageable but def not psychosomatic byproduct of anxiety.

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.

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.

Patient started to experience dizziness, profuse sweating, pale-ashen colored face, and nausea three minutes after the vaccine was administered. Offered to call EMS, but patient declined and remained conscious. Symptoms subsided after approximately 10 minutes. Patient returned home with his girlfriend.

On 5/13/2021 patient developed a cough in the evening. Patient woke up not feeling well on 5/14/2021, and also had nausea and vomiting. Patient was driving a vehicle when he had a seizure. No prior history of seizures. Drifted off the road, no significant damage to vehicle. Patient post-ictal following seizure, seizure activity was witnessed by bystanders. CT brain showed small subdural hematoma. A CTA chest performed due to hypoxemia and tachycardia at Hospital showed Multifocal groundglass type nodular infiltrates throughout the right lung involving the upper lobe, middle lobe, and lower lobe, minimal left lower lobe patchy infiltrate, as well as patient's known thymoma. These multifocal groundglass infiltrates were not previously mentioned on a CT chest performed on 4/10/2021. Patient was transferred to this facility for evaluation by neurosurgery. Patient was mildly tachycardic, hypoxemic to 88% on room air, and tachypneic. Patient reported decreased sense of taste & smell for 1 month, which he attributed to his losartan use. A covid/flu/rsv PCR on 4/10/2021 was negative, and a viral respiratory pathogen panel with covid PCR was negative on 5/14/2021, as was an antigen & NAAT for COVID on 5/14/2021. Patient was treated with antibiotics and admitted for further management.

MOTHER REPORTED HE HAD ADDITIONAL SEIZURES, VOMITING, EXTREME FATIGUE,STIFF ARM, SLURRED SPEECH, COULDN'T WALK WELL. MOSTLY AFFECTED RIGHT SIDE.

Patient was severly dizziness and took it upon himself to lay down on the floor. He was also experiencing nausea, sweating on his head, and fast heartbeat which was conveyed to the EMT. He also requested an ambulance.

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.

Severe chills was initial symptom, followed by moderate temperature (99 - 103), general fatigue & body ache, loss of appetite. Symptoms sustained for 48 hours.

Had severe abdominal pain 3 hrs after shot, and went to Emergency Room at hospital where I was admitted and kept for 3 days. CT scan showed inflammation in small bowel and Sigmoid colon

Almost 24 hours after receiving my shot on 7/20/2021 I felt extreme fatigue, malaise, moderate to severe headache and eye pain, chills all over body with sensitivity to skin all over body, diarrhea, loss of appetite, loss of smell. All of these symptoms have continued 48 hours later with no relief.

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.

Tested (+) for COVID infection after being fully vaccinated - vaccine failure. Patient presented to Urgent Care with cough, chills & nausea after known COVID-19 exposure. Patient was offered treatment with single dose of Regeneron on 7/19/21, which was accepted and received also on 7/19/21.

High fever, chills, nausea, fast heart beat started about 14 hours after the injection and lasted about 8 hours. Very achy and fatigued for an additional 6 hours after the most severe symptoms passed.

Starting about 13 hours after injection, abdominal pain, cramping, nausea, upset stomach, upper stomach pain. Woke up 31 hours after injection with fever (100 F) and abdominal pain. Abdominal pain continuing throughout day and night since (now 6 days after). Loss of appetite, Continued pain in upper stomach. Just had blood labs taken to check pancreas. Labs not received yet.

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

Within two minutes of receiving the shot, began to feel very nauseous. Inside of ears then felt very hot and body below neck felt very chilled. After five minutes these symptoms intensified, feeling hot flushed in face and vision darkened, feeling like a black out may occur. Pharmacist provided water. Symptoms began dissipating after 20 minutes after injection. After 30 minutes, symptoms ended.

24 hours later had all the side effects and feels like my rectum is swollen, and ears are burning, belly is swollen, feels like I have the flu, I feel hot but don't have fever, and I started feeling better and it all came back at one week later, is this normal and will it pass. Lymph nodes hurt from back of head down shoulders, constipation, voice different, smells are different, taste is different, and skin feels half numb.

nausea and minor body aches develop around 5:00 PM low grade fever develops around 7:00 PM full body aches, fatigue, fever and chills fully developed around 9:00 PM high fever, chills, headache, and full body aches continue overnight fever breaks around 6:00 AM intermittent low grade fever, fatigue, and body aches over course of next day (24+ hours post vaccination) no adverse events (48+ hours post vaccination)

He began getting dizzy immediately after vaccine - pale, sweating, and felt like he was going to vomit. He remained in the IMZ room for observation and applied a cool compress to forehead and back of neck. Coloring came back after about 10-15 minutes and he said he felt better. Also mentioned that this happened to him after he got a TDap vaccine about 15 years ago - he said it is a mental thing with him and does not like to get vaccines.

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.

Immediate dizziness and nauseous. Took 20 minutes to resolve. After 12 hours had extreme fatigue and muscle aches that lasted for 2 days. Could still feel some mild symptoms 4 days after the injection.

At 1412, RRT was activated for a 46 y/o M with c/o feeling warm. 5 minutes after this complaint, he threw up about 100 cc of yellowish emesis. Client stated he felt better after vomiting. Vaccinated at 1350 on the L arm. Vitals: BP ? 118/72, 0/0 pain. Head-to-toe assessment completed. No PMH, NKA, and did not take any medications today. During monitoring period, client?s condition improved. At the end of observation period, client was in stable condition and did not feel warm anymore. Client left vaccination clinic at 1432 ambulatory, in stable condition, accompanied by his family (Wife and daughter).

CHILLS; FEVER; MUSCLE ACHE; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 46 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: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 at Right Arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced muscle ache. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from nausea on 05-APR-2021, was recovering from chills, and had not recovered from fever, muscle ache, and headache. This report was non-serious.

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.

He received vaccine and stood to go to monitoring area, noted by vaccinator to lower self to ground. Complained of dizziness, nausea and diaphoresis. No LOC. Did not eat prior to coming to clinic. Provided with juice and crackers. VS stable throughout, He declined ambulance or call to 911. observed for 30 minutes in medical triage area and then d/c to home via friend Advised patient to follow up with PCP

Headache, chills, fever, vomiting, diarrhea, weakness. From just after midnight day of injection for around 12 hours following on and off.

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

Severe Nausea, Some Vomit, Stomach Upset, Stomachache, Mild but continuous Dizziness, Severe Fatigue, Muscle Weakness

EMS, who was working in the clinic, stated that the patient had a partial seizure and directed the Clinic Lead Nurse to call EMS. Patient became pale, 5 second seizure, dizziness and vomiting. EMS was called and vital signs were taken but patient declined to go to the hospital. Patient recovered and drank some water and ate some crackers. Patient waited another 30 minutes and stated he felt much better. Clinic Lead Nurse called the patient, on April 13, 2012, who stated that he went home, ate some food and relax the rest of the day. He stated he felt better and had no more problems. He did not seek additional medical care.

4/9/21 night, about 12hr post vaccination, developed low fever, slight pain in elbow and knees. Took Ibuprofen, recovered next day. 4/13/21 morning around 10am, 4 days post vaccination, mid-level abdominal pain lasted ~1hr, then turned into low level pain, persisted until 4/13 night. 4/14/21, feel normal. 4/15/21 about 7am, abdominal pain again, and persists. Visited family doctor at 11:00am, doctor checked, no lab work was done. Send home with prescription: Ciprofloxacin HCl 500mg Tablet, was instructed to take 1 tablet twice a day for 7 days. Took first tablet at 3pm. Abdominal pain still persists at night.

Date and time adverse event started: 04/11 8-9p.m. (bad headache, flu like symptoms, nausea, chills, lethargy) Adverse events experienced and are they still occurring now: aches and pain subsided , still experiencing dizziness when getting up and working, lightheaded when standing for long periods of time Recommendation: please call your doctor for a check up, I would also recommend you to get tested for COVID just to make sure you don't potentially have it

Burning Arm initially, later that day, high fever, chills, vomiting, body aches, and overall clamminess that lasted for 2 days.

Dizziness, fatigue, body aches, light headedness, very high blood pressure, mild abdominal pain. Symptoms started day after and worsened. Required an office visit by 1 week after vaccine

Pain all over the body! Swelling in both feet ankles, fever, stomach pain, fatigue, chest pain and phlegm! Extreme tiredness, pain and swelling in the vaccinated arm, swollen of the shoulder of the vaccinated arm, severe headache

I have had sparatic stomach pains, fatigue , Severe Headache , Muscle pain, Nausea and Pain in joints. The fatigue, knee pain and chronic headache still remains constistent since vaccination.

Iliac vein thrombosis pt started with right lower quadrant abdominal pain six days after vaccine. Persistent pain since then leading to hospital stay and diagnosis on imaging of right iliac vein thrombosis. no prior history of DVT, no family history of DVT, no inciting event/travel/change in activity level/surgery/illness

Patient presented with shortness of breath and generalized body aches on 3/26/21. Patient has had symptoms for 3 days, with new diarrhea as well. No nausea vomiting, positive fever and chills, no loss of taste or smell. He has chest pain that is pleuritic in nature, central lower sternal region. Patient admitted to the hospital setting from 3/26/21 and still in CCU as of today (4/30/21).

Immediately after patient was given vaccine, the patient passed out for 1-2 minutes, then vomited, became light-headed, and broke out into sweats. After 2 minutes the patient regained consciousness, however, the other symptoms persisted for about 10 minutes.

PATIENT BECAME DIZZY AND FAINTED FOR A FEW MINUTES. WHEN PATIENT WOKE UP HE WAS PALE AND I CHECKED TO MAKE SURE HE WAS BREATHING. HE SAID HE WAS BREATING FINE BUT WAS VERY DIZZY. HE GOT NAUSEAS WITH SENSATION OF VOMITING.

Vaccine administered at 12:30 pm. By 6:30 pm, a fever and chills started. I woke up at 11:00 pm and had a 104.7 fever with vomiting, nausea, join pains, weakness, fatigue, and headache, along sinus tachycardia. Went to the ER to be evaluated, it was determined that this was an adverse reaction. I was released from care around 2:30 am.

COUGH; PERSISTENT RUNNY NOSE; CHILLS; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 46 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: Unknown) dose was not reported, administered on 12-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 chills. On MAY-2021, the subject experienced nausea. On MAY-2021, the subject experienced fatigue. On 19-MAY-2021, the subject experienced cough. On 19-MAY-2021, the subject experienced persistent runny nose. The action taken with covid-19 vaccine was not applicable. The outcome of the cough, chills, nausea, fatigue and persistent runny nose was not reported. This report was non-serious.

Woke up with COVID-like symptoms similar to when I had contracted COVID 5 months earlier. Headache, mild loss of taste, body pains all over body, extreme back pains not typical of back problem, fatigue, nausea, vomiting

Patient started to feel throat contractions and nausea within 5 minutes of the vaccine. He then started throwing up profusely. Patient was given 25 mg of Promethazine IM within 10 minutes of start of the reaction. He was held in the clinic for 30 minutes and checked on every 5 minutes.

24 hour after vaccination patient experienced hot flashes and dizziness that lasted on and off for three consecutive days. On the third day patient experience bilateral lower leg cramps and muscle tightness in both calves, patient also experience the same cramps and muscles tightness lower left abdomen. Symptoms resolved after three day with slight residual tight experienced in lower left calf muscle

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.

Janssen COVID-19 Vaccine EUA (3/6) Fatigue began 4 hours after vaccine. (3/6) Severe headache, severe fatigue, moderate fever, mild aches, mild nausea beginning the next day (3/7) and lasting until (3/8). Mild headache and mild fatigue all day (3/8)

Within 2 hours of receiving vaccination I had a very mild bout of diarrhea that lasted around 20 minutes, had to go to the restroom twice. The next morning at 4:45 am I woke with chills and moderate muscle , joint aches and random sharp muscle pains all over my hips, arms, and legs. Chills, aches, and fever continued until 8:30pm the same night. My fever would go to 102.8 as a high to 100.2 depending on how close I was to my next timeframe to take Tylenol. I took 4 extra strength Tylenol (2000 mg) every 4 hours, give or take 30 minutes. Around 8:30 pm my fever broke and I sweated mildly Until around 10:30pm

I am filling this this out to report similar symptoms and reactions for three of us in the same household (ages 47, 45, and 18). Flu-like symptoms: fever reaching as high as 101.2, night sweats, joint pain, chills, unable to get warm, exceedingly tired, loss of appetite, upset stomach. Missed work (two of us) and school (one of us) within a couple days of the shot.

Runny nose started maybe an hour or so after injection. Felt slight nausea around 6:30PM until I went to bed. Woke up at about 1:30AM with mild nausea. Within about 30 minutes I experienced chills. I hydrated and tried to go back to sleep. In the morning I had a fever of 100.3 degrees. Took 1000 mg of Tylenol and hydrated, another 500 mg 4 hours later. Chills came on and off throughout the day. Added layers of clothing to stop the chills. Ate breakfast and lunch. Drank G2 to hydrate. Temp bounced between 99.6 and 100.8 throughout the day. Experienced heartburn for several hours in the afternoon. Took a nap at 3:30 for 2 hours, ate, rehydrated and removed some layers to clothing and put on a cool towel on my forehead to try to reduce. Took 1000 mg of Tylenol and went to bed. Slept well. All symptoms were gone by 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.

pt states he started feeling nauseas, developed a headache, and had diarrhea. The next day he had fever, chills, body aches, he was shaking. His headache was getting worse. All symptoms were getting better except the headache. He thought he was feeling better but when he woke up today 4/6/2021 he was SOB and diarrhea was back. Pt has taken Pepto Bismol for his symptoms and will probably need to go to the ER since he is having trouble breathing. He feels like he has had such a bad reaction to this since he possibly has had the covid vax in the past 90 days.

Headache, treated with Tylenol for three days Nausea, treated with uncrystallized candied ginger for three days Muscle aches in calves and thighs, treated with rest and Tylenol for three days Fatigue, treated by take many naps over the course of three days. Fever, treated with Tylenol for 1 day Chills on and off for three days

47 YO MALE CONSCIOUS AND ALERT WITH A GCS OF 15 COMPLAINING OF FEELING NAUSEAUS. PT JUST RECIEVED HIS COVID 19 VACINATION. PT DENIED CHEST PAIN, SOB, V/D, HEAD NECK AND BACK PAIN, BLURRED VISION, DIZZINESS. PT HAD A PATENT AIRWAY WITH EQUAL CHEST RISE AND FALL. PT HAD NO NOTED DCAPBTLS, HEENT WAS UNREMARKABLE. PT VITALS WERE TAKEN AND RECORDED. PT WAS OFFERED TRANSPORT TO THE LOCAL HOSPITAL FOR FURTHER EVALUATION. PT REFUSED

SHORTNESS OF BREATH; FULL BODY ACHE; JOINTS HURT; SEVERE HEADACHE; NAUSEA; SENSITIVITY TO LIGHT; LETHARGIC; 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 penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 15:25 for prophylactic vaccination. Concomitant medications included benzylpenicillin for drug used for unknown indication. On APR-2021, the subject experienced lethargic. On 02-APR-2021, the subject experienced sensitivity to light. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021 01:15, the subject experienced shortness of breath. On 02-APR-2021 01:15, the subject experienced full body ache. On 02-APR-2021 01:15, the subject experienced joints hurt. On 02-APR-2021 01:15, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, full body ache, and severe headache on 03-APR-2021 09:35, had not recovered from lethargic, and the outcome of joints hurt, nausea and sensitivity to light 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.

Shot at 1:50pm Saturday. Woke with headache at 2:45am Sunday. By 5:00am Sunday had bad stomach pain and fever of 100.9F. Headache varied, got worse, got better, got worse, etc. Bad stomach pain lasted straight through until about 1:00am Monday. It's now 8am Monday, a little bit of stomach pain but far less than what it was.

Did the adverse event start after the first or second vaccination? only one dose (after the shot 5min after his arm completely went numb) when waiting at the site for 15min he experienced nausea and dizziness Recommendation: Please make sure he drinks lots of fluids he could take Pedialyte and if symptoms worsen please contact doctor and go the nearest ER. Mother would like a follow up call tomorrow at 10:00am I told her we would try to call her back at that time if its not busy, if not expect a call later in the afternoon.

I hurt for three days,headache, body hurt, tired, sick to my stomach, sore arm, tired and felt like I had the flu. I then got better. About a week later, I started coughing a lot. My head hurt,but i didn't run any fever. I thought I was having bad allergies from changing weather, but it lasted longer than usual, over a week. I was sore, tired, not really hungry. I feel better now, but I still have this lingering dry cough and it won't completely go away. I still feel sore and very tired. I get a headache every now and then. I thought it was allergies, but it falls into the time period that people are having reactions to this JJ Janssen shot. The cough is annoying. I get short breathed and winded rather easily or more easily now. I thought I'd at least report it.

On the day after the injection, a severe stiffness in both legs occurred. It was a soreness and stiffness similar to the day after running a marathon race . The soreness and stiffness would not change if I was sitting, walking, standing or kneeling. It was constant discomfort and irritation. It was not painful and therefore I originally did not go to medical. There was no discomfort in my left arm at the injection site. The discomfort increased for the rest of the day. A headache started in mid afternoon and kept increasing throughout the rest of day. I have not had a headache in years. Around 7:00 PM on Thursday, I had to sleep. I was extremely tired. My body had chills and I had to wear a sweatshirt and full set of clothes to bed just to stay warm. That is very unusual. I am usually throwing off covers every night throughout the entire year. I did not eat dinner because there was no appetite. I slept in bed for at least 12 hours. Typical night sleep = 8 hours. The next morning was no issue and therefore I did not go seek medical help because there are supposed to be side effects to vaccines. Now, I am reporting it because headache and the stiff muscles were identified on the news. However, it was around 24-36 hours and not the 6 days on the news.

Started sweating a lot and got very pale soon after injection. Hours after injection got chills, muscles aches, and a bad headache that lasted days. Lot appetite for days. Overall felt like I had the flu.

TWO DAY AFTER VACCINE PATIENT HAD SEVERE LOWER ABDOMINAL CRAMPS AFTER AHVING MILK SHAKE AND ON 4/9/21 HE HAD RECTAL BLEEDING X 3 FIRST TIME BLOOD MIXED WITH STOOL ,SECOND TIME BLOODY DIARRHEA .THIRD TIME BLOOD

Longer-term headaches, tired feelings, abdominal cramping in the mornings, tiring pain in legs. Specially left leg feeling Sharp shooting pains.

47-year old male c/o frontal headache since Friday, 4/9/2021. Received his Johnson & Johnson vaccine on Thursday, 4/8/2021. Still having his headache now. 9/10 pressure-like on the frontal head - constant States, "I never had this kind of headache before". 6/10 burning epigastric pain. Also has bodyaches. Has mild dizziness. Denies any photosensitivity, fever, flu-like sx, nausea/vomiting, chest pain, dyspnea, numbness, tingly sensation, slurred speech, back pain, rectal bleeding.

about 1 hour after injection got a nose bleed, then started experiencing on 2nd week after shot started feeling nauseous and fatigue, 3 rd and 4th week started feeling extreme fatigue, gut issues, no appetite, chills ,sweating profusely, muscle cramping all over body. Went to my Dr. April 6 & 13, all vitals good, had flu and Covid test both negative, Had labs drawn both times, liver enzymes was high with both results. Still currently having all symptoms

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.

1st day: 2hours after the shot, felt dizzy for rest of the day, low grade fever. 2nd day: low grade fever, body aches, muscle weakness 3rd day : low grade fever, body aches, muscle weakness, right fore arm and lower right leg bottom half felt little stiff, moved leg around to avoid getting stiff. 4thday : general weakness , Headache started in the night. 5th day: Nausea, dizziness , head ache 6th day, head ache, dizziness, little stiff right leg bottom half ( as if muscle is become stiff ) 7th day: dizziness , as if I move head one side whole body moves that side ( dizziness still there as of this reporting day)

About 1 week after vaccination, I noted sensations of fullness or bloatedness. It felt like gas trapped in my upper abdomen that could not be relieved by burping. Within 2 days, I began to have pain in lower, left rib cage akin to side cramps/stitch after strenuous running, but persisted the entire day. About 2-3 days later, the pain intensified and spread throughout my diaphragm region (left and right sides). Breathing was somewhat affected, after semi-strenuous activities, such as walking up/down stairs. So, I avoided physical exercise, and took Advil for a couple days to minimize the pain. After another 3-4 days, the pain in the diaphragm region subsided. I have not experienced further discomfort for the past week (today is 4/21/2021). No treatments were sought during this period. I self-researched the symptoms and hypothesize the pain stemmed from a swollen spleen, which might have been caused by an overactive immune system due to the vaccine.

My full list of symptoms were: Pins and needle feeling as well as hypersensitivity all over my skin that originated in my lower legs but traveled up my body to include my entire legs, hips, and arms. It was more severe on the left side of my body which is the side I received the vaccine. I did not notice it on my head, face, and upper torso. I had full muscle control but I did have problems with my bladder and bowels. I'm not sure if I could not control them or did not feel them because the sensitivity was high in my hip area but I could not control them fully. No treatment was administered except to wait and see. Three days later and I am improving but not fully recovered yet.

Very fatigued and nauseated within hours of injection. Worsened next day and then waned over next couple days leaving only fatigue that still lingers

CHILLS; FEVER; MILD HEADACHE; BODY ACHES AND PAINS; DIARRHEA; 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 familial tremors, non alcohol user, and smoker, and other pre-existing medical conditions included the patient had no known allergies and did not had drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included propranolol, and venlafaxine hydrochloride. On 22-MAR-2021, the subject experienced diarrhea. On 23-MAR-2021, the subject experienced body aches and pains. On 23-MAR-2021, the subject experienced fever. On 23-MAR-2021, the subject experienced mild headache. On an unspecified date, the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 22-MAR-2021, and body aches and pains, fever, and mild headache on 23-MAR-2021, and the outcome of chills was not reported. 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.

Cold chills for three days post vaccination. Diarhea for 12 days post vaccination. Lump near ear NOT a gland from day 4 - 13 post vaccination. Numbness in top of left foot from day 4-13 post vaccination. Hazy thinking trouble concentrating from day 9-10 post vaccination. Altered "poop cycle" from day 2-13 post vaccination. Headaches, not migraine intense only 4-5 on a 1-10 scale from day 2-day 15 (currently still have them but only a 2 on a scale to 10).

on the evening of the vaccination , had the expected effects, such as fever, muscle pains, stomach ache, nausea, headache, ..the nest day, my legs were so sore that I could barely stand & I had to wait for. while until I could walk. the headache lasted for a few days, the muscle pain is lessening but not gone until today, it makes my legs & feet grow sore & tired very quickly. last Sunday, April 18 2021, started around 5 pm, I started having nausea , then stomach pain so bad & vomitted many times until I was admitted to ER around midnight . the med staff at the ER did X-ray & citi scan, told me there was some bowel obstruction , gave me ivy, painkiller injection & some others then I was transferred to a medical center. they did another citi scan & found everything was ok, I asked what may cause it, they didn't really know beside probably not enough water etc .

Within 5 minutes, patient was sweating, flushed, and stated that he was about to faint. Patient fainted and was unable to respond to verbal or motor commands. Patient had rapid, shallow breathing. Patient's hands/arms were twitching very slightly. Patient was moved onto the floor and rolled onto his side after he started to gag like he would vomit. Once on the floor, patient regained consciousness within 1-2 minutes and was able to sit up after another 5 minutes. Paramedics arrived and examined him. He left under his own power.

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).

CHILLS; MUSCLE ACHES; NAUSEA; SORENESS AT INJECTION SITE; HEADACHES; 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: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced chills. On 17-MAY-2021, the subject experienced muscle aches. On 17-MAY-2021, the subject experienced nausea. On 17-MAY-2021, the subject experienced soreness at injection site. On 17-MAY-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and nausea on 17-MAY-2021, was recovering from muscle aches, and soreness at injection site, and had not recovered from headaches. This report was non-serious.

Increased pain and swelling in left arm - started within 12 hours and continued for 2 weeks Fever over 100 - started within 12 hours and continued for 1 month (fever between 100 and 102) Nausea - within 12 hours (continued for 1 month) Vomiting - within 24 hours (continued for 3 days) / then again 2 weeks out for 3 days) Migraine Headache - started within 12 hours and continued for 6 weeks (and on-going) Labored breathing - started within 12 hours and continued for 5 weeks (and on-going) Low oxygen - started within 36 hours and continued for 1 month) General muscle and body aches and pains (started within 24 hours and continued for 6 weeks (and on-going) Extreme exhaustion and lethargy (started within 6 hours and continued for 6 weeks (and on-going)

03/10/2021 I started feeling fatigued, hard time breathing, got to point I checked my oxygen, almost felt like I had covid. o appetite. Next day It started with pain, body aches, severe, after pain, fever came 102.1, I was doing advil but fever would not break. It was really bad for the first 3 days. Got to point I had to go get covid test at PA in Wharton, had no test, no smell, lasted about a month. Visited Doctor first week in April because Doctor was out due to loss of kids in house fire so it took a while to get in. He had done some blood work earlier in March, my numbers were bad- WBC, and he put me on a antibiotic, Zpack, just in case I did have covid, but I didn't feel any of these symptoms until after I got J&J shot.

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

I went home got something to eat felt dizzy and nausea. I went to sleep woke up clammy and sweating. I slept 13 hours and woke up with a fever . I took IB-profrin and the fever continued for about 3 days. I still have chest pains

I got my injection at 11:00 am. At 6:00 pm, I started to have body aches, chills, nausea, fever, and headache. Went on for a day.

His clinic gave him Johnson and Johnson COVID vaccination and the next day, he developed abdominal pain, nausea, vomiting and dehydration. It got progressively worse, so he came to the ED. He has been admitted, rehydrated, given antiemetics and feels somewhat improved.

heartburn, nausea, vomit precipitated 18 hours of high fever (103) and chills. Fatigue for 2 days following fever

Full body sweats, migraine for 2 days, threw up 4 times, shakes, pain at injection site/shoulder/chest, extreme fatigue, body aches

Pt was nauseous, diaphoretic, and pale. Pt denies eating anything all day. Juice and crackers offered. stated he felt better about 5 minutes later.

After vaccination, patient in observation area complaining of nausea. Patient diaphoretic and pale. Patient denied eating anything prior to appointment. Patient given juice and crackers. Patient began feeling better after approximately 5 minutes.

CONSTANT NAUSEA AROUND 1 AM; SEVERE HEADACHE; DIZZINESS DESCRIBED AS VERTIGO (WORSENS WHEN HEAD MOVES); FEVER; This spontaneous report received from a consumer concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included bilateral knee replacements, and concurrent conditions included bipolar disorder, non alcohol user, cigarette smoker, migraines, and type 2 diabetes. The patient had no known allergies or drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on left arm 03-APR-2021 at around 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included paliperidone palmitate for bipolar disorder. On 03-APR-2021, around 22:00, the patient experienced severe headache, dizziness described as vertigo (worsened when head moves) and fever around 100 degrees. On 04-APR-2021, around 1:00, the patient experienced constant nausea. Treatment medications (date unspecified) included: acetylsalicylic acid/caffeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, dizziness described as vertigo (worsens when head moves), constant nausea around 1 am, and fever. 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.

Severe achiness, leading to spasms in legs and particularly in chest wall muscles, causing difficulty breathing. Nausea, vomiting. Headache.

Patient was given the J and J by mistake instead of an expected second dose of Moderna brand Covid-19 Vaccine. No immediate reaction was observed. Patient reported what could have been worse than expected vaccine related reactions including vomiting, aches, and fatigue over the next two days.

The fire department came to his house as he is a paraplegic to give him the vaccine, and he can't move, is fatigued, has tightness in his joints, and has stomach issues, and takes Oxybutynin to control his urine and doesn't know what he's supposed to do. Off and on he has had a headache. Doesn't understand why they would give him a shot if it gives people a blood clot and he's a paraplegic. He already has an IVC filter in his veins to prevent him from getting blood clots.

Began with headache. Turned to nausea roughly 8 hours after shot. Nausea turned to sever vomiting and for several hours. Tremors. Sweating. Fatigue. More headache. Loss of appetite. Joint and muscle aches. Continued joint pain, appetite loss and fatigue.

Patient's wife called and stated that he was experiencing stomach pain, vomiting, and diarrhea. She stated her husband said it felt like his stomach was going to burst. Patient received vaccine on 4/7/21 and reported reaction started on 4/13/21.

I started sweating profusely within 30 min of the shot. Was light headed and dizzy for approximately 4-5 hrs. Once the sweating stopped I felt severe pain in both knees and ankles. If felt as if you were trying to snap my knees and ankles in half. That lasted 4-5 hrs. After I slept for a few hrs over night I woke up and felt pretty good. Approximately 3-4 hrs after I woke up I felt light headed and nauseated for approximately 3-4 hrs. I felt pretty much back to normal into the third day after the shot. I was slightly light headed and fatigued for approximately 8 days after the shot. After about the 8th day I felt normal again. I said I will never get that shot again. Approximately 25 years ago I had gotten my first flew shot and I was very sick for a week. Never received another flew shot again. Besides the stress and anxiety issues I am a healthy guy. Every 2 years we get full blood work up and my blood levels have always been spot on of where they should be.

Flu-like symptoms which patient expected but also severe leg pain and loss of appetite. Pt was advised to consult with physician who advised patient seek emergency help if issue persisted which it did not. Patient's spouse reported symptom onset the morning after the vaccination

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.

BLURRY VISION; VOMITING; STOMACH UPSET; HEAD TO TOE SORENESS; WEAKNESS; FEVER; NAUSEA; HEADACHE AGGRAVATED; 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 past medical history included previous neck injury, recent knee surgery, and shoulder injury, and concurrent conditions included penicillin allergy, use reading glasses, and headaches.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced blurry vision. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced stomach upset. On 13-MAR-2021, the subject experienced head to toe soreness. On 13-MAR-2021, the subject experienced weakness. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced headache aggravated. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 15-MAR-2021, was recovering from weakness, nausea, blurry vision, headache aggravated, vomiting, and stomach upset, and had not recovered from head to toe soreness. This report was non-serious.

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

Facial muscle weakness, loss of taste, difficulties swallowing. Suspected vaccine induced multiple cranial neuropathy, most consistent with a Miller Fisher variant type of GBS. Received IVIG with improved symptoms.

Patient received vaccine at 1:23pm 4/30/21. He came back to the pharmacy at 4:45pm 4/30/21 reporting that his throat and tongue were burning, itchy, and felt swollen. He had excessive thirst and nausea. His symptoms were getting worse during the 10 minutes he were talking with him. The patient refused Benadryl and Epipen at the pharmacy as he wasn't sure he needed it. An ambulance was called and he was transported to the hospital.

PT EXPIERENCED SYNCOPE ABOUT 3 MINUTES POST VACCINATION. HAD A SECOND SYNCOPE EPISODE 5-6 MINUTES POST VACCINATION. PT WAS TRANSPORTED TO LOCAL HOSPITAL BY EMS. PT REPORTED EXTREME FATIGUE, NAUSEA AND VOMITING. ABOUT 5 HOURS POST VACCINATION, PTS WIFE REPORTS PATIENT IS FEELING MUCH BETTER.

14 days after the injection developed severe headache and fever. Went to ER. More symptoms developed: Severe Numbness from the waste down Severe pins and needles sensation from the waste down Severe Burning sensation from the waste down Severe coldness on feet that has moved up past ankles Unable to urinate Unable to have a bowel moment Blurry vision

JAW OPENING AND CLOSING VIOLENTLY ON IT OWN; STIFFNESS IN ANKLES; DIFFICULTY WALKING; LACK OF COORDINATION; EQUILIBRIUM AND BALANCE COMPROMISED; BAD DEXTERITY; ITCHING AROUND THE MOUTH; HANDS AND FEET CURLED DOWN; NUMBNESS (HANDS AND FEET); ELECTRICAL IMPULSES IN FACE AND SCALP AND ELECTRICAL IMPULSE AROUND MOUTH AND HAND; TINGLING AROUND THE MOUTH; PAIN IN ANKLES; TINGLING IN EXTREMITIES (HAND AND FEET); CONSTANT BRIGHT LIGHT FLASHING; LIP HANGING; UNCONTROLLABLE MOUTH MOVEMENT AND JERKING; MILD FLU LIKE SYMPTOMS; LACK OF APPETITE; TWITCHING ALL OVER; TREMORS; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 182 pounds, and height was 68 inches. The patient's past medical history included extreme motor vehicle accident (other driver was drunk), and broken neck, and concurrent conditions included penicillin allergy. The patient was previously treated with methadone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2042T21H, and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. Concomitant medications included oxycodone. On MAY-2021, the subject experienced tremors. On MAY-2021, the subject experienced twitching all over. On 05-MAY-2021, the subject experienced mild flu like symptoms. On 05-MAY-2021, the subject experienced lack of appetite. On JUN-2021, the subject experienced uncontrollable mouth movement and jerking. On an unspecified date, the subject experienced numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, tingling around the mouth, pain in ankles, tingling in extremities (hand and feet), constant bright light flashing, and lip hanging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from mild flu like symptoms, and lack of appetite on 08-MAY-2021, was recovering from tremors, had not recovered from numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, uncontrollable mouth movement and jerking, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, pain in ankles, tingling around the mouth, twitching all over, and tingling in extremities (hand and feet), and the outcome of constant bright light flashing and lip hanging was not reported. This report was non-serious.

Fever (99.3), nausea, diarrhea, fatigue, body aches. Symptoms other than fever began around 12:30pm on 3/7/21. Fever began at 3:30 pm on 3/7/21.

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.

Vasovagal event without syncope post vaccine. Clammy and nauseous with tingling to hands. EMS and Dr on site. Blood pressure 90/49 at 18.10. at 18.15 blood pressure was 114/81. Released home and advised to seek medical attention later if needed, client verbalized understanding.

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.

April 01 2021 09:00 Am, Severe Chills with 102.8 Fever lasted until 10:00PM. April 02 2021 11:00 AM Wide Spread Muscle Pain continuing April 03 2021 06:00AM April 03 2021 06:00AM Continuing Wide Muscle Pain with Nausea starting 04:30AM

12-15hrs after injection, general fatigue, loss of appetite, and minor aches treated effectively with IBU, APAP, and sleep. The second morning, itching sensation on forearms with ~6 minor welts forming on right fore arm. 18month prior, had a sever exposure to poision oak treated with high dose prednisone. Forearms were very red, welts, and itchy. Itchy sensation occurs occasionally with exposure to hot shower water, but only transient. Post vaccine, much more severe itching sensation with formation of small (<2mm) hives. Fatigue had subsided by this time.

Patient received Johnson&Johnson COVID vaccine in the afternoon on 3/31/21. Patient reported having right arm pain, diaphoresis, chills, nausea, and muscle aches/pain in upper leg/lower back at 5:30am the following morning. Patient took 2 tablets of 500mg naproxen in the morning and in the afternoon. Symptoms did not resolve and patient had to leave work early. Upon getting home patient took 2 tablets of 650mg tylenol and symptoms resolved within 48 hours. On 4/3/21 patient reported mild to severe pain in heel of left foot. The following day the patient went to WellNow urgent care to get his heel examined. During examination provider noticed patient's lesions and patient stated more lesions have appeared since getting the vaccine. 1 on his stomach, 1 on the dorsum of his left foot, 1 on his back, 1 on his left elbow, in between his toes of his left foot, and in between the fingers of his right hand. Patient stated that these lesions cause a burning sensation and can become itchy. Patient was sent to Hopsital ED as provider at urgent care was concerned patient may have purpura. Patient was seen and discharged on 4/4/21 from the ED. The heel pain was determined to be plantar fascitis which was treated with at home exercises with a heel cup. The patient was given clotrimazole for his lesions. The patient had a follow-up visit with his primary care provider at hospital on 4/6/21 in which he explained the clotrimazole only made his lesions worse. Patient was referred to follow up with dermatology on 4/8/21. Primary care provider believes progression of the lesions since getting the vaccine leads to concern of an underlying autoimmune exacerbated by vaccine.

JUST A BIG KNOT IN ARM AT INJECTION SITE; DIARRHOEA; EXTREME LETHARGY; EXTREME FATIGUE; NAUSEA; FEVER/LOW GRADE FEVER; EXTREME ABDOMINAL PAIN 12HRS AFTER INJECTION; UPPER GASTROINTESTINAL GAS; BLOATING; CHILLS AND SHAKING VERY STRONGLY; VOMITING; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 260 (unit not reported) and height was 73 inches. The patient's concurrent conditions included non alcohol user, non smoker, type 2 diabetes, hypertension, and pain, and other pre-existing medical conditions included patient had no history of allergy to vaccine, drug, or food. patient had no drug abuse. the patient had no family history of any disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on left arm on 26-MAR-2021 10:01 for prophylactic vaccination. Concomitant medications included atorvastatin for cholesterol, dapagliflozin propanediol monohydrate for diabetes mellitus, metformin for diabetes mellitus, amlodipine for hypertension, atenolol for hypertension, irbesartan for hypertension, and capsaicin/menthol for pain. On 26-MAR-2021, the subject experienced extreme abdominal pain 12hrs after injection. On 26-MAR-2021, the subject experienced upper gastrointestinal gas. On 26-MAR-2021, the subject experienced bloating. On 26-MAR-2021, the subject experienced vomiting. On 26-MAR-2021, the subject experienced chills and shaking very strongly. On 26-MAR-2021, the subject experienced nausea. On 26-MAR-2021, the subject experienced fever/low grade fever. Laboratory data included: Body temperature (NR: not provided) 100 (unit not specified). On 27-MAR-2021, the subject experienced extreme lethargy. On 27-MAR-2021, the subject experienced extreme fatigue. On 28-MAR-2021, the subject experienced diarrhoea. On 29-MAR-2021, the subject experienced just a big knot in arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme abdominal pain 12hrs after injection, upper gastrointestinal gas, bloating, extreme fatigue, and nausea on 30-MAR-2021, vomiting, chills and shaking very strongly, and fever/low grade fever on 26-MAR-2021, and diarrhoea on 28-MAR-2021, and the outcome of extreme lethargy and just a big knot in arm at injection site was not reported. This report was non-serious.

Immediately after receiving his covid vaccine patient started feeling nauseaus/dizzy, and threw up. After throwing up he felt better.

Very bad headache, body aches, high fever and horrible pain in lower left abdominal area that lasted just over two days. All symptoms have nearly abated aside from the abdominal pain. However, abdominal pain is lessening each day. If these are considered normal side effects or adverse effects, i am unclear of. I just thought it would be best to report any effects to the vaccine.

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.

Pain started in buttocks; then numbness in legs, then progressed up back to mid back pain, then to neck fullness and tightness, pain on both sides of neck, jaw and chin, feeling of something popping in neck and then Bell's Palsy of right side of face, difficulty speaking, eating, numbness of tongue; right eyelid unable to close, more pain on both sides of neck and back of head; cold and hot sensations on limbs today and no improvement of facial paralysis; hearing cricket noises in right ear at times, burning pain in patches of face.

8:00 PM- felt tired, achy, headache, cough, nausea, tenderness left axilla. Resolved today. On April 4th, felt like he had shingles rash starting, (client has history of shingles) but no rash erupted. Skin affected across chest across the nipple line, and back.

pt says he is not feeling well. He has become light headed, dizzy, and has severe stomach pain. He has developed some diarhea and has a sour taste in his stomach. He says when he stands up he feels like he may fall and he feels like he has a buzzing in head. He has back pain on this lower right side of his body. He has been taking anti-diarhea medicine medicine and Tylenol. He is not getting any better and will have to contact his PCP.

Fever, Chills, Body Aches, Head Ache, Upset Stomach. These symptons lasted for 16 hours once they began. I received the shot on Tuesday at 11:30am and by 3:30am the next day I was sick.

Swollen lymph nodes and abdominal pain from right him bone down to scrotum. Pain on 4/7 was such that i though i was suffering a hernia. Couldn't get out of car or move my right leg across my body. Could put right leg into pants leg. Hurt to bend over and do much of anything on 4/7. Initially thought pain was in testicle but doesn't hurt at all to the touch. Realized it more a swollen area in the groin between hip bone and scrotum. Nothing hurts to the touch at all in that area either which lead my to believe it was swollen lymph nodes. The Feeling is as if i got hit in the right groin and my testicle has been hit and discomfort is 8 inches above right testicle in my groin area. It has been improving every day since then, the more i walk the better it is. It only hurts when i sit now and it seems to aggravate it pretty well but once i start moving the pain goes away. It has been 9 days now and the i don't notice it all day until i come back to the office and sit at my desk and again it gets aggravated and the discomfort feels like my right testicle is near my appendix Since this all started my legs feel heavier in the calf and have little nerve sensations when i sit too, which concerns me about the blood clot possibility and so i have been emailing with my doctor. I am going to make appt for Monday 4/19

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.

Patient seen at medical facility 4/6/2021 with headache, fatigue, lower extremity petechial rash, unexplained bruising, small amount of blood in stool. CBC ordered 4/6/2021 and obtained on 4/8/2021. Platelet count was 4 x 10^9/L. Patient admitted to hospital. Hematology/Oncology consult obtained. Patient diagnosed with Immune Thrombocytopenia Purpura (ITP). 4/9/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone. Platelets increased to 15 x 10^9/L. 4/10/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone, platelets increased to 81 x 10^9/L. Patient discharged on oral prednisone with Hematology/Oncology outpatient follow-up. Patient advised to stop Goodies Powder for Headache. 4/13/2021 patient returned to hospital emergency department with generalized weakness. His platelets were rechecked and were 277 x 10^9/L. D-Dimer was undetectable at <0.27. Patient was discharged home from the emergency department.

Immediately dizzy, nauseous and fatigue lasted 2 days. One week later (5/12) had severe allergic reaction including violent diarrhea with severe cramping and pain, and swollen lips, tongue, face, hands and feet. Acute swelling and diarrhea lasted 12 hours. Ongoing angioedema lasted 4 days and moved from mouth to face and hands and feet. No previous food allergies or allergic reactions.

Unsure of reaction related to vaccination. Pt experienced nausea/vomiting 24 hours following vaccination with Janssen c-19 vaccine. Pt reports "food poisoning" when presenting to clinic >24 hr after receiving covid vaccine.

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.

I went to do my annual physical on 5/31/21 and the following symptoms got worse: Nausea, muscle pain, high temperature, cough, chest pain, and pain in the left side of the stomach.

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

Aching joints, upset stomach, sleepiness, slurred speech, drowsiness, blurred vision, weak muscles, lack of thirst and appetite, fever

3/7: No adverse reactions observed 3/8: 12:30 a.m. Awoke vomiting and with fever of 99.8 F 2:30 a.m. Fever of 102 F Multiple measurements prior to 10 a.m. fever of 101.6-102 F 10:00 a.m. Full adult dose Vick NyQuil Severe Cold & Flu. Additional doses as directed. Scheduled rapid Covid-19 test at pharmacy 2:00 p.m. fever of 99.5 F 4:50 p.m. COVID-19 test, no fever 6:00 p.m. Negative test result Remaining evening of 3/8 and until early morning, 3/12, heavy night sweats, clamminess, extreme fatigue

Severe vertigo, nausea experiences about 5 min after vaccine admin. HR regular, skin diaphoretic, Over course of 15 minutes of observation symptoms subsided, No dysphagia, redness or swelling at site, After observation for additional 15 minutes was able to ambulate and feelings of dizziness subsided. He is not driving and advised to rest for the next 24 hours, and to go immediately to ED or Express Care if any other symptoms develop.

severe body and joint pain, 101.1 fever, chills, nausea started approx 5 1/2 hours after injection. Next morning, approx 20 hours after injection strong head ache in top of head and nausea. 30 hours after injection, all negative effects subsided. 48 hours after injection, normal function- no effects.

Injection site swelling and extreme soreness Fatigue Stomach cramping Nauseous Chills Muscle aches Migrane

Felt a slight numbness is throat, possible slight swelling in throat- felt this 20 minutes after shot and it lasted about 30 minutes.... 30 minutes after the shot my face turned red and my ears were very red, almost purple , and hot. This lasted for several hours after... At 11:30pm, almost 7 hours after the shot, I started to feel lousy. I started to get body aches and chills. Within 30 minutes they were fairly intense body aches and chills, shaking. At 1:00am I started to feel nauseas . At 1:30 am I started dry heaving. At approximately 2:30 I threw up twice, and the dry heaving and nausea lasting until 4am , when I took an anti nausea pill. I finally fell asleep at 430am. I woke up at 8am and felt tired, and no longer nauseated.

LOW ABDOMINAL PAIN; LOW BACK PAIN NEAR SPINE; LOW ABDOMINAL PRESSURE; 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 concurrent conditions included diabetic, copd, hypertension (htn), alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergy 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: Unknown) dose was not reported, administered on 31-MAR-2021 09:30 on right arm for prophylactic vaccination. No concomitant medications were reported. On 01-MAR-2021, Laboratory data included: PCR (NR: not provided) Negative. On 31-MAR-2021 21:30, the subject experienced low abdominal pain. On 31-MAR-2021 21:30, the subject experienced low back pain near spine. On 31-MAR-2021 21:30, the subject experienced low abdominal pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low abdominal pain, low back pain near spine, and low abdominal pressure. This report was non-serious.

5 days post vaccination I experienced sudden onset of generalized hives associated with itchiness. After use of benadryl the hives became more red, less raised, and resembled a confluent measles rash. From association with hives I experienced ear pruritus, sore throat, nausea. And fatigue. Hydrocortisone creme was used on the rash.

About 4 hours after getting the vaccine, I experienced diarrhea. Overnight I had a headache, slight chills. The next morning I was tired, had muscle aches, had a headache, had a bit more diarrhea. The diarrhea has gone away, but still feel aches and tiredness and headache 18 hours after the vaccine shot.

Pt complained of severe body aches, chills, nausea, vomiting, and fever after 5:00 pm on 04/07/2021, which lasted 24 hours. As of 04/09/2021 pt has called the pharmacy about his symptom and is still suffering with nausea and fatigue.

Severe headache. Body temperature modulation was difficult, chills the fever. Extreme vomiting. This lasted about 24 hours.

About 12 or 13 hours after my vaccination I started having severe flu like symptoms. I got vaccinated at about 1am sunday morning , symptoms started between 1 and 2pm sunday afternoon. 101.5 fever Nausea, vomiting Severe headache body aches Had trouble hydrating while this was going on. Nausea was bad enough to cause me to vomit plain drinking water. Luckily, that passed. I self treated with ibuprofen and gatorade mixed with water. I had these symptoms til about 1 or 2am monday early morning. I had a good nights rest and took the day off from work on monday to recover. In spite of this I would get a booster in necessary. A few hours of flu symptoms is preferable to getting sick with covid,

Chills after 6hrs, headache after 12hrs, severe headache after 15hrs, dry heaves and shortness of breath after 18 hrs.

Nausea for 15 minutes shortly after the vaccine, mild flushing of hands and face shortly after the shot, and fatigue for 24 hours after shot.

For about an hour I had severe nausea and vomited and had a bad headache. However, I hadn?t eaten that morning which may have been a contributing factor. I took some ibuprofen and symptoms subsided after about two to three hours

Shortness of breath, mild upper back pain, ache behind both knees, bloating and increased bowel movements, mild headache

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.

Diarrhea, mild temperature, sore body initially. 3 days after pain in right leg. It feels like a sharp stabbing pain. Like a charley horse or dehydration. Drank water and Gatorade does not stop pain. Started to take 81 mg aspirin and did not stop pain. Just went to Dr. for blood test on 4/14/21.

Severe stomack pain. 2 days. Went to the Urgent Care and was sent to the ER for exrays. Nothing found, No explaination. Following up on 4/15.

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

Patient states he has had generalized abdominal pain since getting the vaccine, throughout entire abdomen off and on, for 30 seconds to 30 minutes, 5-15 times a day. No other symptoms (no headache, no leg swelling, no fevers or chills)

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

On the day starting 6pm (injection +8.5 hrs/next day until 2pm: Severe headache, severe nausea/vomiting, dizziness, body ache, chills/hotflashes Two days later, mid afternoon: Nausea Five days later, lunchtime for several hours: severe headache Six days later, lunchtime for several hours: severe headache

Sudden onset Optic Neuritis, going blind. Extreme headache, Nausea. Loss of Color Vision. Gray Vision, Spots. Vision Loss. Extreme eye pain around eyes. continued extreme headache.

8 hours after receiving J&J vaccination, the patient experienced upper stomach pain that radiated into the chest area with an increase in HR to 160 and increase in BP to 220/160. Patient was taken to ER where they treated increased HR and BP. ER found nothing wrong with EKG, enzymes, etc. cardiac work up was unremarkable. Patient again had increase in HR to 165 and increase in BP 2 days later (March 16th) at 6pm with no warning. This time extreme upper abdominal pain that radiated into the chest. Patient again went ER and treated for high Heart rate and BP. Patient was admitted to hospital for 2 days. . 3 weeks later again had episode of increased HR and BP with upper abdominal pain that resulted in ER visit. was released again after treatment.

pt says he started feeling nauseated. He started having severe abdominal cramps that came in waves and raised heart rate. He went to Hospital ER in State. He was admitted for observation. He had blood test and had an EKG. He was given regimen morphine shots. He DX was severe abdominal cramps, raised heart rate and Dehydration. He was told to FU w/ PCP. Pt feels like these symptoms were from taking the vax earlier that day. He did not feel well for about 5 to 6 days. He says he feels better today.

About 3 weeks after the vaccine I started having severe chest and belly aches on the right side. CT scan showed a blood clot on my lungs and pneumonia

Pt phoned our office on 04/19/21 with complaints of abdominal pain and bilateral leg pain. Pt was instructed to seek immediate health care for evaluation. He refused. Pt was very agitated and concerned about covering costs of medical care despite having health care insurance. Pt again instructed to seek health care and he refused.

Achy; No appetite; Mild dizziness; Feeling flushed; Soreness at the vaccine site; Fever; MILD JOINT PAIN; Chills; 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 concurrent conditions included liver disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, administered on 05-MAR-2021 10:45 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced mild joint pain. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 05-MAR-2021 11:00, the subject experienced mild dizziness. On 05-MAR-2021 11:00, the subject experienced feeling flushed. On 05-MAR-2021 11:00, the subject experienced soreness at the vaccine site. On 06-MAR-2021, the subject experienced achy. On 06-MAR-2021, the subject experienced no appetite. On 07-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 (high fever). On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild joint pain, and fever, had not recovered from soreness at the vaccine site, and the outcome of mild dizziness, feeling flushed, chills, achy and no appetite was not reported. This report was non-serious.

Abdominal Pain - ended up being mild pancreatitis with elevated lipase to 423 on 4/17/21 that went to normal on 4/21/21 with value 49.

NAUSEA; DIARRHEA; TIRED; LUMP ON INJECTION SITE; 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: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced lump on injection site. On 13-APR-2021, the subject experienced tired. On 14-APR-2021, the subject experienced diarrhea. On an unspecified date, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lump on injection site on 26-APR-2021, nausea, and tired on 19-APR-2021, and had not recovered from diarrhea. This report was non-serious.

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

throat swelling shut, called ambulance, took Benadryl. Currently nausea, burning lower stomach, severe lethargy, hot skin,

Nausea; Vomiting; Lightheadedness; Collapsing or losing consciousness. Positive LOC. vomiting x1. EMS was called at 1207 and refused further care. patient waited until a ride came and picked him up.

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.

Acute back pain leading to numbness in both legs causing paralysis in both legs, facial paralysis, blurred and double vision, trouble urinating and having bowel movements. Has been diagnosed with GBS/ Miller-fisher disease.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Pt previously had episodes of fainting after getting blood drawn in the past

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Loss of feeling on finger for 30 minutes-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild

Within 24 hours I experienced profuse sweating followed by aching in my neck, shoulders, arms and lower back. This was then followed with severe fatigue, cold chills and diarrhea. Symptoms subsided after approximately 24 hrs of onset.

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.

Day 1: injection site soreness Day 2: Extreme fatigue, muscle soreness, aches, fevers, chills, dizziness, nausea Day 3: Extreme fatigue, muscle and joint soreness, aches, fevers, chills, dizziness, nausea Day 4: moderate fatigue, chills, fever spikes, dizziness

PAIN ON THE INJECTION SITE; DIARRHEA; FATIGUE; NAUSEA; This spontaneous report received from a patient 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: 1808978,and expiry: 13-JUN-2021) dose was not reported, administered on 25-MAR-2021 in right deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced nausea. Treatment medications included: Ibuprofen. On 25-MAR-2021, the subject experienced pain on the injection site. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from pain on the injection site on 26-MAR-2021, and had not recovered from fatigue, diarrhea, and nausea. 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.

Extreme abdominal pain with diarrhea, loss of appetite, nausea. This adverse reactions are still present as of today's date at 12:21pm

Severe Nausea, burning eyes, dizziness, headache, body ache, diarrhea, fatigue. I took my husband to ER on day 5. He was given nausea meds, eye drops and anti- diarrhea meds. I also treated him with an Aleve/Tylenol regimen.

Experienced same typical symptoms such as fatigue and nausea for two days only after getting the vaccine. But also had an adverse reaction to my left eye for week where it became inflamed and very bloodshot red. Eye continued to swell and drain fluids and was extremely soar and painful with blurred vision. Made appointment at my family physicians office on 4/13/2021 where doctor subscribed drops to be administered 3X daily. This is where I am now.

dizzy,nausea. Pt received the J&J vaccine on Saturday. Pt had HA and body aches on Sunday. On Monday, pt has severe HA and ringing in his ears and has not gone away. 51 yo M w/ no known chronic medical conditions, J&J vaccine on Friday, presents w/ dizziness (room-spinning) that started this AM and has since resolved. Initially started when he sat up from bed after waking up; a/w moderate nausea (no vomiting). Pt went back to sleep, no sx when he woke up, but sx re-started when he stood up. Since then, dizziness has resolved. Pt has residual nausea, but currently no dizziness. He also reports constant ringing in his ears since this AM, w/ no associated muffled hearing, ear pain, ear discharge. Initially had fevers/

AFTER 10 MINUTES OF THE VACCINE, HE FELT HOT, TIGLING IN HANDS AND FEET. HE DRANK SOME WATER, THEN HE LAY OUT ON THE SOFA BED FOR 10 MINUTES. AFTER THAT,HE SIT UP, THEN HE THREW UP. HE SAID THAT HE FELT BETTER TO LAY DOWN THAN SIT UP. WE STARTED TO CALL PARAMETIC. AS SOON AS PARAMETIC TEAM CAME, THEY CHECKED HIS VITAL SIGN , BLOOD PRESSURE. HE WAS OK, BUT THEY TOOK PT TO NEAR BY HOSPITAL TO MONITOR. PT WAS DISCHARGE FEW HOURS AFTER WITH ANTINAUSA MEDICATION. WE FOLLOWED UP WIHT PT , AND HE SAID HE WAS OK NOW.

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.

DIARRHEA; INJECTION SITE REACTION; EYE PAIN; TEETH PAIN; CHILLS; TIREDNESS; HEADACHE; GENERALISED ACHING; This spontaneous report received from a patient 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: 202A21A and expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced generalised aching. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced eye pain. On 10-APR-2021, the subject experienced teeth pain. On 14-APR-2021, the subject experienced injection site reaction. On 14-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalised aching, and chills on 11-APR-2021, was recovering from tiredness, had not recovered from headache, injection site reaction, eye pain, and teeth pain, and the outcome of diarrhea was not reported. This report was non-serious.

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.

BULGING VEINS IN LOWER LEGS; MUSCLE TWITCHING; NAUSEA; HEADACHE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 51 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced muscle twitching. On 10-APR-2021, the subject experienced bulging veins in lower legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 03-APR-2021, nausea on APR-2021, and headache on 05-APR-2021, was recovering from muscle twitching, and had not recovered from bulging veins in lower legs. 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.

Exactly 11 days after receiving the J&J vaccine my husband developed leg pain in his right lower inner leg, he was taken to the hospital on 04/20/2021 which a ultrasound was completed but resulted no blood clots, no other labs or treatment was performed that day, the next day he developed severe diarrhea and flu like symptoms with continued leg pain and difficulty breathing, He was then rushed to the hospital by ambulance where he was suffering from very low BP 41/31 was the lowest, a line was placed and he was put on pressors to increase his BP. He was transferred to the hospital where he was diagnosed with a flesh eating bacteria in the right leg where the pain was at and Sepsis. He was taken to surgery to debride the right leg and was started on CVVHD because his new kidney was now failing, he eventually was started back on Hemodialysis and taken to surgery 2 more times where he cardiac arrested on the table in surgery and died. A private autopsy is being performed but the preliminary results shows he had multi-system organ failure, including his liver which was NEVER a problem in the past.

Patient started to feel nauseous, weak, and spiked a fever of 101.4 degrees F today day after vaccine.He is still experiencing these symptoms. Advised patient to rest, hydrate, and take Tylenol for the fever if safe and appropriate.

(@ 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.

Patient's husband reported to us on 5/19 that pt had nausea and vomiting and mild fever after getting the J&J vaccine on Saturday 5/15. patient then had a mild fever on 5/16 which was resolved on its own after 1 day but nausea and vomiting persisted, pt sough care from her PCP on 5/19 and was prescribed 2 antiemetics to treat. Patient's husband verified no other symptoms, patient doing well otherwise.

Pt c/o abd pain x2 days of lower abd and sides. Denies da/ns/v. Pt reports pain worsening while laying on back and while rotating torso. Pt took 800mg ibuprofen with temporary relief. Recieved janssen vaccine 25th May.

Patient received two doses, one in each arm, of the Janssen COVID19 vaccine on 6/3/2021. Patient mistakenly believed he required two doses, one in each arm. Vaccinator administered the extra dose. He asked the patient if he had received the COVID19 shot before, but the patient misunderstood and said that he had not received the shot before that day. Patient reported lightheadedness and nausea approximately 24 hours after the vaccination. Approximately 72 hours after the vaccination, the patient reported no other side effects and said that he was in good condition.

No taste Muscle pains over the entire body Sore Throat Constant Cough Weak & Extremely Fatigued Nausea - throw up after eating Started within 7-8 hours of receiving the vaccine Took 2 Tylenol Felt better by the third day (Monday) - nausea has persisted and throat remains a bit sore and still cannot taste food

Presented with 1 month of nausea and occasional vomiting for the past 4 weeks since receiving J&J vaccine with acute worsening 2-3 days prior to admission with multiple episodes of emesis daily. Patient has history of GERD and cataracts. Complaint of lethargy and itchiness for the last month. Patient sought treatment at ER and was admitted. Wife noticed jaundice on morning of admission. Found to have transaminitis and hyperbilirubinemia on admission with some improvement after IV fluids. Patient admitted to hospital for 4 days. Note: Patient had been treated for Hep B infection for 6 months in 2007 with tenofovir

Headache, chills, fever, body aches, nausea, and a general malaise were experienced beginning approximately 8 hours after receiving the shot and lasted approximately 36 hours. Approximately 4 days after the shot, i experienced a severe bout of vertigo, which I've never experienced in my life. This included severe dizziness and vomiting for about 12 hours and a headache and light dizziness for an additional 24 hours.

Nausea, vomiting, difficulty walking, unable to eat or drink; unable to clear secretions, difficulty breathing

Began feeling dizzy and nauseated. Started vomiting at approximately 5:00pm and continued until 6:30 or 7:00pm. I could not open my eyes because of the extreme dizziness. Chills Sweating I was able to sleep for a few hours and woke up at 10:00pm and the symptoms had subsided. I woke up with a headache on Sunday morning. That went away and have not had any symptoms since

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

swelled immediately after the shot and was given 2 benadryl before leaving the drive through. Experiened chills, fever and was vomiting all night. Feeling tired and dizzy afterwards and ever since.

S: Patient is a 53 y/o male c/o having dizziness and nausea while he is walking towards his car after 5 minutes of getting vaccine. Reports having high blood pressure. He did take his medication this morning. O: 1st reading vitals BP 150/70 HR 64 Oxygen sat 94 pain 0/10 resp. 18 2nd reading 130/80 Hr 68 oxygen saturation 96 Clamy to touch. Negative for shortness of breath, throat swelling, facial swelling, negative for rash. Negative for numbness or tingling of lips or throat. Cardio: Negative for arm pain, back pain, weakness, palpitations Neuro: Alert x4, negative for limb weakness, neg for slurring, neg Medications: losartan 50 mg daily, carveidlol 12.5 mg bid, famotidine 20 mg every other day, simvasta

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.

Recd vaccine at around 6PM Friday March 12, started having symptoms at around 4AM Sat the 15th: horrible headache, fever, nausea, body aches. Lasted all day Saturday, started feeling better Sunday morning. As of Monday morning (the 15th), feeling a bit of lethargy but otherwise much better and back to "normal". this is the first time in my experience of taking vaccines of having this kind of reaction.

Patient was nauseous, and short of breath. Patient had several episodes of vomiting, He stated he had a "tickle" in his throat and felt his airway was obstructed. Pharmacist. administered diphenhydramine 25mg po x2.

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

At ~3:10pm, patient received his vaccination for COVID (Janssen brand). Patient was directed to sit in waiting area for 15 minutes for monitoring; during this time, patient started to complain of the following: chest/abdominal pain, "pounding in his head", felt faint, and "scratchy throat" that was not improving. Around 3:35pm, 9-1-1 was called due to worsening chest pain and scratchy throat. EMTs directed me to administer 25mg of diphenhydramine (which as give at 3:46pm) to patient. EMTs arrived shortly thereafter, noting elevated BP (~154/90). Patient left pharmacy area ~4:10pm and was brought to ER via paramedics for further evaluation.

Patient complaining of severe headache, chills, body aches, sore throat, running nose, cough, nausea and vomiting and watery, itchy, burning eyes

10 min after receiving vaccine patient became flushed, feels like arms are swollen and itching, nausea, and sweating. Patient went to ER and they noted tachycardia and diaphoresis

Patient got dizzy and threw up immediately after receiving vaccine. Very pale. After drinking water and relaxing felt okay, Stayed for 15 minutes and still felt okay

Johnson & Johnson Vaccine: Tired and sleepy with a headache starting at 6:45pm April 8. Then his arms started to have pain and aching in the body more on the arm where he did not get the shot. This happened around 8:30pm. Patient chest started to ache. He went to bed. The entire night he experienced aches and pains in his body, his stomach and hips. When he woke up at 8:00 am on April 9 his legs and the back of his thighs were aching. He could barely move. He took two Tylenol that morning. He continued to experience aching in his body all day. He said it felt like flu like symptoms. Then he took more Tylenol that evening. By 9:30pm he started feeling better. He woke up Saturday, April 10 feeling better.

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).

Reported not feeling well after receiving vaccine. Nausea, vomiting, diarrhea. Along with chest and epigastric pain, body aches, and chills

Mild fever and severe body chills beginning at about 4:00 to 4:30 am on Monday, April 12, 2021 (which lasted for only about two-to-three hours) Mild-to-severe abdominal pain beginning at about 12:30 pm on Tuesday, April 13, 2021 (ongoing and no treatment as of yet)

BODY ACHES; SORE THROAT; RUNNING NOSE; COUGH; VOMITING; WATERY EYES; ITCHY EYES; BURNING EYES; CHILLS; NAUSEA; SEVERE HEADACHE; This spontaneous report received from a health care professional concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, diabetes, hypertension, gastroesophageal reflux diseases, hyperlipidemia, seasonal allergies, and bph, 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, intramuscular, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 08:15 to left arm for prophylactic vaccination. Concomitant medications included atorvastatin, carvedilol, fluticasone, levothyroxine, losartan, metformin, and omeprazole. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced sore throat. On 06-APR-2021, the subject experienced running nose. On 06-APR-2021, the subject experienced cough. On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced watery eyes. On 06-APR-2021, the subject experienced itchy eyes. On 06-APR-2021, the subject experienced burning eyes. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, chills, body aches, sore throat, running nose, cough, nausea, vomiting, watery eyes, itchy eyes, and burning eyes. This report was non-serious.

About 11 hours after I took the shot, I start feeling very hot and my whole body started shivering very badly from toe to head, I had extremely bad headache, felt nauseous and my whole body was hurting. I took 2 Tylenol 650mg but it did not do anything. My temperature was high (reached 101). The whole thing lasted few hours non stop. After that, I have light to moderate headaches almost every day (till this day)

Around 5:00-5:30 PM (about 2 to 2.5 hours after the vaccination), I started to feel a bit tired. I took Tylenol, beginning around 5:00 PM. By 8:00, I was feeling tired enough that I went to bed early. By 9:00, I had terrible chills and body aches throughout my body. The aches were worse in my chest / torso -- maybe from so much shaking. I did not watch any of the men's championship game that night. I also felt nauseous but I seemed to lack the strength to vomit. I can not remember a time when I had so much physical pain in my life. My hands felt numb / tingling. I tried to drink some ginger ale but drinking was difficult. Although I was aware that I was breathing and my heart was beating, I thought that I might die. The terrible pain continued for a few hours. Around 10:30 PM, the pain dissipated. However, after about 10 minutes of relief, the pain returned, perhaps worse than before. At around 11:30, my wife came to bed. She suggested that I try relaxing Yoga breathing. I did that and the pain stopped and I fell asleep. The next day, I woke up with a typical headache and took more Tylenol. I continued to improve the remainder of the day.

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.

LOWER BACK/KIDNEY PAIN; CHILLS (SEVERE, UNCONTROLLABLE SHAKING, COLD HANDS AND FEET); SORE ARM; NAUSEA; FEVER; 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 past medical history included panic attacks. The patient was previously treated with alprazolam for panic attacks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced lower back/kidney pain. On 09-APR-2021, the subject experienced chills (severe, uncontrollable shaking, cold hands and feet). On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 109 F, and Body temperature decreased (NR: not provided) 102.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills (severe, uncontrollable shaking, cold hands and feet), nausea, lower back/kidney pain, sore arm, and fever. This report was non-serious.

SKIN PEELING; SKIN BLISTER; RASH UNDER BREAST; HEADACHE; STOMACH PAIN; DIARRHEA; COUGH; BODY ACHES; FEVER; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, and penicillin allergy. 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 10-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 100.7 F. Treatment medications included: guaifenesin, and paracetamol. On 11-APR-2021, the subject experienced stomach pain. On 11-APR-2021, the subject experienced diarrhea. On 11-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced skin peeling. On 14-APR-2021, the subject experienced skin blister. On 14-APR-2021, the subject experienced rash under breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, cough, body aches, headache, stomach pain, and diarrhea, and had not recovered from rash under breast, skin peeling, and skin blister. This report was non-serious.

Immediately after the injection patient felt a pressure like and felt a ball on the back of his head left side that resolved within a day. Within a week from vaccine patient started having a headache on and off with feeling of like his brain is swelling on the left side. Within another week patient experienced abdominal pain and chest pressure. went to a hospital CT abdomen was negative. On 4/28 patient had a severe headache followed by numbness to left face and left facial droop. 911 was called patient was code stroke in ED.

Severe headache followed by abdominal pain, eventually confirmed portal vein thrombosis (fully blocked), treated as TTS with hospitalization for 5 days

Three days after receiving the vaccine, he developed a headache which was intermittent with pain score of 5-8 out of 10. Headache became consistent around 4/11/21. Pain is in the occipital region and occasionally radiates behind the eyes. Also complains of dizziness, nausea, vomiting, and tingling in his hands bilaterally - worse in the mornings and goes away after waking up. He presented to Medical Center on 4/28/21 and transferred to Medical Center for treatment of vaccine induced thrombocytopenia and nonocclusive straight sinus thrombus. He was started on bivalirudin infusion 4/29 @ 0142 via continuous infusion. Still receiving treatment at the time of this report.

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

Pt had "tingling" on his throat. Bilateral rash on arms. Elevated B/P 170's. Nausea and vomiting Pt was given 25mg Benadryl. Pts b/p lowered. Nausea and vomiting resolved.

Started getting achy and feverish. Diarrhea, vomiting. Told me, I'm as sick as I've ever been in my life. Died. Just want to know if he died from Covid or an adverse reaction from Johnson and Johnson vaccine he received in jail. No one wants to test his blood. He's at the mortuary awaiting cremation, and I thought it best if some government entity drew some blood to determine if he's a Covid or vaccine reaction fatality. Before they cremate his body.

abdominal pain. The pain was so severe that my knees would buckle and several times if I was holding anything, it caused me to drop it. After about a week, I had an appointment at 4:30 and was scheduled for the next morning at 8:30 to meet with a back and spine doctor for xrays. Xrays were negative. I was then schedule with a neck and hand specialist a few days later. This appointment could not provide a diagnosis. Back and abdominal pain increase and soreness had spread to the stomach and groin. After the news broke of the cerebral blood clots in 6 women. See attached Continuation Page.

Patient presented to the ED with complaint of abdominal pain and dysuria. Experiencing suprapubic pressure when trying to urinate, only minimal urine would come out. Patient was found to be COVID positive upon admission on 4/24/2021.

I experienced dizziness, headaches, SOB, chest pains, diarrhea, nausea, occurred when I am under physical stress. Walking 10ft or up the stairs triggered my symptoms. Once I stopped moving, my symptoms would dissipate. I called my PCP along with a cardiologist up until today. I was tested for blood clots, had complete blood panel, stress test and nuclear stress test. My symptoms are getting better but still have mildly present. My last meeting with the cardiologist, what he saw after the nuclear stress test, that there was a lack of blood flow where to the lower right heart chamber. He said it probably due to a blood blockage or plague and at this time he is trying to figure it out.

SHIVERS; NAUSEA; FEVER; 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 allergic reaction to penicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. Concomitant medications included ibuprofen. On 05-JUN-2021, the subject experienced shivers. On 05-JUN-2021, the subject experienced nausea. On 05-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shivers, and the outcome of nausea and fever was not reported. This report was non-serious.

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.

Diarrhea in the morning, fatigue, and headache after that during the next three days. Slight fever also on and off during those three days. By the fourth day, the symptoms were clear. Self-care, nap and resting at home. I may have taken Ibuprofen for headache.

COVID positive on 7/11/2021 in hospital Acute RUQ pain, congestion, and fever Currently hospitalized.

face tingling, couldn't move, neck pain same side as the shot, fell over in bathroom and couldn't move, and constipation

Patient c/o mild chest tightness, dizziness and nausea about 7 minutes after received Jansen cover-19 while siting in observation area around 11:43. He fainted right after. Patient was lowed from chair to yoga mat with assistance of paramedics. He was positioned in supine with legs elevated. Patient regained consciousness once laying supine. He denies chest pain. His first set of vital signs: BP 140/87; P 51; Res 18; O2 saturation 98% at 11:45. Patient reviewed his past medical history including hypertension and palpitation. He states he des not take medication for hypertension and he takes atenolol 25mg PRN for palpitation. Last time he took it was week and half ago. EKG was performed by paramedics and it was sinus bradycardia. Patient states he felt back to normal. His VS at 11:50: BP 131/85; P 57; Res 18. Assisted Patient sitting up then standing up. Patient denies dizziness, chest pain or tightness. His standing BP was 142/82. Patient was observed for another 15 minutes then walked out of observation area.

With in 4 hours of vaccination patient felt nauseated and vomited. Nausea lasted approximately 8 day. At about 8 to 10 days after vaccination began having joint and muscle pain in the lower half of body. Could not stand or walk without assistance, condition continued at same severity for about 7 days, then began to slowly improve. He saw doctor (His current pain specialist for several years) on 7/14/2021 and described his symptoms and condition, but no medication was prescribed for his condition. He currently states that he feels about 80% of himself prior to vaccination. Still has muscle numbness and muscle "burning" while standing and feel fatigued yet. He feels he is still slowly improving

On day of shot (April 9), I had a fever, chills and intense shaking for 45 minutes at 10pm that day of my shot. I felt better that next day and normal the following day. I had terrible diarrhea (went to bathroom every two hours), some stomach pain and low energy for four days (June 29-July 3). I received a prescription for lamotal, which helped. I was not tested for covid.

cough, malaise and fatigue. He states that he started to have symptoms about 3 days ago with chills, subjective fevers, cough, anosmia. He also had some chest pain that he states was left sided/substernal and felt like squeezing/heavy pain. It started yesterday morning and comes and goes. He has some SOB and he also has had a very poor oral intake.

Adverse impact began within 1 hour of receiving the injection. Headache persisted for 2 to 3 days along with fever. Treated with acetaminophen. Also have experienced chills, fatigue, lightheadedness. Loss of appetite. Symptoms were strongest on day one. It is now day three, and symptoms are diminishing.

Nausea and lightheadedness, increased blood pressure 155/101 and heart rate 113. Pt monitored and BP down to 134/90 feeling better after monitoring.

Sore everywhere. Lower stomach & groan is very sore. I can't hardly sit. Motrin is giving me some relief. I was running a fever yesterday 3-29-21. Hands are very stiff and ache.

gastrointestinal distress and discomfort - duration approx. 48 hours. diarrhea - duration approx. 24 hours. lethargy & general malaise - duration approx. 48 hours.

Severe vomiting, diarrhea, fever, nausea and severe headache. Significant Trembling and chills followed by high fever, disorientation and dizziness and fatigue. Symptoms started approximately 5-6 hours after shot - began with trembling followed by severe chills and dizziness - followed then another 4 hours later by fever, significant nausea and extreme vomiting and diarrhea - then loss of appetite, fatigue, dizziness. After 24 hours the severe symptoms stopped and there was just another 15 hours of fatigue. 40 hours later everything felt back to normal. Hour 6 to hour 30 after vaccination were horrible.

Woke at 4 am on 4/11/21 freezing, weak nauseous, dizzy and tried to go to bathroom, stumbled back onto bed as I was passing out

fever of 102.2 for 18 hours followed by 98.6 for 24 hours, joint pain, nausea increased need for insulin to control blood glucose levels.

He got the Johnson and Johnson shot. Soon after going to bed that night he vomited. The next day he felt tired and had little appetite.

Day 15 after covid vaccine I woke up at 12:30am with extreme vertigo and nausea. It woke me up with violent spinning. I could not focus my eyes at all. I felt very ill. I almost threw up multiple times during the day and could not move my head up or down and to the left without spinning out of control. I saw the ENT later that day and he performed the Epley Maneuver on me. I followed his directions for home care but am currently still experiencing vertigo. The doctor told me it should dissipate within one week. It has not. I have never had vertigo in the past.

Janssen COVID-19 Vaccine EUA Injection site pain; muscle stiffness; joint pain in shoulders, elbows, knuckles, hips, knees; severe headache; nasua; fatigue; low grade fever

SOB, CP, Fever, Nausea, Body aches. Seen in ER for cardiac work up. Labs normal and CT chest normal

PRESSURE IN THE HEAD; SORENESS ALL OVER/PAIN; NO TASTE; NO APPETITE; FEVER; BAD HEADACHE; This spontaneous report received from a patient 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: 207A21A, 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 bad headache. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced pressure in the head. On 10-APR-2021, the subject experienced soreness all over/pain. On 10-APR-2021, the subject experienced no taste. On 10-APR-2021, the subject experienced no appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache, fever, pressure in the head, soreness all over/pain, no taste, and no appetite. This report was non-serious.

just 24 hrs. after receiving shot developed fever of around 102 and chills. Fever kept going through the second night, developed several small itchy bumps on body, and also developed pain in lower abdomen. On the third day went to an urgent clinic because of lower abdomen pain and felt as though my diverticulitis had started. Was prescribed antibiotics, Flagyl and Cipro, for the diverticulitis. Fever broke that night I believe.

Lingering, chronic nausea. Continuing. It comes and goes. Recently had a COVID lab test and it was negative.

I started with shivers, then a few hours later I had a fever and a bad headache. I took one Tylenol but that did not help after several hours. I took another and that still didn't help. I started feeling sick to my stomach, then I vomited several times. After emptying my stomach, I started feeling better. After 24 hours after the shot, I felt fine. Then, again, 12 days after the shot, I got another bout of similar symptoms. I had a headache, stomach ache, then vomited. After a few hours of rest, I felt fine again.

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.

Blood clot in each lung. Started in legs, spread through heart and settled in lungs. This occured about 3 weeks AFTER J&J/Jansen vaccine. Immediate symptoms were painful leg cramps on both sides back pain, fever sweating, nausea, clammy skin, headache, neck pain.

SEVERE ABDOMINAL PAIN; VOMITING; BODY ACHES; NAUSEA; This spontaneous report received from a patient concerned a 53-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. The patient was non-alcohol user, and non-smoker. The patient experienced drug allergy (itching and redness) when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808480, and expiry: UNKNOWN) dose was not reported, 1 total administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) which was negative. On 13-APR-2021, the patient experienced severe abdominal pain, body aches and nausea and he went to Emergency room where he received IV pain medication and they performed MRI (Magnetic resonance imaging) and did blood work. Both were normal. Patient returned to the emergency room with severe pain after he took Tylenol and he vomited. He was administered with IV (intravenous) pain medication and started IV fluids. New blood work was done on 14-APR-2021 which was negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe abdominal pain, vomiting, body aches, and nausea on 15-APR-2021 and the outcome of drug allergy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210431932- COVID-19 VACCINE AD26.COV2.S-Severe abdominal pain, Vomiting, Body aches. 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: UNDERLYING DISEASE. V0 20210431932- COVID-19 VACCINE AD26.COV2.S-Nausea. This event(s) is labeled per RSI and is therefore considered potentially related.

Patient received J&J vaccine dose #1. Over the next two weeks, developed fatigue, anorexia, and malaise (had been fatigued prior to dose). Presented to local hospital and ultimately was diagnosed with acute megakaryocytic leukemia. Now in hospital for initial treatment of leukemia. Unlikely to be related to vaccine, reporting due to hospitalization and severity of illness.

Pt did not feel sick the first 15 minutes after receiving the shot, but throwing up and dizzy for two days after. Pt wife reports vomiting day of vaccination (hours post vaccination). Continued to feel nauseas/loss of appetite for ~3 days, then felt better. No other ADR aside from N/V. Patient alert and oriented. All symptoms resolved ~3 days post vaccination, and patient is currently feeling well. Instructed to see PCP if symptoms reappear or worsen

Bradycardia, dizziness, abdominal pain, fatigue, headache. Was not aware of the bradycardia until I went to the emergency room, other symptoms were present Apr 10 - 15. Hospital visit was 13 Apr. treatment was rest, over the counter medications and follow up with doctor.

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.

He fainted 5 minutes after vaccine administration. After he came to on his own, he starting vomiting. Paramedics were called and took him to the emergency room for further evaluation.

BOWELS UPSET AND YELLOW SLIME COMING OUT SINCE DAY OF SHOT; BURNING IN ARM; SEVERE PAIN IN ARM AT INJECTION SITE; PSORIASIS; NECK PAIN; BRUISE HAVING THE SIZE OF 50 CENT PIECE; 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 concurrent conditions included diabetic, severe gastroparesis, internal tremors, and psoriasis, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203a21a, expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. Concomitant medications included adalimumab for psoriasis, ixekizumab for psoriasis, risankizumab for psoriasis, and ustekinumab for psoriasis. On MAY-2021, the subject experienced neck pain. On MAY-2021, the subject experienced bruise having the size of 50 cent piece. On MAY-2021, the subject experienced psoriasis. On 10-MAY-2021, the subject experienced bowels upset and yellow slime coming out since day of shot. On 10-MAY-2021, the subject experienced burning in arm. On 10-MAY-2021, the subject experienced severe pain in arm at injection site. The action taken with covid-19 vaccine was not applicable. The patient was recovering from bowels upset and yellow slime coming out since day of shot, had not recovered from severe pain in arm at injection site, and burning in arm, and the outcome of psoriasis, neck pain and bruise having the size of 50 cent piece was not reported. This report was non-serious.

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.

I took aspirin, tylenol and I ate soup, took 2 days off from work to rest. Vision got blurry Upset stomach Left arm in pain Ever since I took the shot I've been tired.

Patient called on 6/4/2021 to say that about 3 hours after receiving vaccination he started experiencing abdominal pains that have been persistent to the present.

I experienced diarrhea and headaches on the third day. I also experienced cold sweats and I also had a bad taste in my mouth approximately 3 days.

Inflammatory storm, crested at 7 weeks post; affected all joints, incl healthy ones. Daily fever by at least afternoon for 7 weeks. New demyelination w inflammation, new vision problems, dysphagia (permanent). Six days post shot, chest pain started, same as post-virally spring 2020. Chest pain, burning sensation ongoing, presumed carditis. Cardiorespiratory performance beginning to lessen further, beyond last year's damage. Day of vaccination, about 1-2 min post injection, strong dizziness, balance problems, identical to past allergic reactions to other injectables, but time limited, only an apparent blood pressure problem - passes in its own, heavy caffeination helps reduce the problem, temporary nuisance only & apparently affected a fair number of folks at the site. Chose not to report that issue at the time, since familiar and not serious, only unpleasant.

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.

It was basically diarrhea for about a week. With a fever the first three days. No higher than 102.5. Body aches and I had those as long as the fever. I called the doctor they put me on a med that is stronger than Flagyl super strong antibiotic Vancomycin I took it for just one day. We were afraid it was C Diff. They they got a test back that said it wasn't that but didn't know what it was and they put me on Cipro; as well as Flagyl. They took awhile but did start to work. The whole thing was about a week. I haven't had that test of illness for a long time or ever.

patient alerted the technician that the patient stated he felt like he was going to pass out. He was visually sweating, clammy, and bending over. The pharmacist then instructed the patient to lean back in his chair and to breathe. next he started to lean to his side to pass out so the pharmacist grabbed him and held him up, the patient was unaware that he passed out. the patient was passed out for about 20 seconds and may have had a small seizure with no history of seizures on file. we applied a cold pack on the patient to help with the nausea he then dry heaved into the trash can. ems arrived and took patient to the hospital.

Starting 10 hours after the injection at 2AM Local ET on Thursday, June 24th, I began feeling a severe headache, feverish, and fatigue. I was working a midnight shift so I was awake the whole time. At about 4AM local (12 hours after injection), I began feeling severe stomach and groin cramps as well. All of these symptoms got worse of the next 24 hours. the fever, headaches, and cramps were at their worse about 18-30 hours after the injection. I took Tylenol and tried to sleep but did not sleep long as the fever was very high in this period. I nearly went into the Emergency room on 25 June. At this time, I felt a little better, but still very fatigued and having some stomach/groin cramps still at 9PM on Saturday, June 26th.

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.

Severe muscle and joint pain, fever (+1.7 degrees above typical 97.3 = 99.1), upset stomach, lethargic.

I had Covid in June - and felt the same - fever (not real high - 101), chills, nausea, no energy, headache - lasted from 7pm ish until sometime around 5am woke up sweating and only had slight headache that went away after some fluids - it was not fun at all, but didn't last too long - I didnt take any Advil until about 2 am, then could sleep. Stayed home Monday because I could, but by noon felt nearly 100%, by 6pm felt 100%.

Within 10 hours: chills, headache and nausea within 24 hours: chills, headache, nausea, fatigue, body aches, fever within 48 hours: headache, nausea, fatigue, body aches within 72 hours: fatigue, headache within 96 hours: no symptoms

Diarrhea started around 1 PM the day after the vaccine. Currently still occuring at almost 2 PM. Not sure if this should be reported or not. Someone told me we had to report instances. Injection site is still sore.

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

ELEVATED BLOOD PRESSURE; CHEST PAIN; SHORTNESS OF BREATH; VOMITING; NAUSEA; HEADACHE MIGRAINE; This spontaneous report received from a consumer concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and tension headache, 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: 1808980, and expiry: 20-JUN-2021) dose was not reported, administered to left arm, on 02-APR-2021 13:40 for prophylactic vaccination. Concomitant medications included atenolol for high blood pressure. On 02-APR-2021, the subject experienced headache migraine. On 03-APR-2021, the subject experienced elevated blood pressure. On 03-APR-2021, the subject experienced chest pain. On 03-APR-2021, the subject experienced shortness of breath. On 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced nausea. Laboratory data included: Blood pressure (NR: not provided) 180/110 mmHg, and EKG (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, chest pain, shortness of breath, vomiting, headache migraine, and nausea on 03-APR-2021. This report was non-serious.

Patient immediately complained of feeling light headed. Several minutes after receiving the vaccine, they fainted. Resuscitation several minutes after fainting. EMT was called and took blood pressure, temperature and EKG readings. All readings were normal and patient refused transport and hospitalization. Profuse sweating and dizzyness after resuscitation and patient recovered enough to drive himself home 90 minutes later and left the store. After arriving home, patient experienced flu symptoms (nausea, aches, shivering, tiredness) for 24 hours after shot was administered.

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.

Dizzyness, almost fainting, loss of appetite...headaches all day 3-5 after shot....loss off appetite, over 7 days

Early morning woke up with bad headache, diarrhea throughout the day, vomited early evening all on Friday April 2nd. Started to feel better in the evening and started to drink a bit of gatorade. However Saturday morning April 3rd woke up between 6-7am and went to the bathroom and turned around to walk back out and blacked out - most likely dehydrated. Fortunately did not fall down as my wife caught me slumped up against the wall and got me down to the floor. After 5-10 minutes was able to get back to bed and after another hour or so was able to start drinking fluids and keep them down through the day. By late afternoon/early evening had a small meal and was starting to feel better - never did have a fever (checked frequently on Friday and Saturday)

Patient started puking up clotting blood around 10:20PM on 4/13/21 and went to the ER. He was admitted to the hospital and is in procedure currently for a scope to determine more information.

Severe headache, nausea, fatigue, dizziness, felt pressure in head and sinuses, felt like my nose was bleeding but it wasn't but i could feel something draining down.

Severe Chills on 11 April 2021 at 1:30 am, duration approximately 90 minutes. Self-administered ibuprofen. Resolved. Moderate to severe headache from 11 April 2021 to 12 April 2021. Treated with ibupofen. Resolved. Mild nausea, interrmittent from 11 April 2021 to 17 April 2021. Untreated, currently ongoing.

Multiple pulmonary embolisms in bilateral lungs with lung infart, superficial blood clot in the right groin area, significant right abdominal pain, shortness of breath, low oxygen saturation levels admitted 3 days in the hospital. 36 hours of Lovanox injections followed by transition to Eliquis 10 mg twice per day, respiratory exercises, oxycodone given for pain Pain has diminished in lower right lung area, clotting appears to be under control

STOMACH CRAMPS; ON AND OFF FEVER; HEADACHE; DRY HEAVING; NAUSEA; VERY TIRED AND FATIGUE; 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 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: 180508, and batch number: 180508 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced dry heaving. On 12-MAR-2021, the subject experienced nausea. On 12-MAR-2021, the subject experienced very tired and fatigue. On 13-MAR-2021, the subject experienced on and off fever. On 13-MAR-2021, the subject experienced headache. Treatment medications included: ibuprofen. On 15-MAR-2021, the subject experienced stomach cramps. Treatment medications included: bismuth subsalicylate, and dimenhydrinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach cramps, dry heaving, nausea, and on and off fever on MAR-2021, and had not recovered from very tired and fatigue, and headache. This report was non-serious.

DENTURES MADE GAG AFTER RECEIVING VACCINE; 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 past medical history included spinal issues 7 surgeries,, and concurrent conditions included ex-smoker, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: 01/MAY/2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced dentures made gag after receiving vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dentures made gag after receiving vaccine. This report was non-serious.

Presents to emergency department for evaluation of abdominal pain. Subsequently tested positive for COVID-19, >14 days post Janssen vaccination.

pt received vaccine on 5/5/2021, shortly thereafter had severe diarrhea/vomiting. came to ER and was admitted on 5/6 @0104. Pt receiving fluids, Zofran, morphine and potassium. Admitted on observation status. Lot number for vaccine 1808980

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.

Severe head ache30+ hrs started 5hrs after injection . abdominal cramping and musscel pain in leg and butt area.sever joint pain in lower back and hips and knees hands and feet.at 5 hrs of injection. Sore throat and inside if ckeeks and swellind of lower lip1 sat after injection. Joint pain in knees and lower back pain was severe and lasted 3 days. Numbness in fingers at 1 day - oresen confysen in thinkinj

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.

About 8 hours after the vaccine at 2:30am I had a fever and bad sweats, back and stomach pain, diarreha, lost of bowel control, achy all over. Which prompt me to call for an ambulance. I went into the ER I had to get 3 bags of IV fluids for dehydration, anti-nausea medication, pain medication for back pain because I passed out and hurt my back and cut my face. I also had swollen in my left foot. I am still having fatigue feeling. I still don't have my energy levels back from before the adverse event.

103.5 degree F fever, severe chills, body aches, headache, intense pain at injection, nausea, fatigue

SHARP PAIN IN STOMACH; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non smoker, high blood pressure, and testosterone replacement, and other pre-existing medical conditions included patient had no known allergies any 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: 1808986, and expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced sharp pain in stomach. On 29-JUN-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low grade fever, and had not recovered from sharp pain in stomach. This report was non-serious.

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.

Rectal bleeding started 2 days after receiving "jab". 3-5 drops after going poop lasted approx 2 weeks after first noticing. Have not noticed any other bleeding. Scheduled appointment with doctor on 5/3/2021. Dr visually inspected rectum and observed no irregularities. Referred to Gastroenterology for consultation.

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.

High fever, weakness, chills, nauseous. Started at 10am. Was hyperventilating trying to vomit but couldn't took Pepto-Bismol. Fell asleep about 3pm woke up at 630pm soaked from fever breaking. took temperature then was 101.7. Still have fever of 100.7 at 10am 3.7.21

Fever/chills and slight nausea overnight (24 hours post-shot). Temperature check is normal, but sweated through night and general malaise 36 hours after shot still. Hot and cold flashes persist 36 hours after.

Received vaccine at 8:30am . Just before sleep at 10 pm , Started getting chills and slight nausea. Went to work next day still feeling rundown with muscle fatigue but chills not as bad . Went home after full work day to rest then go to bed early. Next day felt fine . All in all I had a great experience . The people (organizers and others ) at the location that day did a fantastic job. Easy Breezy .

General malaise within 1 hour of injection. Worsening to fever, chills, severe headache, and nausea within 6 hours of injection. No medication taken. Symptoms returned to general malaise 30 hours after injection.

Chills began approx 1:30am on 3/12 (13 hrs after dose), mostly resolved 46 hours after dose inflamed lungs / coughing - began approx. 9pm on 3/11 ( 8 hours after dose), mostly resolves by 1am 3/13 (36 hours after dose) Body aches - began approx 9am on 3/12 (20 hours after dose), greatly improved 4:30pm 3/13 (52 hours after dose), took naproxene 3/12-3/13 Headache - began approx. 9am on 3/12 (20 hours after dose), greatly improved by 9am 3/13 ( 52 hours after dose), took naproxene 3/12-3/13 Nausea - began approx 9am on 3/12 (20 hours after dose), continues, not resolved

1. Swollen Lymph nodes on upper chest near shoulder (Left thoracic duct area) and left arm pit large enough to feel by hand, lasting approx 8 hours. 2. Stomach bloating accompanied by stomach discomfort / pain and severe diarrhea for 48+ hours. 3. Intermittent Dizziness and headaches lasting approx 24 hours. 4. left arm and finger joint stiffness, lasting approx 48 hours.

6 hours after the injection the following side effects started: 1) headache 2) severe muscle aches 3) nausea 4) fever throughout the night spiking at 103.4 The following day Headache, muscle aches and fever continued.

The patient received the vaccine at 12:20pm. He was observed per protocol for 15min until 12:35. At 12:35pm he denied feeling any response to the vaccine and ambulated away with a steady gait. At 12:41pm the patient reported back to the nursing area c/o "dizziness" and feeling like he does when he "drinks too much caffeine" and his left arm felt "tingly." Pt was asked to lay down. Vitals were checked at 12:45pm while patient was laying down. BP 180/90, Spo2 96%, HR 69 and regular rhythm per palpation, Temp 97.7, RR 16. Pt was AO x 4. At 12:50pm BP was reassessed 186/100. At 12:55pm pt reported still feeling "dizzy." His face was flushed. His left arm still felt "tingly." He reported feeling "nauseous" and described "heart palpitations." Pt was asked to sit up and given 50mg of Benadryl PO per policy and 911 was called at 12:56pm. Patient laid back down. At 1300 temp 98.5, pulse 63 and RN noted irregular rhythm by palpation, Spo2 97%, RR 16. The ambulance arrived at 1303 and the paramedics resumed care of the patient. The paramedics noted PVCs on their rhythm strip and BP 170/90. At 1311 patient started reporting "epigastric pain" 5/10 pain. At 1313 the paramedics transported the patient to a hospital (unknown which hospital).

DIARRHEA; NAUSEA; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 390 pounds, and height was 68 inches. The patient's past medical history included benign cranial pherengioma, legally blind, history of multiple shunt revision., sigmoid colostomy, rectal fissure, and neoplasm of unspecified nature of brain, and concurrent conditions included latex allergy, allergy to strawberry, non alcohol user, non smoker, and non drug user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose, start therapy date were not reported for prophylactic vaccination at right deltoid on approximately 26/Mar/2021. The batch number was not reported and has been requested. Concomitant medications included phenoxymethylpenicillin potassium. On 28-MAR-2021, the subject experienced diarrhea. On 28-MAR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) Negative for C-Diff, and Stool culture (NR: not provided) Negative for C-Diff. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and nausea on 29-MAR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure, since case assessed as non serious

Patient had mild nausea, BP 120/82 HR100, RR22, no rescue medications required, patient discharged in stable condition

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

pt states he told them he was on blood thinner so they had him stay 30 minutes before leaving after taking the vax. At this time he became nauseated. He went home and laid down and fell asleep. When he woke up he called his PCP because he wasn't feeling well. His heart rate was running from 80-90 and fluctuating like he was about to have a heart attack. He was told to call back if he wasn't feeling better. On 4/9 his heart was running about 90-115. On 4/10 his heart was running from 139-142. He called his doctors office and they told him to go to the ER. He went to hospital. He was given heart EKG, labs and IV. He was given aspirin. His INR was at 2. His heart rate came down to 115. His blood was low. His DX was Sinus Tachycardia. He was admitted to the Heart Floor. He was treated for 2 days and released. They told him they thought he was reacting to taking the vaccination and to FU w/ PCP. He said his heart rate is fluctuating and is currently at 101. He doesn't see a Cardiologist since he cannot have open heart surgery due to his underlying health conditions.

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.

I had stomach pain after eating that developed within an hour to a very hard pain in lower abdomen like all over vs in one place. The next morning the pain was there like a gas stomach pain with diarrhea.

After the Covid-19 Vaccine on Mar 26, 2021 I had an adverse reaction to something that may or may not be related. On Friday, Apr 2, at 2:00pm I felt a weird case of Vertigo that lasted approximately 3 mins. The next day, Sat. Apr 3, at around 9:30pm I had a longer very severe case of the vertigo. I went to bed shortly afterwards. On Sunday,Easter morning April 4, at 6:30am I woke up with a very severe case of vertigo (Meniere's Disease). It lasted about 3 hours of sever heaving and extreme dizziness. I could not cope and had to just lay there not knowing what was wrong/going on. It finally went away after about 3 hours. The next morning, Mon. Apr 5, I called my Dr to make an appointment and went in 2 days later. There were no other cases of it and he could not figure what caused it and I either could I. So far so good that I have not had another reaction and feel fine today after nearly 3 weeks. :-)

The next morning I woke up feleing really tired which progressed to severly tired causing me to sleep between 8-10 hrs in one setting. I was nauseaed but no vomiting. I developed diarreah around the end of the week and within about a week all symptoms had subsided.

Cerebellum Stroke 4/11/2021. Presented in the Emergency Room of both hospitals with dizziness, nausea, unable to walk. Treated 4/12-4/14 and then again 4/15-4/19.

ELEVATED HEART RATE; CHEST PAIN; FELT FAINT; BODY ACHES; STOMACH UPSET; DIARRHEA; FELT JITTERY; HEADACHE; NAUSEA; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 55 year old white male. The patient's height, and weight were not reported. The patient's past medical history included both knees replacement, both hips replacement, and heart attack, and concurrent conditions included heart problems, circulation problems, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 at 10:15 to left arm for prophylactic vaccination. Concomitant medications included warfarin (5mg) for blood thinner, atorvastatin (80mg), baclofen (10mg), furosemide (40mg, 1 to 2 daily), glyceryl trinitrate, losartan (25mg), midodrine (5mg), oxycodone hydrochloride/paracetamol, potassium, and promethazine (25mg). On 08-APR-2021, the patient had heart rate issue after 45 minutes of vaccine administration, while driving to home and went to sleep for 2 hours. The patient felt faint, body aches, stomach upset, diarrhea, headache, nausea, sore arm at injection site and felt jittery. He told vaccination provider that he was on a blood thinner (warfarin 5mg), and had heart and circulation problems. He also took lorazepam (1mg) as treatment for jitters, which was not helpful for it. His heart rate had been fluctuating down to low 70's and up to 100's since he received the vaccine. On 09-APR-2021, he called his nurse about heart rate and nurse advised him to visit to emergency room (ER) if he experience chest pains. On 10-Apr-2021 at 09:00, the patient visited emergency room due to worsening of the elevated heart rate, and chest pain. The patient felt like he had another heart attack. The patient was admitted to the cardiac floor and medicine was provided to stabilize the heart rate. The patient was hospitalized for 2 days and discharged on 11-APR-2021 with the improvement of heart rate on prescribed medicines and advised if heart rate passed 90 to 100 to went back or felt flutter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt faint, body aches, stomach upset, diarrhea, nausea, and sore arm at injection site on 10-APR-2021, was recovering from elevated heart rate, had not recovered from headache, and felt jittery, and the outcome of chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210420626-covid-19 vaccine ad26.cov2.s-Elevated heart rate, Chest pain. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE

On 4/15/21 client contacted public health office to report adverse effects of COVID Vaccines. Reports late afternoon on 4/6/21 he felt "heavy", had a HA, tired, nausea, body aches, high fever (did not take his fever), sweating, only drank water for 3 days, under arm swelling in the right arm. On 4/7/21 reports right shoulder and arm pain all the way down his arm to his hand began with tingling and sharp pain in his hand. On 4/12/21 he was tested for COVID and tested negative. Denies any rash, redness, or swelling at the site of the actual injection. On 4/15/21 was seen by MD for ongoing arm and shoulder pain.

First day after very tired that night started throwing up for three nights with extreme vertigo and exhaustion, stop throwing up after three days , got medicine for the vertigo four days after shot took it for three days slowly the vertigo went away but just reappeared today

PASSED OUT; SEVERE ABDOMINAL CRAMPY PAIN; CRACKED HEAD; 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 seasonal allergies, and penicillin drug allergy. The patient received COVID19 VACCINE AD.26.COV2.S (suspension for injection, route of admin not reported, batch number: 202a21a, expiry: UNKNOWN) dose was not reported, 1 Total administered administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, Saturday evening the patient experienced so severe pain, patient passed out, did not eat anything and did nothing out of ordinary that could have caused the severe abdominal crampy pain and hit his head (cracked head), sending patient to the ER (emergency room). It was reported that, he did not eat anything and did nothing out of ordinary that could have caused the severe abdominal and he did not know 100 percent that it comes from vaccine but nothing else was any different in his live other than vaccine. In ER they did laboratory tests included full blood test, chest X-ray, electrocardiogram and magnetic resonance imaging (MRI) of head and abdomen was normal (NR: not provided for all labs). The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from severe abdominal pain on 02-MAY-2021, and the outcome of passed out and cracked head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210505687-JANSSEN COVID-19 VACCINE-Passed out -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.

After 5 minutes from giving the vaccine. Patient started to say he was getting dizzy. He lost coloration at first, but could speak just fine. Then a few seconds later he appeared to lost consciousness, his head fell back, and he started to have jerking movements. He was making noises that almost sounded like a snore to me right at first, but it was more than likely him gagging on saliva. 911 was called, and his symptoms continued for roughly 30-60 seconds. EMS took him to hospital where they diagnosed it as vasovagal syncope and just gave him some fluids.

SIGNIFICANT GI BLEED; DEATH; SUBORBITAL BLEEDING AROUND BILATERAL EYES; FATIGUE/ FEELING TIRED; This spontaneous report received from a consumer concerned a 55 year old male. The patient's weight was 240 pounds, and height was 60 inches. The patient's past medical history included thrombocytopenia, and concurrent conditions included cirrhosis of the liver, smoker, and non alcoholic, and other pre-existing medical conditions included patient had no known allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 02-APR-2021, the patient experienced fatigue/ feeling tired. On 15-APR-2021, the patient experienced suborbital bleeding around bilateral eyes. On 03-MAY-2021, the patient experienced death. On an unspecified date, the patient experienced significant GI bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died, and outcome of significant GI bleed, suborbital bleeding around bilateral eyes was unknown and not recovered from fatigue/ feeling tired. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210516526-covid-19 vaccine ad26.cov2.s-death. 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). 20210516526-covid-19 vaccine ad26.cov2.s-significant GI bleed, suborbital bleeding around bilateral eyes. 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

Patient experienced acute pulmonary embolism approximately 8 days after administration of the J&J vaccine. He did not have low platelets. No clear cause of the PE was found. It was thought to be possibly related to superficial thrombosis of his upper extremity secondary to IV that was placed 2 days prior when he was briefly admitted for workup of heavy hematocheiza, at which time he was found to have a mild anemia and discharged. He was treated inpatient at Hospital. I am not sure of the where he obtained the vaccine or the exact date.

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 psoriatic arthritis. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported at 1 total frequency, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1133817 expiry: UNKNOWN) dose was not reported, 1 time every 1 total, therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date in 2021, the patient experienced bloody stool and diarrhea. On an unspecified date, the subject experienced sore mouth, and sore gums. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable and for adalimumab was not reported. The outcome of the bloody stool, diarrhea, sore mouth and sore gums was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210601168-COVID-19 VACCINE AD26.COV2.S- Bloody Stool. 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).

Vaccine administered in right deltoid. Patient felt dizzy and fainted in the observation area within a few minute of receiving the vaccine. Patient was pale, nauseated, and felt light headed especially when standing or walking. Blood pressure was 101/51. Patient was taken to urgent care, kept under observation for three hours, and was released when he felt well enough to drive home.

STOMACH PAINS; CHILLS WITH FREEZING SHIVERS; PAIN WHERE VACCINE WAS INJECTED; ENTIRE STOMACH FEELS BLOATED AND GASSY; 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 low testosterone, alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. Concomitant medications included testosterone for low testosterone. On JUN-2021, the subject experienced entire stomach feels bloated and gassy. On 23-JUN-2021, the subject experienced pain where vaccine was injected. On 25-JUN-2021, the subject experienced stomach pains. On 25-JUN-2021, the subject experienced chills with freezing shivers. Laboratory data (dates unspecified) included: Colonoscopy (NR: not provided) colon twisted. Treatment medications (dates unspecified) included: simeticone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills with freezing shivers, and had not recovered from stomach pains, pain where vaccine was injected, and entire stomach feels bloated and gassy. This report was non-serious.

Patient describes nausea and mild dizziness . Patient being sent home with mother who is driver . ER precautions given . Patient advised to follow-up with PCM for persistent symptoms.

Patient passed out for about 15 sec., he became nauseated and vomited. States that he does this every time he gets his blood drawn. When he was easily awakened by touching him and stating his name. He was then able to answer questions appropriately. Blood pressure was 100/68. Heart rate was 100. He was clammy to the touch. After about 15 min stated that he felt better. Stated that he ate only a banana for breakfast. Wife drove his home.

So roughly a week after my vaccine, I started having acid reflux and wheezing and a ringing in my left ear as well. I went to see an ENT and he prescribed a medication which was to help reduce swelling in my esophagus, I do not remember the dates or the medication name I am sorry, I am in the field right now not home. He also told me to refrain from chocolate, caffeine, carbonated drinks and those things. Doing that has helped with those. The ringing in my ear he addressed as well and I went to an audiologist and they told me I had Tinnitus. Since then I have been fitted for hearing aids and that has helped the Tinnitus a little bit.

trout closing , chills , high fever, bells palsy , ringinging in right ear , very sensitive to noise, smell and taste off, dizziness, nauseousness

Adverse Events: Headache, Fever, Diarrhea, Nasal Congestion, Leg Pain, Weakness, Paralysis Dx. Guillain Barre Treatment: Immunoglobulin, Sodium Chloride 0.9%, Respiratory Bypass, Oxygen Outcomes: Patient actually in Intensive Care Unit at Hospital receiving treatment. Continue with oxygen by nasal cannula, whole body paralysis with urinary and feccal incontinence (foley and diaper). Symptoms begin since June 10,2021. Admission to Hospital on June 17, 2021 to present.

Patient presented to the Emergency Department of our hospital with report of nausea, vomiting, fever and chills after receiving a COVID-19 vaccination at the local Health Center. Specific information regarding the vaccine (lot number, vaccination site, etc.) is not available to me at the time of this report as the vaccination was not administered by our organization.

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

Fever and chills, headache, fatigue, slight nausea. Symptoms (except for nausea) were significant and lasted approximately 36 hours.

slight fever (99.5F), chills, nausea, headache, significant aches and pains all over body (especially in all arm joints in both arms: wrists, elbows and shoulders), fatigue; duration 12 hours

Apprx. 6 hrs after the shots (both my girlfriend and I experience almost identical symptoms) Severe chills, Fever, severe headache, severe muscle pain throughout the body, chest pains, diarrhea, nausea, vertigo, increase heart rate! Two days later and I am still experiencing vertigo, diarrhea, nausea!

Began getting chills at *8 p.m. , body aches, headache, and nausea. Temperature hit a high of 104 at 2 a.m. on 3/7/2021. Symptoms continued until around 8 a.m. on 3/7/2021 and was left with dull headache for remainder of the day.

Headache,fatigue, mild body aches, loss of appetite from 0600 Wednesday 03/24/2021 till 0600 Thursday 03/25/2021.

chills Narrative: Patient is a 56-year-old male with history of paranoid schizophrenia, COPD/ emphysema, alcoholic hepatitis and alcohol use remission who presents for ED evaluation of 1 day of pressure-like frontal headache with light sensitivity, myalgias, chills and fatigue, the symptoms are following the first Covid vaccine yesterday. Patient has not tried anything for the headache at this time, describes that is not different from his previous headaches. Does report some nausea without vomiting.

Fever, chills, dizzy, nausea, fast heart beat, headache, very tired , and weakness. Taking Tylenol. It?s been 4 days and still ongoing.

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 stated feeling dizzy, diaphoretic, blurry vision Patient vomited and had syncopal episode EMS called and evaluated patient Patient refused medical transport and signed AMA form Patient stated symptoms resolved and will be going home with son

Headache, 100 degree temp, aches, joint pain that includes neck, shoulders, knees, ankles and fingers. Cramps in legs. Skin sore to touch almost felt like sunburn. Gastrointestinal discomfort that included loose stools and gas. Frequent urination possibly due to water intake, but was unusual. Fever lasted about 24 hours. All symptoms starting to subside around the 24 hour mark.

Headache for two days Elevated temperature 99.9-101.3 for half a day Diarrhea and uneasy stomach for nearly a week Tired for two to three days

+ lightheaded and nausea, and then syncope followed by hypotension consistent with vasovagal response.

Severe headache with mild fever, body aches and chills, nausea, severe fatigue. Began about 4 hours after injection and continued through the night. Feeling mostly better the next day with ongoing fatigue and slight headache. By second day all symptoms resolved.

Client brought to observation area after J & J vaccination to left deltoid. C/O dizziness, nausea, sweating. Initial O2 sat of 87% (note extremities cool to the touch. Placed on 10 LPM NC at 100% At 1028 am 98/69 blood pressure 100% O2 sat on 10 LPM 1031 am 98/69 Client then on RA and continued at 100% Client c/o mild dizziness. Later ambulated to bathroom without aide He works at the college and will rest in his work room. He reported very mild dizziness, MAEW, NAD, Speaking in full sentences. 1103 am VS of 113/72 64 22 Client directed to call 911 for difficulty breath and f/u with a health care provider as needed. Note client stated he does not have health coverage presently Client DCd home at 1105

Severe chills, low-grade fever, headache, nausea, body aches in shoulders and legs. Acetaminophen 1000mg. Lasted 18-20 hours.

dizzy,nauseaus,headache. sick on sunday the 4th called 911 on Tuesday night the 6th for transport to hospital. couldn't walk. had a stoke.

severe chills all night went away around 6 am. Vomit with dry heaves at 1:15 am last round at 5:30 am. Very severe at times. Shortness of breath started in the afternoon or the 6th of March, lasted for 14 days. Cramps in my legs periodically still get them not as often now. Still don't have the same energy I had before the shot. I still tire easily.

slight headache within hours, disappearing within 36 hours. arm soreness beginning next morning, continuing for 5 days, escalating for the first 2 1/2, then decreasing in similar intensity. Yesterday, however, I started to have a bad headache at 4 a.m., then felt generally more ill to a level of almost incapacity by evening - bad headache, general weakness, dizziness, some muscle pain, bad nausea. Used Aleve and Ibuprofen and by 11pm started to feel normal again. By the next morning, I felt fine - tired like I just got over something, but fine. Not sure it was injection related, but wanted to share.

Patient received Jassen vaccine 4/10/21. 4/11/21 began with symptoms of fever, headache, chills, nausea, vomiting, and diarrhea, loss of taste and smell. 4/15/21 he presented to ED with symptoms of fever, chest pain and pressure, shortness o breath, myalgias, headache, tachypnea, tachycardia, hypoxia. Was given IV Decadron, DuoNeb and albuerol in ED. Inprovment seen, but patient continued with tachypnea and difficulty breathing. He was admitted to ED with a diagnosis of COVID 19 , asthma exacerbation and elevated Troponin at 31.52 (Ref Range 19) . During admission, glucose levels were labile, requiring adjustment to routine insulin regimen and Glucovance for hypoglycemia. An Echocardiogram was ordered due to elevated Troponin levels on admission. Echocardiogram 4/19/21 showed a density in the right atrium. Cardiology recommended a cardiac MRI. Patient was transfered to Hospital 4/19/21 for elevated care and evaluation, with diagnosis of

56 years old male called to report an adverse reaction after he received his jhnson and jhnson vaccine on 04/11/2021 @1230. patient reported 30 mins after receiving his vaccine he developed arm pain, diarrhea, and chills. patient reported sinus allergies. patient reported that he takes advil for his allergies. and amlodipine for his high blood pressure. patient was instructed to take advil to help with his symptoms. patient was instructed to seek medical attention if the symptoms got worse.

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.

Freezing ,hot ,cold, sweets disy ,lack of appetite constipation no energy inside feel like burning and boiling ,weak general stomach ache bad ,heart palpitations , tingling legs and feet , dehydrated

First sign was a headache and nausea. Several hours later, I received chills, sweats and body aches for two days. One the second day, in the late evening I had a fever of 101, The chills, sweats and body aches continued, On the third day, I started feeling better, but very tired.

BLOOD IN THE STOOL; SHORTNESS OF BREATHE; TINGLING IN THE FINGERTIPS AND THE TOES; SORENESS IN THE RIBCAGE NEAR THE HEART/LEFT CALF SORENESS; PUMPING SENSATION IN RIGHT SIDE OF HEAD; TIREDNESS; RIGHT ARM SORENESS; COUGHING; LIGHT HEADEDNESS SENSATION; HEMORRHOIDS; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient had no relevant medical history and was not on regular medication. 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, once total administered on 01-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. Patient reported that, he received the vaccine on 01-APR-2021. Approximately 2 days after he coughed and felt lightheaded and noticed some lights around his eyes. Approximately 7 days after patient noticed a list of symptoms including a pumping sensation in the right side of his head, left calf soreness, soreness in the ribcage near the heart, a tingling sensation in the fingertips and toes (but not at the center), sense of tiredness, shortness of breath, blood in stool that he referred to repeatedly as clots, right arm soreness (although the injection was given in the left arm). Patient called his doctor twice and was told to go to the hospital. Patient went to the hospital on 04-MAY-2021. Arrived at 12 PM and discharged at 11 PM approximately. Conducted a chest x-ray, took a blood sample twice, and put some stuff on patient's chest. Patient was discharged on 04-MAY-2021 and given a prescription for Motrin 800 mg taken three times per day as needed, and for cyclobenzaprine 10 mg taken twice a day as needed for spasms. Patient decided not to take these medications as he was unsure if they were pain medications and felt apprehensive. He main concerns seemed to be the pumping sensation in the right side of his head and the blood in his stool which he repeatedly referred to as a clot. His family doctor is aware of the situation and says he thinks its hemorrhoids. He refers to the clot as darker red in colour and also mentions that there is regular red blood in stool alongside the darker clot. Patient notices this about 3 times per week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing, and light headedness sensation on 03-APR-2021, was recovering from right arm soreness, and had not recovered from pumping sensation in right side of head, soreness in the ribcage near the heart/left calf soreness, tingling in the fingertips and the toes, tiredness, shortness of breathe, blood in the stool, and hemorrhoids. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210526242-covid-19 vaccine ad26.cov2.s -blood in stool . 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).

BODY ACHE; MIGRAINE HEADACHE; FEVER; EXTREME FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 56 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: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced body ache. On 07-MAY-2021, the subject experienced migraine headache. On 07-MAY-2021, the subject experienced fever. On 07-MAY-2021, the subject experienced extreme fatigue. On 07-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on MAY-2021, had not recovered from fever, extreme fatigue, and body ache, and the outcome of migraine headache was not reported. This report was non-serious.

My health was great before my vaccine. I was able to have a normal full day five days out of the first 60 without health issues. This week I haven't had one day where I haven't had something going on. I woke up day after vaccination and started feeling feverish, but going into bad chills, extreme headache, a different kind of headache than my migraines, abdominal had pain, heart rate and breathing, heart rate was elevated, breathing not normal, out of breath, deep pain right thigh at bone, did not bruise. I called cardiologist 03/25/2021, about thigh, thought it might be DVT, I followed up 03/29/2021 since I did not hear back, we spoke on the 30th, I had very high blood pressure, doc presumed I had a tress fracture of right thigh bone and that other things were related to my chronic intro viruses. I saw my infectious disease doctor on April 13th he said this could be a major conflict with either current viruses, meds taking in conjunction with vaccination. All of my major lymph nodes were inflamed. I do have non Hodgkin's lymphoma, but they told me it is slow growing. Visited ER on 04/14/2021. Dr met me there.

Nausea, fever/cold chills, Upper right arm and shoulder stiffness and pain discomfort. Lasting over a month until I seeked medical attention from my doctor.

headache, upset stomach, fever, chills, (usually right after the fever broke), loss of desire to eat, shorness of breath, started 1 hr after shot, at this time when entering this, still have fever and loss of desire to eat, and chills . I fell like I had a mild cold with no nasal discharge.

After receiving COVID vaccine, patient reported Shortness of Breath, dizziness, loss of appetite, headache and chest pain. On 05/19/2021, patient exhibited right sided extremity weakness. Upon ED evaluation, was found to have suffered a TIA.

Fatigue and low grade fever started 5/21 about 24 hours. Arm sore as well. Felt tingly skin n chest and stomach for 3 days. That has quit now. 5/24. Continued having low grade temp between 99 and 101 still on 5/25. No real appetite but probably due to fever. Can smell and taste. Just curious as to how much longer temp will continue to come and go? Assume fatigue is tied to fever.

DIARRHEA; REALLY BLOATED/STOMACH DISTENSION; BODY ACHES WORSENING FROM PREVIOUS LEVEL; ABDOMINAL PAIN; RASH ON THE FRONT OF THE RIGHT SHIN / RASH THAT GOES AROUND THE LEFT SHIN; POSSIBLE WORSENING OF PREVIOUS 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 concurrent conditions included degenerative disc disorder, and rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included golimumab for rheumatoid arthritis. On 21-MAY-2021, the subject experienced diarrhea. On 21-MAY-2021, the subject experienced really bloated/stomach distension. On 21-MAY-2021, the subject experienced body aches worsening from previous level. On 21-MAY-2021, the subject experienced abdominal pain. On 21-MAY-2021, the subject experienced rash on the front of the right shin / rash that goes around the left shin. On 21-MAY-2021, the subject experienced possible worsening of previous headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, really bloated/stomach distension, body aches worsening from previous level, possible worsening of previous headaches, rash on the front of the right shin / rash that goes around the left shin, and abdominal pain. This report was non-serious.

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.

I had really severe abdominal pain. I went to ER because of those symptoms. I was treated there. They determined I had a small bowel obstruction. I was hospitalized for three days and eventually was released. Gave me a solution that cleared everything out - no surgery or anything. To be honest, I'm still kind of having the issue. I have changed my diet around and can't eat normal food. If I do, I get pain back. I can't eat a normal meal anymore - I am coping but haven't recovered.

4/13 awoken at 6am with a sharp severe headache on the right side of the head. I had blurry vision the entire day and a little the next day. Since 4/13 I have had almost daily light headaches and light to moderate nausea. I had several doctors appointments after that who treated me for migraine. Since the symptoms persisted into June I was sent for an MRI on 6/1. I received a call on 6/2 stating that I had suffered a stroke. I followed up with an MRA on 6/9. I met physician on 6/10 and stated that there were no issues reported in the MRA, however they confirmed that I had suffered a stroke. I After presenting the physician information that the symptoms described in Jansen vaccine were similar to mine they ordered an MRA scheduled for today and blood tests also today.

FELT DIZZINESS; SORENESS IN RIGHT ARM; WEAKNESS IN RIGHT LEG AND RIGHT ARM / CAN'T PICK UP ANYTHING OVER 5 POUNDS; SORENESS AT INJECTION SITE TRAVELLED DOWN RIGHT ARM; NAUSEOUS; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281, and expiry: 06-SEP-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced felt dizziness. On 02-JUL-2021, the subject experienced soreness in right arm. On 02-JUL-2021, the subject experienced weakness in right leg and right arm / can't pick up anything over 5 pounds. On 02-JUL-2021, the subject experienced soreness at injection site travelled down right arm. On 02-JUL-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt dizziness on 02-JUL-2021, and had not recovered from soreness at injection site travelled down right arm, nauseous, weakness in right leg and right arm / can't pick up anything over 5 pounds, and soreness in right arm. This report was non-serious.

Shingles (Herpes Zoster) symptoms began just over 24 hours following the administration of the vaccine. Initial symptoms were pain and numbness radiating from right hip / gluteal area down right leg. Pain/tingling/numbness spread across belly area in the following days. Patient remained unaware it could be shingles until June 1, 2021 when multiple patches of blisters appeared down lower right leg. Medical help sought the following day June 2, 2021. Acyclovir 800mg (5 times daily) was prescribed for 7 days. To date, some soreness remains at the initial site as well as some sensitivity across belly area.

Diarrhea and soft/loose stools EVERY DAY since to this day! Leg swelling...mostly in right leg & foot. Trouble walking. Some unusual & day long blurred vision.

Began having trouble swallowing about a month later until present. Also had pain behind the right eye and blurring vision. The pain has subsided but the blurry vision persists.

On 6/24/2021 I woke up with gastral issues, which subsided late in the evening of 6/25/2021. On 6/26 went back to my normal routine and worked out in the gym and 6/27 played basketball for 2 plus hours. I was fatigued on 6/28 and 6/29. On 6/30 still fatigued went to the gym and did a light cardio workout and developed a heat rash on buttock and upper thighs. I took a Benadryl which cured the heat rash. on 7/1 in the evening I developed a dry cough that was pretty intense. At this time I noticed my eye sight was blurry at a distance. 7/2 the cough went away, Looking back I now notice I had balance issues on 7/2. On 7/3 eyesight was worse and I was seeing double. I went and had an eye exam and the Dr. thought I may have a retinal issue in my left eye and suggested I go to the hospital which I did.

Headache, nausea, chills, rigors, numbness and tingling body wide... HORRIBLE for about an hour, uncomfortable for another 12hrs, still present 20hrs from onset. Hope it will be over by morning of 3/11. Have had reactions to vaccinations in the past. This was a bad one. Glad I don't have to repeat the dose.

chills, fatigue, ache around both elbows, nausea. Chills and nausea starts early morning at last until late morning early afternoon. Fatigue and elbow ache is stronger during morning hours.

Headache beginning at night (Wednesday). Headache increasing in strength throughout the night until it became very very painful throughout the following morning until mid afternoon (Thursday).. Dizziness and nausea beginning late morning day after shot (Thursday) for about 3 or 4 hours, making it difficult to stand up. By 3:30 or 4:00 most severe symptoms seemed to lesson, or disappear. Over the following 4 days have had slight headache and general fatigue.

After the injection on Friday 03/12 at 1:50 PM at facility, I started to get a slight temperature, Along with chills as well. This continue throughout the weekend. I remained at home and did not have any energy to go out and be around people. The next day, I also got diarrhea and was very dehydrated. Immediately, after I left the vaccine shot location, like within 5 minutes, I started to smell fish and my mouth tasted like salt for three days. I also had excruciating headaches that did not go away with advil. So I rested a lot and had no real big appetite what so ever!. Today, I am concerned that on my left side below my left clavicle, I feel a big bump what appears to be possibly a lymphatic swelling of node? I am concerned because I did not have this swelling before and do not know if it's a reaction to the vaccine. Pls contact me via phone, this is urgent. Thanks

Skull crushing headache that started about 12 hours after injection and lasted for about 18 hours. After 48 hours from injection, headache is 90% improved. Took Advil, but that did nothing for headache. It was the worst headache that I can ever remember having. Extreme muscle pain in various parts of the body started at same time as onset of headache. This, too, died out as the headache got better. Slight nausea on day #2. No fever. Was steady at 96.6 throughout these adverse reactions.

Extreme fatigue and chills, mild body aches, nausea, slight fever (100.8), overall flu like symptoms for 24 hours

Patient presented to ED via ambulance with fatigue weakness, poorly controlled Diabetes, hyperglycemia and abdominal pain. still in hospital on this date

Patients wife states he had a vomiting episode during the night of the shot. Now is currently asymptomatic

First 4 hours post injection no serious side effects, slight headache was settling in. At approx. 8PM (7 hours after shot) I had fairly a severe reaction of horror for the next 16 hours - all night long. Heart racing/energy beyond, deep chills and severe whole body shaking to the point of my back going out (dont' have a bad back), fever, migraine headache so bad (i dont get headaches) and body aches from a horror movie. I'm a jock, run daily, healthy, no smoke, drink or drugs. This lasted all night long well into the morning. At 3Am i considered going to the ER, but didnt. By 2pm the following day most of it went away. Two days later (today) i am dizzy, heart feels fast or racing, naseuous earlier , and exhausted. I can deal with it now, but it's very uncomfortable. Frankly, I regret getting the vaccine, wish i had not. I had covid last March, it was no big deal beyond what a flu would have done...with some shortness of breath on and off for a few months. The reaction to the vaccine is viccious compared to covid itself (for me, just my experience). Hope this all stops and goes away. Thank you for your work!

brief hint of dizziness about 4 hours after shot. 12 hours later (this writing) : dizziness, nausea, headache, body aches, fatigue ? all mild, but don?t feel like doing anything today.

PATIENT FAINTED AT APPROXIMATELY 3:25 PM. ASKED PATEINT HIS NAME, DATE OF BIRTH, AND IF HE IS FEELING WELL? PATIENT STATES HE FEELS MUCH BETTER AND STAES HE WOULD LIKE TO SIT FOR 30 MINUTES. PATIENT WAS OFFERED TO CALL THE AMBULANCE HE DENIED. AT 3:45 PM PATIENT STARTED FEELING NAUSEOUS AND TURNED PALE WITH SWEAT, EMERGENCY SERVICES WAS CALLED EMERGENCY SERVICES CAME IN 5 MINUTES - PATIENT WAS CHECKED AND REMAINED AT PHARMACY. PT'S SISTER PICKED HIM UP AT 5PM, PATIENT WAS FULLY ALERT AND ORIENTED TO TIME AND PERSON.

Headache, chills, muscle aches, dehydration, loss of appetite, blurred vision, loss of taste, and loss of smell.

Janssen COVID-19 Vaccine EUA Passed out while seated, 3-4 minutes after receiving vaccine. Fast onset of extreme nausea followed by blackout. Duration of blackout unknown. Woke up on floor not knowing how I got there. Sat up, nausea and lightheadedness returned, then dissipated with no further blackout. Felt rush of blood from head to toe and felt okay after that. Pharmacy staff took blood pressure, readings were close to normal (slightly elevated). Paramedics were called by pharmacy, and their BP readings were also close to normal. After all that, aside from some fatigue, no other appreciable side effects over the next 48 hours. No nausea, flu-like symptoms or fever, and very little soreness at injection site.

4/10 - after 4 hours, (14:00) felt hot and my face was in red color. Generally OK 4/11 - Generally felt hot, red face, and then around 16:00, arm and let joins started to ache and mild pain occurred. 4/12 - After having a dinner around 17:00, with in 30min, chest pain started at left chest. felt more like heart burn sensation. 19:00 pain stopped by drinking some hot tea. 22:00 took my meds, Brilinta, Carvedilol and Atorvastatin 23:30 chest pain came back instead of left side, in the center of chest. took some tums and drank some hot water 26:00 no more pain and was able to go sleep. 4/13 - 07:00 no pain but off and on with discomfort in the chest area from last night chest pain.

Received vaccine on 3/9/21. Started experiencing facial numbness , difficulty with speech and swallowing on 3/16/21 around 11pm. Had facial drooping of the mouth and eye on my left side of face. Went to Hospital ER around 5:30 am on 3/17/21 as symptoms did not subside. I was later placed in stroke observation unit. I had 2 MRI's, CT scan and Echo tests ran. i was diagnosed with TIA. All test were negative for a cause. I sent a total of about 26 hours hospitalized.

Symptoms of abdominal pain, nausea, fever, headache, chills began evening of vaccine and proceeded to worsen over the next five days. On April 13 I saw my doctor who ordered blood work. The pain continued to worsen and on April 14 I was admitted to the hospital with a ruptured appendix and had surgery to remove it

Pt developed abdominal pain and anorexia beginning two days after receiving vaccine dose. Presented to ED and found to have portal vein, SMV and splenic vein thrombosis. Underwent TIPS c/b recurrent thrombosis x 2 and cecal pneumatosis s/p exploratory laparotomy, open abdomen, delayed closure. He was mechanically ventilated and briefly requiring vasopressor support, now extubated and off pressors. Remains inpatient on anticoagulation and TPN. Hematology work-up while inpatient was negative.

Felt weak and tired by late afternoon. Chills in the early to late eve. Then acute nausea from midnight till 2pm. Finally broke a sweat around 330am. Was fine by 6 am.

Patient called the Facility COVID-19 Nurse Holtline with post-dose vaccine related symptoms or guidance. He stated he just received the J&J covid vac Pt msg re: pause which prompted him to think of ongoing sx he has been experiencing after covid vac. ?sob few days after vaccine, nausea, vomiting, fatigue, congestion, muscle aches (sx on/off since 4/1/2021)

(14 April 2021) I started experiencing stomach discomfort which resulted in diarrhea . It has been constant for the past 24 hours. (15 Apr 2021) I contacted my healthcare provider at 8:10 am and selected the call-back option. The healthcare provider called me back at 8:17 am. The healthcare provider will start case file contact patient before the day is over. I took Imodium at 8:50 am. Got a call from the doctor's office (10:19 am) with instructions: Take fiber and plenty of liquids. I informed them I took an Imodium, directions changed to drink plenty of liquids and let it run its course. There is nothing they can do because the vaccine was already administered.

DIARRHEA; CHILLS; FEVER; This spontaneous report received from a health care professional concerned a 57 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: 042A214, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and was recovering from fever, and chills. This report was non-serious.

when received the vaccine he got nausea that was mild, it continued and got worse on the 11th and 12th, the 13th he threw up from being sick, headache, fatigue, chills were all experienced through this time with muscle pain.

DIARRHEA; FEELING PRESSURE ON BACK OF THE NECK; PRESSURE ON LEFT ARM; NOSE BLEEDS; ELEVATED BLOOD PRESSURE; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 302 pounds, and height was 72 inches. The patient's past medical history included chronic obstructive pulmonary disease, dm type 2, and myasthenia gravis, and concurrent conditions included allergic to penicillin, non-alcoholic, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clarithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced elevated blood pressure. On 10-APR-2021, the subject experienced nose bleeds. On an unspecified date, the subject experienced diarrhea, feeling pressure on back of the neck, and pressure on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from elevated blood pressure, had not recovered from nose bleeds, and the outcome of pressure on left arm, diarrhea and feeling pressure on back of the neck was not reported. This report was non-serious.

CHILLS; SEVERE HEADACHE; SEVERE NAUSEA; FEELING FATIGUE; BEING WEAK; This spontaneous report received from a patient concerned a 57 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: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced severe headache. On APR-2021, the subject experienced severe nausea. On APR-2021, the subject experienced feeling fatigue. On APR-2021, the subject experienced being weak. On 10-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 97.5 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, chills, feeling fatigue, and being weak, and the outcome of severe nausea was not reported. This report was non-serious.

PROBLEMS IN BOWEL AREA; BODY ACHE; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 57 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced problems in bowel area. On APR-2021, the subject experienced body ache. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, body ache, problems in bowel area and fatigue was not reported. This report was non-serious.

patient was fine until a week later when started getting dizzy and throwing up. taken to ER, but didn't tell them had been vaccinated. Couldn't find anything wrong and was sent home after a few days. Went to ER again and this time wife told them he had been vaccinated week before symptoms started. Did brain MRI and found a blood clot. Pt currently in rehab.

This is a 57 year old male, received the Janssen COVID-19 vaccination on 5/4/21, at clinic in Jail, approx 10 minutes post vaccination, patient developed throat tightness, difficulty breathing and swallowing. He was immediately assessed by this writer, EMS activated as code. Given epi-pen to left thigh at 11:23, 50 mg of IM Benadryl to right deltoid at 11:25. Patient reported improvement in his throat tightness, shortness of breath and difficulty swallowing post epi-pen administration. Patient was sent to the ED

Pt reports rash, hives, and itching that began shortly after receiving the vaccine. He also reports vomiting about once a week.

History of Present Illness: Patient has a history of sinus problems. He was schedule for sinuplasty and had preoperative evaluation on 04/21/2021 with WBC 5.8, Hb 15.5, PLT 193,000. He had J&J covid vaccination on 04/27/2021. He underwent sinuplasty on 05/05/2021. Subsequent to his surgery he was having headache. He had some nasal discharge with blood. He took tramadol but had persistent pain. His symptoms were worsening up with some weakness of his right upper extremity. Was having generalized fatigue and weakness. He states he was getting short of breath with a flight of stairs. He had decreased appetite. He was given Vicodin for his headache with some improvement. He noted discoloration and bruising with pain pain in his left internal thigh area. Was noticing some changes in his vision but no loss of vision. He presented to the ED on 05/11/2021 and laboratory showed WBC 8.7 Hb15.2, PLT 6,000, segs 77%, lymphs 9%. He had no dark colored urine. INR 1.4 PTT 33, immature platelets 30.2. His bili was 2.1. He was treated with dexamethasone 40 mg. There is tiny focus of restricted diffusion in the both cerebellar hemispheres measuring up to 0.4 cm white matter left cerebellar hemisphere of left parietal junction measuring 0.5 cm compatible small lacunar infarcts. Chronic paranasal sinusitis. Patient described minimal blood with flushing his sinuses. Patient was ultimately transferred to Hospital after 3 days (on 5/11) for further acute care management given the multiple clots and bleeds associated with severe thrombocytopenia.

the customer just received a janssen covid 19 vaccination . lesser than 5 minutes he came up to the counter to let me know that he felt sick to his stomach (tight), sweat, looked pale but alert . I did not fall or injury. I called 911 and the he was taken to the hospital. He felt better at this time.

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.

11 days after the vaccine I came down with a bad case shingles, It has been 8 weeks and I still haven't recovered, I couldn't eat for three days because I kept vomiting from the pain.

i was ok until the next day. i was drowsy i couldnt get out of bed, my stomach was hurting and diheerra, loss of appitete a blockage saw dr from heart

extreme version of COVID 19 symptoms: extremely hard to breathe only able to take short breaths; vomiting; dry-heaves; coughing; no appetite; fever; cold sweats; chills; lethargy; tired; no energy 15 lb weight loss. This continued from Mid May to June 10, 2021.

Pt states weakness in his arm four days after dose, has not visited with Physician. General fatigue, weakness, excessive night sweats. States low appetite, mood swings, and possible hot flashes.

BAD STOMACH ACHE; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcoholic, 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: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced bad stomach ache. Laboratory data (dates unspecified) included: Abdominal X-ray (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad stomach ache. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Burning of underarm and left part of stomach. This went on for 1 week before my PCP. They took X-ray scans because of the stabbing pain. They came back negative and ran blood tests for internal bleeding. Then they scheduled an MRI which came back negative too. I got with a neurologist and they said I have nerve damage. This has been over the course of 3 months.

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.

Numbness in fingers, toes, and left side of face. Some nausea in stomach and intestines Dizziness and unbalance Malaise with any kind of physical exertion Stiffness/pain in the lower back of head

Fatigue, stomach bloating, shortness of breath, nerve problem-shaking, rash, was provided antihistamine by healthcare professional.

Vaccine on 6/7/2021...after about 1 to 2 weeks, tingling hands, swelled foot, some infrequent shortness of breath, some slurring of words, unusual stutter, abdominal pain, pressure in chest front to back, soreness at shot location, later - a very high blood glucose reading. 6/25/2021 - glucose reading of 225, HBA1c reading of 8.8%! Later diagnosed with LADA because of glucose readings, AND because lifestyle is vegan vegetarian and active workouts, AND no prior high glucose readings. subsequent tests for auto immune, negative.

"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".

Diarrhea started on 6/26/21 and has not resolved. Doctor ran stool tests and all tests were negative. This has never happened before and we think it could be a delayed adverse reaction.

Patient admitted with worsening numbness and weakness 2 weeks after vaccination; Neurology consulted and patient diagnosed with acute inflammatory demyelinating polyradiculoneuropathic form of Guillain-Barré syndrome and underwent plasmapharesis. Patient continued with progressive weakness difficulty with swallowing and choking on food as well as progressive loss of voice. Patient subsequently developed acute respiratory failure, transferred to critical care and was intubated.

Approximately 2 months after the vaccine the patient began to have pain in his right calf. No treatment at that time. About 2 weeks later the pain came back, an ultrasound was done and blood clots were seen. Zorelto was started however patient had a reaction to that of( lips swelling and nausea). At that time Eliquis was started at 5mg BID until current.

- FELT DIZZY & NAUSEA ABOUT TEN MINUTES AFTER RECEIVING VACCINE - DECLINED EMS EVALUATION - HAD FRIEND DRIVE HIM HOME, AGREES TO GO TO DOCTOR / ER If CONTINUES TO fEEL UNWElL TOMORROW OR WORSE SYMPTOMS

ABOUT 4 HRS AFTER SHOT(THAT FRI. NIGHT), LIGHTLY FEELING WEAK, GRADUALLY OVER THE NEXT 6 HRS WEAKNESS STRONGER 3 FULL DAYS. MONDAY MORNING WEAKNESS EVENED OFF. TUESDAY MORNING FEELING SICK,WEAK, NAUSEA, SHAKY, HARDER BREATHING, COUGHING, WIERD TASTE IN MOUTH, DRY MOUTH, LIGHT HEADACHE, SLEPT VERY HEAVY, SWEATY

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

headache, malaise, myalgia, poor appetite x 24 hours - I was flat on my back on 3/6/21, but fully recovered on 3/7/21

Had nausea, body aches, chills and slight aches at injection site. Some diarrhea as well. Symptoms lasted for a few hours (except diarrhea which lasted a couple of days). All fine currently.

About 10 minutes after shot patient vomited and felt dizzy Dizziness lasted about half hour Gave patient chips and donut and water Patient admits to eating a very small bowl of cereal and taking metformin previous night at 7pm Also admits to not taking high blood pressure the e medication this day Patient blood glucose was 202 right before eating chips Patient felt much better after about 40 minutes late Was sent home in a car service and confirmed her got home Also we stated if situation worsens to seek medical attention ASAP hr representative called his emergency contact and informed this person of incident and told to monitor patient

chills, fever, muscle contractions/seizures, severe headache, joint pain, sweats,muscle weakness, acid reflux- time course: began approx 8 hrs after shot (12:15am) and continued until 5am,-acetaminophen 1000mg q8h, naproxen 220mg q12h, gaviscon liquid 10ml, the headache, muscle pain has continued at a lower intensity until 12noon on monday 3/22/21

3/24/21 ER HPI: 58 y.o. male who presents with shortness of breath, palpitations, chest pressure, and hemoptysis. Patient has known history of atrial fibrillation and coronary artery disease. Patient reports he was out in his yard approximately 1 hour ago this evening picking up some items when he bent over and started feeling palpitations. Patient states the palpitations caused a pressure in the center of his chest. He then became short of breath. He then states he got into a coughing fit and coughed up some blood. Patient states he knew something was not right so he told his wife to bring him to the ER. Currently here in ER patient continues to complain of palpitations and trash pressure. Patient currently gives his pain as 6/10. It is nonradiating. Patient reports shortness of breath but denies any lightheadedness, dizziness, nausea, vomiting, or diaphoresis. Of note, patient reports he has been having acid reflux and belching tonight. He states his wife had given him two Pepcid earlier.

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.

Patient had Covid in late November/early December. Same side effects as then. Severe migraine like stabbing headache, fever, chills , body ache and nausea.

The next day, I woke up with fever 100.5 and chills - it lasted 24 hours - stayed the same temp for those 24 hours. Also at the same time, I felt like someone was stabbing around the abdomen - felt like my usual stomach chronic pain only it was worse than my normal chronic pain. My usual "normal" stomach pain is intermittent - as far as it comes at times and goes and medications always help with it but this is different. It doesn't go away and it's all the time and my regular meds don't help. And I have had that pain ever since the vaccine and it hasn't gone away. I'm trying this: Herbal supplement - I started it three days ago - it's for gas and bloating and it seems to be helping my symptoms of pain a little bit. I have also started CBD oil and I do .50 mg at bedtime under the tongue and when I wake up my symptoms are a bit better. On April 20th, I will see an IBS doctor.

Have had constant nausea, diarrhea, cramping, sometimes burning sensation in stomach since getting the shot.

This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced diarrhea, severe vomiting, and severe exhaustion. The action taken with covid-19 vaccine was not applicable. The outcome of the severe vomiting, diarrhea and severe exhaustion was not reported. This report was non-serious.

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

36 hours after injection I started having headaches. Then nausea, regurgitation extreme chills with muscle pain. 6 days later 4/15/21 I still have nausea with lower stomach pain.

BLOOD IN URINE; ABDOMINAL PAIN; ACUTE,SHARP STOMACH PAIN; INDIGESTION; ARM SORENESS; CHILLS; 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 back surgery, and other pre-existing medical conditions included had no medical history except back surgery in 1999 and no concurrent medications. no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 28-FEB-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced fatigue. On 29-MAR-2021, the subject experienced arm soreness. On 02-APR-2021, the subject experienced blood in urine. On 02-APR-2021, the subject experienced abdominal pain. On 02-APR-2021, the subject experienced acute, sharp stomach pain. On 02-APR-2021, the subject experienced indigestion. On 13-APR-2021, Laboratory data included: CT scan (NR: not provided) results came back clear., and Prostate examination (NR: not provided) results came back clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm soreness, chills, and fatigue, had not recovered from blood in urine, abdominal pain, and acute, sharp stomach pain, and the outcome of indigestion was not reported. 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.

Severe Abdominal pain. CT scan and ultrasound revealed inflamed lymph nodes in abdominal cavity. Pain medicine prescribed. Pain is still present today, 04/25/21

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.

GENERAL PERCEPTION FELT DIFFERENT; POUNDING/RACING HEART PALPITATIONS; A WEIRD, HOT CRAWLING SENSATION INSIDE HEAD; DIARRHEA; WEAKNESS; WORST HEADACHE; CHILLS; This spontaneous report received from a patient via a company representative concerned a 58 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced general perception felt different. On MAY-2021, the subject experienced pounding/racing heart palpitations. On MAY-2021, the subject experienced a weird, hot crawling sensation inside head. On MAY-2021, the subject experienced diarrhea. On MAY-2021, the subject experienced weakness. On MAY-2021, the subject experienced worst headache. On MAY-2021, the subject experienced chills. The action taken with covid-19 vaccine was not applicable. The patient recovered from pounding/racing heart palpitations, a weird, hot crawling sensation inside head, diarrhea, worst headache, and chills on 08-MAY-2021, and had not recovered from weakness, and general perception felt different. This report was non-serious.

DIARRHEA; THROWING UP; MOUTH FEELS LIKE GARBAGE; NOT EATING; HEADACHE; WEAKNESS; 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 diabetes, and other pre-existing medical conditions included the patient did not have any known drug allergy. He had not taken any over-the-counter medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 15-MAY-2021, the patient experienced diarrhea. On 15-MAY-2021, the patient experienced throwing up. On 15-MAY-2021, the patient experienced mouth feels like garbage. On 15-MAY-2021, the patient experienced not eating. On 15-MAY-2021, the patient experienced headache. On 15-MAY-2021, the patient experienced weakness. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from diarrhea, throwing up, mouth feels like garbage, headache, weakness, and not eating. This report was non-serious.

Stomach pain very constant for about a week Nonstop liver pain all day and night Dizzy and could not keep balance

Within a couple hours, I felt very tired. At about 9pm, I went to bed and started experiencing chills, sweating, intense body aches and pains, a headache, nausea and abdominal pain. This lasted thru the night. When I woke up, the chills, sweating and intense body aches and pains were less in severity. I took my temperature and it was 101. The temperature was elevated on and off for the next two days. The other symptoms lessened. The abdominal pain remained. I continued to have a headache for over one week. On the 14th (five days after) I felt like I was finally getting better. However, on the night of the 14th, the fever returned and the abdominal pain worsened. I made an appointment with my PCP on the 15th. I was still experiencing a fever, tiredness, body aches and pain, nausea and abdominal pain. I also had loose stools. My PCP requested I be tested for COVID (came back negative) and treated me with antibiotics for diverticulitis. I finished the treatment and shortly after started experiencing issues with a tooth where I had a root canal several years ago. I am still experiencing issues with the tooth and am taking amoxicillin. I have not felt well since the injection on the 9th. I feel tired, do not have the energy that I would expect to have and still have this nagging tooth issue. I'm 100% convinced this is all related to the vaccine on the 9th.

Fatigue, weakness, headaches, nausea continued for at least 8 weeks post-vaccine (to date), with some improvement over time.

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).

Injection site slightly stiff post injection. 06/12/2021 02:00pm. experiencing extreme vertigo symptoms. One hour later reclined for a 2 hour nap. Awoke feeling a small bit better. Upon arising experienced chills, body aches, fatigue and extreme "over the toilet nausea". BP slightly elevated

DIARRHEA; HEADACHE; MILD ABDOMINAL PAIN AND IT HAS GOTTEN A WHOLE LOT WORSE; 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 steel plate left hip (accident), and concurrent conditions included non-smoker, and non alcohol user, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. The patient was previously treated with gabapentin for steel plate left hip (accident). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: 07-AUG-2021) dose was not reported, administered on 11-JUN-2021 11:00 for prophylactic vaccination. Concomitant medications included atorvastatin for heart condition, and lisinopril for heart condition. On 12-JUN-2021, the subject experienced mild abdominal pain and it has gotten a whole lot worse. On 13-JUN-2021, the subject experienced diarrhea. On 13-JUN-2021, the subject experienced headache. Treatment medications included: paracetamol/methocarbamol. Additional treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-JUN-2021, and had not recovered from diarrhea, and mild abdominal pain and it has gotten a whole lot worse. This report was non-serious. This case, involving the same patient is linked to 20210648123.

"Chills and aches" the day and evening of the shot. After a couple of weeks, Pt began to experience various pains at different points of his body. He developed severe indigestion resulting in him visiting his physician on April 19th where he was put on a 7-day steroid regimen. One week later, early on Monday morning, April 26, 2021, Pt collapsed in his bathroom at home, was unresponsive, and pronounced dead by the paramedics who responded.

Leg pain 24 hours later, fever pneumonia, congestive cardiac failure, dialysis access dysfunction, post vaccine fever, hyperkalemia, anemia, vomiting, weakness, hypoxia, hypervolemia; Pt rcvd J & J and next day seen in ER with leg pain, N, V, diarrhea and shortness of breath. Mult stool antigens neg. Lactic acid and WBC elevated. Initial fever resolved as did hyperkalemia and hypervolemia state after urgent dialysis.

Severe chills at 11:30 pm night of vaccine. Lasted 1 1/2 hours. Woke up next day with mild fever and slight headache. Both went away shortly thereafter. Felt lethargic all day, little appetite. Felt 100% better next day.

Moderate flu-like symptoms for 24 hours -- sore muscles, joint pain, headache, fatigue, nausea, constipation, loss of appetite. Severe enough that I took afternoon off from work.

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.

Janssen COVID-19 Vaccine EUA Fever, fatigue, muscle aches, headache, slight nausea. Fever at first was about 101 but has increased to 103. I have taken tylenol to try to control the fever.

lightheaded, nausea; B/P- 160-97, P-58, pulse ox- 96%. Client reports history of diabetes, took med this morning but had not eaten lunch. Client also past history of fainting with blood draws and injections

Headache, Myalgia, Arthralgia, NauseaVomiting, LIGHTHEADED, FATIGUE Narrative: Other Relevant History:

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

13 hours after the injection, I experienced chills, nausea, then sweats, headache, muscle ache. Next day, tired and got chills for a couple hours in the evening. Following day, felt okay.

3min 16s after injection: dizziness, weak and extremely tired, nauseous; flush face and headache (forehead) drank power ade (10oz), moved to cool/cold area; remained inactive; after several minutes (3-6min) symptoms improved, then repeated (symptoms returned but less severe, then mitigated) two more times over next 18 min stayed at dr. office for another 20 minutes with no more adverse reactions (mild headache and slight tiredness; no other symptoms)

Individual called LHD to report adverse reactions to vaccine including, SOB, dizziness, weakness, vomitting, headache and chills lasting 8 - 10 hours.

severe ABD pain and chest pains that started 3-4 days after vaccine given, UA, CMP, CBC, US of ABD and CT ABD done, treated for mild UTI, s/sx did not improve,

The patient is a 59 y.o. male with a hx of COPD who presents to the Emergency Department with SOB. He received the COVID vaccine on 3/18/2021 and has felt bad since then. Patient has experienced increased SOB and a productive cough with yellow sputum.. He experienced fevers for 2 days after receiving the vaccine but has not had any since then. He is on 4-5 liters oxygen at a time. He experienced some diarrhea today but took a laxative. He denies blood in stool, dysuria, or urinary symptoms. Patient reports some body aches. He is on chronic pain medications for back and leg pain. He has not been on any steroids or antibiotics recently.

Patient noticed symptoms of nausea and pain in legs about 24 hours after receiving the J&J COVID-19 vaccination. On Friday, April 9th, a pounding headache developed and is still currently ongoing. Patient visited their doctor soon after symptoms began to check if there were underlying conditions requiring medical attention. Doctor did not find any issues. Patient has been taking ibuprofen 800mg every 4 hours as needed but without relief for the headaches. Headaches still persist even now.

I received the dose on March 12. On March 16 I got sick, throwing up and head ache. Since then I have had no energy with a slight head ache. My right knee has arthritis and I get cortisone shots. However that knee started really hurting after the vaccination.

Abdominal pain, low fever, headache, muscle and joint soreness, fatigue/ weakness, nausea, diarrhea, congestion.

I received the shot at 1:10pm on Friday, April 09, 2021 in my left arm. I woke up at 03:30am the next morning with a temperature of 101*, I was sweating profusely. I would then get the chills. My body ached all over. I had a bad head ache. I had nausea most of the day. At 5:00pm my lower right jaw swelled up and was hard as a rock then subsided and became like jelly. That lasted a couple of hours. By 10:00pm I felt much better.

On 4/14/2021 patient woke up with stomach cramps and diarrhea. states he could not walk, and had no energy from dehydration. patient states he had SOB. Patient has emergency alert system, so he pressed the button and an ambulance took him to the ER.

Muscle pain in both arms/shoulders, headache for 3 days, fatigue, stomach aches for 3 days (since 4/21/21)

o 2-Apr-21, developed fever, chills, nausea, and diarrhea which he was managing at home. o 5-Apr-21 performed a PCR swab at Hospital and received positive results on 6-Apr-21. o 8-Apr-21 developed difficulty breathing and notified his Mgmt. who called for an ambulance. He was transported to Hospital and later to Hospital. o SOB on exertion. Receiving vitamins, P and antibiotics. O2 via face mask. Stable condition was the report provided to his wife from Hospital. o 14-Apr-21 condition deteriorated and he was intubated and placed on the ventilator o 15-Apr-21 was transferred to Hospital

Chills, vomiting, dizziness/vertigo, loss of motor function of right arm and leg, arm and leg were weak, uncoordinated, unbalanced. Could not write. The symptoms starting on May 4 and have been ongoing. Course of steroids have helped but still continue to have symptoms.

VOMITING; HEADACHE; 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 past medical history included smoker, and concurrent conditions included non-alcoholic, and penicillin allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced vomiting. On 12-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from vomiting on 13-MAY-2021, and headache on 20-MAY-2021. This report was non-serious.

CONSTIPATION; LETHARGY; COLD; SWEATING; MUSCLE WEAKNESS; CHILLS; MUSCLE ACHES/MYALGIA; FEVER; DARKLY COLOURED URINE; TREMOR; TINNITUS; LOSS OF APPETITE; STUFFINESS; 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 knee pain, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and he consumed alcohol no more than 2-3 drinks at any one time. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included celecoxib for knee pain, and minerals nos/vitamins nos. On 19-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 24-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE. On 30-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On MAY-2021, the subject experienced stuffiness. Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 F. Treatment medications included: paracetamol. On 06-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 09-MAY-2021, the subject experienced darkly coloured urine. On 09-MAY-2021, the subject experienced tremor. On 09-MAY-2021, the subject experienced tinnitus. On 09-MAY-2021, the subject experienced loss of appetite. On 09-MAY-2021, the subject experienced constipation. On 09-MAY-2021, the subject experienced lethargy. On 09-MAY-2021, the subject experienced cold. On 09-MAY-2021, the subject experienced sweating. On 09-MAY-2021, the subject experienced muscle weakness. On 09-MAY-2021, the subject experienced chills. On 09-MAY-2021, the subject experienced muscle aches/myalgia. On 09-MAY-2021, the subject experienced fever. On 12-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 13-MAY-2021, treatment medications included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from darkly coloured urine on 15-MAY-2021, tremor, tinnitus, loss of appetite, constipation, lethargy, cold, sweating, muscle weakness, chills, muscle aches/myalgia, and fever on 17-MAY-2021, and stuffiness on MAY-2021. This report was non-serious.

THROAT SWELLING; BODY ACHES; STOMACH ACHES; CHILLS; DIZZY; SEVERE HEADACHE; FEVER; INJECTION SITE BLEEDING; MILD SHOULDER PAIN; INJECTION SITE "BUBBLED UP"; 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 past medical history included many surgeries post traumatic car accident, and concurrent conditions included a lot of scar tissue on shoulder (at injection site), and high blood pressure.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A2114, and expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced injection site bleeding. On 18-MAY-2021, the subject experienced mild shoulder pain. On 18-MAY-2021, the subject experienced injection site "bubbled up". On 19-MAY-2021, the subject experienced dizzy. On 19-MAY-2021, the subject experienced throat swelling. On 19-MAY-2021, the subject experienced body aches. On 19-MAY-2021, the subject experienced stomach aches. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced severe headache. On 19-MAY-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site bleeding, and injection site "bubbled up" on 18-MAY-2021, and mild shoulder pain, was recovering from severe headache, throat swelling, fever, chills, and body aches, had not recovered from dizzy, and the outcome of stomach aches was not reported. This report was non-serious.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Additional Details: Patient became unresponsive with gasping but remained with normal pulse, pt came to within a minute

I had diarrhea for 16 hours after the injection and loose stools for another 10 days after the injection. My left forearm became itchy a few minutes after receiving the injection in my left arm and I have developed a rash that has not gone away and my forearm remain itchy.

When he got the shot he felt hot and sweaty and it cleared and a few day later he had a bad reaction having chills, chest pains, pains in left arm and on left side, and nausea and lower back pain

NECK PAIN; UNDER ARM PAIN; PAIN IN THE ARMS RADIATES FROM ONE ARM TO THE OTHER (BOTH ARMS); CHEST PAIN; BURNING SMELL; STOMACH PAIN; DRY EYE; RED EYE; HEADACHE; 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 alcoholic, non smoker, vitamin b12 allergy, and fish product allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced dry eye. On 10-APR-2021, the subject experienced red eye. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced burning smell. Laboratory data included: CT scan (NR: not provided) Normal. On 19-APR-2021, the subject experienced chest pain. On 19-APR-2021, the subject experienced pain in the arms radiates from one arm to the other (both arms). On 22-APR-2021, the subject experienced under arm pain. On 27-APR-2021, the subject experienced neck pain. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry eye, and red eye, was recovering from stomach pain, and had not recovered from chest pain, pain in the arms radiates from one arm to the other (both arms), headache, neck pain, burning smell, and under arm pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.

Pt was hospitalized from 6/3-6/7 for severe hypercalcemia and diagnosed with diffuse metastatic renal cell cancer. He received his J and J vaccine on 5/14/21 and reported "everything went to downhill" with development of nausea, constipation, weight loss, weakness, poor appetite resulting in hospitalization with new severe hypercalcemia and acute functional decline and dx with metastatic renal cell cancer. pt was dx with a bladder tumor 3/19, underwent TURP with bladder biopsy and fulguration and cyctoscopy on 5/19/21. Prostate bx reveals benign nodular hyperplasia, bladder bx revealed urothelial dysplasia felt to be pre neoplastic. Urine Cytology from 4/14/21 negative for high grade urothelial cardinoma. with pamidronate treatment, lasix and ivf and calcitonin his hypercalcemia improved and he was discharged to follow up with oncology and urology as out pt. He has since been readmitted on 6/22/21 with recurrent hypercalcemia and progressive decline. biopsy with I.R. of left renal mass confirmed RCC, biopsy of LN was non-diagnostic. per urology: Given the small size of the renal mass, it would be surprising if this was truly metastatic RCC, this could be metastatic urothelial carcinoma given his history of high grade T1 disease, although the primary site and the urinary tract has presumably been eradicated of disease, metastatic disease prior to initial tumor eradication in the bladder remains a possibility.

patient experienced lower back pain, nausea, dizziness, tightness in chest, asthma symptoms patient went to see the primary doctor and was evaluated

GAS; INDIGESTION; 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 gas/indigestion issues, and multiple sclerosis exposure, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and expiry: 05-AUG-2021) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. Concomitant medications included glatiramer acetate for multiple sclerosis exposure. On 24-JUN-2021, the subject experienced gas. On 24-JUN-2021, the subject experienced indigestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from gas, and indigestion on 25-JUN-2021. This report was non-serious.

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.

1151? Patient stating "I am not feeling well". Patient dry heaved, no emesis. Patient diaphoretic and reporting nausea and dizziness. Legs elevated and code team called to immunization room. 1153? BP 113/77, HR?77, RR?18, 98% on RA. Dr. here to assess patient, code team at patients side. Patient sitting and refusing to lay down, Patient denies chest pain or shortness of breath. Offered juice, small sips. Offered crackers, patient refused. Dr. assessing patient, reports RRR, clear breath sounds 1200? Patient wanting to go home. Discussed with patient that symptoms need to resolve before being cleared to go. O2 sat 98%, HR 72 1205? Attempted stand. Patient reports 'spots'. Patient returned to sitting position. Discussed rationale for laying down. Patient refused. Feet elevated. 1210? Attempted stand, dizziness reported. Patient returned to sit. O2 sat 98% HR 71 1220? Advised patient to call for a ride and that patient should not drive self. Patient continues to reports dizziness with standing. Denies CP or SOB. 1235? Transportation ride called for patient for transportation home. Patient unable to find ride. O2 sat 98% HR 70 1240? Patient stating "I swear I feel 100x better". Discussed with patient MD recommendation that he not drive due to persistent dizziness. 1250? O2 sat 96% 81 HR Patient stating he wants to 'just leave'. Asked patient to sit down so we could notify MD of patients desire to leave. Patient stating he is better and does not want to wait. 1257? Dr assessing patient. Patient standing and ambulating without complaint. Patient stating he is "walking out the door", refuses transportation. Patient denies dizziness, HA, chest pain, or unsteadiness on feet. Patient advised by staff we did not recommend that he drive and should wait for transportation or other driver. Patient offered crackers and juice, declines. Patient ambulated out door and to private vehicle while being observed by staff. Patient drove car out of paring lot.